Acasti Pharma Inc. (ACST) 10K Annual Reports & 10Q SEC Filings

LAVAL, Québec, February 14, 2023 -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced financial and operational results for the third quarter ended December 31, 2022

Recent Highlights

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The Company anticipates receiving clarifying guidance from the Food and Drug Administration (FDA) on its proposed phase 3 study design for GTX-104 through a written Type C meeting in the first calendar quarter of 2023. The Company expects that favorable FDA guidance would allow Acasti to initiate the Phase 3 safety study and begin recruiting clinical sites and enrolling patients. The Company expects the study to take about 18 months to complete once the first patient is enrolled, and if the trial is successful, the Company expects that it will be the final clinical step required to seek FDA approval under the 505(b)(2) regulatory pathway.

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Preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 announced in December 2022 met all primary outcome measures. The objectives of the study were to evaluate the bioavailability, pharmacokinetics, and safety of GTX-102, a novel, concentrated oral-mucosal metered spray of betamethasone in healthy volunteers, and to compare the PK profile to an intramuscular injection of betamethasone, the reference drug, which is approved in the U.S. Acasti’s new and patented formulation of betamethasone is intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T) in a pediatric population for which there are currently no FDA-approved therapies. The Company expects that the next step in the proposed 505(b)(2) regulatory pathway for GTX-102 will be a Phase 3 safety and efficacy study in children with A-T, which could be initiated following a Type B meeting with the FDA.

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Preliminary topline results announced in December 2022 for the Company’s single-dose PK study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug in the U.S., bupivacaine subcutaneous injectable, met all primary outcome measures for the study. The Company anticipates receiving the final clinical study report in the first half of calendar 2023. This PK study was the next step in the Company’s proposed 505(b)(2) regulatory pathway for GTX-101 and it provided important information on the dose and dosing frequency in humans for future clinical studies.

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The Company finished the second fiscal quarter ended December 31, 2022, with $31.3 million in cash, cash equivalents and short-term investments. Management continues to believe that based on current projections, the Company has sufficient capital to fund operations into calendar Q2 of 2024 allowing for the advancement of GTX-104 well into Phase 3 and advancing GTX-102 and GTX-101 to additional important milestones.

Management Discussion

Jan D’Alvise, Chief Executive Officer of Acasti, said “Significant progress was made over the past few months on all three of our clinical programs. We ended calendar 2022 in a very strong fashion with the

The following information was filed by Acasti Pharma Inc. (ACST) on Tuesday, February 14, 2023 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.

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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 contract research organizations ("CROs") and contract manufacturing organizations ("CMOs") 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; and salaries and related expenses for personnel, including expense related to stock options.

Other - Other Highlight
Changes to our assumptions, in particular changes in technological feasibility or changes in the regulatory approval process could materially affect the estimation of the fair value and could result in impairment charges in future quarters.
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, 2023 and March 31, 2022 Summary As at March 31, 2023, cash and cash equivalents totalled $27,875, a net decrease of $2,464 compared to cash and cash equivalents totalling $30,339 at March 31, 2022.
Financial - Expense Highlight
This increase was related to increased expenses for accounting software upgrades, and IP legal costs to support and maintain our patents relating to TX-104, GTX-102 and GTX-101.
Other - Other Highlight
Cash equivalents and marketable securities are primarily 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
The increase in cash generated...Read more
Other - Other
Other Assets Other assets represent...Read more
Financial - Shares
In May 2023, we implemented...Read more
Revenue - Product
Events that could result in...Read more
Financial - Expense
We expect our expenses will...Read more
Financial - Shares
Negative results from studies, if...Read more
Revenue - Product
Under the terms of the...Read more
Financial - Expense
General and administrative expenses totaled...Read more
Other - Other
We identified the strategic realignment...Read more
Financial - Expense
Other expenses increased by $576...Read more
Revenue - Product
Sales and marketing Sales and...Read more
Financial - Shares
Results of Operations Comparison of...Read more
Revenue - Geography
We have credit risk relating...Read more
Financial - Expense
Aggregate depreciation and amortization expense...Read more
Financial - Cash Flow
The projected discounted cash flow...Read more
Other - Other
Future Accounting Changes We have...Read more
Financial - Cash Flow
Interest Rate Risk Interest rate...Read more
M & A - Other
This acquisition method requires, among...Read more
Other - Other
An impairment of indefinite-lived intangible...Read more
Revenue - Product
Measurement of Assets Held for...Read more
Financial - Expense
Aggregate stock-based compensation expense increased...Read more
Financial - Cash Flow
We have incurred operating losses...Read more
Revenue - Product
Under the terms of the...Read more
Financial - Income
Income tax recovery The impairment...Read more
Other - Other
Financing activities During the year...Read more
Other - Other
While we believe our internal...Read more
Other - Other
The result of the impairment...Read more
Revenue - Product
This increase is due to...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
Goodwill of $12,964 was calculated...Read more
Other - Other
The decision to defer further...Read more
Financial - Earnings
We estimated the fair value...Read more
Other - Other
Our assets as at March...Read more
Revenue - Geography
On November 10, 2021, we...Read more
Other - Other
Based on our fair value...Read more
Other - Other
Liquidity risk Liquidity risk is...Read more
Financial - Expense
The program related increases for...Read more
Financial - Expense
Research and development expenses during...Read more
Legal - Other
The decrease was primarily a...Read more
M & A - Other
The following table summarizes the...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 23.1: Consents Of Experts And Counsel

Exhibit 23.2: 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: 0000950170-23-029498
Submitted to the SEC: Fri Jun 23 2023 7:01:30 AM EST
Accepted by the SEC: Fri Jun 23 2023
Period: Friday, March 31, 2023
Industry: Pharmaceutical Preparations