Slide 1: US FDA Approval of PAPZIMEOS
US FDA Approval of PAPZIMEOS August 18, 2025
Slide 2: Forward-looking Statement
Forward-looking Statement This presentation contains “forward-looking” statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,
Slide 3: Call Participants
Call Participants Harry Thomasian Jr. Helen Sabzevari, PhD Chief Financial Officer President and CEO Phil Tennant Rutul Shah Chief Commercial Officer Chief Operating Officer 3
Slide 4: Agenda
Agenda RRP Landscape PAPZIMEOS Prescribing Information and Label Details PAPZIMEOS Pivotal Clinical Data Commercial Strategy and Launch Plans Q&A 4
Slide 5: First and Only FDA-Approved Therapy for Adults with RRP
First and Only FDA-Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP) www.PAPZIMEOS.com 5
Slide 6: RRP Landscape
RRP Landscape 6
Slide 7: Recurrent Respiratory Papillomatosis (RRP), a Rare HPV-driven Disease
Recurrent Respiratory Papillomatosis (RRP), a Rare HPV-driven Disease • RRP is a rare, debilitating disease of the respiratory tract caused by HPV 6 or HPV 11 infection papillomas • RRP was previously managed mainly by surgical (benign tumors) interventions; repeat surgeries are associated with sign
Slide 8: PAPZIMEOS has Potential to Become the Standard-of-care for Adults with RRP
PAPZIMEOS has Potential to Become the Standard-of-care for Adults with RRP Prevalence of RRP in US1 27,000 Approximately adult patients in US PAPZIMEOS has the potential to define a new treatment paradigm for adults with RRP 1 Precigen-commissioned research; analysis derived from claims and electron
Slide 9: PAPZIMEOS Prescribing Information and Label Details
PAPZIMEOS Prescribing Information and Label Details 9
Slide 10: First FDA-approved Therapy for Adults with RRP
First FDA-approved Therapy for Adults with RRP PAPZIMEOS received full approval No requirement for the confirmatory clinical trial BROAD LABEL enables adults with RRP to be eligible for PAPZIMEOS Strong efficacy, durability of response, and favorable safety profile 10
Slide 11: PAPZIMEOS US Prescribing Information Overview
PAPZIMEOS US Prescribing Information Overview INDICATION PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis DOSAGE & ADMINISTRATION PAPZIMEOS is for subcutaneous injection only The recommended dose of P
Slide 12: PAPZIMEOS US Prescribing Information Overview
PAPZIMEOS US Prescribing Information Overview Warnings and Precautions Injection-site reactions: Injection-site reactions, have been observed. Monitor patients for local site reactions for at least 30 minutes after the initial treatment. Thrombotic events: Thrombotic events may occur following admin
Slide 13: PAPZIMEOS Pivotal Clinical Data
PAPZIMEOS Pivotal Clinical Data 13
Slide 14: PAPZIMEOS Targets the Root Cause of RRP
PAPZIMEOS Targets the Root Cause of RRP • Ability for repeat injections • Designed to generate an immune response directed against papilloma cells expressing HPV 6 or HPV11 Actual patient Same patient PAPZIMEOS is administered to before treatment after treatment 1 patient via subcutaneous injection
Slide 15: Pivotal Study Met Primary Efficacy Endpoint
Pivotal Study Met Primary Efficacy Endpoint 51% Complete Response Rate Pre-treatment Post-treatment 12-months p=<0.0001 12-months 10 0 0 (95% CI [34-69%]) 8 8 0 8 0 5 0 5 0 4 0 Durable Complete Responses 4 4 0 0 4 0 15 out of 18 Complete Responders evaluated at 2 years 4 4 0 0 demonstrated continued
Slide 16: Commercial Strategy and Launch Plans
Commercial Strategy and Launch Plans 16
Slide 17: PAPZIMEOS: the First and Only FDA-approved Therapy for Adults with RRP
PAPZIMEOS: the First and Only FDA-approved Therapy for Adults with RRP Poised to become the standard of care for patients with this chronic, debilitating condition Concentrated Patient Durable Population Complete Responses Broad Label IDNs and Community CRs ongoing and hospitals account beyond 2 yea
Slide 18: Targeted Launch Strategy with a Highly Experienced Field Team
Targeted Launch Strategy with a Highly Experienced Field Team Team Structure Launch Readiness Immediate Focus 18 dedicated sales territories will IDN and HCP targeting complete: over 93 IDNs and community hospitals cover >90% of ENT patient potential 90% of account, patient and account for 80% of pr
Slide 19: Key Indicators of Launch Success
Key Indicators of Launch Success Prescription Formulary status KOL asset dynamics at HCP / covered lives Patient Hub advocacy and Institutional with favorable dynamics level access 19
Slide 20: Comprehensive PAPZIMEOS Support Program for HCPs and Patients
Comprehensive PAPZIMEOS Support Program for HCPs and Patients Support for HCPs Support for Patients Order Support Treatment Education Help coordinating ordering and Support through the treatment process, delivery of PAPZIMEOS via specialty including education about PAPZIMEOS and pharmacy services he
Slide 21: PAPZIMEOS Offers a Significant Value Proposition
PAPZIMEOS Offers a Significant Value Proposition First and Only FDA-approved RRP Treatment Transformative Clinical Benefit Chronic, Debilitating Rare Disease Our goal is to ensure every eligible Committed to Serving RRP Community RRP patient has access to PAPZIMEOS 21
Slide 22: Q&A
. CS Q&A Papzimeos” zZopapogene imadenovec-drba PRECIGEN
Slide 23: Quote from RRP Foundation President on FDA approval
“This long-awaited FDA approval represents a momentous milestone for the RRP community. For the first time, adult patients with RRP have access to an FDA-approved therapy that offers the potential to reduce— or even eliminate—endless repeated surgeries. This breakthrough brings long-overdue hope to
Slide 24: 24
24