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Hello!
HOTH, our new NASDAQ alert, released breaking news this morning.
Here is the news from this morning:
“Hoth Therapeutics Issues Shareholder Update: HT-001, HT-KIT, Expanded Treasury Reserve Strategy, and VA Obesity Program Drive Strongest Position in Company History”
“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”
o “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”
o “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”
o “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”
o “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”
o “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."
“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.”
Following our alert this morning, HOTH opened today at 1.84, with a high so far of 1.85.
HOTH has a recent high of 1.87 from Monday.
A breakout and close above this level could present increased upside potential.
Here are a couple of the things to keep in mind as you are watching this opportunity.
Continue to watch for it to make higher lows and higher highs, that’s the first sign.
A close near the highs could be confirmation of the continued uptrend.
We are continuing to monitor it for sustainable breakout potential.
Happy Trading!
SmallCapStocks Team
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