NEW YORK, July 22, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, today announced a CRADA (Cooperative Research and Development Agreement) with the U.S. Department of Veterans Affairs and Foundation for Atlanta Veterans Education and Research (FAVER) to evaluate GDNF (glial cell-derived neurotrophic factor) as a novel metabolic therapy targeting obesity and hepatic steatosis (fatty liver disease).

The study, conducted at the Atlanta VA Medical Center, will benchmark daily GDNF injections against semaglutide in both standard diet-induced obese mice and human liver chimeric mouse models, a gold-standard translational platform.

Dual-Arm Study: Head-to-Head vs. Semaglutide

CRADA Title:

"Efficacy of Parenteral GDNF Administration in the Induction of Weight Loss and Resolution of Hepatic Steatosis"

Study Highlights:

• Arm 1: Western diet-fed CF-1 mice treated with GDNF vs. placebo and semaglutide — tracking weight loss, liver histology, and metabolic markers.
• Arm 2: GDNF administered to TK-NOG human hepatocyte-engrafted mice — assessing human liver-specific gene expression, pathology, and glucose metabolism.

All protocols are IRB-approved and comply with VA and federal research ethics standards.

Deal Structure & Value

Under the agreement:

• Hoth Therapeutics will fund the study
• Hoth will supply GDNF while the VA retains data rights and shares de-identified results per HIPAA-compliant CRADA terms.

Key Collaborators:

• Hoth Therapeutics, Inc.
• U.S. Department of Veterans Affairs
• Foundation for Atlanta Veterans Education and Research (FAVER)

Why It Matters: Scientific Rationale

GDNF has demonstrated the ability to:

• Reduce body weight and hepatic lipid accumulation in prior transgenic models
• Enhance insulin sensitivity and promote fatty acid oxidation
• Show clinical safety in previous human trials (Parkinson's disease)

This CRADA marks the first pharmacologic test of GDNF in human liver-engrafted mice — setting the stage for potential first-in-class metabolic applications beyond CNS indications.

"This landmark agreement allows a real-world, controlled comparison of GDNF's metabolic effects alongside semaglutide — the current gold standard," said Robb Knie, CEO of Hoth Therapeutics. "We are proud to support the VA's efforts in exploring bold new solutions for obesity and liver disease."

Learn more: www.hoththerapeutics.com

About Hoth Therapeutics, Inc.

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.

Forward-Looking Statement

This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.

Investor Contact:
LR Advisors LLC 
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www.hoththerapeutics.com
Phone: (678) 570-6791