AEZS Aeterna Zentaris Inc.

0.42
-0.02  -4%
Previous Close 0.44
Open 0.44
52 Week Low 0.29
52 Week High 1.54
Market Cap $26,513,053
Shares 53,482,263
Float 16,436,292
Enterprise Value $7,607,157
Volume 3,394,550
Av. Daily Volume 1,948,234
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Drug Pipeline

Drug Stage Notes
Macimorelin acetate (AEZS-130)
Paediatric patients with suspected growth hormone deficiency (GHD)
Phase 3
Phase 3
Phase 3 trial to commence 1Q 2021.
Zoptrex
Endometrial cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - May 1, 2017.
Macimorelin Acetate - Macrilen
Adult Growth Deficiency
Approved
Approved
CRL issued November 2014. Approval announced following resubmission December 20, 2017.

Latest News

  1. - Company to receive upfront payment of 5 million replacing a later stage regulatory approval milestone of U.S.$5 million
     

    - Novo Nordisk committing to fund €9 million of the budgeted AEZS-130-P02 ("Study P02") clinical trial costs for childhood-onset growth hormone deficiency expected to be initiated in Q1 2021

    CHARLESTON, S.C., Nov. 16, 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 announced that, through a wholly-owned subsdiary, it has entered into an amendment (the "Amendment") of its existing License Agreement with Novo Nordisk Biopharm Limited ("NNBL") related to the…

    - Company to receive upfront payment of 5 million replacing a later stage regulatory approval milestone of U.S.$5 million

     


    - Novo Nordisk committing to fund €9 million of the budgeted AEZS-130-P02 ("Study P02") clinical trial costs for childhood-onset growth hormone deficiency expected to be initiated in Q1 2021

    CHARLESTON, S.C., Nov. 16, 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 announced that, through a wholly-owned subsdiary, it has entered into an amendment (the "Amendment") of its existing License Agreement with Novo Nordisk Biopharm Limited ("NNBL") related to the development and commercialization of macimorelin.

    Under the terms of the original License Agreement, Novo Nordisk was granted the exclusive right to commercialize macimorelin in the United States ("U.S.") and Canada. Novo Nordisk is currently marketing macimorelin in the U.S. under the tradename Macrilen™ for the diagnosis of adult growth hormone deficiency ("AGHD"). Aeterna, in collaboration with Novo Nordisk, is currently developing the expanded use of macimorelin for the diagnosis of childhood-onset growth hormone deficiency ("CGHD"), an area of significant unmet need. Aeterna has entered into the start-up phase for the clinical safety and efficacy study, Study P02, evaluating macimorelin for the diagnosis of CGHD, which is expected to be initiated in Q1 of 2021.

    Under the Amendment, Aeterna continues to retain all rights to macimorelin outside of the U.S. and Canada but, in demonstration of Novo Nordisk's continued commitment to macimorelin, Novo Nordisk has agreed to make an immediate upfront payment to Aeterna of €5 million, which accelerates and replaces the U.S.$5 million later stage regulatory approval milestone that Novo Nordisk would have been required to pay only upon successful achievement of regulatory approval of macimorelin in the U.S. for the diagnosis of CGHD. Under the Amendment, all other future potential commercialization milestone payments remain unchanged. In addition, under the Amendment, Novo Nordisk and Aeterna have agreed that solely Aeterna will conduct the pivotal Study P02 in partnership with a contract research organization. Given the full transfer of development activities to Aeterna, Novo Nordisk is then adjusting the percentage of Study P02 clinical trial costs that Novo Nordisk is required to reimburse to Aeterna from 70% to 100% of costs up to €9 million, and includes reimbursement of Aeterna's budgeted internal labor costs. Any additional external jointly approved Study P02 trial costs incurred over €9 million will be shared equally between Novo Nordisk and Aeterna. To reflect Novo Nordisk's additional and earlier investment in macimorelin, the royalty payment Aeterna receives on sales in the U.S. and Canada will be reduced from 15% to 8.5% for annual net sales up to U.S.$40 million and returns to 15% or more for annual net sales of macimorelin over U.S.$40 million.

    Under the Amendment, both companies will continue to closely coordinate the activities related to the development and commercialization of macimorelin in the U.S. and Canada through a joint steering committee, with each party having decision rights in certain areas. Novo Nordisk will also receive co-ownership of the U.S. and Canadian patents and trademarks owned by Aeterna on macimorelin but will be required to transfer co-ownership in those patents back to Aeterna on the occurrence of certain termination events.

