NAPLES, FL - September 2, 2025 - Biotech is once again capturing investor attention, with small-cap companies in particular drawing focus for their potential to deliver breakthrough therapies and regulatory milestones. Over the past six months, clinical-stage biotechs reporting meaningful data have moved an average of nearly 12 percent in a single day, showing how quickly the market reacts to progress. With multiple programs across oncology, supportive care, and metabolic disease advancing toward key readouts, the sector is generating a steady stream of opportunities for investors seeking high-impact growth. In this environment, emerging companies with robust pipelines are worth watching closely.

Hoth Therapeutics (NASDAQ: HOTH): Fresh Data Puts HT-KIT in the Spotlight

Earlier today, Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced compelling new preclinical findings for HT-KIT, its antisense candidate targeting mutant KIT mRNA. The data showed potent anti-tumor activity, a clean safety profile, and regulatory-grade bioanalytical validation that surpassed international standards, giving investors a timely reason to pay attention.

HT-KIT: Rapid Tumor Kill and Regulatory Validation

In models of gastrointestinal stromal tumors and systemic mastocytosis, HT-KIT triggered significant tumor cell death within 24 hours and measurable tumor shrinkage by day eight. The candidate also achieved more than 80 percent knockdown of KIT expression in vitro, a strong signal against one of the most persistent oncogenic drivers.

Equally important, multi-dose safety studies confirmed no off-target toxicity across critical organs, including the liver, kidneys, spleen, bone marrow, and thymus. A dose-dependent biological signal was observed, with proportional organ engagement and no gross pathology at any site.

The preclinical program was validated under OECD, FDA, and EMA GLP standards by Altasciences Company, Inc. Results exceeded regulatory benchmarks, with 90.5 percent reproducibility in incurred sample reanalysis compared to the 66.7 percent minimum and serum stability for 37 days, extending beyond the 28-day requirement. No protocol deviations affected study reliability, strengthening the case for clinical advancement.

Chief Executive Officer Robb Knie called the results a rare and powerful story, combining tumor kill within 24 hours, safety across all systems, and reproducibility beyond regulatory standards. Hoth Therapeutics plans to integrate the data into its formal toxicology package as it prepares for an IND submission and potential first-in-human trials.

HT-001: Advancing in Oncology Supportive Care

While HT-KIT now takes center stage, Hoth Therapeutics is also moving forward with HT-001, a topical treatment for skin toxicities caused by epidermal growth factor receptor inhibitors in cancer patients. In July, the company partnered with ICON Clinical Research to expand its Phase II trial into Europe, with regulatory approval expected in as many as three countries. The trial is already enrolling patients in the United States.

Expanding into Europe not only accelerates enrollment but also positions the program for a potential global Phase III study. By alleviating the harsh dermatologic side effects of EGFR inhibitors, HT-001 could allow patients to remain on essential cancer therapies longer, improving both quality of life and treatment outcomes.

Targeting Obesity and Liver Disease with GDNF

Beyond oncology, Hoth Therapeutics is pursuing an ambitious strategy in metabolic disease. On July 22, the company entered into a Cooperative Research and Development Agreement with the U.S. Department of Veterans Affairs and the Foundation for Atlanta Veterans Education and Research to evaluate glial cell-derived neurotrophic factor as a therapy for obesity and fatty liver disease.

The study will benchmark GDNF directly against semaglutide, today’s leading weight loss drug, in both obese mice and human liver chimeric models. The goal is to assess effects on weight reduction, liver health, and insulin sensitivity. All protocols are IRB approved and comply with federal research ethics standards.

This initiative builds on a June announcement that Hoth Therapeutics and Silo Pharma signed a letter of intent to form a 50-50 joint venture around the same GDNF technology, which was co-developed by the VA and Emory University. The program targets obesity, nonalcoholic fatty liver disease, and type 2 diabetes, conditions with a combined global market estimated at 16 billion dollars.

Why Investors Are Watching

Hoth Therapeutics has steadily expanded its story beyond early potential. HT-KIT’s new preclinical findings provide a timely catalyst, demonstrating both efficacy and safety alongside regulatory-ready validation. HT-001 is advancing through a Phase II trial that now spans the U.S. and Europe, while the GDNF platform has secured high-profile partnerships with both the VA and Silo Pharma.

For a small-cap company, this combination of oncology innovation, supportive care development, and bold moves in metabolic disease is significant. With multiple milestones ahead including an IND for HT-KIT, expanded trial data for HT-001, and preclinical readouts for GDNF, Hoth Therapeutics, Inc. (NASDAQ: HOTH), has positioned itself as a name worth keeping on the biotech watchlist.

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