1. REDWOOD CITY, Calif., Feb. 17, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an agreement with Newport Plastic and Reconstructive Surgery Associates for an investigator-initiated study analyzing data from the historical use of DSUVIA (sufentanil sublingual tablet 30 mcg) for various same-day plastic surgery procedures. 

    The principal investigator, Dr. Hisham Seify, is a board-certified plastic surgeon and the past-president of the Orange County Society of Plastic Surgeons. The study will focus on the efficacy and safety of DSUVIA for use in general anesthesia…

    REDWOOD CITY, Calif., Feb. 17, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an agreement with Newport Plastic and Reconstructive Surgery Associates for an investigator-initiated study analyzing data from the historical use of DSUVIA (sufentanil sublingual tablet 30 mcg) for various same-day plastic surgery procedures. 

    The principal investigator, Dr. Hisham Seify, is a board-certified plastic surgeon and the past-president of the Orange County Society of Plastic Surgeons. The study will focus on the efficacy and safety of DSUVIA for use in general anesthesia plastic surgery cases, and "awake" cosmetic procedures performed at Newport Plastic and Reconstructive Surgery's center. Data from a total of 70 patients will be evaluated for endpoints which will include the utilization of DSUVIA (number of doses, timing of doses), overall amount of opioid utilized, use of other concomitant medications, vital signs, adverse events, length of surgery and time in recovery.  

    "We are very interested in analyzing data from patients that were administered DSUVIA across all types of plastic surgery procedures. We have used DSUVIA for over a year in a wide variety of cases and there are no currently published studies focusing on plastic surgery with this sublingual analgesic, which has been a major evolution for our practice," said Dr. Seify. "Evaluating the safety, efficacy, and timing of dosing of DSUVIA for short cases in awake patients, such as liposuction, as well as for more extensive surgeries under general anesthesia, will allow other plastic surgeons to benefit from our experience," continued Dr. Seify.

    "Plastic surgery has been one of the fastest growing specialties where DSUVIA is being used. Dr. Seify is a key thought-leader in this specialty and he quickly understood the potential benefits of DSUVIA for use for plastic surgical procedures," said Dr. Pamela Palmer, co-founder and Chief Medical Officer of AcelRx. "We look forward to the analysis and publication of his clinical data with DSUVIA as plastic surgeons are eager for alternatives to IV opioids when treating moderate-to-severe acute pain."

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study, the scope of the study, and expected analysis and publication of clinical data. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

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  2. REDWOOD CITY, Calif., Jan. 20, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced the pricing of its underwritten public offering of 14.5 million shares of its common stock for gross proceeds of approximately $27.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by AcelRx. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions. In addition, AcelRx has granted the underwriter a 30-day option to purchase up to approximately 2.2 million additional shares…

    REDWOOD CITY, Calif., Jan. 20, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced the pricing of its underwritten public offering of 14.5 million shares of its common stock for gross proceeds of approximately $27.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by AcelRx. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions. In addition, AcelRx has granted the underwriter a 30-day option to purchase up to approximately 2.2 million additional shares of common stock.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    The underwriter may offer the shares from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On January 19, 2021, the last sale price of the shares as reported on the Nasdaq Global Market was $2.35 per share.

    AcelRx intends to use the net proceeds from this offering for working capital and general corporate purposes, including commercialization activities, general and administrative expenses, research and development expenses, capital expenditures, and for making scheduled payments under its debt facility.

    The securities described above are being offered by AcelRx pursuant to a shelf registration statement previously filed with, and declared effective by, the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and the accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. Copies of the final prospectus and the accompanying prospectus relating to this offering may be obtained, when available, from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at ..

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

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

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  3. REDWOOD CITY, Calif., Jan. 19, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an underwritten public offering of its common stock. All shares to be sold in the offering will be sold by AcelRx, subject to customary closing conditions.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 15 percent of the number of shares offered in the public offering.

    AcelRx intends to use the net proceeds from this offering for working capital and…

    REDWOOD CITY, Calif., Jan. 19, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an underwritten public offering of its common stock. All shares to be sold in the offering will be sold by AcelRx, subject to customary closing conditions.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 15 percent of the number of shares offered in the public offering.

    AcelRx intends to use the net proceeds from this offering for working capital and general corporate purposes, including commercialization activities, general and administrative expenses, research and development expenses, capital expenditures, and for making scheduled payments under its debt facility.

    The securities described above are being offered by AcelRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-239156) previously filed with the Securities and Exchange Commission (the "SEC") on June 12, 2020 and declared effective by the SEC on July 8, 2020. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

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

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

     

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  4. REDWOOD CITY, Calif., Jan. 19, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study with University Hospitals (UH) Cleveland Medical Center that will evaluate the postoperative use of DSUVIA in a prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass following a specialized enhanced recovery protocol. Dr. Daniel Asher, cardiac anesthesiologist and Medical Director of the Mather Postanesthesia Care Unit at UH Cleveland Medical Center, will serve as the principal investigator. Key outcomes to be measured…

    REDWOOD CITY, Calif., Jan. 19, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study with University Hospitals (UH) Cleveland Medical Center that will evaluate the postoperative use of DSUVIA in a prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass following a specialized enhanced recovery protocol. Dr. Daniel Asher, cardiac anesthesiologist and Medical Director of the Mather Postanesthesia Care Unit at UH Cleveland Medical Center, will serve as the principal investigator. Key outcomes to be measured include time on mechanical ventilation following completion of the surgical procedure, both intensive care as well as hospital length of stay and total dose of opioids administered from surgery to discharge. These outcomes will be compared to historical controls utilizing current institutional standard of care techniques. 

    "We look forward to evaluating DSUVIA as part of our cardiac surgery enhanced recovery program which is aiming to better prepare our enrolled subjects for the stress of heart surgery by using contemporary preoperative adjuncts, educational tools, intraoperative monitoring techniques and, importantly, actively reducing the exposure of these patients to IV opioids and their side effects," states the study's co-investigator Dr. Edwin Avery, Vice Chair of Clinical Operations and Professor of Anesthesiology at UH Cleveland Medical Center, and Professor, Anesthesiology and Perioperative Medicine, Case Western Reserve University School of Medicine. "We believe the higher therapeutic index of sufentanil and the lower peak plasma concentrations delivered via the sublingual route compared to bolus IV administration will allow DSUVIA to help us achieve our goal," continues Dr. Avery.

    "This investigator-initiated study at UH Cleveland presents another opportunity to assess the benefits of DSUVIA compared to IV opioids," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "The physicians at UH Cleveland Medical Center have chosen DSUVIA for evaluation in their enhanced recovery cardiac bypass program to determine if it provides effective pain relief while minimizing side effects during their postoperative recovery prior to discharge. This cardiac surgery study together with ongoing investigator-initiated trials of DSUVIA for orthopedic and spine surgeries at other top academic institutions allows DSUVIA to be assessed across a broad range of surgical subspecialties as an alternative to IV opioids."

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study and the scope of the study, expected findings from the investigator-initiated study and other studies, and the expected commencement of additional studies. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

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  5. REDWOOD CITY, Calif., Jan. 14, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced preliminary unaudited financial results and other information in connection with its participation in investor presentations, meetings and events during the week of the 39th Annual J.P. Morgan Healthcare Conference. The Company will post its revised corporate presentation in the investor section of its website.

    Key Highlights of 2020

    • DSUVIA® achieved Milestone C approval from the Department of Defense (DoD), a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits…

    REDWOOD CITY, Calif., Jan. 14, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced preliminary unaudited financial results and other information in connection with its participation in investor presentations, meetings and events during the week of the 39th Annual J.P. Morgan Healthcare Conference. The Company will post its revised corporate presentation in the investor section of its website.

    Key Highlights of 2020

    • DSUVIA® achieved Milestone C approval from the Department of Defense (DoD), a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs). Initial stocking orders have begun for U.S. Army SKOs and are expected to approximate $30 million over the next three years, dependent on troop deployment schedules.



    • In March, AcelRx announced an agreement with Brigham and Women's Hospital for an investigator-initiated study of DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School. This study is ongoing and is evaluating the perioperative use of DSUVIA in patients undergoing spine surgery compared to their standard intravenous (IV) opioid regimen.



    • In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet's Dental division. The formal launch is planned in 2021, once Zimmer Biomet receives necessary licenses. The estimated applicable market in dental surgeries is over 7 million annual procedures.



    • In August, AcelRx announced the publication of a study entitled, "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting," by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management (Tvetenstrand and Wolff Study). Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in postanesthesia care unit (PACU) time in the DSUVIA-treated patients compared to historical controls. See Cautionary Statements section below.



    • In August, AcelRx announced an investigator-initiated study with Cleveland Clinic evaluating the effects of DSUVIA on post-operative recovery from orthopedic surgery. This double-blind study is ongoing and compares DSUVIA to IV fentanyl for patients undergoing knee arthroscopy.



    • In September, AcelRx announced that the U.S. military's access to DSUVIA was expanded with the addition of DSUVIA to the DoD Joint Deployment Formulary.



    • In September, the U.S. Army awarded AcelRx a contract of up to $3.6 million over four years for the purchase of DSUVIA to support a DoD study to aid the development of clinical practice guidelines.



    • In December, AcelRx announced the publication of clinical data in an article in the Journal of Universal Surgery entitled, "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain," by lead author Koth Cassavaugh, PharmD, Director of Pharmacy (the Cassavaugh Evaluation), which reported that perioperative dosing of DSUVIA can provide more rapid PACU recovery times compared to standard IV opioid administration. In addition, patients in the control group received 66% higher mean dosing of intraoperative IV opioids compared to patients receiving DSUVIA and postoperative opioid use for the DSUVIA group was less than half of the control IV opioid group, with orthopedic surgery patients having the largest decrease (69%). See Cautionary Statements section below.



    • Achieved 348 formulary approvals through the close of 2020, a significant achievement in a year with COVID-related restrictions and delays.



    • Preliminary unaudited FY 2020 revenues approximated $5.4 million.



    • Preliminary December 31, 2020 cash, cash equivalents and short-term investments balance was $42.9 million.

    "I'm pleased with our team's commercial execution during these challenging times," said Vince Angotti, AcelRx Chief Executive Officer.  "We expect further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids, and we continue to make solid progress on the four pillars of our revenue plan.  I look forward to providing further updates during our year-end earnings call."

    The information above related to the Company's expected operating results for the year ended and as of December 31, 2020, including revenue and cash, cash equivalents and short-term investments, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company's financial statements as of and for the year ended December 31, 2020.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

    Cautionary Statements

    Tvetenstrand and Wolff Study

    The study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study. Study limitations include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients. AcelRx did not provide funding for the conduct of the Tvetenstrand and Wolff Study but did fund medical writing support. Dr. Tvetenstrand is a paid consultant of AcelRx.

    Cassavaugh Evaluation

    The evaluation focused on 140 patients who were dosed with DSUVIA compared to 158 patients who had been dosed with traditional IV opioids during the same time period undergoing the same surgical procedures. Study limitations included that it was a single-center, retrospective study of DSUVIA dosing in a surgical patient population and both inpatient and outpatient surgery data was combined. The study did not control for whether patients were opiate naïve or opiate tolerant in the treatment groups, however, there is no reason for these patients to be present at a substantially higher frequency in either group. AcelRx did not provide funding for the conduct of the evaluation but did fund medical writing support. Dr. Cassavaugh is a paid consultant of AcelRx.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to revenues and cash, cash equivalents and short-term investments AcelRx expects to report for fiscal year 2020, the timing of the procurement of DSUVIA by the military, the timing of the formal launch by Zimmer Biomet, and expectations for further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

     

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  6. REDWOOD CITY, Calif., Dec. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication by the Journal of Universal Surgery of clinical data on the use of DSUVIA for acute perioperative pain management.

    The article entitled "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain" by lead author Koth Cassavaugh, PharmD, Director of Pharmacy, reports that perioperative dosing of the sublingual sufentanil tablet 30 mcg (SST; DSUVIA) can provide enhanced postanesthesia care unit (PACU) recovery compared…

    REDWOOD CITY, Calif., Dec. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication by the Journal of Universal Surgery of clinical data on the use of DSUVIA for acute perioperative pain management.

    The article entitled "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain" by lead author Koth Cassavaugh, PharmD, Director of Pharmacy, reports that perioperative dosing of the sublingual sufentanil tablet 30 mcg (SST; DSUVIA) can provide enhanced postanesthesia care unit (PACU) recovery compared to standard intravenous (IV) opioid administration. The evaluation was conducted at Auburn Community Hospital, Auburn, NY, and included 298 patients in a perioperative setting undergoing a wide variety of inpatient and outpatient procedures including abdominal, orthopedic, gynecologic, genitourinary, otolaryngologic and spinal surgeries.

    The evaluation focused on 140 patients who were dosed with SST 30 mcg compared to 158 patients who had been dosed with traditional IV opioids during the same time period undergoing the same surgical procedures. Key findings included the following:

    • Intraoperative IV opioid use – patients in the control group overall received 66% higher mean dosing of intraoperative IV opioids compared to patients receiving SST (p<0.001).

       
    • Postoperative opioid use – the mean opioid requirement of the SST group was less than half of the control group (p<0.001), with orthopedic surgery patients having the largest decrease (69%).

       
    • PACU time to discharge – Phase 1 recovery time in the PACU was reduced by an average of 14 minutes across patients in the SST group compared with the control group (p<0.001), with the largest decrease in recovery time observed among abdominal surgery patients (23 minutes; 25% reduction).

       
    • Respiratory depression – 3 patients in the control group required naloxone use for respiratory depression whereas no patients in the SST group required naloxone use.

    The authors concluded that overall, SST dosed preoperatively or intraoperatively, significantly reduced both PACU opioid dosing requirements and Phase 1 unit discharge time compared to control patients receiving standard IV opioids intraoperatively. SST was well tolerated with no significant adverse events. In addition, the authors noted that decreasing discharge time per patient can have a substantial financial impact when multiplied over thousands of patients each year taking into account surgical throughput inefficiency that congestion in the PACU creates. Study limitations include that it was a single-center, retrospective study of SST dosing in a surgical patient population and both inpatient and outpatient surgery data was combined. The study did not control for whether patients were opiate naïve or opiate tolerant in the treatment groups, however, there is no reason for these patients to be present at a substantially higher frequency in either group. AcelRx did not provide funding for the conduct of the evaluation but did fund medical writing support. AcelRx did not provide any compensation to the authors for the evaluation.  Dr. Cassavaugh is a paid consultant of AcelRx.

    "We are thrilled this clinical data supports DSUVIA as a well-tolerated and effective pain management solution across a wide variety of both inpatient and outpatient surgical procedures, and also indicates shorter patient recovery time and economic benefits for hospitals," said Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "Importantly, the findings of reduced overall IV opioid use and PACU discharge time are consistent with other recently published clinical data on the use of DSUVIA in the perioperative environment."

