1. MALVERN, Pa., June 18, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has scheduled a Special Meeting of shareholders to approve its proposed increase of the number of authorized shares of common stock from 100 million shares to 190 million shares for Tuesday, July 13, 2021 at 9:00 a.m. Eastern Time. The proposal to increase the Company's authorized shares of capital stock is set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on June 14, 2021.

    Leading independent proxy advisory firms Glass Lewis & Co. and Institutional Shareholder Services, Inc. have both…

    MALVERN, Pa., June 18, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has scheduled a Special Meeting of shareholders to approve its proposed increase of the number of authorized shares of common stock from 100 million shares to 190 million shares for Tuesday, July 13, 2021 at 9:00 a.m. Eastern Time. The proposal to increase the Company's authorized shares of capital stock is set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on June 14, 2021.

    Leading independent proxy advisory firms Glass Lewis & Co. and Institutional Shareholder Services, Inc. have both recommended that Baudax Bio shareholders vote "for" the proposed additional authorized shares. The Special Meeting will be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

    All shareholders are encouraged to vote no matter how many shares you own. You are encouraged to submit your vote as soon as possible. Please submit your vote online at www.proxyvote.com or by telephone at 1-800-690-6903. Shareholders needing assistance voting or have questions may contact the Company's proxy solicitation firm, Okapi Partners, at or (855) 208-8902.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    CONTACT:

    Investor Relations Contact:



    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:



    Argot Partners

    David Rosen

    (212) 600-1902



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  2. MALVERN, Pa., June 10, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will participate in a fireside chat virtually at the JMP Securities Life Sciences Conference on Thursday, June 17, 2021 at 4:00 p.m. ET.

    A live webcast of the fireside chat will be available on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company…

    MALVERN, Pa., June 10, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will participate in a fireside chat virtually at the JMP Securities Life Sciences Conference on Thursday, June 17, 2021 at 4:00 p.m. ET.

    A live webcast of the fireside chat will be available on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    CONTACT:  

    Investor Relations Contact:



    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:



    Argot Partners

    David Rosen

    (212) 600-1902



    Primary Logo

    View Full Article Hide Full Article
  3. MALVERN, Pa., June 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that ANJESO® (meloxicam) injection has achieved approvals at over 100 formularies across the U.S. in under one year of commercialization. ANJESO's presence on formularies is expected to drive usage through regular availability at both hospitals and ambulatory care centers covered by these formularies.

    "Over the past year, Baudax Bio has made significant progress with the ongoing commercial rollout of ANJESO. We have now achieved formulary listing at 100 institutions across the U.S., and we were able to secure these in less than one…

    MALVERN, Pa., June 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that ANJESO® (meloxicam) injection has achieved approvals at over 100 formularies across the U.S. in under one year of commercialization. ANJESO's presence on formularies is expected to drive usage through regular availability at both hospitals and ambulatory care centers covered by these formularies.

    "Over the past year, Baudax Bio has made significant progress with the ongoing commercial rollout of ANJESO. We have now achieved formulary listing at 100 institutions across the U.S., and we were able to secure these in less than one full year on the market," said Gerri Henwood, President and CEO of Baudax Bio. "We continue to receive positive feedback from physicians and we continue to see increases in new accounts, units sold, reorder rates, and usage patterns across the surgical setting. We remain committed to the successful launch of ANJESO and are well prepared for the anticipated increase in demand as the marketplace moves toward a more normal pace of hospital procedures."

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up the commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on its operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:  

    Investor Relations Contact:



    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:



    Argot Partners

    David Rosen

    (212) 600-1902



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  4. MALVERN, Pa., May 31, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 14,028,520 shares of common stock and warrants to purchase up to an aggregate of 14,028,520 shares of common stock at a purchase price of $0.85 per share and accompanying warrant in a registered direct offering. The warrants have an exercise price of $0.90 per share, will become exercisable upon the later of (i) the six-month anniversary of the closing date of the offering, and (ii) the date of approval by the…

    MALVERN, Pa., May 31, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 14,028,520 shares of common stock and warrants to purchase up to an aggregate of 14,028,520 shares of common stock at a purchase price of $0.85 per share and accompanying warrant in a registered direct offering. The warrants have an exercise price of $0.90 per share, will become exercisable upon the later of (i) the six-month anniversary of the closing date of the offering, and (ii) the date of approval by the Baudax Bio shareholders of an increase in the number of Baudax Bio's authorized shares of common stock, and will expire on December 1, 2026. The closing of the offering is expected to occur on or about June 1, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Baudax Bio from the offering are expected to be approximately $11.9 million. In addition, in the event the warrants are exercised in full for cash, Baudax Bio expects to receive approximately $12.6 million in additional gross proceeds. However, there is no assurance that all or any portion of the warrants will be exercised prior to their expiration. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

    The securities described above are being offered by Baudax Bio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-235408) filed with the Securities and Exchange Commission (SEC) on December 6, 2019 and declared effective on December 16, 2019. The offering of the securities described herein is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711, or email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding the expected completion and use of proceeds of the registered direct offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements, including, but not limited risks associated with market and other conditions. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:  

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    Primary Logo

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  5. MALVERN, Pa., May 28, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has determined to withdraw from shareholder consideration Proposal 3 set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on March 11, 2021, with respect to an increase in the number of shares of common stock authorized for issuance under the Company's Amended and Restated Certificate of Incorporation. As a result, the Company has determined to cancel the reconvening of its annual meeting of shareholders for the consideration of Proposal 3, which was previously adjourned solely…

    MALVERN, Pa., May 28, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has determined to withdraw from shareholder consideration Proposal 3 set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on March 11, 2021, with respect to an increase in the number of shares of common stock authorized for issuance under the Company's Amended and Restated Certificate of Incorporation. As a result, the Company has determined to cancel the reconvening of its annual meeting of shareholders for the consideration of Proposal 3, which was previously adjourned solely with respect to Proposal 3 to 10:00 a.m. Eastern Time on June 3, 2021. All other items set forth in the Company's Definitive Proxy Statement were submitted to shareholder vote at the Company's annual meeting of shareholders on April 7, 2021.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  6. MALVERN, Pa., May 27, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will present at the 2021 Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 2:00 p.m. ET.

    A live webcast of the presentation will be available on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing…

    MALVERN, Pa., May 27, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will present at the 2021 Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 2:00 p.m. ET.

    A live webcast of the presentation will be available on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    CONTACT:  

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    Primary Logo

    View Full Article Hide Full Article
  7. MALVERN, Pa., May 17, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the results of the Phase IIIb study evaluating ANJESO (meloxicam) injection administered preoperatively prior to colorectal surgery were published online in the journal Pain Management. ANJESO is the Company's marketed, non-opioid, once daily, intravenous (IV) non-steroidal anti-inflammatory (NSAID) agent for use in adults for the management of moderate to severe pain that is indicated for use alone or in combination with other non-NSAID analgesics.

    "Adequate pain relief is an important component of ERAS (enhanced recovery after surgery) protocols and is associated with…

    MALVERN, Pa., May 17, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the results of the Phase IIIb study evaluating ANJESO (meloxicam) injection administered preoperatively prior to colorectal surgery were published online in the journal Pain Management. ANJESO is the Company's marketed, non-opioid, once daily, intravenous (IV) non-steroidal anti-inflammatory (NSAID) agent for use in adults for the management of moderate to severe pain that is indicated for use alone or in combination with other non-NSAID analgesics.

    "Adequate pain relief is an important component of ERAS (enhanced recovery after surgery) protocols and is associated with various beneficial effects, including shorter length of stay (LOS), enhanced recovery, faster mobilization and better patient satisfaction," said Jennifer Silinsky, MD, Colorectal Surgeon, Tulane University School of Medicine, and lead author of the manuscript. "Opioids have historically been a mainstay of perioperative pain control, however, an important goal of ERAS protocols is to reduce opioid consumption, which in turn may lead to decreased known opioid-related risks and adverse events. In this study, both groups received a standardized ERAS protocol that included pain control and the results demonstrated that ANJESO was superior to placebo when added to the ERAS regimen. In addition, ANJESO was generally well tolerated, with over 92% of patients reporting satisfaction with their post-operative pain medication. ANJESO-treated patients also experienced statistically significant reductions in opioid consumption, time to first bowel sounds, time to first bowel movement and time to hospital discharge, all compared to placebo. These data support the efficacy and safety of ANJESO administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in patients undergoing colorectal procedures."

    "We are honored to have these data published by such a well-regarded medical journal to be shared with the anesthesia, pain management and surgical community," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "We believe the successful outcome of this study represents an important advancement for colorectal surgery physicians and their patients and we are sincerely grateful to all of the patients and investigators who participated in the study. The ANJESO launch is progressing well and these positive results will continue to inform our ongoing physician education initiatives as we work to drive adoption of ANJESO."

    The full manuscript can be accessed here.

    Summary of the Phase IIIb Results

    This multi-center, randomized, double-blind, placebo-controlled Phase IIIb study evaluated preoperative doses of ANJESO in 55 patients undergoing bowel resection and/or anastomosis. Patients were randomized 1:1 to receive ANJESO or placebo with the first dose administered 30 minutes prior to the start of surgery, then every 24 hours on top of a standardized ERAS protocol that included a multimodal pain management plan in addition to study treatment; all patients received gabapentin 300mg once prior to surgery, and acetaminophen 650mg starting prior to surgery and continuing every 8 hours until 24 hours after the last dose of study medication. Following surgery, opioid rescue was available upon request.   The primary objective of the study was to assess the safety of ANJESO when administered pre-operatively, with a key measure being the incidence and severity of adverse events. Numerous additional efficacy parameters were also assessed in this study, including various pain outcomes (e.g., patient global assessment [PGA], brief pain inventory [BPI], etc.), opioid consumption, return of bowel function, healthcare resource utilization and hospital length of stay.

    Safety

    For safety, the incidence of individual adverse events (AEs) was comparable between groups and was numerically lower in the ANJESO group. ANJESO was generally well tolerated. The most common treatment-emergent AEs (TEAEs) in both study groups were nausea and vomiting and the majority of these were mild or moderate in intensity. The incidence of serious AEs was also comparable between groups and numerically lower in the ANJESO group. None of the SAEs was considered related to study medication and all resolved. For AEs commonly associated with opioid use (e.g., nausea, vomiting and ileus) the incidence rate was either comparable to the placebo group or lower in the ANJESO group.

    Opioid Consumption

    Opioid consumption was lower in the ANJESO-treated group at all time intervals, and the differences versus placebo were statistically significant at some time points. Total opioid consumption was 35% lower in the ANJESO group (p=0.03). The largest difference in opioid consumption occurred on post-surgery Day 2 (hour 24-48), when ANJESO was associated with 49% lower opioid consumption (p=0.01). Overall, patients treated with ANJESO received 16.9mg fewer opioids, compared to placebo-treated patients, (49.25mg vs 66.14mg, p=0.04).

    Efficacy

    While patients in the placebo group had higher opioid use, ANJESO-treated patients had similar or better pain scores and similar patient satisfaction. BPI was significantly lower for the ANJESO group on postoperative Day 1 (p=0.03). For other BPI time intervals, there were no meaningful differences between the study groups. Most subjects in both the ANJESO (92.3%) and placebo (92.6%) groups were satisfied with their postoperative pain medication. There were no significant differences in PGA of pain control between the groups.

    Healthcare Resource Utilization

    The mean time from end of surgery to actual hospital discharge and mean total LOS were significantly shorter (28 hours) for the ANJESO group. There was no significant difference in total cost of hospital stay between the study groups, although costs in the ANJESO group, but not the placebo group, were driven by outliers. Regression analysis demonstrated that increased opioid consumption was associated with increased LOS, with every 1mg increase in opioid consumption from hour zero to discharge was associated with a 0.58-hour increase in LOS (p=0.0005). Surgery type (bowel resection vs other) was significantly associated with total costs and LOS, with the highest costs linked to bowel resection.

    Functional Outcomes

    The mean times to first bowel sound, first flatus and first bowel movement were significantly shorter in the ANJESO group (p=0.02, p=0.03 and p=0.02, respectively). Mean times to first ambulation were similar between the ANJESO and placebo groups.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    INDICATION AND USAGE

    ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

    Limitation of Use: Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Risk

    Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

    ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Risk

    NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    CONTRAINDICATIONS

    ANJESO is contraindicated in patients with:

    Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.

    History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

    In the setting of coronary artery bypass graft (CABG) surgery.

    Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion.

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue ANJESO immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    Hypertension: NSAIDs including ANJESO can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ANJESO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Post MI Patients: Avoid the use of ANJESO in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ANJESO is used in these patients, monitor for signs of cardiac ischemia.

    Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. ANJESO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating ANJESO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If ANJESO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

    Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including ANJESO, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity.

    Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including ANJESO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

    DRUG INTERACTIONS

    Drugs That Interfere With Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ANJESO with drugs that interfere with hemostasis. Concomitant use of ANJESO and analgesic doses of aspirin is not generally recommended.

    Angiotensin Converting Enzymes (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

    ACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

    ADVERSE REACTIONS

    The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with ANJESO and at a greater frequency than placebo include: constipation, gamma-glutamyl transferase increased, and anemia.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have trouble conceiving.

    Please see full Prescribing Information, including Boxed Warning at www.anjeso.com.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:  

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  8. MALVERN, Pa., May 13, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that Institutional Shareholder Services, Inc. (ISS), the leading global independent proxy advisory firm, has recommended that Baudax Bio shareholders vote "FOR" Proposal 3, which seeks to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Annual Meeting is expected to resume with respect to Proposal 3 on June 3, 2021 at 10:00 a.m. ET and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2021

    MALVERN, Pa., May 13, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that Institutional Shareholder Services, Inc. (ISS), the leading global independent proxy advisory firm, has recommended that Baudax Bio shareholders vote "FOR" Proposal 3, which seeks to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Annual Meeting is expected to resume with respect to Proposal 3 on June 3, 2021 at 10:00 a.m. ET and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

    ISS is the most prominent independent proxy voting and corporate governance advisory firm, and its recommendations are relied upon by institutional investment firms, mutual funds and other fiduciaries globally. ISS' experienced research team provides comprehensive proxy analyses and complete vote recommendations for approximately 40,000 meetings annually in around 117 markets worldwide.

    "The supportive recommendation by ISS adds to the prior positive recommendation by Glass Lewis & Co. to vote in favor of the proposed increase to authorized shares," commented Gerri Henwood, President and CEO of Baudax Bio. "We believe both of these independent advisory firms recognize that maintaining Baudax's flexibility with respect to utilizing an increased number of authorized shares to raise capital is of significant value to the Company and its shareholders."  

    ISS and Glass Lewis are independent proxy advisory firms and do not have any business relationship with Baudax Bio. Baudax Bio did not engage or compensate either firm for their analysis or recommendations.

    Baudax shareholders are urged to vote as both ISS and Glass Lewis recommend by voting "FOR" the proposed increase in authorized shares. Shareholders with questions may call Okapi Partners LLC at (855) 208-8902 or by email at .

    How to Vote

    If you are a shareholder of record at the close of business on March 1, 2021, you can vote your shares in one of two ways: either by proxy or in person at the special meeting. If you chose to submit a proxy, you may do so by telephone, via the internet or by mail. Please follow the instructions on the proxy card you have received. If you hold shares of Baudax Bio common stock in multiple accounts, you should vote your shares as described in each set of proxy materials you receive. Baudax Bio highly recommends shareholders vote electronically or by phone without delay. Please have your proxy card with you while voting. If you chose to vote via the Internet or phone, you do not have to return the proxy card.

    Shareholders who have already submitted a proxy do not need to vote again for the reconvened Annual Meeting, as the proxies submitted will remain valid. Shareholders who have already submitted proxies and want to change their vote with respect to Proposal 3 can update their vote in the manner set forth in the Proxy Statement. Your vote will be recorded at the Annual Meeting in accordance with your most recently submitted proxy.

    For shareholders who still need assistance voting their shares, or have questions regarding the special meeting, please contact Baudax's proxy solicitation firm, Okapi Partners LLC, either by telephone: (855) 208-8902 or by email: .

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

     

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  9. MALVERN, Pa., May 12, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that Glass Lewis & Co. has recommended that Baudax Bio shareholders vote "FOR" Proposal 3, which seeks to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Annual Meeting is expected to resume with respect to Proposal 3 on June 3, 2021 at 10:00 a.m. ET and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

    Glass Lewis is widely recognized as one of the leading independent…

    MALVERN, Pa., May 12, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that Glass Lewis & Co. has recommended that Baudax Bio shareholders vote "FOR" Proposal 3, which seeks to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Annual Meeting is expected to resume with respect to Proposal 3 on June 3, 2021 at 10:00 a.m. ET and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

    Glass Lewis is widely recognized as one of the leading independent proxy voting and corporate governance advisory firms, and its recommendations are relied upon by thousands of major institutional investment firms, mutual funds and other fiduciaries throughout the United States.

    In response to the favorable recommendation, Gerri Henwood, President and CEO of Baudax Bio said, "We are pleased that Glass Lewis, a highly regarded, independent, leading proxy advisory firm understands the importance of increasing the number of authorized shares to a level that allows us to achieve our corporate objectives and attract a broader and more diverse shareholder base."

    Baudax shareholders are urged to vote as Glass Lewis recommend by voting "FOR" the proposed increase in authorized shares. Shareholders with questions may call Okapi Partners LLC at (855) 208-8902 or by email at .

    How to Vote

    If you are a shareholder of record at the close of business on March 1, 2021, you can vote your shares in one of two ways: either by proxy or in person at the special meeting. If you chose to submit a proxy, you may do so by telephone, via the internet or by mail. Please follow the instructions on the proxy card you have received. If you hold shares of Baudax Bio common stock in multiple accounts, you should vote your shares as described in each set of proxy materials you receive. Baudax Bio highly recommends shareholders vote electronically or by phone without delay. Please have your proxy card with you while voting. If you chose to vote via the Internet or phone, you do not have to return the proxy card.

    Shareholders who have already submitted a proxy do not need to vote again for the reconvened Annual Meeting, as the proxies submitted will remain valid. Shareholders who have already submitted proxies and want to change their vote with respect to Proposal 3 can update their vote in the manner set forth in the Proxy Statement. Your vote will be recorded at the Annual Meeting in accordance with your most recently submitted proxy.

    For shareholders who still need assistance voting their shares, or have questions regarding the special meeting, please contact Baudax Bio's proxy solicitation firm, Okapi Partners LLC, either by telephone: (855) 208-8902 or by email: .

