AZTR

New in FY2025

• For the fiscal years ended December 31, 2025 and 2024, we incurred a net loss of $11.0 million and $9.0, respectively.
• As of December 31, 2025, we had an accumulated deficit of $68.5 million.
• The report of our independent registered public accounting firm for the year ended December 31, 2025 states that due to our accumulated deficit, recurring and negative cash flow from operations there is substantial doubt about our ability to continue as a going concern.
• As of December 31, 2025, we had total assets of $5.0 million and working capital of $2.0 million.
• In January, 2025, we completed a public offering of 729,381 shares of our common stock, at an offering price of $2.00 per share, in which we received net proceeds of approximately $1.2 million, after deducting underwriter discounts and offering expenses, in February 2025 we completed a registered direct offering of 374,696 shares of our common stock, at an offering price of $1.85 per share, in which we received net proceeds of approximately $695 thousand, after deducting placement agent commissions and offering expenses; in April 2025 we entered into an equity line of credit with Alumni Capital LP pursuant to which we have sold 9,255,823 shares and received gross proceeds of approximately $6 million; and in November 2025 we completed an offering of 535,759 shares at an offering price of $0.32, pre-funded warrants to purchase up to an aggregate of 4,151,741 shares and warrants to purchase up to an aggregate 4,687,500 shares, in which we received net proceeds of approximately, $1.3 million, after deducting underwriter discounts and offering expenses.
• After giving effect to these offerings, we believe that our cash on hand as of the date of this report will not be sufficient to cover our proposed plan of operations beyond three months from the date of this report.
• We recently initiated our Phase 1b clinical trial for ATR-12 and dosed our first patient in August 2024 and dosed the first patient in the Phase 1/2 trial of ATR-04 in the third quarter of 2025.
• We dosed the first patient in our Phase 1b clinical trial for ATR-12 in August 2024,and we dosed the first patient in our Phase 1/2 clinical trial for ATR-04 in the third quarter of 2025.
• Emerging issues related to the development and use of artificial intelligence could give rise to legal or regulatory action, damage our reputation, or otherwise materially harm our business.
• We use artificial intelligence to analyze, predict, and help screen our library of strains for drug like molecules and continue to explore the opportunities that artificial intelligence could bring to us.
• Our use of artificial intelligence technologies may not be successful and may present business, compliance, and reputational risks.
• The use of artificial intelligence, particularly generative artificial intelligence, presents opportunities as well as risks that could negatively impact the business.
• Artificial intelligence technologies may be developed using inaccurate, incomplete, flawed, or biased algorithms, training methodologies, or data, which could result in competitive harm, regulatory penalties, legal liability, or brand or reputational harm.
• Further, a failure to timely and effectively use or deploy artificial intelligence and integrate it into new product or service offerings could negatively impact our competitiveness, particularly ahead of evolving industry trends and consumer demands.
• Artificial intelligence technologies are complex and rapidly evolving, and while we aim to develop and use artificial intelligence responsibly and attempt to mitigate ethical and legal issues presented by its use, we may ultimately be unsuccessful in identifying or resolving issues before they arise, and the technologies that we develop or use may ultimately be flawed.
• Particularly given the nascent stage of the technology, the use of artificial intelligence technologies can lead to unintended consequences, including the generation of outputs that appear correct but are factually inaccurate, misleading, or are otherwise flawed, which could harm our reputation and business and expose us to risks related to such inaccuracies or errors in these outputs.
• Moreover, artificial intelligence technology is subject to rapidly evolving domestic and international laws and regulations, which could impose significant costs and obligations on us.
• Emerging regulations may also pertain to data privacy, data protection, and the ethical use of artificial intelligence, as well as clarifying intellectual property considerations.
• Our use of artificial intelligence could give rise to legal or regulatory action or increased scrutiny or liability and may damage our reputation or otherwise materially harm our business.
• With the change in presidential administrations in 2025, there remains substantial uncertainty as to how, if at all, the administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates.
• The FDA has the authority to require a REMS as part of a BLA or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug, such as limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria or requiring patient testing, monitoring and/or enrollment in a registry.
• Orphan drug designation must be requested before submitting a BLA.
• Congress extended the RPD‑PRV program until December 20, 2024, and recently reauthorized the program under the Consolidated Appropriations Act of 2026, or CAA, which was signed into law on February 3, 2026.
• The CAA included the Naylon Give Kids a Chance Act that reauthorizes the Rare Pediatric Disease PRV program until September 30, 2029.
• The RPD-PRV program is currently scheduled to sunset as of September 30, 2026, and the future of this program remains unknown at this time.
• The current presidential administration has taken action intended to reduce the cost of prescription drugs, including drugs purchased directly by consumers.
• The administration issued two Executive Orders aimed at lowering drug prices through multiple directives, including directives to government agencies and officials to identify most-favored-nation pricing targets for prescription drugs (and looking to pharmaceutical manufacturers to make significant progress towards delivering target prices to patients), to facilitate DTC purchasing programs for pharmaceutical manufacturers to sell their products to patients at the most-favored-nation price, to enhance competition for high-cost prescription drugs by accelerating approval of generics and biosimilars, facilitating the process for re-classifying prescription drugs as OTC drugs, and increasing drug importation.
• In the wake of the Executive Orders and related executive initiatives, a number of pharmaceutical manufacturers have announced new or expanded DTC offerings with discounted prices and/or reached agreement with the federal government regarding discounted pricing for drugs, including prices for Medicaid drugs and newly launched products.
• TrumpRx, a website sponsored by the federal government that is anticipated to offer pharmaceutical DTC channels, has also been announced.
• Federal agencies are also developing and proposing new drug pricing and payment pilot programs based on international pricing metrics under Medicare Parts B and D as well as Medicaid.
• Other healthcare reform efforts or actions under the Trump Administration may affect access to healthcare coverage or the funding of health care benefits, although the full impact of such efforts or actions cannot be predicted.
• Since shares of our common stock were sold in our initial public offering, or IPO, in June 2023 at a price of $999.00 per share, the reported high and low sales prices of our common stock have ranged from $1,034.96 to $0.17 through February 26, 2026.
• Our charter limits our ability to issue shares.
• Our charter authorizes us to issue up to 200,000,000 shares of common stock, with 10,740,697 shares of common stock, 139,922 options, and 12,235,052 warrants outstanding, as well as 1,436 shares reserved for issue under our 2016 equity plan and 181,842 shares reserved under our 2023 equity incentive plan, 176,700,851 shares of common stock remain issuable as of the date of this report, prior to the exercise of any warrants issued in our November 2025 offering and our equity line of credit.
• This number may decrease if we enter into any additional capital raising transactions.
• Additional shares may become issuable with the expiration of currently outstanding warrants or if we effect a reverse share split in the future.
• On October 1, 2025, we received written notification from the NYSE American that we are not in compliance with Section 1003(a)(ii) (the “Deficiency Letter”) of the NYSE American Company Guide (the “Company Guide”).
• The Company has submitted a plan (the “Plan”) to regain compliance to the NYSE American and on December 16, 2025, received notice that the NYSE American had accepted the Company’s Plan to regain compliance and granted a plan period through April 1, 2027 (the “Plan Period Deadline”).
• If the Company does not regain compliance with the NYSE American continued listing standards by the Plan Period Deadline, or if the Company does not make progress consistent with its Plan during the plan period, then the NYSE American may initiate delisting proceedings.
• Additionally, if we fail to satisfy the continued listing requirements of the NYSE American, including the corporate governance requirements or the minimum closing bid price requirement, the NYSE American may take steps to delist our common stock.

