Plans to seek FDA submission and approval for first-in-human trials in type 1 diabetes and stiff person syndrome targeted for early 2026
MOUNTAIN VIEW, Calif., August 25, 2025—-Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt”, or the “Company”), a social innovation platform accelerating promising health innovations, today announced an update on its wholly owned subsidiary Adimune, Inc. (“Adimune”), which is pioneering a DNA-based therapeutic platform designed to reprogram the immune system. Adimune’s intellectual property portfolio now includes 96 granted and 22 pending patents that are owned or exclusively licensed by Aditxt, supporting the company’s strategy to address the global autoimmune therapeutics market, which is estimated at over $160 billion by 2030.
“We believe Adimune has the potential to represent a fundamental shift in how we think about the immune system and biology in general,” said Amro Albanna, Co-founder and Chief Executive Officer of Aditxt. “If successful in harnessing DNA instructions and a proprietary delivery platform to reprogram the immune system, Adimune has the potential to lead a new era of addressing diseases through programming instructions designed to create innovative treatments that have the potential to build significant long-term value. With a robust patent portfolio and a focus on a multi-billion-dollar global market, Adimune is central to our mission of making promising innovations possible.”
“Autoimmunity is one of the most complex and urgent challenges in medicine,” said Friedrich Kapp, Co-Chief Executive Officer of Adimune. “Our platform is designed to reprogram the immune system, restoring tolerance without the burden of chronic immunosuppression. By combining DNA instructions with our proprietary delivery platform, we are aiming for digital-like precision in how the immune system is retrained. With the first ADI product candidate ADI-100, we are targeting high-need conditions such as type 1 diabetes, psoriasis, and stiff person syndrome. Our plan to seek FDA submission and approval for first-in-human trials in early 2026 represents a critical milestone toward translating this vision into real solutions for patients.”
About Aditxt
Aditxt, Inc. is a social innovation platform accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress. The Company currently operates two programs focused on immune health and precision health. Through the proposed acquisition of Evofem under the July 2024 Amended and Restated Merger Agreement between Evofem, Aditxt and Adifem, as amended (the “A&R Merger Agreement”), Aditxt aims to introduce an additional program dedicated to women’s health. The companies are working toward a targeted close in the second half of 2025. The closing of the transaction with Evofem is subject to several conditions, including but not limited to approval of the transaction by Evofem’s shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Evofem, which includes approximately $15.0 million required to satisfy Evofem’s senior secured noteholder; should Aditxt fail to secure these funds, Evofem’s senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close.
About Adimune
Adimune is a pre-clinical stage biopharmaceutical company pioneering a new class of immune modulation therapies designed to restore natural immune tolerance. Our mission is to advance immune health by providing targeted, long-term solutions that minimize reliance on chronic immunosuppression—transforming treatment for autoimmune diseases and organ transplantation.