Cero Therapeutics submits IND clinical hold CRL to the FDA

CERo Therapeutics (CERO) provides the following corporate update to stockholders from Interim CEO Chris Ehrlich, “Following the events of the last several months, I believe it appropriate to discuss our recent progress and illuminate the path forward for CERo. As you know, we received notice of a clinical hold for CERO-1236 earlier this year. Since then, we have been diligently working to complete the experimental studies necessary to address and resolve the U.S. Food and Drug Administration’s questions. We recently completed communications with the FDA, in which we were able to gain feedback on our approach to addressing the Agency’s questions. We have now submitted our Complete Response Letter to the Agency and look forward to what we hope will be the authorization to begin human trials. That said, given the blocks of time between submission to the Agency and their expected 30-day response time, we feel it is more realistic to adjust our previous guidance about potential entry into the clinic from 2024 to early 2025. We are also very pleased to have made important changes to our management team and Board of Directors. As previously announced, Al Kucharchuk has joined as our new CFO. Al is well versed in the unique challenges associated with small and microcap life sciences companies in the public markets, having deep experience in both since 2006. In addition, as previously announced, we have promoted Kristen Pierce to the position of Chief Development Officer. Kristen has deep expertise in the management of preclinical oncology programs and has been instrumental in our development of CERO-1236. We believe that that our team is well-positioned to help drive our science and our business forward. We have also made several changes to our Board of Directors, which we believe will enhance our execution of our business plan and we are well-positioned to do so. Finally, we recently disclosed our cash balance of $3.2 million as of September 30, 2024, which we are optimistic should provide sufficient runway to execute on our strategy. I anticipate providing an update on FDA’s determination whether to release the clinical hold, as well as our path forward in the coming weeks and months and remain excited for the future of CERo. Thank you for your continued interest in our company, and the trust you continue to show both our management and our science.”