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

     

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  7. REDWOOD CITY, Calif., Dec. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced it has entered into an agreement with three life sciences-focused investment funds that are existing investors and new investors in AcelRx, for the sale of 8,333,333 shares of common stock at $1.20 per share. AcelRx estimates gross proceeds from the offering of approximately $10.0 million.  The closing of the transaction is expected to occur by December 11, 2020, subject to satisfaction of customary closing conditions.

    The securities described above are being offered by AcelRx pursuant…

    REDWOOD CITY, Calif., Dec. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced it has entered into an agreement with three life sciences-focused investment funds that are existing investors and new investors in AcelRx, for the sale of 8,333,333 shares of common stock at $1.20 per share. AcelRx estimates gross proceeds from the offering of approximately $10.0 million.  The closing of the transaction is expected to occur by December 11, 2020, subject to satisfaction of customary closing conditions.

    The securities described above are being offered by AcelRx pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on July 8, 2020. A final prospectus supplement related to the offering will be filed with the SEC, and will be available on the SEC's website located at http://www.sec.gov.

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

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated closing of the transaction. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the inability to satisfy customary closing conditions. In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  8. REDWOOD CITY, Calif., Dec. 4, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced a partnership with the National Rural Health Association (NRHA) focused on the co-development and execution of a strategic marketing plan to educate and promote DSUVIA® (sufentanil sublingual tablet 30 mcg) in line with the NRHA mission to its members.

    The National Rural Health Association is a national nonprofit membership organization with more than 21,000 members. The association's mission is to provide leadership on rural health issues through advocacy, communications, education and…

    REDWOOD CITY, Calif., Dec. 4, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced a partnership with the National Rural Health Association (NRHA) focused on the co-development and execution of a strategic marketing plan to educate and promote DSUVIA® (sufentanil sublingual tablet 30 mcg) in line with the NRHA mission to its members.

    The National Rural Health Association is a national nonprofit membership organization with more than 21,000 members. The association's mission is to provide leadership on rural health issues through advocacy, communications, education and research. NRHA membership consists of a diverse collection of individuals and organizations, all of whom share the common bond of an interest in rural health. 

    "Rural health facilities face unique challenges, and additional focus is required to improve healthcare in these communities, particularly during this pandemic," said Vince Angotti, AcelRx Chief Executive Officer. "AcelRx is committed to meeting the needs of critical access hospitals and rural health providers. We believe DSUVIA can help fill an unmet need in the rural settings, including supporting opioid stewardship, and improving patient care at these facilities.  We're pleased to have the opportunity to advance the NRHA mission and support better healthcare in rural America."

    "The NRHA is excited to welcome AcelRx as a partner. We believe they will have a positive impact on hospitals and their Opioid Stewardship Programs. Conscientious dosing of opioids and using less overall opioids during and after surgery in the hospital is particularly important in the rural setting," said Larry Bedell, Executive Director, NRHASC.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  9. REDWOOD CITY, Calif., Nov. 18, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the recent publication by Practical Pain Management of a commentary discussing the benefits of using DSUVIA for acute pain management.

    The commentary is by three national thought-leaders in the field of pharmacy, Dr. Jeffrey Fudin, Dr. Jeffrey Bettinger and Dr. Joseph Dasta, and reviews a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand

    REDWOOD CITY, Calif., Nov. 18, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the recent publication by Practical Pain Management of a commentary discussing the benefits of using DSUVIA for acute pain management.

    The commentary is by three national thought-leaders in the field of pharmacy, Dr. Jeffrey Fudin, Dr. Jeffrey Bettinger and Dr. Joseph Dasta, and reviews a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD. This study was previously published in the Journal of Clinical Anesthesia and Pain Management, which the company announced in August 2020.

    "We are pleased with the post-approval data and the peer-reviewed commentary that continue to illustrate physiologic and economic rationales for DSUVIA's use in acute pain management in medically supervised settings," said Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "With an increasing focus on opioid stewardship, DSUVIA is well-suited to effectively manage acute pain while demonstrating in this study the ability to reduce the overall exposure to opioids and contribute to the reduced cost of patient care."

    The Tvetenstrand and Wolff study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study, with the following key findings:

    • Discharge from the PACU occurred 34% faster than control group.



    • Significantly fewer DSUVIA-treated patients required intraoperative IV opioids following preoperative dosing with DSUVIA compared with the control group.



    • DSUVIA patients received a significantly lower preoperative and intraoperative mean opioid dose relative to control group.



    • Fewer DSUVIA-treated patients required any postoperative opioid with overall opioid utilization being reduced by over 50% with DSUVIA use throughout the perioperative setting.



    • Significantly fewer patients in the DSUVIA group received adrenergic agonists for hemodynamic instability and IV acetaminophen for pain.



    • Overall, the preoperative administration of DSUVIA resulted in significant reductions in opioid use during outpatient surgery and facilitated shorter PACU stays.

    Limitations of the Tvetenstrand and Wolff study include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients. AcelRx did not provide funding for the conduct of the Tvetenstrand and Wolff study but did fund medical writing support. AcelRx did not provide any compensation to the authors for the commentary.  Drs. Tvetenstrand, Fudin and Dasta are paid consultants of AcelRx.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia.

    The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  10. REDWOOD CITY, Calif., Nov. 6, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced that management will be presenting at the Credit Suisse 29th Annual Virtual Healthcare Conference to be held November 9 – 12. AcelRx management will provide an overview of the business and company updates during the live presentation and will be available for one-on-one meetings with investors. 

    Details of the event are as follows:

    Credit Suisse 29th Annual Virtual Healthcare Conference
    Date: Tuesday, November 10, 2020
    Presentation Time: 2 pm ET (11 am PT)

    A live webcast link of the…

    REDWOOD CITY, Calif., Nov. 6, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced that management will be presenting at the Credit Suisse 29th Annual Virtual Healthcare Conference to be held November 9 – 12. AcelRx management will provide an overview of the business and company updates during the live presentation and will be available for one-on-one meetings with investors. 

    Details of the event are as follows:

    Credit Suisse 29th Annual Virtual Healthcare Conference

    Date: Tuesday, November 10, 2020

    Presentation Time: 2 pm ET (11 am PT)

    A live webcast link of the event can be found on the Company's website at http://ir.acelrx.com/upcoming-events. For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  11. REDWOOD CITY, Calif., Nov. 5, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its third quarter 2020 financial results.

    "The third quarter represented one of our most active and successful quarters since DSUVIA's approval," said Vince Angotti, Chief Executive Officer of AcelRx. "We've made significant progress on our revenue growth strategy, highlighted by our oral and dental surgery collaboration with Zimmer Biomet, the addition of DSUVIA to the Department of Defense Joint Deployment Formulary and our new U.S. Army contract. With the recent publication…

    REDWOOD CITY, Calif., Nov. 5, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its third quarter 2020 financial results.

    "The third quarter represented one of our most active and successful quarters since DSUVIA's approval," said Vince Angotti, Chief Executive Officer of AcelRx. "We've made significant progress on our revenue growth strategy, highlighted by our oral and dental surgery collaboration with Zimmer Biomet, the addition of DSUVIA to the Department of Defense Joint Deployment Formulary and our new U.S. Army contract. With the recent publication of data supporting DSUVIA's strong value proposition, we have gained momentum in DSUVIA's use within existing hospital and ambulatory surgery center customers, and the rate of scheduled formulary reviews. Progress within the Department of Defense continues and we expect the initial ordering of DSUVIA for deployed troops in the fourth quarter."

    Third Quarter Highlights

    • In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet's Dental division, expanding U.S. availability of DSUVIA. It is estimated that the applicable market in dental surgeries is over 7 million annual procedures.
    • In July, AcelRx completed a $10 million common stock offering priced at the market with two leading life science investors.
    • In August, AcelRx announced the publication of a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting," by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management. Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in PACU time in the DSUVIA-treated patients compared to historical controls.
    • In August, AcelRx announced an investigator-initiated study with Cleveland Clinic that will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery.
    • In September, AcelRx announced that the U.S. military's access to DSUVIA had been expanded with the addition of DSUVIA to the Department of Defense Joint Deployment Formulary (JDF).
    • In September, the U.S. Army awarded AcelRx with an initial contract of up to $3.6 million over four years for the purchase of DSUVIA to support a DoD study to aid the development of clinical practice guidelines.

    Financial Information

    • Cash, cash equivalents and short-term investments balance was $43.0 million as of September 30, 2020.
    • Net revenues for the third quarter 2020 were $1.4 million, of which approximately $1.3 million relates to product sales (compared to $0.3 million in product sales for the second quarter of 2020).
    • Combined R&D and SG&A expenses for the third quarter of 2020 totaled $8.6 million, a significant reduction compared to $12.0 million for the third quarter of 2019. Excluding stock-based compensation expense, these amounts were $7.5 million for the third quarter of 2020 compared to $10.7 million for the third quarter of 2019. The decrease in combined R&D and SG&A expenses in the third quarter of 2020 was primarily due to a reduction of $1.8 million in personnel costs and a $1.1 million reduction in DSUVIA-related commercialization expenses.
    • Net loss for the third quarter of 2020 was $8.9 million, or $0.10 per basic and diluted share, compared to $12.7 million, or $0.16 per basic and diluted share, for the third quarter of 2019.

    Webcast and Conference Call Information

    As previously announced, AcelRx will host a live webcast Thursday, November 5, 2020 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and AcelRx is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures

    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), AcelRx uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. AcelRx believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, AcelRx believes that these non-GAAP financial measures, when considered together with AcelRx's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare AcelRx's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track AcelRx's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate AcelRx's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures

    Forward-Looking and Cautionary Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the timing and size of military orders, the market for DSUVIA in dental and oral surgeries, the expected commencement of an investigator-initiated study and the scope of the study. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that the military and hospital systems delay, or fail to place, orders, that AcelRx may not experience the expected benefits from the Zimmer Biomet commercial opportunity and the uncertainties inherent in the initiation, execution and completion of investigator-initiated studies.  Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Limitations of the published study referenced above include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients.

     

    Selected Financial Data

    (in thousands, except per share data)

    (unaudited)



















     Three Months Ended  



     Nine Months Ended 



    September 30



     September 30 



    2020



    2019



    2020



    2019

    Statement of Comprehensive Loss Data































    Revenue:















       Product sales 

    $                     1,287



    $                       559



    $    1,864



    $    1,453

       Contract and other collaboration

    81



    49



    2,814



    361

          Total revenue

    1,368



    608



    4,678



    1,814

















    Operating costs and expenses:















    Cost of goods sold (1)

    1,851



    2,148



    4,732



    5,188

    Research and development (1)

    956



    1,058



    3,181



    3,598

    Selling, general and administrative (1)

    7,598



    10,936



    28,484



    32,241

    Total operating costs and expenses

    10,405



    14,142



    36,397



    41,027

    Loss from operations

    (9,037)



    (13,534)



    (31,719)



    (39,213)

















    Other income (expense):















    Interest expense

    (824)



    (828)



    (2,551)



    (1,704)

    Interest income and other income (expense), net 

    106



    645



    311



    1,728

    Non-cash interest income (expense) on liability related to sale of future royalties

    825



    986



    2,502



    375

    Total other income (expense)

    107



    803



    262



    399

    Provision for income taxes

    -



    -



    (4)



    (3)

    Net loss

    $                   (8,930)



    $                (12,731)



    $(31,461)



    $(38,817)

















    Basic and diluted net loss per common share

    $                     (0.10)



    $                    (0.16)



    $    (0.38)



    $    (0.49)

















    Shares used in computing basic and diluted net loss per common share

    87,913



    79,461



    82,896



    79,053

































































    (1)   Includes the following non-cash, stock-based compensation expense:





























                Cost of goods sold

    $                          25



    $                         68



    $         98



    $       197

                Research and development

    188



    242



    572



    699

                Selling, general and administrative

    891



    1,016



    2,670



    2,883

                       Total 

    $                     1,104



    $                    1,326



    $    3,340



    $    3,779





































    September 30, 2020



    December 31, 2019









    Selected Balance Sheet Data















    Cash, cash equivalents and investments

    $                   43,023



    $                  66,137









    Total assets

    66,179



    91,356









    Total liabilities

    124,032



    132,774









    Total stockholders' (deficit) equity 

    (57,853)



    (41,418)

























     

    Reconciliation of Non-GAAP Financial Measures

    (Operating Expenses less associated stock-based compensation expense)



















     Three Months Ended  



     Nine Months Ended  



    September 30



    September 30



    2020



    2019



    2020



    2019

















    Operating expenses (GAAP):















    Research and development 

    $    956



    $   1,058



    $   3,181



    $   3,598

    Selling, general and administrative 

    7,598



    10,936



    28,484



    32,241

    Total operating expenses 

    8,554



    11,994



    31,665



    35,839

    Less associated stock-based compensation expense

    1,079



    1,258



    3,242



    3,582

    Operating expenses (non-GAAP) 

    $ 7,475



    $ 10,736



    $ 28,423



    $ 32,257

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  12. REDWOOD CITY, Calif., Oct. 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release third quarter financial results after market close on Thursday, November 5, 2020. AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on November 5, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90…

    REDWOOD CITY, Calif., Oct. 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release third quarter financial results after market close on Thursday, November 5, 2020. AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on November 5, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company's website at www.acelrx.com.

    Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4204 for international callers.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA®(sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg), being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is an investigational drug and not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

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  13. REDWOOD CITY, Calif., Sept. 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced it will host a virtual Key Opinion Leader (KOL) event on the perioperative use of DSUVIA, on Wednesday, October 7, 2020 at 12 pm ET (9 am PT).

    The event will feature discussions and data presentations from two separate studies on the perioperative administration of DSUVIA with Dr. Christian Tvetenstrand, Chairman of Surgery and Director of Trauma, United Health Services Wilson Medical Center, New York, and Dr. Koth Cassavaugh, Director of Pharmacy, Auburn Community Hospital…

    REDWOOD CITY, Calif., Sept. 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced it will host a virtual Key Opinion Leader (KOL) event on the perioperative use of DSUVIA, on Wednesday, October 7, 2020 at 12 pm ET (9 am PT).

    The event will feature discussions and data presentations from two separate studies on the perioperative administration of DSUVIA with Dr. Christian Tvetenstrand, Chairman of Surgery and Director of Trauma, United Health Services Wilson Medical Center, New York, and Dr. Koth Cassavaugh, Director of Pharmacy, Auburn Community Hospital.

    Dr. Tvetenstrand will present data from a recent publication, "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management.  Dr. Cassavaugh will present data from a recently completed perioperative study of DSUVIA across multiple types of surgical specialties at Auburn Community Hospital that has been submitted for publication.

