PRECIGEN, INC.

Previous wording

Our commercial product, Papzimeos (zopapogene imadenovec-drba, PRGN-2012), is the first and only U.S. Food and Drug Administration (“FDA”) approved therapy for the treatment of adults with recurrent respiratory papillomatosis (“RRP”). RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic human papillomavirus (HPV) 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract. Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins. Papzimeos is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP.

Current wording

Our commercial product, Papzimeos (zopapogene imadenovec-drba, PRGN-2012), is the first U.S. Food and Drug Administration (“FDA”) approved therapy for the treatment of adults with recurrent respiratory papillomatosis (“RRP”). RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic human papillomavirus (HPV) 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract. Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins. Papzimeos is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP.

Previous wording

We are developing therapies built on our AdenoVerse immunotherapy platform and our UltraCAR-T therapeutics platform. Our AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens. We have established proprietary manufacturing cell lines and production methodologies from our AdenoVerse immunotherapy platform, which we believe are scalable for commercial supply. We believe that our proprietary gorilla adenovectors, part of the AdenoVerse technology, have superior performance characteristics as compared to current competition, including standard human adenovirus serotype 5, rare human adenovirus types and other non-human primate adenovirus types.

Current wording

We are developing therapies built on our AdenoVerse immunotherapy platform and our UltraCAR-T therapeutics platform. Our AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens. We have established proprietary manufacturing cell lines and production methodologies from our AdenoVerse immunotherapy platform, which we believe are scalable for commercial supply. We believe that our proprietary gorilla adenovectors, part of the AdenoVerse technology, have superior performance characteristics as compared to current competition, including standard human adenovirus serotype 5, rare human adenovirus types and other non-human primate adenovirus types. In September 2026, the FDA granted platform technology designation to our AdenoVerse immunotherapeutic platform. The FDA platform technology designation creates a pathway to leverage existing data to potentially accelerate development of future AdenoVerse programs by utilizing existing manufacturing and preclinical knowledge to support future marketing applications and reduce duplication of development work. The platform technology designation provides opportunities for early FDA engagement, the ability to receive timely advice by having additional engagement with the FDA during development, and consideration of prior FDA manufacturing inspections for future applications.

Previous wording

In August 2025, the FDA granted full approval to Papzimeos for the treatment of adults with RRP. The Papzimeos approval marked a historic milestone for the RRP patient community as the first FDA-approved therapy for the treatment of adults with RRP. We completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos full approval. As a result of Papzimeos receiving full FDA approval, a confirmatory clinical trial is no longer required.

Current wording

RRP. We completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos full approval. As a result of Papzimeos receiving full FDA approval, a confirmatory clinical trial is no longer required.

Previous wording

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins. Papzimeos is delivered via four subcutaneous injections over a 12-week interval. Papzimeos approval is supported by safety and efficacy data from the pivotal Phase 1/2 clinical trial published in the Lancet Respiratory Medicine. The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints. Papzimeos was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% (18 out of 35) of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with Papzimeos. Complete Responses remained durable for over 12 months. Fifteen out of 18 (83%) complete responders demonstrated ongoing complete responses after their Papzimeos treatment for at least 36 months with median follow-up of 36 months (range: 36 to 51 months) as of the April 30, 2026 data cutoff.

Current wording

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins. Papzimeos is delivered via four subcutaneous injections over a 12-week interval. Papzimeos approval is supported by safety and efficacy data from the pivotal Phase 1/2 clinical trial published in the Lancet Respiratory Medicine. The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints. Papzimeos was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% (18 out of 35) of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with Papzimeos. Complete Responses remained durable for over 12 months with complete responders demonstrated ongoing complete responses after their Papzimeos treatment for up to 5 years without any additional treatments for RRP, with median follow-up of 46 months (range: 36 to 60 months) as of the September 15, 2026 data cutoff.

Previous wording

Following the FDA approval, we launched Papzimeos in the United States as the first and only FDA approved treatment for adults with RRP. We estimate that there are approximately 27,000 adult patients in the United States living with RRP.

Current wording

Following the FDA approval, we launched Papzimeos in the United States as the first FDA approved treatment for adults with RRP. We estimate that there are approximately 27,000 adult patients in the United States living with RRP.

