 Positive results from AEZS-130-P01 Study P01 confirmed dosing regimen of macimorelin as a potential diagnostic for childhood-onset growth hormone deficiency 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 efforts evaluating opportunities to re-establish a development pipeline Cash runway to fund operations through 2023 CHARLESTON, S.C., Aug. 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 second quarter ended June 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 are pleased with the progress we have made over the last quarter across our business, despite the challenges of the COVID-19 pandemic. The health and safety of our team remains a top priority and as such, we continue to actively take steps to ensure the highest level of safety for our employees. We are incredibly grateful for their dedication and maintaining operations amidst navigating these unprecedented times. I am happy to report that we have been fortunate enough to not have experienced any significant delays or impacts to our operations to date from the pandemic, commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.We have continued advancing the development of macimorelin for CGHD, which we believe represents a significant opportunity for the Company and, if approved, has the potential to significantly increase the available patient population for macimorelin. Additionally, the EMA accepted our modification to the Pediatric Investigation Plan PIP, which streamlined our clinical efforts, allowing the P02 Study protocol to comply with requirements from both the EMA and FDA, added Dr. Paulini.Recent Highlights Successfully 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; Announced that the abstract on study results of the Companys first pediatric study on macimorelin has been selected for presentation at the 22nd European Congress of Endocrinology e-ECE 2020 being held September 5-9, 2020; Executed on expanding intellectual property portfolio for macimorelin with the filing of two additional patent applications; Entered into an exclusive distribution and related quality agreement with Megapharm Ltd., a leading Israel-based biopharmaceutical company, for the commercialization of macimorelin in Israel and the Palestinian Authority; Received European Medicines Agency EMA acceptance of modification request of the Companys PIP for macimorelin as originally approved in March 2017, which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies; and Achieved positive results for the pediatric dose-escalation study, Study P01, of macimorelin, indicating favorable safety and tolerability data for the use in childhood-onset growth hormone deficiency testing.Dr. Paulini concluded, On the commercial side we continue to work diligently to expand macimorelin for AGHD in key global markets around the world. Our distribution agreement with Megapharm was an important milestone for the Company to address the interesting market opportunity in Israel and the Palestine Authority. In Europe, we are encouraged by our ongoing partnership talks and hope to communicate more about those in the near-term. Beyond macimorelin, we are actively seeking opportunities to re-establish a development pipeline and look forward to providing more updates as they become available.Macimorelin Clinical Program UpdateThe Companys lead product, macimorelin, is the only United States Food and Drug Administration FDA approved oral drug indicated for the diagnosis of AGHD and is currently marketed in the United States U.S. under the tradename MacrilenTM, by Novo Nordisk. Aeterna is currently developing macimorelin for the diagnosis of CGHD, an area of significant unmet need, in collaboration with Novo Nordisk.Upcoming Anticipated Program Milestones Commence CGHD safety and efficacy study, Study P02 multi-national, including U.S.; and Advance business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets.Financings Completed After June 30, 2020On July 7, 2020, the Company closed a public offering of 26,666,666 units at a price to the public of 0.45 per unit, for gross proceeds of 12 million, before deducting placement agent fees and other offering expenses payable by the Company, estimated at 1.5 million. Each unit contained one common share or common share equivalent in lieu thereof and one investor share purchase warrant to purchase one common share. In total, 26,666,666 common shares, 26,666,666 investor share purchase warrants at an exercise price of 0.45 per share expiring July 7, 2025 and 1,866,667 placement agent warrants with an exercise price of 0.5625 per share, expiring July 1, 2025 were issued.Additionally, on August 3, 2020, the Company announced that it had entered into a securities purchase agreement with several institutional investors in the United States providing for the sale and issuance of 12,427,876 common shares at a purchase price of 0.56325 per common share in a registered direct offering priced at-the-market under Nasdaq rules for gross proceeds of approximately 7.0 million, closing on August 5, 2020. Concurrently, the Company also issued to the purchasers unregistered warrants to purchase up to an aggregate of 9,320,907 common shares. The warrants are exercisable for a period of five and one-half years, exercisable immediately following the issuance date and have an exercise price of 0.47 per common share. In addition, the Company has issued unregistered warrants to the placement agent to purchase up to an aggregate of 869,952 common shares, with an exercise price of 0.7040625 per share and an expiration date of August 3, 2025.On August 4, 2020, prior to closing the recently announced financing, the Company had approximately 17 million cash and cash equivalents. Based on current expectations, management believes it has sufficient capital to fund operations through 2023.Summary of Second Quarter 2020 Financial ResultsAll amounts are in U.S. dollars For the three-month period ended June 30, 2020, the Company reported a consolidated net loss of 3.5 million, or 0.15 loss per common share basic, as compared with a consolidated net income of 0.2 million, or 0.01 income per common share basic for the three-month period ended June 30, 2019. The 3.7 million decline in net results is primarily from a change in fair value of warrant liability of 6.1 million partially offset by a reduction of 2.3 million in operating expenses.Revenues The Company reported total revenue for the three-month period ended June 30, 2020 of 0.07 million as compared with 0.2 million for the same period in 2019, representing a decrease of 0.13 million. The 2020 revenue was comprised of 0.01 million in royalty revenue 2019 - 0.01 million, nil in product sales of MacrilenTM macimorelin to Novo 2019 - 0.13 million, 0.04 million in supply chain revenue 2019 - 0.04 million and 0.02 million in licensing revenue 2019 0.02 million.Operating Expenses The Company reported total operating expenses for the three-month period ended June 30, 2020 was 1.5 million as compared with 3.8 million for the same period in 2019, representing a decrease of 2.3 million. This decrease arises primarily from a 0.8 million decline in general and administrative expenses, a 0.8 million decline in restructuring costs, a 0.4 million decline in research and development costs, and a 0.3 million decline in selling expenses. The impact of our June 2019 restructuring in our German subsidiary, namely payroll and share based compensation costs, is a key influence in the declines in general and administrative expenses, selling and research and development expenses. The further impact on the decline in research and development costs is attributed to the different phases of activity of Study P01. In the first half of 2019, study activities included study start with document development, medication manufacturing, study feasibility testing at different sites and clinical trial applications in Hungary, Poland, Belarus, Russia, Ukraine and Serbia, while in 2020, all sites had completed their enrollment and clinical activities.Net Finance Costs Income The Company reported net finance costs for the three-month period ended June 30, 2020 was 2.0 million as compared with a net finance income of 3.9 million for the same period in 2019, representing a decrease of 5.9 million. This is primarily due to a 6.1 million change in fair value of warrant liability offset by 0.2 million from changes in currency exchange rates. 