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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): March 31, 2025

 

Traws Pharma, Inc.

(Exact name of Registrant as specified in its charter)

 

Delaware   001-36020   22-3627252
(State or Other Jurisdiction
of Incorporation or Organization)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

12 Penns Trail

Newtown, PA 18940
(267) 759-3680

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive
Offices)

 

Not Applicable 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, par value $.01 per share TRAW The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

The information provided below in “Item 7.01 - Regulation FD Disclosure” of this Current Report regarding the Earnings Release is incorporated by reference into this Item 2.02.

 

Item 7.01 Regulation FD Disclosure.

 

On March 31, 2025, Traws Pharma, Inc. (the “Company”) issued a press release (the “Earnings Release”) announcing its financial results for the year ended December 31, 2024, a copy of which is attached to this Current Report on Form 8-K (this “Current Report”) as Exhibit 99.1 and incorporated herein by reference.

 

Additionally, on March 31, 2025, the Company will hold an investor call at 10:00 a.m. Eastern Time. A copy of the presentation that will be utilized for the investor call is attached to this Current Report as Exhibit 99.2 and incorporated by reference herein. The presentation will also be posted to the Company’s website after the investor presentation is completed.

 

The information set forth under Item 7.01 of this Current Report, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.

 

Forward-Looking Statements

 

This Current Report, including Exhibits 99.1 and 99.2, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to the Company or its management, are intended to identify such forward-looking statements.

 

Forward-looking statements in this Current Report, including Exhibits 99.1 and 99.2, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission, reports to the stockholders of the Company and other publicly available statements issued or released by the Company involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Securities and Exchange Commission, each of which could adversely affect the Company’s business and the accuracy of the forward-looking statements contained herein.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated March 31, 2025.
99.2   Investor Presentation, dated March 31, 2025.
104   Cover Page Interactive Data File (embedded within the inline XBRL Document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 31, 2025 TRAWS PHARMA, INC.
     
  By: /s/ Werner Cautreels
    Werner Cautreels
    Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

Traws Pharma Reports Full Year 2024 Results and Business Highlights

 

Tivoxavir marboxil’s potential as a single dose therapeutic agent for bird flu supported by significant antiviral activity in three well accepted animal models and positive Phase 1 data

 

Ongoing FDA interaction to align on path forward for tivoxavir marboxil, including potential for accelerated approval utilizing the “Animal Rule”

 

Cash Runway to support planned operations into Q1 2026

 

Investor Update call today, March 31, 2025 at 10:00 AM ET

 

NEWTOWN, PA, March 31, 2025 (GLOBE NEWSWIRE) – Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today reported financial results for the year ended December 31, 2024 and provided recent business highlights, with updates to the Company’s investigational programs including lead product candidate, tivoxavir marboxil (TXM) in development for bird flu, and ratutrelvir in development for COVID.

 

“I believe Traws made outstanding progress over the last year. We re-defined our focus – to treat critical threats to human health from respiratory diseases -- with bird flu as our top priority. Ongoing reports of farm infections and mutated viruses continue to raise the concern that bird flu could present a pandemic risk. We declared tivoxavir marboxil (TXM) as our lead program, and presented preclinical data demonstrating TXM’s potent resistance profile, robust antiviral activity in three validated flu models, plus positive pharmacokinetic results from a Phase 1 study in healthy volunteers. These data supported submission of our pre-IND meeting request to discuss a potential accelerated path to approval under the Animal Rule. In addition, our successful financing, completed in December, provided Traws with $20 million in gross proceeds and complemented our investor base with the addition of new top tier institutional health care investors,” said Werner Cautreels, PhD, Chief Executive Officer for Traws Pharma.

 

“During our upcoming investor call, planned for today, we look forward to providing an overview of the public health risk and treatment landscape for H5N1 bird flu, and reviewing the preclinical and clinical data, and regulatory strategy for tivoxavir marboxil. In addition, we plan to review the ongoing need for improved COVID therapy to reduce the frequency of clinical rebound and the concomitant risk for long COVID, the opportunity for ratutrelvir, and next steps for both programs,” concluded Dr. Cautreels.

 

Register for the Investor Event here.

 

Upcoming Milestones and Recent Highlights:

 

Upcoming Milestones:

 

·Bird flu: Provide an update on FDA discussions regarding the Animal Rule: Q2 2025
·Bird flu: Finalize formulation and CMC scale up
·Bird flu: Finalize the development plan and move forward on the path to approval
·COVID: Submit a pre-IND meeting request to engage with the FDA to understand long COVID endpoints: Q2 2025

 

 

 

 

Recent Product Development & Corporate Highlights:

 

Bird Flu

 

Traws Pharma Antiviral Bird Flu Program, Tivoxavir Marboxil, Shows Positive Data in Non-human Primates – (March 24, 2025) Traws Pharma, Inc. today announced positive topline results from a study evaluating the use of tivoxavir marboxil (TXM) as a treatment for non-human primates challenged with a non-lethal dose of H5N1 bird flu.

