RNAZ 10-K & 10-Q changes, risk factors and insider trading

Investing in our common stock involves a high degree of risk. Before making an investment decision, you should carefully consider the risks described below, as well as the other information in this annual report. Our business, prospects, consolidated financial condition, or consolidated operating results could be harmed by any of these risks, as well as other risks not currently known to us or that we currently consider immaterial. If any such risks or uncertainties actually occur, our business, prospects, consolidated financial condition or consolidated operating results could differ materially from the plans, projections and other forward-looking statements included in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The trading price of our common stock could decline significantly due to any of these risks or other factors, and as a result, you may lose all or part of your investment.

Risks related to our consolidated financial position and need for additional capital

As disclosed in various Current ReportsReport on Form 8-K filings with the SEC, at times we have not been in compliance with various Nasdaq rules atfor variouscontinued timeslisting sinceof Mayour 2023.stock on the Nasdaq Capital Market, LLC, or Nasdaq. We have received letters from the Listing Qualifications Department, or the Staff, of the Nasdaq Stock Market LLC, or Nasdaq, stating that we were not in compliance with certain requirements for continued listing on the Nasdaq Capital Market. In most of these instances, we have appealed the delisting determinations to Nasdaq Hearing Panels where we received extensions of time to regain compliance and maintain our Nasdaq listing. However, there is no assurance that in the event we do not meet Nasdaq listing requirements, we will receive any extensions of time to regain compliance and maintain our Nasdaq listing in which case our stock would be delisted from trading on Nasdaq.

We may be forced to amend, delay, limit, reduce or terminate the scope of our development programs and/or limit or cease our operations if we are unable to obtain additional funding. As of December 31, 2024, we had cash of approximately $5.8 million. We believe that these funds will support our operating expenses and capital requirements into the middle of the second quarter 2025. Our recurring consolidated losses from operations and negative consolidated cash flow raise substantial doubt about our ability to continue as a going concern without sufficient capital resources. Our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements for the years ended December 31, 20242025 and 2023,2024, with respect to this uncertainty. Our ability to continue as a going concern is dependent on our available cash, how well we manage that cash, and our operating requirements. We will need to raise additional capital to continue as a going concern. The failure to obtain sufficient additional funds on commercially acceptable terms to fund our operations and satisfy our obligations to creditors may have a material adverse effect on our business, consolidated results of operations and consolidated financial condition and jeopardize our ability to continue operations in the near-term. We will likely need to consider additional cost reduction strategies, which may include, among others, amending, delaying, limiting, reducing, or terminating our development programs, and we may need to seek an in-court or out-of-court restructuring of our liabilities, including potentially a bankruptcy proceeding, or to substantially reduce or totally cease our operations. In the event of such future restructuring activities, holders of our common stock and other securities will likely suffer a total loss of their investment.

Investment in oncology product development is a highly speculative undertaking and entails substantial upfront capital expenditures and significant risk that any potential therapeutic candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval or become commercially viable. We are still in the early stages of development for most of our therapeutic candidates. WeIn October 2025, we completed aand announced results for our Phase 01a clinical trial with TTX-MC138. Also in whichOctober 2025, we dosedacquired oneSeviprotimut-L, patienta whonovel hadpolyvalent advancedshed solidantigens tumors.vaccine Wefor alsothe initiatedpotential anadjuvant open-labeltreatment of melanoma, that has completed Phase I/II2 studyclinical and so far have successfully enrolled 10 patients in four treatment cohorts.development. We have no products licensed for commercial sale and have not generated any revenue from product sales or otherwise to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. We finance our current operations with funds obtained primarily from equity financings.

We have incurred significant annual net losses in each period since inception. For the years ended December 31, 20242025 and 2023,2024, our net losses were approximately $16.8$34.7 million and $18.5$16.8 million, respectively. As of December 31, 2024,2025, our accumulated deficit was approximately $63.2$97.9 million.

If in the future we obtain regulatory approvals to market TTX-MC138TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526 or other therapeutic candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain marketing approval, the price for the product we obtain, the ability to obtain reimbursement at any price and whether we own the commercial rights for that territory. If the number of addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, the labels for our current therapeutic candidates and any future therapeutic candidates contain significant safety warnings, regulatory authorities impose burdensome or restrictive distribution requirements, or the reasonably accepted patient population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not able to generate sufficient revenue from the sale of any approved products, we could be prevented from or significantly delayed in achieving profitability.

The development of pharmaceutical drugs and biological products is capital intensive. As of December 31, 2024,2025, we had cash totaling approximately $5.8$17.8 million. We believe that these funds together with the net proceeds of approximately $8.8 million from our equity financing completed March 25, 2025, will be sufficient to support our operating expenses and capital expenditure requirements intothrough theapproximately fouthyear quarterend 2025.2026. As a result, we will need to raise additional capital to continue as a going concern. Unless we receive additional funding, we may not be able to complete ourclinical Phasetrials 1we trial.begin. Further, we may only be able to complete the trial in a small subset of patients and in only one tumor type. Even if completed, we will require additional funds to advance further. If we are capital constrained, we may not be able to meet our obligations. If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our therapeutic candidates or even to continue operations, either of which occurrence would have a material adverse effect on us.

Disruptions in the financial markets in general have made equity and debt financing more difficult to obtain and may have a material adverse effect on our ability to meet our fundraising needs. We cannot guarantee that future financing will be available in sufficient amounts or on terms favorable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness could result in fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future therapeutic candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, consolidated operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly delay, scale back or discontinue one or more of our research or development programs or the commercialization of any therapeutic candidates or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, consolidated financial condition and consolidated results of operations.

The amount of our future losses is uncertain, and our quarterly consolidated operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.

Our quarterly and annual consolidated operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual consolidated operating results. As a result, comparing our consolidated operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or consolidated operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even if we meet any guidance we may have provided publicly previously.

We are an early,a clinical-stage oncology company with a limited operating history. We commenced operations in 2016, and until our IPO, our operations were limited to organizing and staffing our company, business planning, raising capital, conducting limited discovery and research activities, filing patent applications, identifying potential therapeutic candidates, undertaking preclinical studies and preparing for clinical trials, process development and manufacturing of initial quantities of our therapeutic candidates and component materials. Our lead therapeutic candidate, TTX-MC138, is currently in the early stages of clinical development. We acquired Seviprotimut-L, a novel polyvalent shed antigens vaccine for the potential adjuvant treatment of melanoma, which has completed Phase 2 clinical development. We have not yet demonstrated our ability to successfully complete anylarge-scale later-stage clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third-party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

We expect our consolidated financial condition and consolidated operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance.

BecauseIn ourdrug therapeuticand candidates are in an early stage ofbiologic development, there is a high risk of failure,failure and we may never succeed in developing marketable products or generating therapeutic revenues.

