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Aeterna Zentaris(AEZS) - 2025 Q4 - Annual Report
2026-03-25 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ Registration Statement Pursuant to Section 12(b) or 12(g) of The Securities Exchange Act of 1934 OR ☒ Annual Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 for the fiscal year ended December 31, 2025 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 OR ☐ Shell Company Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Commis ...
Aeterna Zentaris(AEZS) - 2024 Q4 - Annual Report
2025-04-09 21:29
Company Formation and Structure - COSCIENS Biopharma Inc. was formed following the all-stock merger of Aeterna Zentaris Inc. and Ceapro Inc. on June 3, 2024, with the name change effective August 6, 2024[232][249]. - The merger resulted in former shareholders of Ceapro and Aeterna each owning approximately 50% of the common shares on a fully diluted basis[246]. - The Company reported that its common shares are listed on both Nasdaq and TSX under the symbol "CSCI"[233]. Financial Performance - Total revenue for the three-month period ended December 31, 2024, was $3.3 million, a 174% increase from $1.2 million in the same period in 2023[269]. - Total revenue for the twelve-month period ended December 31, 2024, was $9.6 million, a 34% increase from $7.1 million in 2023[270]. - Gross margin for the three-month period ended December 31, 2024, was $2.0 million, representing a 1,294% increase from $0.1 million in the same period in 2023[269]. - Gross margin for the twelve-month period ended December 31, 2024, was $4.7 million, a 61% increase from $2.9 million in 2023[270]. - The company reported a net loss of $6.7 million for the three months ended December 31, 2024, compared to a net loss of $1.6 million in the same period in 2023[268]. - Total revenue for the twelve-month period ended December 31, 2023, was $7.1 million, a decrease of $7.4 million or 51% compared to $14.5 million in 2022[272]. - Gross margin for the twelve-month period ended December 31, 2023, was $2.9 million, representing a gross margin percentage of 41%, down from 59% in 2022[272]. - Consolidated net loss for the three-month period ended December 31, 2024, was $6.7 million, compared to a net loss of $1.6 million in the same period in 2023, representing an increase of $5.1 million[290]. - The company recorded a $3.195 million impairment on macimorelin patent intangible assets during the year ended December 31, 2024, due to the failure of the Phase 3 DETECT-trial[283]. - Impairment loss of $1.061 million was recognized for certain manufacturing equipment and leasehold improvements during the year ended December 31, 2024[284]. - Net other income for the twelve-month period ended December 31, 2024, was $3.1 million, an increase of $2.8 million compared to $0.3 million in 2023[286]. Research and Development - The Phase 3 DETECT-trial for macimorelin failed to meet its primary endpoints, leading to a strategic review and discontinuation of investment in related pre-clinical programs[244]. - The Company has initiated a strategic review of its pipeline, including exploring potential divestment of macimorelin[244]. - Avenanthramides are being developed for potential applications in inflammation-based diseases, with a Phase 1 safety study initiated in November 2023[266]. - The company has established a clinical and pre-clinical development pipeline for pharmaceutical therapeutic assets addressing unmet medical needs[262]. - The company made a strategic decision to discontinue its AIM Biological, ALS, and Delayed Clearance Parathyroid Hormone programs due to challenging timelines and costs[263]. - Direct research and development expenses for avenanthramides for inflammation-based diseases increased by 274% to $2.149 million for the twelve-month period ended December 31, 2024, compared to $0.575 million in 2023[274]. - Research and development expenses for the three-month period ended December 31, 2024, were $2.9 million, an increase of $2.4 million or 494% compared to $0.5 million in 2023[274]. - Research and development costs rose by $6.3 million primarily due to increased costs associated with the avenanthramides and DETECT clinical trials[291]. Strategic Initiatives - COSCIENS focuses on the extraction and commercialization of active ingredients, particularly oat beta glucan and avenanthramides, which are used in various cosmetic and personal care products[243]. - The company is targeting the commercial launch of a chewable oat beta glucan product for cholesterol reduction in the first half of 2025[256]. - The company commenced a collaboration with NATEX Prozesstechnologie