ADDED
As of March 26, 2026, there were 16,257,652 shares of the Registrant s common stock, par value $0.0001 per share, outstanding.
Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern , which may hinder our ability to obtain future financing.
The marketing approval process is lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for the product candidates we intend to develop, our business may be substantially harmed.
Additional delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial.
Primary Development: HT-001 On February 1, 2020, we entered into a patent license agreement with The George Washington University ( GW ) pursuant to which GW granted us a license to certain patent rights with respect to HT-001 which we intend to seek approval for use for treating dermatological side effects from epidermal growth factor receptor ( EGFR ) inhibitors, and potentially other drugs used for the treatment of cancer.
In November 2022, we submitted an Investigational New Drug ( IND ) application to the U.S.
Food and Drug Administration ( FDA ) with respect to HT-001 as a concomitant therapy with EGFR inhibitors, for a Phase 2a clinical trial in humans and we received FDA approval to proceed with our clinical study on December 28, 2022.
In September 2025, we submitted a clinical trial application to the European Medicines Agency ( EMA ) to expand the Phase 2a clinical trial to Europe, and in January 2026, we received EMA approval to proceed with our clinical study in Spain, Poland and Hungary.
In January 2025, we acquired three provisional patent applications for additional indications that could be treated using the HT-001 formulation and in January 2026 we executed proposals for proof-of-concept studies for the three new indications.
HT-KIT We have obtained from North Carolina State University ( NC State ) an exclusive, worldwide, royalty bearing license to certain intellectual property with respect to cancer and anaphylaxis; this is being developed as HT-KIT.
REMOVED
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C.
As of March 28, 2025, there were 13,170,715 shares of the Registrant s common stock, par value $0.0001 per share, outstanding.
Form 10-K Summary 67 Signatures 68 i Explanatory Note Restatement of Previously Issued Annual and Quarterly Consolidated Financial Statements As previously disclosed in a Current Report on Form 8-K filed by Hoth Therapeutics, Inc.
(the Company ) with the Securities and Exchange Commission ( SEC ) on March 25, 2025, certain of the Company s previously filed interim unaudited and annual audited consolidated financial statements should no longer be relied upon and a restatement is required for these previously issued consolidated financial statements.
As a result of such errors, we concluded that the issued audited consolidated financial statements and unaudited condensed consolidated financial statements discussed above were materially misstated, and we have restated, herein, our previously issued audited consolidated financial statement and unaudited condensed consolidated financial statements for each of the quarterly and year to date periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023.
The December 31, 2022 understatement of prepaid expenses and other current assets of $983,497 was corrected by increasing prepaid expenses and other current assets and decreasing accumulated deficit as of December 31, 2022 by $983,497, as reflected of the consolidated statements of changes in stockholders equity as of December 31, 2022.
The restatement corrections impact certain components within operating cash flows of our audited consolidated financial statements and unaudited condensed consolidated statements of cash flows.
Total operating cash flows, investing activities, financing activities, and cash and cash equivalents are unchanged as a result of the restatements and as a result are not restated herein.
The financial information that was previously filed or otherwise reported for the Prior Quarterly Financial Statements is superseded by the information in this Annual Report on Form 10-K, Note 8 - Restatement of Previously Issued Audited Consolidated Financial Statements and Unaudited Condensed Financial Statements.
We have not filed and do not intend to file amendments to our Annual Report of Form 10-K and Quarterly Reports on Form 10-Q for any of the annual and quarterly periods in fiscal years 2024 and 2023.