SecProbe.io

CORRESP
 1
 filename1.htm

 Precigen,
 Inc.

 20374 Seneca
Meadows Parkway

 Germantown,
Maryland, 20876

 (301) 556-9900

 January
29, 2026

 VIA
EDGAR SUBMISSION

 United
States Securities and Exchange Commission

 Division
of Corporation Finance

 Office
of Trade & Services

 100
F Street, N.E.

 Washington,
D.C. 20549

 Attention:
 Jenn Do

 Kevin Vaughn

 Re:
 Precigen, Inc.

 Form 10-K for Fiscal Year
 Ended December 31, 2024

 Form 10-Q for Quarterly
 Period Ended September 30, 2025

 File No. 001-36042

 Dear
Ms. Do and Mr. Vaughn:

 Precigen,
Inc. ("Precigen, the "Company", or "we," "us," "our"), is submitting this letter
to respond to comments provided by the staff (the "Staff") of the Division of Corporate Finance of the Securities and Exchange
Commission (the "SEC") in your letter dated December 23, 2025, relating to the Company's Form 10-K for Fiscal Year
Ended December 31, 2024, filed on March 19, 2025 (the "Form 10-K") and the Company's Form 10-Q for Quarterly Period
Ended September 30, 2025, filed on November 13, 2025 (the "Form 10-Q"). For the Staff's convenience, the Staff's
comments are restated in italics prior to each of the Company's responses. Except as provided in this letter, terms used in this
letter have the meanings given to them in the Form 10-K or the Form 10-Q, as applicable.

 Form
10-Q for Quarterly Period Ended September 30, 2025

 6.
Inventory, page 22

 1. 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
 are sold .

 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 ready-to-sell finished drug product. Prior to August 14, 2025 (the date the FDA provided full
approval of Papzimeos), the regulatory approval and subsequent commercialization of Papzimeos, and thus the possibility of future economic
benefits from Papzimeos sales, were not considered probable and inventory-related costs were expensed as incurred.

 As
such, the inventory recognized on the balance sheet at December 31, 2025 does not include any costs related to production of inventory
prior to the FDA approval on August 14, 2025, which is referred to as "pre-launch inventory". The Company's pre-launch
inventory at August 14, 2025 consisted primarily of bulk drug product.

 For
your convenience, each bullet of the Staff's comment is reproduced in italicized type below, followed by our responses thereto:

 • the
 amount of estimated revenues, if applicable, represented by your pre-launch inventories
 on hand at December 31, 2025;

 As
of December 31, 2025, the pre-launch inventories are primarily in the form of bulk drug product.
We are in the process of estimating future net revenues represented by existing physical pre-launch inventories as of December 31, 2025,
and we will disclose this amount in our Form 10-K for the fiscal year ended December 31, 2025 ("2025 Form 10-K") as presented
below in our proposed disclosures. Due to the fact that commercialization began in late 2025, these estimates are inherently subject
to significant uncertainty.

 • when
 you expect to finish selling the pre-launch inventories;

 2

 The
Company expects that it will finish selling all of the pre-launch inventories in 2026. Projected sales derived
from pre-launch inventories depend on several factors that could materially impact actual realized results, including the timing and
scale of product adoption within our target patient population and payer coverage.

 • 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

 The
shelf life of our inventory is 24 months from the date the drug product is manufactured.

 Inventories
are reviewed at each reporting period to identify excess, obsolete or slow-moving inventory based on projected sales activity versus
product shelf-life. Expired inventory is disposed of, and the related costs are recognized as cost of sales in our consolidated statement
of operations, when, based on the expiry date, we do not believe we are able to sell the inventory. As of the date of this letter, based
on the product shelf-life and anticipated sales of pre-launch inventory (realized throughout fiscal 2026) we have not recorded an adjustment
for excess or obsolete inventory at December 31, 2025, although our review of this process is ongoing.

 • your
 estimate of what the gross margin percentage will be after the pre-launch inventories
 are sold .

 As
discussed above, the Company expects to finish selling the pre-launch inventories before the end of 2026. As a result, the cost of goods
sold related to Papzimeos will initially reflect a lower average per unit cost, as pre-launch inventory is utilized for commercial production
and sold to customers. As pre-launch inventory continues to absorb costs through the manufacturing process, we expect the current gross
margins will gradually decrease as inventory is sold and will stabilize between high 80 percentages and low 90 percentages when pre-launch
inventories are expected to be completely sold based on current forecasts, which include significant risks given that Papzimeos is the
first therapy available to patients with Recurrent Respiratory Papillomatosis.

 The
Company will modify our disclosures in our Notes to the Consolidated Financial Statements and in Item
7. Management's Discussion and Analysis of Financial Condition and Results of Operations in its 2025 Form
10-K. The additional disclosures will be as follows:

 Notes to the Consolidated
Financial Statements:

 Summary
of Significant Accounting Policies:

 Inventory

 3

 Prior
to an initial regulatory authorization for our drug product candidates, we expense costs relating to raw materials and inventory production
as research and development expenses in our consolidated statements of operations in the period incurred. We capitalize the costs of
production as inventory when we believe regulatory authorization and subsequent commercialization is considered probable and we expect
to realize future economic benefit from the sales of the drug product candidate.