 

Traws Pharma’s Bird Flu Drug Candidate, Tivoxavir Marboxil, Presented at ICAR – (March 21, 2025) Traws Pharma, Inc. today announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a poster at the International Society for Antiviral Research (ICAR 2025), being held in Las Vegas, Nevada.

 

Traws Pharma Reports Positive Results from An Accepted Bird Flu Model for Anti-Viral Candidate, Tivoxavir Marboxil – (March 03, 2025) Traws Pharma, Inc. today announced positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir marboxil as a single dose.

 

Traws Pharma Announces Completion of Phase I Studies with Tivoxavir Marboxil, a Single Dose Oral Investigational Drug for the Treatment and Prevention of H5N1 Bird Flu – (January 23, 2025) Traws Pharma, Inc. today announced completion of Phase I clinical studies of its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention of H5N1 bird flu.

 

COVID

 

Traws Pharma’s COVID-19 Candidate, Ratutrelvir, Presented at ICAR – (March 25, 2025) Traws Pharma, Inc. today announced that positive data supporting the potential for ratutrelvir, a main protease inhibitor, as a treatment for COVID-19, were presented at the International Conference for Antiviral Research (ICAR 2025).

 

Corporate

 

Traws Pharma Announces Management Updates – (March 28, 2025) Traws Pharma, Inc. today announced the retirement of Werner Cautreels, PhD, Chief Executive Officer (CEO), effective on or about the close of business on March 31, 2025. Iain D. Dukes, D Phil, will assume the role of Interim CEO. In addition to his new responsibilities, Dr. Dukes will continue to serve as Traws’ Chairman.

 

Financial Results:

 

Cash, cash equivalents and short-term investments: As of December 31, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $21.3 million, compared to cash, cash equivalents, and short-term investments of approximately $20.8 million at December 31, 2023. The cash balance reflects $20 million in gross proceeds from the December 31, 2024 financing. The Company believes its cash and cash equivalents will be sufficient to support ongoing operations into Q1 2026.

 

 

 

 

Research and development (R&D) expense for the 12 months ended December 31, 2024, totaled $12.8 million, compared to $11.4 million for the comparable period in 2023. This increase of $1.4 million primarily relates to the conduct of clinical and preclinical trials for the Company’s antiviral agents, and increased personnel related expenses due to restructuring activities. These increases were partially offset by a decrease in costs related to the oncology program.

 

General and administrative (G&A) expense for the 12 months ended December 31, 2024, totaled $12.3 million, compared to $9.1 million for the comparable period in 2023. This increase of $3.2 million was primarily attributable to an increase in consulting fees in connection with seeking strategic alternatives which was partially offset by a decrease in public company costs.

 

Net loss: The net loss for the 12 months ended December 31, 2024 was $166.5 million, driven by the acquired in-process research and development expense of $117.5 million and the warrant expense of $24.4 million associated with the December 2024 financing. As a result, the net loss per basic and diluted common share for 2024 was $35.21. This compares to a net loss of $18.9 million, or a net loss of $22.57 per basic and diluted common share, for the year ended December 31, 2023.

 

Shares Outstanding: Traws had 5,073,790 shares of common stock outstanding as of March 26, 2025. The shares outstanding reflect the issuance of 3.9 million shares related to the December 31, 2024 financing.

 

About Tivoxavir Marboxil

 

Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has demonstrated potent in vitro activity against a range of influenza strains in preclinical studies, including the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird flu.

 

About Ratutrelvir

 

Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19, to be used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for long COVID.4 Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity5,6.

 

 

 

 

Source information:

 

1.Per link
2.TRAW data on file
3.https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646
4.Carly Herbert et al. (2025) Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae539
5.Pfizer.com 10K report 2024, Feb 27, 2025
6.Merck & Co 10K, Feb 25 2025

 

About Traws Pharma, Inc.

 

Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable.

 

The Company’s two antiviral programs are investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease).

 

For more information, please visit www.trawspharma.com and follow us on LinkedIn.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, market conditions, regulatory requirements and pathways for approval, the extent of the spread and threat of the bird flu, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for long COVID, and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law.

