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 ...

[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This part details the company's financial performance, condition, and related disclosures for the first quarter of 2023 [Financial Statements](index=6&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q1 2023, including balance sheets, statements of operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2023, shows a significant increase in total assets to $13.5 million, primarily driven by cash from financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $13,044,382 | $6,428,611 | | Total current assets | $13,428,592 | $6,726,381 | | Total assets | $13,461,592 | $6,759,381 | | **Liabilities & Equity** | | | | Total current liabilities | $1,346,059 | $1,387,731 | | Total liabilities | $1,596,059 | $1,637,731 | | Total stockholders' equity | $11,865,533 | $5,121,650 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2023, the company reported a net loss of $2.18 million, an improvement from the prior year, with no revenue generated Statement of Operations Summary (Unaudited, for the three months ended March 31) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $890,845 | $948,379 | | Total operating expenses | $2,192,817 | $2,660,694 | | Loss from operations | $(2,192,817) | $(2,660,694) | | Net loss | $(2,183,507) | $(2,571,507) | | Net loss per share | $(0.88) | $(2.68) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity increased to $11.9 million, primarily due to $8.9 million net proceeds from a private placement of common stock and warrants - In Q1 2023, the company issued **140,000 shares of common stock** and warrants in a private placement, resulting in net proceeds of approximately **$8.9 million**[18](index=18&type=chunk) - The exercise of **1,860,000 pre-funded warrants** during the quarter contributed an additional **$1,860** in proceeds[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2023 saw $2.3 million net cash used in operations and $8.9 million provided by financing, increasing cash to $13.0 million Cash Flow Summary (Unaudited, for the three months ended March 31) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,289,419) | $(2,136,489) | | Net cash used in investing activities | $0 | $(25,000) | | Net cash provided by financing activities | $8,911,390 | $0 | | **Net change in cash** | **$6,621,971** | **$(2,161,489)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business, liquidity, accounting policies, and specific financial items, including a January 2023 financing - The company is a clinical-stage biopharmaceutical firm focused on therapies for cancer treatment side effects (HT-001), mast-cell cancers (HT-KIT), traumatic brain injury (HT-TBI), and Alzheimer's (HT-ALZ), among others[22](index=22&type=chunk) - Management believes current cash is sufficient to fund operations for at least the next **12 months**, following a private placement that closed on January 3, 2023, which raised approximately **$10 million** in gross proceeds[25](index=25&type=chunk)[26](index=26&type=chunk) - The investment in the HaloVax joint venture was fully impaired in Q4 2022 due to adverse changes in its business operations and is valued at **$0** as of March 31, 2023[57](index=57&type=chunk) - In January 2023, the company issued **4,460,000 new warrants** and saw the exercise of **1,860,000 pre-funded warrants**, significantly altering its capital structure[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2023 financial performance, highlighting decreased net loss, R&D expenses, and sufficient cash for 12 months Q1 2023 Research & Development Expense Breakdown | Project | Expense | Purpose | | :--- | :--- | :--- | | HT-001 | ~$0.6 million | Manufacturing, preclinical and clinical activities | | HT-KIT | ~$0.2 million | Manufacturing and preclinical activities | | BioLexa | ~$13,000 | Manufacturing costs | | Scientific Advisory Board | ~$57,000 | Service fees | - General and Administrative Expenses decreased by approximately **$0.4 million** in Q1 2023 compared to Q1 2022, primarily due to a reduction in compensation and related expenses, including stock-based compensation[82](index=82&type=chunk) - As of March 31, 2023, the company had approximately **$13.0 million in cash** and an accumulated deficit of **$47.3 million**[83](index=83&type=chunk) - Management believes existing cash will fund operations for at least the next **12 months**[83](index=83&type=chunk) - Net cash provided by financing activities in Q1 2023 was approximately **$8.9 million**, resulting from proceeds from the issuance of common stock and warrants[90](index=90&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is exempt from providing quantitative and qualitative market risk disclosures - As a "smaller reporting company," Hoth Therapeutics is exempt from the requirement to provide disclosures about market risk[99](index=99&type=chunk) [Controls and Procedures](index=26&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of March 31, 2023, due to a material weakness in segregation of duties - The Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were **not effective** as of March 31, 2023[100](index=100&type=chunk) - The ineffectiveness is due to a material weakness identified previously: a lack of sufficient resources to provide adequate segregation of duties related to financial reporting[101](index=101&type=chunk)[102](index=102&type=chunk) - The company is in the process of remediating the material weakness by expanding controls related to the preparation and review of financial information[103](index=103&type=chunk) [PART II - OTHER INFORMATION](index=28&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This part covers legal proceedings, risk factors, unregistered equity sales, and other significant business updates [Legal Proceedings](index=28&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings or aware of any pending claims - The company is not currently involved in any material legal proceedings[110](index=110&type=chunk) [Risk Factors](index=28&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes have occurred in the company's risk factors since those disclosed in its prior Annual Report on Form 10-K - No material changes have occurred in the company's risk factors from those previously disclosed in the Annual Report on Form 10-K filed on March 31, 2023[111](index=111&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[112](index=112&type=chunk) [Other Information](index=28&type=section&id=ITEM%205.%20Other%20Information) This section discloses the termination of an exclusive license agreement with VCU and a non-binding term sheet with Algorithm Sciences - On May 11, 2023, the company provided notice to terminate its exclusive license agreement with the Virginia Commonwealth University Intellectual Property Foundation, with the termination effective August 9, 2023[115](index=115&type=chunk) - On May 10, 2023, the company and Algorithm Sciences, Inc. mutually agreed to terminate a Non-Binding Confidential Term Sheet dated April 24, 2023[116](index=116&type=chunk) [Exhibits](index=29&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and XBRL data - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by Sections 302 and 906 of the Sarbanes-Oxley Act[117](index=117&type=chunk)

Part I [Business](index=8&type=section&id=Item%201.%20Business) Hoth Therapeutics is a clinical-stage biopharmaceutical company developing therapies for unmet medical needs, leveraging the **505(b)(2)** pathway and external manufacturing - The company's primary development focus is on four key programs: **HT-001** (cancer drug side effects), **HT-KIT** (mast-cell cancers), **HT-TBI** (traumatic brain injury), and **HT-ALZ** (Alzheimer's disease)[27](index=27&type=chunk) Product Development Pipeline Summary | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **HT-001** | Dermatological side effects from EGFR inhibitors | Phase 2a (IND approved Dec 2022) | | **HT-KIT** | Mastocytosis / Mast Cell Neoplasms | Preclinical (Orphan Drug Designation received) | | **HT-ALZ** | Alzheimer's Disease | Preclinical | | **HT-TBI** | Traumatic Brain Injury / Ischemic Stroke | Preclinical | | **BioLexa Platform** | Atopic Dermatitis (Eczema) | Phase 1b (Completed Sep 2022) | | **HT-003** | Acne / Inflammatory Bowel Diseases | Preclinical | | **HT-004** | Asthma / Allergies | Preclinical | | **HT-002** | SARS-CoV-2 Transmission | Preclinical (Proof-of-Concept completed) | | **Direct Detect** | Virus Detection Device | Prototype Development | - Hoth strategically utilizes the Section **505(b)(2)** regulatory pathway for several of its candidates, including **HT-001**, **HT-ALZ**, and the **BioLexa Platform**, to leverage existing **FDA**-approved drug data, potentially reducing development time and cost[29](index=29&type=chunk)[35](index=35&type=chunk)[40](index=40&type=chunk) - The company operates without its own manufacturing capabilities and intends to rely on contract manufacturing organizations (**CMOs**) for production and engage third-party pharmaceutical companies for commercialization upon regulatory approval[54](index=54&type=chunk)[55](index=55&type=chunk) [Risk Factors](index=21&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, product development, intellectual property, and stock-related risks, including a history of losses and need for capital [Risks Related to Our Financial Position and Need for Capital](index=21&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Capital) Financial Performance Summary | Metric | 2022 (in dollars) | 2021 (in dollars) | | :--- | :--- | :--- | | **Net Loss** | $11,371,953 | $14,313,705 | | **Accumulated Deficit** | $45,099,116 | $33,727,163 | - The company has generated no revenue from commercial sales and expects to operate at a net loss for the next several years, requiring substantial additional capital to fund its development and commercialization efforts[91](index=91&type=chunk)[92](index=92&type=chunk) - Failure to raise adequate funds could force the company to delay, scale back, or eliminate research and development activities and may require relinquishing rights to technologies or products[94](index=94&type=chunk) [Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization](index=22&type=section&id=Risks%20Related%20to%20Product%20Development%2C%20Regulatory%20Approval%2C%20Manufacturing%20and%20Commercialization) - The company's business is entirely dependent on the successful development, regulatory approval, and commercialization of its product candidates, which is a high-risk process with a low probability of success[97](index=97&type=chunk) - The **FDA**'s marketing approval process is lengthy, expensive, and unpredictable. There is no guarantee that any product candidates will ever receive approval to be marketed[103](index=103&type=chunk)[106](index=106&type=chunk) - Hoth relies on third-party Contract Research Organizations (**CROs**) and Contract Manufacturing Organizations (**CMOs**) for clinical trials and manufacturing. Poor performance by these third parties could delay or terminate product development[136](index=136&type=chunk)[166](index=166&type=chunk) - The company faces intense competition from large pharmaceutical companies and other institutions with significantly greater financial resources and experience in product development and marketing[157](index=157&type=chunk) [Risks Related to Our Intellectual Property Rights](index=46&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%20Rights) - The company relies on intellectual property licensed from third parties and has limited control over how these licensors defend the patents, which could harm