Previous wording

Papzimeos had been granted Breakthrough Therapy Designation and Orphan Drug designation for the treatment of RRP by the FDA. In May 2026, the FDA granted a seven-year period of orphan drug exclusivity for Papzimeos for the treatment of adults with RRP through August 14, 2032. In addition, zopapogene imadenovec has received Orphan Drug Designation for the Treatment of RRP from the European Commission as well. We submitted a Marketing Authorization Application (“MAA”) for zopapogene imadenovec for the treatment of adults with RRP to the European Medicines Agency (“EMA”). The MAA has been validated by the EMA and is currently under review.

Current wording

Papzimeos had been granted Breakthrough Therapy Designation and Orphan Drug designation for the treatment of RRP by the FDA. In May 2026, the FDA granted a seven-year period of orphan drug exclusivity for Papzimeos for the treatment of adults with RRP through August 14, 2032. In addition, zopapogene imadenovec-drba has received Orphan Drug Designation for the Treatment of RRP from the European Commission as well. We submitted a Marketing Authorization Application (“MAA”) for zopapogene imadenovec-drba for the treatment of adults with RRP to the European Medicines Agency (“EMA”). The MAA has been validated by the EMA and is currently under review.

Previous wording

PRGN-3006 is an investigational autologous CAR-T therapy that utilizes our UltraCAR-T platform to express a CAR to target CD33 (Siglec-3), mbIL15 and a kill switch gene. PRGN-3006 is in a Phase 1/1b clinical trial for the treatment of relapsed or refractory, or r/r, acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. PRGN-3006 has been granted Fast Track designation in patients with r/r AML by the FDA. Previously PRGN-3006 was granted Orphan Drug Designation in patients with AML by the FDA. We have completed the Phase 1 dose escalation trial. We have completed enrollment of the Phase 1b trial for PRGN-3006 in AML. We plan to focus on strategic partnership opportunities to advance PRGN-3006 UltraCAR-T program in AML.

Current wording

PRGN-3006 is an investigational autologous CAR-T therapy that utilizes our UltraCAR-T platform to express a CAR to target CD33 (Siglec-3), mbIL15 and a kill switch gene. PRGN-3006 is in a Phase 1/1b clinical trial for the treatment of relapsed or refractory, or r/r, acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. PRGN-3006 has been granted Fast Track designation in patients with r/r AML by the FDA. Previously PRGN-3006 was granted Orphan Drug Designation in patients with AML by the FDA. We have completed the Phase 1 dose escalation trial. We have completed enrollment of the Phase 1b trial for PRGN-3006 in AML.

Previous wording

Exemplar is committed to enabling the study of life-threatening human diseases through the development of MiniSwine Yucatan miniature pig research models and services. Historically, researchers have lacked animal models that faithfully represent human diseases. As a result, a sizeable barrier has blocked progress in the discovery of human disease mechanisms; novel diagnostics, procedures, devices, prevention strategies and therapeutics; and the ability to predict in humans the efficacy of those next-generation procedures, devices, and therapeutics. Exemplar's MiniSwine models are genetically engineered to exhibit a wide variety of human disease states, which provides a more accurate platform to test the efficacy of new medications and devices.

Current wording

Exemplar is committed to enabling the study of life-threatening human diseases through the development of MiniSwine Yucatan miniature pig research models and services. Historically, researchers have lacked animal models that faithfully represent human diseases. As a result, a sizable barrier has blocked progress in the discovery of human disease mechanisms; novel diagnostics, procedures, devices, prevention strategies and therapeutics; and the ability to predict in humans the efficacy of those next-generation procedures, devices, and therapeutics. Exemplar's MiniSwine models are genetically engineered to exhibit a wide variety of human disease states, which provides a more accurate platform to test the efficacy of new medications and devices.

Previous wording

In the second quarter of 2026, we achieved profitability from continuing operations for the first time since our strategic transformation into a healthcare company in 2020, marking a pivotal milestone in our evolution. Prior to this quarter, we have incurred significant losses since our inception. Although we have recently generated income, our long-term transition to sustained profitability will depend on the continued successful commercialization of Papzimeos and the potential commercialization of other product candidates to achieve sufficient revenues to support the Company's cost structure. Products currently in our clinical pipeline will require regulatory approval and/or commercial scale-up before they may commence significant product sales and operating profits, if any. We may also enter into strategic transactions for individual platforms or programs in the future from which we may generate collaboration and licensing revenues.

