Acasti Pharma Files 2024 10-K

TL;DR

Acasti Pharma filed its 2024 10-K. Check financials.

AI Summary

Acasti Pharma Inc. filed its 10-K for the fiscal year ending March 31, 2024, reporting on its financial condition and business operations. The company, incorporated in Delaware and headquartered in Princeton, NJ, operates within the Pharmaceutical Preparations sector. Key dates mentioned include the filing date of June 21, 2024, and the fiscal year end of March 31, 2024. Specific financial details and operational highlights are detailed within the full filing.

Why It Matters

This 10-K filing provides investors and stakeholders with a comprehensive overview of Acasti Pharma's financial performance and strategic positioning for the fiscal year 2024.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Acasti Pharma is subject to inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• 03-31 — Fiscal Year End (Marks the end of the reporting period for the 10-K.)
• 20240621 — Filing Date (The date the 10-K was officially submitted to the SEC.)

Key Players & Entities

• Acasti Pharma Inc. (company) — Filer of the 10-K
• 20240331 (date) — Fiscal year end
• 20240621 (date) — Filing date
• Princeton, NJ (location) — Company headquarters
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Key Financial Figures

• $3.2 million — translate into savings of approximately $3.2 million for our lead drug candidate, GTX-104. D

Filing Documents

• acst-20240331.htm (10-K) — 2897KB
• acst-ex21_1.htm (EX-21.1) — 4KB
• acst-ex23_1.htm (EX-23.1) — 3KB
• acst-ex23_2.htm (EX-23.2) — 3KB
• acst-ex31_1.htm (EX-31.1) — 13KB
• acst-ex31_2.htm (EX-31.2) — 14KB
• acst-ex32_1.htm (EX-32.1) — 10KB
• acst-ex32_2.htm (EX-32.2) — 11KB
• acst-ex97_1.htm (EX-97.1) — 59KB
• img181340459_0.jpg (GRAPHIC) — 52KB
• img181340459_1.jpg (GRAPHIC) — 19KB
• img181340459_2.jpg (GRAPHIC) — 99KB
• img181340459_3.jpg (GRAPHIC) — 14KB
• img181340459_4.jpg (GRAPHIC) — 67KB
• img181340459_5.jpg (GRAPHIC) — 55KB
• img181340459_6.jpg (GRAPHIC) — 40KB
• img181340459_7.jpg (GRAPHIC) — 170KB
• img181340459_8.jpg (GRAPHIC) — 161KB
• 0000950170-24-075875.txt ( ) — 11765KB
• acst-20240331.xsd (EX-101.SCH) — 1432KB
• acst-20240331_htm.xml (XML) — 1653KB

Business

Business 9 Item 1A .

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 46 Item 2.

Properties

Properties 47 Item 3.

Legal Proceedings

Legal Proceedings 47 Item 4. Mine Safety Disclosures 47 PART II Item 5. Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities 48 Item 6. [Reserved] 53 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operation

Management's Discussion and Analysis of Financial Condition and Results of Operation 54 Item 7A . Quantitative and Qualitative Disclosure About Market Risk 63 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 63 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 63 Item 9A .

Controls and Procedures

Controls and Procedures 63 Item 9B. Other Information 63 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections PART III Item 10. Directors, Executive Officers and Corporate Governance 64 Item 11.

Executive Compensation

Executive Compensation 68 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters 77 Item 13. Certain Relationships and Related Transactions and Director Independence 80 Item 14. Principal Accounting Fees and Services 83 PART IV Item 15. Exhibits, Financial Statement Schedules 85 Item 16. Form 10-K Summary 86

SIGNATURES

SIGNATURES SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains information that may be forward-looking information within the meaning of Canadian securities laws and forward-looking statements within the meaning of U.S. federal securities laws, both of which we refer to in this Annual Report on Form 10-K as forward-looking information. Forward-looking information can be identified by the use of terms such as "may"," "will"," "should"," "expect"," "plan"," "anticipate"," "believe"," "intend"," "estimate"," "predict"," "potential"," "continue" or other similar expressions concerning matters that are not statements about the present or historical facts. Forward-looking information in this Annual Report on Form 10-K includes, among other things, information or statements about: our ability to build a premier, late-stage pharmaceutical company focused in rare and orphan diseases and, on developing and commercializing products that improve clinical outcomes using our novel drug delivery technologies; our ability to apply new proprietary formulations to existing pharmaceutical compounds to achieve enhanced efficacy, faster onset of action, reduced side effects, and more convenient drug delivery that can result in increased patient compliance; the potential for our drug candidates to receive orphan drug designation from the U.S. Food and Drug Administration ("FDA") or regulatory approval under the Section 505 (b)(2) regulatory pathway under the Federal Food, Drug and Cosmetic Act ("FDCA"); the future prospects of our GTX-104 drug candidate, including but not limited to GTX-104's potential to be administered to improve the management of hypotension in patients with aneurysmal subarachnoid hemorrhage ("aSAH"); GTX-104's potential to reduce the incidence of vasospasm in aSAH patients resulting in better outcomes; the ability of GTX-104 to achieve a pharmacokinetic ("PK") and safety profile similar to the oral form of nimodipin

Business

Item 1. Business Overview We are focused on developing and commercializing products for rare and orphan diseases that have the potential to improve clinical outcomes by using our novel drug delivery technologies. We seek to apply new proprietary formulations to approved and marketed pharmaceutical compounds to achieve enhanced efficacy, faster onset of action, reduced side effects, more convenient drug delivery and increased patient compliance; all of which could result in improved patient outcomes. The active pharmaceutical ingredients used in the drug candidates under development by Acasti may be already approved in a target indication or could be repurposed for use in new indications. The existing well understood efficacy and safety profiles of these marketed compounds provides the opportunity for us to utilize the Section 505(b)(2) regulatory pathway under the Federal Food, Drug and Cosmetic Act ("FDCA") for the development of our reformulated versions of these drugs, and therefore may provide a potentially shorter path to regulatory approval. Under Section 505(b)(2), if sufficient support of a product's safety and efficacy either through previous U.S. Food and Drug Administration ("FDA") experience or sufficiently within the existing and accepted scientific literature, can be established, it may eliminate the need to conduct some of the pre-clinical studies and clinical trials that new drug candidates might otherwise require. Our therapeutic pipeline consists of three unique clinical-stage drug candidates supported by an intellectual property portfolio of more than 40 granted and pending patents in various jurisdictions worldwide. These drug candidates aim to improve clinical outcomes in the treatment of rare and orphan diseases by applying proprietary formulation and drug delivery technologies to existing pharmaceutical compounds to achieve improvements over the current standard of care, or to provide treatment for diseases with no currently approved t

View Full Filing

View this 10-K filing on SEC EDGAR