the business if not protected vigorously[182](index=182&type=chunk) - Patent positions in the biopharmaceutical industry are highly uncertain and involve complex legal questions. There is no guarantee that pending applications will issue or that issued patents will provide competitive advantages or withstand challenges[185](index=185&type=chunk) [Risks Related to the Company](index=49&type=section&id=Risks%20Related%20to%20the%20Company) - Future business expansion through acquisitions of new drug candidates could disrupt operations, harm financial conditions, and dilute shareholder ownership[192](index=192&type=chunk) - The business could be adversely affected by health epidemics like the COVID-19 pandemic, which can disrupt clinical trials, supply chains, and access to capital[198](index=198&type=chunk)[199](index=199&type=chunk) [Risks Related to Our Common Stock](index=51&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) - The company's common stock price may fluctuate substantially due to factors such as clinical trial results, regulatory decisions, financing efforts, and general market conditions[203](index=203&type=chunk) - Future sales of equity securities to raise capital are expected, which could result in substantial dilution to existing shareholders[209](index=209&type=chunk) - The company does not intend to pay cash dividends, so any investment return will be limited to potential appreciation in the stock's value[210](index=210&type=chunk) [Unresolved Staff Comments](index=59&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) Not applicable [Properties](index=59&type=section&id=Item%202.%20Properties) The company leases its executive office in New York, NY for $2,500 per month, with the lease ending January 2025, and deems facilities adequate - The company leases its executive office at 1 Rockefeller Plaza, New York, NY for approximately **$2,500** per month, with the lease terminating on January 1, 2025[226](index=226&type=chunk) [Legal Proceedings](index=59&type=section&id=Item%203.%20Legal%20Proceedings) The company is not aware of any material legal proceedings or claims that would adversely affect its business or financial condition [Mine Safety Disclosures](index=59&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable Part II [Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=Item%205.%20Market%20For%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Hoth common stock trades on **Nasdaq** under "**HOTH**" with 98 shareholders as of March 2023, and the company does not plan to pay dividends - The company's common stock began trading on The **Nasdaq** Capital Market under the symbol "**HOTH**" on February 15, 2019[231](index=231&type=chunk) - As of March 17, 2023, there were **98** shareholders of record[232](index=232&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future, retaining funds for business expansion[233](index=233&type=chunk) [Reserved](index=60&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=60&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2022, the company reported an **$11.4 million** net loss, driven by reduced R&D, and requires significant future funding despite current liquidity [Results of Operations](index=61&type=section&id=Results%20of%20Operations) Comparison of Operating Expenses (2022 vs. 2021) | Expense Category | 2022 (in millions) | 2021 (in millions) | | :--- | :--- | :--- | | Research and Development | $4.9 | $7.5 | | General and Administrative | $6.1 | $6.6 | | **Total Operating Expenses** | **$11.1** | **$14.1** | - Research and development expenses decreased to **$4.9 million** in 2022 from **$7.5 million** in 2021. The largest R&D cost in 2022 was approximately **$2.9 million** for **HT-001** manufacturing and clinical activities[238](index=238&type=chunk)[239](index=239&type=chunk) - General and Administrative expenses slightly decreased to **$6.1 million** in 2022 from **$6.6 million** in 2021, primarily consisting of payroll, stock-based compensation, and professional fees[240](index=240&type=chunk)[241](index=241&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20Capital%20Resources) Key Financial Position Data (as of Dec 31, 2022) | Metric | Amount (in millions) | | :--- | :--- | | Cash | $6.4 | | Working Capital | $5.3 | | Accumulated Deficit | $45.0 | - The company believes its existing cash as of December 31, 2022, will fund operations for **at least the next 12 months**[247](index=247&type=chunk) - The company faces potential future milestone payments of up to approximately **$15.6 million** if all development and commercialization events in current agreements are achieved, necessitating additional funding[248](index=248&type=chunk) [Cash Flows](index=63&type=section&id=Cash%20Flows) Consolidated Cash Flow Summary | Cash Flow Activity | Year Ended Dec 31, 2022 (in millions) | Year Ended Dec 31, 2021 (in millions) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($9.3 million) | ($12.1 million) | | Net Cash Provided by (Used in) Investing Activities | $1.2 million | ($0.2 million) | | Net Cash Provided by Financing Activities | $6.0 million | $18.2 million | [Quantitative and Qualitative Disclosures about Market Risk](index=65&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Hoth Therapeutics is exempt from providing market risk disclosures [Financial Statements and Supplementary Data](index=66&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements for 2022 and 2021, showing a 2022 net loss of **$11.4 million** Consolidated Balance Sheet Highlights | Account | Dec 31, 2022 (in dollars) | Dec 31, 2021 (in dollars) | | :--- | :--- | :--- | | **Total Current Assets** | $6,726,381 | $10,575,079 | | **Total Assets** | $6,759,381 | $10,985,079 | | **Total Current Liabilities** | $1,387,731 | $867,787 | | **Total Liabilities** | $1,637,731 | $1,102,787 | | **Total