Aeterna Zentaris Reports Third Quarter 2020 Financial Results and Provides Business Update

– Pivotal Phase 3 safety and efficacy study AEZS-130-P02 (“Study P02”) expected to commence in Q1 2021

– Continue to advance discussions to secure a commercialization partner for macimorelin in Europe and other key global markets

– Ongoing evaluations to expand pipeline beyond macimorelin opportunity

– Cash runway to fund operations and expected to provide significant optionality for growth

CHARLESTON, S.C., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today reported its financial and operating results for the third quarter ended September 30, 2020.

The Company also provided an update on its clinical program to expand the use of macimorelin for the diagnosis of childhood-onset growth hormone deficiency (“CGHD”), an area of significant unmet need, and its plans to expand macimorelin for the diagnosis of adult growth hormone deficiency (“AGHD”) in Europe and other key markets.

“We remain focused on advancing our strategy in order to unlock the Company’s full potential. Looking to the remainder of the year, we are executing on the preparations for our pivotal Phase 3 safety and efficacy study, AEZS-130-P02 (“Study P02”), to evaluate macimorelin for the diagnosis of childhood-onset growth hormone deficiency, and expect to commence this study in the first quarter of 2021,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

“Additionally we continue to evaluate macimorelin for new therapeutic usages, as well as assess the potential of the development candidates from our previous programs to be re-purposed for alternative indications based on prior key findings from data already available to us. We look forward to providing additional updates as we explore these opportunities,” added Dr. Paulini.

Recent Highlights

• Raised a total of $19 million, including a registered direct offering priced at-the-market under Nasdaq rules for gross proceeds of $7.0 million and a public offering for gross proceeds of $12 million to the Company;
• Regained compliance with minimum stockholders’ equity requirement for continued listing on Nasdaq;
• Expanded intellectual property portfolio for macimorelin with the filing of two additional patent applications; and
• Presented results of the Company’s first pediatric study of macimorelin at the 22nd European Congress of Endocrinology (e-ECE 2020) held September 5-9, 2020.  

Macimorelin Clinical Program Update