Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations

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The following Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with interim unaudited condensed consolidated financial statements contained in Part I, Item 1 of this quarterly report on Form 10-Q ("Quarterly Report"), and the audited consolidated financial statements and notes thereto for the year ended December 31, 2024 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our annual report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025 ("Annual Report"). As used in this Quarterly Report, unless the context suggests otherwise, the "Company," "we," "us," "our," "Traws" or "Traws Pharma" refers to Traws Pharma, Inc. and its consolidated subsidiaries.

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Cautionary Note Regarding Forward-Looking Statements

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This Quarterly Report includes forward-looking statements. We may, in some cases, use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in a number of places throughout this Quarterly Report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the implementation of our business model and strategic plans for our business, our ongoing and planned preclinical development and clinical trials, our interactions with the U.S. Food and Drug Administration ("FDA") and similar foreign authorities, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, protection of our intellectual property portfolio, the degree of clinical utility of our products, particularly in specific patient populations, our ability to develop commercial and manufacturing functions, expectations regarding clinical trial data, potential accelerated pathways to FDA approval that may be available for our product candidates, our results of operations, cash needs, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report.

Actual results could differ materially from our forward-looking statements due to a number of factors, including without limitation risks related to:

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Any forward-looking statements that we make in this Quarterly Report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

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You should also read carefully the factors described in the "Risk Factors" in this Quarterly Report and our most recent Annual Report, to better understand significant risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those

anticipated or implied in the forward-looking statements in this Quarterly Report and you should not place undue reliance on any forward-looking statements.

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Overview

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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.

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We are exploring various sources of funding for development and applying for regulatory approval of our research compounds as well as for our ongoing operations. If we raise additional funds through strategic collaborations and alliances or licensing arrangements with third parties, which may include existing collaboration partners, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that are not favorable to us. There can be no assurance, however, that we will be successful in obtaining such financing in sufficient amounts, on terms acceptable to us, or at all. In addition, there can be no assurance that we will obtain approvals necessary to market our product candidates or achieve profitability or sustainable, positive cash flow. If we are unable to successfully raise sufficient additional capital, through future financings or through strategic and collaborative arrangements, we will not have sufficient cash to fund our ongoing trials and operations.

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Our Portfolio/ Product Candidates/ Compounds

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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:

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The first-in-man clinical study of tivoxavir marboxil (designated AV5124 in a previous study) was performed from May to September of 2023 in Russia. The study sponsor was Pharmasyntez, JSC. We have the right to use the data resulting from the study outside of Russia and the Eurasian Economic Community countries. The trial was a single ascending dose study, and, as such, each study participant only received one dose of tivoxavir marboxil. The study consisted of four dose cohorts that received 20, 40, 80 or 120 mg tivoxavir marboxil delivered as 20 mg strength tablets, or placebo. The study enrolled 28 healthy males ages 18-45 years who received either the study drug or placebo. The primary study endpoint was measurement of the safety and tolerability of single drug doses in healthy volunteers. The secondary endpoint was the measurement of pharmacokinetic parameters of single drug doses in healthy volunteers on an empty stomach or after a meal. In the study, one subject who received a single 40 mg dose of the study drug, experienced two adverse events ("AEs"). This subject experienced hyperglycemia, which was deemed to be mild and believed probably related to tivoxavir marboxil, and erosive gastritis with complications in the form of severe iron deficiency anemia, which was considered to be a serious adverse event ("SAE") believed unlikely to be related (doubtful per the protocol) to the study drug.

There were no other AEs in the trial, including at higher doses. The pharmacokinetic measurements indicated a small food effect for tivoxavir marboxil, with increased exposure when drug was taken after a meal but otherwise showed increasing exposure with increasing dose.

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.

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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.

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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.

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Another Phase 1 study of narazaciclib as a monotherapy has also been conducted in patients with relapsed and/or refractory advanced cancer. The objectives of this study were to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of narazaciclib administered orally as escalating daily doses in patients with advanced cancer relapsed or refractory to at least 1 prior line of therapy. Narazaciclib was dosed on a continuous daily schedule in 28-day cycles. In this study, the highest dose tested was 280mg once daily given continuously. This study is now closed to accrual and data analysis is ongoing.

Narazaciclib is also being developed in greater China, under a 2017 license agreement between our company and HanX. The development in greater China is entirely sponsored by HanX. The compound is being studied in China in a clinical trial of patients with Grade III and IV glioma.

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Our objective for narazaciclib is to establish additional partnerships for further development of the compound.

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Recent Developments

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Asset Acquisition

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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.

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At the Market Offering Agreement

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On March 10, 2025, the Company entered into an At The Market Offering Agreement (the "ATM Agreement") with Citizens JMP Securities, LLC ("Citizens"), pursuant to which the Company may offer and sell shares of its common stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement, including the "baby shelf" limitation under General Instruction I.B.6. of Form S-3), from time to time, to or through Citizens, acting as sales agent and/or principal. The Company is not obligated to make any sales of common stock under the ATM Agreement and no assurance can be given that the Company will sell any shares under the ATM Agreement, or, if it does, as to the price or amount of shares that the Company will sell, or the dates on which any such sales will take place. The ATM Agreement may be terminated by the Company at any time with five business days' notice to Citizens, by Citizens at their discretion, or as otherwise permitted in the ATM Agreement.

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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 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.

The Company will pay Citizens a commission at a fixed rate of 3.0% of the gross proceeds of each sale of shares of common stock sold through or to Citizens under the ATM Agreement and will reimburse Citizens for the fees and disbursements of its legal counsel incurred in connection with entering into the transactions contemplated by the ATM Agreement in an amount not to exceed $50,000 in the aggregate, in addition to up to $5,000 per "Representation Date" (as defined in the ATM Agreement) in connection with ongoing diligence arising from the transactions contemplated by the ATM Agreement.

