Transaction Adds Dual BBB Delivery Strategies, Supports Alzheimer's Programs, Combination Therapies, 505(b)(2) Pathways, and CNS Countermeasure Applications
SACRAMENTO, Calif., May 4, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI) today announced the completion of a $20 million preferred equity issuance to acquire intellectual property assets from two counterparties, expanding the Company's central nervous system (CNS) platform with complementary neurotherapeutic compounds and delivery technologies. The acquired portfolio is designed to address a key limitation in neurological disease treatment, including Alzheimer's disease, where the blood-brain barrier (BBB) can restrict therapeutic access to the brain. The expanded intellectual property portfolio introduces complementary CNS delivery technologies and multi-agent, combinatorial therapeutic approaches, which will be integrated into Lunai Bioworks IP, Inc., a wholly owned subsidiary, broadening the Company's growing platform of neurological disease and biodefense applications.
The transaction integrates two distinct CNS delivery approaches into Lunai's platform: a BBB-crossing prodrug system and a nose-to-brain (N2B) delivery pathway that bypasses the BBB via olfactory and trigeminal routes. Together, these approaches are intended to support both individual and combination therapies, align with Lunai's AI-driven patient stratification strategy, expand potential applications across neurological disease, 505(b)(2) development pathways, and CNS-targeted biodefense and countermeasure programs, and position Lunai for potential partnership, licensing, and non-dilutive funding opportunities.
The acquired intellectual property expands Lunai's ability to connect therapeutic discovery with delivery, supporting a more integrated approach to CNS drug development. By pairing compound design with delivery optimization, the Company is advancing a framework aimed at increasing drug concentration in the brain while reducing systemic exposure. This approach addresses both challenges by combining novel neurotherapeutic compounds with complementary delivery technologies, improving CNS access and enabling multi-agent, combinatorial strategies. Together, the portfolio strengthens Lunai's ability not only to deliver therapeutics to the brain, but to develop and deploy both single-agent and combination therapies that target distinct aspects of disease biology. This approach may be applicable across multiple neurological indications as well as in settings requiring rapid CNS access.
Lunai's Augusta platform is designed to stratify patient populations based on underlying biological drivers rather than traditional disease classifications. The integration of these assets is expected to support the development of targeted therapeutic combinations matched to specific patient subgroups, including in the context of neurological disease and acute toxic or environmental exposures. This combined approach is intended to improve the efficiency of candidate selection and advancement.
The combined platform is also expected to support multiple regulatory pathways, including potential 505(b)(2) opportunities for reformulated or repurposed therapeutics. These pathways may enable more efficient development timelines and reduced clinical risk relative to traditional de novo drug development programs.
In addition, the expanded intellectual property portfolio is expected to strengthen Lunai's role in biodefense-related initiatives, including its Pathfinder program, by increasing its capacity to evaluate and deploy CNS-targeted countermeasures. This includes the potential use of established pharmacological agents in combination with alternative delivery approaches designed for rapid administration and central nervous system access following chemical or environmental exposures.
"This transaction brings together complementary CNS delivery approaches that address one of the most persistent challenges in neurological drug development," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "By integrating these technologies with our existing platform, we are expanding our ability to develop and deliver targeted therapies, while also opening additional pathways for partnership, licensing, and non-dilutive funding."
On May 1, 2026, the Company completed the Merger and issued the Series B Preferred Stock having an aggregate Stated Value of $20,000,000 to the Holders. The Merger and the related issuance of the Series B Preferred Stock is the principal transaction undertaken by the Company to achieve compliance with the Nasdaq Stockholders' Equity Rule and the Company will determine and disclose the equity treatment of the Series B Preferred Stock in accordance with applicable accounting standards. After giving effect to the Merger, the issuance of the Series B Preferred Stock, and based on the Company's preliminary accounting and fair-value analysis, the Company believes its stockholders' equity exceeds the $2.5 million minimum required by Nasdaq Listing Rule 5550(b)(1). The Company is awaiting the Panel's formal determination of compliance with the Stockholder's Equity Rule. There can be no assurance that the Panel will determine that the Company has satisfied the Stockholders' Equity Rule, and any such determination by the Panel is subject to the Panel's continuing review of the Company's disclosures, financial condition and progress toward compliance with the Bid Price Rule. If the Panel determines that the Company has not satisfied the conditions set forth in the Panel's decision (as so extended), Nasdaq may take further action to delist the Company's common stock from The Nasdaq Capital Market.
About Lunai Bioworks, Inc.
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven life sciences company advancing drug discovery and chemical defense through its integrated platform. Lunai combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. Lunai is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws. These statements include, but are not limited to, statements regarding the expected benefits of the transaction, potential applications of the acquired intellectual property, development timelines, regulatory pathways, and potential partnership, licensing, or funding opportunities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Lunai undertakes no obligation to update these statements except as required by law.
SOURCE Lunai Bioworks Inc.
