10-K
1
f10k_062221p.htm
FORM 10-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended March 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)
Registrant’s telephone number, including area code: 450-687-2262
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
Common Shares, no par value per share
NASDAQ Stock Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes ☐ No
☒
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
1
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 if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy
or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
☒
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 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 has filed a report on and
attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b)
of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
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 aggregate market value of the voting and non-voting
common shares held by non-affiliates of the registrant, based on the closing sale price of the registrant’s common shares on the
last business day of its most recently completed second fiscal quarter, as reported on the NASDAQ Stock Market, was approximately $19,373,829.
The number of outstanding common shares of the registrant, no par value
per share, as of June 22 , 2021, was 208,375,549.
2
ACASTI PHARMA INC.
FORM 10-K
For the Fiscal Year Ended March 31, 2021
Table of Contents
PART I
Item 1.
Business
6
Item 1A.
Risk Factors
9
Item 1B.
Unresolved Staff Comments
19
Item 2.
Properties
19
Item 3.
Legal Proceedings
20
Item 4.
Mine Safety Disclosures
20
PART II
Item 5.
Market for Registrant’s Common Equity, Related Shareholder Matters
and Issuer Purchases of Equity Securities
60
Item 6.
Selected Financial Data
66
Item 7.
Management’s Discussion and Analysis of Financial Condition
and Results of Operation
66
Item 7A.
Quantitative and Qualitative Disclosure About Market Risk
82
Item 8.
Financial Statements and Supplementary Data
83
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial
Disclosure
83
Item 9A.
Controls and Procedures
83
Item 9B.
Other Information
83
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
84
Item 11.
Executive Compensation
87
Item 12.
Security Ownership of Certain Beneficial Owners and Management and
Related Shareholder Matters
95
Item 13.
Certain Relationships and Related Transactions and Director Independence
96
Item 14.
Principal Accounting Fees and Services
100
PART IV
Item 15.
Exhibits, Financial Statement Schedules
101
SIGNATURES
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains information that may be forward-looking
information within the meaning of Canadian securities laws and forward-looking statements within the meaning of U.S. federal securities
laws, both of which we refer to in this annual report as forward-looking information. Forward-looking information 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 information
in this annual report includes, among other things, information or statements about:
·
our strategy, future operations, prospects and the plans of our management with
a goal to enhance shareholder value, including our proposed merger with Grace Therapeutics Inc. (“Grace”);
·
the outcome of our formal review process to explore and evaluate strategic alternatives
to enhance shareholder value;
·
our ability to establish collaborations or obtain additional funding;
·
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 future financing
and capital requirements;
·
our expectation regarding our financial performance, including our costs and
expenses, liquidity and capital resources; and
·
our projected capital requirements to fund our anticipated expenses.
Although the forward-looking information in this annual report
is based upon what we believe are reasonable assumptions, you should not place undue reliance on that forward-looking information since
actual results may vary materially from it. Important assumptions made by us when making forward-looking statements include, among other
things, assumptions by us that:
·
we are able to complete our proposed merger with Grace;
·
we are able to obtain the additional capital and financing we require when we
need it;
·
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;
·
we face no 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 continue as a going concern;
4
In addition, the forward-looking information in this annual report
is subject to a number of known and unknown risks, uncertainties and other factors, including those described in this annual report under
the heading “Item 1A. Risk 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 information, including, among others:
·
our proposed merger with Grace is subject to various closing conditions and if the proposed merger does
not close we may never identify a suitable alternative opportunity to enhance shareholder value through our strategic review process;
·
if we do not successfully consummate our proposed merger with Grace or an alternative strategic transaction,
our board of directors may decide to pursue a dissolution and liquidation of our company;
·
we are substantially dependent on our remaining employees to facilitate the
consummation of our proposed merger with Grace or another alternative strategic transaction;
·
we may not realize any additional value in a strategic transaction for our intellectual property;
·
our business and operations may be materially and adversely affected by the
COVID-19 pandemic;
·
we may be subject to foreign exchange rate fluctuations;
·
it is difficult and costly to protect our intellectual property rights;
·
we may face infringement of third party intellectual property and other proprietary
rights; and
·
general changes in economic and capital market conditions could adversely affect
us
All of the forward-looking information in this annual report
is 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 information. Except as required
by applicable law, we do not undertake to update or amend any forward-looking information, whether as a result of new information, future
events or otherwise. All forward-looking information is made as of the date of this annual report.
We express all amounts in this annual report in U.S. dollars, except where
otherwise indicated. References to “$” and “US$” are to U.S. dollars and references to “C$” or “CAD$”
are to Canadian dollars.
Except as otherwise indicated, references in this annual report to “Acasti,”
“the Corporation,” “we,” “us” and “our” refer to Acasti Pharma Inc. and its consolidated
subsidiaries.
5
PART I
Item 1.
Business
Overview
We are a biopharmaceutical
innovator that has historically focused on the research, development and commercialization of cardiometabolic prescription drugs using
omega-3, or OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids
have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. Our lead
product candidate was CaPre, an OM3 phospholipid therapeutic. As a result of disappointing results from our two TRILOGY phase 3 trials,
we publicly disclosed that our board had commenced a formal process to explore and evaluate a range of strategic alternatives to enhance
shareholder value, and that it had engaged Oppenheimer & Co. as its financial advisor to assist in that process. Since that announcement,
we continue to maintain an active pharmaceutical development business, including retaining key research and development, finance and administrative
personnel. We have completed a pooled analysis of the TRILOGY data and we have prepared a manuscript for publication, which has been submitted
to a major journal. We continue to manage ongoing regulatory filing obligations with the Federal Drug Administration, or the FDA, and,
evaluate potential strategic partnerships for the continued clinical development of CaPre. We also continue to maintain and further develop
valuable CaPre assets including additional patent filings and ongoing prosecutions, and maintenance of our commercial manufacturing equipment.
Since September 2020, we increased our available cash by approximately $54.4 million through financing activities, which has served to
strengthen Acasti’s balance sheet while providing additional flexibility and leverage while we worked through our strategic evaluation
process and advancement of a potential commercial partnership for CaPre. On May 7, 2021, we announced our intent to acquire Grace through
an acquisition. Grace is a New Jersey-based life sciences company focused on novel and innovative drug delivery technologies designed
to improve clinical outcomes in rare and orphan disease treatments. Grace’s scientific and product development efforts are focused
in cardiovascular, central nervous system and gastrointestinal disorders.
Recent Developments
TRILOGY 1 & 2 Topline Results
Our two Phase 3 clinical trials, designated as
TRILOGY 1 & 2 randomized a total of 242 and 278 patients respectively, and were designed to evaluate the efficacy, safety and tolerability
of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020, and August 31, 2020 respectively,
and neither TRILOGY 1 nor TRILOGY 2 met their primary endpoint for lowering triglycerides at 12 weeks. CaPre was well tolerated in TRILOGY,
with a safety profile similar to placebo, and consistent with our previously conducted Phase 2 and 3 studies. Given the outcome of the
TRILOGY studies we will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe
hypertriglyceridemia, and we do not plan to conduct additional clinical trials for CaPre. Instead, we plan to continue to advance discussions
with third parties who are interested in pursuing clinical development and regulatory approval for CaPre.
Engaged Oppenheimer & Co. Inc. to Assist in Strategic Review
On September 29, 2020, we announced that we had commenced a formal process
to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, we engaged Oppenheimer & Co., Inc.
as our financial advisor to assist in the process. We have devoted significant time and resources to identifying and evaluating strategic
alternatives, which led to the announced pending transaction with Grace. However, there can be no assurance that our proposed merger with
Grace will close, or of the timing of any such outcome. We have also devoted significant time and resources to identify and evaluate potential
strategic partnerships for CaPre; however, there can be no assurance that such activities will result in any agreements or transactions
that will enhance shareholder value. We do not intend to make any further disclosures regarding the strategic process for CaPre unless
and until a specific course of action is approved by our board of directors.
6
Definitive Agreement to Acquire Grace Therapeutics, Inc .
On May 7, 2021, we announced a definitive agreement
to acquire Grace. Subject to the completion of the Proposed Transaction, we will acquire Grace’s pipeline of drug candidates addressing
critical unmet medical needs for the treatment of rare and orphan diseases. The Proposed Transaction has been approved by the boards of
directors of both companies and is supported by a majority of Grace stockholders through voting and lock-up agreements with Acasti. The
transaction remains subject to approval of our shareholders, as well as applicable stock exchanges.
In connection with the Proposed Transaction, we
will acquire Grace’s entire therapeutic pipeline consisting of three unique clinical stage and multiple pre-clinical stage assets
supported by an intellectual property portfolio consisting of more than 40 granted and pending patents in various jurisdictions worldwide.
Grace’s product candidates aim to improve clinical outcomes by applying proprietary formulation and drug delivery technologies to
existing pharmaceutical compounds to achieve improvements over the current standard of care, or to provide treatment for diseases with
no currently approved therapy. Grace’s three lead programs have all received Orphan Drug Designation from the FDA, which could
provide up to seven years of marketing exclusivity in the United States upon the FDA’s approval of the NDA, provided that certain
conditions are met.
Management and Operations
Subject to shareholder approval of the Proposed
Transaction, the combined companies will be led by Jan D’Alvise as President and Chief Executive Officer (“CEO”) and
will continue to maintain our corporate headquarters in Laval, Quebec, Canada. It is expected that all Grace employees will transition
to Acasti and they will continue to maintain an R&D laboratory and commercial presence in North Brunswick, New Jersey. The new board
of directors of the combined company will be composed of 4 representatives from Acasti and 3 representatives from Grace.
About the Proposed Transaction
Pending approval by our shareholders as well as
applicable stock exchange approvals, Grace will merge with a new wholly owned subsidiary of Acasti. Grace stockholders will receive newly
issued Acasti common shares pursuant to an equity exchange ratio formula set forth in the merger agreement. Under the terms of the definitive
agreement, immediately following the consummation of the Proposed Transaction, Acasti’s shareholders on a pro forma basis would
own approximately 55% of the combined company’s common shares, and Grace’s stockholders would own approximately 45% of the
combined company’s common shares, in each case calculated on a fully-diluted basis, subject to upward adjustments in favor of Acasti
shareholders based on each company’s capitalization and net cash balance as set forth in the merger agreement. For illustrative
purposes, assuming no adjustments for each company’s capitalization and net cash balance and based on 208,375,549 Acasti common
shares currently issued and outstanding, an aggregate of up to 170,489,086 Acasti common would be issued to Grace stockholders as consideration
for the Proposed Transaction.
In connection with the entering into the merger
agreement, all significant stockholders of Grace have entered into voting and lock-up agreements with Acasti pursuant to which they have
agreed, amongst other things to (i) vote their shares of Grace in favor of the Proposed Transaction, (ii) be subject to lock-up provisions
for a period of 12 months (subject to certain exceptions), and (iii) support the election of board nominees specified in the voting and
lock-up agreements through to the 2023 annual general meeting of shareholders.
The Proposed Transaction is expected to close
in calendar the third quarter of 2021, immediately following approval by the Acasti shareholders, subject to any applicable U.S. Securities
and Exchange Commission (“SEC”) review and stock exchange approvals, as well as satisfaction of other closing conditions by
each company specified in the definitive agreement.
Oppenheimer & Co. is acting as the Acasti’s
financial advisor for the Proposed Transaction and Osler, Hoskin & Harcourt, LLP is serving as its legal counsel. William Blair &
Company, LLC is serving as financial advisor to Grace, with Reed Smith, LLP serving as its legal counsel.
7
The Proposed Transaction is an arm’s length
transaction in accordance with the policies of the TSX Venture Exchange.
Nasdaq Update
On May 11, 2021, Acasti received written notice
from the Nasdaq Listing Qualifications Department notifying Acasti that based upon Acasti’s non-compliance with the $1.00 bid price
requirement set forth in Nasdaq Listing Rule 5550(a) as of May 10, 2021, Acasti common shares were subject to delisting unless Acasti
timely requests a hearing before the Nasdaq Hearings Panel. Acasti requested a hearing, which stayed any further action by Nasdaq pending
the conclusion of the hearing process.
At the hearing on June 17, 2021, Acasti presented
a detailed plan of compliance for the Nasdaq Listing Panel’s consideration, which included Acasti’s commitment to implement
a share consolidation in connection with the Proposed Transaction. Acasti expects to receive the Nasdaq Listing Panel’s decision
within 30 days after the hearing date. There can be no assurance that Nasdaq will accept Acasti’s plan or that Acasti will be able
to regain compliance with Nasdaq’s listing rules or maintain compliance with any other Nasdaq requirement in the future. The approval
by Nasdaq of (i) the continued listing of Acasti’s common shares on Nasdaq following the effective time and (ii) the listing of
the Acasti common shares being issued in connection with the merger on Nasdaq at or prior to the effective time are conditions to the
closing of the merger.
COVID-19 Update
To date, the ongoing COVID-19 pandemic has not caused significant disruptions
to our business operations and research and development activities.
The extent to which the COVID-19 pandemic impacts our business and prospects
will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning
the severity of the COVID-19 pandemic and the actions to contain the COVID-19 pandemic or treat its impact, among others.
Corporate Structure
Acasti was incorporated on February 1, 2002 under Part 1A of the Companies
Act (Québec) under the name “9113-0310 Québec Inc.” On February 14, 2011, the Business Corporations
Act (Québec), or QBCA, came into effect and replaced the Companies Act (Québec). We are now governed by the QBCA.
On August 7, 2008, pursuant to a Certificate of Amendment, we changed our name to “Acasti Pharma Inc.”, our share capital
description, the provisions regarding the restriction on securities transfers and our borrowing powers. On November 7, 2008, pursuant
to a Certificate of Amendment, we changed the provisions regarding our borrowing powers. We became a reporting issuer in the Province
of Québec on November 17, 2008. On December 18, 2019, we incorporated a new wholly owned subsidiary named Acasti Innovation
AG, or AIAG, under the laws of Switzerland for the purpose of future development of our intellectual property and for global distribution
of our products. AIAG currently does not have any operations.
Available Information
This annual report on Form 10-K, our quarterly reports on Form 10-Q, our
current reports on Form 8-K, and any amendments to these reports are filed, or will be filed, as applicable, with the SEC, and the Canadian
Securities Administrators, or CSA. These reports are available free of charge on our website, www.acastipharma.com, as soon as reasonably
practicable after we electronically file such reports with or furnish such reports to the SEC and the CSA. Information contained on, or
accessible through, our website is not a part of this annual report, and the inclusion of our website address in this document is an inactive
textual reference.
Additionally, our filings with the SEC may be accessed through the SEC’s
website at www.sec.gov and our filings with the CSA may be accessed through the CSA’s System for Electronic Document Analysis and
Retrieval at www.sedar.com.
8
Item 1A.
Risk Factors
Any investment in our common Shares involves a high degree of risk.
The following risk factors and other information included in this Quarterly Report on Form 10-Q should be carefully considered. If any
of these risks actually occur, our business, financial condition, prospects, results of operations or cash flow could be materially and
adversely affected, and you could lose all or a part of the value of your investment. Additional risks or uncertainties not currently
known to us, or that we deem immaterial, may also negatively affect our business operations.
In addition, on May 7, 2021, Acasti entered into a merger agreement
with Grace, pursuant to which, subject to the approval of Acasti shareholders and the satisfaction or waiver of the conditions set forth
in the merger agreement, Grace would become a wholly-owned subsidiary of Acasti, referred to herein as the merger.
Risks Related to the Merger
The equity exchange ratio will not be adjusted in the event of any
change in Acasti's share price.
If the merger is completed, at the effective time of the merger, each issued
and outstanding share of Grace common stock will automatically be converted into the right to receive a number of Acasti common shares
per share of Grace common stock equal to the equity exchange ratio set forth in the merger agreement such that, immediately following
the consummation of the merger, existing Acasti shareholders are expected to own at least 55% and existing Grace stockholders are expected
to own at most 45% of the outstanding capital stock of the combined company on a fully-diluted basis. The equity exchange ratio is subject
to upward adjustment in favor of Acasti shareholders based on each company’s capitalization and net cash balance at the effective
time of the merger, as specified in the merger agreement. For more information on the equity exchange ratio, see the merger agreement
filed as exhibit 2.1 to this annual. The equity exchange ratio will not be adjusted for changes in the market price of Acasti common shares.
As a result, changes in the price of Acasti common shares prior to completion of the merger will affect the market value of the share
considerations that Grace stockholders will receive in the merger. Changes in the Acasti common share price may result from a variety
of factors (many of which are beyond Acasti’s control), including the following:
•
changes in Acasti’s and Grace’s respective businesses, operations and prospects, or the market assessments thereof;
•
market assessments of the likelihood that the merger will be completed; and
•
general market and economic conditions and other factors generally affecting the price of Acasti common shares.
The price of Acasti common shares at the closing of the merger may vary
from the price on the date the merger agreement was executed, the date of this annual report and the date of the annual and special meeting
of Acasti shareholders. As a result, the market value of the merged entity will also vary. For example, based on the range of closing
prices of Acasti common shares during the period from May 6, 2021, which was the last trading day before the public announcement of the
execution of the merger agreement, through June 18, 2021, the estimated equity exchange ratio represented a market value ranging from
a low of approximately $2.47 to a high of approximately $3.07 for each share of Grace common stock.
Because the merger will be completed after the date of the Acasti
annual and special shareholders meeting and the Grace stockholder approval, you will not know, at the time of the Acasti annual and special
shareholder meeting or the Grace stockholder approval, the market value of the Acasti common shares that Grace stockholders will receive
upon completion of the merger.
If the price of Acasti common shares increases between the time of the
Acasti annual and special meeting or the Grace stockholder approval and the time at which Acasti common shares are distributed to Grace
stockholders following completion of the merger, Grace stockholders will receive Acasti common shares that have a market value that is
greater than the market value of such shares at the time of the Acasti annual and special meeting or the Grace stockholder approval. Conversely,
if the price of Acasti common shares decreases between the time of the Acasti annual and special meeting or Grace stockholder approval
and the time at which Acasti common shares are distributed to Grace stockholders following completion of the merger, Grace stockholders
will receive Acasti common shares that have a market value that is less than the market value of such shares at the time of the Acasti
annual and special meeting or the Grace stockholder approval. Therefore, Grace stockholders and Acasti shareholders will not have certainty
at the time of the Acasti annual and special meeting or the Grace stockholder approval of the market value of the consideration that will
be paid to Grace stockholders upon completion of the merger.
9
Failure to complete the merger could negatively impact the share
prices and the future business and financial results of Acasti.
If the merger is not completed, the ongoing businesses of Acasti may be
adversely affected. Additionally, if the merger is not completed and the merger agreement is terminated, in certain circumstances, either
Acasti or Grace may be required to pay to the other a termination fee of $1,000,000 including any reimbursement the other party’s
expenses up to a maximum of $500,000. Even if a termination fee or expenses of the other party are not payable in connection with a termination
of the merger agreement, Acasti has incurred significant transaction expenses in connection with the merger regardless of whether the
merger is completed. The foregoing risks, or other risks arising in connection with the failure of the merger, including the diversion
of management attention from conducting the business of Acasti and pursuing other opportunities during the pendency of the merger, may
have an adverse effect on the business, operations, and financial results of Acasti as well the price of Acasti common shares. In addition,
Acasti could be subject to litigation related to any failure to consummate the merger transaction or any related action that could be
brought to enforce a party’s obligations under the merger agreement.
The merger agreement contains provisions that could discourage a
potential competing acquirer of either Acasti or Grace.
The merger agreement contains “no shop” provisions that, subject
to limited exceptions, restrict Acasti’s and Grace’s ability to solicit, encourage, facilitate, or discuss competing third
party proposals to acquire shares or assets of Acasti or Grace. In specified circumstances, upon termination of the merger agreement,
Acasti or Grace will be required to pay the termination fee to the other party. In the event that either Acasti or Grace receives an alternative
acquisition proposal, the other party has the right to propose changes to the terms of the merger agreement before the Acasti or Grace
board of directors may withdraw or qualify its recommendation with respect to the merger and related transactions.
These provisions could discourage a potential competing acquirer that might
have an interest in acquiring all or a significant part of Acasti from considering or proposing that acquisition, even if it were prepared
to pay consideration with a higher per share cash or market value than the market value proposed to be received or realized in the merger,
or might result in a potential competing acquirer proposing to pay a lower price than it might otherwise have proposed to pay because
of the added expense of the termination fee that may become payable in specified circumstances. Acasti’s and Grace’s right
to match specified alternative acquisition proposals with respect to the other party could also discourage potential competing acquirers
from considering or proposing that acquisition.
If the merger agreement is terminated and Acasti determines to seek another
transaction, it may not be able to negotiate a transaction with another party on terms comparable to, or better than, the terms of the merger.
The merger may be completed even though certain events occur prior
to the closing that materially and adversely affect Acasti or Grace.
The merger agreement provides that either Acasti or Grace can refuse to
complete the merger if there is a material adverse change affecting the other party prior to the closing. However, certain types of changes
do not permit either party to refuse to complete the merger, even if such change could be said to have a material adverse effect on Acasti
or Grace, including, among others:
·
changes, developments or conditions in or relating to general international, political, economic or financial
or capital market conditions, or political, economic or financial or capital market conditions in any jurisdiction in which Acasti and
Grace operate or carry on business;
10
·
changes, developments or conditions resulting from any act of sabotage or terrorism or any outbreak of hostilities
or declared or undeclared war, or any escalation or worsening of such acts of sabotage, terrorism, hostilities or war;
·
any natural disaster;
·
changes or developments in or relating to currency exchange or interest rates;
·
changes or developments affecting the pharmaceutical industry in general;
·
any change in applicable laws (other than orders against a party or a subsidiary thereof) or U.S. GAAP;
·
except for purposes of representations regarding required approvals in connection with the merger and the
absence of violations of law, the parties' respective constating documents or material contracts of the parties or changes in permits
held by the parties as a result of the consummation of the transactions contemplated by the merger agreement, the announcement of the
execution of the merger agreement or the transactions contemplated thereby;
·
any actions taken (or omitted to be taken) by Acasti or Grace upon the express written request of the other;
·
any changes in the share price or trading volume of Acasti common shares or any failure of Grace to meet projections,
guidance, milestones, forecasts or published financial or operating predictions or measures (it being agreed that the facts and circumstances
giving rise to any of the foregoing events or failures, unless expressly excluded, may be taken into account in determining whether a
material adverse effect has occurred);
·
the COVID-19 pandemic or other epidemic or pandemic outbreaks including any continuation or worsening thereof;
or
·
a share consolidation of Acasti.
If an adverse change occurs and Acasti and Grace still complete the merger,
the business, operations or prospects of the combined company, or the market price of its common shares, may suffer. This in turn may
reduce the value received by the shareholders of Acasti in connection with the merger.
If the conditions to the merger are not satisfied or waived, the
merger may not occur. If the merger is consummated, it will result in substantial dilution to Acasti shareholders and may not deliver
the anticipated benefits Acasti expects.
Even if the merger is approved by the shareholders of Acasti and the stockholders
of Grace, specified other conditions must be satisfied or waived to complete the merger. These conditions are set forth in the merger
agreement filed as exhibit 2.1 to this annual report. Acasti cannot assure you that all of the conditions will be satisfied or waived.
Certain of the closing conditions are legally incapable of being waived. If the conditions are not satisfied or waived, the merger may
not occur or will be delayed, and Acasti may lose some or all of the intended benefits of the merger. If consummated, the merger will
result in dilution to Acasti’s shareholders and could result in other restrictions that may affect its business. Further, if completed,
the merger ultimately may not deliver the anticipated benefits or enhance shareholder value.
The combined company may become involved in securities class action
litigation that could divert management’s attention and harm the combined company’s business and insurance coverage may not
be sufficient to cover all costs and damages.
In the past, securities class action or shareholder derivative litigation
often follows certain significant business transactions, such as the sale of a business division or announcement of a merger. The combined
company may become involved in this type of litigation in the future. Litigation is often expensive and diverts management’s attention
and resources, which could adversely affect the combined company’s business.
Acasti has received notice from Nasdaq of non-compliance with the
Nasdaq Listing Rules.
On May 11, 2021, Acasti received written notice from the Nasdaq Listing
Qualifications Department notifying Acasti that based upon Acasti’s non-compliance with the $1.00 bid price requirement set forth
in Nasdaq Listing Rule 5550(a) as of May 10, 2021, Acasti securities were subject to delisting unless the Company timely requested a hearing
before the Nasdaq Hearings Panel.
Acasti requested a hearing, which stayed any further action by Nasdaq pending
the conclusion of the hearing process.
11
At the hearing, on June 17, 2021, Acasti presented a detailed plan of compliance
for the Nasdaq Listing Panel’s consideration, which included Acasti’s commitment to implement a share consolidation if needed
to evidence compliance with Nasdaq listing rules. Acasti expects to receive the Nasdaq Listing Panel’s decision 30 days after the
hearing date. There can be no assurance that Nasdaq will accept Acasti’s plan or that Acasti will be able to regain compliance with
Nasdaq’s listing rules or maintain compliance with any other Nasdaq requirement in the future. The approval by Nasdaq of (i) the
continued listing of Acasti’s common shares on Nasdaq following the effective time and (ii) the listing of the Acasti common shares
being issued in connection with the merger on Nasdaq at or prior to the effective time are conditions to the closing of the merger.
We may be subject to foreign exchange rate fluctuations.
Our reporting currency is the U.S. dollar. However, many of our expenses
are denominated in foreign currencies, including Canadian dollars. As we previously completed financings in both Canadian and U.S. dollars,
both currencies are maintained and used to make required payments in the applicable currency. Though we plan to implement measures designed
to reduce our foreign exchange rate exposure, the U.S. dollar/Canadian dollar and U.S. dollar /European euro exchange rates have fluctuated
significantly in the recent past and may continue to do so, which could have a material adverse effect on our business, financial position
and results of operations.
Risks Related to Intellectual Property
We may not realize any additional value
in a strategic transaction for our intellectual property.
The market capitalization of our corporation is
or may be below the value of our cash, cash equivalents and marketable securities at the time of consummation of any strategic transaction.
Although the CaPre clinical trial failed to meet its primary endpoints, we believe that data from preclinical and other clinical studies
of CaPre may support potential further investigation and development activities. However, potential counterparties in a strategic transaction
involving our corporation may place minimal or no value on our assets, given the limited data regarding their potential application. Further,
the development and any potential commercialization of investigational CaPre will require substantial additional funding associated with
conducting the necessary clinical testing and obtaining regulatory approval. Consequently, any potential counterparty in a strategic transaction
involving our corporation may choose not to spend additional resources and continue development of CaPre and may attribute little or no
value, in such a transaction, to CaPre or our other intellectual property.
It is difficult and costly to protect our intellectual property rights.
