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

LAVAL, Québec, August 11, 2022 -- 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 first quarter ended June 30, 2022.

Recent Highlights

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The Company is preparing the GTX-104 PK bridging study results for submission to the U.S. Food and Drug Administration (FDA) in calendar Q3. The Company also plans to submit the proposed design for the Phase 3 safety study along with a request for a Type C meeting with the FDA to confirm the Phase 3 plans and obtain the agency’s feedback before initiating the study in the first half of calendar 2023. The Phase 3 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 (NDA) to the FDA.

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The Company initiated its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy subjects. This study is expected to be completed on schedule by the end of calendar 2022, and it will provide important information on the dose and dosing frequency in humans.

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The Company remains on track to initiate the PK bridging study of GTX-102 in the third calendar quarter of 2022 and is expected to report out topline results on schedule before the end of calendar 2022. Assuming the PK bridging study meets its primary endpoint, and based on the FDA’s subsequent guidance, the Company plans to conduct a Phase 3 safety and efficacy trial in Ataxia Telangiectasia (A-T) patients. The Phase 3 study is expected to be initiated in the second half of calendar 2023.

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Company finished the first fiscal quarter ending June 30, 2022, with $38.4 million in cash, cash equivalents and short-term investments. Given certain cost savings and overall efficiencies implemented across the organization, management believes that it now has sufficient capital to fund operations through at least March 2024, allowing for the advancement of GTX-104 through 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 are making excellent progress on all three of our clinical programs, each of which have important clinical trials underway or to be initiated this fiscal year. All of our drug candidates have already received Orphan Drug Designation from the FDA, and each has the potential to be considered for fast-track review and approval. We are currently planning the Phase 3 safety trial for our lead drug candidate, GTX-104, a novel IV formulation of nimodipine designed to treat patients with subarachnoid hemorrhage (SAH). We also recently initiated a single dose study for GTX-101, a novel topical spray form of the analgesic bupivacaine, which is designed to treat Postherpetic Neuralgia (PHN), the severe and often debilitating nerve pain that can persist following a shingles infection. Very

The following information was filed by Acasti Pharma Inc. (ACST) on Thursday, August 11, 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 - 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: 32 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.
Financial - Expense Highlight
Other third-party contract research expenses of $154 increased by $78 from $76 for the three months ended June 30, 2021, due to increased IP legal costs to support and maintain our patents that support our three drug candidates GTX-104, GTX-102 and GTX-101.
Other - Other Highlight
The increase in cash generated was a function of an increase in proceeds from maturity of short term investments.
Financial - Expense
General and administrative expenses totaled...Read more
Revenue - Product
Under the terms of the...Read more
Financial - Shares
Issued and outstanding fully paid...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 30 Sales...Read more
Other - Other
Future Accounting Changes We have...Read more
Other - Other
Assuming the PK bridging study...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
Cash equivalents and marketable securities...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
Financial - Expense
Costs incurred relating to prospectus...Read more
Other - Other
Our assets as at June...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 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: 0000950170-22-016632
Submitted to the SEC: Thu Aug 11 2022 7:01:26 AM EST
Accepted by the SEC: Thu Aug 11 2022
Period: Thursday, June 30, 2022
Industry: Pharmaceutical Preparations