    The live webcast of the event can be accessed by using the following link: https://event.webcasts.com/starthere.jsp?ei=1379798&tp_key=a00647f588 or by clicking on the webcast link on the Investors home page of the company's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com. 

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  14. REDWOOD CITY, Calif., Sept. 22, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that the U.S. Army has awarded AcelRx with an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to support a study to aid the development of clinical practice guidelines.  Orders under the contract may be fulfilled over the next four years as specified in the agreement, with an initial purchase expected this year.

    "We are excited to receive this initial contract award for DSUVIA, which exemplifies the continued momentum with the Department of Defense…

    REDWOOD CITY, Calif., Sept. 22, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that the U.S. Army has awarded AcelRx with an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to support a study to aid the development of clinical practice guidelines.  Orders under the contract may be fulfilled over the next four years as specified in the agreement, with an initial purchase expected this year.

    "We are excited to receive this initial contract award for DSUVIA, which exemplifies the continued momentum with the Department of Defense," said Vince Angotti, Chief Executive Officer at AcelRx Pharmaceuticals. "This award is in addition to expected purchases from the U.S. Army for the initial stocking of their medical assemblages, sets, kits and outfits for troop deployment, as well as potential orders from other branches of the military following the recent approval of DSUVIA onto the Joint Deployment Formulary.  We believe that DSUVIA's unique pharmacokinetic profile, high therapeutic index, and efficient sublingual delivery will position it as a key option for acute pain management across all branches of the military," continued Mr. Angotti.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the expected purchasing of DSUVIA by the military and DSUVIA being positioned as a key option for acute pain management across all branches of the military.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

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  15. REDWOOD CITY, Calif., Sept. 14, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that the U.S. military's access to DSUVIA has been expanded with the addition of DSUVIA to the Department of Defense's Joint Deployment Formulary (JDF).  The JDF is a core list of pharmaceutical products that are designated for deploying military units across all service branches.

    "DSUVIA's addition to the Joint Deployment Formulary continues to validate its importance as a key option in the treatment of acute pain and represents yet another significant milestone for AcelRx," said Vince Angotti, Chief Executive Officer at AcelRx Pharmaceuticals. "DSUVIA's advancement within the military coupled with recently published data showing how DSUVIA enhances recovery times in the post-operative setting supports the increasing momentum for DSUVIA use and allows more healthcare practitioners to experience DSUVIA's unique pharmacokinetic characteristics," stated Mr. Angotti.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the expected use of DSUVIA by more healthcare practitioners.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

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  16. REDWOOD CITY, Calif., Sept. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that management will be providing an overview of the business and company updates at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference taking place September 14-16, 2020, and at the Cantor Fitzgerald Virtual Global Healthcare Conference taking place September 15-17, 2020.

    Details of the events are as follows:

    H.C. Wainwright & Co. 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Presentation Time: 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Cantor

    REDWOOD CITY, Calif., Sept. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that management will be providing an overview of the business and company updates at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference taking place September 14-16, 2020, and at the Cantor Fitzgerald Virtual Global Healthcare Conference taking place September 15-17, 2020.

    Details of the events are as follows:

    H.C. Wainwright & Co. 22nd Annual Global Investment Conference

    Date: Monday, September 14, 2020

    Presentation Time: 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Cantor Fitzgerald Virtual Global Healthcare Conference

    Date: Wednesday, September 16, 2020

    Presentation Time (Fireside Chat): 4:00 PM Eastern Time / 1:00 PM Pacific Time

    A live webcast link of both of the events can be found on the Company's website at http://ir.acelrx.com/upcoming-events. Management will also be hosting one-on-one investor meetings throughout the day.

    For those not available to listen to the live webcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  17. REDWOOD CITY, Calif., Aug. 24, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study with Cleveland Clinic.  The study will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery.

    "A recently published study and preliminary data from other open-label studies using DSUVIA in the perioperative environment suggest a substantial decline in the amount of opioids used in the PACU, and a dramatic decrease in time to discharge from the PACU with DSUVIA-treated patients compared to historical controls," states Dr…

    REDWOOD CITY, Calif., Aug. 24, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study with Cleveland Clinic.  The study will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery.

    "A recently published study and preliminary data from other open-label studies using DSUVIA in the perioperative environment suggest a substantial decline in the amount of opioids used in the PACU, and a dramatic decrease in time to discharge from the PACU with DSUVIA-treated patients compared to historical controls," states Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "By supporting investigator-initiated, double-blind studies conducted at highly respected institutions, we look to further demonstrate the benefits of DSUVIA in the intra- and post-operative environment. We also look forward to additional studies of the effectiveness, efficiency and safety of DSUVIA in settings outside the post-surgical arena.  We strongly believe the findings from all of these trials will further support DSUVIA becoming a key analgesic medication for the management of acute pain in medically supervised settings," continued Dr. Palmer.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study and the scope of the study, expected findings from the investigator-initiated study and other studies, and the expected commencement of additional studies. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  18. REDWOOD CITY, Calif., Aug. 19, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management.

    "The observations in this study strongly support utilizing DSUVIA over intravenous bolus opioids, consistent with opioid stewardship programs and enhanced recovery after surgery…

    REDWOOD CITY, Calif., Aug. 19, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management.

    "The observations in this study strongly support utilizing DSUVIA over intravenous bolus opioids, consistent with opioid stewardship programs and enhanced recovery after surgery protocols, which focus on minimizing opioid dosing in multimodal analgesic protocols," said Dr. Christian Tvetenstrand, Chairman of Surgery and Director of Trauma, United Health Services Wilson Medical Center, New York. "I strongly believe this data on preoperative DSUVIA administration will result in a paradigm shift in pain management protocols across all ambulatory surgeries, as we have already seen significant cost savings due to less medical intervention and improved patient recovery."

    The study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study, with the following key findings:

    • Discharge from the PACU occurred 34% faster than controls (36.3 min vs. 54.9 min; p < 0.001).
    • Significantly fewer DSUVIA treated patients required intraoperative IV opioid following preoperative dosing with DSUVIA compared with the control group (61.7% vs. 97.5%, respectively; p < 0.001).
    • DSUVIA patients received a total preoperative and intraoperative mean opioid dose of 10.9 milligram morphine equivalents (MME), while the mean dose for controls was 20.0 mg MME (p < 0.001).
    • Fewer DSUVIA-treated patients required any postoperative opioid (10.5% vs. 63.0%; p < 0.001) with overall opioid utilization being reduced by over 50% with DSUVIA use throughout the perioperative setting (11.8 MME vs. 24.6 MME; p < 0.001). 
    • Significantly fewer patients in the DSUVIA group received adrenergic agonists and IV acetaminophen.

    The study concluded that the preoperative administration of DSUVIA results in significant reductions in opioid use during outpatient surgery and facilitates shorter PACU stays. Study limitations include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients.

    "The results of this study build on an ever-increasing clinical dataset demonstrating the benefits of sublingual sufentanil. The standard of care for perioperative opioid administration has not been disrupted for over 100 years. We should no longer accept the rapid plasma fluctuations of IV bolus opioid administration as the status quo, as it impacts the patient's hemodynamic status and requires repeated redosing which ultimately results in higher overall opioid exposure," commented Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "DSUVIA for the first time offers a unique pharmacokinetic profile for an opioid in the perioperative setting and other medically supervised settings.  We expect this study to be one of several upcoming datasets to support the broad acceptance of DSUVIA as an alternative to IV opioids."

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to our expectations for upcoming datasets to support the broad acceptance of DSUVIA as an alternative to IV opioids. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that upcoming datasets are not published. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  19. REDWOOD CITY, Calif., Aug. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its second quarter 2020 financial results.

    "Despite the challenges with COVID in the second quarter, we made meaningful progress towards generating long-term shareholder value and expanding the DSUVIA launch through advancements with the Department of Defense and our exclusive agreement with Zimmer Biomet for dental surgeries," said Vince Angotti, Chief Executive Officer of AcelRx. "We expect these two revenue streams, both of which require minimal AcelRx commercial investment…

    REDWOOD CITY, Calif., Aug. 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its second quarter 2020 financial results.

    "Despite the challenges with COVID in the second quarter, we made meaningful progress towards generating long-term shareholder value and expanding the DSUVIA launch through advancements with the Department of Defense and our exclusive agreement with Zimmer Biomet for dental surgeries," said Vince Angotti, Chief Executive Officer of AcelRx. "We expect these two revenue streams, both of which require minimal AcelRx commercial investment, to be the main drivers of our near-term revenue growth.  Hospital and ambulatory surgery centers remain the core focus of our commercial team, and we expect recent hospital system wins to positively impact revenues in the mid to long term. We continue to execute on our strategy while focusing on prudent cash management."

    Second Quarter and Recent Highlights

    • DSUVIA achieved Milestone C approval from the Department of Defense, a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs). AcelRx expects that initial stocking orders beginning later this year for U.S. Army SKOs alone will approximate $30 million over the next three years, dependent on troop deployment schedules.
    • The DoD issued a Notice of Intent, converting to a Request for Proposal (RFP), for the purchase of up to 12,200 boxes or 122,000 DSUVIA units, expected to be ordered in the third quarter of 2020, which is separate from expected purchases for SKOs.
    • In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA® (sufentanil sublingual tablet), 30 mcg, within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet's Dental division, expanding U.S. availability of DSUVIA. It is estimated that the applicable market in dental surgeries is over 7 million annual procedures.
    • In July, AcelRx completed a $10 million common stock offering priced at the market with two leading life science investors.

    Financial Information

    • As previously announced:
      • Cash, cash equivalents and short-term investments balance of $43.7 million as of June 30, 2020;
      • Second quarter 2020 net revenues were $2.9 million, of which approximately $2.6 million relates to the recognition of revenue related to the Company's Zalviso® agreement with Grünenthal that was previously deferred;
      • Combined R&D and SG&A expenses for the second quarter of 2020 totaled $8.4 million compared to $12.5 million for the second quarter of 2019. Excluding stock-based compensation expense, these amounts were $7.3 million for the second quarter of 2020 compared to $11.2 million for the second quarter of 2019. R&D and SG&A expenses for the first half of 2020 totaled $23.1 million compared to $23.8 million in the first half of 2019. Excluding stock-based compensation expense, these figures were $20.9 million for the first half of 2020 compared to $21.5 million for the first half of 2019. The decrease in combined R&D and SG&A expenses in the second quarter of 2020 was primarily due to a reduction of $1.9 million in DSUVIA-related commercialization expenses, a $1.7 million reduction in personnel costs, and a net benefit of $0.5 million from the receipt of a breakup fee from Tetraphase, net of expenses incurred related to the transaction in the quarter. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures.
    • For the second quarter of 2020, net loss was $6.6 million, or $0.08 per basic and diluted share, compared to $12.4 million, or $0.16 per basic and diluted share, for the second quarter of 2019. Net loss for the first half of 2020 was $22.5 million, or $0.28 basic and diluted net loss per share, compared to $26.1 million, or $0.33 basic and diluted net loss per share, for the prior year period.

    Webcast and Conference Call Information

    As previously announced, AcelRx will host a live webcast Monday, August 10, 2020 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and AcelRx is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures

    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), AcelRx uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. AcelRx believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, AcelRx believes that these non-GAAP financial measures, when considered together with AcelRx's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare AcelRx's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track AcelRx's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate AcelRx's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to near-term revenue drivers, the expected impact of recent hospital system wins on revenue and the timing of such impact, the timing and size of military orders and the ongoing effects of the COVID-19 pandemic and its anticipated impacts on AcelRx's business.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that the military and hospital systems delay, or fail to place, orders, that AcelRx may not experience the expected benefits from the Zimmer Biomet commercial opportunity or that the impacts AcelRx is experiencing from the ongoing COVID-19 pandemic may be prolonged or exacerbated.  Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Media Contacts

    Investor Contacts

    Evoke

    Raffi Asadorian, CFO AcelRx

    Theresa Dolge / Jessica Ross

    215-928-2748 / 215-928-2346

    Brian Korb, Solebury Trout

    /

    646-378-2923

     

    Selected Financial Data

    (in thousands, except per share data)

    (unaudited)



















     Three Months Ended  



     Six Months Ended 



    June 30



     June 30 



    2020



    2019



    2020



    2019

    Statement of Comprehensive Loss Data































    Revenue:















       Product sales 

    $             303



    $                       768



    $           577



    $          894

       Contract and other collaboration

    2,621



    173



    2,733



    312

          Total revenue

    2,924



    941



    3,310



    1,206

















    Operating costs and expenses:















    Cost of goods sold (1)

    1,370



    1,810



    2,881



    3,040

    Research and development (1)

    813



    1,163



    2,225



    2,540

    Selling, general and administrative (1)

    7,575



    11,329



    20,886



    21,305

    Total operating costs and expenses

    9,758



    14,302



    25,992



    26,885

    Loss from operations

    (6,834)



    (13,361)



    (22,682)



    (25,679)

















    Other income (expense):















    Interest expense

    (872)



    (500)



    (1,727)



    (876)

    Interest income and other income (expense), net 

    270



    456



    205



    1,083

    Non-cash interest income (expense) on liability related to sale of future royalties

    834



    996



    1,677



    (611)

    Total other income (expense)

    232



    952



    155



    (404)

    Provision for income taxes

    (4)



    (3)



    (4)



    (3)

    Net loss

    $         (6,606)



    $                (12,412)



    $     (22,531)



    $    (26,086)

















    Basic and diluted net loss per common share

    $           (0.08)



    $                    (0.16)



    $         (0.28)



    $        (0.33)

















    Shares used in computing basic and diluted net loss per common share

    80,662



    78,902



    80,360



    78,846

















    (1)   Includes the following non-cash, stock-based compensation expense:

















                Cost of goods sold

    $               27



    $                         68



    $             73



    $          129

                Research and development

    184



    233



    384



    457

                Selling, general and administrative

    879



    1,045



    1,779



    1,867

                       Total 

    $          1,090



    $                    1,346



    $        2,236



    $       2,453





































    June 30, 2020



    December 31, 2019









    Selected Balance Sheet Data















    Cash, cash equivalents and investments

    $        43,686



    $                  66,137









    Total assets

    67,400



    91,356









    Total liabilities

    127,532



    132,774









    Total stockholders' (deficit) equity 

    (60,132)



    (41,418)









     

    Reconciliation of Non-GAAP Financial Measures

    (Operating Expenses less associated stock-based compensation expense)



















     Three Months Ended  



     Six Months Ended  



    June 30



    June 30



    2020



    2019



    2019



    2018

















    Operating expenses (GAAP):















    Research and development 

    $    813



    $   1,163



    $   2,225



    $   2,540

    Selling, general and administrative 

    7,575



    11,329



    20,886



    21,305

    Total operating expenses 

    8,388



    12,492



    23,111



    23,845

    Less associated stock-based















         compensation expense 

    1,063



    1,278



    2,163



    2,324

    Operating expenses (non-GAAP) 

    $ 7,325



    $ 11,214



    $ 20,948



    $ 21,521

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-reports-second-quarter-2020-financial-results-301109318.html

    SOURCE AcelRx Pharmaceuticals, Inc.

