Protection through 2039, ensuring long-term commercial exclusivity.NEW YORK, June 12, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing innovative therapies, today announced that they have obtained Japan Country Patent No. 7677628 for the HT-KIT platform. The patent was officially granted by the Japan Patent Office on May 7, 2025, and exclusive protection is granted until August 27, 2039.The granted patent, titled "Targeting KIT with Splice Sw ...

For the Quarterly Period Ended: March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: Commission File Number: 001-38803 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Hoth Therapeutics, Inc. (Exact name of registrant as specified in its charter) Nevada 82-1553794 (State or other jurisdiction ...

Core Viewpoint - Hoth Therapeutics has been granted a significant patent by the Japan Patent Office, enhancing its intellectual property portfolio in RNA-based cancer therapeutics, particularly targeting the KIT gene associated with various cancers [1][2][4]. Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative RNA-targeted precision therapies aimed at improving patient quality of life [5]. Patent Details - The newly issued patent covers antisense oligomers that target the KIT gene, which is linked to aggressive cancers such as gastrointestinal stromal tumors, leukemia, and mastocytosis [2][4]. - The patent includes antisense RNA molecules comprising 10–50 nucleotides, Morpholino and chemically modified antisense variants, as well as pharmaceutical compositions and expression vectors [7]. Strategic Importance - The patent strengthens Hoth's position in the RNA therapeutics market and supports its global strategy, providing validation and momentum for advancing its RNA platform towards clinical applications [3][4]. - Targeting the KIT pathway with antisense technology represents a precision-driven approach that could potentially overcome traditional small molecule resistance mechanisms [4][8]. Market Implications - The patent creates opportunities for licensing and partnerships in high-growth therapeutic areas, particularly in oncology, immunology, and rare diseases [8].

Core Insights - Hoth Therapeutics announced positive interim results from the Phase 2a clinical trial, CLEER-001, for HT-001, which showed a 50% reduction in pruritus severity in patients experiencing skin toxicities from EGFR inhibitors [1][3][8] Group 1: Clinical Trial Results - The mean pruritus score decreased from 1.6 on Day 1 to 0.8 by Day 21, indicating significant symptom relief [1][8] - Rapid improvement was noted, with mean scores reaching 1.0 by Day 7, and some patients achieving complete resolution of pruritus within the 21-day period [8][9] - HT-001 was well tolerated, with no serious adverse events reported related to the treatment [8][9] Group 2: Product and Company Overview - HT-001 is a proprietary, non-steroidal topical formulation aimed at treating pruritus and inflammatory skin conditions associated with targeted cancer therapies [5] - The company focuses on developing innovative therapies for patients with high unmet medical needs, emphasizing a patient-centric approach in its research and development efforts [6]

Core Insights - Hoth Therapeutics, Inc. has announced a collaboration with Washington University School of Medicine to advance Alzheimer's disease research through a novel therapeutic strategy involving HT-ALZ, an FDA-approved NK-1 receptor antagonist [1][4] - The research aims to study the potential of HT-ALZ to reduce neuroinflammation and improve cognitive function in Alzheimer's disease [1][2] Research Collaboration - The collaboration is led by Dr. Carla M. Yuede, focusing on the "Cell Type Specificity of Neurokinin-1 Receptor Antagonists on Cognitive Improvement" [2] - The goal is to understand the neurological mechanisms and cellular targets responsible for the cognitive benefits observed with HT-ALZ [2] Preclinical Studies - Preclinical studies at Washington University showed that chronic oral administration of HT-ALZ significantly improved cognitive functions, reduced anxiety-like behaviors, and decreased neuroinflammation in the APP/PS1 mouse model of Alzheimer's [3] - Acute treatment with HT-ALZ reduced brain interstitial fluid Aβ40 levels by approximately 15% within 20 hours [3] Company Commitment - The CEO of Hoth Therapeutics expressed pride in supporting the research team and emphasized the significance of the grant application in understanding NK-1 receptor biology in neurological diseases [4] - Hoth Therapeutics has supplied GMP-quality HT-ALZ to Washington University to ensure high standards in preclinical research [4] Future Implications - If funded, the grant will further elucidate the cellular specificity of NK-1 receptor antagonism and its implications for treating neuroinflammatory conditions [4]

Core Insights - Hoth Therapeutics, Inc. has received an official Filing Receipt from the USPTO for a new patent application related to HT-001, its lead clinical asset [1][3] - The new patent application aims to expand the company's intellectual property portfolio and protect the unique formulation and delivery method of HT-001, which is designed to alleviate dermatologic side effects in cancer patients undergoing EGFR inhibitor therapy [2][3] Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments to improve patient quality of life [4] - The company emphasizes a patient-centric approach and collaborates with scientists, clinicians, and key opinion leaders to explore therapeutics with significant potential [4]

