Corporate Actions - CERo Therapeutics Holdings, Inc. completed a merger with Predecessor, resulting in the issuance of 7,597,638 shares of Common Stock, including 2,200,000 Earnout Shares[171]. - The Company raised approximately $10.0 million in February 2024 through a private placement of Series A Preferred Stock and common warrants[175]. - A reverse stock split of 1:40 was approved by stockholders to help regain compliance with Nasdaq listing requirements[186]. - The Company plans to evaluate options to resolve compliance deficiencies and maintain its Nasdaq listing[185]. Regulatory and Clinical Developments - The Company submitted an Investigational New Drug Application for CER-1236 on June 28, 2024, but faced a clinical hold due to insufficient data[178]. - The FDA cleared the IND for CER-1236 on November 15, 2024, with plans to initiate clinical trials by early 2025[179]. Financial Performance - The Company has not recognized any revenue from product sales and does not expect to generate revenue in the foreseeable future[190]. - For the three-month period ended September 30, 2024, total operating expenses were $4.4 million, an increase of 186% compared to $1.5 million for the same period in 2023[200]. - General and administrative expenses for the three-month period ended September 30, 2024, were $2.6 million, reflecting an increase of $2.4 million from $0.3 million in the same period in 2023[201]. - Research and development expenses for the three-month period ended September 30, 2024, were $1.8 million, up from $1.3 million in the same period in 2023, marking a 38% increase[202]. - The net loss for the three-month period ended September 30, 2024, was $4.2 million, compared to a net loss of $1.3 million for the same period in 2023, representing an increase of 214%[200]. - For the nine-month period ended September 30, 2024, total operating expenses were $14.1 million, an increase of 115% compared to $6.6 million for the same period in 2023[208]. - General and administrative expenses for the nine-month period ended September 30, 2024, were $7.9 million, reflecting an increase of $5.7 million from $2.3 million in the same period in 2023[209]. - 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, indicating a 44% increase[211]. - Other income for the nine-month period ended September 30, 2024, was $5.1 million, compared to $0.5 million for the same period in 2023, reflecting a significant increase of $4.6 million[213]. Cash Flow and Liquidity - As of September 30, 2024, the company had $3.4 million in cash and cash equivalents, which is expected to be insufficient to fund operations for the next 12 months[216]. - Net cash used in operating activities increased by $6.6 million from $4.8 million in the nine-month period ended September 30, 2023, to $11.4 million in 2024[221]. - 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 2024[223]. - The increase in financing activities was driven by net proceeds of $7.3 million from the issuance of Series A and B Preferred Stock and $4.3 million from the sale of common stock under the ELOC[223]. - The company reported a net increase in cash and cash equivalents of $864,809 for the nine-month period ended September 30, 2024, compared to a decrease of $4.3 million in 2023[220]. Operational Insights - The company anticipates significant increases in R&D expenses in the future due to increased headcount and contracted services for clinical development[203][212]. - Cash used in operating activities was offset by a larger non-cash adjustment for stock-based compensation of $1.9 million in the nine-month period ended September 30, 2024, compared to 2023[221]. - There were no contractual obligations or other commitments reported[224]. - The company does not believe that inflation had a material effect on its financial condition or results of operations for the period ended September 30, 2024[241]. - The company continues to qualify as an emerging growth company, allowing it to take advantage of reduced disclosure requirements[243]. - The company has not recorded any interest or penalties associated with income tax since inception[236].
Phoenix Biotech Acquisition (PBAX) - 2024 Q3 - Quarterly Report