AEZS Aeterna Zentaris Inc.

0.37
0  -1%
Previous Close 0.37
Open 0.37
52 Week Low 0.34
52 Week High 1.67
Market Cap $23,053,194
Shares 53,482,263
Float 16,436,292
Enterprise Value $7,607,157
Volume 1,269,999
Av. Daily Volume 4,620,989
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Drug Pipeline

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

Latest News

  1. 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

    E:

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  2. - 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:

    Primary Logo

    View Full Article Hide Full Article
  3. - PK and PD profiles of macimorelin for pediatric use were within the expected range and comparable to results observed in adults -

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

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

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

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

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

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

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

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

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

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

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

    About e-ECE 2020

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

    About Macimorelin

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

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

    About Aeterna Zentaris Inc.

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

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

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

    Forward-Looking Statements

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

    Investor Contact:

    Jenene Thomas

    JTC Team

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

    E:

    Primary Logo

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  4.  – 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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  5. 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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