 

Traws Pharma Contact:

 

Nora Brennan
Traws Pharma, Inc.
[email protected]

www.trawspharma.com

 

Investor Contact:

 

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

 

 

 

 

Traws Pharma, Inc.

Consolidated Balance Sheets

 

   December 31, 
   2024   2023 
Assets        
Current assets:          
Cash and cash equivalents  $21,338,000   $20,821,000 
Tax incentive and other receivables   1,765,000    18,000 
Prepaid expenses and other assets   1,848,000    1,821,000 
Total current assets   24,951,000    22,660,000 
Property and equipment, net   10,000    22,000 
Other assets   1,000    1,000 
Total assets  $24,962,000   $22,683,000 
Liabilities and stockholders’ (deficit) equity          
Current liabilities:          
Accounts payable  $8,186,000   $5,619,000 
Accrued expenses and other liabilities   3,121,000    3,375,000 
Deferred revenue   226,000    226,000 
Total current liabilities   11,533,000    9,220,000 
Deferred revenue, non-current   2,565,000    2,791,000 
Warrant liabilities   42,494,000     
Total liabilities   56,592,000    12,011,000 
           
Stockholders’ (deficit) equity:          
Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued and 7,398 shares outstanding at December 31, 2024 and no shares issued and outstanding at December 31, 2023        
Common stock, $0.01 par value, 250,000,000 shares authorized, 3,650,731 and 840,251 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively   36,000    9,000 
Additional paid in capital   617,530,000    493,317,000 
Accumulated deficit   (649,154,000)   (482,631,000)
Accumulated other comprehensive loss   (42,000)   (23,000)
Total stockholders’ (deficit) equity   (31,630,000)   10,672,000 
Total liabilities and stockholders’ (deficit) equity  $24,962,000   $22,683,000 

 

 

 

 

Traws Pharma, Inc.

Consolidated Statements of Operations

 

   Years ended December 31, 
   2024   2023 
Revenue  $226,000   $226,000 
Operating expenses:          
Acquired in-process research and development   117,464,000     
Research and development   12,847,000    11,430,000 
General and administrative   12,289,000    9,094,000 
Total operating expenses   142,600,000    20,524,000 
Loss from operations   (142,374,000)   (20,298,000)
Series A warrant and pre-funded warrant expense   (24,438,000)    
Other income, net   289,000    1,350,000 
Net loss  $(166,523,000)  $(18,948,000)
Net loss attributable to common stockholders, basic and diluted  $(54,674,000)  $(22.57)
Weighted-average shares of common stock outstanding, basic and diluted   1,552,685    839,554 
Net loss per share of common stock, basic and diluted  $(35.21)  $ 
Net loss attributable to Series C Preferred stockholders, basic and diluted  $(111,849,000)  $ 
Weighted-average shares of Series C Preferred outstanding, basic and diluted   7,941     
Net loss per share of Series C Preferred, basic and diluted  $(14,085.00)  $ 

 

 

 

Exhibit 99.2

 

Investor Event March 31, 2025 Targeting Critical Threats to Human Health

 

 

Forward - looking statements 2  This presentation contains, and certain oral statements made by management from time to time may contain, “forward - looking state ments” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securiti es Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include actions, events, results, strategies and expectations and are often identifiable by use of t he words “believes”, “expects”, “intends”, “anticipates”, “plans”, “seeks”, “estimates”, “projects”, “may”, “will”, “could”, “might”, or “continues” or similar expressions. Forward - looking statem ents within this presentation include, but are not limited to, express or implied statements regarding the nature, strategy, opportunities and focus of Traws Pharma, Inc. (“Traws”); the de vel opment, commercial potential and potential benefits of any product candidates; anticipated clinical drug development activities, related timelines and expected milestones; anticipated int eractions with the FDA; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward - looking sta tements. 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 the company 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 th at 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 limit ed to (i) the uncertainties associated with Traws’ product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, includin g p otential delays in the commencement and completion of clinical trials, studies and evaluations; (ii) risks related to the inability of Traws to obtain sufficient additional capita l t o continue to advance its product candidates and operate its business; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (i v) 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 suc cessfully bringing product candidates to market; (v) uncertainties in retaining key personnel, including the executive team and directors; and (vi) risks that may stem from changes in the regu lat ory and/or political landscape, and (vii) risks associated with the possible failure to realize certain anticipated benefits of Traws’ 2024 merger with Trawsfynydd Therapeutics, Inc., including wi th respect to future financial and operating results and the other risks and uncertainties included in Traws’ Annual Report on Form 10 - K for the year ended December 31, 2024 and Traws’ subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”). Actual results and the timing of events could differ materially from those anticipated in such forward - looking stat ements as a result of these risks and uncertainties. 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 indic ated in the forward - looking statements. Traws expressly disclaims any obligation or undertaking, unless required by applicable law, to release publicly any updates or revisions to a ny 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 stateme nts are based. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Traws. This presentation is for informational pu rposes only and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of the Traws, nor shall there be any sale of any such securities in any state or jurisdicti on in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made, exc ept by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom.

