Under the new entitlement agreement, Hoth Therapeutics secures annual NVIDIA AI Enterprise Essentials licenses to support its GPU-powered infrastructure, enabling advanced machine learning and neural network modeling capabilities for pharmaceutical research The NVIDIA AI Enterprise environment will allow Hoth's scientific and data teams to: current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Ac ...

Presentation to highlight advancements in Hoth's clinical pipeline, including HT-001 for cancer-therapy-induced rash and HT-KIT, a novel oncology program targeting KIT-driven tumors , /PRNewswire/ --Â Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing first-in-class therapeutics for dermatological, oncology, and Alzheimer's, today announced that Chief Executive Officer Robb Knie will be presenting at the upcoming BIO-Europe 2025 Conference, taking place ...

Accessibility StatementSkip Navigation MENIN inhibitors are a promising class of targeted oncology drugs in development for acute leukemias and certain solid tumors, but their use is often limited by severe dermatological side effects. HT-001 aims to address these toxicities, helping patients remain on therapy and realize the full benefit of treatment. Key Highlights NEW YORK, Sept. 24, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing next-g ...

Artificial intelligence is the greatest investment opportunity of our lifetime. The time to invest in groundbreaking AI is now, and this stock is a steal! AI is eating the world—and the machines behind it are ravenous. Each ChatGPT query, each model update, each robotic breakthrough consumes massive amounts of energy. In fact, AI is already pushing global power grids to the brink. Wall Street is pouring hundreds of billions into artificial intelligence—training smarter chatbots, automating industries, and b ...

In this article, we will be taking a look at the 15 Best Biotech Penny Stocks to Invest in Right Now.Jared Holz, the healthcare strategist for Mizuho, spoke on CNBC’s “Closing Bell Overtime” in July on whether the biotech industry is ready for a breakthrough. Given that there are hundreds of publicly traded stocks that don’t amount to anything overall, he said that the biotech industry has been a “super tough sector” in any case. He went on to say that it is difficult to make an industrial decision because ...

Core Insights - Hoth Therapeutics, Inc. is experiencing significant momentum across its clinical programs and corporate strategy, marking the strongest position in its history [1][3] Group 1: Clinical Developments - HT-001 is advancing globally with a Clinical Trial Application submitted to the European Medicines Agency (EMA) for a Phase II trial, with European patient enrollment expected to begin in early 2026 [6] - HT-KIT has successfully completed the Good Laboratory Practice (GLP) bioanalytical phase, exceeding regulatory thresholds, and is moving towards toxicology studies and regulatory submission [6] - The VA obesity program is focused on innovative approaches to address obesity in the veteran population, highlighting the company's commitment to tackling significant health challenges [6] Group 2: Financial Strategy - The Board of Directors has approved the expansion of Hoth's treasury reserve strategy to include Bitcoin, Ethereum, and Solana, allowing for potential purchases of up to $1 million in these digital assets [6] - This strategy reflects management's confidence in digital assets as a long-term store of value and a diversification strategy for the balance sheet [6] Group 3: Technological Integration - The adoption of Lantern Pharma's PredictBBB.ai platform, which achieves approximately 94% predictive accuracy for blood-brain barrier permeability, is facilitating faster, data-driven decision-making across Hoth's programs [6]

Core Insights - Hoth Therapeutics has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a topical treatment for skin toxicities related to Epidermal Growth Factor Receptor inhibitors (EGFRi) [1][2] - This submission is a significant regulatory milestone for the company, aiming to tap into a large oncology support market that currently lacks approved treatments [2][3] - The company plans to begin patient recruitment in Europe in early 2026, complementing ongoing enrollment in the U.S. [2][6] Company Strategy - Hoth Therapeutics is focused on advancing innovative therapies to enhance patient quality of life, with a patient-centric and global development strategy [4] - The CEO emphasized the urgent need for treatments addressing skin toxicities from EGFRi therapies, highlighting the opportunity for HT-001 to improve patient outcomes and create shareholder value [3] Future Developments - The EMA's decision on the CTA is anticipated in the coming months, with plans for broader EU expansion and additional sites to accelerate patient enrollment [6] - The U.S. Phase 2a trial is progressing, evaluating the efficacy, safety, and tolerability of HT-001 [6]

