NEW YORK, Oct. 2, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced the Pre-IND meeting requested on September 8th for HT-KIT with the U.S. Food and Drug Administration (FDA) has been granted to receive written responses only from the FDA that are targeted for delivery on November 7, 2023..

纽约，2023年10月2日/PRNewswire/-Hoth Therapeutics，Inc。（纳斯达克股票代码：Hoth），一家以患者为重点的生物制药公司，今天宣布了9月8日要求与美国食品和药物管理局（FDA）仅收到FDA于2023年11月7日交付的书面回复。。

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA.

HT-KIT是一种反义寡核苷酸，通过诱导mRNA移码来靶向原癌基因cKIT，并且已经从FDA获得孤儿药名称。

The Pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls. The proposed clinical trial designs for the first clinical studies in the HT-KIT program are also included in the Pre-IND meeting topics to receive FDA feedback..

IND前会议主题包括HT-KIT总体药物开发计划的可接受性，包括非临床，临床药理学，临床，化学和制造控制的要求。HT-KIT计划中首次临床研究的拟议临床试验设计也包含在IND前会议主题中，以接收FDA反馈。。

'We are looking forward to receiving feedback from the FDA to continue advancing the HT-KIT program towards the clinic as efficiently as possible,' stated Robb Knie, Chairman and CEO of Hoth Therapeutics. 'Receiving feedback from the FDA in November positions us well to achieve our planned IND-enabling development activities on time with the eventual goal of initiating the first HT-KIT clinical trial in patients.'.

Hoth Therapeutics主席兼首席执行官Robb Knie说：“我们期待收到FDA的反馈，继续尽可能有效地将HT-KIT计划推向临床。”11月份收到FDA的反馈意见，使我们能够按时完成我们计划的IND开发活动，最终目标是在患者中启动第一个HT-KIT临床试验。

About Hoth Therapeutics, Inc.

关于Hoth Therapeutics，Inc。

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop 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.

Hoth Therapeutics是一家临床阶段的生物制药公司，致力于开发创新，有影响力和突破性的治疗方法，旨在提高患者的生活质量。我们是早期药物研究和开发的催化剂，将药物从实验室提升到临床前和临床试验。

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/ ..

利用以患者为中心的方法，我们与科学家，临床医生和主要意见领袖团队合作并合作，寻找和研究具有巨大潜力的治疗方法，以创造突破和多样化治疗方案。要了解更多信息，请访问https://ir.hoththerapeutics.com/ ..

Forward-Looking Statement

前瞻性声明

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.

本新闻稿包括基于Hoth当前预期的前瞻性声明，这些声明可能构成1995年“私人证券诉讼改革法”和其他联邦证券法下的安全港条款的前瞻性声明，并且存在重大风险，不确定性和假设。

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.

这些陈述涉及Hoth的业务策略；监管提交的时间；获得并保持我们可能开发的现有候选产品和任何其他候选产品的监管批准的能力，以及我们可能获得的任何批准下的标签；临床试验的时间和成本，其他费用的时间和成本；市场接受我们的产品；当前冠状病毒大流行或任何其他健康流行病对我们的业务，我们的临床试验，我们的研究计划，医疗保健系统或整个全球经济的最终影响；我们的知识产权；我们对第三方组织的依赖；我们的竞争地位；我们的行业环境；我们预期的财务和运营成果，包括预期的收入来源；我们对可用市场规模，产品收益，产品定价，产品发布时间的假设；管理层对未来收购的期望；关于我们的目标，意图，计划和期望的陈述，包括新产品和市场的推出；以及我们的现金需求和融资计划。

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,' 'esti.

有许多因素可能导致实际事件与此类前瞻性陈述所表明的事件有很大差异。您不应该依赖这些前瞻性陈述，其中包括“可以”，“相信”，“预期”，“打算”，“估计”等词语。

Investor Contact: LR Advisors LLC Email: [email protected] www.hoththerapeutics.com Phone: (678) 570-6791

投资者联系人：LR Advisors LLC电子邮件：[电子邮件保护]www.hoththerapeutics.com电话：（678）570-6791

SOURCE Hoth Therapeutics, Inc.

SOURCE Hoth Therapeutics，Inc。