1. Company executing on growth strategy to build-out pipeline of development assets

    – Pivotal Phase 3 safety and efficacy study AEZS-130-P02 ("Study P02") expected to commence in Q2 2021

    – Strong balance sheet enables significant optionality for growth and accelerated advancement of pipeline programs

    CHARLESTON, S.C., March 25, 2021 (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 fourth quarter and year ended December 31, 2020.

    The Company also provided an update on the recent expansion of its development…

    Company executing on growth strategy to build-out pipeline of development assets

    – Pivotal Phase 3 safety and efficacy study AEZS-130-P02 ("Study P02") expected to commence in Q2 2021

    – Strong balance sheet enables significant optionality for growth and accelerated advancement of pipeline programs

    CHARLESTON, S.C., March 25, 2021 (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 fourth quarter and year ended December 31, 2020.

    The Company also provided an update on the recent expansion of its development pipeline and clinical program of macimorelin for the diagnosis of childhood-onset growth hormone deficiency ("CGHD"), an area of significant unmet medical need.

    "As a company, one of our key objectives over the past year was to advance our goal of maximizing the value of macimorelin and to expand our pipeline with multiple development programs. I am extremely pleased that we have been successful in progressing our goals across multiple fronts," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "Not only are we preparing to launch the pivotal Study P02 for the diagnosis of CGHD but we are working with the University of Queensland to explore the potential therapeutic use of macimorelin for the treatment of a serious neurodegenerative disease. Additionally, we made significant progress with our pipeline expansion efforts and entered into a number of previously announced agreements with university partners providing Aeterna with the right to develop a number of potential therapeutics and vaccines. Lastly, we have secured significant capital that we believe provides us with optionality as we continue to pursue growth as well as to accelerate our planned pipeline development opportunities in potentially high-value indications."

    Recent Highlights:

    • Regained compliance with minimum bid price requirement for continued listing on Nasdaq;
    • Closed bought deal offering of common shares for gross proceeds of $34.2 million;
    • Received $20.0 million in proceeds from exercise of warrants in 2021;
    • Entered into a material transfer agreement with The University of Queensland ("Queensland University"), for the advancement of macimorelin as a therapeutic for the treatment of an undisclosed neurodegenerative disease which provides Aeterna with an option to negotiate a license to any intellectual property developed by Queensland University using macimorelin as therapeutic for the undisclosed neurodegenerative disease;
    • Executed on building pipeline to expand assets in development for potential high-value indications through multiple licensing agreements with universities in Europe;
    • Announced an exclusive European licensing agreement with Consilient Health Ltd. for the commercialization of macimorelin; and
    • Amended its existing License Agreement with Novo Nordisk Biopharm Limited ("Novo Nordisk") for the development and commercialization of Macrilen™ (macimorelin) in U.S. and Canada.

    Macimorelin Clinical and Preclinical Program Update

    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 pivotal study expected to enroll approximately 100 subjects worldwide. At least 40 pre-pubertal and 40 pubertal subjects are expected to be enrolled and a minimum of 25 subjects are expected to be enrolled in the USA. The study design is expected to be suitable to support a claim for potential stand-alone testing with macimorelin, if successful. The Company expects to commence its CGHD safety and efficacy study, Study P02, in the second quarter of 2021.

    Additionally, Aeterna has begun exploring the potential therapeutic use of macimorelin in other indications. The Company entered into a Material Transfer Agreement with Queensland University, one of Australia's leading research and teaching institutions, to conduct preclinical and clinical studies evaluating macimorelin as a potential therapeutic for the treatment of an undisclosed neurodegenerative disease. Queensland University researchers aim to conduct preclinical studies in multiple models to demonstrate the therapeutic reach of macimorelin on disease progression and disease-specific pathology and, if supported by the data from those studies, then plan a subsequent investigator initiated clinical study.

    Pipeline Expansion

    Aeterna continues to strive to balance risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline which we believe best leverages the Company's expertise and experience. The Company remains focused on utilizing its network with researchers in Europe and the U.S. to seek opportunities to access innovative development candidates, with a focus on rare or orphan indications and potential for pediatric use.

    Targeted Immunosuppressive Therapeutics: Targeted, highly specific AIM Biologicals for the potential treatment of NMOSD

    In January 2021, the Company entered into an exclusive license agreement with Julius-Maximilians-University of Wuerzburg, Germany for worldwide rights to develop, manufacture and commercialize targeted, highly specific immunosuppressive therapeutic proteins ("AIM Biologicals") for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") currently in pre-clinical development.

    Next Steps

    • Conduct further preclinical research to identify and characterize an AIM Biologicals based development candidate for the treatment of NMOSD.
    • Meet with regulatory authorities to confirm the further preclinical data required to advance into human clinical trials.

    COVID-19 Vaccine: Potential orally active COVID-19 (SARS-CoV-2) live-attenuated bacterial vaccine

    In February 2021, Aeterna entered into an exclusive option agreement with Julius-Maximilians-University to evaluate a preclinical, potential COVID-19 vaccine developed at the University. In March 2021, the Company exercised its option and entered into a license agreement where the Company was granted an exclusive, world-wide, license to certain patents and know-how owned by the University to research and develop, manufacture, and sell a potential COVID-19 vaccine.



    The University also granted Aeterna an option for the exclusive use of certain patents and know-how in an additional undisclosed field. The Company has six (6) months from the date of the License Agreement to exercise that option. Additionally, Aeterna entered into a Research Agreement under which the Company has engaged the University on a fee-for-service basis to conduct supplementary research activities and preclinical development studies on the potential vaccine, the results of which will be included within the scope of the license agreement.

    Next Steps

    • Select from a set of vaccine candidates to perform further in vitro and in vivo characterization before selecting the most active and stable bacterial strain for further preclinical and potentially clinical development.
    • Initiate development work on an oral dosage form of such COVID-19 vaccine which is also potentially active against mutated virus variants.

    Primary Hypoparathyroidism: Delayed clearance parathyroid hormone fusion polypeptides (DC-PTH) for potential treatment of primary hypoparathyroidism

    In March 2021, Aeterna entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual property relating to DC-PTH fusion polypeptides with delayed clearance covering the field of all human use. Aeterna has also engaged the University of Sheffield under a research contract to conduct certain research activities to be funded by Aeterna, the results of which will be included within the scope of the license agreement.

    Next Steps

    • Working with the University, Aeterna will undertake certain additional confirmatory research prior to initiating formal preclinical toxicology studies and GMP development before finalizing plans for the potential initiation of human clinical trials.

    Financing and Warrant Exercises

    Between January 1, 2021 and March 24, 2021, the Company has raised net proceeds of approximately $31.0 million from a registered public offering and $20.0 million from warrant exercises. On February 19, 2021, the Company closed a public offering of 20,509,746 common shares at a price to the public of $1.45 per common share, for gross proceeds of $29.7 million, before deducting underwriting discounts, commissions and offering expenses payable by the Company, in the amount of $2.8 million. Aeterna also granted the underwriter a 30-day overallotment option (the "Underwriter Option") to purchase up to 3,076,461 additional common shares at the public offering price, less underwriting discounts and commissions, and 1,435,682 warrants with an exercise price of $1.8125 and expiring on February 17, 2026. The net cash proceeds to the Company from the offering totaled $26.9 million. On February 22, 2021, the underwriter exercised the Underwriter Option in full and received 3,076,461 common shares for gross proceeds to the Company of $4.5 million. In connection with the public offering and the exercise of the Underwriter Option, the Company paid commissions and other expenses of $0.4 million and issued 215,352 warrants priced at $1.8125 and expiring on February 17, 2026.

    Summary of Fourth Quarter and Full Year 2020 Financial Results

    All amounts are in U.S. dollars

    Results of operations for the three-month period ended December 31, 2020

    For the three-month period ended December 31, 2020, we reported a consolidated net loss of $1.3 million, or $0.02 loss per common share (basic), as compared with a consolidated net loss of $1.0 million, or $0.05 loss per common share for the three-month period ended December 31, 2019. The $0.3 million increase in net results is primarily from an increase in total operating expenses of $1.8 million, an increase in net finance costs of $0.2 million, a change of tax expenses of $0.6 million partially offset by an increase in revenues of $2.3 million.

    Revenues

    • Our total revenue for the three-month period ended December 31, 2020 was $2.4 million as compared with $0.02 million for the same period in 2019, representing an increase of $2.4 million. The 2020 revenue was comprised of $1.4 million in product sales (2019 - $nil), $0.9 million in licensing revenue (2019 - $0.02 million), $0.02 million in royalty revenue (2019 - $0.2 million) and $0.1 million in supply chain revenue (2019 – ($0.02) million).
    • On November 16, 2020, the Company announced that it had entered into the Amendment of its existing License Agreement with Novo Nordisk and received an upfront payment of €5.0 million ($6.1 million) in December 2020. In accordance with its accounting policy on contract amendments, the Company recognized $0.6 million to the Adult Indication as in revenues and deferred $5.5 million to be recognized over time on a straight-line basis until the expected FDA approval date of June 2023.

    Operating Expenses

    • Our total operating expense for the three-month period ended December 31, 2020 was $3.6 million as compared with $1.8 million for the same period in 2019, representing an increase of $1.8 million. This increase arises primarily from a $1.1 million increase in cost of sales, $0.4 million increase in research and development costs, $0.4 million increase in selling expenses and $0.5 million in costs incurred in the fourth quarter of 2019 and not incurred in the fourth quarter of 2020 (comprised of $0.3 million in restructuring costs and approximately $0.2 million in impairment of right of use asset), offset by a decline of $0.4 million in general and administrative expenses and a reversal of $0.1 million of write off of other asset.
    • In the fourth quarter of 2020, cost of sales increased from the sale of a batch of macimorelin to Novo Nordisk. The increase in research and development costs reflect the Company's initial pipeline expansion activities in 2020 as compared to close out activities for Study P01 in 2019.

    Net Finance Income

    • Our net finance income for the three-month period ended December 31, 2020 was $0.3 million as compared with $0.6 million for the same period in 2019, representing a decrease of $0.3 million. This is primarily due to a $0.5 million lower gain in the change in fair value of warrant liability offset by $0.3 million from changes in currency exchange rates. By December 31, 2020, the Company had registered all of the common shares underlying all of its issued and outstanding warrants.

    Results of operations for the year ended December 31, 2020

    For the twelve-month period ended December 31, 2020, we reported a consolidated net loss of $5.1 million, or $0.12 loss per common share, as compared with a consolidated net loss of $6.0 million, or $0.35 loss per common share (basic), for the twelve-month period ended December 31, 2019. The $0.9 million improvement in net results is primarily from an increase in total revenues of $3.1 million and a reduction of operating expenses of $1.4 million partially offset by a $3.0 million decline in net finance income and an increase in income tax expense of $0.6 million.

    Revenues

    • Our total revenue for the twelve-month period ended December 31, 2020 was $3.7 million as compared with $0.5 million for the same period in 2019, representing an increase of $3.2 million. The 2020 revenue was comprised of $2.4 million in product sales (2019 – $0.1 million), $0.9 million in licensing revenue (2019 - $0.07 million), $0.3 million in supply chain (2019 - $0.3 million) and $0.0.07 million in royalty income (2019 - $0.05 million).
    • On November 16, 2020, the Company announced that it had entered into the Amendment of its existing License Agreement with Novo Nordisk and received an upfront payment of €5.0 million ($6.1 million) in December 2020. In accordance with its accounting policy on contract amendments, the Company recognized $0.6 million to the Adult Indication as in revenues and deferred $5.5 million to be recognized over time on a straight-line basis until the expected FDA approval date of June 2023.

    Operating Expenses

    • Our total operating expense for the twelve-month period ended December 31, 2020 was $9.4 million as compared with $10.8 million for the same period in 2019, representing a decrease of $1.4 million. This decline arises primarily from a $1.9 million reduction in general and administration expenses, a decrease of $0.5 million in restructuring costs, a $0.3 million reduction in research and development costs, a $0.3 million reversal in write off of other asset, a $0.2 million gain on modification of building lease and $0.1 million reduction in selling costs, offset by an increase of $1.9 million in cost of sales. This decline in operating expenses is in-line with the expected impact of our cost control initiatives as previously implemented and the impact of the 2019 restructuring at our German subsidiary.

    Net Finance Income

    • Our net finance income for the twelve-month period ended December 31, 2020 was $1.0 million as compared with $4.0 million for the same period in 2019, representing a decrease of $3.0 million. This is primarily due to a $3.4 million change in fair value of warrant liability, an increase of $0.1 million in other finance costs and a $0.5 million increase in gain due to foreign currency exchange rates. Throughout 2020 and by December 31, 2020, the Company registered the common shares underlying all of its issued and outstanding warrants which removed the cashless exercise option from all 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 fourth quarter and full year 2020, as well as the Company's audited consolidated financial statements as of December 31, 2020 and 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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "potential," "possible," and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to: Aeterna's expectation with respect to Study P02 (including the ability to commence in the second quarter of 2021, to enroll subjects in the USA or elsewhere in Study P02, and expectations that Study P02 are suitable to support a claim (regulatory approval) for potential stand-alone testing with macimorelin); Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom; the aims and details of the pre-clinical and potential clinical studies involving the potential use of macimorelin to treat an undisclosed neurodegenerative disease being conducted by Queensland University; the potential of the coronavirus vaccine platform technology licensed from Julius-Maximilians-University (and any vaccine candidates using that technology) to be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease or to offer an alternative to other approved vaccines against COVID-19; the ability to obtain approval to commence any clinical trial or the timeline to develop any potential vaccine and the characteristics of any potential vaccine; plans regarding the DC-PTH fusion polypeptides licensed from the University of Sheffield, plans regarding AIM Biologicals in-licensed from Julius-Maximilians-University and the potential to treat NMOSD; and Aeterna's intentions with respect to growth opportunities and its business focus, including with respect to its cash position and development pipeline (including the ability to accelerate its development pipeline).

    Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our reliance on the success of the pediatric clinical trial in the European Union and U.S. for Macrilen™ (macimorelin); the commencement of Study P02 may be delayed or we may not obtain regulatory approval to initiate that study, we may be unable to enroll the expected number of subjects in Study P02 and the result of Study P02 may not support receipt of regulatory approval in CGHD, we may be delayed or unsuccessful in obtaining pricing and reimbursement approvals in Europe and the UK to market macimorelin; the coronavirus vaccine platform technology (and any vaccine candidates using that technology) licensed from Julius-Maximilians-University has never been tested in humans and so further pre-clinical or clinical studies of that technology and any vaccine developed using that technology may not be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease; that the timeline to develop a vaccine may be longer than expected; that such technology or vaccines may not be capable of being used orally, may not have the same characteristics as vaccines previously approved using the Salmonella Typhi Ty21a carrier strain; results from ongoing or planned pre-clinical studies of macimorelin by Queensland University or for our other products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; 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 Nordisk; the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 40-F and annual information form, under the caption "Risk Factors". Given the 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.