    In addition, upon regulatory approval of macimorelin in the U.S. for the diagnosis of CGHD, if Novo Nordisk determines not to commercialize macimorelin in Canada, then Aeterna has the option to exclusively license rights to macimorelin in Canada (but not in U.S.) to a third party. The Amendment also confirms that Aeterna has the right to use the results from Study P02, if successful, to support Aeterna seeking regulatory approval and ongoing efforts to seek partnering opportunities for macimorelin in Europe and other regions outside of the two countries licensed to Novo Nordisk, the U.S. and Canada.

    "We are pleased with our continued partnership with Novo Nordisk and the work we are doing to advance the expanded use of macimorelin for the diagnosis of CGHD after successfully completing the dose range finding Study P01," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. "The Amendment of the License Agreement with Novo Nordisk puts a significant emphasis on the importance of our pediatric co-development of macimorelin and Novo Nordisk's commitment to the continued commercialization and expansion of macimorelin. The Amendment lowers not only our financial obligation for conducting Study P02, but also provides us with the benefit of an upfront non-dilutive payment of €5 million."

    The Amendment will be filed on SEDAR at www.sedar.com. The foregoing description of the terms of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company's lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen™ through a License Agreement with Novo Nordisk where Aeterna Zentaris receives royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

    Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

    The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to anticipated benefits of the Amendment, potential payments to the Company under the Amendment, the Company obtaining approval of macimorelin for CGHD and the resulting potential to significantly increase the available patient population for macimorelin, the Company's ability to secure marketing partners for macimorelin for GHD in Europe and elsewhere, the commencement of the CGHD Study P02, the ability of the Company to identify and develop therapeutic uses for macimorelin in new indications and the ability of the Company to expand its pipeline of products, and may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union ("E.U.") and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E:



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  2. – 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…

    – 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

    The Company's 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 Macrilen™, by Novo Nordisk. Aeterna is currently developing macimorelin for the diagnosis of CGHD, an area of significant unmet need, in collaboration with Novo Nordisk.

    Preparations are underway to initiate Study P02, an open-label, single dose, multicenter and multinational study expected to enroll approximately 100 subjects worldwide, with at least 40 pre-pubertal and 40 pubertal subjects and a minimum of 25 subjects expected to be enrolled in the USA. The study design is expected to be suitable to support a claim for potential stand-alone testing, if successful.

    Upcoming Anticipated Program Milestones

    • Commence CGHD safety and efficacy study, Study P02 (multi-national, including U.S.); and
    • Advance business development efforts towards securing a potential marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets.

    Aeterna has also begun exploring the potential therapeutic use of macimorelin in various other indications. The Company plans to evaluate the development of alternative formulations or administration routes with the goal of ensuring sufficient bioavailability and expects to provide updates on its progress as results become available over the course of the next several months.

    Pipeline Expansion Opportunities

    Aeterna Zentaris intends to balance risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline to which the Company can best leverage its expertise and experience. The Company is focused on opportunistically utilizing its network with universities in Europe and the U.S. which provides, what the Company believes will be, vital access to innovative development candidates in different indications, with a focus on rare or orphan indications and potential for pediatric use.

    Financings Completed During the Third Quarter 2020

    On 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, in the amount of $1.4 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 with 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.

    On August 5, 2020, the Company closed 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. The offering resulted in gross proceeds of $7 million. Concurrently, the Company 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 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. The net cash proceeds to the Company from the offering totaled $6.3 million. Effective September 14, 2020, the Company registered the common shares underlying the 9,320,907 investor warrants and 869,952 placement agent warrants issued on August 3, 2020 by way of a registration statement which removed the cashless exercise option for registered warrants.

    As of September 30, 2020 the Company had approximately $21.7 million cash and cash equivalents. Based on current expectations, management believes it has sufficient capital to fund its current operations through 2023.

    Summary of Third Quarter 2020 Financial Results

    All amounts are in U.S. dollars

    For the three-month period ended September 30, 2020, the Company reported a consolidated net loss of $1.1 million, or $0.02 loss per common share (basic), as compared with a consolidated net loss of $0.3 million, or $0.02 loss per common share for the three-month period ended September 30, 2019. The $0.8 million decline in net results is primarily from a change in fair value of warrant liability of $1.3 million partially offset by a reduction of $0.2 million in operating expenses.

