Increased cash balance and momentum with both Nasdaq and Phase 1 trial initiation mark strong beginning for 2025 SOUTH SAN FRANSCISCO, Calif., Feb. 06, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, provides investors with a corporate update highlighting its improved cash balance following its recent capital raise ...

SOUTH SAN FRANSCISCO, Calif., Feb. 05, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (NASDAQ:CERO) ("CERo" or the "Company") an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, today announced the pricing of its "reasonable best efforts" public offering with participation from a member of the Company's board and a single institutional investor for the purchase and sale of 2,551,020 shares of its common s ...

SOUTH SAN FRANSCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, today announced that its board of directors has determined to effect a one-for-one hundred reverse stock split of the Company’s common stock, par value $0.0001 per share (the “Common Stock”). The reverse stock split will take eff ...

Stock Issuance and Financing Activities - The company issued an aggregate of 7,597,638 shares of Common Stock as consideration for the Merger, including 2,200,000 Earnout Shares and 382,651 shares issuable upon exercise of rollover options or warrants[174] - In February 2024, the company completed the first tranche of a private placement, raising approximately $10.0 million through the issuance of Series A Preferred Stock and warrants[175] - In April 2024, the company raised approximately $0.5 million through a private placement of Series B Preferred Stock[176] - In September 2024, the company raised approximately $1.25 million through a private placement of Series C Preferred Stock and common warrants[177] - Net cash provided by financing activities increased by $11.7 million from $0.6 million in the nine-month period ended September 30, 2023 to $12.2 million in the nine-month period ended September 30, 2024[223] - The increase in cash provided by financing activities was related to the net proceeds of $7.3 million from the issuance of Series A and B Preferred Stock, $0.7 million from the issuance of Series C Preferred Stock and associated warrants, and $4.3 million for the sale of common stock under the ELOC[223] Clinical Development and Regulatory Progress - The company submitted an Investigational New Drug Application (IND) for CER-1236 on June 28, 2024, and received FDA clearance on November 15, 2024, with plans to initiate clinical trials by early 2025[178][179] Financial Performance and Expenses - The company has not recognized any revenue and does not expect to generate revenue from product sales in the foreseeable future[190] - R&D expenses are expected to increase significantly as the company advances its product candidates through clinical development[194] - General and administrative expenses are anticipated to rise due to increased headcount, operational support, and compliance costs associated with being a public company[196] - Research and development expenses increased to $1.8 million for the three-month period ended September 30, 2024, up from $1.3 million in the same period in 2023, reflecting a $0.5 million increase[202] - General and administrative expenses rose to $2.6 million for the three-month period ended September 30, 2024, compared to $0.3 million in the same period in 2023, a $2.4 million increase primarily due to public company operational costs[201] - Net loss for the three-month period ended September 30, 2024, was $4.2 million, compared to $1.3 million in the same period in 2023, reflecting a $2.9 million increase in losses[200] - Research and development expenses for the nine-month period ended September 30, 2024, were $6.2 million, up from $4.3 million in the same period in 2023, a $1.9 million increase[211] - General and administrative expenses for the nine-month period ended September 30, 2024, were $7.9 million, compared to $2.3 million in the same period in 2023, a $5.7 million increase driven by public company compliance costs[209] - Net loss for the nine-month period ended September 30, 2024, was $9.0 million, compared to $6.0 million in the same period in 2023, reflecting a $3.0 million increase in losses[208] - The company anticipates significant future increases in R&D expenses due to expanded headcount, compensation, and contracted services for preclinical and clinical development[203][212] - Other income for the nine-month period ended September 30, 2024, was $5.1 million, compared to $0.5 million in the same period in 2023, primarily due to a $4.7 million change in the value of the company's Earnout Liability[213] - Net cash used in operating activities increased by $6.6 million from $4.8 million to $11.4 million in the nine-month period ended September 30, 2023 and 2024 respectively[221] - The increase in cash used in operating activities was largely related to a $4.8 million increase in the adjustment to net loss related to the gain on the revaluation of derivative liabilities[221] Cash Position and Funding Needs - The company had $3.4 million in cash, restricted cash, and cash equivalents as of September 30, 2024, and expects to need substantial additional funding to support operations[216] - The company does not expect to generate revenue for at least the next few years and relies on additional financing to achieve its business objectives[214][219] Market and Regulatory Risks - The company received Nasdaq notices of non-compliance due to the Common Stock's bid price falling below $1.00 and the Market Value of Publicly Held Shares (MVPHS) falling below $15,000,000[180][182] - The company's stockholders approved a reverse stock split ranging from 1:25 to 1:150, with the Board of Directors authorizing a 1:40 reverse stock split expected to be effective around November 2024[186] - The company's primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates[239] - The company may be subject to fluctuations in foreign currency rates in the future if it contracts with vendors invoicing in a foreign denominated currency[240] - Inflation may materially impact the company in later periods of 2024 and beyond by increasing the cost of labor and costs associated with preclinical and clinical trials and future manufacturing and commercialization activities[241] Emerging Growth Company Status - The company is an emerging growth company and may take advantage of reduced disclosure and other requirements applicable to public companies[243] - The company expects to continue to take advantage of the benefits of the extended transition period for complying with new or revised accounting standards[243] - The company may cease to qualify as an emerging growth company if it exceeds $1.07 billion in total annual gross revenues or if the market value of its Common Stock held by non-affiliates exceeds $700.0 million[245]

SOUTH SAN FRANCISCO, Calif, Nov. 15, 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 augmented with phagocytic mechanisms derived from the innate arm of the immune system, announces that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug Application (IND) for Phase 1 clinical trials of its lead compound, CER-1236, in acut ...

Data presented as part of a poster at the SITC 2024 Conference SOUTH SAN FRANCISCO, Calif., Nov. 11, 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 the presentation of preclinical data demonstrating the capability of its lead compound CER-1236 to kill ovarian cancer cells in preclinical models with no indications of tox ...

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 bel ...

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 ...

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 June 30, 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) | --- | --- | |-------------------------- ...