and 2 more.

Gone since FY2024

• For the fiscal years ended December 31, 2024 and 2023, we incurred a net loss of $9.0 million and $11.3, respectively.
• As of December 31, 2024, we had an accumulated deficit of $57.6 million.
• The report of our independent registered public accounting firm for the year ended December 31, 2024 states that due to our accumulated deficit, recurring and negative cash flow from operations there is substantial doubt about our ability to continue as a going concern.
• As of December 31, 2024, we had total assets of $7.4 million and working capital of $3.9 million.
• In January, 2025, we completed a public offering of 4,857,780 shares of our common stock, at an offering price of $0.30 per share, in which we received net proceeds of approximately $1.3 million, after deducting underwriter discounts and offering expenses, and February 2025 we completed a registered direct offering of 2,495,518 shares of our common stock, at an offering price of $0.2785 per share, in which we received net proceeds of approximately $695 thousand, after deducting placement agent commissions and offering expenses.
• After giving effect to both offerings, we believe that our cash on hand as of the date of this report will not be sufficient to cover our proposed plan of operations beyond six months from the date of this report.
• We recently initiated our Phase 1b clinical trial for ATR-12 and dosed our first patient in August 2024 and expect to dose the first patient in the Phase 1/2 trial of ATR-04 in the first half of 2025.
• We dosed the first patient in our Phase 1b clinical trial for ATR-12 in August 2024,and we expect to dose the first patient in our Phase 1/2 clinical trial for ATR-04 in the first half of 2025.
• With the change in presidential administrations in 2025, there is substantial uncertainty as to how, if at all, the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates.
• The FDA has the authority to require a REMS as part of an BLA or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug, such as limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria or requiring patient testing, monitoring and/or enrollment in a registry.
• Orphan drug designation must be requested before submitting an BLA.
• Congress has extended the RPD‑PRV program until December 20, 2024, with potential for vouchers to be granted until 2026.
• The RPD-PRV program is currently scheduled to sunset as of September 30, 2026.
• Since shares of our common stock were sold in our initial public offering, or IPO, in June 2023 at a price of $150.00 per share, the reported high and low sales prices of our common stock have ranged from $5.18 to $0.20 through February 24, 2025.
• If we fail to satisfy the continued listing requirements of the NYSE American, such as the corporate governance requirements or the minimum closing bid price requirement, the NYSE American may take steps to delist our common stock.
• As of the date of this report, we have 12,483,836 shares of common stock issued and outstanding, all of which are eligible for sale by means of ordinary brokerage transactions in the open market pursuant to Rule 144, promulgated under the Securities Act, subject to certain limitations under Rule 144.
• We intend to increase staffing within our accounting infrastructure sufficient to facilitate proper segregation of accounting functions.