    No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release.

    Investor Contact:

    Jenene Thomas

    JTC Team

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

    E:



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  2. CHARLESTON, S.C., March 22, 2021 (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 on March 22, 2021, it received notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum $1.00 bid price per share requirement under Nasdaq's Listing Rule 5550(a)(2).

    On July 29, 2020, the Company received notice from Nasdaq that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by Nasdaq. On January 26, 2021, the Company was granted an additional 180 calendar day period…

    CHARLESTON, S.C., March 22, 2021 (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 on March 22, 2021, it received notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum $1.00 bid price per share requirement under Nasdaq's Listing Rule 5550(a)(2).

    On July 29, 2020, the Company received notice from Nasdaq that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by Nasdaq. On January 26, 2021, the Company was granted an additional 180 calendar day period to regain compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market.

    Now that the Company has regained compliance with Listing Rule 5550(a)(2), Nasdaq has advised the Company that this matter is now closed.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 in this press release include Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom. Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Actual results could differ materially from those currently anticipated due to a number of factors and risks, including, without limitation, our ability to obtain receipt of pricing and reimbursement approvals as well as those risks 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 U.S. Securities and Exchange Commission. Given the 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. - Company secures next step to continue to build-out pipeline of assets

    - Company exercised its option to enter into an exclusive license of intellectual property for the development of a proprietary and orally active bacterial vaccine platform technology currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19

    CHARLESTON, S.C., March 15, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that the Company exercised its option announced on February 2, 2021 and…

    - Company secures next step to continue to build-out pipeline of assets

    - Company exercised its option to enter into an exclusive license of intellectual property for the development of a proprietary and orally active bacterial vaccine platform technology currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19

    CHARLESTON, S.C., March 15, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that the Company exercised its option announced on February 2, 2021 and has entered into an exclusive worldwide sub-licensable patent and know-how license agreement for a potential COVID-19 vaccine currently in preclinical development that was invented at the Julius-Maximilians-University Wuerzburg (the "University"), one of Germany's leading research and teaching universities. Additionally, the Company has entered into a research agreement with the University to conduct supplementary research activities and preclinical development studies on the potential vaccine.

    The vaccine technology developed at the University uses the approved typhoid fever vaccine Salmonella Typhi Ty21a as a carrier strain and has the potential to be an orally active, live-attenuated bacterial vaccine to prevent SARS-CoV-2 infection leading to COVID-19.

    "Over the last months, we learned that the original SARS-CoV-2 strain mutates rapidly, and these mutant strains continue to spread throughout the population. It has been reported that the currently available vaccines for COVID-19 are still effective against the known mutant strains. However, we believe there is the potential to develop an improved vaccine which relies on several SARS-CoV-2 antigens in parallel with the goal of improving the immune response against mutated viruses. Additionally, our vaccine has the potential to become a cost-effective oral alternative with less demanding storage and logistics requirements", commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. "We look forward to advancing our scientific collaboration with Prof. Rudel and his group at the University. Aeterna plans to select from a set of vaccine candidates to perform further in vitro and in vivo characterization before selecting the most active and stable bacterial strain for further preclinical and potentially clinical development. The goal is to develop an oral dosage form of COVID-19 vaccine which is also active against mutated viruses that can be stored in a common fridge and manufactured with relatively low costs of goods.

    Prof. Thomas Rudel of the University added, "We are looking forward to our collaboration with Aeterna and a new phase of accelerated preclinical and potential clinical development. Our oral vaccine candidates based on the Salmonella Typhi Ty21a vaccine platform technology open the possibility to integrate more than one SARS-CoV-2 related antigen into the expression system of the modified vaccine bacteria and may improve the immune response of an individual against mutated viruses."

    About the Potential COVID-19 Vaccine

    The approved Salmonella Typhi Ty21a bacterial strain is the basis of the new vaccine approach against corona virus infections. The typhoid fever vaccine Ty21a is effective, safe, easy to handle, and the capsule formulation can be stored at fridge temperature of 2°C to 8°C. The most common vaccine capsule Vivotif® has been used worldwide in more than 150 million administered doses.

    The carrier strain has been modified by plasmid insertion with two expression cassettes together with a special E. coli-based secretion system to secrete two or more coronavirus antigens fused to an immunological adjuvant peptide. Additionally, a balanced lethal system based on an essential tRNA synthetase has been integrated to stabilize the plasmid in the absence of antibiotic resistance genes. The specific bacterial vector strain is expected to enable oral application and release of the proteins into the gut system which may consequently stimulate mucosal and systemic immunity.

    Transaction Terms and Conditions

    On March 14, 2021, the Company exercised the Option and entered into the License Agreement. Pursuant to the terms of the License Agreement, the Company has been granted an exclusive, world-wide, license to certain patents and know-how owned by the University to research and develop, manufacture, and sell a potential COVID-19 vaccine using the University's bacterial vaccine platform technology (the "Licensed Rights"). The Company will pay an up-front payment under the License Agreement of €140,000 as well as make certain milestones payments to be paid upon the achievement of certain development, and regulatory and sales milestones as well as a percentage of any sub-licensing revenue received by the Company and royalty payments on net sales of the licensed vaccine products (including for by the Company or its sub-licensees). The License Agreement will expire upon the latter of (i) the existence of a valid patent claim of a Licensed Right or (ii) 10 years after the first commercial sale of a product that was developed, manufactured, marketed, and sold using a least one Licensed Right. The License Agreement may be terminated by the Company by providing six (6) months' notice to the University.

    Pursuant to the License Agreement, the University has also granted the Company an exclusive option for the exclusive use of the Licensed Rights in an undisclosed field. The Company has six (6) months from the date of the License Agreement to exercise that is option.

    Additionally, the Company has entered into the Research Agreement under which the Company has engaged the University on a fee-for-service basis to conduct supplementary research activities and preclinical development studies on the potential vaccine.

    About COVID-19

    COVID-19 is the disease caused by a new coronavirus called SARS-CoV-2, and was first reported in December 2019 in Wuhan, Hubei province, China. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. 

    Globally over 116 million confirmed cases and over 2.5 million deaths are reported since the start of the pandemic. Currently, there are no definite approved therapies endorsed by the World Health Organization for COVID-19, focusing on supportive care and preventive immunization.

    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 receives royalties on net sales. According to a commercialization and supply agreement, Megapharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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. 

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 in this press release include those relating to the potential of the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) to be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer an alternative to other approved vaccines against COVID-19, the ability to obtain approval to commence any clinical trial or the timeline to develop any potential vaccine and the characteristics of any potential vaccine (including cost, storage temperatures and oral availability and Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom and the initiation of Study P02, which is expected to be initiated in Q2 of 2021. 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, that the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) has never been tested in humans and so further pre-clinical or clinical studies of that technology and any vaccine developed using that technology may not be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease, that such technology or vaccines may not receive the necessary approvals to be studied in human clinical trials, that the timeline to develop a vaccine may be longer than expected, that such technology or vaccines may not be capable of being used orally, may not have the same characteristics (including storage temperatures) as vaccines previously approved using the Salmonella Typhi Ty21a carrier strain, any such vaccine developed using the University's technology may not lower the evolution of resistant viral mutants or may not be competitive with vaccines developed by third parties against COVID-19, 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 Nordisk, 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), the outcome of our pre-clinical and clinical development efforts of in-licensed products, 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. – Company obtains an exclusive license from The University of Sheffield, UK to intellectual property relating to parathyroid hormone (PTH) fusion polypeptides covering the field of human use which will initially be studied by Aeterna for the potential therapeutic treatment of primary hypoparathyroidism

    Continued execution on growth strategy to establish a diversified, yet focused, pipeline of development assets leveraging the Company's expertise and experience

    CHARLESTON, S.C., March 11, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic…

    – Company obtains an exclusive license from The University of Sheffield, UK to intellectual property relating to parathyroid hormone (PTH) fusion polypeptides covering the field of human use which will initially be studied by Aeterna for the potential therapeutic treatment of primary hypoparathyroidism

    Continued execution on growth strategy to establish a diversified, yet focused, pipeline of development assets leveraging the Company's expertise and experience

    CHARLESTON, S.C., March 11, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that it is continuing to expand its development pipeline by initiating a preclinical development program to develop parathyroid hormone fusion polypeptides (PTH) with delayed clearance based on proprietary intellectual property exclusively licensed by Aeterna from The University of Sheffield, UK (the "University").

    Primary hypoparathyroidism, the first indication to be pursued, is an orphan indication in the field of endocrinology. It is an uncommon condition in which the body produces abnormally low levels of PTH. PTH is a key regulating hormone essential for calcium homeostasis and renal phosphate clearance for maintaining a balance of those two minerals in the body. Untreated, primary hypoparathyroidism will cause, among others effects, renal dysfunction, muscle cramping, twitching, seizures, and cardiac arrhythmias. Approximately 23 to 37 in every 100,000 individuals in Europe and the U.S. are estimated to suffer from hypoparathyroidism.

    Aeterna will collaborate with Prof. Dr. Richard J. Ross and his laboratory at the University to continue to advance this exciting potential new therapeutic treatment option being studied for chronic hypoparathyroidism in adults. It uses a proprietary fusion protein consisting of a modified growth hormone binding protein (GHBP) linked to PTH1-34 with the goal of providing PTH1-34 with a delayed clearance of one or two weeks. This new therapy approach has the potential to be self-administered via a pharmaceutical pen and help patients maintain normal serum calcium and phosphate levels during chronic use. Working with the University, the Company will undertake certain additional confirmatory research studies prior to initiating formal pre-clinical toxicology and GMP studies and finalizing plans for the potential initiation of human clinical trials.

    "We are continuing to advance on our stated goal of expanding our pipeline beyond diagnostics with multiple development programs in potentially high-value indications. With our well-established knowledge and expertise in the endocrinology space, we are executing on our goal of adding synergistic assets to our pipeline to execute on our pipeline expansion strategy. We look forward to combining the expertise of the Aeterna scientific team with The University of Sheffield and Prof. Dr. Ross as we work towards our common goal of helping patients suffering from hypoparathyroidism while also potentially unlocking significant value in this proprietary asset," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

    Prof. Dr. Richard J. Ross of the University of Sheffield added, "We are excited about the opportunity to work with Aeterna Zentaris to further research on this new concept of delayed clearance PTH molecules and potential therapeutic treatment options. We look forward working with Aeterna to further the development of PTH fusion polypeptides which I believe have the potential to address an existing unmet medical need in the treatment of hypoparathyroidism and may also have the potential in certain other conditions such as osteoporosis."

    Aeterna continues to strive to balance risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline which we believe best leverages the Company's expertise and experience. The Company remains focused on utilizing its network with researchers in Europe and the U.S. to seek opportunities to access innovative development candidates, with a focus on rare or orphan indications and potential for pediatric use.

    Transaction Terms and Conditions

    Under the terms of the exclusive patent and know-how license agreement entered into with the University, Aeterna obtained worldwide rights to develop, manufacture and commercialize PTH fusion polypeptides covered by the licensed patents for all human uses for an up-front cash payment of £100,000 and milestone payments to be paid upon the achievement of certain development, regulatory and sales milestones, as well as low single digit royalty payments on net sales of those products and certain fees payable in connection with sublicensing. Aeterna will be responsible for the further development, manufacturing, approval and commercialization of the licensed products. Aeterna has also engaged the University under a research contract to conduct certain research activities to be funded by Aeterna, the results of which will be included within the scope of the license granted to Aeterna.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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. 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 Q2 of 2021.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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.

    About The University of Sheffield

    With almost 29,000 of the brightest students from over 140 countries, learning alongside over 1,200 of the best academics from across the globe, the University of Sheffield is one of the world's leading universities. A member of the UK's prestigious Russell Group of leading research-led institutions, Sheffield offers world-class teaching and research excellence across a wide range of disciplines.

    Unified by the power of discovery and understanding, staff and students at the university are committed to finding new ways to transform the world we live in. Sheffield is the only university to feature in The Sunday Times 100 Best Not-For-Profit Organizations to Work For 2018 and for the last eight years has been ranked in the top five UK universities for Student Satisfaction by Times Higher Education.

    Sheffield has six Nobel Prize winners among former staff and students and its alumni go on to hold positions of great responsibility and influence all over the world, making significant contributions in their chosen fields. Global research partners and clients include Boeing, Rolls-Royce, Unilever, AstraZeneca, Glaxo SmithKline, Siemens and Airbus, as well as many UK and overseas government agencies and charitable foundations.

    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 in this press release include those relating to the development and expansion of the Company's diversified pipeline of development assets, the initiation of a preclinical program for the development of a new therapeutic treatment option for primary hypoparathyroidism or any other conditions based on the intellectual property licensed from the University and Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom and the initiation of Study P02, which is expected to be initiated in Q2 of 2021. 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 Nordisk, 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), the outcome of our pre-clinical and clinical development efforts of in-licensed products, 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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  5. CHARLESTON, S.C., Feb. 24, 2021 (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 virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company's website (www.zentaris.com). The webcast replay will be archived for 90 days following the event.

    For more…

    CHARLESTON, S.C., Feb. 24, 2021 (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 virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company's website (www.zentaris.com). The webcast replay will be archived for 90 days following the event.

    For more information about the conference, please visit the conference website here.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    The Company 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 Asia 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 TwitterLinkedIn 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 in this press release include those relating to Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom. Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Actual results could differ materially from those currently anticipated due to a number of factors and risks, including, without limitation, our ability to obtain receipt of pricing and reimbursement approvals as well as those risks 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 U.S. Securities and Exchange Commission. Given the 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

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  6. CHARLESTON, S.C., Feb. 19, 2021 (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 the closing of its previously announced public offering of 20,509,746 common shares of Aeterna, at a price to the public of $1.45 per share. The gross proceeds from the offering were approximately $29.7 million, before deducting underwriting discounts, commissions and offering expenses payable by Aeterna.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    Aeterna also has granted to the underwriter a 30-day option to purchase up to 3,076,461 additional common…

    CHARLESTON, S.C., Feb. 19, 2021 (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 the closing of its previously announced public offering of 20,509,746 common shares of Aeterna, at a price to the public of $1.45 per share. The gross proceeds from the offering were approximately $29.7 million, before deducting underwriting discounts, commissions and offering expenses payable by Aeterna.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    Aeterna also has granted to the underwriter a 30-day option to purchase up to 3,076,461 additional common shares at the public offering price, less underwriting discounts and commissions.



    Aeterna intends to use the net proceeds from the offering for general corporate purposes, which includes, among other purposes, the investigation of further therapeutic uses of Macrilen™ (macimorelin), the expansion of pipeline development activities, the further expansion of commercialization of macimorelin in available territories and the potential funding of a pediatric clinical trial in the E.U. and U.S. for macimorelin.

