Crystal Research Associates has released an 11-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.
Aeterna Zentaris Inc. (“Aeterna” or “the Company”) is a specialty biopharmaceutical company developing and commercializing novel pharmaceutical therapies to enhance and improve patient lives. Focused 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 pediatric and adult growth hormone deficiencies; and (2) Armune BioScience’s Apifiny®, a non-PSA blood test for evaluating prostate cancer risk. Aeterna’s development program currently includes Macrilen™ (macimorelin), which has completed a confirmatory Phase 3 trial for the evaluation of Adult Growth Hormone Deficiency (AGHD), with the Company intending to file a new drug application (NDA) seeking approval for this treatment following its successful meeting with the U.S. Food and Drug Administration (FDA). Aeterna is further working to acquire or in-license other commercial products while also out-licensing Macrilen™ for non-U.S. territories. Overall, Aeterna is focused on pursuing strategic initiatives consistent with becoming a commercially operating specialty biopharmaceutical company.
Key Points from the Update
- On May 8, 2017, Aeterna announced financial and operating results for the first quarter ended March 31, 2017. Revenues were $261,000 for the three months ended March 31, 2017 versus $242,000 for the same period in 2016. Net loss for the three months ended March 31, 2017 was $(4.1) million, or $(0.31) per basic and diluted share versus a net loss of $(3.7) million, or $(0.37) per basic and diluted share, for the same period in 2016. The increase in net loss is largely attributable to lower operating expenses offset by lower net finance income.
- On May 1, 2017, Aeterna reported that the ZoptEC (zoptarelin doxorubicin in endometrial cancer) Phase 3 study of Zoptrex™ in women with locally advanced, recurrent, or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex™ when compared to patients treated with doxorubicin. Therefore, results of the study did not support regulatory approval of Zoptrex™. Based on this outcome, the Company announced that it did not anticipate conducting clinical trials with respect to any other indications of Zoptrex™.
- On the heels of this news, Aeterna is now completely focused on filing its new drug application (NDA) for Macrilen™ and, should the product be approved, would look to have its commercial launch as soon as possible following regulatory approval. The Company further announced that it would optimize its resources to be consistent with a focus on Macrilen™-related efforts.
- Aeterna expects its monthly average use of cash in operations during the remainder of 2017 to range from $1.7 million to $1.9 million, down roughly 22% versus first quarter 2017.
- The Company looks forward to the potential from Macrilen™ on its path to becoming a successful specialty pharmaceutical company and expects to submit the Macrilen™ NDA in 3Q17 and, pending receipt of U.S. FDA approval, to commercially launch in 1Q18.
- Aeterna is actively pursuing additional portfolio opportunities via its product in-license/acquisition strategy. The Company’s leadership team has a strong track record of creating shareholder value.