Core Viewpoint - Hoth Therapeutics' shares surged 178.2% following the announcement of positive interim safety and efficacy results from a mid-stage study of HT-001, aimed at treating skin toxicities in cancer patients undergoing EGFR inhibitor therapy [1] Group 1: Study Results - All patients in the phase IIa study achieved the primary efficacy endpoint of an ARIGA score ≤1, indicating significant improvement in skin toxicity by the six-week mark [2] - 66% of patients reported reduced pain and itching scores, enhancing their quality of life, while all patients maintained their full EGFR inhibitor dosage, avoiding treatment interruptions [3] - The interim results suggest HT-001 has the potential to become the new standard of care for severe skin toxicities associated with EGFR inhibitors, with no treatment-related adverse events reported [5] Group 2: Future Development Plans - Hoth plans to report more data as the phase IIa study progresses, further validating HT-001's therapeutic benefits for skin toxicities [8] - The company continues to enroll patients in the mid-stage study and has previously reported rapid resolution of EGFR inhibitor-induced skin conditions using HT-001 [6] Group 3: Development Pipeline - Beyond HT-001, Hoth's clinical pipeline includes BioLexa, an investigational candidate for atopic dermatitis, along with several pre-clinical candidates targeting various oncology, neurology, dermatology, and inflammatory indications [9]

On Tuesday, Hoth Therapeutics, Inc. HOTH shared interim safety and efficacy results from its Phase 2a clinical trial of HT-001, designed to address skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors in cancer patients.Data from the open-label portion of the CLEER-001 trial demonstrated:100% of patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.66% of patients reported reduced pain and itching scores, fur ...

Hoth Therapeutics Enters Exclusive Patent License Agreement with VA and Emory University Hoth Also Expands Its' Intellectual Property to Further Its' Market Opportunity for HT-001 NEW YORK, Dec. 26, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative therapies, today announced that it has entered into an exclusive patent license agreement with the U.S. Department of Veterans Affairs (VA). This agreement provides Hoth with exclusive rights ...

NEW YORK, Nov. 20, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient focused biopharmaceutical company, today announced that the Company's Board of Directors approved the purchase of up to $1 million in Bitcoin."As Bitcoin continues to grow, gaining investor attention and acceptance as a major and primary asset class, we believe that Bitcoin will serve as a strong treasury reserve asset," said Robb Knie, CEO of Hoth. "With recent approval of Bitcoin ETFs and increasing activity from ins ...

Research and Development Expenses - Research and development expenses decreased by $77,000 (7.9%) for the three months ended September 30, 2024 compared to the same period in 2023[134] - Research and development expenses for the three months ended September 30, 2024 were $0.9 million, with $0.6 million allocated to HT-001, $154,300 to HT-KIT, $18,700 to HT-004, and $96,500 to HT-ALZ[135] - Research and development expenses decreased by $635,700 (24.8%) for the nine months ended September 30, 2024 compared to the same period in 2023[141] - Research and development expenses for the nine months ended September 30, 2024 were $1.9 million, with $1.2 million allocated to HT-001, $112,800 to HT-ALZ, $363,300 to HT-KIT, and $96,100 to HT-004[142] General and Administrative Expenses - General and administrative expenses increased by $116,100 (10.4%) for the three months ended September 30, 2024 compared to the same period in 2023[138] - General and administrative expenses increased by $473,500 (13.8%) for the nine months ended September 30, 2024 compared to the same period in 2023[144] Net Loss - Net loss for the three months ended September 30, 2024 was $2.1 million, a decrease of $45,500 compared to the same period in 2023[141] - Net loss for the nine months ended September 30, 2024 was $5.8 million, a decrease of $0.3 million compared to the same period in 2023[150] Cash and Capital Resources - As of September 30, 2024, the company had $8.0 million in cash and cash equivalents and working capital of $7.4 million[151] - The company issued 2,500,000 shares of common stock for net proceeds of $3.8 million during the nine months ended September 30, 2024[152] - Issued new unregistered warrants to purchase up to 3,750,000 shares of common stock at $1.50 per share, expiring on July 3, 2028[154] - Potential milestone payments of up to approximately $10.5 million if all milestones in current agreements are achieved[155] - Net cash used in operations for the nine months ended September 30, 2024, was approximately $5.0 million, primarily due to a net loss of $5.8 million[157] - Net cash provided by financing activities for the nine months ended September 30, 2024, was approximately $3.7 million, resulting from net proceeds from the exercise of warrants[159] - Net cash provided by financing activities for the nine months ended September 30, 2023, was approximately $11.3 million, from the issuance of common stock and warrants[160] Stock-Based Compensation and Valuation - The company estimates the fair value of stock option grants using the Black-Scholes option pricing model, involving inherent uncertainties and management's judgment[164] - Restricted stock awards vest over a service period of zero to three years, with stock-based compensation expense recognized on a straight-line basis[167] - Warrants issued to non-employees vest over a term of zero to ten years, with stock-based compensation expense recognized on a straight-line basis[168] Accounting Standards and Disclosures - The company is evaluating the impact of ASU 2023-09 on income tax disclosures, effective for annual periods beginning after December 15, 2024[171] - The company has a single reportable segment and is evaluating the impact of ASU 2023-07 on segment reporting disclosures, effective for fiscal years beginning after December 15, 2023[175]

NEW YORK, Oct. 29, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company dedicated to developing new generation therapies for unmet medical needs, is excited to announce highly promising early data from a preclinical study of its latest cancer treatment. The preliminary results demonstrate that the treatment successfully stabilizes tumor growth with remarkable consistency across subjects, showing potential as an effective therapeutic option in oncology. This ...

NEW YORK, Oct. 15, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative treatments, is proud to announce the granting of a U.S. patent for its pioneering Alzheimer's treatment, HT-ALZ. This milestone patent secures the company's intellectual property rights to its novel therapeutic approach, as Hoth accelerates preparations for clinical trials. HT-ALZ represents a breakthrough in Alzheimer's treatment, specifically targeting ...

Early observations suggest that the vehicle-treated Alzheimer's mice exhibit a larger population of reactive astrocytes, while the HT-ALZ treated groups show fewer reactive astrocytes, pointing to a potential breakthrough in the treatment of Alzheimer's. NEW YORK, Sept. 17, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative treatments for unmet medical needs, today announced encouraging preclinical results for its investigational Alzheim ...

Shares of Hoth Therapeutics (HOTH) surged 81.4% on Sept. 5, after the company announced positive data from the treatment of the first patient with its lead candidate, HT-001, who was experiencing papulopustular eruptions (PPEs). Notably, PPEs are a common and debilitating side effect of EGFR inhibitor (EGFRI) therapy in cancer patients. Hoth's HT-001 Demonstrates Superior Efficacy in PPEs Treatment In this groundbreaking case, the 59-year-old female patient undergoing treatment for metastatic breast cancer ...

Dana-Farber Cancer Institute in Boston, MA and Montefiore Medical Center in New York, NY Join Clinical Trial NEW YORK, Sept. 5, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced today that it has received Institutional Review Board approval from the Montefiore Medical Center and the Dana-Farber Cancer Institute to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with ...