    A shelf registration statement on Form F-3 (Registration No. 333-232935) was filed with the Securities and Exchange Commission ("SEC") and became effective on August 15, 2019 and the related registration statement on Form F-3 (File No. 333-253178), was filed with the SEC under Rule 462(b) of the Securities Act of 1933, as amended, relating to the securities being offered. The offering was made only by means of a prospectus supplement and accompanying base prospectus. A final prospectus supplement and the accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC's website located at www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or by email to .



    In obtaining the approval of the Toronto Stock Exchange ("TSX") of the offering, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible lnterlisted Issuers", since the Company's common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the offering.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares in connection with the offering.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 TwitterLinkedIn 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 anticipated use of proceeds, the potential of the Julius-Maximilians-University Wuerzburg's (the "University") coronavirus vaccine platform technology (and any vaccine candidates using that technology) to be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer an alternative to other approved vaccines against COVID-19, the ability to obtain approval to commence any clinical trial or the timeline to develop any potential vaccine, the characteristics of any potential vaccine (including cost, storage temperatures and oral availability) and the ability of the Company to negotiate a mutually agreeable license agreement with the University, those relating to the Company obtaining approval of macimorelin for CGHD, the Company's ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, 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," "potential" 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, that the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) has never been tested in humans and so further pre-clinical or clinical studies of that technology and any vaccine developed using that technology may not be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease, that such technology or vaccines may not receive the necessary approvals to be studied in human clinical trials, that the timeline to develop a vaccine may be longer than expected, that such technology or vaccines may not be capable of being used orally, may not have the same characteristics (including storage temperatures) as vaccines previously approved using the Salmonella Typhi Ty21a carrier strain, any such vaccine developed using the University's technology may not lower the evolution of resistant viral mutants or may not be competitive with vaccines developed by third parties against COVID-19, and that the Company may not be successful in negotiating a license to such technology from the University if the Company elects to exercise its option to negotiate, 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 Nordisk, 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 ("EU") 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 EU for 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

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  7. CHARLESTON, S.C., Feb. 16, 2021 (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, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 20,509,746 common shares of Aeterna, at a price to the public of $1.45 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 19, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering…

    CHARLESTON, S.C., Feb. 16, 2021 (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, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 20,509,746 common shares of Aeterna, at a price to the public of $1.45 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 19, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    Aeterna also has granted to the underwriter a 30-day option to purchase up to 3,076,461 additional common shares at the public offering price, less underwriting discounts and commissions.

    The gross proceeds are expected to be approximately $29.7 million, before deducting underwriting discounts and commissions and other offering expenses payable by Aeterna. Aeterna intends to use the net proceeds from the offering for general corporate purposes, which includes, among other purposes, the investigation of further therapeutic uses of Macrilen™ (macimorelin), the expansion of pipeline development activities, the further expansion of commercialization of macimorelin in available territories and the potential funding of a pediatric clinical trial in the E.U. and U.S. for macimorelin.

    A shelf registration statement on Form F-3 (Registration No. 333-232935) was filed with the Securities and Exchange Commission ("SEC") and was declared effective on August 15, 2019 and the related registration statement on Form F-3 (File No. 333-253178), was filed with the SEC under Rule 462(b) of the Securities Act of 1933, as amended, relating to the securities being offered. The offering is being made only by means of a prospectus supplement and accompanying base prospectus. A preliminary prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC and are available for free on the SEC's website located at http://www.sec.gov. When available, electronic copies of the final prospectus supplement and accompanying base prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or by email to .

    In obtaining the approval of the Toronto Stock Exchange ("TSX") of the offering, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible lnterlisted Issuers", since the Company's common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying base prospectus forming a part of the effective registration statement.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 TwitterLinkedIn 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 completion of the offering and the anticipated use of proceeds, the potential of the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) to be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer an alternative to other approved vaccines against COVID-19, the ability to obtain approval to commence any clinical trial or the timeline to develop any potential vaccine, the characteristics of any potential vaccine (including cost, storage temperatures and oral availability) and the ability of the Company to negotiate a mutually agreeable license agreement with the University, those relating to the Company obtaining approval of macimorelin for CGHD, the Company's ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, 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," "potential" 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, that the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) has never been tested in humans and so further pre-clinical or clinical studies of that technology and any vaccine developed using that technology may not be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease, that such technology or vaccines may not receive the necessary approvals to be studied in human clinical trials, that the timeline to develop a vaccine may be longer than expected, that such technology or vaccines may not be capable of being used orally, may not have the same characteristics (including storage temperatures) as vaccines previously approved using the Salmonella Typhi Ty21a carrier strain, any such vaccine developed using the University's technology may not lower the evolution of resistant viral mutants or may not be competitive with vaccines developed by third parties against COVID-19, and that the Company may not be successful in negotiating a license to such technology from the University if the Company elects to exercise its option to negotiate, 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 Nordisk, 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 ("EU") 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 EU for 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: 

    https://www.globenewswire.com/newsroom/ti?nf=ODE0NTIzNiMzOTU1MTM5IzUwMDA3MjY3Nw==





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  8. CHARLESTON, S.C., Feb. 16, 2021 (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 it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 6,896,552 common shares of Aeterna, at a price to the public of $1.45 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 19, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the…

    CHARLESTON, S.C., Feb. 16, 2021 (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 it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 6,896,552 common shares of Aeterna, at a price to the public of $1.45 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 19, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    Aeterna also has granted to the underwriter a 30-day option to purchase up to 1,034,482 additional common shares at the public offering price, less underwriting discounts and commissions.

    The gross proceeds are expected to be approximately $10.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Aeterna. Aeterna intends to use the net proceeds from the offering for general corporate purposes, which includes, among other purposes, the investigation of further therapeutic uses of Macrilen (macimorelin), the expansion of pipeline development activities, the further expansion of commercialization of macimorelin in available territories and the potential funding of a pediatric clinical trial in the E.U. and U.S. for macimorelin.

    A shelf registration statement on Form F-3 (Registration No. 333-232935) was filed with the Securities and Exchange Commission ("SEC") and was declared effective on August 15, 2019. The offering is being made only by means of a prospectus supplement and accompanying base prospectus. A preliminary prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC and are available for free on the SEC's website located at http://www.sec.gov. When available, electronic copies of the final prospectus supplement and accompanying base prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or by email to .

    In obtaining the approval of the Toronto Stock Exchange ("TSX") of the offering, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible lnterlisted Issuers," since the Company's common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying base prospectus forming a part of the effective registration statement.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 TwitterLinkedIn 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 completion of the offering and the anticipated use of proceeds, the potential of the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) to be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer an alternative to other approved vaccines against COVID-19, the ability to obtain approval to commence any clinical trial or the timeline to develop any potential vaccine, the characteristics of any potential vaccine (including cost, storage temperatures and oral availability) and the ability of the Company to negotiate a mutually agreeable license agreement with the University, those relating to the Company obtaining approval of macimorelin for CGHD, the Company's ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, 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," "potential" 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, that the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) has never been tested in humans and so further pre-clinical or clinical studies of that technology and any vaccine developed using that technology may not be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease, that such technology or vaccines may not receive the necessary approvals to be studied in human clinical trials, that the timeline to develop a vaccine may be longer than expected, that such technology or vaccines may not be capable of being used orally, may not have the same characteristics (including storage temperatures) as vaccines previously approved using the Salmonella Typhi Ty21a carrier strain, any such vaccine developed using the University's technology may not lower the evolution of resistant viral mutants or may not be competitive with vaccines developed by third parties against COVID-19, and that the Company may not be successful in negotiating a license to such technology from the University if the Company elects to exercise its option to negotiate, 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 Nordisk, 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 ("EU") 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 EU for 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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  9. - Company secures next step to continue to build-out pipeline of assets

    - University researchers developed a proprietary and orally active bacterial vaccine platform technology currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19

    - Aeterna Zentaris to evaluate the University's coronavirus vaccine platform technology including COVID-19 under an exclusive option agreement

    CHARLESTON, S.C., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that the Company…

    - Company secures next step to continue to build-out pipeline of assets

    - University researchers developed a proprietary and orally active bacterial vaccine platform technology currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19

    - Aeterna Zentaris to evaluate the University's coronavirus vaccine platform technology including COVID-19 under an exclusive option agreement



    CHARLESTON, S.C., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that the Company has entered into an exclusive option agreement to evaluate a preclinical potential COVID-19 vaccine developed at the Julius-Maximilians-University Wuerzburg (the "University"), one of Germany's leading research and teaching universities. The vaccine technology developed at the University uses a typhoid fever vaccine as a carrier strain and has the potential to be an orally active COVID-19 (SARS-CoV-2) live-attenuated bacterial vaccine.

    Under the option agreement entered into with the University, Aeterna has the right to negotiate an exclusive worldwide license to develop this technology for the prevention of coronavirus diseases, including COVID-19. A scientific advice meeting with the German authorities at Paul-Ehrlich Institute has been scheduled by the University to discuss a roadmap towards initiating a first-in-human clinical trial. Aeterna believes that, if it is determined that there is sufficient data to advance into human clinical trials, the development program for this particular COVID-19 vaccine is expected to be abbreviated because extensive clinical safety data is already available for the underlying vaccine strain, Salmonella Typhi Ty21a. Aeterna expects to make a decision whether to exercise its option to negotiate a license for that technology by mid 2021.

    "While vaccines for COVID-19 have been developed, we believe there is opportunity for improvement. That includes the potential to develop a more cost-effective oral alternative with less onerous storage requirements than the currently approved COVID-19 vaccines," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. "We are optimistic that results from further studies of this new vaccination approach may offer a much needed, safe and effective immunization alternative against COVID-19. Aeterna will contribute its expertise and experience in preclinical development and GMP-compliant manufacturing to the project."

    Prof. Thomas Rudel of the University added: "Our new vaccine technology based on the live-attenuated Salmonella Typhi Ty21a strain modified to present two viral antigens, opens the opportunity for a new oral vaccination strategy which may have the potential to prevent people from infection with SARS-CoV-2. In addition, the use of dual antigens in one vaccine strain, may lower the likelihood of evolution of resistant viral mutants. We believe that a positive decision by Aeterna Zentaris to license this technology will start a fruitful collaboration with Aeterna, with the aim to begin the clinical development as soon as possible."

    About the University's Potential COVID-19 Vaccine

    The technology underlying the new vaccine approach is based on the bacterium Salmonella Typhi Ty21a which has been engineered to express and secrete two coronavirus antigens fused to an immunological adjuvant peptide. The plasmid-maintenance system is free of antibiotic resistance genes. The specific bacterial vector strain enables oral application and release of the proteins into the gut system which will consequently via M-cells stimulate mucosal and systemic immunity.

    The Salmonella Typhi Ty21a carrier strain has been safely used worldwide in more than 150 million administered doses. Some of those existing vaccine products have been shown to be stable at fridge temperature of 2°C to 8°C. While the use and characteristics of the University's COVID-19 vaccine candidate remain to be demonstrated through further preclinical and clinical studies, the goal is to develop an oral dosage form COVID-19 vaccine that can be stored in a common fridge or at room temperature.

    About COVID-19

    COVID-19 is the disease caused by a new coronavirus called SARS-CoV-2, and was first reported in December 2019 in Wuhan, Hubei province, China. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. 

    Globally over 102 million cases and over 2.2 million deaths are reported since the start of the pandemic. Currently, there are no definite approved therapies endorsed by the World Health Organization for COVID-19, focusing only on supportive care and preventive immunization.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 the potential of the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) to be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer an alternative to other approved vaccines against COVID-19, the ability to obtain approval to commence any clinical trial or the timeline to develop any potential vaccine, the characteristics of any potential vaccine (including cost, storage temperatures and oral availability) and the ability of the Company to negotiate a mutually agreeable license agreement with the University, those relating to the Company obtaining approval of macimorelin for CGHD, the Company's ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, 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," "potential" 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, that the University's coronavirus vaccine platform technology (and any vaccine candidates using that technology) has never been tested in humans and so further pre-clinical or clinical studies of that technology and any vaccine developed using that technology may not be effective as a vaccine against COVID-19 (SARS-CoV-2) or any other coronavirus disease, that such technology or vaccines may not receive the necessary approvals to be studied in human clinical trials, that the timeline to develop a vaccine may be longer than expected, that such technology or vaccines may not be capable of being used orally, may not have the same characteristics (including storage temperatures) as vaccines previously approved using the Salmonella Typhi Ty21a carrier strain, any such vaccine developed using the University's technology may not lower the evolution of resistant viral mutants or may not be competitive with vaccines developed by third parties against COVID-19, and that the Company may not be successful in negotiating a license to such technology from the University if the Company elects to exercise its option to negotiate, 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 Nordisk, 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 ("EU") 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 EU for 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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  10. - Company licenses exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific immunosuppressive therapeutic proteins for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") from Julius-Maximilians-University of Wuerzburg, Germany

    - Initial step in growth strategy to build-out pipeline of assets

    - Aeterna Zentaris to develop potential therapeutic treatment option for neuromyelitis optica spectrum disorder ("NMOSD"), an orphan indication with strong unmet medical need and significant market opportunity

    CHARLESTON, S.C., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company…

    - Company licenses exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific immunosuppressive therapeutic proteins for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") from Julius-Maximilians-University of Wuerzburg, Germany



    - Initial step in growth strategy to build-out pipeline of assets



    - Aeterna Zentaris to develop potential therapeutic treatment option for neuromyelitis optica spectrum disorder ("NMOSD"), an orphan indication with strong unmet medical need and significant market opportunity

    CHARLESTON, S.C., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that it has licensed the exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific, autoimmunity modifying proteins ("AIM Biologicals") for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") from the Julius-Maximilians-University Wuerzburg (the "University").

    "This demonstrates Aeterna's commitment to execute on our stated plans of expanding our pipeline to have multiple assets in research and development. The work that Dr. Valentin Bruttel and Prof. Joerg Wischhusen have conducted at the University represents what we believe to be a compelling opportunity for innovative development in the high-value indication NMOSD, an orphan indication with significant unmet need," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

    Prof. Joerg Wischhusen of the University added, "Based on pre-clinical data obtained by the University to date, the AIM Biologicals technology has the potential to be a breakthrough in the treatment of autoimmune-related diseases. It is based on a mechanism developed by nature to protect the fetus from the mother's immune system without compromising immune protection against foreign antigens. This has the potential to offer a new treatment for NMOSD patients. We believe that the collaboration with Aeterna will accelerate the further development towards the clinic."

    Autoimmunity Modifying ("AIM") Biologicals - Targeted Immunosuppressive Therapeutics

    During pregnancy, the maternal immune system tolerates paternal antigens from the embryo but is still effective to protect mother and embryo from foreign antigens. Parts of the natural mechanisms responsible for this feto-maternal immune tolerance form the scientific basis for the concept of AIM Biologicals.