Our therapeutic candidates are clinical and preclinical development-stage technologies which require more, complex future development as well as regulatory approval prior to commercialization. It is impossible to fully mitigate the risks associated with bringing forward new technology and developing therapeutic candidates. These therapeutic candidates may fail at any point in development, manufacturing or in clinical trials. Therefore, there is no assurance that any of our therapeutic candidates will be successfully developed, be approved or cleared for sale by regulators, be accepted in the market or be profitable. Any delay or setback in the development of a product-candidate could materially adversely affect us.

Our business is highly dependent on the success of TTX-MC138, our lead candidatecandidate, whichas iswell atas theour earlyother stagesproduct ofcandidates, development.including Seviprotimut-L, UIO 524, UIO 525, and UIO 526. All of our therapeutic candidates may require significant additional manufacturing, preclinical and clinical development before we may be able to seek regulatory approval for and launch a product commercially.

We currently have no products that are approved for commercial sale and may never be able to develop marketable products. WeMost are very early inof our development efforts,effort andare at early stages; only onetwo of our therapeutic candidates, TTX-MC138,TTX-MC138 isand Seviprotimut-L, have reached clinical development. In October 2025, we completed and announced results for our Phase 1a clinical trial with TTX-MC138. Also in clinicalOctober development2025, withwe anacquired openSeviprotimut-L, a novel polyvalent shed antigens vaccine for the potential adjuvant treatment of melanoma, that has completed Phase I/II2 clinical trial.development. If we are unable to successfully develop, obtain regulatory approval for, and commercialize TTX-our MC138,therapeutic candidates, or we experience significant delays in doing so, our business will be materially harmed. Advancing TTX-MC138our therapeutic candidates will require substantial investment before we can seek regulatory approval and potentially launch commercial sales. Further development of TTX-MC138our therapeutic candidates will require production scaleup, clinical studies, regulatory review and approval in the U.S. and other jurisdictions, development of sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales, if approved.ever.

In developing TTX-MC138,TTX-MC138 or any of our other current or future product candidates, among other risks, we may not be successful in synthesizing or producing the components of our proprietary formulation, orformulations, there may be toxicology issues from key components of our formulationformulations that we have not anticipated.anticipated, or we may encounter other problems. We have not manufactured TTX-MC138 using the current synthesis protocol, production processes, equipment and materials in the larger quantities that would be necessary to meet clinical trial treatment demands for all anticipated patients.

Undesirable side effects or death caused by any of our therapeutic candidates could cause IRBs, our contract research organizations, or CROs, the FDA or other regulatory authorities to interrupt, delay or discontinue clinical trials and could result in the denial of regulatory approval for our therapeutic candidates. This, in turn, could prevent us from commercializing our therapeutic candidates and generating revenues from their sale. Immunotherapy, and its method of action of harnessing the body’s immune system, is powerful and could lead to serious side effects that we only discover in clinical trials. Unforeseen side effects could arise either during clinical development or, if such side effects are rare, after our product candidates have been approved by regulatory authorities and the approved product has been marketed, resulting in the exposure of additional patients.

To obtain the requisite regulatory approvals to commercialize any therapeutic candidates, we must demonstrate through extensive preclinical studies and clinical trials that our therapeutic candidates are safe and effective in humans. Clinical trials are expensive and can take many years to complete, and its outcome is inherently uncertain. In particular, the general approach for FDA approval of a new drug is dispositive data from two well-controlled, Phase 3 clinical trials of the relevant drug in the relevant patient population. Phase 3 clinical trials typically involve hundreds of patients, have significant costs and take years to complete. A therapeutic candidate can fail at any stage of testing, even after observing promising signals of activity in earlier preclinical studies or clinical trials. The results of preclinical studies and early clinical trials of our therapeutic candidates may not be predictive of the results of later-stage clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed. There is typically an extremely high rate of attrition from the failure of therapeutic candidates proceeding through clinical trials. Therapeutic candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biotechnology and biopharmaceutical industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most therapeutic candidates that commence clinical trials are never approved as therapeutic products, and there can be no assurance that any of our future clinical trials will ultimately be successful or support further clinical development of TTX-MC138TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526 or any of our other therapeutic candidates. Therapeutic candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:

In addition, differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials. Our FIH clinical trial with radiolabeled TTC-MC138 was designed as a single microdose trial, the purpose of which was to demonstrate safety and proof of delivery of TTX-MC138 to metastatic lesions. This design was not meant or expected to produce efficacy signals or to show that TTX-MC138 reaches into metastatic tumor cells. Our open Phase I/II clinical trial with TTX-MC138 is a Bayesian Optimal Interval Design, or BOIN design, with dose escalation and expansion. Key assessments in the clinical trial characterize the safety, pharmacokinetic, pharmacodynamic and anti-tumor activity thus identifying a maximum tolerated dose (MTD) and ensuring the mechanism of action is on target. The study also is exploring the effect of TTX-MC138 on biomarker expression, which may include miR-10b expression, and miR-10b downstream targets (ribonucleic acidacid, [RNA]or RNA, sequencing). Clinical assessments to further evaluate TTX=MC138TTX-MC138 include clinical laboratory exams, CT scan assessments, and response assessments per RECIST. In October 2025, we completed and announced results for our Phase 1a clinical trial with TTX-MC138.

Caution should be taken when interpreting the preliminary results of our preclinical studies or clinical trials, including those for TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526, or any of our completedother Phaseproduct 0 and currently-open Phase I/II clinical trials.candidates. These data may differ from future results of thisadditional study,studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.

From time to time, we may publicly disclose interim, preliminary or topline data from our preclinical studies and clinical trials, including our Phase 0 trial with radiolabeled TTX-MC138 and Phase I/II clinical trials, which are based on preliminary analyses of then-available data. These results and related findings and conclusions are subject to change following more comprehensive reviews of the data related to the particular study or trial. We also may make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary or topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results once additional data have been received and fully evaluated.

If the interim, preliminary or topline data that we report differs from subsequent results, or if others, including regulatory authorities, disagree with the conclusions we reach, our ability to seek and obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, consolidated operating results, prospects or consolidated financial condition. In addition, disclosure of interim, preliminary or topline data by us or by our competitors could result in volatility in the price of our common stock.

If we encounter difficulties enrolling eligible patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We have limited financial and human resources and intend to initially focus on research programs and therapeutic candidates for a limited set of indications. As a result, we may forgo or delay pursuit of opportunities with other therapeutic candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. In addition, we may seek to accelerate our development timelines, including by initiating certain clinical trials of our therapeutic candidates before earlier-stage studies have been completed. This approach may cause us to commit significant resources to prepare for and conduct later-stage trials for one or more therapeutic candidates that subsequently fail earlier-stage clinical testing. Therefore, our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities or expend resources on therapeutic candidates that are not viable. Similarly, our decisions to delay, terminate, or collaborate with third parties in respect of certain product development programs may also prove not to be optimal and could cause us to miss valuable opportunities.

There can be no assurance that we will ever be able to identify additional therapeutic opportunities for our therapeutic candidates or to develop suitable potential therapeutic candidates through internal research programs, which could materially adversely affect our future growth and prospects. We may focus our efforts and resources on potential therapeutic candidates or other potential programs that ultimately prove to be unsuccessful. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, it could have a material adverse effect on our consolidated financial results and prospects. If we develop our therapeutic candidates, or commercialize any approved therapeutic candidates, through collaboration, licensing or other royalty arrangements in cases where it would have been more advantageous for us to retain sole development and commercialization rights to such candidate, it could materially adversely affect our consolidated financial results and prospects.

We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of TTX-MC138TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526 or any of our other therapeutic candidates in development.

Clinical trials are required to apply for regulatory approval to market TTX-MC138 or any of our other therapeutic candidates. Clinical trials are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. Failure can occur at any stage of the process. We do not know whether any clinical trials we begin will continue as planned, will need to be restructured or will be completed on schedule or at all. Significant clinical trial delays also could allow competitors to bring products to market before we do and could impair our ability to successfully commercialize our therapeutic candidates, any of which could materially harm our business.

We also may experience numerous unforeseen events during, or as a result of, any future clinical trials that could delay or prevent our ability to receive marketing approval for, or to commercialize, TTX-MC138TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526 or any of our other therapeutic candidates in development, including the following:

Our product development costs will increase if we experience delays in clinical trials or in obtaining marketing approvals. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. If we do not achieve our product development goals in the time frames we announce and expect, the approval and commercialization of our therapeutic candidates may be delayed or prevented entirely. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our therapeutic candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our therapeutic candidates and harming our business and consolidated results of operations. Any delays in our clinical development programs may harm our business, consolidated financial condition and consolidated results of operations significantly.

As therapeutic candidates progress through preclinical to late-stage clinical trials to marketing approval and commercialization, various aspects of the development program, such as manufacturing methods and the product’s formulation, may be altered along the way in an effort to optimize yield, manufacturing batch size, minimize costs and achieve consistent quality and results. These changes carry the risk that they will not achieve their intended objectives. Any of these changes could cause our therapeutic candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our therapeutic candidates and jeopardize our ability to commercialize our therapeutic candidates and generate revenue.

In addition, there are risks associated with process development and large-scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with current good manufacturing practice, or cGMP, requirements, lot consistency and timely availability of raw materials. Even if we obtain marketing approval for any of our therapeutic candidates, there is no assurance that our third-party manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or to meet potential future demand. If our contract manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, our development and commercialization efforts would be impaired, which would have an adverse effect on our business, consolidated financial condition, consolidated results of operations and growth prospects.

Quality problems could delay or prevent delivery of our productsproduct candidates to clinical trials or the market.

As it relates to the manufacturing of both our drug substance and drug product, or biological product, we are required to adhere to FDA’s current good manufacturing practice, or cGMP, regulations.regulations and, if applicable, the FDA’s current good tissue practice, or CGTP, for the use of human cellular and tissue products. Additionally, we must follow guidelines promulgated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, or ICH Guidelines. The ICH Guidelines to which we are subject are ICH E6 (R2) and ICH E8 (R1), “Designing quality into clinical studies,” for all tasks related to clinical programs, and ICH Q7 for the manufacture of our drug substance and drug product.

Research programs to identify new therapeutic candidates require substantial technical, financial and human resources. If we are unable to identify suitable compounds for preclinical and clinical development, we will not be able to obtain product revenue in future periods, which likely would result in significant harm to our consolidated financial position and adversely impact our stock price.

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop. We will need to obtain insurance for clinical trials as TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526 and any of our other therapeutic candidates begin clinical development. However, we may be unable to obtain, or may obtain on unfavorable terms, clinical trial insurance in amounts adequate to cover any liabilities from any of our clinical trials. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

We are very early in our development efforts. Only one of our therapeutic candidates has reached clinical development. If we are unable to advance our therapeutic candidates tothrough clinical development,development to obtain regulatory approval and ultimately commercialize our therapeutic candidatescandidates, or we experience significant delays in doing so, our business will be materially harmed.

Any analysis of data from preclinical and clinical activities that we perform is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to new government regulations, for example, from future legislation or administrative action, or from changes in FDA policypolicy, funding or leadership during the period of product development, clinical trials and FDA regulatory review. It is impossible to predict whether legislative changes will be enacted, or whether FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be.

We have received Orphan Drug Designations for TTX-MC138 and TTX-siPDL1 for pancreatic cancer, and may in the future seek Orphan Drug Designation for TTX-MC138our current or future product candidates in other indications and for some of our other current and future therapeutic candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.

As part of our business strategy, we may seek orphan drug designation for any any eligible product cndidates we develop, and we may be unsuccessful. Under the Orphan Drug Act, the FDA may grant orphan designation to a therapeutic candidate or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. There can be no assurances that we will be able to obtain orphan designations for our product candidates.

A Fast Track designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development ordevelopment, regulatory review or approval process,approval, and does not increase the likelihood that our product candidates will receive marketing approval.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation for a particular indication. WeFast track designation has been granted for Seviprotimut-L (for adjuvant use in Stage IIB/IIC melanoma), and we may seek Fast Track designation for some or all of our current and future product candidates, but there is no assurance that the FDA will grant this status to any of our current or future product candidates. Marketing applications filed by sponsors of products in Fast Track development may qualify for Priority Review under the policies and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketing approval by the FDA. The FDA has broad discretion whether or not to grant Fast Track designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast Track designation does not provide assurance of ultimate FDA approval. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. In addition, the FDA may withdraw any Fast Track designation at any time.

AcceleratedWe may seek an accelerated approval bypathway FDA,for one or more of our current or future product candidates, including TTX-MC138, but even if grantedgranted, for TTX-MC138 or any other future therapeutic candidate,it may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our therapeutic candidates will receive marketing approval.

