Reconstituted Board to Revitalize COSCIENS TORONTO, May 30, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI; TSX: CSCI) today announced that it has entered into a resolution agreement (the “Resolution Agreement”) with Goodwood Inc., Goodwood Fund and Puccetti Funds Management Inc. (collectively, “Goodwood”) to resolve matters relating to the upcoming annual and special meeting of COSCIENS’ shareholders that had been scheduled to be held on June 26, 2025 (the “2025 Annual Meeting”). Pursuant t ...

Core Viewpoint - COSCIENS Biopharma Inc. has received director nominations from Goodwood Fund and Puccetti Funds Management Inc. for its upcoming Annual and Special Meeting of Shareholders, indicating potential changes in governance and strategic direction [1][2]. Company Overview - COSCIENS Biopharma Inc. is a life sciences company focused on developing and commercializing a diverse range of cosmeceutical, nutraceutical, and pharmaceutical products, utilizing proprietary extraction technology from renewable plant resources [3]. - The company's product portfolio includes macimorelin (Macrilen®; Ghryvelin®), which is the first and only FDA and EMA approved oral test for diagnosing adult growth hormone deficiency [3]. Market Position - COSCIENS is publicly traded on both the NASDAQ Capital Market and the Toronto Stock Exchange under the ticker symbol "CSCI" [4].

Core Viewpoint - COSCIENS Biopharma Inc. has repositioned itself as a pure-play natural-based product company following a strategic review and pipeline prioritization, while continuing efforts to streamline operations and cut costs [1] Financial Overview - The company reported a consolidated net loss of $3.7 million, or $1.16 loss per common share, for the first quarter of 2025, compared to a net loss of $1.4 million, or $0.76 loss per common share, for the same period in 2024 [6] - Total revenue for the first quarter of 2025 was $1.5 million, down from $2.1 million in the same period in 2024, primarily due to a $0.7 million decrease in sales of Avenanthramides, Beta Glucan, and Oat Oil [7] - Operating expenses increased to $4.0 million from $2.7 million in the same period in 2024, mainly due to higher selling, general, and administrative costs following a merger [13] Cash Position - As of March 31, 2025, the company had $13.8 million in cash and cash equivalents [5] Clinical Development - The company is advancing its Phase 2 clinical trial for Avenanthramide tablets, having successfully completed Phase 1 with no significant adverse events observed [4] - The Phase 2a clinical efficacy study commenced on March 15, 2025, with the first cohort of 10 patients completing their treatment, and the Data and Safety Monitoring Board recommended continuation with a second cohort [4] Product Development - COSCIENS is working on a new portfolio of nutraceuticals, including an Oat Beta Glucan Chewable Bar for cholesterol reduction and a Yeast Beta Glucan Powder as an immune booster [4] - The company has completed the scale-up project for Pressurized Gas eXpanded Technology (PGX) at its Edmonton facility, ready to produce Yeast Beta Glucan at a small-scale commercial level [4]

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 Company’s common shares are traded on Nasdaq and TSX under the symbol "CSCI" following the merger[233][250]. - Following the merger, former shareholders of Ceapro and Aeterna each own approximately 50% of the common shares on a fully diluted basis[246]. Financial Performance - Total revenue for Q4 2024 was $3.3 million, a 174% increase from $1.2 million in Q4 2023, primarily driven by a $1.2 million increase in sales of Avenanthramides, Beta Glucan, and Oat Oil[268]. - For the twelve-month period ended December 31, 2024, total revenue reached $9.6 million, up 34% from $7.1 million in 2023, with a significant contribution from Macrilen revenue due to the acquisition of Aeterna[270]. - 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]. - 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 reported a consolidated net loss of $15.3 million for the twelve-month period ended December 31, 2024, compared to a net loss of $3.5 million in 2023, an increase of $11.8 million[290]. 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 and is exploring alternatives for macimorelin, including potential divestment[244]. - Research and development expenses for Q4 2024 were $2.9 million, significantly higher than $0.5 million in Q4 2023, reflecting increased investment in product development[268]. - Total research and development expenses for the twelve-month period ended December 31, 2024, were $8.3 million, an increase of $6.3 million or 307% compared to $2.0 million in 2023[274]. - Avenanthramides are being developed for nutraceutical applications to treat inflammation-based conditions, with a Phase 1-2a study currently underway[266]. Strategic Initiatives - The company is currently engaged in a search for a new President and CEO to lead future growth and integration efforts[251]. - The company is targeting the launch of a chewable oat beta glucan product for cholesterol reduction in the first half of 2025, leveraging approved claims in multiple regions[256]. - The company has established a collaboration with NATEX to scale up PGX Technology, with completion expected in Q2 2025 in Austria[254]. - The company discontinued its AIM Biological and ALS programs in Q3 2024 due to challenging timelines and costs[263]. 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 twelve months ended December 31, 2024, compared to cash used of $(730,000) in the same period in 2023[301]. - 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 highlighted various risks that may materially affect its business, including credit risk, liquidity risk, and market risk[318]. - The Company is exposed to foreign exchange risk due to investments in foreign operations with a functional currency of the Canadian Dollar[588]. - As of December 31, 2024, the Company reported $16,393 in cash and cash equivalents, indicating a material uncertainty regarding its ability to continue as a going concern[587]. - One counterparty comprised 75% of total receivables as of December 31, 2024, up from 40% in 2023, with no amounts past due[582].

