HOTH Hoth Therapeutics Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) March 21, 2025

 

Hoth Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada		001-38803		82-1553794
(State or other jurisdiction of incorporation)		(Commission File Number)		(I. R. S. Employer Identification No.)

 

1177 Avenue of the Americas, 5th Floor, Suite 5066

New York, NY 10036

(Address of principal executive offices, including ZIP code)

 

(646) 756-2997

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, $0.0001 par value		HOTH		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On March 24, 2024, Hoth Therapeutics, Inc. (“Hoth” or the “Company”) entered into a Project Order Agreement (the “Agreement”) with OnTargetx R&D Inc. (“OnTargetx”) pursuant to the terms of an existing Master Service Agreement originally entered into on November 8, 2024,

 

Under the Agreement, OnTargetx, in collaboration with ITR Laboratories, will perform a 4-week intravenous injection toxicity study followed by a 14-day recovery period in C57BL/6 mice, referred to as Study No. 701821 (P210614002-B). The study includes dose formulation, toxicokinetic analysis, clinical pathology, necropsy, histopathology, and detailed reporting. A total of 448 main study animals and 44 spares will be used.

 

The study has been designed to test the Company’s proposed treatment for mast-cell derived cancers (HT-KIT), with respect to which the Company has an exclusive, worldwide, royalty bearing license to certain intellectual property to, among other things, discover, develop, make, have made, use and sell certain licensed products and sell, use and practice certain licensed services with respect to cancer (and anaphylaxis) from North Carolina State University (“NC State”).

 

Recently, the Company, in conjunction with NC State, filed amendments to a pending patent application related to its antisense oligonucleotide (ASO) technology platform. The amended claims broaden and clarify the scope of intellectual property protections around antisense oligomers targeting specific pre-mRNA sequences involved in gene expression and immune response pathways.

 

The amended claims include compositions and methods involving antisense oligomers designed to modulate splicing of specific genes and reduce expression of immune-related cell surface receptors. The claims also describe potential pharmaceutical compositions and therapeutic uses across various species.

 

These amendments reflect routine practice and are intended to strengthen the Company’s patent position in anticipation of further preclinical development and potential licensing discussions.

 

Item 4.02 Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review. 

 

During the preparation of our 2024 audited consolidated financial statements and notes thereto, we concluded that there were material errors related to recording of prepaid research and development and the timing of the related research and development expense in our previously issued audited consolidated financial statements as of and for the years ended December 31, 2023, and in our previously issued unaudited condensed consolidated financial statements as of and 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, relating to the recording of prepaid expenses, and the timing of recognition of research and development expenses.

 

On March 21, 2025, the audit committee (the “Audit Committee”) of the board of directors of the Company (the “Board”), in consultation with management, concluded that it is appropriate to correct the errors in accounting in the Company’s unaudited condensed consolidated financial statements for each of its interim periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023 and the audited consolidated financial statements for the year ended December 31, 2023 (collectively, the “Non-Reliance Periods”) included in the associated Quarterly Reports on Form 10-Q and Annual Report on Form 10-K for each of the Non-Reliance Periods filed with the Securities Exchange Commission (the “SEC”), by restating such audited and unaudited financial information. The Company will disclose in its Annual Report on Form 10-K for the year ended December 31, 2024 the restated audited consolidated and unaudited condensed consolidated financial statements for each of the Non-Reliance Periods (“Restatements”). As a result, the audited consolidated and unaudited condensed consolidated financial statements for each of the Non-Reliance Periods should no longer be relied on. Similarly, any previously issued or filed reports, press releases, earnings releases, and investor presentations or other communications describing the Company’s financial statements and other related financial information covering the Non-Reliance Periods should no longer be relied upon.

 

1)

The Company’s analysis concluded that the following items were improperly recorded as of December 31, 2023, 2022 and 2021, and for the year ended December 31, 2023.

 

 

As of December 31, 2023, the Company’s consolidated balance sheets did not reflect prepaid expenses and other current assets related to advance payments made in 2022 and 2021 for clinical studies. These errors in the accounting for prepaid expenses and other current assets and research and development expenses resulted in an understatement of prepaid assets and other current assets of $722,765 as of December 31, 2023, an understatement of research and development expenses, operating expenses and net loss of $260,732 for the year ended December 31, 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 in the consolidated statements of changes in stockholders’ equity as of December 31, 2022.

 

2)

The Company noted the following items were improperly recorded as of March 31, 2024 and 2023, and during the three months ended March 31, 2024 and 2023:

 

●

As of March 31, 2024, prepaid expenses and other current assets were understated by $617,019 and for the three months ended March 31, 2024, research and development expenses were understated by $105,746.