It is possible that our patents and/or proprietary technologies in the
future could be circumvented through the adoption of competitive, though non-infringing, processes or products. The patent positions of
pharmaceutical companies can be highly uncertain and involve complex legal, scientific and factual questions for which important legal
principles remain unresolved. Changes in either the patent laws or in interpretations of patent laws may diminish the value of our intellectual
property. We cannot predict the breadth of claims that may be allowable or enforceable in our patents, or of patents licensed to us.
We face risks that:
·
our rights under our U.S., Canadian or foreign patents or other licensed patents
that other third parties license to us could be curtailed;
·
we may not be the first inventor of inventions covered by our issued patents
or pending applications or be the first to file patent applications for those inventions;
·
our pending or future patent applications may not be issued with the breadth
of claim coverage sought by us, or be issued at all;
12
·
our competitors could independently develop or patent technologies that are
substantially equivalent or superior to our technologies;
·
our trade secrets could be learned independently by our competitors;
·
the steps we take to protect our intellectual property may not be adequate;
and
·
effective patent, trademark, copyright and trade secret protection may be unavailable,
limited or not sought by us in some foreign countries.
Further, patents have a limited lifespan. In the United States, a patent
generally expires 20 years after it is filed (or 20 years after the filing date of the first non-provisional U.S. patent application to
which it claims priority). While extensions may be available, the life of a patent, and the protection it affords, is limited. Further,
the extensive period of time between patent filing and regulatory approval for a product candidate limits the time during which we can
market that product candidate under patent protection. Patents owned by third parties could have priority over patent applications filed
or in-licensed by us, or we or our licensors could become involved in interference, opposition or invalidity proceedings before U.S.,
Canadian or foreign patent offices. The cost of defending and enforcing our patent rights against infringement charges by other patent
holders may be significant and could limit our operations.
We may be involved in lawsuits to protect or enforce our patents
or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents or the patents of our licensors. To
counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. If
we or our licensors were to initiate legal proceedings against a third party to enforce a patent our technology, the defendant could counterclaim
that our or our licensor’s patent is invalid or unenforceable. In patent litigation, defendant counterclaims alleging invalidity
or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements;
for example, lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone
connected with prosecution of the patent withheld relevant information from the patent office, such as the USPTO, or made a misleading
statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable.
With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we or our licensors
and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability,
we would lose at least part, and perhaps all, of the patent protection or certain aspects of our platform technology. Such a loss of patent
protection could have a material adverse impact on our business. Patents and other intellectual property rights also will not protect
our technology if competitors design around our protected technology without legally infringing our patents or other intellectual property
rights.
In addition, in an infringement proceeding, a court may refuse to stop
the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse
result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable,
or interpreted narrowly and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit,
would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
Interference proceedings provoked by third parties or brought by the USPTO
may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors.
An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology
or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us
a license on commercially reasonable terms, or at all. Litigation or interference proceedings may result in a decision adverse to our
interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not
be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries
where the laws may not protect those rights as fully as in the United States and Canada. Furthermore, because of the substantial amount
of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings,
motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could
have a substantial adverse effect on the price of our common shares.
13
Obtaining and maintaining our patent protection depends on compliance with
various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection
could be reduced or eliminated for non-compliance with these requirements.
Changes in patent law could diminish the value of patents in general,
thereby impairing our ability to protect product candidates.
Numerous recent changes to the patent laws and proposed changes to the
rules of the various patent offices around the world may have a significant impact on our ability to protect our technology and enforce
our intellectual property rights. These changes may lead to increasing uncertainty with regard to the scope and value of our issued patents
and to our ability to obtain patents in the future.
Once granted, patents may remain open to opposition, re-examination, post-grant
review, inter partes review, nullification derivation and opposition proceedings in court or before patent offices or
similar proceedings for a given period after allowance or grant, during which time third parties can raise objections against the initial
grant. In the course of any such proceedings, which may continue for a protracted period of time, the patent owner may be compelled to
limit the scope of the allowed or granted claims attacked or may lose the allowed or granted claims altogether. Depending on decisions
by authorities in various jurisdictions, the laws and regulations governing patents could change in unpredictable ways that may weaken
our and our licensors’ ability to obtain new patents or to enforce existing patents we and our licensors or partners may obtain
in the future.
We may not be able to protect our intellectual property rights throughout
the world.
Many companies have encountered significant problems in protecting and
defending intellectual property rights in foreign jurisdictions. The legal systems of some countries, particularly certain developing
countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, which could make it difficult
for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings
to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk
of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the
damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property
rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop
or license.
Risks Relating to Our Common Shares
The price of our common shares may be volatile.
Market prices for pharmaceutical companies can fluctuate significantly.
Factors such as the announcement to the public or in various scientific or industry forums of technological innovations; new commercial
products; patents or exclusive rights obtained by us or others; disputes or other developments relating to proprietary rights, including
patents, litigation matters and our ability to obtain patent protection for our technologies; the commencement, enrollment or announcement
of results of clinical trials we conduct, or changes in the development status of our product candidates; results or delays of pre-clinical
and clinical studies by us or others; any delay in our regulatory filings for our product candidates and any adverse development or perceived
adverse development with respect to the applicable regulatory authority’s review of such filings; a change of regulations; additions
or departures of key scientific or management personnel; overall performance of the equity markets; general political and economic conditions;
publications; failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;
research reports or positive or negative recommendations or withdrawal of research coverage by securities analysts; actual or anticipated
variations in quarterly operating results; announcements of significant acquisitions, strategic partnerships, joint ventures or capital
commitments by us or our competitors; public concerns over the risks of pharmaceutical products and dietary supplements; unanticipated
serious safety concerns related to the use of our product candidates; the ability to finance, future sales of securities by us or our
shareholders; and many other factors, many of which are beyond our control, could have considerable effects on the price of our common
shares. The price of our common shares has fluctuated significantly in the past and there can be no assurance that the market price of
our common shares will not experience significant fluctuations in the future.
14
In addition, pharmaceutical companies often experience extreme price and
volume fluctuations that are unrelated or disproportionate to the operating performance of those companies. Broad market and industry
factors may negatively affect the market price of our common shares, regardless of our actual operating performance. In the past, securities
class action litigation has often been instituted against pharmaceutical companies following periods of volatility in the market price
of their securities. This type of litigation, if instituted against us, could result in substantial costs and a diversion of management’s
attention and resources, which would harm our business, operating results or financial condition.
Raising additional capital may cause dilution to our existing shareholders,
restrict our operations or require us to relinquish rights to our technologies or product candidates.
We may need to raise additional capital in order to execute on our business
plan. We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships
and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt
securities, the ownership interests of our shareholders will be diluted, and the terms may include liquidation or other preferences that
adversely affect the rights of our shareholders. The incurrence of indebtedness by us would result in increased fixed payment obligations
and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability
to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct
our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties,
we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms unfavorable to us.
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.
Our net losses and expenses may fluctuate significantly and any failure
to meet financial or clinical expectations may disappoint securities analysts or investors and result in a decline in the price of our
common shares. Our net losses and expenses have fluctuated in the past and are likely to do so in the future. The market price of our
common shares has fluctuated significantly in the past and may continue to do so. Some of the factors that could cause the market price
for our common shares to fluctuate include the following:
·
the fluctuations in valuation of our derivative warrant liabilities;
·
the outcome of any litigation;
·
changes in foreign currency fluctuations;
·
competition;
·
the timing of achievement and the receipt of milestone payments from current
or future third parties;
·
failure to enter into new or the expiration or termination of current agreements
with third parties;
·
execution of any new collaboration, licensing or similar arrangement, and the
timing of payments we may make or receive under such existing or future arrangements or the termination or modification of any such existing
or future arrangements;
15
·
any intellectual property infringement lawsuit or opposition against us or our
competition that could have a negative impact on or any proceedings in which we may become involved;
·
additions and departures of key personnel;
·
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures,
strategic investments or changes in business strategy;
·
inability to achieve strategic outcome from review of strategic alternatives;
and
·
changes in general market and economic conditions.
If our quarterly operating results fall below the expectations of investors
or securities analysts, the market price of our common shares could decline substantially. Furthermore, any quarterly fluctuations in
our operating results may, in turn, cause the market price of our common shares to fluctuate substantially. We believe that quarterly
comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.
There can be no assurance that an active market for our common shares
will be sustained.
There can be no assurance that an active market for our common shares will
be sustained. Holders of common shares may be unable to sell their investments on satisfactory terms. As a result of any risk factor discussed
herein, the market price of our common shares at any given point in time may not accurately reflect our long-term value. Furthermore,
responding to these risk factors could result in substantial costs and divert management’s attention and resources. Substantial
and potentially permanent declines in the value of our common shares may adversely affect the liquidity of the market for our common shares.
Other factors unrelated to our performance that may have an effect on the
price and liquidity of our common shares include: positive or negative industry or competitor news; extent of analyst coverage; lessening
in trading volume and general market interest in our common shares; the size of our public float; and any event resulting in a delisting
of our common shares.
A large number of common shares may be issued and subsequently sold
upon the exercise of existing warrants. The sale or availability for sale of existing warrants or other securities convertible into common
shares may depress the price of our common shares.
As of March 31, 2021, there were 15.6 million common shares issuable under
outstanding warrants at various exercise prices. To the extent that holders of existing warrants sell common shares issued upon the exercise
of warrants, the market price of our common shares may decrease due to the additional selling pressure in the market. The risk of dilution
from issuances of common shares underlying existing warrants may cause shareholders to sell their common shares, which could further contribute
to any decline in our common share market price.
Any downward pressure on the price of our common shares caused by the sale
of common shares issued upon the exercise of existing warrants could encourage short sales by third parties. In a short sale, a prospective
seller borrows common shares from a shareholder or broker and sells the borrowed common shares. The prospective seller anticipates that
the common share price will decline, at which time the seller can purchase common shares at a lower price for delivery back to the lender.
The seller profits when the common share price declines because it is purchasing common shares at a price lower than the sale price of
the borrowed common shares. Such short sales of common shares could place downward pressure on the price of our common shares by increasing
the number of common shares being sold, which could lead to a decline in the market price of our common shares.
We do not currently intend to pay any cash dividends on our common
shares in the foreseeable future.
We have never paid any cash dividends on our common shares and we do not
anticipate paying any cash dividends on our common shares in the foreseeable future because, among other reasons, we currently intend
to retain any future earnings to finance our business. The future payment of cash dividends will be dependent on factors such as cash
on hand and achieving profitability, the financial requirements to fund growth, our general financial condition and other factors our
board of directors may consider appropriate in the circumstances. Until we pay cash dividends, which we may never do, our shareholders
will not be able to receive a return on their common shares unless they sell them.
16
If we fail to meet applicable listing requirements, the NASDAQ Stock
Market or the TSXV may delist our common shares from trading, in which case the liquidity and market price of our common shares could
decline.
Our common shares are currently listed on the NASDAQ Stock Market and the
TSXV, but we cannot assure you that our securities will continue to be listed on the NASDAQ Stock Market and the TSXV in the future. In
the past, we have received notices from the NASDAQ Stock Market that we have not been in compliance with its continued listing standards,
and we have taken responsive actions and regained compliance.
On February 28, 2020, we received written notification from the NASDAQ
Listing Qualifications Department for failing to maintain a minimum bid price of $1.00 per share for the preceding 30 consecutive business
days, as required by NASDAQ Listing Rule 5550(a)(2) – bid price (the “Minimum Bid Price Rule”). Under NASDAQ Listing
Rule 5810(c)(3)(A) – compliance period, we initially had 180 calendar days to regain compliance.
On April 17, 2020, we were informed that NASDAQ had granted temporary regulatory
relief related to its minimum bid price requirement due to the COVID-19 pandemic for all NASDAQ-listed companies and therefore extended
the deadline for us to regain compliance to November 9, 2020.
On November 11, 2020, we were further informed that NASDAQ had granted
an additional 180 calendar days, or until May 10, 2021, for us to regain compliance.
On May 11, 2021, we received notice from the Nasdaq Listing Qualifications
Department indicating that, based upon our non-compliance with the $1.00 bid price requirement set forth in (the Minimum Bid Price Rule)
as of May 10, 2021, our common shares were subject to delisting unless we timely requested a hearing before the Nasdaq Hearings Panel
(the “Panel”).
We requested and were granted a hearing on June 17, 2021, which will stay
any further action by Nasdaq pending the conclusion of the hearing process.
At the hearing, we presented a detailed plan of compliance for the Panel’s
consideration, which included our commitment to implement a share consolidation if needed to evidence compliance with the Minimum Bid
Price Rule. Should we determine that a share consolidation is necessary or otherwise advisable to regain compliance with the Minimum Bid
Price Rule, we would likely take such action concurrently with the completion of our proposed acquisition of Grace.
If we fail to comply with listing standards and the NASDAQ Stock Market
or TSXV delists our common shares, we and our shareholders could face significant material adverse consequences, including:
·
a limited availability of market quotations for our common shares;
·
reduced liquidity for our common shares;
·
a determination that our common shares are “penny stock”, which
would require brokers trading in our common shares to adhere to more stringent rules and possibly result in a reduced level of trading
activity in the secondary trading market for our common shares;
·
a limited amount of news about us and analyst coverage of us; and
·
a decreased ability for us to issue additional equity securities or obtain additional
equity or debt financing in the future.
17
We may pursue opportunities or transactions that adversely affect
our business and financial condition.
Our management, in the ordinary course of our business, regularly explores
potential strategic opportunities and transactions. These opportunities and transactions may include strategic joint venture relationships,
significant debt or equity investments in us by third parties, the acquisition or disposition of material assets, the licensing, acquisition
or disposition of material intellectual property, the development of new drug candidates, significant distribution arrangements, the sale
of our common shares and other similar opportunities and transactions. The public announcement of any of these or similar strategic opportunities
or transactions might have a significant effect on the price of our common shares. Our policy is to not publicly disclose the pursuit
of a potential strategic opportunity or transaction unless we are required to do so by applicable law, including applicable securities
laws relating to periodic disclosure obligations. There can be no assurance that investors who buy or sell common shares are doing so
at a time when we are not pursuing a particular strategic opportunity or transaction that, when announced, would have a significant effect
on the price of our common shares.
In addition, any such future corporate development may be accompanied by
certain risks, including exposure to unknown liabilities relating to the strategic opportunities and transactions, higher than anticipated
transaction costs and expenses, the difficulty and expense of integrating operations and personnel of any acquired companies, disruption
of our ongoing business, diversion of management’s time and attention, and possible dilution to shareholders. We may not be able
to successfully overcome these risks and other problems associated with any future acquisitions and this may adversely affect our business
and financial condition.
We are a “smaller reporting company” under the SEC’s
disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.
We are a “smaller reporting company” under the SEC’s
disclosure rules, meaning that we have either:
·
a public float of less than $250 million; or
·
annual revenues of less than $100 million during the most recently completed
fiscal year; and
o
no public float; or
o
a public float of less than $700 million.
As a smaller reporting company, we are permitted to comply with scaled-back
disclosure obligations in our SEC filings compared to other issuers, including with respect to disclosure obligations regarding executive
compensation in our periodic reports and proxy statements. We have elected to adopt the accommodations available to smaller reporting
companies. Until we cease to be a smaller reporting company, the scaled-back disclosure in our SEC filings will result in less information
about our company being available than for other public companies.
If investors consider our common shares less attractive as a result of
our election to use the scaled-back disclosure permitted for smaller reporting companies, there may be a less active trading market for
our common shares and our share price may be more volatile.
As a non-accelerated filer, we are not required to comply with the
auditor attestation requirements of the Sarbanes-Oxley Act.
We are a non-accelerated filer under the Securities Exchange Act of 1934,
as amended, or the Exchange Act, and we are not required to comply with the auditor attestation requirements of Section 404(b) of the
Sarbanes-Oxley Act of 2002. Therefore, our internal controls over financial reporting will not receive the level of review provided by
the process relating to the auditor attestation included in annual reports of issuers that are subject to the auditor attestation requirements.
In addition, we cannot predict if investors will find our common shares less attractive because we are not required to comply with the
auditor attestation requirements. If some investors find our common shares less attractive as a result, there may be a less active trading
market for our common shares and trading price for our common shares may be negatively affected.
18
U.S. investors may be unable to enforce certain judgments.
We are a company existing under the Business Corporations Act (Québec).
Some of our directors and officers are residents of Canada, and substantially all of our assets are currently located outside the United
States. As a result, it may be difficult to effect service within the United States upon us or upon some of our directors and officers.
Execution by U.S. courts of any judgment obtained against us or any of our directors or officers in U.S. courts may be limited to assets
located in the United States. It may also be difficult for holders of securities who reside in the United States to realize in the United
States upon judgments of U.S. courts predicated upon civil liability of us and our directors and executive officers under the U.S. federal
securities laws. There may be doubt as to the enforceability in Canada against non-U.S. entities or their controlling persons, directors
and officers who are not residents of the United States, in original actions or in actions for enforcement of judgments of U.S. courts,
of liabilities predicated solely upon U.S. federal or state securities laws.
There is a significant risk that we may be classified as a PFIC for
U.S. federal income tax purposes.
Current or potential investors in our common shares who are U.S. Holders
(as defined below) should be aware that, based on our most recent financial statements and projections and given uncertainty regarding
the composition of our future income and assets, there is a significant risk that we may have been classified as a “passive foreign
investment company” or “PFIC” for the taxable year that ended on March 31, 2021, and may be classified as a PFIC for
our current taxable year and possibly subsequent years. If we are a PFIC for any year during a U.S. Holder’s holding period of our
common shares, then such U.S. taxpayer generally will be required to treat any gain realized upon a disposition of such common shares
or any so-called “excess distribution” received on such common shares, as ordinary income (with a portion subject to tax at
the highest rate in effect), and to pay an interest charge on a portion of such gain or excess distribution. In certain circumstances,
the sum of the tax and the interest charge may exceed the total amount of proceeds realized on the disposition, or the amount of excess
distribution received, by the U.S. Holder. Subject to certain limitations, a timely and effective QEF Election (as defined below) under
Section 1295 of the U.S. Internal Revenue Code of 1986, as amended, or the Code, or a Mark-to-Market Election (as defined below) under
Section 1296 of the Code may be made with respect to the common shares. A U.S. Holder who makes a timely and effective QEF Election generally
must report on a current basis its share of our net capital gain and ordinary earnings for any year in which we are a PFIC, whether or
not we distribute any amounts to our shareholders. A U.S. Holder who makes the Mark-to-Market Election generally must include as ordinary
income each year the excess of the fair market value of their common shares over the holder’s basis therein. This paragraph is qualified
in its entirety by the discussion under the heading “Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters
and Issuer Purchases of Equity Securities - U.S. Federal Income Tax Considerations of the Acquisition, Ownership, and Disposition of Common
Shares - Passive Foreign Investment Company Rules” and does not take into account any changes to the composition of our income and
assets resulting from the merger. Each current or potential investor who is a U.S. Holder should consult its own tax advisor regarding
the U.S. federal, state and local, and non-U.S. tax consequences of the acquisition, ownership, and disposition of our common shares,
the U.S. federal tax consequences of the PFIC rules, and the availability of any election that may be available to the holder to mitigate
adverse U.S. federal income tax consequences of holding shares in a PFIC.
Item 1B.
Unresolved Staff Comments
Not applicable.
Item 2.
Properties
Our head office and operations are located at 3009 boul. de la Concorde
East, Suite 102, Laval, Québec, Canada H7E 2B5 and our research and development and quality control laboratory is located at Espace
Lab, 2650 Maximilien-Chagnon, Sherbrooke, Québec, Canada, J1E 0M8. We currently lease our office and laboratory space. We do not
own our own manufacturing facility to produce CaPre; however, we do own the proprietary equipment for producing the related active pharmaceutical
ingredient, or API, and drug product.
19
Item 3.
Legal Proceedings
Due to the fact that a portion of our intellectual property rights are
licensed to us by Neptune/Aker, we rely on Neptune/Aker to protect a certain of the intellectual property rights that we use under our
license agreement with Neptune/Aker. Neptune/Aker are engaged in a number of legal actions related to their intellectual property.
Item 4.
Mine Safety Disclosures
Not applicable.
PART II
Item 5.
Market for Registrant’s Common Equity, Related Shareholder
Matters and Issuer Purchases of Equity Securities
Market Information
Our common shares are traded on The Nasdaq Capital Market and the TSX Venture
Exchange under the symbol “ACST.”
Holders
As of June 22, 2021, there were approximately 26 holders of record of our
common shares. The actual number of shareholders is greater than this number of record holders and includes shareholders who are beneficial
owners but whose shares are held in street name by brokers and other nominees.
Dividends
We do not anticipate paying any cash dividend on our common shares in the
foreseeable future. We presently intend to retain future earnings to finance the expansion and growth of our business. Any future determination
to pay dividends will be at the discretion of our board of directors and will depend on our financial condition, results of operations,
capital requirements and other factors the board of directors deems relevant. In addition, the terms of any future debt or credit facility
may preclude us from paying dividends.
Taxation
The following is a summary of certain U.S. federal income tax considerations
arising from and relating to the acquisition, ownership, and disposition of our common shares to a U.S. Holder (as defined below) as capital
assets.
This summary provides only general information and does not purport to
be a complete analysis or listing of all potential U.S. federal income tax consequences that may apply to a U.S. Holder as a result of
the acquisition, ownership, and disposition of our common shares. In addition, this summary does not take into account the individual
facts and circumstances of any particular U.S. Holder that may affect the U.S. federal income tax consequences applicable to that U.S.
Holder. Accordingly, this summary is not intended to be, and should not be construed as, legal or U.S. federal income tax advice with
respect to any U.S. Holder. Each U.S. Holder should consult its own tax advisor regarding the U.S. federal, state and local, and non-U.S.
tax consequences arising from or relating to the acquisition, ownership, and disposition of our common shares.
No legal opinion from U.S. legal counsel or ruling from the Internal Revenue
Service, or IRS, has been requested, or will be obtained, regarding the U.S. federal income tax consequences to U.S. Holders of the acquisition,
ownership, and disposition of our common shares. This summary is not binding on the IRS, and the IRS is not precluded from taking a position
that is different from, and contrary to, the positions taken in this summary. In addition, because the authorities on which this summary
is based are subject to various interpretations, the IRS and the U.S. courts could disagree with one or more of the positions taken in
this summary.
20
Scope of this Disclosure
Authorities
This summary is based on the Code, U.S. Treasury Regulations promulgated
thereunder (whether final, temporary or proposed), published IRS rulings, judicial decisions, published administrative positions of the
IRS, and the Convention between Canada and the United States of America with Respect to Taxes on Income and on Capital, signed September
26, 1980, as amended (the Canada-U.S. Tax Treaty), in each case, as in effect as of the date of this report. Any of the authorities on
which this summary is based could be changed in a material and adverse manner at any time, and any such change could be applied on a retroactive
basis. Unless otherwise discussed, this summary does not discuss the potential effects, whether adverse or beneficial, of any proposed
legislation.
U.S. Holders
For purposes of this summary, a “U.S. Holder” is a beneficial
owner of common shares that, for U.S. federal income tax purposes, is (a) an individual who is a citizen or resident of the United States,
(b) a corporation, or other entity classified as a corporation for U.S. federal income tax purposes, that is created or organized in or
under the laws of the U.S., any state in the United States or the District of Columbia, (c) an estate if the income of such estate is
subject to U.S. federal income tax regardless of the source of such income, or (d) a trust if (i) such trust has validly elected to be
treated as a U.S. person for U.S. federal income tax purposes or (ii) a U.S. court is able to exercise primary supervision over the administration
of such trust and one or more U.S. persons have the authority to control all substantial decisions of such trust.
U.S. Holders Subject to Special U.S. Federal Income Tax Rules Not
Addressed
This summary does not address the U.S. federal income tax consequences
applicable to U.S. Holders that are subject to special provisions under the Code, including, but not limited to, the following U.S. Holders:
(a) U.S. Holders that are tax-exempt organizations, qualified retirement plans, individual retirement accounts, or other tax deferred
accounts; (b) U.S. Holders that are financial institutions, insurance companies, real estate investment trusts, or regulated investment
companies; (c) U.S. Holders that are dealers in securities or currencies or U.S. Holders that are traders in securities that elect to
apply a mark-to-market accounting method; (d) U.S. Holders that have a “functional currency” other than the U.S. dollar; (e)
U.S. Holders subject to the alternative minimum tax provisions of the Code; (f) U.S. Holders that own common shares as part of a straddle,
hedging transaction, conversion transaction, integrated transaction, constructive sale, or other arrangement involving more than one position;
(g) U.S. Holders that acquired common shares through the exercise of employee stock options or otherwise as compensation for services;
(h) U.S. Holders that hold common shares other than as a capital asset within the meaning of Section 1221 of the Code; (i) U.S. Holders
that beneficially own (directly, indirectly or by attribution) 10% or more of our equity securities (by vote or value); and (j) U.S. expatriates.
U.S. Holders that are subject to special provisions under the Code, including U.S. Holders described above, should consult their own tax
advisor regarding the U.S. federal, U.S. federal alternative minimum, U.S. federal estate and gift, U.S. state and local, and non-U.S.
tax consequences arising from and relating to the acquisition, ownership, and disposition of the common shares.
If an entity or arrangement that is classified as a partnership for U.S.
federal income tax purposes holds common shares, the U.S. federal income tax consequences to that partnership and the partners of that
partnership generally will depend on the activities of the partnership and the status of the partners. Partners of entities that are classified
as partnerships for U.S. federal income tax purposes should consult their own tax advisors regarding the U.S. federal income tax consequences
arising from and relating to the acquisition, ownership and disposition of the common shares.
Tax Consequences Other than U.S. Federal Income Tax Consequences
Not Addressed
This summary does not address the U.S. estate and gift, alternative minimum,
state, local or non-U.S. tax consequences to U.S. Holders of the acquisition, ownership, and disposition of our common shares. Each U.S.
Holder should consult its own tax advisor regarding the U.S. estate and gift, alternative minimum, state, local and non-U.S. tax consequences
arising from and relating to the acquisition, ownership, and disposition of our common shares.
21
U.S. Federal Income Tax Considerations of the Acquisition, Ownership,
and Disposition of Common Shares
Distributions on Common Shares
Subject to the discussion under “—Passive Foreign Investment
Company Rules” below, a U.S. Holder that receives a distribution, including a constructive distribution or a taxable stock distribution,
with respect to the common shares generally will be required to include the amount of that distribution in gross income as a dividend
(without reduction for any Canadian income tax withheld from such distribution) to the extent of our current or accumulated “earnings
and profits” (as computed for U.S. federal income tax purposes). To the extent that a distribution exceeds our current and accumulated
“earnings and profits”, the excess amount will be treated (a) first, as a tax-free return of capital to the extent of a U.S.