    AIM Biologicals utilize a novel mechanism which is believed to demonstrate that peptide antigens presented on immunosuppressive MHC class I molecules can selectively and efficiently induce antigen-specific tolerance. Based on this mechanism, the targeted immunosuppressive therapeutics are being designed as optimized soluble molecules with the goal that they may be adapted to selectively induce tolerance to various autoantigens. Pre-clinical studies conducted by the University thus far indicate that tolerance induction appears to be achieved via selective elimination of antigen-specific immune effector cells and via induction of antigen-specific regulatory T cells from naïve T cells. AIM Biologicals thus have the potential to become highly specific and effective yet not personalized treatments of NMOSD.

    For the treatment of NMOSD, it is believed that the AIM Biologicals will present a specific antigen derived from the water channel protein aquaporin-4 (AQP4) loaded to soluble immunoregulatory HLA-G protein to selectively induce immunological tolerance in the central nervous system.

    In collaboration with the University and the University clinic, Aeterna plans to conduct further pre-clinical research to identify and characterize an AIM Biologicals based development candidate for the treatment of NMOSD, including meeting with the regulatory authorities to confirm the further pre-clinical data required as we work towards advancing such candidate into human clinical trials.

    About Neuromyelitis Optica Spectrum Disorder (NMOSD)

    NMOSD is an antibody mediated inflammatory central nervous system ("CNS") disorder that affects about one per million population per year. NMOSD, also known as Devic disease, is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and of the spinal cord (myelitis). Typical symptoms include visual loss, muscle spasms, paraparesis, and incontinence. If left untreated, 50% of individuals with NMOSD will be wheelchair bound and blind, and 30% will have died within five years after the first attack. The water channel protein AQP4 is widely expressed in the brain, spinal cord, and optic nerves. Auto-antibodies directed against the AQP4 channel play an important role in the pathogenesis of NMOSD.

    Currently there are only three approved medications available for the treatment of NMOSD with very high annual treatment costs, and the risk of the patient contracting serious infections. Therefore, there is a strong medical need to offer new therapeutic options to the patients.

    In the U.S. and Europe there are currently approximately 10,000 to 15,000 patients living with NMOSD. Of these the AQP4 antibody seropositive patients who represent about 80% of the NMOSD population are the targeted patients for a potential therapy based on the AIM Biologicals technology.

    Transaction Terms and Conditions

    Under the terms of the exclusive patent license agreement entered into with the University, Aeterna obtained worldwide rights to develop, manufacture and commercialize products for the treatment of NMOSD using the AIM Biologicals technology for an up-front cash payment of 100,000 and milestone payments to be paid upon the achievement of certain development and regulatory milestones as well as royalty payments on net sales. Aeterna will be responsible for the formal preclinical and clinical development, regulatory activities, and manufacturing of the licensed products. Aeterna has also engaged the University and University clinic to conduct certain pre-development activities with respect to the AIM Biologicals program to be funded by Aeterna.

    The Company intends to continue balancing risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline to which Aeterna can best leverage its expertise and experience. Aeterna is focused on opportunistically utilizing its network with universities in Europe and the U.S. The license of the AIM Biologicals program for NMOSD demonstrates Aeterna's progress towards achieving its goal to obtain access to innovative development candidates in different indications, with a focus on rare or orphan indications with potential significant commercial opportunity.

    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 receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

    Aeterna 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.

    Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia 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 potential to obtain the necessary pre-clinical data and regulatory approvals necessary to advance any product using the AIM Biologicals technology into human clinical trials or to develop the AIM Biologicals to treat NMOSD or any other indication into an approved product, the ability of any product using the AIM Biologicals technology to compete with existing approved products (or any other products in development) for NMOSD, the ability of the Company to obtain approval of macimorelin for CGHD, the Company's ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, 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", "potential" 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 Nordisk, 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), the outcome of our pre-clinical and clinical development efforts of in-licensed products (including the AIM Biologicals), 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.

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  11. CHARLESTON, S.C., Jan. 26, 2021 (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 it has received a notification letter from The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it has been granted an additional 180 calendar day period to regain compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market.

    This current notification from Nasdaq has no immediate effect on the listing or trading of the Company's shares, which will continue to trade on the Nasdaq Capital Market under the symbol "AEZS…

    CHARLESTON, S.C., Jan. 26, 2021 (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 it has received a notification letter from The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it has been granted an additional 180 calendar day period to regain compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market.

    This current notification from Nasdaq has no immediate effect on the listing or trading of the Company's shares, which will continue to trade on the Nasdaq Capital Market under the symbol "AEZS". The Company has an additional 180 calendar days from the date of notification, which occurred on January 26, 2021, or until July 26, 2021, to regain compliance with the minimum bid price requirement. If at any time before July 26, 2021, the bid price of the Company's common shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification to the Company that it has achieved compliance with the minimum bid price requirement.

    If the Company does not meet the minimum bid requirement during the additional 180-day grace period, Nasdaq will provide written notification to the Company that its shares will be subject to delisting. At such time, the Company may appeal the delisting determination to a Nasdaq Hearings Panel. The Company would remain listed pending the Panel's decision. There can be no assurance that if the Company does appeal a subsequent delisting determination, that such appeal would be successful.

    The Company is also listed on the Toronto Stock Exchange and the notification letter does not affect the Company's compliance status with such listing.

    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. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd and Aeterna Zentaris will receive royalties on sales and other potential payments.

    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 Asia 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 in this press release include those relating to Aeterna's ability to regain compliance with the Nasdaq's minimum bid price requirement as well as the consequences for failing to do so and Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom. Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Actual results could differ materially from those currently anticipated due to a number of factors and risks, including, without limitation, our ability to obtain receipt of pricing and reimbursement approvals as well as those risks 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 U.S. Securities and Exchange Commission. Given the 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.

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  12. – Live video webcast with CEO, Dr. Klaus Paulini, on Wednesday, January 20th at 12:00 PM ET –

    CHARLESTON, S.C., Jan. 15, 2021 (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 NobleCon17 - Noble Capital Markets' Seventeenth Annual Investor Conference on Wednesday, January 20, 2021 at 12:00 PM ET.

    A high-definition, video webcast will be available at the time of the Company's presentation to those registered to attend the event. The conference is virtual, with no cost, obligation or restrictions to attend: www.noblecon17.com

    – Live video webcast with CEO, Dr. Klaus Paulini, on Wednesday, January 20th at 12:00 PM ET –

    CHARLESTON, S.C., Jan. 15, 2021 (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 NobleCon17 - Noble Capital Markets' Seventeenth Annual Investor Conference on Wednesday, January 20, 2021 at 12:00 PM ET.

    A high-definition, video webcast will be available at the time of the Company's presentation to those registered to attend the event. The conference is virtual, with no cost, obligation or restrictions to attend: www.noblecon17.com.

    A webcast replay will be available approximately 24 hours following the presentation on the Events page in the Investors section of the Company's website (www.zentaris.com), and as part of a complete catalog of presentations to be rebroadcast on Channelchek, www.channelchek.com, next month.

    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. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd and Aeterna Zentaris will receive royalties on sales and other potential payments.

    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 Asia 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 in this press release include those relating to Aeterna's expectation that, upon receipt of pricing and reimbursement approvals, macimorelin will be marketed in Europe and the United Kingdom. Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Actual results could differ materially from those currently anticipated due to a number of factors and risks, including, without limitation, our ability to obtain receipt of pricing and reimbursement approvals as well as those risks 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 U.S. Securities and Exchange Commission. Given the 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

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  13. CHARLESTON, S.C., Jan. 05, 2021 (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 BioConnect 2021 Virtual Conference taking place January 11-14, 2021.

    The video webcast presentation will be available for viewing on-demand beginning Monday, January 11, 2021, at 6:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company's website (www.zentaris.com).

    For more information about the event, please visit the conference website…

    CHARLESTON, S.C., Jan. 05, 2021 (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 BioConnect 2021 Virtual Conference taking place January 11-14, 2021.

    The video webcast presentation will be available for viewing on-demand beginning Monday, January 11, 2021, at 6:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company's website (www.zentaris.com).

    For more information about the event, please visit the conference website here.

    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. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd and Aeterna Zentaris will receive royalties on sales and other potential payments.

    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 Asia 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

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  14. CHARLESTON, S.C., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that it has entered into an exclusive licensing agreement (the "Agreement") with Consilient Health, Ltd. ("CH" or "Consilient Health"), a privately owned pharmaceutical company focused on commercializing medicines in Europe and Middle East, for the commercialization in Europe and the United Kingdom of macimorelin, Aeterna's orally available ghrelin agonist, in any diagnostic application, including the diagnosis of patients with adult growth hormone deficiency…

    CHARLESTON, S.C., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), through its wholly-owned subsidiary, ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that it has entered into an exclusive licensing agreement (the "Agreement") with Consilient Health, Ltd. ("CH" or "Consilient Health"), a privately owned pharmaceutical company focused on commercializing medicines in Europe and Middle East, for the commercialization in Europe and the United Kingdom of macimorelin, Aeterna's orally available ghrelin agonist, in any diagnostic application, including the diagnosis of patients with adult growth hormone deficiency ("AGHD") and, subject to receipt of regulatory approval, childhood-onset growth hormone deficiency ("CGHD").

    Under the terms of the Agreement, CH will be responsible for obtaining pricing and reimbursement approval in the European economic area and the United Kingdom, as well as bearing the regulatory cost for the label extension for pediatric use pending successful outcome of the upcoming safety and efficacy study, AEZS-130-P02 ("Study P02"), evaluating macimorelin for the diagnosis of CGHD. This pivotal Phase 3 Study P02 is expected to be initiated in Q1 of 2021. Aeterna and Consilient Health have also entered into a separate commercial supply agreement under which Consilient Health will purchase macimorelin from Aeterna and Aeterna will be responsible for supply and product quality. Aeterna will continue to maintain control of its patents covering macimorelin in Europe and the United Kingdom.

    As agreed, Consilient Health will make an up-front payment to Aeterna of Euro 1 million and will pay to Aeterna royalties on net sales of macimorelin ranging from 10% to 20% depending on the level of net sales achieved by Consilient Health in the particular year. Aeterna will also be eligible to receive milestone payments associated with the achievement of pricing and reimbursement approvals in certain countries in Europe and in the United Kingdom, upon approval of macimorelin in CGHD, and on the attainment by Consilient Health of other sales based events.

    "This license agreement represents another significant milestone for the Company as we continue to secure and bolster our portfolio of marketing partners for macimorelin in key markets. As a synergistic partner of choice with insight and commercialization capabilities, we believe that Consilient Health brings noteworthy expertise that is the right fit for Aeterna. We are grateful for their partnership and look forward to leveraging their experience in driving innovative marketing to our international distribution network for macimorelin," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris.

    Commenting on the agreement, Ahmed Al-Derzi, Consilient Health's CEO stated, "We are delighted to build this partnership with Aeterna Zentaris for macimorelin. Not only does the brand further strengthen our growing offering to endocrinology specialists and their patients but it also strengthens CH's position across Europe. Macimorelin is an exciting innovation in the field of growth hormone deficiency."

    In addition to advancing its pediatric program, Aeterna is actively pursuing its business development activities with the goal of securing marketing partners for macimorelin for the diagnosis of growth hormone deficiency in additional markets where the Company does not already have partnership agreements.

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

    About Consilient Health

    Consilient Health is a pharmaceutical company with a rich heritage of commercializing products in areas such as women's health, urology and endocrinology.

    In all of Consilient Health's planning, the patient is very much at the center. Considering the needs of both the healthcare professional and the payer, as well as those of the patient is key to its commercial success.

    Established in 2005, Consilient Health's success has been built on cultivating strong partnerships with pharma companies and on ensuring access and then marketing prescription healthcare products across Europe and the Middle East.

    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 macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency. Macrilen™ has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. 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, 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. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd and Aeterna Zentaris will receive royalties on sales and other potential payments.

    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, the Company's ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, 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 Nordisk, 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.



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  15. - 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

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  16. – 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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  17. 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

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

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  18. - 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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  19. - 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:

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  20.  – 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…

     – 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 Company's 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 Company's 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 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.

    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, 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, 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 Results

    All 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 Macrilen (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. Effective June 16, 2020, the Company registered the common shares underlying the 2,608,696 investor warrants and 243,478 placement agent warrants issued on February 21, 2020 and the 3,325,000 investor warrants issued on September 20, 2019 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 second quarter of 2020, as well as the Company's audited consolidated financial statements as of June 30, 2020, 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, 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.

    Condensed Consolidated Statements of Comprehensive (Loss) Income

    (in thousands, except share and per share data) (unaudited)

      Three months ended Six months ended
      June 30 June 30
      2020  2019  2020  2019 
      $  $ $ $
    Revenues         
    Royalty income 10  8  24  21 
    Product sales   129  1,016  129 
    Supply chain 40  39  81  45 
    Licensing revenue 18  18  37  36 
    Total revenues 68  194  1,158  231 
    Operating expenses        
    Cost of sales 12  101  874  101 
    Research and development costs 189  571  508  1,099 
    General and administrative expenses 1,141  1,923  2,265  3,560 
    Selling expenses 199  495  447  799 
    Restructuring costs   773    773 
    Impairment of right of use asset   64    401 
    Gain on modification of building lease (34)   (219)  
    Impairment of prepaid asset       169 
    Total operating expenses 1,507  3,927  3,875  6,902 
    Loss from operations (1,439) (3,733) (2,717) (6,671)
    Gain (loss) due to changes in foreign currency exchange rates  130  (6) 26  58 
    (Loss) gain on change in fair value of warrant liability (2,139) 3,926  331  1,865 
    Other finance (costs) income (2) 19  (311) 43 
    Net finance income (costs) (2,011) 3,939  46  1,966 
    Net (loss) income (3,450) 206   (2,671) (4,705 )
    Other comprehensive (loss):        
    Items that may be reclassified subsequently to profit or loss:       
    Foreign currency translation adjustments (209) (110) 1  (26)
    Items that will not be reclassified to profit or loss:       
    Actuarial (loss) on defined benefit plans (1,418) (756) (30) (1,491)
    Comprehensive (loss)  (5,077) (660) (2,700) (6,222)
    Net (loss) income per share [basic and diluted](0.15) 0.01  (0.12) (0.28)
    Weighted average number of shares outstanding:        
    Basic 23,515,579  16,622,415  22,519,497  16,532,090 
    Diluted 23,515,579  17,260,016  22,519,497  16,532,090 

    Condensed Consolidated Interim Statements of Financial Position

      As at June 30, 2020 As at December 31, 2019  
    (in thousands)(Unaudited)   
      $ $  
    Cash and cash equivalents 6,743 7,838   
    Trade and other receivables and other current assets 1,937 1,869   
    Inventory 375 1,203   
    Restricted cash equivalents 313 364   
    Property, plant and equipment 25 35   
    Right of use assets 190 582   
    Other non-current assets 8,086 8,090   
    Total assets 17,669 19,981   
    Payables and accrued liabilities and income taxes payable 1,697 3,596   
    Current portion of provision for restructuring and other costs 107 418   
    Current portion of deferred revenues 596 991   
    Lease liabilities 222 903   
    Warrant liability 12 2,255   
    Non-financial non-current liabilities (1) 14,104 14,281   
    Total liabilities 16,738 22,444   
    Shareholders' equity (deficiency)  931 (2,463)  
    Total liabilities and shareholders' equity (deficiency)   17,699 19,981   
      

    _________________________

    (1) Comprised mainly of employee future benefits, provisions for restructuring and other costs and non-current portion of deferred revenues.

