Benzinga | Nov 30, 2021 04:44PM EST

EXCLSUIVE: Hoth Therapeutics Says Enrollment And Dosing Has Begun For Second Cohort In First In-Human Clinical Trial Investigating Topical BioLexa For The Treatment Of Mild-To-Moderate Atomic Dermatitis

NEW YORK, NY November 30, 2021/ PR Newswire/ Hoth Therapeutics, Inc. (NASDAQ:

HOTH), a clinical-stage biopharmaceutical company focused on developing new generation

therapies for unmet medical needs, is pleased to announce that enrollment and dosing has begun

for the second cohort in its First in Human clinical trial investigating topical BioLexa for the

treatment of mild to moderate atopic dermatitis, also known as eczema.

"We are excited to have reached this pivotal milestone in our BioLexa development program to

begin dosing adult patients," stated Stefanie Johns, Chief Scientific Officer of Hoth

Therapeutics. "The second cohort is exclusively made up of current atopic dermatitis patients

and we look forward to sharing top of the line data in 2022."

Hoth is conducting the BioLexa clinical trial in Australia Patient enrollment continues for Phase

1. Anyone in Australia that is interested may review trial requirements at ClinicalTrials.Gov.

About BioLexa

BioLexa is a patented, proprietary antimicrobial topical formulation being developed for

treatment of diseases mediated by Staphylococcal biofilms. Bacterial biofilms are specialized

communities consisting of bacteria adhered to a surface (both biological and abiotic surfaces)

and to other bacteria, and often with a protective extracellular matrix. Mature bacterial biofilms

often result in chronic, recurrent infections that are difficult to treat due to the barrier effect of

the biofilm that facilitates antibiotic resistance and avoiding immune system mechanisms. The

BioLexa formulation is optimized to prevent Staphylococcal biofilm formation, keeping the

bacteria in a more susceptible state to antimicrobial therapy. This novel mechanism of action has

the potential to broadly treat clinical manifestations resulting from Staphylococcal biofilm

formation.

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, 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 www.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 we may

develop, and the labeling under any approval we may obtain; the timing and costs of clinical

trials, the timing and costs of other expenses; market acceptance of our products; the ultimate

impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our

clinical trials, our research programs, healthcare systems or the global economy as a whole; our

intellectual property; our reliance on third party organizations; our competitive position; our

industry environment; our anticipated financial and operating results, including anticipated

sources of revenues; our assumptions regarding the size of the available market, benefits of our

products, product pricing, timing of product launches; management's expectation with respect to

future acquisitions; statements regarding our goals, intentions, plans and expectations, including

the introduction of new products and markets; and our 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 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 the Company believes that the expectations

reflected in the forward-looking statements are reasonable, the Company 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 made. Consequently, forward-looking statements should be

regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue

reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of

activity, performance or achievements. Hoth does not undertake and specifically declines any

obligation to update, republish, 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.