 The Company evaluates
inventory recoverability at each reporting period and adjusts net realizable value for excess, slow-moving or obsolete inventory based
on projected sales activity versus product shelf-life. If the net realizable value is lower than costs, the inventory is written down
accordingly, and the resulting charge is recognized as a component of cost of goods sold in the Company's consolidated statements
of operations.

 Inventory
used for clinical development purposes is expensed to research and development expense when consumed.

 Footnote
X. Inventory:

 On August 14, 2025,
the FDA approved Papzimeos (zopapogene imadenovec-drba), marking the first immunotherapy approved for treatment of RRP, and the Company
commenced capitalization of inventory from that date.

 Prior
to August 14, 2025, regulatory approval and subsequent commercialization of Papzimeos and thus the possibility of future economic benefits
from Papzimeos sales were not considered probable and inventory-related costs were expensed as incurred; as such, the inventory recognized
on the balance sheet at December 31, 2025 does not include any costs incurred prior to August 14, 2025.

 The
components of inventory are as follows:

 December 31,

 2025
 2024

 Raw Material
 $ XX
 $ -

 Work in process
 XX
 -

 Finish Goods
 XX
 -

 Total inventory
 $ XX
 $ -

 The
shelf life of our inventory is generally 24 months from the date the drug product is manufactured. As of December 31, 2025, the Company
has not recorded an adjustment for excess or obsolete inventory.

 Item
7. Management's Discussion and Analysis of Financial Condition and Results of Operations :

 Costs
of products and services and gross margin

 4

 For
the year ended December 31, 2025, the cost of products and services includes the costs of Papzimeos sales. Prior to August 14, 2025,
regulatory approval and subsequent commercialization of Papzimeos and thus the possibility of future economic benefits from Papzimeos
sales were not considered probable and inventory-related costs were expensed as incurred; as such, the inventory recognized on the consolidated
balance sheet at December 31, 2025 does not include any costs incurred prior to August 14, 2025, which is referred to as pre-launch inventory.
In addition, the cost of products related to Papzimeos on the consolidated statement of operations for the year ended December 31, 2025
is comprised of the sale of pre-launch inventory, which only includes costs incurred subsequent to August 14, 2025. As of December 31,
2025, the amount of future estimated net revenues represented by existing physical pre-launch inventories is approximately $[XX] million
based on our current pricing assumptions and projected demand for our recently approved commercial product. Due to the fact that commercialization
began in late 2025, these estimates are inherently subject to significant uncertainty.

 The
Company expects that it will finish selling all, or substantially all, of the pre-launch inventories in 2026. Projected sales derived
from pre-launch inventories depend on several factors that could materially impact actual realized results, including the timing and
scale of product adoption within our target patient population, and payer coverage. As a result, the cost of products sold related to
Papzimeos will initially reflect a lower average per unit cost of materials, as pre-launch inventory is utilized for commercial production
and sold to customers. As pre-launch inventory continues to absorb costs through the manufacturing process, we expect the current gross
margins will gradually decrease as pre-launch inventory is sold and will stabilize between high 80 percentages and low 90 percentages
when pre-launch inventories are expected to be completely sold based on current forecasts, which include significant risks given that
Papzimeos is the first therapy available to patients with RRP.

 15.
Segments, page 31

 2. 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.

 5

 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 interim impairment charge recorded during the second quarter of 2025, as disclosed within
Note 7, Goodwill and intangibles, net , of the Notes to the Condensed Consolidated Financial Statements of the
Company's Form 10-Q for the Quarterly Period Ended June 30, 2025, filed on August 9, 2025.

 The
Company advises the Staff that in all applicable future filings commencing with 2025 Form 10-K, we will disclose the fact that the Company
has two reporting units consisting of Biopharmaceuticals and Exemplar.

 • 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.

 As
described above, the Company has two separate components, or reporting units that were not aggregated under 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.

 Using
ASC 280-10-50-1 and ASC 280-10-50-10 guidance in the fourth quarter of 2024, the Chief Operating Decision Maker ("CODM")
received a financial package which included discrete Adjusted EBITDA information for Biotherapeutics and Exemplar and the Company concluded
it had two operating and two reportable segments. In the first quarter of 2025, in conjunction with the February 2025 FDA approval for
priority review of the Company's PRGN-2012 product, the Company's CODM no longer regularly reviewed separate discrete financial
information for Biopharmaceuticals or Exemplar. Starting in the first quarter of 2025 and throughout 2025, the CODM regularly reviewed
consolidated operating results of the Company to make decisions and allocate resource and also changed its performance measure to net
loss. The discrete financial information was only used for goodwill impairment purposes for the Exemplar reporting unit in the second
quarter of 2025; however in accordance with ASC 280-10-50-1b it is not regularly reviewed by the CODM to assess performance and make
decisions about the resources to be allocated, as this is done on a consolidated basis. Therefore in our 2025 Form 10-K we plan to continue
to disclose the net loss as our performance measure of our one operating segment and one reportable segment in accordance with ASC 280-10-50.

 6

 Results
of operations, page 37

 3. 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.

 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 p