Stockholders' Equity** | $5,121,650 | $9,882,292 | Consolidated Statement of Operations Highlights | Account | Year Ended Dec 31, 2022 (in dollars) | Year Ended Dec 31, 2021 (in dollars) | | :--- | :--- | :--- | | **Research and Development** | $4,844,578 | $7,354,708 | | **Total Operating Expenses** | $11,065,554 | $14,101,440 | | **Loss from Operations** | ($11,065,554) | ($14,101,440) | | **Net Loss** | ($11,371,953) | ($14,313,705) | | **Net Loss Per Share** | ($9.50) | ($16.02) | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=88&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) None [Controls and Procedures](index=88&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management identified a material weakness in internal controls due to insufficient segregation of duties, implementing a new closing process for remediation - Management concluded that internal control over financial reporting was not effective as of December 31, 2022, due to a material weakness[371](index=371&type=chunk) - The identified material weakness was a lack of sufficient resources to provide adequate segregation of duties in the preparation and review of financial information, including cutoff related to accruals and prepaids[372](index=372&type=chunk) - To remediate the weakness, the company has implemented a new closing process for each quarter and year-end to properly account for and book expenses[375](index=375&type=chunk) [Other Information](index=90&type=section&id=Item%209B.%20Other%20Information) The company signed a new three-year employment agreement with CEO Robb Knie, detailing salary, bonus, equity, and severance terms - On March 28, 2023, the company entered into a new employment agreement with CEO Robb Knie for a three-year term with a base salary of **$450,000** and a potential annual bonus of up to **$350,000**[379](index=379&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=90&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) Not applicable Part III [Directors, Executive Officers and Corporate Governance](index=91&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details executive officers, board members, and the independent composition and responsibilities of the Audit, Compensation, and Nominating committees Executive Officers and Directors (as of March 17, 2023) | Name | Age | Position | | :--- | :--- | :--- | | Robb Knie | 54 | President, Chief Executive Officer and Director | | David Briones | 46 | Chief Financial Officer | | Wayne Linsley | 66 | Director | | David B. Sarnoff | 55 | Director | | Graig Springer | 43 | Director | | Jeff Pavell | 56 | Director | - The Board of Directors maintains three standing committees: Audit, Compensation, and Nominating and Governance. All members of these committees are considered independent under **Nasdaq** rules[399](index=399&type=chunk)[400](index=400&type=chunk) [Executive Compensation](index=97&type=section&id=Item%2011.%20Executive%20Compensation) This section details 2022 executive compensation, including CEO Robb Knie's **$1.06 million** total, and non-employee director compensation of **$50,000** annually Summary Compensation Table (2022) | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Robb Knie, CEO & President | 2022 | 450,000 | 300,000 | 216,361 | 94,009 | 1,060,370 | | Stefanie Johns, Former CSO | 2022 | 382,443 | 20,000 | 108,181 | 185,263 | 695,886 | - Non-employee directors receive **$50,000** in cash compensation annually for their service on the board[439](index=439&type=chunk) - On December 9, 2022, the employment of Chief Scientific Officer Stefanie Johns ceased. She entered into a separation agreement providing for **six months** of base salary and continued health benefits[423](index=423&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=105&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 2023, directors and NEOs owned **3.29%** of common stock, with **Armistice Capital** holding **9.99%**, and equity plans having available shares Beneficial Ownership as of March 17, 2023 | Beneficial Owner | Percentage Owned | | :--- | :--- | | All Named Executive Officers and Directors as a Group | 3.29% | | **Armistice Capital, LLC** | 9.99% | [Certain Relationships and Related Transactions, and Director Independence](index=107&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company disclosed a **$10 million** securities purchase with **Armistice Capital** and maintains a policy for related party transactions, with a majority of independent directors - On December 29, 2022, the company entered into a securities purchase agreement with **Armistice Capital Master Fund Ltd.**, a greater than 5% shareholder, for gross proceeds of approximately **$10 million**[447](index=447&type=chunk) - The Board of Directors has determined that Wayne Linsley, David Sarnoff, Graig Springer, and Jeff Pavell are independent directors[452](index=452&type=chunk) [Principal Accountant Fees and Services](index=108&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The company paid **WithumSmith+Brown, PC** **$156,441** in 2022 for audit and tax services, all pre-approved by the audit committee Accountant Fees | Fee Type | 2022 (in dollars) | 2021 (in dollars) | | :--- | :--- | :--- | | Audit Fees | $149,791 | $98,365 | | Tax Fees | $6,650 | $3,605 | | **Total** | **$156,441** | **$101,970** | Part IV [Exhibit and Financial Statement Schedules](index=109&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists financial statements and exhibits filed with the Form 10-K, with schedules omitted as not applicable or included elsewhere [Form 10-K Summary](index=114&type=section&id=Item%2016.%20Form%2010-K%20Summary) Not applicable