 

 

Introduction 3 Werner Cautreels, PhD Chief Executive Officer

 

 

Agenda Advancing novel treatment for critical threats to human health: bird flu and COVID 4 Welcome Bird Flu COVID Discussion and Q&A Closing Statements Werner Cautreels, PhD, CEO, and Iain D. Dukes, D Phil, Executive Chairman Pandemic risk and the opportunity for tivoxavir marboxil (TXM): Robert R. Redfield, MD, CMO, and C. David Pauza, PhD, CSO Ongoing risk of mortality and long - COVID and the opportunity for ratutrelvir: Robert R. Redfield, MD, CMO, and C. David Pauza, PhD, CSO Traws Management Team Werner Cautreels, PhD, CEO, and Iain D. Dukes, D Phil, Executive Chairman

 

 

A team with a strong track record of executing and creating value Robert R. Redfield, MD Chief Medical Officer C. David Pauza, PhD Chief Scientific Officer Werner Cautreels, PhD Chief Executive Officer Nora Brennan Interim Chief Financial Officer Board of Directors Demonstrated expertise in anti - viral drug development and innovative clinical trial strategies Nikolay Savchuk, PhD Chief Operating Officer Executive Chairman Iain D. Dukes, D Phil COO, Director Nikolay Savchuk, PhD CEO, Director Werner Cautreels, PhD Director Trafford Clarke Director Teresa Shoemaker Director Jack E. Stover 5 Iain D. Dukes, D Phil Executive Chairman

 

 

Comments/Potential Next Steps Phase 3 Phase 2 Phase 1 Preclinical Program/Market Respiratory Viruses • Demonstrated protection against mortality and disease in 3 species • Positive Phase 1 safety and PK data • Ongoing interactions with FDA Bird Flu Tivoxavir marboxil • Demonstrated suppression of a broad range of native and resistant strains. • Positive Phase 1 safety, PK/PD data without ritonavir • Plan to interact with FDA in Q2 2025 COVID - 19 Ratutrelvir High - potential antiviral pipeline focused on critical threats to human health from respiratory viral diseases 6

 

 

Bird Flu H5N1 b ird flu and the increasing risk for wider spread in the human population 7 Robert Redfield, MD, CMO

 

 

Why is bird flu a critical threat to human health today? High pandemic potential with no currently approved treatments 8 Major expanding agricultural impact Limited countermeasures available for both animal and human disease 4 5 High human mortality S ignificant limitation of current flu vaccines Seasonal flu and drug resistance to current antiviral agents

 

 

9 Millions of infected animals Thousand of infected workers One event starts a pandemic Why is bird flu a critical threat to human health today? Pandemic risk: broad spread among animals increases the risk of human transmission, mutation Sources: TRAWS internal

 

 

The tivoxavir marboxil (TXM) value proposition for bird flu 10 Differentiating features of TXM, a potent oral anti - viral agent One dose provided protection from disease and mortality in 3 well - accepted preclinical models One dose maintained plasma levels above the EC 90 for approximately 3 weeks in Phase 1 4 5 Broad resistance profile against avian flu strains including “Texas dairy worker strain” Produced massive virus reductions in the lung in three animal models Good overall tolerability profile enables higher concentrations of TXM to treat and prevent bird flu

 

 

Bird Flu/Influenza Tivoxavir marboxil (TRX100) A single - dose investigational, CAP - dependent endonuclease inhibitor for treatment or prevention of H5N1 bird flu 11 C. David Pauza, PhD, CSO

 

 

Potent preclinical inhibition of highly pathogenic avian influenza viruses 12 TRX101 (the active metabolite of TRX100) inhibits replication of HPAI H5N1 avian influenza viruses and reference (H3N2) influenza viruses 2 Note: Based on avian influenza virus circulating in 2022 - 2023, 2. Results from the Influenza replication inhibition neuraminidas e - based assay, provided by the US CDC (Atlanta) Tivoxavir (TRX101) Strain Designation EC 50 (nM) H5N1 viruses 0.40 A/ chicken /Idaho/22 - 011347 - 004/2022 0.52 A/Canada_ goose /Wyoming/22 - 011671 - 001/2022 0.43 A/Red_Shoulder_ Hawk /Minnesota/22 - 012000 - 004/2022 0.34 A/ dolphin /Florida/22 - 025319 - 002/2022 0.41 A/black_ vulture /Florida/22 - 012333 - 001/2022 - c30 Reference A(H3N2) Viruses 1.21 A/Louisiana/50/2017 (Wt) 10.28 A/Louisiana/49/2017 (PA - I38M)