    COVID-19



    In 2020, the COVID-19 pandemic began causing significant financial market declines and social dislocation. The situation is dynamic with various cities and countries around the world responding in different ways to address the outbreak. The spread of COVID-19 may impact the Company's operations, including the potential interruption of our clinical trial activities and the Company's supply chain, or that of the Company's licensee. For example, the COVID-19 outbreak may delay enrollment in the Company's clinical trials due to prioritization of hospital resources toward the outbreak, and some patients may be unwilling to be enrolled in the Company's trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay the Company's ability to conduct clinical trials or release clinical trial results and could delay the Company's ability to obtain regulatory approval and commercialize the Company's product candidates. The pandemic may also impact the ability of the Company's suppliers to deliver components or raw materials on a timely basis or at all. In addition, hospitals may reduce staffing and reduce or postpone certain treatments in response to the spread of an infectious disease. The Company's licensee may be impacted due to significant delays of diagnostic activities in the U.S. To date, the Company has not experienced significant business disruption from COVID-19.

    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 expand macimorelin for AGHD in key global markets around the world, including its ability to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and pursue market opportunities in Israel and the Palestine Authority, the commencement of the CGHD safety and efficacy study and the impact of COVID-19 on the Company's operations, including regarding the potential interruption of the Company's clinical trial activities and the Company's supply chain, or that of the Company's licensee, as well as the impact COVID-19 may have on hospital staffing and treatments, the Company's ability to fund 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 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:

     

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  21. CHARLESTON, S.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS, TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, announced today the closing of its previously announced registered direct offering with several institutional investors in the United States for 12,427,876 common shares, at a purchase price of $0.56325 per common share, priced at-the-market under Nasdaq rules. Additionally, the Company issued to the investors unregistered warrants to purchase up to an aggregate of 9,320,907 common shares in a concurrent private placement. The warrants have an exercise price of $0.47 per common share, are exercisable immediately and will expire…

    CHARLESTON, S.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS, TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, announced today the closing of its previously announced registered direct offering with several institutional investors in the United States for 12,427,876 common shares, at a purchase price of $0.56325 per common share, priced at-the-market under Nasdaq rules. Additionally, the Company issued to the investors unregistered warrants to purchase up to an aggregate of 9,320,907 common shares in a concurrent private placement. The warrants have an exercise price of $0.47 per common share, are exercisable immediately and will expire five and one-half years following the date of issuance. The gross proceeds to the Company from the offering totaled approximately $7.0 million, before deducting placement agent fees and offering expenses.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen™ (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

    The common shares described above (but not the warrants or the common shares underlying the warrants) were offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935), which was previously declared effective by the U.S. Securities and Exchange Commission ("SEC") on August 15, 2019. Such common shares were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

    A final prospectus supplement and the accompanying prospectus relating to the registered direct offering was filed by Aeterna Zentaris with the SEC and may be obtained at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    The warrants described above were offered in a private placement pursuant to an exemption from the Securities Act of 1933, as amended (the "Act"), and along with the common shares issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

    In obtaining the approval of the Toronto Stock Exchange ("TSX") of the offering, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible Interlisted Issuers", since the Company's common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to the TSX to approve the offering.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares or the warrants in connection with the offering.

    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 intended use of the proceeds from the offering 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 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:

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  22. CHARLESTON, S.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, announced today that it has entered into a securities purchase agreement with several institutional investors in the United States providing for the sale and issuance of approximately 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 is expected to result in gross proceeds to Aeterna Zentaris of approximately $7.0 million.

    Aeterna Zentaris will also issue to the purchasers unregistered warrants to purchase up to an…

    CHARLESTON, S.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, announced today that it has entered into a securities purchase agreement with several institutional investors in the United States providing for the sale and issuance of approximately 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 is expected to result in gross proceeds to Aeterna Zentaris of approximately $7.0 million.

    Aeterna Zentaris will also issue to the purchasers unregistered warrants to purchase up to an aggregate of 9,320,907 common shares. The warrants will be 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.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

    The registered direct offering and concurrent private placement is expected to close on or about August 5, 2020, subject to the satisfaction of customary closing conditions.

    The common shares described above (but not the warrants or the common shares underlying the warrants) are being offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935), which was previously declared effective by the U.S. Securities and Exchange Commission ("SEC") on August 15, 2019. Such common shares may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

    A prospectus supplement relating to the common shares will be filed by Aeterna with the SEC. When filed with the SEC, copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering, may be obtained at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    The warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares or the warrants in connection with the offering.

    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 offering of the Company' securities, including as to the consummation of the offering described above, the expected proceeds from the offering, the intended use of proceeds and the timing of the closing of the offering 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 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:

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  23. CHARLESTON, S.C., July 31, 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 the filing of two patent applications on July 22, 2020 related to its substance macimorelin, an orally available ghrelin agonist to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD") and childhood-onset growth hormone deficiency ("CGHD").

    Based on the positive results from AEZS-130-P01 ("Study P01") evaluating macimorelin as a growth hormone stimulation test for the evaluation of CGHD, the Company filed a U.S. provisional application as well as a patent application…

    CHARLESTON, S.C., July 31, 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 the filing of two patent applications on July 22, 2020 related to its substance macimorelin, an orally available ghrelin agonist to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD") and childhood-onset growth hormone deficiency ("CGHD").

    Based on the positive results from AEZS-130-P01 ("Study P01") evaluating macimorelin as a growth hormone stimulation test for the evaluation of CGHD, the Company filed a U.S. provisional application as well as a patent application under PCT (Patent Cooperation Treaty). Both patent applications relate to the invention of macimorelin as a method to diagnose growth hormone deficiency in pediatric patients.

    "We are encouraged with the data macimorelin has demonstrated to date and believe it holds significant potential to expand into pediatric use. These patent applications, once granted, are expected to support Aeterna's business case for its continued development and efforts to seek regulatory approval pending the outcome of our second pediatric study, P02, evaluating macimorelin acetate in pediatric patients from 2 years of age to 18 years of age with suspected growth hormone deficiency," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

    For results of Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.

    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 macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency. Macrilen™ has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. 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 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 potential of Macrilen™ (macimorelin) to expand into pediatric use and the granting of the two patent applications 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 to obtain approvals for the two patent applications, our ability 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 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:

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  24. CHARLESTON, S.C., July 30, 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 the abstract on study results of its 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.

    The accepted abstract titled Pharmacokinetics and pharmacodynamics of macimorelin acetate (AEZS-130) in paediatric patients with suspected growth hormone deficiency (GHD), will be presented as an ePoster accommodated by an audio commentary during the event.

    Abstracts are under embargo until published…

    CHARLESTON, S.C., July 30, 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 the abstract on study results of its 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.

    The accepted abstract titled Pharmacokinetics and pharmacodynamics of macimorelin acetate (AEZS-130) in paediatric patients with suspected growth hormone deficiency (GHD), will be presented as an ePoster accommodated by an audio commentary during the event.

    Abstracts are under embargo until published in Endocrine Abstracts before the start of e-ECE 2020. Endocrine Abstracts is an entirely online, open-access and fully citable collection of all the abstracts from e-ECE 2020. Once the abstract is made public, it will be available on the Company's website.

    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 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 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 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.

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    Jenene Thomas

    JTC Team

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  25. CHARLESTON, S.C., July 29, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that on July 27, 2020, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company's common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the "Rule").

    In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a grace period of 180…

    CHARLESTON, S.C., July 29, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that on July 27, 2020, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company's common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the "Rule").

    In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a grace period of 180 calendar days, through January 25, 2021, to evidence compliance with the Rule. To evidence compliance with the Rule, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days, but generally not more than 20 consecutive business days, on or before January 25, 2021. In the event the Company does not timely evidence compliance with the Rule, the Company may be eligible for an additional 180-day grace period or may face delisting. In the latter case, the Company would be entitled to request a hearing before the Nasdaq Hearings Panel, which request would stay any delisting action by the Staff pending completion of the hearing process.

    Nasdaq's notice has no immediate effect on the listing of the Company's common shares on Nasdaq and does not otherwise impact the Company's listing on the Toronto Stock Exchange. The Company is considering the options available to it to evidence compliance with the Rule prior to the expiration of the grace period.

    In addition, as previously disclosed via Form 6-K filed with the Securities and Exchange Commission on July 1, 2020, Aeterna Zentaris priced an approximate $12 million public offering of its common stock and warrants, pursuant to which the Company ultimately raised approximately $10.5 million in net proceeds.

    As a result of the offering, the Company believes it has stockholders' equity of at least $2.5 million as of the date of this filing and thereby satisfies the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(3). The Company is awaiting Nasdaq's formal confirmation of such compliance and will provide additional disclosure upon receipt of a compliance determination from the Staff.

    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 certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's ability to regain compliance with the minimum bid price requirement, the impact of Nasdaq's notice on the listing of the Company's common shares on Nasdaq and the Toronto Stock Exchange and the Company's ability to meet the minimum stockholders' equity requirement for continued listing under Nasdaq Listing Rule 5550(b)(3). These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas

    JTC Team

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  26. CHARLESTON, S.C., July 07, 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 closing of its previously announced public offering of 17,544,516 units at a price to the public of $0.45 per unit and 9,122,150 pre-funded units at a price to the public of $0.4499 per pre-funded unit. Each unit sold in this offering contains one common share and one common warrant to purchase one common share. Each pre-funded unit sold in this offering contains one pre-funded warrant to purchase one common share at an exercise price of $0.0001 per share and one common warrant to purchase one common share…

    CHARLESTON, S.C., July 07, 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 closing of its previously announced public offering of 17,544,516 units at a price to the public of $0.45 per unit and 9,122,150 pre-funded units at a price to the public of $0.4499 per pre-funded unit. Each unit sold in this offering contains one common share and one common warrant to purchase one common share. Each pre-funded unit sold in this offering contains one pre-funded warrant to purchase one common share at an exercise price of $0.0001 per share and one common warrant to purchase one common share. The gross proceeds to the Company from the offering totaled approximately $12 million, before deducting placement agent fees and offering expenses.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    Each common share warrant has an exercise price of $0.45 per share, is exercisable immediately and will expire five years from the date of issuance. Each pre-funded warrant is exercisable immediately until all other pre-funded warrants have been exercised.

    The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen™ (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

    The securities described above were offered by Aeterna Zentaris pursuant to an effective registration statement on Form F-1 (File No. 333-232935) which was previously declared effective by the U.S. Securities and Exchange Commission ("SEC") on July 1, 2020.

    The offering was made only by means of a prospectus forming part of the effective registration statement. The terms of the offering were disclosed in a final prospectusfiled by Aeterna Zentaris with the SEC and may be obtained at the SEC's website at www.sec.gov. Electronic copies of the final prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    In obtaining the approval of the Toronto Stock Exchange ("TSX") of the offering, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible lnterlisted Issuers", since the Company's common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares or the warrants in connection with the offering.

    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 intended use of proceeds of the offering 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 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

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  27. CHARLESTON, S.C., July 01, 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 pricing of 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. Each unit contains one common share (or common share equivalent) and one common warrant to purchase one common share. The common shares (or common share equivalents) and common share warrants included in the units can only be purchased together in this offering but will be issued separately…

    CHARLESTON, S.C., July 01, 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 pricing of 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. Each unit contains one common share (or common share equivalent) and one common warrant to purchase one common share. The common shares (or common share equivalents) and common share warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about July 7, 2020, subject to satisfaction customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    Each common share warrant has an exercise price of $0.45 per share, is exercisable immediately and will expire five years from the date of issuance.

    The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen™ (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

    The securities described above are being offered by Aeterna Zentaris pursuant to an effective registration statement on Form F-1 (File No. 333-232935) filed with the Securities and Exchange Commission ("SEC") and declared effective on July 1, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. The final terms of the offering will be disclosed in a final prospectus to be filed with the SEC and made available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares or the warrants in connection with the offering.

    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 public offering of the Company' units, including as to the consummation of the offering described above, the expected proceeds from the offering, the intended use of proceeds and the timing of the closing of the offering 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 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

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  28. CHARLESTON, S.C, June 25, 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 it has entered into an exclusive distribution and related quality agreement (the "Agreement") with Megapharm Ltd. ("Megapharm"), a leading Israel-based biopharmaceutical company, for the commercialization in Israel and the Palestinian Authority of macimorelin, Aeterna Zentaris' orally available ghrelin agonist to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD") and child-onset growth hormone deficiency ("CGHD"). 

    Under the terms of the agreement, Megapharm will be…

    CHARLESTON, S.C, June 25, 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 it has entered into an exclusive distribution and related quality agreement (the "Agreement") with Megapharm Ltd. ("Megapharm"), a leading Israel-based biopharmaceutical company, for the commercialization in Israel and the Palestinian Authority of macimorelin, Aeterna Zentaris' orally available ghrelin agonist to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD") and child-onset growth hormone deficiency ("CGHD"). 

    Under the terms of the agreement, Megapharm will be responsible for obtaining registration to market macimorelin in Israel and the Palestinian Authority, while Aeterna Zentaris will be responsible for manufacturing, product supply, quality assurance and control, regulatory support, and maintenance of IP. The regulatory process for macimorelin in Israel is expected to be completed in the second half of 2021.

    Dr. Klaus Paulini, Chief Executive Officer of Aeterna commented, "This represents a significant milestone in our ongoing business development strategy to expand our international distribution network for macimorelin. We are pleased to add such a well-respected company as Megapharm to our marketing partners for macimorelin for the diagnosis of AGHD and CGHD and look forward to working with them."

    Miron Drucker, CEO of Megapharm, said, "Macimorelin has demonstrated potential in assessing growth hormone deficiencies in both adults and children. We are proud to establish this agreement with Aeterna Zentaris to bring macimorelin to Israel and the Palestinian Authority."

    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 macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency. Macrilen™ has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. 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. 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, 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.

    About Megapharm Ltd.

    Megapharm Ltd. is a leading Israeli private pharma marketing company, founded in 1989, exclusively representing a number of major American, European and Japanese pharmaceutical companies. Megapharm provides its partners with a full set of commercial capabilities, including registration, market access and sales and marketing. Megapharm has demonstrated dynamic sales growth by developing a strong company presence and expertise in selected therapeutic areas (i.e. Oncology, Hematology, CNS, Orphan and metabolic drugs) and a proven track record for obtaining national reimbursement and inclusion of its products in Health Funds in Israel. Additional information can be found at: www.megapharm.co.il.

