Hoth Therapeutics Announces Plans to Submit Expanded Access Application for HT-001 to Support Cancer Patients in Need

HT-001 is being developed to alleviate the adverse dermatological effects experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments. With positive progress in ongoing clinical studies, Hoth Therapeutics aims to provide patients access to HT-001 outside of traditional clinical trials through the Expanded Access Program (EAP), commonly known as "compassionate use."

NEW YORK, March 10, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies, today announced its intention to submit an Expanded Access application for HT-001, its novel therapeutic candidate for the treatment of dermatological conditions associated with cancer therapy.

HT-001 is being developed to alleviate the adverse dermatological effects experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments. With positive progress in ongoing clinical studies, Hoth Therapeutics aims to provide patients access to HT-001 outside of traditional clinical trials through the Expanded Access Program (EAP), commonly known as "compassionate use."

"Submitting an Expanded Access application is an important step in our commitment to ensuring patients who may benefit from HT-001 have the opportunity to receive this promising treatment," said Robb Knie, CEO of Hoth Therapeutics. "We remain dedicated to advancing solutions that address critical unmet medical needs and improve quality of life for patients undergoing cancer treatment."

The Expanded Access Program is designed to provide investigational treatments to patients with serious or life-threatening conditions who lack comparable treatment options. Through this program, Hoth Therapeutics seeks to offer HT-001 to eligible patients while continuing to gather valuable data on its safety and efficacy.

For more information about HT-001, ongoing clinical trials, or the Expanded Access Program, please visit 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 
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.