Current wording

Beginning in the second quarter of 2026, we achieved profitability from continuing operations for the first time since our strategic transformation into a healthcare company in 2020, marking a pivotal milestone in our evolution. In addition, in the third quarter of 2026, we achieved positive cash flow from operating activities of $11.9 million. Prior to the second quarter of 2026, we have incurred significant losses since our inception. Although we have recently generated income, our long-term transition to sustained profitability will depend on the continued successful commercialization of Papzimeos and the potential commercialization of other product candidates to achieve sufficient revenues to support the Company's cost structure. Products currently in our clinical pipeline will require regulatory approval and/or commercial scale-up before they may commence significant product sales and operating profits, if any. We may also enter into strategic transactions for individual platforms or programs in the future from which we may generate collaboration and licensing revenues.

Previous wording

We do not anticipate that we will be recognizing material collaboration revenue in the near term, except in cases of future strategic transactions involving our platforms or programs. Should new collaboration agreements or strategic transactions be executed, revenue could be impacted.

Current wording

We do not anticipate that we will be recognizing material collaboration revenue in the near term, except in cases of future strategic transactions involving our platforms, products and programs. Should new collaboration agreements or strategic transactions be executed, revenue could be impacted.

Previous wording

Cost of products and services consists of manufacturing costs, transportation and freight-in, and indirect overhead costs (including salary and benefits related and stock-based compensation expenses) associated with the commercial manufacturing and distribution of Papzimeos, and costs related to our Exemplar business, which includes primarily labor, supplies, feed used in production, and facility charges. Approximately $1.1 million and $2.1 million of our cost of products and services for the three and six months ended June 30, 2026, respectively, relates to our Exemplar business. Cost of products and services may also include periodic costs related to certain manufacturing services, including costs related to excess or obsolete inventory, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances.

Current wording

Cost of products and services consists of manufacturing costs, transportation and freight-in, and indirect overhead costs (including salary and benefits related and stock-based compensation expenses) associated with the commercial manufacturing and distribution of Papzimeos, and costs related to our Exemplar business, which includes primarily labor, supplies, feed used in production, and facility charges. Approximately $1.1 million and $3.2 million of our cost of products and services for the three and nine months ended September 30, 2026, respectively, relates to our Exemplar business. Cost of products and services may also include periodic costs related to certain manufacturing services, including costs related to excess or obsolete inventory, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances.

Previous wording

For the three and six months ended June 30, 2026, 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 condensed consolidated balance sheetsas of June 30, 2026 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 condensed consolidated statements of operations for the three and six months ended June 30, 2026 is comprised of the sale of pre-launch inventory, which only includes costs incurred subsequent to August 14, 2025, and includes certain period costs incurred during the three and six months ended June 30, 2026 that were not absorbed into inventory. As of June 30, 2026, the amount of future estimated net revenues represented by existing physical pre-launch inventories is approximately $9 million based on our current pricing assumptions and projected demand for our recently approved commercial product.

Current wording

For the three and nine months ended September 30, 2026, 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 condensed consolidated balance sheets as of September 30, 2026 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 condensed consolidated statements of operations for the three and nine months ended September 30, 2026 primarily reflects the sale of units manufactured in part prior to August 14, 2025, and therefore includes only the portion of costs incurred subsequent to that date, as well as certain period costs that were not absorbed into inventory.

Previous wording

We recognize research and development expenses as they are incurred. Our research and development ("R&D") expenses consist primarily of:

Current wording

We recognize research and development ("R&D") expenses as they are incurred. Our research and development expenses consist primarily of:

Previous wording

Our research and development expenses primarily relate to either costs incurred to expand or otherwise improve our technologies or the costs incurred to develop our own products and services, including regulatory costs. We have initiated an open-label clinical trial to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP. Additionally, we plan to initiate a clinical trial to evaluate safety and efficacy of zopapogene imadenovec-drba in pediatric RRP patients. We continue to advance PRGN-2009, and we have completed enrollment in the Phase 1b clinical trial of PRGN-3006 in AML. Costs incurred with respect to each of these trials will be recorded as research and development expenses in the period for which they are incurred. Exemplar's research and development activities relate to new and improved pig research models, and those costs are not significant.