    Revenues

    • The Company reported that total revenue for the three-month period ended September 30, 2020 was $0.1 million as compared with $0.3 million for the same period in 2019, representing a decrease of $0.2 million. The 2020 revenue was comprised of $0.02 million in royalty revenue (2019 - $0.01 million), $0.09 million in supply chain revenue (2019 - $0.3 million) and $0.02 million in licensing revenue (2019 – $0.02 million).           

    Operating Expenses

    • The Company reported that total operating expense for the three-month period ended September 30, 2020 was $1.9 million as compared with $2.1 million for the same period in 2019, representing a decrease of $0.2 million. This decrease arises primarily from a $0.2million decline in general and administrative, a $0.1 million decline in research and development costs, and a $0.1 million decline in selling expenses. The impact of the Company's June 2019 restructuring in its German subsidiary, namely for 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. During 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 Income

    • The Company reported net finance income for the three-month period ended September 30, 2020 was $ 0.6 million as compared with a net finance income of $1.5 million for the same period in 2019, representing a decrease of $0.9 million. This is primarily due to a $1.3 million lower gain in the change in fair value of warrant liability offset by a $0.2 million from changes in currency exchange rates and $0.2 million from other finance costs. Effective September 14, 2020, the Company registered the common shares underlying the 9,320,907 investor warrants and 869,952 placement agent warrants issued on August 3, 2020 by way of a registration statement which removed the cashless exercise option for registered warrants.

    Consolidated Financial Statements and Management's Discussion and Analysis

    For reference, the Management's Discussion and Analysis of Financial Condition and Results of Operations for the third quarter of 2020, as well as the Company's audited consolidated financial statements as of December 31, 2019, will be available at www.zentaris.com in the Investors section or at the Company's profile at www.sedar.com and www.sec.gov.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company's lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen™ through a license agreement with Novo Nordisk where Aeterna Zentaris receives royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

    Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

    The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to the Company obtaining approval of macimorelin for CGHD and the resulting potential to significantly increase the available patient population for macimorelin, the Company's ability to secure marketing partners for macimorelin for GHD in Europe and elsewhere, the commencement of the CGHD Study P02, the ability of the Company to identify and develop therapeutic uses for macimorelin in new indications, the ability of the Company to expand its pipeline of products and the ability of the Company to have sufficient funding for its operations through 2023, and may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union ("E.U.") and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E:

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  3. Recently secured funding bolsters cash runway to fund operations and provides significant optionality for growth

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

    Ongoing evaluations to expand pipeline seeking to transform into Company with multiple assets in development

    – Efforts to secure a commercialization partner for macimorelin in Europe and other key global markets continuing

    CHARLESTON, S.C., Sept. 16, 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 provided a corporate update.

    "Over the course of the last year…

    Recently secured funding bolsters cash runway to fund operations and provides significant optionality for growth

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

    Ongoing evaluations to expand pipeline seeking to transform into Company with multiple assets in development

    – Efforts to secure a commercialization partner for macimorelin in Europe and other key global markets continuing

    CHARLESTON, S.C., Sept. 16, 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 provided a corporate update.

    "Over the course of the last year since my appointment as CEO, a tremendous amount has been achieved. With the set intention to first assess and determine how best to support our current development partnership and how to maximize its success, followed by pursuing the expansion of macimorelin into pediatric use, I believe we are now well-positioned to advance Aeterna into its next phase of growth," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "A catalyst that has significantly powered the Company with the momentum we have today was successfully raising a total of $23.5 million since the beginning of this year. By strategically and opportunistically securing this capital, we believe we have both a solid foundation to support optionality moving forward and equipped the Company with necessary resources to enhance our pipeline in a meaningful way."

    "Our team is first and foremost focused on continuing our efforts to bring the expanded use of macimorelin over the finish line for the diagnosis of childhood-onset growth hormone deficiency ("CGHD"), an area of significant unmet need and, if approved, has the potential to significantly increase the available patient population for macimorelin. We are actively preparing, and hope to be able to commence, our pivotal Phase 3 safety and efficacy study AEZS-130-P02 ("Study P02") in the first quarter of 2021," added Dr. Paulini.

    Macimorelin Clinical Program Update

    The Company's 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 Macrilen™, by Novo Nordisk. Aeterna is currently developing macimorelin for the diagnosis of CGHD, an area of significant unmet need, in collaboration with Novo Nordisk.

