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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) December 30, 2021

 

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.)

 

1 Rockefeller Plaza, Suite 1039

New York, New York 10020

(Address of principal executive offices, including ZIP code)

 

(646756-2997

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

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 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

 

On December 30, 2021, Hoth Therapeutics, Inc. (the “Company”) was notified (the “Notification Letter”) by The Nasdaq Stock Market, LLC (“Nasdaq”) that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq  Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq  Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s common stock between November 16, 2021 and December 29, 2021, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq  Capital Market and, at this time, the common stock will continue to trade on The Nasdaq  Capital Market under the symbol “HOTH.” 

 

The Notification Letter provides that the Company has 180 calendar days, or until June 28, 2022, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the bid price of the Company's common stock must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. If the Company does not regain compliance by June 28, 2022, an additional 180 days may be granted to regain compliance, so long as the Company meets The Nasdaq Capital Market continued listing requirements (except for the bid price requirement) and notifies Nasdaq in writing of its intention to cure the deficiency during the second compliance period. If the Company does not qualify for the second compliance period or fails to regain compliance during the second 180-day period, then Nasdaq will notify the Company of its determination to delist the Company's common stock, at which point the Company will have an opportunity to appeal the delisting determination to a Hearings Panel.

 

The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options, including, but not limited to, implementing a reverse stock split of its outstanding securities, to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules.

 

Item 8.01 Other Events.

 

On January 4, 2022, the Company issued a press release announcing the proof-of-concept data generated using an Alzheimer’s disease mouse model, supporting the therapeutic potential of HT-ALZ pursuant to research conducted as part of the Company’s Sponsored Research Agreement with Washington University. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press release of Hoth Therapeutics, Inc. dated January 4, 2022
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

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: January 4, 2022 Hoth Therapeutics, Inc.
   
  /s/ Robb Knie
  Robb Knie
  Chief Executive Officer

 

 

2

 

 

Exhibit 99.1

 

 

Hoth Therapeutics Announces HT-ALZ Therapeutic Shows Positive Results - Reduce Amyloid β in Alzheimer’s Disease

 

Significant decrease in Aβ seen in an Alzheimer’s disease mouse model after acute treatment with HT-ALZ, supporting that HT-ALZ has the potential to modify Aβ plaque formation in the brain

 

NEW YORK, NY January 4, 2022/PR Newswire/ Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced proof-of-concept data generated using an Alzheimer’s disease mouse model, supporting the therapeutic potential of HT-ALZ. The research was conducted as part of the company’s Sponsored Research Agreement with Washington University in St. Louis. HT-ALZ is a therapeutic in development under the 505(b)(2) regulatory pathway for the treatment of dementia related to Alzheimer’s disease (AD).

 

AD is a neurodegenerative disease that is characterized by aggregates of amyloid β (Aβ) plaques and neurofibrillary tangles of Tau protein in the brain, which contribute to the clinical symptoms of the disease such as dementia. The initial experiments, conducted by Carla Yuede, PhD, Associate Professor of Psychiatry, and John Cirrito, PhD, Associate Professor of Neurology, at Washington University School of Medicine, focused on investigating the effect of orally administered HT-ALZ to reduce the concentration of Aβ in the brain interstitial fluid, using an established Alzheimer’s Disease mouse model (aged APP/PS1+/- mice). The initial data from these studies shows a significant decrease in Aβ in both male and female APP/PS1+/- mice after acute treatment with HT-ALZ, compared to placebo-treated animals and baseline Aβ levels, supporting that HT-ALZ has the potential to modify Aβ plaque formation in the brain and be developed as an AD therapeutic.

 

“The overall positive result from these studies is a first step but a big one in the development of HT-ALZ as an Alzheimer’s therapeutic,” said Stefanie Johns, Chief Scientific Officer of Hoth Therapeutics, Inc. “HT-ALZ is a unique therapeutic in the AD development space because it is eligible for streamlined development under the 505(b)(2) pathway, including available safety data. This allows Hoth to reach efficacy clinical trials faster and bring a new potential treatment for patients with Alzheimer’s disease.”

 

“The results of these experiments show a reduction in circulating brain Aβ in our model, and we are looking forward to determining how these changes influence behavior and cognitive function,” said Dr. Yuede.  

 

Future research studies to be conducted by Dr. Cirrito and Dr. Yuede will investigate the effect of HT-ALZ on memory, anxiety, and executive function in the APP/PS1+/- mice model after chronic dosing with HT-ALZ.

 

About Hoth Therapeutics, Inc.

 

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth’s pipeline development is focused to improve the quality of life for patients suffering from indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell derived cancers and anaphylaxis and pneumonia. Hoth has also entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19. To learn more, please visit https://ir.hoththerapeutics.com/.

 

 

 

 

 

 

Forward-Looking Statement

 

This press release includes forward-looking statements based upon Hoth’s current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth’s business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of Hoth’s products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth’s business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth’s intellectual property; Hoth’s reliance on third party organizations; Hoth’s competitive position; Hoth’s industry environment; Hoth’s anticipated financial and operating results, including anticipated sources of revenues; Hoth’s assumptions regarding the size of the available market, benefits of Hoth’s products, product pricing, timing of product launches; management’s expectation with respect to future acquisitions; statements regarding Hoth’s goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth’s cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place undue reliance on these forward-looking statements, which include words such as “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” or similar terms, variations of such terms or the negative of those terms. Although Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled “Risk Factors” in Hoth’s most recent Annual Report on Form 10-K and Hoth’s other filings made with the U.S. Securities and Exchange Commission. All such statements speak only as of the date of this press release. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.

 

Investor Contact:

 

LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791