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

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. We have never generated any revenues, and cannot estimate with precision the extent of our future losses. We expect to incur increasing levels of operating losses for the foreseeable future as we execute on theour planplans to continue research and development activities, including the ongoing and planned clinical development of our product candidates, potentially acquire new products and/or product candidates, seek regulatory approvals of and potentially commercialize any approved product candidates, hire additional personnel, protect our intellectual property, and incur the additional costs of operating as a public company. We expect to continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future. These losses have had and will continue to have an adverse effect on our financial position and working capital.

To become and remain profitable, we must develop or acquire and eventually commercialize a product with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval, manufacturing, marketing and selling any product candidate for which we obtain marketing approval, and satisfying post-marketing requirements, if any. We may never succeed in these activities and, even if we succeed in obtaining approval for and commercializing one or more products, we may never generate revenues that are significant enough to achieve profitability. In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges. Furthermore, because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis and may continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Our failure to become and remain profitable would decrease the value of usour company and could impair our ability ability to raise capital, maintain our research and development efforts, expand the business or continue operations. A decline in our value could also cause you to lose all or part of your investment.

Under current federal tax law, federal net operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal net operating losses arising in tax years beginning after December 31, 2020 is limited to 80% of taxable income. ItNot is uncertain if and to what extent variousall states and localities willfully conform to federal tax laws. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change” which is generally defined as a greater than 50% change in its equity ownership value over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post- change income or taxes may be limited. We have experienced ownership changes in the past and we may also experience additional ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations. In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, if we earn net taxable income, we may be unable to use all or a material portion of our net operating loss carryforwards and other tax attributes,attributes to offset such income, which could potentially result in increased future cash tax liability to us and adversely affect our future cash flows.

The April 2024 Common Warrants are speculative in nature.

The April 2024 Common Warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time. Specifically, the April 2024 Common Warrants are exercisable upon issuance at an exercise price of $5.25 per share and may be exercised at any time on or prior to the earlier of (i) April 10, 2027 and (ii) the date that is 90 days after the public announcement that the Company has demonstrated a six-month complete responseCR rate of minimum 42% from at least 25 BCG-Unresponsive patients in the ADVANCED-2 (Cohort B) clinical trial. trial. There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the April 2024 Common Warrants and consequently, whether it will ever be profitable for holders of the April 2024 Common Warrants to exercise the warrants.

Further, if the outstanding April 2024 Common Warrants are exercised in full, we would be entitled to receive the cash exercise price of $5.25 per warrant. We would be able to use these additional proceeds to fund our operations. To the extent the market price of our common stock does not equal or exceed the exercise price of the April 2024 Common Warrants before they expire, we would not be entitled to these proceeds, and we may be required to pursue additional financing alternatives.

The success of our business, including our ability to finance our operations and generate revenue in the future, primarily depends on the successful development, regulatory approval and commercialization of our product candidates, including of TARA-002 and IV Choline Chloride. The clinical and commercial success of our product candidates, including TARA-002 and IV Choline ChlorideChloride, depend on a number of factors, including the following:

Disruptions at the FDA or other comparable foreign regulatory authorities may also slowextend the time necessary for new products to be reviewed and/or approved, which would adversely affect affect our business. In addition, there is substantial uncertainty regarding new initiatives under the newcurrent U.S. Presidential Administration’s initiativesAdministration and how these might impact the FDA, its implementation of laws, regulations, policies and guidance and its personnel. Similar initiatives may also be directed towards other agencies. These initiatives could prevent, limit or delay development and regulatory approval of our product candidates, which would adversely affect our business.

Disruptions at the FDA or other other comparable foreign regulatory authorities may also slowextend the time necessary for new products to be reviewed and/or approved, which would adversely affect our business. For example, starting in January 2025, the current U.S. Presidential Administration has reduced the number of federal employees, including at the FDA, by establishing voluntary termination programs, by position eliminations and by involuntary terminations. Changes in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review submissions submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. Similar consequences wouldmay also occur as a result in the event of anothera significant shutdown of the federal government. For example, over the last several years, and most recently in 2024, late 2025, the U.S. government was on the verge of a shutdown and has previously shut down several times, and certain regulatory agencies, such as the FDA, had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, or if the volume of applications to the FDA for new product candidates increases materially, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns or delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. If the FDA is constrained in its ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

In addition, FDA-regulated industries, such as ours, face substantial uncertainty in regard to the regulatory environment we will face as we proceed with research and and development efforts following the inauguration of Presidentthe Trumpcurrent U.S. Presidential Administration in January 2025. Some of these efforts have manifested to date as efforts to reduce the size of the federal government, including large-scale reductions in force at the formFDA. The loss of key personnel measuresat thatthe couldFDA, including those in leadership positions, is likely to impact operations at the FDA’s ability to hire and retain key personnel,FDA, which could result inin, among other things, delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development, developmentlonger review times, and obtaindelays in obtaining the requisite regulatory approvals inof theour future.product candidates. Moreover, the new current U.S. Presidential Administration has proposedpaused actionpayments toby, freeze or reducereduced the budget ofof, and terminated grants provided by the National National Institutes of Health, or NIH, as related to its funding for medical research, which couldhas decreasedecreased, and may continue to decrease, the ability of facilities that rely on NIH funding to enroll and conduct clinical trials or increase the costs to us of conducting clinical trials. Some Thereof these actions have been challenged in court and there remains general uncertainty regarding future activities. The newcurrent U.S. Presidential Administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations. If we become negatively impacted by future governmental orders, regulations, policies or guidance as a result of the new current U.S. Presidential Administration, there could be a material adverse effect on us and our business.

Preclinical and clinical development involveinvolves lengthy and expensive processes with uncertain outcomes. We may incur additional expenses or experience delays in completing, or ultimately be unable to complete, the development of our current product candidates or any future product candidates.

All of our current product candidates are in clinical development and their risk of failure is high. It is impossible to predict when or if any of our product candidates will receive regulatory approval. To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive non-clinical studies and lengthy, complex and expensive clinical trials that our product candidates are safe and effective in humans. Clinical testing can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of non-clinical studies and early clinical trials or early cohorts of our clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials or later cohorts of our clinical trials. Moreover, a clinical trial can fail at any stage of testing. Differences in clinical 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. Additionally, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products. A number of companies in the biotechnology industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or to unfavorable safety profiles, notwithstanding promising results in earlier clinical trials. There is typically a high rate of failure of product candidates proceeding through clinical trials. Most product candidates that commence clinical trials are never approved as products and there can be no assurance that any of our current or future clinical trials will ultimately be successful or support clinical development of our current or any of our future product candidates.