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  20. REDWOOD CITY, Calif., Aug. 3, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release second quarter financial results after market close on Monday, August 10, 2020. AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on August 10, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90 days…

    REDWOOD CITY, Calif., Aug. 3, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release second quarter financial results after market close on Monday, August 10, 2020. AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on August 10, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company's website at www.acelrx.com.

    Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4204 for international callers.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA®(sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is an investigational drug and not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

     

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  21. REDWOOD CITY, Calif., July 23, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced an agreement to market DSUVIA®, a sublingual opioid tablet in a single-dose applicator, within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet's Dental division. The agreement expands the U.S. availability of the non-invasive, sublingual analgesic for use by dental healthcare professionals in medically supervised settings who currently use injectable opioids for surgical analgesia.

    DSUVIA is indicated for use in adults in certified medically supervised healthcare settings for the management of acute pain severe enough to require an opioid analgesic, and…

    REDWOOD CITY, Calif., July 23, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced an agreement to market DSUVIA®, a sublingual opioid tablet in a single-dose applicator, within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet's Dental division. The agreement expands the U.S. availability of the non-invasive, sublingual analgesic for use by dental healthcare professionals in medically supervised settings who currently use injectable opioids for surgical analgesia.

    DSUVIA is indicated for use in adults in certified medically supervised healthcare settings for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA manages acute pain during procedures with its unique pharmacokinetic profile, which avoids the high peak plasma levels and short duration of action observed with bolus IV administration. The single dosage-strength tablet administered sublingually mitigates potential clinical issues such as dosage miscalculations or IV administration challenges.

    "We are proud to be partnering with Zimmer Biomet to provide DSUVIA as an option for acute pain management in adults during oral surgeries," said Vince Angotti, CEO of AcelRx Pharmaceuticals. "This strategic alliance with an established and reputable partner with a strong, solution-based sales network enables AcelRx to support dental professionals and their care of patients during the millions of oral surgeries in the United States each year. This partnership, together with other ongoing business development activities and the recent military Milestone C approval, are evidence of the continued execution on our strategy to build long-term value."

    DSUVIA is expected to be available for order by certified dental and oral surgeons exclusively through Zimmer Biomet in the United States after satisfaction of applicable licensing requirements.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. For more information, please visit www.DSUVIA.com.

    LIMITATIONS OF USE

    Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. Not for use for more than 72 hours.

    The use of DSUVIA beyond 72 hours has not been studied.  Only to be administered by a healthcare provider. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, or are not expected to be tolerated; have not provided adequate analgesia, or are not expected to provide adequate analgesia.

    The Full Prescribing Information for DSUVIA contains the following Boxed Warning:

    WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

    Accidental Exposure and DSUVIA Risk Evaluation and Mitigation Strategy (REMS) Program:  Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, DSUVIA is only available through a restricted program called the DSUVIA REMS Program. DSUVIA must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of DSUVIA prior to discharge or transfer from the certified medically supervised healthcare setting.

    Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.

    Addiction, Abuse, and Misuse: DSUVIA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing DSUVIA, and monitor all patients regularly for the development of these behaviors or conditions.

    Cytochrome P450 3A4 Interaction: The concomitant use of DSUVIA with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or inducer.

    Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

    IMPORTANT SAFETY INFORMATION

    DSUVIA is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and known hypersensitivity to sufentanil or components of DSUVIA.

    DSUVIA contains sufentanil, a Schedule II controlled substance. As an opioid, DSUVIA exposes users to the risks of addiction, abuse, and misuse. Potential serious adverse events caused by opioids include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal withdrawal syndrome, risks of concomitant use or discontinuation of cytochrome P450 3A4 inhibitors and inducers, risks from concomitant use with benzodiazepines or other CNS depressants, risk of life threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, adrenal insufficiency, severe hypotension, risks of use in patients with increased intracranial pressure or impaired consciousness, gastrointestinal disorders and seizure disorders. DSUVIA should be used with caution in patients with severe liver or kidney impairment.  

    This is not a complete list of risks associated with DSUVIA. For additional Important Safety Information please see full Prescribing Information at www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the commercial opportunity of AcelRx's agreement with Zimmer Biomet and the anticipated timing of the availability of DSUVIA to certified dental and oral surgeons. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that AcelRx may not experience the expected benefits from the commercial opportunity and Zimmer Biomet may be unable to acquire the necessary licenses. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  22. REDWOOD CITY, Calif., July 23, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced it has entered into an agreement with funds affiliated with Armistice Capital and Rock Springs Capital for the sale of 9,433,962 shares of common stock at $1.06 per share, the closing market price on July 22, 2020. AcelRx estimates gross proceeds from the offering of approximately $10.0 million. The closing of the transaction is expected to occur by July 24, 2020, subject to satisfaction of customary closing conditions.

    The securities described above are being offered by AcelRx pursuant…

    REDWOOD CITY, Calif., July 23, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced it has entered into an agreement with funds affiliated with Armistice Capital and Rock Springs Capital for the sale of 9,433,962 shares of common stock at $1.06 per share, the closing market price on July 22, 2020. AcelRx estimates gross proceeds from the offering of approximately $10.0 million. The closing of the transaction is expected to occur by July 24, 2020, subject to satisfaction of customary closing conditions.

    The securities described above are being offered by AcelRx pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on July 8, 2020. A final prospectus supplement related to the offering will be filed with the SEC, and will be available on the SEC's website located at http://www.sec.gov.

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

    About AcelRx Pharmaceuticals, Inc.

    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated closing of the transaction. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the inability to satisfy customary closing conditions. In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  23. REDWOOD CITY, Calif., June 3, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it does not intend to revise further its offer under the terms of its previously announced agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), and it expects the agreement to be terminated by Tetraphase. On June 1, 2020, Tetraphase disclosed that its board of directors had determined that an amended proposal from Melinta Therapeutics, Inc. constituted a "Superior Offer" under the terms of the AcelRx Merger Agreement. Under the terms of the agreement…

    REDWOOD CITY, Calif., June 3, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it does not intend to revise further its offer under the terms of its previously announced agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), and it expects the agreement to be terminated by Tetraphase. On June 1, 2020, Tetraphase disclosed that its board of directors had determined that an amended proposal from Melinta Therapeutics, Inc. constituted a "Superior Offer" under the terms of the AcelRx Merger Agreement. Under the terms of the agreement, in connection with a termination of the merger agreement, AcelRx will be paid a break-up fee of approximately $1.8 million.

    Vince Angotti, Chief Executive Officer at AcelRx said, "AcelRx is financially disciplined, and while we continue to recognize the merits of an AcelRx and Tetraphase combination, we do not believe that any further increases to our offer would be in the best interests of our stockholders. As a result, we have decided not to further increase our offer and will focus on other exciting opportunities to expand and diversify our product portfolio and create a platform for growth with other potential collaboration partners." 

    The co-promotion agreement between AcelRx and Tetraphase (or any successor to Tetraphase) remains in place – safeguarded by significant financial obligations. The training of both the AcelRx and Tetraphase teams is complete and co-promotion efforts for DSUVIA® and XERAVA™ are currently underway. 

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to the expected termination of the merger agreement with Tetraphase and payment of a break-up fee, anticipated benefits of the co-promotion agreement between AcelRx and Tetraphase, the business strategy to expand and diversify AcelRx's product portfolio, and potential collaborations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including AcelRx's ability to execute on its business strategy. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  24. REDWOOD CITY, Calif., June 1, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced that management will be providing an overview of the business and company updates at the Jeffries Virtual Healthcare Conference to be held June 2 at 1:30 p.m. ET (10:30 a.m. PT). A live webcast link of the event can be found on the Company's website at http://ir.acelrx.com/upcoming-events. Management will also be hosting one-on-one investor meetings throughout the day.

    For those not available to listen to the live webcast, a replay will be archived for 90 days and available through…

    REDWOOD CITY, Calif., June 1, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced that management will be providing an overview of the business and company updates at the Jeffries Virtual Healthcare Conference to be held June 2 at 1:30 p.m. ET (10:30 a.m. PT). A live webcast link of the event can be found on the Company's website at http://ir.acelrx.com/upcoming-events. Management will also be hosting one-on-one investor meetings throughout the day.

    For those not available to listen to the live webcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  25. REDWOOD CITY, Calif., May 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the execution of an amendment to its merger agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), with revised consideration of $37.0 million in stock and cash based on the AcelRx closing share price on May 28, 2020, plus up to $16.0 million in contingent value rights (CVRs) payable in cash.

    The total consideration payable to Tetraphase stockholders and warrant holders includes AcelRx stock valued at $24.2 million, based upon the closing share price…

    REDWOOD CITY, Calif., May 29, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the execution of an amendment to its merger agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) (NASDAQ:TTPH), with revised consideration of $37.0 million in stock and cash based on the AcelRx closing share price on May 28, 2020, plus up to $16.0 million in contingent value rights (CVRs) payable in cash.

    The total consideration payable to Tetraphase stockholders and warrant holders includes AcelRx stock valued at $24.2 million, based upon the closing share price of AcelRx stock of $1.50 on May 28, 2020, plus $12.8 million in cash.

    Tetraphase stockholders will receive, for each share of Tetraphase common stock, (1) $0.59 in cash and 0.7409 shares of AcelRx common stock, representing approximately $1.70 in upfront per share value, based upon the closing share price of AcelRx stock of $1.50 on May 28, 2020, and (2) one CVR, which would entitle the Tetraphase stockholders to receive potential aggregate payments of up to $16.0 million in cash upon the achievement of certain future XERAVA™ net sales milestones starting in 2021. 

    Tetraphase's board of directors has determined that as a result of the amendment to the merger agreement, competing bidders' proposals were not superior and recommends the merger agreement, as amended, to its stockholders. In addition to delivering overall higher value, the AcelRx agreement delivers a higher per share valuation to Tetraphase warrant holders and stockholders.

    Vince Angotti, Chief Executive Officer at AcelRx said, "We continue to believe there is significant value created for our stockholders in the combination of Tetraphase and AcelRx and stand ready to close this transaction in June."

    Under the terms of the merger agreement, the transaction is expected to close following Tetraphase's stockholder meeting, which is currently set for June 8, 2020.  Closing of the transaction is subject to receipt of approval of its stockholders, as well as satisfaction of other customary closing conditions. The transaction does not require a vote by AcelRx stockholders.

    Cooley LLP is acting as legal counsel to AcelRx.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    About Tetraphase Pharmaceuticals, Inc.
    Tetraphase Pharmaceuticals, Inc. is a biopharmaceutical company using its proprietary chemistry technology to develop and commercialize novel tetracyclines for serious and life-threatening conditions, including bacterial infections caused by many multidrug-resistant, or MDR, bacteria. There is a medical need for new antibiotics as resistance to existing antibiotics increases. The company's commercial product, XERAVA™ (eravacycline), a fully synthetic fluorocycline, is an intravenous, or IV, antibiotic that is approved for use as a first-line empiric monotherapy for the treatment of MDR infections, including those found in complicated intra-abdominal infections, or cIAI.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to future prospects or results, strategy, intentions, plans, hopes, beliefs, anticipations, expectations or predictions of the future, or the expected closing and timing of the Tetraphase acquisition and the potential benefits of the proposed transaction.  These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that we may not be able to close the acquisition of Tetraphase or achieve the expected benefits and cost synergies from the proposed transaction with Tetraphase, that actions taken by competing bidders for Tetraphase or fluctuations in the market price of AcelRx's common stock could delay or prevent the consummation of the proposed transaction, or that the impacts AcelRx experiences from the ongoing COVID-19 pandemic may be prolonged or exacerbated.  In addition, such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Additional Information and Where to Find It
    In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx filed with the SEC a registration statement on Form S-4 (No. 333-237584) (the "Registration Statement") containing a document constituting a prospectus of AcelRx and a proxy statement of Tetraphase.  The Registration Statement was declared effective by the SEC on April 24, 2020, and Tetraphase mailed the definitive proxy statement/prospectus to stockholders of Tetraphase on or about April 28, 2020. AcelRx and Tetraphase also plan to file other relevant documents with the SEC regarding the transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders are able to obtain free copies of the Registration Statement and the definitive proxy statement/prospectus and other relevant documents filed or that will be filed by AcelRx or Tetraphase with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by AcelRx are available free of charge within the Investors section of AcelRx's website at http://ir.acelrx.com. Copies of the documents filed with the SEC by Tetraphase are available free of charge within the Investors section of Tetraphase's website at https://ir.tphase.com/investor-relations.

    Participants in the Solicitation
    Each of AcelRx and Tetraphase and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Tetraphase stockholders in connection with the proposed transaction. Information about AcelRx's directors and executive officers is included in the definitive proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020. Information about Tetraphase's directors and executive officers is included in Tetraphase's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 12, 2020. Other information regarding the participants in the solicitation of proxies in connection with the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement/prospectus filed with the SEC on April 24, 2020. When available, investors may obtain free copies of these documents from AcelRx or Tetraphase as indicated above.

    No Offer or Solicitation
    This communication is being made in respect of the proposed transaction involving AcelRx and Tetraphase. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  26. REDWOOD CITY, Calif., May 11, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its first quarter 2020 financial results.

    "During this unprecedented time, I am proud of the commitment demonstrated by our employees as we continue making progress towards our year-end strategic and operational 2020 goals," said Vince Angotti, Chief Executive Officer of AcelRx. "The Milestone C approval for DSUVIA® in April was a significant catalyst for the Company and validates DSUVIA's key role in modernizing the treatment of acute pain. We expect to see a strong volume of…

    REDWOOD CITY, Calif., May 11, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its first quarter 2020 financial results.

    "During this unprecedented time, I am proud of the commitment demonstrated by our employees as we continue making progress towards our year-end strategic and operational 2020 goals," said Vince Angotti, Chief Executive Officer of AcelRx. "The Milestone C approval for DSUVIA® in April was a significant catalyst for the Company and validates DSUVIA's key role in modernizing the treatment of acute pain. We expect to see a strong volume of orders from the U.S. Army beginning later this year and into the future. The approval also opens doors to other branches of the military, additional areas of the Federal government, and to state governments and agencies. Specifically, we expect the next step with the Department of Defense will be DSUVIA's inclusion on the Joint Deployment Formulary. We are pleased with the swift integration of our commercial team with Tetraphase under our co-promotion agreement, which we believe will benefit both companies moving forward."  