Core Insights - Hoth Therapeutics is adopting Lantern Pharma's PredictBBB.ai platform, which boasts a 94% accuracy in predicting blood-brain barrier permeability, positioning the company at the forefront of AI-driven drug development [1][2][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 emphasizes a patient-centric approach and collaborates with scientists, clinicians, and key opinion leaders to explore therapeutics with significant potential [5] Strategic Impact - The integration of PredictBBB.ai allows Hoth to enhance precision in candidate selection, reduce development risks, and potentially create faster regulatory pathways for its drug pipeline [4] - The ability to cross the blood-brain barrier is identified as a critical success factor for drug candidates, and the AI tool is expected to streamline this process [4] Leadership Statements - Hoth's CEO, Robb Knie, highlighted the commitment to utilizing disruptive technologies like AI to drive efficiency and unlock new opportunities for patients and shareholders [5] - Lantern Pharma's CEO, Panna Sharma, expressed enthusiasm for the collaboration, noting the potential of PredictBBB.ai to accelerate CNS drug development [3]

[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's analysis for Q2 2025 and FY 2024 [ITEM 1. Financial Statements](index=6&type=page&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements of Hoth Therapeutics, Inc. for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's organization, accounting policies, license agreements, fair value measurements, stockholders' equity, commitments, and subsequent events [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20(Unaudited)%20and%20December%2031%2C%202024) This section details the company's financial position, including assets, liabilities, and equity, for June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (Unaudited) | ASSETS | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $9,014,108 | $7,038,923 | | Prepaid expenses and other current assets | $1,038,794 | $605,948 | | Total Current Assets | $10,052,902 | $7,644,871 | | Total Non-Current Assets | $54,900 | $67,894 | | **Total Assets** | **$10,107,802** | **$7,712,765** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Accounts payable | $75,510 | $412,071 | | Accrued expenses | $267,794 | $390,760 | | Operating lease liability, current portion | $21,326 | $28,366 | | Total Current Liabilities | $364,630 | $831,197 | | Total Long-Term Liabilities | $- | $2,709 | | **Total Liabilities** | **$364,630** | **$833,906** | | Total Stockholders' Equity | $9,743,172 | $6,878,859 | | **Total Liabilities and Stockholders' Equity** | **$10,107,802** | **$7,712,765** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section outlines the company's financial performance, including revenues, expenses, and net loss for Q2 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Net Revenues | $- | $- | $- | $- | | Research and development expenses | $1,039,713 | $644,025 | $2,998,315 | $1,215,667 | | General and administrative expenses | $1,159,936 | $1,079,504 | $2,677,351 | $2,667,766 | | Total operating expenses | $2,199,649 | $1,723,529 | $5,675,666 | $3,883,433 | | Loss from operations | $(2,199,649) | $(1,723,529) | $(5,675,666) | $(3,883,433) | | Total other income, net | $173 | $13,365 | $354 | $26,740 | | **Net Loss** | **$(2,199,476)** | **$(1,710,164)** | **$(5,675,312)** | **$(3,856,693)** | | Net Loss Per Common Share (Basic and diluted) | $(0.17) | $(0.25) | $(0.44) | $(0.68) | | Weighted Average Number of Common Shares Outstanding (Basic and diluted) | 13,180,243 | 6,876,331 | 12,959,901 | 5,637,621 | | Foreign currency translation adjustment | $3,478 | $1,634 | $2,981 | $(4,134) | | Total comprehensive loss | $(2,195,998) | $(1,708,530) | $(5,672,331) | $(3,860,827) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section details changes in equity, reflecting net loss, stock issuance, and warrant exercises for Q2 2025 and 2024 - Total Stockholders' Equity increased from **$6,878,859** as of December 31, 2024, to **$9,743,172** as of June 30, 2025, primarily driven by common shares issued for warrant exercise (**$5,625,000**), stock-based