Core Insights - COSCIENS Biopharma has repositioned itself as a pure-play natural-based product company following a strategic review and pipeline prioritization [1][3] - The company reported a revenue increase of 35.2% year-over-year, with total revenues of $9.6 million for the year ended December 31, 2024, compared to $7.1 million in 2023 [1][16] - The company ended the quarter with $16.4 million in cash and cash equivalents [1][11] Financial Performance - For Q4 2024, COSCIENS reported a consolidated net loss of $6.7 million, or $2.15 loss per share, compared to a net loss of $1.6 million, or $0.85 loss per share in Q4 2023 [12] - Total revenue for Q4 2024 was $3.3 million, an increase from $1.2 million in Q4 2023, primarily driven by increased sales of Avenanthramides and Beta Glucan [13] - Total operating expenses for Q4 2024 were $8.4 million, up from $2.2 million in Q4 2023, due to higher research and development costs and impairment expenses [14] Yearly Overview - For the full year 2024, the consolidated net loss was $15.3 million, or $5.93 loss per share, compared to a net loss of $3.5 million, or $1.89 loss per share in 2023 [15] - Total revenue for the year was $9.6 million, an increase of $2.4 million from $7.1 million in 2023, attributed to higher sales of Avenanthramides and Beta Glucan [16] - Total operating expenses for the year were $23.0 million, significantly higher than $7.5 million in 2023, driven by increased research and development and impairment expenses [18] Development Projects - The company has launched a new website for its JuventeDC product line, enhancing its online presence [5] - Avenanthramides Tablets are in clinical development, with successful Phase 1 results and a Phase 2a clinical efficacy study launched [7] - The Oat Beta Glucan Chewable Bar is set for commercial launch in H2 2025, while the Yeast Beta Glucan Powder is being finalized for commercialization as an immune booster [8] Strategic Direction - Following the negative results of the Phase 3 DETECT-Trial for macimorelin, the company has ceased investment in related pre-clinical programs and is exploring strategic options for this asset [3] - The company aims to reduce the cash burn rate while advancing promising programs from its legacy organizations [2] - COSCIENS is focused on leveraging its proprietary extraction technology to develop active ingredients from renewable plant resources for its product portfolio [23]

Core Viewpoint - COSCIENS Biopharma Inc. has received a management cease trade order (MCTO) from the Ontario Securities Commission due to delays in filing its annual financial statements and related documents, but it is actively working to resolve the issues and expects to file by April 7, 2025 [1][2][3]. Group 1: Management Cease Trade Order (MCTO) - The MCTO was issued effective April 1, 2025, in connection with the potential delay in filing the annual financial statements for the years ended December 31, 2024, 2023, and 2022, along with related management discussions and analysis [2]. - The Company confirms it was unable to meet the filing deadline of March 31, 2025, but is working diligently with auditors to complete the required filings as soon as possible [3]. - The MCTO restricts trading in the Company's securities by its CEO and CFO until the required filings are completed, but does not affect other shareholders [5]. Group 2: Filing and Compliance - The Company plans to comply with alternative information guidelines set out in NP 12-203, including issuing bi-weekly default status reports while remaining in default of its filing obligations [4]. - There is no immediate effect on the listing of the Company's common shares on the Nasdaq Capital Market due to the MCTO and filing delay [6]. - The Company will issue a news release once the required filings have been completed [4]. Group 3: Company Overview - COSCIENS Biopharma Inc. is a life science company formed from the merger of Aeterna Zentaris and Ceapro Inc., focusing on developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical, and pharmaceutical products [8]. - The Company leverages proprietary extraction technology for producing active ingredients from renewable plant resources, which are used in leading skincare products [8]. - COSCIENS is listed on both the Nasdaq Capital Market and the Toronto Stock Exchange under the ticker symbol "CSCI" [9].

