Completion of DLT observation period for Cohort 1; first patient in Cohort 2 dosed at higher cell level; additional dosing in Cohort 1 SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces recent advances to the CertainT-1 trial that is focused on patients with acute myeloid leukemia (AML). Following completion of the ...

As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 2836 81-4182129 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 Haskins Way, Suite 230 Sout ...

As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) UNDER THE SECURITIES ACT OF 1933 Delaware 2836 81-4182129 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 Haskins Way, Suite 230 Sout ...

Core Points - CERo Therapeutics Holdings, Inc. will trade on the OTCQB market under the ticker symbol CERO effective December 2, 2025 [2] - The company is exploring options for an up-list to a major exchange to enhance liquidity and investor accessibility [2] - CERo is focused on advancing its Phase 1 clinical trial of CER-1236 for acute myeloid leukemia (AML), with a significant increase in starting dosage compared to previous cohorts [3] - CERo's proprietary T cell engineering approach integrates innate and adaptive immunity to target tumors more effectively, potentially offering advantages over existing CAR-T therapies [4] - The company has initiated clinical trials for its lead product candidate, CER-1236, aimed at treating hematologic malignancies [4]

Financial Position - As of September 30, 2025, the company reported approximately $1.9 million in cash and cash equivalents, with an accumulated deficit of approximately $86.3 million[283]. - The company has not recognized any revenue from product sales and does not expect to generate revenue in the foreseeable future[301]. - As of September 30, 2025, the company had approximately $1.9 million in cash and cash equivalents, which is insufficient to fund operations for the next 12 months[324]. - The company does not expect to generate revenue for at least the next few years, relying on additional financing to achieve its business objectives[322]. Capital Raising Activities - The company raised approximately $4.4 million in net proceeds from its equity line of credit and an additional $4.2 million from a public offering that closed on February 7, 2025[296]. - The company entered into a Fourth Securities Purchase Agreement to issue and sell up to 10,000 shares of Series D Preferred Stock for an aggregate purchase price of up to $8 million[285]. - The company sold an additional 938 shares of Series D Preferred Stock for gross cash proceeds of $750,400 in June 2025[287]. - The company has raised approximately $4.2 million from the exercise of Series A Preferred Warrants and other funding sources during the nine months ended September 30, 2025[284]. - The company has arranged two equity lines of credit, one for the sale of up to 25,000,000 shares of common stock and another for the purchase of up to $17.5 million of common stock[324]. - The company entered into a Fifth Securities Purchase Agreement to issue and sell up to 9,750 shares of Series E Preferred Stock for an aggregate purchase price of up to $7 million[325]. Operating Expenses - Research and development (R&D) expenses for Q3 2025 were $2,386,244, an increase of 34.5% from $1,774,210 in Q3 2024[309]. - General and administrative expenses decreased by 24.8% to $1,976,335 in Q3 2025 from $2,628,028 in Q3 2024[309]. - The total operating expenses for Q3 2025 were $4,362,579, a slight decrease of 0.9% compared to $4,402,238 in Q3 2024[309]. - Research and development expenses increased to $8,048,000 for the nine months ended September 30, 2025, up from $6,157,000 in the same period of 2024, reflecting a 30.7% increase[316]. - General and administrative expenses decreased to $5,989,000 for the nine months ended September 30, 2025, down from $7,946,000 in the same period of 2024, representing a 24.6% decrease[319]. Net Loss - The net loss for Q3 2025 was $4,856,395, representing a 14.9% increase from a net loss of $4,227,967 in Q3 2024[314]. - Net loss attributable to common stockholders for Q3 2025 was $11,506,223, a significant increase of 172.1% from $4,227,967 in Q3 2024[309]. - Net loss for the nine months ended September 30, 2025, was $15,380,000, compared to a net loss of $8,976,000 for the same period in 2024, indicating a 71.3% increase in net loss[321]. - Net loss attributable to common stockholders amounted to $47,078,000 for the nine months ended September 30, 2025, compared to $8,976,000 in the same period of 2024, a significant increase of 424.5%[321]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025 was $(12,273,817), compared to $(11,375,873) for the same period in 2024, reflecting a difference of $(897,944)[329]. - Net cash provided by investing activities for the nine months ended September 30, 2025 amounted to $500,000, compared to $0 for the same period in 2024, due to the sale of equity securities[332]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $10,468,829, a decrease from $12,240,682 in 2024[333]. - The financing activities in 2025 included net proceeds of $3,704,000 from the sale of common stock under the ELOC and $2,561,000 from the sale of Series D Preferred Stock[334]. - The company reported a net decrease in cash, restricted cash, and cash equivalents of $(1,304,988) for the nine months ended September 30, 2025[329]. Research and Development Outlook - The company anticipates a significant increase in R&D expenses in the future due to expanded clinical development efforts[311]. - The company anticipates significant increases in R&D expenses in the future due to increased headcount, compensation, and contracted services for clinical development[318]. Compliance and Notifications - The company received a notification letter from Nasdaq stating it had regained compliance with the continued listing standard under Nasdaq Listing Rule 5550(b)(1)[296]. Other Financial Metrics - Other expenses for Q3 2025 were $(494,000), a negative change of $668,000 compared to other income of $174,000 in Q3 2024[313]. - The company recorded deemed dividends of $6,649,828 related to Series D Preferred Stock during Q3 2025[314]. - Other expenses, net, were $(1,343,000) for the nine months ended September 30, 2025, compared to other income of $5,126,000 in the same period of 2024, reflecting a negative change of $6,469,000[320]. - The company recognized an earnout liability of $4.9 million as a result of the merger in February 2024, which is remeasured at each reporting period[337]. - Stock-based compensation for the nine months ended September 30, 2025 included expenses of $1,904,000, reflecting the cost of share-based payments to employees and consultants[338]. - The company recorded a gain from the change in fair value of the earnout liability of $4,870,000 for the nine months ended September 30, 2024, included in other income[337].

