Acasti Pharma Inc. (ACST) 10-K Annual Report June 2022

LAVAL, Québec, June 21, 2022 (PR NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company with drug delivery capability and technologies addressing rare and orphan diseases, today announced financial and operational results for the fiscal year ended March 31, 2022.

Recent Highlights

•

Acasti’s 3 lead programs are on schedule to initiate new clinical trials in the second half of calendar 2022 including:

GTX-104 – Initiate Phase 3 safety trial (Q4 calendar year)

GTX-102 – Initiate PK Bridging Study (Q3 calendar year)

GTX-101 – Initiate Single Dose and Multiple Ascending Dose PK studies (Q3 calendar year)

•

Company ended the year (March 31, 2022) with $43.7 million in cash, cash equivalents and short-term investments.

•

Achieved positive top line results for the pharmacokinetic (PK) bridging study with IV GTX-104, our lead drug candidate for the treatment of Subarachnoid Hemorrhage (SAH), with the study having met all its planned endpoints.

•

Preparing the GTX-104 PK bridging study results for submission to the U.S. Food and Drug Administration (FDA), along with the Company’s proposed design for the Phase 3 safety study, which remains on track to start in the second half of calendar 2022. The safety study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting a New Drug Application to the FDA.

•

European Patent Office provided notice of allowance of the Company’s composition of matter patent for GTX-104. The patent is expected to be valid until 2037.

•

United States Patent and Trademark Office issued a notice of allowance for the Company’s composition of matter patent for GTX-102, a novel, easy-to-use oral mucosal formulation of betamethasone, intended to improve symptoms of ataxia-telangiectasia (A-T). The patent is expected to be valid until 2037.

•

Japanese Patent Office granted a composition of matter patent for the Company’s GTX-101 topical spray targeting postherpetic neuralgia (PHN). The granted patent is valid until 2036.

•

Appointed Michael L. Derby to our board of directors.

Management Discussion

The following information was filed by Acasti Pharma Inc. (ACST) on Tuesday, June 21, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

Please wait while we load the requested 10-K report or click the link below:

https://last10k.com/sec-filings/report/1444192/000095017022011842/acst-20220331.htm

View differences made from one year to another to evaluate Acasti Pharma Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ) — *Sample 10-K Year-over-Year (YoY) Comparison*

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were ~~removed~~ , added and changed by Acasti Pharma Inc..

Continue

Assess how Acasti Pharma Inc.'s management team is paid from their Annual Proxy

Acasti Pharma Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

Voting Procedures
Board Members
Executive Team
Salaries, Bonuses, Perks
Peers / Competitors

Continue

Rating
Learn More

Filter Sentiment:

All

Positive

Negative

Filter Category:

All

Financial

Revenue

M & A

Legal

Other

Filter Subcategory:

All

Expense

Product

Geography

Cash Flow

Other

Inside Acasti Pharma Inc.'s 10-K Annual Report:

Financial - Expense Highlight
Research and development expenses Research and development expenses consist primarily of: fees paid to external service providers such as clinical research organizations and contract manufacturing organizations related to clinical trials, including contractual obligations for clinical development, clinical sites, manufacturing and scale-up, and formulation of clinical drug supplies; fees paid to contract service providers related to drug discovery efforts including chemistry and biology services; patent-related services; and salaries and related expenses for personnel, including expense related to stock options.

Financial - Expense Highlight
Aggregate depreciation and amortization expense decreased by $924 for the year ended March 31, 2022, to nil as compared to $924 for the year ended March 31, 2021.
Financial - Shares Highlight
Issued and outstanding fully paid shares, stock options, restricted shares units and warrants, were as follows for the periods ended (all amounts in the table below give effect to the 1-for-8 share consolidation we completed on August 31, 2021): Cash Flows and Financial Condition between the years ended March 31, 2022 and March 31, 2021 Summary As at March 31, 2022, cash and cash equivalents totalled $30,339, a net decrease of $20,603 compared to cash and cash equivalents totalling $50,942 at March 31, 2021.
Other - Other Highlight
Cash equivalents and marketable securities are primarily made in guaranteed investment certificates, term deposits and high-interest savings accounts, which are issued and held with Canadian chartered banks, highly rated promissory notes issued by government bodies and commercial paper.
Other - Other Highlight
Other Assets Other assets represent krill oil (RKO) held by us that was expected to be used in the conduct of R&D activities and commercial inventory scale up related to the development and commercialization of our previous drug candidate, CaPre.
Financial - Shares
Results of Operations Comparison of...Read more
Revenue - Product
Sales and marketing Sales and...Read more
Revenue - Product
Under the terms of the...Read more
M & A - Other
The following table summarizes the...Read more
Financial - Expense
General and administrative expenses totalled...Read more
M & A - Other
Acquired In-Process Research and Development...Read more
Financial - Expense
Aggregate stock-based compensation expense decreased...Read more
Other - Other
Leases On March 14, 2022,...Read more
Other - Other
On February 25, 2022, we...Read more
Financial - Expense
Third party contract research expenses...Read more
Revenue - Geography
We have credit risk relating...Read more
Financial - Expense
Total costs incurred relating to...Read more
Other - Other
Future Accounting Changes We have...Read more
Other - Other
This is not reflected in...Read more
Financial - Cash Flow
Interest Rate Risk Interest rate...Read more
Legal - Other
This increase was a result...Read more
M & A - Other
This acquisition method requires, among...Read more
Other - Other
An impairment of indefinite-lived intangible...Read more
Other - Other
An impairment of indefinite-lived intangible...Read more
Revenue - Product
Measurement of Assets Held for...Read more
Revenue - Product
This decrease was due to...Read more
Revenue - Geography
Derivative Warrant Liabilities A total...Read more
Other - Other
During the year ended March...Read more
Other - Other
While we believe our internal...Read more
M & A - Other
Acquisition-related expenses, which were comprised...Read more
M & A - Other
Critical Accounting Policies Valuation of...Read more
M & A - Other
The value of which has...Read more
Other - Other
The December 2017 warrants are...Read more
Other - Other
Our assets as at March...Read more
Revenue - Geography
On November 10, 2021, we...Read more
Other - Other
Liquidity risk Liquidity risk is...Read more
Other - Other
Furthermore, a portion of our...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Acasti Pharma Inc. provided additional information to their SEC Filing as exhibits

Exhibit 4.6: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.3: Material Contract

Exhibit 10.6: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: ACST
CIK: 1444192
Form Type: 10-K Annual Report
Accession Number: 0000950170-22-011842
Submitted to the SEC: Tue Jun 21 2022 8:08:44 AM EST
Accepted by the SEC: Tue Jun 21 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations