19Q3000144419210false03-31190001444192us-gaap:GeneralAndAdministrativeExpenseMemberacst:StockOptionPlanMember2020-10-012020-12-310001444192us-gaap:CommonStockMember2020-03-310001444192acst:StockOptionPlanMemberus-gaap:ResearchAndDevelopmentExpenseMember2020-04-012020-12-310001444192acst:StockOptionPlanMember2020-12-310001444192acst:StockOptionPlanMember2021-10-012021-12-310001444192acst:RKOSupplyAgreementMember2019-10-250001444192us-gaap:AdditionalPaidInCapitalMember2021-06-300001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberus-gaap:ComputerEquipmentMember2021-04-012021-12-310001444192us-gaap:MeasurementInputSharePriceMemberacst:WarrantsIssuedInMay2018Member2021-03-310001444192us-gaap:MeasurementInputPriceVolatilityMemberacst:WarrantsIssuedInMay2018Member2021-03-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-09-300001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberacst:LaboratoryEquipmentMember2021-12-310001444192us-gaap:MeasurementInputExercisePriceMemberacst:WarrantsIssuedDecember272017Member2021-03-310001444192acst:WarrantsIssuedInMay2018Member2020-12-310001444192acst:BrokerWarrantsIssuedMay2018Member2021-12-310001444192acst:BrokerWarrantsIssuedDecember2017Member2021-12-310001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberacst:FurnitureAndOfficeEquipmentMember2021-12-310001444192us-gaap:AdditionalPaidInCapitalMember2020-12-310001444192acst:OverallotmentOptionWarrantsIssuedDecember2017Member2017-12-270001444192acst:CanadianDepositsMember2021-12-310001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberus-gaap:ComputerEquipmentMember2021-12-310001444192acst:WarrantsIssuedDecember272017Member2020-03-3100014441922021-10-012021-12-310001444192acst:StockOptionPlanMember2021-04-012021-12-310001444192acst:WarrantsIssuedInMay2018Member2020-03-310001444192us-gaap:InProcessResearchAndDevelopmentMemberacst:GraceTherapeuticsIncMember2020-08-272020-08-270001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-04-012021-06-300001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-06-3000014441922021-03-310001444192us-gaap:AdditionalPaidInCapitalMember2021-12-310001444192us-gaap:SellingAndMarketingExpenseMemberacst:StockOptionPlanMember2021-10-012021-12-310001444192acst:WarrantsIssuedInMay2018Member2018-05-090001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-03-3100014441922019-02-1400014441922021-12-310001444192us-gaap:SellingAndMarketingExpenseMemberacst:StockOptionPlanMember2021-04-012021-12-310001444192acst:WarrantsIssuedInMay2018Member2021-04-012021-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-310001444192us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001444192us-gaap:MeasurementInputRiskFreeInterestRateMemberacst:WarrantsIssuedInMay2018Member2021-12-310001444192acst:StockOptionPlanMember2021-12-3100014441922021-06-3000014441922022-02-140001444192acst:AtTheMarketOfferingMember2019-02-142019-02-140001444192acst:AtTheMarketOfferingMember2021-04-012021-12-3100014441922021-09-300001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberacst:ProductionEquipmentMember2021-12-310001444192acst:WarrantsIssuedInMay2018Member2020-04-012020-12-3100014441922020-03-310001444192us-gaap:MeasurementInputExercisePriceMemberacst:WarrantsIssuedInMay2018Member2021-03-310001444192acst:WarrantsIssuedDecember272017Member2020-12-310001444192us-gaap:RetainedEarningsMember2021-06-300001444192us-gaap:RetainedEarningsMember2020-09-300001444192us-gaap:RetainedEarningsMember2020-06-3000014441922019-02-012019-02-280001444192acst:StockOptionPlanMemberus-gaap:ResearchAndDevelopmentExpenseMember2021-04-012021-12-310001444192acst:WarrantsIssuedInMay2018Memberus-gaap:MeasurementInputExercisePriceMember2021-12-310001444192acst:DerivativeLiabilityWarrantsMember2021-12-310001444192acst:ReverseStockSplitMember2021-08-312021-08-310001444192us-gaap:MeasurementInputExpectedTermMemberacst:WarrantsIssuedDecember272017Member2021-03-310001444192acst:GraceTherapeuticsIncMember2020-08-270001444192acst:WarrantsIssuedInMay2018Member2021-12-310001444192us-gaap:GeneralAndAdministrativeExpenseMemberacst:StockOptionPlanMember2020-04-012020-12-3100014441922020-06-300001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberacst:ProductionEquipmentMember2021-04-012021-12-310001444192us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-300001444192acst:StockOptionPlanMember2020-08-012020-08-260001444192us-gaap:AdditionalPaidInCapitalMember2021-03-310001444192srt:MaximumMember2019-02-142019-02-140001444192acst:CanadianDepositsMember2021-03-310001444192acst:StockOptionPlanMember2021-03-310001444192us-gaap:MeasurementInputRiskFreeInterestRateMemberacst:WarrantsIssuedDecember272017Member2021-03-310001444192us-gaap:CommonStockMember2021-07-012021-09-300001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberacst:FurnitureAndOfficeEquipmentMember2021-04-012021-12-310001444192acst:DerivativeLiabilityWarrantsMember2021-03-310001444192us-gaap:CommonStockMember2021-03-310001444192acst:WarrantsIssuedInMay2018Member2021-12-310001444192us-gaap:DepositsMember2021-03-3100014441922020-06-290001444192us-gaap:CommonStockMember2020-12-310001444192us-gaap:CommonStockMember2021-06-300001444192acst:GraceTherapeuticsIncMember2021-10-012021-12-310001444192us-gaap:RetainedEarningsMember2020-07-012020-09-300001444192us-gaap:RetainedEarningsMember2020-10-012020-12-310001444192us-gaap:ResearchAndDevelopmentExpenseMember2021-04-012021-12-310001444192us-gaap:CommonStockMember2020-06-300001444192us-gaap:CommonStockMember2020-04-012020-06-300001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-04-012020-06-300001444192us-gaap:RetainedEarningsMember2021-03-310001444192acst:StockOptionPlanMember2020-10-012020-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001444192acst:StockOptionPlanMemberacst:RelatedPartyMember2021-04-012021-12-310001444192acst:WarrantsIssuedDecember272017Member2021-03-310001444192us-gaap:CommonStockMember2021-10-012021-12-310001444192us-gaap:ResearchAndDevelopmentExpenseMember2020-04-012020-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-07-012021-09-300001444192us-gaap:MeasurementInputExercisePriceMemberacst:WarrantsIssuedDecember272017Member2021-12-310001444192us-gaap:AdditionalPaidInCapitalMember2020-04-012020-06-300001444192acst:WarrantsIssuedDecember272017Member2021-12-310001444192us-gaap:GeneralAndAdministrativeExpenseMemberacst:StockOptionPlanMember2021-10-012021-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-09-300001444192acst:OverallotmentOptionWarrantsIssuedInMay2018Member2021-12-310001444192us-gaap:MeasurementInputRiskFreeInterestRateMemberacst:WarrantsIssuedDecember272017Member2021-12-310001444192acst:WarrantsIssuedInConnectionWithPublicOfferingFebruary2017Member2021-12-310001444192us-gaap:AdditionalPaidInCapitalMember2021-09-3000014441922020-09-300001444192us-gaap:SellingAndMarketingExpenseMemberacst:StockOptionPlanMember2020-04-012020-12-310001444192acst:StockOptionPlanMember2020-03-310001444192acst:WarrantsIssuedDecember272017Member2021-12-310001444192us-gaap:RetainedEarningsMember2020-12-310001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMemberacst:LaboratoryEquipmentMember2021-04-012021-12-310001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMember2021-12-310001444192us-gaap:MeasurementInputSharePriceMemberacst:WarrantsIssuedDecember272017Member2021-12-310001444192acst:WarrantsIssuedDecember272017Member2021-04-012021-12-310001444192acst:RKOSupplyAgreementMember2021-12-3100014441922021-04-012021-06-3000014441922021-11-100001444192acst:GraceTherapeuticsIncMember2020-08-272020-08-270001444192us-gaap:MeasurementInputPriceVolatilityMemberacst:WarrantsIssuedDecember272017Member2021-12-310001444192acst:StockOptionPlanMember2020-04-012020-12-310001