Holder’s adjusted tax basis in the common shares with respect to which the distribution is made (resulting in a corresponding reduction
in the tax basis of those common shares) and, (b) thereafter, as gain from the sale or exchange of those common shares (see the more detailed
discussion at “—Disposition of Common Shares” below). We do not intend to calculate our current or accumulated earnings
and profits for U.S. federal income tax purposes and, therefore, will not be able to provide U.S. Holders with that information. U.S.
Holders should therefore assume that any distribution by us with respect to our common shares will constitute a dividend. However, U.S.
Holders should consult their own tax advisors regarding whether distributions from us should be treated as dividends for U.S. federal
income tax purposes. Dividends paid on our common shares generally will not be eligible for the “dividends received deduction”
allowed to corporations under the Code with respect to dividends received from U.S. corporations.
A dividend paid by us generally will be taxed at the preferential tax rates
applicable to long-term capital gains if, among other requirements, (a) we are a “qualified foreign corporation” (as defined
below), (b) the U.S. Holder receiving the dividend is an individual, estate, or trust, and (c) the dividend is paid on common shares that
have been held by the U.S. Holder for at least 61 days during the 121-day period beginning 60 days before the “ex-dividend date”
(i.e., the first date that a purchaser of the common shares will not be entitled to receive the dividend).
For purposes of the rules described in the preceding paragraph, we generally
will be a “qualified foreign corporation”, or a QFC, if (a) we are eligible for the benefits of the Canada-U.S. Tax Treaty,
or (b) our common shares are readily tradable on an established securities market in the United States, within the meaning provided in
the Code. However, even if we satisfy one or more of the requirements, we will not be treated as a QFC if we are classified as a PFIC
(as discussed below) for the taxable year during which we pay the applicable dividend or for the preceding taxable year. The dividend
rules are complex, and each U.S. Holder should consult its own tax advisor regarding the application of those rules to them in their particular
circumstances. Even if we satisfy one or more of the requirements, as noted below, there can be no assurance that we will not be a PFIC
in the current taxable year or become a PFIC in the future. Thus, there can be no assurance that we will qualify as a QFC.
Disposition of Common Shares
Subject to the discussion under “—Passive Foreign Investment
Company Rules” below, a U.S. Holder will recognize gain or loss on the sale or other taxable disposition of common shares (that
is treated as a sale or exchange for U.S. federal income tax purposes) equal to the difference, if any, between (a) the U.S. dollar value
of the amount realized on the date of the sale or disposition and (b) the U.S. Holder’s adjusted tax basis (determined in U.S. dollars)
in the common shares sold or otherwise disposed of. Any such gain or loss generally will be capital gain or loss, which will be long-term
capital gain or loss if the common shares are held for more than one year. A U.S. Holder's initial tax basis in the common shares generally
will equal the U.S. dollar cost of such common shares. Each U.S. Holder should consult its own tax advisor as to the tax treatment of
dispositions of common shares in exchange for Canadian dollars.
Preferential tax rates apply to long-term capital gains of a U.S. Holder
that is an individual, estate, or trust. There are currently no preferential tax rates for long-term capital gains of a U.S. Holder that
is a corporation. Deductions for capital losses are subject to complex limitations.
22
Passive Foreign Investment Company Rules
If we are or become a PFIC, the preceding sections of this summary may
not describe the U.S. federal income tax consequences to U.S. Holders of the acquisition, ownership, and disposition of our common shares.
Passive Foreign Investment Company Status.
Special, generally unfavorable, rules apply to the ownership and disposition
of the stock of a PFIC. For U.S. federal income tax purposes, a non-U.S. corporation is classified as a PFIC if:
·
at least 75% of its gross income for the taxable year is “passive”
income (referred to as the “income test”); or
·
at least 50% of the average value of its assets held during the
taxable year is attributable to assets that produce passive income or are held for the production of passive income (referred to as the
“asset test”).
Passive income generally includes the following types of income:
·
dividends, royalties, rents, annuities, interest, and income equivalent
to interest; and
·
net gains from the sale or exchange of property that gives rise
to dividends, interest, royalties, rents, or annuities and certain gains from the commodities transactions.
In determining whether we are a PFIC, we will be required to take into
account a pro rata portion of the income and assets of each corporation in which we own, directly or indirectly, at least 25% by value.
As described above, PFIC status of a non-U.S. corporation depends on the
relative values of certain categories of assets and the relative amount of certain kinds of income for a taxable year. Therefore, our
status as a PFIC for any given taxable year depends upon the financial results for such year and upon relative valuations, which are subject
to change and beyond our ability to predict or control. Based on our most recent financial statements and projections and given uncertainty
regarding the composition of our future income and assets, there is a significant risk that we may have been classified as a PFIC for
the taxable year that ended on March 31, 2021, and may be classified as a PFIC for our current taxable year and possibly subsequent years.
However, PFIC status is fundamentally factual in nature, depends on the application of complex U.S. federal income tax rules (which are
subject to differing interpretations), generally cannot be determined until the close of the taxable year in question and is determined
annually. In addition, in evaluating the risk that we may be classified as a PFIC for our current taxable year and subsequent years, we
have not taken into account any changes to the composition of our income and assets that may result from the merger. Accordingly, there
can be no assurance that we will not be a PFIC in our current taxable year or subsequent years. The PFIC rules are complex, and each U.S.
Holder should consult its tax advisor regarding the application of the PFIC rules to us.
Default PFIC Rules Under Section 1291 of the Code.
Generally, if we are or have been treated as a PFIC for any taxable year
during a U.S. Holder’s holding period of common shares, subject to the special rules described below applicable to a U.S. Holder
who makes a Mark-to-Market Election or a QEF Election (each as defined below), any “excess distribution” with respect to the
common shares would be allocated ratably over the U.S. Holder’s holding period. The amounts allocated to the taxable year of the
excess distribution and to any year before we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable
year would be subject to tax at the highest rate in effect for individuals or corporations in that taxable year, as appropriate, and an
interest charge would be imposed on the amount allocated to that taxable year. Distributions made in respect of common shares during a
taxable year will be excess distributions to the extent they exceed 125% of the average of the annual distributions on common shares received
by the U.S. Holder during the preceding three taxable years or the U.S. Holder’s holding period, whichever is shorter. In addition,
dividends generally will not be qualified dividend income if we are a PFIC in the taxable year of payment or the preceding year.
Generally, if we are treated as a PFIC for any taxable year during which
a U.S. Holder owns common shares, any gain on the disposition of the common shares would be treated as an excess distribution and would
be allocated ratably over the U.S. Holder’s holding period and subject to taxation in the same manner as described in the preceding
paragraph and would not be eligible for the preferential long-term capital gains rate.
23
Certain elections (including the Mark-to-Market Election and the QEF Election,
as defined and discussed below) may sometimes be used to mitigate the adverse impact of the PFIC rules on U.S. Holders, but these elections
may accelerate the recognition of taxable income and have other adverse results.
Each current or prospective U.S. Holder should consult its own tax advisor
regarding potential status of us as a PFIC, the possible effect of the PFIC rules to such holder in their particular circumstances, information
reporting required if we were treated as a PFIC and the availability of any election that may be available to the holder to mitigate adverse
U.S. federal income tax consequences of holding shares in a PFIC.
QEF Election.
A U.S. Holder of common shares in a PFIC generally would not be subject
to the PFIC rules discussed above if the U.S. Holder had made a timely and effective election (a “QEF Election”) to treat
us as a “qualified electing fund” (a “QEF”). Instead, such U.S. Holder would be subject to U.S. federal income
tax on its pro rata share of our (i) net capital gain, which would be taxed as long-term capital gain to such U.S. Holder,
and (ii) ordinary earnings, which would be taxed as ordinary income to such U.S. Holder, in each case regardless of whether such amounts
are actually distributed to such U.S. Holder. However, a U.S. Holder that makes a QEF Election may, subject to certain limitations, elect
to defer payment of current U.S. federal income tax on such amounts, subject to an interest charge. If such U.S. Holder is not a corporation,
any such interest paid will be treated as “personal interest,” which is not deductible.
A U.S. Holder that makes a timely and effective QEF Election generally
(a) may receive a tax-free distribution from us to the extent that such distribution represents our “earnings and profits”
that were previously included in income by such U.S. Holder because of such QEF Election and (b) will adjust such U.S. Holder’s
tax basis in the common shares to reflect the amount included in income or allowed as a tax-free distribution because of such QEF Election.
In addition, for U.S. federal income tax purposes, a U.S. Holder that makes a timely QEF Election generally will recognize capital gain
or loss on the sale or other taxable disposition of the common shares.
A QEF Election will be treated as “timely” if such QEF Election
is made for the first taxable year in the U.S. Holder’s holding period for the common shares in which we are a PFIC. A U.S. Holder
may make a timely QEF Election by filing the appropriate QEF Election documents at the time such U.S. Holder files a U.S. federal income
tax return for such first year. If a U.S. Holder makes a QEF Election after the first taxable year in the U.S. Holder’s holding
period for the common shares in which we are a PFIC, then, in addition to filing the QEF Election documents, a U.S. Holder may elect to
recognize gain (which will be taxed under the rules discussed under “— Default PFIC Rules Under Section 1291 of the Code ”)
as if the common shares were sold on the qualification date. The “qualification date” is the first day of the first taxable
year in which we are a QEF with respect to such U.S. Holder. The election to recognize such gain can only be made if such U.S. Holder’s
holding period for the common shares includes the qualification date. By electing to recognize such gain, such U.S. Holder will be deemed
to have made a timely QEF Election. In addition, under very limited circumstances, it is possible that a U.S. Holder might make a retroactive
QEF Election if such U.S. Holder failed to file the QEF Election documents in a timely manner. If a U.S. Holder fails to make a QEF Election
for the first taxable year in the U.S. Holder’s holding period for the common shares in which we are a PFIC and does not elect to
recognize gain as if the common shares were sold on the qualification date, such holder will not be treated as having made a “timely”
QEF Election and will continue to be subject to the special adverse taxation rules discussed above under “— Default PFIC
Rules Under Section 1291 of the Code ”.
A QEF Election will apply to the taxable year for which such QEF Election
is made and to all subsequent taxable years, unless such QEF Election is invalidated or terminated or the IRS consents to revocation of
such QEF Election. If a U.S. Holder makes a QEF Election and, in a subsequent taxable year, we cease to be a PFIC, the QEF Election will
remain in effect (although it will not be applicable) during those taxable years in which we are not a PFIC. Accordingly, if we become
a PFIC in another subsequent taxable year, the QEF Election will be effective, and the U.S. Holder will be subject to the rules described
above during any such subsequent taxable year in which we qualify as a PFIC.
24
A U.S. Holder cannot make and maintain a valid QEF Election unless we provide
certain U.S. tax information necessary to make such an election. On an annual basis, we intend to use commercially reasonable efforts
to make available to U.S. Holders, upon their written request (a) timely information as to our status as a PFIC, and (b) for each year
in which we are a PFIC, information and documentation that a U.S. Holder making a QEF Election with respect to us is required to obtain
for U.S. federal income tax purposes. Each U.S. Holder should consult its own tax advisor regarding the availability of, and procedure
for making, a QEF Election with respect to us.
Mark-to-Market Election.
A U.S. Holder of common shares in a PFIC would not be subject to the PFIC
rules discussed above under “— Default PFIC Rules Under Section 1291 of the Code ” if the U.S. Holder had made
a timely and effective election to mark the PFIC common shares to market (a “Mark-to-Market Election”).
A U.S. Holder may make a Mark-to-Market Election with respect to the common
shares only if such shares are marketable stock. Such shares generally will be “marketable stock” if they are regularly traded
on a “qualified exchange,” which is defined as (a) a national securities exchange that is registered with the SEC, (b) the
national market system established pursuant to section 11A of the Exchange Act, or (c) a non-U.S. securities exchange that is regulated
or supervised by a governmental authority of the country in which the market is located, provided that (i) such non-U.S. exchange has
trading volume, listing, financial disclosure, surveillance, and other requirements, and the laws of the country in which such non-U.S.
exchange is located, together with the rules of such non-U.S. exchange, ensure that such requirements are actually enforced and (ii) the
rules of such non-U.S. exchange ensure active trading of listed stocks. Our common shares will generally be treated as “regularly
traded” in any calendar year in which more than a de minimis quantity of common shares is traded on a qualified
exchange for at least 15 days during each calendar quarter. Each U.S. Holder should consult its own tax advisor with respect to the availability
of a Mark-to-Market Election with respect to the common shares.
In general, a U.S. Holder that makes a timely Mark-to-Market Election with
respect to the common shares will include in ordinary income, for each taxable year in which we are a PFIC, an amount equal to the excess,
if any, of (a) the fair market value of the common shares as of the close of such taxable year over (b) such U.S. Holder’s tax basis
in such shares. A U.S. Holder that makes a Mark-to-Market Election will be allowed a deduction in an amount equal to the lesser of (a)
the excess, if any, of (i) such U.S. Holder’s adjusted tax basis in the common shares over (ii) the fair market value of such shares
as of the close of such taxable year or (b) the excess, if any, of (i) the amount included in ordinary income because of such Mark-to-Market
Election for prior taxable years over (ii) the amount allowed as a deduction because of such Mark-to-Market Election for prior taxable
years. If a U.S. Holder makes a Mark-to-Market Election after the first taxable year in which we are a PFIC and such U.S. Holder has not
made a timely QEF Election with respect to us, the PFIC rules described above under “— Default PFIC Rules Under Section
1291 of the Code ” will apply to certain dispositions of, and distributions on, the common shares, and the U.S. Holder’s
mark-to-market income for the year of the election. If we were to cease being a PFIC, a U.S. Holder that marked its common shares to market
would not include mark-to-market gain or loss with respect to its common shares for any taxable year that we were not a PFIC.
A U.S. Holder that makes a Mark-to-Market Election generally will also
adjust such U.S. Holder’s tax basis in his common shares to reflect the amount included in gross income or allowed as a deduction
because of such Mark-to-Market Election. In addition, upon a sale or other taxable disposition of the common shares subject to a Mark-to-Market
Election, any gain or loss on such disposition will be ordinary income or loss (to the extent that such loss does not to exceed the excess,
if any, of (a) the amount included in ordinary income because of such Mark-to-Market Election for prior taxable years over (b) the amount
allowed as a deduction because of such Mark-to-Market Election for prior taxable years). A Mark-to-Market Election applies to the taxable
year in which such Mark-to-Market Election is made and to each subsequent taxable year unless the common shares cease to be “marketable
stock” or the IRS consents to revocation of such election. Each U.S. Holder should consult its own tax advisor regarding the availability
of, and procedure for making, a Mark-to-Market Election with respect to the common shares.
Reporting .
If we were to be treated as a PFIC in any taxable year, a U.S. Holder will
generally be required to file an annual report with the IRS containing such information as the U.S. Treasury Department may require.
25
Each U.S. Holder should consult its own tax advisor regarding our potential
status as a PFIC, the possible effect of the PFIC rules to such holder and information reporting required if we were a PFIC, as well as
the availability of any election that may be available to the holder to mitigate adverse U.S. federal income tax consequences of holding
shares in a PFIC.
Receipt of Foreign Currency
The amount of a distribution paid in Canadian dollars or Canadian dollar
proceeds received on the sale or other taxable disposition of common shares will generally be equal to the U.S. dollar value of the currency
on the date of receipt. If any Canadian dollars received with respect to the common shares are later converted into U.S. dollars, U.S.
Holders may realize foreign currency gain or loss on the conversion. Any gain or loss generally will be treated as ordinary income or
loss and generally will be from sources within the United States for U.S. foreign tax credit purposes. Each U.S. Holder should consult
its own tax advisor concerning the possibility of foreign currency gain or loss if any such currency is not converted into U.S. dollars
on the date of receipt.
Foreign Tax Credit
Subject to certain limitations, a U.S. Holder who pays (whether directly
or through withholding) Canadian or other non-U.S. income tax with respect to the common shares may be entitled, at the election of the
U.S. Holder, to receive either a deduction or a credit for Canadian or other non-U.S. income tax paid. Dividends paid on common shares
generally will constitute income from sources outside the United States. Any gain from the sale or other taxable disposition of the common
shares by a U.S. Holder generally will constitute U.S. source income. The foreign tax credit rules (including the limitations with respect
thereto) are complex, and each U.S. Holder should consult its own tax advisor regarding the foreign tax credit rules, having regard to
such holder’s particular circumstances.
Information Reporting; Backup Withholding
Generally, information reporting and backup withholding will apply to distributions
on, and the payment of proceeds from the sale or other taxable disposition of, the common shares unless (i) the U.S. Holder is a corporation
or other exempt entity, or (ii) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number,
certifies that the U.S. Holder is not subject to backup withholding and otherwise complies with the applicable requirements of the backup
withholding rules.
Backup withholding is not an additional tax. Any amount withheld generally
will be creditable against a U.S. Holder’s U.S. federal income tax liability or refundable to the extent that it exceeds such liability
provided the required information is provided to the IRS in a timely manner.
In addition, certain categories of U.S. Holders must file information returns
with respect to their investment in a non-U.S. corporation. For example, certain U.S. Holders must file IRS Form 8938 with respect to
certain “specified foreign financial assets” (such as the common shares) with an aggregate value in excess of US$50,000 (and,
in some circumstances, a higher threshold). Failure to do so could result in substantial penalties and in the extension of the statute
of limitations with respect to such holder’s U.S. federal income tax returns. Each U.S. Holder should consult its own tax advisor
regarding application of the information reporting and backup withholding rules to it in connection with an investment in our common shares.
Medicare Contribution Tax
U.S. Holders that are individuals, estates or certain trusts generally
will be subject to a 3.8% Medicare contribution tax on, among other things, dividends on, and capital gains from the sale or other taxable
disposition of, common shares, subject to certain limitations and exceptions. Each U.S. Holder should consult its own tax advisor regarding
possible application of this additional tax to income earned in connection with an investment in our common shares.
Recent Sales of Unregistered Securities
None.
26
Issuer Repurchases of Equity Securities
None.
Item 6.
Selected Financial Data
Not applicable.
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results
of Operation
The following discussion should be read in conjunction with the attached
consolidated financial statements and notes thereto. This annual report contains forward-looking statements within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause actual
results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion
of these risks and uncertainties, see Item 1A, “Risk Factors” of this annual report. We caution the reader not to place undue
reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this annual report. We
undertake no obligation to update forward-looking statements which reflect events or circumstances occurring after the date of this annual
report, unless required by applicable securities laws.
Introduction
This management’s discussion and analysis, or MD&A, is presented
in order to provide the reader with an overview of the financial results and changes to our financial position as at March 31, 2021 and
for the three and twelve-month periods then ended. This MD&A explains the material variations in our financial statements of operations,
financial position and cash flows for the three and twelve-month periods ended March 31, 2021, and 2020.
Market data and certain industry data and forecasts included in this MD&A
were obtained from internal corporation surveys, market research, and publicly available information, reports of governmental agencies
and industry publications and surveys. We have relied upon industry publications as our primary sources for third-party industry data
and forecasts. Industry surveys, publications and forecasts generally state that the information they contain has been obtained from sources
believed to be reliable, but that the accuracy and completeness of that information is not guaranteed. We have not independently verified
any of the data from third-party sources or the underlying economic assumptions they made. Similarly, internal surveys, industry forecasts
and market research, which we believe to be reliable based upon our management’s knowledge of our industry, have not been independently
verified. Our estimates involve risks and uncertainties, including assumptions that may prove not to be accurate, and these estimates
and certain industry data are subject to change based on various factors, including those discussed under Item 1.A “Risk Factors”
in this annual report. While we believe our internal business, research is reliable and the market definitions we use in this MD&A
are appropriate, neither our business research nor the definitions we use have been verified by any independent source. This MD&A
may only be used for the purpose for which it has been published.
This MD&A, approved by the Board of Directors on June 22, 2021, should
be read in conjunction with our audited consolidated financial statements for the year ended March 31, 2021, and 2020. Our audited financial
statements were prepared in accordance with generally accepted accounting principles issued by the Financial Accounting Standards Board
in the United States, or GAAP. Up to and including the third quarter ended December 31, 2019, we prepared our consolidated financial statements
in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. Our
financial results are now published in United States dollars. Effective March 31, 2020, the reporting currency used in the consolidated
financial statements changed from Canadian dollars to U.S. dollars. This change in reporting currency has been applied in the financial
statements retrospectively such that all amounts expressed in our consolidated financial statements and the accompanying notes thereto
are in U.S. dollars. All amounts appearing in this MD&A for the period-by-period discussions are in thousands of U.S. dollars, except
share and per share amounts or unless otherwise indicated.
27
Basis of presentation of the financial statements
Our consolidated financial statements, which include the accounts of our
subsidiary AIAG, have been prepared in accordance with GAAP and the rules and regulations of the SEC related to annual reports filed on
Form 10-K. All intercompany transactions and balances are eliminated on consolidation.
The following summarizes the principal conditions or events relevant to
our going concern assessment, which primarily considers the period of one year from the issuance date of our financial statements.
We have incurred operating losses and negative cash flows from operations
since our inception. In prior years there was substantial doubt regarding our ability to realize our assets and discharge our liabilities
and commitments in the ordinary course of business. During year ended March 31, 2021, we raised net proceeds of $59.3 million under our
ATM program. Our assets as at March 31, 2021, include cash and cash equivalents and short-term investments totaling $60.8 million. Our
current liabilities total $1.6 million as at March 31, 2021 and are comprised primarily of amounts due to or accrued for creditors.
Our ability to continue as a going concern is
dependent upon our ability to achieve a successful completion of our proposed merger with Grace or another strategic alternative and ultimately
generate cashflows to meet our obligations. To date, we have financed our operations primarily through public offerings of common shares,
private placements, and the proceeds from research tax credits, and will require additional financing in the future. There is no assurance
that our proposed merger with Grace or another strategic transaction will be consummated as such transaction is not within our control.
As a result of our current liquidity profile, the reduction of operating expenses and the limited liabilities, management has assessed
that substantial doubt no longer exists regarding our ability to continue as a going concern for one year from the issuance date of these
financial statements.
Comparative financial information for the three-month periods and years ended March 31, 2021,
and 2020.
Three-month
periods ended
Year
ended
March 31, 2021
March 31, 2020
March 31, 2021
March 31, 2020
$
$
$
$
Net income (loss)
(5,646
)
16,625
(19,678
)
(25,513
)
Basic and diluted gain (loss) per share
(0.03
)
0.18
(0.17
)
(0.30
)
Total assets
62,458
22,853
62,458
22,853
Working capital 1
60,793
8,684
60,793
8,684
Total non-current financial liabilities
5,219
2,464
5,219
2,464
Total shareholders’ equity
55,660
12,994
55,660
12,994
_____________________________________
1 Working capital is calculated by subtracting current liabilities
from current assets. Because there is no standard method endorsed by GAAP, the results may not be comparable to similar measurements presented
by other public companies.
28
Statement of Net Loss
Three-month
periods ended
Year
ended
March 31, 2021
March 31, 2020
March 31, 2021
March 31, 2020
$
$
$
Revenue
115
-
196
-
Cost sales of products
(40
)
-
(76
)
-
Research and development expenses
(453
)
(1,918
)
(4,173
)
(15,974
)
General and administrative expenses
(1,443
)
(1,549
)
(5,521
)
(5,799
)
Sales and marketing expenses
(66
)
(563
)
(1,142
)
(2,665
)
Impairment of Intangible assets
-
-
(3,706
)
-
Impairment of Equipment
-
-
(1,584
)
-
Impairment of Other assets and prepaids
(413
)
-
(413
)
-
Financial Income (expenses)
(3,346
)
20,646
(3,259
)
(1,075
)
Net loss
(5,646
)
16,616
(19,678
)
(25,513
)
Results of operations for the three and twelve-month periods ended
March 31, 2021, and 2020
Three months ended March 31, 2021, and 2020
The net loss of $5,646 or $0.03 per share for the three months ended March
31, 2021, increased by $22,262 from the net income of $16,616 or $0.18 per share for the three months ended March 31, 2020.
The increase in net loss resulted primarily from net financial expenses
decreasing by $23,992 to an expense of $3,346 for the three months ended March 31, 2021, as compared to net financial income of $20,646
for the three months ended March 31, 2020. This is due mostly to a decrease from the change in fair value of the derivative warrant liability
as compared to the comparative fiscal quarter in 2020 caused by a proportionately higher decrease in the quarter over quarter closing
share price partly offset by a reduction in the number of warrants outstanding due to exercises during the prior year.
In October 2020, the Corporation entered into an agreement with the Centre
Integre Universitaire et des services sociaux de L’Estrie – Centre hospitalier Universitaire de Sherbrooke to start producing
and selling viral transport medium tubes to be utilized in testing related to the COVID-19 pandemic.
In addition, a decrease in research and development expenses of $1,465
occurred as the TRILOGY Phase 3 clinical program for CaPre was winding down. General and administrative expenses decreased from the prior
period, with the current period being impacted by lower legal and professional fees. Sales and marketing expenses also decreased as a
result of the termination of CaPre commercialization activities due to the TRILOGY 2 Phase 3 clinical trial results.
Fiscal years ended March 31, 2021, and 2020
The net loss of $19,678 or $0.17 per share for the year ended March 31,
2021, decreased by $5,835 from the net loss of $25,513 or $0.30 per share for the year ended March 31, 2020.
The decreased net loss resulted in part from a decrease in research and
development expenses of $11,801 occurred as the TRILOGY Phase 3 clinical program for CaPre was winding down. General and administrative
expenses decreased from the comparative period due to decreased stock-based compensation. Sales and marketing expenses also decreased
by $1,523, as a result of the termination of any CaPre commercialization activities due to the TRILOGY 2 Phase 3 clinical trial results.
Furthermore, operational events related to the TRILOGY results resulted in increased loss related to the impairment of equipment and intangible
assets amounting to $5,290. The decreased net loss also resulted from financial expenses of $3,259 for the year ended March 31, 2021,
as compared to net financial expenses of $1,075 for the year ended March 31, 2020, due mostly to the change in fair value of the warrant
derivative liability.
29
Two separate derivative warrant liabilities are included in the statement
of financial position as at March 31, 2021, and March 31, 2020. These derivative warrant liabilities stem from financing transactions
that took place in May 2018 and December 2017. These derivative warrant liabilities are re-measured to fair value at each reporting date
using the Black-Scholes option pricing model. The valuations are mainly driven by the fluctuation in our share price resulting in an increased
or decreased loss or gain related to the change in fair value of the warrant liabilities and increasing or decreasing the corresponding
liability in the balance sheet.