In 2024, we released preliminary data from our clinical trials. From time to time, we may publicly disclose further preliminary, interim or topline data from our preclinical, non-clinical studies and clinical trials, which is based on a preliminary analysis of then-available data. For example, in 2026, we released interim data from our clinical trials and expect to continue to release interim data from such trials in advance of releasing final, fully-evaluated data. The results and related findings and conclusions of any interim or preliminary data, including from our 20242026 data releases,release, as well as any future releases of any interim or preliminary data are subject to change as patient enrollment and treatment continues and more patient data become available. Adverse differences between previous preliminary or interim data and future interim or final data could significantly harm our business prospects. We may also announce topline data following the completion of a preclinical study or clinical trial, which may be subject to change following a more comprehensive review of the data related to the particular study or clinical trial. We also 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, topline or preliminary results that we report may differ from future results of the same studies, or different conclusions conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Preliminary, interim, or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the data we previously published. Accordingly, preliminary, interim, and topline data should be viewed with caution until the final data are available.

The clinical development of our product candidates has included and may continue to include clinical trial sites outside the United States,U.S., and the FDA and applicable foreign regulatory regulatory authorities may not accept data from such sites.

The clinical development of our product candidates has included and may continue to include clinical trial sites outside the United StatesU.S. and we may in the future choose to conduct one or more of our full clinical trials outside of the United States.U.S. For example, our ongoing Phase 2 ADVANCED-2 clinical trial of TARA-002 in NMIBC is being conducted in the U.S., Canada, Argentina and Ukraine.in a number of other countries. Although the FDA or applicable foreign regulatory authority may accept data from clinical trials conducted outside the United StatesU.S. or the applicable jurisdiction, acceptance of such study data by the FDA or applicable foreign regulatory authorities may be subject to certain conditions or exclusions. Where data from foreign clinical trials or clinical trial sites are intended to serve as the basis for marketing approval in the United States,U.S., the FDA will not approve the application on on the basis of foreign data alone unless such data are applicable to the U.S. population and U.S. medical practice; the studies were performed performed by clinical investigators of recognized competence; and the data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or or other appropriate means. Many foreign regulatory bodies have similar requirements. In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance the FDA or applicable foreign regulatory authority will accept data from clinical trials conducted outside of the United StatesU.S. or the applicable home country. If the FDA or applicable foreign regulatory authority does not accept such data, it would likely result in the need for additional clinical trials, trials, which would be costly and time-consuming and delay aspects of our business plan.

Our current product candidates are targeting certain disorders that have low incidence and prevalence. For example, we estimate the prevalenceincidence of LMs in the United StatesU.S. is approximately 1,400-1,800 1,400-1,800 cases per year. This could be a significant obstacle to the timely recruitment and enrollment of a sufficient number of eligible patients patients into our clinical trial. Further, we expect to rely in part on our relationships with patient advocacy groups to assist in identifying eligible patients, and any deterioration of those relationships could impede our ability to successfully enroll patients. Patient enrollment may be affected by other factors including:

Additionally, our projections of the number of people who have these disorders, including LMs, are based on estimates, including third-party analyses commissioned by us. The total addressable market opportunity for our product candidates will ultimately depend upon, among other things, the final approved product labeling for each of our product candidates, if our product candidates are approved for sale in our target indications, acceptance by the medical community and patient access, drug pricing and reimbursement. The number of patients globally may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business. Our products may potentially be dosed on a one-time basis, which means that certain patients who enroll in our clinical trials may nothave becomplete eligibleresolution toof receivetheir ourLM productsand never require additional treatment on a commercial basis if they arebasis.

The FDA has granted Fast Track DesignationFTD to IV Choline Chloride as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. We may seek Fast Track Designation for other potential indications for IV Choline Chloride or for our other product candidates. 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 Fast Track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we receive Fast Track Designation, we may not experience a faster development process, review or approval, including for IV Choline Chloride as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated and TARA-002 for the treatment of pediatric patients with macrocystic and mixed cystic LMs. We may seek FTD for other potential indications for IV Choline Chloride or TARA-002 or for our other product candidates. 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 FTD. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we receive FTD, we may not experience a faster development process, review or approval, including for IV Choline Chloride as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated or TARA-002 for pediatric patients with macrocystic and mixed cystic LMs or any other indication. The FDA may withdraw Fast Track DesignationFTD if it believes that the designation is no longer supported by data from our clinical development program.

We have obtained Orphan Drug DesignationODD from the FDA for TARA-002 for the treatment of LMs and for IV Choline Chloride for the prevention and/or treatment of choline deficiency in patients on long-term PN. We have also obtained Orphan DrugMedicinal Product Designation from the European Commission for TARA-002 for the treatment of LMs. We may seek Orphan Drug DesignationODD for future product candidates or other indications, and we may be unsuccessful.unsuccessful in those efforts. Regulatory authorities in some jurisdictions, including the United StatesU.S. and Europe, may designate drugs for relatively small patient populations populations as orphan drugs and provide them with marketing exclusivity upon approval. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States,U.S., or a patient population greater than 200,000 in the United StatesU.S. where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.U.S. In the UnitedU.S., States, Orphan Drug DesignationODD entitles a party to financial incentives such as tax advantages and user-fee waivers. Opportunities for grant funding toward clinical trial costs may also be available for clinical trials of drugs for rare diseases, regardless of whether the drugs are designated for the orphan use. In addition, if a product that has Orphan Drug Designation ODD subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same product for the same indication for seven years, except in limited circumstances.

Although we have obtained Orphan Drug Designation ODD for TARA-002 for the treatment of LMs and IV Choline Chloride for the prevention and/or treatment of choline deficiency in patients on long-term PN, and even if we obtain Orphan Drug DesignationODD for additional product candidates or other indications, we may not be the first to obtain marketing marketing approval of these product candidates for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical pharmaceutical products. If a competitor with a product that is determined by the FDA to be the same as one of our product candidates obtains marketing approval before us for the same indication we are pursuing and obtains orphan drug exclusivity, our product candidate may not be approved until the period of exclusivity ends unless we are able to demonstrate that our product candidate is clinically superior. Even after obtaining approval, we may be limited in our ability to market our product. In addition, exclusive marketing rights in the United States U.S. may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different principal molecular structural features can be approved for the same condition. Even after a product is approved with orphan drug exclusivity, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care. Orphan Drug DesignationODD neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

The FDA has granted BTD for TARA-002 for the treatment of pediatric patients with macrocystic and mixed cystic LMs. We may seek a Breakthrough Therapy DesignationBTD for TARA-002 for other indications theor treatmentfor ofour NMIBC.other product candidates. A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existingavailable therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the clinical trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA are also eligible for priority review if supported by clinical data at the time of the submission of the marketing application.