Core Viewpoint - COSCIENS Biopharma Inc. announced a potential delay in filing its annual financial statements and related documents due to complexities arising from its merger with Ceapro Inc. and identified material weaknesses in financial controls [1][2][7]. Group 1: Financial Filing Delays - The company may delay the filing of its annual financial statements for the years ended December 31, 2024, 2023, and 2022, along with related management discussions and analysis, beyond the March 31, 2025 deadline [1][2]. - The delay is attributed to the complexities of the first audit of the combined entity post-merger, requiring additional time to review Ceapro's internal controls [2][3]. Group 2: Internal Control Issues - Management identified material weaknesses in the company's financial controls as of December 31, 2024, based on the COSO framework, including deficiencies in control environment, control activities, information and communication, and monitoring components [2][3]. - The auditors are also reviewing the impact of prospective U.S. tariffs, adding another layer of complexity to the audit process [2]. Group 3: Regulatory Actions - As a precaution, the company has applied for a management cease trade order (MCTO) from the Ontario Securities Commission, which may be imposed if the filing deadline is not met [4][5]. - If granted, the MCTO will not generally affect non-management individuals' ability to trade in the company's securities [5][6]. Group 4: Current Status and Future Plans - The company is actively working with its auditors to complete the required filings as soon as possible and will issue a news release once completed [3][7]. - The potential delay in filing does not currently affect the listing of the company's common stock on the Nasdaq Capital Market [7].

Core Viewpoint - COSCIENS Biopharma Inc. has initiated its Phase 2a clinical efficacy study for its avenanthramides product, aimed at managing inflammation-related conditions, following a successful Phase 1 trial that demonstrated a favorable safety profile [1][4][5]. Group 1: Clinical Study Details - The Phase 1-2a clinical trial, named the AvenActive study, began in November 2023 and involved 72 healthy subjects, with no significant adverse events reported [3][8]. - The Phase 2a study will enroll 20 patients with mild to moderate inflammation, testing doses of 480 mg and 960 mg per day [4][5]. - Initial dosing for the Phase 2a study is expected to occur on March 14, 2025, at the Montreal Heart Institute [4][8]. Group 2: Product Information - Avenanthramides are di-phenolic compounds found in oats, known for their antioxidant and anti-inflammatory properties [2]. - The study will assess inflammatory biomarkers in blood, focusing on cytokines, chemokines, and high-sensitivity C-reactive protein [5]. Group 3: Company Strategy and Market Potential - The successful completion of the Phase 1 study is viewed as a critical milestone, positioning the company for potential out-licensing and commercialization opportunities [6]. - The company aims to become a global leader in natural-based health and wellness products, with avenanthramides seen as a transformative product [6][10].

Core Company Information - COSCIENS Biopharma Inc. is a specialty biopharmaceutical company focused on developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical, and pharmaceutical products [3] - The company utilizes proprietary extraction technology to produce active ingredients from renewable plant resources, which are currently used in leading skincare brands [3] - COSCIENS is listed on the NASDAQ Capital Market and the Toronto Stock Exchange under the ticker symbol "CSCI" [4] Recent Developments - A new corporate presentation outlining key development areas and upcoming milestones is scheduled for release in January 2025 [2][10] - The company has streamlined operations and implemented cost-cutting measures to refine its development pathway [10] - Following a merger, the company has prioritized its product pipeline, focusing on high-value opportunities in natural-based products [11] Product Pipeline Updates Pharmaceuticals - The Phase 1 part of the clinical trial for Avenanthramides Tablets has been completed with 72 subjects tested, showing no significant side effects [11] - The Phase 2a efficacy study for Avenanthramides is expected to begin in Q1 2025 and complete by Q3 2025 [11] Cosmeceuticals - Small batches of Enriched Oat Flour with high concentrations of Avenanthramides have been produced and sold for cream formulations [12] - A new website for the JuventeDC product line was launched on December 19, 2024 [12] Nutraceuticals - Yeast Beta Glucan Powder is being finalized in capsule form for commercialization as an immune booster in Q2 2025 [13] - A unique formulation for an Oat Beta Glucan Chewable Bar has been developed, with a commercial launch anticipated in Q1 2025 [13] Macimorelin Update - The DETECT-trial for macimorelin in diagnosing Childhood Onset Growth Hormone Deficiency failed to meet its primary endpoints, leading to a strategic shift in the company's focus [15] - The company will not invest further in macimorelin for Childhood Onset Growth Hormone Deficiency but will maintain its current indication for Adult Growth Hormone Deficiency [15] - Management roles, including that of the Chief Medical Officer, are being reduced to streamline operations and reduce costs [15][16]