Hoth Therapeutics Announces Positive Pre Clinical Data HT-ALZ Shows Promising Breakthrough in Alzheimer's Disease Research Acute treatment with HT-ALZ led to a rapid (~15%) reduction in brain interstitial fluid Aβ levels, within 20 hours

Results underscore the dual-action profile of HT-ALZ—impacting both pathology and

symptomology.

NEW YORK, April 2, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ:HOTH), a biopharmaceutical company focused on developing innovative treatments for unmet medical needs, today announced groundbreaking preclinical data supporting the therapeutic potential of its lead Alzheimer's candidate, HT-ALZ, in improving cognitive function and reducing neuroinflammation in Alzheimer's disease (AD).

HT-ALZ, a proprietary formulation of an FDA-approved NK-1 receptor antagonist, has shown significant cognitive and behavioral benefits in APP/PS1 mouse models of Alzheimer's disease. The study demonstrated that chronic oral administration of HT-ALZ led to marked improvement in memory, reduction of anxiety-like behavior, and enhanced sensorimotor gating, all without impairing motor function.

Crucially, HT-ALZ significantly decreased the number of GFAP-positive reactive astrocytes, key contributors to neuroinflammation and cognitive decline in AD. These results suggest that HT-ALZ exerts its therapeutic effect through modulation of astrocyte activity via NK-1 receptor antagonism, presenting a novel mechanism for targeting Alzheimer's-related neurodegeneration.

"Our findings highlight a powerful new therapeutic approach for Alzheimer's by targeting astrocyte-driven neuroinflammation," said Robb Knie, CEO of Hoth Therapeutics. "Unlike conventional strategies that focus solely on amyloid plaques, HT-ALZ addresses a broader range of pathological processes—including inflammation—that contribute to cognitive impairment."

In addition to chronic benefits, acute treatment with HT-ALZ led to a rapid (~15%) reduction in brain interstitial fluid Aβ levels, as measured by in vivo micro dialysis. This underscores the dual-action profile of HT-ALZ—impacting both pathology and symptomology.

Importantly, HT-ALZ is orally bioavailable, crosses the blood-brain barrier, and has an established safety record, making it a compelling candidate for rapid clinical advancement. Preliminary studies showed no therapeutic effect in healthy wild-type mice, indicating HT-ALZ selectively improves function in the presence of Alzheimer's pathology.

"This research lays the groundwork for the development of HT-ALZ as a first-in-class, astrocyte-targeted therapy for Alzheimer's disease," said Robb Knie, CEO of Hoth Therapeutics. "With HT-ALZ, we have the potential to revolutionize how we treat neurodegenerative diseases by focusing on the critical role of neuroinflammation."

Hoth Therapeutics plans to advance HT-ALZ into clinical development to further evaluate its potential as a safe, effective treatment for early-stage Alzheimer's disease.

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: [email protected]

www.hoththerapeutics.com

Phone: (678) 570-6791

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