444192us-gaap:CommonStockMember2020-10-012020-12-310001444192us-gaap:CommonStockMember2021-12-310001444192acst:GraceTherapeuticsIncMember2021-04-012021-12-310001444192us-gaap:RetainedEarningsMember2021-10-012021-12-310001444192us-gaap:AdditionalPaidInCapitalMember2020-09-300001444192us-gaap:MeasurementInputPriceVolatilityMemberacst:WarrantsIssuedInMay2018Member2021-12-310001444192us-gaap:RetainedEarningsMember2021-04-012021-06-3000014441922020-06-292020-06-290001444192acst:WarrantsIssuedDecember272017Member2021-03-310001444192us-gaap:CommonStockMember2021-09-300001444192us-gaap:MeasurementInputSharePriceMemberacst:WarrantsIssuedInMay2018Member2021-12-310001444192us-gaap:SellingAndMarketingExpenseMemberacst:StockOptionPlanMember2020-10-012020-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-06-300001444192us-gaap:AdditionalPaidInCapitalMember2020-03-310001444192us-gaap:MeasurementInputExpectedTermMemberacst:WarrantsIssuedInMay2018Member2021-12-3100014441922019-02-142019-02-140001444192us-gaap:MeasurementInputExpectedTermMemberacst:WarrantsIssuedInMay2018Member2021-03-3100014441922020-04-012020-06-300001444192us-gaap:AdditionalPaidInCapitalMember2020-10-012020-12-310001444192us-gaap:DepositsMember2021-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-10-012020-12-3100014441922020-07-012020-09-300001444192acst:WarrantsIssuedDecember272017Member2020-04-012020-12-310001444192us-gaap:AdditionalPaidInCapitalMember2020-06-300001444192srt:MaximumMember2019-09-012019-09-3000014441922021-04-012021-12-310001444192us-gaap:GeneralAndAdministrativeExpenseMemberacst:StockOptionPlanMember2021-04-012021-12-310001444192us-gaap:MeasurementInputSharePriceMemberacst:WarrantsIssuedDecember272017Member2021-03-310001444192acst:AtTheMarketOfferingMember2020-04-012020-12-3100014441922020-04-012020-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-10-012021-12-3100014441922021-07-012021-09-300001444192us-gaap:MeasurementInputExpectedTermMemberacst:WarrantsIssuedDecember272017Member2021-12-310001444192us-gaap:RetainedEarningsMember2020-04-012020-06-3000014441922020-10-012020-12-310001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-03-310001444192acst:WarrantsIssuedInConnectionWithPublicOfferingFebruary2017Member2021-03-310001444192acst:StockOptionPlanMember2020-08-260001444192acst:WarrantsIssuedInMay2018Member2021-03-310001444192us-gaap:RetainedEarningsMember2021-12-310001444192acst:OverallotmentOptionWarrantsIssuedInMay2018Member2021-03-310001444192us-gaap:RetainedEarningsMember2021-09-300001444192us-gaap:MeasurementInputPriceVolatilityMemberacst:WarrantsIssuedDecember272017Member2021-03-310001444192us-gaap:CommonStockMember2020-09-300001444192acst:StockOptionPlanMemberacst:ConsultantMember2021-04-012021-12-310001444192us-gaap:AdditionalPaidInCapitalMember2021-10-012021-12-310001444192srt:MaximumMember2020-10-012020-10-310001444192us-gaap:RetainedEarningsMember2020-03-310001444192acst:BrokerWarrantsIssuedDecember2017Member2021-03-310001444192us-gaap:MeasurementInputRiskFreeInterestRateMemberacst:WarrantsIssuedInMay2018Member2021-03-310001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMember2021-03-310001444192us-gaap:CommonStockMember2020-07-012020-09-300001444192us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-07-012020-09-300001444192us-gaap:AdditionalPaidInCapitalMember2020-07-012020-09-300001444192us-gaap:RetainedEarningsMember2021-07-012021-09-300001444192srt:MinimumMember2019-02-142019-02-1400014441922020-12-310001444192acst:StockOptionPlanMemberus-gaap:ResearchAndDevelopmentExpenseMember2021-10-012021-12-310001444192us-gaap:DisposalGroupHeldforsaleNotDiscontinuedOperationsMember2021-04-012021-12-310001444192acst:StockOptionPlanMemberus-gaap:ResearchAndDevelopmentExpenseMember2020-10-012020-12-31iso4217:CADxbrli:sharesxbrli:pureiso4217:USDxbrli:sharesxbrli:sharesiso4217:CADiso4217:USD