Core Insights - CERo Therapeutics Holdings, Inc. has initiated the second cohort of its Phase 1 clinical trial for CER-1236, targeting patients with acute myeloid leukemia (AML) [1][2] - The first patient in this cohort received an initial dose of CER-1236 at twice the initial dose given to patients in the first cohort, with a follow-up dose 48 hours later [1][2] - The trial aims to evaluate the safety and preliminary efficacy of CER-1236 in various AML patient populations, including those who are relapsed/refractory or newly diagnosed with TP53 mutated MDS/AML [2] Clinical Trial Details - The Phase 1/1b study is designed to assess safety and preliminary efficacy, with primary outcome measures including adverse events, dose-limiting toxicities, and overall response rates [2] - The study consists of a dose escalation phase to determine the highest tolerated dose, followed by an expansion phase to further evaluate safety and efficacy [2] - Secondary outcome measures include pharmacokinetics [2] Company Strategy and Future Outlook - The CEO of CERo expressed optimism regarding the trial's progress, highlighting the safety data and cell expansion observed so far [3] - The company is focused on the development of CER-1236 and is considering options for listing on a public exchange while continuing the clinical study [3] - CERo's innovative approach integrates innate and adaptive immunity in T cell engineering, potentially offering advantages over existing CAR-T therapies [4]

Core Insights - CERo Therapeutics Holdings, Inc. is presenting data on its lead compound CER-1236 at the Society for Immunotherapy of Cancer (SITC) conference from November 5-9, 2025 [1] - The poster presentation highlights preclinical data demonstrating the sustained effector function and resistance to exhaustion of CER-1236, showing durability of activity compared to traditional stimulation methods [2] - The CEO of CERo expressed confidence in the data supporting the ongoing Phase 1 trial, which aims to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, integrating both innate and adaptive immunity in its approach [4] - The company’s proprietary platform, which includes Chimeric Engulfment Receptor T cells (CER-T), aims to enhance tumor targeting capabilities compared to existing CAR-T therapies [4] - CERo has initiated clinical trials for CER-1236 specifically targeting hematologic malignancies [4]