PART I. FINANCIAL INFORMATION Presents the unaudited condensed consolidated financial statements and related notes for the interim period [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements and their accompanying notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Summarizes the company's financial position, showing assets, liabilities, and stockholders' equity at specific dates **Condensed Consolidated Balance Sheet Highlights:** | Metric | September 30, 2022 (Unaudited) | December 31, 2021 | | :-------------------------------- | :----------------------------- | :------------------ | | Cash | $8,935,081 | $8,538,270 | | Marketable equity securities | $330,901 | $1,892,837 | | Total current assets | $9,507,406 | $10,575,079 | | Total assets | $9,894,806 | $10,985,079 | | Total current liabilities | $1,008,427 | $867,787 | | Total liabilities | $1,283,427 | $1,102,787 | | Total stockholders' equity | $8,611,379 | $9,882,292 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's revenues, expenses, and net loss for the three and nine months ended September 30 **Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights:** | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development expenses | $1,451,280 | $2,123,548 | $3,370,841 | $5,408,166 | | Total operating expenses | $2,684,413 | $3,253,196 | $7,644,654 | $10,721,325 | | Net loss | $(2,644,231) | $(3,296,048) | $(7,893,331) | $(10,833,611) | | Net loss per share (basic and diluted) | $(2.05) | $(3.45) | $(6.78) | $(12.44) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Outlines changes in stockholders' equity, including stock-based compensation, stock issuance, and net loss **Changes in Stockholders' Equity (Nine Months Ended September 30, 2022):** | Item | Amount | | :---------------------------------------------------- | :------------- | | Balance at December 31, 2021 | $9,882,292 | | Stock-based compensation | $605,330 | | Issuance of common stock (net of offering costs) | $5,985,103 | | Foreign currency translation adjustment | $31,985 | | Net loss | $(7,893,331) | | Balance at September 30, 2022 | $8,611,379 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Presents the cash inflows and outflows from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended September 30):** | Cash Flow Activity | 2022 | 2021 | | :------------------------------------ | :------------- | :------------- | | Net cash used in operating activities | $(6,747,791) | $(8,187,931) | | Net cash provided by (used in) investing activities | $1,169,194 | $(147,876) | | Net cash provided by financing activities | $5,985,103 | $18,194,646 | | Net change in cash | $406,506 | $9,858,839 | | Cash, end of period | $8,935,081 | $12,445,379 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1-Organization and description of business operations](index=11&type=section&id=Note%201-Organization%20and%20description%20of%20business%20operations) Describes Hoth Therapeutics as a clinical-stage biopharmaceutical company and its funding and recent corporate actions - Hoth Therapeutics is a clinical-stage biopharmaceutical company developing therapies for unmet medical needs, including a topical formulation for cancer drug side effects (HT-001), treatments for mast-cell derived cancers (HT-KIT), traumatic brain injury (HT-TBI), Alzheimer's (HT-ALZ), atopic dermatitis (BioLexa), asthma/allergies (HT-004), and inflammatory bowel diseases (HT-003) and is also evaluating a peptide for SARS-CoV-2 (HT-002) and developing a diagnostic device[27](index=27&type=chunk)[81](index=81&type=chunk) - The company's operations are funded by proceeds from equity and debt securities sales, with net proceeds from an April 2022 public offering totaling **$6.0 million**[29](index=29&type=chunk)[31](index=31&type=chunk) - Management believes current cash is sufficient to fund operations for at least the next **12 months**, but significant additional capital will be required for future product candidate development and regulatory approvals[30](index=30&type=chunk) - A **1-for-25** reverse stock split became effective on **October 26, 2022**, retrospectively adjusting all share and per-share data[32](index=32&type=chunk) [Note 2-Significant accounting policies](index=12&type=section&id=Note%202-Significant%20accounting%20policies) Outlines the key accounting principles and estimates used in preparing the interim financial statements - The interim financial statements are prepared in accordance with GAAP for interim financial information, reflecting normal recurring adjustments, and should be read in conjunction with the annual consolidated financial statements[33](index=33&type=chunk) - Significant estimates in the financial statements relate to stock-based compensation and the valuation allowance of deferred tax assets resulting from net operating losses[35](index=35&type=chunk) - Fair value measurements are classified into three levels: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1 prices), and Level 3 (unobservable inputs requiring significant judgment or estimation)[39](index=39&type=chunk) [Note 3-License agreements](index=14&type=section&id=Note%203-License%20agreements) Details research and development expenses related to various intellectual property license agreements **Research and Development Expenses - Licenses Acquired (Including Stock-Based Compensation):** | Period | 2022 | 2021 | | :-------------------------------- | :--------- | :--------- | | Three Months Ended September 30 | $16,953 | $38,967 | | Nine Months Ended September 30 | $94,678 | $164,812 | - Expenses include warrant grants and license maintenance fees to The George Washington University, as well as license fees to North Carolina State University, Virginia Commonwealth University, and University of Cincinnati[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) [Note 4-Note Receivable](index=15&type=section&id=Note%204-Note%20Receivable) Addresses the maturity and subsequent payoff of a convertible promissory note from Isoprene Pharmaceuticals - The **$50,000** convertible promissory note from Isoprene Pharmaceuticals, Inc. matured on **September 10, 2022**, without conversion into preferred stock or common stock[50](index=50&type=chunk) - As of **September 30, 2022**, the Isoprene Note was deemed a receivable of the Company[50](index=50&type=chunk) - The Isoprene Note and accrued interest were paid off on **October 21, 2022**[50](index=50&type=chunk) [Note 5-Investments in Marketable Securities](index=15&type=section&id=Note%205-Investments%20in%20Marketable%20Securities) Reports gains and losses on marketable securities, including unrealized gains/losses and dividend income **Gains (Losses) on Marketable Securities:** | Item | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :-------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Unrealized gain (loss) | $26,572 | $9,566 | $(132,063) | $(37,843) | | Realized loss | $- | $(41,214) | $(194,179) | $(41,798) | | Dividend income | $14,202 | $17,931 | $59,334 | $27,983 | | Total | $40,774 | $(13,717) | $(266,908) | $(51,658) | [Note 6-Fair Value of Financial Assets and Liabilities](index=15&type=section&id=Note%206-Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) Categorizes financial assets by fair value levels and details changes in Level 3 investments **Fair Value Measurement of Assets (September 30, 2022):** | Asset | Total Fair Value | Level 1 | Level 2 | Level 3 | | :-------------------------- | :--------------- | :-------- | :-------- | :-------- | | Marketable securities - mutual funds | $330,901 | $330,901 | $- | $- | | Investment in joint ventures | $387,400 | $- | $- | $387,400 | | Note receivable - current | $50,000 | $- | $- | $50,000 | **Changes in Fair Value of Level 3 Financial Assets (Investment in Joint Ventures):** | Item | Amount | | :---------------------------------------------------- | :------------- | | Investment in joint ventures at fair value at Dec 31, 2021 | $410,000 | | Change in fair value of investments in joint ventures | $(22,600) | | Investment in joint ventures at fair value at Sep 30, 2022 | $387,400 | - The investment in Zylö was valued at **$37,000** as of **September 30, 2022**, down from **$60,000** at **December 31, 2021**, reflecting an approximate **$23,000** unrealized loss recorded in the second quarter of 2022 based on a 409A valuation[58](index=58&type=chunk) [Note 7-Stockholders' Equity](index=18&type=section&id=Note%207-Stockholders'%20Equity) Discusses changes in equity plans, stock-based compensation, and outstanding equity instruments - The number of shares reserved under the 2018 Equity Incentive Plan was increased to **156,878** as of **February 2, 2022**[60](index=60&type=chunk) - The 2022 Omnibus Equity Incentive Plan was adopted on **March 24, 2022**, reserving **96,000** shares, and became effective upon shareholder approval on **June 23, 2022**[61](index=61&type=chunk) **Stock-Based Compensation Expense:** | Period | 2022 | 2021 | | :-------------------------------- | :--------- | :--------- | | Three Months Ended September 30 | $12,354 | $40,430 | | Nine Months Ended September 30 | $605,330 | $1,196,830 | **Outstanding Equity Instruments (as of September 30, 2022):** | Instrument | Number of Shares/Warrants | Weighted Average Exercise Price | | :-------------------------- | :------------------------ | :------------------------------ | | Warrants | 402,840 | $49.83 | | Options | 104,651 | $49.80 | | Non-vested restricted stock awards | 36 | $75.00 | [Note 8-Commitments and contingencies](index=20&type=section&id=Note%208-Commitments%20and%20contingencies) Covers office lease obligations and confirms the absence of material legal proceedings - The company leases office space for approximately **$4,500** per month[67](index=67&type=chunk) **Rent Expense:** | Period | 2022 | 2021 | | :-------------------------------- | :--------- | :--------- | | Three Months Ended September 30 | $18,000 | $6,000 | | Nine Months Ended September 30 | $47,000 | $33,000 | - The company is not a party to any material legal proceedings and is not aware of any pending or threatened claims that could materially adversely affect its business[68](index=68&type=chunk) [Note 9-Risk and Uncertainties](index=20&type=section&id=Note%209-Risk%20and%20Uncertainties) Highlights significant risks and uncertainties, particularly those stemming from the COVID-19 pandemic - The COVID-19 pandemic poses substantial risks, including potential delays or interruptions to business operations, clinical trials, and research and development activities due to factors like shelter-in-place orders and hospital policy changes[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) - Supply chain disruptions for raw materials used in product candidate manufacturing may occur if third-party suppliers are adversely impacted by COVID-19 restrictions[73](index=73&type=chunk) - The pandemic may disrupt global financial markets, negatively impacting the company's ability to access capital on favorable terms, and could materially affect its business and stock value[74](index=74&type=chunk) - The ultimate impact of the COVID-19 pandemic is highly uncertain, and the company continues to monitor the situation closely[75](index=75&type=chunk) [Note 10-Subsequent events](index=21&type=section&id=Note%2010-Subsequent%20events) Discloses significant events occurring after the reporting period, including stock issuance and employment agreement amendments - On **November 2, 2022**, the company created and sold **2,000,000** shares of Series B Preferred Stock for an aggregate purchase price of **$1,000**[77](index=77&type=chunk)[78](index=78&type=chunk) - The Series B Preferred Stock are entitled to **ten votes per share**, exclusively for an Authorized Stock Increase, and will be redeemed for **$10** upon board order or effectiveness of the Authorized Stock