8-K: Precigen Announces Full Year 2023 Results and Provides Business Update, Anticipates BLA Submission for PRGN-2012 in Second Half of 2024

Precigen reports its full year 2023 financial results and provides a business update, highlighting progress in its clinical programs and plans for a BLA submission for PRGN-2012 in the second half of 2024.

Summary

• Precigen announced its full year 2023 financial results and provided a business update.
• The company is planning to submit a Biologics License Application (BLA) for PRGN-2012 under an accelerated approval pathway in the second half of 2024.
• Commercial readiness activities are ramping up for a potential launch of PRGN-2012 in 2025.
• Precigen's PRGN-2012 received Breakthrough Therapy Designation and accelerated approval pathway from the FDA for the treatment of RRP.
• The company received IND clearance for a Phase 2 study of PRGN-2009 in combination with pembrolizumab for cervical cancer.
• Interim data from the Phase 1b study of PRGN-3006 in AML is expected in the second half of 2024.
• Preliminary data from the Phase 1 study of PRGN-3007 in advanced cancers is also anticipated in the second half of 2024.
• As of December 31, 2023, Precigen had $62.9 million in cash, cash equivalents, and investments.
• Selling, general, and administrative (SG&A) costs decreased by 16% for the year ended December 31, 2023, compared to the prior year.

Sentiment

Score: 6

Explanation: The document presents a mixed picture. There is positive progress in clinical development and cost management, but significant revenue decline and increased losses temper the overall sentiment. The potential need for a capital raise also adds a note of caution.

Positives

• The company is making significant progress in the development of PRGN-2012, with a planned BLA submission in the second half of 2024.
• PRGN-2012 has shown strong efficacy and a favorable safety profile in the Phase 1 study, with 50% of patients achieving a durable complete response.
• The company has received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for PRGN-2012.
• Precigen is actively advancing its UltraCAR-T programs, which have garnered interest from potential partners.
• The company has reduced SG&A costs by 16%, demonstrating a focus on cost containment.
• The company has $62.9 million in cash, cash equivalents, and investments.

Negatives

• Total revenues decreased by $20.7 million, or 76.9%, compared to the year ended December 31, 2022.
• Collaboration and licensing revenues decreased by $14.6 million, or 99.5%, compared to the year ended December 31, 2022.
• Product and services revenues decreased by $5.9 million, or 48.8%, compared to the year ended December 31, 2022.
• The company recorded a $10.4 million impairment charge related to its Exemplar subsidiary.
• Loss from continuing operations was $95.9 million, compared to a loss of $79.8 million in the prior year.

Risks

• The company is evaluating various financing opportunities to strengthen its balance sheet, indicating a potential need for additional capital.
• The company's future success is dependent on the successful development and commercialization of its therapies.
• The company's financial results show a significant decrease in revenue and an increase in losses from continuing operations.
• The company faces risks associated with clinical trials, regulatory approvals, and market competition.

Future Outlook

Precigen anticipates multiple value inflection points in 2024, including the presentation of Phase 2 data for PRGN-2012 and the submission of a BLA. The company is also looking forward to updates from its UltraCAR-T programs and is evaluating financing opportunities to strengthen its balance sheet in preparation for the potential commercial launch of PRGN-2012 in 2025.

Management Comments

• 2024 is poised to be a transformative year for Precigen, as we are on track to present pivotal Phase 2 data in the second quarter and submit a BLA for PRGN-2012 in the second half, a milestone bolstered by the Breakthrough Therapy Designation and accelerated approval pathway granted by the FDA, said Helen Sabzevari, PhD, President and CEO of Precigen.
• We are preparing our manufacturing facility and commercial operations in anticipation of the launch of PRGN-2012 in 2025.
• We are also looking forward to exciting updates from our UltraCAR-T programs, which offer a novel approach compared to traditional CAR-T therapies and have garnered significant interest from potential partners due to the safety, preliminary efficacy, and manufacturing advantages.
• With multiple value inflection points anticipated in 2024, we remain steadfastly committed to a strategy of sound financial management, said Harry Thomasian Jr., CFO of Precigen.
• We are evaluating various financing opportunities to strengthen our balance sheet as we prepare our lead asset PRGN-2012 for potential commercial launch in 2025.

Industry Context

This announcement highlights Precigen's progress in the competitive gene and cell therapy space, particularly in immuno-oncology. The company's focus on novel approaches like UltraCAR-T and AdenoVerse immunotherapies positions it to potentially address unmet needs in cancer treatment. The planned BLA submission for PRGN-2012 is a significant milestone, and the company's ability to secure partnerships for its UltraCAR-T platform will be important for its future growth.

Comparison to Industry Standards

• The 50% complete response rate in the Phase 1 study of PRGN-2012 is promising compared to standard treatments for RRP, which often involve repeated surgeries.
• The UltraCAR-T platform's overnight manufacturing process is a potential advantage over traditional CAR-T therapies, which typically require longer manufacturing times and more complex logistics, such as those used by companies like Gilead (Yescarta) and Novartis (Kymriah).
• The reduction in SG&A costs by 16% indicates a focus on financial discipline, which is important for biotech companies in the development stage, and is a positive sign compared to companies with high burn rates.
• The significant decrease in revenue is a concern, and the company will need to demonstrate its ability to generate revenue from its products and services in the future, which is a common challenge for companies in this sector.

Stakeholder Impact

• Shareholders may be concerned about the decrease in revenue and increased losses, but encouraged by the clinical progress and potential for future growth.
• Employees may be impacted by the company's cost containment efforts, but also motivated by the progress in clinical development.
• Patients may benefit from the potential approval and commercialization of new therapies.
• Potential partners may be interested in the company's UltraCAR-T platform and other technologies.

Next Steps

• Precigen plans to present Phase 2 data for PRGN-2012 in the second quarter of 2024.
• The company anticipates submitting a BLA for PRGN-2012 in the second half of 2024.
• Interim data from the Phase 1b study of PRGN-3006 is expected in the second half of 2024.
• Preliminary data from the Phase 1 study of PRGN-3007 is anticipated in the second half of 2024.
• The company is preparing for a potential commercial launch of PRGN-2012 in 2025.
• Precigen is evaluating various financing opportunities to strengthen its balance sheet.

Key Dates

Keywords

PRGN-2012, UltraCAR-T, AdenoVerse, Immunotherapy, RRP, AML, Biologics License Application, Breakthrough Therapy Designation, Financial Results, Clinical Trials