Product Development and Clinical Trials - HT-001 is under development for treating skin toxicities associated with EGFR inhibitors, with 49-100% of patients experiencing such toxicities during treatment[34]. - The FDA approved the clinical study for HT-001 on December 28, 2022, and positive interim results have been reported from the ongoing Phase 2a trial[33]. - HT-KIT has received Orphan Drug Designation from the FDA for the treatment of mastocytosis, providing 7-year marketing exclusivity and tax incentives[38]. - The company is conducting IND-enabling studies for HT-KIT, targeting advanced systemic mastocytosis and mast cell leukemia[39]. - HT-ALZ has been granted a patent for treating Alzheimer's disease, with development planned under the FDA's Section 505(b)(2) regulatory pathway[40]. - The BioLexa Platform is being developed for eczema treatment, utilizing a patented drug compound to prevent infectious biofilm formation[42]. - HT-004 is being investigated for asthma and allergies, with preclinical proof-of-concept data supporting its efficacy after inhalational delivery[46]. - The marketing approval process for product candidates is lengthy and uncertain, with no product candidates currently having gained marketing authorization[96]. - The company may encounter substantial delays in completing clinical studies, which could increase costs and impair revenue generation[104]. - Patient enrollment in clinical trials is challenging and can be affected by various factors, including protocol attractiveness and competition from other trials[123]. - Delays in clinical studies may arise from protocol modifications that require FDA evaluation, potentially extending trial timelines[124]. - The company may need to conduct additional clinical studies to support approval, which could incur significant costs and delays[111]. - Clinical trials are expensive and uncertain, with a high likelihood of unforeseen events that could delay or prevent regulatory approval[110]. Regulatory Environment and Compliance - The process of obtaining regulatory approvals requires substantial time and financial resources, with potential sanctions for non-compliance[62]. - The FDA conducts pre-approval inspections of manufacturing facilities to ensure compliance with current good manufacturing practices (cGMP)[68]. - The FDA may require Phase 4 clinical trials to further assess drug safety and effectiveness post-approval[69]. - The FDA may condition approval on the requirement for risk evaluation and mitigation strategies (REMS) to ensure safe use of drugs[69]. - The company is subject to extensive healthcare regulations that may affect its ability to operate and market products[81]. - The company faces risks related to regulatory approvals, which could significantly impact its financial condition and operational viability[98]. - The company faces significant risks in obtaining regulatory approvals for its product candidates, which could limit its ability to generate revenue[109]. - Compliance with FDA regulations is critical; failure to do so could result in enforcement actions that harm the company's reputation and sales[137]. - The company is subject to ongoing inspections by regulatory authorities to ensure compliance with manufacturing standards, which could result in sanctions if not adhered to[167]. - The regulatory environment for biosimilars remains uncertain, which could require changes to the company's current strategies[176]. Financial Performance and Capital Needs - The company reported net losses of $8.2 million and $8.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $60.4 million and $52.2 million as of the same dates[88]. - The company has generated no revenue from commercial sales to date, and future profitability remains uncertain[88]. - The company will need to raise substantial additional capital to fund operations and the development of product candidates[89]. - The company’s accumulated deficit indicates ongoing financial challenges, necessitating careful capital management[88]. - Future capital needs for operations, including research and development, may lead to substantial dilution for existing shareholders if additional equity securities are issued[215]. - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, limiting returns to shareholders to potential increases in share price[216]. Manufacturing and Supply Chain - The company relies on contract manufacturing organizations for production, as it currently lacks manufacturing capabilities[53]. - The company relies on third-party manufacturers for clinical product supplies, which exposes it to risks that could delay clinical trials and commercialization[129]. - The company is dependent on foreign CROs and CDMOs, including WuXi, for manufacturing HT-KIT, which may be subject to U.S. legislation and trade restrictions that could impact supply and costs[133]. - The company relies on single-sourced manufacturing with WuXi, increasing the risk of delays or issues that could materially affect HT-KIT development[134]. - Changes in CMOs could lead to delays in clinical trials and increased manufacturing costs, potentially affecting the development timelines of product candidates[168]. Market and Competitive Landscape - The commercial success of the company's products will be substantially dependent on whether third-party coverage and reimbursement are available[141]. - Even with regulatory approval, the commercial success of product candidates will depend on acceptance by the medical community, which is influenced by factors such as clinical safety, efficacy, and pricing[150][152]. - The company’s products will face significant competition from larger pharmaceutical companies and research institutions, which may have greater financial resources and development capabilities[154]. - The company may face increased difficulty and costs in obtaining marketing approval due to current and future legislation affecting the healthcare system[142]. Legal and Governance Issues - The company faces significant legal, accounting, and other expenses due to its obligations as a publicly traded company in the United States[229]. - The company’s Articles of Incorporation and Amended and Restated Bylaws may discourage potential acquisition proposals and limit shareholder rights[225]. - The exclusive forum provision in the Amended and Restated Bylaws may increase costs for shareholders and limit their ability to bring claims in favorable judicial forums[227]. - The company must maintain compliance with Nasdaq's listing requirements to avoid delisting, which could adversely affect stock price and liquidity[220]. - The company has anti-takeover provisions that could discourage potential acquisitions, potentially impacting stock price negatively[221]. Human Resources and Operational Challenges - The company employed a total of 2 full-time employees, 3 employee consultants, and 1 part-time employee as of March 28, 2025[83]. - The company may face challenges in hiring and retaining key employees, which could adversely affect its operations and growth[198]. - Rapid growth to support larger clinical trials may strain the company's financial and operational resources, necessitating effective management of growth[199]. Cybersecurity and Technology Risks - Cybersecurity threats pose risks to the company's technology and network infrastructure, which could negatively affect its reputation and operational capabilities[182]. - The company is increasingly dependent on complex information technology systems, which may expose it to significant vulnerabilities, including data breaches and service interruptions[203]. - The company may face increased operational costs and reputational damage due to cybersecurity breaches or disruptions[184].

