Hoth Therapeutics Expands HT-001 Development with Patent Filings Targeting Drug-Induced Hypersensitivity, Radiotherapy-Induced Rash, and MENIN Inhibitor-Associated Skin Toxicities

MENIN inhibitors are a promising class of targeted oncology drugs in development for acute leukemias and certain solid tumors, but their use is often limited by severe dermatological side effects. HT-001 aims to address these toxicities, helping patients remain on therapy and realize the full benefit of treatment.

Key Highlights

•  U.S. Provisional Patents filed expanding HT-001's therapeutic reach.
  
  
• Indications covered:
• Drug-Induced Hypersensitivity Syndrome
• Radiotherapy-Induced Rash
• Dermatological Conditions Associated with MENIN Inhibitor Therapy
• MENIN inhibitors are an emerging oncology class with significant promise in acute leukemias and select solid tumors, but treatment-limiting rashes remain a major clinical challenge.
  
  
• HT-001 designed to improve tolerability of cancer therapies by addressing dermatological side effects, potentially enabling patients to remain on therapy longer.

NEW YORK, Sept. 24, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing next-generation treatments for dermatological and inflammatory conditions, today announced the expansion of its intellectual property portfolio for HT-001, its lead topical therapeutic candidate. The Company has filed multiple U.S. Provisional Patent Applications covering novel dermatological indications, broadening the commercial and clinical potential of HT-001.

The filings include:

• Treatment of Drug-Induced Hypersensitivity Syndrome
  
  
• Treatment of Radiotherapy-Induced Rash
  
  
• Treatment of Dermatological Conditions Associated with MENIN Inhibitor Therapy

"These additional patent applications demonstrate our commitment to unlocking the full therapeutic potential of HT-001 across multiple high-value indications," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Drug-induced hypersensitivity, radiotherapy-related rash, and MENIN inhibitor-associated dermatological conditions represent areas of significant unmet need. Expanding our IP protection into these indications strategically positions Hoth to address major markets in oncology supportive care and beyond."

MENIN Inhibitor Therapy and the Role of HT-001

MENIN inhibitors are an emerging class of targeted oncology drugs designed to block the interaction between the menin protein and MLL1/KMT2A fusion proteins — genetic drivers implicated in acute leukemias and other cancers. Early clinical data from leading oncology companies have shown that MENIN inhibitors can induce strong antitumor activity, making them one of the most closely watched new therapeutic classes in cancer drug development.

However, patients receiving MENIN inhibitors frequently experience significant dermatological side effects, including painful or disfiguring rashes that can lead to dose reductions or treatment discontinuation. These adverse events may limit the full therapeutic potential of MENIN inhibitor therapy.

HT-001's novel topical formulation is designed to address these dermatological toxicities directly, offering patients relief from rash and skin irritation without interrupting or reducing their cancer treatment. By improving tolerability, HT-001 could help patients stay on therapy longer and maximize the clinical benefit of MENIN inhibitors.

Expanding the Potential of HT-001

HT-001 is currently being advanced as a topical therapeutic for chemotherapy-induced rash, a dose-limiting side effect affecting patients receiving EGFR inhibitors and other targeted therapies. The patent filings broaden the potential utility of HT-001 to additional drug-induced and treatment-related skin disorders, further establishing the program as a versatile platform candidate.

"With this expanded IP portfolio, HT-001 is positioned not only as a targeted solution for oncology-related rash but also as a potential cornerstone therapy for a range of dermatological conditions driven by emerging cancer treatments," added Knie. "This expansion underscores our strategy to build durable value through innovation, intellectual property, and pipeline diversification."

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
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.