Onconova Therapeutics, Inc. and Trawsfynydd Therapeutics, Inc. Announce Business Combination to Form Traws Pharma, Inc, a Best-in-Class Virology and Oncology Company
- Merger between Onconova Therapeutics, Inc. and Trawsfynydd Therapeutics, Inc. forming Traws Pharma, Inc.
- New ticker symbol 'TRAW' on NASDAQ resulting from the merger.
- Planned private placement to raise $14 million, expecting a cash balance of $28 million.
- Focus on developing viroksavir, travaltrevir, and narazaciclib for influenza, COVID-19, and LGEEC.
- Multiple catalysts expected in 2024 for viroksavir and travaltrevir.
- None.
Insights
The merger between Onconova Therapeutics and Trawsfynydd Therapeutics, forming Traws Pharma, represents a significant consolidation within the biotech industry, particularly in the antiviral drug development space. The financial infusion of $14 million through a private placement led by notable investors OrbiMed and Torrey Pines underscores confidence in Traws Pharma's potential. The expected closing cash balance of $28 million provides Traws with a robust runway to progress its three key assets through important clinical milestones.
Investors should note the strategic positioning of Traws Pharma's assets, including viroksavir, travaltrelvir and narazaciclib, which target influenza, COVID-19 and endometrial cancer, respectively. The diversified portfolio mitigates risk and capitalizes on current market needs for novel antiviral therapies and cancer treatments. The projected timelines for top-line readouts in H2 2024 for viroksavir and travaltrelvir and the dose ranging study for narazaciclib, are pivotal events that could significantly influence Traws' stock performance and market valuation.
It is important for investors to monitor the progress of these assets, as successful clinical outcomes could lead to substantial upside, while any setbacks might negatively impact investor sentiment and stock price. The merger and subsequent R&D advancements could also attract potential partnership opportunities, further bolstering the company's financial position and growth prospects.
From a medical research perspective, the merger between Onconova and Trawsfynydd and the subsequent development of their combined pipeline is a strategic move that could potentially address significant unmet medical needs. The focus on developing best-in-class or class-leading assets in viroksavir, travaltrelvir and narazaciclib is particularly noteworthy.
Viroksavir's progress into Phase 2 studies following a successful Phase 1 that demonstrated safety and tolerability is promising. Its potential as a single oral dose for both treatment and prophylaxis of influenza could be a game-changer in managing seasonal and pandemic flu outbreaks. Similarly, travaltrelvir's potential as an oral inhibitor for COVID-19 that does not require co-administration with a CYP inhibitor could simplify treatment regimens and expand patient eligibility.
Narazaciclib's advancement is also significant, as it targets low-grade endometrioid endometrial cancer (LGEEC), a specific cancer subtype with limited treatment options. The compound's potential to offer a better efficacy/safety ratio and reduced toxicities compared to existing CDK4/6 inhibitors could lead to improved patient outcomes and adherence.
The medical community will be closely watching the RP2D determination for narazaciclib, as it will inform the drug's therapeutic window and potential for broader clinical applications. The success of these assets in their respective trials could lead to new, effective treatments for patients and represent a major advancement in the field of antiviral and cancer therapeutics.
The merger between Onconova Therapeutics and Trawsfynydd Therapeutics to form Traws Pharma is a strategic move that is likely to have a considerable impact on the biotechnology market, especially in the infectious disease and oncology sectors. The combined entity's focus on developing potential best-in-class assets aligns with the increasing demand for innovative treatments in these therapeutic areas.
Market trends indicate a growing emphasis on targeted therapies and Traws Pharma's pipeline, which includes a next-generation CDK4/6 inhibitor and novel antivirals, is well-positioned to capitalize on this trend. The antiviral market, in particular, has seen a surge in interest due to the COVID-19 pandemic and continued innovation is critical as viral pathogens evolve.
The company's ability to execute on its clinical development plans and meet the projected milestones will be important for maintaining investor confidence and market competitiveness. The successful development and potential approval of Traws Pharma's assets could lead to significant market share capture and revenue generation, especially if the products demonstrate superiority or distinct advantages over existing therapies.
Additionally, the appointment of a leadership team with a strong track record in viral disease and oncology research may provide Traws Pharma with the expertise necessary to navigate the complex regulatory and market landscapes, which is vital for commercial success in the biotech industry.
- Closing cash balance of approximately
$28 million expected from concurrent private placement led by OrbiMed and Torrey Pines - Funding expected to advance development of three potential best-in-class/class leading assets: viroksavir, a cap-dependent endonuclease inhibitor for influenza; travaltrelvir, a protease inhibitor for COVID19; and narazaciclib, a next generation CDK4/6 inhibitor for low grade endometriod endometrial cancer (LGEEC)
- Multiple near-term catalysts, for viroksavir and travaltrevir in 2024, with first top-line read-outs expected in H2 2024
- Traws Pharma to be led by incoming CEO, Werner Cautreels, Ph.D.