Breakdown of major components of the statement of loss and comprehensive loss
Research and development expenses
Three Months Ended
Year Ended
March 31, 2021
March 31, 2020
March 31, 2021
March 31, 2020
$
$
$
$
Salaries and benefits
344
476
1,459
1,759
Research contracts
2
669
917
10,260
Professional fees
57
119
467
1,117
Other
37
81
188
392
Government grants & tax credits
(36
)
(117
)
(127
)
(313
)
Sub-total
404
1,228
2,904
13,215
Stock-based compensation
49
93
353
443
Depreciation and amortization
-
597
916
2,316
Total
453
1,918
4,173
15,974
General and administrative expenses
Three Months Ended
Year Ended
March 31, 2021
March 31, 2020
March 31, 2021
March 31, 2020
$
$
$
$
Salaries and benefits
434
385
1,321
1,506
Professional fees
593
615
2,337
2,018
Other
294
291
1,027
1,058
Sub-total
1,321
1,291
4,685
4,582
Stock-based compensation
122
258
828
1,217
Depreciation
-
-
8
-
Total
1,443
1,549
5,521
5,799
Sales and Marketing Expenses
Three Months Ended
Year Ended
March 31, 2021
March 31, 2020
March 31, 2021
March 31, 2020
$
$
$
$
Salaries and benefits
65
389
1,050
1,206
Professional fees
-
48
75
711
Other
1
32
24
455
Sub-total
66
469
1,149
2,372
Stock-based compensation
-
94
(7
)
293
Total
66
563
1,142
2,665
30
Three months ended March 31, 2021, compared to the three months ended March 31, 2020
During the three months ended September 30, 2020, we released our TRILOGY
2 Phase 3 clinical study results for CaPre. TRILOGY 2 failed to meet the primary endpoint, and consequently we decided we will not file
an NDA with the FDA. Research and development expenses are reduced due to the completion of the TRILOGY program, and we discontinued all
CaPre related marketing activities, while we evaluated a range of strategic alternatives. As a result, research and development expenses
before depreciation, amortization and stock-based compensation expense for the three months ended March 31, 2021, totaled $404 compared
to $1,228 for the three months ended March 31, 2020. The net decrease of $824 was mainly attributable to a reduction in research contracts
with the completion of the TRILOGY research and development activities of $667 as well as a reduction in headcount within the department
resulting in a decrease of salaries of $132. The remaining decrease of $23 is a result of various other operational reductions.
General and administrative expenses totaled $1,321 before depreciation
and stock-based compensation expense for the three-months ended March 31, 2021 and increased by $31 from $1,291 for the three months ended
March 31, 2020. This increase is mostly a result of increased salaries of $49 related to retention amounts offset by a decrease in professional
fees of $22.
Sales and marketing expenses were $66 before stock-based compensation expense
for the three months ended March 31, 2021, compared to $469 for the three months ended March 31, 2020. The decrease of $403 was mostly
due to a decrease in salaries related to the reduction in headcount in the department of $324 as well as a decrease of $79 related to
other sales activities as a result of discontinuing planned pre-launch marketing activities for CaPre.
Stock-based compensation expense decreased by $274 to $171 for the three-month
period ended March 31, 2021, as compared to $445 for the three-month period ended March 31, 2020. The decrease in expense is due to forfeited
options as well as the fact that no options have been granted in the current period.
The depreciation expense decreased by $597 for the three-month period ended
March 31, 2021, as compared to $597 for the three-month period ended March 31, 2020. This is due to the impact of the equipment being
classified as held for resale and no additional depreciation recognized.
Year ended March 31, 2021, compared to year ended March 31, 2020
During the three months ended September 30, 2020, we released our TRILOGY
2 Phase 3 clinical study results for our lead product in development, CaPre. TRILOGY 2 failed to meet its primary endpoint, and consequently
we will not file an NDA with the FDA. Research and development expenses have been reduced due to the completion of the TRILOGY program,
and we discontinued all CaPre related marketing activities while we evaluate a range of strategic alternatives. As a result, research
and development expenses before depreciation, amortization and stock-based compensation expense for the year ended March 31, 2021, totaled
$2,904 compared to $13,215 for the year ended March 31, 2020. The net decrease of $10,311 was mainly attributable to a reduction in research
contracts with the completion of the CaPre R&D activities of $9,343 as well as a reduction in headcount within the department resulting
in a decrease of salaries of $300. In addition, a decrease of $854 related to various other operational reductions such as professional
fees resulted, as well as a decrease to the government tax credits of $186.
General and administrative expenses totaled $4,685 before depreciation
and stock-based compensation expense for the year ended March 31, 2021 and increased by $103 from $4,582 for the year ended March 31,
2020. This increase was mainly attributable to a $100 increase associated with our insurance policies, as well as an increase of $186
in legal fees, which was offset by a $185 decrease in salaries related to a reversal in bonus amounts accrued.
Sales and marketing expenses were $1,149 before stock-based compensation
expense for the year ended March 31, 2021, compared to $2,372 for the year ended March 31, 2020. The decrease of $1,223 was mostly due
to a reduction in salaries of $156 due to a reduction in headcount, as well as a reduction in professional fees and other sales activities
of $1,067 due to the end of the planned pre-launch marketing activities for CaPre.
31
Stock-based compensation expense decreased by $779 to $1,174 for the year
ended March 31, 2021, as compared to $1,953 for the year ended March 31, 2020. The decrease in expense is due to forfeited options as
well as the fact that no options have been granted in the current period.
The depreciation expense decreased by $1,392 to $924 for the year ended
March 31, 2021, as compared to $2,316 for the year ended March 31, 2020. This is due to the impact of the equipment being classified as
held for resale and no additional depreciation recognized.
Liquidity and Capital Resources
Share Capital Structure
Our authorized share capital consists of an unlimited number of Class A,
Class B, Class C, Class D and Class E shares, without par value. Issued and outstanding fully paid shares, stock options, restricted shares
units and warrants, were as follows for the periods ended:
March 31, 2021
March 31, 2020
Number outstanding
Number outstanding
Class A shares, voting, participating and without par value
208,375,549
90,209,449
Stock options granted and outstanding
7,294,919
9,936,486
May 2018 public offering of warrants exercisable at CAD $1.31, until May 9, 2023
6,593,750
6,593,750
Public offering broker warrants May 2018 exercisable at CAD $1.05 until May 9, 2023
1
222,976
December 2017 U.S. public offering of warrants exercisable at US$1.26, until December 19, 2022
7,072,962
7,072,962
December 2017 U.S. broker warrants exercisable at US $1.2625, until December 27, 2022
259,121
259,121
February 2017 public offering of warrants exercisable at CAD $2.15, until February 21, 2022
1,723,934
1,723,934
Total fully diluted shares
231,320,236
116,018,678
Cash Flows and Financial Condition between the years ended March
31, 2021 and 2020
Summary
As at March 31, 2021, cash and cash equivalents totaled $50,942, a net
increase of $36,702 compared to cash and cash equivalents totaling $14,240 at March 31, 2020.
Operating activities
During the years ended March 31, 2021, and March 31, 2020, our operating
activities used cash of $14,319 and $22,951, respectively, the decrease of which is a reflection of the completion of our Phase 3 program
for CaPre and related reduction of accounts payables and accruals.
Investing activities
During the year ended March 31, 2021, we used cash of $9,858 due primarily
to the acquisition of investments. During the year ended March 31, 2020, we generated cash of $8,138 due primarily to the maturity of
investments.
32
Financing activities
During the year ended March 31, 2021, the Corporation’s financing
activities provided cash totaling $59,490 due to proceeds from the sale of shares under the “at-the-market”, or ATM, program,
compared to cash generated of $13,183 due to proceeds from the sale of shares under the “at-the-market” and exercise of warrants,
net of repayment of convertible debentures of $1,556 during the year ended March 31, 2020.
On June 29, 2020, we filed a registration statement on Form S-3 with the
SEC to register up to US $200 million of common shares, warrants and units that may be offered and sold by us from time to time (the “Registration
Statement”). The Registration Statement was declared effective by the SEC on July 7, 2020.
ATM Program
On February 14, 2019, the Corporation entered into an “at-the-market”
(ATM) sales agreement with B. Riley FBR, Inc. (“B. Riley”) pursuant to which the Common Shares may be sold from time to time
for aggregate gross proceeds of up to $30 million, with sales only being made on the NASDAQ Stock Market. The Common Shares would be issued
at market prices prevailing at the time of the sale and, as a result, prices may vary between purchasers and during the period of distribution.
The ATM has a 3-year term and requires the Corporation to pay between 3% and 4% commission to B. Riley based on volume of sales made.
On June 29, 2020, the Corporation entered into an amended and restated sales agreement (the Sales Agreement) with B. Riley, Oppenheimer&
Co. Inc. and H.C. Wainwright & Co., LLC (collectively, the “Agents”) to amend the existing ATM program. Under the terms
of the Sales Agreement, the Corporation may issue and sell from time to time its common shares having an aggregate offering price of up
to US $75,000,000 through the Agents. Subject to the terms and conditions of the Sales Agreement, the Agents will use their commercially
reasonable efforts to sell the common shares from time to time, based upon the Corporation’s instructions. The Corporation has no
obligation to sell any of the common shares and may at any time suspend sales under the Sales Agreement. The Corporation and the Agents
may terminate the Sales Agreement in accordance with its terms. Under the terms of the Sales Agreement, the Corporation has provided the
Agents with customary indemnification rights and the Agents will be entitled to compensation, at a commission rate equal to 3.0% of the
gross proceeds from each sale of the common shares. As at March 31, 2021, a total of 117.7 million common shares (March 31, 2020 –
4.1 million common shares) were sold for total net proceeds of approximately $59.3 million (March 31, 2020 - $7.0 million) under the ATM
program. Commission, legal and costs related to share sale amounted to $2.0 million (March 31, 2020 - $291). The shares were sold at the
prevailing market prices, which resulted in an average price of approximately $0.52 per share (March 31, 2020 - $1.79 per share). Accordingly,
proportional costs of $18 related to the common shares sold, have been reclassified from deferred financings costs to equity (March 31,
2020 - $40). Total costs incurred to register the Sales Agreements were initially recorded as deferred financing costs in the Consolidated
Balance Sheet. As at March 31, 2021, the remaining balance of the costs incurred of $264 were written off to financing expenses.
Financial Position
The following table details the significant changes to the statements of
financial position as at March 31, 2021, compared to the prior fiscal year end at March 31, 2020:
Accounts
Increase
(Decrease) $
Comments
Cash and cash equivalents
36,702
See cash flow statement
Investments
9,789
Increase in cash available to invest
Receivables
(16)
Timing of reimbursement of sales taxes
Deferred financing costs
(121)
New costs, net of write off
Prepaid expenses
(634)
Expensing of insurance, impairment and other prepaid expenses
Other assets
(281)
Use of other assets in research and development activities and impairment
Equipment
(1,529)
Amortization & Impairment
Right of use asset
(61)
Adjustment to the net present value of lease contract for Sherbrooke
Intangible assets
(4,244)
Amortization and Impairment of license
Trade and other payables
(5,826)
Timing of payments net of accruals
Derivative warrant liabilities
2,826
Change in fair value of derivative warrants
Lease liability
(61)
Payment of lease liability
33
See the statement of changes in equity in our financial statements for
details of changes to the equity accounts since March 31, 2020.
Treasury Operations
Our treasury policy is to invest cash that is not required immediately
into instruments with an investment strategy based on capital preservation. 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. We hold cash denominated in both U.S. and CAD dollars.
Funds received in U.S. dollars from equity financings are invested as per our treasury policy in U.S. dollar investments and converted
to CAD dollars as appropriate to fulfill operational requirements and funding.
Impairment loss Intangible assets:
The Corporation tests intangible assets for impairment
should circumstances change or events occur that would indicate that the fair value of an asset may be below its carrying value. During
the second quarter of fiscal 2021, the Corporation released its topline TRILOGY 2 Phase 3 clinical trial results and the resulting decision
to not file an NDA to obtain FDA approval for CaPre as a result of TRILOGY 2 not meeting its primary endpoint. As a result, a significant
share price reduction occurred. Due to these indicators of impairment under ASC 350, the Corporation undertook an analysis to determine
the fair value of its intangible asset this quarter.
In prior years, the Corporation entered into agreements
with Neptune Wellness Solutions Inc. (“Neptune”) pursuant to which the Corporation obtained a license and exercised its option
under this license agreement to pay in advance all of the future royalties payable to Neptune. This license allows the Corporation to
exploit the intellectual property rights in-order to develop novel active pharmaceutical ingredients into commercial products for the
prescription drugs market. In assessing the magnitude of any impairment of the license the Corporation considered all available evidence
including i) significant adverse impact from business climate due to the TRILOGY Phase 3 clinical programs failure to meet its primary
endpoints, and the resulting decision to not file an NDA to obtain FDA approval for CaPre, and the resulting internal forecasts that no
cash flows from the use of the license was possible, and (ii) management’s estimate that a market place participant would place
minimal to no value on the license if it were to be sold on its own or in combination with other assets, recognized or not, which is a
level 3 measurement in the fair value hierarchy which included unobservable inputs. Accordingly, an impairment loss of $3,706 was recognized
during the year ended March 31, 2021, which represents the totality of the intangible assets net book value prior to the impairment trigger.
For the year ended March 31, 2021, amortization expense was $781 (2020 - $1,910) and was included in research and development expenses.
Assets held for sale
During the period the Corporation committed to
a plan and is actively marketing for sale Other assets and Equipment and has met the criteria for classification of assets held for sale:
March 31,
2021
March 31,
2020
$
$
Other assets
387
668
Equipment
381
1,910
768
2,578
34
Other assets
Other assets represent krill oil (RKO) held by
the Corporation that was expected to be used in the conduct of R&D activities and commercial inventory scale up related to the development
and commercialization of the CaPre drug. Given that the development of CaPre will no longer be pursued, the Corporation is expected to
sell this reserve. The other asset is being recorded at the fair value less costs to sell, which has resulted in an impairment loss of
$413. Management’s estimate of the fair value of the RKO less cost -to sell, is based primarily on estimated market prices obtained
from an appraiser specialized in the krill oil market. These projections are based on Level 3 inputs of the fair value hierarchy and reflect
management’s best estimate of market participants’ pricing of the assets as well as the general condition of the asset. The
total impairment loss recognized, includes amounts paid for krill oil in advance, but not yet received and was recorded as a prepaid.
Equipment
March 31, 2021
Cost
Accumulated
depreciation
Impairment
loss
Net book
value
$
$
$
$
Furniture and office equipment
17
(5
)
-
12
Computer equipment
148
(30
)
(54
)
64
Laboratory equipment
756
(436
)
(171
)
149
Production equipment
2,538
(1,023
)
(1,359
)
156
3,459
(1,494
)
(1,584
)
381
March 31, 2020
Cost
Accumulated
depreciation
Net book value
$
$
$
Furniture and office equipment
15
3
12
Computer equipment
64
18
46
Laboratory equipment
684
343
341
Production equipment
2,341
830
1,511
3,104
1,194
1,910
For the year ended March 31, 2021, depreciation expense
was $143 (2020 $410) and was included in research and development expenses.
Equipment is made up of laboratory, production,
computer and office equipment that was utilized in the development of CaPre. Given that the development of CaPre will no longer be pursued
by the Corporation, it is expected to sell this equipment. Similar, to how the intangible assets are treated, the announcement of the
outcomes of the TRILOGY clinical trials resulted in an impairment trigger for the laboratory and production equipment. The impairment
loss is based on management’s estimate of the fair value of the equipment less cost -to sell, which is based primarily on estimated
market prices obtained from brokers specialized in selling used equipment. These projections are based on Level 3 inputs of the fair value
hierarchy and reflect the management’s best estimate of market participants’ pricing of the assets as well as the general
condition of the assets.
Derivative warrant liabilities
The 10,188,100 warrants issued as part of our May 2018 public offering
in Canada were recognized as derivative warrant liabilities with a fair value of $3,323. As of March 31, 2021, the derivative warrant
liability for the remaining 6,593,750 warrants totaled $2,597, which represents the fair value of these warrants. The weighted average
fair value of the warrants issued in the May 2018 public offering in Canada was determined to be CAD$0.39 per warrant at inception and
approximately CAD$0.49 (USD $0.39) per warrant as at March 31, 2021.
35
On December 27, 2017, 9,801,861 warrants were issued as part of our U.S.
public offering and recognized as derivative warrant liabilities. The December 2017 warrants are derivative warrant liabilities for accounting
purposes due to the currency of the exercise price (US$) being different from our Canadian dollar functional currency. As of March 31,
2021, the derivative warrant liability for the remaining 7,072,962 warrants totaled $2,622 which represents the fair value of these warrants.
The weighted average fair value of the 2017 warrants issued was determined to be CAD$0.60 per warrant at inception and approximately CAD$0.47
(USD $0.37) per warrant as at March 31, 2021.
The increase in the fair value of both existing derivative warrant liabilities
as at March 31, 2021 is due to the decrease in our share price and the dilution factor.
During the year ended March 31, 2021, no warrants were exercised. In fiscal
2020, the following warrants were exercised with the resulting cash proceeds:
March
31, 2020
Number
Proceeds
exercised
$
May 2018 over-allotment warrants 2018
3,594,350
3,567
December 2017 US public offering warrants 2017
2,676,611
3,373
Canadian public offering warrants February 2017
180,100
292
Canadian public offering broker warrants May 2018
325,000
257
Contingent warrants private placement 2017
150,000
217
6,926,061
7,706
Contractual Obligations and Commitments
As at March 31, 2021, our liabilities totaled $6,744, of which $1,525 was
due within 1 year, and $5,219 related to derivative warrant liabilities that are expected to be settled in common shares.
A summary of the contractual obligations at March 31, 2021, is as follows:
Contractual Obligations
Total
Less
than
1 year
1-3
years
More
than
3 years
$
$
$
$
Trade and other payables
1,479
1,479
-
-
Operating lease obligations
86
86
-
-
RKO supply agreement
2,800
2,800
-
-
Total
4,365
4,365
-
-
Lease
On March 5, 2020, we renewed the lease agreement for our research and development
and quality control laboratory facility located in Sherbrooke, Québec, resulting in an obligation of $160 over 24 months of the lease
term. As at March 31, 2021, the remaining balance of the commitment amounted to $86.
RKO supply agreement
On October 25, 2019, we signed a supply agreement with Aker to purchase
RKO for a committed volume of commercial starting material for CaPre at a fixed price for a total value of $3.1 million (take or pay).
The delivery of the RKO has been established following a calendar year basis and it is expected to be completed in the 4 th
calendar quarter of 2021. As at March 31, 2021, the remaining balance of the commitment with Aker amounts to $2.8 million. There are no
termination provisions within the supply agreement. Management is currently assessing whether the Corporation can recover any value from
the raw krill oil product and given the uncertainty of recoverability, there is a risk that the Corporation may have a loss on this contract
in the near term.
36
Financial advisor agreement
On September 23, 2020, we engaged Oppenheimer & Co., Inc, as our financial
advisor to assist in the formal process to explore and evaluate strategic alternatives to enhance shareholder value. This arrangement
includes fees of $1.2 million to be paid on the success of a strategic outcome.
Contingencies
We evaluate contingencies on an ongoing basis and establish loss provisions
for matters in which losses are probable and the amount of the loss can be reasonably estimated.
Off-Balance Sheet Arrangements
As of the date of this annual report, we do not have any off-balance sheet
arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
Use of estimates and measurement of uncertainty
The preparation of the financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets, liabilities, income, and expenses. Actual results
may differ from these estimates.
Estimates are based on management’s best knowledge of current events
and actions that management may undertake in the future. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions
to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Estimates and assumptions include the measurement of derivative warrant
liabilities (see note 10 of the consolidated financial statements), stock-based compensation (see note 14 of the consolidated financial
statements), and impairment and recoverability of other assets – RKO (see note 7 of the consolidated financial statements). Estimates
and assumptions are also involved in measuring the accrual of services rendered with respect to research and developments expenditures
at each reporting date, are determining which research and development expenses qualify for research and development tax credits and in
what amounts. We recognize the tax credits once we have reasonable assurance that they will be realized. Recorded tax credits are subject
to review and approval by tax authorities and therefore, could be different from the amounts recorded.
Critical Accounting Policies
Impairment of Long-Lived Assets
We review the recoverability of our long-lived assets and Assets held for
sale whenever events or changes in circumstances indicate that their carrying amount may not be recoverable. The carrying amount is first
compared with the undiscounted cash flows. If the carrying amount is higher than the sum of undiscounted cash flows, then we determine
the fair value of the underlying asset group. Any impairment loss to be recognized is measured as the difference by which the carrying
amount of the asset group exceeds the estimated fair value of the asset group.
Measurement of Assets held for sale
Assets that are classified as held for sale are measured at
the lower of their carrying amount or fair value less expected selling costs (“estimated selling price”) with a loss recognized
to the extent that the carrying amount exceeds the estimated selling price. The classification is applicable at the date upon which the
sale of assets is probable, and the assets are available for immediate sale in their present condition. Assets once classified as held
for sale, are not subject to depreciation or amortization and both the assets and any liabilities directly associated with the assets
held for sale are classified as current in our Consolidated Balance Sheets. Subsequent changes to the estimated selling price of assets
held for sale are recorded as gains or losses to the Consolidated Statements of Income wherein the recognition of subsequent gains is
limited to the cumulative loss previously recognized.
37
Financial Instruments
Credit risk
Credit risk is the risk of a loss if a customer or counterparty
to a financial asset fails to meet its contractual obligations. We have credit risk relating to cash, cash equivalents and marketable
securities, which we manage by dealing only with highly rated Canadian institutions. The carrying amount of financial assets, as disclosed
in the statements of financial position, represents our credit exposure at the reporting date.
Currency risk
We are exposed to the financial risk related to the fluctuation of foreign
exchange rates and the degrees of volatility of those rates. Foreign currency risk is limited to the portion of our business transactions
denominated in currencies other than the Canadian dollar. Fluctuations related to foreign exchange rates could cause unforeseen fluctuations
in our operating results.
A portion of the expenses, mainly related to research contracts
and salaries is incurred in U.S. dollars and in Euros, for which no financial hedging is in place. There is a financial risk related to
the fluctuation in the value of the U.S. dollar and the Euro in relation to the Canadian dollar. In order to minimize the financial
risk related to the fluctuation in the value of the U.S. dollar in relation to the Canadian dollar, funds which were part of U.S. dollar
financings continue to be invested as short-term investments in the U.S. dollar.
Furthermore, a portion of our cash and cash equivalents and marketable
securities are denominated in U.S. dollars, further exposing us to fluctuations in the value of the U.S. dollar in relation to the Canadian
dollar.
The following table provides an indication of our significant
foreign exchange currency exposures as stated in Canadian dollars at the following dates:
March
31, 2021
March
31, 2020
Denominated in
US
$
Euro
US
$
Euro
Cash and cash equivalents
58,176
-
5,694
-
Investments
9,475
-
-
-
Trade and other payables
(687
)
(2,141
)
(7,275
)
(579
)
66,964
(2,141
)
(1,581
)
(579
)
The following exchange rates are those applicable to the following
periods and dates:
March
31, 2021
March
31, 2020
Average
Reporting
Average
Reporting
CAD$ per US$
1.3212
1.2562
1.3120
1.4062
CAD$ per Euro
1.5409
1.4736
1.4789
1.5514
Based on our foreign currency exposures noted above, varying
the above foreign exchange rates to reflect a 5% strengthening of the U.S. dollar and Euro would have an increase (decrease) in net loss
as follows, assuming that all other variables remain constant:
38
March 31, 2021
March 31, 2020
$
$
Increase (decrease) in net loss
4,235
156
An assumed 5% weakening of the foreign currencies would have
an equal but opposite effect on the basis that all other variables remained constant.
Interest rate risk
Interest rate risk is the risk that the fair value or future
cash flows of a financial instrument will fluctuate because of changes in market rates.
Our exposure to interest rate risk as at March 31, 2021 and
March 31, 2020 is as follows:
Cash and cash equivalents
Short-term fixed interest rate
Investments
Short-term fixed interest rate
Our capacity to reinvest the short-term amounts with equivalent
return will be impacted by variations in short-term fixed interest rates available on the market. Management believes the risk we will
realize a loss as a result of the decline in the fair value of our short-term investments is limited because these investments have short-term
maturities and are held to maturity.
Liquidity risk
Liquidity risk is the risk that we will not be able to meet
our financial obligations as they fall due. We manage liquidity risk through the management of our capital structure and financial leverage.
We also manage liquidity risk by continuously monitoring actual and projected cash flows. The Board of Directors reviews and approves
our operating budgets and reviews material transactions outside the normal course of business.
Our contractual obligations related to financial instruments
and other obligations and liquidity resources are presented in the liquidity and capital resources of this MD&A.
Future accounting changes
The following new standards, and amendments to standards and
interpretations, are not yet effective for the period ended March 31, 2021, and have not been applied in preparing our consolidated financial
statements.
In June 2016, the Financial Accounting Standards Board, or FASB,
issued ASU 2016-13-Financial Instruments-Credit Losses (Topic 326), which amends guidance on reporting credit losses for assets held at
amortized cost basis and available for sale debt securities. For assets held at amortized cost, the new guidance eliminates the probable
initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit
losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets
to present the net amount expected to be collected. ASU 2016-13 will affect loans, debt securities, trade receivables, net investments
in leases, off balance sheet credit exposures, and any other financial assets not excluded from the scope that have the contractual right
to receive cash. ASU 2016-13 is effective for annual periods, and interim periods within those annual periods, beginning after December
15, 2022. Management has not yet evaluated the impact of this ASU on the consolidated financial statements.
Item 7A.
Quantitative and Qualitative Disclosure About Market Risk
Information relating to quantitative and qualitative disclosures about
market risks is detailed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation.”
39
Item 8.
Financial Statements and Supplementary Data
See our consolidated financial statements beginning on page F-1 of this annual report on Form
10-K.
Item 9.
Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
None.
Item 9A.
Controls and Procedures
Disclosure Controls and Procedures
As of the end of the period covered by this annual report, our management,
with the participation of our CEO and chief financial officer (“CFO”), has performed an evaluation of the effectiveness of
our disclosure controls and procedures within the meaning of Rules 13a-15 (e) and 15d-15(e) of the Exchange Act. Based upon this evaluation,
our management has concluded that, as of March 31, 2021, our existing disclosure controls and procedures were effective. It should be
noted that while the CEO and CFO believe that our disclosure controls and procedures provide a reasonable level of assurance that they
are effective, they do not expect the disclosure controls and procedures to be capable of preventing all errors and fraud. A control system,
no matter how well conceived or operated, can provide only reasonable, not absolute, assurance that the objectives of the control system
are met.
Management’s Report on Internal Controls over Financial Reporting
Our management, with the participation of our CEO and CFO, is responsible
for establishing and maintaining adequate internal control over financial reporting. Our internal control system was designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation and fair presentation of our financial statements.
All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective
may not prevent or detect misstatements and can provide only reasonable assurance with respect to financial statement preparation and
presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Our management
conducted an assessment of the design and operation effectiveness of our internal control over financial reporting as of March 31, 2021.
