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Hoth Therapeutics Provides Pipeline Update

Hoth Therapeutics, Inc., a biopharmaceutical company focused on clinical-stage therapeutics, has recently published a comprehensive update regarding its drug development pipeline. This update highlights the significant progress that the company has achieved across various clinical programs, including HT-001, HT-KIT, and HT-ALZ, along with a new initiative involving GDNF, aimed at metabolic dysfunction.

Pipeline Highlights

HT-001 (Topical Epidermal Growth Factor Inhibitor)

The HT-001 program continues to make strides in the Phase 2 clinical trial known as CLEER-001. This particular trial is designed to address EGFR-inhibitor associated rash, which is a critical concern in oncology patient care. Recent developments from this program have been encouraging:

• - Strong Safety Profile: To date, HT-001 has shown a robust safety profile, with no dose-limiting toxicities reported.
• - Improvement in Symptoms: There have been consistent trends indicating improvements in the severity of rash and associated itching in clinical participants.
• - Engagement from Clinical Sites: The level of engagement from clinical sites has increased, showcasing favorable feedback from investigators.

An additional update is expected in the coming months as patient enrollment continues to progress.

HT-KIT (Orphan Drug Designation for Mast Cell Diseases)

The HT-KIT program, which targets mastocytosis and related diseases, is moving forward with its IND preparation. The achievements thus far include:

• - FDA Orphan Drug Designation: This status has already been granted, marking significant progress towards regulatory approval.
• - Preclinical Success: Compelling preclinical results have demonstrated effective KIT inhibition and a suppression of mast-cell activation.
• - Completion of Toxicology Studies: The toxicology studies required for IND submission are nearing completion, and manufacturing processes are being scaled up simultaneously.

The company anticipates finalizing its IND submission in 2026, which will pave the way for human clinical studies.

HT-ALZ (Alzheimer's Therapeutic Development)

The HT-ALZ program is progressing through good laboratory practices (GLP) and pharmacokinetic (PK) development phases. Recent highlights emphasize:

• - Positive GLP Outcomes: Current reports are showing favorable PK, biodistribution, and central nervous system (CNS) penetration modeling.
• - Regulatory Package Development: The documentation and data for regulatory review expected to mature significantly in 2026.

GDNF-Based Metabolic Program (New Initiative)

The newest venture from Hoth Therapeutics focuses on leveraging Glial-Derived Neurotrophic Factor (GDNF) to tackle obesity, hepatic steatosis, and metabolic dysfunction. This program stands out due to:

• - Initiation of Study Preparations: Preparations are underway in collaboration with the Atlanta VA Medical Center, including the completion of mouse procurement.
• - Current Research Phase: Research has now commenced, with the first aim of the project already underway, and anticipation of early data by 2026.

Intellectual Property and Strategic Collaborations
Hoth Therapeutics is also dedicated to expanding its intellectual property portfolio with new filings to reinforce protection around its developments. Collaborations have been forged with notable institutions, enhancing both research and development initiatives.

Milestones Ahead

Key future milestones include:

• - An update on the Phase 2 HT-001 trial data.
• - The completion of toxicology studies and IND filing for HT-KIT.
• - Additional updates regarding the HT-ALZ and VA metabolic program findings.

Management's Insight

Robb Knie, CEO of Hoth Therapeutics, expressed strong optimism regarding the therapeutic pipeline: “Our therapeutic pipeline has never been more focused or better positioned. With HT-001 advancing in the clinic, HT-KIT nearing IND submission, HT-ALZ progressing through GLP development, and our new GDNF program targeting some of the largest markets in medicine, we are excited for the future.”

About Hoth Therapeutics

Founded with a purpose of improving patient quality of life, Hoth Therapeutics is at the forefront of biopharmaceutical innovation. The company employs a patient-centric approach, working alongside researchers and healthcare professionals to explore groundbreaking therapeutic solutions.

For more details, visit Hoth Therapeutics Investor Relations.