- Combined board to be led by Executive Chairman Iain Dukes DPhil (OrbiMed) along with Nikolay Savchuk, Ph.D. (Torrey Pines)
- Companies to host joint webcast, April 2, 2024 at 8:30 a.m. ET
NEWTOWN, Pa. and ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), and Trawsfynydd Therapeutics, Inc. (“Trawsfynydd”), a privately-held biotechnology company developing next-generation, best-in-class antivirals for influenza, COVID and other infectious diseases, today announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction (the “Merger”). Under the terms of the agreement, Onconova acquired
In connection with the Merger, Traws announced that it will raise
“I am pleased to announce the combination of Onconova and Trawsfynydd at this important time, as Trawsfynydd readies to initiate Phase 2 studies in H2 2024 for its lead antiviral programs for influenza and COVID19, supported by advisors with unparalleled expertise in viral disease, and Onconova is preparing to finalize the recommended Phase 2 dose (RP2D) for narazaciclib,” said Dr. Cautreels incoming Chief Executive Officer of the combined company.
Commented Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova and President and CSO, Oncology of the combined company, ”Trawsfynydd has a differentiated pipeline and an accomplished leadership team poised to advance their lead programs. With a shared focus on developing best-in-class medicines for patients with unmet needs, we look forward to Traws’ continued progress with its anti-viral programs and narazaciclib.”
Traws Proprietary Portfolio:
TRX100 (viroksavir): a cap-dependent endonuclease inhibitor for influenza: Phase 1
- Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains
- Preclinical data showed that TRX100 inhibits viral replication of pandemic-potential influenza viruses circulating in nature during 2022, and importantly, also in oseltamivir and baloxavir-resistant viruses
- Completed a first Phase 1 study that demonstrated safety and tolerability in healthy volunteers. The study also provided pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose administration for either treatment or prophylaxis
Next milestones: H2 2024
- Phase 1 dose extension will evaluate two additional, higher doses prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025
TRX01 (travaltrevir): Mpro protease inhibitor for COVID19: Phase 1
- Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, with potentially superior properties to nirmatrelvir (Pfizer’s Mpro inhibitor, PAXLOVID™)
- Does not require co-administration with a human cytochrome P450 (CYP) inhibitor such as ritonavir, avoiding potential significant drug:drug interactions, with the opportunity to expand the number of eligible patients
- Safe in GLP toxicology studies with no adverse events (AEs) in the expected human dose range. The drug candidate’s pharmacokinetic (PK) profile may enable a once-daily 10 day treatment regimen, to reduce the likelihood of viral rebound
Next milestones:
- Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers initiated screening in Q1 2024. Topline data are expected H2 2024
- Phase 2 study planned to be initiated in H2 2024. The study will enroll people with moderate to severe COVID19. Topline data are expected H1 2025
Narazaciclib: CDK 4/6 inhibitor for LGEEC: Phase 1/2
- Narazaciclib’s mechanism of action in LGEEC has been validated by Phase 2 studies with other approved CDK4/6 inhibitors: palbociclib (Pfizer), ribociclib (Novartis), and abemaciclib (Lilly). Available preclinical and clinical data suggest that narazaciclib has the potential to provide a better efficacy/safety ratio compared to approved products with respect to reduced gastrointestinal (GI) and hematological toxicities. These characteristics may permit daily administration with no need for the drug holidays employed by other approved agents to manage severe bone marrow suppression.
- In pre-clinical studies, narazaciclib demonstrated reduced neutropenia compared to palbociclib and inhibited the growth of cancer cell lines resistant to palbociclib
- Currently in Phase 1/2a study to define the RP2D
Next milestone:
- Define the RP2D and development strategy for LGEEC/other indications
Management and Organization
Traws will be led by incoming Chief Executive Officer, Werner Cautreels, Ph.D.; President and Chief Scientific Officer, Oncology, Steven Fruchtman M.D., (Onconova); Chief Financial Officer, Mark Guerin (Onconova), Chief Medical Officer, Robert Redfield, M.D., (Trawsfynydd), Chief Scientific Officer, Virology, C. David Pauza, Ph.D., (Trawsfynydd) and Chief Operating Officer, Nikolay Savchuk, Ph.D., (Trawsfynydd/Torrey Pines), as well as several other members of the Onconova and Trawsfynydd teams.
