PRTK Paratek Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
|
sNDA Filing
sNDA Filing
|
sNDA filing submitted July 2020.
|
|
Omadacycline
Complicated urinary tract infections (cUTI) / acute pyelonephritis
|
Phase 2
Phase 2
|
Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
|
|
Omadacycline
Urinary tract infections
|
Phase 2
Phase 2
|
Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
|
|
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
|
Approved
Approved
|
FDA Approval announced October 2, 2018.
|
|
Omadacycline
Community-acquired bacterial pneumonia (CABP)
|
Approved
Approved
|
FDA Approval announced October 2, 2018.
|
|
Sarecycline
Severe acne vulgaris
|
Approved
Approved
|
FDA Approval announced October 2, 2018.
|
|
Intermezzo
Insomnia
|
Approved
Approved
|
Approved November 23, 2011.
|
Latest News
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BOSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at H.C. Wainwright 22nd Annual Global Investment Conference, Monday, September 14, 2020 at 5:00 p.m. ET.
To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/hcw7/prtk/1629433.
Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.CONTACT:
Investor and Media Relations: Ben Strain 617-807-6688 [email protected] 
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-- Paratek Raises Full Year 2020 Revenue Guidance; Total Revenue guidance expected to be Between $78 and $83 Million Driven by Strong NUZYRA Net Revenue
-- Company Lowering 2020 R&D and SG&A Expense Guidance to approximately $135 million Driven by Continued Focus on Operational Efficiencies
-- FDA Pre-EUA Review Remains Ongoing; NUZYRA Procurement by BARDA for the Strategic National Stockpile Anticipated by year-end 2020
-- Company Strengthens Long-term Cash Position through Amendment to Hercules Loan Agreement
BOSTON, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended June 30, 2020.
"Demand for NUZYRA was strong in the first half of 2020 with the momentum continuing into the third quarter," said Evan Loh, M.D., Chief Executive Officer. "I am particularly pleased that these results were achieved despite a healthcare environment where the unprecedented global pandemic temporarily closed many healthcare practices and eliminated essentially all face to face access for our sales representatives. Our results reinforce our continued belief and confidence that NUZYRA is well-positioned to help address current and future unmet medical needs at a time when antibiotic resistance is a growing global threat."
"BARDA and Paratek continue to effectively execute on the anthrax development program and U.S. onshoring activities for NUZYRA," Dr. Loh continued. "The FDA review of the pre-EUA application remains ongoing and BARDA continues to be fully committed to procuring NUZYRA for the Strategic National Stockpile once the FDA review process is completed. We appreciate BARDA's confidence in Paratek and their significant investment in this innovative, long-term public-private partnership for the development of NUZYRA in the fight against bioterrorism and antimicrobial resistance in order to save lives and protect Americans."
Recent NUZYRA Commercial Highlights
- NUZYRA generated $8.1 million in net revenue in the second quarter of 2020, an 11% increase over the prior quarter and 378% increase over the second quarter of 2019. NUZYRA revenue growth continues to validate the Company's initial launch strategy with 90% of demand being generated from hospitals and adjacent sites of care.
Other Highlights
- The initial NUZYRA procurement by Biomedical Advanced Research and Development Authority (BARDA) for the Strategic National Stockpile (SNS) valued at approximately $38 million is now anticipated to be secured by year end 2020.
° The Food and Drug Administration (FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. The Company believes the review was delayed due to internal resourcing at FDA caused by the COVID-19 pandemic and other review priorities at FDA unrelated to NUZYRA. As part of the ongoing review, FDA has requested supplemental mouse pharmacokinetic data to support the human dose recommendation in case of an immediate anthrax outbreak. This work has been initiated and expected to be completed in 8 to 10 weeks.
- In July 2020, the supplemental NDA to support an oral-only dosing label for Community-Acquired Bacterial Pneumonia (CABP) was submitted to FDA with an approval expected during the 2020-2021 pneumonia season.
- In August 2020, Paratek modified its outstanding loan agreement with Hercules Capital.
° Under the terms of the agreement, Paratek repaid $10 million of the principal $70 million loan balance reducing the outstanding loan to $60 million.
° The interest-only period under the new loan agreement is now extended through December 2021, with further extension of the interest-only period of up to an additional 12 months, contingent on Paratek achieving certain performance-based milestones.Second Quarter 2020 Financial Results
Paratek reported a net loss of $23.1 million, or ($0.53) per share, for the second quarter of 2020, compared to a net loss of $33.2 million, or ($1.02) per share, for the same period in 2019.Total revenue was $9.3 million for the second quarter of 2020, an increase of 18% versus the prior quarter and 356% versus the same quarter in the prior year.
