Hungary Approves Trial Expansion as HT-001 Meets Primary Endpoint in Interim Analysis with Patients Reaching ARIGA ≤1 by Week Six

Over 65% of Patients Reported Reduced Pain and Itching; Zero Disruptions to EGFR Cancer Therapy with ~99% Lower Systemic Exposure

NEW YORK, April 1, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ:HOTH), a clinical-stage biopharmaceutical company, today announced positive clinical results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis, with patients reaching an ARIGA rash severity score of ≤1 by week six.

In addition to the strong results in Ariga score, HT-001 demonstrated strong patient benefit across multiple clinically meaningful measures. Over 65% of patients reported meaningful reductions in pain and itching, supporting HT-001's potential to significantly improve quality of life for patients suffering from dermatologic toxicities, including those associated with epidermal growth factor receptor inhibitor (EGFR) cancer therapies.

Importantly, zero patients required dose reduction or discontinuation of their EGFR inhibitor therapy while receiving HT-001, highlighting the potential for HT-001 to manage dermatologic side effects without interfering with life-saving cancer treatments.

HT-001 was also well tolerated, with no treatment discontinuations reported.

Pharmacokinetic (PK) analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies, supporting a targeted delivery profile designed to maximize local efficacy while minimizing systemic side effects.

Building on these positive results, Hoth has received regulatory approval in Hungary, enabling expansion of the Phase 2 clinical trial into Europe. The Company anticipates additional regulatory approvals in Spain and Poland, with site activations expected in the near term. In the United States, an additional clinical site is expected to be activated, further accelerating patient enrollment and data generation.

"The achievement of these interim results, combined with strong patient-reported outcomes and the ability to maintain uninterrupted cancer therapy, represents a meaningful advancement for HT-001," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "With over 65% of patients reporting reductions in pain and itching, along with a favorable safety profile and expanding global clinical footprint, we believe HT-001 is well positioned as a differentiated therapy addressing a critical unmet need in oncology supportive care."

Dermatologic toxicities remain a significant challenge for patients undergoing cancer treatment, often leading to discomfort, reduced quality of life, and in some cases treatment modification or discontinuation. HT-001's ability to demonstrate primary endpoint achievement, meaningful symptom improvement, and zero disruption to EGFR inhibitor therapy may represent a compelling advancement over existing treatment options.

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.