Core Insights - Hoth Therapeutics, Inc. announced positive data from a case study involving its novel therapy HT-001 for managing epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular eruptions (PPEs) in cancer patients [2][5] - The therapy demonstrated rapid symptom relief, allowing a 59-year-old female patient to cease treatment after just one week due to significant improvement [4][5] - HT-001 addresses a common side effect of EGFRI treatments, which can affect up to 90% of patients, potentially improving the quality of life for those undergoing cancer therapy [3][5] Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies to meet unmet medical needs and improve patient quality of life [6] - The company is currently conducting a Phase 2a clinical trial to further evaluate the efficacy and safety of HT-001 in managing EGFRI-associated skin toxicities, with multiple clinical sites involved [5] Industry Context - EGFRIs are widely used in treating various epithelial-origin cancers but are often associated with significant cutaneous side effects, leading to treatment interruptions [3] - The introduction of HT-001 represents a potential breakthrough in managing these side effects, which can cause discomfort and impact ongoing cancer treatments [3][5]

Hoth Therapeutics (NASDAQ:HOTH) stock is on the move Wednesday after the clinical-stage biopharmaceutical company announced a new partnership with LTS Therapy Systems. The agreement with LTS Therapy Systems will see it handle the production of the HT-ALZoral film prototype. This will aid Hoth Therapeutics as it seeks a future Investigational New Drug (IND) Application for clinical trials of the drug. How This Affects HOTH Stock Investors will want to keep reading for more of the most recent stock market sto ...

This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing ...

Three New Sites Join HT-001 Trial, GW University Hospital, UC Irvine and Northwell Health NEW YORK, July 16, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it has received written approval from the GW University Hospital, UC Irvine and Northwell Health to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) ...

NEW YORK, June 10, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient focused biopharmaceutical company, today announced the entry into a joint development agreement with Wise Systems International SRL to leverage artificial intelligence utilizing the BioNeMo AI platform of Nvidia. Robert Antofe of Wise Systems International SRL commented, "We're excited to work with Hoth and leverage our existing AI expertise to help bring further value to both companies through the development of Hoth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: March 31, 2024 ☐ 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 Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 82-1553794 | | --- | --- | | (State or other j ...

NEW YORK, May 1, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced that Robb Knie, Chief Executive Officer, is scheduled to attend the EF Hutton Annual Global Conference in New York, NY.  To learn more about the EF Hutton Annual Global Conference please visit https://efhutton.com/conference/. About Hoth Therapeutics, Inc.Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking tr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number 001-38803 HOTH THERAPEUTICS, INC. (Exact name of registrant as specified in charter) | Nevada | 82-1553794 | | --- | --- | | (State or ot ...

