NEW YORK, Feb. 5, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, today announced over the last several days investors have contacted the company re our exposure to digital assets such as Bitcoin , Solana and Ethereum.   Hoth holds no cryptocurrency assets, and its maximum exposure never reached more than $350,000 USD over the last year.   Hoth continues to exe ...

Core Insights - Hoth Therapeutics, Inc. announced positive interim results from the CLEER-001 clinical trial, demonstrating significant improvements in disease severity and patient-reported symptoms for cancer patients receiving EGFR inhibitor therapy [1][2][6]. Group 1: Primary Endpoint Results - The primary endpoint, assessed using the ARIGA scale, showed a ~50% reduction in disease severity, with mean ARIGA scores improving from 1.67 at baseline to 0.83 by Week 6 [3][4]. - All evaluable patients achieved ARIGA 1 by Week 6, indicating they fell within the low-severity disease range, with improvements noted as early as Week 3 [4]. Group 2: Additional Endpoints - The trial also reported a ~34% improvement in oncology toxicity (CTCAE), with scores decreasing from 2.0 at baseline to 1.33 at Week 6 [7]. - Patient-reported pruritus scores improved by ~37%, from a mean of 4.22 at baseline to 2.67 at Week 6, indicating a significant reduction in symptom severity [7]. Group 3: Treatment Context and Implications - EGFR inhibitors are critical in treating various cancers, but they often lead to treatment-related toxicity that can hinder patient outcomes [6]. - The results from CLEER-001 suggest that HT-001 could play a vital role in supportive care, helping patients maintain their cancer treatment regimens [6][8]. Group 4: Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies aimed at improving the quality of life for cancer patients [9].

Core Viewpoint - Hoth Therapeutics has received a key patent approval in China for its HT-KIT cancer program, which targets KIT signaling pathways to induce apoptosis in cancer cells, enhancing its intellectual property position in a significant oncology market [1][2][3]. Group 1: Patent Approval and Technology - The patent, originating from a PCT international application, provides essential intellectual property protection in China, a rapidly growing oncology market [2]. - HT-KIT is designed to disrupt aberrant KIT-driven signaling implicated in multiple cancers, utilizing splice-switching and molecular targeting strategies to trigger programmed cell death [3][4]. - The newly approved patent covers systems and methods for targeting KIT to induce apoptosis, reinforcing Hoth's strategy of developing precision oncology therapeutics [4]. Group 2: Strategic Importance of China - China is a critical jurisdiction for oncology intellectual property due to its expanding biopharmaceutical market and increasing oncology drug adoption [5]. - Patent protection in China may enhance future partnering, licensing, and strategic transaction opportunities related to HT-KIT [5]. - Hoth continues to convert its international patent filings into issued assets, a key value inflection point for biotech investors [6]. Group 3: Global Oncology IP Portfolio - The HT-KIT patent adds to Hoth's expanding portfolio of oncology and immunology assets, emphasizing the company's commitment to building long-duration shareholder value through IP-driven drug development [7]. - Hoth plans to advance HT-KIT while pursuing additional regulatory, development, and strategic milestones across its pipeline [7].

Core Insights - Hoth Therapeutics has achieved a significant regulatory milestone in Europe for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies [1][2][3] - The company received a positive conclusion under the European Union Clinical Trials Information System (CTIS) for Part I, confirming the trial design and investigational products [2][3] - Hoth plans to activate clinical trial sites and initiate the study across multiple European countries, with country-specific decisions expected by January 19, 2026 [3][4] Regulatory and Clinical Development - The positive regulatory conclusion marks a critical inflection point for Hoth's oncology-focused pipeline, confirming the acceptability of their application for cancer-related indications [3][7] - The HT-001 program aims to address EGFRI-induced dermatologic toxicities, which are common complications for cancer patients and can negatively impact their quality of life [3][4] - The company anticipates rapid, multi-national clinical execution following the expected regulatory decisions in Hungary, Spain, and Poland [3][4] Operational Execution - Hoth expects to initiate patient enrollment and advance the HT-001 program into active clinical execution, representing a significant step toward validating a new supportive-care therapy for oncology patients [4][7] - The company is positioned for near-term regulatory and operational catalysts that will facilitate the progress of its clinical trials [7]