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________________________________

 

FORM 10-Q

______________________________________

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended December 31, 2021

 

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to

Commission file number: 001-35776

______________________________________

 

Acasti Pharma Inc.

(Exact name of registrant as specified in its charter)

______________________________________

 

Québec, Canada

98-1359336

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer
Identification Number)

 

3009 boul. de la Concorde East, Suite 102

Laval, Québec, Canada H7E 2B5

(Address of principal executive offices, including zip code)

 

450-686-4555

(Registrants telephone number, including area code)

______________________________________

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Shares, no par value per share

ACST

NASDAQ Stock Market

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

 

Non-accelerated filer

 

Smaller reporting company

 

Emerging growth company

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes No ☒

 

The number of outstanding common shares of the registrant, no par value per share, as of February 14 2022, was 44,288,183.

 


 

ACASTI PHARMA INC.

 

QUARTERLY REPORT ON FORM 10-Q

 

For the Quarter Ended December 31, 2021

 

Table of Contents

 

 

 

Page

PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements

7

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

41

 

 

 

Item 4.

Controls and Procedures

41

 

 

 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

42

 

 

 

Item 1A.

Risk Factors

42

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

60

 

 

 

Item 3.

Defaults upon Senior Securities

60

 

 

 

Item 4.

Mine Safety Disclosures

60

 

 

 

Item 5.

Other Information

60

 

 

 

Item 6.

Exhibits

61

 

2


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This quarterly report contains information that may be forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and forward-looking information within the meaning of Canadian securities laws, both of which we refer to in this quarterly report as forward-looking statements. Forward-looking statements can be identified by the use of terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “potential”, “continue” or other similar expressions concerning matters that are not statements about the present or historical facts. Forward-looking statements in this quarterly report include, among other things, information or statements about:

 

our ability to build a premier, late-stage specialty pharmaceutical company focused in rare and orphan disease and, on developing and commercializing products that improve clinical outcomes using our novel drug delivery technologies;
our ability to apply new proprietary formulations to existing pharmaceutical compounds to achieve enhanced efficacy, faster onset of action, reduced side effects, and more convenient drug delivery that can result in increased patient compliance;
the potential for our drug candidates to receive orphan drug designation from the U.S. Food and Drug Administration (“FDA”) or regulatory approval under the Section 505 (b)(2) regulatory pathway under the Federal Food, Drug and Cosmetic Act;
the future prospects of our GTX-104 drug candidate, including but not limited to GTX-104’s potential to be administered to improve the management of hypotension in patients with subarachnoid hemorrhage (“SAH”); GTX-104’s potential to reduce the incidence of vasospasm in SAH patients resulting in better outcomes; the ability of GTX-104 to achieve a pharmacokinetic (“PK”) and safety profile similar to the oral form of nimodipine; GTX-104’s potential to provide improved bioavailability and the potential for reduced use of rescue therapies, such as vasopressors in patients with SAH; the timing of the completion of the PK bridging study, and the timing and outcome of the Phase 3 safety study for GTX-104; our ability to ultimately file a new drug application (“NDA”) for GTX-104 under Section 505 (b)(2) of the Federal Food, Drug and Cosmetic Act; and the timing and ability to receive FDA approval for marketing GTX-104;
the future prospects of our GTX-101 drug candidate, including but not limited to GTX-101’s potential to be administered to postherpetic neuralgia (“PHN”) patients to treat the severe nerve pain associated with the disease; assumptions about the biphasic delivery mechanism of GTX-101, including its potential for rapid onset and continuous pain relief for up to eight hours; and the timing and outcomes of single ascending dose/multiple ascending dose and PK bridging studies, and a Phase 2 and Phase 3 efficacy and safety study; the timing of an NDA filing under Section 505 (b)(2) for GTX-101; and the timing and ability to receive FDA approval for marketing GTX-101;
the future prospects of our GTX-102 drug candidate, including but not limited to GTX-102’s potential to provide clinical benefits to decrease symptoms associated with Ataxia Telangiectasia (“A-T”); GTX-102’s potential ease of drug administration; the timing and outcomes of a PK bridging study and a Phase 3 efficacy and safety study for GTX-102; the timing of an NDA filing under Section 505 (b)(2) in connection with GTX-102; and the ability to receive FDA approval for marketing GTX-102;
the quality of our clinical data, the cost and size of our development programs, expectations and forecasts related to our target markets and the size of our target markets; the cost and size of our commercial infrastructure and manufacturing needs in the United States, European Union, and the rest of the world; and our expected use of a range of third-party contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”) at multiple locations;
expectations and forecasts related to our intellectual property portfolio, including but not limited to the probability of receiving orphan drug designation from the FDA for our leading pipeline products; our patent portfolio strategy; and outcomes of our patent protection filings;
our strategy, future operations, prospects and the plans of our management with a goal to enhance shareholder value, following our recent merger with Grace Therapeutics Inc. (“Grace”);
our intellectual property position and duration of our patent rights;
the potential adverse effects that the COVID-19 pandemic may have on our business and operations;
our need for additional financing, and our estimates regarding our operating runway and timing for future financing and capital requirements;
our expectation regarding our financial performance, including our costs and expenses, liquidity, and capital resources;
our projected capital requirements to fund our anticipated expenses; and
our ability to establish strategic partnerships or commercial collaborations or obtain non-dilutive funding.