Designation as a breakthrough therapy is at the discretion of the FDA. Accordingly, even if we believe that a product candidate meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy DesignationBTD for a drug may not necessarily result in a faster development process, review, or approval compared to drugs considered for approval under under conventional FDA procedures and it would not assure ultimate approval by the FDA. In addition, even if the product candidate qualifies as a breakthrough therapy, the FDA may later decide that the product candidate no longer meets the conditions for qualification or that the time period for FDA review.

Although the FDA has granted Rare Pediatric Disease Designation for TARA-002 for the treatment of LMs, a BLA for TARA-002, if approved, may not meet the eligibility criteria for a priority review voucher.PRV.

Rare Pediatric Disease DesignationRPDD has been granted by the FDA for TARA-002 for the treatment of LMs. In 2012, Congress authorized the FDA to award PRVs to sponsors of certain rare pediatric disease product applications. This provision is designed to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. Specifically, under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product. The sponsor of a rare pediatric disease drug product receiving a PRV may transfer (including by sale) the voucher to another sponsor. The voucher may be further transferred any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. The FDA may also revoke any PRV if the rare pediatric disease drug for which the voucher was awarded is not marketed in the U.S. within one year following the date of approval.

For the purposes of this program, a “rare pediatric disease” is a (a) serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents; and (b) rare disease or conditions within the meaning of the Orphan Drug Act. AsUnder ofcurrent Decemberlaw, 20,after 2024,September and unless the law is extended,30, 2029, the FDA may no longernot award any PRVsRPDD underPRVs, although the RareFDA’s Pediatric Disease Priority Review Voucher program, unless the rare pediatric disease product application (a) is for a drug that, not later than December 20, 2024, is designated as a drug for a rare pediatric disease and (b) is, not later than September 30, 2026, approved under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act. We understand that the FDA has continuedauthority to grantdo Rareso Pediatriccould Disease Designations after December 20, 2024; however, unless the program isbe extended by Congress,Congress ain productthe that was designated after December 20, 2024 may not be awarded a PRV upon approval, even if approved prior to September 30, 2026.future.

If TARA-002 foris the treatment of LMsapproved, it may not be approved by thatSeptember date, or30, at all,2029, and, therefore, we may not be in a position to obtain a PRV prior to expiration of the program, unless Congress further reauthorizes the program. Additionally, designation of a drug for a rare pediatric disease does not guarantee that an NDA or BLA will meet the eligibility criteria for a rare pediatric disease priority review voucherPRV at the time the application is approved.approved, including the requirement that the NDA or BLA was granted priority review. Finally, a Rare Pediatric Disease DesignationRPDD does not lead to faster development or regulatory review of the product or increase the likelihood that it will receive marketing approval. We may or may not realize any benefit from receiving a designation.

Chugai Pharmaceutical, over which we have no control, has the rights to commercialize TARA-002 and the originator therapy to TARA-002, OK-432, which is currently marketed under the name Picibanil, in Japan for various indications. In addition, clinical trials using Picibanil are currently ongoing in various countries around the world. If serious adverse eventsSAEs occur with patients using Picibanil or during any clinical trials of Picibanil conducted by third parties, the FDA may delay, limit or deny approval of TARA-002 or require us to conduct additional clinical trials as a condition to marketing approval, which would increase our costs. If we receive FDA approval for TARA-002 and a new and serious safety issue is identified in connection with use of Picibanil or in clinical trials of Picibanil conducted by third parties, the FDA may withdraw the approval of the product or otherwise restrict our ability to market and sell TARA-002. In addition, treating physicians may be less willing to administer TARA-002 due to concerns over such adverse events,AEs, which would limit our ability to commercialize TARA-002.

With respect to our lead product candidate, TARA-002, for the treatment of NMIBC and LMs, the active ingredient in TARA-002 is a genetically distinct strain of Streptococcus pyogenes (group A, type 3) Su strain, which is inactivated during the manufacturing process. TARA-002 is produced through a proprietary manufacturing process. We anticipate that, if approved by the FDA, TARA-002 will be protected by 12 years of biologic exclusivity. In addition, based on the prevalence of the disease, TARA-002 is likely to have seven years of concurrent Orphan Drug DesignationODD exclusivity for the treatment of LMs. Further, the USPTO issued to us Patent No. 12,551,514 claiming a method of LMs.treating non-muscle invasive bladder cancer with a combination of non-viable cells of streptococcus pyogenes and an immune checkpoint inhibitor, with a term expiring in 2044.

TARA-002, if approved for the treatment of NMIBC, would be subject to competition from existing treatment methods of surgery, chemotherapy and immunomodulatory therapy. For example, the current standard of care for NMIBC includes intravesical BCG TICE (manufactured by Merck & Co., Inc.). Other products approved for the treatment of NMIBC include Merck & Co., Inc.’s Keytruda, Endo International plc’s Valstar, andFerring Ferring B.V.’s Adstiladrin andAdstiladrin, ImmunityBio, Inc.’s VesAnktiva in combination with BCG.BCG and Janssen’s Inlexzo. Additional product candidates in development include but may not be limited to Japanese BCG Laboratory’s BCG Tokyo, Pfizer Inc.’s Sasanlimab in combination with BCG, CG Oncology Inc.’s CG0070, enGene Inc.’s, EG-70, Pfizer Inc’sInc.’s PADCEV, Janssen’s TAR200 combined with gemcitabineTAR-200 plus or minus Cetrelimab, Urogen Pharma Ltd.’s Jelmyto, Theralase Technologies Inc.’s Ruvidar, and Auro BioSciences, Inc.’s Aura-0011. Aura-0011. Additional pharmaceutical and biotechnology companies with product candidates in development for the treatment of NMIBC include but may not be limited to Verity, AstraZeneca PLC, Bristol-Myers Squibb Company, Roche Group, Asieris Pharmaceuticals, BeiGene, Ltd, NanOlogy, LLC, Linton Pharm Co., Ltd., Lindis Biotech GmbH, Taizhou Hanzhong biomedical co. Ltd., Shionogi & Co. Ltd., Rapamycin Holdings, Inc., Vaxiion Therapeutics Inc., Incyte Corporation, LiPac Oncology, Inc., Anika Therapeutics Inc., Surge Pharmaceuticals Pvt. Ltd., and Istari Oncology, Inc.

There are no treatments currently available for patients on PS who are choline-deficient. IV Choline Chloride is the only sterile injectable form of choline chloride that can be combined with parenteral nutrition.PN. Further, the USPTO, issued to us Patent No. US 11,311,503 claiming a sterile aqueous choline salt composition, and Patent No. US 12,083,081 claiming a method of treating choline deficiency with a choline composition, each with a term expiring in 2041.