In making this assessment, we used the criteria established within the Internal Control—Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, our management has concluded that,
as of March 31, 2021, our internal control over financial reporting was effective.
Changes in Internal Control over Financial Reporting
No changes were made to our internal controls over financial reporting
that occurred during the quarter ended March 31, 2021, that have materially affected, or are reasonably likely to materially affect, our
internal controls over financial reporting.
We are a non-accelerated filer under the Exchange Act and not required
to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002. Therefore, this annual report
does not include an attestation report of our registered public accounting firm regarding our management’s assessment of internal
control over financial reporting.
Item 9B.
Other Information
None.
40
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
The following table sets forth information as of June 22, 2021
with respect to our directors:
Name
Age
Position(s) held within Acasti
In Office Since
Current Term to Expire
Directors
Jan D’Alvise
66
President, Chief Executive Officer, Director and Corporate Secretary
June 2016
September 2021
Roderick N. Carter
57
Chairman of the Board
October 2015
September 2021
Jean-Marie (John) Canan
64
Director and Chairman of Audit Committee
July 2016
September 2021
Donald Olds
61
Director and Chairman of Governance and Human Resources Committee
April 2018
September 2021
Senior Management
Jan D’Alvise
66
President, Chief Executive Officer, Director and Corporate Secretary
June 2016
-
Pierre Lemieux
56
Chief Operating Officer and Chief Scientific Officer
April 2010
-
Brian Ford
62
CFO
September 2020
-
The following is a brief biography of our current directors and senior
management:
Jan D’Alvise
Ms. D’Alvise has extensive experience in the pharmaceutical, diagnostic,
medical device, and drug discovery research segments of the healthcare industry, and has served as the president and CEO of Acasti since
2016. Prior to Acasti, Ms. D’Alvise was the President and Chairman of Pediatric Bioscience, a private company that was developing
a diagnostic test for autism. Before that, she was the CEO of Gish Biomedical, a cardiopulmonary medical device company that she sold
to the Sorin Group. Prior to Gish, Ms. D’Alvise was the CEO of the Sidney Kimmel Cancer Center (SKCC), a drug discovery research
institute focused on translational medicine in oncology. Prior to SKCC, she was the Co- Founder/President/CEO/Chairman of NuGEN, Inc.,
and was also the Co-Founder and Executive VP/COO of Metrika Inc. Ms. D’Alvise built both companies from technology concept through
to successful regulatory approvals, product introduction and sustainable revenue growth. Prior to Metrika, Ms. D’Alvise was a VP
of Drug Development at Syntex/Roche and Business Unit Director of their Pain and Inflammation business, and prior to that, VP of Commercial
Operations at SYVA, (Syntex’s clinical diagnostics division). Ms. D’Alvise began her career with Diagnostic Products Corporation.
Ms. D’Alvise has a B.S. in Biochemistry from Michigan Technological University. She has completed post-graduate work at the University
of Michigan, Stanford University, and the Wharton Business School. In addition to Acasti, Ms. D’Alvise currently serves on the board
and audit committee for Spectral Medical (EDT:TO) and is the Chairman of The ObG Project, Inc, a private company. She has previously served
on the boards of numerous private companies and non-profits.
Dr. Roderick N. Carter
Dr. Carter has a strong history of contributions to healthcare through
clinical, research, business, and people leadership. He has significant experience developing and commercializing nutraceutical and pharmaceutical
products and has successfully led clinical research and business development strategies for cardiovascular and inflammation-related diseases.
Dr. Carter is currently Principal at Aquila Life Sciences LLC, a consulting firm he founded in April 2008 focusing on pharmaceutical development
and commercialization. Prior to this, he was Vice President of Clinical Development at Reliant Pharmaceuticals, which developed the omega-3
cardiovascular drug LOVAZA, and today is a wholly owned subsidiary of GlaxoSmithKline. He also served as Executive Director at Merck and
Co., USA, President and Chief Executive Officer of WellGen and Senior Medical Director at Pfizer Inc., USA. Dr. Carter received his Medical
Degree from the University of Witwatersrand, Johannesburg, along with a Master of Science degree in Sports Medicine from Trinity College,
Dublin.
41
Jean-Marie (John) Canan
Mr. Canan is an accomplished business executive with over 34 years of strategic,
business development and financial leadership experience. Mr. Canan recently retired from Merck & Co., Inc. where his last senior
position was as Senior Vice-President, Global Controller, and Chief Accounting Officer for Merck from November 2009 to March 2014. He
has managed all interactions with the audit committee of the Merck board of directors, while participating extensively with the main board
and the compensation & benefits committee. Mr. Canan serves as a director of REV Group, a public company, where he chairs the audit
committee and is the lead independent director. He also serves on the board of trustees of Angkor Hospital for Children Inc. Mr. Canan
is a graduate of McGill University, Montreal, Canada, and is a Canadian Professional Accountant.
Donald Olds
Until May 2019, Mr. Olds was the President and Chief Executive Officer
of the NEOMED Institute, a research and development organization dedicated to advancing Canadian research discoveries to commercial success.
Prior to NEOMED, he was the Chief Operating Officer of Telesta Therapeutics Inc., a TSX-listed biotechnology company, where he was responsible
for finance and investor relations, manufacturing operations, business development, human resources, and strategy. In 2016, he led the
successful sale of Telesta to a larger public biotechnology company. Prior to Telesta, he was President and Chief Executive Officer of
Presagia Corp., and Chief Financial Officer and Chief Operating Officer of Aegera Therapeutics, where he was responsible for clinical
operations, business development, finance, and mergers and acquisitions. At both Telesta and Aegera, Mr. Olds was responsible for raising
more than C$100 million in equity financing and leading regional and global licensing transactions with life sciences companies. Mr. Olds
is currently lead director of Goodfood Market Corp, Chair of Aifred Health, lease director of Cannara Biotech Inc, and director of Presagia
Corp. Since December 2019, Mr. Olds has also been the Chairman of the board of directors for Alfred Health Inc. He has extensive past
corporate governance experience serving on the boards of private and public for-profit and not-for-profit organizations. He holds an MBA
(Finance & Strategy) and M.Sc. (Renewable Resources) from McGill University.
Dr. Pierre Lemieux
Dr. Lemieux has been our Chief Operating Officer since April 12, 2010,
and our Chief Scientific Officer since June 2018 . Previously, Mr. Lemieux was CEO, Co-Founder and Chairman of BiolActis Inc. which
he sold in 2009 to interests affiliated with the Nestlé multinational group. Mr. Lemieux joined Suprateck Pharma in 1999 as Director
and Vice-President involved in the development of formulations for gene therapy on behalf of Rhone-Poulenc Rorer and Genzyme, which today
are under the Sanofi banner. Prior to this, Mr. Lemieux was involved in the development of cardiovascular products at Angiotech Pharmaceuticals.
Mr. Lemieux has a Ph.D. in biochemistry from Université Laval (Québec). He holds more than 16 patents and has authored over
50 publications. Mr. Lemieux’s research was conducted at Université Laval as well as at the anti-cancer center Paul Papin D’Angers
(France) and the University of Nottingham (England). His research focused on ovarian cancer and its treatment with monoclonal antibodies
used to target cancer drugs. After completing his graduate studies, Mr. Lemieux joined the Oncology division of the Center for Health
Research, University of Texas. He obtained a postdoctoral fellowship from the Susan G. Komen Foundation (Breast Cancer). Mr. Lemieux has
served on the boards of BioQuébec, Montreal in vivo and PharmaBio Development.
Brian Ford
Mr. Ford has been our CFO since September 24, 2021. Prior to joining Acasti,
Mr. Ford served both publicly traded as well as privately owned organizations. Mr. Ford has been responsible for developing business recovery
strategies, negotiating M&A transactions, as well as managing quarterly and yearly accounting reports. In 2017 Mr. Ford started his
own consulting firm, Petersford Consulting, where he provided clients with finance and business risk services. From 2017 to 2020, through
his consulting firm, Mr. Ford served as Chief Financial Officer and Senior Business Advisor at a private group of Ontario based medical
clinics, including the largest chronic pain management practice in Canada. Prior to that, Mr. Ford served as Chief Financial Officer at
Telesta Therapeutics. At Telesta Therapeutics, Mr. Ford helped develop a new business plan and was heavily involved in all capital transactions
Mr. Ford began his career in 1982 at Ernst & Young, working his way to Principal, Business Risk Services, developing essential business
plans that evaluated revenue and cost profiles supporting budget planning and understanding drivers of growth, specifically with healthcare
companies. Additionally, at Ernst & Young, Mr. Ford participated in and often led teams in due diligence assignments in relation to
mergers and acquisitions or the sale of a business, having extensive experience in developing financial forecasts, product and market
valuation, and audits of critical accounting and processes. Mr. Ford holds a B.A. in Economics, History, and English from the University
of Guelph and has a Graduate Diploma in Accounting from the University of McGill. Mr. Ford is a member of the Ontario Institute of Chartered
Accountants.
42
Family Relationships
There are no family relationships between any directors or officers
of the Company.
Delinquent Section 16(a) Reports
Section 16(a) of the Exchange Act requires directors, executive officers,
and shareholders owning more than 10% of any class of a company’s outstanding equity shares to file reports of ownership and changes
of ownership with the SEC. As of April 1, 2020, we are required to comply with Section 16(a) because we are no longer eligible to rely
upon foreign private issuer exemptions under U.S. securities laws and NASDAQ’s corporate governance rules.
Based solely upon its review of the copies of such forms it received, or
written representations from certain reporting persons for whom no such forms were required, we are aware of no late Section 16(a) filings.
Code of Business Conduct and Ethics
Please see the section entitled “Code of Business Conduct and Ethics”
in “Item 13. Certain Relationships and Related Transactions and Director Independence.”
Audit Committee
Our audit committee is responsible for assisting the board of
directors in fulfilling its oversight responsibilities with respect to financial reporting, including:
·
reviewing our procedures on overall financial reporting and internal control framework.
·
reviewing and approving the engagement of the auditor.
·
reviewing annual and quarterly financial statements and all other material continuous
disclosure documents, including our annual information form and management’s discussion and analysis.
·
assessing our financial and accounting personnel.
·
assessing our accounting policies.
·
reviewing our risk management procedures; and
·
reviewing any significant transactions outside our ordinary course of business
and any pending litigation involving us.
The audit committee has direct communication channels with our management
performing financial functions and our external auditor, to discuss and review such issues as the audit committee may deem appropriate.
As of March 31, 2021, the audit committee was composed of Mr. Canan, as chairperson, Dr. Carter, and Mr. Olds. Each of Mr. Canan, Dr.
Carter and Mr. Olds is “financially literate” and “independent” within the meaning of the Exchange Act. As of
the date of this annual report, the composition of the audit committee remains the same as at March 31, 2021.
Audit Committee Financial Expert
Our board of directors has determined that Mr. Canan is the “audit
committee financial expert”, as defined by applicable regulations of the SEC. The SEC has indicated that the designation of Mr.
Canan as an audit committee financial expert does not make him an “expert” for any purpose, impose any duties, obligations
or liability on Mr. Canan that are greater than those imposed on members of the audit committee and board of directors who do not carry
this designation or affect the duties, obligations or liability of any other member of the audit committee or board of directors.
43
Item 11.
Executive Compensation
Summary of our Compensation Programs
Our executive compensation program is intended to attract, motivate and
retain high-performing senior executives, encourage and reward superior performance, and align the executives’ interests with ours
as well as shareholders by providing compensation that is competitive with the compensation received by executives employed by comparable
companies, and ensuring that the achievement of annual objectives is rewarded through the payment of bonuses, and providing executives
with long-term incentive through the grant of stock options.
Our governance and human resources committee, or GHR committee, has authority
to retain the services of independent compensation consultants to advise its members on executive and board compensation and related matters,
and to determine the fees and the terms and conditions of the engagement of those consultants. During our fiscal year ended March 31,
2021, the GHR committee retained compensation consulting services from FW Cook to review our executive compensation programs, including
base salary, short-term and long-term incentives, total cash compensation levels and total direct compensation of certain senior positions,
against those of peer groups of similar and larger size, as measured by market capitalization, biotechnology and pharmaceutical companies
listed or headquartered in North America. The consultants also reviewed board compensation, including advisory fees and equity incentives.
All of the services provided by the consultants were provided to the GHR committee. The GHR committee assessed the independence of the
consultants and concluded that its engagement of the consultants did not raise any conflict of interest with us or any of our directors
or executive officers.
Compensation for our CEO was below the peer company median following FW
Cook’s review during fiscal period 2020.
Use of Fixed and Variable Pay Components
Compensation of our named executive officers, or NEOs, is revised each
year and has been structured to encourage and reward executive officers on the basis of short-term and long-term corporate performance.
In the context of its analysis of compensation for our fiscal year ended March 31, 2021, the following components were examined by the
GHR committee:
·
base salary;
·
short term incentive plan, consisting of a cash bonus;
·
long term incentive plan, consisting of stock options and equity incentive grants
based on performance and/or time vesting conditions; and
·
other elements of compensation, consisting of group benefits and perquisites.
Base Salary
We intend to be competitive over time, with comparator companies and to
attract and retain top talent. The GHR committee reviews compensation periodically to be sure that it meets this strategic imperative.
Base salary is set to reflect an individual’s skills, experience, and contributions within a salary structure consistent with peer
group data, and with our gender pay equity policy. Base salary structure is revised annually by the GHR committee as our financial and
market conditions evolve.
Retention Agreements
In connection with our strategic review process and upon the recommendation
of our Governance and Human Resources Committee, in October 2020 we entered into retention incentive agreements with Ms. Jan D’Alvise,
our President and CEO, and Mr. Pierre Lemieux, our Chief Operating Officer (“COO”) and Chief Scientific Officer (the “ Retention
Agreements ”).
The Retention Agreements provide that we will pay Ms. D’Alvise an
employment retention incentive of $100,000 provided that she remains employed with the Corporation until the earlier of April 30, 2021,
or the closing of a merger or like transaction with a third party. This amount is also payable by the Corporation to Ms. D’Alvise
in the event of the termination of her employment without cause prior to the achievement of such milestones.
44
Mr. Lemieux was also awarded and paid a $25,000 retention bonus in April 2021.
In addition, the Retention Agreements also provide that we will pay each
of Ms. D’Alvise and Mr. Lemieux an amount of up to $125,000 in the event that certain milestones are met in relation to the monetization
by the Company of its assets relating to CaPre. A minimum amount of $75,000 is also payable by the Corporation to each of Ms. D’Alvise
and Mr. Lemieux in the event of the termination of their employment without cause prior to the achievement of such milestones.
Short Term Incentive Plan (STIP)
Our Short-Term Incentive Plan, or STIP, provides for potential rewards
when a threshold of corporate performance is met. Personal objectives that support corporate goals are established annually with each
employee and are assessed at the end of each financial year. Personal objectives are assessed through a performance grid, with pre-specified,
objective performance criteria. STIP awards are paid out in proportion to overall company performance which establishes the STIP pool,
and individual performance, which is determined in end-of-year performance reviews. For the most senior participants in the STIP, greater
weight is assigned to corporate objectives. Target payout is expressed as a percentage of base salary, and is determined by benchmarking
against peer group data, and board discretion. Annual salary for STIP purposes is the annual salary in effect at the end of the plan year
(i.e., prior to any annual salary increases awarded for the subsequent year).
The STIP is a discretionary variable compensation plan, and all STIP payments
are subject to board approval. Participants must be employed by us at the end of the financial year to qualify. We reserve the right to
modify or discontinue the STIP at any time.
Ms. D’Alvise, our CEO, is eligible for up to a 50% bonus of her annual
base salary. Dr. Lemieux, our COO, is eligible for up to a 40% bonus of their annual base salary.
These performance goals will take into account the achievement of corporate
milestones within timelines and budget and individual objectives determined annually by the board according to short-term priorities.
Long Term Incentive Plan (LITP)
The LTIP has been adopted as a reward and retention mechanism. Participation
is determined annually at the discretion of the board. Employees approved by our board of directors may participate in our stock option
plan, which is designed to align the long-term interests of participants with those of shareholders, in order to promote shareholder value.
The GHR committee may also determine, in its sole discretion, ad hoc stock option awards to be granted to participants in order
to address extraordinary situations. Awards at any level may be adjusted as necessary to maintain an equity burn rate and overhang similar
to comparator companies. In addition to our stock option plan, the board is also empowered to grant ad hoc awards, from time to
time, under our equity incentive plan to provide for a share-related mechanism to attract, retain and motivate qualified directors, senior
employees, and consultants.
The GHR committee determines the number of stock options to be granted
to a participant based on peer group data and taking into account corporate performance and the employee’s level in the organization.
The LTIP calculation for NEOs is determined from both reviewing grant values and a dilution-based methodology that considers the annual
grant rate as a percent of shares outstanding. The board did not award stock option grants for FY’21.
Our directors and executive officers are not permitted to purchase financial
instruments, such as prepaid variable forward contracts, equity swaps, collars or units of exchange funds that are designed to hedge or
offset a decrease in market value of equity securities granted as compensation or held, directly or indirectly, by the director or officer.
Share Ownership Guidelines
To further align the interests of our executives and board members with
those of our other shareholders, the board has adopted share ownership guidelines. Under these guidelines, non-employee directors, the
CEO, and other executives (i.e., CFO, COO, VPs) are required to retain and hold 50% of the shares acquired by them under any equity incentive
award granted on or after June 7, 2017 (after subtracting shares sold to pay for option exercise costs, and relevant federal, state, and
local taxes which are assumed to be at the highest marginal tax rates). In addition, the share retention rule applies unless the executive
or non-employee director beneficially owns shares with a value at or in excess of the following share ownership guidelines:
45
·
Non-employee directors — 2x then-current total annual cash retainer
·
CEO — 2x then-current annual base salary
·
Other executives — 1x then-current annual base salary.
The value of an individual’s shares for purposes of the share ownership
guidelines is deemed to be the greater of the then- current fair market value of the shares, or the individual’s cost basis in the
shares. Shares counted in calculating the share ownership guidelines include shares beneficially owned outright, whether from open market
purchases, shares retained after option exercises, and shares of restricted stock or deferred stock units that have fully vested. In addition,
in the case of vested, unexercised, in-the-money stock options, the in-the-money value of the stock options will be included in the share
ownership calculation. Executives have five years from their date of hire or promotion to satisfy the share ownership guidelines.
Stock Option Plan
Our stock option plan was adopted by our board of directors on October
8, 2008, and has been amended from time to time, as most recently amended on September 30, 2020, and approved by shareholders on September
30, 2020. The grant of options is part of the long-term incentive component of executive and director compensation and an essential part
of compensation. Qualified directors, employees and consultants may participate in our stock option plan, which is designed to encourage
option holders to link their interests with those of our shareholders, in order to promote an increase in shareholder value. Awards and
the determination of any exercise price are made by our board of directors, after recommendation by the GHR committee. Awards are established,
among other things, according to the role and responsibilities associated with the participant’s position and his or her influence
over appreciation in shareholder value. Any award grants a participant the right to purchase a certain number of common shares during
a specified term in the future, after a vesting period and/or specific performance conditions, at an exercise price equal to at least
100% of the market price (as defined below) of our common shares on the grant date. The “market price” of common shares as
of a particular date generally means the highest closing price per common share on the TSXV, NASDAQ, or any other exchange on which the
common shares are listed from time to time, for the last preceding date on which there was a sale of common shares on that exchange (subject
to certain exceptions set forth in the stock option plan in the event that we are no longer traded on any stock exchange). Previous awards
may sometimes be taken into account when new awards are considered.
In accordance with the stock option plan, all of an option holder’s
options will immediately fully vest on the date of a Change of Control event (as defined in the stock option plan), subject to the terms
of any employment agreement or other contractual arrangement between the option holder and us.
However, in no case will the grant of options under the plan, together
with any proposed or previously existing security based compensation arrangement, result in (in each case, as determined on the grant
date): the grant to any one consultant within any 12-month period, of options reserving for issuance a number of common shares exceeding
in the aggregate 2% of our issued and outstanding common shares (on a non-diluted basis); or the grant to any one employee, director and/or
consultant, which provides investor relations services, within any 12-month period, of options reserving for issuance a number of common
shares exceeding in the aggregate 2% of our issued and outstanding common shares (on a non-diluted basis).
Options granted under the stock option plan are non-transferable and are
subject to a minimum vesting period of 36 months for management, and 18 months for non-executive board members, in each case with gradual
and equal vesting on no less than a quarterly basis. They are exercisable, subject to vesting and/or performance conditions, at a price
equal to the highest closing price of the common shares on the TSXV, NASDAQ, or any other exchange on which the common shares are listed
from time to time, on the day prior to the grant of such options. In addition, and unless otherwise provided for in the agreement between
us and the holder, options will also lapse upon termination of employment or the end of the business relationship with us except that
they may be exercised for 90 days after termination, ceasing to hold office or the end of the business relationship (30 days for investor
relations services employees), in each case to the extent that they will have vested on such date of termination of employment, end of
the business relationship or ceasing to hold office, as applicable, except in the case of death, disability or retirement where this period
is extended to 12 months.
46
Subject to the approval of relevant regulatory authorities, including the
TSXV, NASDAQ, if applicable, and compliance with any conditions attached to that approval (including, in certain circumstances, approval
by disinterested shareholders) if applicable, the board of directors has the right to amend or terminate the stock option plan. However,
unless option holders’ consent to the amendment or termination of the stock option plan in writing, any such amendment or termination
of the stock option plan cannot affect the conditions of options that have already been granted and that have not been exercised under
the stock option plan.
Options for common shares representing a fixed rate of 15% of our outstanding
issued common shares as of August 26, 2020, may be granted by the board under the stock option plan. As of the date of this annual report,
there were 14,533,881 common shares reserved for issuance under the stock option plan and 7,294,919 options outstanding under the stock
option plan.
Equity Incentive Plan
On May 22, 2013, our equity incentive plan was adopted by the board in
order to, among other things, provide us with a share-related mechanism to attract, retain and motivate qualified directors, employees
and consultants. The adoption of the equity incentive plan was initially approved by shareholders at our 2013 Shareholders’ meeting
held on June 27, 2013, and has been amended from time to time, as most recently amended on August 27, 2020, and approved by shareholders
on September 30, 2020.
Eligible persons may participate in the equity incentive plan. “Eligible
persons” under the equity incentive plan consist of any director, officer, employee, or consultant (as defined in the equity incentive
plan) of our Company or a subsidiary who may participate in the equity incentive plan. A participant is an eligible person to whom an
award has been granted under the equity incentive plan. The equity incentive plan provides us with the option to grant to eligible persons
bonus shares, restricted shares, restricted share units, performance share units, deferred share units and other share-based awards.
If, and for so long as our common shares are listed on the TSXV, no more
than 2% of the issued and outstanding common shares may be granted to any one consultant or employee conducting investor relations activities
in any 12-month period.
The board has the right to determine that any unvested or unearned restricted
share units, deferred share units, performance share units or other share-based awards or restricted shares subject to a restricted period
outstanding immediately prior to the occurrence of a change in control will become fully vested or earned or free of restriction upon
the occurrence of a change in control. The board may also determine that any vested or earned restricted share units, deferred share units,
performance share units or other share-based awards will be cashed out at the market price as of the date a change in control is deemed
to have occurred, or as of such other date as the board may determine prior to the change in control. Further, the board has the right
to provide for the conversion or exchange of any restricted share unit, deferred share unit, performance share unit or other share-based
award into or for rights or other securities in any entity participating in or resulting from the change in control.
The equity incentive plan is administered by the board and the board has
sole and complete authority, in its discretion, to determine the type of awards under the equity incentive plan relating to the issuance
of common shares (including any combination of bonus shares, restricted share units, performance share units, deferred share units, restricted
shares or other share-based awards) in such amounts, to such persons and under such terms and conditions as the board may determine, in
accordance with the provisions of the equity incentive plan and the recommendations made by the GHR committee.
47
Subject to the adjustment provisions provided for in the equity incentive
plan and the applicable rules and regulations of all regulatory authorities to which we are subject (including any stock exchange), the
total number of common shares reserved for issuance pursuant to awards granted under the equity incentive plan will be equal to a number
that (A) if, and for so long as the common shares are listed on the TSXV, will not exceed the lower of (i) 1,953,318 common shares, and
(ii) 15% of the issued and outstanding common shares, which as of April 9, 2019, representing 11,719,910 common shares, which includes
common shares issuable pursuant to options issued under our stock option plan.
Other Forms of Compensation
Retirement Plans . Effective June 1, 2016, we sponsor a voluntary
Registered Retirement Savings Plan, or RRSP, matching program, which is open to all eligible employees, including NEOs who reside in Canada.
The RRSP matching program matches employees’ contributions up to a maximum of $1,500 per fiscal year for eligible employees who
participate in the program. Effective January 1, 2019, a 401K plan was implemented for US employees. Because of the small size of our
current employee population in the US and to assure passage of anti-discrimination testing, the 401K administrator, TransAmerica, required
either a 4% match or a 3% “safe harbor” contribution. Balancing cost considerations with a plan design that is both externally
competitive and internally equitable, Acasti adopted the “safe harbor” provision which provides a contribution of 3% of salary
to the 401K accounts of all eligible US employees, including NEOs who reside in the US.
Other Benefits and Perquisites. Our executive employee benefit program
also includes life, medical, dental and disability insurance. These benefits and perquisites are designed to be competitive overall with
equivalent positions in comparable organizations. We do not have a pension plan for employees.
Compensation Governance
Compensation of our executive officers and directors is recommended to
the board of directors by the GHR committee. In its review process, the GHR committee informally reviews executive and corporate performance
on a quarterly basis, with input from management. Annually, the GHR committee conducts a more formal review and assessment of executive
and corporate performance. During the fiscal year ended March 31, 2021, the GHR committee was composed of the following members, each
of whom is independent: Mr. Olds (Chairman), Dr. Carter, and Mr. Canan. The GHR committee establishes management compensation policies
and oversees their general implementation. All members of the GHR committee have direct experience, which is relevant to their responsibilities
as GHR committee members. All members are or have held senior executive or director roles within significant businesses in our industry,
several also having public companies experience, and have a good financial understanding which allows them to assess the costs versus
benefits of compensation plans. The GHR committee’s members combined experience in our sector provides them with a good understanding
of our success factors and risks, which is very important when determining metrics for measuring success.
Risk management is a primary consideration of the GHR committee when implementing
its compensation program. We do not believe that our compensation program results in unnecessary or inappropriate risk taking, including
risks that are likely to have a material adverse effect on us. Payments of bonuses, if any, are not made unless performance goals are
met.