GesmbH to scale up PGX Technology, expected to complete in Q2 2025 in Austria[254]. - The Company’s proprietary PGX technology is aimed at generating high-value yields of active ingredients from natural resources for use in various product markets[243]. Management and Governance - Management is actively seeking a new President and CEO to lead COSCIENS forward following the initial integration of the merger[251]. Financial Position and Cash Flow - Cash and cash equivalents at the end of the period were $16,393,000, up from $6,678,000 at the end of December 2023[295]. - Total assets increased to $35,070,000 as of December 31, 2024, compared to $23,745,000 as of December 31, 2023[295]. - The company reported a net cash used in operating activities of $(14,568,000) for the twelve months ended December 31, 2024, compared to $(2,582,000) for the same period in 2023[298]. - Cash provided by investing activities totaled $25,083,000 for the year ended December 31, 2024, compared to cash used of $(730,000) in the same period in 2023[301]. - The company had an accumulated deficit of $12,100,000 and a net loss of $15,300,000 as of December 31, 2024[306]. - The company plans to finance future operations primarily through product sales and existing cash on hand, which is expected to be sufficient for at least the next 12 months[306]. Risks and Uncertainties - The Company has noted risks that may materially affect its business, including those described in the "Risk Factors" section of the Annual Report[315]. - The Company is exposed to foreign exchange risk due to investments in foreign operations with a functional currency of the Canadian Dollar[588]. - The Company manages liquidity risk by monitoring rolling forecasts of cash and cash equivalents based on expected cash flows[586]. - Credit risk exposure is primarily related to financial assets at amortized cost, with ongoing credit reviews performed for all customers[583]. - The Company has provided for all outstanding and unpaid amounts relating to its operations as of December 31, 2024[583]. - The financial assets at amortized cost include cash and cash equivalents, trade and other receivables, and restricted cash equivalents[585]. - One counterparty comprised 75% of total receivables as of December 31, 2024, compared to 40% in 2023, with no amounts past due[582]. - The Company does not have any interests in special purpose entities or off-balance sheet arrangements as of December 31, 2024[314].
Aeterna Zentaris(AEZS) - 2024 Q2 - Quarterly Report
2024-08-13 12:05
Financial Performance - As of June 30, 2024, COSCIENS Biopharma Inc. reported total assets of $50,045,000, a significant increase from $23,745,000 as of December 31, 2023, representing a growth of 110.5%[2] - The company achieved revenues of $4,394,000 for the six months ended June 30, 2024, compared to $3,977,000 for the same period in 2023, reflecting a year-over-year increase of 10.5%[5] - The net loss for the six months ended June 30, 2024, was $2,823,000, compared to a net loss of $1,145,000 for the same period in 2023, indicating a deterioration in performance[5] - The company reported a comprehensive loss of $3,329,000 for the six months ended June 30, 2024, compared to a comprehensive loss of $599,000 for the same period in 2023[5] - Revenue for the three months ended June 30, 2024, was $2,337,000, compared to $1,392,000 for the same period in 2023, representing a 67.9% increase[40] - For the six months ended June 30, 2024, total revenue was $4,394,000, representing a 10.5% increase from $3,977,000 in the same period of 2023[75] - The gross margin for the Active ingredient segment was $820,000 for the three months ended June 30, 2024, compared to $797,000 in the same period of 2023, indicating a slight increase of 2.9%[74] - Gross margin for the six months ended June 30, 2024, was $1,723,000, a decrease of 13.2% compared to $1,985,000 in 2023[75] - The loss from operations for the six months ended June 30, 2024, was $5,579,000, compared to a loss of $1,482,000 in the same period of 2023[75] Assets and Liabilities - Cash and cash equivalents increased to $27,804,000 as of June 30, 2024, from $6,678,000 at the beginning of the year, marking a rise of 316.5%[2] - The company’s total liabilities rose to $23,818,000 as of June 30, 2024, up from $2,710,000 at the end of 2023, an increase of 775.3%[2] - The deferred revenue balance as of June 30, 2024, totaled $1,710,000, with $97,000 classified as current and $1,613,000 as non-current[43] - Trade accounts payable surged to $3,585,000 as of June 30, 2024, compared to $281,000 at the end of 2023, marking a significant increase[54] - Employee