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Traws Pharma, Inc.

For the period ended Sep 30, 2025. Filed Nov 13, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 13, 2025

TRAW$0.22+0.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-14.

0001558370-25-011469

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-13.

0001104659-25-110845

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 86 previous paragraphs and 92 current paragraphs.

55 unchanged; 24 reworded; 11 added; 3 removed; 4 previous and 2 current paragraphs rearranged.

Tables are not compared: 34 previous and 33 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (11)

Current report

initiation and patient enrollment, and regulatory approval of protocols for future clinical trials;

Current report

On September 9, 2025, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Viriom, Inc. (“Viriom”), a related party, pursuant to which we purchased certain assets (the “Purchased Assets”) from Viriom in exchange for $2,350,000 in cash. The Purchased Assets include certain intellectual property and other assets related to a pyrrolidine antiviral compound (the “Compound”), Viriom’s program pipeline related thereto (the “Program”) and any pharmaceutical product containing or comprising the Compound (a “Product”), including without limitation certain patents and patent applications; all other intellectual property controlled by Viriom related to the Program, Compound and Product; a third-party license agreement and rights and obligations related thereto; any and all material regulatory or similar filings, applications or associated correspondence related to the development, manufacture of commercialization of the Compound or product; all materials owned or controlled by Viriom related to the Program, Compound or Product; and certain other related assets. We also incurred legal costs in consummating the Purchase Agreement of $235,000 to the acquired patent. See Note 3, Asset Acquisition, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report for more information regarding the Purchase Agreement.

Current report

On October 8, 2025 the Company issued 652,526 shares of common stock to a holder of pre-funded warrants upon exercise of such pre-funded warrants by the holder.

Current report

On October 1, 2025, the Board appointed John Leaman, MD as an independent director of the Company, with a term expiring at the Company’s 2025 annual meeting of stockholders. Dr. Leaman was also appointed as a member of the Audit Committee of the Board.

Current report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Current report

Revenues were $2.8 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively, related to the Company’s license agreement with Symbio. The increase of $2.6 million is primarily due to the immediate revenue recognition of the remaining deferred revenue of $2.7 million as a result of terminating the license agreement with Symbio on April 17, 2025. No further revenue will be recognized going forward in connection with this agreement.

Current report

Uncertainty in the business, political and macroeconomic environments in which we operate present significant risks to our business and could materially impact our expected cash requirements and our ability to raise additional financing when needed. We are subject to continuing risks and uncertainties, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, changing tariff policies and trade restrictions, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system, cybersecurity events, the impact of war or military conflicts, including regional conflicts around the world, and public health pandemics. We closely monitor the impact of these factors on all aspects of our business, including the impacts on our clinical trial patients, employees, partner, suppliers, and vendors.

Current report

The ultimate impact of global and domestic economic conditions on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside

Current report

of our control and could exist for an extended period of time. As a result, we are subject to continuing risks and uncertainties and continue to closely monitor the impact of the current conditions on our business.
Removed paragraphs (3)

Previous report

Effective February 5, 2025, Mark Guerin resigned from his role as Chief Financial Officer of the Company and Nora Brennan was appointed as Interim Chief Financial Officer.
Reworded paragraphs (24)

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $13.1 million and an accumulated deficit of $628.6 million. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this report to support our operations for at least the 12 months following the date that these financial statements are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $6.4 million and an accumulated deficit of $632.5 million. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this Quarterly Report to support our operations for at least the 12 months following the date that the condensed consolidated financial statements included herein are issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that such financial statements are issued.

Previous wording

We are a clinical-stage biopharmaceutical company aiming to address unmet medical needs in respiratory viral diseases and cancer. Following the closing of the Merger in which we acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, we have four clinical programs:

Current wording

We are a clinical-stage biopharmaceutical company aiming to address unmet medical needs in respiratory viral diseases and cancer. Following the closing of the merger in which we acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024 (the “Merger”), we have four clinical programs:

