Hoth Therapeutics Issues Shareholder Update: HT-001, HT-KIT, Expanded Treasury Reserve Strategy, and VA Obesity Program Drive Strongest Position in Company History

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, announced significant progress across multiple programs. The company's lead candidate HT-001 is expanding globally with a Clinical Trial Application submitted to EMA for Phase II trials. Their HT-KIT program completed GLP bioanalytical phase, while a new VA obesity program targets veteran health challenges.

In a strategic move, Hoth's board approved a treasury reserve expansion to include up to $1 million in Bitcoin, Ethereum, and Solana. The company has also partnered with ICON Clinical Research for EU trial expansion and integrated Lantern Pharma's AI platform achieving 94% predictive accuracy for blood-brain barrier permeability.

Positive

• None.

Negative

• Cryptocurrency investment strategy introduces market volatility risk
• European patient enrollment not expected until early 2026
• Multiple programs in early stages requiring significant development time

Insights

Biotech Investment Analyst

Hoth's positive pipeline progress and unusual crypto treasury strategy create a mixed outlook despite management's optimistic framing.

Hoth Therapeutics presents a mixed picture in this update, showcasing incremental progress across several programs while adding an unusual cryptocurrency treasury component to its strategy. On the clinical front, the company is expanding its HT-001 Phase II trial into Europe pending EMA approval, while HT-KIT has completed GLP bioanalytical testing – a regulatory stepping stone, though still in preclinical stages. The partnership with the VA on obesity represents another potential growth area, though specific details on mechanism or approach remain limited.

What stands out most unusually is Hoth's decision to allocate up to $1 million to cryptocurrencies (Bitcoin, Ethereum, and Solana) as part of its treasury reserve strategy. This represents a significant deviation from traditional biotech treasury management practices, where capital preservation typically takes priority over speculative investments. While cryptocurrency exposure might appeal to certain investor segments, it introduces substantial volatility risk for a clinical-stage biotech that traditionally requires stable, long-term capital planning for clinical development.

The company's infrastructure developments – including engagement with ICON Clinical Research for EU site expansion and adoption of AI tools from Lantern Pharma – represent standard industry practices rather than competitive advantages. The CEO's characterization of this being "the strongest position in company history" appears optimistic given that the company still has no approved products and its lead programs remain in early to mid-stage development with significant regulatory hurdles ahead.

Financial Blockchain Specialist

Hoth's expansion of its treasury reserve strategy to include not just Bitcoin but also Ethereum and Solana represents a highly unconventional approach for a clinical-stage biotech company. The board-approved allocation of up to $1 million toward cryptocurrencies constitutes a significant diversification away from traditional cash reserves that most biotechs maintain to fund clinical development.

This strategy introduces a substantial volatility factor into Hoth's balance sheet. While cryptocurrencies have demonstrated significant appreciation potential over multi-year horizons, they also experience extreme short-term price fluctuations that could materially impact quarterly financial statements. For a company in capital-intensive clinical trials, such volatility typically contradicts the stable funding requirements of pharmaceutical development timelines.

The inclusion of Solana alongside the more established Bitcoin and Ethereum is particularly notable, suggesting a more aggressive cryptocurrency stance than peers who have typically limited exposure to Bitcoin alone. This three-cryptocurrency approach indicates a more sophisticated digital asset strategy than typical corporate treasury forays into the space, though it amplifies both opportunity and risk.

While innovative, this treasury strategy raises questions about capital allocation priorities for a company without marketed products generating revenue. The $1 million potential allocation represents funds that could otherwise support clinical development, and shareholders may question whether cryptocurrency exposure aligns with the primary business objectives of advancing therapeutics through regulatory approval.

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: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.

FAQ

What are the main developments in Hoth Therapeutics (NASDAQ: HOTH) latest update?

Hoth announced expansion of HT-001 trials to Europe, completion of HT-KIT bioanalytical phase, launch of VA obesity program, and approval for up to $1M investment in cryptocurrency reserves.

When will Hoth Therapeutics begin European patient enrollment for HT-001?

European patient enrollment is expected to begin in early 2026, pending EMA approval of the Clinical Trial Application.

How much cryptocurrency can Hoth Therapeutics (HOTH) purchase under its new treasury strategy?

Hoth's board approved purchases of up to $1 million in Bitcoin, Ethereum, and/or Solana as part of its corporate reserve strategy.

What is the accuracy rate of Hoth's new AI platform for drug development?

Hoth integrated Lantern Pharma's PredictBBB.ai platform, which achieves 94% predictive accuracy for blood-brain barrier permeability.

What are the upcoming catalysts for Hoth Therapeutics stock?

Key catalysts include EMA regulatory decision on HT-001, European site expansion, Phase II data readouts, HT-KIT toxicology advancement, VA obesity program updates, and cryptocurrency reserve implementation.