Cosciens Biopharma Stock Price, News & Analysis

COSCIENS Biopharma (NASDAQ/TSX: CSCI) announced potential delays in filing its annual financial statements, CEO/CFO certificates, and annual information form (Form 20-F) beyond the March 31, 2025 deadline. The delay stems from complications following the 2024 all-stock merger with Ceapro, requiring additional time for accounting procedure conversion and internal control review.

The company identified material weaknesses in financial controls as of December 31, 2024, with deficiencies in the COSO framework principles. Additional review is also needed regarding the impact of prospective U.S. tariffs.

As a precautionary measure, COSCIENS has applied for a management cease trade order (MCTO) with the Ontario Securities Commission. The company confirms this potential delay does not immediately affect its Nasdaq Capital Market listing and will issue bi-weekly status updates if an MCTO is granted.

COSCIENS Biopharma (NASDAQ/TSX: CSCI) announced potential delays in filing its annual financial statements, CEO/CFO certificates, and annual information form (Form 20-F) beyond the March 31, 2025 deadline. The delay stems from complications related to their 2024 all-stock merger with Ceapro, requiring accounting procedure conversions to meet SEC reporting obligations.

The company identified material weaknesses in financial controls as of December 31, 2024, with deficiencies in the COSO framework principles. Additional review is also needed regarding the impact of prospective U.S. tariffs. As a precautionary measure, COSCIENS has applied for a management cease trade order (MCTO) with the Ontario Securities Commission, though this won't affect non-management trading.

While the delay doesn't immediately impact CSCI's Nasdaq Capital Market listing, the company commits to issuing bi-weekly status updates and completing the required filings as soon as possible.

COSCIENS Biopharma (NASDAQ: CSCI) has announced successful Phase 1 results for its avenanthramides product, leading to the initiation of a Phase 2a clinical efficacy trial. The study, known as AvenActive, demonstrated no significant adverse events in Phase 1, which included 72 healthy subjects receiving doses from 30mg to 960mg per day.

The Phase 2a portion will evaluate 20 patients with mild to moderate inflammation, testing doses of 480mg and 960mg daily. The first patient treatment is scheduled for March 14, 2025, at the Montreal Heart Institute. Avenanthramides, di-phenolic compounds found exclusively in oats, have shown potential antioxidant and anti-inflammatory effects in previous studies.

The trial will assess inflammatory biomarkers in blood, including cytokines, chemokines, and high-sensitivity C-reactive protein. The company aims to pursue out-licensing opportunities and potential commercialization with a major pharmaceutical partner following the completion of Phase 2a.

COSCIENS Biopharma (NASDAQ/TSX: CSCI) provided a corporate update focusing on pipeline prioritization and strategic developments. The company is streamlining operations to focus on natural-based products across cosmeceuticals, nutraceuticals, and pharmaceuticals. Key developments include:

- Phase 1 completion of Avenanthramides Tablets clinical trial with Phase 2a expected in Q1 2025
- Successful production of Enriched Oat Flour
- Launch of JuventeDC website
- Development of Yeast Beta Glucan immune booster for Q2 2025 launch
- Planned Q1 2025 launch of Oat Beta Glucan chewable bar

The company announced the failure of macimorelin DETECT-trial for CGHD diagnosis and will discontinue its development while maintaining its AGHD indication. Cost-cutting measures include management restructuring, with CMO Dr. Nicola Ammer departing in March 2025.

COSCIENS Biopharma (NASDAQ: CSCI) reported Q3 2024 financial results with a net loss of $5.8 million compared to $0.8 million in Q3 2023. Revenue decreased to $1.9 million from $2.0 million year-over-year. The company ended the quarter with $20.0 million in cash. Operating expenses increased to $7.3 million from $1.9 million last year.

Following pipeline prioritization, COSCIENS is focusing on cosmeceutical and nutraceutical products while discontinuing investment in AIMS Biologicals and DC-PTH programs. The Phase 1/2a trial of Avenanthramide remains on track, with Phase 1 completion expected by end of 2024 and Phase 2a by Q3 2025. The DETECT trial for macimorelin in CGHD failed to meet primary endpoints.

COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI), a specialty biopharmaceutical company, has announced a change to its Board of Directors. Carolyn Egbert has resigned from the Board, effective immediately. Egbert served on the Board for twelve years, including eight years as Chair. The company has decided to streamline its board structure, moving forward with six members, including five independent directors. This decision aligns more closely with industry standards for companies at COSCIENS' stage. Ronald Miller, the current Chair of the Board, expressed gratitude for Egbert's dedicated service and valuable contributions to the company, previously known as Aeterna Zentaris.

COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI), a specialty biopharmaceutical company, has appointed Pierre Labbé to its board of directors and as Chair of the Company's Audit Committee, effective October 1, 2024. This appointment fills the vacancy created by the resignation of Dennis Turpin. Mr. Labbé brings over 30 years of financial leadership experience to COSCIENS, currently serving as Executive Vice-President, Finance of Fonds QScale S.E.C.

Mr. Labbé's extensive experience includes roles as CFO at IMV Inc., LeddarTech Inc., and Medicago Inc. He has been instrumental in financing and M&A transactions exceeding $1 billion. Additionally, he serves as a director of Osisko Gold Royalties since 2015. Mr. Labbé holds a Bachelor's Degree in Business Administration, is a Chartered Professional Accountant, and has the ICD.D designation from the Institute of Corporate Directors.

COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) has provided an update on its merger integration with Ceapro Inc., including management changes and development program advancements. CEO Gilles Gagnon announced plans for leadership transition, with a search for a new President and CEO underway. The company is implementing cost reduction measures, including eliminating positions and reducing spend on certain programs.

COSCIENS is reviewing results from the Phase 3 DETECT-Trial of macimorelin for childhood growth hormone deficiency and has discontinued the ALS research program. Updates on development projects include:

• Completion of the Single Ascending Dose arm for Avenanthramides tablets
• Publication of pre-clinical studies on yeast beta glucan
• Presentation of AIM Biologicals for Parkinson's Disease at a European congress
• Development of yeast beta glucan powder as an immune booster
• Positive pre-clinical data on Avenanthramides and Oat beta glucan for wound healing
• Progress on PGX technology scale-up in Edmonton and Austria

COSCIENS Biopharma Inc. (NASDAQ: CSCI) announced top-line results for its Phase 3 DETECT-trial evaluating macimorelin for diagnosing Childhood Onset Growth Hormone Deficiency (CGHD). The study did not meet its primary efficacy endpoint as defined in the protocol, despite macimorelin demonstrating its ability to stimulate growth hormone release. The trial enrolled 102 subjects aged 3 to 17 years across multiple countries.

Key findings include:

• An unexpectedly high 'optimal' growth hormone cut-off point of 25.59 ng/mL
• Potential high false positive rate from comparator tests (arginine and clonidine)
• Confirmation of macimorelin's safety in the pediatric population

The company plans further analysis of the results and discussions with health authorities to determine the next steps for macimorelin in CGHD diagnosis.