UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) 1177 Avenue of the Americas, 5 Floor, Suite 5066, New York, NY 10036 (Address of principal executive offices) (Zip Code) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: June 30, 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 Hoth ...

Core Viewpoint - Hoth Therapeutics, Inc. is expanding its Phase II clinical trial for HT-001, targeting cancer patients with skin toxicities related to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in the European Union [1][2][3] Group 1: Clinical Trial Expansion - The company is engaging with ICON Clinical Research Limited to broaden its Phase II clinical trial in EU countries [1][2] - Additional regulatory approval for the trial is anticipated from potentially three EU countries in the coming months [2] - The trial is currently enrolling patients at multiple sites in the United States, focusing on the efficacy, safety, and tolerability of topical HT-001 [2] Group 2: Strategic Goals - The CEO of Hoth Therapeutics expressed satisfaction with the partnership with ICON, highlighting their experience in clinical trial management and interest in novel therapies [3] - Expanding clinical sites in the EU aims to complete enrollment for the Phase II trial and lays the groundwork for a future global Phase III trial [3] Group 3: Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments to enhance patient quality of life [4] - The company collaborates with scientists, clinicians, and key opinion leaders to explore therapeutics with significant potential [4]

Core Viewpoint - Hoth Therapeutics, Inc. has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and the Foundation for Atlanta Veterans Education and Research to evaluate GDNF as a novel metabolic therapy for obesity and hepatic steatosis [1][4]. Study Overview - The study will compare daily GDNF injections against semaglutide in diet-induced obese mice and human liver chimeric mouse models, which are recognized as a gold-standard translational platform [2]. - The study is titled "Efficacy of Parenteral GDNF Administration in the Induction of Weight Loss and Resolution of Hepatic Steatosis" and has received IRB approval, adhering to VA and federal research ethics standards [3]. Deal Structure & Value - Hoth Therapeutics will fund the study and supply GDNF, while the VA will retain data rights and share de-identified results in compliance with HIPAA [6]. - The agreement represents the first pharmacologic test of GDNF in human liver-engrafted mice, potentially paving the way for first-in-class metabolic applications beyond central nervous system indications [4][6]. Scientific Rationale - GDNF has shown the ability to reduce body weight and hepatic lipid accumulation in previous transgenic models, enhance insulin sensitivity, and promote fatty acid oxidation [6]. - Clinical safety of GDNF has been demonstrated in prior human trials related to Parkinson's disease [6]. Company Background - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments aimed at improving patient quality of life [5].

Core Viewpoint - Hoth Therapeutics, Inc. has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and the Foundation for Atlanta Veterans Education and Research to evaluate GDNF as a novel metabolic therapy for obesity and hepatic steatosis [1][4]. Study Overview - The study will compare daily GDNF injections against semaglutide in diet-induced obese mice and human liver chimeric mouse models, which are considered a gold-standard translational platform [2]. - The study is titled "Efficacy of Parenteral GDNF Administration in the Induction of Weight Loss and Resolution of Hepatic Steatosis" and has received IRB approval, adhering to VA and federal research ethics standards [3]. Deal Structure & Value - Hoth Therapeutics will fund the study and supply GDNF, while the VA will retain data rights and share de-identified results in compliance with HIPAA [6]. - The agreement represents the first pharmacologic test of GDNF in human liver-engrafted mice, potentially paving the way for first-in-class metabolic applications beyond central nervous system indications [4][6]. Scientific Rationale - GDNF has shown the ability to reduce body weight and hepatic lipid accumulation in previous transgenic models, enhance insulin sensitivity, and promote fatty acid oxidation [6]. - Clinical safety of GDNF has been demonstrated in prior human trials related to Parkinson's disease [6]. Company Background - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments aimed at improving patient quality of life [5][7].

Core Insights - Hoth Therapeutics' investigational candidate HT-001 achieved a 100% response rate in at least one primary efficacy endpoint in its ongoing Phase 2a clinical study for EGFR inhibitor-induced skin toxicities [2][7] - The company will host a Key Opinion Leader event to discuss the interim results and potential impact of HT-001 on supportive care standards for oncology patients [1] Clinical Trial Highlights - The Phase 2a trial (CLEER-001) demonstrated that 100% of enrolled patients achieved at least one primary endpoint of clinical dermatologic improvement [7][8] - Over 65% of patients reported reductions in pain and pruritus, with 0% requiring dose reduction or discontinuation of their EGFR inhibitor therapy [7][8] - HT-001 is a once-daily topical gel that targets neuroinflammatory pathways without causing immunosuppression or systemic toxicity [4] Mechanism of Action - HT-001 is formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA) that mitigates inflammatory pathways triggered by EGFR inhibition, particularly those driven by Substance P [4][5] - Preclinical data showed significant reductions in dermatitis and alopecia severity, as well as inflammatory markers in rat models co-treated with erlotinib [5][9] Regulatory and Development Pathway - HT-001 is being advanced under the 505(b)(2) regulatory pathway, which allows the use of existing safety data to expedite development [10] - The company is currently planning a Phase 2b/3 trial following the ongoing Phase 2a trial [13]