 

 

Mutation profile of H5N1 Virus from a Texas dairy worker Multiple mutations related to increased transmission and growth in mammalian cells and natural resistance to oseltamivir and baloxavir 13 Nine Mutations in A/Texas/37/2024 were Not Present in the Bovine Isolate Oseltamivir and Baloxavir are Less Potent Against A/Texas/37/2024 Compared to Other H1N1 and H5N1 Virus Isolates Sources: Adapted from Mostafa, et al (2025) DOI: 10.1080/22221751.2024.2447614

 

 

Mouse antiviral study using bird flu (H5N1) transmitted from cattle to a dairy worker 14 Notes: Challenge dose via intranasal delivery. TRX - 100 = tivoxavir marboxil, TVX. 5 animals per group sacrificed on D3 for deter mination of virus titer in lungs (data pending). Data on file, TRAWS Pharma. Virus Challenge Protocol Virus stock: H5N1(A/Texas/37/2024) Stock titer: 1.47x10 9 TCID 50 /mL Challenge dose: 7.34x10 0 TCID 50 /dose Oral TVX: Dosed 0 and 12 hours after challenge (total 50 mg/kg – equivalent to 240 mg in human) Two Groups: 15 animals per group Bird Flu Human isolate H5N1 intranasal Oral dose TRX100 TXM provides 100% protection against lethal bird flu challenge in mice

 

 

15 1. Virus challenge protocol per slide 13. TCID = tissue culture infectious dose Virus Titer Group Animal 7x10 8 Vehicle 31 1.3x10 7 32 1.3x10 8 33 8.2x10 8 34 1.2x10 7 35 Virus Titer Group Animal BLLQ TXM Day 1 dose of 50 mg/kg 46 BLLQ 47 BLLQ 48 BLLQ 49 BLLQ 50 Virus titer – TCID 50 /gram of tissue; BLLQ – below lower limit of quantitation (2.2x10 3 TCID 50 /gram) Day 3 Lung Virus Titers (TCID 50 ) Tivoxavir achieved complete viral clearance in the lung Based on murine viral challenge studies 1

 

 

Virus challenge study in ferrets could provide key data to support clinical and regulatory strategy for tivoxavir marboxil in bird flu 16 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days after viral inoculation for lung virus burden determinations Oral treatment: 8 hours after virus inoculation Doses: 120 mg human equivalent 240 mg in human equivalent Two Groups: 10 Animals per group (5F/5M), 13 - 15 weeks of age Treated and control Endpoints: Survival, changes in body weight, virus burden in lung and nasal tissues Topline Data: Substantial changes in disease progression observed after a single dose of tivoxavir marboxil (TXM) • Lethal challenge showed that TXM increased the proportion of surviving animals • Lowered the viral burden in lungs and nasal tissues • No virus - induced weight loss Promising topline data in ferret model using virus isolated from a dairy worker. Viral inoculum: 1X10 3 TCID 50 of A/Texas/37/2024 H5N1 via intranasal instillation Ferret model

 

 

Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose TXM doses increased survival in ferrets infected with bird flu 17 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days after viral inoculation for lung virus burden determinations

 

 

Vehicle Control High dose (equivalent to 240 mg human dose Low dose (equivalent to 120 mg human dose) Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose TXM doses prevented rapid body weight loss in ferrets infected with bird flu 18 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days after viral inoculation for lung virus burden determinations

 

 

Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose Single, oral dose of TXM reduced lung virus burden in ferrets 19 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days after viral inoculation for lung virus burden determinations. TCID = tissue culture infectious doses

 

 

Control – no drug 0% survival Equivalent to 240 mg human dose 50% survival Equivalent to 120 mg human dose 30% survival Viral RNA copies per mL Single, oral dose of TXM increases survival and reduces lung virus burden in bird flu - infected ferrets 20 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days after viral inoculation for lung virus burden determinations

 

 