compensation (**$219,929**), common stock issued for cash (**$1,441,964**), and common stock issued for patent (**$850,500**), partially offset by a net loss of **$(5,675,312)**[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section reports cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow from Operating Activities | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :---------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(5,675,312) | $(3,856,693) | | Research and development-acquired patent, expensed | $850,500 | $- | | Stock-based compensation | $219,929 | $520,404 | | Stock-based professional fees | $55,525 | $- | | Change in fair value of investment in joint ventures | $- | $581 | | Lease costs | $3,245 | $- | | Prepaid expenses and other current assets | $(155,221) | $19,089 | | Accounts payable and accrued expenses | $(459,527) | $938 | | **NET CASH USED IN OPERATING ACTIVITIES** | **$(5,160,861)** | **$(3,315,681)** | | **CASH FLOWS FROM FINANCING ACTIVITIES:** | | | | Proceeds from issuance common stock, net of offering costs | $1,508,065 | $- | | Proceeds from exercise of warrants | $5,625,000 | $3,682,300 | | **NET CASH PROVIDED BY FINANCING ACTIVITIES** | **$7,133,065** | **$3,682,300** | | **NET INCREASE IN CASH AND CASH EQUIVALENTS** | **$1,972,204** | **$366,619** | | Effect of exchange rate changes on cash and cash equivalents | $2,981 | $(4,134) | | CASH AND CASH EQUIVALENTS - beginning of period | $7,038,923 | $9,292,352 | | **CASH AND CASH EQUIVALENTS - end of period** | **$9,014,108** | **$9,654,837** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context and detailed breakdowns for the unaudited condensed consolidated financial statements, covering the company's business operations, significant accounting policies, specific financial instruments, equity changes, and contractual obligations [NOTE 1 – Organization and Description of Business Operations](index=11&type=section&id=NOTE%201%20%E2%80%93%20Organization%20and%20Description%20of%20Business%20Operations) Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, with several product candidates in development. The company has incurred significant losses and negative cash flows, holding an accumulated deficit of $66.1 million and $9.0 million in cash as of June 30, 2025. It relies on equity sales for funding and anticipates needing additional capital for its long-term business plan, including an At The Market (ATM) offering agreement to sell up to $7.7 million in common stock - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing therapies for unmet medical needs, including HT-001 (cancer drug side effects), HT-KIT (mast-cell derived cancers), HT-ALZ (Alzheimer's), BioLexa (atopic dermatitis), HT-004 (asthma/allergies), and HT-VA (obesity)[22](index=22&type=chunk) Financial Position (June 30, 2025) | Metric | Amount ($ million) | | :------------------ | :------------- | | Accumulated Deficit | $(66.1) million | | Cash and Cash Equivalents | $9.0 million | - The company has an At The Market (ATM) Offering Agreement to sell up to **$7,700,000** of common stock, with approximately **$2.8 million** sold as of August 12, 2025. This is a key part of its capital raising strategy[26](index=26&type=chunk) [NOTE 2 – Summary of Significant Accounting Policies](index=12&type=section&id=NOTE%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's significant accounting policies, including the basis of presentation, use of estimates, cash and cash equivalents, fair value measurements (Level 1, 2, 3 hierarchy), lease accounting, investment in joint ventures, research and development costs (expensed as incurred), stock-based compensation valuation (Black-Scholes model), income taxes, net loss per share, warrant classification, foreign currency translation, and segment reporting (single operating segment). No material changes to previously disclosed accounting policies were reported - No material changes to the Company's significant accounting policies were reported compared to the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[30](index=30&type=chunk) Cash and Cash Equivalents | Date | Amount ($) | | :---------------- | :----------- | | June 30, 2025 | $9,014,108 | | December 31, 2024 | $7,038,923 | - The Company operates as a single operating segment, focusing on developing new generation therapies, with the CEO identified as the chief operating decision maker[56](index=56&type=chunk) [NOTE 3 – License Agreements and Acquired Patent Applications](index=18&type=section&id=NOTE%203%20%E2%80%93%20License%20Agreements%20and%20Acquired%20Patent%20Applications) The