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal", "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  10. MALVERN, Pa., May 11, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has adjourned its 2021 Annual Meeting of Shareholders (the "Annual Meeting") solely with respect to Proposal 3 set forth in its Definitive Proxy Statement ("Proxy Statement") filed with the Securities and Exchange Commission on March 11, 2021. Proposal 3 is a proposal to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Company has adjourned the Annual Meeting with respect to Proposal 3…

    MALVERN, Pa., May 11, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has adjourned its 2021 Annual Meeting of Shareholders (the "Annual Meeting") solely with respect to Proposal 3 set forth in its Definitive Proxy Statement ("Proxy Statement") filed with the Securities and Exchange Commission on March 11, 2021. Proposal 3 is a proposal to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Company has adjourned the Annual Meeting with respect to Proposal 3 to provide its shareholders additional time to vote on Proposal 3. The Annual Meeting will resume with respect to Proposal 3 at 10:00 a.m. Eastern time on June 3, 2021 and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

    The record date for determining shareholders eligible to vote at the annual meeting will remain the close of business on March 1, 2021. Shareholders who have already submitted a proxy do not need to vote again for the reconvened Annual Meeting, as the proxies submitted will remain valid. Shareholders who have already submitted proxies and want to change their vote with respect to Proposal 3 can update their vote in the manner set forth in the Proxy Statement. Your vote will be recorded at the Annual Meeting in accordance with your most recently submitted proxy.

    Shareholders as of close of business on the March 1, 2021 record date who have not voted are encouraged to vote online at www.proxyvote.com or by telephone at 1-800-690-6903. Shareholders needing assistance voting or have questions may contact the Company's proxy solicitation firm, Okapi Partners, at or (855) 208-8902.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal", "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

     

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



    Primary Logo

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  11. ANJESO® Demonstrates Continued Progress with Launch; Growth in End-User Unit Sales Increased 40% in Q1 compared to Q4'20

    Average Sales per Account Increased 30% in Q1 compared to Q4'20

    Richard S. Casten Strengthens Management Team in Chief Financial Officer Role

    Management to Host Investor Conference Call and Webcast Today at 8:00 a.m. ET

    MALVERN, Pa., May 05, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today reported financial results for the three months ended March 31, 2021.

    "The first quarter has been busy and fruitful at Baudax. ANJESO sustained marked progress in the areas of new account wins…

    ANJESO® Demonstrates Continued Progress with Launch; Growth in End-User Unit Sales Increased 40% in Q1 compared to Q4'20

    Average Sales per Account Increased 30% in Q1 compared to Q4'20

    Richard S. Casten Strengthens Management Team in Chief Financial Officer Role

    Management to Host Investor Conference Call and Webcast Today at 8:00 a.m. ET

    MALVERN, Pa., May 05, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today reported financial results for the three months ended March 31, 2021.

    "The first quarter has been busy and fruitful at Baudax. ANJESO sustained marked progress in the areas of new account wins, increasing units sold, reorder rates, and deepening usage across the hospital and ambulatory surgery center space. Although we are seeing some relief from COVID in the marketplace, it continues to impact elective surgical procedures and hospital administration's focus as well as access into accounts, which the team will need to continue to monitor to maintain the growth of ANJESO," said Gerri Henwood, President and CEO of Baudax Bio. "We continue to receive positive feedback from physicians using ANJESO for the management of moderate to severe pain in the acute care setting."

    First Quarter 2021 and Recent Business Highlights

    • Continued Progress on U.S. Launch of ANJESO. Baudax Bio built infrastructure, executed group purchasing organization agreements with the top three medical distributors and began developing awareness and knowledge of ANJESO in 2020. In the first quarter of 2021 we have seen more meaningful progress in deepening usage of ANJESO in early users as reflected in sales to existing hospitals and ambulatory surgery centers, which doubled in the first quarter of 2021 compared to the fourth quarter of 2020. Total unit sales grew 40% in the first quarter of 2021 compared to the fourth quarter of 2020 and the reorder rate was nearly 70% for the same comparable period.



      During the first quarter, formulary wins grew by 22 institutions, for a total of 90 institutions as of March 31, 2021, an increase of over 30% from the fourth quarter.
    • Publication of ANJESO Phase IIIb Data in Pain Medicine. In April 2021, the company announced the online publication of ANJESO Phase IIIb data in the peer-reviewed medical journal Pain Medicine. The data highlights the safety and pain management efficacy of preoperative ANJESO injection in total knee arthroplasty (TKA). This study also reported that ANJESO decreased the need for opioids following surgery. The findings published were especially compelling because they suggest select measures of health care resource utilization (HRU) were lower in the ANJESO treated patients.
    • Announced Partial Adjournment of Annual Meeting of Shareholders. In April 2021, Baudax Bio partially adjourned its 2021 Annual Meeting of Shareholders solely with respect to Proposal 3 set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on March 11, 2021. Proposal 3 is a proposal to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized, not issued, shares of common stock from 100 million shares to 190 million shares. This adjournment provides its shareholders additional time to vote on Proposal 3. The Annual Meeting will resume with respect to Proposal 3 at 10:00 a.m. Eastern time on May 6, 2021.
    • Richard S. Casten Strengthens Management Team in Chief Financial Officer Role. In March 2021, Baudax Bio announced the appointment of Richard S. Casten, CPA, MBA as Chief Financial Officer. In this role, Mr. Casten will be responsible for leading and directing the financial activities of the Company. Mr. Casten brings to Baudax Bio 25 years of diversified financial experience across pharmaceutical, Fortune 500 consumer products and public accounting.
    • In February, Announced $17.6 Million Offering Priced At-the-Market under Nasdaq Rules. Baudax Bio announced that it entered into a definitive agreement with institutional and accredited investors for the purchase and sale of an aggregate of 11,000,000 shares of common stock at a purchase price of $1.60 per share in a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds from the offering were approximately $17.6 million, prior to deducting fees and expenses.
    • In January, Announced Exercise of Warrants for Gross Proceeds of $13.4 Million. Baudax Bio announced the agreement by an accredited healthcare-focused institutional investor to cash exercise certain warrants to purchase up to an aggregate of 10,300,430 shares of common stock having an exercise price of $1.18 issued by the company in December 2020. In connection therewith, Baudax Bio sold the exercising holder new warrants, which are cash exercisable for an aggregate of 10,300,430 shares of common stock at an exercise price of $1.60 per share, for an aggregate purchase price $1,287,554, or $0.125 per warrant. The gross proceeds to Baudax Bio from the exercise of the warrants and the sale of the additional warrants was $13.4 million, prior to deducting fees and expenses.

    First Quarter 2021 Financial Results

    As of March 31, 2021, Baudax Bio had cash, cash equivalents and short-term investments of $38.2 million.

    Net product revenue for the three months ended March 31, 2021 was $0.2 million, related to sales of ANJESO in the U.S. There was no product revenue recognized during the three months ended March 31, 2020.

    Cost of sales for the three months ended March 31, 2021 was $0.8 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue during the three months ended March 31, 2021 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. Baudax Bio expects that over time, its cost of sales will increase as sales increase and as inventory values change to include all direct and indirect costs and expenses post FDA approval. No cost of sales was recorded for the three months ended March 31, 2020.

    Research and development expenses for the three months ended March 31, 2021 were $1.1 million, compared to $3.1 million for the three months ended March 31, 2020. The decrease of $2.0 million was primarily due to a decrease of $1.7 million as a result of re-allocating costs related to supply chain, regulatory, quality, and medical affairs associated with support of the commercial launch of ANJESO from research and development expense to cost of sales and selling, general and administrative expense and a decrease in personnel costs of $0.3 million.

    Selling, general and administrative expenses for the three months ended March 31, 2021 were $12.1 million, compared to $8.0 million for the same prior year period. The increase of $4.1 million was primarily due to the commercial launch of ANJESO, specifically, an increase in personnel related costs of $1.6 million, an increase of $1.3 million attributable to medical affairs and regulatory support reallocated from research and development expense post FDA approval, an increase of $0.3 million in public company costs and an increase of $0.3 million in marketing costs. In addition, the first quarter of 2020 included $0.5 million in reimbursed general and administrative expenses related to the Transition Services Agreement with Recro Pharma, which ended on December 31, 2020.

    Baudax Bio reported a net loss, including non-cash charges of $5.1 million, of $16.9 million, or $(0.27) per share, for the three months ended March 31, 2021. The non-cash charge of $5.1 million was associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. This compares to a net loss, including non-cash charges of $32.0 million, of $40.3 million, or $(4.03) per share, for the comparable period in 2020. The non-cash charge of $32.0 million in 2020 was associated with changes in fair value of contingent consideration, stock-based compensation, change in warrant valuation, depreciation and amortization.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACTS:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    BAUDAX BIO, INC.

    Consolidated Balance Sheets

    (Unaudited)

    (amounts in thousands, except share and per share data) March 31, 2021  December 31, 2020 
    Assets        
    Current assets:        
    Cash and cash equivalents $30,690  $30,342 
    Short-term investments  7,495    
    Accounts receivable, net  163   51 
    Inventory, net  2,773   2,978 
    Prepaid expenses and other current assets  2,569   3,346 
    Total current assets  43,690   36,717 
    Property, plant and equipment, net  5,039   5,052 
    Intangible assets, net  23,610   24,254 
    Goodwill  2,127   2,127 
    Other long-term assets  520   583 
    Total assets $74,986  $68,733 
    Liabilities and Shareholders' Equity        
    Current liabilities:        
    Accounts payable $1,140  $3,653 
    Accrued expenses and other current liabilities  4,680   5,326 
    Current portion of long-term debt, net  1,196   683 
    Current portion of contingent consideration  7,107   8,467 
    Total current liabilities  14,123   18,129 
    Long-term debt, net  8,185   8,469 
    Warrant liability  83   65 
    Long-term portion of contingent consideration  53,348   56,576 
    Other long-term liabilities  241   293 
    Total liabilities  75,980   83,532 
    Commitments and contingencies        
    Shareholders' equity:        
    Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and

    outstanding
          
    Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and

    outstanding, 70,142,608 shares at March 31, 2021 and 48,688,480 shares at

    December 31, 2020
      701   487 
    Additional paid-in capital  127,537   97,034 
    Accumulated deficit  (129,232)  (112,320)
    Total shareholders' equity (deficit)  (994)  (14,799)
    Total liabilities and shareholders' equity $74,986  $68,733 



    BAUDAX BIO, INC.

    Consolidated and Combined Statements of Operations

    (Unaudited)

      For the Three Months Ended March 31, 
    (amounts in thousands, except share and per share data) 2021  2020 
    Revenue, net $198  $ 
             
    Operating expenses:        
    Cost of sales  821    
    Research and development  1,108   3,070 
    Selling, general and administrative  12,088   8,046 
    Amortization of intangible assets  644   215 
    Change in warrant valuation  18   1,378 
    Change in contingent consideration valuation  1,841   27,626 
    Total operating expenses  16,520   40,335 
    Operating loss  (16,322)  (40,335)
    Other expense:        
    Interest and other expense  (590)  37 
    Net loss $(16,912) $(40,298)
             
    Per share information:        
    Net loss per share of common stock, basic and diluted $(0.27) $(4.03)
    Weighted average common shares outstanding, basic and diluted  62,584,129   10,001,228 
             


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  12. MALVERN, Pa., April 29, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it will report first quarter 2021 financial results on Wednesday, May 5, 2021. Baudax Bio's management team will host a conference call and webcast at 8:00 a.m. ET on Wednesday, May 5, 2021 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 5444429. A live audio webcast of the call will be available under "Events" in the Investor section of…

    MALVERN, Pa., April 29, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it will report first quarter 2021 financial results on Wednesday, May 5, 2021. Baudax Bio's management team will host a conference call and webcast at 8:00 a.m. ET on Wednesday, May 5, 2021 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 5444429. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIB program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  13. Patients Administered ANJESO Prior to the Start of Surgery had Significantly Lower Summed Pain Intensity Scores on the First Postsurgical Day and Throughout Their Inpatient Course

    ANJESO Treated TKA Patients Demonstrated Decreased Opioid Consumption Following Surgery, Particularly in the First 24 hours Post-Surgery.

    Total Mean Hospital Charges for Hospital Stay and Total Overall Charges Were Lower in the ANJESO Group Compared to Placebo

    MALVERN, Pa., April 26, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the online publication of data highlighting the safety and efficacy of preoperative ANJESO® (meloxicam) injection in patients undergoing…

    Patients Administered ANJESO Prior to the Start of Surgery had Significantly Lower Summed Pain Intensity Scores on the First Postsurgical Day and Throughout Their Inpatient Course

    ANJESO Treated TKA Patients Demonstrated Decreased Opioid Consumption Following Surgery, Particularly in the First 24 hours Post-Surgery.

    Total Mean Hospital Charges for Hospital Stay and Total Overall Charges Were Lower in the ANJESO Group Compared to Placebo

    MALVERN, Pa., April 26, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the online publication of data highlighting the safety and efficacy of preoperative ANJESO® (meloxicam) injection in patients undergoing unilateral total knee arthroplasty (TKA) when used within a multimodal analgesic regimen, in the peer-reviewed medical journal Pain Medicine. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

    Preemptive administration allows providers to better control pain at the outset of surgery, rather than waiting until inflammation and pain have already set in. Preoperative use of NSAIDs is recommended by the American Society for Enhanced Recovery (ASER) and the Perioperative Quality Initiative (POQI). Further multimodal analgesia involves the administration of 2 or more drugs that act by different mechanism for providing analgesia, the aim of which is to improve pain relief while reducing opioid requirements and opioid-related adverse effects.

    "Patients typically report high levels of pain after orthopedic surgery and managing this pain can be challenging. In this study we administered ANJESO prior to the start of the surgery helping us to stay ahead of the pain. Which is a critical component of patient care," said Richard Berkowitz, M.D., University Orthopedic and Joint Replacement Center, Tamarac, Florida. "In the past there has been a tendency to resort to opioids for pain control, given the risks associated with opioids such as addiction, gastrointestinal adverse events, pruritus, and respiratory depression, among others, there has been an increased need for alternative medications for patients undergoing elective or nonelective surgical procedures and it is encouraging to see these results."

    "The data published by Pain Medicine continues to support ANJESO as an advantageous option for the management of moderate to severe pain. The data not only highlight the efficacy and tolerability of ANJESO when administered preoperatively within a multimodal analgesic regimen to patients undergoing TKA, but also conveys a decreased need for opioids following surgery," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "The findings are especially compelling because they suggest select measures of health care resource utilization (HRU) also tended to be lower in the ANJESO treated group, including 10% lower mean total hospital charges. These data suggest ANJESO has a promising role in multimodal analgesic regimens in this clinical setting."

    Efficacy and Safety Results Following Administration of Preoperative ANJESO Compared to Placebo

    During the 1st 24 hours, ANJESO patients used ~32% less opioids and reported ~22% greater pain reduction relative to placebo treated patients. ANJESO-treated patients had a significantly lower Summed Pain Intensity score on the first postsurgical day and throughout their inpatient course (p≤0.0001). Additionally, ANJESO-treated patients had significantly lower opioid consumption during the first postsurgical day, with a 31.7% reduction compared to placebo (mean 19mg vs. 28mg; p<0.0001). Significant reductions in opioid use were observed on subsequent days and throughout treatment. ANJESO-treated patients had a significantly longer time to first opioid rescue after surgery compared to placebo treated patients. ANJESO-treated subjects had lower incidences of all cause hospital readmissions, fewer patients admitted to skilled nursing facilities upon discharge, and fewer emergency room visits, and doctor calls related to pain during the follow-up period.

    With respect to safety, adverse events (AEs) were primarily mild or moderate in intensity and not related to study treatment, with a higher incidence of AEs reported in the placebo group. Additionally, the incidence of serious AEs was higher in the placebo group. All serious AEs in the ANJESO group were assessed by the primary investigators to be not related to study treatment. No subject discontinued due to an AE. The overall rate of AEs of special interest (AESI; events related to concerns associated with NSAIDS) were lower in the ANJESO-treated group at 9.7% than the placebo group at 21.6%. Rates of individual events in the ANJESO group occurred at similar or lower rates compared to the placebo group. Laboratory and surgical wound healing assessments were similar between treatment groups. This study supports the efficacy and safety of ANJESO administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in subjects undergoing primary unilateral TKA.

    Healthcare Resource Utilization (HRU) Results Following Preoperative ANJESO Compared to Placebo

    This study also evaluated HRU and costs, including total hospital costs, hospital length of stay (LOS), hospital readmissions, ER visits, physician office visits, and phone calls due to pain, associated with preoperative administration of ANJESO compared to placebo, through postoperative day 30. This study was not powered to show statistical differences in HRU endpoints.

    The total mean charges for the hospital stay, and total overall charges were lower in the ANJESO group compared to the placebo group, ($56,424 vs $62,864), however, the differences were not statistically significant. Mean hospital LOS in days was lower in the ANJESO group compared to the placebo group (2.05 vs. 2.24 days), which was 8.6% lower compared to placebo, however, the difference was not statistically significant. There were fewer hospital readmissions (1 vs. 3), ER visits (0 vs. 4), and phone calls due to pain (4 vs. 9) for ANJESO versus placebo, respectively. There were no reports of unscheduled physician office visits due to pain in either group.

    Mean total opioid use from hour 0-24, 0-48, and 0-72 hours was significantly lower among meloxicam IV compared to placebo (p<0.0001) and from hour 0 through hospital discharge (33.28mg vs. 44.87mg); (p<0.001). Time to the first oral opioid rescue medication was longer for the ANJESO group than placebo (7.31 vs. 5.22 hours; p=0.0226) and a similar trend was observed for mean time to first use of IV or oral opioid analgesia (4.75 vs. 3.09 hours; p=0.0126). While there was no significant association between opioid consumption and total hospital charges, every unit (1mg IV morphine equivalent) increase in opioid consumption was associated with a 0.5% increase in LOS in days (p=0.0001). The proportion of subjects with ≥1 opioid related adverse drug effects were significantly higher for placebo than ANJESO (70.5% vs. 48.4%; p=0.003). Six ANJESO-treated patients (6.5%) had ≥1 AESI in comparison to 12 placebo subjects (13.6%). Serious AEs were observed among 3 ANJESO-treated patients (3.2%) and 9 placebo subjects (10.2%).

    The Overall Benefit of Analgesia Scores (OBAS) were also assessed. The OBAS is a simple, multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy. Opioid symptom distress, pain relief, and patients' satisfaction are combined in a reliable and valid tool. A lower score indicates better pain management and lower opioid symptom distress. The OBAS score was significantly lower for meloxicam IV compared with placebo-treated subjects on the first postoperative day (LS mean [SE] 4.45 [0.360] vs 5.90 [0.375] for meloxicam and placebo, respectively; difference [95% CI], –1.45 [–2.39, –0.51]; P = 0.0027).