Core Points - Hoth Therapeutics, Inc. has regained full compliance with Nasdaq's minimum bid price requirement, closing at or above $1.00 for 10 consecutive trading sessions from June 4 to June 17, 2025 [1][2] - The CEO of Hoth Therapeutics, Robb Knie, stated that regaining compliance is a significant milestone that reflects growing market confidence in the company's strategy and pipeline [3] - The company is strategically focused on delivering key milestones across multiple therapeutic areas, including inflammatory diseases, oncology, and rare diseases [3] Company Overview - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative therapies for patients with unmet medical needs, targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions [4]

Core Viewpoint - Hoth Therapeutics has reported positive preclinical safety data for its investigational oncology candidate HT-KIT, demonstrating dose-dependent liver activity with no observed toxicity, which is a significant milestone as the company prepares for an Investigational New Drug (IND) filing [1][2][4]. Preclinical Findings - The study showed a clear dose-responsive effect on liver mass, with liver weight increasing from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, indicating pharmacological engagement [7][8]. - No adverse effects were observed on the kidney, spleen, or thymus, confirming a 100% clean safety profile with no visible lesions or gross pathology in any treated animal [7][8]. - The favorable safety profile of HT-KIT supports the company's plans to advance to Good Laboratory Practice (GLP) studies and submit an IND application soon [4][3]. Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for rare and inflammatory diseases, aiming to improve patient quality of life through early-stage pharmaceutical research and development [5].

Core Insights - Hoth Therapeutics has secured Japan Country Patent No. 7677628 for its HT-KIT platform, providing exclusive protection until August 27, 2039 [1][6] - The patent covers a novel method using splice-switching oligonucleotides (SSOs) to target KIT gene expression in mast cells, which are involved in various conditions including chronic hives and rare cancers [2][6] - The CEO of Hoth Therapeutics emphasized the strategic importance of this patent in the Asian pharmaceutical market and the potential for licensing opportunities [3] Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies aimed at improving patient quality of life [4] - The company is actively seeking global partners for co-development and commercialization of its therapeutic platforms, particularly in Asia [3] Patent Details - The granted patent is specifically applicable to mast cell-driven inflammatory and oncologic conditions, positioning the company for orphan indications and expedited regulatory pathways [6]

Core Viewpoint - Hoth Therapeutics is advancing its lead asset HT-001 by engaging Premier Research to support the submission of an Expanded Access Program (EAP) application, aiming to provide compassionate access to cancer patients suffering from skin toxicities caused by EGFR inhibitor therapies, addressing a significant unmet medical need [1][2][3]. Company Developments - Hoth Therapeutics has reported promising clinical benefits from HT-001 in early evaluations and is preparing to make the drug available to qualified patients outside of clinical trials through the Expanded Access initiative, which allows access to experimental treatments when no approved alternatives exist [3][4]. - The CEO of Hoth Therapeutics, Robb Knie, emphasized that the Expanded Access initiative reflects the company's commitment to patient care and enhances HT-001's clinical visibility and commercial potential [2][4]. Market Potential - There is a high unmet need in the market, with over 100,000 cancer patients annually receiving EGFR inhibitors, most of whom experience skin toxicities that currently lack targeted treatments [9]. - HT-001 targets a rapidly growing segment in oncology supportive care, positioning the company to capture attention from both the medical community and investors [4][9]. Regulatory and Strategic Positioning - The engagement in the Expanded Access program creates a faster route to commercialization for HT-001 and increases the generation of real-world data, which is crucial for future market acceptance [9]. - Hoth Therapeutics aims to establish itself as a leader in cancer supportive care with a clearly defined regulatory pathway and a fast-growing addressable market [4].

