Acasti Pharma Inc. (ACST) 10-Q Quarterly Report November 2022

LAVAL, Québec, November 14, 2022 -- 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 second quarter ended September 30, 2022.

Recent Highlights

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The Company expects to receive guidance from the Food and Drug Administration (FDA) on its proposed phase 3 study design for GTX-104 in the form of a Type C meeting by the end of 2022 or early in the first calendar quarter of 2023. This FDA guidance should allow the Company to initiate the Phase 3 safety study and begin enrolling the first patients as planned in the first half of 2023. The study is expected to take about 18 months to complete and is expected to be the final clinical step required to seek approval under the 505(b)(2) regulatory pathway.

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The pharmacokinetic (PK) bridging study for GTX-102 was initiated on September 13, 2022. The Company expects to report topline results on schedule before the end of calendar 2022. Assuming the PK bridging study meets its primary endpoint, the next development step is to conduct a Phase 3 safety and efficacy trial in Ataxia-Telangiectasia (A-T) patients. The Company plans to request a Type B meeting with the FDA following the completion of the PK study to confirm the Phase 3 study design, and assuming the PK bridging study meets its primary endpoint, the Phase 3 safety study is expected to be initiated in the second half of 2023. If both studies meet their primary endpoints, a new drug application (NDA) filing for GTX-102 under Section 505(b)(2) is expected to follow.

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The single dose PK study of GTX-101, was initiated on July 26, 2022, in healthy human volunteers. This PK study is the next step in the Company’s proposed 505(b)(2) regulatory pathway for GTX-101. The PK study is expected to be completed by the end of calendar 2022 as planned and will provide important information on the dosing strength and frequency which will be used for additional clinical studies of GTX-101.

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The Company finished the second fiscal quarter ended September 30, 2022, with $34.9 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 through at least March 2024, allowing for the advancement of GTX-104 well into Phase 3 and advancing GTX-102 and GTX-101 to key value inflection points.

Management Discussion

Jan D’Alvise, Chief Executive Officer of Acasti said, “We remain focused on advancing our three clinical programs, and I’m pleased to report that significant progress was made during the second fiscal quarter.

The following information was filed by Acasti Pharma Inc. (ACST) on Monday, November 14, 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-Q Quarterly 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-Q Quarterly Report:

Financial - Shares Highlight
Issued and outstanding fully paid shares, stock options, and warrants, were as follows for the periods indicated (after giving effect to our 8:1 share consolidation, which became effective on August 31, 2021): 33 Cash Flows and Financial Condition for the six months ended September 30, 2022 and 2021 Summary As at September 30, 2022, cash and cash equivalents totaled $34,926, a net increase of $4,587 compared to cash and cash equivalents totaling $30,339 at March 31, 2022.

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.
Revenue - Product Highlight
Intangible assets of $69,810 relate to the value of IPR&D, related to Graces therapeutic pipeline, consisting of three unique clinical stage programs/assets supported by intellectual property, the value of which has been attributed as follows: Assets Held for Sale We determined to actively market for sale Other assets and Production equipment and have met the criteria for classification of assets held for sale: Other assets Other assets represent krill oil (RKO) held by us that was expected to be used in commercial inventory scale up related to the development and commercialization of the CaPre drug candidate.
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
The increase in cash generated was a function of an increase in proceeds from maturity of short-term investments.
Financial - Expense
Other third-party contract research expenses...Read more
Financial - Expense
General and administrative expenses totaled...Read more
Revenue - Product
Under the terms of the...Read more
Financial - Expense
For the three months ended...Read more
Revenue - Product
Under the terms of the...Read more
Other - Other
This unique nimodipine injectable formulation...Read more
Other - Other
These drug candidates aim to...Read more
Other - Other
More consistent dosing is expected...Read more
M & A - Other
Intangible assets On August 27,...Read more
Revenue - Product
Sales and marketing Sales and...Read more
Other - Other
Future Accounting Changes We have...Read more
Other - Other
Assuming the PK bridging study...Read more
Financial - Expense
ODD status can also result...Read more
Financial - Cash Flow
Interest Rate Risk Interest rate...Read more
Other - Other
An impairment of indefinite-lived intangible...Read more
Revenue - Product
Measurement of Assets Held for...Read more
Revenue - Product
This increase is due to...Read more
Financial - Expense
Third party contract research expenses...Read more
Revenue - Geography
We have credit risk relating...Read more
M & A - Other
Critical Accounting Policies Valuation of...Read more
Other - Other
Our three most advanced programs...Read more
Other - Other
Our assets as at September...Read more
Other - Other
Therefore, GTX-104 could be considered...Read more
Other - Other
No serious adverse events and...Read more
Revenue - Geography
On November 10, 2021, we...Read more
Other - Other
Liquidity Risk Liquidity risk is...Read more
Financial - Shares
During the six months ended...Read more
Other - Other
Based on our fair value...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

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-Q Quarterly Report
Accession Number: 0000950170-22-024666
Submitted to the SEC: Mon Nov 14 2022 7:01:10 AM EST
Accepted by the SEC: Mon Nov 14 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations