Aeterna Zentaris(AEZS)
Search documents
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].
Aeterna Zentaris Provides Update on Timing for Annual Meeting of Shareholders and Due Bill Redemption Date
globenewswire.com· 2024-05-29 22:35
Core Viewpoint - Aeterna Zentaris Inc. is seeking a court order to extend the deadline for holding its annual shareholder meeting to no later than July 31, 2024, to allow former Ceapro Inc. shareholders to participate in the meeting and vote on key matters related to the upcoming merger [1][2]. Group 1: Court Application and Meeting Details - The application for the extension will be heard on June 3, 2024, at 11:00 a.m. via videoconference [1]. - Aeterna has received an extension from the Toronto Stock Exchange to hold its annual meeting by July 31, 2024 [3]. - The annual meeting will include votes on the new name and director nominees for the combined company following the transaction with Ceapro [2]. Group 2: Transaction with Ceapro Inc. - Aeterna is in the process of completing a transaction with Ceapro Inc., which is expected to close around June 3, 2024, subject to necessary approvals [2]. - The extension is aimed at ensuring that former Ceapro shareholders can attend and vote at the annual meeting [2]. Group 3: Company Overview - Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing a diverse portfolio of pharmaceutical and diagnostic products [4]. - The company's lead product, macimorelin, is the first FDA and European Commission approved oral test for diagnosing adult growth hormone deficiency [4]. - Aeterna is also developing therapeutic assets for various conditions, including neuromyelitis optica spectrum disorder, Parkinson's disease, hypoparathyroidism, and amyotrophic lateral sclerosis [5].