PaxMedica提交纳斯达克退市上诉通知，并为即将召开的美国食品药品监督管理局PAX-101会议做准备-动脉网

PaxMedica Files Nasdaq Delisting Appeal Notice and Prepares for Upcoming FDA Meeting on PAX-101

BioSpace 等信源发布 2024-05-15 21:09

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TARRYTOWN, New York, May 15, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (the “Company” or “PaxMedica”) (OTC:PXMD), a biopharmaceutical company dedicated to advancing treatments for neurological disorders, today announced it has timely filed a formal notice of appeal with the Nasdaq Office of Appeals and Review to reverse the decision of a Nasdaq Hearings Panel to delist the Company from Nasdaq.

纽约塔里敦，2024年5月15日（环球通讯社）--通过IBN--PaxMedica，Inc.（以下简称“公司”或“PaxMedica”）（OTC:PXMD），一家致力于推进神经系统疾病治疗的生物制药公司，今天宣布它已及时向纳斯达克上诉和审查办公室提交正式上诉通知，以推翻纳斯达克听证会小组将该公司从纳斯达克退市的决定。

Following receipt of notification from Nasdaq on April 30th, PaxMedica determined to appeal the decision and intends to maintain that the Hearings Panel did not consider sufficiently or appropriately crucial aspects of PaxMedica’s recent achievements and ongoing actions to regain compliance with all applicable requirements for continued listing.

在4月30日收到纳斯达克的通知后，PaxMedica决定对该决定提出上诉，并打算维持听证会小组没有充分或适当地考虑PaxMedica最近取得的成就和正在采取的行动的关键方面，以重新遵守继续上市的所有适用要求。

PaxMedica has retained Jacob Frenkel, Dickinson Wright, PLLC as its lead counsel in the appeal, working with the consulting firm that interacted previously with the Hearings Panel..

PaxMedica已聘请Jacob Frenkel、Dickinson Wright、PLLC作为上诉的首席律师，与之前与听证会小组互动的咨询公司合作。。

Howard Weisman, CEO of PaxMedica, commented, 'We are seeking a reevaluation of Nasdaq’s recent action based on new developments that underscore our ongoing progress and commitment to addressing global health challenges. Notably, following our announcements on the completion of registration lots of PAX-101 in mid-April, the Company just submitted a briefing book for an important FDA Type C meeting scheduled for June 27th, during which we will present key updates on our plans for NDA submission later this year.

PaxMedica首席执行官霍华德·魏斯曼（HowardWeisman）评论道，“我们正在寻求根据新的发展重新评估纳斯达克最近的行动，这些新发展强调了我们在应对全球健康挑战方面正在取得的进展和承诺。值得注意的是，在我们于4月中旬宣布完成PAX-101注册批次后，该公司刚刚为定于6月27日举行的重要FDA C型会议提交了一份简报，在此期间，我们将在今年晚些时候介绍我们提交NDA计划的关键更新。

We believe this, as well as our financing plans, which we made known to the Hearings Panel, support persuasively our arguments to appeal and restore trading on Nasdaq.'.

我们相信这一点，以及我们向听证会小组公布的融资计划，都有力地支持了我们上诉并恢复纳斯达克交易的论点。”。

Recent milestones for PaxMedica include:

PaxMedica最近的里程碑包括：

April 11th: Completion of three pivotal registration/validation batches of PAX-101, an IV formulation of suramin, crucial for ongoing regulatory submissions.

4月11日：完成PAX-101的三个关键注册/验证批次，PAX-101是苏拉明的IV制剂，对于正在进行的监管提交至关重要。

April 16th: Receipt of an urgent request from Malawi’s Ministry of Health for emergency access to suramin to address a looming humanitarian crisis due to the scarcity of treatment for TBr HAT, a fatal form of African Sleeping Sickness.

4月16日：收到马拉维卫生部的紧急请求，要求紧急进入苏拉明，以应对迫在眉睫的人道主义危机，因为TBr HAT（一种致命的非洲昏睡病）缺乏治疗。

April 23rd: Agreement to supply Malawi with PAX-101 from our stock, reinforcing our role in combating global health emergencies.

4月23日：同意从我们的库存中向马拉维供应PAX-101，加强了我们在应对全球卫生紧急情况中的作用。

May 10th: PaxMedica submits FDA Briefing Book for June 27, 2024, Type C meeting.