We may seek approval of TTX-MC138 and may seek approval of future therapeutic candidates using the FDA’san accelerated approval pathway.pathway for one or more of our current or future product candidates, including TTX-MC138. A therapeutic candidateproduct may be eligible for accelerated approval if it treatsis designed to treat a serious or life-threatening disease or condition and generally provides a meaningful advantage over available therapies.therapies Inafter addition,a itdetermination mustthat demonstratethe product candidate has an effect on a surrogate endpointendpoint, or intermediate clinical endpoint, that is reasonably likely to predict clinical benefit.benefit Asor on a conditionclinical endpoint that can be measured earlier than irreversible morbidity or mortality, or IMM, that is reasonably likely to predict an effect on IMM or other clinical benefit. There can be no assurance that the FDA would allow any of approval,the product candidates we may develop to proceed on an accelerated approval pathway, and even if the FDA did allow such pathway, there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all.. Moreover, the FDA is empowered to take action, such as issuing fines, against companies that fail to conduct with due diligence any post-approval confirmatory study or submit timely reports to the agency on their progress. The FDA may requirefurther thatwithdraw a sponsorapproval of a drug receivingor biologic granted accelerated approval performon adequatean andexpedited well-controlledbasis post-marketingif the sponsor fails to conduct such studies in a timely manner, send the necessary updates to the FDA, or if such post-approval studies fail to verify the drug’s predicted clinical trials.benefit. TheseAccordingly, confirmatoryeven trialsif mustwe be completed with due diligence. In addition, unless it determines otherwise, FDA currently requires pre-approval of promotional materials for products receivingreceive accelerated approval, any post-approval studies required to confirm and verify clinical benefit may not show such benefit, which could adverselylead affectto the timingwithdrawal of theany commercialapprovals launchwe ofhad the product.obtained. Thus, even if we seek to utilize the accelerated approval pathway, we may not be able to obtain accelerated approval and, even if we do, we may not experience a faster development, regulatory review or approval process for that therapeutic candidate. In addition, receiving accelerated approval does not assure that the product’s accelerated approval will eventually be converted to a traditional approval.

The ability of FDA to review and approve new products and clinical trial applications can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel, accept payments of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result of these and other factors. In particular, it has been reported that FDA’s planned expansion of its oncology division is delayed. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Even if we receive regulatory approval of TTX-MC138TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526, or any of our other therapeutic candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense. We may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates.

Any regulatory approvals that we receive for TTX-MC138TTX-MC138, Seviprotimut-L, UIO 524, UIO 525, UIO 526, or another product-candidate may require post-marketing surveillance to monitor the safety and efficacy of the product and may require us to conduct post-approval clinical studies. The FDA may also require a REMS in order to approve our therapeutic candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves our therapeutic candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our therapeutic candidates will be subject to extensive and ongoing regulatory requirements. These requirements can include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and GCP, for any clinical trials that we conduct post-approval and applicable product tracking and tracing requirements. Compliance with ongoing and changing requirements takes substantial resources and, should we be unable to remain in compliance, our business could be materially and adversely affected.

Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and consolidated results of operations.

Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example, (1) changes to our manufacturing and supply arrangements; (2) additions or modifications to product labeling; (3) the recall or discontinuation of our products; (4) modifications to pricing and costs; or (5) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. See the section of this Annual Report titled “Business-CurrentBusiness—Government Regulation—Current and Future Healthcare Reform Legislation.”

You should read the following discussion and analysis of our consolidated financial condition and consolidated results of operations together with the “Consolidated Financial Statements” section of this Annual Report on Form 10-K including the related notes appearing elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those set forth in the “Cautionary Note Regarding Forward Looking Statements” and “Risk Factors” sections of this Annual Report, our actual results could differ materially from the consolidated results described in or implied by the forward-looking statements contained in the following discussion and analysis.

For decades, ribonucleic acid, or RNA, has been a topic of investigation by the scientific community as a potentially attractive therapeutic modality because it can target any genegene, and it lends itself to rational and straightforward drug design. RNA-based therapeutics are highly selective to their targets and potentially applicable to a broad array of previously undruggable targets in the human genome. We believe that one of the major challenges to widespread use of RNA therapeutics in oncology and other indications has been the inability to deliver these molecules inside cells.

To customize the development of targetedRNA therapeutics, we have developed a design engine that is modular at both the levels of the core nanoparticle and the therapeutic loading. The size, charge, and surface chemistry of the core iron oxide nanoparticle are designed so that it can be tuned to optimize the particles for the intended target and therapeutic load. The therapeutic load is designed to consist of synthetic oligonucleotides and other molecular moieties such as proteins, peptides, radionuclides, and small molecules that can be adapted to the specific approach being developed. The approach can range from RNA interference, or RNAi, including small interfering RNAs, antisense oligonucleotides, and non-coding RNA mimics to Pattern Recognition Receptors such as RIG-I. We believe the TTX platform can further be used for developing targeted radiolabeled therapeutics and diagnostics and other custom products targeting known and novel biomarkers and other genetic elements as they are discovered and validated.

Our TTX technology has gone through approximatelymore than 20 years of research and development, or R&D, and optimization, including 12 years at Harvard Medical School and the Massachusetts General Hospital, by our scientific co-founders prior to company formation.

Nanoparticles similar in formulation to ours have an excellent clinical safety record of low toxicity and immunogenicity. Because their iron core is magnetic and visible with magnetic resonance imaging, or MRI, they have the additional benefit of enabling quantification of the particles’delivery deliveryof the particles to target organs. Our nanoparticles carry functional groups to provide stable links to the therapeutic oligonucleotides of interest through covalent bonds.

In September 2021, research conducted by MGH was published in Cancer Nanotechnology, entitled “Radiolabeling and PET-MRI microdosing of the experimental cancer therapeutic, MN-anti-miR10b, demonstrates delivery to metastatic lesions in a murine model of metastatic breast cancer.” This paper reported on an MGH study using a radiolabeled derivative of TTX-MC138 (referred to in the paper as MN-anti-miR10b). In this study, TTX-MC138 was tagged with copper-64, or Cu-64. As a result, highly sensitive and specific quantitative determination of pharmacokinetics and biodistribution, as well as observation of delivery of the radiolabeled TTX-MC138 to metastases, was made in laboratory tests using noninvasive PET-MRI. The key results of the study suggest that when injected intravenously, TTX-MC138 accumulates in metastatic lesions. These results suggest that our TTX platform delivers its therapeutic candidate as intended and support clinical evaluation of TTX-MC138. In addition, the MGH investigation describes a microdosing PET-MRI approach to measure TTX-MC138 biodistribution in cancer patients and its delivery to clinical metastases. (Microdoses are minute, subpharmacologic doses of a test compound, not greater than 100 micrograms.) The capacity to carry out microdosing PET-MRI studies in patients under an exploratory IND, or eIND, application could be important because they have the potential to support additional clinical trials we may propose for FDA consideration. The research described in this paper, published by Dr. Zdravka Medarova, our Chief Scientific Officer and scientific co-founder, and others, describes what we believe is an effective approach to assessing delivery of TTX-MC138 in metastatic cancer patients. Since the PET-MRI technique is sensitive enough to determine the concentration of radiolabeled drug candidate in the sub-picomolar range, microgram quantities of the radiolabeled drug candidate are believed to be sufficient to perform such a study in humans. We believe this capability has significant advantages in the initial phases of drug development. Because the low mass of radiolabeled TTX-MC138 is subtherapeutic, it may inform future clinical trials with this candidate.

Because of the potential benefits from a microdose Phase 0 clinical trial, and reflecting the studies described in Cancer Nanotechnology, our First-in-Human Phase 0 trial was designed to deliver a microdose of our therapeutic candidate. Preliminary resultsResults from the Phase 0 microdose trial suggest the validity of our TTX pipeline for drug delivery generally, potentially opening-up additional relevant RNA targets that have been previously undruggable.