 

Although the forward-looking statements in this quarterly report are based upon what we believe are reasonable assumptions, you should not place undue reliance on those forward-looking statements since actual results may vary materially from them. Important assumptions made by us when making forward-looking statements include, among other things, assumptions by us that:

3


 

 

we are able to attract and retain key management and skilled personnel;
third parties provide their services to us on a timely and effective basis;
we are able to take advantage of new business opportunities in the pharmaceutical industry;
we are able to secure and defend our intellectual property rights, and to avoid infringing upon the intellectual property rights of third parties;
the shareholder litigation relating to our merger with Grace is resolved in a manner favorable to us and we face no additional lawsuits or other proceedings, or any such matters, if they arise, are satisfactorily resolved;
there are no material adverse changes in relevant laws or regulations; and
we are able to obtain the additional capital and financing we require when we need it.

 

In addition, the forward-looking statements in this quarterly report are subject to a number of known and unknown risks, uncertainties and other factors many of which are beyond our control, that could cause our actual results and developments to differ materially from those that are disclosed in or implied by the forward-looking statements, including, among others:

 

We may not achieve our publicly announced milestones on time, or at all.
Our future results will suffer if we do not effectively manage our expanded operations.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
We may be subject to foreign exchange rate fluctuations.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
Lawsuits have been filed, and other lawsuits may be filed, against us and members of our board of directors challenging the Grace merger, and any adverse ruling in any such lawsuit may result in an award of damages against us.
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations and our ability to compete.
We may face future product liability, and if claims are brought against us, we may incur substantial liability.
We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.
Even if our drug candidates receive regulatory approval in the United States, we may never obtain regulatory approval or successfully commercialize our products outside of the United States.
We are subject to uncertainty relating to healthcare reform measures and reimbursement policies which, if not favorable to our drug candidates, could hinder or prevent our drug candidates’ commercial success.
Our commercial success depends upon attaining significant market acceptance of our drug products and drug candidates, if approved, among physicians, nurses, pharmacists, patients and the medical community.
Guidelines and recommendations published by government agencies can reduce the use of our drug candidates and negatively impact our ability to gain market acceptance and market share.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug products, if approved, we may be unable to generate any revenue.
If we obtain approval to commercialize any approved drug products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
If we are unable to differentiate our drug products from branded reference drugs or existing generic therapies for similar treatments, or if the FDA or other applicable regulatory authorities approve products that compete with any of our drug products, our ability to successfully commercialize our drug products would be adversely affected.
We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
We could incur substantial costs and disruption to our business and delays in the launch of our drug products if our competitors and/or collaborators bring legal actions against us, which could harm our business and operating results.

4


 

The COVID-19 pandemic, or a similar pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our drug candidates.
We are subject to numerous complex regulatory requirements and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business.
We are heavily dependent on the success of our lead drug candidates, GTX-104, GTX-102 and GTX-101.
If the FDA does not conclude that our drug candidates satisfy the requirements for the 505(b)(2) regulatory approval pathway, or if the requirements for approval of any of our drug candidates under Section 505(b)(2) are not as we expect, the approval pathway for our drug candidates will likely take longer, cost more and we could encounter significantly greater complications and risks than anticipated, and in any case may not be successful.
Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Failure can occur at any stage of clinical development.
Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and could jeopardize or delay our ability to obtain regulatory approval and commence product sales. We may also find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our drug candidates.
Our drug products or drug candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance, or result in significant negative consequences following marketing approval, if any.
The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed.
An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our drug candidate. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Our business is subject to extensive regulatory requirements and our drug candidates that obtain regulatory approval will be subject to ongoing and continued regulatory review, which may result in significant expense and limit our ability to commercialize such products.
Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
Any relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors are and will continue to be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, marketing expenditure tracking and disclosure, or sunshine laws, government price reporting and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face penalties, including, without limitation, civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring of our operations.
We are required to obtain regulatory approval for each of our drug candidates in each jurisdiction in which we intend to market such drug products, and the inability to obtain such approvals would limit our ability to realize their full market potential.
If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
Our success depends in part upon our ability to protect our intellectual property for our drug candidates, such as GTX-104, GTX-102 and GTX-101.
Our drug development strategy relies heavily upon the 505(b)(2) regulatory pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs. Such certifications often result in third-party claims of intellectual property infringement, the defense of which can be costly and time consuming, and an unfavorable outcome in any such litigation may prevent or delay our development and commercialization efforts, which would harm our business.
If we fail to comply with our obligations in the agreements under which we license rights to technology from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.
We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.
We may be subject to claims challenging our inventorship or ownership of our patents and other intellectual property.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect any of our other future drug products and drug candidates.
We may not be able to protect our intellectual property rights throughout the world.