Core Insights - Hoth Therapeutics has filed two U.S. provisional patent applications to expand its intellectual property portfolio, focusing on a new oncology-related dermatology platform aimed at treating skin toxicity caused by modern cancer therapies [1][3]. Patent Applications - The first patent application addresses the topical treatment of radiation-induced skin toxicity in oncology patients [2]. - The second patent application targets dermatologic toxicities associated with emerging targeted cancer therapies, including second and third-generation menin inhibitors [2]. Intellectual Property Expansion - The dual patent filings secure priority rights for the use of HT-001 to treat dermatologic toxicities across various oncology treatment modalities, including radiation therapy and next-generation targeted agents [3]. - Managing treatment-limiting skin toxicities is increasingly critical as cancer treatments improve and patients remain on therapy longer [3]. Treatment Landscape - Current treatment options for radiotherapy-induced dermatitis and dermatologic adverse effects from targeted therapies are largely supportive, with few mechanism-driven therapies available [4]. - Hoth's approach with HT-001 aims to target neurogenic and inflammatory pathways involved in therapy-induced skin injury, potentially representing a first-in-class strategy in oncology supportive care [5]. Strategic Vision - The company views these patent filings as a significant expansion into an important area of oncology care, emphasizing the need to manage treatment-related toxicities as cancer therapies advance [6]. - Hoth aims to develop a scalable oncology-adjacent platform with applications across radiation oncology, targeted cancer therapies, dermatology, and inflammatory skin disorders [6]. Development Focus - Hoth Therapeutics is committed to building a diversified, IP-centric development portfolio that targets large, underserved markets, focusing on therapies that enhance patient outcomes and quality of life [7].

1&h=537704384&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2889507- 1%26h%3D1377821239%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D2823479- 1%2526h%253D536261162%2526u%253Dhttp%25253A%25252F%25252Fwww.hoththerapeutics.com%25252F%2526a%253Dwww.hoththerapeutics.com%26a%3Dww (678) 570-6791SOURCE Hoth Therapeutics, Inc. NEW Y ...

Company Overview - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments aimed at improving patient quality of life [2] - The company engages in early-stage pharmaceutical research and development, advancing drugs from bench to pre-clinical and clinical testing [2] Recent Developments - Robb Knie, the CEO of Hoth Therapeutics, is scheduled to present at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference in Boca Raton, FL [1] - Hoth Therapeutics has been accepted into the NVIDIA Connect Program, which will enhance its AI and accelerated computing capabilities [6] Research Focus - The company is dedicated to developing breakthrough therapies for various conditions, including metabolic, dermatologic, and other diseases [7] - Hoth Therapeutics has launched a VA-backed study of a novel GDNF weight loss therapy targeting obesity and fatty liver disease [7]

Core Insights - Hoth Therapeutics, Inc. has been accepted into the NVIDIA Connect Program, enhancing its capabilities in AI-powered research and development [1][2][4] Group 1: NVIDIA Connect Program Benefits - The acceptance into the NVIDIA Connect Program provides Hoth Therapeutics with access to accelerated computing resources, technical guidance, and marketing support [2][4] - This partnership is expected to streamline Hoth's R&D strategy, reducing computational bottlenecks and enhancing predictive modeling [3][4] Group 2: Strategic Implications - The collaboration with NVIDIA is anticipated to improve the speed and efficiency of Hoth's drug-development programs, particularly in preclinical and clinical decision-making [4][7] - Hoth will utilize NVIDIA's GPU-accelerated developer tools to enhance computational biology workflows, including target identification and protein-structure modeling [7] Group 3: Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments aimed at improving patient quality of life [5] - The company employs a patient-centric approach, collaborating with scientists and clinicians to explore therapeutics with significant potential [5]

