CERo Therapeutics, Inc. Provides Corporate Update

Rhea-AI Summary

CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has provided a corporate update to stockholders. Key points include:

• Submission of a Complete Response Letter to the FDA addressing the clinical hold on CERO-1236
• Adjustment of potential clinical trial entry from 2024 to early 2025
• Appointment of Al Kucharchuk as new Chief Financial Officer
• Promotion of Kristen Pierce to Chief Development Officer
• Changes to the Board of Directors to enhance business plan execution
• Disclosure of a $3.2 million cash balance as of September 30, 2024

The company remains optimistic about its future and anticipates providing updates on the FDA's determination regarding the clinical hold in the coming weeks.

Positive

• Submission of Complete Response Letter to FDA addressing clinical hold on CERO-1236
• Appointment of experienced CFO Al Kucharchuk
• Promotion of Kristen Pierce to Chief Development Officer
• Changes to Board of Directors to enhance business plan execution
• $3.2 million cash balance as of September 30, 2024

Negative

• Delay in potential clinical trial entry from 2024 to early 2025
• Ongoing clinical hold on CERO-1236

Insights

Biotech Analyst

The submission of the Complete Response Letter to address the FDA's clinical hold on CERO-1236 is a critical step for CERo Therapeutics. While the delay in potential clinical entry to early 2025 is a setback, it's not uncommon in biotech development. The $3.2 million cash balance as of September 30, 2024, provides some runway, but it's relatively tight for a biotech company, potentially necessitating additional funding soon.

The management changes, particularly the addition of Al Kucharchuk as CFO with microcap experience, could be beneficial for navigating financial challenges. Kristen Pierce's promotion to CDO may streamline preclinical development. However, the company's future hinges heavily on the FDA's response to the Complete Response Letter. Investors should watch closely for the FDA's decision, as it will significantly impact CERo's trajectory and potential need for capital raise.

Regulatory Affairs Specialist

The submission of the Complete Response Letter is a important regulatory milestone for CERo Therapeutics. The company's engagement with the FDA prior to submission is a positive sign, potentially increasing the chances of a favorable review. However, the adjustment of the clinical entry timeline from 2024 to early 2025 indicates significant regulatory hurdles.

The 30-day FDA response time mentioned is standard, but resolution of clinical holds often takes longer, especially if additional data or clarifications are required. Investors should be prepared for potential further delays. The company's transparency about the timeline shift is commendable from a regulatory perspective, but it also signals the complexity of the issues raised in the clinical hold. The outcome of this regulatory interaction will be pivotal for CERo's development pipeline and investor confidence.

Company announces submission of IND Clinical Hold Complete Response Letter

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo”), an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, provides the following corporate update to stockholders from Interim CEO Chris Ehrlich.

To our Valued Stockholders:

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 (the “Agency” or the “FDA”) 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 Chief Financial Officer. 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.

Sincerely,
Chris Ehrlich
Interim CEO
CERo Bio

About CERo Therapeutics, Inc.
CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in early 2025 for hematological malignancies.

Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy, clinical development of CER-1236, and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.

Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investors:
CORE IR
investors@cero.bio

FAQ

What is the current status of CERO-1236's clinical hold?

CERo Therapeutics has submitted a Complete Response Letter to the FDA addressing the clinical hold on CERO-1236 and is awaiting the agency's response.

When does CERo Therapeutics (CERO) expect to begin human trials for CERO-1236?

CERo Therapeutics has adjusted its guidance for potential entry into clinical trials from 2024 to early 2025, pending FDA authorization.

Who are the new key management appointments at CERo Therapeutics (CERO)?

CERo Therapeutics has appointed Al Kucharchuk as the new Chief Financial Officer and promoted Kristen Pierce to Chief Development Officer.

What is CERo Therapeutics' (CERO) current cash position as of September 30, 2024?

CERo Therapeutics reported a cash balance of $3.2 million as of September 30, 2024.