Previous wording

We advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee. This study enrolled four cohorts of 8 participants each, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort. Participants were required to be healthy males or females ages 18-64 years. Participants took either one dose of the study drug or one dose of placebo. Dose levels evaluated in this study included 80, 120, 240 and 480 mg in capsules, taken orally. The primary endpoint of the study was the determination of safety and tolerability; the secondary and other endpoints included the determination of the drug pharmacokinetic profile. Topline data showed good overall tolerability and a pharmacokinetic profile that appears to support the potential use of tivoxavir marboxil as a one-time treatment for influenza. Sixteen AEs were recorded, of which three were reported as possibly related to study drug during the study; all were mild headaches. Topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 and within the predicted therapeutic window for more than 23 days. On March 21, 2025, we submitted a request for a meeting with the FDA to align on a path forward, including to seek guidance regarding the potential for accelerated approval utilizing the “Animal Rule” for further development of tivoxavir marboxil in the treatment of H5N1 bird flu. The FDA “Animal Rule” allows approval of therapeutic interventions in cases where there is a risk of severe disease and a controlled human trial would be unethical or infeasible. Our meeting request was granted, and we submitted our briefing package to the FDA on April 24, 2025. On May 27, 2025, we received written responses from the FDA for a Type B pre-Investigational New Drug Application meeting (“pre-IND”). The FDA provided feedback on development paths for potential approval of tivoxavir marboxil for bird flu and seasonal flu, including on the potential use of the Animal Rule. On June 30, 2025, we announced our submission of briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu, as a follow up to the pre-IND FDA interactions.

Current wording

We advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee (“HREC”). This study enrolled four cohorts of 8 participants each, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort. Participants were required to be healthy males or females ages 18-64 years. Participants took either one dose of the study drug or one dose of placebo. Dose levels evaluated in this study included 80, 120, 240 and 480 mg in capsules, taken orally. The primary endpoint of the study was the determination of safety and tolerability; the secondary and other endpoints included the determination of the drug pharmacokinetic profile. Topline data showed good overall tolerability and a pharmacokinetic profile that appears to support the potential use of tivoxavir marboxil as a one-time treatment for influenza. Sixteen AEs were recorded, of which three were reported as possibly related to study drug during the study; all were mild headaches. Topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 and within the predicted therapeutic window for more than 23 days. On March 21, 2025, we submitted a request for a meeting with the FDA to align on a path forward, including to seek guidance regarding the potential for accelerated approval utilizing the “Animal Rule” for further development of tivoxavir marboxil in the treatment of H5N1 bird flu. The FDA “Animal Rule” allows approval of therapeutic interventions in cases where there is a risk of severe disease and a controlled human trial would be unethical or infeasible. Our meeting request was granted, and we submitted our briefing package to the FDA on April 24, 2025. On May 27, 2025, we received written responses from the FDA for a Type B pre-Investigational New Drug Application meeting (“pre-IND”). The FDA provided feedback on development paths for potential approval of tivoxavir marboxil for bird flu and seasonal flu, including on the potential use of the Animal Rule. On June 30, 2025, we announced our submission of briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu, as a follow up to the pre-IND FDA interactions.

Previous wording

In addition, on June 30, 2025, we announced our proposed Phase 2 dose-ranging, non-inferiority study, which will evaluate the effects of tivoxavir marboxil in patients with seasonal influenza. A separate single arm will evaluate the effects of tivoxavir marboxil in patients infected with H5N1 bird flu. The proposed study has been submitted for Human Research Ethics Committee (“HREC”) review and, once initiated, is expected to enroll subjects in Australia and selected countries in Southeast Asia with high rates of human bird flu infections. During a Type D meeting, the FDA affirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. We have determined to defer the initiation of this study at this time due to the low immediate likelihood of successfully recruiting a Phase 2 study incorporating bird flu-infected subjects. However, recent approval of our Phase 2 bird flu/seasonal flu phase 2 protocol by Australian and South Korean regulatory authorities will allow us to quickly initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rate of bird flu increase.

Current wording

In addition, on June 30, 2025, we announced our proposed Phase 2 dose-ranging, non-inferiority study, which will evaluate the effects of tivoxavir marboxil in patients with seasonal influenza. A separate single arm will evaluate the effects of tivoxavir marboxil in patients infected with H5N1 bird flu. The proposed study has been submitted for HREC review and, once initiated, is expected to enroll subjects in Australia and selected countries in Southeast Asia with high rates of human bird flu infections. During a Type D meeting, the FDA affirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. We have determined to defer the initiation of this study at this time due to the low immediate likelihood of successfully recruiting a Phase 2 study incorporating bird flu-infected subjects. However, we believe that recent approval of our Phase 2 bird flu/seasonal flu phase 2 protocol by Australian and South Korean regulatory authorities will allow us to quickly initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rate of bird flu increase.

