APRE

We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. ● If we fail to maintain compliance with the minimum listing requirements, our common stock will be subject to delisting and our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock is delisted. ● Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
If we are unable to raise capital when needed, we may be forced to delay, reduce and/or eliminate our research and drug development programs or future commercialization efforts. ● Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations. ● We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern. Risks related to the discovery, development and commercialization of our product candidates ● We are substantially dependent on the success of APR-1051 and ATRN-119.
Our clinical trials of APR-1051 and ATRN-119 may not be successful.
If we are unable to obtain approval for and commercialize APR-1051 or ATRN-119 or experience significant delays in doing so, our business will be materially harmed. ● We are in the early stages of testing APR-1051 and ATRN-119.
Our net loss was $12.6 million and $13.0 million for the years ended December 31, 2025 and 2024, respectively.
Our accumulated deficit was $333.6 million as of December 31, 2025.
We have not generated any commercial revenue to date from sales of any drugs and have financed our operations principally through private placements and the net proceeds received from the initial public offering (IPO) of our common stock.
In addition, as of December 31, 2025, we had approximately $14.6 million in cash and cash equivalents and expect to continue to incur significant cash outflows and incur future additional losses to execute our operating plan.
Due to the uncertainty in securing additional funding, and the insufficient amount of cash and cash equivalents as of December 31, 2025, we have concluded that substantial doubt exists about our ability to continue as a going concern within one year after the date of the filing of this Annual Report.
APR-1051 and ATRN-119, are in clinical development and our other product candidates are in preclinical development.
We have currently paused further patient enrollment in both the once daily and twice daily monotherapy dosing arms of ABOYA-119 and started the orderly wind-down of certain clinical trial site activities associated with the monotherapy arms as we explore ATTN-119 in potential combination approaches.
If we are unable to raise capital when needed or on attractive terms, we may be forced to delay, reduce and/or eliminate our research and drug development programs or future commercialization efforts. We believe that our existing cash and cash equivalents as of December 31, 2025 and the proceeds from our January 2026 private placement will be sufficient to meet our currently projected operating expenses and capital expenditure requirements into the first quarter of 2027.
Our future capital requirements will depend on many factors, including: ● the scope, progress, results and costs of our current and future clinical trials of APR-1051 and ATRN-119 and our other product candidates for our current targeted indications; ● the scope, progress, results and costs of drug discovery, preclinical research and clinical trials for APR-1051, ATRN-119 and our other product candidates; ● the scope, progress, and results of exploring ATTN-119 in potential combination approaches ; ● the number of future product candidates that we pursue and their development requirements; ● the costs, timing and outcome of regulatory review of our product candidates; ● the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for product candidates on favorable terms, although we currently have no commitments or agreements to complete any such transactions; ● the costs and timing of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time; ● the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; ● the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims; ● our headcount growth and associated costs as we expand our business operations and our research and development activities; and ● the costs of operating as a public company.
Sanctions and enhanced export controls imposed by the United States and other countries in response to such conflicts may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. Changes in regulations and policies by the U.S. administration and the resulting political and economic uncertainty in the United States may also impact us, the financial markets and the global economy.
For example, in April 2025, increased tariffs were imposed on all countries and individualized “reciprocal” higher tariffs on certain countries with which the United States has the largest trade deficits, with the highest tariffs imposed on imports from China.
China and other countries responded by announcing retaliatory tariffs on U.S. imports.
A few days later, the tariffs imposed on most countries were reduced to 10 percent, with the exception of China, for a period of 90 days to allow trade negotiations with those countries.
It is unclear whether the tariff increases with China will continue to escalate.
The tariff increases have significantly disrupted the global markets and may significantly escalate tensions between the U.S. and other countries, especially China.
We procure APIs and other raw materials from a supplier in China .
The extent of the impact that such tariffs, trade policies, or new legislation or regulations will have on our business specifically, or on the U.S. market and global economy generally, are uncertain and in the long term, unpredictable, and could adversely affect our business, financial condition, and results of operations.
The continued impact of these tariffs may impair our plans for further drug development in the U.S. market as well as our ability to generate revenues. The current U.S. administration has recently issued regulations to restrict direct and indirect investment by U.S. persons into companies with specified connections to China that use specific technologies of concern.
Such changes in the regulations and policies by the current U.S. administration and the resulting political and economic uncertainty materially impact our operations and those of our third-party service providers and reduce our ability to access capital, which could negatively affect our liquidity and adversely affect our business and the value of our common stock.
The current U.S. administration may also enact other new regulations or policies that affect trade with China or otherwise impact the pharmaceutical industry by enacting laws to restrict U.S. pharmaceutical companies from contracting with Chinese companies on the development, research or manufacturing of pharmaceutical products.
