ADDED
As of March 30, 2026, the registrant had 904,469 and 904,468 shares of common stock, $0.001 par value per share, issued and outstanding, respectively.
Overview and Mission We believe the world needs and deserves a new approach to innovation that harnesses the power of large groups of stakeholders who work together to ensure that the most promising innovations reach people who need them most.
The Company was founded with a mission of redefining how health innovations are discovered, developed, and deployed transforming a highly centralized industry into a socially owned and guided ecosystem to advance human well-being.
Since then, we expanded our portfolio of innovations and subsidiaries, and we continue to evaluate a variety of promising health innovations.
ADI-100, the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase ( GAD ), which is implicated in type-1 diabetes (T1D), psoriasis, and in many autoimmune diseases of the CNS and has been successfully tested in several preclinical models (e.g., skin grafting, psoriasis, and T1D).
All preclinical studies for ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring durable tolerance as illustrated in 10-month studies in prevention and treatment of T1D in nonclinical animal models.
Preclinical safety and toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs evaluated except the skin (at the injection site).
Lastly, one remaining drug product release stability assay specifically designed for ADI-100 is in the final stages of qualification to be used once the final drug product is ready.
Food and Drug Administration, a human trial for SPS is expected to get underway in 2026 with enrollment of 10-20 patients, some of whom may also have T1D.
In these studies, the primary readouts for ADI-100 will be safety and tolerability as well as clinical and immunological signals of tolerance induction.
REMOVED
As of March 28, 2025, the registrant had 1,159,201 and 1,159,200 shares of common stock, $0.001 par value per share, issued and outstanding, respectively.
The 2024 Proxy Statement will be filed with the Securities and Exchange Commission (the SEC ) within 120 days after the end of the fiscal year to which this report relates.
federal government; we do not expect to pay dividends in the foreseeable future; we have issued a significant number of restricted stock awards, restricted stock units, options and warrants and may continue to do so in the future.
The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock; future sales or issuances of substantial amounts of our common stock, including, potentially as a result of future acquisitions or strategic transactions, including the transactions with Evofem Biosciences, Inc.
could result in significant dilution; while we have entered into a Merger Agreement with Evofem Biosciences, Inc.
and an Arrangement Agreement with Appili Therapeutics, Inc., we cannot assure you that such transactions will be consummated or, that if such transaction is consummated, that it will be accretive to stockholder value; we may engage in future acquisitions or strategic transactions, including the transactions Evofem Biosciences, Inc.
and Appili Therapeutics, Inc., which may require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management; we have entered into a Common Stock Purchase Agreement with an equity line investor pursuant to which we may issue and sell up to $150 million of our common stock, which could result in significant dilution; we have entered into an At The Market Offering Agreement with H.C.
Wainwright Co., LLC pursuant to which we may issue and sell up to $35 million of our common stock, which could result in significant dilution; we were notified by the Listing Qualifications Staff of Nasdaq that it has determined that as of March 6, 2025, the Company s securities had a closing bid price of $0.10 or less for ten consecutive trading days.
As a result, we are subject to the provisions contemplated under Listing Rule 5810(c)(3)A)(iii) and the Staff has determined to delist our securities from The Nasdaq Capital Market.
On March 12, 2025, we filed with the Secretary of State of the State of Delaware a certificate of amendment to our certificate of incorporation to effect a 1:250 reverse stock split.