For executives, more than half of their target compensation (base salary
+ target STIP awards + target LTIP awards) is considered “at risk”. We believe this mix results in a strong pay-for-performance
relationship and alignment with shareholders and is competitive with other firms of comparable size in similar fields. The CEO (or any
person acting in that capacity) makes recommendations to the GHR committee as to the compensation of our executive officers, other than
herself for review and approval by the board. The GHR committee makes recommendations to the board of directors as to the compensation
of the CEO, for approval. The CEO’s salary is based on comparable market consideration, and the GHR committee’s assessment
of her performance, with regard to our financial performance, and progress in achieving key strategic business goals.
48
Qualitative factors beyond the quantitative financial metrics are also
a key consideration in determination of individual executive compensation payments. How executives achieve their financial results and
demonstrate leadership consistent with our values are key to individual compensation decisions.
Compensation Paid to Named Executive Officers
The following table sets forth the compensation information for our principal
executive officers, and our most highly paid executive officers, during the fiscal years ended March 31, 2021, and 2020, respectively.
Name
and
Year
Salary
Bonus
($)
Stock
Option
Nonequity
All
Other
Total
Principal
($)
Awards
Awards
Incentive
Compensation
Compensation
Position
($)
($) (1) (2)
Plans
($)
($)
($)
Jan D’Alvise
March
31, 2021
428,040
-
-
-
-
-
428,040
President
and CEO
March 31, 2020
410,703
154,781
-
1,620,863
-
-
2,186,347
Pierre Lemieux
March 31, 2021
276,377
-
-
-
-
-
276,377
COO
March 31, 2020
264,128
80,018
-
603,458
-
-
947,604
Brian Ford 3
March 31, 2021
190,605
-
-
-
-
-
190,605
CFO
March
31, 2020
-
-
-
-
-
-
-
Brian Groch 4
March
31, 2021
229,680
-
-
-
-
-
229,680
Former
CCO
March
31, 2020
289,615
87,000
-
357,461
-
-
734,106
___________________________
Notes:
(1) The fair value of stock options is estimated at the grant
date using the Black-Scholes option pricing model. This model requires the input of a number of parameters, including share price, share
exercise price, expected share price volatility, expected time until exercise and risk-free interest rates. Although the assumptions used
reflect management’s best estimates, they involve inherent uncertainties based on market conditions generally outside of our control
(2) The fair value of the option-based awards granted on March
31, 2020, was CAD$0.41.
(3) Mr.Ford was appointed our CFO September 24, 2020.
(4) Departure of Brian Groch, Chief Commercial Officer, from
his position with the Corporation effective December 31, 2020
Outstanding Equity Awards at March 31, 2021
The following tables provide information about the number and value of
the outstanding option-based awards held by the NEOs as of March 31, 2021.
Option
awards
Name
Number of securities underlying
unexercised options (#) exercisable
Number of securities underlying
unexercised options (#) unexercisable
Equity incentive plan awards:
Number of securities underlying unexercised unearned options (#)
Option exercise price ($) (1)
Option expiration
date
525,000
–
–
$
1.56
May
12, 2023
258,000
–
–
$
1.77
June 14, 2027
Jan D’Alvise
172,000
–
–
$
1.77
June 14, 2027
830,000
75,521
75,521
$
0.77
July 2, 2028
150,733
75,367
75,367
$
1.28
April 15, 2029
514,600
257,300
275,300
$
1.28
April 15, 2029
445,500
890,000
890,000
$
0.53
March 31, 2030
16,900
–
–
$
4.50
June 1, 2022
31,400
–
–
$
1.99
May 30, 2023
50,000
–
–
$
1.65
February
24, 2027
Pierre Lemieux
93,000
–
–
$
1.77
June 14, 2027
62,000
–
–
$
1.77
June 14, 2027
335,055
30,460
30,460
$
0.77
July 2, 2028
52,867
59,475
59,475
$
1.28
April 15, 2029
180,467
203,025
203,025
$
1.28
April 15, 2029
195,667
587,000
587,000
$
0.53
March 31, 2030
______________________________
Notes:
(1) Canadian dollars.
49
Employment Agreements with Named Executive Officers
Jan D’Alvise, President and CEO
On May 11, 2015, we entered into an executive employment agreement with
Ms. D’Alvise. Pursuant to her executive employment agreement, Ms. D’Alvise’s annual base salary was set at $330,000
and she is eligible to receive annual performance bonuses based on target amount of 40% of her annual base salary with a maximum of up
to 80% of her annual base salary. In accordance with the terms and provisions of the executive employment agreement we entered into with
Ms. D’Alvise, we may terminate the executive’s employment at any time for “good and sufficient cause”, as defined
in the employment agreement, without notice or severance. We may terminate the executive’s employment at any time without cause
or upon a change of control, as defined in our Stock Option Plan, by providing the executive with sixty days’ notice of termination
and payment equal to twelve months’ base salary plus any bonus payable. The executive may decide to resign from employment and must
provide us with at least sixty days' advance written notice. The executive may decide to terminate employment with “good reason”,
as defined in the employment agreement, and we are required to make payment equal to twelvemonths’ base salary plus any bonus payable.
Pierre Lemieux, COO
On September 26, 2017, we entered into an executive employment agreement
with Dr. Lemieux. Pursuant to his executive employment agreement, Dr. Lemieux’s annual base salary was set at CAD$253,700 and he
is eligible to receive annual performance bonuses of up to 40% of his annual base salary. In accordance with the terms and provisions
of the executive employment agreement we entered into with Dr. Lemieux, we may terminate the executive’s employment at any time
for “good and sufficient cause”, as defined in the employment agreement, without notice or severance. We may terminate the
executive’s employment at any time without cause or upon a change of control, as defined in our Stock Option Plan, by providing
the executive with thirty days’ notice of termination and payment equal to twelve months’ base salary plus any bonus payable.
The executive may decide to resign from employment and must provide us with at least sixty days' advance written notice. The executive
may decide to terminate employment with “good reason”, as defined in the employment agreement, and we are required to make
payment equal to twelve months of base salary.
Brian Ford, CFO
On September 14, 2021, we entered into a consulting agreement with PFC
Business Advisory Services Inc., an entity through which Mr. Ford provides consulting services (the “Consulting Agreement”).
The Consulting Agreement provides, among other things, that Mr. Ford will serve as a non-employee Chief Financial Officer on a full-time
basis, in exchange for a fee of CAD$36,000 per month. There is no arrangement or understanding between Mr. Ford and any other persons
pursuant to which Mr. Ford was selected as an officer.
50
Compensation of Directors
Our directors’ compensation
consists of an annual fixed compensation of $60,000 for the chairman of the board and $30,000 for the other non-executive board members.
In addition, the chairperson of the audit committee and the chairperson of the governance and human resources committee receive additional
compensation of $15,000 and $10,000, respectively, while members of the audit committee and the governance and human resources committee
receive additional compensation of $7,500 and $5,000, respectively. The directors are also entitled to a fee of $1,000 per non-regularly
scheduled board meeting as well as a reimbursement for travelling and other reasonable expenses properly incurred by them in attending
meetings of the board or any committee or in otherwise serving us, in accordance with our policy on travel and expenses.
Following their first election to
our board of directors, non-executive directors are eligible to receive an initial equity grant of up to 150% of their annual cash retainer
worth of stock options vesting monthly in equal installments over a 12-month period, subject to the other terms and conditions set forth
under the heading “Stock Option Plan”. In addition to their initial grant, non-executive directors are eligible to receive
an annual equity-based award equal to 100% of their total annual cash retainer vesting monthly in equal installments over a 12-month period.
These awards will be granted at the same time that we are performing our annual performance review for our employees, subject to availability
of common shares and subject to the terms and conditions described under the headings “Stock Purchase Plan” and “Equity
Incentive Plan”. The level of these awards will be consistent with equivalent awards in comparable companies obtained from the benchmark
exercise and in accordance with the recommendations obtained from our independent compensation consultant.
The total compensation for our non-executive
directors during fiscal year ended March 31, 2021, was as follows:
Name
Fees
earned or
Stock
Option
Non-equity
incentive plan
Nonqualified
deferred
compensation
All other
paid in cash
awards
awards
compensation
earnings
compensation
Total
($)
($)
($)
($)
($)
($)
($)
Roderick N. Carter
106,500
–
-
–
–
–
106,500
Jean-Marie (John) Canan
84,000
–
-
–
–
–
84,000
Donald Olds
81,500
–
-
–
–
–
81,500
Item 12.
Security Ownership of Certain
Beneficial Owners and Management and Related Shareholder Matters
Equity Compensation Plan Information
51
The following table sets forth certain
information regarding the Company’s equity compensation plans as of March 31, 2021:
Plan category
(a) Number of securities to be issued upon exercise of outstanding
options, warrants and rights
(b) Weighted-average exercise price of outstanding options, warrants
and rights
(c) Number of securities remaining available for future issuance
under equity compensation plans (excluding securities reflected in column (a))
Equity compensation plans approved by security holders ( Stock
Option Plan )(1):
7,294,919
CAD$1.04
6,896,271
Equity compensation plans approved by security holders ( Equity Incentive
Plan )(2):
–
$–
–
Equity compensation plans not approved by security holders ( Stock Option
Plan ):
–
$–
–
Equity compensation plans not approved by security holders ( Equity Incentive
Plan ):
–
$–
–
Total
7,294,919
CAD$1.04
6,896,271
______________________________
Notes:
(1) A summary of certain material
provisions of the Company’s Stock Option Plan is available under “Item 11. Executive Compensation – Summary of our Compensation
Programs – Stock Option Plan”.
(2) The total number of common shares
reserved for issuance under the Company’s Equity Incentive Plan is limited by the number of options that are outstanding under the
Stock Option Plan such that the total number of common shares available for issuance under both stock-based compensation plans shall not
exceed 11,719,910. A summary of certain material provisions of the Company’s Equity Incentive Plan is available under “Item
11. Executive Compensation – Summary of our Compensation Programs – Equity Incentive Plan”.
Security ownership of certain
beneficial owners
The following table sets forth certain
information regarding beneficial ownership of our common shares as of May 31 , 2021, by each director
and the executive officer identified above, and all directors and executive officers as a group. Beneficial ownership is determined in
accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. All common shares are
common shares with the same voting rights.
For the purposes of calculating percent
ownership, as of May 31, 2021, 208,375,505 common shares were issued and outstanding, and, for any individual who beneficially owns shares
represented by options exercisable within sixty days of May 31, 2021, these shares are treated as if outstanding for that person, but
not for any other person.
Name and Address of Beneficial Owner (1)
Amount and
Nature of Beneficial Ownership
Percentage
of Common Shares
Jan D’Alvise
2,948,560 (2)
1.4%
Roderick N. Carter
505,577 (3)
*
Jean-Marie (John) Canan
383,983 (4)
*
Donald Olds
226,200 (5)
*
Pierre Lemieux
1,024,353 (7)
*
Directors and officers as a group (5 persons)
3,392,655
2.4%
____________
* Less than 1%.
Notes :
(1) Unless otherwise indicated, the address of each of
the executive officers and directors named above is 3009 boul. de la Concorde East, Suite 102, Laval, Québec, Canada H7E 2B5
(2) Includes 2,896,060 common shares that Jan D’Alvise
may acquire through the exercise of share options within 60 days hereof.
(3) Includes 505,577 common shares that Roderick N. Carter
may acquire through the exercise of share options within 60 days hereof.
(4) Includes 283,983 common shares that Jean-Marie (John)
Canan may acquire through the exercise of share options within 60 days hereof.
(5) Includes 188,200 common shares that Donald Olds may
acquire through the exercise of share options within 60 days hereof. Includes 38,000 common shares held and controlled by Mr. Olds’
spouse, Ofra Aslan.
(7) Includes 1,017,356 common shares that Pierre Lemieux
may acquire through the exercise of share options within 60 days hereof.
52
To the best of our knowledge, there
are no beneficial owners of 5% or more of any class of our voting securities.
Changes in Control
There existed no change in control
arrangements at March 31, 2021.
Item 13.
Certain Relationships and Related Transactions and Director Independence
Related Transactions
None.
Director Independence
Our board of directors believes that,
in order to maximize its effectiveness, the board must be able to operate independently. A majority of directors must satisfy the applicable
tests of independence, such that the board of directors complies with all independence requirements under applicable corporate and securities
laws and stock exchange requirements applicable to us. No director will be independent unless the board of directors has affirmatively
determined that the director has no material relationship with us or any of our affiliates, either directly or indirectly or as a partner,
shareholder or officer of an organization that has a relationship with us or our affiliates. Such determinations will be made on an annual
basis and, if a director joins the board of directors between annual meetings, at such time.
Independent Directors
The board of directors determined
that Mr. Canan, Dr. Carter, and Mr. Olds are independent within the meaning of NI 52-110 and NASDAQ Stock Market rules.
Directors Who are Not Independent
The board of directors determined
that Ms. D’Alvise is not independent within the meaning of NI 52-110 and NASDAQ Stock Market rules given that she is our President
and Chief Executive Officer.
During the fiscal year ended March
31, 2021, the board of directors held 3 special meetings for independent directors.
All directors were in attendance
for each regularly scheduled quarterly and annual meeting of the Board.
Chairman of the Board
Dr. Carter acts as chairman of the
board. His duties and responsibilities consist of the oversight of the quality and integrity of the board of directors’ practices.
Board Mandate
The board of directors is responsible
for overseeing management in carrying out the business and affairs of the Company. Directors are required to act and exercise their powers
with reasonable prudence in the best interests of the Company. The board agrees with and confirms its responsibility for overseeing management's
performance in the following particular areas:
•
approving and monitoring the Company’s compliance procedures;
•
establishing and developing of the Company’s corporate governance principles
and committees;
•
evaluating the strategic plan of the Company;
53
•
identification and oversight of the principal risks associated with the business
of the Company and application of appropriate systems to manage and mitigate such risks;
•
planning for succession of management;
•
the Company's policies regarding communications with its shareholders and others;
and
•
the integrity of the internal controls and management information systems of
the Company.
In carrying out its mandate, the
board relies primarily on management to provide it with regular detailed reports on the operations of the Company and its financial position.
The board reviews and assesses these reports and other information provided to it at meetings of the board and/or of its committees. At
least annually, the board approves a strategic plan for the Company taking into account, among other things, the opportunities and risks
of the Company’s business, its risk appetite, emerging trends, and the competitive environment in the industry.
Position Descriptions
Written position description has
been approved for the chairs of each committee of the board of directors. The primary role and responsibility of the chair of each committee
of the board of directors is to: (i) in general, ensure that the committee fulfills its mandate, as determined by the board of directors
and in accordance with the committee’s charter; (ii) chair meetings of the committee; (iii) report to the board of directors; and
(iv) act as liaison between the committee and the board of directors and our management.
The board of directors has adopted
a written position description for the chairman of the board of directors.
Chairman of the Board
The chairman of the board of directors
is responsible for leading the board to fulfill its duties under the board’s mandate as independent of management and acting as
an advisor to the chief executive officer.
The chairman’s duties include,
but are not limited to, setting meeting agendas, approving, and supervising management’s progress towards achieving strategic goals,
chairing meetings and working with the respective committee and management to ensure, to the greatest extent possible, the effective functioning
of the committee and the board of directors. The chairman must oversee that the relationship between the board of directors, management
of the Company, the Company’s shareholders and other stakeholders are effective, efficient, and further to the best interests of
the Company.
Orientation and Continuing
Education
We provide orientation for new appointees
to the board of directors and committees in the form of informal meetings with members of the board and senior management, complemented
by presentations on the main areas of our business. The board does not formally provide continuing education to its directors, as directors
are experienced members. The board of directors relies on third party professional assistance, when judged necessary, in order to be educated/updated
on a particular topic.
Code of Business Conduct and
Ethics
The board of directors adopted a
Code of Business Conduct and Ethics, or Code of Conduct, for our directors, officers and employees on May 31, 2007, as amended from time
to time. Our Code of Conduct can be found on SEDAR at www.sedar.com and on our web site on www.acastipharma.com. A copy of the Code of
Conduct can also be obtained by contacting our corporate secretary. Since its adoption by the board of directors, any breach of the Code
of Conduct must be brought to the attention of the board of directors by our CEO or other senior executives. No report has ever been filed
which pertains to any conduct of a director or executive officer that constitutes a breach to our Code of Conduct.
Since the adoption of the Code of
Conduct and the following policies, the board of directors actively monitors compliance with the Code Conduct and promotes a business
environment where employees are encouraged to report malfeasance, irregularities, and other concerns. The Code of Conduct provides for
specific procedures for reporting non-compliant practices in a manner which, in the opinion of the board of directors, encourages and
promotes a culture of ethical business conduct.
54
The board of directors also adopted
a disclosure policy, insider trading policy, majority voting policy, management and board compensation policies, and a whistleblower policy.
In addition, under the Civil Code
of Québec, to which we are subject as a legal person incorporated under the Business Corporations Act (Québec) (L.R.Q.,
c. S-31), a director must immediately disclose to the board any situation that may place him or her in a conflict of interest. Any such
declaration of interest is recorded in the minutes of proceeding of the board of directors. The director abstains, except if required,
from the discussion and voting on the question. In addition, it is our policy that an interested director recuse himself or herself from
the decision-making process pertaining to a contract or transaction in which he or she has an interest.
Nomination of Directors
The board of directors receives recommendations
from the GHR committee, but retains responsibility for managing its own affairs by, among other things, giving its approval for the composition
and size of the board of directors, and the selection of candidates nominated for election to the board of directors. The GHR committee
initially evaluates candidates for nomination for election as directors, having regard to the background, employment, and qualifications
of possible candidates.
The selection of the nominees for
the board of directors is made by the other members of the board, based on our needs and the qualities required for the board of directors,
including ethical character, integrity and maturity of judgment of the candidates; the level of experience of the candidates, their ideas
regarding the material aspects of our business, the expertise of the candidates in fields relevant to us while complementing the training
and experience of the other members of the board of directors; the will and ability of the candidates to devote the necessary time to
their duties to the board of directors and its committees, the will of the candidates to serve on the board of directors for numerous
consecutive financial periods and finally, the will of the candidates to refrain from engaging in activities which conflict with the responsibilities
and duties of a director. The board researches the training and qualifications of potential new directors which seem to correspond to
the selection criteria of the board of directors and, depending on the results of said research, organizes meetings with the potential
candidates.
In the case of incumbent directors
whose terms of office are set to expire, the board will review such directors’ overall service to us during their term of office,
including the number of meetings attended, level of participation, quality of performance and any transactions of such directors with
us during their term of office.
We may use various sources in order
to identify the candidates for the board of directors, including our own contacts and the references of other directors, officers, advisors
and executive placement agencies. We will consider director candidates recommended by shareholders and will evaluate those director candidates
in the same manner in which we evaluate candidates recommended by other sources. In making recommendations for director nominees for the
annual meeting of shareholders, we will consider any written recommendations of director candidates by shareholders received by our corporate
secretary not later than 120 days before the anniversary of the previous year’s annual meeting of shareholders. Recommendations
must include the candidate’s name, contact information and a statement of the candidate’s background and qualifications, and
must be mailed to us. Following the selection of the candidates by the board of directors, we will propose a list of candidates to the
shareholders, for our annual meeting of shareholders.
The board of directors does not have
a nominating committee and has not adopted any formal written director term limit policy. Proposed nominations of director candidates
are evaluated by our GHR committee.
55
GHR Committee
The mandate of the GHR committee
consists of the evaluation of the proposed nominations of senior executives and director candidates to our board of directors, recommending
for board approval, if appropriate, revisions of our corporate governance practices and procedures, developing new charters for any new
committees established by the board of directors, monitoring relationships and communication between management and the board of directors,
monitoring emerging best practices in corporate governance and oversight of governance matters and assessing the board of directors and
its committees. The GHR committee is also in charge of establishing the procedure which must be followed by us to comply with applicable
guidelines of the TSXV and NASDAQ Stock Market regarding corporate governance.
The GHR committee has the responsibility
of evaluating the compensation, performance incentives as well as the benefits granted to our upper management in accordance with their
responsibilities and performance as well as to recommend the necessary adjustments to our board of directors. The GHR committee also reviews
the amount and method of compensation granted to the directors. The GHR committee may retain an external firm in order to assist it during
the execution of its mandate. The GHR committee considers time commitment, comparative fees, and responsibilities in determining compensation.
The GHR committee is composed of
independent members within the meaning of NI 52-110 and NASDAQ Stock Exchange rules, namely Mr. Olds, Dr. Carter, and Mr. Canan.
Periodic Assessments
The board of directors, its committees
and each director are subject to periodic evaluations of their efficacy and contribution. The evaluation procedure consists in identifying
any shortcomings and implementing adjustments proposed by directors at the beginning and during meetings of the board of directors and
of each of its committees. Among other things, these adjustments deal with the level of preparation of directors, management and consultants
employed by us, the relevance and sufficiency of the documentation provided to directors and the time allowed to directors for discussion
and debate of items on the agenda.
Director Term Limits
The board actively considers the
issue of term limits from time to time. At this time, the board does not believe that it is in our best interests to establish a limit
on the number of times a director may stand for election. While such a limit could help create an environment where fresh ideas and viewpoints
are available to the board, a director term limit could also disadvantage us through the loss of the beneficial contribution of directors
who have developed increasing knowledge of, and insight into, us and our operations over a period of time. As we operate in a unique industry,
it is difficult to find qualified directors with the appropriate background and experience and the introduction of a director term limit
would impose further difficulty.
Policies Regarding the Representation
of Women on the Board and Among Executive Officers
We have not adopted a formal written
policy regarding diversity amongst executive officers and members of the board of directors, including mechanisms for board renewal, in
connection with, among other things, the identification and nomination of women directors. Nevertheless, we recognize that gender diversity
is a significant aspect of diversity and acknowledges the important role that women with appropriate and relevant skills and experience
can play in contributing to the diversity of perspective on the board of directors.
Rather than considering the level
of representation of women for directorship and executive officer positions when making board or executive officer appointments, we consider
all candidates based on their merit and qualifications relevant to the specific role. While we recognize the benefits of diversity at
all levels within its organization, we do not currently have any targets, rules or formal policies that specifically require the identification,
consideration, nomination, or appointment of candidates for directorship or executive management positions or that would otherwise force
the composition of our board of directors and executive management team. Currently, we have one women director who is also our CEO.
56
Item 14.
Principal Accounting Fees and Services
Audit Fees
“Audit fees” consist of fees for professional
services for the audit of our annual financial statements, interim reviews, and fees related to securities filings. Audit fees for KPMG
LLP, our external auditors are CAD $364,870 for the fiscal year ended March 31, 2021, and CAD $308,160 for the fiscal year ended March
31, 2020. Audit fees for the fiscal year ended March 31, 2021, include fees related to securities filings.
Audit-Related Fees
“Audit-related fees” consist of fees for professional services
that are reasonably related to the performance of the audit or review of our financial statements, and which are not reported under “Audit
Fees” above. KPMG LLP billed CAD nil for the fiscal year ended March 31, 2021, and CAD $82,390 for the fiscal year ended March 31,
2020. Audit-Related fees for the fiscal year ended March 31, 2020, include fees related to securities filings.
Tax Fees
“Tax fees” consist of fees for professional services for tax
compliance, tax advice and tax planning. KPMG LLP billed CAD $42,067 for tax fees for fiscal year ended March 31, 2021, and CAD $46,660
for tax fees for fiscal year ended March 31, 2020. Tax fees include, but are not limited to, preparation of tax returns.
All Other Fees
“Other fees” include all other fees billed for professional
services other than those mentioned hereinabove. KPMG LLP billed no fees under this category for the fiscal years ended March 31, 2021,
and March 31, 2020.
Pre-Approval Policies and Procedures
The audit committee approves all audit, audit-related services, tax services
and other non-audit related services provided by the external auditors in advance of any engagement. Under the Sarbanes-Oxley Act of 2002,
audit committees are permitted to approve certain fees for non-audit related services pursuant to a de minimus exception prior to the
completion of an audit engagement. Non-audit related services satisfy the de minimus exception if the following conditions are met:
·
the aggregate amount of all non-audit services that were not pre-approved is
reasonably expected to constitute no more than five per cent of the total amount of fees paid by us and our subsidiaries to our external
auditors during the fiscal year in which the services are provided;
·
we or our subsidiaries, as the case may be, did not recognize the services as
non-audit services at the time of the engagement; and
·
the services are promptly brought to the attention of the audit committee and
approved, prior to the completion of the audit, by the audit committee or by one or more of its members to whom authority to grant such
approvals had been delegated by the audit committee.
None of the services described above under “Principal Accounting
Fees and Services” were approved by the audit committee pursuant to the de minimus exception.
PART IV
Item 15.
Exhibits, Financial Statement Schedules
(a)(1) Financial Statements—The financial statements included in
Item 8 are filed as part of this annual report on Form 10-K.
57
(a)(2) Financial Statement Schedules—All schedules have been omitted
because they are not applicable or required, or the information required to be set forth therein is included in the consolidated Financial
Statements or notes thereto included in Item 8 of this annual report on Form 10-K.
(a)(3) Exhibits—The exhibits required by Item 601 of Regulation S-K
are listed in paragraph (b) below.
(b) Exhibits—The exhibits listed on the Exhibit Index below are filed
herewith or are incorporated by reference to exhibits previously filed with the SEC.
EXHIBITS INDEX
Exhibit No.
Description
2.1
Agreement
and Plan of Merger, dated as of May 7, 2021, among Acasti Pharma Inc., Grace Therapeutics Inc. and Acasti Pharma U.S., Inc. (incorporated
by reference to Exhibit 2.1 of from Form 8-K (File No. 001-35776 ) filed with the Commission on
May 7, 2021)
3.1
Articles
of Incorporation (incorporated by reference to Exhibit 4.1 from Form S-8 (File No. 333-191383) filed with the Commission on
September 25, 2013)
3.2
Amended
and Restated General By-Law (incorporated by reference to Exhibit 99.1 from Form 6-K (File No. 001-35776) filed with the Commission
on February 21, 2017)
3.3
Advance
Notice bylaw No. 2013-1 (incorporated by reference to Exhibit 4.3 from Form S-8 (File No. 333-191383) filed with the Commission
on September 25, 2013)
4.1
Specimen
Certificate for Common Shares of Acasti Pharma Inc. (incorporated by reference to Exhibit 2.1 from Form 20-F (File No. 001-35776)
filed with the Commission on June 6, 2014)
4.2
Warrant
Indenture dated December 3, 2013 between Acasti Pharma Inc. and Computershare Trust Company of Canada (incorporated by reference to Exhibit
99.1 from Form 6-K (File No. 001-35776) filed with the Commission on December 3, 2013)
4.3
Warrant
Indenture dated February 21, 2017 between Acasti Pharma Inc. and Computershare Trust Company of Canada (incorporated by reference to Exhibit
2.3 from Form 20-F (File No. 001-35776) filed with the Commission on June 27, 2017)
4.4
Warrant
Agency Agreement dated December 27, 2017 between Acasti Pharma Inc. and Computershare Inc. and its wholly-owned subsidiary, Computershare
Trust Company N.A. (incorporated by reference to Exhibit 2.4 from Form 20-F (File No. 001-35776) filed with the Commission on
June 29, 2018)
4.5
Amended
and Restated Warrant Indenture dated May 10, 2018 between Acasti Pharma Inc. and Computershare Trust Company of Canada (incorporated by
reference to Exhibit 2.5 from Form 20-F (File No. 001-35776) filed with the Commission on June 29, 2018)
10.1
Prepayment
Agreement, dated December 4, 2012, between Neptune Technologies & Bioressources Inc. and Acasti Pharma Inc. (incorporated by reference
to Exhibit 99.1 from Form 6-K (File No. 001-35776) filed with the Commission on October 29, 2013)
10.2
Acasti Pharma Inc., Equity Incentive Plan, as amended August 27, 2020.
