ZoptEC moving ahead
AEterna Zentaris Inc. (NASDAQ:AEZS) reported at the 2014 ASCO that 158 patients have been randomised as of 26 May 2014 in the zoptarelin doxorubicin in endometrial cancer (ZoptEC) Phase III trial, moving closer to the first interim analysis scheduled to take place in mid-2015. It has cash and cash equivalents of $45.8m at the end of March 2014, which should be enough to support its operation into mid-2015 when the first interim analysis of ZoptEC takes place.
ZoptEC moving ahead
A poster detailing the design of the Phase III ZoptEC trial was presented at the 2014 annual meeting of ASCO (American Society of Clinical Oncology) held from 30 May to 2 June in Chicago. The open-label, randomised controlled, Phase III trial compares efficacy and safety of zoptarelin doxorubicin (AEZS-108) and doxorubicin in advanced, recurrent or metastatic platinum-taxane pretreated endometrial cancer. Planned to enrol 500 patients, the trial has built in two interim analyses, one at 128 events (for futility only) and the second at 192 events (for safety and efficacy). Final analysis is planned for at 384 events with primary endpoint of overall survival, assuming OS of 12 and nine months in treatment and control, respectively. With 158 patients randomised as of May, we believe the company will meet its goal of conducting first interim analysis at events of 128.
MACRILEN: A niche product
Aeterna filed a new drug application (NDA) in November 2013 for MACRILEN to be used in the evaluation of AGHD. The company reported that the FDA is conducting a substantive review of the NDA. If approved (PDUFA date 5 November 2014), Aeterna plans to launch the product into a $40-80m US market (our estimate is based on company data) with a c 20-person sales team in H115.
Enough cash to reach first ZoptEC interim analysis
With an operating cash burn of $33-35m in 2014 (per company guidance), Aeterna’s current cash position should support its operation through the first interim analysis. The company may need additional funds (via partnership or capital market) to support the MACRILEN launch and complete the zoptarelin doxorubicin Phase III.
Valuation: Upside remains
Aeterna’s EV (including shares from exercising stock options and warrants) of c $50m is relatively modest for a company with a product in NDA and another in Phase III development. We see upside on MACRILEN approval and positive zoptarelin doxorubicin interim analyses.
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