    First Quarter and Recent Highlights

    • DSUVIA achieved Milestone C approval from the Department of Defense, a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs) with an expectation of expanded use across all branches of the military and the potential for use across additional federal and state agencies. AcelRx expects that initial stocking orders beginning later this year for U.S. Army SKOs alone will approximate $30 million over the next three years based on troop deployment schedules.
    • Prior to the impact from the COVID-19 pandemic, AcelRx was on pace to exceed formulary approvals and REMS-certified facilities goals for 2020. Following the initial impact of COVID, as of April 30, 2020, 221 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 223 formulary approvals have been achieved. As previously communicated, in response to the COVID-19 pandemic, hospitals and ambulatory surgery centers have restricted in-person meetings with pharmaceutical company personnel. Accordingly, year-end 2020 REMS-certified facilities and formulary approvals goals will be re-evaluated once COVID-19 restrictions are lifted and there is greater visibility into healthcare facility access.
    • Expect the publication of two hospital studies of real-world data of DSUVIA in the perioperative setting which analyze DSUVIA's impact on IV opioid requirements in the post-anesthesia care unit (PACU) and discharge time from the PACU in the coming months.
    • Announced an agreement with Brigham and Women's Hospital for an investigator-initiated study of DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School. The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.

    Financial Information

    • As previously announced:
      • Cash, cash equivalents and short-term investments balance of $52.7 million as of March 31, 2020;
      • First quarter 2020 net revenues were $0.4 million;
      • Combined R&D and SG&A expenses for the first quarter of 2020 totaled $14.7 million compared to $11.4 million for the first quarter of 2019. Excluding stock-based compensation expense, these amounts were $13.6 million for the first quarter of 2020 compared to $10.3 million for the first quarter of 2019. The increase in combined R&D and SG&A expenses is primarily due to business development costs related to the proposed acquisition of Tetraphase and increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures.
    • For the first quarter of 2020, net loss was $15.9 million, or $0.20 per basic and diluted share, compared to $13.7 million, or $0.17 per basic and diluted share, for the first quarter of 2019.

    Tetraphase Transaction Update

    On March 15, 2020, AcelRx entered into a definitive agreement (the Merger Agreement) to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) and a co-promotion agreement with Tetraphase. Training of both the AcelRx and Tetraphase teams is complete and co-promotion efforts for DSUVIA and XERAVA are underway. 

    AcelRx is aware of the May 8, 2020 disclosure by Tetraphase indicating it received a competing acquisition proposal from La Jolla Pharmaceutical Company (La Jolla) that the Tetraphase board of directors (Tetraphase Board) believes constitutes or could reasonably be expected to lead to a superior offer. The Tetraphase Board also stated that it continued to recommend the AcelRx merger and has not made any recommendations with respect to the other competing acquisition proposal by La Jolla. Our understanding is as follows:

    • The La Jolla proposal is for an upfront value of $22 million, payable in cash, inclusive of an estimate of approximately $11.9 million in Black-Scholes consideration due to select warrant holders and approximately $10.1 million for Tetraphase common equity holders (an implied price per share of $0.93), and contingent value rights of up to $12.5 million.
    • This compares to the AcelRx proposal for an upfront value of approximately $21.7 million payable in stock, based on the closing price of AcelRx stock on May 8th, inclusive of an estimate of approximately $11.8 million in Black-Scholes consideration due to select warrant holders and approximately $9.9 million for Tetraphase common equity holders (an implied price per share of $0.92), and contingent value rights of up to $12.5 million.

    Under the Merger Agreement with Tetraphase, should the Tetraphase Board indicate that it intends to change its recommendation in favor of the Merger Agreement, AcelRx would have the opportunity to respond within a specified time period. 

    Regardless of whether the Tetraphase Board ultimately chooses to accept an offer (including the La Jolla offer) other than the AcelRx transaction under the Merger Agreement, the co-promotion agreement between the two companies would remain in place – safeguarded by significant financial obligations. If a party other than AcelRx ultimately combines with Tetraphase, they will promote DSUVIA and AcelRx will continue to promote XERAVA. AcelRx will provide additional updates to its stockholders regarding Tetraphase at the appropriate time. 

    Webcast and Conference Call Information
    As previously announced, AcelRx will host a live webcast Monday, May 11, 2020 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and AcelRx is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures
    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), AcelRx uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. AcelRx believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, AcelRx believes that these non-GAAP financial measures, when considered together with AcelRx's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare AcelRx's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track AcelRx's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate AcelRx's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated procurement by the military, the expected closing and timing and the likelihood of the Tetraphase acquisition, expected benefits from the acquisition of Tetraphase and the co-promotion agreement, and ongoing effects and anticipated impacts to AcelRx's business as a result of the COVID-19 pandemic.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that AcelRx may not be able to close the acquisition of Tetraphase or achieve the expected benefits and cost synergies from the transactions, including through actions taken by competing bidders for Tetraphase, that there may be changes in estimated cash position based on the completion of AcelRx's financial statement closing procedures and the review by AcelRx's independent registered public accounting firm of such financial statements, that potential sales volumes to the Department of Defense may not materialize, or that the impacts AcelRx is experiencing from the ongoing COVID-19 pandemic may be prolonged or exacerbated.  Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Additional Information and Where to Find It
    In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx filed with the SEC a registration statement on Form S-4 (No. 333-237584) (the Registration Statement) containing a document constituting a prospectus of AcelRx and a proxy statement of Tetraphase. The Registration Statement was declared effective by the SEC on April 24, 2020, and Tetraphase mailed the definitive proxy statement/prospectus to stockholders of Tetraphase on or about April 28, 2020. AcelRx and Tetraphase also plan to file other relevant documents with the SEC regarding the transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the Registration Statement and the definitive proxy statement/prospectus and other relevant documents filed or that will be filed by AcelRx or Tetraphase with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by AcelRx will be available free of charge within the Investors section of AcelRx's website at http://ir.acelrx.com. Copies of the documents filed with the SEC by Tetraphase will be available free of charge within the Investors section of Tetraphase's website at https://ir.tphase.com/investor-relations.

    Participants in the Solicitation
    Each of AcelRx and Tetraphase and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Tetraphase stockholders in connection with the proposed transaction. Information about AcelRx's directors and executive officers is included in the definitive proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020. Information about Tetraphase's directors and executive officers is included in Tetraphase's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 12, 2020. Other information regarding the participants in the solicitation of proxies in connection with the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement/prospectus filed with the SEC on April 24, 2020. When available, investors may obtain free copies of these documents from AcelRx or Tetraphase as indicated above.

    No Offer or Solicitation
    This communication is being made in respect of the proposed transaction involving AcelRx and Tetraphase. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

    Selected Financial Data

    (in thousands, except per share data)

    (unaudited)






     Three Months Ended  


    March 31


    2020


    2019

    Statement of Comprehensive Loss Data








    Revenue:




       Product sales 

    $                 274


    $                       126

       Contract and other collaboration

    112


    139

          Total revenue

    386


    265





    Operating costs and expenses:




    Cost of goods sold (1)

    1,511


    1,230

    Research and development (1)

    1,412


    1,377

    Selling, general and administrative (1)

    13,311


    9,976

    Total operating costs and expenses

    16,234


    12,583

    Loss from operations

    (15,848)


    (12,318)





    Other income (expense):




    Interest expense

    (855)


    (376)

    Interest income and other income (expense), net 

    (65)


    627

    Non-cash interest income (expense) on liability related to sale of future royalties

    843


    (1,607)

    Total other income (expense)

    (77)


    (1,356)

    Net loss

    $          (15,925)


    $                (13,674)





    Basic and diluted net loss per common share

    $              (0.20)


    $                    (0.17)





    Shares used in computing basic and diluted net loss per common share

    80,057


    78,789

















    (1)   Includes the following non-cash, stock-based compensation expense:








                Cost of goods sold

    $                   46


    $                         61

                Research and development

    200


    224

                Selling, general and administrative

    900


    822

                       Total 

    $              1,146


    $                    1,107











    March 31, 2020


    December 31, 2019

    Selected Balance Sheet Data




    Cash, cash equivalents and investments

    $            52,725


    $                  66,137

    Total assets

    77,339


    91,356

    Total liabilities

    132,620


    132,774

    Total stockholders' (deficit) equity 

    (55,281)


    (41,418)

     

    Reconciliation of Non-GAAP Financial Measures

    (Operating Expenses less associated stock-based compensation expense)



     Three Months Ended  


    March 31


    2020


    2019





    Operating expenses (GAAP):




    Research and development 

    $   1,412


    $   1,377

    Selling, general and administrative 

    13,311


    9,976

    Total operating expenses 

    14,723


    11,353

    Less associated stock-based compensation expense 

    1,100


    1,046

    Operating expenses (non-GAAP) 

    $ 13,623


    $ 10,307

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  27. Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals; Acquisition Expected to Close in June 2020

    Continued double digit quarter over quarter growth of XERAVA in U.S. Hospitals and other Institutions with High Antibiotic Usage

    Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, today reported financial results for the first quarter ended March 31, 2020.

    "In the first quarter, we announced a merger agreement with AcelRx Pharmaceuticals, Inc., an essential step forward for Tetraphase and more importantly, for XERAVA and the patients with serious life threatening infections in need of this treatment…

    Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals; Acquisition Expected to Close in June 2020

    Continued double digit quarter over quarter growth of XERAVA in U.S. Hospitals and other Institutions with High Antibiotic Usage

    Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, today reported financial results for the first quarter ended March 31, 2020.

    "In the first quarter, we announced a merger agreement with AcelRx Pharmaceuticals, Inc., an essential step forward for Tetraphase and more importantly, for XERAVA and the patients with serious life threatening infections in need of this treatment," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "In the midst of the ongoing COVID-19 pandemic and the continued rise of antibiotic resistance, our conviction in providing patients with different antibiotic treatment options is stronger than ever, and we believe that together with AcelRx we will be able to more effectively bring XERAVA to patients in healthcare institutions. With an approximate 20% growth in XERAVA net sales in the first quarter compared to the fourth quarter of 2019, we look forward to seeing continued success from the combined Tetraphase and AcelRx teams following the planned close of the acquisition this quarter."

    First Quarter and Recent Highlights

    • Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals, Inc.

    In March 2020, the Company announced the execution of a definitive merger agreement pursuant to which AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) would acquire Tetraphase in a stock for stock transaction. Under the terms of the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, valued at approximately $14.4 million as of the close of trading on March 13, 2020, and one contingent value right (CVR), which would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future XERAVA™ net sales milestones starting in 2021. The transaction was unanimously approved by both the AcelRx and Tetraphase boards of directors and is expected to close in the second quarter of 2020. Concurrently with signing the merger agreement, Tetraphase and AcelRx entered into a co-promotion agreement to market and promote XERAVA™ for the treatment of complicated intra-abdominal infections (cIAI) and DSUVIA® for the treatment of acute pain in medically supervised settings.

    • Continued to Progress Launch of XERAVA in U.S. Hospitals With High Antibiotic Usage

    The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date and $1.8 million in XERAVA net sales for the first quarter of 2020, an increase of approximately 20% over the fourth quarter of 2019. Tetraphase's salesforce is focusing on bringing XERAVA to targeted institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be strong, with reorder rates as high as 65% for all accounts and approximately 77% within the Tier 1 account segment. XERAVA is on formulary or available at more than 1,239 accounts. XERAVA continues to outperform all recent IV antibiotic launches anywhere from 3 to 10 fold in patient days of therapy (PDOTs).

    • Completed Equity Financing Totaling Net Proceeds of $15.9 Million

    In January 2020, the Company completed a private placement with Armistice Capital, LLC, a healthcare-focused institutional investor, priced at-the-market, that generated gross proceeds of approximately $10 million. In addition, the Company concurrently completed a registered direct offering with certain healthcare-focused institutional investors, priced at-the-market, that generated gross proceeds of approximately $7.5 million. The net proceeds from the concurrent January 2020 private placement and registered direct offering were approximately $15.9 million. The Company issued warrants in connection with each financing.

    First Quarter 2020 Financial Results

    As of March 31, 2020, Tetraphase had cash and cash equivalents of $26.1 million and 7.3 million shares outstanding.

    For the first quarter of 2020, Tetraphase reported a net loss of $12.1 million, or $1.31 per share, compared to a net loss of $19.5 million, or $7.25 per share, for the same period in 2019, driven by increased product revenues, lower operating expenses and an increase in the weighted-average number of shares outstanding.

    Total revenues were $1.8 million for the first quarter of 2020, all of which was from sales of XERAVA, compared to $1.3 million for the same period in 2019, of which $0.3 million was from sales of XERAVA and $0.9 million was government contract revenue.

    Research and development (R&D) expenses for the first quarter of 2020 were $1.9 million, compared to $6.7 million for the same period in 2019. The decrease in R&D expenses was driven by the completion of XERAVA development and our corporate reorganization in June 2019, which included the cessation of development of our pipeline candidates.

    Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were $10.7 million, compared to $13.3 million for the same period in 2019. The decrease was driven by our 2019 corporate reorganization as well as tight expense control during Q1 2020, offset by increased expenses related to the AcelRX merger transaction announced in March 2020.

    About XERAVATM

    XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

    XERAVATM Important Safety Information

    XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

    XERAVA is not indicated for the treatment of complicated urinary tract infections.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

    The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

    XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

    To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

    Please see full prescribing information for XERAVA.

    About Tetraphase Pharmaceuticals, Inc.

    Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company using its proprietary chemistry technology to create novel tetracyclines for serious and life-threatening conditions, including infections caused by many of the multidrug-resistant bacteria highlighted as urgent public health threats by the World Health Organization and the Centers for Disease Control and Prevention. The Company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's lead product XERAVA™ is approved for the treatment of complicated intra-abdominal infections by the U.S. Food and Drug Administration and the European Medicines Agency. The Company's pipeline also includes antibiotics TP-271 and TP-6076, which are Phase 2 ready, and TP-2846, which is in preclinical testing for acute myeloid leukemia. The Company intends to out license its pipeline candidates. Please visit www.tphase.com for more company information.

    Additional Information and Where to Find it

    The Company filed a proxy statement with the Securities and Exchange Commission ("SEC") in connection with the proposed transaction with AcelRx, including a form of proxy card, on April 24, 2020. The proxy statement and form of proxy card have been mailed to the Company's stockholders beginning on April 28, 2020. The proxy statement contains important information about the Company, AcelRx, the merger and related matters. Investors and security holders are urged to read the proxy statement carefully.

    Investors and security holders can obtain free copies of the proxy statement and other documents filed with the SEC by the Company through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders can obtain free copies of the proxy statement from the Company by written request to the Company at Tetraphase Pharmaceuticals, Inc., 480 Arsenal Way, Watertown, Massachusetts 02472, Attn: Secretary or by calling (617) 715-3600.

    The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect to the transactions contemplated by the merger agreement. Information regarding the Company's directors and executive officers, including the direct and indirect interests of the Company's directors and executive officers in the merger, is contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 12, 2020 and in the proxy statement dated April 24, 2020, each of which is filed with the SEC. These documents can be obtained free of charge from the sources listed above.

