PRECIGEN, INC. (PGEN)

Company response: to prior comment two with a view toward ascertaining the extent to which Biopharmaceuticals and Exemplar continue to constitute two separate operating segments as defined in ASC 280-10-50-1: · Regarding the second bullet, you have told us that you have two separate components or reporting units that were not aggregated under ASC 350-20-35-33 through 35-36. You also appear to indicate that your chief operating decision maker (CODM) continues to receive at least some level of separate discrete financial information for these reporting units. Please tell us what financial information is received by the CODM, and how it changed in the first quarter of 2025 and subsequent periods. · Clarify how… response letter →

Company response: We respectfully acknowledge the Staff’s comment and provide the following information in response. Papzimeos™ (zopapogene imadenovec-drba), is manufactured in three stages: 1) the Company manufactures bulk drug substance which yields the active pharmaceutical ingredient (“API”), zopapogene imadenovec-drba; 2) our contract manufacturer then develops bulk drug product utilizing the bulk drug substance manufactured by the Company, which yields filled drug product vials containing formulated zopapogene imadenovec-drba (i.e., Papzimeos); and 3) our contract manufacturer then performs the labeling, serialization, and packaging of the filled drug product vials in individual cartons, which yields a… response letter →

Company response: We respectfully acknowledge the Staff’s comment and provide the following information in response. For your convenience, each bullet of the Staff’s comment is reproduced in italicized type below, followed by our responses thereto: • Tell us and revise your future filings to clarify whether Biopharmaceuticals and Exemplar remain separate reporting units. The Company respectfully acknowledges the Staff's comment and advises the Staff that Biopharmaceuticals and Exemplar remain separate reporting units for purposes of ASC 350-20. We also advise the Staff that as of December 31, 2025, there was no intangible assets nor goodwill associated with the Exemplar reporting unit subsequent to an… response letter →

Company response: The Company respectfully acknowledges the Staff's comment and provides the following information in response. We do not track research and development (“R&D”) expenses by candidate or program. Therefore, preparing such information solely for external disclosure would not reflect management’s view of the business or how R&D activities operate and are managed. A significant portion of our R&D spending relates to the development, optimization, and operation of our core therapeutic platforms rather than any single drug candidate. The Company will disclose the fact that it does not track R&D expenses by candidate or program in our MD&A. The Company tracks R&D by the nature of the following… response letter →