Virus challenge study in non - human primate could provide key data to support clinical and regulatory strategy for tivoxavir marboxil in bird flu 21 Oral treatment 12 hours after non - lethal virus inoculation Dose: One dose (480 mg human equivalent dose) Two Groups: 5 animals per group (treated and control) Endpoints: Virus burden in lung and nasal tissues, body weight Non - human primate model Topline Data: Substantial changes in disease progression observed after a single dose of tivoxavir marboxil • Non - lethal challenge showed that tivoxavir marboxil significantly lowered lung viremia • No virus - induced weight loss Promising topline data in non - human primate (NHP) model using virus isolated from a dairy worker. Viral inoculum:1X10 6 TCID 50 of A/Texas/37/2024 H5N1 with half delivered via intranasal instillation and half delivered to the oropharynx Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group

 

 

Percent body weight changes by Study Day 10 in treated versus control TXM dose prevented body weight loss in bird flu - infected non - human primates (** p < 0.004) 22 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group

 

 

Control Animals – no drug treatment • Results for individual animals are depicted • Results from bronchoalveolar lavage samples collected on Study Day 3 and analyzed by TCID 50 assay • < 10e3 – below the lower limit of quantitation Animals treated with equivalent of human dose 480 mg Virus Infectivity per mL Single oral dose of TXM blocks bird flu replication in the lungs of NHPs 23 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group

 

 

Phase 1 study designed to inform dose selection of tivoxavir marboxil 24 Notes: TRAW data on file. Sentinels observed for 24 hours before dosing Main Group. Tivoxavir marboxil dose given as powder - in - c apsule. Safety Review Committee evaluation 10 days after dosing. Pharmacokinetic study continued until 28 days after dosing. Eligibility : Healthy volunteers Flu - negative men and women, ages 18 - 64 years of age Endpoints: Primary: • Safety and tolerability Secondary: • Ability to maintain plasma blood levels above the EC 90 • Pharmacokinetics Treatment 80 mg,120 mg, 240 mg, 480 mg doses • 8 patients/dose (6 active, 2 placebo) • All cohorts were fasted and included an initial 2 - patient sentinel safety dose (1 active, 1 placebo) Single - dose regimen Assessments • Plasma drug level assessment multiple times over three weeks

 

 

Positive Phase 1 data show that tivoxavir marboxil maintains plasma blood levels > EC 90 for ~3 weeks (NCT06757738) 25 No treatment related adverse events Notes: Four doses evaluated (80, 120, 240, 480mg, all fasted). Each group included a sentinel dose with 24h observation (1 ac tiv e, 1 placebo), following by the main group (5 active, 1 placebo). Tivoxavir marboxil dosed as powder - in - capsule. Safety Review Committee evaluation 10 days after dosing. P harmacokinetic study continued until 28 days after dosing.. Data on file, TRAWS Pharma. Tivoxavir in plasma (ng/mL) Plasma drug levels above EC 90 for ~3 weeks days after single 480 mg dose in healthy volunteers Time (hours) EC90 ~0.82 ng/mL 3 weeks

 

 

Pre - IND meeting request submitted March 21, 2025 26 Regulatory strategy is focused on accelerating development by accessing the “Animal Rule” Note: CFR314.600 thru 314.650 , October 2015 , https://www.fda.gov/media/88625/download Product Development Under the Animal Rule ▪ Intended to provide a path to approval in situations when human challenge studies would not be ethical and field trials are not possible ▪ Allows FDA to rely on adequate and well - controlled animal efficacy studies to support approval of a drug ▪ Demonstration of human safety is a requirement

 

 

Note: CFR314.600 thru 314.650, October 2015, https://www.fda.gov/media/88625/download. bird flu case fatality rate: WHO information : https://cdn.who.int/media/docs/default - source/wpro --- documents/emergency/surveillance/avian - influenza/ai_20250131.pdf TXM could be a fit for the “Animal Rule” Human challenge studies of bird flu are not possible Virus evolved to a more virulent strain (dairy worker, mild symptoms) History of A/H5N1 virus strains with up to 50% case fatality rate Virus can be 100% fatal in 3 - 5 days in animals (mice, ferrets, NHP) Placebo - controlled trials would be unethical Preclinical studies used commonly accepted flu models (mice, ferrets and non - human primates) Positive Phase 1 safety/dosing escalation data (healthy volunteers) includes dose levels that were protective in animal studies Maintained plasma levels above the EC 90 for more than 3 weeks, with good overall safety Requires Adequate and Well - Controlled Animal Studies Exceptional Pathogenic Potential Human Safety and Pharmacokinetics are Required 27

 

 

28 COVID - 19 …continues to spread … continues to mutate … continues to kill Robert Redfield, MD, CMO

 

 