 

●

As of March 31, 2023, prepaid expenses and other current assets were understated by $931,456 and for the three months ended March 31, 2023, research and development expenses were understated by $52,041.

 

3)

The Company noted the following items were improperly recorded as of June 30, 2024 and 2023, and during the three and six months ended June 30, 2024 and 2023:

 

●

As of June 30, 2024, prepaid expenses and other current assets were understated by $539,329 and for the three and six months ended June 30, 2024, research and development expenses were understated by $77,690 and $183,436, respectively.

 

●

As of June 30, 2023, prepaid expenses and other current assets were understated by $908,416 and for the three and six months ended June 30, 2023, research and development expenses were understated by $23,040 and $75,081, respectively.

 

4)

The Company noted the following items were improperly recorded as of September 30, 2024 and 2023, and during the three and nine months ended September 30, 2024 and 2023:

 

●

As of September 30, 2024, prepaid expenses and other current assets were understated by $442,365 and for the three and nine months ended September 30, 2024, research and development expenses were understated by $96,964 and $280,400, respectively.

 

●

As of September 30, 2023, prepaid expenses and other current assets were understated by $817,340 and for the three and nine months ended September 30, 2023, research and development expenses were understated by $91,076 and $166,157, respectively.

 

 

For all periods presented, the errors in the accounting for research and development expenses resulted in an understatement of prepaid assets and other current assets and an understatement of research and development expenses, operating expenses and net losses for the periods presented, respectively.

 

The restatement corrections impact certain components within operating cash flows of the respective 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.

 

The Company is currently working to complete the on time filing of its Annual Report on Form 10-K for the year ended December 31, 2024, which will include the Restatements.

 

The Company’s management and the Board have discussed the matters disclosed in this Current Report on Form 8-K pursuant to this Item 4.02(a) with WithumSmith+Brown, PC, the Company’s independent registered public accounting firm.

 

Forward-Looking Statements

 

This Current Report on Form 8-K contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company’s plans related to restatement of the financial statements as of and for each of the quarterly periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023 and the year ended December 31, 2023, and the Company’s estimates related to the errors included in the financial statements covering the Non-Reliance Periods. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including the outcome of the Company’s completion of the quantification and evaluation of the specific impact of the errors related to the classification and recording of certain prepaid expenses and other current assets and research and development expenses, including the possibility of material adjustments thereto, the discovery of additional and unanticipated information during the procedures required to be completed before the Company is able to file its Annual Report on Form 10-K for the year ended December 31, 2024. See also additional risk factors set forth in the Company’s periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled “Risk Factors,” in the Company’s Annual Report on Form 10-K filed with the SEC. All forward-looking statements in this Current Report on Form 8-K are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
10.1		Agreement by and between the Company and OnTargetx R&D Inc. dated March 24, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 25, 2025	Hoth Therapeutics, Inc.
	/s/ Robb Knie
	Robb Knie
	Chief Executive Officer

 

 

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Exhibit 10.1

 

CONFIDENTIAL

Project Order / Proposal N-0006

24-MAR-2025

 

OnTargetx R&D Inc.

 

THIS PROJECT ORDER NO. N-0006 is between Hoth Therapeutics (“CLIENT”) and OnTargetx R&D Inc. (“PROVIDER”), which upon execution by both parties, shall be incorporated into and subject to the terms and conditions of the Master Service Agreement between Hoth Therapeutics and PROVIDER.

 

CLIENT hereby engages PROVIDER to provide services as follows:

 

I.

Services

 

PROVIDER shall render to CLIENT the following Services:

 

P210614002-B: A 4-Week Intravenous Injection Toxicity Study Followed by a 14-Day Recovery Period in C57BL/6 Mice

 

II.	Project Scope / Work Plan Details (Study Outline)

 

ITR Study No:	701821
Dose formulation prep:	On days of dosing
Dose formulation analysis:	samples will be collected on the first and last preparation. Samples will be analysed at ITR using a validated HPLC method (study# 44901)
Number of mice**:	448 (224 males and 224 females) + 44 spares (22/sex)

 

					No. of Main Animals								No. of Recovery Animals								No. of TK Animals
Group No.		Treatment			Males				Females				Males				Females				Males				Females
1		Control			10				10				6				6				9				9
2		Low Dose			10				10				6				6				45				45
3		Mid Dose			10				10				6				6				45				45
4		High Dose			10				10				6				6				45				45
5		High dose - Murine			10				10				6				6				-				-

 