Core Insights - Hoth Therapeutics, Inc. has announced significant advancements in its proprietary antisense oligonucleotide (ASO) cancer drug candidate, HT-KIT, focusing on allergic and inflammatory diseases [1][4] Intellectual Property Developments - The company has filed amended claims with the U.S. Patent and Trademark Office for its lead ASO technology targeting MS4A6A and FcεRIβ, enhancing intellectual property protection for HT-KIT [2] - These refined claims position HT-KIT as a novel therapeutic platform with potential applications in treating conditions such as anaphylaxis, mastocytosis, and allergic asthma [2] Preclinical Studies - Hoth has initiated a GLP-compliant 4-week intravenous toxicity study in C57BL/6 mice, which includes a 14-day recovery period [3] - This preclinical study aims to evaluate the safety profile of HT-KIT and will involve multiple dose groups, detailed pathology assessments, and pharmacokinetic profiling [3] Future Development Plans - The company is committed to advancing HT-KIT toward clinical evaluation and is conducting additional preclinical studies to validate its efficacy and safety [4] - Plans are in place to initiate regulatory discussions for first-in-human trials as part of the development process [4]

Core Insights - Hoth Therapeutics, Inc. announced breakthrough preclinical findings for HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors (GIST), demonstrating significant tumor burden reduction and disruption of KIT signaling pathways [2][3][4] Group 1: Key Findings from Preclinical Study - HT-KIT triggered significant tumor cell death as early as 24 hours post-treatment, with lower doses leading to substantial cell death at 72 hours [6][7] - HT-KIT treatment inhibited cell growth and proliferation in GIST-T1 cells, confirmed by reductions in cell count and decreased fluorescence intensity in proliferation assays [6][7] - In a humanized xenograft model, HT-KIT treatment (12.5 mg/kg IV every three days) led to significant tumor growth reduction, with statistically significant differences observed by day 8 [6][7] - Excised tumors from HT-KIT-treated mice were smaller and lighter than those in the control group, reinforcing tumor volume measurements [6][7] Group 2: Treatment Mechanism and Potential - HT-KIT effectively reduced KIT receptor expression within 24 hours, with effects sustained for 72 hours [7] - By targeting KIT mutations, HT-KIT has shown remarkable efficacy in preclinical models, indicating its potential as a transformative treatment option for GIST [3][4][5] Group 3: Next Steps in Development - Hoth Therapeutics is advancing HT-KIT toward clinical evaluation, conducting additional preclinical studies to validate its efficacy and safety profile [5] - Plans are in place to initiate regulatory discussions for first-in-human trials [5]

Core Viewpoint - Hoth Therapeutics is advancing HT-001, a therapeutic candidate aimed at alleviating dermatological side effects in cancer patients undergoing EGFR inhibitor treatments, and plans to submit an Expanded Access application to provide access to this treatment outside traditional clinical trials [1][2]. Company Overview - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies to improve patient quality of life, emphasizing a patient-centric approach in its research and development efforts [3]. Expanded Access Program - The Expanded Access Program (EAP) is designed to provide investigational treatments to patients with serious or life-threatening conditions who lack comparable treatment options, allowing Hoth Therapeutics to offer HT-001 to eligible patients while collecting data on its safety and efficacy [2]. Leadership Commitment - Robb Knie, CEO of Hoth Therapeutics, highlighted the submission of the Expanded Access application as a significant step in the company's commitment to addressing critical unmet medical needs and improving the quality of life for cancer patients [2].