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Hoth Therapeutics Announces Production of HT-001 for Cancer Treatment

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Hoth Therapeutics, Inc. (NASDAQ: HOTH) has signed a production agreement with Tergus Pharma for GLP and GMP materials related to its cancer treatment drug, HT-001. This follows their request for a Pre-Investigational New Drug meeting with the FDA regarding HT-001, which targets skin disorders associated with EGFR inhibitor therapy. Hoth aims to alleviate dose-limiting skin toxicities, thus enhancing patient outcomes in cancer treatments. CEO Robb Knie expressed optimism for the drug's development and its potential to benefit patients.

Positive
  • Production agreement with Tergus Pharma for HT-001 materials.
  • Request submitted for a Pre-IND meeting with the FDA.
  • HT-001 targets skin disorders caused by EGFR inhibitors, improving treatment adherence.
Negative
  • None.

NEW YORK, Dec. 31, 2020 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced that it has signed a production agreement for both GLP and GMP materials associated with HT-001  with Tergus Pharma for its novel cancer treatment drug, HT-001.

This announcement follows the recent news that Hoth has requested a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss a proposed drug development program for the novel treatment. 

HT-001 is a topical formulation designed for the treatment of patients with mild to moderate rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy.   EGFR inhibitors are used for treatment of cancers with EGFR up-regulation (such as non-small cell lung cancer, pancreatic cancer, breast cancer, and colon cancer). EGFR inhibitors are often associated with dose-limiting skin toxicities that can result in interruption of treatment.  HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential outcomes of EGFR therapy.

"Hoth management is pleased with the advancement of our HT-001 treatment throughout the developmental process," said Robb Knie, CEO of Hoth Therapeutics. "Patients struggling with dermatological ailments have been known to halt, and even discontinue potentially life-saving oncology treatments.  Our hope that is our topical therapeutic will provide care to those in need."

About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth's pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. Hoth has also recently entered into two different agreements to further the development of two different 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.

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

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SOURCE Hoth Therapeutics, Inc.

FAQ

What is Hoth Therapeutics announcing regarding HT-001?

Hoth Therapeutics announced a production agreement with Tergus Pharma for HT-001 materials.

When did Hoth Therapeutics make this announcement?

The announcement was made on December 31, 2020.

What is the purpose of HT-001?

HT-001 is designed to treat skin disorders caused by EGFR inhibitors in cancer patients.

What has Hoth Therapeutics requested from the FDA?

Hoth has requested a Pre-Investigational New Drug meeting to discuss HT-001's development.

What is the stock symbol for Hoth Therapeutics?

The stock symbol for Hoth Therapeutics is HOTH.

Hoth Therapeutics, Inc.

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Biotechnology
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