In April 2021, we received a Fast-Track Small Business Innovation Research award, or SBIR Award, from the National Cancer Institute that provided approximately $2.4 million to fund a two-phased research partnership between us and Massachusetts General Hospital. The program commenced in April 2021 and ended in March 2024. We received SBIR Award funds of $308,861 in May 2021, $1,129,316 in the second year of the award and $870,597 in April 2023 for the third year of the Award. In the SBIR Award application, we proposed performing key translational experiments including IND-enabling and supporting imaging studies using MRI to assess delivery and target engagement of TTX-MC138 in metastatic lesions of breast cancer patients. The experiments were designed to achieve the following aims:

We believe that we have achieved all three aims under this SBIR.

In September 2024, the Companywe received itsour second NIH Award (the “2024 Award”), a Direct to Phase II SBIR Award, from the National Cancer Institute of the NIH. The 2024 Award is a Direct to Phase II SBIR Award to support IND-enabling and clinical trial activities in the Company’s Phase 1aour clinical trial with its lead candidate, TTX-MC138,TTX-MC138 over two years. The total 2024 Award is for $1,999,972 of which $1,011,207 applies to the first year and $988,765 applies to the second year.

Phase 1I/II Clinical Trial

OnWe April 15, 2024, we announced that FDA had completed its review of our IND application to conductcommenced a Phase I/II clinical trial with our lead therapeutic candidate, TTX-MC138, and concluded that we may proceed with this clinical trial. The trial is a multicenter, open-label, dose-escalation and dose-expansion study ofTTX-MC138 in patients with advanced solid tumors. We commenced the trial in the third quarterSeptember 2024 at MD Anderson and three other clinical trial sites. This trial has been designed as a multicenter, open-label, dose-escalation and dose-expansion study in patients with advanced solid tumors. The firstPhase 1a stage of this trial,trial the Phase 1a, calls forinvolved administration of escalating therapeutic dose levels of our drug candidate in up to as many as six cohorts of approximately three patients or more per cohort. The first cohort received the lowest therapeutic dose level. In October 2024, the trial’s Safety Review Committee (the “SRC”), approved commencing dosing of patients in the second cohort. Patients in the second and third cohorts have received dosing that is approximately double the level received by patients in each prior cohort. After three patients in each cohort received their initial dose of our drug candidate, the SRC assessed the data and determined that there were no drug-related serious adverse effects or dose limiting toxicities. The SRC approved commencement of dosing in the fourth cohort at a dosage that is approximately fifty percent higher than that administered in the third cohort. The SRC also approved enrollment of additional patients in Cohort 3 to build upon the safety profile of TTX-MC138. Preliminary data indicate no significant safety or dose limiting toxicities have been reported in Cohortsthe 1,trial. 2,To ordate, 377 doses of TTX-MC138 have been administered to 16 patients with advanced solid tumors. Three patients remain on trial. The median treatment duration of treatment is four months. Importantly, the duration of treatment for all patients ranged from two to twelve cycles indicative of tolerability and PKdisease andcontrol. PD data fromSixteen patients inshowed Cohortpositive 1pharmacodynamic andeffects Cohortover 2a iswide dose range, consistent with preclinical results and results from ourTransCode’s Phase 0 clinical trial. Key assessments in the clinical trial characterize the safety, pharmacokinetic, pharmacodynamic and anti-tumor activity thusof identifyingTTX-MC138 from which we have estimated a maximum tolerated dosedose, (MTD)or MTD, and ensuringwhich suggest that the mechanism of action of TTX-MC138 is on target. The studytrial also is exploring the effect of TTX-MC138 on biomarker expression, which may include miR-10b expression, and miR-10b downstream targets (RNA sequencing). Clinical assessments to further evaluate TTX=MC138TTX-MC138 include clinical laboratory exams, CT scan assessments, and response assessments per RECIST.RECIST criteria. The Phase 2a stage of the trial is expected to commence in the first half of 2026.

July 2024Yorkville Financing

Factors that could cause our actual results to differ materially from those in this Quarterly Report on Form 10-Q are any of the risks described in our Annual Report on Form 10-K for the year ended December 31, 2025, or our Annual Report, filed with the SEC, as amended and supplemented by the information in our subsequent Quarterly Reports on Form 10-Q or other subsequent filings, together with all of the other information contained in this Quarterly Report, including our unaudited consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report, and the risk factors set forth below. The risk factors disclosure in our Annual Report and subsequent Quarterly Reports on Form 10-Q is qualified by the information that is described in this Quarterly Report. Any of these factors could result in a significant or material adverse effect on our business, consolidated results of operations or consolidated financial condition. Additional risk factors not currently known to us or that we currently deem immaterial may also have a material adverse effect on our business, consolidated financial condition or consolidated results of operations. You should review the risk factors in our Annual ReportReport, subsequent SEC filings and the risk factors discussed below for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

We could lose our listing on the Nasdaq Capital Market if our stockholders’ equity or the closing bid price of our common stock do not meet Nasdaq requirementsrequirements, if we do not meet Nasdaq’s new requirement with respect to a Nasdaq-listed company’s market value of listed securities, or if we do not comply with other Nasdaq requirements. The loss of our Nasdaq listing would in all likelihood make our common stock significantly less liquid and adversely affect its value, including a total loss of value. Loss of our Nasdaq listing would in all likelihood also make it much more difficult for us to raise additional capital.

Our stockholders’ equity in this Quarterly Report on Form 10-Q does not meet Nasdaq Capital Market, LLC, or Nasdaq, rules for continued listing of our stock on the Nasdaq Capital Market, LLC, or Nasdaq. WeAs expectpreviously todisclosed, receiveon May 19, 2026, we received a deficiency notice to this effect from Nasdaq with the opportunity to present our plan to Nasdaq for regaining compliance. WeOn believeJuly that20, if2026, we obtainobtained shareholderstockholder approval for the conversion of our preferred stock,stock and, between July 20, 2026, and August 10, 2026, all of our outstanding shares of preferred stock converted into Common Stock. As a result, we willbelieve that we now exceed the minimum stockholders’ equity requirement butand Nasdaq has confirmed this conclusion. Nevertheless, there is no guaranteeassurance that such approvalwe will becontinue obtained.to meet Nasdaq rules for continued listing of our stock.

In the event of a delisting from the Nasdaq Capital Market,Nasdaq, our stock would likely be traded in the over-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market,Nasdaq, or Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, our stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, many institutional investors are prohibited from investing in OTC stocks, and it might be more challenging to raise capital when needed. Further, a delisting of our stock from trading on Nasdaq could also adversely affect our reputation, relationships with business partners, and access to strategic opportunities.

As further described elsewhere in this Quarterly Report on Form 10-Q, in light of our financial position and our need to raise additional capital, delisting of our common stock from the Nasdaq Capital Market would materially limit our ability to obtain additional equity capital.

