Hoth Therapeutics Announces Positive Data from First-of-its-Kind Human Patient Treatment of EGFRI-Associated Skin Toxicities with HT-001

Cancer Patient Ceased Treatment After One Week Due to Rapid Success

In the reported case, the patient, a 59-year-old female undergoing treatment at George Washington University for metastatic breast cancer, experienced significant improvement in symptoms just one week after initiating HT-001 therapy. Due to the swift resolution of lesions and the alleviation of discomfort, the patient was able to discontinue the treatment after just seven days. Over the following three weeks, no new lesions developed, further highlighting the potential of HT-001 as an effective and safe therapy for EGFRI-associated PPEs.

NEW YORK, Sept. 5, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing next-generation therapies for unmet medical needs, is excited to announce positive data from the treatment of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular eruptions (PPEs) with its novel therapeutic HT-001. During this first-of-its-kind human patient case, the patient was able to cease treatment after just one week due to the rapid and successful resolution of symptoms, marking a significant advancement in managing a common and debilitating side effect experienced by cancer patients undergoing EGFRI therapy.

EGFRIs are widely used to treat various cancers of epithelial origin but are frequently associated with cutaneous side effects, most notably PPEs like acneiform rash, which can occur in up to 90% of patients. These PPEs can cause significant discomfort, including pruritus and burning, and often lead to interruptions or discontinuation of critical cancer therapies. HT-001 offers a new approach to managing these skin toxicities, showing rapid symptom relief without compromising the patient’s ongoing cancer treatment.

In the reported case, the patient, a 59-year-old female undergoing treatment at George Washington University for metastatic breast cancer, experienced significant improvement in symptoms just one week after initiating HT-001 therapy. Due to the swift resolution of lesions and the alleviation of discomfort, the patient was able to discontinue the treatment after just seven days. Over the following three weeks, no new lesions developed, further highlighting the potential of HT-001 as an effective and safe therapy for EGFRI-associated PPEs.

“We are thrilled with the positive data from this first investigator led study patient case,” said Robb Knie, CEO of Hoth Therapeutics. “HT-001 has the potential to significantly improve the quality of life for cancer patients suffering from EGFRI-induced skin toxicities. This rapid and successful treatment is an important milestone as we continue to explore HT-001’s potential to meet this critical unmet need.”

A Phase 2a clinical trial is currently underway to further evaluate the efficacy and safety of HT-001 in the management of EGFRI-associated skin toxicities. Current sites include MD Anderson Cancer Center, University of Miami, Dana Farber Cancer Institute, University of California Irvine, the George Washington University, Montefiore Medical Center, and Northwell Health, Inc. For more information, please visit clinical trials.

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.

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