Hoth Therapeutics Stock Price, News & Analysis

Hoth Therapeutics, Inc. (NASDAQ: HOTH) is a clinical-stage biopharmaceutical company that focuses on developing therapies for serious and underserved medical conditions. According to the company’s public statements, Hoth positions itself as a catalyst in early-stage pharmaceutical research and development, moving drug candidates from discovery through pre-clinical and clinical testing with the goal of improving patient quality of life.

The company collaborates with scientists, clinicians, and key opinion leaders to identify and investigate therapeutic candidates that it believes have significant potential. Hoth’s pipeline includes programs in oncology supportive care, oncology, neurodegenerative disease, metabolic disease, and inflammatory and dermatologic conditions, as described in its press releases and investor communications.

Oncology-supportive care and dermatology: HT-001

A central program in Hoth’s pipeline is HT-001, described by the company as a topical therapeutic candidate for cancer-therapy–related skin toxicities. Hoth reports that HT-001 is being developed for the treatment of skin toxicities and rash associated with epidermal growth factor receptor inhibitor (EGFRi) therapies and radiotherapy in oncology patients. Company disclosures refer to a Phase 2 CLEER-001 clinical trial targeting EGFR-inhibitor–associated rash, and to a first-in-human Phase 2a study evaluating the efficacy, safety, and tolerability of topical HT-001 for EGFRi-related skin toxicities.

Hoth has also announced dual U.S. provisional patent filings that it states are intended to expand its intellectual property around an oncology-focused dermatology platform using HT-001. One provisional application addresses topical treatment of radiation-induced skin toxicity in oncology patients, and a second addresses dermatologic toxicities associated with emerging targeted cancer therapies. The company has further disclosed a Patent Cooperation Treaty application for HT-001, described as a topical formulation for treating side effects from drugs used for the treatment of cancer.

Oncology: HT-KIT antisense program

Another key program is HT-KIT, which Hoth describes as a precision antisense oligonucleotide (ASO) designed to silence KIT mRNA. Company communications state that HT-KIT targets KIT-driven diseases, including systemic mastocytosis and gastrointestinal stromal tumors (GIST), and that it is intended to address limitations associated with kinase inhibitors by acting at the transcript level. Hoth has highlighted preclinical data indicating suppression of KIT expression and tumor-volume reduction in systemic mastocytosis and GIST models, along with a favorable tolerability profile in the reported preclinical work.

Hoth reports that HT-KIT has received U.S. Food and Drug Administration Orphan Drug Designation for mast-cell–driven diseases and that GLP-validated bioanalytical methods and other IND-enabling activities are underway. The company also notes patent protection in certain jurisdictions, including a Japanese patent referenced in its public disclosures.

Neurodegenerative disease: HT-ALZ

The company’s pipeline includes HT-ALZ, described in Hoth’s communications as a therapeutic candidate for Alzheimer’s disease and other neuroinflammatory conditions. According to the company, HT-ALZ has been advancing through GLP and pharmacokinetic development, with work focused on absorption, distribution, and central nervous system–related parameters. Earlier descriptions also refer to HT-ALZ as a treatment and/or prevention approach for Alzheimer’s or other neuroinflammatory diseases.

Metabolic and obesity-focused programs

Hoth has disclosed work on metabolic disease and obesity, including what it calls a GDNF-based metabolic program. In its public statements, the company describes this program as leveraging glial cell line–derived neurotrophic factor (GDNF) to target obesity, hepatic steatosis, and broader metabolic dysfunction. Hoth has announced a U.S. Department of Veterans Affairs–backed study at the Atlanta VA Medical Center evaluating GDNF as a potential therapy for obesity and fatty liver disease, and has referred to this as a weight-loss and metabolic initiative supported by academic collaboration.

In addition to the GDNF program, Hoth has referenced an obesity treatment program and work on obesity-related diseases and conditions in earlier descriptions of its pipeline.

Additional pipeline assets and indications

Beyond these lead programs, Hoth’s prior and current public descriptions reference additional assets:

• BioLexa, described as an asset being developed for atopic dermatitis (eczema).
• HT-004, described as a treatment for asthma and allergies using inhalational administration.

Hoth has also characterized its broader focus as including metabolic, dermatologic, and inflammatory diseases, alongside oncology and neurodegenerative indications.

Use of artificial intelligence and advanced computing

Hoth has announced initiatives to integrate artificial intelligence and accelerated computing into its research and development activities. The company reports participation in the NVIDIA Connect Program and the use of NVIDIA AI Enterprise licenses to support GPU-powered infrastructure. According to Hoth, these tools are intended to enhance computational biology workflows, predictive pharmacology and toxicity modeling, target identification, protein-structure modeling, and clinical-trial–related analytics across programs such as HT-001, HT-KIT, HT-ALZ, and its metabolic initiatives.

Regulatory and clinical development footprint

Public disclosures indicate that Hoth is pursuing a multi-regional clinical and regulatory strategy. For HT-001, the company has reported a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I of its oncology-supportive-care trial, describing this as confirming the scientific and regulatory acceptability of the trial design and investigational products. Hoth has also announced Institutional Review Board approvals from Montefiore Medical Center and Dana-Farber Cancer Institute for a first-in-human Phase 2a trial of HT-001 for EGFRi-associated skin toxicities.

In the United States, the company has reported interactions with the FDA related to Orphan Drug Designation for HT-KIT and described ongoing IND-enabling work. Hoth’s communications describe a development model that moves candidates from pre-clinical studies toward first-in-human and later-stage clinical evaluation, subject to regulatory review.

Corporate and listing information

Hoth Therapeutics, Inc. is incorporated in Nevada and reports its principal executive offices in New York, New York, according to its SEC filings. The company’s common stock trades on The Nasdaq Capital Market under the ticker symbol HOTH. In a June 2025 Form 8-K, Hoth reported that it had regained compliance with Nasdaq’s minimum bid price requirement for continued listing on The Nasdaq Capital Market.

Company filings with the U.S. Securities and Exchange Commission (SEC) also describe Hoth’s use of investor presentations and other materials to communicate its operations and performance. These materials, along with press releases, outline the company’s pipeline, regulatory milestones, intellectual property strategy, and collaborations.

Business model focus

Based on its public statements, Hoth’s business model centers on early-stage drug discovery and development rather than on commercialized products. The company emphasizes identifying differentiated therapeutic mechanisms, building an intellectual-property–centric portfolio, and advancing candidates through pre-clinical and clinical stages. Hoth highlights collaborations with institutions such as the Atlanta VA Medical Center and references work with AI-assisted discovery platforms and life-science data partners in support of its programs.

Risk and forward-looking considerations

Hoth’s press releases routinely include cautionary language noting that many aspects of its development plans are forward-looking and subject to substantial risks, uncertainties, and assumptions. The company points to factors such as regulatory approvals, clinical-trial timing and outcomes, market acceptance, intellectual property, reliance on third parties, and broader industry and economic conditions as variables that can affect its progress. Investors typically review the company’s SEC filings and risk-factor disclosures for more detailed information on these topics.