Precigen, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Precision Full Year 2025 Financial Results and Business Updates Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, March 25th, 2026. I would now like to turn the conference over to Steve Harrison. Please go ahead.

Thank you, Operator, and thank you to all those joining us for our fourth quarter and year-end 2025 update call. Joining me today are Helen Sumsby, our President and CEO, Bill Tennant, our Chief Commercial Officer, and Harry Tomasi, our CFO. Before we begin our prepared remarks, I remind everyone that we will be making certain forward-looking statements. These statements are based on our current expectations and beliefs. We encourage you to review the slide in the presentation and in our SEC filings, which include risks and uncertainties that could cause actual results to differ from today's forward-looking statements. With that, I will now turn the call over to Helen.

Thank you, Steve. I would like to extend a warm welcome to all those joining us for our update call today. In the short time since the early and full approval of pap smear in August, the standard of care first line treatment for adults RRP, we are seeing a tremendous progress with the first ever therapeutic commercial launch in RRP. This substantial advancement constitutes a pivotal milestone for all the stakeholders impacted by RRP, including patients, their families, healthcare providers, and the RRP Foundation. As we commence commercial sales in Q4, Precision has completed the transformation from an R&D company to a product revenue generating commercial biotech company. Bill will detail the specifics of the launch progress later in the call, but I wanted to highlight the accelerating trajectory we are seeing in the revenue growth. We do not plan to provide a revenue guidance on a regular basis, but instead focus on indicators we believe are important for gaining progress of the launch trajectory from a long-term perspective. That said, as we are only a few days away from completion of Q1, which is the first full quarter of Paximia's commercial sales, we think it is helpful to provide investors with color on the pap smear cells ramp up. As reported in our 10-K, net product revenue for Q4 2025 was $3.4 million, with shipments commencing in November. As prescribers at major medical centers and community practices continue to add pap smear to their practice, We are seeing a strong momentum in Q1. As a result, based on a commercial activity to date, we expect revenues in Q1 to exceed $18 million. This is a clear sign of the enthusiasm we are seeing from patients and physicians alike, leading to a robust uptake in the therapy. I will now provide a brief recap on the reasons we believe we are seeing such a strong interest in Tapsimeus. Tapsimeus received full FDA approval with a broad label for adult RRP with no restriction based on the number of prior surgeries. This reflects the truly transformative clinical data, including unmatched efficacy a strong and durable ongoing responses, and a pivotal study powered by prospectively defined primary endpoint of complete response rate. Thanks to its mechanism of action, taximius also offers the potential for re-dosing if needed, which is being evaluated in the clinic now. With the full approval powered by unmatched efficacy, we have significantly raised the bar for any future competitor entering the adult RRP space. Let's examine the key facts which led to FDA's approval. Taximius directly addresses the root cause of RRP by eliciting a targeted immune response against HPV6 and R11. To be clear, We enrolled and treated more severe RRP patients and achieved an unmatched complete response rate with an impressive durability of responses with more than three years of follow-up, which is echoed and appreciated by physicians in the field. It not only surpassed the highest statistical bar using the most rigorous efficacy endpoint ever evaluated in RRP, but produced the strongest data demonstrated in the field to date. Given the underlying cause of RRP, these results readily extrapolate to less severe patients as reflected in the FDA's broad label approval for pap smear. In contrast, extrapolating results from a less severe population to a more severe cases is far more challenging and less reliable. What I just detailed has been supported by landmark expert consensus paper sponsored by the RRP Foundation and authored by 16 leading U.S. physicians specializing in RRP published in Laryngoscope, a top peer-reviewed journal in the field. The paper recommends Papsime is the first immunotherapy, which is the newest standard of care and preferred first-line treatment for adults with recurrent respiratory papillomatosis, or RRP. These developments represent a pivotal advancement for the RRP community, prioritizing medical therapy over repeated surgical interventions to improve patients' outcomes. I will now turn the call over to Phil for details around our commercial launch. Phil?