Department of Commerce initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962, which could result in the imposition of new tariffs on imports within the pharmaceutical industry.
Further, in April 2025, an executive order to lower prescription drug prices was signed.
The details of such proposed regulations and policies are unclear, and the final terms and impact remain uncertain and may pose long-term risks to our business. In addition, natural and man-made disasters and global health emergencies, including pandemics and epidemics, may adversely affect the financial markets and global economy, increase inflation and result in significant business disruptions.
The cost of insurance has increased significantly, including as a result of the impact of climate change and inflation, and we may not be able to obtain sufficient coverage at a reasonable cost to protect us against losses from such disasters and unforeseen events. The volatile business environment or continued unpredictable and unstable market conditions may result in further deterioration of the equity and credit markets, significant volatility in commodity prices, as well as supply chain interruptions and result in an economic downturn, which would make any equity or debt financing more difficult, costly and dilutive.
Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay, limit, reduce, or terminate our product development or future commercialization efforts. Although our business has not been materially impacted by the tariffs adopted to date or adverse effects of geopolitical events, natural or man-made disasters or other business disruptions to date, such matters may affect our business in the future and it is impossible to predict the extent to which our operations, or those of our suppliers and manufacturers, will be impacted in the short and long term, or the ways in which such matters may impact our business.
The extent and duration of such adverse geopolitical events, natural or man-made disasters or other business disruptions and actual or perceived political or economic instability and resulting market disruptions are impossible to predict but could be substantial.
Any such disruptions may also magnify the impact of other risks described herein. Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, government shutdowns or global health emergencies, their inability to hire, retain or deploy key leadership and other personnel, a high turnover of key leadership positions, or significant changes in policies and processes based on political considerations could prevent products from being developed, approved or commercialized in a timely manner or at all or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our operations. The ability of the FDA and other government agencies to review and approve products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, a government agency’s ability to hire and retain key personnel and accept the payment of user fees, high turnover in key leadership positions, and other events that may otherwise affect the government agency’s ability to perform routine functions.
Such disruptions at the FDA and other agencies may also increase the time necessary for new therapies or modifications to approved therapies to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. The political and economic environment in the United States could materially impact our business operations and financial performance, and uncertainty surrounding the potential legal, regulatory and policy changes by the U.S. administration may directly affect us and the global economy.
The political and economic environment in the United States and elsewhere has resulted in and will continue to result in some uncertainty.
Changing regulatory policies because of the changing political environment could impact our regulatory and compliance costs and future revenues, all of which could materially and adversely affect our business, financial condition and operating results.
For example, significant layoffs or turnover at FDA could affect the FDA’s ability to respond to regulatory filings.
High turnover of key FDA leadership positions could result in regulatory inconsistency and unpredictability that may undermine product development and approval.
Failure to adapt to or comply with evolving regulatory requirements or investor or stakeholder expectations and standards could negatively impact our reputation, ability to do business with certain partners, access to capital and our stock price.
Further, the current U.S. administration and congressional seat turnover may result in increased regulatory and economic uncertainty.
Changes in federal policy by the executive branch and regulatory agencies may occur over time through the new presidential administration’s and/or Congress’s policy and personnel changes, which could lead to changes involving the level of oversight and focus on the pharmaceutical industry; however, the nature, timing and economic and political effects of such potential changes remain highly uncertain.
Any future changes in federal and state laws and regulations, as well as the interpretation and implementation of such laws and regulations, could affect us in substantial and unpredictable ways.

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Gone since FY2024

We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. ● Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
If we are unable to raise capital when needed, we may be forced to delay, reduce and/or eliminate our research and drug development programs or future commercialization efforts. ● Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations. ● We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern. Risks related to the discovery, development and commercialization of our product candidates ● We are substantially dependent on the success of ATRN-119 and APR-1051, which are currently in clinical development.
Our clinical trials of ATRN-119 and APR-1051 may not be successful.
If we are unable to obtain approval for and commercialize ATRN-119 or APR-1051 or experience significant delays in doing so, our business will be materially harmed . ● We are in the early stages of testing ATRN-119 and APR-1051 in Phase 1 clinical trials and we have not tested ATRN-119 or APR-1051 in later phase clinical trials.
Our net loss was $13.0 million and $14.3 million for the years ended December 31, 2024 and 2023, respectively.
Our accumulated deficit was $321.0 million as of December 31, 2024.
We have not generated any commercial revenue to date from sales of any drugs and have financed our operations principally through private placements of our preferred stock and the net proceeds received from the initial public offering (IPO) of our common stock.
In addition, as of December 31, 2024, we had approximately $22.8 million in cash and cash equivalents and expect to continue to incur significant cash outflows and incur future additional losses to execute our operating plan.