5


 

We do not have internal manufacturing capabilities, and if we fail to develop and maintain supply relationships with various third-party manufacturers, we may be unable to develop or commercialize our drug candidates.
Our contract manufacturers may encounter manufacturing failures that could delay the clinical development or regulatory approval of our drug candidates, or their commercial production, if approved.
We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business could be substantially harmed.
We rely on third parties to manufacture commercial and clinical supplies of our drug candidates, and we intend to rely on third parties to manufacture commercial supplies of any approved drug products. The commercialization of any of our drug products could be stopped, delayed, or made less profitable if those third parties fail to provide us with sufficient quantities of active pharmaceutical ingredients, excipients, or drug products, or fail to do so at acceptable quality levels or prices or fail to maintain or achieve satisfactory regulatory compliance.
The design, development, manufacture, supply, and distribution of our drug candidates are highly regulated and technically complex.
We may not be successful in establishing development and commercialization collaborations which could adversely affect, and potentially prevent, our ability to develop our drug candidates.
We may not be successful in maintaining development and commercialization collaborations, and any partner may not devote sufficient resources to the development or commercialization of our drug candidates or may otherwise fail in development or commercialization efforts, which could adversely affect our ability to develop certain of our drug candidates and our financial condition and operating results.
We may be treated as a passive foreign investment corporation for U.S. federal income tax purposes.
We may not be able to use our net operating loss carryforwards to offset future taxable income for Canadian or U.S. federal income tax purposes.
We do not expect to pay any cash dividends for the foreseeable future.
The price of our common shares may be volatile.
Raising additional capital in the future may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates.
The market price of our common shares could decline as a result of operating results falling below the expectations of investors or fluctuations in operating results each quarter.
An active market for our common shares may not be sustained.
If we fail to meet applicable listing requirements, the NASDAQ Stock Market or the TSX Venture Exchange may delist our common shares from trading, in which case the liquidity and market price of our common shares could decline.
We may pursue opportunities or transactions that adversely affect our business and financial condition.
We are a “smaller reporting company” under the U.S. Securities and Exchange Commission’s (“SEC’s”) disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.
As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.
We are a Québec incorporated company headquartered in Canada, and U.S. investors may be unable to enforce certain judgments against us.

 

All of the forward-looking statements in this quarterly report are qualified by this cautionary statement. There can be no guarantee that the results or developments that we anticipate will be realized or, even if substantially realized, that they will have the consequences or effects on our business, financial condition, or results of operations that we anticipate. As a result, you should not place undue reliance on the forward-looking statements. Except as required by applicable law, we do not undertake to update or amend any forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are made as of the date of this quarterly report.

 

We express all amounts in this quarterly report in U.S. dollars, except where otherwise indicated. References to “$” and “U.S.$” are to U.S. dollars and references to “C$” or “CAD$” are to Canadian dollars.

 

Except as otherwise indicated, references in this quarterly report to “Acasti,” “the Corporation,” “we,” “us” and “our” refer to Acasti Pharma Inc. and its consolidated subsidiaries, including Acasti Pharma U.S., which is formerly Grace.

 

6


 

PART I. FINANCIAL INFORMATION

 

Item 1: Financial Information

 

Unaudited Condensed Consolidated Interim Financial Statements

 

Condensed Consolidated Interim Balance Sheets

 

9

 

 

 

Condensed Consolidated Interim Statements of Loss and Comprehensive Loss

 

10

 

 

 

Condensed Consolidated Interim Statements of Changes Shareholders’ Equity

 

11

 

 

 

Condensed Consolidated Interim Statements of Cash Flows

 

12

 

 

 

Notes to the Condensed Consolidated Interim Financial Statements

 

13

 

7


 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Interim Financial Statements of
(Unaudited)

 

ACASTI PHARMA INC.