Increase[77](index=77&type=chunk) - On **November 10, 2022**, the employment agreement for Dr. Stefanie Johns, Chief Scientific Officer, was amended to shorten her term to no more than **six months** and remove her eligibility for annual bonuses or equity awards[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's analysis of the company's financial condition, operational results, liquidity, and critical accounting estimates [Overview](index=22&type=section&id=Overview) Introduces Hoth Therapeutics as a clinical-stage biopharmaceutical company developing various therapies and diagnostic devices - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs across various indications, including cancer side effects (HT-001), mast-cell derived cancers (HT-KIT), traumatic brain injury (HT-TBI), Alzheimer's (HT-ALZ), atopic dermatitis (BioLexa), asthma/allergies (HT-004), acne/inflammatory bowel diseases (HT-003), and a novel peptide for SARS-CoV-2 (HT-002)[81](index=81&type=chunk) - The company is also developing a diagnostic device via a mobile platform and holds interests in third-party assets for lupus (Zylö Therapeutics) and COVID-19 prevention (Voltron Therapeutics)[81](index=81&type=chunk) [Recent Developments](index=22&type=section&id=Recent%20Developments) Summarizes key corporate events, including a reverse stock split and the issuance of Series B Preferred Stock - A **1-for-25** reverse stock split became effective on **October 26, 2022**, with fractional shares rounded up[82](index=82&type=chunk) - On **November 2, 2022**, the company created and sold **2,000,000** shares of Series B Preferred Stock for **$1,000**, which carry **ten votes each** exclusively for an Authorized Stock Increase and are redeemable for **$10**[82](index=82&type=chunk)[83](index=83&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Compares the company's operating expenses and financial performance for the current and prior periods [Comparison of the Three Months Ended September 30, 2022 and 2021](index=23&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20September%2030%2C%202022%20and%202021) Analyzes changes in research and development and general and administrative expenses for the quarter - Research and development expenses decreased by approximately **$0.7 million** to **$1.5 million** in Q3 2022 from **$2.2 million** in Q3 2021, primarily due to decreased R&D activities[85](index=85&type=chunk) - General and administrative expenses increased by approximately **$0.1 million** to **$1.2 million** in Q3 2022 from **$1.1 million** in Q3 2021, mainly due to an increase in professional fees[86](index=86&type=chunk) [Comparison of the Nine Months Ended September 30, 2022 and 2021](index=23&type=section&id=Comparison%20of%20the%20Nine%20Months%20Ended%20September%2030%2C%202022%20and%202021) Examines changes in research and development and general and administrative expenses for the nine-month period - Research and development expenses decreased by approximately **$2.1 million** to **$3.5 million** for the nine months ended September 30, 2022, from **$5.6 million** in the prior year, due to decreased R&D activities[87](index=87&type=chunk) - General and administrative expenses decreased by approximately **$0.9 million** to **$4.2 million** for the nine months ended September 30, 2022, from **$5.1 million** in the prior year, primarily due to a decrease in professional fees and compensation[89](index=89&type=chunk) - Specifically, the fair value of options granted to officers and directors decreased by approximately **$0.4 million** compared to the same period in 2021[89](index=89&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, working capital, and future funding requirements **Liquidity and Financial Position (as of September 30, 2022):** | Metric | Amount | | :-------------------- | :------------- | | Cash | $8.9 million | | Marketable securities | $0.3 million | | Working capital | $8.5 million | | Accumulated deficit | $41.6 million | **Net Cash Used in Operating Activities (Nine Months Ended September 30):** | Year | Amount | | :--- | :------------- | | 2022 | $6.7 million | | 2021 | $8.2 million | - The company expects its existing cash to fund operating expenses and capital expenditure requirements for at least **12 months** from the report date[90](index=90&type=chunk) - Additional funding will be necessary for future clinical and pre-clinical activities, potentially through equity/debt sales or strategic partnerships, with uncertainty due to the COVID-19 pandemic[93](index=93&type=chunk) - Future commitments include license maintenance fees, out-of-pocket expenses, development/commercialization expenses, annual/quarterly minimum payments, diligence expenses, revenue interest payments, minimum royalties (middle to high five figures), sales-based/running royalties (low single to low double digits), and milestone payments (up to approximately **$17 million**)[91](index=91&type=chunk) [Critical Accounting Estimates](index=25&type=section&id=Critical%20Accounting%20Estimates) Identifies key accounting estimates that involve significant judgment and potential impact on financial results - Critical accounting estimates require uncertain assumptions and could materially impact financial results if different estimates were used or actual results vary[99](index=99&type=chunk) - The most significant estimates relate to stock-based compensation and the valuation allowance of deferred tax assets resulting from net operating losses[35](index=35&type=chunk)[99](index=99&type=chunk) [Recently Issued Accounting Standards Not Yet Effective or Adopted](index=25&type=section&id=Recently%20Issued%20Accounting%20Standards%20Not%20Yet%20Effective%20or%20Adopted) States management's assessment of the impact of new accounting pronouncements - Management does not believe that any recently issued, but