Current wording

Our R&D expenses primarily relate to either costs incurred to expand or otherwise improve our technologies or the costs incurred to develop our own products and services, including regulatory costs. We have initiated an open-label clinical trial to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP. Additionally, we plan to initiate a clinical trial to evaluate safety and efficacy of zopapogene imadenovec-drba in pediatric RRP patients. We continue to advance PRGN-2009, and we have completed enrollment in the Phase 1b clinical trial of PRGN-3006 in AML. Costs incurred with respect to each of these trials will be recorded as research and development expenses in the period for which they are incurred. Exemplar's research and development activities relate to new and improved pig research models, and those costs are not significant.

Previous wording

In addition, although not significant, shipping and handling costs on outgoing shipments to customers are recorded as incurred in SG&A and were approximately $813 and $0 for the three months ended June 30, 2026 and 2025, respectively, and $1,208 and $0 for the six months ended June 30, 2026 and 2025, respectively.

Current wording

In addition, although not considered significant, shipping and handling costs on outgoing shipments to customers are recorded as incurred in SG&A and were approximately $642 and $0 for the three months ended September 30, 2026 and 2025, respectively, and $1,849 and $0 for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

Advertising costs are expensed as incurred and included in selling, general and administrative expenses. Advertising expense was approximately $747 and $76 for the three months ended June 30, 2026 and 2025, respectively, and $857 and $77 for the six months ended June 30, 2026 and 2025, respectively.

Current wording

Advertising costs are expensed as incurred and included in selling, general and administrative expenses. Advertising expense was approximately $1,100 and $9 for the three months ended September 30, 2026 and 2025, respectively, and $1,957 and $86 for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

SG&A expenses may fluctuate in the future depending on the scaling of our corporate functions required to support our corporate initiatives, the strategic prioritization, the build-up of our commercialization efforts and the outcomes of legal claims and assessments against us.

Current wording

SG&A expenses may fluctuate in the future depending on the scaling of our corporate functions required to support our corporate initiatives, the strategic prioritization and the build-up of our commercialization efforts.

Previous wording

Total revenues increased by $54.1 million, or >200%, compared to the three months ended June 30, 2025. The significant increase in total revenues for the three months ended June 30, 2026, was primarily due to the recording of commercial sales of Papzimeos following its FDA approval in August 2025. Revenues related to the sale of Papzimeos for the three months ended June 30, 2026 were $53.1 million. No Papzimeos sales were recorded for the three months ended June 30, 2025, as the product had not yet been approved or launched.

Current wording

Total revenues increased by $71.2 million, or >200%, compared to the three months ended September 30, 2025. The increase in total revenues for the three months ended September 30, 2026, was primarily due to the recording of commercial sales of Papzimeos following its FDA approval in August 2025. Net product revenues from Papzimeos for the three months ended September 30, 2026 were $72.9 million. No Papzimeos sales were recorded for the three months ended September 30, 2025, as the product received FDA approval in August 2025 and significant revenue generating activities had not yet commenced during the period. The increase in total revenues was partially offset by a $1.8 million decrease in collaboration and licensing revenues. The three months ended September 30, 2025 included recognition of the remaining deferred revenue under the PTC Therapeutics collaboration agreement upon its termination; no such revenue was recognized in the three months ended September 30, 2026.

Previous wording

Cost of products and services increased by $1.7 million, or 156.9%, compared to the three months ended June 30, 2025 almost entirely due to costs related to the recording of commercial sales of Papzimeos following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of Papzimeos were expensed as research and development in accordance with our accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

Current wording

Cost of products and services increased by $5.5 million, or >200%, compared to the three months ended September 30, 2025, primarily due to costs related to the commercial sale of Papzimeos following its FDA approval in August 2025. These costs include the cost of products sold as well as other production-related costs that do not meet the criteria for capitalization as inventory. Prior to regulatory approval, costs associated with the production of Papzimeos were expensed as research and development in accordance with our accounting policy.