future benefit obligations decreased to $21,879,000 as of June 30, 2024, down from $22,136,000 at the beginning of the period[55] - The carrying amount of property and equipment as of June 30, 2024, was $21,692,000, reflecting an increase from $21,449,000 at the end of 2023[47] Acquisition and Market Presence - COSCIENS Biopharma Inc. completed the acquisition of Aeterna Zentaris Inc. on June 3, 2024, which is expected to enhance its product portfolio and market presence[12] - Ceapro acquired Aeterna Zentaris Inc. on June 3, 2024, with a total consideration of $13,262,000, including shares and warrants[30] - Aeterna contributed revenue of $3,000 and a net loss of $214,000 to Ceapro's results post-acquisition[37] - If the acquisition had occurred on January 1, 2024, estimated revenue would have been $4,399,000, with a consolidated net loss of $12,035,000 for the year[37] - The fair value of shares deemed issued to Aeterna shareholders was $8,485,000, based on a share price of $6.99[34] - Acquisition-related costs incurred by Ceapro amounted to $4,081,000, included in selling, general and administrative expenses[39] - The identifiable intangible assets from the acquisition consist of patents expiring between 2027 and 2041, valued using discounted cash flow models[37] - The transaction was accounted for as a reverse acquisition, with Ceapro as the accounting acquirer[32] Research and Development - Research and development expenses for the six months ended June 30, 2024, were $2,592,000, compared to $1,115,000 for the same period in 2023, reflecting an increase of 132.5%[5] Stock and Shareholder Information - The weighted average number of shares outstanding increased to 2,033,539 for the six months ended June 30, 2024, compared to 1,846,759 for the same period in 2023, indicating a dilution effect from the acquisition[5] - The balance of common shares increased to 3,061,560 as of June 30, 2024, from 1,847,593 as of December 31, 2023, reflecting a growth of 65.5%[59] - The company had 747,948 warrants outstanding as of June 30, 2024, with a weighted average exercise price of $13.32[11] - The total stock options balance increased to 80,878 as of June 30, 2024, from 74,371 at the beginning of the year, reflecting a growth of 8.5%[62] - The expected volatility for stock options was 65% as of June 30, 2024, indicating a stable outlook based on historical rates[60] Revenue Sources and Commitments - The company’s revenue is generated from supply and licensing agreements for finished goods, semi-finished goods, and active pharmaceutical ingredients[23] - The company has significant commitments under contracted supply agreements totaling $4,406,000, with $4,352,000 due within one year[76] - The company may have to pay up to $38,573,000 upon achieving certain sales volumes and regulatory milestones related to specific products[76] - The company has entered into license agreements requiring annual royalty payments of 2.0% on specific avenanthramides sales and up to 3.5% on PGX sales[77] - A purchase commitment of $678,000 remains for the construction of a PGX-100 pilot plant, expected to be completed in 2024[78]
Aeterna Zentaris Inc. Announces Name Change to COSCIENS Biopharma Inc.
Newsfilter· 2024-08-06 22:00
Company Overview - COSCIENS Biopharma Inc. is a specialty biopharmaceutical company focused on developing and commercializing a diverse portfolio of pharmaceutical and diagnostic products for healthcare and cosmetics industries [4] - The company has a lead product, macimorelin (Macrilen; Ghryvelin), which is the first and only FDA and European Commission approved oral test for diagnosing adult growth hormone deficiency [4] Name Change Announcement - The company has officially changed its name from Aeterna Zentaris Inc. to COSCIENS Biopharma Inc. effective August 6, 2024 [1] - The common shares will begin trading under the new symbol "CSCI" on the Toronto Stock Exchange and NASDAQ effective August 9, 2024, ceasing to trade under the former symbol "AEZS" [1][2] Shareholder Information - The name change was approved by shareholders at the annual general and special meeting held on July 16, 2024, and is subject to final approval from TSX and NASDAQ [2] - There will be no change in the company's capitalization, and existing shareholders or warrantholders will not need to take any action regarding the name change [2] New Identifiers - The new CUSIP number for the common shares is 22112H101, and the new ISIN is CA22112H1010 [3] - The new CUSIP number for the warrants is 22112H119, and the new ISIN for the warrants is CA22112H1192 [3]
Aeterna Zentaris Inc. Announces Name Change to COSCIENS Biopharma Inc.