- U.S. NUZYRA net revenue of $8.1 million for the second quarter of 2020 grew 11% versus the prior quarter and 378% versus the same quarter in the prior year.
- Government contract service and grant revenue was $0.9 million for the second quarter of 2020 versus $0.3 million in the prior quarter. No revenue was generated from the BARDA contract in 2019.
- Second quarter 2020 collaboration and royalty revenue was $0.3 million, which is consistent with both the prior quarter and the same quarter in prior year.
Research and development (R&D) expenses were $4.6 million for the second quarter of 2020, compared to $10.7 million for the second quarter of 2019. The $6.1 million decrease is primarily the result of lower personnel-related costs, lower clinical study costs associated with our Phase 2 UTI program and other operational efficiencies.
Selling, general and administrative (SG&A) expenses were $21.0 million for the second quarter of 2020, compared to $20.9 million for the second quarter of 2019.
As of June 30, 2020, Paratek had $186.8 million in cash, cash equivalents and marketable securities.
Financial Guidance
Paratek is raising its full year 2020 revenue guidance primarily based on the stronger than anticipated U.S. NUZYRA net product revenue modestly offset by lower than anticipated royalty revenue from SEYSARA.- Paratek now estimates 2020 total revenue to be between $78 and $83 million, an increase from our prior guidance of $75 and $80 million.
° The Company now anticipates the initial BARDA procurement of 2,500 anthrax treatment courses valued at approximately $38 million to occur by the end of 2020 contingent on the completion of the pre-EUA application review by FDA.
- 2020 R&D and SG&A expense is now expected to be approximately $135 million compared to the prior guidance of $140 million, driven by an increased focus on operational efficiencies and other favorability driven by the COVID-19 pandemic. Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to be modestly lower when compared to 2019.
° Based upon our current operating plan, which includes estimated NUZYRA U.S. product revenue and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $186.8 million, as of June 30, 2020, provide for a cash runway through the end of 2023 with a pathway to cash flow break even. This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement.
Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.
Call and Webcast
Paratek's earnings conference call for the quarter ended June 30, 2020 will be broadcast at 8:30 a.m. EDT on August 10, 2020. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.Domestic investors wishing to participate in the call should dial: 888-256-1007 and international investors should dial: 323-994-2093. The conference ID is 8856661. Investors can also access the call at http://public.viavid.com/index.php?id=141013.
Website Information
Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document.About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA's procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalties and SEYSARA -backed loan funded on May 1, 2019, the strategy, execution and progression of our commercial launch of NUZYRA, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.PARATEK PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)June 30,
2020December 31,
2019Cash, cash equivalents and marketable securities $ 186,818 $ 215,379 Total assets 227,126 251,079 Working capital 188,278 219,154 Total current liabilities 33,925 24,200 Long-term debt, less current portion 251,586 260,728 Common stock and additional paid-in capital 698,222 671,537 Accumulated deficit (761,934 ) (711,258 ) Total stockholders' deficit (63,458 ) (39,647 ) Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except loss per share data)Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Product revenue, net $ 8,133 $ 1,702 $ 15,436 $ 3,049 Government contract service revenue 439 — 775 — Government contract grant revenue 437 — 437 — Collaboration and royalty revenue 317 343 597 594 Net revenue $ 9,326 $ 2,045 $ 17,245 $ 3,643 Expenses: Cost of product revenue 2,236 567 3,707 773 Research and development 4,561 10,679 10,949 22,071 Selling, general and administrative 20,975 20,920 44,613 44,238 Total operating expenses 27,772 32,166 59,269 67,082 Loss from operations (18,446 ) (30,121 ) (42,024 ) (63,439 ) Other income and expenses: Interest income 363 935 1,067 1,881 Interest expense (4,971 ) (3,991 ) (9,797 ) (7,217 ) Other gains (losses), net (5 ) (24 ) 78 (36 ) Net loss $ (23,059 ) $ (33,201 ) $ (50,676 ) $ (68,811 ) Other comprehensive loss Unrealized gain (loss) on available-for-sale securities, net of tax (217 ) 144 180 344 Comprehensive loss $ (23,276 ) $ (33,057 ) $ (50,496 ) $ (68,467 ) Basic and diluted net loss per common share $ (0.53 ) $ (1.02 ) $ (1.19 ) $ (2.12 ) Weighted average common stock outstanding Basic and diluted 43,629,836 32,446,202 42,635,520 32,390,691 Investor and Media Relations:
Ben Strain
617-807-6688
[email protected] - NUZYRA generated $8.1 million in net revenue in the second quarter of 2020, an 11% increase over the prior quarter and 378% increase over the second quarter of 2019. NUZYRA revenue growth continues to validate the Company's initial launch strategy with 90% of demand being generated from hospitals and adjacent sites of care.