Previous wording

R&D expenses decreased by $9.0 million, or 41.2%, compared to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of Papzimeos manufacturing costs. Prior to the FDA approval of Papzimeos in August 2025, costs associated with the manufacturing of Papzimeos were expensed as R&D, as regulatory approval and the probability of future economic benefit had not yet been established. Following the FDA approval and the commencement of commercial sales, these production costs are no longer expensed as research and development, but are capitalized as inventory on the balance sheet and recognized as cost of product and services as the product is sold. We expect that R&D expenses will increase as the year progresses.

Current wording

R&D expenses decreased by $5.7 million, or 46.4%, compared to the three months ended September 30, 2025, primarily due to the change in the accounting treatment of Papzimeos manufacturing costs. Prior to the FDA approval of Papzimeos in August 2025, costs associated with the manufacturing of Papzimeos were expensed as R&D, as regulatory approval and the probability of future economic benefit had not yet been established. Following the FDA approval and the commencement of commercial sales, these production costs are no longer expensed as research and development, but are capitalized as inventory on the balance sheet and recognized as cost of products and services as the product is sold. The decrease also reflects lower performance based compensation expense of approximately $1.8 million, as certain performance based compensation was tied to the FDA approval of Papzimeos in the prior year period.

Previous wording

Total other expense, net was $2.6 million for the three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7 million, or 150.2%, compared to the three months ended June 30, 2025. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant liabilities that was recorded in the prior-year period. The prior-year increase in warrant liabilities was mainly driven by a rise in Precigen’s stock price and, to a lesser extent, by an increase in the liability for additional warrants that were expected at that point to be issued as paid-in-kind dividends on the Company’s Series A Preferred Stock. The remaining change primarily relates to an increase of $3.0 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.

Current wording

Total other expense, net was $2.7 million for the three months ended September 30, 2026 compared to other expense, net of $111.9 million for the three months ended September 30, 2025, a decrease of $109.2 million, or 97.6%, compared to the three months ended September 30, 2025. This decrease was primarily attributable to the absence of a $111.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The increase in fair value of warrant liabilities was primarily driven by an increase in the Company's common stock price at the valuation date relative to June 30, 2025. This decrease was offset by an increase of $2.1 million in interest expense related to long-term debt entered into in the third quarter of 2025.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (dollars in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (dollars in thousands):

Previous wording

Total revenues increased by $76.0 million, or >200%, compared to the six months ended June 30, 2025. The significant increase in total revenues for the six months ended June 30, 2026, was primarily due to the recording of commercial sales of Papzimeos following its FDA approval in August 2025. Revenues related to the sale of Papzimeos for the six months ended June 30, 2026 were $74.7 million. No Papzimeos sales were recorded for the six months ended June 30, 2025, as the product had not yet been approved or launched.

Current wording

Total revenues increased by $147.3 million, or >200%, compared to the nine months ended September 30, 2025. The significant increase in total revenues for the nine months ended September 30, 2026, was primarily due to the recording of commercial sales of Papzimeos following its FDA approval in August 2025. Revenues related to the sale of Papzimeos for the nine months ended September 30, 2026 were $147.6 million. No Papzimeos sales were recorded for the nine months ended September 30, 2025, as the product received FDA approval in August 2025 and significant revenue generating activities had not yet commenced during the period. Service revenues also increased $1.4 million, primarily due to higher revenue generated by our Exemplar subsidiary. These increases were partially offset by a $1.8 million decrease in collaboration and licensing revenue, as the prior-year period included recognition of the remaining deferred revenue under the PTC Therapeutics collaboration agreement upon its termination, with no comparable revenue recognized in 2026.

Previous wording

Cost of products and services increased by $3.2 million, or 144.7%, compared to the six months ended June 30, 2025 almost entirely due to costs related to the recording of commercial sales of Papzimeos following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of Papzimeos were expensed as research and development in accordance with our accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

Current wording

Cost of products and services increased by $8.6 million, or >200%, compared to the nine months ended September 30, 2025 primarily due to costs related to the commercial sale of Papzimeos following its FDA approval in August 2025. These costs include the cost of products sold as well as other production-related costs that do not meet the criteria for capitalization as inventory. Prior to regulatory approval, costs associated with the production of Papzimeos were expensed as research and development in accordance with our accounting policy.