TransCode is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. Our lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. InWe 2023,obtained weour conductedsecond aprincipal Phasetherapeutic 0candidate, clinical trialSeviprotimut-L, in one patientconnection with advancedour solid tumors. The intentacquisition of thePolynoma Phaseas 0discussed trial was to demonstrate quantitative delivery of radiolabeled TTX-MC138 to metastatic lesions. In September 2024, we commenced a Phase I/II clinical trial with TTX-MC138 which substantially met its primary safety endpoint by the end of 2025. Analysis of the Phase I/II clinical trial results is ongoing. We expect to commence a Phase 2a clinical trial in the first half of 2026.below.

ABCJ owns 100% of the issued and outstanding membership interests of Polynoma, LLC, a Delaware limited liability company, (“Polynoma”) previously headquartered in San Diego, California. Polynoma is an immuno-oncology focused biopharmaceutical company developing Seviprotimut-L, an investigational polyvalent antigen vaccine intended to reduce the risk of recurrence of cancer in patients with stage IIB and IIC melanoma who have limited options. Seviprotimut-L has completed a Phase III clinical trial and has been safely administered in clinical trials to more than 1,000 patients. Seviprotimut-L is a novel allogeneic, polyvalent partially-purified shed antigens vaccine (alum adjuvanted) for the adjuvant treatment of Stage IIB and IIC melanoma patients age 60 years and younger. Seviprotimut-L is derived from three proprietary human melanoma cell lines. Seviprotimut-L works by stimulating both humoral and cellular immune responses. It has completed an initial Phase 3 clinical trial and has been administered to approximately 1,000 patients in clinical trials.

We intend to work on developing both TTX-MC138 andand, depending on funding availability, Seviprotimut-L, with theour initial focus on advancing TTX-MC138 in a plannedthe Phase 2a clinical trial. We are evaluating various approaches for continuing development of Seviprotimut-L which will require additional CMC work (chemistry, manufacturing and control) as well as at least one additional Phase III clinical trial. We believe there ismay be potential to augment Seviprotimut-L's focus with TTX-MC138 by addressing micrometastases in stage IIB and IIC melanoma patients.

Concurrent with the Acquisition, we entered into an Investment Agreement (the “Investment Agreement”) with DEFJ. Pursuant to the Investment Agreement, DEFJ agreed to purchase, and we agreed to issue and sell, in a private placement an aggregate of 223.7337 shares of Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share, (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”) at a price per share of $111,740, for an aggregate purchase price of approximately $25 million. The aggregate purchase price consisted of a cash subscription of $20 million paid on October 8, 2025, and issuance by DEFJ of a promissory note (the “Promissory Note”) in the aggregate principal amount of approximately $5 million (together, the “Investment”). The Promissory Note accrued interest at a rate of 4% per annum, calculated as simple interest on a 365-day year. The principal and accrued interest were paid on December 30, 2025. Each share of Series B Preferred Stock is convertible into 10,000 shares of Common Stock.

Unleash Licensing Agreement. In March 2026, we entered into the Unleash Licensing Agreement with Unleash pursuant to which the we acquired a pre-clinical candidate program involving genetically-engineered adenoviruses to harness the immune system to fight cancer, as well as an exclusive, perpetual, irrevocable, worldwide, fully-paid up, royalty-free, sublicensable right and license to related technology.

As consideration for the Unleash Licensing Agreement, pursuant to an Equity Issuance and Registration Rights Agreement with Unleash (the “Unleash Registration Rights Agreement”), we issued to Unleash 1,136,364 shares of our Series C Non-Voting Convertible Preferred StockStock. andAdditionally, we issued 77,840 shares of our Series C Non-Voting Convertible Preferred Stock to Tungsten Advisors (together with its affiliates, “Tungsten”) as compensation for services rendered by Tungsten. TheConversion of the Series C Preferred Stock isrequired notapproval convertible untilby our stockholders approve its conversion into Common Stock in accordance with the listing rules of Nasdaq (thewhich “Unleashapproval Stockholderwas Approval”).obtained Followingon theJuly Unleash20, Stockholder2026. Approval,Between July 20, 2026, and August 10, 2026, each share of Series C Preferred Stock ishas convertibleconverted into one share of our Common Stock.

In addition to TTX-MC138,TTX-MC138 and Seviprotimut-L, we have a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. TTX-siPDL1 is an siRNA-based modulator of programmed death-ligand 1, or PD-L1. TTX-RIGA is an RNA-based agonist of the retinoic acid-inducible gene I, or RIG-I, targeting activation of innate immunity in the tumor microenvironment. TTX-siMYC is a siRNA-based inhibitor of c-MYC, a widely expressed but currently undruggable oncogene. Seviprotimut-LThe isimmune-oncology aprogram novelwe allogeneic,licensed polyvalentfrom partially-purifiedUnleash shedincludes antigensoncolytic vaccinevirus (alumconstructs adjuvanted)initially being developed for the adjuvant treatment of Stagemuscle IIBinvasive andbladder IIC melanoma patients age 60 years and younger. Seviprotimut-L is derived from three proprietary human melanoma cell lines. Seviprotimut-L works by stimulating both humoral and cellular immune responses. It has completed an initial Phase 3 clinical trial and has been administered to approximately 1,000 patients in clinical trials.cancer.

In April 2021, we received a Fast-Track Small Business Innovation Research award, or SBIR Award, from the National Cancer Institute that provided approximately $2.4 million to fund a two-phased research partnership between us and Massachusetts General Hospital. The program commenced in April 2021 and ended in March 2024. In the SBIR Award application, we proposed performing key translational experiments including IND-enabling and supporting imaging studies using MRI to assess delivery and target engagement of TTX-MC138 in metastatic lesions of breast cancer patients. The experiments were designed to achieve the following aims:

The Phase Ia1a stage of this trial involved administration of escalating therapeutic dose levels of our drug candidate in four cohorts of an aggregate of 16 patients. Preliminary data indicate noNo significant safety or dose limiting toxicities have been reported in the trial. To date, approximately 86 doses of TTX-MC138 have been administered to the 16 patients, all of whom had advanced solid tumors. Three patients remain on trial. The median duration of treatment is 79 days. Importantly, the duration on study for all patients in this trial ranged from two to 2022 cycles,cycles of treatment, indicative of tolerability and disease control. PreliminaryData datafrom analysisthis trial demonstrated evidence of dose response over a wide dose range, consistent with preclinical results and our Phase 0 clinical trial. Key assessments in the clinical trial characterize the safety, pharmacokinetic, pharmacodynamic and anti-tumor activity of TTX-MC138 from which we have estimated a maximum tolerated dose, or MTD, and which suggest that the mechanism of action of TTX-MC138 is on target. The trial also is exploring the effect of TTX-MC138 on biomarker expression, which may include miR-10b expression, and miR-10b downstream targets (RNA sequencing). Clinical assessments to further evaluate TTX-MC138 include clinical laboratory exams, CT scan assessments, and response assessments per RECIST criteria.