    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 intended use of proceeds 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 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:

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  29. CHARLESTON, S.C., June 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 that it has regained compliance with the minimum bid price for continued listing on the Nasdaq Capital Market, as the closing bid price of the Company's common stock has been at $1.00 or greater for 10 consecutive trading days.

    On April 8, 2020, the Company received notice that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by Nasdaq. Now that the Company has regained compliance with this listing rule, Nasdaq has advised the Company…

    CHARLESTON, S.C., June 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 that it has regained compliance with the minimum bid price for continued listing on the Nasdaq Capital Market, as the closing bid price of the Company's common stock has been at $1.00 or greater for 10 consecutive trading days.

    On April 8, 2020, the Company received notice that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by Nasdaq. Now that the Company has regained compliance with this listing rule, Nasdaq has advised the Company that this matter is now closed.

    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 intended use of proceeds 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 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:

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  30. CHARLESTON, S.C., June 04, 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 the Company has received a positive decision from the staff of the Listing Qualifications Department of The Nasdaq Stock Market LLC (the "Staff"), granting the Company's request for an extension through October 5, 2020 to achieve compliance with the minimum $2.5 million stockholders‘ equity requirement for continued listing on The Nasdaq Capital Market. The Staff's determination followed the Company's submission of its compliance plan for the Staff's consideration on May 26, 2020. 

    The Company is pursuing…

    CHARLESTON, S.C., June 04, 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 the Company has received a positive decision from the staff of the Listing Qualifications Department of The Nasdaq Stock Market LLC (the "Staff"), granting the Company's request for an extension through October 5, 2020 to achieve compliance with the minimum $2.5 million stockholders‘ equity requirement for continued listing on The Nasdaq Capital Market. The Staff's determination followed the Company's submission of its compliance plan for the Staff's consideration on May 26, 2020. 

    The Company is pursuing a number of initiatives to increase stockholders‘ equity, the completion of which are expected to enable it to achieve compliance with the minimum stockholders' equity requirement by no later than October 5, 2020 and to thereafter maintain compliance with the listing requirements.

    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 intended use of proceeds 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 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:

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  31. CHARLESTON, S.C., May 15, 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 the results from its Annual General Meeting ("AGM") held today, May 15, 2020.

    The individuals noted below were elected as Directors of the Company. The report on proxies provided by the Company's transfer agent indicated the following:

    Name of Nominee Votes For % Votes Withheld %
    Pierre-Yves Desbiens 1,586,750 79.07 420,138 20.93
    Peter Edwards 1,626,648 81.05 380,240 18.95
    Carolyn Egbert 1,628,609 81.15 378,279 18.85
    Gilles Gagnon 1,624,133 80.93 382,755 19.07
    Klaus Paulini 1,587,796 79.12 419,092

    CHARLESTON, S.C., May 15, 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 the results from its Annual General Meeting ("AGM") held today, May 15, 2020.

    The individuals noted below were elected as Directors of the Company. The report on proxies provided by the Company's transfer agent indicated the following:

    Name of Nominee Votes For % Votes Withheld %
    Pierre-Yves Desbiens 1,586,750 79.07 420,138 20.93
    Peter Edwards 1,626,648 81.05 380,240 18.95
    Carolyn Egbert 1,628,609 81.15 378,279 18.85
    Gilles Gagnon 1,624,133 80.93 382,755 19.07
    Klaus Paulini 1,587,796 79.12 419,092 20.88

    The Company would like to welcome Peter Edwards to the Board of Directors.

    The Company would also like to extend its sincere thanks and best wishes to Gérard Limoges, Dr. Brent Norton, and Robin Smith Hoke who have been valued members of Aeterna's Board of Directors.

    The Company also reported the re-appointment of PricewaterhouseCoopers LLP as the Company's independent auditor.

    For full voting details please see the voting results of Aeterna Zentaris Inc. as filed on SEDAR at www.sedar.com and EDGAR at 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, 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 intended use of proceeds 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 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:

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  32. CHARLESTON, S.C., May 08, 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 its Annual General Meeting ("AGM") will be held on May 15, 2020 at 10:00 a.m. ET. Due to the impact of the COVID-19 pandemic, the meeting will be held virtually.

    Shareholders will not be able to attend the AGM in-person at a physical location. However, the platform for the virtual AGM will provide shareholders as of the close of business on April 1, 2020 the ability to listen to the AGM live, submit questions and submit their vote during the meeting.

    To be admitted to the virtual AGM, shareholders…

    CHARLESTON, S.C., May 08, 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 its Annual General Meeting ("AGM") will be held on May 15, 2020 at 10:00 a.m. ET. Due to the impact of the COVID-19 pandemic, the meeting will be held virtually.

    Shareholders will not be able to attend the AGM in-person at a physical location. However, the platform for the virtual AGM will provide shareholders as of the close of business on April 1, 2020 the ability to listen to the AGM live, submit questions and submit their vote during the meeting.

    To be admitted to the virtual AGM, shareholders need to visit www.virtualshareholdermeeting.com/AEZS2020 and enter the control number included on the proxy form or voting instruction form, as applicable. Online check-in will begin 15 minutes prior, at 9:45 a.m. ET. The AGM will begin promptly at 10:00 a.m. ET on May 15, 2020. If you are planning to attend the AGM, please refer to and observe the "Rules of Conduct and Procedures" available here.

    Aeterna Zentaris strongly encourages its shareholders to read its management proxy circular dated April 2, 2020 and other AGM materials carefully. If you are unable to attend the AGM or if you wish to vote in advance of the AGM, please carefully follow the instructions on the proxy or voting instruction form. Shareholders that hold their common shares with a bank, broker or financial intermediary that wish to vote at the AGM must carefully follow the instructions provided by their intermediary. In order to be effective, proxies must be received by the Chair of the AGM no later than 48 hours (if voting by mail) or 24 hours (if voting by telephone or Internet) prior to the close of business on the date of the AGM or any adjournment or postponement thereof. The time limit for the deposit of proxies may be waived by the Chair of the AGM without notice. If you are attending the AGM, please log-on to the virtual meeting in advance to ensure that your vote will be counted.

    Even if shareholders intend to attend the virtual AGM, it is strongly recommended that votes are made in advance by telephone or Internet to ensure that votes are received before the AGM. To cast your vote by telephone or Internet, please have your proxy card or voting instruction form in hand and carefully follow the instructions contained therein. Your telephone or Internet vote authorizes the named proxies to vote your common shares in the same manner as if you mark, sign and return your proxy card. If shareholders of record vote by mail, your vote must be received before 5:00 p.m. ET on May 13, 2020. If shareholders of record vote by telephone or Internet, your vote must be received before 5:00 p.m. ET on May 14, 2020.

    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 intended use of proceeds 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 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:

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  33. – First quarter marked by positive results from AEZS-130-P01 ("Study P01"), of macimorelin, providing clinical framework to advance pediatric investigation plan ("PIP") for macimorelin as a growth hormone deficiency diagnostic –

    – Planned safety and efficacy study AEZS-130-P02 ("Study P02") of macimorelin expected to commence in Q4 2020 –

    Advancing ongoing business development discussions to secure a commercialization partner for macimorelin in Europe and other key global markets –

    CHARLESTON, S.C., May 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…

    – First quarter marked by positive results from AEZS-130-P01 ("Study P01"), of macimorelin, providing clinical framework to advance pediatric investigation plan ("PIP") for macimorelin as a growth hormone deficiency diagnostic –

    – Planned safety and efficacy study AEZS-130-P02 ("Study P02") of macimorelin expected to commence in Q4 2020 –

    Advancing ongoing business development discussions to secure a commercialization partner for macimorelin in Europe and other key global markets –

    CHARLESTON, S.C., May 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 three months ended March 31, 2020.

    The Company also provided an update on its clinical program to develop macimorelin for the diagnosis of child-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.    

    Dr. Klaus Paulini, Chief Executive Officer of Aeterna commented, "Over the course of the first quarter, we made significant progress on clinical and corporate fronts. We successfully executed Study P01 in our clinical program to develop macimorelin for the diagnosis of CGHD, an area of significant unmet need. We are encouraged by the final results from the study, which demonstrated positive safety and tolerability data for use of macimorelin in CGHD. With these positive Study P01 results, we have the necessary data to lay the foundation for our test validation, Study P02, which we expect to commence later this year. Additionally, we were pleased to have received the decision from the EMA to accept a modification to our agreed pediatric investigation plan for macimorelin, ultimately supporting the development of one globally harmonized study protocol for Study P02, which will be accepted both in Europe and the United States of America."

    Dr Paulini concluded, "In tandem, we have continued to work alongside our U.S. and Canadian commercialization partner, Novo Nordisk, to raise awareness and position Macrilen™ (macimorelin) for the diagnosis of AGHD. We remain focused on advancing our business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets. We are pleased with the progress we have made over the first quarter and believe that 2020 holds significant potential for the advancement of macimorelin."

    Recent Highlights

    • Announced the decision of the European Medicines Agency ("EMA") to accept a modification request by Aeterna of the Company's 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;
    • Announced the positive results for the dose-finding pediatric study, Study P01, of macimorelin as a growth hormone stimulation test for the evaluation of CGHD; and
    • Closed a $4.5 million registered direct offering priced at-the-market (the "February 2020 Financing").

    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.   

    The Company recently announced positive results for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of CGHD. The dose-finding results from Study P01 provides the clinical framework to advance the Company's pediatric investigation plan for macimorelin as a growth hormone deficiency diagnostic. 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 were 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 electrocardiogram parameters and safety laboratory values were noted in any of the three dosing cohorts.

    The pharmacokinetic and pharmacodynamic profile of macimorelin proved to be in the expected range and in general comparable to data in adults.

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

    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.

    The Company is closely monitoring the evolving situation with coronavirus, or COVID-19, and is following guidance from health authorities. COVID-19 is affecting the global community and is adversely affecting our business operations, in a manner which at this time cannot be fully determined or quantified. The situation with COVID-19 is rapidly evolving and the impact of COVID-19, including travel and business restrictions, and other impediments to undertaking clinical studies, may significantly affect the Company's business, operations, results, projected timelines and market price for Aeterna's common shares. Aeterna has developed protocols and procedures should they be required to deal with any potential epidemics and pandemics and has implemented these protocols and procedures to address the current COVID-19 pandemic. Despite appropriate steps being taken to mitigate such risks, there can be no assurance that existing policies and procedures will ensure that the Company's operations will not be further adversely affected. For more information, please see the Risk Factor entitled, "The economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price of our Common Shares," in the Company's Annual Report on Form 20-F for the year ended December 31, 2019.

    Summary of First Quarter 2020 Financial Results

    All amounts are in U.S. dollars

    For the three-month period ended March 31, 2020, the Company reported a consolidated net income of $0.8 million, or $0.04 income per common share (basic), as compared with a consolidated net loss of $4.9 million, or $0.30 loss per common share (basic) for the three-month period ended March 31, 2019. The $5.7 million improvement in net results is primarily from a gain in fair value of warrant liability of $4.5 million and increase in revenues of $1.1 million.

    Revenues

    • The Company reported total revenue for the three-month period ended March 31, 2020 of $1.1 million as compared with $0.04 million for the same period in 2019, representing an increase of $1.06 million. The 2020 revenue was comprised of $0.01 million in royalty revenue (2019 - $0.01 million), $1.0 million in product sales of Macrilen™ (macimorelin) to Novo Nordisk (2019 - $nil), $0.04 million in supply chain revenue (2019 - $0.01 million) and $0.02 million in licensing revenue (2019 – $0.02 million). The product sales in 2020 represented sales of Macrilen™ (macimorelin) to Novo Nordisk.

    Operating Expenses

    • The Company reported total operating expenses for the three-month period ended March 31, 2020 of $2.4 million as compared with $3.0 million for the same period in 2019, representing a decrease of $0.6 million. This decrease arises primarily from a $0.5 million decline in general and administrative, a $0.2 million decline in research and development costs, a $0.2 million gain on modification of building lease, $0.3 million impact from impairment in right of use assets, $0.2 million impact in impairment of prepaid asset, and a $0.1 million decline in selling expenses, offset by a $0.9 million increase in cost of sales. 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. In the first quarter 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 Income

    • The Company reported net finance income for the three-month period ended March 31, 2020 of $2.1 million as compared with net finance costs of $2.0 million for the same period in 2019, representing an increase of $4.1 million. This is primarily due to a $4.5 million change in fair value of warrant liability offset by increased finance costs of $0.3 million from the February 2020 Financing and $0.1 million from changes in currency exchange rates. Such a non-cash change in fair value of warrant liability results from the periodic "mark-to-market" revaluation, which occurs through the application of the Company‘s pricing model, of Aeterna's outstanding share purchase 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 first quarter of 2020, as well as the Company's audited consolidated financial statements as of March 31, 2020, 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, 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.


    Condensed Consolidated Statements of Comprehensive Income (Loss)

      (in thousands of US dollars, except share and per share data)
         
        Three months ended
    March 31,
    (Unaudited)   2020       2019  
        $     $
    Revenues              
    Royalty income     14         13  
    Product sales     1,016          
    Supply chain     41         6  
    Licensing revenue     19         18  
    Total revenues     1,090         37  
    Operating expenses              
    Cost of sales     862          
    Research and development costs     319         528  
    General and administrative expenses     1,124         1,637  
    Selling expenses     248         304  
    Impairment of right of use asset             337  
    Modification of building lease     (185 )        
    Impairment of prepaid asset             169  
    Total operating expenses     2,368         2,975  
    Loss from operations     (1,278 )       (2,938 )
    (Loss) gain due to changes in foreign currency exchange rates      (104 )       64  
    Change in fair value of warrant liability     2,470         (2,061 )
    Other finance (costs) income     (309 )       24  
    Net finance income (costs)     2,057         (1,973 )
                   
    Net income (loss)     779         (4,911 )
    Other comprehensive income (loss):              
    Items that may be reclassified subsequently to profit or loss:              
    Foreign currency translation adjustments      210         84  
    Items that will not be reclassified to profit or loss:              
    Actuarial gain (loss) on defined benefit plans      1,388         (735 )
    Comprehensive income (loss)     2,377         (5,562 )
    Net income (loss) per share [basic]     0.04         (0.30 )
    Net income (loss) per share [diluted]     0.04         (0.30 )
    Weighted average number of shares outstanding:              
    Basic     21,523,416       16,440,760  
    Diluted     21,860,416       16,440,760  



    Condensed Consolidated Interim Statements of Financial Position

         
     

    (in thousands)
      As at March 31,
    2020

    (Unaudited)
      As at December 31,
    2019
        $   $
    Cash and cash equivalents   9,182     7,838  
    Trade and other receivables and other current assets   1,498     1,869  
    Inventory   367     1,203  
    Restricted cash equivalents   358     364  
    Property, plant and equipment   31     35  
    Right of use assets   288     582  
    Other non-current assets   7,917     8,090  
    Total assets   19,641     19,981  
    Payables and accrued liabilities and income taxes payable   2,293     3,596  
    Current portion of provision for restructuring and other costs   96     418  
    Current portion of deferred revenues   585     991  
    Lease liabilities   360     903  
    Warrant liability   2,110     2,255  
    Non-financial non-current liabilities (1)   12,510     14,281  
    Total liabilities   17,954     22,444  
    Shareholders' equity (deficiency)   1,687     (2,463 )
    Total liabilities and shareholders' equity (deficiency)   19,641     19,981  

    _________________________

    (1)  Comprised mainly of employee future benefits, provisions for restructuring and other costs and non-current portion of deferred revenues.