We currently have limited marketing capabilities and no sales organization. To commercialize our product candidates, if approved, in the United States,U.S., Canada, the European Union, Latin America and other jurisdictions we may seek to enter, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. Although our employees have experience in the marketing, sale and distribution of pharmaceutical products, and business development activities activities involving external alliances, from prior employment at other companies, we, as a company, have no prior experience in the marketing, sale sale and distribution of pharmaceutical products, and there are significant risks involved in building and managing a sales organization, including including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing, distribution and pricing/reimbursement/access capabilities would impact adversely the commercialization commercialization of these products.

The BPCIA, created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the its reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which theits reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation and meaning are subject to uncertainty.

We believe that any of our product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that the FDA will not consider our product candidates toeligible befor reference productsproduct for competing products,exclusivity, potentially creating the opportunity for biosimilar competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of litigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

Even if we obtain regulatory approval to begin commercializing any of our products, we would remain subject to ongoing regulatory review, which could subsequently result in a suspension or termination of sale of these productsproducts, limitations on the approved indication or otheradditional penaltieswarnings, or, if we fail to comply with regulatory requirements.requirements, other penalties.

Even after we achieve U.S. regulatory approval for a product candidate, if any, we will be subject to continued regulatory review and compliance obligations. For example, with respect to our product candidates, the FDA may impose significant restrictions on the approved indicated uses for which the product may be marketed or on the conditions of approval. A product candidate’s approval may contain requirements for potentially costly post-approval studies and surveillance to monitor the safety and efficacy of the product. We will also be subject to ongoing FDA obligations and continued regulatory review with respect to, among other things, the manufacturing, processing, labeling, packaging, distribution, pharmacovigilance and adverseAE event reporting, storage, advertising, promotion and recordkeeping for our product candidates. In addition, manufacturers of drug and biologic products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a regulatory agency discovers previously unknown problems with a product, such as adverseAEs events of unanticipated severity or frequency, or problems with the manufacturing, processing, distribution or storage facility where, or processes by which, the product is made, a regulatory agency may impose restrictions on that product or us, including:

We have obtained product liability insurance coverage for our clinical trials. Large judgments have been awarded in class action or individual lawsuits against other pharmaceutical companies based on drugs that had unanticipated side effects. Our insurance coverage may not be sufficient to cover all of our product liability-related expenses or losses and may not cover us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, restrictive and narrow, and, in the future, we may not be able to maintain adequate insurance coverage at a reasonable cost, in sufficient amounts or upon adequate terms to protect us against losses due to product liability or other similar legal actions. We will need to increase our product liability coverage if any of our product candidates receive regulatory approval, which will be costly, and we may be unable to obtain this increased product liability insurance on commercially reasonable terms or at all and for all geographies in which we wish to launch. A successful product liability claim or series of claims brought against us, if judgments exceed our insurance coverage, could decrease our cash and harm our business, financial condition, operating results and future prospects.

The FDA strictly regulates the advertising and promotion of drug products, and drug products may only be marketed or promoted for their FDA-approved uses, consistent with the product’s approved labeling. Advertising and promotion of any product candidate that obtains approval in the United StatesU.S. will be heavily scrutinized by the FDA, the Department of Justice,DOJ, the Office of Inspector General of the Department of Health and Human Services,HHS, state attorneys general, members of Congress and the public. For example, the FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Although physicians may prescribe products for off-label uses as the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued. Companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labeling. Violations, including promotion promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil, criminal criminal and/or administrative sanctions by the FDA. Additionally, advertising and promotion of any product candidate that obtains approval outside outside of the United StatesU.S. will be heavily scrutinized by relevant foreign regulatory authorities.

In the United States,U.S., engaging in in impermissible promotion of our product candidates for off-label uses can also subject us to false claims litigation under federal and state statutes, which can lead to significant civil, criminal and/or administrative penalties and fines and agreements, such as a corporate integrity agreement, that materially restrict the manner in which we promote or distribute our product candidates. If we do not lawfully promote our products once they have received regulatory approval, we may become subject to such litigation and, if we are not successful in defending against such actions, those actions could have a material adverse effect on our business, financial condition and operating results and even result in having an independent compliance monitor assigned to audit our ongoing operations for a lengthy period of time.

If TARA-002 or IV Choline Chloride only becomes available by prescription, successful sales by us or by any partners with which we may collaborate depend on the availability of coverage and adequate reimbursement from third-party payors. Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse most or part of the costs associated with their prescription drugs. The availability of coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the UnitedU.S., States, and private third-party payors is often critical to new product acceptance. Coverage decisions may depend on clinical and economic standards standards that disfavor new drug products when more established or lower-cost therapeutic alternatives are already available or subsequently become become available, or may be affected by the budgets and demands on the various entities responsible for providing health insurance to patients patients who will use TARA-002 or IV Choline Chloride. Even if we obtain coverage for our products, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use a product unless coverage coverage is provided, and reimbursement is adequate to cover a significant portion of the cost.

Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the United States,U.S., although private third-party payors tend to follow Medicare practices, no uniform or consistent policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor as well as from state to state. Consequently, the coverage determination process is often a time-consuming and costly process that must be played out across many jurisdictions and different entities and that will require us to provide scientific, clinical and health economics support for the use of our products compared to current alternatives and do so to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained and in what time frame.

Further, we believe that future coverage and reimbursement likely will be subject to increased restrictions both in the United StatesU.S. and in international markets. Third-party Third-party coverage and reimbursement for our products may not be available or adequate in either the United StatesU.S. or international markets, which could harm our business, financial condition, operating results and prospects. Further, coverage policies and third-party reimbursement rates may change at any time. Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of any future product candidates we may develop, or affect pricing and third-party payment for our product candidates, which could negatively affect our business, financial condition and prospects. In the United States,U.S., there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in 2010, the ACA was enacted to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

Additionally, there has been increasing legislative and enforcement interest in the United StatesU.S. with respect to drug pricing practices since the ACA was enacted. For example, in November 2020, the HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. The implementation of the rule was delayed until January 1, 2032 by the IRA. In addition, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs has been eliminated. Elimination of this cap has, in some cases, required pharmaceutical manufacturers to pay more in rebates than they have received on the sale of products. In 2024, CMS issued a final rule that decreased Medicare reimbursement for physician services by 2.8%, effective January 1, 2025. If federal spending is further reduced, anticipated budgetary shortfalls may also impact the ability of relevant agencies, such as the FDA, to continue to function at current levels. Amounts allocated to federal grants and contracts may be reduced or eliminated. These reductions may also impact the ability of relevant agencies to timely review and approve research and development, manufacturing, and marketing activities, which may delay our ability to develop, market and sell any products we may develop.