    ANJESO® Phase IIIb Study Design

    The study was designed to evaluate the effect of perioperative meloxicam IV on opioid consumption in primary TKA. This was a multicenter, randomized, double-blind, placebo-controlled trial and evaluated 181 adults undergoing elective primary TKA. Subjects received meloxicam 30 mg or placebo via IV bolus every 24 hours, with the first dose administered prior to surgery as part of a multimodal pain management protocol. The primary efficacy parameter was total opioid use over a 24-hour period following surgery. Findings from the study suggest perioperative meloxicam IV 30 mg as part of a multimodal analgesic regimen for elective primary TKA reduced opioid consumption in the 24-hour period following surgery versus placebo and was associated with a lower incidence of AEs typically associated with opioid use.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information, please visit www.baudaxbio.com.

    INDICATION

    ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

    Limitation of Use: Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Risk

    • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.



    • ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Risk

    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    CONTRAINDICATIONS

    ANJESO is contraindicated in patients with:

    • Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.



    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.



    • In the setting of coronary artery bypass graft (CABG) surgery.



    • Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion.

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue ANJESO immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    Hypertension: NSAIDs including ANJESO can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ANJESO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Post MI Patients: Avoid the use of ANJESO in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ANJESO is used in these patients, monitor for signs of cardiac ischemia.

    Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. ANJESO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating ANJESO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If ANJESO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

    Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including ANJESO, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity.

    Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including ANJESO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

    DRUG INTERACTIONS

    Drugs That Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ANJESO with drugs that interfere with hemostasis. Concomitant use of ANJESO and analgesic doses of aspirin is not generally recommended.

    Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

    ACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

    ADVERSE REACTIONS

    The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with ANJESO and at a greater frequency than placebo include: constipation, gamma-glutamyl transferase increased, and anemia.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have trouble conceiving.

    Please see full Prescribing Information, including Boxed Warning at www.anjeso.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  14. MALVERN, Pa., April 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has adjourned its 2021 Annual Meeting of Shareholders (the "Annual Meeting") solely with respect to Proposal 3 set forth in its Definitive Proxy Statement ("Proxy Statement") filed with the Securities and Exchange Commission on March 11, 2021. Proposal 3 is a proposal to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Company has adjourned the Annual Meeting with respect to Proposal 3 to provide its shareholders additional…

    MALVERN, Pa., April 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has adjourned its 2021 Annual Meeting of Shareholders (the "Annual Meeting") solely with respect to Proposal 3 set forth in its Definitive Proxy Statement ("Proxy Statement") filed with the Securities and Exchange Commission on March 11, 2021. Proposal 3 is a proposal to amend the Company's Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 100 million shares to 190 million shares. The Company has adjourned the Annual Meeting with respect to Proposal 3 to provide its shareholders additional time to vote on Proposal 3. The Annual Meeting will resume with respect to Proposal 3 at 10:00 a.m. Eastern time on May 6, 2021 and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

    The record date for determining shareholders eligible to vote at the annual meeting will remain the close of business on March 1, 2021. Shareholders who have already submitted a proxy do not need to vote again for the reconvened Annual Meeting, as the proxies submitted will remain valid. Shareholders who have already submitted proxies and want to change their vote with respect to Proposal 3 can update their vote in the manner set forth in the Proxy Statement. Your vote will be recorded at the Annual Meeting in accordance with your most recently submitted proxy.

    Shareholders as of close of business on the March 1, 2021 record date who have not voted are encouraged to vote online at www.proxyvote.com or by telephone at 1-800-690-6903. Shareholders needing assistance voting or have questions may contact the Company's proxy solicitation firm, Okapi Partners, at or (855) 208-8902.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal", "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  15. MALVERN, Pa., April 01, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved an inducement grant of stock options to purchase an aggregate of 7,500 shares of Baudax Bio's common stock and restricted stock units covering 2,000 shares of Baudax Bio's common stock in connection with one newly-hired employee with a grant date of March 31, 2021. The equity award was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of the individual's employment compensation and was granted as an inducement material to his acceptance of employment with Baudax…

    MALVERN, Pa., April 01, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved an inducement grant of stock options to purchase an aggregate of 7,500 shares of Baudax Bio's common stock and restricted stock units covering 2,000 shares of Baudax Bio's common stock in connection with one newly-hired employee with a grant date of March 31, 2021. The equity award was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of the individual's employment compensation and was granted as an inducement material to his acceptance of employment with Baudax Bio.

    The options have an exercise price equal to $1.29 per share, the closing price of Baudax Bio's common stock as reported by Nasdaq on March 31, 2021. The options have a ten-year term and vest over four years, with 25% of the number of shares underlying the stock option vesting on the one-year anniversary of the grant date and the remaining shares vesting monthly over 36 months thereafter. The restricted stock units vest annually over four years. The equity awards are subject to the employee's continued service with Baudax Bio through the applicable vesting dates.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  16. MALVERN, Pa., March 10, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, President and Chief Executive Officer, will participate in a fireside chat at the virtual Oppenheimer 31st Annual Healthcare Conference on Thursday, March 18, 2021 at 9:20 a.m. ET.

    A live webcast of the fireside chat will be available on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be made available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch…

    MALVERN, Pa., March 10, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, President and Chief Executive Officer, will participate in a fireside chat at the virtual Oppenheimer 31st Annual Healthcare Conference on Thursday, March 18, 2021 at 9:20 a.m. ET.

    A live webcast of the fireside chat will be available on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be made available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.



    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  17. MALVERN Pa., March 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the appointment of Richard S. Casten, CPA, MBA as Chief Financial Officer. In this role, Mr. Casten will be responsible for leading and directing the financial activities of the Company. Mr. Casten brings to Baudax 25 years of diversified financial experience across pharmaceutical, Fortune 500 consumer products and public accounting. He replaces Ryan D. Lake, CPA who is transitioning to full time Chief Financial Officer for Recro.

    "I am delighted to welcome Richard to the Baudax team and believe his expertise and leadership skills will be critically important to us as we…

    MALVERN Pa., March 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the appointment of Richard S. Casten, CPA, MBA as Chief Financial Officer. In this role, Mr. Casten will be responsible for leading and directing the financial activities of the Company. Mr. Casten brings to Baudax 25 years of diversified financial experience across pharmaceutical, Fortune 500 consumer products and public accounting. He replaces Ryan D. Lake, CPA who is transitioning to full time Chief Financial Officer for Recro.

    "I am delighted to welcome Richard to the Baudax team and believe his expertise and leadership skills will be critically important to us as we continue to execute on the commercial rollout of ANJESO® in the U.S. and pursue our ongoing growth initiatives," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "Richard is a proven leader in our industry and his extensive financial experience will be a valuable addition to the Company."

    Ms. Henwood continued, "The Board and I wish to express our sincere gratitude to Ryan for his many contributions and service and wish him well in his role as full time Chief Financial Officer at Recro."

    Mr. Casten commented: "Baudax is an exciting growth story and an emerging leader in the acute care setting. The team has been making great strides since its launch toward bringing ANJESO to patients in the U.S. and I am pleased to be joining at such a pivotal time. I look forward to working with the entire leadership team and contributing to the Company's future success."

    Prior to joining Baudax, Mr. Casten served as Vice President of Finance, Controller and Treasurer at Lupin Pharmaceuticals, Inc. Previous to Lupin, Mr. Casten served in roles of increasing responsibility at Endo International plc, culminating in his role as Senior Director, Financial Planning and Analysis. Prior to Endo, he served in various financial roles at the Campbell Soup Company. Mr. Casten spent the initial ten years of his career in public accounting, with eight years at Ernst & Young LLP, rising to a Senior Manager, Assurance and Advisory Business Services, and at Fishbein & Company as an Assurance Staff Accountant. He holds a Bachelor of Science in Business and Economics, with a major in Accounting, from Lehigh University and a Master's in Business Administration from the Johnson School at Cornell University. Mr. Casten is a Certified Public Accountant in both Pennsylvania and California and is a member of American and Pennsylvania Institute of Certified Public Accountants.

    Inducement Grant under NASDAQ Listing Rule 5635(c)(4)

    In connection with the hiring of Mr. Casten, the Compensation Committee of Baudax Bio's Board of Directors approved an inducement grant of stock options to purchase an aggregate of 270,000 shares of Baudax Bio's common stock and restricted stock units covering 100,000 shares of Baudax Bio's common stock, with a grant date of March 8, 2021. The equity award was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of Mr. Casten's employment compensation and was granted as an inducement material to his acceptance of employment with Baudax Bio.

    The options have an exercise price equal to the closing price of Baudax Bio's common stock as reported by Nasdaq on March 8, 2021. The options have a ten-year term and vest over four years, with 25% of the number of shares underlying the stock option vesting on the one-year anniversary of the grant date and the remaining shares vesting monthly over 36 months thereafter. The restricted stock units vest annually over four years. The equity award is subject to Mr. Casten's continued service with Baudax Bio through the applicable vesting dates.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information, please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

     

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  18. MALVERN, Pa., March 02, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, President and Chief Executive Officer, will give a corporate presentation at the H.C. Wainwright Global Life Sciences Conference, being held virtually March 9-10, 2021.

    The presentation will be made available for on-demand listening beginning Tuesday, March 9th at 7:00 a.m. Eastern Time and may be accessed on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The recording will be made available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a…

    MALVERN, Pa., March 02, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, President and Chief Executive Officer, will give a corporate presentation at the H.C. Wainwright Global Life Sciences Conference, being held virtually March 9-10, 2021.

    The presentation will be made available for on-demand listening beginning Tuesday, March 9th at 7:00 a.m. Eastern Time and may be accessed on the "Presentations" page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The recording will be made available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  19. Deepening Usage of ANJESO Evidenced by a Reorder Rate of 60% by the End of 2020 and 58% Growth in Vials Sold from the Sequential Quarter

    Secured Approximately $55 Million in Gross Proceeds from Equity Offerings Over the Past Four Months

    Management to Host Investor Conference Call and Webcast Today at 8:00 a.m. ET

    MALVERN, Pa., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported its financial results for the year ended December 31, 2020.

    "As we continue to navigate the ongoing global pandemic, we continue to see a slower rate of commercialization of ANJESO than we would have expected without COVID-19, but feedback from users of ANJESO…

    Deepening Usage of ANJESO Evidenced by a Reorder Rate of 60% by the End of 2020 and 58% Growth in Vials Sold from the Sequential Quarter

    Secured Approximately $55 Million in Gross Proceeds from Equity Offerings Over the Past Four Months

    Management to Host Investor Conference Call and Webcast Today at 8:00 a.m. ET

    MALVERN, Pa., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported its financial results for the year ended December 31, 2020.

    "As we continue to navigate the ongoing global pandemic, we continue to see a slower rate of commercialization of ANJESO than we would have expected without COVID-19, but feedback from users of ANJESO and our third-party market research is encouraging," said Gerri Henwood, President and CEO of Baudax Bio. "Interest in the product continues to grow as we raise awareness and educate health care providers on the benefits of ANJESO for the management of moderate to severe pain in the acute care setting. We are happy to have added our fifth additional Orange Book listed patent in November, which has an expiry date of May 2030 and we have seen continued support for the safety and efficacy of ANJESO from peer-reviewed publications."

    "The fourth quarter and full year 2020 was marked by several significant milestones for Baudax Bio. We secured approximately $24 million of gross proceeds in the fourth quarter of 2020 and $31 million in the first quarter of 2021 from registered direct offerings and warrant exercises," concluded Ms. Henwood.

    Recent Highlights

    ANJESO

    • Update on Vials Sold to End-Customer. In 2020, over 65 institutions added ANJESO to their formulary. The number of vials sold to end-customers has increased 58% in the fourth quarter of 2020 versus the third quarter of 2020. The number of vials sold to hospitals and ambulatory surgical centers increased over 80% during the same time period. The average quarterly orders per account increased over 60% in the fourth quarter of 2020 versus the third quarter of 2020 and the re-order rate is approximately 55% with a deepening usage pattern.
    • Commercialization Update. While the Company reduced its commercial headcount in November, it launched a virtual tele-sales team to help increase awareness and broaden usage in a cost-efficient manner. This team, deployed in December, has had early success increasing awareness of ANJESO in hospitals not currently targeted by our sales team and has expanded modestly in late January 2021. Another approach deployed in late January 2021 enlists individuals with medical device background and previous relationships with orthopedic surgeons to further expand our access and reach in orthopedics.
    • Publication of ANJESO Network Meta-Analysis in Peer-Reviewed Journal BMC Anesthesiology. In November 2020, the company announced the online publication of a Network Meta-Analysis for ANJESO injection in the peer-reviewed medical journal BMC Anesthesiology. ANJESO was found to be superior in pain reduction for abdominoplasty, bunionectomy and hysterectomy with similar or better safety compared to other approved IV non-opioid analgesics.

    • Receipt of Additional Orange Book Listed Patent for ANJESO. In November 2020, the company announced the issuance of an additional United States patent on July 14, 2020. The patent covers the use of ANJESO to treat moderate to severe pain and has been listed in the U.S. Food and Drug Administration's (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to ANJESO. This patent is an additional ANJESO patent to be listed in the Orange Book with an expiry date of May 2030 and joins four other patents listed in the Orange Book, amongst others owned or licensed by Baudax that currently provide exclusivity to the ANJESO franchise.

    Corporate and Financial

    • Announced a $17.6 Million Registered Direct Offering. In February 2021, the company entered into a definitive agreement with institutional and accredited investors for the purchase and sale of an aggregate of 11,000,000 shares of common stock at a purchase price of $1.60 per share in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds from the offering were approximately $17.6 million, prior to deducting fees and expenses.

    • Announced Exercise of Warrants for Gross Proceeds of $13.4 Million. In January 2021, the company entered into an agreement with an accredited healthcare-focused institutional investor to cash exercise its warrants to purchase 10,300,430 shares of common stock having an exercise price of $1.18. In connection therewith, the company sold the exercising holder new warrants, which are cash exercisable for an aggregate of 10,300,430 shares of common stock at an exercise price of $1.60 per share. The purchase price of the additional warrants was $1,287,554, or $0.125 per warrant. The gross proceeds to the company from the exercise of the warrants and the sale of the additional warrants were $13.4 million, prior to deducting fees and expenses. The offering was conducted as a registered direct offering priced at-the-market under Nasdaq rules.

    • Closed Two $12 Million Registered Direct Offerings. In November and December 2020, the company entered into two definitive agreements with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,126,583 and 10,300,430 shares of common stock (or pre-funded warrants in lieu of shares of common stock) and warrants to purchase up to an aggregate of 10,126,583 and 10,300,430 shares of common stock, respectively. Both offerings were registered direct offerings priced at-the-market under Nasdaq rules. The gross proceeds to Baudax Bio from the offerings were approximately $24 million, prior to deducting fees and expenses.

    Financial Results for the Year Ended December 31, 2020

    As of December 31, 2020, Baudax had cash and cash equivalents of $30.3 million.

    Net product revenue for the year ended December 31, 2020 was $0.5 million related to sales of ANJESO in the U.S. since its launch in June 2020. There was no product revenue recognized for the year ended December 31, 2019.

    Cost of sales for the year ended December 31, 2020 was $1.7 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue for the year ended December 31, 2020 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. Baudax Bio expects that over time, its cost of sales will increase as sales increase and as inventory values change to include all direct and indirect costs and expenses post FDA approval. No cost of sales was recorded for the year ended December 31, 2019.

    Research and development expenses for the year ended December 31, 2020 were $9.1 million compared to $20.1 million for the year ended December 31, 2019. Excluding $0.9 million and $2.8 million of costs associated with restructuring initiatives recorded for the years ended December 31, 2020 and 2019, respectively, research and development expenses decreased $9.1 million. The decrease was primarily due to a decrease in pre-commercial manufacturing and clinical costs of $5.9 million, a decrease of $1.3 million as a result of re-allocating costs related to supply chain, regulatory, quality, and medical affairs associated with support of the commercial launch of ANJESO, a decrease of $1.2 million in preclinical costs and a decrease of $0.7 million in other general expenses.

    Selling, general and administrative expenses for the year ended December 31, 2020 were $43.3 million, compared to $27.0 million for the same prior year period, an increase of $16.3 million. Excluding $0.8 million and $4.4 million of costs associated with restructuring initiatives recorded for the years ended December 31, 2020 and 2019, respectively, selling, general and administrative expenses increased $19.9 million. This increase was primarily due to the commercial launch of ANJESO, specifically, an increase in personnel related costs of $11.6 million, an increase in marketing and consulting costs of $6.4 million, and an increase of $3.9 million attributable to medical affairs and regulatory support. Other general costs increased $0.9 million. These increases were partially offset by the decrease in costs associated with the separation from Recro of $2.9 million in 2019.

    For the year ended December 31, 2020, Baudax reported a net loss, including non-cash charges of $31.4 million, of $76.1 million, or $3.93 per share, compared to a net loss of $32.6 million, including non-cash income of $8.6 million, or $3.48 per share, for the comparable period in 2019. The non-cash charges of $31.4 million in 2020 were associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. The non-cash income of $8.6 million in 2019 was associated with changes in fair value of contingent consideration, stock-based compensation, and depreciation.

    Conference Call Information

    Baudax will host a conference call today, Tuesday, February 16, 2021, at 8:00 a.m. Eastern Time, to discuss the full year 2020 financial results and recent corporate achievements. To access the conference call, please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 4354098. A live audio webcast of the call will be available under "Events" in the News & Investors section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    BAUDAX BIO, INC. AND SUBSIDIARIES
    Consolidated Balance Sheets
     
         
    (amounts in thousands, except share and per share data)    
         
    Assets December 31, 2020 December 31, 2019
    Current assets:    
    Cash and cash equivalents$30,342 $17,740 
    Accounts receivable, net 51   
    Inventory 2,978   
    Prepaid expenses and other current assets 3,346  2,395 
    Total current assets$36,717 $20,135 
         
    Property, plant and equipment, net 5,052  4,821 
    Right-of-use asset 583  730 
    Intangible assets, net 24,254  26,400 
    Goodwill 2,127  2,127 
    Total assets$68,733 $54,213 
    Liabilities and Shareholders' Equity     
    Current liabilities:    
    Accounts payable 3,653  271 
    Accrued expenses & other current liabilities 4,993  3,532 
    Current portion of long-term debt, net 683   
    Current portion of operating lease liability 333  318 
    Current portion of contingent consideration 8,467  3,592 
    Total current liabilities 18,129  7,713 
    Long-term debt, net 8,469   
    Long-term operating lease liability 293  455 
    Warrant liability 65   
    Long-term portion of contingent consideration 56,576  62,766 
    Total liabilities 83,532  70,934 
    Shareholders' equity:    
    Preferred stock, $0.01 par value. Authorized, 10,000,000 shares;    
    none issued and outstanding.    
    Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and

    outstanding, 48,688,480 shares at December 31, 2020 and 9,350,709 shares at

    December 31, 2019
     487  94 
    Additional paid in-capital 97,034  19,405 
    Accumulated deficit (112,320) (36,220)
    Total shareholders' equity (14,799) (16,721)
    Total liabilities and shareholders' equity$68,733 $54,213 







    BAUDAX BIO, INC. AND SUBSIDIARIES
    Consolidated Statements of Operations and Comprehensive Loss
     
         
    (amounts in thousands, except share and per share data)    
         
      Twelve Months Ended
      December 31,
      2020  2019 
     $493 $ 
         
    Operating expenses:    
    Cost of sales 1,732   
    Research and development 9,087  20,061 
    Selling, general and administrative 43,335  27,012 
    Amortization of intangible assets 2,146   
    Change in warrant valuation 16,734   
    Change in contingent consideration valuation 2,245  (14,554)
    Total operating expenses 75,279  32,519 
    Operating loss (74,786) (32,519)
    Other income (expense):    
    Other income (expense) 45  (38)
    Interest expense (1,359)  
     Net loss$(76,100)$(32,557)
         
    Per share information:    
    Net loss per share of common stock, basic and diluted$(3.93)$(3.48)
         
    Weighted average common shares outstanding, basic and diluted 19,355,944  9,350,709 

     



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  20. MALVERN, Pa., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it will report full year 2020 financial results on Tuesday, February 16, 2021. Baudax's management team will host a conference call and webcast at 8:00 a.m. ET on Tuesday, February 16, 2021 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 4354098. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's…

    MALVERN, Pa., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it will report full year 2020 financial results on Tuesday, February 16, 2021. Baudax's management team will host a conference call and webcast at 8:00 a.m. ET on Tuesday, February 16, 2021 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 4354098. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information, please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

     

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

     

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  21. MALVERN, Pa., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it has entered into a definitive agreement with institutional and accredited investors for the purchase and sale of an aggregate of 11,000,000 shares of common stock at a purchase price of $1.60 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about February 10, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Baudax Bio from…

    MALVERN, Pa., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it has entered into a definitive agreement with institutional and accredited investors for the purchase and sale of an aggregate of 11,000,000 shares of common stock at a purchase price of $1.60 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about February 10, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Baudax Bio from the offering are expected to be approximately $17.6 million. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

    The shares described above are being offered by Baudax Bio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-243488) filed with the Securities and Exchange Commission (SEC) on August 10, 2020 and declared effective on October 2, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information, please visit www.baudaxbio.com

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:   

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  22. MALVERN, Pa., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the agreement by an accredited healthcare-focused institutional investor to cash exercise certain warrants to purchase up to an aggregate of 10,300,430 shares of common stock having an exercise price of $1.18 issued by the company in December 2020. The shares of common stock issuable upon exercise of the warrants are registered pursuant to a registration statement on Form S-3 (File No. 333-243488). In consideration for the immediate exercise of the warrants for cash, the company will sell to the exercising holder an additional warrant pursuant to the registration statement…

    MALVERN, Pa., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the agreement by an accredited healthcare-focused institutional investor to cash exercise certain warrants to purchase up to an aggregate of 10,300,430 shares of common stock having an exercise price of $1.18 issued by the company in December 2020. The shares of common stock issuable upon exercise of the warrants are registered pursuant to a registration statement on Form S-3 (File No. 333-243488). In consideration for the immediate exercise of the warrants for cash, the company will sell to the exercising holder an additional warrant pursuant to the registration statement. The new warrant will be cash exercisable for an aggregate of up to 10,300,430 shares of common stock at an exercise price of $1.60 per share and have a term of exercise equal to five years. The purchase price of the additional warrant will be $1,287,553.75, or $0.125 per warrant share.

    The gross proceeds to the company from the exercise of the warrants and the sale of the additional warrants are expected to be approximately $13,442,061, prior to deducting placement agent fees and estimated offering expenses.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

    The shares issuable upon exercise of the warrants and the issuance of the new warrants described above are being offered by Baudax Bio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-243488) filed with the Securities and Exchange Commission (SEC) on August 10, 2020 and declared effective on October 2, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  23. MALVERN, Pa., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, the Company's President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright BioConnect 2021 Conference, being held virtually January 11-14, 2021.

    The presentation will be available for on-demand listening beginning Monday, January 11th at 6:00 a.m. Eastern Time and may be accessed on the "Presentations" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The recording will be available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is…

    MALVERN, Pa., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, the Company's President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright BioConnect 2021 Conference, being held virtually January 11-14, 2021.

    The presentation will be available for on-demand listening beginning Monday, January 11th at 6:00 a.m. Eastern Time and may be accessed on the "Presentations" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The recording will be available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential COX-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



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  24. MALVERN, Pa., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it has entered into a definitive agreement with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,300,430 shares of common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to an aggregate of 10,300,430 shares of common stock at a purchase price of $1.165 per share (or $1.155 per prefunded warrant) and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.18 per share, are exercisable immediately…

    MALVERN, Pa., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it has entered into a definitive agreement with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,300,430 shares of common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to an aggregate of 10,300,430 shares of common stock at a purchase price of $1.165 per share (or $1.155 per prefunded warrant) and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.18 per share, are exercisable immediately, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about December 21, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Baudax Bio from the offering are expected to be approximately $12 million. In addition, in the event the warrants are exercised in full for cash, Baudax Bio expects to receive approximately $12.15 million in additional gross proceeds. However, there is no assurance that all or any portion of the warrants will be exercised prior to their expiration. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

    The securities described above are being offered by Baudax Bio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-243488) filed with the Securities and Exchange Commission (SEC) on August 10, 2020 and declared effective on October 2, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:   

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



       

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  25. MALVERN, Pa., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, the Company's President and Chief Executive Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held virtually December 1-3, 2020. The company will conduct institutional investor meetings on December 2, 2020; meetings may be requested through Piper Sandler.

    A pre-recorded fireside chat with Ms. Henwood is now available on the Piper Sandler conference site and on the "Events" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The recording will be available…

    MALVERN, Pa., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Gerri Henwood, the Company's President and Chief Executive Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held virtually December 1-3, 2020. The company will conduct institutional investor meetings on December 2, 2020; meetings may be requested through Piper Sandler.

    A pre-recorded fireside chat with Ms. Henwood is now available on the Piper Sandler conference site and on the "Events" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The recording will be available for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential COX-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    Primary Logo

    View Full Article Hide Full Article
  26. MALVERN, Pa., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it has entered into a definitive agreement with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,126,583 shares of common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to an aggregate of 10,126,583 shares of common stock at a purchase price of $1.185 per share (or $1.175 per prefunded warrant) and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.20 per share, are exercisable immediately…

    MALVERN, Pa., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, ("Baudax Bio" or the "Company") today announced that it has entered into a definitive agreement with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,126,583 shares of common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to an aggregate of 10,126,583 shares of common stock at a purchase price of $1.185 per share (or $1.175 per prefunded warrant) and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.20 per share, are exercisable immediately, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about November 25, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Baudax Bio from the offering are expected to be approximately $12 million. In addition, in the event the warrants are exercised in full for cash, Baudax Bio expects to receive approximately $12.15 million in additional gross proceeds. However, there is no assurance that all or any portion of the warrants will be exercised prior to their expiration. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

    The securities described above are being offered by Baudax Bio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-243488) filed with the Securities and Exchange Commission (SEC) on August 10, 2020 and declared effective on October 2, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:   

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902

     

       

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  27. MALVERN, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the online publication of a Network Meta-Analysis (NMA) for ANJESO (meloxicam) injection in the peer-reviewed medical journal BMC Anesthesiology. ANJESO was recently launched in the U.S. and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

    "The management of post-operative pain remains a significant issue, including providing adequate pain control beyond immediate postsurgical recovery," said Jonathan Jahr, M.D., Professor Emeritus, Anesthesiology, University of California, Los Angeles School of Medicine…

    MALVERN, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the online publication of a Network Meta-Analysis (NMA) for ANJESO (meloxicam) injection in the peer-reviewed medical journal BMC Anesthesiology. ANJESO was recently launched in the U.S. and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

    "The management of post-operative pain remains a significant issue, including providing adequate pain control beyond immediate postsurgical recovery," said Jonathan Jahr, M.D., Professor Emeritus, Anesthesiology, University of California, Los Angeles School of Medicine. "Based on the results of multiple clinical trials, ANJESO (meloxicam) injection has been found to provide relief of moderate to severe acute pain, alone or in combination with other analgesics within the first 15 minutes after dosing and up to 24 hours after dosing compared to placebo. Specifically, ANJESO (meloxicam) injection provided superior pain relief for abdominoplasty, bunionectomy and hysterectomy when compared with acetaminophen, ibuprofen, and ketorolac, while also demonstrating a compelling profile with respect to reducing morphine consumption. Notably, ANJESO (meloxicam) injection was significantly more effective at reducing pain intensity than all comparators for those procedures in which pain intensity scores were recorded."

    "We believe that ANJESO offers an effective, non-opioid therapeutic option for the management of postsurgical pain for eligible patients," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "As the only intravenous IV NSAID that lasts up to 24 hours, ANJESO has an equal or better safety profile than that of other IV non-opioids, and benefits patients by reducing their opioid consumption post-surgery. The results of this meta-analysis add to the growing body of data supporting our ongoing ANJESO commercial launch efforts."

    ANJESO Network Meta-Analysis Results

    The published NMA results are based on the screening of over 2,300 studies, whereby 27 studies were identified and included in the analysis. Randomized clinical trials from 2000 to 2019 which involved at least one of the following procedures: open abdominal surgery, bunionectomy, open hysterectomy, orthopedic joint replacement surgery (including knee, ankle, hip, shoulder) were evaluated for inclusion. The literature search included publications that reported clinical effectiveness, safety and tolerability in adult patients receiving post-operative pain treatments. For this NMA, ANJESO was indirectly compared with only those IV treatments that were available at the time in the U.S., including acetaminophen, ibuprofen, and ketorolac. Studies for other non-opioid analgesics such as parecoxib and diclofenac were used for indirect comparison with the placebo arms in those studies.

    The NMA found that among patients reporting moderate to severe postoperative pain, ANJESO was superior in pain reduction for abdominoplasty, bunionectomy and hysterectomy when compared with acetaminophen, ibuprofen, and ketorolac. In reducing morphine consumption, ANJESO was associated with significantly less morphine milligram equivalents (MME) utilization versus all comparators for abdominal procedures, hysterectomy, and versus acetaminophen in orthopedic procedures. Elsewhere MME utilization outcomes for ANJESO were largely equivalent or nominally better than other comparators.

    The odds of opioid-related adverse events (ORADEs) were significantly higher for all comparators compared to ANJESO for orthopedic (gastrointestinal) and hysterectomy (respiratory). These results suggest ANJESO may provide better pain relief with a similar or better reduction in ORADEs compared to other approved IV NSAIDS.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential COX-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     



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  28. MALVERN, Pa., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, recently announced the issuance of United States Patent No.10,709,713 (the ‘713 Patent) on July 14, 2020. The ‘713 Patent covers the use of ANJESO® to treat moderate to severe pain, and has been listed in the United States Food and Drug Administration's (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to ANJESO®.

    The ‘713 Patent is an additional ANJESO® patent to be listed in the Orange Book with an expiry date of May of 2030. The ‘713 Patent joins four other patents listed in the Orange Book, amongst others owned or licensed by Baudax that…

    MALVERN, Pa., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, recently announced the issuance of United States Patent No.10,709,713 (the ‘713 Patent) on July 14, 2020. The ‘713 Patent covers the use of ANJESO® to treat moderate to severe pain, and has been listed in the United States Food and Drug Administration's (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to ANJESO®.

    The ‘713 Patent is an additional ANJESO® patent to be listed in the Orange Book with an expiry date of May of 2030. The ‘713 Patent joins four other patents listed in the Orange Book, amongst others owned or licensed by Baudax that currently provide exclusivity to the ANJESO® franchise.

    "We are pleased by the progress we have made in the United States Patent and Trademark Office and the recognition of the inventive nature of our ANJESO® franchise," said Gerri Henwood, Baudax Bio's President and Chief Executive Officer. "The ‘713 Patent is expected to provide a significant barrier for generic entry and will likely be joined by other patents currently pending in the USPTO."

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    Primary Logo

    View Full Article Hide Full Article
  29. ANJESO® Launch Underway; Over 50 Institutions have Added ANJESO to Their Formularies with Users Giving Highly Positive Feedback and Average Monthly Orders Increasing over 125% Since Launch

    Secured and Implemented Permanent J-Code for ANJESO from CMS October 1, Along with Two Major Group Purchasing Agreements with Vizient and Premier

    Management to Host Investor Conference Call and Webcast Today at 9:00 a.m. ET

    MALVERN, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three and nine months ended September 30, 2020.

    "The third quarter of 2020 was marked by several important…

    ANJESO® Launch Underway; Over 50 Institutions have Added ANJESO to Their Formularies with Users Giving Highly Positive Feedback and Average Monthly Orders Increasing over 125% Since Launch

    Secured and Implemented Permanent J-Code for ANJESO from CMS October 1, Along with Two Major Group Purchasing Agreements with Vizient and Premier

    Management to Host Investor Conference Call and Webcast Today at 9:00 a.m. ET

    MALVERN, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three and nine months ended September 30, 2020.

    "The third quarter of 2020 was marked by several important achievements, including continued progress with the commercial launch of ANJESO, the securing of group purchasing agreements with two leading healthcare improvement companies, Vizient and Premier, and the receipt and implementation, on October 1, 2020, of our permanent J-code from the Centers for Medicare and Medicaid Services (CMS), facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We are pleased with the highly positive feedback we have been receiving from the vast majority of users about ANJESO, together with average monthly orders per account more than doubling. The commercial rollout progress continues, but remains impacted by the ongoing COVID-19 pandemic and as we have said, we continue to believe the launch revenue ramp will likely take more time than originally anticipated."

    "ANJESO has made progress with GPO organizations, formularies, and with meaningful use of the product in acute care centers where formulary approval and EHR, or electronic health record, incorporation has been obtained. The vast majority of users report a high level of satisfaction that ANJESO delivers at or beyond their expectations in terms of pain relief and duration of action. All of these factors give us reasons to believe that this product can continue to deepen usage, grow and ultimately fulfill its promise as a product. The combination of an ongoing pandemic, which has significantly impacted hospitals and other acute care settings, along with the natural adoption curve seen historically with hospital products, has caused us to adjust our plan during this early launch period."

    "Our adjusted plan is to focus on territories with high promise and with early indicators of adoption and usage with a reduced but very focused team during this pandemic of uncertain duration. This approach reduces the total company by approximately 40 professionals and includes additional cost reductions in other areas (manufacturing, out of pocket spend, etc.) which we believe will better position the company to sustain our efforts. We would like to convey our gratitude to the employees who are leaving and who have contributed to the accomplishments of the Company of ultimate approval and launch of ANJESO, as well as forging a path for continued growth of the product."

    "Looking ahead to the remainder of 2020 and beyond, we are actively working with the surgical and anesthesia community to drive hospital formulary adoption and the incorporation of ANJESO into standard pain management protocols, and look forward to reporting on our continued growth" concluded Ms. Henwood.

    Third Quarter 2020 and Recent Business Highlights

    ANJESO

    • ANJESO Launch and Commercial Rollout. In June 2020, ANJESO, Baudax's lead asset indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics, became broadly available through wholesalers in the U.S. The commercial rollout is progressing well and as of late October 2020, over 50 institutions have added ANJESO to their formulary and average monthly orders per account has increased over 125% since launch. The ANJESO re-order rate is approximately 50% with a deepening usage pattern. Additionally, sales from hospitals are growing with 60% of October unit sales coming from hospitals. The number of hospitals ordering has tripled since launch and the number of orders from hospitals has quadrupled. In just over 5 months on the market, ANJESO has been utilized across a wide variety of surgical and non-surgical procedures and is now beginning to be incorporated into surgical protocols and electronic health record (EHR) order sets, with demand increasing monthly. Baudax's ongoing commercial efforts continue to be impacted by COVID-19 pandemic related obstacles, and as a result, the Company believes the launch revenue ramp for ANJESO will likely take more time than originally anticipated.



    • Secured Two Major Group Purchasing Agreements with Vizient and Premier. During the third quarter, Baudax secured agreements with two major group purchasing organizations, Vizient, Inc. and Premier, Inc. The Vizient agreement offers savings to Vizient's diverse membership, which includes more than 50% of the nation's acute care systems, including 95% of the nation's academic medical centers, and more than 20% of the nation's ambulatory care market. The Premier agreement provides access to an alliance of approximately 4,100 hospitals and more than 200,000 other providers and organizations. Collectively, these agreements significantly expand the commercial reach of ANJESO.



    • Receipt of J-Code from CMS. In early August 2020, CMS established a new permanent J-code for ANJESO, facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. Importantly, the code, J1738 (Injection, meloxicam, 1 mg), took effect on October 1, 2020 and replaced the previously issued C-code (C9059) and during October could improve the "time to payment/reimbursement" for our outpatient setting users (ASCs, Hospital outpatient facilities, etc.)



    • Presented New Phase IIIb ANJESO Data at American Society of Colon and Rectal Surgeons (ASCRS) Meeting. In July 2020, Baudax presented a virtual poster highlighting new Phase IIIb ANJESO data from a double-blind placebo-controlled trial, as part of the ASCRS 2020 Annual Scientific Meeting. The published data supports the use of ANJESO administered preoperatively to patients undergoing colorectal surgery. The key findings from this study include statistically significant reductions in opioid use, as well as time to bowel function recovery and hospital discharge, resulting in cost savings for ANJESO-treated patients.

    Corporate and Financial

    • Reorganized and Streamlined Workforce to Focus Commercial Efforts Further and Reduce Expenses during the pandemic. Due to the impacts of COVID-19 and the resultant slower than expected commercial ramp of ANJESO, effective November 9, 2020, Baudax implemented a reduction of its workforce by approximately 40 employees. Baudax expects that the reorganization will result in annualized savings of an estimated $10.6 million in personnel and other related costs. There were also significant cost reductions made for 2021 manufacturing and launch related activities. The Company estimates that the reorganization will be substantially completed in November 2020 and that it will incur approximately $1.5 million of charges for severance and other costs, primarily during the fourth quarter of 2020.