10.3
Acasti Pharma Inc., Stock Option Plan, as amended August 27, 2020.
58
10.4
Employment
Agreement with Jan D’Alvise, dated May 11, 2015 (incorporated by reference to Exhibit 10.6 from Form F-1 (File No. 333-220755)
filed with the SEC on September 29, 2017)
10.5
Employment
Agreement with Pierre Lemieux, dated September 26, 2017 (incorporated by reference to Exhibit 10.7 from Form F-1 (File No. 333-220755)
filed with the SEC on September 29, 2017)
10.6
Independent contractor agreement with PFC Business Advisory Services Inc. dated September 14, 2020, and amended March 15, 2021, and June 16, 2021.
10.7
Amended and Restated
Sales Agreement, dated June 29, 2020, by and among Acasti Pharma Inc., B. Riley FBR, Inc. and Oppenheimer & Co. Inc. and H.C. Wainwright
& Co., LLC (incorporated by reference to Exhibit 1.2 from Form S-3 (File No. 333-239538) filed with the Commission on June 29, 2020)
10.8
Retention agreement,
dated October 27, 2020, between Acasti Pharma Inc. and Jan D’Alvise (incorporated by reference to Exhibit 10.2 from the quarterly
report on Form 10-Q filed with the Commission on November 16, 2020)
10.9
Retention
agreement, dated October 29, 2020 between Acasti Pharma Inc. and Pierre Lemieux (incorporated by reference to Exhibit 10.3 from the quarterly
report on Form 10-Q filed with the Commission on November 16, 2020)
23.1
Consent of KPMG LLP, an Independent
Registered Public Accounting Firm.
31.1
Certification of Chief Executive
Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
31.2
Certification of Chief Financial
Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
32.1
Certification of the Chief Executive
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
Certification of the Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
59
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: June 22, 2021
ACASTI PHARMA INC.
By:
/s/ Janelle
D’Alvise
Name: Janelle D’Alvise
Title: President and Chief Executive Officer
and Director (Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Janelle D’Alvise
President and Chief Executive Officer and Director
June 22, 2021
Janelle D’Alvise
(Principal Executive Officer)
/s/ Brian Ford
Chief Financial Officer
June 22, 2021
Brian Ford
(Principal Financial Officer and Principal Accounting Officer)
/s/ Dr. Roderick N. Carter
Director
June 22, 2021
Dr. Roderick N. Carter
/s/ Jean-Marie (John) Canan
Director
June 22, 2021
Jean-Marie (John) Canan
/s/ Donald Olds
Director
June 22, 2021
Donald Olds
60
Consolidated Financial Statements of
Acasti pharma inc.
For the years ended March 31, 2021 and 2020
F- 1
Acasti pharma inc.
Consolidated Financial Statements
For the years ended March 31, 2021 and 2020
Financial Statements
Consolidated Balance Sheets
F-4
Consolidated Statements of Loss and Comprehensive Loss
F-5
Consolidated Statements of Changes in Shareholders’
Equity
F-6
Consolidated Statements of Cash Flows
F-7
Notes to the Consolidated Financial Statements
F-8
F- 2
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors Acasti
Pharma Inc.
Opinion on
the Consolidated Financial Statements
We have audited the accompanying consolidated balance
sheets of Acasti Pharma Inc. (the "Company") as of March 31, 2021 and 2020, the related consolidated statements of loss, comprehensive
loss, shareholders’ equity, and cash flows for the years ended March 31, 2021 and 2020, and the related notes (collectively, the
"consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material
respects, the consolidated financial position of the Company as of March 31, 2021 and 2020, and the consolidated results of its operations
and its consolidated cash flows for the years ended March 31, 2021 and 2020, in conformity with U.S. generally accepted accounting principles.
Basis for
Opinion
These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
Critical Audit
Matter
Critical audit matters are matters arising from the
current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee
and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially
challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
We have served as the Company’s auditor since 2009.
Montréal, Québec
June 22, 2021
F- 3
Acasti pharma inc.
Consolidated Balance Sheets
March 31, 2021
March 31, 2020
(Expressed in thousands of U.S. dollars except share data)
Notes
$
$
Assets
Current assets:
Cash and cash equivalents
50,942
14,240
Short- term investments
5
9,789
-
Receivables
4
530
546
Assets held for sale
7
768
2,578
Deferred financing costs
12(b)
-
121
Prepaid expenses
343
977
Total current assets
62,372
18,462
Right of Use Asset
86
147
Intangible assets
6
-
4,244
Total assets
62,458
22,853
Liabilities and Shareholders’ equity
Current liabilities:
Trade and other payables
9
1,493
7,319
Lease liability
86
76
Total current liabilities
1,579
7,395
Derivative warrant liabilities
10, 12(b)
5,219
2,393
Lease Liability
-
71
Total liabilities
6,798
9,859
Shareholders’ Equity:
Common shares
12
197,194
137,424
Additional paid-in capital
12
10,817
9,797
Accumulated other comprehensive loss
(6,333)
(7,887
)
Accumulated deficit
(146,018)
(126,340
)
Total Shareholder’s equity
55,660
12,994
Commitments and contingencies
20
Total liabilities and shareholders’ equity
62,458
22,853
The accompanying notes are an integral part of these consolidated financial
statements
F- 4
ACASTI PHARMA INC.
Consolidated Statements of Loss and Comprehensive Loss
Year ended
Year ended
March 31, 2021
March 31, 2020
(Expressed in thousands of U.S. dollars
except share data)
Notes
$
$
Revenues
Revenues from product sales
13
196
-
Operating Expenses
Cost of sales of products
(76)
-
Research and development expenses, net of government
assistance
8
(4,173
)
(15,974
)
General and administrative expenses
(5,521)
(5,799
)
Sales and marketing
(1,142
)
(2,665
)
Impairment of Intangible assets
6
(3,706
)
-
Impairment of Equipment
7
(1,584
)
-
Impairment of Other assets and prepaid
7
(413
)
-
Loss from operating activities
(16,419
)
(24,438
)
Financial Expenses
14
(3,259)
(1,075
)
Net loss and total comprehensive loss
(19,678)
(25,513
)
Basic and diluted loss per share
16
(0.17)
(0.30
)
Weighted average number of shares outstanding
118,625,833
84,581,764
The accompanying notes are an integral part of these consolidated
financial statements
F- 5
Acasti pharma inc.
Consolidated Statements of Changes in
Shareholders’ Equity
(Expressed in thousands of U.S. dollars except share data)
Common
Shares
Notes
Number
Dollar
$
Additional
Paid-in
Capital
$
Accumulated
other
comprehensive
loss
$
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
-
-
-
-
(19,678)
(19,678)
Cumulative translation adjustment
-
-
-
1,554
-
1,554
Warrants exercised
10, 14
222,975
274
(91)
-
-
183
Net proceeds from shares issued under the at-the-market (ATM)
program
12(b)
117,724,769
59,336
-
-
-
59,336
Stock based compensation
218,356
160
1,111
-
-
1,271
Balance at March 31, 2021
208,375,549
197,194
10,817
(6,333)
(146,018)
55,660
Common
Shares
Notes
Number
Dollar
$
Additional
Paid-in
Capital
$
Accumulated
other
comprehensive
loss
$
Deficit
$
Total
$
Balance, March 31, 2019
2, 20
78,132,734
110,857
8,150
(7,135
)
(100,827
)
11,045
Net loss and total comprehensive loss for the period
-
-
-
-
(25,513
)
(25,513
)
Cumulative translation adjustment
-
-
-
(752
)
-
(752
)
Warrants exercised
10, 14
7,056,103
18,810
(262
)
-
-
18,548
Net proceeds from shares issued under the at-the-market (ATM)
program
12(b)
4,065,986
6,941
-
-
-
6,941
Shares issued as a settlement
900,000
738
-
-
-
738
Stock based compensation
54,626
78
1,909
-
-
1,987
Balance at March 31, 2020
90,209,449
137,424
9,797
(7,887
)
(126,340
)
12,994
The accompanying notes are an integral part of these consolidated financial
statements
F- 6
Acasti pharma inc.
Consolidated
Statements of Cash Flows
Year Ended
Year Ended
(Expressed in thousands of U.S. dollars except
share data)
March 31, 2021
March 31, 2020
Notes
$
$
Cash flows used in operating activities:
Net loss for the year
(19,678)
(25,513
)
Adjustments:
Amortization of intangible assets
6
781
1,910
Depreciation of equipment
7
143
410
Impairment of intangible assets
6
3,706
-
Impairment of Equipment
7
1,584
-
Impairment of other assets and prepaids
7
413
-
Stock-based compensation expense
15
1,174
1,953
Change in fair value of warrant liabilities
10
2,426
1,116
Accretion of interest on convertible debenture
-
145
Write off-of deferred financing costs of at-the-market (ATM) program
264
-
Unrealized exchange loss
814
246
Changes in non-cash working capital items
17
(5,971)
(2,993
)
Changes in other assets
25
(225
)
Net cash used in operating activities
(14,319
)
(22,951
)
Cash flows from (used in) investing activities:
Acquisition of equipment
7
(69)
(319
)
Acquisition of short-term investments
(9,810)
(1,923
)
Maturity of short-term investments
21
10,380
Net cash from (used in) investing activities
(9,858)
8,138
Cash flows from (used in) financing activities:
Net proceeds from shares issued under the at-the-market (ATM) program
59,332
6,981
Deferred financing costs
(14
3)
7
Proceeds from exercise of warrants
183
7,706
Proceeds from exercise of stock options
118
45
Payment of convertible debenture
-
(1,556
)
Net cash from financing activities
59,490
13,183
Effect of exchange rate fluctuations on cash and cash equivalents
6,329
(254
)
Translation effect on cash and cash equivalents related to reporting currency
(4,940)
(747
)
Net (decrease) increase in cash and cash equivalents
36,702
(2,631
)
Cash and cash equivalents, beginning of year
14,240
16,871
Cash and cash equivalents, end of year
50,942
14,240
Cash and cash equivalents are comprised of:
Cash
38,406
4,869
Cash equivalents
12,536
9,371
F- 7
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
1.
Nature of Operations
Acasti Pharma Inc. (“ Acasti” or the “ Corporation” )
is incorporated under the Business Corporations Act (Québec) (formerly Part 1A of the Companies Act (Québec)).
The Corporation is domiciled in Canada and its registered office is located at 3009 boul. de la Concorde East, Suite 102, Laval, Québec,
Canada H7E 2B5. In December 2019, Acasti incorporated a new wholly owned subsidiary named Acasti Innovation AG (“AIAG”) under
the laws of Switzerland for the purpose of future development of the Corporation’s intellectual property.
In January 2020 and August 2020, the Corporation released Phase 3 clinical
study results for the Corporation’s lead drug candidate, CaPre. The TRILOGY studies did not to meet the primary endpoint resulted
in the Corporation making a decision not to proceed with a filing of an NDA with the FDA. With the completion of the TRILOGY studies research
and development activities and expenses were reduced.
In September 2020, the Corporation commenced a
formal process to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, the Corporation has engaged
a financial advisor to assist in the process. The Corporation has also greatly reduced its commercial activities including a reduction
in workforce to reduce operating expenses, while it evaluates these opportunities. In addition, the equipment and other assets are classified
as held for resale as they are expected to be sold.
In May 2021 (note 21), the Corporation announced
a definitive agreement to acquire Grace Therapeutics Inc. a privately held emerging biopharmaceutical company focused on developing innovative
drug delivery technologies for the treatment of rare and orphan diseases. Subject to the completion of the Proposed Transaction, the Corporation
will acquire Grace’s pipeline of drug candidates. The Proposed Transaction has been approved by the boards of directors of both
companies and is supported by Grace’s shareholders through voting and lock-up agreements with the Corporation. The transaction remains
subject to approval of Acasti stockholders, as well as applicable stock exchanges. The Corporation remains subject to a number of risks
similar to other companies in the biotechnology industry, including compliance with government regulations, protection of proprietary
technology, dependence on third parties and product liability.
2.
Summary of significant accounting policies
Basis of presentation
These consolidated financial statements of Acasti Pharma Inc.,
which include the accounts of its subsidiary have been prepared in accordance with U.S. GAAP. All intercompany transactions and balances
are eliminated on consolidation.
The following summarizes the principal conditions or events relevant to
the Corporation’s going concern assessment, which primarily considers the period of one year from the issuance date of these financial
statements.
The Corporation has incurred operating losses and negative cash flows from
operations since its inception. In prior years there was substantial doubt regarding the Corporation’s ability to realize its assets
and discharge its liabilities and commitments in the ordinary course of business. During year ended March 31, 2021, the Corporation has
raised net proceeds of $59.3 million under the ATM program. The Corporation’s assets as at March 31, 2021 include cash and cash
equivalents and short-term investments totaling $60.7 million. The Corporation’s current liabilities total $1.6 million as at March
31, 2021 and are comprised primarily of amounts due to or accrued for creditors.
F- 8
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
The Corporation’s ability to continue as a going concern
is dependent upon its ability to achieve a successful strategic alternative and ultimately generate cashflows to meet its obligations.
To date, the Corporation has financed its operations primarily through public offerings of common shares, private placements, and the
proceeds from research tax credits, and will require additional financing in the future. Refer to note 21 Subsequent Events regarding
the Corporation’s agreement to acquire Grace Therapeutics Inc. There is no assurance that a strategic transaction will be consummated
as such transaction is not within the Corporation’s control. As a result of the Corporation’s current liquidity profile, the
reduction of operating expenses and limited liabilities management has assessed that substantial doubt no longer exists regarding its
ability to continue as a going concern for one year from the issuance date of these financial statements.
Significant accounting policies, estimates and judgments:
The preparation of the financial statements in conformity with
U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, income, and expenses.
Actual results may differ from these estimates.
Estimates are based on management’s best knowledge of current
events and actions that management may undertake in the future. Estimates and underlying assumptions are reviewed on an ongoing basis.
Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Estimates and assumptions include the measurement of derivative
warrant liabilities ( note 10 ) and stock-based compensation ( note 15 )) and impairment of intangibles and assets held for
sale (notes 6 and 7) and the take-or-pay contract (note 20(a)). Estimates and assumptions are also involved in measuring the accrual of
services rendered with respect to research and developments expenditures at each reporting date, are determining which research and development
expenses qualify for research and development tax credits and in what amounts. The Corporation recognizes the tax credits once it has
reasonable assurance that they will be realized. Recorded tax credits are subject to review and approval by tax authorities and, therefore,
could be different from the amounts recorded.
Functional and reporting currency:
Effective March 31, 2020, the consolidated financial statements reporting
currency has changed from Canadian dollars to U.S dollars. This change in reporting currency has been applied retrospectively such that
all amounts are expressed in the consolidated financial statements of the Corporation and the accompanying notes thereto are expressed
in thousands of U.S dollars, except for per share data. References to “$” are U.S dollars and references to “CAD $”
are to Canadian dollars. Translation gains and losses from the application of the U.S. dollar as the reporting currency while the Canadian
dollar is the functional currency are included as part of the cumulative foreign currency translation adjustment, which is reported as
a component of shareholders’ equity under accumulated other comprehensive loss.
The Corporation’s functional currency is the Canadian
dollar. The effects of exchange rate fluctuations on translating foreign currency monetary assets and liabilities into Canadian dollars
are included in the statement of loss and comprehensive loss as foreign exchange gain/loss. Expense transactions are translated into the
U.S. dollar reporting currency at the average exchange rate during the period, and assets and liabilities are translated at end of period
exchange rates, except for equity transactions, which are translated at historical exchange rates.
F- 9
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
Cash and Cash Equivalents:
Cash and cash equivalents comprise cash balances and highly
liquid investments purchased with original maturities of three months or less. Cash and cash equivalents consist of term deposits held
at the bank and recorded at cost, which approximates fair value.
Investments:
The Corporation’s investments consist of term deposits and are classified
as held-to-maturity securities. These investments are recorded at amortized cost. Investments with original maturities exceeding three
months and less than one year are categorized as short-term.
Receivables:
Receivables are classified at amortized cost and recorded at
the outstanding amount net of any provisions for uncollectible amount.
Deferred Financing Costs:
Deferred financing costs consists of fees charged by underwriters,
attorneys, accountants, and other fees directly attributable to future issuances of shares. Provided these costs are determined to be
recoverable, these costs are deferred and charged subsequently against the gross proceeds of the related equity transaction when it occurs.
If at such time, the Corporation deems that these costs are no longer recoverable, they will be expensed as a component of finance expenses.
Assets held for sale:
Assets that are classified as held for sale are measured at
the lower of their carrying amount or fair value less expected selling costs (“estimated selling price”) with a loss recognized
to the extent that the carrying amount exceeds the estimated selling price. The classification is applicable at the date upon which the
sale of assets is probable, and the assets are available for immediate sale in their present condition. Assets once classified as held
for sale, are not subject to depreciation or amortization and both the assets and any liabilities directly associated with the assets
held for sale are classified as current in the Corporation’s Consolidated Balance Sheets. Subsequent changes to the estimated selling
price of assets held for sale are recorded as gains or losses to the Consolidated Statements of Income wherein the recognition of subsequent
gains is limited to the cumulative loss previously recognized.
Equipment:
(i) Recognition
and measurement:
Equipment is measured at cost less accumulated depreciation
and accumulated impairment losses, if any.
Cost includes expenditures that are directly attributable to
the acquisition of the asset, including all costs incurred in bringing the asset to its present location and condition. Purchased software
that is integral to the functionality of the related equipment is capitalized as part of that equipment. Gains and losses on disposal
of equipment are determined by comparing the proceeds from disposal with the carrying amount of equipment and are recognized net within
operating expenses in the Consolidated Statement of Loss and Comprehensive Loss.
(ii) Subsequent
costs:
The costs of the day-to-day servicing of equipment are recognized
in profit or loss as incurred.
F- 10
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
(iii) Depreciation:
Depreciation is recognized in profit or loss on either a straight-line
basis or a declining basis over the estimated useful lives of each part of an item of equipment, since this most closely reflects the
expected pattern of consumption of the future economic benefits embodied in the asset. Items of equipment are depreciated from the date
that they are available for use or, in respect of assets not yet in service, from the date they are ready for their intended use.
The estimated useful lives and rates for the current and comparative
periods are as follows:
Assets
Method
Period/Rate
Furniture and office equipment
Declining balance
20%
to
30%
Computer equipment
Declining balance
30%
Laboratory equipment
Declining balance
30%
Production equipment
Declining balance
10%
to
30%
Depreciation methods, useful lives and residual values are reviewed
periodically and adjusted prospectively if appropriate.
Intangible assets:
Intellectual property and licenses that are acquired by the
Corporation from a third party are capitalized and subsequently measured at cost less accumulated amortization and accumulated impairment
losses, if they have finite useful lives, they are for approved products or if there are alternative future uses.
Amortization group
Amortization is calculated over the cost of the intangible asset
less its residual value. Amortization is recognized in profit or loss on a straight-line basis over the estimated useful lives of intangible
assets from the date that they are available for use, since this most closely reflects the expected pattern of consumption of the future
economic benefits embodied in the asset. The estimated useful lives for the current and comparative periods are as follows:
Assets
Period
(years)
Patents
20
License
8
to
14
Subsequent expenditure:
Subsequent expenditure is capitalized only when it increases
the future economic benefits embodied in the specific asset to which it relates. All other expenditures, including expenditure on internally
generated goodwill and brands, are recognized in profit or loss as incurred.
Research and Development Costs
Research and developments expenditures are expensed as incurred.
These costs primarily consist of employees’ salaries and benefits related to research and development activities, contractors and
consultants that conduct the Corporation’s clinical trials, independent auditors and consultants to perform investigation activities
on behalf of the Corporation, laboratory material and small equipment, clinical trial materials, stock-based compensation expense, and
other non-clinical costs and regulatory fees. Advance payments for goods and services that will be used in future research and development
are recognized in prepaids or other assets and are expensed when the services are performed, or the goods are used.
F- 11
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
Impairment of Long-Lived Assets:
The Corporation reviews the recoverability of its long-lived
assets whenever events or changes in circumstances indicate that it is carrying amount may not be recoverable. The carrying amount is
first compared with the undiscounted cash flows. If the carrying amount is higher than the sum of undiscounted cash flows, then the Corporation
determines the fair value of the underlying asset group. Any impairment loss to be recognized is measured as the difference by which the
carrying amount of the asset group exceeds the estimated fair value of the asset group. An impairment of $5,703 was recognized in the
year ended March 31, 2021, and nil in the year ended March 31, 2020.
Stock based compensation:
The Corporation has in place a stock option plan for directors, officers,
employees, and consultants of the Corporation, with grants under the stock option plan approved by the Corporation’s Board of Directors.
The plan provides for the granting of options to purchase Common Shares and the exercise price of each option equals the closing trading
price of Common Shares on the day prior to the grant. The terms and conditions for acquiring and exercising options are set by the Corporation’s
Board of Directors in accordance with and subject to the terms and conditions of the stock option plan. The Corporation measures the cost
of such awards based on the fair value of the award at grant date, net of estimated forfeiture, and recognizes stock-based compensation
expense in the Consolidated Statements of Loss and Comprehensive Loss on a graded vesting basis over the requisite service period. The
requisite service period equals the vesting periods of the awards. The fair value of options is estimated for each tranche of an award
that vests on a graded basis. The fair value of options is estimated using the Black-Scholes option pricing model, which uses various
inputs including estimated fair value of the Common Shares at the grant date, expected term, estimated volatility, risk-free interest
rate and expected dividend yields of the Common Shares. The Corporation applies an estimated forfeiture rate derived from historical employee
termination behaviour. If the actual forfeitures differ from those estimated by management, adjustment to compensation expense may be
required in future periods.
Non-employee stock-based compensation transactions in which the Corporation
receives goods or services as consideration for its own equity instruments are accounted for as stock-based compensation transactions.
The Corporation establishes the fair value at the grant date for non-employee awards and measures the fair value based on the fair value
of equity instruments issued. The fair value of a non-employee award is estimated using the Black-Scholes option pricing model, which
uses various inputs including estimated fair value of the Common Shares at the grant date, contractual term, estimated volatility, risk-free
interest rate and expected dividend yields of the Common Shares.
Government grants:
Government grants are recorded as a reduction of the related expense or
cost of the asset acquired. Government grants are recognized when there is reasonable assurance that the Corporation has met the requirements
of the approved grant program and there is reasonable assurance that the grant will be received.
Grants that compensate the Corporation for expenses incurred
are recognized in profit or loss in reduction thereof on a systematic basis in the same years in which the expenses are recognized. Grants
that compensate the Corporation for the cost of an asset are recognized in profit or loss on a systematic basis over the useful life of
the asset.
F- 12
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
Leases:
Adoption of Topic 842 (Leases)
On April 1, 2019, the Corporation adopted Topic 842.
There was no material impact on the consolidated financial statement from adopting the new standard given the Corporation only had short
term leases at the time of adoption and the Corporation elected to apply the short-term lease exemption. Subsequent to April 1, 2019,
at the inception of an arrangement, the Corporation determines whether the arrangement is or contains a lease based on the unique facts
and circumstances present in the arrangement and in accordance with the guidance of ASC Topic 842 “Leases”.
Operating lease liabilities and their corresponding right-of-use
assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments
to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically
not readily determinable. As a result, the Corporation utilizes its incremental borrowing rate to discount lease payments, which reflects
the fixed rate at which the Corporation could borrow on a collateralized basis the amount of the lease payments in the same currency,
for a similar term, in a similar economic environment. The Corporation does not have financing leases.
The Corporation has elected not to recognize leases with an original
term of one year or less on the balance sheet. The Corporation typically only includes an initial lease term in its assessment of a lease
arrangement. Options to renew a lease are not included in the Corporation’s assessment unless there is reasonable certainty that
the Corporation will renew. In the year ended March 31, 2020, the Corporation modified the lease for its lab facility and recognized a
right of use asset and a corresponding lease liability of $147. The new lease is for a two-year term, and it was discounted using an incremental
borrowing rate of 8%. The undiscounted obligation is $80 per year. The Corporation’s lease expense is recognized in research and
development expenses.
Income tax:
Income tax expense comprises current and deferred taxes. Current
and deferred taxes are recognized in profit or loss except to the extent that they relate to items recognized directly in equity or in
other comprehensive income.
Current tax is the expected tax payable or receivable on the
taxable income or loss for the year, using tax rates enacted at the reporting date, and any adjustment to tax payable in respect of previous
years.
F- 13
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
Deferred tax is recognized in respect of temporary differences
between the carrying amounts (tax base) of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes.
Deferred tax assets and liabilities are measured at the tax rate expected to apply when the underlying asset or liability is realised
(settled) based on the rates that are enacted at the reporting date. Deferred tax assets and liabilities are offset if the Corporation
has the right to set off the amount owed by with the amount owed by the other party, the Corporation intends to set off and the offset
right is enforceable at law. A deferred tax asset is recognized for unused tax losses and tax credits, reduced by a valuation allowance
to the extent that it is more likely than not that some portion or all of the deferred tax asset will not be realized.
Earnings per share:
The Corporation presents basic and diluted earnings per share
( EPS ) data for its Common Shares. Basic EPS is calculated by dividing the profit or loss attributable to the holders of Common
Shares by the weighted average number of Common Shares outstanding during the year. Diluted EPS is determined by adjusting the profit
or loss attributable to the holders of Common Shares and the weighted average number of Common Shares outstanding adjusted for the effects
of all dilutive potential Common Shares, which comprise warrants and share options granted to employees.
Segment reporting:
An operating segment is a component of the Corporation that
engages in business activities from which it may earn revenues and incur expenses. The Corporation has one reportable operating segment:
the development and commercialization of pharmaceutical applications of its patent portfolio and licensed rights for cardiovascular diseases.
The majority of the Corporation’s assets are located in Canada, while one major production unit, with a carrying value of $156 (March
31, 2020 - $1,510), is located in France at a third-party contract manufacturing facility.