Additionally, several healthcare reform initiatives culminated in the enactment of the IRA in 2022, which, among other things, eliminated, beginning in 2025, the coverage gap under Medicare Part D by significantly lowering the enrollee maximum out-of-pocket costs and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket limit, and 20% once the out-of-pocket limit has been reached. The IRA also extended enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025, but those subsidies expired at the end of 2025. The IRA also allows HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D. The negotiated price may not exceed a statutory ceiling price. Only high-expenditure single-source biologics that have been approved for at least 11 years (seven years for single-source drugs) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced. These negotiations resulted in significant price reductions for the products from their 2023 list prices, ranging from 38 to 79 percent, with an average price reduction of 59.4 percent. In addition, CMS has selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs forwhich negotiatedwill maximumbecome fair pricingeffective in 2027. For 2028, CMS has selected an additional 15 drugs, whichcomprised mayof bedrugs covered under eitherMedicare Part D and, for the first time, drugs under Medicare Part BB. orFor Part D, will be selected, 2029 and for 2029 and subsequent years, 20 Part B or Part D drugs will be selected. A drug or biological product that has an orphan drug designationODD for only one rare disease or condition are excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it receives designations designations for more than one rare disease or condition, or if is approved for an indication that is not within that single designated rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation. The negotiated prices have represented, and will continue to represent, a significant discount from average prices to wholesalers and direct purchasers. The IRA also imposes rebates on Medicare Part B and Part D drugs whose prices have increased at a rate greater than the rate of inflation, and in 2024, CMS finalized regulations for the Medicare Part B and Part D inflation rebates. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

At the state level, legislatures are increasingly enacting legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, the FDA released a final rule in 2020 providing guidance for states to build and submit importation proposals for drugs from Canada,Canada. andThe the FDA authorized the first such plan in Florida in 2024.2024, but the implementation of Florida’s plan has been extended. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States U.S. or Canada. Other states have also submitted proposals that are pending review by the FDA.

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse, privacy, transparency, and patients’ rights are and will be applicable to our business. We are subject to regulation by both the federal government and the states in which we or our partners conduct business. The healthcare laws and regulations that may affect our ability to operate include but are not limited to: the federal Anti-Kickback Statute; federal civil and criminal false claims laws and civil monetary penalty laws; the federal Health Insurance Portability and Accountability Act of 1996,HIPAA, as amended by the Health Information Technology for Economic and Clinical Health ActHITECH; the Prescription Drug Marketing Act (for sampling of drug product among other things); the federal physician sunshine requirements under the ACA; the Foreign Corrupt Practices ActFCPA as it applies to activities outside of the United StatesU.S.; the federal Right-to-Try legislation; and similar state laws of such federal laws, which may be broader in scope.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent healthcare reform legislation has strengthened these laws. For example, the ACA, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the ACA provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.FCA.

In order to conduct larger or late-stage clinical trials for our product candidates and supply sufficient commercial quantities of any of our products, if approved, our contract manufacturers and suppliers will need to produce our API and other substances and materials used in our product candidates in larger quantities, more cost-effectively and, in certain cases, at higher yields than they currently achieve. If our third-party contractors are unable to scale up the manufacturemanufacturing of any of our product candidates successfully in sufficient quality and quantity and at commercially reasonable prices, or are shut down or put on clinical hold by government regulators, and we are unable to find one or more replacement suppliers or manufacturers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality, and we are unable to transfer the processes successfully on a timely basis, the development of that product candidate and regulatory approval or commercial launch for any resulting products may be delayed, or there may be a shortage in supply, either of which could significantly harm our business, financial condition, operating results and prospects.

We expect to continue to depend on third-party contract suppliers and manufacturers for the foreseeable future. Our supply and manufacturing agreements, if any, do not guarantee that a contract supplier or manufacturer will provide services adequate for our needs. Additionally, any damage to or destruction of our third-party manufacturers’ or suppliers’ facilities or equipment, even by force majeure, may significantly impair our ability to have our products and product candidates manufactured on a timely basis. Our reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access to their facilities, will have access to and may misappropriate our trade secrets or other proprietary information. In addition, the manufacturing facilities of certain of our suppliers may be located outside of the United States.U.S. This may give rise to difficulties in importing our products or product candidates or their components into the United StatesU.S. or other countries.

The manufacturemanufacturing of biologics is complex and our third-party manufacturers may encounter difficulties in production. If our CDMO encounters such difficulties, the ability to provide supply of TARA-002 for clinical trials, our ability to obtain marketing approval, or our ability to obtain commercial supply of TARA-002, if approved, could be delayed or stopped.

From time to time, the UnitedU.S. States has experienced a decrease in unemployment rates and an increasingly competitive labor market, which has at times resulted in difficulties in hiring or retaining sufficient qualified personnel to maintain and grow our business. We are uncertain as to the employment environment in the future, or how that environment will impact our workforce, including our ability to attract and retain qualified management and other key personnel.

Our office is located in New York, New York. If a disaster, power outage, computer hacking, or other event occurred that prevented us from using all or a significant portion of an office, that damaged critical infrastructure, such as enterprise financial systems, IT systems, manufacturing resource planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. For example, we have expanded our clinical development of TARA-002 in NMBIC to clinical trial sites outside the United States, including in Ukraine, Canada, ArgentinaU.S. and may expandcontinue expanding to other geographies. If political or civil conditions require it, our sites may need to delay or suspend clinical trial activities. In addition, enrollment and retention of patients at such sites could be disrupted by geopolitical events, including civil or political unrest, such as the current ongoing conflict between Russia and Ukraine. Ukraine. All of the aforementioned risks may be further increased if we do not implement a disaster recovery plan or our partners’ or manufacturers’ disaster recovery plans prove to be inadequate. To the extent that any of the above should result in delays in the research, development, regulatory approval, manufacture, distribution or commercialization of TARA-002 or IV Choline Chloride, our business, financial condition, operating results and prospects would suffer.

We will not receive a significant amount, or potentially any, additional funds upon the exercise of our April 2024 Pre-Funded Warrants and December 2024 Pre-Funded Warrants; however, any exercise would increase the number of shares eligible for future resale in the public market and result in substantial dilution to our stockholders.

In April 2024 and December 2024, we issued the April 2024 Pre-Funded Warrants and December 2024 Pre-Funded Warrants to purchase a total of 1,700,000 and 2,325,372 shares of our common stock, respectively, all3,400,272 of which are outstanding as of the date of this report. Each April 2024 Pre-Funded Warrant and December 2024 Pre-Funded Warrant is exercisable for $0.001 per share of common stock underlying such Pre-Funded Warrant. Accordingly, we will not receive a significant amount of additional funds upon the exercise of the April 2024 Pre-Funded Warrants and December 2024 Pre-Funded Warrants. To the extent such Pre-Funded Warrants are exercised, additional shares of common stock will be issued for nominal consideration, which will result in dilution to the then existing holders of our common stock and will increase the number of shares eligible for resale in the public market. Sales of substantial numbers of such shares in the public market could adversely affect the market price of the common stock, causing our stock price to decline.