    Results from the AEZS-130-P01 ("Study P01"), the first of two studies as agreed with the European Medicines Agency ("EMA") in the Company's Pediatric Investigation Plan ("PIP") for macimorelin, were announced in April 2020. The positive dose-finding results from Study P01 provide the clinical framework for Study P02 and establish a dose that could both be safely administered to pediatric patients and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD.

    Study P02 is planned as open-label, single dose, multicenter and multinational study expected to enroll ~100 subjects worldwide, with at least 40 pre-pubertal and 40 pubertal subjects and a minimum of 25 subjects expected to be enrolled in the USA. Enrolled subjects in the study will be children and adolescents from 2 years of age to less than 18 years of age with suspected GHD. Enrolled subjects in Study P02 will have macimorelin GHST performed twice (for repeatability data) in comparison to two standard GHSTs as controls, arginine (i.v.) and clonidine (p.o.). The study design is suitable to support a claim for potential stand-alone testing, if successful.

    Aeterna has also begun exploring the potential therapeutic use of macimorelin in various other indications. The Company has ongoing plans to evaluate the development of alternative formulations or administration routes with the goal of ensuring sufficient bioavailability and expects to be providing updates on its progress as results become available over the course of the next several months.

    In addition to advancing its pediatric program, Aeterna is intensifying its business development activities with the goal of securing marketing partners for macimorelin for the diagnosis of GHD in Europe and other key markets.

    Pipeline Expansion Opportunities

    Aeterna Zentaris intends to balance risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline to which the Company can best leverage its expertise and experience. The Company is focused on opportunistically utilizing its well-established, extensive network with universities in Europe and the US. This strong network of strategic collaborations with universities, provides, what the Company believes will be, vital access to innovative development candidates in different indications, with a focus on rare or orphan indications and potential for pediatric use.

    Dr. Paulini concluded, "Aeterna Zentaris was established with strong expertise in research and development, which I believe is an incredible asset to the Company and one that we plan to leverage moving forward. Apart from investigating opportunities for new therapeutic usages of macimorelin, we are assessing whether development candidates from our previous programs may be re-purposed for alternative indications based on prior key findings from data already available to us. With our capabilities and specific know-how, we believe we are well-positioned as we explore these opportunities and consider potential co-development strategies that could be synergistic for the Company moving forward."

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company's lead product, Macrilen™ (macimorelin), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen™ is currently marketed in the United States through a license agreement with Novo Nordisk and Aeterna Zentaris receives double-digit royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

    Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need. 

    The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.



    Forward-Looking Statements

    This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to the Company obtaining approval of macimorelin for CGHD and the resulting potential to significantly increase the available patient population for macimorelin, the Company's ability to to secure marketing partners for macimorelin for GHD in Europe and elsewhere, the commencement of the CGHD Study P02, the ability of the Company to identify and develop therapeutic uses for macimorelin in new indications and the ability of the Company to expand its pipeline of products, and may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union ("E.U.") and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    Investor Contact:

    Jenene Thomas

    JTC Team

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  4. - Live video webcast with CEO, Dr. Klaus Paulini, on Wednesday, September 16th at 11:00 AM EDT -

    CHARLESTON, S.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 11:00 AM EDT.

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information…

    - Live video webcast with CEO, Dr. Klaus Paulini, on Wednesday, September 16th at 11:00 AM EDT -

    CHARLESTON, S.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 11:00 AM EDT.

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website here.

    A live video webcast of the presentation will be available on the Events and Presentations page in the Investors section of the Company's website (www.zentaris.com). The video webcast replay will be made available two hours following the event and will be archived for 90 days.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company's lead product, Macrilen™ (macimorelin), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen™ is currently marketed in the United States through a license agreement with Novo Nordisk and Aeterna Zentaris receives double-digit royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

    Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need.

    The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E:

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  5. - PK and PD profiles of macimorelin for pediatric use were within the expected range and comparable to results observed in adults -

    - Data from this study support the choice of 1.0 mg/kg dose of macimorelin for validity testing in a Phase 3 trial, expected to commence in Q1 2021 -

    CHARLESTON, S.C., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the presentation of results from its first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of childhood-onset growth hormone deficiency ("CGHD") at the 22nd European Congress of Endocrinology

    - PK and PD profiles of macimorelin for pediatric use were within the expected range and comparable to results observed in adults -

    - Data from this study support the choice of 1.0 mg/kg dose of macimorelin for validity testing in a Phase 3 trial, expected to commence in Q1 2021 -

    CHARLESTON, S.C., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the presentation of results from its first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of childhood-onset growth hormone deficiency ("CGHD") at the 22nd European Congress of Endocrinology (e-ECE 2020), being held September 5-9, 2020.

