Precigen Announces Q2 and H1 2024 Financial Results and Business Updates

In August 2024, Precigen, Inc., a biopharmaceutical company focusing on innovative gene and cell therapies, disclosed its financial results for the second quarter and first half of 2024. The company also shared significant updates about its business operations.

Key Highlights from 2024:

1. PRGN-2012 Gene Therapy: Precigen announced groundbreaking pivotal study data for its PRGN-2012 gene therapy at the ASCO annual meeting in June 2024. The therapy, designed to treat recurrent respiratory papillomatosis (RRP), showed more than half of the patients achieving a Complete Response. In July 2024, Phil Tennant was appointed as Chief Commercial Officer to lead the potential commercial launch of PRGN-2012. By August 2024, Precigen shifted its strategic focus primarily on advancing PRGN-2012. The company also initiated the rolling BLA submission process under an accelerated approval pathway, expected in the latter half of 2024, and began enrolling patients in a confirmatory clinical trial.

2. Financial Position: In August 2024, Precigen strengthened its financial position by raising approximately $31.4 million through a public offering of common stock.

3. Strategic Reprioritization: In light of the promising results and the anticipated accelerated approval pathway for PRGN-2012, Precigen reprioritized its clinical portfolio. This included a reduction of more than 20% of its workforce and streamlining of resources to focus on the potential commercialization of PRGN-2012.

4. Other Programs: The company plans to continue the PRGN-2009 Phase 2 clinical trials for cervical and oropharyngeal cancers in collaboration with the National Cancer Institute (NCI). However, enrollment for the PRGN-2009 cervical cancer clinical trial at non-NCI sites will be paused. Precigen has also completed enrollment for the Phase 1b trial of PRGN-3006 in acute myeloid leukemia, which has Fast Track designation from the FDA. Other clinical trials, including PRGN-3005 and PRGN-3007, will be paused, and investment in UltraCAR-T programs will be minimized to focus on strategic partnerships.

5. Operational Changes: The company initiated the shutdown of its Belgium-based subsidiary, ActoBio, resulting in over $34 million in impairment charges and additional severance costs. The intellectual property portfolio of ActoBio will be available for potential transactions.

6. Financial Performance for Q2 2024: Research and development expenses rose by $3.8 million (32%) compared to the same period in 2023, primarily due to severance charges and increased professional fees. SG&A expenses increased by $1.0 million (11%) due to severance costs and costs related to PRGN-2012 commercial readiness. Total revenues fell by $1.1 million (59%) compared to the prior year, attributed to declines in product and service revenues at Exemplar. Net loss for Q2 2024 was $58.8 million, compared to a net loss of $20.3 million in Q2 2023.

7. First Half Financial Performance: Research and development expenses increased by $5.9 million (25%) compared to the first half of 2023. SG&A expenses slightly decreased by $0.5 million (2%). Total revenues dropped by $1.9 million (51%), leading to a net loss of $82.5 million, compared to a net loss of $43.1 million in the same period of the previous year.

Precigen is committed to advancing its gene and cell therapy programs, particularly PRGN-2012, to meet significant unmet medical needs. The company's strategic focus, strengthened financial position, and operational adjustments are aimed at paving the way for the successful commercialization of its lead therapeutic programs.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!