Previous wording

TRX01 was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group. The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo in each cohort) for 10 consecutive days. The study was completed in September 2024. There were few recorded AEs reported up to the highest dose, and none were determined to be related to study drug. Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days. On June 30, 2025, we announced our proposed Phase 2 non-inferiority study which will evaluate the effects of ratutrelvir in newly diagnosed COVID patients. The proposed study has been submitted for HREC review and is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID®. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID.

Current wording

TRX01 was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group. The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo in each cohort) for 10 consecutive days. The study was completed in September 2024. There were few recorded AEs reported up to the highest dose, and none were determined to be related to study drug. Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days. On June 30, 2025, we announced our proposed Phase 2 non-inferiority study, which will evaluate the effects of ratutrelvir in newly diagnosed COVID patients, and on August 18, 2025, we announced receipt of approval from the HREC to proceed with the Phase 2 study. The study is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID®. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID. On October 14, 2025, we announced the dosing of the first subject in our Phase 2 study to evaluate ratutrelvir. We intend to initiate a separate single arm to evaluate the safety and efficacy of Ratutrelvir in newly diagnosed COVID patients who are ineligible for treatment with PAXLOVID®. Our expectation is to report the results of both Phase 2 studies by year-end 2025.

Previous wording

The shares of common stock sold to Citizens under the ATM Agreement will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-273081), filed with the SEC on June 30, 2023, and declared effective by the Commission on July 11, 2023, including the base prospectus contained therein, as supplemented by those prospectus supplements dated March 10, 2025 and April 7, 2025 (the “Prospectus Supplements”) and filed with the SEC pursuant to Rule 424(b) under the Securities Act, or subsequently filed prospectus supplements as applicable. In accordance with the terms of the ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $7.4 million (which is in addition to the gross proceeds of approximately $0.1 million from sales completed prior to April 7, 2025), from time to time, to or through Citizens, which was the Company’s current “baby shelf” limitation under General Instruction I.B.6. of Form S-3 as of the date of filing the Prospectus Supplement. In the quarter ended June 30, 2025, the Company sold and issued an aggregate of 1,522,947 shares of its common stock under the ATM Agreement for net proceeds of $3.0 million.

Current wording

subsequently filed prospectus supplements as applicable. In accordance with the terms of the ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $7.4 million (which is in addition to the gross proceeds of approximately $0.1 million from sales completed prior to April 7, 2025), from time to time, to or through Citizens, which was the Company’s current “baby shelf” limitation under General Instruction I.B.6. of Form S-3 as of the date of filing the Prospectus Supplement. In the quarter ended September 30, 2025, the Company sold and issued an aggregate of 62,003 shares of its common stock under the ATM Agreement for net proceeds of $0.1 million.

Previous wording

Effective as of the close of business on March 31, 2025, Werner Cautreels retired and resigned from his role as Chief Executive Officer of the Company and Iain Dukes, who was serving as Executive Chairman as of such date, was appointed as Interim Chief Executive Officer and his director role changed from Executive Chairman to Chairman of the Board. Dr. Cautreels continues to serve as a director on the Board and now provides certain consulting services to the Company.

Current wording

Effective as of the close of business on March 31, 2025, Werner Cautreels retired and resigned from his role as Chief Executive Officer of the Company and Iain Dukes, who was serving as Executive Chairman as of such date, was appointed as Interim Chief Executive Officer and his director role changed from Executive Chairman to Chairman of the Board. Dr. Cautreels continues to serve as a director on the Company’s Board of Directors (the “Board”) and now provides certain consulting services to the Company.

Previous wording

On April 15, 2025, Dr. Dukes stepped down as Chairman of the Company’s Board, and the Board appointed Jack Stover, an independent director who has served as a member of the Board since 2016, as Chairman. Dr. Dukes continues to serve as a member of the Board and as Interim Chief Executive Officer.

Current wording

On April 15, 2025, Dr. Dukes stepped down as Chairman of the Board, and the Board appointed Jack Stover, an independent director who has served as a member of the Board since 2016, as Chairman. Dr. Dukes continues to serve as a member of the Board. On October 1, 2025, the Board eliminated the “interim” notation in Dr. Iain Dukes’ title, who now holds the title of Chief Executive Officer.

Previous wording

On July 2, 2025, Nora Brennan notified the Company of her decision to resign from her role as Interim Chief Financial Officer of the Company, effective as of July 5, 2025, which was the final day of the interim period contemplated by that offer letter entered into by and between the Company and Ms. Brennan on February 5, 2025. Effective as of July 5, 2025, Charles Parker was appointed to serve as the Company’s Interim Chief Financial Officer. Mr. Parker has been retained to provide such services as a non-employee consultant of the Company.