Due to the uncertainty in securing additional funding, and the insufficient amount of cash and cash equivalents as of December 31, 2024, we have concluded that substantial doubt exists about our ability to continue as a going concern within one year after the date of the filing of this Annual Report.
ATRN-119 and APR-1051 are in clinical development, and our other product candidates are in preclinical development.
If we are unable to raise capital when needed or on attractive terms, we may be forced to delay, reduce and/or eliminate our research and drug development programs or future commercialization efforts. We believe that our existing cash and cash equivalents as of December 31, 2024 will be sufficient to meet our currently projected operating expenses and capital expenditure requirements into the first quarter of 2026.
Our future capital requirements will depend on many factors, including: ● the scope, progress, results and costs of our current and future clinical trials of ATRN-119 and APR-1051 and our other product candidates for our current targeted indications; ● the scope, progress, results and costs of drug discovery, preclinical research and clinical trials for ATRN-119, APR-1051 and our other product candidates; ● the number of future product candidates that we pursue and their development requirements; ● the costs, timing and outcome of regulatory review of our product candidates; ● the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for product candidates on favorable terms, although we currently have no commitments or agreements to complete any such transactions; ● the costs and timing of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time; ● the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; ● the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims; ● our headcount growth and associated costs as we expand our business operations and our research and development activities; and ● the costs of operating as a public company.
Sanctions and enhanced export controls imposed by the United States and other countries in response to such conflicts may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. Changes in regulations and policies by the new U.S. administration and the resulting political and economic uncertainty in the United States may also impact us, the financial markets and the global economy.
In particular, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, tariffs, taxes and other limitations on cross-border operations that impact U.S.-China relations and escalate tensions between China and Taiwan.
For example, legislation such as the BIOSECURE Act, which was not enacted in 2024, has been introduced in Congress to limit certain U.S. biotechnology companies from using equipment or services produced or provided by selected Chinese biotechnology companies, and others in Congress have advocated for the use of existing executive branch authorities to limit those Chinese service providers’ ability to engage in business in the U.S.
In addition, the current U.S. administration has recently issued regulations to restrict direct and indirect investment by U.S. persons into companies with specified connections to China that use specific technologies of concern.
Such changes in the regulations and policies by the current U.S. administration and the resulting political and economic uncertainty materially impact our operations and those of our third-party service providers and reduce our ability to access capital, which could negatively affect our liquidity and adversely affect our business and the value of our common stock. In addition, natural and man-made disasters and global health emergencies, including pandemics and epidemics, may adversely affect the financial markets and global economy, increase inflation and result in significant business disruptions.
The cost of insurance has increase significantly, including as a result of the impact of climate change and inflation, and we may not be able to obtain sufficient coverage at a reasonable cost to protect us against losses from such disasters and unforeseen events.
The volatile business environment or continued unpredictable and unstable market conditions may result in further deterioration of the equity and credit markets, significant volatility in commodity prices, as well as supply chain interruptions and result in an economic downturn, which would make any equity or debt financing more difficult, costly and dilutive.
Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay, limit, reduce, or terminate our product development or future commercialization efforts. Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, government shutdowns or global health emergencies or their inability to hire, retain or deploy key leadership and other personnel, could prevent new or modified products from being developed, approved or commercialized in a timely manner or at all or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our operations. The ability of the FDA and other government agencies to review and approve new or modified products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, a government agency’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the government agency’s ability to perform routine functions.
Such disruptions at the FDA and other agencies may also increase the time necessary for new therapies or modifications to approved therapies to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations. Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.
Any bankruptcy or insolvency, or the failure to make payments when due, of any counterparty of ours, or the loss of any significant relationships, could result in material losses to us and may material adverse impacts on our business. Risks related to the discovery, development and commercialization of our product candidates We are substantially dependent on the success of ATRN-119 and APR-1051, which are in clinical development.
If we are unable to obtain approval for and commercialize ATRN-119 or APR-1051 or experience significant delays in doing so, our business will be materially harmed. We have no products approved for sale.
