Regulatory Clearance in Spain Advances Randomized, Placebo-Controlled Study; Patients Show Meaningful Reductions in EGFR-Inhibitor Skin Toxicities with No Treatment Disruptions

NEW YORK, May 5, 2026 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced that it has secured regulatory authorization in Spain for its Phase 2a CLEER Trial of HT-001, while concurrently reporting encouraging interim clinical results demonstrating meaningful efficacy and safety in cancer patients experiencing EGFR inhibitor-associated skin toxicities.

The authorization supports the continued advancement of Hoth’s randomized, placebo-controlled, dose-ranging Phase 2a study evaluating HT-001 for the treatment of dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor therapies.

Interim Clinical Results Highlight Strong Efficacy Signal

Preliminary data from the ongoing study indicate:

• Patients achieved the primary efficacy endpoint, with rash severity reduced to clinically manageable levels (ARIGA ≤1) by Week 6
• Over 65% of patients reported meaningful reductions in pain and itching
• Zero patients required dose reduction or discontinuation of their underlying EGFR inhibitor cancer therapy
• Favorable safety profile, with no treatment-limiting adverse events observed

These findings suggest that HT-001 may enable patients to remain on life-saving cancer therapies longer, addressing a major limitation of current oncology treatment regimens.

Regulatory Momentum + Clinical Validation
“Regulatory advancement paired with strong clinical signals has helped open up a new avenue for patients in Spain,” said Robb Knie, Chief Executive Officer of Hoth Therapeutics. “Securing European authorization while demonstrating meaningful patient benefit reinforces our belief that HT-001 has the potential to become a critical supportive care therapy in oncology.”

The Spain authorization marks an important step in Hoth’s European strategy and supports continued trial execution and expansion across additional regions.

About the CLEER Trial
The CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions) is a Phase 2a randomized, placebo-controlled, parallel, dose-ranging study evaluating HT-001 in patients experiencing EGFR inhibitor-related dermatologic toxicities.

About HT-001
HT-001 is a novel topical therapeutic designed to target inflammatory pathways associated with cancer therapy-induced skin toxicities, with the goal of improving tolerability and enabling uninterrupted treatment.

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.