February 2017 Update Released on Aeterna Zentaris (AEZS)

Crystal Research Associates has released a 10-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 and regulatory filing milestones, and financial position. 

Company Description

Aeterna Zentaris Inc. (“Aeterna” or “the Company”) is a specialty biopharmaceutical company developing and commercializing therapies to enhance and improve patient lives. With a focus on establishing revenues and profitability while optimizing resources to reduce its burn rate, the Company co-promotes two commercial products in multiple U.S. markets: (1) EMD Serono’s Saizen® [somatropin (rDNA origin) for injection] for growth hormone deficiencies; and (2) 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 or in-license other commercial compounds. One of the Company’s wholly owned product candidates, Zoptrex™ [zoptarelin doxorubicin (doxorubicin peptide conjugate targeting LHRH receptor–expressing tumors)], has completed the clinical program of a Phase 3 trial in advanced, recurrent, or metastatic endometrial cancer (EC)—a disease for which patients typically have a poor prognosis and there is no approved systemic therapy (except in Germany). Aeterna’s development program further includes Macrilen™ (macimorelin), which has also completed a confirmatory Phase 3 trial for the evaluation of 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

• Zoptrex™, if approved, will be the first FDA approved treatment for advanced (stage III & IV) EC. An ongoing pivotal Phase 3 trial to treat advanced EC is under Special Protocol Assessment. Pivotal Phase 3 trial top-line results are expected in H1 2017, and if sufficient, the Company could submit an NDA in H2 2017.

• Apifiny® is the only non-PSA based blood test for evaluating the risk of prostate cancer. The Company has an exclusive U.S. promotion agreement with Armune BioScience on a commission basis. This is a large market opportunity with 20+ million PSA tests performed annually. Apifiny® measures specific biological markers known to be associated with an immune system response to prostate cancer.

• Macrilen™, if approved, will be the only FDA approved drug for assessing AGHD. The drug is patented through 2027 and has been granted Orphan Drug Designation. There is significant market expansion opportunity for traumatic brain injury (TBI) patients at risk of developing AGHD.

• Saizen® for growth hormone replacement therapy in children and adults via a needle-free delivery system is co-promoted with EMD Serono in the U.S. on a commission basis. The U.S. market opportunity is significant at $1.6 billion.

• As of September 30, 2016, Aeterna held cash and cash equivalents of approximately $21.1 million, and subsequently, in November 2016, closed a registered direct offering for $7.56 million in gross proceeds from the sale of common shares, pre-funded warrants, and warrants.

• The Company is actively pursuing additional portfolio opportunities via its product in-license/acquisition strategy. Aeterna Zentaris’ leadership team has a strong track record of creating shareholder value.