PR Newswire
NEW YORK
, Sept. 16, 2025 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced a comprehensive shareholder update, underscoring momentum across its lead clinical programs and corporate strategy. With HT-001 advancing globally, HT-KIT achieving key validation milestones, the expansion of its treasury reserve strategy to include Bitcoin, Ethereum, and Solana, and the advancement of its VA obesity program, management emphasized that Hoth is operating from the strongest position in its history.
Key Developments Driving Momentum
- HT-001: Advancing Globally
Hoth has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for EGFR inhibitor-induced skin toxicities. Pending approval, European patient enrollment is expected to begin in early 2026, complementing active enrollment already underway in the U.S. - HT-KIT: Achieving Preclinical Milestones
The Company successfully completed the Good Laboratory Practice (GLP) bioanalytical phase for HT-KIT, exceeding internationally recognized regulatory thresholds. This achievement supports advancement into formal toxicology studies and regulatory submission, reinforcing the strength and depth of Hoth’s pipeline. - VA Obesity Program
Hoth is advancing its obesity initiative in partnership with the U.S. Department of Veterans Affairs (VA), focused on developing and evaluating novel approaches to address the rising prevalence of obesity in the veteran population. This program underscores Hoth’s commitment to tackling widespread health challenges with innovative solutions and broadening the Company’s reach into high-impact therapeutic areas. - Treasury Reserve Expansion – Company’s Board of Directors approved the expansion of Hoth’s treasury reserve strategy to include Ethereum and Solana, alongside Bitcoin. Under this plan, Hoth may purchase up to $1 million in Bitcoin, Ethereum, and/or Solana as part of its corporate reserve. This move reflects management’s confidence in digital assets as a long-term store of value and a complementary diversification strategy for the Company’s balance sheet.
- Expansion of Phase II Clinical Trial Infrastructure
Engagement with ICON Clinical Research to expand HT-001 enrollment into EU sites will accelerate trial timelines and lay groundwork for potential global pivotal studies. - AI Integration for Smarter Development
Adoption of Lantern Pharma’s PredictBBB.ai platform, which achieves ~94% predictive accuracy for blood-brain barrier permeability, is enabling faster, data-driven decision-making across Hoth’s programs.
CEO Commentary
“Hoth Therapeutics is in the strongest position in its history,” said Robb Knie, Chief Executive Officer of Hoth Therapeutics. “HT-001 is advancing globally, HT-KIT has achieved critical validation milestones, and our VA obesity program is targeting one of the most pressing health issues of our time. Combined with the adoption of AI and a forward-looking treasury strategy that embraces Bitcoin, Ethereum, and Solana, we are firing on all cylinders. This is the most exciting and pivotal moment in Hoth’s journey, and I could not be more optimistic about the path ahead as we work to deliver transformative therapies and long-term shareholder value.”
Outlook:
The Company anticipates several near-term catalysts
- Regulatory Decision on EMA CTA submission for HT-001.
- European Site Expansion and accelerated Phase II enrollment.
- Data Readouts for HT-001 in EGFR inhibitor-related skin toxicities.
- HT-KIT Progress advancing toward toxicology and regulatory submission.
- Further Updates from the VA obesity program as it advances in development.
- Treasury Diversification as the Company implements its approved digital asset reserve strategy.
- Continued Pipeline Innovation leveraging AI-driven platforms for oncology-support programs.
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-issues-shareholder-update-ht-001-ht-kit-expanded-treasury-reserve-strategy-and-va-obesity-program-drive-strongest-position-in-company-history-302557395.html
SOURCE Hoth Therapeutics, Inc.