not yet effective accounting pronouncements, if currently adopted, would have a material impact on the Company's condensed consolidated financial statements[43](index=43&type=chunk)[101](index=101&type=chunk) [JOBS Act](index=26&type=section&id=JOBS%20Act) Explains the company's status as an emerging growth company and its election of certain JOBS Act exemptions - The company is an "emerging growth company" (EGC) under the JOBS Act[3](index=3&type=chunk)[102](index=102&type=chunk) - The company has chosen to take advantage of extended transition periods for complying with new or revised accounting standards, which may result in financial statements not being comparable to those of companies complying with public company effective dates[103](index=103&type=chunk) - As an EGC, the company intends to rely on exemptions from providing an auditor's attestation report on internal controls over financial reporting and complying with mandatory audit firm rotation requirements[104](index=104&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) States the company's exemption from market risk disclosures as a smaller reporting company - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company" under Rule 12b-2 of the Exchange Act[105](index=105&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Reports on the effectiveness of disclosure controls and internal control over financial reporting - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of **September 30, 2022**[106](index=106&type=chunk) - There have been no material changes in the company's internal control over financial reporting during the most recent fiscal quarter[107](index=107&type=chunk) - Management recognizes that controls and procedures, no matter how well designed, cannot provide absolute assurance due to inherent limitations and resource constraints[108](index=108&type=chunk) PART II. OTHER INFORMATION Presents additional information not included in the financial statements, such as legal matters and exhibits [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) Confirms the absence of material legal proceedings affecting the company's business or financial condition - The company is not currently a party to any material legal proceedings[110](index=110&type=chunk) - The company is not aware of any pending or threatened legal proceedings that could have a material adverse effect on its business, operating results, cash flows, or financial condition[110](index=110&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) Refers to previously disclosed risk factors and notes no material changes in the current period - There have been no material changes in the company's risk factors from those previously disclosed in its Annual Report on Form 10-K for the year ended **December 31, 2021**[111](index=111&type=chunk) - Investors should carefully consider the risks described in the Annual Report, as well as additional risks and uncertainties not currently known or deemed immaterial, which could materially adversely affect the business[111](index=111&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Details the issuance of common stock to directors as unregistered sales of equity securities - During the three months ended **September 30, 2022**, the company issued an aggregate of **72** shares of common stock to members of its board of directors for services[112](index=112&type=chunk) - These shares were subject to a vesting schedule and were issued as unregistered sales of equity securities, exempt from registration under Section 4(a)(2) of the Securities Act[112](index=112&type=chunk)[113](index=113&type=chunk) [Item 3. Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Confirms that the company reported no defaults upon senior securities during the period - The company reported no defaults upon senior securities[114](index=114&type=chunk) [Item 4. Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that this disclosure item is not applicable to the company's operations - This item is not applicable to the company[115](index=115&type=chunk) [Item 5. Other Information](index=27&type=section&id=Item%205.%20Other%20Information) Discloses an amendment to the Chief Scientific Officer's employment agreement - On **November 10, 2022**, the employment agreement for Dr. Stefanie Johns, Chief Scientific Officer, was amended[116](index=116&type=chunk) - The amendment shortens her employment term to no more than **six months** and removes her eligibility for annual bonuses or equity awards[116](index=116&type=chunk) - Upon separation and execution of a release of claims, Dr. Johns will receive accrued but unpaid compensation, unused vacation, reimbursement of unreimbursed expenses, and other benefits[116](index=116&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) Lists all documents filed as exhibits to the Form 10-Q report - The exhibits include an amendment to the company's bylaws, the Third Amendment to Employment Agreement with Stefanie Johns, certifications of the Principal Executive Officer and Principal Financial Officer (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act), and Inline XBRL documents[118](index=118&type=chunk) [Signatures](index=29&type=section&id=Signatures) Confirms the official signing of the Quarterly Report on Form 10-Q by executive officers - The report was signed on **November 10, 2022**[122](index=122&type=chunk) - Signatories include Robb Knie, Chief Executive Officer (Principal Executive Officer), and David Briones, Chief Financial Officer (Principal Financial and Accounting Officer)[122](index=122&type=chunk)

For the quarterly period ended June 30, 2022 OR ☐ 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Hoth Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 March 31, 2022 OR ☐ 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 its Charter) (State or ...