Acasti Pharma Inc. (ACST) 10-Q Quarterly Report February 2023

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-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 - 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.

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.
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 our CaPre former 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
Other - Other
If it is favorable, we...Read more
Financial - Expense
General and administrative expenses totaled...Read more
Revenue - Product
Events that could result in...Read more
Revenue - Product
Under the terms of the...Read more
Financial - Shares
Issued and outstanding fully paid...Read more
Financial - Expense
We expect our expenses will...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
Revenue - Product
Sales and marketing Sales and...Read more
Financial - Expense
Research and development expenses during...Read more
Financial - Expense
Third-party contract research expenses related...Read more
Financial - Cash Flow
The projected discounted cash flow...Read more
Other - Other
Future Accounting Changes We have...Read more
Other - Other
The PK bridging study to...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
Other - Other
Negative results from studies, if...Read more
Financial - Cash Flow
We have incurred operating losses...Read more
Other - Other
Results showed that GTX-102 betamethasone...Read more
Revenue - Geography
We have credit risk relating...Read more
M & A - Other
Critical Accounting Policies Valuation of...Read more
Other - Other
20 Our three most advanced...Read more
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Our assets as at December...Read more
M & A - Other
Intangible Assets On August 27,...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 nine months ended...Read more
Other - Other
Based on our fair value...Read more
M & A - Other
This increase of $506 and...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: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32: Section 1350 Certification

Ticker: ACST
CIK: 1444192
Form Type: 10-Q Quarterly Report
Accession Number: 0000950170-23-002695
Submitted to the SEC: Tue Feb 14 2023 7:00:54 AM EST
Accepted by the SEC: Tue Feb 14 2023
Period: Saturday, December 31, 2022
Industry: Pharmaceutical Preparations