    • Completed Strategic Transaction to Exchange Warrants. Effective October 19, 2020, the Company entered into exchange agreements with holders of its short dated (13 months) Series B Warrants and long dated (5 year) Series A Warrants. As a result of the warrant exchange transaction, and subsequent warrant exercises thereafter, holders exercised or exchanged approximately 12.6 million warrants resulting in the issuance of approximately 7.9 million shares of the Company's common stock in the aggregate to date related to this transaction. This Warrant restructuring transaction was done to remove certain financial impediments and overhang for the 4-year plus life of the Series A Warrants, while reducing dilution for its existing shareholders. Holders of approximately 90% of the Company's warrants participated in the exchange.

       
    • Appointed Dr. Arnold Baskies and Andrew Drechsler to Board of Directors. In August 2020, the Company announced the appointment of Arnold Baskies, M.D., and Andrew Drechsler to its board of directors. Dr. Baskies' experience in the surgical setting and Mr. Drechsler's background in finance, most recently as the Chief Financial Officer for Provention Bio and previously of Insmed Incorporated, will prove beneficial as the Company strengthens their efforts to communicate the benefits of ANJESO as an advantageous option for the management of moderate to severe pain.

    COVID-19 Impact

    The Company's efforts to commercialize ANJESO have been impacted and may continue to be impacted by the COVID-19 pandemic. Hospitals have reduced elective surgeries and many have not yet returned to their prior number of surgeries even where the pandemic has, for a time, abated. In addition, COVID-19 has, in many cases, impacted revenues for hospitals, reduced staffing, diverted resources from other normal activities to patients suffering from COVID-19 and limited hospital access for nonpatients, including the Company's sales professionals, which the Company believes is impacting its marketing and commercialization efforts. The Company believes that the reduction in elective surgeries during the COVID-19 pandemic has and may continue to result in decreased demand for ANJESO.

    The Company anticipates that many hospitals and health care providers will continue to suffer negative financial consequences due to an increase in unexpected costs, personal protective equipment and ventilators, along with a dramatic reduction in revenue due to fewer elective procedures being performed, which may result in a decreased demand for ANJESO. While access restrictions have eased in some locations, cycling spikes of COVID-19 cases in certain states or regions may further impact the Company's sales force as access to hospitals may be restricted and elective surgeries may be limited in those areas. In addition, the absence of hospital formulary meetings where new drugs can be adopted has impacted our efforts to commercialize ANJESO. Many hospital formularies recently resumed meetings after a 6-month absence. Despite the existence of a backlog of agents scheduled to be reviewed, the Company believes it will make progress getting ANJESO added to additional hospital formularies in the near term. Due to the rapidly evolving environment, continued uncertainties from the impact of the COVID-19 global pandemic, and recent regional outbreaks that are impacting the recovery, the Company cannot estimate the full extent to which the Company's commercialization of ANJESO and financial results may be adversely impacted.

    Third Quarter 2020 Financial Results

    As of September 30, 2020, Baudax had cash and cash equivalents of $24.6 million.

    Net product revenue for the three months ended September 30, 2020 was $0.1 million, related to sales of ANJESO in the U.S. While in the title model of distribution, product revenue represents shipments to our third-party logistics (3PL) provider. As the second quarter of 2020 included stocking orders to our 3PL, the third quarter revenue is not a reflection of units sold to the end-customers. The number of vials sold to end-customers (e.g., hospitals, ambulatory surgical centers) has increased almost three-fold in the third quarter of 2020 versus the second quarter of 2020. There was no product revenue recognized during the three months ended September 30, 2019.

    Cost of sales for the three months ended September 30, 2020 was $0.5 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue during the three months ended September 30, 2020 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. Baudax expects over time its cost of sales will increase as it builds new inventory not expensed during the pre-approval period and depletes its initial inventory levels. No cost of sales was recorded for the three months ended September 30, 2019.

    Research and development expenses for the three months ended September 30, 2020 were $1.5 million, compared to $1.8 million for the three months ended September 30, 2019. The decrease of $0.3 million resulted from a decrease in personnel and overhead expenses of $0.5 million as Baudax allocated or recategorized certain expenses related to supply chain, regulatory, quality and medical affairs associated with support of the commercial launch of ANJESO and a decrease in pre-commercialization manufacturing and clinical costs for ANJESO of $0.4 million.

    Selling, general and administrative expenses for the three months ended September 30, 2020 were $13.8 million, compared to $4.5 million for the same prior year period. The increase of $9.3 million was primarily due to increased selling and marketing expenses in connection with the commercial launch of ANJESO. Selling and marketing expenses of $7.6 million for the three months ended September 30, 2020 increased $6.8 million due to increased personnel costs of $4.9 million and increased commercial costs of $1.9 million. General and administrative expenses of $6.2 million for the three months ended September 30, 2020 increased $2.5 million primarily due to increased personnel costs, over half of which was attributed to medical affairs field personnel and regulatory support functions that had previously been recorded within research and development expense in the prior year period.

    Baudax reported a net income (including non-cash benefit of $25.1 million) of $11.7 million, or $0.62 per diluted share, for the three months ended September 30, 2020. The non-cash benefit of $25.1 million was associated with changes in fair value of contingent consideration and changes in warrant valuations offset by non-cash charges for interest expense, depreciation, amortization, and stock-based compensation. This compares to a net loss of $10.3 million, or $(1.10) per share, for the comparable period in 2019. For the three months ended September 30, 2020, there was $11.8 million in cash used in operating activities which included cash used related to the build of inventory for ANJESO and a $2.5 million milestone payment to Alkermes, plc.

    Nine Months Ended September 30, 2020 Financial Results

    Net product revenue for the nine months ended September 30, 2020 was $0.4 million, related to sales of ANJESO in the U.S. There was no product revenue recognized during the nine months ended September 30, 2019.

    Cost of sales for the nine months ended September 30, 2020 was $1.2 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue during the nine months ended September 30, 2020 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. Baudax expects over time its cost of sales will increase as it builds new inventory not expensed during the pre-approval period and depletes its initial inventory levels. No cost of sales was recorded for the nine months ended September 30, 2019.

    Research and development expenses for the nine months ended September 30, 2020 were $5.9 million, compared to $18.6 million for the nine months ended September 30, 2019, a decrease of $12.7 million. Excluding $2.8 million of costs associated with the 2019 strategic restructuring initiative recorded in the nine months ended September 30, 2019, Baudax's research and development expenses decreased $9.9 million primarily resulting from a decrease in pre-commercialization manufacturing and clinical costs for ANJESO of $6.6 million, a decrease in personnel and overhead expenses of $1.7 million as we re-allocated costs related to supply chain, regulatory, quality and medical affairs associated with support of the commercial launch of ANJESO and a decrease in other development costs of $1.6 million.

    Selling, general and administrative expenses for the nine months ended September 30, 2020 were $33.0 million, compared to $21.8 million for the same prior year period, an increase of $11.2 million. Excluding $4.4 million of costs associated with the 2019 strategic restructuring initiative recorded in the nine months ended September 30, 2019, our selling, general and administrative expenses increased $15.6 million primarily due to increased selling and marketing expenses in connection with the commercial launch of ANJESO. Selling and marketing expenses of $16.5 million for the nine months ended September 30, 2020 increased $10.1 million primarily due to increased personnel costs of $6.6 million and increased commercial costs of $3.5 million. General and administrative expenses of $16.5 million for the nine months ended September 30, 2020 increased $5.5 million primarily due to increased personnel costs of $4.9 million, over half of which was attributed to medical affairs field personnel and regulatory support functions that had previously been recorded within research and development expense in the prior year period and increased public company costs of approximately $0.6 million as the prior year costs represent an allocated portion of the costs in the historical combined financial statements of Baudax Bio and Recro Pharma, Inc. (Recro) prior to our separation from Recro.

    Baudax reported a net loss (including non-cash charges of $26.7 million) of $59.1 million, or $(3.84) per diluted share, for the nine months ended September 30, 2020. The non-cash charges of $26.7 million were associated with changes in fair value of contingent consideration, changes in warrant valuations, non-cash interest expense, depreciation, amortization, and stock-based compensation. This compares to a net loss of $25.2 million, or $(2.70) per share, for the comparable period in 2019.

    Conference Call Information

    Baudax will host a conference call today, Monday, November 9, 2020, at 9:00 a.m. Eastern Time, to discuss the third quarter 2020 financial results and recent corporate achievements. To access the conference call, please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 1173387. A live audio webcast of the call will be available under "Events" in the News & Investors section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902





    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436



    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    BAUDAX BIO, INC.

    Consolidated Balance Sheets

    (Unaudited)

    (amounts in thousands, except share and per share data) September 30, 2020  December 31, 2019 
    Assets        
    Current assets:        
    Cash and cash equivalents $24,608  $17,740 
    Inventory  1,784    
    Prepaid expenses and other current assets  2,563   2,395 
    Total current assets  28,955   20,135 
    Property, plant and equipment, net  4,835   4,821 
    Intangible assets, net  24,898   26,400 
    Goodwill  2,127   2,127 
    Other long-term assets  652   730 
    Total assets $61,467  $54,213 
    Liabilities and Shareholders' Equity        
    Current liabilities:        
    Accounts payable $1,782  $271 
    Accrued expenses and other current liabilities  7,292   3,850 
    Current portion of long-term debt, net  171    
    Current portion of contingent consideration  10,677   3,592 
    Total current liabilities  19,922   7,713 
    Long-term debt, net  8,753    
    Warrant liability  10,228    
    Long-term portion of contingent consideration  67,433   62,766 
    Other long-term liabilities  361   455 
    Total liabilities  106,697   70,934 
    Commitments and contingencies        
    Shareholders' equity:        
    Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and

    outstanding
          
    Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and

    outstanding, 18,374,604 shares at September 30, 2020 and 9,350,709 shares at

    December 31, 2019
      184   94 
    Additional paid-in capital  49,864   19,405 
    Accumulated deficit  (95,278)  (36,220)
    Total shareholders' equity (deficit)  (45,230)  (16,721)
    Total liabilities and shareholders' equity $61,467  $54,213 
             



    BAUDAX BIO, INC.

    Consolidated and Combined Statements of Operations

    (Unaudited)

      For the Three Months Ended September 30,  For the Nine Months Ended September 30, 
    (amounts in thousands, except share and per share data) 2020  2019  2020  2019 
    Revenue, net $68  $  $417  $ 
                     
    Operating expenses:                
    Cost of sales  540      1,190    
    Research and development  1,469   1,845   5,889   18,578 
    Selling, general and administrative  13,763   4,524   33,026   21,809 
    Amortization of intangible assets  643      1,502    
    Change in warrant valuation  (11,182)     2,863    
    Change in contingent consideration valuation  (17,427)  3,909   14,252   (15,241)
    Total operating expenses  (12,194)  10,278   58,722   25,146 
    Operating income (loss)  12,262   (10,278)  (58,305)  (25,146)
    Other expense:                
    Other expense  (577)  (37)  (753)  (86)
    Net income (loss) $11,685  $(10,315) $(59,058) $(25,232)
                     
    Per share information:                
    Net income (loss) per share of common stock, basic $0.64  $(1.10) $(3.84) $(2.70)
    Net income (loss) per share of common stock, dilutive $0.62  $(1.10) $(3.84) $(2.70)
                     
    Weighted average common shares outstanding, basic  18,374,604   9,350,709   15,366,861   9,350,709 
    Weighted average common shares outstanding, diluted  18,768,376   9,350,709   15,366,861   9,350,709 

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  30. MALVERN, Pa., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it will report third quarter 2020 financial results on Monday, November 9, 2020. Baudax's management team will host a conference call and audio webcast at 9:00 a.m. ET on Monday, November 9, 2020 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 1173387. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events

    MALVERN, Pa., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it will report third quarter 2020 financial results on Monday, November 9, 2020. Baudax's management team will host a conference call and audio webcast at 9:00 a.m. ET on Monday, November 9, 2020 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 1173387. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies, Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up its commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on its operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in its filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     

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  31. ANJESO® Launch Underway; Over 50 Institutions have Added ANJESO to Their Formularies

    ANJESO Users Giving Highly Positive Feedback; Average Order Size Has Increased 75% Since Launch, Despite Ongoing COVID-related Impact to Access

    Company Executes Strategic Transaction to Simplify Capital Structure and Exchange Warrants

    MALVERN, Pa., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today provided an update regarding the initial commercial launch of ANJESO and provided an overview of other corporate initiatives and achievements.

    "During the first half of 2020, we saw the approval and commercial launch of ANJESO, the first and only non-opioid, once daily…

    ANJESO® Launch Underway; Over 50 Institutions have Added ANJESO to Their Formularies

    ANJESO Users Giving Highly Positive Feedback; Average Order Size Has Increased 75% Since Launch, Despite Ongoing COVID-related Impact to Access

    Company Executes Strategic Transaction to Simplify Capital Structure and Exchange Warrants

    MALVERN, Pa., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today provided an update regarding the initial commercial launch of ANJESO and provided an overview of other corporate initiatives and achievements.

    "During the first half of 2020, we saw the approval and commercial launch of ANJESO, the first and only non-opioid, once daily, intravenous (IV) non-steroidal anti-inflammatory (NSAID) agent for the management of moderate to severe pain," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "Overall, the ANJESO launch is progressing well and we are pleased with the early commercial uptake and feedback from physicians. Although we are seeing more customers placing orders and the order size is increasing, the commercial rollout continues to be impacted by the ongoing COVID-19 pandemic and we believe the revenue ramp will likely take more time than originally anticipated. Looking ahead to the remainder of 2020 and beyond, we are focused on securing hospital formulary adoption and incorporation into standard pain management protocols. We are also working with the surgical and anesthesia community to increase awareness of ANJESO and help ensure physicians and patients have access to this important product."

    ANJESO Launch and Commercial Rollout

    The U.S. commercial rollout of ANJESO, Baudax's lead asset indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics, is progressing well. ANJESO became broadly available through wholesalers in the U.S in June 2020. As of today, over 50 institutions have added ANJESO to their formulary and the average order size has increased by nearly 75% since launch. The ANJESO re-order rate is a robust 50% with a deepening usage pattern. In just over 3 months on the market, ANJESO has been utilized across a wide variety of surgical and non-surgical procedures and is now beginning to be incorporated into surgical protocols and electronic health record (EHR) order sets, with demand increasing monthly. However, Baudax's ongoing commercial efforts continue to be impacted by COVID-19 pandemic related obstacles, including an absence of hospital formulary meetings where new drugs can be adopted, as well as access within hospitals. Many hospital formularies just recently resumed meetings after a 6-month absence. Despite there being a backlog of agents scheduled to be reviewed, the Company believes it will make steady progress getting ANJESO added to further hospital formularies in the months and quarters ahead.

          

    "For the significant number of patients undergoing surgical procedures, there is an important need for new non-opioid options to manage their pain post-surgically," said Harold K. Humphries, M.D., Anesthesiologist and Operations Officer at Greater Sacramento Surgery Center. "At our center, we have noticed that ANJESO alone works as well as peripheral nerve blocks for controlling postoperative pain in total knee replacement cases. We've also found that with ANJESO the utilization of our 23-hour stay program is reduced, resulting in significant savings with overhead costs, which markedly offsets the cost of the product itself. ANJESO is an excellent addition to our patient care protocols."

    Effective October 1, 2020, ANJESO is reimbursed by the Centers for Medicare and Medicaid Services (CMS), under a unique J code, facilitating reimbursement for use in the hospital outpatient, ambulatory surgery center and physician office settings of care.

    Strategic Transaction to Simplify Capital Structure and Exchange Warrants

    Effective October 19, 2020, the Company entered into exchange agreements with holders of its short dated (13 months) Series B Warrants and long dated (5 year) Series A Warrants providing for the immediate exchange of 0.2 shares of common stock per warrant, for either all Series A Warrants or Series B Warrants held by each holder, at the holders election. As a result of the warrant exchange, the exercise price of the remaining outstanding warrants (whether Series A Warrants or Series B Warrants, including warrants held by holders not participating in the exchange) was adjusted to $0.01 per share. Holders participating in the exchange also agreed to amend their Warrants not so exchanged to remove certain anti-dilution and variable pricing protective provisions. Additionally, following the completion of the warrant exchange, for holders participating in the exchange, to the extent such holder's outstanding warrant is a Series A Warrant, the expiration date for such warrant was amended to April 26, 2021.

    As a result of the warrant exchange, the exercise and exchange of all of the Series A Warrants and Series B Warrants (approximately 15 million warrants outstanding prior to the exchange) is expected to result in the issuance of approximately 9.8 million shares of the Company's common stock in the aggregate. This Warrant restructuring transaction was done to improve the Company's capital structure and remove certain financial overhang, which the Company believes negatively impacted its expected valuation and ability to attract additional capital investments.

    "By executing this strategic warrant restructuring, we have cleaned up the balance sheet and significantly improved the capital structure of the Company through elimination of certain provisions that would have contributed to a financial overhang for the remaining 4-year plus life of the Series A warrants, all while minimizing the anticipated dilution for our shareholders by over 25%," said Ryan D. Lake, Chief Financial Officer of Baudax Bio. "As of today, holders of approximately 90% of the Warrants are participating in the exchange. We sincerely appreciate the ongoing support of all of our shareholders and their willingness to work constructively with the Company and our bankers to execute this important transaction."

    Other material terms related to the Series A Warrant and Series B Warrant exchange and amendments can be found in the Company's current report on Form 8-K, which was filed with the Securities and Exchange Commission on October 20, 2020.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    INDICATION AND USAGE

    ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

    Limitation of Use: Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Risk

    Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

    ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Risk

    NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    CONTRAINDICATIONS

    ANJESO is contraindicated in patients with:

    Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.

    History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

    In the setting of coronary artery bypass graft (CABG) surgery.

    Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue ANJESO immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    Hypertension: NSAIDs including ANJESO can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ANJESO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Post MI Patients: Avoid the use of ANJESO in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ANJESO is used in these patients, monitor for signs of cardiac ischemia.

    Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. ANJESO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating ANJESO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If ANJESO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

    Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including ANJESO, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity.

    Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including ANJESO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

    DRUG INTERACTIONS

    Drugs That Interfere With Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ANJESO with drugs that interfere with hemostasis. Concomitant use of ANJESO and analgesic doses of aspirin is not generally recommended.

    Angiotensin Converting Enzymes (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

    ACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

    ADVERSE REACTIONS

    The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with ANJESO and at a greater frequency than placebo include: constipation, gamma-glutamyl transferase increased, and anemia.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have trouble conceiving.