    Forward-Looking Statements

    Statements in this press release regarding the proposed transaction between AcelRx and Tetraphase, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company and any other statements about our future expectations, beliefs, goals, plans or prospects constitute forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing "believes," "anticipates," "plans," "expects," "may," "will," "would," "intends," "estimates" and similar expressions) should also be considered to be forward‑looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether our cash runway and expected revenue will be sufficient to fund our operations in the future; the risk that the proposed merger may not be completed in a timely manner, or at all, which may adversely affect our business and the price of our common stock; the failure to satisfy all of the closing conditions of the proposed merger, including the adoption of the merger agreement by Tetraphase's stockholders; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the proposed merger on Tetraphase's business, operating results and relationships with customers, suppliers, competitors and others; potential difficulties retaining employees as a result of the proposed merger; the outcome of any legal proceedings that may be instituted against us related to the merger agreement or the proposed merger; risks relating to the impact of COVID-19 on our business and operations, including the impact on [demand for our product, our ability to operate remotely given the shut-down of our offices and our ability to access accounts]; risks relating to product development and commercialization; risks associated with competition; and other commercial and other risk factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on [May 7, 2020]. In addition, the forward-looking statements included in this press release represent our views as of [May 7, 2020]. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.

     
    Tetraphase Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets (unaudited)
    (In thousands)
     

    March 31,

    December 31,

     

    2020

     

    2019

    Assets
    Cash and cash equivalents

    $

    26,146

    $

    21,239

    Accounts receivable, net

     

    1,706

     

    1,503

    Inventory

     

    788

     

    1,595

    Prepaid expenses and other current assets

     

    1,178

     

    2,156

    Property and equipment, net

     

    78

     

    98

    Intangible assets, net

     

    4,160

     

    4,259

    Operating lease right-of-use assets

     

    2,598

     

    4,836

    Restricted cash

     

    699

     

    699

    Total assets

    $

    37,353

    $

    36,385

     
    Liabilities and Stockholders' equity
    Accounts payable and accrued expenses

    $

    7,212

    $

    8,223

    Operating lease liabilities

     

    2,686

     

    4,995

    Total stockholders' equity

     

    27,455

     

    23,167

    Total liabilities and stockholders' equity

    $

    37,353

    $

    36,385

     
     
    Tetraphase Pharmaceuticals, Inc.
    Condensed Consolidated Statement of Operations (Unaudited)
    (In thousands, except per share data)
     

    Three Months Ended

    March 31,

     

    2020

     

     

    2019

     

     
    Revenues:
    Product revenue, net

    $

    1,755

     

    $

    341

     

    Government revenue

     

    -

     

     

    932

     

    Total revenue

     

    1,755

     

     

    1,273

     

    Expenses:
    Cost of revenue - product sales

     

    1,360

     

     

    164

     

    Cost of revenue - intangible asset amortization

     

    98

     

     

    98

     

    Research and development

     

    1,893

     

     

    6,737

     

    Selling, general and administrative

     

    10,668

     

     

    13,314

     

    Total expenses

     

    14,019

     

     

    20,313

     

    Loss from operations

     

    (12,264

    )

     

    (19,040

    )

    Other income and expenses

     

    140

     

     

    (448

    )

    Net loss

    $

    (12,124

    )

    $

    (19,488

    )

    Net loss per share-basic and diluted

    $

    (1.31

    )

    $

    (7.25

    )

    Weighted-average number of common shares used in net loss per
    share-basic and diluted

     

    9,273

     

     

    2,687

     

     

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  28. REDWOOD CITY, Calif., May 4, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release first quarter financial results after market close on Monday, May 11, 2020. AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 11, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90 days following…

    REDWOOD CITY, Calif., May 4, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release first quarter financial results after market close on Monday, May 11, 2020. AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 11, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company's website at www.acelrx.com.

    Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA®(sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is an investigational drug and not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  29. REDWOOD CITY, Calif., April 30, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced that DSUVIA achieved Milestone C approval, a decision that clears the path for DSUVIA to be included in military sets, kits and outfits (SKOs).

    "After many years of development and collaboration with the U.S. Army to create a sublingual alternative to injectable opioids for acute pain management on the battlefield, we are excited to now have approval to fulfill an unmet need for our military," said Vince Angotti, CEO of AcelRx Pharmaceuticals. "The AcelRx and U.S. Army teams have…

    REDWOOD CITY, Calif., April 30, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced that DSUVIA achieved Milestone C approval, a decision that clears the path for DSUVIA to be included in military sets, kits and outfits (SKOs).

    "After many years of development and collaboration with the U.S. Army to create a sublingual alternative to injectable opioids for acute pain management on the battlefield, we are excited to now have approval to fulfill an unmet need for our military," said Vince Angotti, CEO of AcelRx Pharmaceuticals. "The AcelRx and U.S. Army teams have worked diligently to reach this affirmative Milestone C decision. We expect the next phase of our collaboration with the Department of Defense will make DSUVIA widely available throughout all branches of the military, and we look forward to significant orders for DSUVIA later this year and beyond."

    Other business updates

    • AcelRx's registration statement on Form S-4 related to the acquisition of Tetraphase Pharmaceuticals, Inc. ("Tetraphase") was declared effective by the Securities and Exchange Commission on April 24, 2020. AcelRx expects to close the acquisition following the special meeting of Tetraphase's stockholders, which is scheduled to be held on June 8, 2020.
    • The AcelRx and Tetraphase commercial and medical affairs teams have been fully trained on each company's respective product and co-promotion efforts have been initiated.
    • In response to the COVID-19 pandemic, hospitals and ambulatory surgery centers have postponed elective surgeries and restricted in-person meetings with pharmaceutical company personnel. Promotional and educational meetings by our commercial and medical affairs teams are therefore being conducted virtually, if available, until access is again granted. As a result, DSUVIA sales have been adversely affected and the previously announced year-end 2020 REMS-certified facilities and formulary approvals goals will be re-evaluated once the COVID-19 restrictions are lifted and there is greater visibility into healthcare facility access.
    • Preliminary first quarter 2020 operating expenses (SG&A and R&D) are expected to be $14.7 million and include increased legal and professional costs incurred in connection with the pending Tetraphase acquisition. AcelRx expects quarterly combined R&D and SG&A expense for each of the remaining quarters of 2020, without taking into account the closing of the Tetraphase acquisition, to range from $10 million to $11.0 million, which is reduced from the previous guidance range of $10 million to $13 million.  Excluding an estimated $1.0 million to $1.5 million of non-cash stock-based compensation per quarter, the quarterly operating expense is expected to be in the $9.0 million to $9.5 million range. See "Non-GAAP Financial Measures" below for a discussion of quarterly operating expense, excluding non-cash costs, described above.
    • Preliminary first quarter 2020 revenues are expected to be $0.4 million.
    • Preliminary cash, cash equivalents and short-term investments are expected to be $52.7 million as of March 31, 2020.

    Mr. Angotti continued, "Our sales team has done a great job preparing for co-promotion efforts and transitioning to virtual meetings with physicians when available, but the COVID-19 pandemic has had a broad impact, including the delay of elective surgeries and reduction in number of ER visits. While we expect to see some DSUVIA sales impact and some of the planned 2020 REMS certifications and formulary approvals pushed to later in the year or into next year, our broader commercial goals remain the same. We are focused on the completion of the Tetraphase acquisition, which we continue to see providing excellent synergies, and look forward to providing further updates in the future."   

    The information above related to the Company's expected operating results for the three months ended and as of March 31, 2020, including revenue, cash operating expenses and cash, cash equivalents and short-term investments, is preliminary, has not been audited or reviewed and is subject to change upon completion of the review of the Company's financial statements as of and for the three months ended March 31, 2020.  Fiscal year 2020 financial guidance is based on the Company's current expectations and are forward-looking statements.  Actual results could differ materially depending on market conditions and the factors set forth under the "Forward-Looking Statements" heading below.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg

    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures
    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. The Company believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, the Company believes that these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated procurement by the military, the expected closing and timing of the Tetraphase acquisition, revenues, operating expenses, cash, cash equivalents and short-term investments the Company expects to report for the three months ended and as of March 31, 2020, quarterly operating expense guidance for the remainder of 2020, and ongoing effects and anticipated impacts to the Company's business as a result of the COVID-19 pandemic. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the uncertainty surrounding the continuation of shelter-in-place orders and related restrictions on access to our customers due to COVID-19, the uncertainty of longer-term economic impacts from COVID-19, our ability to close and achieve the anticipated benefits from the Tetraphase acquisition, and uncertainty as to the timing and volume of orders expected from the U.S. military. In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Additional Information and Where to Find It
    In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx filed with the SEC a registration statement on Form S-4 (No. 333-237584) (the "Registration Statement") containing a document constituting a prospectus of AcelRx and a proxy statement of Tetraphase. The Registration Statement was declared effective by the SEC on April 24, 2020, and Tetraphase mailed the definitive proxy statement/prospectus to stockholders of Tetraphase on or about April 28, 2020. AcelRx and Tetraphase also plan to file other relevant documents with the SEC regarding the transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the Registration Statement and the definitive proxy statement/prospectus and other relevant documents filed or that will be filed by AcelRx or Tetraphase with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by AcelRx will be available free of charge within the Investors section of AcelRx's website at http://ir.acelrx.com. Copies of the documents filed with the SEC by Tetraphase will be available free of charge within the Investors section of Tetraphase's website at https://ir.tphase.com/investor-relations.

    Participants in the Solicitation
    Each of AcelRx and Tetraphase and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Tetraphase stockholders in connection with the proposed transaction. Information about AcelRx's directors and executive officers is included in the definitive proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020. Information about Tetraphase's directors and executive officers is included in Tetraphase's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 12, 2020. Other information regarding the participants in the solicitation of proxies in connection with the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement/prospectus filed with the SEC on April 24, 2020. When available, investors may obtain free copies of these documents from AcelRx or Tetraphase as indicated above.

    No Offer or Solicitation
    This communication is being made in respect of the proposed transaction involving AcelRx and Tetraphase. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  30. REDWOOD CITY, Calif., March 16, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its fourth quarter and full year 2019 financial results.

    "After only two quarters in 2019 with an expanded sales team, exceeding last year's formulary and REMS objectives is a solid indicator of the growing acceptance of DSUVIA® as a treatment option for the management of acute pain.  We fully expect DSUVIA's success to continue and look forward to the Department of Defense's Milestone C meeting, which we believe will provide even more opportunities," continued Angotti.  "I'm…

    REDWOOD CITY, Calif., March 16, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its fourth quarter and full year 2019 financial results.

    "After only two quarters in 2019 with an expanded sales team, exceeding last year's formulary and REMS objectives is a solid indicator of the growing acceptance of DSUVIA® as a treatment option for the management of acute pain.  We fully expect DSUVIA's success to continue and look forward to the Department of Defense's Milestone C meeting, which we believe will provide even more opportunities," continued Angotti.  "I'm also excited about the announcement earlier today related to our acquisition of Tetraphase Pharmaceuticals, Inc., which will add a key, high growth product to the portfolio, enhancing our offering to healthcare institutions, while increasing the productivity of the commercial teams."

    Fourth Quarter and Recent Highlights

    • Announced an agreement to acquire Tetraphase Pharmaceuticals in a stock for stock transaction at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, valuing Tetraphase at $14.4 million as of the close of trading on March 13, 2020. Also entered into a co-promotion agreement to immediately begin realizing commercial combination benefits prior to closing of the acquisition.
    • The Company is on track to achieve its previously communicated target of 465 REMS-certified facilities and formulary approvals by the end of 2020. As of March 15, 2020, 218 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 223 formulary approvals have been achieved.
    • Confirmed timing for April 2020 DSUVIA Milestone C meeting with the Department of Defense, with procurement recommendation expected post-meeting.
    • Announced an agreement with Brigham and Women's Hospital for an investigator-initiated study led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School. The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.

    Financial Information

    • Cash, cash equivalents and short-term investments balance of $66.1 million as of December 31, 2019;
    • Fourth quarter 2019 net revenues were $0.5 million, and for the full year 2019 were $2.3 million, as previously announced;
    • Combined R&D and SG&A expenses for the fourth quarter of 2019 totaled $13.8 million compared to $10.4 million for the fourth quarter of 2018. Excluding stock-based compensation expense, these amounts were $12.6 million for the fourth quarter of 2019 compared to $9.2 million for the fourth quarter of 2018. R&D and SG&A expenses for the year ended December 31, 2019 totaled $49.7 million compared to $33.9 million for the year ended December 31, 2018. Excluding stock-based compensation expense, these figures were $44.9 million for the year ended December 31, 2019 compared to $29.1 million for the year ended December 31, 2018. The increase in combined R&D and SG&A expenses is primarily due to increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
    • Net cash outflow for the fourth quarter of 2019 was $14.3 million, including $0.6 million in debt service, and for the year-ended December 31, 2019 was $39.6 million, and;
    • For the fourth quarter of 2019, net loss was $14.4 million, or $0.18 per basic and diluted share, compared to $12.6 million, or $0.18 per basic and diluted share, for the fourth quarter of 2018. Net loss for the year ended December 31, 2019 was $53.2 million, or $0.67 per basic and diluted share, compared to $47.1 million, or $0.81 per basic and diluted share, for the year ended December 31, 2018.

    2020 Guidance
    As previously announced, the Company's year-end goals include obtaining 465 REMS-certified facilities and 465 formulary approvals in 2020.  Quarterly combined R&D and SG&A expense in 2020 is expected to range from $10 million to $13 million, depending on the quarter, and includes approximately $1 million of non-cash stock-based compensation per quarter ($9 million to $12 million excluding stock-based compensation expense).  Annual debt service is expected to approximate $6 million.  Annual capital expenditures are expected to range from $4-$5 million attributed mainly to the installation of a new high-volume, automated packaging line at our contract manufacturer.  These amounts do not consider the impact from the previously announced acquisition of Tetraphase Pharmaceuticals but reflect the benefits of the co-promotion agreement.

    2020 financial guidance is based on the Company's current expectations and are forward-looking statements.  Actual results could differ materially depending on market conditions and the factors set forth under the "Forward-Looking Statements" heading below.