PART I – FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=ITEM%201.%20Financial%20Statements) Q1 2025 saw no revenue, a **$3.5 million** net loss (up from **$2.1 million**), but cash rose to **$11.3 million** from **$7.0 million** due to **$7.1 million** in financing [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$12.4 million** as of March 31, 2025, primarily due to a significant rise in cash from financing, with equity growing to **$11.5 million** Condensed Consolidated Balance Sheets (Unaudited) | | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,317,365 | $7,038,923 | | Total Current Assets | $12,293,890 | $7,644,871 | | Total Assets | $12,355,218 | $7,712,765 | | **Liabilities & Equity** | | | | Total Liabilities | $815,299 | $833,906 | | Total Stockholders' Equity | $11,539,919 | $6,878,859 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 saw no revenue and a **$3.5 million** net loss, up from **$2.1 million** in Q1 2024, mainly due to R&D expenses rising to **$2.0 million** Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net Revenues | $0 | $0 | | Research and development expense | $1,958,602 | $571,642 | | General and administrative expenses | $1,517,415 | $1,588,262 | | Loss from Operations | ($3,476,017) | ($2,159,904) | | Net Loss | ($3,475,836) | ($2,146,529) | | Net Loss Per Common Share (Basic and diluted) | ($0.27) | ($0.49) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity increased from **$6.9 million** to **$11.5 million** in Q1 2025, driven by **$5.6 million** from warrant exercises and **$1.4 million** from stock sales, offset by a **$3.5 million** net loss - Key activities impacting stockholders' equity in Q1 2025 included: - Common shares issued for exercise of warrants: **$5,625,000** - Common stock issued for cash, net: **$1,441,964** - Common stock issued for patent: **$850,500** - Net loss: (**$3,475,836**) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 net cash used in operations was **$2.8 million**, offset by **$7.1 million** from financing (warrant exercises, stock issuance), resulting in a **$4.3 million** net cash increase Condensed Consolidated Statements of Cash Flows (Unaudited) | | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($2,788,025) | ($1,723,956) | | Net Cash Provided by Financing Activities | $7,066,964 | $0 | | Net Increase (Decrease) in Cash | $4,278,939 | ($1,723,956) | | Cash and Cash Equivalents - End of Period | $11,317,365 | $7,562,628 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the biopharmaceutical business, confirm **$11.3 million** cash for 12 months, and highlight **$1.25 million** R&D for a patent, **$5.6 million** from warrants, and **$1.4 million** from an ATM offering - The company is a clinical-stage biopharmaceutical company focused on developing therapies for unmet medical needs, including treatments for cancer side effects (HT-001), mast-cell derived cancers (HT-KIT), and Alzheimer's disease (HT-ALZ)[24](index=24&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$63.9 million** and cash of **$11.3 million**; management believes current cash is sufficient for at least the next 12 months but will need additional capital for longer-term plans[26](index=26&type=chunk)[27](index=27&type=chunk) - On January 13, 2025, the company acquired patent applications for **$400,000** in cash and 450,000 shares of common stock valued at **$850,500**, resulting in a total R&D expense of **$1,250,500** for the acquisition[68](index=68&type=chunk)[70](index=70&type=chunk) - In Q1 2025, the company raised **$5,625,000** from the exercise of 3,750,000 warrants and an additional **$1,441,964** in net proceeds from the sale of 927,968 shares through its At-The-Market (ATM) offering agreement[90](index=90&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Q1 2025 net loss increased to **$3.5 million** due to **$2.0 million** in R&D expenses, while G&A decreased, and cash improved to **$11.3 million** from **$7.1 million** in financing, sufficient for 12 months - Research and development expenses increased to approximately **$2.0 million** in Q1 2025 from **$0.6 million** in Q1 2024, primarily due to a **$1.3 million** expense for patent application acquisition and **$0.5 million** for HT-001 program activities[117](index=117&type=chunk)[118](index=118&type=chunk) - General and administrative expenses decreased by approximately **$71,000** (4.5%) to **$1.5 million** in Q1 2025, mainly due to a **$293,000** decrease in stock-based compensation, partially offset by other increases[119](index=119&type=chunk)[121](index=121&type=chunk) - The company's cash position increased to **$11.3 million** as of March 31, 2025, which management believes is sufficient to fund operations for at least the next 12 months[125](index=125&type=chunk) - Net cash provided by financing activities in Q1 2025 was approximately **$7.1 million**, consisting of **$5.6 million** from warrant exercises and **$1.4 million** in net proceeds from an ATM agreement[135](index=135&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Hoth Therapeutics is exempt from providing market risk disclosures - As a "smaller reporting company," Hoth Therapeutics is exempt from the requirement to provide disclosures about market risk[150](index=150&type=chunk) [Controls and Procedures](index=37&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective as of March 31, 2025, due to a material weakness in internal control over financial reporting related to expense classification, with remediation underway - Management concluded that disclosure controls and procedures were not effective as of March 31, 2025[152](index=152&type=chunk) - The ineffectiveness is due to a material weakness identified in the audit of the 2024 financial statements, related to the classification of prepaid expenses and R&D expenses[153](index=153&type=chunk) - A remediation plan is underway, which includes enhancing review procedures for significant contracts and strengthening the overall review process[154](index=154&type=chunk)[156](index=156&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports no material legal proceedings and is unaware of any pending or threatened actions - The company reports no material legal proceedings[158](index=158&type=chunk) [Risk Factors](index=38&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes in risk factors have occurred since the filing of the Annual Report on Form 10-K for fiscal year 2024 - No material changes in risk factors have occurred since the filing of the Annual Report on Form 10-K for the fiscal year 2024[159](index=159&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued 450,000 unregistered shares of common stock on January 13, 2025, for a patent acquisition, relying on Section 4(a)(2) exemption - The company issued 450,000 unregistered shares of common stock on January 13, 2025, to acquire patent applications[160](index=160&type=chunk) [Defaults Upon Senior Securities](index=38&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[161](index=161&type=chunk) [Other Information](index=38&type=section&id=ITEM%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading plans, and Chris Camarra was appointed to the Board on May 8, 2025 - No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the quarter ended March 31, 2025[162](index=162&type=chunk) - On May 8, 2025, Chris Camarra was appointed to the Board of Directors and its key committees[162](index=162&type=chunk) [Exhibits](index=39&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including an agreement with OnTargetx R&D Inc., certifications, and Inline XBRL data