    Please see full Prescribing Information, including Boxed Warning at www.baudaxbio.com.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies, Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up its commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on its operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in its filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

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  32. MALVERN, Pa., Oct. 02, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved inducement grants of stock options to purchase an aggregate of 24,000 shares of Baudax Bio's common stock and restricted stock units covering 6,000 shares of Baudax Bio's common stock to 3 newly-hired employees, with a grant date of September 30, 2020. The equity awards were granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of each individual's employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax…

    MALVERN, Pa., Oct. 02, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved inducement grants of stock options to purchase an aggregate of 24,000 shares of Baudax Bio's common stock and restricted stock units covering 6,000 shares of Baudax Bio's common stock to 3 newly-hired employees, with a grant date of September 30, 2020. The equity awards were granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of each individual's employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax Bio.

    The options have an exercise price equal to $2.77 per share, the closing price of Baudax Bio's common stock as reported by Nasdaq on September 30, 2020. The options have a ten-year term and vest over four years, with 25% of the number of shares underlying the stock option vesting on the one-year anniversary of the grant date and the remaining shares vesting monthly over 36 months thereafter. The restricted stock units vest annually over four years. The equity awards are subject to each individual's continued service with Baudax Bio through the applicable vesting dates.

    About Baudax Bio, Inc.

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio's first commercial product, ANJESO®, began in June of 2020. Baudax's New Drug Application for ANJESO was approved by the U.S. Food and Drug Administration on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies, Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up its commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on its operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in its filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT: 

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



      

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

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  33. MALVERN, Pa., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will present at the Oppenheimer Fall Healthcare Life Sciences & Medtech Summit on Tuesday, September 22, 2020 at 3:20 p.m. ET.

    A live webcast of the presentation will be available on the "Presentations" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care…

    MALVERN, Pa., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will present at the Oppenheimer Fall Healthcare Life Sciences & Medtech Summit on Tuesday, September 22, 2020 at 3:20 p.m. ET.

    A live webcast of the presentation will be available on the "Presentations" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of the Company's first commercial product, ANJESO®, began in June of 2020. Baudax's New Drug Application for ANJESO was approved by FDA on February 20, 2020 for the management the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  34. MALVERN, Pa., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has been awarded a Group Purchasing Agreement with Premier Inc.  Effective August 2020, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for ANJESO (meloxicam) injection, for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

    "Securing this agreement with Premier provides Baudax with access to industry-leading resources and customers that we believe will lead to increased usage of ANJESO," said Gerri Henwood, President and CEO of…

    MALVERN, Pa., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has been awarded a Group Purchasing Agreement with Premier Inc.  Effective August 2020, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for ANJESO (meloxicam) injection, for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

    "Securing this agreement with Premier provides Baudax with access to industry-leading resources and customers that we believe will lead to increased usage of ANJESO," said Gerri Henwood, President and CEO of Baudax Bio. "We look forward to expanding our commercial reach to now include Premier members who will benefit from meaningful contract savings."

    Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,000 U.S. hospitals and 175,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost. 

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

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  35. MALVERN, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Arnold Baskies, M.D. and Andrew Drechsler, have been appointed to the Company's Board of Directors.

    Dr. Baskies is a past Chief Science Officer and Chairman of the National Board of Directors of the American Cancer Society. He is a fellowship trained surgical oncologist recognized with numerous major awards in the field. Mr. Drechsler serves as the Chief Financial Officer of Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, and previously as Chief Financial Officer of Insmed Incorporated.

    "We are pleased…

    MALVERN, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Arnold Baskies, M.D. and Andrew Drechsler, have been appointed to the Company's Board of Directors.

    Dr. Baskies is a past Chief Science Officer and Chairman of the National Board of Directors of the American Cancer Society. He is a fellowship trained surgical oncologist recognized with numerous major awards in the field. Mr. Drechsler serves as the Chief Financial Officer of Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, and previously as Chief Financial Officer of Insmed Incorporated.

    "We are pleased to welcome both Arnold Baskies, M.D. and Andy Drechsler to Baudax's Board," said Alfred Altomari, Chairman of the Board at Baudax Bio. "Arnold's breadth of experience in all facets of general surgical problems as well as validation through receipt of many national awards in the field of surgery, will prove to be beneficial as we advance our pipeline. Similarly, Andy's experience, and background in finance, most recently as Chief Financial Officer for Provention Bio and previously of Insmed Incorporated, comes at a perfect time in our commercialization efforts of ANJESO®. We look forward to the expertise they bring to our board, and feel we are well positioned to strengthen our efforts to communicate the benefits of ANJESO as an option for the management of moderate to severe pain in surgical settings."

    Dr. Baskies has served as the Chief Medical Officer for the American Cancer Society of New York and New Jersey, and has served on the Executive Committee and the Board of Directors, and was elected as President, of the American Cancer Society for New York and New Jersey in September 2010. He is the recipient of major awards in cancer research from the Society of Surgical Oncology, the American Radium Society, the Society of Head and Neck Surgeons and the American Cancer Society. In addition, he has received the EPIC Award from the NJ Institute of Nursing and the Silver Chalice Award from the American Cancer Society, for his role in providing leadership in cancer prevention and treatment for the citizens of New Jersey. He has maintained a medical practice in southern New Jersey for 37 years and has personally treated over 3,000 patients with various types of cancer and has performed over 10,000 surgical procedures. Dr. Baskies received his Bachelor of Arts degree summa cum laude at Boston University, graduated from the Boston University School of Medicine, and completed his surgical residency at Boston Medical Center. He received his fellowship in surgical oncology at the National Cancer Institute.

    "I am eager to join Baudax's Board of Directors and support them in clinical areas including the development of the neuromuscular blocker product group," said Dr. Baskies M.D. "I believe my well-versed experience in the surgical setting will prove advantageous as the Company advances these product candidates through the clinic, with aims of improving the patient experience."

    Mr. Drechsler brings over 20 years of financial and life science industry experience to Baudax Bio. Prior to his Chief Financial Officer roles at Provention Bio and Insmed, Mr. Drechsler served as Chief Financial Officer for VaxInnate Corporation, a privately-held company that developed vaccines for infectious diseases, including seasonal and pandemic flu, where he played a critical role in securing approximately $200 million in U.S. government funding for the company's vaccine programs. Before joining VaxInnate, Mr. Drechsler served as Chief Financial Officer for Valera Pharmaceuticals, Inc. where he helped Valera raise funding through an initial public offering. Mr. Drechsler received a B.S. in Accountancy from Villanova University, graduating Magna Cum Laude. He obtained his Certified Public Accountant license in the State of New Jersey and actively raises funds for and awareness of juvenile diabetes via the Juvenile Diabetes Research Foundation.

    "I am very much looking forward to supporting Baudax on their mission to develop and commercialize innovative products for patients in the acute care setting," said Mr. Drechsler. "Having worked in the life science industry for over 20 years, and serving as Chief Financial Officer for several corporations, I feel strongly that my experience will be beneficial in supporting the launch of ANJESO."

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO and any future product candidates; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up its commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on its operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  36. Commenced Commercial Launch of ANJESO®in the U.S.

    Awarded J-Code from CMS

    Executed Contract with a top National GPO for hospital purchases, Vizient, and one of the top 3 IDNs Nationally

    Secured $50 Million Credit Facility

    MALVERN, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three and six months ended June 30, 2020.

    "The second quarter of 2020 was most important because of the full commercial launch of ANJESO," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We believe that with our experienced acute care sales force, receipt of our J-code from the…

    Commenced Commercial Launch of ANJESO® in the U.S.

    Awarded J-Code from CMS

    Executed Contract with a top National GPO for hospital purchases, Vizient, and one of the top 3 IDNs Nationally

    Secured $50 Million Credit Facility

    MALVERN, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three and six months ended June 30, 2020.

    "The second quarter of 2020 was most important because of the full commercial launch of ANJESO," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We believe that with our experienced acute care sales force, receipt of our J-code from the Centers for Medicare and Medicaid Services (CMS) (effective in October 2020), entry into an agreement with the Group Purchasing Organization (GPO) Vizient Inc., and other strategic initiatives underway, we are well positioned to continue to target the acute care space. We look forward to continuing to raise awareness and educate acute care providers about ANJESO as an advantageous option for the management of moderate to severe pain."

    Second Quarter 2020 and Recent Business Highlights

    • Commenced Full Commercial Launch of ANJESO. In June 2020, the Company commenced the commercial launch of ANJESO, following its approval by the U.S. Food and Drug Administration (FDA) in February 2020. ANJESO is the only approved 24-hour, intravenous COX-2 preferential NSAID that offers once-daily dosing. Baudax has hired, trained, and now deployed 50 acute care sales representatives to match key territories identified in the U.S.

       
    • Receipt of J-Code from CMS. In early August 2020, CMS established a new permanent J-code for ANJESO, facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. The code, J1738 (Injection, meloxicam, 1 mg), will take effect on October 1, 2020 and it is expected to replace the previously issued C-code (C9059).

       
    • Company Secures Pharmacy Supplier Agreement with Vizient Inc. In July 2020, Baudax entered into an agreement with the GPO Vizient Inc., the largest member-driven healthcare performance improvement company in the U.S., to offer ANJESO with enhanced savings to Vizient's diverse membership, which includes more than 50% of the nation's acute care providers, 95% of the nation's academic medical centers, and more than 20% of ambulatory care providers. Vizient represents more than $100 billion in annual purchasing volume.

       
    • Company signed agreement with top IDN.  In July 2020, the Company signed an agreement with one of the top 3 Integrated Delivery Networks (IDNs) for terms for availability of ANJESO to their member institutions and the company has begun the regional formulary processes associated with this central review and approval.

       
    • Presented New Phase IIIb ANJESO Data at American Society of Colon and Rectal Surgeons (ASCRS) Meeting. In July 2020, Baudax presented a virtual poster highlighting new Phase IIIb ANJESO (meloxicam) injection clinical data as part of the ASCRS 2020 Annual Scientific Meeting. The published data supports the use of ANJESO administered preoperatively to patients prior to undergoing colorectal surgery. The key findings from this study include statistically significant reductions in opioid use, as well as time to bowel function recovery and hospital discharge, resulting in cost savings for ANJESO-treated patients.



    • Secured $50 Million Credit Facility. In June 2020, the company announced the close of a credit facility of up to $50 million from funds managed by Marathon Asset Management, a global credit solutions partner. Proceeds from the facility will generally be used to support the commercial launch of ANJESO (meloxicam) injection, and for working capital purposes. JMP Securities LLC acted as exclusive financial advisor and sole placement agent to Baudax on this transaction.

    COVID-19 Impact

    The Company's efforts to commercialize ANJESO have been, and may continue to be, impacted by the COVID-19 pandemic. Hospitals have reduced and diverted staffing, diverted resources to patients suffering from COVID-19 and limited hospital access for nonpatients, including our sales professionals, which the Company believes may impact their marketing and commercialization efforts. The Company believes that the reduction in elective surgeries during the COVID-19 pandemic has and may continue to result in decreased demand for ANJESO. The Company anticipates that many hospitals and health care providers will continue to suffer negative financial consequences due to an increase in unexpected costs, including for additional staff, personal protective equipment and ventilators, along with a reduction in revenue due to fewer elective procedures being performed, which may result in a decreased demand for ANJESO.  While access restrictions have eased in some locations, spikes of COVID-19 cases in certain states or regions may further impact the Company's sales force as access to hospitals may be restricted and elective surgeries may be limited in those areas. Due to the rapidly evolving environment, continued uncertainties from the impact of the COVID-19 global pandemic, and recent regional outbreaks that are impacting the recovery, the Company cannot estimate the full extent to which the Company's commercialization of ANJESO and financial results may be adversely impacted.

    Second Quarter 2020 Financial Results

    As of June 30, 2020, Baudax had cash and cash equivalents of $39.4 million.

    For the three months ended June 30, 2020, net product revenue was $350,000, related to sales of ANJESO in the U.S. There was no product revenue recognized during the three months ended June 30, 2019.

    For the three months ended June 30, 2020, cost of sales was $0.7 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue during the three months ended June 30, 2020 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. We expect cost of sales to increase as we build new inventory not expensed during the pre-approval period, validate a larger manufacturing suite and deplete our initial inventory levels. No cost of sales were recorded for the three months ended June 30, 2019.

    For the three months ended June 30, 2020, research and development expenses were $1.4 million, compared to $7.2 million for the three months ended June 30, 2019, a decrease of $5.8 million. Excluding $2.6 million of costs associated with the strategic restructuring initiative recorded in the three months ended June 30, 2019, our research and development expenses decreased $3.2 million primarily resulting from a decrease in pre-commercialization manufacturing and clinical costs for ANJESO of $2.3 million and a decrease in personnel costs and overhead expenses of $0.9 million as we allocated or recategorized certain expenses related to supply chain, regulatory, quality and medical affairs associated with support of the commercial launch of ANJESO.

    For the three months ended June 30, 2020, selling, general and administrative expenses were $11.2 million, compared to $7.4 million for the same prior year period, an increase of $3.8 million. Excluding $3.4 million of costs associated with the strategic restructuring initiative recorded in the three months ended June 30, 2019, our selling, general and administrative expenses increased $7.2 million primarily due to selling and marketing expenses in connection with the commercial launch of ANJESO. Selling and marketing expenses of $5.6 million for the three months ended June 30, 2020 increased $5.0 million due to increased personnel costs of $3.1 million and increased commercial costs of $1.9 million. General and administrative expenses of $5.6 million for the three months ended June 30, 2020 increased $2.2 million primarily due to increased personnel costs, including over half of which was attributed to medical affairs and regulatory support functions which had previously been recorded within research and development expense in the prior year period.

    For the three months ended June 30, 2020, Baudax reported a net loss (including non-cash charges of $19.8 million) of $30.4 million, or $1.72 per share. The non-cash charges of $19.8 million were associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. This compares to a net loss of $10.6 million, or $1.13 per share, for the comparable period in 2019. For the three months ended June 30, 2020, there was $10.6 million in cash based expenses and an additional $0.7 million use of cash associated with working capital adjustments primarily related to the build of inventory for ANJESO.

    Six months ended June 30, 2020 Financial Results

    For the six months ended June 30, 2020, net product revenue was $350,000, related to sales of ANJESO in the U.S. There was no product revenue recognized during the six months ended June 30, 2019.

    For the six months ended June 30, 2020, cost of sales was $0.7 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue during the six months ended June 30, 2020 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. We expect cost of sales to increase as we build new inventory not expensed during the pre-approval period, validate a larger manufacturing suite and deplete our initial inventory levels. No cost of sales were recorded for the six months ended June 30, 2019.

    For the six months ended June 30, 2020, research and development expenses were $4.4 million, compared to $16.7 million for the six months ended June 30, 2019, a decrease of $12.3 million. Excluding $2.8 million of costs associated with the strategic restructuring initiative recorded in the six months ended June 30, 2019, our research and development expenses decreased $9.5 million primarily resulting from a decrease in pre-commercialization manufacturing and clinical costs for ANJESO of $6.2 million, a decrease in development costs for other pipeline products of $2.1 million and a decrease in personnel and overhead expenses of $1.2 million as we re-allocated costs related to supply chain, regulatory, quality and medical affairs associated with support of the commercial launch of ANJESO.

    For the six months ended June 30, 2020, selling, general and administrative expenses were $19.3 million, compared to $17.3 million for the same prior year period, an increase of $2.0 million. Excluding $4.4 million of costs associated with the strategic restructuring initiative recorded in the six months ended June 30, 2019, our selling, general and administrative expenses increased $6.4 million primarily due to increased selling and marketing expenses in connection with the commercial launch of ANJESO. Selling and marketing expenses of $8.9 million for the six months ended June 30, 2020 increased $3.5 million primarily due to increased personnel costs of $1.9 million and increased commercial costs of $1.6 million. General and administrative expenses of $10.4 million for the six months ended June 30, 2020 increased $2.9 million primarily due to increased personnel costs of $2.4 million, including over half of which was attributed to medical affairs and regulatory support functions which had previously been recorded within research and development expense in the prior year period and increased public company costs of approximately $0.5 million as the prior year costs represent an allocated portion of the costs in the historical combined financial statements prior to our separation from Recro Pharma, Inc.

    For the six months ended June 30, 2020, Baudax reported a net loss (including non-cash charges of $51.8 million) of $70.7 million, or $5.11 per share. The non-cash charges of $51.8 million were associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. This compares to a net loss of $14.9 million, or $1.60 per share, for the comparable period in 2019.

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements.  These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902



    BAUDAX BIO, INC.
    Consolidated Balance Sheets
    (Unaudited)
            
    (amounts in thousands, except share and per share data)     
            
    Assets June 30, 2020  December 31, 2019
    Current assets:     
     Cash and cash equivalents$39,410  $17,740 
     Accounts receivable 382    
     Inventory  753    
     Prepaid expenses and other current assets 2,122   2,395 
     Total current assets$42,667  $20,135 
            
     Property, plant and equipment, net 4,610   4,821 
     Right of Use asset 542   730 
     Intangible assets, net 25,541   26,400 
     Goodwill  2,127   2,127 
     Total assets$75,487  $54,213 
    Liabilities and Shareholders' Equity      
    Current liabilities:     
     Accounts payable 2,190   271 
     Accrued expenses & other current liabilities 3,972   3,532 
     Current portion of long-term debt, net 598    
     Current portion of operating lease liability 258   318 
     Current portion of contingent consideration 13,135   3,592 
     Total current liabilities 20,153   7,713 
     Long-term debt, net 8,097    
     Long-term operating lease liability 329   455 
     Warrant liability 21,410    
     Long-term portion of contingent consideration 84,902   62,766 
     Total liabilities 134,891   70,934 
    Shareholders' equity:     
     Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and outstanding.     
     Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and outstanding, 18,374,604 shares at June 30, 2020 and 9,350,709 shares at December 31, 2019 184   94 
     Additional paid in-capital 47,375   19,405 
     Accumulated deficit (106,963)  (36,220)
     Total shareholders' equity (59,404)  (16,721)
     Total liabilities and shareholders' equity$75,487  $54,213 
            





    BAUDAX BIO, INC.
    Consolidated and Combined Statements of Operations
    (Unaudited)
                   
    (amounts in thousands, except share and per share data)            
                   
         Three Months Ended  Six Months Ended
         June 30,  June 30,
         2020   2019   2020   2019 
    Revenue, net  $349  $  $349  $ 
                   
    Operating expenses:            
     Cost of sales (excluding amortization of intangible assets)650      650    
     Research and development  1,350   7,180   4,420   16,734 
     Selling, general and administrative  11,217   7,449   19,263   17,284 
     Amortization of intangible assets  644      859    
     Change in warrant valuation  12,667      14,045    
     Change in contingent consideration valuation  4,053   (4,059)  31,679   (19,150)
     Total operating expenses  30,581   10,570   70,916   14,868 
     Operating income / (loss)  (30,232)  (10,570)  (70,567)  (14,868)
    Other income (expense):            
     Interest income (expense)  (213)  (12)  (176)  (49)
     Net loss before income taxes $(30,445) $(10,582) $(70,743) $(14,917)
    Income tax benefit            
     Net loss  $(30,445) $(10,582) $(70,743) $(14,917)
                   
    Per share information:            
    Net loss per share of common stock, basic and diluted $(1.72) $(1.13) $(5.11) $(1.60)
                   
    Weighted average common shares outstanding, basic and diluted

       17,691,700   9,350,709   13,846,464   9,350,709 
                   

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  37. MALVERN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it will report second quarter 2020 financial results on Monday, August 10, 2020. Baudax's management team will host a conference call and audio webcast at 9:00 a.m. ET on Monday, August 10, 2020 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 6734469. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events

    MALVERN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it will report second quarter 2020 financial results on Monday, August 10, 2020. Baudax's management team will host a conference call and audio webcast at 9:00 a.m. ET on Monday, August 10, 2020 to discuss the financial results and recent operational highlights.