    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 intended use of proceeds 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 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:

     

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  34. CHARLESTON, S.C., April 15, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that on April 8, 2020, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the minimum $1.00 per share bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) as the bid price for the Company's common stock had closed below $1.00 per share for the prior 30 consecutive business day period, and that the Company has been provided a grace period of 180…

    CHARLESTON, S.C., April 15, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that on April 8, 2020, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the minimum $1.00 per share bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) as the bid price for the Company's common stock had closed below $1.00 per share for the prior 30 consecutive business day period, and that the Company has been provided a grace period of 180 calendar days, through October 5, 2020, to evidence compliance with that requirement. The grace period was granted pursuant to Nasdaq Listing Rule 5810(c)(3)(A). To evidence compliance with the bid price requirement, the Company must report a closing bid price of at least $1.00 per share for a minimum of 10, and generally not more than 20, consecutive business days on or before October 5, 2020.

    The Company was also notified that, based upon the net loss for the fiscal year ended December 31, 2019, the Company no longer satisfies the minimum net income requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(3) and does not otherwise satisfy the alternative requirements of market value of listed securities or stockholders' equity. The Company plans to timely submit its plan to regain compliance with Nasdaq Listing Rule 5550(b)(3) for the Staff‘s review within the 45-day window provided. The Staff has the discretion to grant the Company an extension of up to 180 days, through October 5, 2020, to evidence compliance with this requirement.

    Nasdaq's notice has no immediate effect on the listing of the Company's common shares on Nasdaq and does not otherwise impact the Company's listing on the Toronto Stock Exchange. In the event the Company does not evidence compliance with the Nasdaq Listing Rules within any prescribed period and is not otherwise eligible for additional time to do so, the Company would be subject to delisting from Nasdaq. In that event, the Company would have the right to request a hearing before a Nasdaq Hearings Panel, which request would stay any further action by the Staff pending such hearing.

    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 certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas
    JTC Team
    T (US): +1 (833) 475-8247
    E:

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  35. CHARLESTON, S.C., April 15, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris will present at the April 2020 Virtual Investor Summit on Thursday, April 23, 2020 at 10:00 AM ET.

    A live audio webcast of the presentation will be available on the Events and Presentations page of the Investors section of the Company's website (www.zentaris.com). Immediately following the presentation, management will participate in an interactive Q&A session with interested parties, allowing participants to type in questions…

    CHARLESTON, S.C., April 15, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris will present at the April 2020 Virtual Investor Summit on Thursday, April 23, 2020 at 10:00 AM ET.

    A live audio webcast of the presentation will be available on the Events and Presentations page of the Investors section of the Company's website (www.zentaris.com). Immediately following the presentation, management will participate in an interactive Q&A session with interested parties, allowing participants to type in questions and receive live responses. A webcast replay will be available two hours following the live presentation and will be accessible for one year.

    To schedule a one-on-one call with management, please contact the conference at and for more information, please visit virtualinvestorsummit.com.

    About Virtual Investor Summit

    The Virtual Investor Summit is an online platform that offers both public and private companies, across multiple industries the ability to stay active and engaged with the investment community. Our inaugural summit on April 22-23, 2020 will feature company webcast presentations followed by a virtual, interactive Q&A session, allowing participants to type in questions and receive live responses. Interested participants also have the ability to request one-on-one calls with a featured company. For more information, please visit virtualinvestorsummit.com.

    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 certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas
    JTC Team
    T (US): +1 (833) 475-8247
    E:

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  36. Access the event and schedule of presenting companies at virtualinvestorsummit.com

    Live audio webcast presentations and interactive Q&A

    Company presentations will be held from 10 AM-12 PM ET and 1 PM-3 PM ET on both days

    JTC Team ("JTC") and LaVoieHealthScience ("LHS"), today announced their partnership to host the April 2020 Virtual Investor Summit on April 22nd and 23rd from 10:00 AM - 12:00 PM ET and 1:00 PM - 3:00 PM ET on both days. The Virtual Investor Summit will feature public and private companies from multiple industries including life sciences/biotech, infrastructure and transportation. As part of the event, management teams will present a live audio webcast accompanied by a slide presentation and be available to participate…

    Access the event and schedule of presenting companies at virtualinvestorsummit.com

    Live audio webcast presentations and interactive Q&A

    Company presentations will be held from 10 AM-12 PM ET and 1 PM-3 PM ET on both days

    JTC Team ("JTC") and LaVoieHealthScience ("LHS"), today announced their partnership to host the April 2020 Virtual Investor Summit on April 22nd and 23rd from 10:00 AM - 12:00 PM ET and 1:00 PM - 3:00 PM ET on both days. The Virtual Investor Summit will feature public and private companies from multiple industries including life sciences/biotech, infrastructure and transportation. As part of the event, management teams will present a live audio webcast accompanied by a slide presentation and be available to participate in virtual Q&A sessions immediately following their presentation.

    Investors, media and interested parties can access the event schedule and individual company webcast details at the event website, virtualinvestorsummit.com.

    Public companies to present at the Virtual Investor Summit include:

    Aeterna Zentaris Inc. (NASDAQ:AEZS, TSX:AEZS), American Resources Corporation (NASDAQ:AREC), Ceapro Inc. (OTCQX:CRPOF, TSXV:CZO), Cocrystal Pharma Inc. (NASDAQ:COCP), Guardion Health Sciences, Inc. (NASDAQ:GHSI), Matinas BioPharma (NYSE AMER: MTNB), Outlook Therapeutics, Inc. (NASDAQ:OTLK), TFF Pharmaceuticals Inc. (NASDAQ:TFFP), and Xenetic Biosciences Inc. (NASDAQ:XBIO).

    Private companies to present include:

    Celavie Biosciences & Celavet, Inc., Charge, Inc., DeMelle OncoPharma, EuMentis Therapeutics, Omega Therapeutics and SIRION Biotech.

    For more information about the event, please visit the conference website at virtualinvestorsummit.com or contact .

    About JTC Team, LLC

    JTC is a fully integrated corporate communications firm that is dedicated to helping you tell your story to the right audiences in order to build awareness and achieve your goals. JTC was founded over 8 years ago and has developed a reputation of excellence for executing on robust communication strategies that deliver results. The Company's client roster over the years has included both public and private companies across the Life Sciences and Technology industries to help them establish and execute their corporate communications, raise awareness and build shareholder value. For more information, please visit www.jtcir.com or connect with the company on Twitter and LinkedIn.

    About LaVoieHealthScience

    LaVoieHealthScience partners with leading health and science brands to build value for their companies, attract capital and reach key stakeholders through integrated communications, access and marketing. The firm provides public relations, investor relations and strategic consulting to build recognition and increase sales and value for health science innovations. The agency has received over 50 awards in recognition of the work it has done for its health and science industry-leading clients and was inducted in the 2018 Inc. 5000 Hall of Fame List of Fastest Growing Private Companies, as well as ranked on the O'Dwyer's list of Healthcare Public Relations Firms. In January 2020, LHS and Omnicom Public Relations Group (OPRG), a division of Omnicom Group (NYSE:OMC), formed a strategic alliance to bring global clients a broader set of integrated health- and science-experienced teams.

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  37. – Modifications recommended for some key elements of planned safety and efficacy Study P02 –

    – Modifications to the outline of Study P02 requested to ensure a harmonized global study protocol complying with requirements from EMA as well as FDA –

    CHARLESTON, S.C., April 07, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the decision of the European Medicines Agency ("EMA") to accept a modification request by Aeterna Zentaris of the Company's Pediatric Investigation Plan ("PIP") for macimorelin as originally approved in March 2017 which covered the conduct of…

    – Modifications recommended for some key elements of planned safety and efficacy Study P02 –

    – Modifications to the outline of Study P02 requested to ensure a harmonized global study protocol complying with requirements from EMA as well as FDA –

    CHARLESTON, S.C., April 07, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the decision of the European Medicines Agency ("EMA") to accept a modification request by Aeterna Zentaris of the Company's Pediatric Investigation Plan ("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.

    The Company recently announced the positive results and successful completion of the first of these studies, Study P01. The goal of Study P01 was to 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.

    The second pediatric study, Study P02, is designed to investigate the diagnostic efficacy and safety of macimorelin acetate in pediatric patients from 2 years of age to 18 years of age with suspected growth hormone deficiency.

    "This EMA decision is an important milestone for us, as it supports the development of one globally harmonized study protocol for test validation - Study P02 - which will be accepted both in Europe and the United States of America," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris.

    "A request for modification of the PIP related to some of the key elements of Study P02 became necessary for Aeterna Zentaris, as we wanted to ensure that the study protocol will comply with expectations and requirements from both EMA as well as United States Food and Drug Administration.  This represents a very exciting advancement for our pediatric development program," commented, Dr. Nicola Ammer, Chief Medical Officer of Aeterna Zentaris.

    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 macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD"). Macrilen™ has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. 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 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 the Company's website at www.zentaris.com.

    Forward Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas

    JTC Team

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

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  38. – Positive results provide clinical framework to advance the Company's Pediatric Investigation Plan for macimorelin as a growth hormone deficiency diagnostic –

    – Pediatric PK/PD profile of macimorelin proved to be in the expected range and generally comparable to data in adults –

    – Planned safety and efficacy Study P02 expected to commence in Q4 2020 –

    CHARLESTON, S.C., April 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 announced positive results for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of child-onset growth hormone…

    – Positive results provide clinical framework to advance the Company's Pediatric Investigation Plan for macimorelin as a growth hormone deficiency diagnostic –

    – Pediatric PK/PD profile of macimorelin proved to be in the expected range and generally comparable to data in adults –

    – Planned safety and efficacy Study P02 expected to commence in Q4 2020 –

    CHARLESTON, S.C., April 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 announced positive results for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of child-onset growth hormone deficiency ("CGHD").

    This study, AEZS-130-P01 ("Study P01"), was the first of two studies as agreed with the European Medicines Agency ("EMA") in the Company's Pediatric Investigation Plan ("PIP") for macimorelin. The goal of Study P01 was to 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.

    "The completion of Study P01 is a noteworthy accomplishment in our pediatric development program for macimorelin. We are pleased with the final results of Study P01 which demonstrated positive safety and tolerability data for use of macimorelin in child-onset growth hormone deficiency. Furthermore, the PK/PD data observed are in the range as expected from the adult studies, which bolsters our confidence in the potential of macimorelin to address the significant market expansion opportunity. With the results from Study P01 in hand, we have the necessary data as a promising basis for test validation Study P02," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris.

    Study P01 was an international, multicenter study conducted in Hungary, Poland, Ukraine, Serbia, Belarus and Russia. In three cohorts comprising 8 subjects each, macimorelin doses of 0.25, 0.5 and 1.0 mg/kg body weight were investigated. In accordance with the study protocol, all enrolled patients completed four study visits after successful completion of the screening period. At Visit 1 and Visit 3, a provocative GH stimulation test was conducted according to the study sites' local practices. At Visit 2, the macimorelin test was performed: following the oral administration of the macimorelin solution, blood samples were taken at predefined times for PK/PD assessment. Visit 4 was a safety follow-up visit at study end.

    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.

    The pharmacokinetic and pharmacodynamic profile of macimorelin proved to be in the expected range and in general comparable to data in adults.

    "In Cohort 3, all eight subjects presented a prominent exposure to macimorelin in their PK data as well as growth hormone (GH) values above a threshold of 10ng/mL, which is the upper cut-off point in children for the pediatric GHSTs," commented, Dr. Nicola Ammer, Chief Medical Officer of Aeterna Zentaris. "Based on these data, and in line with faster metabolism in children, a macimorelin dose of 1.0 mg/kg was identified as the dose to be evaluated in the second study AEZS-130-P02 ("Study P02") on diagnostic efficacy and safety of macimorelin as GHD diagnostic in children."

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

    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 macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD"). Macrilen™ has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. 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 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 the Company's website at www.zentaris.com.

    Forward Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas
    JTC Team
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  39. Strengthened cash position with recently closed financing as well as royalty payments from Novo Nordisk for U.S. sales of Macrilen™ –

    Robust ongoing business development discussions to secure a commercialization partner for macimorelin in Europe and other key global markets –

    Leveraging clinical success of macimorelin for AGHD and expertise of Novo Nordisk in pediatric clinical development of macimorelin to address significant market opportunity –

    Closely monitoring COVID-19 and its impact on our business and operations –

    CHARLESTON, S.C., March 30, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and…

    Strengthened cash position with recently closed financing as well as royalty payments from Novo Nordisk for U.S. sales of Macrilen™ –

    Robust ongoing business development discussions to secure a commercialization partner for macimorelin in Europe and other key global markets –

    Leveraging clinical success of macimorelin for AGHD and expertise of Novo Nordisk in pediatric clinical development of macimorelin to address significant market opportunity –

    Closely monitoring COVID-19 and its impact on our business and operations –

    CHARLESTON, S.C., March 30, 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 fourth quarter and year ended December 31, 2019.

    The Company also provided an update on its clinical program to develop macimorelin for the diagnosis of child-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.    

    "We have been working diligently with our U.S. and Canadian commercialization partner, Novo Nordisk, to increase the awareness and access to Macrilen™ (macimorelin) for the diagnosis of AGHD and are pleased with the progress made in this regard over the fourth quarter of 2019. The inclusion of macimorelin in the American Association of Clinical Endocrinologists 2019 Guidelines was an important milestone that reflects the hard work of both teams and we intend to build on this momentum," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. "Additionally, our business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets remain ongoing."

    Recent Highlights

    • Closed $4.5 million registered direct offering priced at-the-market;
    • Announced the completion of patient recruitment in the AEZS-130-P01 ("Study P01") dose-finding pediatric study of macimorelin; and
    • Announced the inclusion of macimorelin in the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) 2019 Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning from Pediatric to Adult Care.

    Dr. Paulini continued, "We also see a significant opportunity in the use of macimorelin for the diagnosis of CGHD and with the upcoming results of the P01 study expected early next quarter, we believe we will be well positioned with a validated dose to move into our planned P02 study, an efficacy and safety registration study."

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

    Macimorelin

    The Company's lead product, macimorelin, is the only FDA approved oral drug indicated for the diagnosis of AGHD and is currently marketed in the United States 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.   

    Upcoming Anticipated Program Milestones

    • Announce results of CGHD dose-ranging study (AEZS-130-P01) in Q2 2020;
    • Commence CGHD safety and efficacy study (AEZS-130-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.

