Aditxt Subsidiary Adimune Announces Positive Results from Mayo Clinic Pre-Clinical Studies to Support FDA and European Regulatory Submissions for Type 1 Diabetes, Psoriasis, and Stiff Person Syndrome Human Trials

Findings Further Support the Safety Profile and Immunomodulatory Effects of ADI-100, Adimune’s Lead Therapeutic Candidate for Autoimmune Diseases

Aditxt, Inc. (NASDAQ: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, today announced that a recently completed study conducted by the Mayo Clinic further validates the preclinical findings of ADI-100, the lead therapeutic candidate developed by Aditxt’s wholly owned subsidiary, Adimune™, Inc. (“Adimune”).

The independent study, led by Dr. Sean Pittock and Dr. Charles Howe of the Mayo Clinic’s neuroimmunology team, confirmed that ADI-100 induces immune tolerance to glutamic acid decarboxylase (GAD)—a key autoantigen implicated in multiple autoimmune conditions, including type 1 diabetes, stiff person syndrome, cerebellar ataxia, and autoimmune epilepsy.

“These results mark an important milestone not only for Adimune’s platform but also for Aditxt’s broader vision of transforming the way we approach autoimmune diseases,” said Amro Albanna, co-founder and CEO of Aditxt. “We believe that autoimmunity represents one of the most underserved and challenging areas of medicine. ADI-100’s potential ability to restore immune tolerance without broad immunosuppression is a meaningful step toward safer, more targeted treatments.”

Key Findings from the Mayo Clinic Study Include:

• Encouraging Safety Profile: ADI-100 did not increase T cell reactivity to GAD, reinforcing the product candidate’s preclinical safety profile.
• Immune Modulation at the Cellular Level: Dendritic cells treated with ADI-100 apoptotic bodies displayed increased tolerogenic markers.
• Antigen-Specific Suppression: ADI-100-induced tolerogenic dendritic cells reduced activation of T cells from GAD-sensitive patients, even in the presence of proinflammatory stimuli.

“Selection of a product candidate for clinical testing must demonstrate preclinical safety above all. The recent findings by Mayo Clinic using patient derived T cells corroborate Adimune’s preclinical findings showing an absence of disease exacerbation,” said Dr. Friedrich Kapp, Co-CEO of Adimune. “Demonstrating that ADI-100 treatment of patient-derived immune cells downregulates anti-GAD aggressive immune response is extremely reassuring as we prepare for clinical studies. It is our goal to restore immune tolerance and address both treatment and prevention needs of intervention. Treatment and prevention aspects will be key especially in Type 1 Diabetes where it is well established that people develop anti-GAD activity well prior to full disease manifestation. In other anti-GAD dependent disorders, we will have to see if we can halt or heal the disease.”

These findings were presented in abstract form at the American Academy of Neurology (AAN) Annual Meeting, with a peer-reviewed manuscript in development to include Mayo Clinic and Adimune datasets. The data will also support upcoming regulatory submissions in both the U.S. and Germany.

“Our recent findings verifying the ability of ADI-100 to effectively tolerize a patient’s own ‘immune-system-in-a-dish’ against GAD and the observation that ADI-100 alters human T cell function in a manner that appears to be safe and non-inflammatory, really suggests that this therapy will make an impact in patients with anti-GAD autoimmunity. We are excited about moving ADI-100 forward into clinical testing in patients suffering from severe neurological impairments precipitated by GAD autoreactive T cells. Critically, we are also quite hopeful that the application of ADI-100 in these patients will open up the future development of tailored tolerization trials in patients with an array of neurological disorders, including neurodegenerative diseases in which CD8+ T cells have been implicated,” said Dr. Charles Howe, Chair of the Division of Experimental Neurology at Mayo Clinic and Director of Research for the Mayo Clinic Center for Multiple Sclerosis and Autoimmune Neurology.

With pre-clinical efficacy and safety studies complete and GMP manufacturing finalized, Adimune is working to advance ADI-100 toward the clinic. Stability testing is currently underway, and regulatory submissions are planned for the second half of 2025, potentially paving the way for first-in-human clinical trials shortly thereafter.

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.

At the core of Adimune’s innovation is ADI-100™, a first-in-class Apoptotic DNA Immunotherapy™ that mimics the body’s natural mechanisms for maintaining immune tolerance. This proprietary platform uses nucleic acid technology to deliver two coordinated signals: one encoding BAX, a protein that promotes targeted apoptosis, and another encoding a modified disease-specific antigen to re-establish immune tolerance.

To learn more and view the corporate presentation, please visit adimune.com .

About ADI-100

ADI-100 is an investigational, innovative antigen-specific gene therapy that consists of two DNA molecules designed to restore immune tolerance in autoimmune diseases or to induce tolerance to transplanted organs. This approach is designed to retrain the immune system to recognize antigens as "self" without relying on immunosuppression, offering the possibility of significant safety and efficacy benefits.

The therapy consists of a pro-apoptotic DNA molecule (BAX), which has been shown in preclinical models to induce localized apoptotic cell death combined with a methylated sGAD55 DNA molecule that encodes a modified form of GAD to retrain the immune system to become tolerant to the antigen.

ADI-100 is designed to work through precision immune reprogramming, downregulating pro-inflammatory cytokines while upregulating anti-inflammatory cytokines in an antigen-specific manner. It tolerizes to GAD, which is a target of autoimmunity, directly or indirectly involved in Type 1 Diabetes, Psoriasis, and certain CNS autoimmune disorders. In the mouse model for type 1 diabetes, ADI-100 demonstrated a reduction in the number of aggressive T cells directed against insulin, which is another antigen in the pancreas that is a target of autoimmune attack. This bystander effect is an important factor to counteract a phenomenon often observed where autoimmunity spreads to other regions of a protein or to other proteins in a cell. Another potential benefit of downregulating anti-GAD antibodies by ADI-100 is restoration of GABA levels, further enhancing the tolerization process.

About Aditxt, Inc.

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.

Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 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 either of the transactions will ultimately close.

For more information, www.aditxt.com .

Follow us on:

LinkedIn: https://www.linkedin.com/company/aditxt

Facebook: https://www.facebook.com/aditxtplatform/

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute its strategic M&A initiatives; the Company’s ability to obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth, and strategies; the Company’s ability to raise additional capital; expected usage of the Company’s ELOC and ATM facilities; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in Aditxt’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250414955183/en/