Overview of Financial Performance

Precigen, a biotechnology company focused on developing innovative gene and cell therapies, reported its financial results for the year ended December 31, 2024. The company has faced a challenging year, with a net loss of $126.2 million, up from a net loss of $95.9 million in the prior year.

The primary driver of Precigen’s losses has been its continued investment in research and development, particularly around its lead program PRGN-2012, a gene therapy for the treatment of recurrent respiratory papillomatosis (RRP). In 2024, the company completed the rolling submission of a Biologics License Application (BLA) to the FDA for PRGN-2012 and received priority review, with a target action date set for August 2025.

To focus its resources on the potential commercialization of PRGN-2012, Precigen announced a strategic prioritization of its pipeline in August 2024. This included minimizing spending on its UltraCAR-T programs, pausing enrollment in certain clinical trials, and reducing its focus on preclinical programs. The company also completed the shutdown of its ActoBio subsidiary.

Revenue and Profit Trends

Precigen’s revenues declined 36.9% in 2024 to $3.9 million, down from $6.2 million in the prior year. This decrease was primarily due to a 100% drop in collaboration and licensing revenues, as the company terminated its license agreement with Alaunos in 2024. Product and service revenues from the company’s Exemplar reporting segment also declined by 36.6% to $3.9 million.

The decline in revenues, combined with continued investment in research and development, led to a significant increase in Precigen’s net loss. R&D expenses grew 9.2% to $53.1 million, driven by costs associated with the PRGN-2012 BLA submission, the confirmatory clinical trial, and manufacturing preparations. Selling, general, and administrative (SG&A) expenses also increased by 2.2% to $41.3 million.

Precigen’s Biopharmaceuticals segment, which includes the PRGN-2012 program, saw its Segment Adjusted EBITDA loss grow by 9.2% to $82.3 million. This was partially offset by a 28.0% increase in the Segment Adjusted EBITDA loss for the Exemplar segment to $0.9 million.

Strengths and Weaknesses

One of Precigen’s key strengths is its focus on advancing its lead program, PRGN-2012, through the regulatory approval process. The company’s successful BLA submission and receipt of priority review from the FDA for this gene therapy candidate is a significant milestone. If approved, PRGN-2012 could provide a much-needed treatment option for patients with RRP, a rare and debilitating condition.

However, Precigen’s heavy reliance on PRGN-2012 also represents a weakness. The company’s decision to deprioritize its other pipeline programs, including its UltraCAR-T therapies, leaves it vulnerable if PRGN-2012 encounters any setbacks or delays in the approval process. Additionally, the company’s Exemplar segment, which provides revenue from the sale of genetically engineered miniature swine models, has seen a significant decline in both revenues and profitability.

Another weakness is Precigen’s ongoing financial challenges. The company has incurred losses since its inception and has had to rely on a combination of equity offerings, debt financing, and asset sales to fund its operations. As of December 31, 2024, Precigen had $97.9 million in cash, cash equivalents, and short-term investments, but its ability to continue as a going concern is dependent on the successful commercialization of PRGN-2012 and its ability to raise additional capital.

Outlook and Future Prospects

Precigen’s immediate focus is on securing regulatory approval for PRGN-2012 and preparing for its potential commercial launch. The company’s successful BLA submission and priority review designation from the FDA are positive signs, but there is still significant uncertainty around the timing and outcome of the approval process.

If PRGN-2012 is approved, Precigen will face the challenge of building out its commercial infrastructure and successfully launching the product. The company’s ability to generate sufficient revenue from PRGN-2012 to fund its ongoing operations will be critical to its long-term success.

Beyond PRGN-2012, Precigen’s future prospects are less clear. The company’s decision to deprioritize its other pipeline programs, including its UltraCAR-T therapies, leaves it with a limited number of potential growth drivers. Precigen will need to carefully evaluate its strategic options and determine whether to invest in advancing these other programs or to seek out new opportunities through partnerships or acquisitions.

Financially, Precigen will likely need to raise additional capital in the near future to fund its operations and support the potential launch of PRGN-2012. The company’s ability to secure this funding on favorable terms will be crucial, as it continues to burn through cash and faces substantial uncertainty around its long-term profitability.

In summary, Precigen’s financial performance in 2024 was marked by continued losses, a strategic shift to focus on PRGN-2012, and ongoing challenges in its Exemplar segment. The company’s near-term success will hinge on the approval and successful commercialization of PRGN-2012, while its long-term prospects will depend on its ability to diversify its pipeline, secure additional funding, and navigate the complex and competitive biotechnology landscape.