company incurred expenses for license fees from The George Washington University, North Carolina State University, and the University of Cincinnati. A significant event in 2025 was the acquisition of patent applications from Med30, LLC for $1,250,500 (cash and common stock), which was expensed immediately as in-process research and development (IPRD) due to no alternative future use Research and Development Expenses for Licenses and Patent Applications | Source | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | The George Washington University | $1,250 | $8,597 | $2,500 | $9,847 | | North Carolina State University | $938 | $1,563 | $1,875 | $3,125 | | University of Cincinnati | $2,708 | $417 | $3,333 | $417 | | Patent applications acquired | $— | $— | $1,250,500 | $— | | **Total** | **$4,896** | **$10,577** | **$1,258,208** | **$13,389** | - On January 13, 2025, the Company acquired certain patent applications from Med30, LLC for an aggregate purchase price of **$1,250,500**, consisting of **$400,000** cash and **450,000 shares** of common stock (fair value **$850,500**). This was expensed immediately as in-process research and development (IPRD) as it had no alternative future use[64](index=64&type=chunk) [NOTE 4 – Fair Value of Financial Assets and Liabilities](index=19&type=section&id=NOTE%204%20%E2%80%93%20Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) The company measures its investment in joint ventures at fair value using Level 3 inputs, which involve significant unobservable inputs. As of June 30, 2025, and December 31, 2024, the investment in joint ventures (Zylö Therapeutics and Atticus Pharma) was valued at $36,819, with no change in fair value during the six months ended June 30, 2025 Fair Value of Financial Assets (Investment in Joint Ventures) | Date | Total at Fair Value (Level 3) ($) | | :---------------- | :---------------------------- | | June 30, 2025 | $36,819 | | December 31, 2024 | $36,819 | - The investment in joint ventures, specifically Zylö Therapeutics and Atticus Pharma, is measured at fair value using Level 3 inputs, which include probabilities of scenarios, timing of occurrence, future valuation, and risk-adjusted discount rates[73](index=73&type=chunk)[69](index=69&type=chunk) - There was **no change** in the fair value of investment in joint ventures for the three and six months ended June 30, 2025, compared to a **$(581) change** for the six months ended June 30, 2024[66](index=66&type=chunk)[68](index=68&type=chunk) [NOTE 5 – Stockholders' Equity](index=21&type=section&id=NOTE%205%20%E2%80%93%20Stockholders'%20Equity) This note details the company's capital structure, including authorized preferred stock (Series A and B, none outstanding), common stock, and warrant activity. Significant events include the exercise of 3,750,000 April 2024 Inducement Warrants for $5,625,000 cash in January 2025, and the issuance of 300,000 warrants for investor relations services in June 2025. The company also issued 450,000 common shares for patent acquisition and 927,968 shares through an ATM agreement in Q1 2025. Equity incentive plans (2018 and 2022) saw increases in reserved shares and new stock option grants, leading to stock-based compensation expenses of $275,454 for the six months ended June 30, 2025 - As of June 30, 2025, the Company had **13,234,027 common shares** issued and outstanding, an increase from **8,042,747 shares** as of December 31, 2024[13](index=13&type=chunk) - On January 7, 2025, **3,750,000 common shares** were issued from the exercise of April 2024 Inducement Warrants, generating **$5,625,000** in cash proceeds[86](index=86&type=chunk)[90](index=90&type=chunk) - On June 4, 2025, the Company issued warrants to purchase **300,000 common shares** at an exercise price of **$1.00** for investor relations services, with a grant date fair value of **$333,150**[87](index=87&type=chunk) Stock-Based Compensation Expense | Period | 2025 (Six Months) ($) | 2024 (Six Months) ($) | | :-------------------------------- | :---------------- | :---------------- | | Employee stock option awards | $219,929 | $512,685 | | Non-employee restricted stock awards | $— | $1,330 | | Non-employee stock warrant awards | $55,525 | $6,389 | | **Total Stock-Based Compensation** | **$275,454** | **$520,404** | [NOTE 6 – Commitments and Contingencies](index=29&type=section&id=NOTE%206%20%E2%80%93%20Commitments%20and%20Contingencies) The company's commitments primarily involve an office lease. A new 14-month lease agreement was entered into in December 2024, expiring February 