Precigen, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Precision Third Quarter 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 Thursday, November 13, 2025. I would now like to turn the conference over to Steve Harasim. Please go ahead.

Thank you, Operator, and thank you to all those joining us for our third quarter 2025 update call. Joining me today are Helen Sabzabari, our President and CEO, Phil Tennant, our Chief Commercial Officer, Ritul Shah, our Chief Operating 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 this presentation and in our SEC filings, which include risks and uncertainties that could cause actual results to differ materially from today's forward-looking statements. With that, I will now turn the call over to Helen. Helen?

Thank you, Steve, and thank you to all those joining us for our third quarterly update call. The approval of Paximius in August marked a monumental turning point for all those impacted by recurrent respiratory papillomatosis, or RRP. Patients, families, physicians, and the RRP Foundation alike. We would like to welcome you to the new era of RRP treatment with Pepsimus poised to become the standard of care. Pepsimus is the first and only available treatment for adults with RRP, and it represents the best data, and that's by a wide margin, ever generated in adults with RRP. Why is pap smear a groundbreaking therapy? Let's look at the facts. First, pap smear addresses underlying root cause of RRP by generating an immune response against HPV6 and 11-infected papilloma cells. Secondly, pap smear has demonstrated transformative clinical benefit. What do I mean by that? 51% of patients achieved complete response requiring no surgery for 12 months post-treatment, with the durability shown in 15 of 18 complete responders remaining surgery-free at medium duration of three years without any additional treatment. Also, Overall, 86% of our patients had reduction in their surgical burden after Pepsimus treatment. Pepsimus has a very favorable safety profile with nothing greater than grade 2 TRAs, which are similar to those of all receiving a flu vaccine, for instance. Also, the ease of administration of pap smear, it's given as a subcutaneous administration that can be administered at any clinic or any of the physician offices. Furthermore, pap smear is not associated with a painful device necessary for administration. Let me be very clear here. We have treated the most severe RRP patients and demonstrated unmatched complete response rate, which has been durable with excellent safety profile. Based on the RRP pathology, it is easy to extrapolate pap smear results to a less severe patient population, which has been reflected in FDA's review and subsequent grant of a broad label for all adult RRP patients, irrespective of severity of their disease. In contrast, it is very difficult to extrapolate the results achieved in a less severe patient population to a more severe RRP population, as is the case with the competitor. I would like to emphasize that PAP-semias pivotal study is the first and today the only clinical trial in RRP conducted with this robust, prospectively defined statistical primary endpoint. PAP-semias clinical data not only beat the high statistical bar set for the pivotal study using the most robust clinical efficacy endpoints ever evaluated in RRP, It furthermore demonstrated the strongest data shown to date for RRP. In summary, Papsinias was granted full approval by the FDA with a broad label of adult RRP that does not include restriction on a number of prior surgeries. This is a testament to the transformative clinical data. that include unmatched efficacy and a strong, ongoing, durable responses from a pivotal study with a prospectively defined statistical primary efficacy endpoints of complete response rate. In addition, due to the mechanism of action of Papzimius, there is an opportunity for redosing of Papzimius. And with full approval, we have significantly raised the bar for clinical data for any competitor to enter the adult RRPA space in the future. This approval also marks a pivotal transition for Precision, propelling the company into a commercial stage, delivering this transformative therapy to market with exceptional speed and agility is a remarkable achievement. In the short time since approval, we have made great strides toward recognizing the robust commercial opportunity and building this strong foundation for pap smear to be the newest standard of care treatment. As always, our dialogue with the FDA continues to be very productive. including the completion of a successful post-approval meeting. We are currently working toward initiation of Paximius clinical trial for the pediatric RRP population. In addition, we have initiated our efforts for geographic expansion of Paximius. With that in mind, I'm pleased to announce that we have submitted marketing authorization application with the EMA. I will now turn the call over to our Chief Commercial Officer, Phil, to walk us through our commercial development. Phil?