Financial Performance - The net loss for Q3 2025 was approximately $4.11 million, or $0.30 per common share, compared to a net loss of $2.2 million, or $0.32 per common share, in Q3 2024[147]. - The company incurred a net loss of approximately $9.8 million for the nine months ended September 30, 2025, compared to a net loss of $6.1 million for the same period in 2024[156]. Expenses - Research and development expenses for Q3 2025 were approximately $1.6 million, up from $0.9 million in Q3 2024, representing an increase of about 77.8%[141][142]. - General and administrative expenses for Q3 2025 amounted to approximately $2.5 million, a significant increase of 98.2% compared to $1.2 million in Q3 2024[143]. - For the nine months ended September 30, 2025, research and development expenses totaled approximately $4.6 million, compared to $2.21 million for the same period in 2024, reflecting a 108.6% increase[148][149]. - General and administrative expenses for the nine months ended September 30, 2025, were approximately $5.1 million, up from $3.9 million in 2024, marking an increase of about 31.2%[153]. Cash Flow - As of September 30, 2025, the company had approximately $7.8 million in cash and cash equivalents and an accumulated deficit of approximately $70.2 million[157]. - For the nine months ended September 30, 2025, net cash used in operating activities was approximately $7.65 million, primarily due to a net loss of approximately $9.78 million[165]. - For the nine months ended September 30, 2024, net cash used in operations was approximately $5.0 million, resulting from a net loss of approximately $6.1 million[166]. - For the nine months ended September 30, 2025, net cash provided by financing activities was approximately $8.76 million, primarily from net proceeds of approximately $3.5 million from the issuance of common stock and approximately $5.6 million from the exercise of warrants[168]. - For the nine months ended September 30, 2024, net cash provided by financing activities was approximately $3.7 million, resulting from net proceeds from the exercise of warrants[169]. Future Outlook - The company anticipates an increase in research and development activities and general and administrative expenses in future periods due to ongoing projects and potential new acquisitions[150][154]. - Additional funding will be necessary to support future clinical and pre-clinical activities, with no assurances of obtaining adequate financing due to the economic downturn[164]. Agreements and Obligations - A Cooperative Research and Development Agreement was initiated with the VA to assess technology for obesity and fatty liver disease, with results expected in early 2026[140]. - The Company may be required to make minimum royalty payments ranging from middle to high five figures, sales-based royalties ranging from low single digits to low double digits, and milestone payments of up to approximately $35 million if all milestones in current agreements are achieved[163]. Stock and Dividends - The Company accounts for stock-based compensation based on the estimated grant date fair value, with stock options generally issued fully vested[172]. - The Company has never declared or paid any cash dividends on its common shares and does not plan to do so in the foreseeable future[175]. Accounting Standards - The Company does not expect the adoption of the new accounting standards to have a material impact on its consolidated financial statements[182].

Core Insights - Penny stocks can be risky but may also present significant upside potential for investors with a high risk appetite and a long-term investment horizon [1] Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company valued at $18.4 million, focusing on innovative medicines for unmet medical needs in oncology, dermatology, neurology, and inflammatory diseases [3] - The stock has surged 87.1% year-to-date, outperforming the broader market, with analysts predicting further upside [3] Product Pipeline - Hoth has a diversified pipeline strategy with multiple studies across various therapeutic areas [4] - The lead clinical program, HT-001, is a topical formulation aimed at addressing skin toxicity from EGFR inhibitors during cancer therapy, with plans to expand its Phase 2 trial to Europe pending EMA approval [4] - Another key asset, HT-KIT, targets mast cell-related cancers and has shown promising preclinical results, receiving Orphan Drug Designation from the U.S. FDA [5] Strategic Initiatives - Hoth is expanding into metabolic health through a collaboration with the U.S. Department of Veterans Affairs on a VA obesity program [6] - The company is integrating advanced AI tools, specifically Lantern Pharma's PredictBBB.ai platform, to enhance its research and development processes [6]