PRECIGEN, INC. Q1 FY2023 earnings call

Helen Sabzevari emphasized 4 clinical principles: focusing on high unmet need indications, developing differentiated therapies with cost-effective pricing, pursuing programs with rapid commercialization potential, and executing a cost-effective R&D model. She discussed the AdenoVerse platform, including PRGN-2012 (targeting HPV 6 and 11-related rare disease with favorable safety and efficacy data) and PRGN-2009 (targeting HPV 16 and 18-related cancers, with data to be presented at ASCO and moving into front-line therapy). The UltraCAR-T platform was also covered, including PRGN-3006 (AML patient population with favorable safety and preliminary efficacy data), PRGN-3005 (ovarian cancer with data to be presented at ASCO and consideration of split dosing), PRGN-3007 (next-generation UltraCAR-T with ROR1 target and intrinsic checkpoint inhibitor regulation, first patient dosed in the quarter), and regaining rights for CD19, BCMA, and IL-12. Harry Thomasian discussed repurchasing convertible notes, reducing G&A expense by 15% in Q1, and cash burn details with redirection of capital towards R&D.

Harry Thomasian stated that the company's program of financial discipline, combined with public equity offering in January and early debt retirement, provides a solid cash runway to support priorities into late 2024, consistent with previously provided guidance on cash runway.

Q: Jason Butler asked about PRGN-2009 data at ASCO and mechanistic rationale for ROR1 in PRGN-3007.

A: Helen Sabzevari said PRGN-2009 data at ASCO includes safety, mechanism of action, and efficacy with objective responses and durability of responses discussed; ROR1 is expressed on hematological and solid tumors and PRGN-3007's design addresses tumor microenvironment checkpoint inhibition issues.

Q: Jennifer Kim asked about PRGN-3007 interim data and PRGN-3005 split dosing.

A: Helen Sabzevari said PRGN-3007 will have some preliminary data by end of year; PRGN-3005 split dosing involves intraperitoneal and IV dosing for ovarian cancer patients.

Q: Jennifer Kim asked about PRGN-2012 FDA discussions.

A: Helen Sabzevari said ongoing productive discussions with FDA, finished PRGN-2012 Phase 2 enrollment, and waiting for FDA strategy finalization.

Q: Carolina Ibanez Ventoso asked about PRGN-2012 additional results and booster expectation.

A: Helen Sabzevari said next data presentation will be on Phase 2 full follow-up, and there will be follow-on trials for boosting.

Q: Arthur He asked about repeating dosing for 3005 and 3006, average doses per batch, and strategy for CD19 and BCMA.

A: Helen Sabzevari said repeating dosing at physician discretion, can redose with original material, and strategy for CD19 and BCMA is to use their platform to change the paradigm with commercially viable and scalable approach