Aditxt advances autoimmune therapy ADI-100 toward trials

Published 06/03/2025, 14:22
Aditxt advances autoimmune therapy ADI-100 toward trials

MOUNTAIN VIEW, Calif. - Aditxt, Inc. (NASDAQ: ADTX), a micro-cap biotech company with a market capitalization of $0.85 million and focused on health innovation, announced progress in its subsidiary Adimune, Inc., related to the development of ADI-100, a therapeutic candidate aimed at treating autoimmune diseases such as Psoriasis, Type I Diabetes (T1D), and Stiff Person Syndrome. According to InvestingPro data, the company faces significant financial challenges with revenue of just $0.21 million in the last twelve months.

The preclinical studies for ADI-100 have been completed, and the drug substances for final formulation are on schedule for shipment in March. These studies suggest ADI-100’s potential in restoring immune tolerance over a 10-month period in T1D models, without drug toxicity or immunosuppression risks. Additionally, the studies indicated that ADI-100 does not compromise the immune system’s ability to fight infections or cancer. InvestingPro analysis shows the company is quickly burning through cash, with a concerning current ratio of 0.09, indicating potential challenges in meeting short-term obligations.

Adimune has successfully manufactured Good Manufacturing Process (GMP) clinical-grade drug substances, which will be formulated into the final drug product pending regulatory submissions. The company is in the final stages of validating two drug product release assays for ADI-100.

Adimune is preparing for clinical trials in Germany, having engaged a Contract Research Organization (CRO) for site selection. In the U.S., the company is collaborating with the Mayo Clinic to prepare an Investigational New Drug (IND) package for FDA submission, with a pre-IND meeting expected in the second quarter of this year.

The company emphasizes that ADI-100 is an antigen-specific gene therapy designed to restore immune tolerance without relying on immunosuppression. It targets Glutamic Acid Decarboxylase (GAD), implicated in several autoimmune diseases. ADI-100 works by reprogramming the immune response, aiming to reduce pro-inflammatory cytokines and increase anti-inflammatory ones.

Aditxt’s broader mission involves advancing health innovations through a collaborative platform involving research institutions, industry partners, and shareholders. The company is also expanding its focus to include public health and women’s health through partnerships and merger agreements, subject to funding and shareholder approvals. InvestingPro data reveals concerning financial metrics, including a weak Financial Health Score of 1.17 and negative gross margins of -297%. Subscribers can access 14 additional ProTips and comprehensive financial analysis to better understand the company’s investment potential.

This update is based on a press release statement from Aditxt, Inc. and does not include any speculative information.

In other recent news, Aditxt, Inc. announced that its subsidiary, Pearsanta, Inc., is preparing for an initial public offering (IPO) with Dominari Securities LLC as the lead underwriter. The IPO, anticipated in the second half of 2025, is intended to support Pearsanta’s commercial launch and the development of its Mitomic® Technology for early cancer detection. This move aligns with Aditxt’s broader strategy to promote health innovations and address unmet healthcare needs. Additionally, Aditxt held a special meeting where stockholders approved a reverse stock split, allowing the board discretion over the split ratio within a year. The meeting was adjourned to gather more votes on proposals related to stock issuance, complying with Nasdaq Marketplace rules.

Aditxt’s plans for Pearsanta include expanding its diagnostic pipeline and securing funding, as evidenced by a recent $2.3 million proposal to the Department of Defense. Despite a previous funding setback for another test, Pearsanta continues to seek additional opportunities. The company is also exploring strategic agreements with Appili Therapeutics, Inc. and Evofem Biosciences, Inc. to introduce new health programs. However, these initiatives depend on securing sufficient capital, as demonstrated by the withdrawal of a merger proposal with Evofem due to funding issues.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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