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=ITEM%201.%20Financial%20Statements) The company reported a reduced net loss of $6.1 million for the nine months ended September 30, 2023, and strengthened its cash position to $11.8 million through financing activities [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $12.1 million by September 30, 2023, driven by an increase in cash, while stockholders' equity rose to $10.5 million due to capital raises Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $11,828,242 | $6,428,611 | | Total current assets | $12,053,137 | $6,726,381 | | Total assets | $12,086,137 | $6,759,381 | | **Liabilities & Equity** | | | | Total current liabilities | $1,578,869 | $1,387,731 | | Total liabilities | $1,578,869 | $1,637,731 | | Total stockholders' equity | $10,507,268 | $5,121,650 | | Total liabilities and stockholders' equity | $12,086,137 | $6,759,381 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for the nine months ended September 30, 2023, improved to $6.1 million from $7.9 million year-over-year, driven by lower operating expenses Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,246,061 | $1,451,280 | $2,777,865 | $3,370,841 | | Total operating expenses | $2,092,980 | $2,684,413 | $5,994,426 | $7,644,654 | | Loss from operations | $(2,092,980) | $(2,684,413) | $(5,994,426) | $(7,644,654) | | Net loss | $(2,086,583) | $(2,644,231) | $(6,143,121) | $(7,893,331) | | Net loss per share | $(0.60) | $(2.05) | $(1.99) | $(6.78) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity increased to $10.5 million in the first nine months of 2023, primarily from $11.3 million in net proceeds from stock and warrant issuances - Stockholders' equity increased by approximately **$5.4 million** during the first nine months of 2023, driven by capital raises[24](index=24&type=chunk) Changes in Stockholders' Equity (Nine Months Ended Sep 30, 2023) | Description | Amount | | :--- | :--- | | Balance as of Dec 31, 2022 | $5,121,650 | | Proceeds from private placement (net) | $11,314,998 | | Stock-based compensation | $210,643 | | Net loss | $(6,143,121) | | Balance as of Sep 30, 2023 | $10,507,268 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from financing activities was $11.3 million for the nine months ended September 30, 2023, resulting in a net cash increase of $5.9 million Net Cash Flow Summary (Nine Months Ended) | Cash Flow Category | Sep 30, 2023 | Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,375,695) | $(6,747,791) | | Net cash provided by investing activities | $0 | $1,169,194 | | Net cash provided by financing activities | $11,317,353 | $5,985,103 | | Net change in cash | $5,941,658 | $406,506 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The company secured sufficient funding for the next 12 months through two private placements and formed a new AI-focused subsidiary, merveille.ai - The company is a clinical-stage biopharmaceutical firm focused on developing therapies for unmet medical needs, including treatments for cancer side effects, mast-cell cancers, traumatic brain injury, and Alzheimer's disease[32](index=32&type=chunk) - The company raised approximately **$10 million** in gross proceeds from a private placement in January 2023 and another **$2.9 million** in September 2023, which it believes is sufficient to fund operations for at least the next 12 months[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) - A gain of **$275,000** was recognized during the nine months ended September 30, 2023, due to the termination of the exclusive license agreement with Virginia Commonwealth University[62](index=62&type=chunk)[63](index=63&type=chunk) - On October 4, 2023, the company formed a new wholly-owned subsidiary, **merveille.ai**, to focus on drug discovery for rare diseases using artificial intelligence[100](index=100&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating expenses decreased for the nine months ended September 30, 2023, and liquidity improved significantly with $11.8 million in cash Comparison of Operating Expenses (Nine Months Ended Sep 30) | Expense Category | 2023 | 2022 | | :--- | :--- | :--- | | Research and Development | ~$2.6 million | ~$3.5 million | | General and Administrative | ~$3.4 million | ~$4.2 million | - The decrease in R&D expenses for the nine months ended Sep 30, 2023 was mainly due to reduced spending on HT-001 and BioLexa programs and a gain from a settlement with a clinical trial vendor[108](index=108&type=chunk)[109](index=109&type=chunk) - The company's cash position increased to **$11.8 million** as of September 30, 2023, with working capital of **$10.5 million**, which management believes is sufficient to fund operations for at least the next 12 months[114](index=114&type=chunk) - Future operations will require additional funding, which the company may seek through equity/debt sales or strategic partnerships; failure to secure funding could curtail development plans[116](index=116&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures about market risk - As a "smaller reporting company," Hoth Therapeutics, Inc. is exempt from the requirement to provide disclosures about market risk under this item[127](index=127&type=chunk) [Controls and Procedures](index=31&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective as of September 30, 2023, due to a material weakness in internal control over financial reporting - The company's principal executive and financial officers concluded that **disclosure controls and procedures were not effective** as of September 30, 2023[128](index=128&type=chunk) - The ineffectiveness is due to a **material weakness** identified as of December 31, 2022, specifically a lack of sufficient resources for adequate segregation of duties in the financial reporting process[129](index=129&type=chunk)[130](index=130&type=chunk) - Remediation efforts are underway to expand controls, but the full implementation was still in process as of the end of the quarter[131](index=131&type=chunk) [PART II - OTHER INFORMATION](index=33&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=33&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company reports **no material legal proceedings**[137](index=137&type=chunk) [Risk Factors](index=33&type=section&id=ITEM%201A.%20Risk%20Factors) Key risks include intense competition, new challenges related to its AI subsidiary, and cybersecurity threats - The company faces **intense competition** from larger, better-funded competitors in the pharmaceutical industry[139](index=139&type=chunk) - A new risk is identified from increased competition in the AI drug discovery space following the formation of its subsidiary, **merveille.ai**[140](index=140&type=chunk) - The company acknowledges vulnerability to **cyber-attacks and security threats**, which could lead to financial liability and reputational harm, and highlights the need for compliance with data privacy laws such as HIPAA[141](index=141&type=chunk)[142](index=142&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=34&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) No unregistered sales of equity securities, use of proceeds, or issuer purchases were reported for the period - None reported for the period[143](index=143&type=chunk) [Defaults Upon Senior Securities](index=34&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[144](index=144&type=chunk) [Other Information](index=34&type=section&id=ITEM%205.%20Other%20Information) No other information was reported under this item - None[145](index=145&type=chunk) [Exhibits](index=35&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the report, including warrants, incentive plans, and officer certifications - Exhibits filed include forms of warrants from the September 2023 financing, the Amended and Restated 2022 Omnibus Equity Incentive Plan, and certifications by the CEO and CFO[147](index=147&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: 1 Rockefeller Plaza, Suite 1039 New York, NY 10020 (Address of principal executive offices) (Zip Code) (646) 756-2997 (Registrant's telephone number, includi ...