Traws’ Board of Directors will be comprised of Trawsfynydd’s Chairman Iain Dukes, DPhil (Venture Partner at OrbiMed), Executive Chairman, Werner Cautreels, Nikolay Savchuk, Ph.D. (General Partner of Torrey Pines) as well as existing Onconova Directors Trafford Clarke, Ph.D, James Marino, J.D. and M. Theresa Shoemaker and Jack E. Stover.
About the Merger and Private Financing
Onconova issued the following in the transactions: in connection with the merger, the stockholders of Traswfynydd received an aggregate of 3,549,538 shares of common stock and 10,359.0916 shares of newly issued Series C non-voting convertible preferred stock (with a conversion ratio of preferred to common at 1:10,000) (the "Series C preferred stock”), and in connection with the private financing, OrbiMed and Torrey Pines received an aggregate of 496,935 shares of common stock and 1,578.2120 shares of Series C preferred stock. This represents, on a fully diluted basis,
The shares of common stock issuable upon conversion of the Series C preferred stock issued in the Merger and the private financing shall be subject to stockholder approval in compliance with the rules of the NASDAQ Stock Market.
Tungsten Advisors served as the exclusive financial advisor and placement agent to Onconova. Orrick, Herrington & Sutcliffe, LLP and Morgan, Lewis & Bockius LLP are serving as legal counsel to Onconova. Snell & Wilmer L.L.P. is serving as legal counsel to Trawsfynydd.
Webcast Presentation
The companies will host a webcast presentation to discuss the proposed transaction tomorrow, April 2 at 8:30 a.m. ET.
Dial-in details are:
- Investors Dial-in: 1-877-407-0784
- International Investors Dial-in: 1-201-689-8560
- Conference ID: 13745512
Call me™: Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event.
- https://callme.viavid.com/viavid/?callme=true&passcode=13745512&h=true&info=company-email&r=true&B=6
- Call me™ link will be made active 15 minutes prior to scheduled start time.
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1663864&tp_key=8103bfd962:
A replay of the webcast will also be available via Onconova’s investor website approximately two hours after the call’s conclusion.
About Onconova Therapeutics, Inc.
Onconova is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. Onconova has been focused on developing targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation including the novel, multi-kinase inhibitor narazaciclib, under evaluation for low grade endometroid endometrial cancer (LGEEC).
About Trawsfynydd Therapeutics, Inc.
Trawsfynydd is an antiviral drug development company committed to reducing disease and death among people with respiratory viral diseases including Influenza and COVID19. Trawsfynydd combines excellence in medicinal chemistry with the tools of AI and machine learning, to guide and accelerate the drug development process. We are especially committed to developing best-in-class treatments for the elderly, immunocompromised and other vulnerable populations who are at increased risk for severe disease and death from respiratory virus infections.
About Traws Pharma, Inc.
Traws is developing next-generation, best-in-class antivirals for influenza, COVID and other respiratory infections and narazaciclib. Traws was formed from the business combination of Onconova Therapeutics, Inc. and Trawsfynydd Therapeutics, Inc. and is headquartered in Newtown, PA and will trade on NASDAQ as “TRAW” starting on April 3, 2024.
Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding the structure, the combined company’s listing on Nasdaq; expectations regarding the ownership structure of the combined company; expectations regarding the issuance and value of CVRs; expectations regarding the conversion of the Series C preferred stock and related stockholder approval; expectations regarding the structure, timing and funding of the private placement financing, expected proceeds and impact on ownership structure; each company’s and the combined company’s expected cash position at the closing of the Merger and the expected cash runway of the combined company following the Merger and private financing; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated clinical drug development activities, related timelines and expected milestones; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and were based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. There can be no assurance that future developments affecting Traws, the Merger or the private placement financing will be those that have been anticipated.
Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Traws’ control. Traws’ actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing and the funding of the private financing; (iii) risks related to Traws’ ability to manage its operating expenses and its expenses associated with the Merger; (iv) unexpected costs, charges or expenses resulting from the transaction; (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; (vi) the uncertainties associated with Traws’ product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement and completion of clinical trials, studies and evaluations; (vii) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these or other product candidates; (viii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (ix) risks related to the failure to realize any value from product candidates currently being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (x) risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including the factors described in the section titled “Risk Factors” in Onconova’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on April 1 2024, subsequent Quarterly Reports on Form 10-Q filed with the SEC, and in other filings that Traws makes and will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Traws expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Traws.
Company Contacts:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/
Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com
FAQ
What is the new ticker symbol for the combined company after the merger?
How much is expected to be raised through the planned private placement?
What is the anticipated closing cash balance resulting from the private placement and cash from both companies?
What assets will Traws Pharma focus on developing?
When are the first top-line read-outs expected for viroksavir and travaltrevir?