Why improving COVID therapy matters Significant cause of human disease and mortality in vulnerable population 29 Increasing clinical and economic burden of Long COVID Significant limitations for current approved antiviral, PAXLOVID®, in vulnerable populations including the elderly, immunocompromised individuals and pediatrics The drop in vaccine use and poor match of vaccine with current variants increases the spread and potential for disease COVID is now established as a long - term public health challenge Note: PAXLOVID® is a registered trade mark of Pfizer, Inc

 

 

Why is COVID a critical threat to human health today? Risk of viral rebound (>20% of PAXLOVID treated cases) and long COVID (10 - 20% of cases) 30 Notes: PAXLOVID® is a registered trade mark of Pfizer, Inc. COVID estimates: https://www.cdc.gov/covid/php/surveillance/burde n - e stimates.html. Long COVID: Carly Herbert et al. (2025): https://doi.org/10.1093/cid/ciae539. COVID rebound: https://www.acpjournals.org/doi/10.7326/M23 - 1756

 

 

The ratutrelvir value proposition for COVID/Long COVID 31 Differentiating features of ratutrelvir, a potent oral anti - viral agent Dose at RP2D maintains favorable PK, with plasma drug levels at ~13X the EC 50, with high lung accumulation compared to the blood Broad resistance profile against native, emerging variants and treatment resistant strains compared to nirmatrelvir and ibuzatrelvir P1 data indicate that drug metabolism is not induced, and achievement of target blood plasma levels supports the ritonavir - independent use of ratutrelvir Good overall tolerability enables Increased duration and intensity of treatment may reduce the rate of clinical rebound and, consequently, reduce the risk of Long COVID Good overall safety profile allows a treatment interval to 10 days compared to 5 days for other industry benchmarks Favorable profile could enable accessibility to a larger number of vulnerable individuals Notes: TRAW data on file. Nirmatrelvir is the active agent in PAXLOVID® (a registered trademark of Pfizer, Inc); ibuzatrelvi r i s being developed by Pfizer, Inc.

 

 

32 COVID - 19 Ratutrelvir (TRX01) Investigational Main protease (Mpro) inhibitor Ritonavr - independent,10 - day, single - daily dosing regimen C. David Pauza, PhD, CSO

 

 

Ratutrelvir is consistently more potent for suppression of COVID in vitro 33 Greater inhibition than benchmark, nirmatrelvir, the active ingredient in PAXLOVID® (preclinical studies), or Pfizer’s next generation Mpro inhibitor, Ibuzatrelvir, across multiple strains of COVID viruses Notes: Data represents a comparison of literature data v. Traws’ in vitro assay results. EC50 – effective concentration for 50% inhibition of virus replication in vitro; EC90 – effective concentration for 90% inhibition of virus replication in vitro, COVID = SARS - CoV - 2. PAXLOVID® is a registered trademar k of Pfizer, Inc. ibuzatrelvir is being developed by Pfizer, Inc. Traws data on file. EC50 values for Mpro inhibitors against multiple COVID strains (results in nM) Representative EC50 values for Mpro inhibitors and the number of strains tested (results in nM)

 

 

Emerging resistance to nirmatrelvir and ensitrelvir will not impact ratutrelvir usage 34 Ratutrelvir has a differentiated profile of drug resistance mutations, compared to resistance emerging in clinical trials of nirmatrelvir or ensitrelvir Frequency of Nirmatrelvir - Resistance Mutations 1 M49L Sequences by Country of Origin 2 Notes: 1: Tamura, T.J. et al (2024): 2: Uehara, T., H. et al (2025). 3: Traws data on file Data represents a comparison o f l iterature data v. Traws’ in vitro assay results. EC50 – effective concentration for 50% inhibition of virus replication in vitro; EC90 – effective concentration for 90% inhibition of v irus replication in vitro, COVID = SARS - CoV - 2. Nirmatrelvir is the active agent in PAXLOVID® (a registered trade mark of Pfizer, Inc); ensitrelvir is being developed by Sh ion ogi

 

 

Phase 1 MAD Results: Daily oral 600 mg dose sustains drug levels above EC 90 for 10 days in healthy volunteers (NCT06402136) 35 No treatment related adverse events Source: TRAWS data on file, Notes: MAD = multiple ascending dosing 9,415 nM (Exposure Limit) 25 nM EC90 (3xEC50) Multiple Ascending Doses in human trough concentrations 0 1 2 3 4 5 6 7 8 9 10 11 12 13 1 10 100 1000 10000 100000 Days R a t u t r e l v i r , n M 48 nM 600 mg, QDx10 days Multiple Ascending Doses in human 0 4 8 12 16 20 24 28 1 10 100 1000 10000 100000 Hours R a t u t r e l v i r , n M 48 nM 600 mg, QDx10 days (Day 0) 600 mg, QDx10 days (Day 9) Plasma drug levels are similar during 0 - 24 h on first (Day 0) and last (Day 9) of 600 mg, daily dosing, showing no induction of drug metabolism Daily plasma drug levels (24 h after dosing) remain above EC 90 for daily dosing of 600 mg