In April 2024 and December 2024, we issued the April 2024 Pre-Funded Warrants, December 2024 Pre-Funded Warrants and theApril 2024 Common Warrants. Each EachApril 2024 Common Warrant is exercisable solely by means of a cash exercise, except that the April 2024 Common Warrant is exercisable via cashless exercise if at the time of exercise, a registration statement registering the issuance of the shares of common stock underlying the common stock warrants under the Securities Act of 1933, as amended, is not then effective. The April 2024 Common Warrants include certain rights upon “fundamental transactions” as described in the April 2024 Common Warrants. Additionally, each holder of warrants will not be entitled to exercise any portion of any April 2024 Pre-Funded Warrant, December 2024 Pre-Funded Warrant or April 2024 Common Warrant, which, upon giving effect to such exercise, would cause (A) for the holders of the April 2024 Pre-Funded Warrants and April 2024 Common Warrants, (i) the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed 9.99%, or for certain holders, 4.99%, of the number of shares of our common stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of our securities beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the combined voting power of all of our securities then outstanding immediately after giving effect to the exercise and (B) for the holders of the December 2024 Pre-Funded Warrants, the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed 4.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise. However, for the April 2024 Pre-Funded Warrants, December 2024 Pre-Funded Warrants and April 2024 Common Warrants, any holder may increase or decrease such percentage to any other percentage (not in excess of 19.99%) upon prior notice from the holder to us.

Our success with respect to our product candidates will depend, in part, on our ability to obtain and maintain patent protection in both the United StatesU.S. and other countries, to preserve our trade secrets and to prevent third parties from infringing on our proprietary rights. Our ability to protect our product candidates from unauthorized or infringing use by third parties depends in substantial part on our ability to obtain and maintain valid and enforceable patents around the world.

We are a New York City based clinical-stage biopharmaceutical company committed to advancing transformative therapies for the treatment of cancer and rare diseases. We were founded on the principle of applying modern scientific, regulatory or manufacturing advancements to established mechanisms in order to create new development opportunities. We prioritize creativity, diverse perspectives, integrity and tenacity to expedite our our goal of bringing life-changing therapies to people with limited treatment options.

Our portfolio includes two development programs utilizing TARA-002, an investigational cell therapy based on the broad immunopotentiator, OK-432, which was originally granted marketing approval by the Japanese Ministry of Health and Welfare as an immunopotentiating cancer therapeutic agent. This cell therapy is currently approved in Japan and Taiwan for lymphatic malformations, or LMs,LMs and multiple oncologic indications. We have secured worldwide rights to the asset excluding Japan and Taiwan and are exploring its use in oncology and rare disease indications. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432 (marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd., or Chugai Pharmaceutical). We are currently developing TARA-002 in non-muscle invasive bladder cancer, or NMIBC,NMIBC and in LMs.

We are also pursuing intravenous,IV or IV, Choline Chloride, an investigational phospholipid substrate replacement therapy, for patients receiving parenteral support, or PS,PS which includes both nutrition and fluids. Choline is a known important substrate for phospholipids that are critical for healthy liver function and also plays an important role in modulating gene expression, cell membrane signaling, brain development anddevelopment, neurotransmission, muscle function and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. choline.See “Item 1. Business” for additional information regarding our various clinical trial programs.

For additional information regarding our various clinical trials and programs, see “Item 1. Business.” We have devoted substantial efforts to the development of theseour programs and do not have any approved products andand, to date, have not generated any revenuerevenues from product sales. Neither TARA-002 nor IV Choline Chloride have been approved by the FDA or other comparable regulatory authorities for use for any indications. We do not expect to generate revenues in the near-term, and it is possible we may never generate revenues in the future. To finance our current strategic plans, including the conduct of ongoing and future clinical trials and further research and development costs, we will need to raise additional capital. See “Item 7. Management’s Discussion and Analysis of Financial Condition Condition and Results of Operations—Liquidity and Capital Resources” for additional information about our liquidity and capital resource needs.

Since inception, we have incurred significant operating losses. As of December 31, 2024,2025, we had an accumulated deficit of approximately $245.0$302.4 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next few years as we continue our development of, and seek marketing approvals for, our product candidates, prepare for and begin the commercialization of any approved products,products and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States.U.S.

As of December 31, 2024, 2025, we had approximately $170.3$197.9 million in unrestricted cash and cash equivalents, and marketable debt securities.

Research and development expenses consist primarily of costs incurred for the development of TARA-002our current and IVpotential Cholinefuture Chloride,product candidates, which include personnel-related expenses, including salaries, benefits, travel and stock-based compensation expense, external expenses incurred under agreements with contract research organizations, or CROs, contract development and manufacturing organizations,CROs or CDMOs, the cost of acquiring, developing and manufacturing clinical trial materials, clinical and non-clinical related costs,costs and costs associated with regulatory operations and facilities, which includes depreciation and other expenses, which include expenses forsuch rentas andrent, maintenance of facilities and other supplies.

General and administrative expenses consist primarily of personnel-related expenses, costs, including salaries, benefits, travel expenses and stock-based compensationcompensation, expense,for executive in executivemanagement and other administrative functions. Otherpersonnel. generalGeneral and administrative expenses also include professional fees for businesslegal, investor andrelations, marketconsulting, development, legal, intellectual property matters, consultingauditing and accounting services, facilitybusiness relatedand costs,market development activities, as well as costs related to human resources, information technology and facilities. In addition, these expenses include costs associated with operating as a public company, such as expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with our Nasdaq listing and SecuritiesSEC compliance and Exchange Commission, or SEC, requirements, director and officer liability insurance premiums and investor relations costs associated with being a public company.premiums.

Other Incomeincome (Expenseexpense), net consists of interest and investment income (expense) and other income.income (expense). Interest and investment income (expense) consists of interest and dividend income on our cash and cash equivalents and marketable debt securities and amortization of premiums and/or accretion of discounts. Other income (expense) may also include non-operating items, such as refundable tax credits and other miscellaneous income not related to our core operating activities.

Our critical accounting policy is the accounting for prepaid and accrued research and development prepaid and accrued expenses.