    The Company is closely monitoring the evolving situation with coronavirus, or COVID-19, and is following guidance from health authorities. COVID-10 is affecting the global community and is adversely affecting our business operations, in a manner which at this time cannot be fully determined or quantified. The situation with coronavirus is rapidly evolving and the impact of COVID-19, including travel and business restrictions, and other impediments to undertaking clinical studies, may significantly affect our business, operations, results, projected timelines and market price for our common shares. Like many of our peers, we have put into place a robust risk mitigation plan to ensure the safety of our employees, partners and community. For more information, please see the Risk Factor entitled "The economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price of our Common Shares" in our Annual Report on Form 20-F for the year ended December 31, 2019.

    Summary of Full Year 2019 Financial Results

    All amounts are in U.S. dollars

    For the twelve-month period ended December 31, 2019, the Company reported a consolidated net loss of $6.0 million, or $0.35 loss per common share (basic), as compared with a consolidated net income of $4.2 million, or $0.25 income per common share (basic), for the twelve-month period ended December 31, 2018. The $10.2 million decline in net results is primarily from a reduction of $26.3 million in revenue offset by $5.6 million in tax expense, $6.3 million decline in operating expenses, $2.8 million increase in net finance income and $1.4 million decline in settlements.

    Revenues

    • The Company reported total revenue for the twelve-month period ended December 31, 2019 of $0.5 million as compared with $26.9 million for the same period in 2018, representing a decline of $26.4 million. The decline in total revenue in 2019 relates primarily to the one-time $24.0 million cash payment received from executing the License Agreement in January 2018 and the initial delivery of Macrilen™ (macimorelin) to our licensee.

    Operating Expenses

    • The Company reported total operating expense for the twelve-month period ended December 31, 2019 of $10.8 million as compared with $17.0 million for the same period in 2018, representing a decrease of $6.2 million. This net decline arises primarily from a $2.3 million reduction in general and administration expenses, a $1.9 million reduction in selling costs, a $1.7 million decline in cost of sales and a $1.1 million reduction in research and development costs, offset by $0.5 million increase in restructuring costs, $0.02 million impairment in right to use asset[s] and $0.2 million write-off of other current assets.

    Net Finance Income

    • The Company reported net finance income for the twelve-month period ended December 31, 2019 of $4.0 million as compared with $1.2 million for the same period in 2018, representing an increase of $2.8 million. This is primarily due to a $4.3 million increase change in fair value of warrant liability, offset by a reduction in gain due to foreign currency exchange rates of $0.6 million and a $0.9 million increase in other finance costs.

    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 fourth quarter and fiscal 2019, as well as the Company's audited consolidated financial statements as at December 31, 2019, 2018 and for the years ended December 31, 2019, 2018 and 2017 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, 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. Aeterna Zentaris retains its 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 the Company's website at www.zentaris.com.

    Condensed Consolidated Statements of Comprehensive Loss Information

        Three months ended December 31,   Years ended December 31,
    (in thousands, except share and per share data)   2019   2018   2019   2018   2017
        $   $   $   $   $
    Revenues                    
    License fees   19     (332 )   74     24,325     458  
    Product sales       1,446     129     2,167      
    Royalty income   16     184     45     184      
    Sales commission               110     465  
    Supply chain   (17 )   94     284     95      
    Total revenues   18     1,392     532     26,881     923  
    Operating expenses                    
    Cost of sales   309     1,413     410     2,104      
    Research and development costs   263     767     1,837     2,932     10,704  
    General and administrative expenses   1,691     1,665     6,615     8,894     8,198  
    Selling expenses   38     588     1,214     3,109     5,095  
    Restructuring costs   (266 )       507          
    Impairment of right of use asset   (254 )       22          
    Write-off of other current assets           169          
    Total operating expenses   1,781     4,433     10,774     17,039     23,997  
    (Loss) income from operations   (1,763 )   (3,041 )   (10,242 )   9,842     (23,074 )
    Settlements       (1,400 )       (1,400 )    
    Gain due to changes in foreign currency exchange rates   26     64     87     656     502  
    Change in fair value of warrant liability   533     (1,489 )   4,518     263     2,222  
    Other finance (costs) income   10     104     (593 )   278     75  
    Net finance income (costs)   569     (1,321 )   4,012     1,197     2,799  
    (Loss) income before income taxes   (1,194   (5,762 )   (6,230 )   9,639     (20,275 )
    Income tax recovery (expense)   188     636     188     (5,452 )   3,479  
    Net (loss) income   (1,006 )   (5,126 )   (6,042 )   4,187     (16,796 )
    Other comprehensive (loss) income:                    
    Foreign currency translation adjustments   (268   (13 )   83     (260 )   (1,430  

    )
    Actuarial gain (loss) on defined benefit plans   959     (418 )   (1,068 )   193     694  
    Comprehensive (loss) income   (315   (5,557 )   (7,027 )   4,120     (17,532 )
    Net loss per share (basic)   (0.05   (0.31 )   (0.35 )   0.25     (1.12 )
    Net loss per share (diluted)   (0.05   (0.31 )   (0.35 )   0.24     (1.12 )

    Condensed Statement of Financial Position Information

        December 31,
    (in thousands)   2019   2018
        $   $
    Cash and cash equivalents   7,838       14,512  
    Trade and other receivables and other current assets   1,869       1,504  
    Inventory   1,203       240  
    Restricted cash equivalents   364       418  
    Property, plant and equipment   35       65  
    Right of use assets   582        
    Other non-current assets   8,090       8,272  
    Total assets   19,981       25,011  
    Payables and accrued liabilities and income taxes payable   3,596       4,635  
    Current portion of provision for restructuring and other costs   418       887  
    Current portion of deferred revenues   991       74  
    Lease liabilities   903        
    Warrant liability   2,255       3,634  
    Non-financial non-current liabilities (1)   14,281       13,874  
    Total liabilities   22,444       23,104  
    Shareholders' (deficiency) equity   (2,463 )     1,907  
    Total liabilities and shareholders' (deficiency) equity   19,981
          25,011  

    _________________________

    (1)Comprised mainly of employee future benefits, provisions for restructuring and other costs and non-current portion of deferred revenues.

    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 intended use of proceeds 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 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.

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  40. CHARLESTON, S.C., Feb. 12, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna, will present at NobleCon16 - Noble Capital Markets' 16th Annual Investor Conference on Monday, February 17th at 11:30 a.m. ET in Hollywood, Florida.

    As part of his presentation, Dr. Paulini will provide a corporate overview and update on the Company's lead product, Macrilen™ (macimorelin), the only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Dr. Paulini's slide…

    CHARLESTON, S.C., Feb. 12, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Dr. Klaus Paulini, Chief Executive Officer of Aeterna, will present at NobleCon16 - Noble Capital Markets' 16th Annual Investor Conference on Monday, February 17th at 11:30 a.m. ET in Hollywood, Florida.

    As part of his presentation, Dr. Paulini will provide a corporate overview and update on the Company's lead product, Macrilen™ (macimorelin), the only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Dr. Paulini's slide presentation will be made available on the Company's website on Monday, February 17th.

    In addition to the presentation, management will be available to participate in investor meetings with registered qualified investors attending the conference. To request a meeting, please contact the NobleCon16 one-on-one desk.

    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 pediatric growth hormone deficiency (PGHD), 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 the Company's website at www.zentaris.com.

    About Noble Capital Markets, Inc.

    Noble Capital Markets ("Noble") is a research driven boutique investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed broker dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the last decade. In 2018 Noble launched www.channelchek.com – a new investment community dedicated exclusively to small and micro-cap companies and their industries. Channelchek is tailored to meet the needs of self-directed investors and financial professionals. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 emerging growth companies are listed on the site, with growing content including webcasts, podcasts, and balanced news.

    Forward-Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas
    JTC Team
    T (US): +1 (833) 475-8247
    E:

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  41. – Study P01 is the first of two studies as agreed with the EMA in the Company's Pediatric Investigation Plan for macimorelin as a growth hormone deficiency diagnostic –

    – Study P01 final study results expected in Q2 2020 –

    CHARLESTON, S.C., Jan. 28, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, today announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of growth hormone deficiency ("GHD") in children. This study, AEZS-130-P01 ("Study P01"), is the first of two studies as agreed with the…

    – Study P01 is the first of two studies as agreed with the EMA in the Company's Pediatric Investigation Plan for macimorelin as a growth hormone deficiency diagnostic –

    – Study P01 final study results expected in Q2 2020 –

    CHARLESTON, S.C., Jan. 28, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, today announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of growth hormone deficiency ("GHD") in children. This study, AEZS-130-P01 ("Study P01"), is the first of two studies as agreed with the European Medicines Agency ("EMA") in the Company's Pediatric Investigation Plan ("PIP") for macimorelin.  Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.

    The goal of Study P01 is to establish a dose that can both be safely administered to pediatric patients and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD. The recommended dose derived from Study P01 will be evaluated in the pivotal second study AEZS-130-P02 on diagnostic efficacy and safety. Study P01 is an international, multicenter study which is being conducted in Hungary, Poland, Ukraine, Serbia, and Russia.

    Dr. Nicola Ammer, Chief Medical Officer of Aeterna, commented, "We are pleased to have completed patient recruitment in this important study for the pediatric development of macimorelin. In all dosing cohorts of Study P01, macimorelin administration was completed safely at the end of December 2019."

    Study P01 is an open label, group comparison, dose escalation trial designed to investigate the safety, tolerability, and pharmacokinetic/pharmacodynamic ("PK/PD") of macimorelin acetate after ascending single oral doses of macimorelin at 0.25, 0.5, and 1.0 mg per kg body weight in pediatric patients from 2 to less than 18 years of age with suspected GHD. The Company enrolled a total of 24 pediatric patients across the three cohorts of the study.

    "The completion of patient recruitment in Study P01 represents a significant milestone and an important step in the pediatric development of macimorelin in this important patient population. We are looking forward to the successful completion of Study P01 and expect to report final results in the second quarter of 2020," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

    Per study protocol, all enrolled patients will complete four study visits after successful completion of the screening period. At Visit 1 and Visit 3, a provocative GH stimulation test will be conducted according to the study sites' local practices. At Visit 2, the macimorelin test will be performed: following the oral administration of the macimorelin solution, blood samples will be taken at predefined times for PK/PD assessment. Visit 4 is a safety follow-up visit at study end.

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

    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 macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD"). Macrilen™ has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. 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 engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements. Aeterna Zentaris is the licensor and party to a license and assignment agreement with Novo Nordisk A/S to carry out joint development, manufacturing, registration, regulatory, and supply chain for the commercialization of Macrilen™ (macimorelin), which is to be used in the diagnosis of patients with adult growth hormone deficiency in the United States and Canada. The clinical development of Macrilen™ (macimorelin) for pediatric use is ongoing. In addition, we are actively pursuing business development opportunities for macimorelin in the rest of the world and to monetize the value of our non-strategic assets. For more information, please visit the Company's website at www.zentaris.com.

    Forward Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Jenene Thomas
    JTC Team
    T (US): +1 (833) 475-8247
    E:

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  42. CHARLESTON, S.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, today announced that it has received notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq's minimum bid price for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) ("Bid Price Rule").

    On January 23, 2020, Aeterna received a letter from Nasdaq stating that because the Company's shares had a closing bid price at $1.00 per share or greater for a minimum of ten (10) consecutive business days, Aeterna's stock has regained compliance…

    CHARLESTON, S.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, today announced that it has received notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq's minimum bid price for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) ("Bid Price Rule").

    On January 23, 2020, Aeterna received a letter from Nasdaq stating that because the Company's shares had a closing bid price at $1.00 per share or greater for a minimum of ten (10) consecutive business days, Aeterna's stock has regained compliance with the Bid Price Rule. Nasdaq considers the matter closed.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements. Aeterna Zentaris is the licensor and party to a license and assignment agreement with Novo Nordisk A/S to carry out joint development, manufacturing, registration, regulatory, and supply chain for the commercialization of Macrilen™ (macimorelin), which is to be used in the diagnosis of patients with adult growth hormone deficiency in the United States and Canada. The clinical development of Macrilen™ (macimorelin) for pediatric use is ongoing. In addition, we are actively pursuing business development opportunities for macimorelin in the rest of the world and to monetize the value of our non-strategic assets. For more information, please visit the Company's website at www.zentaris.com.

    Forward Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential", "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor and Media Contact:

    Jenene Thomas
    JTC Team
    T (US): +1 (833) 475-8247
    E:

     

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  43. CHARLESTON, S.C., Oct. 04, 2019 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) today announced the appointment of Klaus Paulini as President and Chief Executive Officer of the Company, effective today, replacing Michael Ward. Dr. Paulini will also serve as a Director of the Company.

    Dr. Paulini will continue to be based in Frankfurt, Germany, and his appointment as President and Chief Executive Officer aligns with the Company's refocus on its operations in Germany. The Company's registered office will remain in Toronto, Ontario, Canada.

    Dr. Paulini began his career in the pharmaceutical industry at ASTA Medica AG in 1997. He had an active role in the spinoff and formation of Aeterna Zentaris GmbH from ASTA Medica. Dr. Paulini…

    CHARLESTON, S.C., Oct. 04, 2019 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) today announced the appointment of Klaus Paulini as President and Chief Executive Officer of the Company, effective today, replacing Michael Ward. Dr. Paulini will also serve as a Director of the Company.

    Dr. Paulini will continue to be based in Frankfurt, Germany, and his appointment as President and Chief Executive Officer aligns with the Company's refocus on its operations in Germany. The Company's registered office will remain in Toronto, Ontario, Canada.

    Dr. Paulini began his career in the pharmaceutical industry at ASTA Medica AG in 1997. He had an active role in the spinoff and formation of Aeterna Zentaris GmbH from ASTA Medica. Dr. Paulini has managed many of the Company's clinical development projects including research and development of Macrilen™ (macimorelin). Dr. Paulini obtained his PhD (Dr. Ing.) in chemistry at the Technical University Darmstadt (Germany) in 1993 and specialized in medicinal chemistry and drug discovery during subsequent postdoctoral fellowships at Strathclyde University (Glasgow, Scotland) and J.W. Goethe University (Frankfurt, Germany).

    The board of directors of the Company thanks Mr. Ward for his contribution to the Company and wishes him all the best in the future.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements. Aeterna Zentaris is the licensor and party to a license and assignment agreement with Novo Nordisk A/S to carry out development, manufacturing, registration, regulatory, and supply chain for the commercialization of Macrilen™ (macimorelin), which is to be used in the diagnosis of patients with adult growth hormone deficiency in the United States and Canada. In addition, we are actively pursuing business development opportunities for macimorelin in the rest of the world and to monetize the value of our non-strategic assets.

    Contact:
    Leslie Auld
    Chief Financial Officer
    Aeterna Zentaris Inc.

    (843) 900-3211

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