    To access the conference call please dial (866) 220-5595 (local) or (615) 622-8062 (international) at least 10 minutes prior to the start time and refer to conference ID 6734469. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

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  38. MALVERN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Centers for Medicare and Medicaid Services (CMS) established a new permanent J-code for ANJESO (meloxicam) injection facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. The code, J1738 (Injection, meloxicam, 1 mg), published online on the CMS website at https://www.cms.gov/files/document/2020-hcpcs-application-summary-quarter-2-2020-drugs-and-biologicals-updated-07312020.pdf (page 25) will take effect on October 1, 2020 and it is expected to replace the previously issued C-code.

    "We are very pleased…

    MALVERN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Centers for Medicare and Medicaid Services (CMS) established a new permanent J-code for ANJESO (meloxicam) injection facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. The code, J1738 (Injection, meloxicam, 1 mg), published online on the CMS website at https://www.cms.gov/files/document/2020-hcpcs-application-summary-quarter-2-2020-drugs-and-biologicals-updated-07312020.pdf (page 25) will take effect on October 1, 2020 and it is expected to replace the previously issued C-code.

    "We are very pleased that ANJESO® will have its own product-specific J-code beginning on October 1, 2020," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "This J-code brings us one step closer to ensuring greater patient access to non-opioid alternatives by providing outpatient providers and physician offices with a uniform code and clearer reimbursement pathway when administering ANJESO and further supports our efforts during our ongoing launch."

    J codes are routine reimbursement codes assigned to outpatient and physician administered "buy and bill" products under Medicare Part B. With the J-code taking effect in October, all hospital outpatient departments, ambulatory surgery centers and physician offices in the United States will have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of ANJESO insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans.

    CMS announced the new J-code for ANJESO in July, allowing time for Medicare Administrative Contractors as well as Medicare Advantage plans and commercial payers to program the new code into their systems in advance of the October 1, 2020 effective date. 

    About ANJESO®

    ANJESO® (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:  

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



      

    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

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  39. MALVERN, Pa., July 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting new Phase IIIb ANJESO® (meloxicam) injection clinical data at the American Society of Colon and Rectal Surgeons (ASCRS) 2020 Annual Scientific Meeting.

    "The data published virtually this year by the ASCRS supports the use of ANJESO® administered preoperatively as part of an Enhanced Recovery After Surgery (ERAS) protocol to patients prior to undergoing colorectal surgery," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio.  "The key findings from this study include statistically significant reductions in…

    MALVERN, Pa., July 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting new Phase IIIb ANJESO® (meloxicam) injection clinical data at the American Society of Colon and Rectal Surgeons (ASCRS) 2020 Annual Scientific Meeting.

    "The data published virtually this year by the ASCRS supports the use of ANJESO® administered preoperatively as part of an Enhanced Recovery After Surgery (ERAS) protocol to patients prior to undergoing colorectal surgery," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio.  "The key findings from this study include statistically significant reductions in opioid use, as well as faster time to bowel function recovery and earlier hospital discharge.  These positive results will inform our future physician education initiatives as we support the ongoing commercial launch of ANJESO."

    The virtual presentation describes clinical outcomes from a randomized, placebo-controlled Phase IIIb study evaluating preoperative doses of ANJESO in 55 patients undergoing bowel resection and/or anastomosis.  Patients were randomized 1:1 to receive ANJESO or placebo with the first dose administered 30 minutes prior to the start of surgery, then every 24 hours on top of a Standardized ERAS protocol that included a multimodal pain management plan in addition to study treatment all patients received gabapentin 300mg once prior to surgery, and acetaminophen 650mg starting prior to surgery and continuing every 8 hours until 24 hours after the last dose of study medication.  Following surgery, opioid rescue was available upon request.  The primary objective of the study was to assess the safety of ANJESO when administered pre-operatively, with a key measure being the incidence and severity of adverse events. Numerous additional efficacy parameters were also explored in this study including opioid consumption, return of bowel function, and hospital length of stay.

    The incidence of individual adverse events (AEs) were comparable between groups or numerically lower in the meloxicam IV group. The majority of AEs were mild or moderate in severity. The incidence of serious AEs was also higher in the placebo group.  ANJESO-treated patients experienced statistically significant reductions in opioid consumption (35%; p<0.05), in time to first bowel sounds (59%; p<0.05), time to first bowel movement (18%; p<0.05), and time to hospital discharge (27%; p<0.05), all compared to placebo.  This study supports the efficacy and safety of ANJESO administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in patients undergoing colorectal procedures.

    Title: Safety and Efficacy of Preoperative Meloxicam IV in Colorectal Surgery

    Lead Author: Conor Delaney

    Presentation #: MED.0320-136.a

    About ANJESO®

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements, including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the other risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

    CONTACT:  

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902





    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    xbio.com

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     

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  40. MALVERN, Pa., July 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has entered into a Pharmacy Supplier Agreement with Vizient, Inc. effective as of July 1, 2020, to offer ANJESO (meloxicam) injection, a non-opioid option for managing moderate to severe pain. The agreement offers enhanced savings to Vizient's diverse membership, which includes more than 50% of the nation's acute care providers, including 95% of the nation's academic medical centers, and more than 20% of ambulatory care providers.

    "Agreements like this one with Vizient are important to Baudax and our customers as it helps increase patient access to important medicines…

    MALVERN, Pa., July 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has entered into a Pharmacy Supplier Agreement with Vizient, Inc. effective as of July 1, 2020, to offer ANJESO (meloxicam) injection, a non-opioid option for managing moderate to severe pain. The agreement offers enhanced savings to Vizient's diverse membership, which includes more than 50% of the nation's acute care providers, including 95% of the nation's academic medical centers, and more than 20% of ambulatory care providers.

    "Agreements like this one with Vizient are important to Baudax and our customers as it helps increase patient access to important medicines like ANJESO," said Gerri Henwood, President and CEO of Baudax Bio. "Since the official launch of ANJESO in June, Baudax Bio has deployed its sales force across the U.S., with the goal of bringing ANJESO to as many patients as possible. Thus far, clinician interest has been strong and we look forward to expanding our commercial reach to now include Vizient members who will benefit from meaningful contract savings."

    Vizient, Inc. is the largest member-driven healthcare performance improvement company in the United States. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $100 billion in annual purchasing volume, to improve patient outcomes and lower costs.

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

     

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  41. MALVERN, Pa., July 03, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved inducement grants of stock options to purchase an aggregate of 450,816 shares of Baudax Bio's common stock and restricted stock units covering 119,923 shares of Baudax Bio's common stock to 57 newly-hired employees, with a grant date of June 30, 2020.  The equity awards were granted pursuant to the NASDAQ Rule 5635(c)(4) inducement grant exception as a component of each individual's employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax…

    MALVERN, Pa., July 03, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved inducement grants of stock options to purchase an aggregate of 450,816 shares of Baudax Bio's common stock and restricted stock units covering 119,923 shares of Baudax Bio's common stock to 57 newly-hired employees, with a grant date of June 30, 2020.  The equity awards were granted pursuant to the NASDAQ Rule 5635(c)(4) inducement grant exception as a component of each individual's employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax Bio.

    The options have an exercise price equal to $4.15 per share, the closing price of Baudax Bio's common stock as reported by NASDAQ on June 30, 2020. The options have a ten-year term and vest over four years, with 25% of the number of shares underlying the stock option vesting on the one-year anniversary of the grant date and the remaining shares vesting monthly over 36 months thereafter. The restricted stock units vest annually over four years. The equity awards are subject to each individual's continued service with Baudax Bio through the applicable vesting dates.

    About Baudax Bio, Inc.

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT: 

      

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902





    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  42. MALVERN, Pa., June 15, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the commercial launch of ANJESO™ (meloxicam) injection. ANJESO was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020. Baudax has hired, trained, and now deployed 50 acute care sales representatives across the country. Baudax also announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and established a new reimbursement code for ANJESO. The code, C9059, is scheduled to become effective July 1, 2020.

    "We have assembled an acute care sales team with deep experience in the hospital market…

    MALVERN, Pa., June 15, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the commercial launch of ANJESO™ (meloxicam) injection. ANJESO was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020. Baudax has hired, trained, and now deployed 50 acute care sales representatives across the country. Baudax also announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and established a new reimbursement code for ANJESO. The code, C9059, is scheduled to become effective July 1, 2020.

    "We have assembled an acute care sales team with deep experience in the hospital market, and they completed their comprehensive virtual training by the end of May. As of June 1, the field has been meeting with key customers live and virtually across hospitals, ambulatory surgery centers and other strategic accounts to introduce ANJESO," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "At Baudax, we believe ANJESO is a major advancement for physicians managing moderate to severe pain following a wide variety of surgical procedures. The receipt of pass-through status and the assignment of a unique C-code from CMS also marks another important milestone in our commercialization efforts for ANJESO. Hospitals and ambulatory surgical centers can use this new code in July to obtain reimbursement for the product."

    A C-code is a unique product code established by CMS to report claims for hospital outpatient department and ambulatory surgical center services and procedures. The formal receipt of the C-code facilitates the reimbursement of ANJESO until such later time as CMS may potentially approve a J-code and such approval becomes effective. Drugs that are administered in these settings can be reimbursed under a CMS administered transitional-pass-through payment. The pass-through payment was established by the U.S. government to help foster innovative drug development. Drug applications must meet certain qualifications for inclusion. The transitional pass-through status is temporary for three years and products are reimbursed under a C-code.

    ANJESO is the first and only once-daily IV analgesic. It provides up to 24 hours of efficacy for the management of moderate to severe pain, has demonstrated safety and tolerability, is a COX-2 preferential IV NSAID and is available as a once-daily IV push.

    For more information about ANJESO, visit www.ANJESO.com or call 1-855-405-9983.

    INDICATION AND USAGE

    ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

    Limitation of Use: Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Risk

    • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.  This risk may occur early in treatment and may increase with duration of use.
    • ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Risk

    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    CONTRAINDICATIONS

    ANJESO is contraindicated in patients with:

    • Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
    • In the setting of coronary artery bypass graft (CABG) surgery.
    • Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion.

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue ANJESO immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    Hypertension: NSAIDs including ANJESO can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ANJESO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Post MI Patients: Avoid the use of ANJESO in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ANJESO is used in these patients, monitor for signs of cardiac ischemia.

    Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. ANJESO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating ANJESO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If ANJESO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

    Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including ANJESO, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity.

    Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including ANJESO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

    DRUG INTERACTIONS

    Drugs That Interfere With Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ANJESO with drugs that interfere with hemostasis. Concomitant use of ANJESO and analgesic doses of aspirin is not generally recommended.

    Angiotensin Converting Enzymes (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

    ACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

    ADVERSE REACTIONS

    The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with ANJESO and at a greater frequency than placebo include:  constipation, gamma-glutamyl transferase increased, and anemia.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have trouble conceiving.

    Please see full Prescribing Information, including Boxed Warning at www.ANJESO.com.

    About ANJESO™

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:

    Argot Partners

    Sam Martin / Claudia Styslinger

    (212) 600-1902



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  43. MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has closed on a credit facility of up to $50 million from funds managed by Marathon Asset Management, a global credit solutions partner. Proceeds from the facility will generally be used to support the commercial launch of ANJESOTM (meloxicam) injection, and for working capital purposes.  JMP Securities LLC acted as exclusive financial advisor and sole placement agent to Baudax on this transaction.

    "This strategic non-dilutive financing represents our strong belief in the future commercial prospects for ANJESO as a new, intravenous non-opioid option for the management…

    MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has closed on a credit facility of up to $50 million from funds managed by Marathon Asset Management, a global credit solutions partner. Proceeds from the facility will generally be used to support the commercial launch of ANJESOTM (meloxicam) injection, and for working capital purposes.  JMP Securities LLC acted as exclusive financial advisor and sole placement agent to Baudax on this transaction.

    "This strategic non-dilutive financing represents our strong belief in the future commercial prospects for ANJESO as a new, intravenous non-opioid option for the management of moderate to severe pain," said Gerri Henwood, CEO of Baudax Bio. "The availability of these new funds, as well as incremental amounts of up to an additional $50 million, at Marathon's discretion, to help support complementary and accretive acquisitions provides important financial flexibility for our commercial-stage organization and leaves us well positioned to execute on the launch of ANJESO and to grow our acute care franchise.  Our newly hired sales force is on track to commence the launch this month."

    This financing is in the form of a five-year term loan bearing interest at a fixed rate of 13.5%.  Baudax will pay interest only for the first 24 months of the loan.  The funds are structured in five tranches, to provide financial flexibility as needed, while balancing debt leverage and managing interest expense, with $10 million available immediately upon closing of the transaction.  The additional four tranches will be available upon achieving certain minimum net revenue thresholds within set periods of times from the closing date. If Baudax achieves $10 million trailing 12-month EBITDA within 24 months of closing, then the term of the loan can be extended to six years with an interest only period of 36 months.

    In connection with the credit facility, Baudax issued to Marathon warrants to purchase 527,100 shares of Baudax common stock at an exercise price of $4.59 per share.  Further information with respect to the credit facility and the warrants is set forth in the Form 8-K which will be filed by the Company with the Securities and Exchange Commission.

    About ANJESO™

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis.  ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.  Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies.  As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain.  ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    About Marathon Asset Management

    Marathon Asset Management L.P. ("Marathon") is a global credit solutions partner. Marathon seeks attractive absolute returns through investments in the global credit markets and real estate related markets with a long-term goal of building a world-class asset management platform. Marathon's core competency is opportunistic investing in the global corporate, emerging market and structured credit markets based on fundamental, bottom-up research across distinct investment funds, managed vehicles, and separate accounts. Marathon's private credit business includes direct lending, asset-based lending, including healthcare and aircraft leasing along with real estate lending. The team has significant experience investing in credit dislocations through multiple cycles and is fully integrated to capitalize on credit opportunities globally. Marathon possesses a unique, broad-based skill set and proprietary platform to research, analyze and act upon complex capital structures and situations.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio's ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio's ability to comply with the financial and other covenants under its credit facility, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:  

    Investor Relations Contact:
    Argot Partners
    Sam Martin / Claudia Styslinger
    (212) 600-1902

      

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

    Primary Logo

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  44.  ANJESO™ Approved by FDA for the Management of Moderate to Severe Pain; Product
    Now Available for Ordering and Delivery for Customers

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public
    Offering Resulting in Net Proceeds of $23.1 Million

    Company on Track to Commence Commercial ANJESO Launch by Early June 2020

    MALVERN, Pa., May 08, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three months ended March 31, 2020.

    "During the first quarter of 2020, we received regulatory approval from the U.S. Food and Drug Administration (FDA) for ANJESO™ (meloxicam) injection," said Gerri Henwood, President…

     ANJESO™ Approved by FDA for the Management of Moderate to Severe Pain; Product
    Now Available for Ordering and Delivery for Customers

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public
    Offering Resulting in Net Proceeds of $23.1 Million

    Company on Track to Commence Commercial ANJESO Launch by Early June 2020

    MALVERN, Pa., May 08, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three months ended March 31, 2020.

    "During the first quarter of 2020, we received regulatory approval from the U.S. Food and Drug Administration (FDA) for ANJESO™ (meloxicam) injection," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We are also making significant progress strengthening the balance sheet and securing capital to execute on the planned launch and commercialization of ANJESO. Despite the challenging macro-market conditions due to the COVID-19 pandemic, we are on track to advance into a commercial launch by early June 2020."

    First Quarter 2020 and Recent Business Highlights

    • FDA Approves ANJESO for Management of Moderate to Severe Pain. On February 20, 2020, Baudax received approval from the FDA for ANJESO, which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.  ANJESO will be administered as a once-a-day intravenous (IV) bolus.

    • ANJESO Now Available in the U.S. In April 2020, Baudax announced that ANJESO, the only 24-hour, IV COX-2 preferential NSAID to offer once-daily dosing for acute pain, is available for ordering and delivery to customers. In April, Baudax had its first product sale to an end user customer. Baudax is in the process of hiring and training its field sales force and expects to execute the ANJESO commercial launch by early June 2020.

    • Strengthened the Balance Sheet Through the Completion of a $25 Million Public Offering of Securities. In March 2020, Baudax announced completion of an underwritten public offering reflective of 7,692,308 shares of its common stock, Series A Warrants to purchase 7,692,308 shares of common stock and Series B Warrants to purchase 7,692,308 shares of common stock, at an exercise price of $4.59 per share for Series A Warrants and at an exercise price of $3.25 per share for Series B Warrants. Each share of common stock was sold together with one Series A warrant and one Series B warrant for a combined price of $3.25 per share. Net proceeds to Baudax from this offering were approximately $23.1 million.

    • Company Signs Non-Binding Term Sheet for Debt Facility. In March 2020, Baudax signed a non-binding term sheet with an undisclosed party for a secured term loan for up to $20 million in non-dilutive funding over the next 12 to 18 months. It did so as part of its overall capital financing strategy to fund the Company and support the upcoming commercial launch of ANJESO. The Company continues to pursue this debt facility.

    First Quarter 2020 Financial Results

    As of March 31, 2020, Baudax had cash and cash equivalents of $38.3 million.

