Precigen Reports $126.2 Million Net Loss for Fiscal Year 2024, Focuses on PRGN-2012 Development

Precigen, Inc. reported a net loss of $126.2 million for the fiscal year ending December 31, 2024, compared to a net loss of $95.9 million in the previous year, marking a 31.6% increase in losses. Total revenues for the year were $3.9 million, a decline of 36.9% from $6.2 million in 2023. This decrease was primarily attributed to the termination of a licensing agreement with Alaunos Therapeutics and a reduction in product and service revenues from its Exemplar segment, which fell by 36.6% to $3.9 million. The company’s operating expenses rose by 31.1% to $139 million, driven by increased research and development costs associated with its lead product candidate, PRGN-2012, and impairment charges related to the shutdown of its ActoBio subsidiary.

In a strategic shift, Precigen has focused its resources on the development of PRGN-2012, an investigational gene therapy for recurrent respiratory papillomatosis (RRP). The company has paused enrollment in two other clinical trials (PRGN-3005 and PRGN-3007) to streamline operations and minimize spending on its UltraCAR-T programs. The FDA has accepted the Biologics License Application (BLA) for PRGN-2012 and granted it priority review, with a target action date set for August 27, 2025. This prioritization aims to enhance the company’s chances of commercial success and improve its financial outlook.

As of December 31, 2024, Precigen had cash and cash equivalents totaling $29.5 million, alongside short-term investments of $68.4 million. However, the company has raised concerns about its ability to continue as a going concern due to ongoing losses and the need for substantial additional capital to fund operations. The company’s accumulated deficit reached $2.1 billion, and it has indicated that it may need to raise additional funds through various means, including equity offerings or strategic partnerships, to support its operations and development efforts.

Operationally, Precigen has reduced its workforce by over 20% as part of its restructuring efforts. The company’s total employee count as of December 31, 2024, was 143, with 99 employees dedicated to research and development. The strategic focus on PRGN-2012 and the decision to cease operations at ActoBio reflect the company's commitment to enhancing its core therapeutic areas, which include immuno-oncology and autoimmune disorders. The company is also exploring potential partnerships to advance its UltraCAR-T programs while concentrating on the commercialization of PRGN-2012.

Looking ahead, Precigen's future performance will largely depend on the successful development and commercialization of PRGN-2012, as well as its ability to secure additional funding. The company faces significant risks, including regulatory hurdles, competition in the biotechnology sector, and the challenges associated with bringing new therapies to market. The management's plans to navigate these challenges will be critical in determining the company's financial stability and growth trajectory in the coming years.