28, 2026, with a monthly base rent of $2,732 from March 2025. The ROU asset and lease liability were adjusted accordingly. Additionally, the exclusive license agreement with Isoprene Pharmaceutical, Inc. was terminated on March 23, 2025 - The Company entered into a new office lease agreement in December 2024, effective December 20, 2024, for a **14-month term** expiring February 28, 2026, with a monthly base rent of **$2,732** from March 1, 2025[108](index=108&type=chunk) Operating Lease ROU Asset and Liability | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------ | :---------------- | | Office lease ROU asset, net | $18,081 | $31,075 | | Current portion of operating lease liability | $21,326 | $28,366 | | Long-term portion of operating lease liability | $- | $2,709 | | **Total operating lease liability** | **$21,326** | **$31,075** | - The exclusive license agreement with Isoprene Pharmaceutical, Inc. was terminated on March 23, 2025[113](index=113&type=chunk) [NOTE 7 – Subsequent Events](index=30&type=section&id=NOTE%207%20%E2%80%93%20Subsequent%20Events) Subsequent to the reporting period, on May 9, 2025, the board of directors approved an increase of 2,000,000 shares reserved for issuance under the Amended and Restated 2022 Plan, which was subsequently approved by shareholders on August 5, 2025 - On May 9, 2025, the board approved an increase of **2,000,000 shares** for the Amended and Restated 2022 Omnibus Equity Incentive Plan, approved by shareholders on August 5, 2025[115](index=115&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=page&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance, liquidity, and capital resources for the three and six months ended June 30, 2025, compared to the prior year. It highlights significant increases in research and development expenses, particularly due to patent acquisition, and discusses the company's ongoing need for additional funding to support its clinical development programs [Overview](index=31&type=section&id=Overview) Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, with a pipeline of product candidates targeting various conditions including cancer treatment side effects, mast-cell derived cancers, Alzheimer's, atopic dermatitis, asthma/allergies, and obesity - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, with product candidates including HT-001, HT-KIT, HT-ALZ, BioLexa, HT-004, and HT-VA[117](index=117&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company experienced a significant increase in research and development expenses for both the three and six months ended June 30, 2025, primarily due to increased clinical activities and a substantial patent application acquisition. General and administrative expenses remained relatively stable, while net losses widened for both periods [Three Months Ended June 30, 2025 vs. 2024](index=31&type=section&id=Comparison%20of%20Our%20Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) For the three months ended June 30, 2025, research and development expenses increased by 61.4% to $1.04 million, driven by HT-001 and HT-KIT activities. General and administrative expenses rose by 7.5% to $1.16 million, mainly due to higher professional and consulting fees. The net loss increased by 28.6% to $2.20 million Operating Costs and Expenses (Three Months Ended June 30) | Expense Category | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :----------- | :--------- | | Research and development expenses | $1,039,713 | $644,025 | $395,688 | 61.4% | | General and administrative expenses | $1,159,936 | $1,079,504 | $80,432 | 7.5% | | **Total operating expenses** | **$2,199,649** | **$1,723,529** | **$476,120** | **27.6%** | | **Net Loss** | **$(2,199,476)** | **$(1,710,164)** | **$(489,312)** | **28.6%** | | Net Loss Per Common Share (Basic and diluted) | $(0.17) | $(0.25) | $0.08 | -32.0% | - Increase in General and Administrative Expenses (3 months): Primarily attributed to an increase in professional and consulting expenses of approximately **$178,000** (legal, accounting, stock-based professional fees, directors fees), offset by decreases in compensation and other general and administrative expenses[121](index=121&type=chunk) [Six Months Ended June 30, 2025 vs. 2024](index=33&type=section&id=Comparison%20of%20Our%20Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) For the six months ended June 30, 2025, research and development expenses surged by 146.6% to $3.00 million, largely due to a $1.3 million expense for acquired patent applications. General and administrative expenses remained stable at $2.68 