Core Insights - Hoth Therapeutics, Inc. is participating in the BIO International Convention, a significant event in the biotechnology sector, taking place from June 16-19, 2025, in Boston, MA [1][2] Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies aimed at improving patient quality of life [3] - The company engages in early-stage pharmaceutical research and development, advancing drugs from bench to pre-clinical and clinical testing [3] - Hoth Therapeutics employs a patient-centric approach, collaborating with scientists, clinicians, and key opinion leaders to explore therapeutics with high potential for breakthroughs and diversified treatment options [3]

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

Core Insights - Hoth Therapeutics has announced promising preclinical data for HT-KIT, an antisense oligonucleotide therapeutic targeting aberrant KIT gene expression linked to rare, treatment-resistant cancers [1][2] - HT-KIT is designed to selectively bind to mutant KIT mRNA transcripts, blocking their translation and preventing the production of the KIT protein, which drives tumor growth in various cancers [2][3] - The company plans to file an Investigational New Drug (IND) application with the FDA in early 2026, with Phase 1 human trials to follow shortly thereafter [4] Preclinical Data - HT-KIT has demonstrated over 80% reduction in KIT expression in vitro using cancer cell lines with activating KIT mutations [6][7] - Significant inhibition of tumor growth has been observed in preclinical models of gastrointestinal stromal tumors (GIST) and systemic mastocytosis following systemic administration of HT-KIT [6][7] - No observable off-target toxicity in liver, kidney, or bone marrow suggests a favorable safety profile for HT-KIT [6][7] Treatment Advantages - Current treatment options for KIT-driven cancers often rely on tyrosine kinase inhibitors (TKIs), which can lead to drug resistance and systemic side effects [3] - HT-KIT offers a targeted alternative by addressing the disease at the mRNA level, potentially avoiding resistance mechanisms associated with small-molecule therapies [3][5] - The company believes HT-KIT represents a first-in-class approach to treating KIT-mutated cancers at the genetic level, providing hope for patients who have exhausted traditional therapies [2][5] Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments to improve patient quality of life [6] - The company utilizes a patient-centric approach and collaborates with scientists and key opinion leaders to explore therapeutics with significant potential [8]

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].