Research and development expenses were $31.7$42.6 million for the year ended December 31, 2024,2025, which represented an increase of approximately $6.7$10.9 million as compared to the year ended December 31, 2023.2024. This increase was primarily due to a $6.1$10.1 million increase in direct expenses for our product candidates and a $0.6$0.9 million increase in indirect expenses. The increase in direct expenses was primarily due to site expansion and enrollment efforts for the ADVANCED-2 trial for NMIBC, start-up costs related to the ADVANCED-3 trial for NMIBC, as well as start-up and enrollment costs related to the THRIVE-3 trial for IV Choline Chloride. The increase in indirect expenses was primarily due to a $1.0$2.0 million increase in personnel-related expenses offset by a decrease of $0.3 $1.1 million in indirectresearch clinicaland manufacturingdevelopment expenses.expenses not directly attributable to one specific product candidate.

General and administrative expenses were $17.5$21.9 million for the year ended December 31, 2024,2025, which represented aan decreaseincrease of approximately $1.2$4.5 million as compared to the year ended December 31, 2023.2024. This decrease increase was primarily due to aan net decreaseincrease of $1.2$2.3 million in personnel-related expenses.expenses, as well as an increase of $2.1 million in other general and administrative expenses primarily related to professional and consulting services.

Other income (expense), net was $4.6$7.1 million for the year ended December 31, 2024,2025, which represented an increase of approximately $1.4$2.6 million as compared to the year ended December 31, 2024. The $2.2 million increase in interest and investment income (expense) is due primarily to investment returns on a higher invested balance. The $0.3 million increase in other income (expense) is due to an increase in refundable tax credits received in the year ended December 31, 2023, due primarily to higher investment returns on a higher invested balance as well as a $0.4 million increase in other income.2025.

As of December 31, 20242025 and 2023,2024, our unrestricted cash and cash equivalents, and marketable debt securities were $170.3$197.9 million and $65.6 $170.3 million, respectively. We have not generated revenues since our inception and have incurred net losses of approximately $44.6$57.4 million and $40.4$44.6 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had working capital of approximately $161.2 $148.6 million and stockholder’s equity of approximately $167.1 $196.4 million. During the year ended December 31, 2024,2025, cash flows used in operating activities were approximately $35.8$56.4 million, consisting primarily of a net loss of approximately $44.6$57.4 million, which includes non-cash activities of approximately $4.8$4.0 million, inclusive of $4.1 $3.8 million in stock-based compensation expense, as well as workingcash capitalused for adjustmentschanges in operating assets and liabilities of $4.0$2.9 million. Since inception, we have met our liquidity requirements principally through the sale of our common stock, preferred stock and pre-funded warrants in private placements of securities and public offerings.offerings of securities. In addition, we may receive proceeds upon the exercise of the common warrants issued in the April 2024 private placement described below.

On November 3, 2023, we filed a shelf registration statement on Form S-3, or the Shelf Registration Statement, which became effective in November 2023. The Shelf Registration Statement permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination. In December 2024, we sold and issued approximately $100.1$102.8 million in gross proceeds of common stock and pre-funded warrants in a public offering, or the December 2024 Public Offering, under the Shelf Registration Statement. The net proceeds were approximately $93.4$95.9 million. In JanuaryDecember 2025, thewe underwriterssold partiallyand exercisedissued theirapproximately option,$86.3 or the Underwriters’ Option, to purchase a portion of the additional shares of common stock pursuant to the underwriting agreement, or the Underwriting Agreement, which resultedmillion in gross proceeds of approximatelycommon $2.7stock millionin anda public offering, or the December 2025 Public Offering, under the Shelf Registration Statement. The net proceeds ofwere approximately $2.5$80.4 million.

In April 2024, the Company entered into a private placement transaction, or the April 2024 Private Placement, whereby the Company sold and issued common stock, warrants and in, in some circumstances, pre-funded warrants to certain purchasers. At the close of the April 2024 Private Placement, the Company received approximately $45.0 million in gross proceeds. The net proceeds ofwere approximately $42.0 million. Additionally, as part of the April 2024 Private Placement, purchasers were offered common warrants. Common warrants exercised as of December 31, 2025 have resulted in $3.8 million afterin deductingproceeds placementand, agentif feesexercised, proceeds andfrom offeringthe expenses.remaining common warrants as of December 31, 2025 could result in an additional $53.1 million.

We believe that our current financial resources, as of the date of the issuance of our consolidated financial statements included elsewhere in this Annual Report on this Form 10-K,resources are sufficient to satisfy our estimated liquidity needs for at least 12 months.months from the date of issuance of our consolidated financial statements included elsewhere in this Annual Report on this Form 10-K.

As a result of volatility in the capital markets, economic conditions, general global economic uncertainty, political change, global pandemics,pandemics and other factors, we do not know whether additional capital will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. If we are unable to raise additional capital due to volatile global financial markets, general economic uncertainty or other factors, we may need to curtail planned development activities. Despite recent moderation, the sustained elevated interest rates in recent years have had, and may continue to have, a negative effect on market prices for common stock of public companies, especially those in the biotech industry and those that have no current or near-term revenue. Further, a recession or market correction, supply chain disruptions and/or continued inflation could materially affect our business and the value of our common stock.

Net cash provided by (used in) operating activities was approximately $(35.856.4) million for the year ended December 31, 20242025 compared to approximately $(37.635.8) million for the year ended December 31, 2023.2024. The decrease increase of approximately $1.7$20.6 million in cash used in operating activities was primarily driven by aan decreaseincrease in workingnet capitalloss adjustments, of $12.8 million, an increase in cash used for operating assets and liabilities, primarily related to changes in prepaid expenses and other current assets, accounts payable, and accrued expenses and other current liabilities, resulting from the timing timing of payments to our service providers of $8.1$6.9 million, offset in part by an increase in net loss of $4.2 million and by a $2.2 million decrease in non-cash items, consisting principally of accretion of discount on marketable debt securities and stock-based compensation expense.expense of $0.8 million.

Net cash provided by (used in) investing activities was approximately $19.2$(139.5) million for the year ended December 31, 20242025 compared to approximately $53.1$19.2 million for the year ended December 31, 2023.2024. The decreaseincrease in cash used of $34.0$158.7 million resulted primarily from an increase ofin $17.2 millionpurchases of marketable marketable debt securities purchased as well as a decrease of $16.7$175.2 million ofoffset slightly by an increase in proceeds from marketable debt securities matured.matured and redeemed of $16.6 million.

Since inception, we have incurred significant operating losses. As of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $320.2$341.9 million. We expect to to continue to incur significant expenses and increasing operating losses for at least the next few years as we continue our development of, and seek marketing approvals for, our product candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States.

As of MarchJune 31,30, 2026, we had approximately $177.4$161.9 million in unrestricted cash and cash equivalents and marketable debt securities.

In March 2026, we announced that we have received confirmation on the six-month CR rate of the 25th BCG-Unresponsive patient in our ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with CIS (± Ta/T1) NMIBC. The average six-month CR rate in the 25 BCG-Unresponsive patients iswas 68.0%, which iswas consistent with the 68.2% CR rate at six months that was announced by us in February 2026, and iswas meaningfully above 41.9%.

