Company: PGEN
Filing Date: 2025-03-19
Form Type: 10-K
Source: 0001356090-25-000007
Chunk: 58

Company: PRECIGEN, INC.
Filing Date: 2025-03-19
Form: 10-K
Item: Item 1A
Chunk 58
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 clinical and preclinical programs. Our ability to generate product revenues, which we do not expect will occur until a product candidate is approved by FDA, if ever, will depend heavily on the successful development and eventual commercialization of some or all of these product candidates, and any future product candidates we develop, which may never occur. Our current and future product candidates will require additional preclinical or clinical development, management of clinical, preclinical and manufacturing activities, marketing approval in the United States and other jurisdictions, coverage from pricing and reimbursement authorities, sufficient cGMP manufacturing supply for both preclinical and clinical development and commercial production, building of a commercial organization and substantial investment, and significant marketing efforts before we generate any revenues from product sales.

The clinical and commercial success of our current and future product candidates will depend on several factors, including the following:

•sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;

•timely and successful completion of preclinical studies and clinical trials;

•acceptance of INDs for future product candidates;

•successful enrollment in and completion of clinical trials;

•data from our clinical programs that supports an acceptable risk-benefit profile of our product candidates in the intended patient populations;

•our ability to consistently manufacture our product candidates on a timely basis or to establish agreements with third-party manufacturers that can do so;

•whether we are required by the FDA or comparable foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned or anticipated to support approval of our product candidates;

•acceptance of our proposed indications and the primary endpoint assessments evaluated in the clinical trials of our product candidates by the FDA and comparable foreign regulatory authorities;

•receipt and maintenance of timely marketing approvals from applicable regulatory authorities;

•the build up of a commercialization organization and successful launch of commercial sales of our product candidates, if approved;

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•the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if approved;

•entry into collaborations to further the development of our product candidates;

•our ability to obtain and maintain patent and other intellectual property protection or regulatory exclusivity for our product candidates;

•acceptance of the benefits and uses of our product candidates, if approved, by patients, the medical community, and third-party payers;

•maintenance of a continued acceptable safety, tolerability and efficacy profile of the product candidates following approval;

•our compliance with any post-approval requirements imposed on our products, such as postmarketing studies, a REMS, or additional requirements that