Previous wording

R&D expenses decreased by $4.2 million, or 36.6%, compared to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of Papzimeos manufacturing costs. Prior to the FDA approval of Papzimeos in August 2025, costs associated with the manufacturing of Papzimeos were expensed as R&D, as regulatory approval and the probability of future economic benefit had not yet been established. Following the FDA approval and the commencement of commercial sales, these production costs are no longer expensed as research and development, but are capitalized as inventory on the balance sheet and recognized as cost of product and services as the product is sold. We expect that R&D expenses will increase as the year progresses.

Current wording

R&D expenses decreased by $14.8 million, or 43.1%, compared to the nine months ended September 30, 2025, primarily due to the change in the accounting treatment of Papzimeos manufacturing costs. Prior to the FDA approval of Papzimeos in August 2025, costs associated with the manufacturing of Papzimeos were expensed as R&D, as regulatory approval and the probability of future economic benefit had not yet been established. Following the FDA approval and the commencement of commercial sales, these production costs are no longer expensed as research and development, but are capitalized as inventory on the balance sheet and recognized as cost of products and services as the product is sold.

Previous wording

SG&A expenses increased by $6.1 million, or 37.9%, compared to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to Papzimeos following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

Current wording

SG&A expenses increased by $13.2 million, or 25.1%, compared to the nine months ended September 30, 2025. This increase was primarily driven by commercial activities related to Papzimeos following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, including third party commercialization costs, freight expenses, expanded marketing and promotional activities to drive product awareness and adoption, and increased software subscription costs.

Previous wording

In the six months ended June 30, 2025, we recorded $3.9 million in impairment related to our Exemplar reporting unit with no comparable charge in the six months ended June 30, 2026.

Current wording

In the nine months ended September 30, 2025, we recorded $3.9 million in impairment related to our Exemplar reporting unit with no comparable charge in the nine months ended September 30, 2026.

Previous wording

Total other expense, net decreased by $21.9 million, or 83.0%, compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The prior-year increase in warrant liabilities was mainly driven by a rise in Precigen’s stock price and, to a lesser extent, by an increase in the liability for additional warrants that were expected at that point to be issued as paid-in-kind dividends on the Company’s Series A Preferred Stock. The remaining change (an increase in other expense) primarily relates to an increase of $5.9 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.

Current wording

Total other expense, net decreased by $131.1 million, or 94.8%, compared to the nine months ended September 30, 2025. This decrease was primarily attributable to the absence of a $139.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The prior-year increase in warrant liabilities was mainly driven by a rise in Precigen’s stock price and, to a lesser extent, by an increase in the liability for additional warrants that were expected at that point to be issued as paid-in-kind dividends on the Company’s then outstanding Series A Preferred Stock. This decrease was offset by an increase of $8.0 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.

Previous wording

In the second quarter of 2026, we achieved profitability from continuing operations for the first time since our strategic transformation into a healthcare company in 2020, marking a pivotal milestone in our evolution. Prior to this quarter, we have incurred significant losses since our inception, and had an accumulated deficit of $2.3 billion as of June 30, 2026. From inception through June 30, 2026, we have funded our operations principally with proceeds received from private and public equity and debt offerings, cash received from our collaborators, cash received through sales of businesses, and through product and service sales made directly to customers. As of June 30, 2026, we had cash and cash equivalents of $16.3 million and investments of $22.4 million. Cash in excess of immediate requirements is typically invested primarily in money market funds, certificates of deposit and U.S. government debt securities in order to maintain liquidity and preserve capital.

Current wording

Beginning in the second quarter of 2026, we achieved profitability from continuing operations for the first time since our strategic transformation into a healthcare company in 2020, marking a pivotal milestone in our evolution. In addition, in the third quarter of 2026, we generated positive cash flow from operating activities of $11.9 million. Prior to the second quarter of 2026, we have incurred significant losses since our inception, and had an accumulated deficit of $2.3 billion as of September 30, 2026. From inception through September 30, 2026, we have funded our operations principally with proceeds received from private and public equity and debt offerings, cash received from our collaborators, cash received through sales of businesses, and through product and service sales made directly to customers. As of September 30, 2026, we had cash and cash equivalents of $15.0 million and investments of $36.0 million. Cash in excess of immediate requirements is typically invested primarily in money market funds, certificates of deposit and U.S. government debt securities in order to maintain liquidity and preserve capital.

