NEW RESEARCH: Quarterly Update Released on Aeterna Zentaris (AEZS)

Crystal Research Associates has released a 16-page Quarterly Update on specialty biopharmaceutical company, Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). The Update specifically details Aeterna's recent news and developments, recent and anticipated clinical trial milestones, and financial position. 

Company Description

Aeterna is transitioning into a specialty biopharmaceutical company. With a focus on establishing revenues and profitability while optimizing resources to reduce its burn rate, the Company co-promotes three commercial products in multiple U.S. markets: (1) Ascend Therapeutics’ EstroGel® (estradiol gel), a non-patch estrogen replacement therapy; (2) EMD Serono’s Saizen® [somatropin (rDNA origin) for injection] for growth hormone deficiencies; and (3) Armune BioScience’s APIFINY®, a non-PSA blood test for evaluating prostate cancer risk. Aeterna further holds a pipeline of product candidates in development and is working to acquire, in-license, or co-promote other commercial compounds. The Company’s most advanced wholly owned product candidate, Zoptrex™ [zoptarelin doxorubicin (doxorubicin peptide conjugate targeting LHRH receptor–expressing tumors)], is in a fully enrolled Phase 3 trial in advanced, recurrent, or metastatic endometrial cancer—a disease for which patients typically have a poor prognosis and there is no approved systemic therapy. Aeterna’s development program also includes Macrilen™ (macimorelin), which is in active enrollment for a Phase 3 confirmatory trial for Adult Growth Hormone Deficiency (AGHD). Overall, the Company is focused on pursuing strategic initiatives consistent with becoming a commercially operating specialty biopharmaceutical company.

Key Points from the Update

• Two of Aeterna’s lead product candidates—Zoptrex™ for endometrial cancer and Macrilen™ for AGHD—are in pivotal Phase 3 trials expected to be completed by the end of the third quarter 2016, with top-line results expected by year-end 2016. The Company aims to submit a New Drug Application (NDA) for each of these candidates in 2017.

• An independent Data and Safety Monitoring Board has recommended twice (after April 2015 and October 2015 pre-specified points for interim analysis on safety and efficacy) that the Zoptrex™ Phase 3 trial in advanced endometrial cancers continue to full completion as planned. Zoptrex™ also recently met its primary endpoint and demonstrated good tolerability in a Phase 2 investigator-sponsored trial for castration- and taxane-resistant prostate cancer.

• On March 29, 2016, Aeterna reported financial results for the fourth quarter and full-year 2015. Aeterna reported a loss from operations of $34.9 million in 2015 versus a loss from operations of $37.4 million in 2014. The decrease is mainly explained by the impact of the Resource Optimization Program as well as the weakening of the EUR (€) in 2015 versus 2014, and was offset by an increase in third-party clinical trial expenses in 2015, an expansion of the Company’s contracted sales force, and higher transaction costs allocated to warrants.

• The Company’s leadership is experienced and has established ability in building significant value in the pharmaceutical industry. After raising approximately $34.4 million in early 2015 and $15.0 million in December 2015, Aeterna reported that it held cash and cash equivalents of $41.5 million as of December 31, 2015.