Acclimation:	14 days
Treatment:	intravenous injection on Days 1, 4, 7, 10, 13, 16, 19, 22, 25 and 28
Study duration:	28 days
Recovery:	14 days
Cage side observation and mortality:	daily (cage side am and mortality at the end of the working day)
Detailed exam:	weekly, all Main and Recovery mice
Body weights:	weekly
Food consumption:	weekly, all Main and Recovery mice
Ophthalmoscopy:	all Main and Recovery mice, 2 occasions (pre-treatment and during Week 4)
	Ophthalmoscopic examination of Recovery mice at the end of recovery period will be at the request of the Client and at additional cost
Clinical pathology:	haematology (5/sex/group Main, 3/sex/group Recovery) and blood chemistry (remaining 5/sex/group Main, 3/sex/group Recovery) - all Main and Recovery mice, 1 occasion (at termination)

 

 

TK:	all treated TK mice (terminal bleed, 3/sex/group/timepoint), 2 occasions (Days 1 and 28) at 7 timepoints/occasion (pre-dose and at 6 timepoints over a period of 24 hours post- dose) as well as 1 occasion (Day 42) at 1 timepoint. Control TK mice (terminal bleed, 3/sex), 3 occasions (Days 1, 28 and 42) at 1 timepoint/occasion. 288 Samples will be shipped frozen to the sponsor’s designated laboratory for analysis
TK non-compartmental Analysis:	WinNonlin Table Assembly (for 1 analyte) will be performed at ITR
Immunochemistry:	may be conducted upon further discussions and at additional cost
Necropsy:	all Main (Day 29) and Recovery (Day 42) mice (including preparation of bone marrow smears)
Organ weights:	all Main and Recovery mice
Tissue preservation:	full list, all Main and Recovery mice
Histopathology:	full list, all Main mice of the control and high dose groups as well as unscheduled deaths and any gross abnormalities from animals of all groups
	Examination of tissues of the target organs of all Main mice of the low and mid dose as well as all Recovery mice groups will be at the request of the Client and at additional cost.
	Peer-review will be at the request of the Client and at additional cost.
Archives:	1 year (any disposal, shipment or extended archiving will be at additional cost)
Draft Reporting:	12 weeks following the end of the study
Final Reporting:	4 weeks after receipt of client comments (the first two rounds of modifications to the report will be free of charge, changes made subsequent to the second round of changes will be at additional cost), only report sections that were subject to change will be submitted to the Client by the SD for final review.
SEND Datasets:	4-6 weeks post final report, may be subcontracted to Instem (Note that additional charges will apply if SEND is also produced at Draft)
	Additional charges may also apply if Client chooses to populate domains with data which is not modelled in SEND, hence not required by FDA (such as ADA, cytokines or Draize scoring)

  

III.	Research Partner/Third Party Provider

 

PROVIDER will use ITR Laboratories (ITR). as the Third Party Provider.

 

IV.

Timelines

 

The study start date is to be agreed upon between the PROVIDER and the CLIENT, and is to be determined.

 

V.	Study Location and Contacts

 

This study will be managed by OnTargetx R&D Inc. in the facilities of ITR.

 

	Provider Program Director:	Nicolay Ferrari
	Client Representative:	Amy Kaczmarek
	ITR Study Director:	Imran Shaikh

 

 

VI.	Compensation

 

VI.1.

Costing: (prices shown are in $US):

 

Description		Total ($US)
P210614002-B: A 4-WEEK INTRAVENOUS INJECTION TOXICITY STUDY FOLLOWED BY A 14-DAY RECOVERY PERIOD IN C57BL/6 MICE		$	354,219

 

VI.2.

Payment Schedule (term net 30 days):

 

Milestone		Description		%				Total ($US)*
Milestone 1		Due Upon Study Authorization			30	%		$	106,265.70
Milestone 2		Upon start of treatment			30	%		$	106,265.70
Milestone 3		Upon end of in-life treatment			30	%		$	106,265.70
Milestone 4		Upon receipt of draft report			10	%		$	35,421.90
Total					100	%		$	354,219

 

*	All payments are due 30 days following invoices except for the first instalment which is due immediately after receipt. If the final report is delayed through no fault of PROVIDER, any remaining invoices will be issued 3 months after the date on which the draft report was sent.

 

VII.	Early Termination/Postponement

 

CLIENT agrees to same terms and conditions as PROVIDER is bound to with Third Party Provider as shown below:

 

1.

The study start date will be defined as the animal arrival date.

 

2.