million. The net loss increased by 47.1% to $5.68 million Operating Costs and Expenses (Six Months Ended June 30) | Expense Category | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :----------- | :--------- | | Research and development expenses | $2,998,315 | $1,215,667 | $1,782,648 | 146.6% | | General and administrative expenses | $2,677,351 | $2,667,766 | $9,585 | 0.4% | | **Total operating expenses** | **$5,675,666** | **$3,883,433** | **$1,792,233** | **46.1%** | | **Net Loss** | **$(5,675,312)** | **$(3,856,693)** | **$(1,818,619)** | **47.1%** | | Net Loss Per Common Share (Basic and diluted) | $(0.44) | $(0.68) | $0.24 | -35.3% | - Increase in Research and Development Expenses (6 months): Primarily due to approximately **$1.3 million** in-process research and development expenses from acquired patent applications, and increased manufacturing and clinical activities for HT-001 and HT-KIT[125](index=125&type=chunk) - General and Administrative Expenses (6 months): Increased by approximately **$9,000**, driven by a **$295,000 increase** in professional and consulting expenses, offset by a **$209,000 decrease** in compensation and related expenses[129](index=129&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Hoth Therapeutics, Inc. has historically funded its operations through equity and debt sales. As of June 30, 2025, the company had $9.0 million in cash and cash equivalents, $9.7 million in working capital, and an accumulated deficit of $66.1 million. Net cash used in operating activities was $5.2 million for the six months ended June 30, 2025, while net cash provided by financing activities was $7.1 million, primarily from common stock issuance and warrant exercises. The company believes its current cash is sufficient for at least 12 months but will require additional funding for future clinical and pre-clinical activities Financial Position (June 30, 2025) | Metric | Amount ($ million) | | :------------------------ | :------------- | | Cash and cash equivalents | $9.0 million | | Working capital | $9.7 million | | Accumulated deficit | $66.1 million | Cash Flows (Six Months Ended June 30) | Activity | 2025 ($ million) | 2024 ($ million) | | :-------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(5.2) million | $(3.3) million | | Net cash provided by financing activities | $7.1 million | $3.7 million | - The company believes its existing cash as of June 30, 2025, is sufficient to fund operations for at least **12 months**, but significant additional funding will be necessary for future clinical and pre-clinical activities[133](index=133&type=chunk)[138](index=138&type=chunk) [Critical Accounting Estimates](index=36&type=section&id=Critical%20Accounting%20Estimates) The company's critical accounting estimates involve significant judgment and assumptions, particularly in valuing stock-based compensation using the Black-Scholes option pricing model and in accounting for income taxes, including deferred tax assets and valuation allowances - Critical accounting estimates include stock-based compensation (fair value estimation using Black-Scholes model with assumptions for expected term, volatility, risk-free rate, and dividend) and income taxes (deferred tax assets and valuation allowances)[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) [Recently Adopted Accounting Standards](index=37&type=section&id=Recently%20Adopted%20Accounting%20Standards) The company adopted ASU 2023-07 (Segment Reporting) on January 1, 2024. It does not expect ASU 2024-03 (Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures), effective for fiscal years beginning after December 15, 2026, to have a material impact on its financial statements - The Company adopted ASU 2023-07, Segment Reporting, on January 1, 2024[56](index=56&type=chunk) - The Company does not expect ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to have a material impact on its unaudited condensed consolidated financial statements upon its effective date (fiscal years beginning after December 15, 2026)[57](index=57&type=chunk)[154](index=154&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=page&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Hoth Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk in this Quarterly Report on Form 10-Q - The Company is **not required** to provide quantitative and qualitative disclosures about market risk as it is a "smaller reporting company"[155](index=155&type=chunk) [ITEM 4. Controls and Procedures](index=38&type=page&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025, due to a material