Core Insights - CERo Therapeutics Holdings, Inc. continues to trade under the ticker symbol CERO on the OTC Markets, with no action required from investors [1] - The company is exploring options for an up-list to enhance liquidity and investor accessibility [1] - CEO Chris Ehrlich emphasized the company's commitment to maximizing shareholder value and advancing its clinical trials, particularly for CER-1236 in AML [2] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, integrating both innate and adaptive immunity [3] - The company's proprietary platform aims to redirect patient-derived T cells towards tumor cells using both adaptive and innate mechanisms, creating Chimeric Engulfment Receptor T cells (CER-T) [3] - CERo believes that CER-T cells may provide advantages over existing CAR-T therapies and could be effective for both hematologic malignancies and solid tumors [3] - Clinical trials for CER-1236, the lead product candidate, have been initiated for hematologic malignancies [3]

Core Points - CERo Therapeutics Holdings, Inc. will have its shares suspended from trading on Nasdaq starting October 31, 2025, following a determination by the Nasdaq Hearings Panel to deny the company's request for continued listing [1] - The company plans to appeal the Panel's decision and is seeking to trade its shares on the OTC Markets while continuing its clinical operations [1][5] Financial Compliance - CERo has struggled to comply with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2.5 million [2] - In April 2025, the company believed it had regained compliance after a financing round that included the issuance of Series D Convertible Preferred Stock valued at $5 million [2] - However, due to difficulties in valuing Marketable Securities, the company sold them at a substantial discount, leading to a determination of non-compliance with the Equity Rule [3][4] Panel Decision - The Nasdaq Panel's decision was based on a retroactive assessment of non-compliance as of April 22, 2025, disregarding the company's plans for future compliance [4] - The company has executed parts of its compliance plan, including receiving approximately $2.25 million from the sale of Series E Convertible Preferred Stock and subscriptions for an additional $4.75 million [4] Future Plans - CERo has submitted a request for review of the Panel's decision and is exploring trading on the OTC Markets, although this market is less liquid than Nasdaq [5] - The company intends to continue its clinical trials, specifically for its lead product candidate, CER-1236, which has shown promising early-stage results in patients with AML [6][7] - CERo is reviewing its cash resources and potential financing alternatives to support ongoing operations [7] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a unique approach that combines innate and adaptive immunity [8] - The company's proprietary technology aims to enhance tumor targeting through Chimeric Engulfment Receptor T cells (CER-T), which may offer advantages over existing CAR-T therapies [8]

Core Insights - CERo Therapeutics Holdings, Inc. has completed the first tranche of a $7 million financing, amounting to approximately $2.3 million, to extend its cash runway and maintain compliance with Nasdaq listing requirements [2][4] - The company is advancing its Phase 1 clinical trial for CER-1236, with a third infusion administered to a patient to gather more safety and dosing information [1][3] - The ongoing clinical trial aims to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia, focusing on various patient conditions [3] Financing and Compliance - The financing is expected to support the company's efforts to maintain Nasdaq compliance and extend its operational cash runway [2][4] - The successful completion of the first tranche reinforces the company's capital structure and positions it to begin the second cohort of the clinical trial once regulatory approvals are obtained [4] Clinical Trial Details - The Phase 1/1b study is designed to assess the safety and efficacy of CER-1236 in patients with acute myeloid leukemia, including those who are relapsed/refractory or newly diagnosed with TP53 mutated MDS/AML [3] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, and overall response rates, while secondary measures focus on pharmacokinetics [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a unique approach that combines innate and adaptive immunity [5] - The company's proprietary technology aims to enhance tumor targeting through Chimeric Engulfment Receptor T cells (CER-T), potentially offering advantages over existing CAR-T therapies [5]