    The data were presented during the event in an ePoster titled, Pharmacokinetics and pharmacodynamics of macimorelin acetate (AEZS-130) in paediatric patients with suspected growth hormone deficiency (GHD), accommodated by an audio commentary. The full poster is now available on the Company's website.

    "We are grateful to have the opportunity to present at the e-ECE 2020 congress. We are incredibly encouraged by the results from this study, which demonstrated macimorelin's safety and tolerability, and a PK and PD profile in a range expected from the adult development program," commented Dr. Nicola Ammer, Chief Medical Officer of Aeterna Zentaris. "As we advance into our pivotal Study P02, which we expect to initiate in the first quarter of 2021, we are confident that we have selected with 1.0 mg/kg macimorelin the correct dosing regimen based on insights gained from the Study P01."

    The AEZS-130-P01 study ("Study P01"), was an open-label, group comparison, dose escalation trial and the first of two studies as agreed with the European Medicines Agency ("EMA") in the Company's Pediatric Investigation Plan ("PIP") for macimorelin. Study P01 was designed to investigate the pharmacokinetics ("PK"), pharmacodynamics ("PD"), safety, and tolerability of macimorelin after single oral dosing of 0.25, 0.5, and 1.0 mg/kg in pediatric patients with suspected growth hormone deficiency ("GHD").

    The Company completed the study and announced positive results in April 2020. The completed study included 24 subjects aged 4 to 15 years. In the subjects who completed the study in accordance with the protocol, macimorelin demonstrated an excellent safety and tolerability profile. There were 88 adverse events ("AE") reported in 23 subjects, none of which was assessed by the investigator as related to macimorelin. The majority of AEs (approximately 70%) were expected side effects related to the hypoglycemia introduced by the Insulin Tolerance Test. No significant changes in ECG parameters and safety laboratory values were noted in any of the three dosing cohorts.

    Abstracts for the e-ECE 2020 conference have been published in Endocrine Abstracts. Endocrine Abstracts is an entirely online, open-access and fully citable collection of all the abstracts from e-ECE 2020.

    For more information about Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.

    About e-ECE 2020

    The European Congress of Endocrinology is the European Society of Endocrinology's premier event, attracting over 3,500 international delegates each year across the spectrum of endocrinology. The event is a showcase of the best of science and clinical practice across the fields of endocrinology and metabolism, and aims to deliver to all audiences interested in the field, whether you are an experienced consultant, a scientist or a nurse, and whether you are well advanced in your career or just starting out. e-ECE 2020 is this year's fully digital Congress bringing you the latest innovations in endocrine research and patient care. For more information, please visit the event website.

    About Macimorelin

    Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD.

    In December 2017, the United States Food and Drug Administration ("FDA") granted Aeterna Zentaris marketing approval for Macrilen to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). Macimorelin acetate has been granted Orphan Drug designation by the FDA for diagnosis of GHD. In January 2019, the European Commission granted marketing authorization for macimorelin to Aeterna Zentaris for diagnosis of growth hormone deficiency in adults. In March 2017, the Pediatric Committee of the EMA agreed to the Company's PIP for macimorelin, a prerequisite for filing a marketing authorization application for any new medicinal product in Europe.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company's lead product, Macrilen (macimorelin), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen is currently marketed in the United States through a license agreement with Novo Nordisk and Aeterna Zentaris receives double-digit royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

    Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

    The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements regarding the timeline of the initiation of the Study P02 and include statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the SEC, and other factors discussed under the heading "Risk Factors" in the Company's Registration Statement on Form F-1 (File No. 333-232935) filed with the SEC and other documents subsequently filed with or furnished to the SEC. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to regain compliance with the continued listing requirements of the NASDAQ and continue to list our Common Shares on the NASDAQ, our ability to continue as a going concern is dependent, in part, on our ability to transfer cash from Aeterna Zentaris GmbH to Aeterna Zentaris and the U.S. subsidiary and secure additional financing, our now heavy dependence on the success of Macrilen (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union ("E.U.") and U.S. for Macrilen (macimorelin), the degree of market acceptance of Macrilen (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

    Investor Contact:

    Jenene Thomas

    JTC Team

    T (US): +1 (833) 475-8247

    E:

    Primary Logo

    View Full Article Hide Full Article
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