    For the three months ended March 31, 2020, research and development expenses were $3.1 million, compared to $9.6 million for the three months ended March 31, 2019. The decrease of $6.5 million was primarily due to a decrease in pre-commercialization manufacturing and clinical costs for ANJESO, a decrease in development costs for other pipeline products, and a decrease in personnel costs.

    For the three months ended March 31, 2020, selling, general and administrative expenses were $8.0 million, compared to $9.8 million for the three months ended March 31, 2019. The decrease of $1.8 million was due to decreases in personnel and pre-commercial consulting costs. These decreases in costs were partially offset by increases in public company costs as the prior year costs represent an allocated portion of the costs in the historical combined financial statements prior to the separation of Baudax from Recro Pharma, Inc. in November 2019.

    For the three months ended March 31, 2020, Baudax reported a net loss of $40.3 million, or $4.03 per share, which includes non-cash charges of approximately $32 million associated with a change in contingent consideration and in-process research and development intangible amortization because of FDA approval of ANJESO, depreciation, marked to market expense on the warrants, and stock-based compensation. This compares to a net loss of $4.3 million, or $0.46 per share, for the comparable period in 2019. Cash used in operating activities was $6.3 million for the three months ended March 31, 2020 which reflects the net loss excluding non-cash items offset by changes in working capital.

    About ANJESO™

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.  Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The Company expects commercial launch of ANJESO by early June 2020. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal," "intend," and "expect," and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO, Baudax Bio's ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio's ability to raise future financing for continued product development and ANJESO commercialization, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:  

    Investor Relations Contact:
    Argot Partners
    Sam Martin / Claudia Styslinger
    (212) 600-1902

    cla  

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

       
    BAUDAX BIO, INC.  
    Consolidated Balance Sheets  
       
         
    (amounts in thousands, except share and per share data)  
         
    Assets   March 31, 2020   December 31, 2019  
    Current assets:          
      Cash and cash equivalents $ 38,284   $ 17,740    
      Prepaid expenses and other current assets   2,211     2,395    
          Total current assets   40,495     20,135    
                 
      Property, plant and equipment, net   4,716     4,821    
      Right of use asset   631     730    
      Intangible assets   26,185     26,400    
      Goodwill   2,127     2,127    
           Total assets $ 74,154   $ 54,213    
    Liabilities and Shareholders' Equity          
    Current liabilities:          
      Accounts payable $ 2,062   $ 271    
      Accrued expenses and other current liabilities   3,842     3,532    
      Current operating lease liability   278     318    
      Current portion of contingent consideration   12,523     3,592    
            Total current liabilities   18,705     7,713    
      Long-term operating lease liability   391     455    
      Warrant liability   9,489     —     
      Long-term portion of contingent consideration   81,461     62,766    
             Total liabilities   110,046     70,934    
    Shareholders' equity:          
      Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and
    outstanding, 17,569,988 shares at March 31, 2020 and 9,350,709 shares at
    December 31, 2019
      176     94    
      Additional paid in-capital   40,450     19,405    
      Accumulated deficit   (76,518 )   (36,220 )  
            Total shareholders' equity   (35,892 )   (16,721 )  
            Total liabilities and shareholders' equity $ 74,154   $ 54,213    
                 


    BAUDAX BIO, INC.  
    Consolidated and Combined Statements of Operations  
       
               
    (amounts in thousands, except share and per share data)          
               
        Three Months Ended  
        March 31,  
        2020     2019    
    Revenue $ —    $ —     
               
    Operating expenses:          
    Cost of sales   —      —     
    Research and development   3,070     9,554    
    Selling, general and administrative   8,046     9,835    
    Amortization of intangible assets   215     —     
    Change in warrant valuation   1,378     —     
    Change in contingent consideration valuation   27,626     (15,091 )  
           Total operating expenses   40,335     4,298    
           Operating loss   (40,335 )   (4,298 )  
    Other income (expense):          
    Other income (expense)   37     (37 )  
    Net loss $ (40,298 ) $ (4,335 )  
               
    Per share information:          
    Net loss per share of common stock, basic and diluted $ (4.03 ) $ (0.46 )  
               
    Weighted average common shares outstanding, basic and diluted   10,001,228     9,350,709    
               


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  45. MALVERN, Pa., May 05, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting ANJESO™ (meloxicam) injection data at Digestive Disease Week (DDW) 2020.

    "The data virtually published by DDW demonstrate that ANJESO has positive impacts on many elements of healthcare resource utilization when administered preoperatively to patients prior to colorectal surgeries as part of a multimodal analgesic (MMA) regimen," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "Key findings included statistically significant reductions in opioid use and in length of hospital stay by approximately 1 day…

    MALVERN, Pa., May 05, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting ANJESO™ (meloxicam) injection data at Digestive Disease Week (DDW) 2020.

    "The data virtually published by DDW demonstrate that ANJESO has positive impacts on many elements of healthcare resource utilization when administered preoperatively to patients prior to colorectal surgeries as part of a multimodal analgesic (MMA) regimen," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "Key findings included statistically significant reductions in opioid use and in length of hospital stay by approximately 1 day, as well as lower incidence of opioid-related adverse events, all while achieving similar or slightly reduced average cost of the hospital stay. We are thrilled ANJESO is now available for ordering and delivery to U.S. customers, and we are actively preparing for the full commercial launch by June 2020."

    The virtual presentation describes an economic sub-study of a double-blind, placebo-controlled Phase IIIb study evaluating preoperative administration of ANJESO as part of a MMA regimen compared to placebo in 55 patients who had undergone open or laparoscopic colorectal surgeries. The Phase IIIb study was designed to replicate conditions consistent with current clinical practice, including use of a standardized enhanced recovery after surgery protocol based on common best practices for colorectal surgeries. Patients were randomized 1:1 to receive ANJESO (30mg) or placebo. The first study dose was administered 30 minutes prior to the start of surgery.  Subsequent doses of ANJESO were administered every 24 hours.  The primary objective of the Phase IIIb study was to evaluate the safety and tolerability of preoperative dosing of ANJESO in subjects undergoing open or laparoscopic colorectal surgeries compared to placebo. The economic sub-study primary objective was to evaluate the impact of preoperative dosing of ANJESO on healthcare resource use (HRU) and healthcare costs.

    HRU Results Following Preoperative ANJESO Compared to Placebo

    This economic sub-study evaluated HRU and costs, including total hospital costs, hospital length of stay (LOS) and opioid use associated with preoperative administration of ANJESO compared to placebo. A subject-level database was developed to capture quantity of service, charges and date of service from UB-04 forms (from admission date to discharge), captured in the IIIB clinical trial. A national cost:charge ratio was applied to convert ‘charges' to ‘costs'.

    A total of 55 subjects (mean age: 60, female: 43%) were treated in the trial, with 54 subjects included in HRU analysis (n=27 per treatment; 1 excluded due to missing UB-04). The total mean costs of hospital stay were similar between the ANJESO group compared to the placebo group ($23,115 vs. $22,682; p=0.3370). After removing outliers (top 99th percentile), the total costs for the ANJESO group was numerically lower than the placebo group ($20,492 vs. $22,682; p=0.2196). Mean hospital LOS in days was numerically lower in the ANJESO group compared to the placebo group (86.2 vs. 111.7 hr; p=0.0162) and was statistically significant. 

    Mean total opioid use was significantly lower among the ANJESO group compared to placebo and from hour 0 through hospital discharge (29.22mg vs. 45.17mg; p<0.0339). The proportion of subjects with ≥1 opioid related adverse drug effects (ORADE) were higher for the placebo group than for the ANJESO group (63% vs. 41%). Presence of >1 ORADE was associated with a significant increase in LOS (exp (β)=1.303, p=0.0238) in hours (exp(β)=1.264, p =0.031) as compared to not having any ORADEs.

    Title: Healthcare Resource Utilization (HRU) Associated with Preoperative Meloxicam IV in Colorectal Surgery
    Lead Author: Libby Black
    Presentation #: 503-2020
    URL: https://ddw.apprisor.org/epsAbstractDDW.cfm?id=96

    For more information on this meeting, visit: www.ddw.org.

    About ANJESOTM

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. The Company expects full commercial launch of ANJESO by late Q2 2020. The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal", "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO™, Baudax Bio's ability to successfully commercialize ANJESO™; the acceptance of ANJESO™ by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO™, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO™, Baudax Bio's ability to raise future financing for continued product development and ANJESO™ commercialization, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO™, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:

    Investor Relations Contact:
    Argot Partners
    Sam Martin / Claudia Styslinger
    (212) 600-1902

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

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  46. MALVERN, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on therapeutics for acute care settings, today announced that due to the emerging health impact of the coronavirus pandemic, the Company has changed the location of its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") to its corporate headquarters at 490 Lapp Road, Malvern, Pennsylvania 19355. As previously announced, the meeting is being held on Wednesday, May 6, 2020 at 9:00 A.M. (Eastern Time).

    Shareholders who vote their shares by proxy do not need to attend the Annual Meeting. Attendees may be subject to health screening procedures upon entering the building consistent with practices advised by…

    MALVERN, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the "Company"), a pharmaceutical company focused on therapeutics for acute care settings, today announced that due to the emerging health impact of the coronavirus pandemic, the Company has changed the location of its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") to its corporate headquarters at 490 Lapp Road, Malvern, Pennsylvania 19355. As previously announced, the meeting is being held on Wednesday, May 6, 2020 at 9:00 A.M. (Eastern Time).

    Shareholders who vote their shares by proxy do not need to attend the Annual Meeting. Attendees may be subject to health screening procedures upon entering the building consistent with practices advised by governmental authorities or as otherwise in place for visitors to the Company's corporate office, and seating may be limited to comply with applicable social distancing guidelines.

    The Company urges all shareholders of record as of the Record Date of March 17, 2020 to promptly submit their proxy by executing and returning the proxy card previously mailed to them or by following the alternative voting procedures described on their proxy card.

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal", "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:   

    Investor Relations Contact:
    Argot Partners
    Sam Martin / Claudia Styslinger
    (212) 600-1902

       

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

     

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  47. MALVERN, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced two virtual poster presentations highlighting new ANJESO™ (meloxicam) injection data at the 45th Annual Regional Anesthesiology and Acute Pain Medicine Meeting, hosted by the American Society of Regional Anesthesia (ASRA) and Pain Medicine.

    "The data virtually published by ASRA this year demonstrate that ANJESO is not only efficacious and well tolerated when administered preoperatively to patients prior to total knee arthroplasty (TKA), but it is also associated with a decreased need for opioids following surgery," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer…

    MALVERN, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced two virtual poster presentations highlighting new ANJESO™ (meloxicam) injection data at the 45th Annual Regional Anesthesiology and Acute Pain Medicine Meeting, hosted by the American Society of Regional Anesthesia (ASRA) and Pain Medicine.

    "The data virtually published by ASRA this year demonstrate that ANJESO is not only efficacious and well tolerated when administered preoperatively to patients prior to total knee arthroplasty (TKA), but it is also associated with a decreased need for opioids following surgery," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "From a health economic perspective, the study also demonstrated that use of ANJESO is associated with an average of approximately $2,300 in cost savings per patient, lower length of stay (LOS) and fewer hospital readmissions and emergency room (ER) visits during recovery. ANJESO is now available for ordering and delivery to U.S. customers, and we are actively preparing for the full commercial launch by June 2020."

    Both posters describe outcomes from a double-blind, placebo-controlled Phase IIIb study evaluating preoperative administration of ANJESO in 181 patients who had undergone a unilateral TKA.  The first poster describes efficacy and safety data (ID# 759) and the second poster describes health resource utilization data (ID# 651). The study was designed to replicate conditions consistent with current clinical practice, including use of a standardized clinical care protocol based on common best practices for TKA procedures, including multimodal analgesia.  Patients were randomized 1:1 to receive ANJESO (30mg) or placebo. The first study dose was administered after spinal anesthesia and prior to the start of surgery. Subsequent doses of ANJESO were administered every 24 hours. The primary objective of the study was to assess the effect of preoperative administration of ANJESO on opioid consumption in subjects undergoing open unilateral TKA compared to placebo. Secondary objectives included safety and tolerability, and effects on postoperative pain and healthcare utilization costs.

    Efficacy and Safety Results Following Administration of Preoperative ANJESO Compared to Placebo

    ANJESO-treated patients had significantly lower opioid consumption during the first postsurgical day, with a 31.7% reduction compared to placebo (mean 19mg vs. 28mg; p<0.0001). Significant reductions in opioid use were observed on subsequent days and throughout treatment. ANJESO-treated patients had a significantly lower Summed Pain Intensity (SPI) score on the first postsurgical day and throughout their inpatient course (p≤0.0001). ANJESO-treated patients had a significantly longer time to first opioid rescue after surgery compared to placebo. ANJESO-treated subjects had lower incidences of all cause hospital readmissions, fewer subjects discharged to skilled nursing facilities, and fewer emergency room visits and doctor calls related to pain during the follow-up period.

    With respect to safety, adverse events (AEs) were primarily mild or moderate in intensity and not related to study treatment, with a higher incidence of AEs reported in the placebo group. The incidence of serious AEs was higher in the placebo group. All serious AEs in the ANJESO group were assessed by the primary investigators to be not related to study treatment. No subject discontinued due to an AE. The overall rate of AEs of special interest (AESI; events related to concerns associated with NSAIDS) were lower in the ANJESO-treated group at 9.7% than the placebo group at 21.6%. Rates of individual events in the ANJESO group occurred at similar or lower rates compared to the placebo group. Laboratory and surgical wound healing assessments were similar between treatment groups. This study supports the efficacy and safety of ANJESO administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in subjects undergoing primary unilateral TKA.

    Healthcare Resource Utilization (HRU) Results Following Preoperative ANJESO Compared to Placebo

    This study also evaluated HRU and costs, including total hospital costs, hospital LOS, hospital readmissions, ER visits, physician office visits, and phone calls due to pain, associated with preoperative administration of ANJESO compared to placebo, through postoperative day 30.

    The total mean costs of hospital stay and total overall costs were lower in the ANJESO group compared to the placebo group, however, the differences were not statistically significant.  Mean hospital LOS in days was lower in the ANJESO group compared to the placebo group (2.05 vs. 2.24 days). ANJESO was associated with 8.6% lower LOS in days compared to placebo, however, the difference was not statistically significant. There were fewer hospital readmissions (1 vs. 3), ER visits (0 vs. 4), and phone calls due to pain (4 vs. 9) for ANJESO versus placebo, respectively. There were no reports of unscheduled physician office visits due to pain in either group.

    Mean total opioid use from hour 0-24, 0-48, and 0-72 hours was significantly lower among meloxicam IV compared to placebo (p<0.0001) and from hour 0 through hospital discharge (33.28mg vs. 44.87mg); (p<0.001). Time to the first oral opioid rescue medication was longer for the ANJESO group than placebo (7.31 vs. 5.22 hours; p=0.0226) and a similar trend was observed for mean time to first use of IV or oral opioid analgesia (4.75 vs. 3.09 hours; p=0.0126).  While there was no significant association between opioid consumption and total hospital costs, every unit (1mg IV morphine equivalent) increase in opioid consumption was associated with a 0.5% increase in LOS in days (p=0.0001). The proportion of subjects with ≥1 opioid related adverse drug effects (ORADEs) were significantly higher for placebo than ANJESO (70.5% vs. 48.4%; p=0.003). Six ANJESO-treated patients (6.5%) had ≥1 AESI in comparison to 12 placebo subjects (13.6%). Serious AEs were observed among 3 ANJESO-treated patients (3.2%) and 9 placebo subjects (10.2%).

    The posters can be accessed online at https://epostersonline.com/ASRASPRING20/search/meloxicam or the following:

    Title: Efficacy and Safety of Preoperative Meloxicam IV in Primary Total Knee Arthroplasty
    Lead Author: Alex Freyer
    ID Number: 759
    URL: https://epostersonline.com/ASRASPRING20/node/48

    Title: Healthcare Resource Utilization Associated with Preoperative Meloxicam IV in Primary Total Knee Arthroplasty
    Lead Author: Libby Black
    ID Number: 651
    URL: https://epostersonline.com/ASRASPRING20/node/19

    For more information on this meeting, visit: https://www.asra.com/.

    About ANJESOTM

    ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis.  ANJESO was approved by the U.S. Food and Drug Administration in February 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.  Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.  The Company expects full commercial launch of ANJESO by late Q2 2020.  The ANJESO product approval was supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies.  As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain.  ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

    About Baudax Bio

    Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO™, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.  

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "goal", "intend" and "expect" and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio's performance to differ materially from those expressed in, or implied by, these forward-looking statements. Baudax Bio assumes no obligation to update any such forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO™ or disruption in supply chain, Baudax Bio's ability to maintain regulatory approval for ANJESO™, Baudax Bio's ability to successfully commercialize ANJESO™;  the acceptance of ANJESO™ by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio's ability and that of Baudax Bio's third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO™, Baudax Bio's ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO™, Baudax Bio's ability to raise future financing for continued product development and ANJESO™ commercialization, Baudax Bio's ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio's estimates of the potential market for ANJESO™, Baudax Bio's ability to achieve its financial goals; and Baudax Bio's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio's business and future results included in Baudax Bio's filings with the Securities and Exchange Commission at www.sec.gov.

    CONTACT:   

    Investor Relations Contact:
    Argot Partners
    Sam Martin / Claudia Styslinger
    (212) 600-1902

       

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

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  48. ANJESO Is The Only Approved 24-Hour, Intravenous COX-2 Preferential NSAID that Offers Once-Daily Dosing

    Full Commercial Launch Expected to Commence by June 2020

    MALVERN, Pa., April 07, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that ANJESO™ (meloxicam) injection, the only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory drug (NSAID), is now available for ordering and delivery to customers.  ANJESO was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020 and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 

    "We are delighted…

    ANJESO Is The Only Approved 24-Hour, Intravenous COX-2 Preferential NSAID that Offers Once-Daily Dosing

    Full Commercial Launch Expected to Commence by June 2020

    MALVERN, Pa., April 07, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that ANJESO™ (meloxicam) injection, the only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory drug (NSAID), is now available for ordering and delivery to customers.  ANJESO was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020 and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 

    "We are delighted to announce the availability of ANJESO for ordering and delivery in the U.S.," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio.  "These are challenging times for everyone involved in the delivery of healthcare in the United States and the well-being of everyone involved remains our top priority.  I am pleased with the virtual outreach our current commercial team has been conducting and we believe ANJESO is a major advancement in the physician's armamentarium for managing moderate to severe pain for a wide variety of surgical procedures.  We are excited to offer this novel, non-opioid therapeutic option that has the potential to transform the acute pain treatment paradigm.  We are diligently working to hire and tr