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The Company made certain customary representations, warranties and covenants in the ATM Agreement concerning the Company and its subsidiaries, the registration statement and base prospectus contained therein, prospectus supplement and other documents and filings relating to the offering of the shares under the ATM Agreement. In addition, the Company has also provided Citizens with customary indemnification rights.

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Warrants

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On February 17, 2025, the Company held a special meeting of its stockholders, at which, the Company's stockholders approved (i) in accordance with Nasdaq Listing Rule 5635(d), the issuance of more than 19.99% of the outstanding shares of the Company's common stock upon exercise of the pre-funded warrants and Series A Warrants sold and issued to investors in a private placement on December 31, 2024 (the "December 2024 Offering"), and (ii) in accordance with Nasdaq Listing Rule 5635(c), the issuance of shares of the Company's common stock upon exercise of the pre-funded warrants and Series A Warrants sold and issued to certain insiders in the December 2024 Offering. As a result of such approvals, the pre-funded warrants became immediately exercisable and limitations on the exercisability of the Series A Warrants under applicable Nasdaq rules were lifted. Subsequent to such shareholder meeting, and through September 30, 2025, certain purchasers have exercised their pre-funded warrants for an aggregate of 1,582,559 shares of the Company's common stock.

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On February 18, 2025, the Company and certain of the purchasers of units in the December 2024 Offering entered into amendments to the Series A Warrants issued to such purchasers in the offering (the "Series A Warrant Amendment"), pursuant to which the Series A Warrants issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not within the Company's control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock consolidation, or a recapitalization or similar event involving the Company's common stock based on the volume weighted average price of the Company's common stock over the eleven trading day period commencing five trading days immediately preceding such event and the five trading days immediately following such event.

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On March 27, 2025, the Company and the holders of all outstanding pre-funded warrants issued in the December 2024 Offering entered into amendments to the pre-funded warrants issued to such purchasers in the offering (the "PFW Amendment"), pursuant to which the pre-funded warrants issued to such purchasers were amended to increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company.

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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.

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Changes in Management and the Board of Directors

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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.

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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.

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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.

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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.

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Reverse Stock Split

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In September 2024, the Company effected a one-for-25 reverse stock split of its issued and outstanding shares of common stock (the "Reverse Stock Split"). All share and per share amounts for our common stock, as well as the number of shares of common stock issuable upon conversion of outstanding preferred stock, exercise of options and warrants outstanding (and the exercise prices thereof) and settlement of outstanding restricted stock units, from dates prior to completion of the Reverse Stock Split that are included in this Quarterly Report, including the financial statements and footnotes thereto included herein, have been retroactively adjusted to give effect to the Reverse Stock Split.

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Nasdaq Compliance

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We received multiple notifications from The Nasdaq Stock Market LLC ("Nasdaq") staff (the "Staff") in 2024 regarding non-compliance with continued listing requirements. On February 25, 2025, we received a letter from Nasdaq confirming that we have regained compliance with Listing Rule 5550(b)(1) related to minimum stockholders' equity requirements, as required by the Hearings Panel of Nasdaq's decision dated December 13, 2024. Pursuant to Listing Rule 5815(d)(4)(B), we will be subject to a mandatory panel monitor for a period of one year from the date of such letter.

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Results of Operations

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

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Revenues

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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.

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Research and development expenses

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The details of our research and development expenses are:

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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.

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General and administrative expenses

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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.

Change in fair value of warrant liability

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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.

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

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Revenues

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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.

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Acquired in-process research and development

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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.

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Research and development expenses

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The details of our research and development expenses are:

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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.

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General and administrative expenses

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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.

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Change in fair value of warrant liability

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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.

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Liquidity and Capital Resources

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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

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.

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We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to execute our strategy. To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to explore various dilutive and non-dilutive sources of funding, including debt and equity financings (including pursuant to the ATM Agreement), strategic alliances, business development and/or combinations, and other sources. The future success of the Company is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us, or at all. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that the financial statements included in this Quarterly Report are issued.

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The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

Cash Flows

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

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Operating Activities

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.

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.

Investing Activities

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.

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Financing Activities

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.

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Material Cash Requirements

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.

We are exploring various sources of funding for continued development and any potential in-licensed compounds as well as our ongoing operations. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development and clinical trials of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. If we obtain regulatory approval for any of our product candidates, we expect to incur significant new drug application preparation and commercialization expenses. We do not currently have a relationship with an organization for the sales, marketing and distribution of pharmaceutical products. In the future, we may rely on licensing and co-promotion agreements with strategic or collaborative partners for the commercialization of our products in the United States and other territories. If we choose to build a commercial infrastructure to support marketing in the United States for any of our product candidates that achieve regulatory approval, such commercial infrastructure could be expected to include a sales force supported by sales management, internal sales support, an internal marketing group and distribution support. To develop the appropriate commercial infrastructure internally, we would have to invest financial and management resources, some of which would have to be deployed prior to having any certainty about marketing approval. Furthermore, we have and expect to continue to incur additional costs associated with operating as a public company.

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.

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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

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.

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For additional risks, please see "Risk Factors" in Part II of this Quarterly Report and previously disclosed in our Annual Report.

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Critical Accounting Policies and Estimates

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This Management's Discussion and Analysis of our Financial Condition and Results of Operations is based on our interim unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, revenue recognition, deferred revenue, stock-based compensation, acquired in-process research and development and the contingent value rights. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. As of September 30, 2025, there have been no significant changes in our critical accounting policies and estimates as discussed in our Annual Report.

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