SRSEC Reporting Desk

PRECIGEN, INC. (PGEN) – SEC staff letter

2025-12-23 · Re: Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Accession 0000000000-25-011799 · 3 staff comment(s) issued

Company response(s): 2026-01-29

Segment Reporting (ASC 280)MD&A: Results & Known TrendsGoodwill & Asset Impairment

2025-12-23 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 1 · 6. Inventory, page 22 Agreed to revise
Staff comment: Regarding your inventory-related costs previously expensed as research and development (R&D) expenses (also referred to as your "pre-launch inventories"), please disclose the following beginning in your Form 10-K for the fiscal year ended December 31, 2025: • the amount of estimated revenues, if applicable, represented by your pre-launch inventories on hand at December 31, 2025; • when you expect to finish selling the pre-launch inventories; • the shelf life of your inventory and your consideration of whether or not any additional inventory will be determined to be obsolete in future periods; and • your estimate of what the gross margin percentage will be after the pre- launch inventories… 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 →
2025-12-23 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 2 · 15. Segments, page 31 Agreed to revise
Staff comment: Please address the following related to your disclosure regarding the realignment of your former two operating segments, Biopharmaceuticals and Exemplar, into one operating segment during the first quarter of 2025: • Tell us and revise your future filings to clarify whether Biopharmaceuticals and Exemplar remain separate reporting units. • Please provide us with your analysis for the aggregation of these components into one operating segment, noting they appear to possess dissimilar economic and other characteristics. Refer to ASC 350-20-35-33 through 35-36. • Tell us how you determined that your presentation of a single operating segment is appropriate under the guidance of ASC 280-10-50. 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 →
Segment Reporting (ASC 280)Goodwill & Asset Impairment
2025-12-23 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 3 · Results of operations, page 37 Agreed to revise
Staff comment: Please tell us and revise to disclose, beginning with your Form 10-K for the year ended December 31, 2025, whether you track research and development (R&D) expenses by candidate or program and, if not, explain why not. To the extent you track any of your R&D expenses by candidate or program, provide a breakout of such amounts. For the R&D expenses you do not track by candidate or program, revise to provide a quantitative breakout of remaining R&D expenses by type, which should reconcile to total R&D expenses on your Consolidated Statements of Operations for each period presented. 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 →
MD&A: Results & Known Trends

Full letter on EDGAR → · Filing index · All PRECIGEN, INC. (PGEN) correspondence

Segment Reporting (ASC 280) – what to check: Check ASU 2023-07 significant segment expense disclosure, CODM identification, and that MD&A segment discussion matches the ASC 280 note.

MD&A: Results & Known Trends – what to check: Quantify drivers of changes (price vs. volume), discuss known trends and uncertainties, and avoid repeating the financial statements.

Goodwill & Asset Impairment – what to check: Disclose reporting units at risk, headroom, key assumptions and triggering-event analysis, especially if market cap is below book value.

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