GlobeNewswire News Room· 2024-08-06 22:00
Core Points - COSCIENS Biopharma Inc. has officially changed its name from Aeterna Zentaris Inc. effective August 6, 2024 [1] - The company's common shares will begin trading under the new symbol "CSCI" on the TSX and NASDAQ starting August 9, 2024, ceasing to trade under the previous symbol "AEZS" [1][2] - The name change was approved by shareholders at the annual general meeting held on July 16, 2024, and is subject to final approval from the TSX and NASDAQ [2] Company Overview - COSCIENS is a specialty biopharmaceutical company focused on developing and commercializing a diverse portfolio of pharmaceutical and diagnostic products, addressing significant unmet medical needs [4] - One of the lead products is macimorelin (Macrilen; Ghryvelin), the first and only FDA and European Commission approved oral test for diagnosing adult growth hormone deficiency [4] - The company is also developing therapeutic assets and proprietary extraction technology for producing active ingredients from renewable plant resources, which are used in cosmeceutical products [4] Trading Information - The new CUSIP number for the common shares is 22112H101, and the new ISIN is CA22112H1010; for the warrants, the new CUSIP is 22112H119 and the new ISIN is CA22112H1192 [3]
Aeterna Zentaris Announces Results of Virtual 2024 Meeting of Shareholders
GlobeNewswire News Room· 2024-07-16 20:05
Core Points - Aeterna Zentaris Inc. held its virtual annual general and special meeting of shareholders (AGSM) on July 16, 2024, where voting results for the election of directors were announced [1] - The company will change its name to COSCIENS Biopharma Inc. in the coming weeks following the approval of the Name Change Resolution at the AGSM [3] Voting Results - Ronald W. Miller was re-elected as Chair with 668,451 votes (84.64% for) [2] - Carolyn Egbert received 491,197 votes (62.20% for) but faced significant opposition with 298,534 votes against [2] - Geneviève Foster was re-elected with 667,668 votes (84.54% for) [2] - Gilles Gagnon received only 404,154 votes (51.18% for), indicating a close call for his re-election [2] - Ulrich Kosciessa was re-elected with 638,832 votes (80.89% for) [2] - William Li was re-elected with 670,416 votes (84.89% for) [2] - Dennis Turpin, despite not receiving a majority, will continue on the board for 90 days to ensure a smooth transition [2] Company Developments - Peter G. Edwards resigned prior to the AGSM, leading to a nomination of seven directors instead of eight [3] - Deloitte LLP was appointed as the company's auditor during the AGSM [3] - The company is classified as an "Eligible Interlisted Issuer," allowing it to bypass certain Canadian requirements regarding its long-term incentive plan [4] Company Overview - Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing pharmaceutical and diagnostic products, including macimorelin, the first FDA and European Commission approved oral test for adult growth hormone deficiency [5] - The company also develops active ingredients from renewable plant resources for use in cosmeceutical products [5] - Aeterna is listed on both NASDAQ and the Toronto Stock Exchange under the ticker symbol "AEZS" [6]
Aeterna Zentaris Announces Results of Virtual 2024 Meeting of Shareholders
Newsfilter· 2024-07-16 20:05
Core Points - Aeterna Zentaris Inc. held its virtual annual general and special meeting of shareholders (AGSM) on July 16, 2024, where voting results for the election of directors were announced [1] - The company will change its name to COSCIENS Biopharma Inc. in the coming weeks following the approval of the Name Change Resolution at the AGSM [3] Voting Results - Ronald W. Miller was re-elected as Chair with 668,451 votes (84.64% for) [2] - Carolyn Egbert received 491,197 votes (62.20% for) but faced significant opposition with 298,534 votes against [2] - Geneviève Foster was re-elected with 667,668 votes (84.54% for) [2] - Gilles Gagnon received only 404,154 votes (51.18% for), indicating a close call for his re-election [2] - Ulrich Kosciessa was re-elected with 638,832 votes (80.89% for) [2] - William Li was re-elected with 670,416 votes (84.89% for) [2] - Dennis Turpin, despite not receiving a majority (300,528 votes or 38.05% for), will continue on the board for 90 days to ensure a smooth transition [2] Company Developments - Peter G. Edwards resigned prior to the AGSM, leading to a reduction in the number of nominated directors from eight to seven [3] - Deloitte LLP was appointed as the new auditor for the company [3] - The company is classified as an "Eligible Interlisted Issuer," allowing it to bypass certain Canadian requirements regarding its long-term incentive plan [4] Company Overview - Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing pharmaceutical and diagnostic products, including macimorelin, the first FDA and European Commission approved oral test for adult growth hormone deficiency [5] - The company also develops active ingredients from renewable plant resources for use in cosmeceutical products [5] - Aeterna is listed on both NASDAQ and the Toronto Stock Exchange under the ticker symbol "AEZS" [6]
Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency
GlobeNewswire News Room· 2024-06-13 13:10
Core Viewpoint - Aeterna Zentaris Inc. has completed its Phase 3 DETECT-trial for macimorelin, aimed at diagnosing Childhood Onset Growth Hormone Deficiency (CGHD), and expects to report top-line data in Q3 2024 [1][2][3] Company Overview - Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing a diverse portfolio of pharmaceutical and diagnostic products, including macimorelin for growth hormone deficiency [1][7] - Macimorelin is the first and only FDA and European Commission approved oral test for diagnosing adult growth hormone deficiency (AGHD) [5][7] Clinical Trial Details - The DETECT-trial is a multicenter, open-label study that enrolled 100 subjects across Europe and North America to evaluate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test in pediatric patients [2][3] - The trial's completion is a significant milestone, expanding the market for macimorelin in endocrinology and providing a diagnostic tool for children [3] Future Expectations - The company anticipates presenting top-line data and full study results from the DETECT-trial in the third quarter of 2024 [1][3]
Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency
Newsfilter· 2024-06-13 13:10
Core Insights - Aeterna Zentaris Inc. has completed its Phase 3 safety and efficacy study (DETECT-trial) for macimorelin, aimed at diagnosing Childhood Onset Growth Hormone Deficiency (CGHD) [1][2][3] - The company plans to report top-line data and complete study results in Q3 2024 [1][2] Company Overview - Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing a diverse portfolio of pharmaceutical and diagnostic products [7] - One of its lead products, macimorelin, is the first and only FDA and European Commission approved oral test for diagnosing adult growth hormone deficiency (AGHD) [7] Study Details - The DETECT-trial is a multicenter, open-label trial that enrolled 100 subjects in Europe and North America, testing a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test [2][3] - This trial is the second and final study required for evaluating macimorelin's use as a diagnostic test in children, as per agreements with the FDA and EMA [3] Product Information - Macimorelin (Macrilen®; GHRYVELIN™) is an oral drug that stimulates growth hormone secretion from the pituitary gland and is used for diagnosing AGHD [5][6] - The drug was approved by the FDA in 2017 and by the EMEA in 2019, demonstrating accuracy comparable to standard insulin tolerance testing but with a better safety profile [6]
Aeterna Zentaris and Ceapro Complete Merger Transaction
Newsfilter· 2024-06-03 13:15
Core Viewpoint - Aeterna Zentaris Inc. and Ceapro Inc. have successfully completed an all-stock merger, creating a diversified biopharmaceutical company expected to generate long-term value for shareholders [1][2]. Group 1: Merger Details - The merger was officially announced on December 14, 2023, and has now been completed, marking a significant milestone for both companies [1]. - The new combined company aims to leverage shared resources and competencies to enhance its product development pipeline and revenue-generating capabilities [1][2]. Group 2: Financial and Operational Benefits - The merger is expected to provide greater potential for stable cash flow, which will support research and development of high-return pharmaceutical products [1]. - The company currently generates revenue from two main active ingredients, oat beta glucan and avenanthramides, which will be utilized to fund the development of new products [1]. - A diversified product pipeline is anticipated to lower risk and enhance the company's ability to focus resources effectively [1][2]. Group 3: Expanded Capabilities - The combined company will benefit from expanded pharmaceutical research and development capabilities, with a talented team bringing deep expertise to advance the development pipeline [2]. - The operational presence in both North America and Europe will allow the company to optimize its focus on the North American biotechnology market [2]. Group 4: Leadership and Governance - Following the merger, Aeterna's board of directors now consists of eight members, including Ronald W. Miller as Chair and Gilles Gagnon as CEO [3]. - The executive leadership team is committed to prioritizing the development pipeline to maximize potential for the company and its stakeholders [2]. Group 5: Shareholder Information - Former Ceapro shareholders will receive 0.02360 of an Aeterna share for each Ceapro share held, with specific instructions provided for the exchange process [6][7]. - Ceapro shares are expected to be delisted from the TSX Venture Exchange within five business days following the merger [5].