Previous wording

In September 2025, the Company entered into a loan agreement with investment entities managed by Pharmakon Advisors, LP. The Company received net proceeds of $92,818 after deducting fees and expenses of $7,182. See "Notes to the Condensed Consolidated Financial Statements - Note 9" appearing elsewhere in this Report for further discussion on this loan agreement.

Current wording

In September 2025, the Company entered into a loan agreement with investment entities managed by Pharmakon Advisors, LP. The Company received net proceeds of $92,818 after deducting fees and expenses of $7,182. See "Notes to the Condensed

Previous wording

During the six months ended June 30, 2026, our net income was $12.1 million, which includes the following significant noncash expenses and benefits totaling $9.4 million: (i) $6.6 million of stock-based compensation expense, (ii) $2.2 million of depreciation and amortization expense, (iii) $0.7 million of accretion of debt discount, (iv) $0.5 million of shares issued as payment for services, partially offset by (v) $0.6 million of amortization of discounts on investments. In addition, changes in operating assets and liabilities used $83.2 million of cash for operating activities, driven primarily by increases in accounts receivable and inventory in connection with the commercial launch and ramp-up of Papzimeos sales. Our customer payment terms on sales of Papzimeos are 127 days, driving the significant increase in accounts receivables.

Current wording

During the nine months ended September 30, 2026, our net income was $47.9 million, which includes the following significant noncash expenses and benefits totaling $14.6 million: (i) $10.4 million of stock-based compensation expense, (ii) $3.3 million of depreciation and amortization expense, (iii) $1.1 million of accretion of debt discount, (iv) $0.5 million of shares issued as payment for services, partially offset by (v) $0.7 million of amortization of discounts on investments. In addition, changes in operating assets and liabilities used $112.2 million of cash for operating activities, driven primarily by increases in accounts receivable and inventory in connection with the commercial launch and ramp-up of Papzimeos sales. Our customer payment terms on sales of Papzimeos are 127 days, driving the significant increase in accounts receivable.

Previous wording

During the six months ended June 30, 2025, our net loss was $80.8 million, which includes the following significant noncash expenses and benefits totaling $36.8 million: (i) $28.0 million of unrealized appreciation in the fair value of warrant liabilities, (ii) $3.9 million impairment of goodwill, (iii) $4.3 million of stock-based compensation expense, (iv) $1.3 million of depreciation and amortization expense, and (v) $0.5 million of shares issued as payment for services, partially offset by non-cash benefits of $1.2 million due to amortization of discounts on investments. In addition, changes in operating assets and liabilities provided $8.6 million of cash for operating activities.

Current wording

During the nine months ended September 30, 2025, our net loss was $227.1 million, which includes the following significant noncash expenses and benefits totaling $153.3 million: (i) $139.5 million of appreciation in the fair value of warrant liabilities prior to their reclassification to permanent equity in the third quarter of 2025, (ii) $3.9 million impairment of goodwill, (iii) $8.7 million of stock-based compensation expense, (iv) $2.1 million of depreciation and amortization expense, and (v) $0.5 million for shares issued as payment for services, and (vi) $0.1 million related to accretion of debt discount and amortization of financing costs, partially offset by non-cash benefits of $1.5 million due to amortization of discounts on investments. In addition, changes in operating assets and liabilities provided $9.5 million of cash for operating activities.

Previous wording

During the six months ended June 30, 2026, we received $48.3 million of cash from sales and maturities of investments, net of purchases, and purchased $0.7 million of property, plant and equipment, primarily related to our manufacturing facility.

Current wording

During the nine months ended September 30, 2026, we received $34.8 million of cash from sales and maturities of investments, net of purchases, and purchased $1.1 million of property, plant and equipment, primarily related to our manufacturing facility.

Previous wording

During the six months ended June 30, 2025, we received $23.6 million of cash, from sales and maturities of investments, net of purchases, and purchased $1.6 million of property, plant and equipment, primarily related to the build-out of our manufacturing facility.

Current wording

During the nine months ended September 30, 2025, we purchased $39.4 million of investments, net of sales and maturities, and purchased $2.0 million of property, plant and equipment, primarily related to the build-out of our manufacturing facility.

Previous wording

During the six months ended June 30, 2026, we received $1.6 million of cash from the exercise of stock options and paid $1.5 million to taxing authorities in connection with the vesting of performance stock units.