 

Three and Nine Months ended December 31, 2021 and 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8


 

ACASTI PHARMA INC.

Condensed Consolidated Interim Balance Sheet

(Unaudited)

 

 

 

 

 

December 31,
2021

 

 

March 31,
2021

 

(Expressed in thousands of U.S. dollars except share data)

 

Notes

 

$

 

 

$

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

 

 

33,013

 

 

 

50,942

 

Short-term investments

 

5

 

 

13,312

 

 

 

9,789

 

Receivables

 

 

 

 

238

 

 

 

530

 

Assets held for sale

 

7

 

 

587

 

 

 

768

 

Prepaid expenses

 

 

 

 

1,847

 

 

 

343

 

Total current assets

 

 

 

 

48,997

 

 

 

62,372

 

 

 

 

 

 

 

 

 

 

Right of Use asset

 

 

 

 

22

 

 

 

86

 

Intangible assets

 

4

 

 

65,208

 

 

 

 

Total assets

 

 

 

 

114,227

 

 

 

62,458

 

 

 

 

 

 

 

 

 

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Trade and other payables

 

 

 

 

2,843

 

 

 

1,493

 

Lease liability

 

 

 

 

22

 

 

 

86

 

Derivative warrant liabilities

 

8

 

 

32

 

 

 

 

Total current liabilities

 

 

 

 

2,897

 

 

 

1,579

 

 

 

 

 

 

 

 

 

 

Derivative warrant liabilities

 

8

 

 

268

 

 

 

5,219

 

Total liabilities

 

 

 

 

3,165

 

 

 

6,798

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

Common shares

 

4,9(a)

 

 

257,990

 

 

 

197,194

 

Additional paid-in capital

 

 

 

 

11,538

 

 

 

10,817

 

Accumulated other comprehensive loss

 

 

 

 

(6,533

)

 

 

(6,333

)

Accumulated deficit

 

 

 

 

(151,933

)

 

 

(146,018

)

Total shareholder’s equity

 

 

 

 

111,062

 

 

 

55,660

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total liabilities and shareholders’ equity

 

 

 

 

114,227

 

 

 

62,458

 

 

See accompanying notes to unaudited Interim financial statements.

9


 

ACASTI PHARMA INC.

Condensed Consolidated Interim Statements of Loss and Comprehensive Loss

(Unaudited)

 

Three and Nine Months ended December 31, 2021 and 2020

 

 

 

 

 

Three-month ended

 

 

Nine Months ended

 

 

 

 

 

December 31,
2021

 

 

December 31,
2020

 

 

December 31,
2021

 

 

December 31,
2020

 

(Expressed in thousands of U.S dollars, except per share data)

 

Notes

 

$

 

 

$

 

 

$

 

 

$

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues from product sales

 

 

 

 

 

 

81

 

 

 

 

 

81

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales of products

 

 

 

 

 

 

 

(36

)

 

 

 

 

 

(36

)

Research and development expenses, net of government assistance

 

10

 

 

(2,179

)

 

 

(678

)

 

 

(3,233

)

 

 

(3,720

)

General and administrative expenses

 

 

 

 

(1,808

)

 

 

(1,105

)

 

 

(7,441

)

 

 

(4,078

)

Sales and marketing expenses

 

 

 

 

(238

)

 

 

(226

)

 

 

(263

)

 

 

(1,076

)

Impairment of intangible assets

 

6

 

 

 

 

 

 

 

 

 

 

 

(3,706

)

Impairment of equipment

 

7

 

 

 

 

 

 

 

 

 

 

 

(1,584

)

Impairment of Other asset and prepaid

 

7

 

 

(249

)

 

 

 

 

 

(249

)

 

 

 

Loss from operating activities

 

 

 

 

(4,474

)

 

 

(1,964

)

 

 

(11,186

)

 

 

(14,119

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial income (expenses)

 

12

 

 

696

 

 

 

(1,256

)

 

 

5,271

 

 

 

87

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and total comprehensive loss

 

 

 

 

(3,778

)

 

 

(3,220

)

 

 

(5,915

)

 

 

(14,032

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per share

 

 

 

 

(0.09

)

 

 

(0.26

)

 

 

(0.23

)

 

 

(1.18

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding

 

 

 

 

44,288,183

 

 

 

12,533,584

 

 

 

25,785,579

 

 

 

11,922,119

 

 

See accompanying notes to unaudited interim financial statements

10


 

ACASTI PARMA INC.