    Webcast and Conference Call Information
    As previously announced, AcelRx will host a live webcast Monday, March 16, 2020 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of the Company's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the Company's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    For more information, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures
    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. The Company believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, the Company believes that these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to the number of REMS-certified facilities and formulary approvals expected by the end of 2020, the timing of the Department of Defense Milestone C meeting and procurement of DSUVIA by the military, opportunities that may result from the Milestone C meeting, the continuing success of DSUVIA, expected commencement of an investigator-initiated study, expected R&D and SG&A expenses, debt service and capital expenditures, expected benefits from the acquisition of Tetraphase and the co-promotion agreement, and the acquisition being consummated.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in the Company's most recent annual, quarterly or current report as filed or furnished with the SEC. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Selected Financial Data

    (in thousands, except per share data)

    (unaudited)










     Three Months Ended  


     Twelve Months Ended 


    December 31


     December 31 


    2019


    2018


    2019


    2018

    Statement of Comprehensive Loss Data
















    Revenue:








       Product sales 

    $                       377


    $                       390


    $                    1,830


    $                       825

       Contract and other collaboration

    98


    223


    459


    1,326

          Total revenue

    475


    613


    2,289


    2,151









    Operating costs and expenses:








    Cost of goods sold (1)

    1,618


    1,238


    6,806


    3,976

    Research and development (1)

    1,063


    2,704


    4,661


    13,137

    Selling, general and administrative (1)

    12,786


    7,648


    45,027


    20,765

    Total operating costs and expenses

    15,467


    11,590


    56,494


    37,878

    Loss from operations

    (14,992)


    (10,977)


    (54,205)


    (35,727)









    Other income (expense):








     Interest expense

    (831)


    (459)


    (2,535)


    (2,217)

     Interest income and other income (expense), net 

    438


    495


    2,166


    1,138

     Non-cash interest income (expense) on liability related to sale of future royalties

    962


    (1,617)


    1,337


    (10,341)

    Total other income (expense)

    569


    (1,581)


    968


    (11,420)

    Provision for income taxes

    -


    -


    (3)


    (2)

    Net loss

    $                (14,423)


    $                (12,558)


    $                (53,240)


    $                (47,149)









    Basic and diluted net loss per common share

    $                    (0.18)


    $                    (0.18)


    $                    (0.67)


    $                    (0.81)









    Shares used in computing basic and diluted net loss per common share

    79,573


    70,623


    79,184


    58,409

































    (1)   Includes the following non-cash, stock-based compensation expense:















                Cost of goods sold

    $                         63


    $                         78


    $                       260


    $                       358

                Research and development

    221


    392


    920


    1,970

                Selling, general and administrative

    994


    762


    3,877


    2,840

                       Total 

    $                    1,278


    $                    1,232


    $                    5,057


    $                    5,168



















    December 31, 2019


    December 31, 2018





    Selected Balance Sheet Data








    Cash, cash equivalents and investments

    $                  66,137


    $                105,715





    Total assets

    91,356


    120,533





    Total liabilities

    132,774


    116,280





    Total stockholders' (deficit) equity 

    (41,418)


    4,253





     

    Reconciliation of Non-GAAP Financial Measures







    (Operating Expenses less associated stock-based compensation expense)













     Three Months Ended  


     Twelve Months Ended  


    December 31, 2019


    December 31, 2019


    2019


    2018


    2019


    2018









    Operating expenses (GAAP):








    Research and development 

    $                   1,063


    $                   2,704


    $                   4,661


    $                 13,137

    Selling, general and administrative 

    12,786


    7,648


    45,027


    20,765

    Total operating expenses 

    13,849


    10,352


    49,688


    33,902

    Less associated stock-based compensation expense

    1,215


    1,154


    4,797


    4,810

    Operating expenses (non-GAAP) 

    $                 12,634


    $                   9,198


    $                 44,891


    $                 29,092

     

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  31. REDWOOD CITY, Calif., March 16, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced the execution of a definitive merger agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) in a stock for stock deal at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, or approximately $14.4 million as of the close of trading on March 13, 2020, plus a contingent value right (CVR). The CVR represents additional consideration upon XERAVA™ (eravacycline for injection) achieving certain net sales starting in 2021.  The acquisition is consistent…

    REDWOOD CITY, Calif., March 16, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced the execution of a definitive merger agreement to acquire Tetraphase Pharmaceuticals, Inc. (Tetraphase) in a stock for stock deal at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, or approximately $14.4 million as of the close of trading on March 13, 2020, plus a contingent value right (CVR). The CVR represents additional consideration upon XERAVA™ (eravacycline for injection) achieving certain net sales starting in 2021.  The acquisition is consistent with AcelRx's strategic plan to expand and diversify the company's product portfolio and create a growth platform towards becoming a leader in providing innovative treatments to healthcare institutions. The transaction was unanimously approved by both the AcelRx and Tetraphase Boards of Directors and is expected to close in the second quarter of 2020, subject to customary closing conditions.  Tetraphase's four largest shareholders, including Armistice Capital, have signed voting agreements in favor of the transaction.

    AcelRx and Tetraphase have also entered into a co-promotion agreement to commercialize XERAVA™ for the treatment of complicated intra-abdominal infections (cIAI) and DSUVIA® for the management of acute pain in medically supervised settings. The co-promotion agreement will take effect immediately and enable the AcelRx and Tetraphase teams to benefit from the promotion of multiple products, leverage each company's customer relationships, and create efficiencies amongst commercial teams prior to the closing of the merger. The combined sales team covering 35 territories will reach in excess of 70% of each company's originally targeted hospitals, illustrating the revenue and expense synergy potential of the transaction.

    "We are excited to have reached agreement with Tetraphase, a company with a well-established US salesforce and a high-growth hospital product that complements AcelRx's commercial strategy," said Vince Angotti, Chief Executive Officer of AcelRx. "This transaction highlights our focus on efficiently commercializing DSUVIA with a salesforce promoting multiple products and is the first step in our plan to create a growth platform to further consolidate hospital-focused pharmaceutical companies and products. We look forward to integrating XERAVA™ and the existing Tetraphase commercial infrastructure with our own as we strengthen our position on promoting innovative products to healthcare institutions."

    "This transaction marks an exciting time for both companies, and we are thrilled to collaborate with AcelRx, a partner whose strategic goals complement our own," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "We continue to believe that XERAVA is a key addition to the hospital anti-infective armamentarium, and together with AcelRx we will be able to more effectively deliver a diverse portfolio of new patient treatments to healthcare institutions."

    Under the terms of the merger agreement, each share of Tetraphase common stock will be converted into the right to receive 0.6303 shares of AcelRx common stock, subject to adjustment in certain circumstances, and a CVR that could provide up to an additional aggregate $12.5 million to Tetraphase stockholders upon the achievement of net sales of XERAVA™ of $20 million, $35 million and $55 million within the applicable timeframes, and as soon as year-end 2021. AcelRx shareholders will own approximately 85.4% of the combined company and Tetraphase shareholders will own approximately 14.6% on a pro forma, fully diluted basis, giving effect to all dilutive securities at the time of announcement, and excluding any settlement of the CVR through issuance of AcelRx common stock.

    Closing of the transaction – expected in the second quarter of 2020 – is subject to Tetraphase having a defined cash level at closing and receipt of approval of its shareholders, as well as satisfaction of other customary closing conditions.  The transaction does not require a vote by AcelRx stockholders.

    Cooley LLP is acting as legal counsel to AcelRx.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    About Tetraphase Pharmaceuticals, Inc.
    Tetraphase Pharmaceuticals, Inc. is a biopharmaceutical company using its proprietary chemistry technology to develop and commercialize novel tetracyclines for serious and life-threatening conditions, including bacterial infections caused by many multidrug-resistant, or MDR, bacteria. There is a medical need for new antibiotics as resistance to existing antibiotics increases. The company's commercial product, XERAVA™ (eravacycline), a fully synthetic fluorocycline, is an intravenous, or IV, antibiotic that is approved for use as a first-line empiric monotherapy for the treatment of MDR infections, including those found in complicated intra-abdominal infections, or cIAI. The Tetraphase pipeline also includes TP-271 IV and Oral, and TP-6076 IV only, which are Phase 2 ready, and TP-2846, which is in preclinical testing for acute myeloid leukemia.

    For additional information about Tetraphase, please visit www.tphase.com.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated changes in the business environment in which AcelRx operates, future prospects or results, strategy, intentions, plans, hopes, beliefs, anticipations, expectations or predictions of the future, or the ability and timing of consummation of the transactions and the potential benefits of the transactions.  These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that we may not be able to close the acquisition of Tetraphase or achieve the expected benefits and cost synergies from the transactions.  In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Additional Information and Where to Find It
    In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx will file with the SEC a registration statement on Form S-4 that will include a document constituting a prospectus of AcelRx and will also contain a proxy statement of Tetraphase.  AcelRx and Tetraphase also plan to file other relevant documents with the SEC regarding the proposed transactions.  After the registration statement on Form S-4 is declared effective by the SEC, a definitive proxy statement/prospectus will be mailed to the stockholders of Tetraphase. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the registration statement on Form S-4 and the proxy statement/prospectus (when available) and other relevant documents filed or that will be filed by AcelRx or Tetraphase with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by AcelRx will be available free of charge within the Investors section of AcelRx's website at http://ir.acelrx.com. Copies of the documents filed with the SEC by Tetraphase will be available free of charge within the Investors section of Tetraphase's website at https://ir.tphase.com/investor-relations.

    Participants in the Solicitation
    Each of AcelRx and Tetraphase and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Tetraphase stockholders in connection with the proposed transaction. Information about AcelRx's directors and executive officers is included in the definitive proxy statement for its 2019 annual meeting of stockholders, which was filed with the SEC on May 14, 2019. Information about Tetraphase's directors and executive officers is included in Tetraphase's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 12, 2020. Other information regarding the participants in the solicitation of proxies in connection with the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. When available, investors may obtain free copies of these documents from AcelRx or Tetraphase as indicated above.

    No Offer or Solicitation
    This communication is being made in respect of the proposed transaction involving AcelRx and Tetraphase. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

     

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  32. AcelRx to Acquire Tetraphase in an all-stock transaction

    Tetraphase equity holders to own 14.6% of the combined company and receive Contingent Value Rights worth up to $12.5 Million

    Acquisition Expected to Close in Q2 2020

    Companies Enter into a Co-Promotion Agreement

    Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, today announced the execution of a definitive merger agreement pursuant to which AcelRx Pharmaceuticals (NASDAQ:ACRX) would acquire Tetraphase in a stock for stock transaction. Under the terms of the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock…

    AcelRx to Acquire Tetraphase in an all-stock transaction

    Tetraphase equity holders to own 14.6% of the combined company and receive Contingent Value Rights worth up to $12.5 Million

    Acquisition Expected to Close in Q2 2020

    Companies Enter into a Co-Promotion Agreement

    Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, today announced the execution of a definitive merger agreement pursuant to which AcelRx Pharmaceuticals (NASDAQ:ACRX) would acquire Tetraphase in a stock for stock transaction. Under the terms of the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, valued at approximately $14.4 million as of the close of trading on March 13, 2020, and one contingent value right (CVR), which would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future XERAVA™ net sales milestones starting in 2021. The transaction was unanimously approved by both the AcelRx and Tetraphase boards of directors and is expected to close in the second quarter of 2020. Select Tetraphase stockholders and warrant holders, including Armistice Capital, LLC, holding in the aggregate approximately 31% of Tetraphase's outstanding common stock, have signed voting agreements in favor of the transaction.

    Concurrently with signing the merger agreement, Tetraphase and AcelRx entered into a co-promotion agreement to market and promote XERAVA™ for the treatment of complicated intra-abdominal infections (cIAI) and DSUVIA® for the treatment of acute pain in medically supervised settings. The co-promotion agreement will allow the AcelRx and Tetraphase teams to benefit immediately from the promotion of multiple products, leverage each company's customer relationships, and create efficiencies among commercial teams. The combined sales team will cover in excess of 70% of each company's originally targeted hospitals.

    "This transaction is an important move forward for Tetraphase and more importantly, for XERAVA and the patients who need this treatment," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "We are excited to collaborate with AcelRx, a partner whose strategic goals complement our own. We continue to believe that XERAVA is a key addition to the hospital anti-infective armamentarium, and believe that together with AcelRx we will be able to more effectively bring new treatments to patients in healthcare institutions."

    "We are excited to have reached agreement with Tetraphase, a company with a well-established U.S. salesforce and a high-growth hospital product that complements AcelRx's commercial strategy," said Vince Angotti, Chief Executive Officer of AcelRx. "This transaction highlights our focus on efficiently commercializing DSUVIA with a salesforce promoting multiple products and is the first step in our plan to create a growth platform to further consolidate hospital-focused pharmaceutical companies and products. We look forward to integrating XERAVA and the existing Tetraphase commercial infrastructure with our own as we strengthen our position on promoting innovative products to healthcare institutions allowing patients access to new and improved treatments."

    Based on the closing price of AcelRx stock on March 13, 2020, the stock consideration to be received by Tetraphase equityholders is valued at approximately $14.4 million, with approximately $7.4 million of this amount allocated to the Company's outstanding common stock warrants. In the merger, Tetraphase stockholders would also be entitled to receive, for each share of Tetraphase common stock, one non-tradeable CVR, the holders of which will be entitled to receive payments of up to an additional $12.5 million in the aggregate upon the achievement of net sales of XERAVA™ in the United States of at least (i) $20 million during 2021, (ii) $35 million during any year ending on or before December 31, 2024 and (iii) $55 million during any year ending on or before December 31, 2024. The total cost synergy expectation from the combined company exceeds 90% of the Tetraphase operating expenses and are expected to be fully realized in 2021.

    Closing of the transaction is subject to specified closing conditions, including Tetraphase having a minimum amount of net cash as of the closing and approval by Tetraphase stockholders. Upon the closing of the transaction, Tetraphase will become a privately held company and shares of Tetraphase's common stock will no longer be listed on any public market. Subject to certain limited exceptions, the CVRs will be non-transferable.

    Janney Montgomery Scott is acting as financial advisor to Tetraphase and has rendered a fairness opinion to Tetraphase's board of directors in connection with the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor to Tetraphase in connection with the transaction.

    About XERAVATM

    XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

    XERAVATM Important Safety Information

    XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.

    XERAVA is not indicated for the treatment of complicated urinary tract infections.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

    The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

    XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

    To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

    Please see full prescribing information for XERAVA.

    About Tetraphase Pharmaceuticals, Inc.

    Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company using its proprietary chemistry technology to create novel tetracyclines for serious and life-threatening conditions, including infections caused by many of the multidrug-resistant bacteria highlighted as urgent public health threats by the World Health Organization and the Centers for Disease Control and Prevention. The Company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's lead product XERAVA™ is approved for the treatment of complicated intra-abdominal infections by the U.S. Food and Drug Administration and the European Medicines Agency. The Company's pipeline also includes antibiotics TP-271 and TP-6076, which are Phase 2 ready, and TP-2846, which is in preclinical testing for acute myeloid leukemia. The Company intends to out license its pipeline candidates. Please visit www.tphase.com for more company information.