We recently announcedlaunched a newPhase collaboration2a clinical trial to evaluate TTX-MC138 asin partpatients ofwith ct-DNA positive colorectal cancer with Minimal Residual Disease (MRD), a setting characterized by significant unmet need with the PRE-I-SPYpotential clinicalto intervene before metastatic recurrence. The Phase 2a trial platformis operatedbeing byconducted in collaboration with Quantum Leap Health Care Collaborative (“Quantum Leap”). as part of its PRE-I-SPY clinical trial platform. The PRE-I-SPY program will incorporateincorporates TTX-MC138 into a Phase IIa clinical trial designed as a multicenter, open-label, one-year treatment duration with one year follow up, dose-expansion trial.up. The trial will evaluate event-free survival, ctDNA dynamics and pharmacokinetics of TTX-MC138 in up to 45 patients who (i) withhave stage I-III adenocarcinoma of the colon or rectum whoand are ctDNA positive with minimal residual disease detected by tumor-informed ctDNA assays, (ii) who have completed standard curative-intent therapy, and (iii) who show no radiographic evidence of recurrence or metastasis. This trial iswas planned to begininitiated in the second quarter 2026 andwith willinitial bepatient ledenrollments byexpected Principalin Investigatorthe third quarter 2026. Dr. Paula Pohlmann of the MD Anderson Cancer Center.Center is the Principal Investigator. The study is being conducted under a Quantum Leap IND and cross-referenced to our IND. The total amount of the Quantum Leap agreement is approximately $7.3 million payable against milestones tied to Quantum Leap’s performance under the terms of the collaboration agreement.

In connection with the SEPA, and subject to the conditions set forth therein, Yorkville has also agreed to advance to us up to $6.0 million, less certain amounts as described below, to be paid in two tranches (each, a “Pre-Paid Advance” and, together, the “Pre-Paid Advances”), in exchange for our issuance to Yorkville of convertible promissory notes (each, a “Convertible Note” and, together, the “Convertible Notes”). Pursuant to the Convertible Notes and the SEPA, Yorkville may convert all or any portion of the outstanding principal amount, accrued but unpaid interest, and other amounts outstanding under the Convertible Notes into shares of Common Stock, at any time and from time to time during the term of the Convertible Notes.

The second tranche of the Pre-Paid Advance shall bewas disbursed to the Company in exchange for the issuance to Yorkville of a Convertible Note in the principal amount of $5.0 million (the “Second Convertible Note”). The Second Convertible Note will bewas issued with a purchase price discount of 5.0% (or $250,000) and will beis convertible into Common Stock at the lower of (i) a price equal to 115% of the VWAP on the day prior to the issuance of the Second Convertible Note and (ii) 95% of the lowest daily VWAP during the seven consecutive trading days immediately preceding the conversion date, but in no event lower than the Floor Price (the “Second Convertible Note Conversion Price,” and together with the First Convertible Note Conversion Price, the “Conversion Price”). The Second Convertible Note will bewas issued on theJuly second22, trading2026, day after the later of (i) the registration statement filed pursuant to the SEPA, including any prospectus, amendments and supplements thereto, (the “Yorkville Registration Statement”) first becoming effective under the Securities Act, (ii)following our receipt of stockholder approval to issue shares of Common Stock to Yorkville under the SEPA in excess of the Exchange Cap (defined below) and (iii) the approval by Nasdaq of the initial listing application required under Nasdaq Listing Rules 5110 and 5635(b). After accounting for the purchase price discount, we expect to receivereceived gross proceeds of $4,750,000 pursuant to the Second Convertible Note.

Interest on the outstanding balances of the Convertible Notes will accrueaccrues at an annual rate of 5.0%, subject to an increase to 18% upon an event of default as described in the Convertible Notes. The maturity date of each Convertible Note will beis 18 months from the date upon which the Convertible Note iswas issued. The applicable maturity date of each Convertible Note may be extended by us, at our option, for a period of six months on two occasions by providing written notice to Yorkville. On the applicable maturity date, any portion of the outstanding principal amount and accrued but unpaid interest that remains outstanding on such Convertible Note will automatically be converted into Common Stock at the then applicable Conversion Price, provided that if any Equity Condition (as defined in the Form of Promissory Note ) is not satisfied, the applicable maturity date will be automatically extended until all Equity Conditions have been satisfied.

OnFollowing Juneour 2,stockholders’ 2025,approval we receivedat a lettermeeting fromof stockholders held on July 20, 2026, of the conversion of our Series A Preferred Stock, Nasdaq Stock Market (“Nasdaq”) notifying usconfirmed that we werehad deemed inregained compliance with Nasdaqthe ListingStockholders’ RuleEquity 5550(a)(2), requiring that a company maintain a minimum closing bid price of $1.00 per share.Requirement. As a result, and subject to our remaining in compliance with Nasdaq listing requirements, our stock will continue to be listed on the Nasdaq.

Following our IPO in July 2021, we expanded our R&D activities and company operations. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have limited experience with clinical trials, have not obtained any regulatory approvals to sell any products, have not manufactured any drug candidate at commercial-scale, or conducted sales and marketing activities. Through MarchJune 31,30, 2026, we received approximately $95.8$96.7 million of net proceeds, primarily from our IPO, other equity financings including the Investment Agreement, and our SBIR Awards and from borrowings under convertible promissory notes between 2018 and 2020.Awards.

We have incurred significant operating losses since inception. Our net losses were approximately $17.8$24.5 million and $12.1$16.4 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. At MarchJune 31,30, 2026, we had an accumulated deficit of approximately $115.6$122.4 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates for which there is no assurance of occurrence. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

As a result, we will need substantial additional funding to support our continuing operations and pursue our business strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through sales of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we will likely need to consider additional cost reduction strategies, which may include, among others, amending, delaying, limiting, reducing, or terminating our development programs, and we may need to seek an in-court or out-of-court restructuring of our liabilities. In the event of such future restructuring activities, holders of our Common Stock and other securities would likely suffer a total loss of their investment.

As of MarchJune 31,30, 2026, we had cash of approximately $12.8$8.4 million. We believe that this cash, along with receiptthe proceeds from the sale of payment from DEFJ for reimbursement of approximately $2.3 million of certain expenses that we expect to receive in the firstSecond halfConvertible of 2026,Note, will be sufficient to support our operating expenses and capital expenditure requirements through approximately year end 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Although our business has not been materially impacted directly by these global economic and political developments to date, it is impossible to predict the extent to which we may be impacted in the short and long term, or the ways in which our business, consolidated financial condition and consolidated results of operations could be affected by any of the foregoing or by other events which may occur in the future. Any such disruptions may also magnify the impact of other risks described herein or in our other filings with the SEC.

