RESEARCH TRIANGLE PARK, N.C., July 21, 2026 (GLOBE NEWSWIRE) -- Merakris Therapeutics, Inc., a clinical-stage biotechnology company developing regenerative biologic medicines for chronic wounds, today announced that it has received a Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), to support clinical development of MTX-001 for the treatment of diabetic foot ulcers (DFUs).

The award provides approximately $2.2 million of non-dilutive funding over two years, expanding Merakris’ clinical-stage pipeline into diabetic foot ulcers and complementing the Company’s FDA Fast Track designated venous leg ulcer (VLU) program.

“This award represents independent validation of our science, our GMP manufacturing platform, and our clinical development strategy. We believe the combination of NIH support, our ongoing clinical programs, and our differentiated dual-action biology significantly strengthens the long-term value proposition of MTX-001,” said Chris Broderick, Chief Executive Officer of Merakris Therapeutics. “Receiving a Direct-to-Phase II award from NIH reflects independent scientific validation in both our therapeutic platform and our clinical development program.”

This award represents another significant milestone in Merakris' strategy of systematically advancing its clinical, regulatory, and manufacturing capabilities while preserving capital through non-dilutive funding.

Advancing a Differentiated Dual-Action Biologic

MTX-001 is Merakris' lead investigational biologic and is designed to address the underlying biology responsible for chronic wound persistence.

Unlike therapies that primarily provide wound coverage or target a single pathway, MTX-001 is designed with a dual-action mechanism intended to:

• Modulate excessive inflammation and protease activity, helping restore a wound environment capable of healing; and
• Activate endogenous cells involved in cutaneous tissue repair and re-epithelialization, promoting regeneration of healthy tissue.

Merakris believes simultaneously addressing these complementary biological processes may provide a differentiated therapeutic approach for patients with chronic wounds, including DFUs and VLUs.

Advancing Clinical Development in Chronic Wounds

Merakris plans to engage the U.S. Food and Drug Administration to discuss its clinical development strategy for MTX-001 in DFUs. The Company expects the NIH-supported study to build upon its ongoing clinical experience and manufacturing capabilities while supporting advancement toward later-stage clinical development.

The NIH-supported study is expected to evaluate MTX-001 in patients with DFUs using a randomized, placebo-controlled clinical design, with both treatment groups receiving current standard of care, including appropriate debridement, off-loading, and wound management.

The Company recently initiated production of GMP pilot-scale clinical material for MTX-001 and continues advancing its Chemistry, Manufacturing and Controls (CMC) platform to support later-stage development.

The NIH-supported DFU program complements Merakris' ongoing Phase II clinical program evaluating MTX-001 in VLUs (NCT04647240). Merakris’ VLU program was recently awarded Fast Track from the U.S. Food and Drug Administration.

Together, the Company's DFU and VLU programs establish MTX-001 as a clinical-stage biologic platform targeting two of the largest advanced chronic wound indications, representing a substantial market opportunity with significant unmet medical need.

About MTX-001

MTX-001 is Merakris Therapeutics' lead investigational biologic locally administered by injection for chronic wound healing. The product is designed as a dual-action biologic intended to reduce excessive inflammation and protease activity while activating endogenous basal epithelial cells involved in tissue regeneration and re-epithelialization. By addressing both the destructive wound microenvironment and the regenerative processes necessary for healing, MTX-001 is being developed as a novel therapeutic approach for chronic wounds, including diabetic foot ulcers and venous leg ulcers.

About Merakris Therapeutics

Merakris Therapeutics is a clinical-stage biotechnology company developing regenerative biologic medicines designed for chronic wound healing through novel biological mechanisms. The Company's pipeline is focused on chronic wounds and other diseases characterized by persistent inflammation and impaired tissue repair. Merakris is headquartered in Research Triangle Park, North Carolina.

NIH Acknowledgement

Research reported in this announcement is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R44DK146625. The content is solely the responsibility of Merakris Therapeutics and does not necessarily represent the official views of the National Institutes of Health. This acknowledgement follows the language required by the Notice of Award.

Merakris Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.

Contact:
Chad Ingulsrud, MBA
Investor Relations
cingulsrud@merakris.com