weakness identified in the proper classification of prepaid expenses and other current assets and research and development expenses. A remediation plan is being implemented to enhance review procedures over significant contracts and strengthen the overall review process - Disclosure controls and procedures were **not effective** as of June 30, 2025[156](index=156&type=chunk) - A material weakness was identified related to the proper classification of prepaid expenses and other current assets and research and development expenses[157](index=157&type=chunk) - Remediation plan includes enhancing review procedures over significant contracts with research and clinical studies organizations and strengthening the review process[158](index=158&type=chunk)[160](index=160&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This part provides additional information including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. Legal Proceedings](index=39&type=page&id=ITEM%201.%20Legal%20Proceedings) Hoth Therapeutics, Inc. is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could significantly impact its business, operating results, cash flows, or financial condition - The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal proceeding that could have a material adverse effect on its business, operating results, cash flows or financial condition[162](index=162&type=chunk) [ITEM 1A. Risk Factors](index=39&type=page&id=ITEM%201A.%20Risk%20Factors) The company refers to its Annual Report on Form 10-K for a comprehensive list of risk factors, supplementing it with new risks related to current and future legislative and regulatory reforms in the healthcare system. These reforms, including the Medicare Modernization Act, the Affordable Care Act, and the "One Big Beautiful Bill Act," could increase costs, affect product pricing, and limit market access for its product candidates, potentially harming its business and financial results - Risk factors from the Annual Report on Form 10-K for the year ended December 31, 2024, are incorporated by reference[163](index=163&type=chunk) - New risk factors include the impact of current and future legislative and regulatory reforms in the healthcare system (e.g., Medicare Modernization Act, Affordable Care Act, "One Big Beautiful Bill Act") which could increase costs, affect product pricing, and limit market access for product candidates[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=page&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On June 4, 2025, Hoth Therapeutics, Inc. issued warrants to purchase up to 300,000 shares of its common stock to a consultant for investor relations services. These warrants, with an exercise price of $1.00 per share and expiring on June 4, 2027, were issued under the exemption from registration provided by Section 4(a)(2) of the Securities Act - On June 4, 2025, the Company issued warrants to purchase up to **300,000 shares** of common stock at an exercise price of **$1.00 per share** to a consultant for investor relations services, expiring on June 4, 2027. These were issued under the Section 4(a)(2) exemption from registration[171](index=171&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=40&type=page&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the fiscal quarter ended June 30, 2025 - **No defaults** upon senior securities were reported[172](index=172&type=chunk) [ITEM 5. Other Information](index=40&type=page&id=ITEM%205.%20Other%20Information) During the fiscal quarter ended June 30, 2025, none of the company's directors or executive officers adopted or terminated any Rule 10b5-1 trading plans - **No Rule 10b5-1 trading plans** were adopted or terminated by directors or executive officers during the fiscal quarter ended June 30, 2025[173](index=173&type=chunk) [ITEM 6. Exhibits](index=41&type=page&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including various certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents for financial data - Exhibits include certifications (**31.1, 31.2, 32.1, 32.2**) from the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents, and Cover Page Interactive Data File)[174](index=174&type=chunk) [SIGNATURES](index=42&type=section&id=SIGNATURES) This section contains the official signatures of the company's authorized officers, certifying report accuracy - The report was signed on August 12, 2025, by Robb Knie, Chief Executive Officer, and David Briones, Chief Financial Officer, on behalf of Hoth Therapeutics, Inc[180](index=180&type=chunk)

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]