Current wording

On July 2, 2025, Nora Brennan notified the Company of her decision to resign from her role as Interim Chief Financial Officer of the Company, effective as of July 5, 2025, which was the final day of the interim period contemplated by that offer letter entered into by and between the Company and Ms. Brennan on February 5, 2025. Effective as of July 5, 2025, Charles Parker was appointed to serve as the Company’s Interim Chief Financial Officer. On October 1, 2025, the Board eliminated the “interim” notation in Mr. Parker’s title, who now holds the title of Chief Financial Officer. Mr. Parker has been retained to provide such services as a non-employee consultant of the Company.

Previous wording

Revenues increased by $2.6 million, to $2.7 million for the three months ended June 30, 2025 from $0.1 million for the three months ended June 30, 2024. Effective April 17, 2025, the Company and Symbio Pharmaceuticals Limited (“Symbio”) mutually terminated the license agreement originally entered into by and between the parties in 2011. As a result, on April 17, 2025, the Company recognized $2.7 million of previously deferred revenue.

Current wording

Revenues during the three months ended September 30, 2024 were $0.1 million, related to the Company’s license agreement with Symbio Pharmaceuticals Limited (“Symbio”). Effective April 17, 2025, the Company and Symbio mutually terminated the license agreement originally entered into by and between the parties in 2011. As a result, on April 17, 2025, the Company recognized $2.7 million of previously deferred revenue. No further revenue will be recognized going forward in connection with this agreement.

Previous wording

Research and development expenses decreased by $1.7 million, or (42)%, to $2.3 million for the three months ended June 30, 2025 from $4.0 million for the three months ended June 30, 2024. This decrease was primarily related to a $1.0 million decrease in oncology expenses and a decrease in personnel expenses of $0.9 million.

Current wording

Research and development expenses decreased by $2.8 million, or (55)%, to $2.3 million for the three months ended September 30, 2025 from $5.1 million for the three months ended September 30, 2024. This decrease was primarily related to a $1.7 million decrease in virology expenses as we deferred the initiation of the Phase 2 study in tivoxavir marboxil and shifted emphasis to preparation for patient enrollment in the Phase 2 study for TRX01 in which dosing was initiated in October 2025 and a $1.1 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets.

Previous wording

General and administrative expenses decreased by $0.3 million, or (14)%, to $1.7 million for the three months ended June 30, 2025, from $2.0 million for the three months ended June 30, 2024. This decrease was primarily attributable to a $0.6 million decrease in personnel related expenses and a $0.3 million decrease in stock based compensation expenses, partially offset by a $0.6 million increase in professional and consulting fees.

Current wording

General and administrative expenses decreased by $1.7 million, or (50)%, to $1.7 million for the three months ended September 30, 2025, from $3.5 million for the three months ended September 30, 2024. This decrease was primarily attributable to a $1.0 million decrease in professional and consulting fees, a $0.3 million decrease in personnel related expenses, a $0.2 million decrease in stock based compensation expenses, a $0.2 million decrease in insurance and other costs and a $0.1 million decrease in public company costs.

Previous wording

Change in fair value of warrant liability of $0.1 million during the three months ended June 30, 2025, represents the remeasurement of the Series A Warrant liability as of June 30, 2025.

Current wording

The change in fair value of warrant liability of $3.0 thousand during the three months ended September 30, 2025 represents the remeasurement of the Series A Warrant liability as of September 30, 2025.

Previous wording

In connection with the acquisition of Trawsfynydd, during the three months ended June 30, 2024, the Company recognized a non-cash in-process research and development expense of $117.5 million related to the acquired virology programs that had no alternative future use at the time of acquisition which required immediate expense recognition.

Current wording

In connection with the acquisition of Trawsfynydd in the Merger, during the nine months ended September 30, 2024, the Company recognized a non-cash in-process research and development expense of $117.5 million related to the acquired virology programs that had no alternative future use at the time of acquisition, which required immediate expense recognition.

Previous wording

Research and development expenses decreased by $1.1 million, or (18)%, to $4.8 million for the six months ended June 30, 2025 from $5.9 million for the six months ended June 30, 2024. This decrease was primarily related to a $1.9 million decrease in oncology expenses and a decrease in personnel expenses of $1.1 million, partially offset by a $2.0 million increase in virology expenses.