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts and the development of product candidates. We expense research and development costs as incurred, which at times include:

We seek to track our research and development expenses on a program-by-program basis. Our direct external research and development expenses comprise primarily payments to outside consultants, CROs, CMOs, research laboratories, and suppliers. Our direct external research and development expenses also include fees incurred under license and option agreements. We do not intend generally to allocate costs of certain management personnel, certain costs associated with our discovery efforts, certain supplies used in the laboratory, and certain facilities costs, including depreciation or other indirect costs, to specific programs when these costs are incurred across multiple programs and where it may not be practical to track them by program. We use internal resources along with outside parties primarily to conduct our research and discovery as well as for managing our preclinical development, process development, manufacturing and clinical development activities.

In September 2021, we signed a statement of work with a European CMO to manufacture TTX-MC138 in accordance with current good manufacturing practices, or cGMP. Separately, we engaged a consulting toxicologist to assist us in designing and conducting IND-enabling studies including toxicology and pharmacokinetic, or PK, studies. These studies are designed to examine multiple parameters with a range of analytical assessments in support of regulatory submissions using radiolabeled or non-radiolabeled test substances. Toxicokinetic assessments can be conducted in parallel or concurrent with ongoing toxicology programs and in compliance with good laboratory practice, or GLP, requirements. We also engaged an analytical testing laboratorylaboratories to provide testing and other services, as well as documentation and reporting that meet regulatory requirements.

In late 2024, we and The University of Texas M. D. Anderson Cancer Center (“MD Anderson”) agreed to amend our five-year strategic collaboration agreement in favor of MD Anderson focusing solely on participation in our Phase I/II clinical trial. This amendment relieved us from the obligation to make up to $10 million of collaboration payments. We are obligated to pay charges incurred by MD Anderson in connection with clinical trial services. In January 2023, we made an initial payment of $250,000 to MD Anderson recorded as a Prepaid Expense pending such time as payments under the collaboration became due. Initial expenses of the clinical trial have been charged against the initial payment and for the threesix months ended MarchJune 31,30, 2026 and 2025, were $7,933$15,866 and $81,561,$138,439, respectively.

In September 2021, we engaged an independent compensation advisory firm to supportadvise theour continuedBoard’s developmentCompensation ofCommittee with respect to our compensation programs and governance model for officers, directors and employees. Our goal is to ensure that our culture, values, and strategic priorities are effectively represented in our compensation philosophy and strategy.

Interest expense previouslyrepresents consisted primarily of accrued interest on convertible promissory notes and otherfinancing charges related to the notes. Since the notes converted into shares of common stock concurrent with our IPO, we no longer incur interest expense on these notes. Underunder our payment program for our directors and officers liability insurance,insurance. we incur certain financing charges, and weWe previously incurred imputed interest expense in connection with our former right-of-use asset.

From time to time, we apply for grant funding from government programs and may, in the future, apply for grants from non-government sources as well. There is no assurance that any grants will be awarded to us or, if awarded, that we will receive all the funds expected from such award. Grant income is recognized in our statements of operations as and when earned for performance of the specific R&D activities for which the grants are awarded. Grant payments received in advance of us performing the work for which the grant was awarded are recorded as deferred grant income on our balance sheets. Grant income is recognized in our statements of operations as and when earned for performance of the specific R&D activities for which the grants are awarded. Grant income earned in excess of grant payments received is recorded as grant receivable on our balance sheets.

Comparison of the three and six months ended MarchJune 31,30, 2026 and 2025

Research and development, or R&D, expenses increased $13,313$1,128 thousand and $4,015 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, compared to the same periodperiods in 2025. The increaseincreases reflectsreflect primarily spending on the Unleash license shown as “Acquired in-process research and development expense” in the table above, increases in clinical trial spending, costs of production of drug used in the clinical trial, and intellectual property expenses, offset in part by reductions in certain preclinical testing and reduced lab facilities costs. In addition, in the six months ended June 30, 2026, we incurred a one-time non-cash R&D charge with respect to the Unleash license shown as “Acquired in-process research and development expense” in the table above.

General and administrative expenses increased $1,270$881 thousand and $2,151 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, compared to the same periodperiods in 2025. The increaseincreases reflectsreflect primarily increased fees for professional services, primarily financial advisory, legal and accounting services related to the Acquisition and the Unleash license, and increased compensation costs, offset in part by decreased share-based compensation expense, spending for directors and officers liability insurance, investor relations services, and facilities expenses. In the three and six months ended June 30, 2026, we also incurred $559 thousand in costs related to the SEPA.

The change in fair value of warrant liability expenseresulted wasin $9,110non-cash gains of $229 thousand lessand $104 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, changes of $391 thousand and $9,501 thousand, respectively, compared to the same periodperiods in 2025. The results in the six months ended June 30, 2025, resultingresulted primarily from exercises of Series D warrants in the first quarter of 2025that year that did not occurrecur in the 2026 period.periods.

The change in fair valuevalues of contingent consideration wasincreased a $116$217 thousand increaseand $101 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, compared to the same periodperiods in 2025. Contingent consideration arose in connection with the Acquisition; there was no contingent consideration in the 2025 period.periods.

Grant income decreased $208$133 thousand and $341 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, compared to the same periodperiods in 2025 primarily reflecting thecompletion fact thatof much of the work underrelated to the 2024 Award was completed prior to 2026.

Loss on currency exchange wasdecreased $6$11 thousand lessand $17 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, compared to the same periodperiods in 2025, reflecting changes in exchange rates on billings in Euros from certain vendors.

Interest income wasincreased $92$52 thousand and $144 thousand, respectively, in the three and six months ended MarchJune 31,30, 2026, compared to the same periodperiods in 2025 reflecting earnings on higher cash balances from equity financings.

Deferred income tax provision was $231 thousand in the six months ended June 30, 2026, and was $0 in three months ended MarchJune 31,30, 2026, comparedas towell $0as in theboth of those same periodperiods in 2025.

Payment-in-kindPaid-in-kind dividends

The accrualcharges of $1,725$115 thousand and $1,840 thousand, respectively, for payment-in-kindpaid-in-kind dividends in the three and six months ended MarchJune 31,30, 2026, compared to $0 in the same periodperiods in 2025 reflectsreflect a portionone-time ofnon-cash dividends,dividend paid in shares of Series A Non-Voting Convertible Preferred Stock, under a one-time obligationStock related to the Acquisition.

Comparison of the threesix months ended MarchJune 31,30, 2026 and 2025

During the threesix months ended MarchJune 31,30, 2026, we used cash of $4,978$10,430 thousand in operating activities compared to $3,097$7,291 thousand in the same period in 2025. Cash used in operating activities in the 2026 period primarily reflected our net loss of $17,785$24,334 thousand offset primarily by a $10,426 non-cash charge for the acquisition of the Unleash program, an increase of $1,775$1,107 thousand in increased accounts payable and accrued expenses, a decrease of $2,298 thousand in reimbursement right asset, and a reduction of $952 thousand in grant receivable, offset in part by an increase of $696$1,253 thousand in prepaid expenses and other current assets.