Current wording

During the nine months ended September 30, 2026, we received $2.5 million of cash from the exercise of stock options and paid $1.7 million to taxing authorities in connection with the vesting of performance stock units.

Previous wording

During the six months ended June 30, 2025, we paid $0.4 million in issuance costs related to a prior year equity issuance, $0.5 million related to the prior year preferred stock issuance cost, and $1.8 million to taxing authorities related to vesting of equity awards, and received $0.2 million from the exercise of stock options.

Current wording

During the nine months ended September 30, 2025, we received $93.5 million under the Loan Agreement with entities managed by Pharmakon Advisors, LP (see "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 9" appearing elsewhere in this Quarterly Report) and $1.1 million from the exercise of stock options, and made the following financing activity payments: $0.4 million for costs related to a prior year equity issuance, $0.5 million for costs related to the prior year preferred stock issuance, $1.8 million to taxing authorities related to vesting of equity awards, and $1.3 million for performance share units settled in cash.

Previous wording

Until such time, if ever, as we can regularly generate positive operating cash flows, we plan to finance our cash needs through a combination of collection of accounts receivables from the sale of Papzimeos, debt and/or royalty financings, equity offerings, government, or other third-party funding, strategic alliances, sales of assets, and licensing arrangements. We may not be able to raise sufficient additional funds on terms that are favorable to us, if at all. To the extent that we raise additional capital through the sale of equity, convertible debt, warrants or preferred securities, the ownership interests of our common shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Our current stock price may make it more difficult to pursue equity financings and lead to substantial dilution if the price of our common stock does not increase. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through strategic transactions, collaborations, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates, or to grant licenses on terms that may not be favorable to us.

Current wording

Until such time, if ever, as we can regularly generate positive operating cash flows, we plan to finance our cash needs through a combination of collection of accounts receivable from the sale of Papzimeos, debt and/or royalty financings, equity offerings, government, or other third-party funding, strategic alliances, sales of assets, and licensing arrangements. We may not be able to raise sufficient additional funds on terms that are favorable to us, if at all. To the extent that we raise additional capital through the sale of equity, convertible debt, warrants or preferred securities, the ownership interests of our common shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Our current stock price may make it more difficult to pursue equity financings and lead to substantial dilution if the price of our common stock does not increase. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through strategic transactions, collaborations, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates, or to grant licenses on terms that may not be favorable to us.

Previous wording

Based on current projections, management believes that its existing cash, cash equivalents and short and long-term investments, combined with anticipated collection of accounts receivables from the commercialization of Papzimeos (including future sales), will enable us to continue our operations for at least one year from the date of this filing. We are subject to all of the risks inherent in the development of new products (including manufacturing and commercialization of Papzimeos), and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Current wording

Based on current projections, management believes that its existing cash, cash equivalents and short and long-term investments, combined with anticipated collection of accounts receivable from the commercialization of Papzimeos (including future sales), will enable us to continue our operations for at least one year from the date of this filing. We are subject to all of the risks inherent in the development of new products (including manufacturing and commercialization of Papzimeos), and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Previous wording

(*)Interest is calculated using a static annual rate of 10.25%, although our long-term debt carries a variable interest rate (see "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 9" appearing elsewhere in this Quarterly Report).

Current wording

(*)Interest is calculated using a static annual rate of 10.25%, although our long-term debt carries a variable interest rate (see "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 9" appearing elsewhere in this Quarterly

Previous wording

In addition to the obligations in the table above, as of June 30, 2026, we are party to license agreements with various third parties that contain future milestones and royalty payment obligations related to development milestones and/or commercial sales of products that incorporate or use their technologies. Because these agreements are generally subject to termination by us or are dependent on certain conditions precedent within our control, no amounts are included in the tables above. As of June 30, 2026, we also had research and development commitments with third parties totaling $5.4 million that had not yet been incurred.

Current wording

In addition to the obligations in the table above, as of September 30, 2026, we are party to license agreements with various third parties that contain future milestones and royalty payment obligations related to development milestones and/or commercial sales of products that incorporate or use their technologies. Because these agreements are generally subject to termination by us or are dependent on certain conditions precedent within our control, no amounts are included in the tables above. As of September 30, 2026, we also had research and development commitments with third parties totaling $5.3 million that had not yet been incurred.