Current wording

Research and development expenses decreased by $3.9 million, or (35)%, to $7.1 million for the nine months ended September 30, 2025 from $11.0 million for the nine months ended September 30, 2024. This decrease was primarily related to a $3.0 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets, a $1.1 million decrease in personnel expenses and a $0.1 million decrease in stock based compensation expenses, partially offset by a $0.3 million increase in virology expenses due to the focus on initiating Phase 2 studies for both tivoxavir marboxil and TRX01 prior to our strategic shift announced in the third quarter of 2025.

Previous wording

General and administrative expenses decreased by $0.9 million, or (16)%, to $4.4 million for the six months ended June 30, 2025 from $5.3 million for the six months ended June 30, 2024. This decrease was primarily attributable to a $0.5 million decrease in personnel related expenses and a $0.3 million decrease in stock based compensation expenses.

Current wording

General and administrative expenses decreased by $2.6 million, or (30)%, to $6.2 million for the nine months ended September 30, 2025 from $8.8 million for the nine months ended September 30, 2024. This decrease was primarily attributable to a $1.3 million decrease in professional and consulting fees, a $0.7 million decrease in personnel related expenses, a $0.5 million decrease in stock based compensation expenses, and a $0.1 million decrease in insurance and other expenses.

Previous wording

Change in fair value of warrant liability of $26.7 million during the six months ended June 30, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants issued in the December 2024 Offering, the exercise of pre-funded warrants, and the remaining Series A Warrants as of June 30, 2025.

Current wording

Change in fair value of warrant liability of $26.7 million during the nine months ended September 30, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants issued in the December 2024 Offering, the exercise of pre-funded warrants, and the remaining Series A Warrants as of September 30, 2025.

Previous wording

Since inception, we have experienced negative cash flows from our operations and expect to continue to incur significant expenses in connection with our ongoing activities. As of June 30, 2025, the Company had an accumulated deficit of $628.6 million, working capital of $8.0 million, and cash and cash equivalents of $13.1 million. As of June 30, 2025, the Company had sold and issued an aggregate of 1,565,047 shares of its common stock under the ATM Agreement for net proceeds of $3.2 million, 1,522,947 of which shares were sold by the Company in the three months ended June 30, 2025 for net proceeds of $3.0 million. Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the date that the financial statements included in this Quarterly Report are issued. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biopharmaceutical products, we may have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us.

Current wording

Since inception, we have experienced negative cash flows from our operations and expect to continue to incur significant expenses in connection with our ongoing activities. As of September 30, 2025, the Company had an accumulated deficit of $632.5 million, working capital of $1.7 million, and cash and cash equivalents of $6.4 million. As of September 30, 2025, the Company had sold and issued an aggregate of 1,627,050 shares of its common stock under the ATM Agreement for net proceeds of $3.3 million, 62,003 of which shares were sold by the Company in the three months ended September 30, 2025 for net proceeds of $0.1 million. Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the date that the financial statements included in this Quarterly Report are issued. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern. Due to the inherent uncertainty involved in making estimates and the risks associated

Previous wording

The following table summarizes the Company’s cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes the Company’s cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

Net cash used in operating activities was $11.4 million for the six months ended June 30, 2025, which consisted of non-cash charges of $26.4 million primarily attributable to the change in fair value of warrant liability of $26.7 million and a $5.6 million change in operating assets and liabilities, partially offset by net income of $20.6 million. Significant changes in operating assets and liabilities included a net decrease in accounts payable, accrued expenses, and deferred revenue of $6.9 million due to timing of invoices and payments to our vendors, which was partially offset by net decreases in prepaid expenses and other assets and receivables of $1.3 million.

Current wording

Net cash used in operating activities was $15.4 million for the nine months ended September 30, 2025, which consisted of non-cash charges of $26.2 million primarily attributable to the change in fair value of warrant liability of $26.7 million and a $5.8 million change in operating assets and liabilities, partially offset by net income of $16.6 million. Significant changes in operating assets and liabilities included a net decrease in accounts payable, accrued expenses, and deferred revenue of $7.4 million due to timing of invoices and payments to our vendors, which was partially offset by net decreases in prepaid expenses and other assets and receivables of $0.8 million.

Previous wording

Net cash used in operating activities was $14.3 million for the six months ended June 30, 2024 and consisted primarily of a net loss of $128.1 million and $4.3 million change in operating assets and liabilities. Significant changes in operating assets and liabilities included a net decrease in accounts payable and accrued expenses of $4.3 million due to timing of invoices and payments to our vendors. These operating uses of cash were offset by $118.2 million in non-cash charges primarily attributable to the immediate expensing of in-process research and development acquired in connection with the acquisition of Trawsfynydd of $117.5 million and $0.7 million related to stock-based compensation expense.