5月10日：PaxMedica为2024年6月27日的C类会议提交FDA简报。

Weisman stated 'these actions not only demonstrate our operational effectiveness, but also our vital role in the global healthcare landscape. We are encouraged that the upcoming FDA meeting, and our continuous efforts to supply life-saving treatments, will result in favorable consideration by Nasdaq in our appeal.' Nevertheless, PaxMedica acknowledges that it cannot predict the outcome of the appeal.

魏斯曼表示，“这些行动不仅证明了我们的运营效率，也证明了我们在全球医疗保健领域的重要作用。我们感到鼓舞的是，即将召开的FDA会议，以及我们不断努力提供挽救生命的治疗方法，将在我们的呼吁中得到纳斯达克的积极考虑。”然而，帕克梅迪卡承认，它无法预测上诉的结果。

Weisman added that “we are committed to advancing expeditiously our efforts to maximize shareholder opportunities and value and pursue approval of our solutions for neurological disorders.”.

魏斯曼补充说，“我们致力于迅速推进我们的努力，以最大限度地增加股东的机会和价值，并寻求批准我们的神经疾病解决方案。”。

PaxMedica remains resolute in its mission to develop and provide innovative treatments for neurological disorders, ensuring significant contributions to public health worldwide. For more information on PaxMedica’s ongoing initiatives and developments, please visit www.paxmedica.com.

PaxMedica仍然坚定地致力于开发和提供神经疾病的创新治疗方法，确保为全球公共卫生做出重大贡献。有关PaxMedica正在进行的举措和发展的更多信息，请访问www.PaxMedica.com。

About PaxMedica

关于PaxMedica

PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field.

PaxMedica，Inc.是一家具有前瞻性的临床阶段生物制药公司，专门从事尖端的抗嘌呤能药物治疗（APT），旨在解决一系列具有挑战性的神经系统疾病。我们的综合投资组合涵盖了一系列疾病，包括自闭症谱系障碍（ASD）等神经发育障碍，以及神经病学领域的其他关键领域。

Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense..

此外，我们打算为世界其他地区提供额外的可靠苏拉明来源，苏拉明是罗得西亚布氏锥虫第一阶段公认的护理标准。。

We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions.

我们致力于不断开发和评估我们的开创性计划PAX-101，这是一种静脉注射苏拉明制剂，是我们努力的核心，特别专注于创新的ASD治疗解决方案。我们正在进行的研究计划不仅优先考虑ASD患者的需求，而且还扩展到探索相关疾病的潜在治疗应用。

To learn more about our transformative work, please visit www.paxmedica.com..

要了解有关我们变革性工作的更多信息，请访问www.paxmedica.com。。

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.paxmedica.com/email-alerts and by following PaxMedica on Twitter and LinkedIn.

鼓励感兴趣的投资者和股东通过注册电子邮件警报注册新闻稿和行业更新https://www.paxmedica.com/email-alerts通过在Twitter和LinkedIn上关注PaxMedica。

Forward-Looking Statements

前瞻性声明

This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions.

本新闻稿包含“前瞻性声明”。前瞻性声明反映了我们目前对未来事件的看法。投资者可以用“可能”、“将”、“可能”、“预期”、“预期”、“目标”、“估计”、“打算”、“计划”、“相信”、“是/可能”、“提议”、“潜在”、“继续”或类似的词语或短语来识别这些前瞻性陈述。

These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, and distribution and demand for our product candidates. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs.

这些前瞻性声明包括我们预期的临床计划，预期数据发布的时间和成功，临床前和临床试验以及监管文件，以及对候选产品的分布和需求。这些前瞻性陈述涉及已知和未知的风险和不确定性，并基于公司目前对未来事件的预期和预测，公司认为这些事件可能会影响其财务状况、经营成果、业务战略和财务需求。

Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn, regulatory approvals and risks associated with intellectual property and infringement claims.

此类风险和不确定性包括但不限于与公司开发工作相关的风险，包括公司产品开发和临床试验的时间、成本和成功的任何延迟或变化，资本资源不足的风险，现金资助和现金消耗，监管批准以及与知识产权和侵权索赔相关的风险。

The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may.

公司没有义务公开更新或修改任何前瞻性声明，以反映随后发生的事件或情况，或其预期的变化，除非法律可能要求。虽然公司认为这些前瞻性声明中表达的期望是合理的，但它不能向您保证这些期望将证明是正确的，公司提醒投资者，实际结果可能是正确的。

Contacts

联系人

PaxMedica, Inc.

PaxMedica公司。

303 S Broadway,

百老汇大街303号，

Suite 125.

125号套房。

Tarrytown, NY 10591

纽约州塔里敦10591

www.paxmedica.com