The success of ATRN-119 and APR-1051 will depend on several factors, including the following: ● successful patient enrollment and timely completion of clinical trials of ATRN-119 and APR-1051; ● successful initiation and successful patient enrollment and completion of additional clinical trials, for ATRN-119 or APR-1051 or our other product candidates; ● our ability to demonstrate ATRN-119’s and APR-1051’s safety and efficacy to the FDA or any comparable foreign regulatory authority for marketing approval; ● timely receipt of marketing approvals for ATRN-119 and APR-1051; ● obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; ● successfully defending and enforcing our rights in our intellectual property portfolio; ● avoiding and successfully defending against any claims that we have infringed, misappropriated or otherwise violated any intellectual property of any third party; ● the performance of our future collaborators, if any; ● the extent of, and our ability to timely complete, any post-marketing approval commitments or requirements imposed by FDA or other applicable regulatory authorities; ● successfully developing a companion diagnostic test on a timely and cost effective basis; ● establishment of supply arrangements with third-party raw materials and drug product suppliers and manufacturers who are able to manufacture clinical trial and commercial quantities of ATRN-119 and APR-1051 drug substance and drug product and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices, or cGMP, at a scale sufficient to meet anticipated demand and over time enable us to reduce our cost of manufacturing; ● establishment of scaled production arrangements with third-party manufacturers to obtain finished products that are compliant with cGMP and appropriately packaged for sale; ● successful launch of commercial sales following any marketing approval; ● a continued acceptable safety and efficacy profile following any marketing approval; ● commercial acceptance by patients, the medical community and third-party payors; ● the availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities; ● the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments; and ● our ability to compete with other therapies.
If we are not successful in commercializing ATRN-119 or APR-1051, or are significantly delayed in doing so, our business will be materially harmed.
We are in the early stages of testing ATRN-119 and APR-1051 in Phase 1 clinical trials and we have not tested ATRN-119 or APR-1051 in later phase clinical trials.
Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage clinical trials. We are in the early stages of testing ATRN-119 and APR-1051 in clinical trials and we have note tested ATRN-119 or APR-1051 in later phase clinical trials.
For example, even if successful, the results of our Phase 1 clinical trials of our product candidates ATRN-119 and APR-1051 and other product candidates may not be predictive of the results of further clinical trials of these product candidates or any of our other product candidates.
Our current and future clinical trials for ATRN-119 and APR-1051 may not ultimately be successful or support further clinical development.
Any such setbacks in our clinical development could materially harm our business, results of operations, financial condition and prospects. We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed . We have filed and obtained issuance of INDs for ATRN-119 and APR-1051, but we may not be able to file and obtain issuance of INDs that may be required for our other product candidates on the timelines we expect.
The successful commercialization of any product candidate may require us to perform a variety of functions, including: ● continuing to undertake preclinical development; ● designing and obtaining approval to commence clinical trials; ● successfully planning and enrolling subjects in clinical trials; ● successfully completing clinical trials to obtain data that support regulatory approvals; ● participating in regulatory approval processes; ● formulating and manufacturing products; and ● conducting sales and marketing activities We have limited experience designing, conducting and enrolling subjects in clinical trials.
Our operations to date provide a limited basis to assess our ability to develop and commercialize our product candidates. Because of this lack of experience, any future clinical trials we may conduct may not be completed on time, if at all.
Patient enrollment may also be affected by other factors, including: ● size and nature of the patient population; ● severity of the disease under investigation; ● availability and efficacy of approved drugs for the disease under investigation; ● patient eligibility criteria for the trial in question; ● patients’ and clinicians’ perceived risks and benefits of the product candidate under study; ● competing clinical trials or compassionate use programs; ● efforts to facilitate timely enrollment in clinical trials; ● physicians’ attitudes and practices with respect to clinical trial enrollment; ● the ability to monitor patients adequately during and after treatment; ● proximity and availability of clinical trial sites for prospective patients; and ● continued enrollment of prospective patients by clinical trial sites.
If serious adverse or unacceptable side effects are identified during the development of our product candidates or we observe limited efficacy of our product candidates, we may need to abandon or limit the development of one or more of our product candidates. Adverse events or unacceptable side effects caused by, or other unexpected properties of, our product candidates could cause us, any future collaborators, an institutional review board, or IRB, ethics committee, or EC, or regulatory authorities to interrupt, delay or halt clinical trials of one or more of our product candidates and could result in the (i) delay or denial of marketing approval by the FDA or comparable foreign regulatory authorities, (ii) approval with significant restrictions on distribution or use or (iii) required labeling information regarding safety concerns, if approved. In general, our clinical trials of APR-1051 and ATRN-119 will include cancer patients who are very sick and whose health is deteriorating.
We expect that patients may experience adverse events, serious adverse events or may die during their participation in our future clinical trials for APR-1051 and ATRN-119 or other product candidates.
The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs. We do not know whether ongoing clinical trials will be completed on schedule or at all, or whether future clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all.
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate If we are required to in the future and if we are unable to successfully develop companion diagnostic tests for our product candidates that require such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these product candidates. We may be required by the FDA to develop, either by ourselves or with collaborators, companion diagnostic tests for our product candidates for certain indications.
We face competition with respect to ATRN-119 and our other product candidates, and will face competition with respect to any product candidates that we may seek to discover and develop or commercialize in the future, from major pharmaceutical, specialty pharmaceutical and biotechnology companies.
We are developing ATRN-119, which is an orally bioavailable small molecule product candidate that targets Ataxia ATR protein within the DNA damage response pathway.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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