Current wording

Net cash used in operating activities was $25.8 million for the nine months ended September 30, 2024 and consisted primarily of a net loss of $136.6 million and a $7.7 million change in operating assets and liabilities. Significant changes in operating assets and liabilities included a net decrease in accounts payable and accrued expenses of $5.8 million due to timing of invoices and payments to our vendors. These operating uses of cash were offset by $118.5 million in non-cash charges primarily attributable to the immediate expensing of in-process research and development acquired in connection with the acquisition of Trawsfynydd in the Merger of $117.5 million and $1.1 million related to stock-based compensation expense.

Previous wording

There were no investing activities during the six months ended June 30, 2025. Net cash used in investing activities was $3.6 million for the six months ended June 30, 2024, and primarily related to the transaction costs paid in cash of $3.6 million in connection with the acquisition of Trawsfynydd.

Current wording

Net cash used in investing activities was $2.6 million for the nine months ended September 30, 2025 and was attributable to the purchase of intangible assets. Net cash used in investing activities was $3.6 million for the nine months ended September 30, 2024, and primarily related to the transaction costs paid in cash of $3.6 million in connection with the acquisition of Trawsfynydd in the Merger.

Previous wording

Net cash provided by financing activities was $3.1 million for the six months ended June 30, 2025, and was attributable to the net proceeds received from the sale of shares of our common stock under the ATM and proceeds from exercised warrants, partially offset by the payment of offering costs. Net cash provided by financing activities was $14.0 million for the six months ended June 30, 2024, and attributable to the net proceeds received from the private placement of our common stock.

Current wording

Net cash provided by financing activities was $3.0 million for the nine months ended September 30, 2025, and was attributable to the proceeds received from the sale of shares of our common stock under the ATM and proceeds from exercised warrants, partially offset by the payment of offering costs. Net cash provided by financing activities was $14.0 million for the nine months ended September 30, 2024 and was attributable to the net proceeds received from the private placement of our common stock.

Previous wording

We have not achieved profitability since our inception and we expect to continue to incur operating losses for the foreseeable future. We expect our research and development expenditures in 2025 to be higher than 2024 due to our virology programs. We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that, currently, our non-cancelable obligations under these agreements are not material. Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the date that the financial statements included in this Quarterly Report are issued. These conditions raise substantial doubt about our ability to continue as a going concern through the one-year period after the date that the financial statements are issued.

Current wording

We have not achieved profitability since our inception and we expect to continue to incur operating losses for the foreseeable future. Our research and development expenditures are expected to increase as our TRX01 study progresses. We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that, currently, our non-cancelable obligations under these agreements are not material. Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the date that the financial statements included in this Quarterly Report are issued. These conditions raise substantial doubt about our ability to continue as a going concern through the one-year period after the date that the financial statements are issued.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

The shares of common stock sold to Citizens under the ATM Agreement will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-273081), filed with the SEC on June 30, 2023, and declared effective by the Commission on July 11, 2023, including the base prospectus contained therein, as supplemented by those prospectus supplements dated March 10, 2025 and April 7, 2025 (the “Prospectus Supplements”) and filed with the SEC pursuant to Rule 424(b) under the Securities Act, or

Current report — wording carried from elsewhere

with the research, development, and commercialization of biopharmaceutical products, we may have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us.
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

A separate single arm will evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID patients who are ineligible for treatment with PAXLOVID®. We intend to progress the development of ratutrelvir in the coming months, starting with a Phase 2 study planned to begin soon in the Southern Hemisphere.

Previous report — wording carried elsewhere

Revenues increased by $2.6 million, to $2.7 million for the six months ended June 30, 2025 from $0.1 million for the six months ended June 30, 2024. Effective April 17, 2025, the Company and Symbio mutually terminated the license agreement originally entered into by and between the parties in 2011. As a result, on April 17, 2025, the Company recognized $2.7 million of revenue.

Previous report — wording carried elsewhere

Acquired in-process research and development

Previous report — wording carried elsewhere

In connection with the acquisition of Trawsfynydd, during the three months ended June 30, 2024, the Company recognized a non-cash in-process research and development expense of $117.5 million related to the acquired virology programs that had no alternative future use at the time of acquisition which required immediate expense recognition.