Core Viewpoint - CERo Therapeutics Holdings, Inc. has submitted a Complete Response Letter to the FDA regarding the clinical hold on its lead product candidate, CERO-1236, and anticipates a potential start of human trials in early 2025 [2][4]. Company Updates - The company has made significant changes to its management team, including the appointment of Al Kucharchuk as Chief Financial Officer and the promotion of Kristen Pierce to Chief Development Officer, both of whom bring valuable experience to the company [2][3]. - CERo disclosed a cash balance of $3.2 million as of September 30, 2024, which is expected to provide sufficient runway for executing its strategy [3]. Product Development - CERo is focused on advancing engineered T cell therapeutics, specifically through its proprietary Chimeric Engulfment Receptor T cells (CER-T), which aim to enhance cancer therapy by integrating characteristics of both innate and adaptive immunity [4]. - The company plans to initiate clinical trials for CERO-1236 targeting hematological malignancies in early 2025, following the resolution of the clinical hold [4].

SOUTH SAN FRANCISCO, Calif, Oct. 02, 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, announces key appointments to the Company's management team to support recently named interim CEO, Chris Ehrlich. Andrew Albert "Al" Kucharchuk has been named Chief Financial Officer and Kristen Pierce, Ph.D., has been appointed Chief Development O ...

Company requests Type A Meeting with U.S. Food and Drug Administration regarding clinical hold for CER1236; announces key management changes SOUTH SAN FRANCISCO, Calif., Sept. 25, 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, today announced that existing investors have committed a financing of $1.25 million. With these funds the ...

Revenue and Financial Performance - CERo Therapeutics Holdings, Inc. has not recognized any revenue from product sales and does not expect to generate revenue in the foreseeable future[128]. - The net loss for the three-month period ended June 30, 2024, was $2.4 million, compared to a net loss of $2.1 million for the same period in 2023, an increase of 17%[136]. - For the six-month period ended June 30, 2024, research and development expenses were $4.4 million, up from $3.0 million in the same period in 2023, reflecting a 47% increase[145]. - General and administrative expenses for the six-month period ended June 30, 2024, were $5.3 million, compared to $1.9 million for the same period in 2023, indicating a 179% increase[144]. - Total operating expenses for the six-month period ended June 30, 2024, were $9.7 million, compared to $4.9 million for the same period in 2023, representing a 99% increase[143]. - Interest and other income, net, was $5.0 million for the six-month period ended June 30, 2024, compared to $0.3 million for the same period in 2023, reflecting an increase of 1567%[147]. - The Company reported a net increase in cash and cash equivalents of $1.1 million for the six months ended June 30, 2024, compared to a decrease of $2.9 million in the same period of 2023[153]. Research and Development - The company plans to significantly increase its R&D expenses as it continues the development of its product candidates through clinical development[130]. - Research and development expenses increased to $2.7 million for the three-month period ended June 30, 2024, compared to $1.2 million for the same period in 2023, reflecting a 125% increase[138]. - The company anticipates significant increases in R&D expenses in the future due to expanded preclinical and clinical development activities[146]. Compliance and Regulatory Matters - On June 28, 2024, the company submitted an Investigational New Drug Application for its product candidate CER-1236, but the FDA placed a clinical hold due to insufficient data[121]. - The company received a letter from Nasdaq indicating that the closing bid price for its common stock has been below the minimum $1.00 per share required for continued listing[122]. - The company has until January 15, 2025, to regain compliance with the Bid Price Requirement and until October 29, 2024, for the Market Value of Publicly Held Shares Requirement[125]. - The company is actively monitoring its stock price and market value to address compliance with Nasdaq listing standards[126]. Financing and Capital Structure - The company completed a private placement in February 2024, raising approximately $10.0 million from the issuance of Series A Preferred Stock and warrants[120]. - The company has arranged two equity lines of credit, one for the sale of up to 25 million shares and another for the purchase of up to $25 million of Common Stock[150]. - The Company expects to continue relying on additional financing to achieve its business objectives, as commercial revenues from product candidates are not expected in the near term[152]. - The Company may need to seek additional funds sooner than planned due to changing circumstances that could affect cash availability[150]. - The Company has no guarantee that the conditions for the equity line of credit will be satisfied, which may impact future funding[150]. General and Administrative Expenses - General and administrative expenses rose to $2.4 million for the three-month period ended June 30, 2024, up from $1.2 million in the same period in 2023, marking a 108% increase[137]. Emerging Growth Company Status - The company is classified as an "emerging growth company" and is utilizing the extended transition period for compliance with new accounting standards[172]. - The company is permitted to present only two years of audited financial statements, along with required unaudited interim financial statements[173]. - The company is exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act[173]. - The company will cease to qualify as an emerging growth company if total annual gross revenues exceed $1.07 billion[175]. - The company may also lose its status if the market value of its Common Stock held by non-affiliates exceeds $700 million[175]. - The company has taken advantage of certain reduced reporting requirements in its Form 10-Q[175]. - The company has the option to choose which reduced reporting burdens to take advantage of[175]. - The information provided may differ from that of other public companies due to the reduced reporting requirements[175].

Core Insights - CERo Therapeutics is preparing for initial human trials of its lead compound CER-1236 targeting acute myeloid leukemia (AML) following IND clearance [1][4] - The company presented data at the Global Cell & Gene Therapy Summit 2024, highlighting the prevalence of TIM-4-L in AML and its potential as a target for engineered T cell therapy [2][3] Company Overview - CERo Therapeutics is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that combines innate and adaptive immunity [5] - The company aims to create Chimeric Engulfment Receptor T cells (CER-T) that can potentially treat both hematological malignancies and solid tumors, with clinical trials for CER-1236 anticipated to start in 2024 [5] Research Findings - The poster presented at the summit indicates that TIM-4-L is commonly expressed in various AML subsets but absent in healthy tissues, making it a viable therapeutic target [2] - CER-1236 demonstrated significant in vitro and in vivo cytotoxicity against TP53 mutant AML, with toxicity studies showing no adverse effects on healthy tissue even at high doses [2][3]

As filed with the Securities and Exchange Commission on June 27, 2024 Registration No. 333-279156 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 81-4182129 (I.R.S. Employer Identifi ...

As filed with the Securities and Exchange Commission on June 27, 2024 Registration No. 333-279156 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 81-4182129 (I.R.S. Employer Identifi ...

As filed with the Securities and Exchange Commission on June 5, 2024 Registration No. 333-279156 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 81-4182129 (I.R.S. Employer Identific ...

As filed with the Securities and Exchange Commission on June 5, 2024 Registration No. 333-279156 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 81-4182129 (I.R.S. Employer Identific ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-40877 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) | Delaware | 87-1088814 | | --- | --- | ...