 

 

Consistent high plasma drug levels could allow for protection against new variants 36 No treatment related adverse events Source: TRAWS data on file, Notes: MAD = multiple ascending dosing study 9,415 nM (Exposure Limit) 25 nM EC90 (3xEC50) 110 nM (13xEC50) Plasma drug l evels (24 h C trough values for Days 1 - 9) Above EC 90 for virus suppression and within the target PK window (>25 nM and below the exposure limit): based on more intensive data collection after first and last dose Phase 1 Multiple Ascending Dose Study

 

 

Long COVID associates with slow viral clearance and viral rebound during acute COVID infection 37 Slower virus clearance associates with greater risk of long COVID Herbert, C., et al., Poster 0935, 2025 Conference on Retroviruses and Opportunistic Infection (CROI) Days after Peak Viral Load Modeled Ln (Viral Load) 4.97 times higher Risk of Long COVID With 5+ symptoms

 

 

Long COVID associates with slow viral clearance and viral rebound during acute SARS - CoV - 2 infection 38 Symptoms associated with the risk of Long COVID Herbert, C., et al., Poster 0935, 2025 Conference on Retroviruses and Opportunistic Infection (CROI)

 

 

Consistent high plasma drug levels could allow for protection against new variants 39 No treatment related adverse events Source: TRAWS data on file, Notes: MAD = multiple ascending dosing study 9,415 nM (Exposure Limit) 25 nM EC90 (3xEC50) 110 nM (13xEC50) Plasma drug l evels (24 h C trough values for Days 1 - 9) above EC 90 for virus suppression and within the target PK window (>25 nM and below the exposure limit): based on more intensive data collection after first and last dose Phase 1 Multiple Ascending Dose Study

 

 

40 Ratutrelvir has successfully completed Phase 1 studies Phase 1 safety and dose escalation studies have demonstrated excellent overall safety and tolerability and defined a target dose Plan to submit a pre - IND meeting request to align with FDA on Long - COVID endpoints Note: TRAW data on file

 

 

Final Remarks 41 Iain D. Dukes, D Phil Executive Chairman

 

 

Key Take Aways 42 Source: TRAW data on file. Notes: PK = pharmacokinetics. PAXLOVID® is a registered trademark of Pfizer, Inc. Bird Flu – Tivoxavir marboxil COVID - Ratutrelvir Potent broad resistance profile, including strains resistant to other agents Data in 3 well - accepted bird - flu models confirm efficacy potential One dose of TXM showed favorable Phase 1 PK with plasma blood levels > EC 90 for ~3 weeks with good safety Single dose therapy provides the opportunity for bird flu treatment and prophylaxis Strong support to seek accelerated approval under the FDA Animal Rule (FDA meeting request submitted March 21, 2025) Potent broad resistance profile, for in vitro suppression of COVID against benchmarks and emerging candidates Ritonavir - independent regimen mitigates drug - drug interaction limitation, opening the door to patients who cannot take PAXLOVID® Single dose (every 24h) showed favorable Phase 1 PK with good safety, allowing a proposed 10 - day dose regimen The 10 day dosing regimen has the potential to be effective in the prevention of both COVID - rebound and Long COVID

 

 

Cash , cash equivalents and short - term investments as of Dec 31, 2024, were $21.3 million 1 Cash position to support planned operations into Q1 2026 Selected Financial Information Anticipated Upcoming Milestones Milestone Program Update on FDA discussions regarding the Animal Rule in Q2 2025 Bird flu Finalize formulation and CMC scale up Bird flu Finalize development plan in bird flu and move forward on path to approval Bird flu Submit a pre - IND meeting request to engage with the FDA to understand long COVID endpoints in Q2 2025 COVID Outlook on Financials, Market Potential and Milestones Source: TRAW data on file, Existing therapies include PAXLOVID is a registered trademark of Pfizer, Inc., and LAGREVRIO is tr ade mark of Merck Sharpe & Dohme Corp. Financial information as of press release on March 31, 2025 Flu: Bird flu antiviral product estimate to build US stockpile approximately 300,000,000 - 600,000,000 doses COVID: Potential b est - in - class agent to replace existing therapies, and prevent clinical rebound, as well as Long COVID Market Potential 43

 

 

Q&A 44 Traws Management

 

 

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