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

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 September 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 Hoth Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State ...

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 ...