Condensed Consolidated Interim Statements of Changes in Shareholder’s Equity

(Unaudited)

 

Three and Nine Months ended December 31, 2021 and 2020

 

 

 

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

(Expressed in thousands of U.S. dollars except share data)

 

Notes

 

 

Number

 

 

Dollar

 

 

Additional
paid-in
capital

 

 

Accumulated
other
comprehensive
loss

 

 

Accumulated
deficit

 

 

Total

 

 

 

 

 

 

 

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Balance, March 31, 2021

 

 

1

 

 

 

26,046,950

 

 

 

197,194

 

 

 

10,817

 

 

 

(6,333

)

 

 

(146,018

)

 

 

55,660

 

Net loss and total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,118

)

 

 

(3,118

)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

762

 

 

 

 

 

 

762

 

Stock based compensation

 

 

13

 

 

 

 

 

 

 

 

 

153

 

 

 

 

 

 

 

 

 

153

 

Balance at June 30, 2021

 

 

 

 

 

26,046,950

 

 

 

197,194

 

 

 

10,970

 

 

 

(5,571

)

 

 

(149,136

)

 

 

53,457

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income and total comprehensive income for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

981

 

 

 

981

 

Cumulative translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,149

)

 

 

 

 

 

(1,149

)

Stock based compensation

 

 

13

 

 

 

 

 

 

 

 

 

114

 

 

 

 

 

 

 

 

 

114

 

Common shares issued in relation to merger with Grace via share-for-share

 

 

4

 

 

 

18,241,233

 

 

 

60,801

 

 

 

 

 

 

 

 

 

 

 

 

60,801

 

Balance at September 30, 2021

 

 

 

 

 

44,288,183

 

 

 

257,995

 

 

 

11,084

 

 

 

(6,720

)

 

 

(148,155

)

 

 

114,204

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,778

)

 

 

(3,778

)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

187

 

 

 

 

 

 

187

 

Stock based compensation

 

 

13

 

 

 

 

 

 

 

 

 

454

 

 

 

 

 

 

 

 

 

454

 

Fees related to share-for-share issuance for merger with Grace

 

 

4

 

 

 

 

 

 

(5

)

 

 

 

 

 

 

 

 

 

 

 

(5

)

Balance at December 31, 2021

 

 

 

 

 

44,288,183

 

 

 

257,990

 

 

 

11,538

 

 

 

(6,533

)

 

 

(151,933

)

 

 

111,062

 

 

 

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

(Expressed in thousands of US dollars except for share data)

 

Notes

 

Number

 

 

Dollar

 

 

Additional
paid-in
capital

 

 

Accumulated
other
comprehensive
loss

 

 

Accumulated
deficit

 

 

Total

 

 

 

 

 

 

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Balance, March 31, 2020

 

 

 

 

90,209,449

 

 

 

137,424

 

 

 

9,797

 

 

 

(7,887

)

 

 

(126,340

)

 

 

12,994

 

Net loss and total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,666

)

 

 

(4,666

)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

308

 

 

 

 

 

 

308

 

Net proceeds from shares issued under the at-the-market (ATM) program

 

9(a)

 

 

2,278,936

 

 

 

1,765

 

 

 

 

 

 

 

 

 

 

 

 

1,765

 

Stock based compensation

 

13

 

 

 

 

 

 

 

 

635

 

 

 

 

 

 

 

 

 

635

 

Balance at June 30, 2020

 

 

 

 

92,488,385

 

 

 

139,189

 

 

 

10,432

 

 

 

(7,579

)

 

 

(131,006

)

 

 

11,036

 

Net loss and total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,146

)

 

 

(6,146

)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

179

 

 

 

 

 

 

179

 

Net proceeds from shares issued under the at-the-market (ATM) program

 

9(a)

 

 

4,404,152

 

 

 

3,427

 

 

 

 

 

 

 

 

 

 

 

 

3,427

 

Stock based compensation

 

 

 

 

(23,394

)

 

 

(46

)

 

 

423

 

 

 

 

 

 

 

 

 

377

 

Balance at September 30, 2020

 

 

 

 

96,869,143

 

 

 

142,570

 

 

 

10,855

 

 

 

(7,400

)

 

 

(137,152

)

 

 

8,873

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,220

)

 

 

(3,220

)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

466

 

 

 

 

 

 

466

 

Net proceeds from shares issued under the at-the-market (ATM) program

 

9(a)

 

 

59,204,624