    Important Information for Investors and Stockholders

    This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. It does not constitute a prospectus or prospectus equivalent document. In connection with the proposed transaction between AcelRx and Tetraphase, AcelRx and Tetraphase will file relevant materials with the Securities and Exchange Commission (the "SEC"), including an AcelRx registration statement on Form S-4 that will include a proxy statement of Tetraphase that also constitutes a prospectus of AcelRx, and a definitive proxy statement/prospectus will be mailed to stockholders of Tetraphase. INVESTORS AND SECURITY HOLDERS OF TETRAPHASE ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the registration statement and the proxy statement/prospectus (when available) and other documents filed with the SEC by AcelRx or Tetraphase through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by Tetraphase will be available free of charge on the "Investors—Financials and Filings" portion of Tetraphase's internet website at www.tphase.com.

    Tetraphase and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the merger agreement. Information regarding Tetraphase's directors and executive officers is contained in Tetraphase's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 12, 2020. Additional information regarding the direct and indirect interests of Tetraphase's directors and executive officers in the proposed transaction will be included in the proxy statement when it is filed with the SEC.

    Forward-Looking Statements

    Statements in this press release regarding the proposed transaction between AcelRx and Tetraphase, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company and any other statements about Tetraphase management's future expectations, beliefs, goals, plans or prospects constitute forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing "believes," "anticipates," "plans," "expects," "may," "will," "would," "intends," "estimates" and similar expressions) should also be considered to be forward‑looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward‑looking statements, including the risk that the proposed merger may not be completed in a timely manner, or at all, which may adversely affect Tetraphase's business and the price of its common stock; the failure to satisfy all of the closing conditions of the proposed merger, including the adoption of the merger agreement by Tetraphase's stockholders; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the proposed merger on Tetraphase's business, operating results and relationships with customers, suppliers, competitors and others; risks that the proposed merger may disrupt Tetraphase's current plans and business operations; potential difficulties retaining employees as a result of the proposed merger; risks related to the diverting of management's attention from Tetraphase's ongoing business operations; the outcome of any legal proceedings that may be instituted against Tetraphase related to the merger agreement or the proposed merger; risks relating to product development and commercialization, demand for Tetraphase's products and limited number of customers; risks associated with competition and other commercial and other risk factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 12, 2020. In addition, the forward-looking statements included in this press release represent our views as of March 16, 2020. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Tetraphase's views as of any later date.

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  33. REDWOOD CITY, Calif., March 11, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release fourth quarter and annual financial results before market open on Monday, March 16, 2020. AcelRx management will host a live webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) on March 16, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website…

    REDWOOD CITY, Calif., March 11, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company, today announced that it will release fourth quarter and annual financial results before market open on Monday, March 16, 2020. AcelRx management will host a live webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) on March 16, 2020 to discuss the financial results and provide an update on the company's business.

    The webcast is accessible by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation.  A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company's website at www.acelrx.com.

    Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA®(sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. Zalviso is an investigational drug and not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  34. REDWOOD CITY, Calif., March 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced confirmation that the Department of Defense Milestone C meeting will be held next month.  The Milestone C meeting marks the end of the project development phase and leads to the recommendation for the procurement phase of the project. 

    "We are excited to have a confirmed date for the Milestone C meeting and expect DSUVIA® will soon be made available more broadly for military use," said Vince Angotti, Chief Executive Officer of AcelRx Pharmaceuticals.  "The Department of Defense has…

    REDWOOD CITY, Calif., March 10, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced confirmation that the Department of Defense Milestone C meeting will be held next month.  The Milestone C meeting marks the end of the project development phase and leads to the recommendation for the procurement phase of the project. 

    "We are excited to have a confirmed date for the Milestone C meeting and expect DSUVIA® will soon be made available more broadly for military use," said Vince Angotti, Chief Executive Officer of AcelRx Pharmaceuticals.  "The Department of Defense has been a great partner supporting the development of DSUVIA since 2011, and this is the final stage in the process that enables us to provide DSUVIA to fulfill an unmet need for our injured soldiers," continued Angotti.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    For more information, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to the timing of the Department of Defense Milestone C meeting and anticipated procurement by the military.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  35. REDWOOD CITY, Calif., March 6, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an agreement with Brigham and Women's Hospital for an investigator-initiated study led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School.  The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.  Perioperative use of DSUVIA in a prospective cohort of patients undergoing spine surgery will be compared to historical…

    REDWOOD CITY, Calif., March 6, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an agreement with Brigham and Women's Hospital for an investigator-initiated study led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School.  The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.  Perioperative use of DSUVIA in a prospective cohort of patients undergoing spine surgery will be compared to historical controls.  Analysis will include whether DSUVIA is associated with a reduction in: pain intensity in the recovery room, opioid consumption, number of IV fentanyl boluses, opioid-induced side effects, and hospitalization costs.

    "An important part of our post-approval research strategy is to obtain data from top-tier hospitals about the effectiveness of DSUVIA in minimizing IV opioid administration while maintaining an effective level of analgesia for the patient," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "By supporting investigator-initiated studies by highly respected institutions, such as Brigham and Women's Hospital, we look to further test the effectiveness, efficiency and safety of DSUVIA in a wide variety of patients as well as its unique pharmacokinetic profile and non-invasive route of administration.  We believe DSUVIA will soon become a key analgesic medication in the healthcare practitioners' armamentarium for the management of acute pain in medically supervised settings," continued Dr. Palmer.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    For more information, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study and the scope of the study.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  36. REDWOOD CITY, Calif., Jan. 13, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today provided an update on its business and DSUVIA® launch metrics.

    "Exceeding our 2019 formulary approvals and number of REMS-certified facilities targets after only two full quarters with our 40-person sales team demonstrates DSUVIA's early acceptance by healthcare facilities," said Vince Angotti, Chief Executive Officer of AcelRx. "We begin 2020 with a solid foundation of REMS-certified healthcare facilities, and will now increase our focus on DSUVIA's adoption and orders from this installed…

    REDWOOD CITY, Calif., Jan. 13, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today provided an update on its business and DSUVIA® launch metrics.

    "Exceeding our 2019 formulary approvals and number of REMS-certified facilities targets after only two full quarters with our 40-person sales team demonstrates DSUVIA's early acceptance by healthcare facilities," said Vince Angotti, Chief Executive Officer of AcelRx. "We begin 2020 with a solid foundation of REMS-certified healthcare facilities, and will now increase our focus on DSUVIA's adoption and orders from this installed base while continuing our expansion to an expected 465 REMS-certified facilities and 465 formulary approvals by the end of 2020.  This increased focus on adoption is expected to accelerate revenue growth in 2020," continued Angotti.

    Business Updates and Highlights

    • 166 healthcare facilities are REMS-certified and able to purchase DSUVIA and 148 formulary approvals have been achieved through December 31, 2019, exceeding year-end goals of 125 for each metric.
    • Preliminary unaudited FY 2019 total revenues of $2.3 million.
    • Cash, cash equivalents and short-term investments of $66.1 million as of December 31, 2019.
    • Year-end 2020 goals of 465 REMS-certified facilities and 465 formulary approvals.
    • Department of Defense Milestone C meeting for DSUVIA is expected in the second quarter of 2020; the Company expects the military to begin procuring DSUVIA following successful completion of this meeting.
    • Commencement of investigator-initiated studies of DSUVIA in post-operative pain management and Enhanced Recovery protocols at prominent university hospitals is anticipated beginning in the first half of 2020.
    • The Company is hosting investor meetings in San Francisco this week during the JP Morgan Healthcare Conference.

    The information above related to the Company's expected operating results for the year ended and as of December 31, 2019, including revenue and cash, cash equivalents and short-term investments, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company's financial statements as of and for the year ended December 31, 2019.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    For more information, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to revenues, cash, cash equivalents and short-term investments the Company expects to report for fiscal year 2019, the number of REMS-certified facilities and formulary approvals expected by the end of 2020, the timing of the Department of Defense Milestone C meeting and procurement of DSUVIA by the military, expected commencement of investigator-initiated studies and anticipated acceleration of revenue growth.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the challenges in achieving market adoption of DSUVIA, REMS-certified facilities and formulary approvals, or acceleration of revenue growth in a timely manner, or at all.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in the Company's most recent annual, quarterly or current report as filed or furnished with the SEC. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.


    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  37. REDWOOD CITY, Calif., Nov. 13, 2019 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced a publication analyzing pooled dosing and efficacy data from use of the sufentanil sublingual tablet (SST) 30 mcg among multiple demographic subgroups (age, sex, race, and body mass index).  This data, published in the Journal of PeriAnesthesia Nursing, was analyzed to aid nurses in understanding the effectiveness and duration of action of SST 30 mcg in the management of moderate-to-severe acute pain across a variety of patient demographics.

    In this study, patient characteristics were…

    REDWOOD CITY, Calif., Nov. 13, 2019 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced a publication analyzing pooled dosing and efficacy data from use of the sufentanil sublingual tablet (SST) 30 mcg among multiple demographic subgroups (age, sex, race, and body mass index).  This data, published in the Journal of PeriAnesthesia Nursing, was analyzed to aid nurses in understanding the effectiveness and duration of action of SST 30 mcg in the management of moderate-to-severe acute pain across a variety of patient demographics.

    In this study, patient characteristics were pooled from three postoperative studies, and one open-label emergency department study, while drug dosing and efficacy data were pooled from postoperative studies. Mean drug doses administered from 0-12 hours was 3.9 for SST 30 mcg, and was less frequent for older (≥65 years) compared to younger patients but was similar among other subgroups. Summed pain intensity difference to baseline over 12 hours (SPID12) was higher (superior) in the SST 30-mcg group compared with placebo across all demographic subgroups.

    "We are pleased with the results of this analysis, particularly that a single dosage-strength tablet has efficacy across all the demographic subgroups," commented Dr. Pamela Palmer, AcelRx Chief Medical Officer. "An important reason behind the development of DSUVIA® was to avoid common opioid medication errors occurring with the clear injectable opioids, which come in widely differing concentrations. Also, the timely onset of analgesia and the duration of action allow DSUVIA to fit nicely into the fast-paced environment of the post-surgical recovery room and emergency departments."

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    For more information, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA®(sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. For additional information about AcelRx, please visit www.acelrx.com.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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  38. REDWOOD CITY, Calif., Nov. 6, 2019 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its third quarter 2019 financial results.

    "Achieving 125 REMS-certified facilities two months ahead of our year-end goal demonstrates healthcare providers' increasing interest in DSUVIA," said Vince Angotti, Chief Executive Officer of AcelRx. "We also expect to achieve our year-end objective of 125 formulary approvals and anticipate expanded use across a variety of healthcare settings as the feedback on DSUVIA® from healthcare professionals continues to be very positive," continued…

    REDWOOD CITY, Calif., Nov. 6, 2019 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its third quarter 2019 financial results.

    "Achieving 125 REMS-certified facilities two months ahead of our year-end goal demonstrates healthcare providers' increasing interest in DSUVIA," said Vince Angotti, Chief Executive Officer of AcelRx. "We also expect to achieve our year-end objective of 125 formulary approvals and anticipate expanded use across a variety of healthcare settings as the feedback on DSUVIA® from healthcare professionals continues to be very positive," continued Angotti.

    Third Quarter and Recent Highlights

    • 130 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 105 formulary approvals have been achieved through October 31, 2019; approximately 60% of REMS certifications and formulary approvals have occurred since the date of the Company's last earnings call
    • AcelRx was selected to present at one of the two plenary sessions of the 2019 Military Health System Research Symposium; the presentation was entitled "Pooled Safety Analysis of Patients Who Were Exposed to < 300 mcg vs. ≥300 mcg of Sublingual Sufentanil in a 24 Hour Period for Treatment of Acute Pain"
    • Pooled dosing and efficacy data from use of the sufentanil sublingual tablet (SST) 30 mcg among multiple demographic subgroups (age, sex, race, and body mass index) was accepted for publication in the Journal of PeriAnesthesia Nursing to aid nurses in understanding the effectiveness and duration of action of SST 30 mcg in the management of moderate-to-severe acute pain across a variety of patient demographics

    Financial Information

    • Cash, cash equivalents and short-term investments balance of $80.4 million as of September 30, 2019;
    • Combined R&D and SG&A expenses for the third quarter of 2019 totaled $12.0 million compared to $8.8 million for the third quarter of 2018. Excluding stock-based compensation expense, these amounts were $10.7 million for the third quarter of 2019 compared to $7.1 million for the third quarter of 2018. R&D and SG&A expenses for the first nine months of 2019 totaled $35.8 million compared to $23.6 million in the first nine months of 2018. Excluding stock-based compensation expense, these figures were $32.3 million for the first nine months of 2019 compared to $19.9 million for the first nine months of 2018. The increase in R&D and SG&A expenses is primarily due to increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
    • Net cash outflow for the third quarter of 2019 was $11.1 million, which included $0.6 million in debt service;
    • For the third quarter of 2019, net loss was $12.7 million, or $0.16 per basic and diluted share, compared to $12.5 million, or $0.21 per basic and diluted share, for the third quarter of 2018. Net loss for the first nine months of 2019 was $38.8 million, or $0.49 per basic and diluted share, compared to $34.6 million, or $0.64 per basic and diluted share, for the prior year period.

    Webcast and Conference Call Information
    As previously announced, AcelRx will host a live webcast Wednesday, November 6, 2019 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of the Company's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the Company's website at www.acelrx.com.

    About DSUVIA (sufentanil sublingual tablet), 30 mcg
    DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

    For more information, please visit www.DSUVIA.com.

    About AcelRx Pharmaceuticals, Inc.
    AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

    For additional information about AcelRx, please visit www.acelrx.com.

    Non-GAAP Financial Measures
    To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. The Company believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, the Company believes that these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's condensed consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Forward-Looking Statements
    This press release contains forward-looking statements, including, but not limited to, statements related to anticipated formulary approvals and use of DSUVIA.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in the Company's most recent annual, quarterly or current report as filed or furnished with the SEC. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Selected Financial Data

    (in thousands, except per share data)

    (unaudited)








     Three Months Ended  


     Nine Months Ended 


     September 30 


    September 30


    2019

    2018


    2019

    2018







    Net product sales 

    $                        116

    $         -


    $       218

    $            -

    Collaboration agreement

    492

    177


    $    1,596

    $       802

    Contract and other

    -

    200


    -

    736

          Total revenue

    608

    377


    1,814

    1,538







    Operating costs and expenses:






    Cost of goods sold

    2,148

    875


    5,188

    2,738

    Research and development

    1,058

    3,642


    3,598

    10,433

    General and administrative

    10,936

    5,188


    32,241

    13,117

    Total operating costs and expenses

    14,142

    9,705


    41,027

    26,288

    Loss from operations

    (13,534)

    (9,328)


    (39,213)

    (24,750)







    Other income (expense):






    Interest expense

    (828)

    (529)


    (1,704)

    (1,758)

    Interest income and other income (expense), net

    645

    312


    1,728

    643

    Non-cash interest income (expense) on liability related to sale of future royalties

    986

    (2,913)


    375

    (8,724)

    Total other income (expense)

    <