Hoth Therapeutics Announces Expansion of Clinical Sites for HT-001 Phase 2a Trial

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) has expanded its clinical sites for the HT-001 Phase 2a trial, adding Dana-Farber Cancer Institute in Boston and Montefiore Medical Center in New York. The trial, approved by Institutional Review Boards, aims to evaluate HT-001 for treating skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi). This First-in-Human study will assess the efficacy, safety, and tolerability of topical HT-001. CEO Robb Knie expressed optimism about the trial's potential to help cancer patients suffering from EGFRi-related skin toxicities. Notably, Hoth ended the previous quarter with over $9 million in cash and has no plans for further capital raising in 2024.

Positive

• Expansion of clinical trial sites to include prestigious institutions
• Institutional Review Board approval received for Phase 2a trial
• Strong cash position of over $9 million
• No plans for additional capital raising in 2024

Negative

• None.

Insights

Clinical Research Analyst

The expansion of clinical sites for Hoth Therapeutics' HT-001 Phase 2a trial is a positive development in their research pipeline. The addition of prestigious institutions like Dana-Farber and Montefiore enhances the trial's credibility and potential patient recruitment. This move could accelerate the study's progress and provide more robust data.

The focus on treating skin toxicities associated with EGFRi is addressing an unmet medical need in cancer supportive care. If successful, HT-001 could significantly improve quality of life for cancer patients undergoing EGFRi treatments. However, investors should note that Phase 2a results are still preliminary and success is not guaranteed.

The company's strong cash position of over $9 million and no plans for capital raising in 2024 indicate financial stability for the near term, which is important for a small biotech firm conducting clinical trials.

Financial Analyst

Hoth Therapeutics' announcement is moderately positive for investors. The expansion of clinical sites suggests progress in their lead candidate's development, potentially increasing the company's value if successful. However, as a small-cap biotech, Hoth remains a high-risk investment.

The $9 million cash position is a key highlight, providing runway for operations without immediate dilution concerns. This financial stability is important for a development-stage biotech, especially given the volatile market conditions.

Investors should monitor the trial's progress closely, as positive results could significantly impact the stock price. However, it's important to note that many Phase 2 trials fail and Hoth's market cap suggests high risk. Diversification and careful portfolio management are advised when considering such speculative investments.

Dana-Farber Cancer Institute in Boston, MA and Montefiore Medical Center in New York, NY Join Clinical Trial

NEW YORK, Sept. 5, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced today that it has received Institutional Review Board approval from the Montefiore Medical Center and the Dana-Farber Cancer Institute to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).

"We are very pleased to have received approval from these two world class medical centers for our FIH clinical trial," said Hoth Therapeutics Chief Executive Officer, Robb Knie. "We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001 and bring hope to cancer patients suffering from skin toxicities associated with EGFRi treatments." Knie further stated, "Hoth ended the prior quarter with over $9 million in cash and has no plans for further capital raise in 2024."

This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at clinicaltrials.gov.

About Hoth Therapeutics, Inc.  

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. 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 we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and 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, and 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 titled "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 the purpose of Hoth Therapeutics' HT-001 Phase 2a trial?

The HT-001 Phase 2a trial aims to investigate the efficacy, safety, and tolerability of topical HT-001 for treating skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients.

Which new clinical sites have been added to Hoth Therapeutics' HT-001 trial?

Hoth Therapeutics (HOTH) has added Dana-Farber Cancer Institute in Boston, MA and Montefiore Medical Center in New York, NY as new clinical sites for the HT-001 Phase 2a trial.

What is Hoth Therapeutics' (HOTH) financial position as of September 2024?

As of September 2024, Hoth Therapeutics (HOTH) reported ending the previous quarter with over $9 million in cash and stated they have no plans for further capital raising in 2024.

Has Hoth Therapeutics (HOTH) received regulatory approval for the HT-001 trial?

Yes, Hoth Therapeutics (HOTH) has received Institutional Review Board approval from both Montefiore Medical Center and Dana-Farber Cancer Institute to proceed with the HT-001 Phase 2a clinical trial.