Maxim Update on coverage-
How Quickly Can PISCES Rise? Aggressive or Conservative, Either Way we see Upside
The PISCES P2b study (N=48) is set to initiate in June with a protocol in place and Merck (MRK - $63.90 - NR) set to supply Keytruda. The study will enroll late-stage melanoma patients that have previously failed checkpoint therapy. The primary endpoint of the study is overall response rate (ORR) at 24 weeks.
Timelines and scenarios:
Aggressive:Oncosec'splanstousedatafromthefirst16patients(4Q17)
to approach the FDA and discuss using the total 48 patient data set to support registration, potentially as early as 2019. If successful there is more upside to our "conservative" $5 price target. Probability ~25%
Conservative:WeassumethatdatafromN=16comesin1H18asthefirst patient will be enrolled in June, enrollment takes time and the endpoint is 24 week ORR. We do believe the FDA could allow the study to be used for registration, but may require more than 48 patients as most checkpoint studies that led to approval(s), even in difficult to treat populations, enrolled hundreds of patients. As such we estimate a 2021 launch, which supports a $5 price target. Probability ~75%
Conclusion: A detailed analysis of the prior P2 data, suggest that Oncosec can be successful in Melanoma (turning cold tumors hot). We see more than one scenario in terms of timelines to the marketplace, but regardless of which scenario we select (aggressive or conservative) at the current sub-$20M valuation, success, (any scenario) is not factored into the current "distressed" valuation level.
