Phase III Cervical Dysplasia Trial of VGX-3100 Hits Primary Endpoint in China

研报英文原文证据摘录

Phase III Cervical Dysplasia Trial of VGX-3100 Hits Primary Endpoint in China

ia. The trial randomized 198 women (2:1) to VGX-3100 or placebo. VGX-3100 52-Week High / Low US$2.98 / US$1.03

met the primary endpoint of composite response rate at 36 weeks, defined as clearance Shares Out (mil) 82.3

of HPV infection and complete regression or regression of lesions to low-grade histology Form 10Q as of May12th

(CIN1). ApolloBio noted that the safety and tolerability profile was favorable. ApolloBio Market Cap. (mil) US$109.4

plans to submit for regulatory approval of VGX-3100 in cervical dysplasia, and also Total Assets ($mil) NA

Avg Daily Vol (000) 2,472 plans to conduct trials in other HPV-related indications. INOVIO partnered VGX-3100

Book Value/Share NA

with ApolloBio in 2018 and remains eligible for up to $20 million in milestone payments Net Cash Per Share US$0.65

plus double-digit royalties. Positive Phase III VGX-3100 data in cervical dysplasia has 1Q:26 cash + recent financing

important readthrough to INOVIO's DNA medicine platform. Debt to Total Capital 0.0%

Div (ann) NA

• INO-3107 Has October 30th PDUFA Date. The FDA completed the mid-cycle review Fiscal Year End Dec

of INOVIO's BLA for INO-3107 to treat adults with RRP. The agency noted as a potential

Price Performance - 1 Year

review issue that the submission has insufficient information to support accelerated

approval. INOVIO submitted additional data in February and is awaiting an informal USD

meeting with FDA to discuss accelerated approval of INO-3107. We expect INO-3107 3

approval by the October 30th PDUFA date based on the clean safety, strong efficacy 2.5

and remaining unmet medical need as Precigen's (PGEN, not covered) PAPZIMEOS is

not appropriate for all RRP patients.