Hoth Therapeutics (HOTH) Stock News, Apr-Jun 2025

Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, announced that CEO Robb Knie will attend the BIO International Convention in Boston from June 16-19, 2025. The event is recognized as the largest biotechnology convention globally, bringing together approximately 20,000 industry leaders from the biotech ecosystem. The BIO International Convention serves as a significant platform for networking and industry insights in the biotechnology sector.

Hoth Therapeutics (NASDAQ: HOTH) has secured Japanese Patent No. 7677628 for its HT-KIT platform technology, providing protection until August 27, 2039. The patent, titled "Targeting KIT with Splice Switching Oligonucleotides to Induce Apoptosis of Mast Cells," covers their innovative approach using splice-switching oligonucleotides to disrupt KIT gene expression in mast cells. This technology targets conditions ranging from chronic hives to rare cancers. CEO Robb Knie highlighted the strategic importance of securing IP protection in Japan's pharmaceutical market, indicating potential licensing opportunities across Asia. The company is actively seeking strategic global partners for co-development and commercialization of the HT-KIT platform.

Hoth Therapeutics (NASDAQ: HOTH) has announced a significant advancement for its lead drug HT-001 by engaging Premier Research to support an Expanded Access Program (EAP) application. The initiative aims to provide compassionate access to HT-001 for cancer patients experiencing skin toxicities from EGFR inhibitor therapies. The company reports encouraging signals from their Phase 2a open-label cohort study. HT-001 addresses a significant market opportunity, with over 100,000 cancer patients annually receiving EGFR inhibitors, most of whom experience skin toxicities with no currently approved targeted treatments. The EAP status could accelerate commercialization while generating valuable real-world data. This strategic move positions Hoth to capture a growing segment in oncology supportive care while demonstrating their commitment to patient care.

Hoth Therapeutics (NASDAQ: HOTH) announced a KOL event to showcase HT-001, their novel topical treatment for skin toxicities caused by EGFR inhibitor cancer therapies. The event, scheduled for June 24, 2025, will feature experts Dr. Jonathan Zippin and Dr. Adam Friedman discussing preliminary Phase 2a trial results and a case study. HT-001 aims to address a significant market need, as the chemotherapy drug market is projected to grow from $10.87B (2024) to $18.35B (2031). The company recently received a USPTO Filing Receipt for HT-001's formulation, strengthening its IP portfolio. CEO Robb Knie emphasized HT-001's potential as a first-of-its-kind treatment for cancer patients suffering from EGFR therapy-related skin toxicities, which often force patients to reduce or discontinue essential cancer treatments.

Hoth Therapeutics (NASDAQ: HOTH) has announced positive preclinical results for HT-KIT, its antisense oligonucleotide therapy targeting KIT-driven cancers. The treatment demonstrated over 80% reduction in KIT expression in vitro and significant tumor growth inhibition in gastrointestinal stromal tumors (GIST) and mast cell tumor models.

Key achievements include successful targeting of mutant KIT mRNA transcripts with no observable off-target toxicity in liver, kidney, or bone marrow. The company plans to file an Investigational New Drug (IND) application with the FDA in early 2026, followed by Phase 1 trials. HT-KIT represents a potential alternative to current tyrosine kinase inhibitors (TKIs), addressing drug resistance concerns through its mRNA-level targeting approach.

Hoth Therapeutics (NASDAQ: HOTH) has announced promising preclinical results for HT-KIT, its antisense oligonucleotide therapy targeting KIT-driven cancers. The treatment demonstrated over 80% reduction in KIT expression in cancer cell lines and showed significant tumor growth inhibition in GIST and mast cell tumor models. Key highlights include no observable off-target toxicity in vital organs and a favorable safety profile. HT-KIT represents a novel approach to treating KIT-mutated cancers at the genetic level, potentially offering advantages over current tyrosine kinase inhibitors by avoiding resistance mechanisms. The company plans to file an IND application with the FDA in early 2026, followed by Phase 1 trials.

Hoth Therapeutics (NASDAQ: HOTH) has secured a significant patent from the Japan Patent Office for its RNA-based cancer therapy targeting the KIT gene. The patent provides broad coverage for antisense oligomers designed to modify pre-mRNA splicing or reduce KIT protein expression.

The granted patent specifically covers:

• Antisense RNA molecules (10-50 nucleotides) targeting KIT pre-mRNA splicing sequences
• Morpholino and chemically modified antisense variants
• Pharmaceutical compositions and expression vectors
• Applications in both human and veterinary medicine

The KIT gene is associated with various cancers including gastrointestinal stromal tumors (GIST), leukemia, and mastocytosis. This patent strengthens Hoth's position in RNA therapeutics and provides exclusive rights to develop, partner, and commercialize ASO-based therapies targeting KIT in Japan.

Hoth Therapeutics (NASDAQ: HOTH) has reported positive interim data from the open-label portion of its Phase 2a CLEER-001 clinical trial for HT-001, a treatment targeting pruritus associated with EGFR inhibitor-induced skin toxicities in cancer patients.

The key interim results from Day 1-21 demonstrate:

• A 50% reduction in pruritus severity (mean scores decreased from 1.6 to 0.8)
• Rapid symptom improvement by Day 7 (mean score: 1.0)
• Complete pruritus resolution in some patients
• No treatment-related serious adverse events reported

The CLEER-001 study continues with both cohorts active, including the randomized, double-blind portion of the trial. The treatment aims to address quality of life issues and treatment compliance challenges faced by cancer patients using EGFR inhibitors.

Hoth Therapeutics (NASDAQ: HOTH) has partnered with Washington University School of Medicine in St. Louis on an NIH grant application to advance Alzheimer's disease research using HT-ALZ, an FDA-approved NK-1 receptor antagonist.

The research, led by Dr. Carla M. Yuede, aims to understand the mechanisms behind HT-ALZ's cognitive benefits. Preclinical studies have shown promising results:

• Significant improvement in cognitive functions
• Reduced anxiety-like behaviors
• Decreased astrocyte-driven neuroinflammation in APP/PS1 mouse models
• 15% reduction in brain interstitial fluid Aβ40 levels within 20 hours of acute treatment

The company has provided GMP-quality HT-ALZ to support the studies. If funded, the grant will investigate NK-1 receptor antagonism's cellular specificity and its potential for treating neuroinflammatory conditions.