Precigen (NASDAQ:PGEN) executives used a fireside chat hosted by H.C. Wainwright to outline the company’s transition into a commercial-stage organization following the FDA approval of Papzimeos, the first immunotherapy approved for adults with recurrent respiratory papillomatosis (RRP). The discussion, led by Swayampakula Ramakanth, managing director and senior equity analyst at H.C. Wainwright, featured President and CEO Dr. Helen Sabzevari and Chief Commercial Officer Phil Tennant.
Papzimeos platform and mechanism
Sabzevari described Papzimeos (also referenced as PRGN-2012) as an immunotherapy built on Precigen’s proprietary “gorilla-based adenovectors,” which she said are differentiated from conventional adenovirus vectors. She emphasized several features of the platform, including higher payload capacity and the ability to repeat-dose.
Sabzevari said Papzimeos is administered subcutaneously and is designed to train a patient’s T cells to recognize epitopes associated with HPV 6 and HPV 11, the viruses linked to RRP. The goal, she said, is to address the underlying viral cause of the disease rather than relying on repeated surgeries to remove lesions.
Pivotal study results and rationale for redosing
Ramakanth noted that Precigen’s pivotal study showed a 51% complete response rate. Sabzevari said the trial targeted a severe patient population defined as having at least three surgeries per year, with some patients undergoing more than 10 annually. She also highlighted the trial’s definition of complete response as at least 12 months without surgery or other treatment.
Sabzevari said durability has extended, with some complete responders now beyond three years. She added that across all patients the overall reduction in surgeries was 86%, and that 35% of patients who did not meet the complete response endpoint still reduced their number of surgeries.
As for why some patients did not achieve complete response, Sabzevari said the company observed increased HPV 6/11 immune responses and CD8 expansion in partial responders, though not to the same extent as in complete responders. She attributed this to differences in patients’ immune system status and potential immune exhaustion due to long-standing infection. Sabzevari said discussions with the FDA led to the view that additional dosing could potentially push partial responders toward complete response, which she said is enabled by the platform’s repeat-dosing capability.
Early commercial launch: adherence, targeting, and patient funnel
Tennant said Precigen began dosing patients in November and that patients were starting to complete the four-dose regimen administered over 12 weeks. He said the company was not aware of any patients who had failed to complete all four doses, calling the schedule relatively straightforward for centers accustomed to more complex regimens. He also noted the label allows flexibility in scheduling.
On commercialization strategy, Tennant described a partner-supported field model in which Precigen’s commercial leadership are company employees while the field organization is employed by Avanza but dedicated to Papzimeos. He said Precigen had analyzed claims and electronic health records prior to launch and identified about 500 hospital systems where most RRP patients are treated, with roughly 100 systems representing about 80% of the opportunity. Tennant said the initial footprint was designed to cover about 90% of patient potential and is supplemented by digital and non-personal promotion channels.
Ramakanth asked about the company’s hub metrics. Tennant explained that the “hub” refers to a manufacturer patient support program where patients can be registered for benefit verification and treatment coordination. He said Precigen reported “over 300” patients in the hub and noted that another source of patients comes directly through institutional patient support services. Tennant said the company views hub growth as a lead indicator it will continue to discuss, alongside revenue.
Disease prevalence, coverage, and the impact of a J-code
Both executives argued that RRP prevalence has been historically underreported. Sabzevari said older reports from the 1990s cited 10,000 to 14,000 patients, and that Precigen has worked closely with investigators and advocacy groups since 2021 to raise awareness, including around an RRP awareness day held on June 11 in collaboration with the RRP Foundation.
Tennant said Precigen conducted an analysis of electronic health records and claims data to estimate prevalence despite the lack of an ICD-10 code, using diagnostic and surgical patterns. He said this work led the company to estimate about 27,000 adults with RRP and that diagnosed prevalence could increase with education and the availability of Papzimeos.
On payer access, Tennant said the company has been “thrilled” with the speed of coverage, citing 215 million covered lives in the commercial segment and nearly 300 million when including Medicare and Medicaid. He acknowledged some plans have restrictions tied to prior surgery counts but said Precigen believes clinicians can appeal using unmet need, patient history, clinical data, and a consensus statement from the foundation and 16 thought leaders supporting Papzimeos as the new standard of care for all adults with RRP. Tennant said Precigen was not aware of any payer that had “flatly rejected” a patient for treatment.
Looking to reimbursement logistics, Tennant said the permanent J-code is expected to streamline access and activate institutions that prefer to wait for buy-and-bill reimbursement clarity. He said it should “smooth and streamline the whole patient access process.”
Pipeline updates: pediatric plans, PRGN-2009, and platform designation
Sabzevari said Precigen plans to start pediatric trials for Papzimeos by the end of 2026, citing the ease of administration and a safety profile she characterized as generally limited to mild reactions similar to a flu shot. She said the redosing arm has begun and that the company expects to start providing data in 2028.
Sabzevari also highlighted PRGN-2009, an investigational immunotherapy on the same gorilla adenovirus backbone designed to target HPV 16 and 18 in HPV-related cancers. She said phase I data in relapsed/refractory patients who had failed multiple lines of therapy, including checkpoint inhibitors, showed 30% objective responses when PRGN-2009 was combined with a checkpoint inhibitor, including complete responses ongoing for more than two years. She said the company has initiated phase II trials in cervical cancer and in head and neck oropharyngeal carcinoma, and is expecting to report an initial dataset from the head and neck trial by the end of 2026.
Sabzevari said Precigen is interested in discussions with the FDA about a platform technology designation, arguing it could enable faster reviews by leveraging established manufacturing, safety, and other data from the same non-replicating AdenoVerse backbone across multiple products.
In closing, Sabzevari said the company ended the year with “a little bit over $100 million” in cash and that budgets already include redosing, pediatric trial initiation, and PRGN-2009 expansion for the year. Tennant added that the company provided first-quarter revenue expectations because the earnings call came late in the quarter, but said Precigen does not plan to provide similar intra-quarter guidance going forward, instead pointing to ongoing updates on adoption, institutional activation, payer coverage, and reported quarterly revenue.
About Precigen (NASDAQ:PGEN)
Precigen, Inc (NASDAQ: PGEN) is a biotechnology company focused on the discovery, development and commercialization of genetic medicines. The company leverages proprietary gene and cell therapy platforms to design targeted therapies for oncology, infectious diseases and rare conditions. Precigen’s approach combines synthetic biology, immuno-oncology and microbiome engineering to create precision treatments intended to enhance efficacy while minimizing off-target effects.
The centerpiece of Precigen’s technology is its OmniCAR platform, which enables the rapid generation of adaptable chimeric antigen receptor (CAR) T-cell products.