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BOSTON, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at two upcoming healthcare conferences.
The BTIG Biotechnology Conference 2020
Tuesday, August 11, 2020 at 11:30 a.m. ET.
To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/btig/prtk/.2020 Wedbush PacGrow Healthcare Virtual Conference
Wednesday, August 12, 2020 at 2:55 p.m. ET.
To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/wedbush36/prtk/2262299.Please connect to the sites at least 15 minutes prior to the live presentations to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.CONTACT:
Investor and Media Relations:
Ben Strain
617-807-6688
[email protected] -
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BOSTON, July 28, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Monday, August 10, 2020 at 8:30 a.m. EDT to report its financial results for the quarter ended June 30, 2020 and provide a corporate update.
The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com.
Domestic investors wishing to participate in the call should dial: 888-256-1007 and international investors should dial: 323-994-2093. The conference ID is 8856661. Investors can also access the call at http://public.viavid.com/index.php?id=141013.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use.The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
About NUZYRA®
NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.CONTACT:
Investor and Media Relations:
Ben Strain
617-807-6688
[email protected] -
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- Experienced healthcare industry executive with 35 years of experience
- Additions to the board of directors to support the company's advancing its lead program, NTX-001, along with its pipeline products
Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer. Mr. Radie also will serve as Chairman of Neuraptive's Board of Directors.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200623005779/en/
Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)
"We are very pleased to have attracted an experienced and accomplished industry executive to lead Neuraptive," said Ivan Gergel, MD, a partner at New Rhein Healthcare Investors and a member of Neuraptive's Board of Directors. "Having led numerous companies from their development stage through acquisition or commercialization, Bob brings deep knowledge from the pharmaceutical and biotech industries, with significant executive, development, commercial, and deal-making capabilities."
Mr. Radie brings more than three decades of industry experience, working in both public and private pharmaceutical and biotech companies, and across a range of therapeutic areas. He has held senior executive positions in six companies, including serving as Chief Executive Officer of Zyla Life Sciences, Inc. Transmolecular Inc, and Topaz Pharmaceuticals, Inc., which was acquired by Sanofi Pasteur. Mr. Radie also served as Chief Business Officer at Prestwick Pharmaceuticals, Inc., which was sold to Biovail Pharmaceutics, Morphotek, Inc., which was sold to Eisai Co., Ltd., and Senior Vice President of Strategy and Planning at Vicuron Pharmaceuticals, Inc., which was sold to Pfizer.
Mr. Radie currently serves on the board of directors of several companies, including Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), and Rockwell Medical Technologies Inc. (NASDAQ:RMTI). He also serves as a member of the board of directors of Life Sciences Pennsylvania (LSPA), the Pennsylvania industry advocacy group.
"I am eager to get started with Neuraptive as the company transitions into a clinical-stage organization on the verge of enrolling the first patients in an important Phase 2 trial and having recently received Fast Track designation from the FDA," said Bob Radie. "I look forward to working with the board of directors and the experienced team of executives and employees to bring potentially game-changing technologies to patients who have experienced nerve injuries and to the surgeons who treat them."
The following changes are being made to the board of directors as the company progresses to a clinical-stage organization. Gino DiSciullo, Ph.D., a co-founder of Neuraptive, has stepped down as a director. "We want to thank Gino for his contributions to the company over the last two years," said Ivan Gergel. In the coming months, an additional independent director will be added.
In addition, the New Rhein Investors collectively have indicated their intention to invest at least $3,000,000 in the next Qualified Financing, provided that the terms and conditions of such financing are acceptable to the New Rhein Investors, New Rhein previously invested $7.5M in the company's Series A Financing.
About Neuraptive Therapeutics
Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company's franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, PA, and has offices near Boulder, CO, as well as surgical translational medical facilities at the Colorado University Anschutz Medical Center in Aurora, CO. For more information, see www.neuraptive.com.
About New Rhein Healthcare Investors
New Rhein is a venture capital/early growth stage fund manager whose investment strategy focuses on proven molecules used in new ways, such as new delivery forms and potential new uses and indications. In this way, New Rhein limits science-based risk and concentrates on development and execution. Prior investments have included medicines for Alzheimer's disease, ophthalmic disorders, respiratory disease, and molecular oncology diagnostics. New Rhein's partners, associates, and advisors are knowledgeable former industry executives with solid track records of operational, investment, and transactional experience. New Rhein combines significant deal-making expertise with deep operating experience, allowing it to tailor the right deal for the right situation and work with its portfolio companies to achieve maximum value for their products. For more information, see www.newrhein.com.
Cautionary Note on Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200623005779/en/