Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 206

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Item 8
Chunk 206
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. Costs incurred in obtaining technology licenses through
asset acquisitions, if incurred, will be charged to R&D expense if the licensed technology has not reached technological feasibility
and has no alternative future use. R&D expenses include or could include:

●employee-related
                                            expenses, including salaries, bonuses, benefits, stock-based compensation and other related
                                            costs for those employees involved in R&D efforts;

●external
                                            R&D expenses incurred under agreements with preclinical research organizations, clinical
                                            research organizations, investigative sites, centralized clinical laboratories, and consultants
                                            to conduct preclinical and clinical studies;

●costs
                                            related to manufacturing material for preclinical studies and clinical trials, including
                                            fees paid to contract development and manufacturing organizations;

●product-liability
                                            insurance for clinical development product(s);

●laboratory
                                            supplies and research materials;

●software
                                            and systems related to R&D activities;

●costs
                                            related to regulatory filing and compliance; and

●facilities,
                                            depreciation and other allocated expenses, which include direct and allocated expenses for
                                            rent, maintenance of facilities, and equipment.

Product
candidates in later stages of development generally have higher development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials. The Company plans to substantially increase its R&D
expenses for the foreseeable future as it continues the development of its product candidates through clinical development. The Company
cannot determine with certainty the timing of initiation, the duration or the costs of current or future preclinical studies and clinical
trials required for regulatory approval due to the inherently unpredictable nature of preclinical and clinical development. Clinical
and preclinical development timelines, the probability of success and development costs can differ materially from expectations. The
Company anticipates that it will make determinations as to which product candidates to pursue and how much funding to direct to each
product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory
developments and ongoing assessments as to each product candidate’s commercial potential. The Company will need to, and plans to,
raise substantial additional capital in the future. Future R&D expenses may vary significantly between periods and from current expectations
based on factors such as:

●expenses
                                            incurred to conduct preclinical studies required to advance product candidates into clinical
                                            trials;

●per
                                            patient clinical trial costs based on a number of factors, including number of patient clinical
                                            visits, clinical laboratory testing,