Get 40% Off
🤯 This Tech Portfolio is up 29% YTD! Join Now to Get April’s Top PicksGet The Picks – Just 99 USD

Aeterna Zentaris: ZoptEC Moving Ahead

Published 06/11/2014, 02:15 AM
Updated 07/09/2023, 06:31 AM

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.

To Read the Entire Report Please Click on the pdf File Below

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.