In January 2026, we advancedinitiated theTHRIVE-3, development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PS and initiated THRIVE-3, a registrational Phase 3 clinical trial. THRIVE-3 is a seamless Phase 2b/3 trial with a dose confirmation portion (n=24) followed by a double-blinded, randomized, placebo-controlled portion to assess the efficacy and safety of IV Choline Chloride over 24 weeks in adolescents adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=100). The primary endpoint of the clinical trial is a pharmacokinetic, or PK, endpoint measuring the change from baseline in plasma choline concentration. We also plan to include a number of secondary endpoints related to liver, bone and memory. We anticipate reporting interim results from the dose-confirmation portion of the trial in the secondfourth halfquarter of 2026.

We intend to provide an update on STARBORN-1 and complete enrollment of STARBORN-1 in the fourth quarter of 2026. Based on engagement with the FDA, we intend to submit a Biologics License Application, Applicationor BLA, for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027 and will continue to submit safety and efficacy data from the trial on an ongoing basis to support the FDA’s evaluation of the risks and benefits of TARA-002 in LMs.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses were $13.6$17.0 million for the three months ended MarchJune 31,30, 2026, which represented an increase of approximately $4.4$6.2 million as compared to the three months ended MarchJune 31, 30, 2025. This increase was primarily due to a $2.2$3.2 million increase in direct expenses for our product candidates and a $2.2$3.0 million increase in indirect expenses. The increase in direct expenses was primarily due to higher ongoing costs associated with theall ADVANCED-2of trialour forongoing NMIBC as well as start-up costs related to the ADVANCED-3 trial for NMIBC.clinical trials. The increase in indirect expenses was primarily due to a $1.5$1.8 million increase in personnel-related expenses and a $0.7$1.2 million increase in research and development expenses not directly attributable to one specific product candidate.candidate, which were primarily attributable to chemistry, manufacturing and controls, or CMC, related activities.

General and administrative expenses were $6.1$6.4 million for the three months ended MarchJune 31,30, 2026, which represented an increase of approximately $1.1$0.6 million as compared to the three months ended MarchJune 31, 30, 2025. This increase was primarily due to an increase of $0.9$0.7 million in personnel-related expenses, as welloffset asby ana increasedecrease of $0.2$0.1 million in other general and administrative expenses.

Other income (expense), net net was $1.8$1.7 million for the three months ended MarchJune 31,30, 2026, which represented aan decreaseincrease of approximately $0.4$0.1 million as compared to to the three months ended MarchJune 31,30, 2025. The decreaseincrease was driven by ahigher $0.5interest millionand decrease in otherinvestment income (expense) due to nonrecurring refundable tax credits received in the three months ended MarchJune 30, 31, 2025.2026.

As of MarchJune 31,30, 2026 and December 31, 2025, our unrestricted cash and cash equivalents, and marketable debt securities were $177.4$161.9 million and $197.9 million, respectively. We have not generated revenues since our inception and have incurred net losses of $17.8$39.5 million and $11.9$26.9 million for the six months ended June 30, 2026 and 2025, respectively and $21.7 million and $15.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had working capital of $131.1$132.8 million and stockholder’s equity of $181.2$161.3 million. During the threesix months ended MarchJune 31,30, 2026, net cash flows used in operating activities were $21.3$36.7 million, consisting primarily of a net loss of $17.8$39.5 million including non-cash expenses of $1.5 million, as well asand cash used for changes in operating assets and liabilities of $5.1$0.4 million. These uses of cash were offset by non-cash expenses of approximately $3.1 million. Since inception, we have met our liquidity requirements principally through the sale of our common stock, preferred stock and pre-funded warrants in private placements and public offerings. In addition, we may receive additional proceeds upon the exercise of the common warrants issued in the April 2024 Private Placement.

On November 3, 2023, we filed filed a shelf registration statement on Form S-3, or the Shelf Registration Statement, which became effective in November 2023. The Shelf Registration Statement permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination. In December 2024, we sold and issued approximately $102.8 million in gross proceeds of common stock and pre-funded warrants in a public offering under the Shelf Registration Statement. The net proceeds were approximately $95.9 million. In December 2025, we sold and issued approximately $86.3 million in gross proceeds of common stock in a public offering under the Shelf Registration Statement. The net proceeds were approximately $80.4 million. The remaining unsold securities under this shelf were rolled into a new shelf filed in May 2026 as described below.

As part of the April 2024 Private Placement, purchasers were offered common warrants. CommonThrough June 29, 2026, common warrants exercised as of March 31, 2026 have resulted in $5.7 million in proceedsproceeds. and, if exercised, proceeds from theThe remaining unexercised common warrants as of March 31, 2026 could result in an additional $51.2 million. The common warrants outstanding are set to expireexpired on June 29, 2026.

Comparison of the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

Net cash provided by (used in) operating activities was approximately $(21.336.7) million for the threesix months ended MarchJune 31,30, 2026 compared to approximately $(14.727.0) million for the threesix months ended MarchJune 31,30, 2025. The increase of approximately $6.6$9.8 million in cash used in operating activities was primarily driven by an increase in net loss of $5.9 $12.6 million, anoffset increaseby a decrease in cash used for operating assets and liabilities, primarily related to changes in other assets, accrued expenses and expenses, other current liabilities, offset by a decrease inand accounts payable, resulting principally from the timing of payments to our service providers of $1.3$(1.6) million,million and byand, an increase in non-cash items, consisting principally of accretion of discount on marketable debt securities and stock-based compensation expense of $0.5$1.2 million.

Net cash provided by (used in) investing activities was approximately $(14.7) $3.0 million for the threesix months ended MarchJune 31,30, 2026 compared to approximately $(58.4106.1) million for the threesix months ended MarchJune 31, 30, 2025. The decrease in cash used of $43.6$109.1 million resulted primarily from a decrease in purchases of marketable debt securities of $22.0 $54.4 million as well as an increase in proceeds from marketable debt securities matured and redeemed of $21.6 $55.0 million.

Net cash provided by (used in) financing activities was $1.1 million for the threesix months ended MarchJune 31,30, 2026 compared to $1.7 million for the threesix months ended March 31,June 30, 2025. The $0.6 million decrease was primarily driven by proceeds received in the prior-year period of $2.5$1.9 million from the net proceeds of the underwriters’ overallotment option exercised in connection with the December 2024 Public Offering, as compared to, proceeds received during the current period ofto $1.9 million in proceeds from the exercise of common warrants.warrants offset against offering costs paid during the current period of $0.5 million in connection with public offerings.