Delay by the CLIENT of the study start date will result in opportunity cost charges of $2,500 USD/week/room for each week the study is delayed if the delay occurs within two months of the scheduled study start date, or $5,000 USD/week/room for each week the study is delayed if the delay occurs within one month of the scheduled study start date. Any incurred costs caused by such a delay will be charged to the CLIENT. The study will be considered cancelled once the time of study delay exceeds 8 weeks.

 

3.

PROVIDER will make every effort to accommodate a CLIENT’s request for delay of the start of a study; however, may not be able to reschedule the study precisely as requested.

 

4.

Cancellation of the study by the CLIENT, through no fault of the PROVIDER, within 90 days of animal arrival will be subject to charges as follows:

 

Number of Days Notice		Cancellation Charges
1-30 days		20% of study price
30 to 60 days		10% of study price
60 to 90 days		5% of study price
Over 90 days		0% of study price

 

 

	5.	If the CLIENT cancels a study after animal arrival/transfer and before initiation of dosing, the following charges will apply:
		10% of the cancelled portion of the study cost plus animal costs plus husbandry at a rate of $5,000/week/room until relocation of animals or disposal. In addition, PROVIDER may request compensation for expenses actually incurred and/or irrevocably committed to (such as dedicated equipment, perishable or non-reusable supplies), and any non-recoverable expenses incurred (equipment lease, subcontractor charges, consultant charges, etc.).

 

6.

In the event the CLIENT terminates an on-going study (i.e. early termination following initiation of dosing), the CLIENT will be responsible for all incurred costs, committed costs and lost opportunity charges of $5,000 USD/room/week remaining in the Study, up to a total of 8 weeks.

 

7.

Exception to the above terms may be made on a case-by-case basis at PROVIDER’s sole discretion, (example: if the study cancellation or postponement has no financial impact on PROVIDER, etc).

 

VIII.

General

 

The Study work will commence and the draft report delivered as per the confirmed timeline agreed upon with the CLIENT or the CLIENT’s approved protocol and amendments, provided that the Third Party Provider receives all necessary Test Material and other data required to initiate the Study on the scheduled start date.

 

If no timeline is agreed upon on the signing date of this Study Contract and the Study is not initiated within 6 months of this date, or if the Study is not initiated within 3 months of the scheduled start date, the PROVIDER may revise the Study price. Any such change will be at the PROVIDER’s sole discretion, will be communicated with the CLIENT and will be captured in a separate Project Order, amendment or signed Supplementary Quotation.

 

It is understood that upon delivery by the PROVIDER of the draft report to the CLIENT, the CLIENT shall have ninety (90) days with which to file comments with PROVIDER. Failure by the CLIENT to provide any comments or communicate with PROVIDER respecting the draft report and its finalization will constitute the CLIENT’s acceptance of the draft report and authorization to PROVIDER to finalize the report. PROVIDER shall complete such finalization at its own convenience.

 

Repeat Sample Analysis

 

If applicable, the parties agree that as of commencement of work, in some instances, repeat of sample analysis may be required. If this arises, PROVIDER will notify the CLIENT as soon as possible. The price per sample analysis/occasion, as indicated in the pertinent study contract, will apply to any additional repeats requested by the CLIENT, as well as any samples above the analytical range, which require dilution. The PROVIDER will endeavour, when possible, to proceed with current batches of sample analysis and use a pre-dilution approach to minimize the number of re-analysis relating to the dilution of samples.

 

Authorization Statement

 

CLIENT hereby authorizes the PROVIDER to proceed with the necessary activities to initiate these services by the Third Party Performer. By executing this document CLIENT understands and agrees to the financial responsibility for all service fees, costs and expenses in accordance with Project Order Contract, including those incurred by Third Party Performer in preparation of Services. Any modification that requires an increase in cost subsequent from the effective date of this Project Order will be adjusted through an amended or additional Project Order.

 

 

Project Order Agreed To And Accepted by:

 

Hoth Therapeutics			OnTargetx R&D Inc.
By:	/s/ Hayley Springer		By:	/s/ Nicolay Ferrari
Print Name:	Hayley Springer		Print Name:	Nicolay Ferrari, PhD
Title:	EVP Operations		Title:	Senior Director of Research
Date:	March 24, 2025		Date:	March 24, 2025

 

 

 

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v3.25.1

Cover	Mar. 21, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 21, 2025
Entity File Number	001-38803
Entity Registrant Name	Hoth Therapeutics, Inc.
Entity Central Index Key	0001711786
Entity Tax Identification Number	82-1553794
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	1177 Avenue of the Americas
Entity Address, Address Line Two	5th Floor
Entity Address, Address Line Three	Suite 5066
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10036
City Area Code	646
Local Phone Number	756-2997
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Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.0001 par value
Trading Symbol	HOTH
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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