Convertible Debentures:
The unsecured convertible debentures that existed in the financial
statements for the year ended March 31, 2020, were fully paid at maturity in February 2020. The unsecured convertible debentures could
have been converted to Common Shares at the option of the holder, and the number of shares to be issued was fixed. The embedded conversion
option in the convertible debentures meet the criteria to not be separately accounted for as a derivative. The convertible debentures
were separated into liability and equity components. The liability component was recognized initially at the fair value of a similar liability
that does not have an equity conversion option. The equity component was recognized initially as the difference between the fair value
of the financial instrument as a whole and the fair value of the liability component. Any directly attributable transaction costs were
allocated to the liability and equity components in proportion to their initial carrying amounts. Subsequent to initial recognition, the
liability component was measured at amortized cost using the effective interest method. The equity component of the convertible debt was
not remeasured subsequent to initial recognition.
Derivative financial instruments:
The Corporation has issued warrants of which some are accounted
for as liability-classified derivatives over its own equity. Derivatives are recognized initially at fair value; attributable transaction
costs are recognized in profit and loss as incurred. Subsequent to initial recognition, derivatives are measured at fair value, and all
changes in their fair value are recognized immediately in profit or loss as a component of financial expenses.
F- 14
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
2.
Summary of significant accounting policies (continued):
Other equity instruments :
Warrants that do not meet the definition of a liability instrument
are recognized in equity as additional paid in capital.
Fair Value Measurements
Certain of the Corporation’s accounting policies and disclosures
require the determination of fair value, for both financial assets and liabilities. Fair values have been determined for measurement and/or
disclosure purposes based on the following methods.
Financial assets and liabilities:
In establishing fair value, the Corporation uses a fair value
hierarchy based on levels as defined below:
·
Level 1: defined as observable inputs such as quoted prices in active markets.
·
Level 2: defined as inputs other than quoted prices in active markets that are
either directly or indirectly observable.
·
Level 3: defined as inputs that are based on little or no observable market
data, therefore requiring entities to develop their own assumptions.
The Corporation has determined that the carrying values of its short-term
financial assets and liabilities (cash and cash equivalents, short-term investments and trade and other payables) approximate their fair
value given the short-term nature of these instruments. The Corporation measured its derivative warrant liabilities at fair value on a
recurring basis using level 3 inputs .
3.
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13-Financial Instruments-Credit
Losses (Topic 326), which amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt
securities. For assets held at amortized cost, the new guidance eliminates the probable initial recognition threshold in current GAAP
and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation
account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. ASU
2016-13 will affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, and any
other financial assets not excluded from the scope that have the contractual right to receive cash. ASU 2016-13 is effective for annual
periods, and interim periods within those annual periods, beginning after December 15, 2022. Management has not yet evaluated the impact
of this ASU on the consolidated financial statements.
F- 15
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
4.
Receivables:
March 31, 2021
March 31, 2020
Notes
$
$
Sales tax receivables
160
301
Government assistance
8
339
209
Interest receivable
13
11
Other receivables
18
25
Total receivables
530
546
5.
Short-term Investments:
The Corporation holds various marketable securities with maturities greater than
3 months at the time of purchase as follows:
March 31, 2021
March 31, 2020
$
$
Term deposits issued
in US currency earning interest at ranges between 0.23% and 0.40% and maturing on various dates from June 22, 2021 to July 27, 2021
7,542
-
Term
deposits issued in CAD currency earning interest at ranges between 0.58% and 0.67% and maturing on various dates from April 16, 2021 to
July 27, 2021
2,247
-
Total investments
9,789
-
Short-term investments
9,789
-
Investments
-
-
6.
Impairment loss Intangible assets:
In prior years, the Corporation entered into agreements
with Neptune Wellness Solutions Inc. (Neptune) pursuant to which the Corporation obtained a license and exercised its option under this
license agreement to pay in advance all of the future royalties payable to Neptune. This license allows the Corporation to exploit the
intellectual property rights in-order to develop novel active pharmaceutical ingredients into commercial products for the prescription
drugs market. The Corporation tests intangible assets for impairment should circumstances change or events occur that would indicate that
the fair value of an asset may be below its carrying value. During the second quarter of fiscal 2021, the Corporation released its Phase
3 clinical programs data and its failure to meet its primary endpoints, and the resulting decision to not file an NDA to obtain FDA approval
for CaPre. In addition, a significant share price reduction occurred. Due to these indicators of impairment under ASC 350, the Corporation
undertook an analysis to determine the fair value of its intangible asset this quarter.
In assessing the magnitude of any impairment of
the license the Corporation considered all available evidence including i) significant adverse impact from business climate due to Phase
3 clinical programs failure to meet its primary endpoints, and the resulting decision to not file an NDA to obtain FDA approval for CaPre,
and the resulting internal forecasts that no cash flows from the use of the license was possible, and (ii) management’s estimate
that a market place participant would place minimal to no value on the license if it were to be sold on its own or in combination with
other assets, recognized or not, which is a level 3 measurement in the fair value hierarchy which included unobservable inputs. Accordingly,
an impairment loss of $3,706 was recognized in the second quarter of the year ended March 31, 2021, which represents the totality of the
intangible assets net book value prior to the impairment trigger. For the year ended March 31, 2021, amortization expense, prior
to the impairment was $781 (2020 - $1,910) and was included in research and development expenses.
F- 16
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
7.
Assets held for sale:
During the period the Corporation committed to
a plan and is actively marketing for sale Other assets and Equipment and has met the criteria for classification of assets held for sale:
March 31,
2021
March 31,
2020
$
$
Other assets
387
668
Equipment
381
1,910
768
2,578
a.
Other assets
Other assets represent krill oil (RKO) held by
the Corporation that was expected to be used in the conduct of R&D activities and commercial inventory scale up related to the development
and commercialization of the CaPre drug. Given that the development of CaPre will no longer be pursued, the Corporation is expected to
sell this reserve. The other asset is being recorded at the fair value less costs to sell, which has resulted in an impairment loss of
$413. Management’s estimate of the fair value of the RKO less cost -to sell, is based primarily on estimated market prices obtained
from an appraiser specialized in the krill oil market. These projections are based on Level 3 inputs of the fair value hierarchy and reflect
management’s best estimate of market participants’ pricing of the assets as well as the general condition of the asset. The
total impairment loss recognized, includes amounts paid for krill oil in advance, but not yet received and was recorded as a prepaid.
b.
Equipment
March 31, 2021
Cost
Accumulated
depreciation
Impairment
loss
Net book
value
$
$
$
$
Furniture and office equipment
17
(5
)
-
12
Computer equipment
148
(30
)
(54
)
64
Laboratory equipment
756
(436
)
(171
)
149
Production equipment
2,538
(1,023
)
(1,359
)
156
3,459
(1,494
)
(1,584
)
381
March 31, 2020
Cost
Accumulated
depreciation
Net
book value
$
$
$
Furniture and office equipment
15
3
12
Computer equipment
64
18
46
Laboratory equipment
684
343
341
Production equipment
2,341
830
1,511
3,104
1,194
1,910
For the year ended March 31, 2021, depreciation
expense was $143 (2020 $410) and was included in research and development expenses. Equipment is made up of Laboratory, Production, Computer
and Office equipment that was utilized in the development of CaPre. Given that the development of CaPre will no longer be pursued, the
Corporation is expected to sell this equipment. Similarly, to the intangible assets, the announcement of the outcomes of the TRILOGY clinical
trials resulted in an impairment trigger for the laboratory and production equipment. The impairment loss is based on management’s
estimate of the fair value of the equipment less cost -to sell, which is based primarily on estimated market prices obtained from brokers
specialized in selling used equipment. These projections are based on Level 3 inputs of the fair value hierarchy and reflect the Corporations
best estimate of market participants’ pricing of the assets as well as the general condition of the assets.
F- 17
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
8.
Government assistance:
March 31,
2021
March 31,
2020
$
$
Investment tax credit
339
182
Government grant
-
27
Total government assistance
339
209
Government assistance is comprised of a government
grant from the Canadian federal government and research and development investment tax credits receivable from the Quebec provincial government
which relate to qualifiable research and development expenditures under the applicable tax laws. The amounts recorded as receivables are
subject to a government tax audit and the final amounts received may differ from those recorded. For the years ended March 31, 2021, and
2020, the Corporation recorded $127 and $149, respectively, as a reduction of research and development expenses in the Consolidated Statements
of Loss and Comprehensive Loss.
The amounts recorded as receivables are subject
to a government tax audit and the final amounts received may differ from those recorded. Unrecognized Canadian federal tax credits may
be used to reduce future Canadian federal income tax and expire as follows:
$
2029
9
2030
23
2031
36
2032
343
2033
351
2034
347
2035
413
2036
228
2037
251
2038
180
2039
247
2040
369
2041
170
2,967
In September 2019, the Corporation was awarded
up to CAD $750,000 in non-dilutive and non-repayable funding from the National Research Council of Canada Industrial Research Assistance
Program (NRC IRAP) to apply towards eligible research and development disbursements of the Corporation’s unique commercial production
platform for CaPre. As at March 31, 2021 the Corporation has claimed $79 in connection with this program, which has been recorded as a
reduction of research and development expenses in the Consolidated Statements of Loss and Comprehensive Loss.
In October 2020, the Corporation received correspondence
from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) that the eligible amount awarded to the
Corporation for non-dilutive and non-repayable funding was reduced from up to CAD $750,000 to up to CAD $326,357.
F- 18
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
9.
Trade and other payables:
March 31, 2021
March 31, 2020
$
$
Trade payables
115
1,713
Accrued liabilities and other payables
607
4,247
Employee salaries and benefits payable
771
1,359
Total trade and other payables
1,493
7,319
10.
Derivative warrant liabilities:
On May 9, 2018, the Corporation closed a Canadian public offering issuing
9,530,000 units at a price of CAD $1.05 per unit for gross proceeds of $7.8 million (CAD$10 million). The units issued consist of 9,530,000
Common Shares and 9,530,000 warrants. Each warrant entitles the holder thereof to acquire one Common Share at an exercise price of CAD
$1.31 at any time until May 9, 2023. On May 14, 2018, the underwriters exercised their over-allotment option by purchasing an additional
1,429,500 units at a price of CAD $1.05 per unit, for additional gross proceeds of $1.1 million (CAD $1.5 million). The units issued consist
of 1,429,500 Common Shares and 1,429,500 warrants. Each Warrant entitles the holder thereof to acquire one Common Share of the Corporation
at an exercise price of CAD $1.31 at any time until May 9, 2023. The warrants issued are derivative warrant liabilities given the warrant
indenture contains certain contingent provisions that allow for cash settlement.
On December 27, 2017, the Corporation closed a U.S. public offering of
9,900,990 units at a price of US$1.01 per unit for gross proceeds of $10 million. The units issued consist of 9,900,990 Common Shares
and 8,910,891 warrants to purchase one Common Share. As part of this closing, the underwriters also partially exercised for nil consideration
the over-allotment option for warrants, which were issued for a right to purchase 892,044 Common Shares at an exercise price of $1.26.
Warrants issued are derivative warrant liabilities given the currency of the exercise price is different from the Corporation’s
functional currency.
The derivative warrant liabilities are measured at fair value at each reporting
period and the reconciliation of changes in fair value is presented in the following tables:
Warrants
issued May 2018
Warrants
issued December 27, 2017
March 31,
2021
March 31,
2020
March 31,
2021
March 31,
2020
$
$
$
$
Balance – beginning of year
1,146
6,177
1,247
6,005
Issued during the year
-
-
Amount transferred to Equity
-
(6,072
)
-
(4,770
)
Change in fair value
1,252
1,115
1,174
1
Translation effect
199
(74
)
201
(11
)
Balance – end of year
2,597
1,146
2,622
1,247
Fair value per warrant issuable
0.39
0.17
0.37
0.18
The fair value of the derivative warrant liabilities was estimated using
the Black-Scholes option pricing model and based on the following assumptions:
F- 19
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
10.
Derivative warrant liabilities (continued):
Warrant
liabilities issued May 2018
Warrant
liabilities issued December 27, 2017
March 31,
2021
$
March 31,
2020
$
March 31,
2021
$
March 31,
2020
$
Exercise price
CAD $1.31
CAD $1.31
USD $1.26
USD $1.26
Share price
CAD $0.76
CAD $0.53
USD $0.60
USD $0.38
Risk-free interest
1.39
%
0.66
%
0.92
%
0.37
%
Contractual life (years)
2.11
3.11
1.74
2.74
Expected volatility
156.00
%
107.59
%
171.12
%
125.03
%
The Corporation measured its derivative warrant liabilities at fair value
on a recurring basis. These financial liabilities were measured using level 3 inputs (see Note 12) .
As at March 31, 2021, the effect of an increase or a decrease of 5% of
the volatility used, which is the significant unobservable input in the fair value estimate, would result in a loss of $241 or a gain
of $257, respectively.
As at March 31, 2021, the effect of a 5% strengthening of the U.S. dollar
against the Canadian dollar, would result in a loss of $129. An assumed 5% weakening of the U.S. dollar against the Canadian dollar would
have an equal but opposite effect on the basis that all other variables remained constant.
11.
Unsecured convertible debentures
On February 21, 2017, the Corporation issued $ 1,522 (CAD$ 2,000) aggregate
principal amount of unsecured convertible debentures maturing February 21, 2020, and contingent warrants to acquire up to 1,052,630 Common
Shares. The debentures were paid in full at maturity. The proceeds were split between liability and equity. Both the conversion option
and contingent warrants were considered the equity component of the Private Placement. The split between the liability and equity component
portions are summarized below:
Liability component
Equity component
Total Private Placement
$
$
$
Balance at March 31, 2019
1,361
220
1,581
Accretion of interest on convertible debenture
145
-
145
Translation effect
50
-
50
Shares issued upon exercise of warrants
-
(33
)
(33
)
Payment upon maturity of debentures
(1,556
)
-
(1,556
)
Balance at March 31, 2020
-
187
187
F- 20
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
12.
Capital and other components of equity
(a)
Common Shares:
Authorized capital stock:
Unlimited number of shares:
Ø
Class A shares (Common Shares), voting (one vote per share), participating and without
par value.
Ø
Class B shares, voting (ten votes per share), non-participating, without par value and
maximum annual non-cumulative dividend of 5% on the amount paid per share. Class B shares are convertible, at the holder’s discretion,
into Class A shares (Common Shares), on a one-for-one basis, and Class B shares are redeemable at the holder’s discretion for CAD
$0.80 per share, subject to certain conditions. There are none issued and outstanding.
Ø
Class C shares, non-voting, non-participating, without par value and maximum annual
non-cumulative dividend of 5% on the amount paid per share. Class C shares are convertible, at the holder’s discretion, into Class
A shares (Common Shares), on a one-for-one basis, and Class C shares are redeemable at the holder’s discretion for CAD $0.20 per
share, subject to certain conditions. There are none issued and outstanding.
Ø
Class D and E shares, they are non-voting, non-participating, without par value and
maximum monthly non-cumulative dividend between 0.5% and 2% on the amount paid per share. Class D and E shares are convertible, at the
holder’s discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class D and E shares are redeemable at the
holder’s discretion, subject to certain conditions. There are none issued and outstanding.
(b)
“At-the-market” sales agreement
On February 14, 2019, the Corporation entered into an “at-the-market”
(ATM) sales agreement with B. Riley FBR, Inc. (“B. Riley”) pursuant to which the Common Shares may be sold from time to time
for aggregate gross proceeds of up to $30 million, with sales only being made on the NASDAQ Stock Market. The Common Shares would be issued
at market prices prevailing at the time of the sale and, as a result, prices may vary between purchasers and during the period of distribution.
The ATM has a 3-year term and requires the Corporation to pay between 3% and 4% commission to B. Riley based on volume of sales made.
On June 29, 2020, the Corporation entered into an amended and restated sales agreement (the Sales Agreement) with B. Riley, Oppenheimer&
Co. Inc. and H.C. Wainwright & Co., LLC (collectively, the “Agents”) to amend the existing ATM program. Under the terms
of the Sales Agreement, which has a three-year term, the Corporation may issue and sell from time to time its common shares (the Shares)
having an aggregate offering price of up to US $75,000,000 through the Agents. Subject to the terms and conditions of the Sales Agreement,
the Agents will use their commercially reasonable efforts to sell the Shares from time to time, based upon the Corporation’s instructions.
The Corporation has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement. The Corporation
and the Agents may terminate the Sales Agreement in accordance with its terms. Under the terms of the Sales Agreement, the Corporation
has provided the Agents with customary indemnification rights and the Agents will be entitled to compensation, at a commission rate equal
to 3.0% of the gross proceeds from each sale of the Shares. For the year ended March 31, 2021, a total of 117.7 million common shares
(March 31, 2020 – 4.1 million common shares) were sold for total net proceeds of approximately $59.3 million (March 31, 2020, $7.0
million) under the ATM program. Commission, legal and costs related to share sale amounted to $2.0 million (March 31, 2020 - $291). The
shares were sold at the prevailing market prices, which resulted in an average price of approximately $0.52 per share (March 31, 2020
- $1.79 per share). Accordingly, proportional costs of $18 related to the common shares sold, have been reclassified from deferred financings
costs to equity (March 31, 2020 - $40). Total costs incurred to register the Sales Agreements were initially recorded as deferred financing
costs in the Consolidated Balance Sheet. As at March 31, 2021, the remaining balance of the costs incurred of $264 were written off to
financing expenses.
F- 21
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
12.
Capital and other components of equity (continued):
(b)
Warrants:
The warrants of the Corporation are composed of the following:
March
31, 2021
March
31, 2020
Number
outstanding
Amount
Number
outstanding
Amount
$
$
Liability
May 2018 public offering warrants 2018 (i)
6,593,750
2,597
6,593,750
1,146
Series December 2017 U.S. public offering warrants 2017 (ii)
7,072,962
2,622
7,072,962
1,247
13,666,712
5,219
13,666,712
2,393
Equity
Public offering warrants
Public offering broker warrants May 2018 (iii)
1
-
222,976
89
Public offering U.S. broker warrants December 2017 (iv)
259,121
161
259,121
161
Public offering warrants February 2017 (v)
1,723,934
631
1,723,934
631
1,983,056
792
2,206,031
881
(i)
Warrant to acquire one Common Share at an exercise price of CAD $1.31, expiring on May 9, 2023.
(ii)
Warrant to acquire one Common Share at an exercise price of $1.26, expiring on December 27, 2022.
(iii)
Warrant to acquire one Common Share o at an exercise price of CAD $1.05, expiring on May 9, 2023.
(iv)
Warrant to acquire one Common Share at an exercise price of $1.2625, expiring on December 19, 2022.
(v)
Warrant to acquire one Common Share at an exercise price of CAD $2.15, expiring on February 21, 2022.
During the year ending March 31, 2021, 222,975 broker warrants offered
as part of the May 2018 public offering were exercised at a price of $0.83 per Common Share of the Company, resulting in $183 of cash
proceeds.
During the year ended March 31, 2020, 235,929 broker warrants and 52,288
derivative warrants offered as part of the December 2017 U.S. public offering were exercised on a cashless basis to acquire 136,013 Common
Shares.
13.
Revenues:
In October 2020, the Corporation entered into an agreement with the Centre
Integre Universitaire et des services sociaux de L’Estrie - Centre hospitalier Universitaire de Sherbrooke to start producing and
selling Viral transport medium tubes to be utilized in testing related to the Covid-19 pandemic. Revenue is recognized when the product
is received by the customer.
F- 22
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
14.
Financial expenses:
March 31,
2021
March 31,
2020
$
$
Foreign exchange gain (loss)
(676)
(2
)
Interest payable on convertible debenture
-
(102
)
Accretion of interest on convertible debenture
-
(145
)
Financing costs
(264
)
(46
)
Interest income
107
336
Change in fair value of warrant liabilities
(2,426)
(1,116
)
Financial expenses
(3,259)
(1,075
)
15.
Stock based compensation:
At March 31, 2021, the Corporation has the following stock-based compensation
arrangement:
(a)
Corporation stock option plan:
The Corporation has in place a stock option plan for directors, officers,
employees, and consultants of the Corporation. An amendment of the stock option plan was approved by shareholders on September 30, 2020.
The amendment provides for an increase to the existing limits for Common Shares reserved for issuance under the Stock Option Plan as well
as certain changes to the minimum vesting period applicable to options granted to directors under the Stock Option Plan. The stock option
plan continues to provide for the granting of options to purchase Common Shares. The exercise price of the stock options granted under
this amended plan is not lower than the closing price of the Common Shares on the TSXV at the close of markets the day preceding the grant.
The maximum number of Common Shares that may be issued upon exercise of options granted under the amended Stock Option Plan was increased
from 11,719.910 representing 15% of the issued and outstanding Common Shares of the Company as of April 9, 2019, to 14,533,881 representing
15% of the issued and outstanding Common Shares of the Company as of August 26, 2020. The terms and conditions for acquiring and exercising
options are set by the Corporation’s Board of Directors, subject among others, to the following limitations: the term of the options
cannot exceed ten years and (i) all options granted to a director will be vested evenly on a monthly basis over a period of at least twelve
(12) months, and (ii) all options granted to an employee will be vested evenly on a quarterly basis over a period of at least thirty-six
(36) months.
The total number of shares issued to any one consultant within any twelve-month
period cannot exceed 2% of the Corporation’s total issued and outstanding Common Shares (on a non-diluted basis). The Corporation
is not authorized to grant within any twelve-month period such number of options under the stock option plan that could result in a number
of Common Shares issuable pursuant to options granted to (a) related persons exceeding 2% of the Corporation’s issued and outstanding
Common Shares (on a non-diluted basis) on the date an option is granted, or (b) any one eligible person in a twelve-month period exceeding
2% of the Corporation’s issued and outstanding Common Shares (on a non-diluted basis) on the date an option is granted.
F- 23
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
15.
Stock based compensation (continued):
(a)
Corporation stock option plan (continued):
The following tables summarize information about activities within the
stock option plan:
Number of
options
Weighted average
exercise price
Weighted average
grant date fair value
CAD $
CAD $
Outstanding, March 31, 2019
4,046,677
1.25
0.81
Granted
6,140,517
0.85
0.85
Exercised
(30,874
)
0.81
0.79
Forfeited
(212,334
)
1.62
1.16
Expired
(7,500
)
6.50
3.02
Outstanding, March 31, 2020
9,936,486
1.00
0.83
Granted
-
-
-
Exercised
(241,750)
0.62
0.47
Forfeited
(2,399,817)
0.90
0.74
Expired
-
-
-
Outstanding, March 31, 2021
7,294,919
1.04
0.87
Exercisable at end of year
5,025,583
1.17
0.93
March
31,
2021
March
31,
2020
Weighted average fair value of the options granted
to employees and directors of the Corporation
-
CAD$0.85
Compensation expense recognized under the stock option plan is summarized
as follows:
March 31,
2021
March 31,
2020
$
$
Research and development expenses
353
443
General and administrative expenses
828
1,217
Sales and marketing expenses
(7)
293
1,174
1,953
As of March 31, 2021, there was CAD $476 (March 31, 2020 – CAD $2,802)
of total unrecognized compensation cost, related to non-vested share options, which is expected to be recognized over a remaining weighted
average vesting period of 1.03 years (March 31, 2020 - 1.35 years).
A summary of the non-vested stock option activity and related information
for the Corporation’s stock options granted is as follows:
Number of
options
Weighted average
grant date fair value
CAD ($)
Non- vested, March 31, 2020
6,764,252
0.83
Options granted
-
-
Options vested
1,720,280
0.83
Options forfeited and cancelled
2,774,636
0.90
Non- vested, March 31, 2021
2,269,336
0.76
F- 24
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
15.
Stock based compensation (continued):
(a)
Corporation stock option plan (continued):
The fair value of options granted was estimated using the Black-Scholes
option pricing model, resulting in the following weighted average assumptions for options granted during the periods ended:
March 31, 2020
CAD
Weighted average
Exercise price
$
0.85
Share price
$
1.09
Dividend
—
Risk-free interest
0.88
%
Estimated life (years)
5.71
Expected volatility
99.11
The following tables summarize the status of the outstanding and exercisable
options of the Corporation:
March 31,
2021
Exercise price CAD
Weighted average
remaining
contractual life
Number of
options
outstanding
Number of
options
exercisable
$
0.53
–
0.65
8.99
2,418,167
988,167
$
0.66
–
1.02
7.25
1,527,573
1,300,529
$
1.03
–
1.42
8.04
1,680,058
1,067,766
$
1.43
–
1.61
2.11
525,000
525,000
$
1.62
–
1.71
5.90
108,333
108,333
$
1.72
–
1.88
6.20
737,500
737,500
$
1.89
–
3.25
2.16
262,500
262,500
$
3.26
–
4.65
1.17
22,500
22,500
$
4.66
–
4.80
1.38
13,288
13,288
7.31
7,294,919
5,025,583
Stock-based compensation payment transactions and broker warrants:
The fair value of stock-based compensation transactions is measured using
the Black-Scholes option pricing model. Measurement inputs include share price on measurement date, exercise price of the instrument,
expected volatility (based on weighted average historic volatility for a duration equal to the weighted average life of the instruments,
life based on the average of the vesting and contractual periods for employee awards as minimal prior exercises of options in which to
establish historical exercise experience; contractual life for broker warrants), and the risk-free interest rate (based on government
bonds). Service and performance conditions attached to the transactions, if any, are not considered in determining fair value. The expected
life of the stock options is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption
that the historical volatility over a period similar to the life of the options is indicative of future trends, which may also not necessarily
be the actual outcome.
F- 25
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
15.
Stock based compensation (continued):
(b)
Corporation equity incentive plan:
The Corporation established an equity incentive plan for employees,
directors and consultants. The plan provides for the issuance of restricted share units ( RSUs ), performance share units, restricted
shares, deferred share units and other stock-based awards, subject to restricted conditions as may be determined by the Board of Directors.
There were no such awards outstanding as of March 31, 2021, and March 31, 2020, and no stock-based compensation was recognized for the
period ended March 31, 2021 and March 31, 2020.
16.
Loss per share:
Diluted loss per share was the same amount as basic loss per share, as
the effect of options, RSUs and warrants would have been anti-dilutive, as the Corporation has incurred losses in each of the periods
presented. All outstanding options, RSUs and warrants could potentially be dilutive in the future.
17.
Supplemental cash flow disclosure:
(a)
Changes in working capital items:
March 31,
2021
March 31,
2020
$
$
Receivables
58
581
Prepaid expenses
672
(185
)
Trade and other payables
(6,701)
(3,389
)
Total changes in working capital items
(5,971)
(2,993
)
(b)
Non-cash transactions:
March 31,
2021
March 31,
2020
$
$
ATM transaction costs included in trade and other payables
18
-
Shares issued as settlement
-
738
Deferred financing costs reclassified to Equity
(23)
40
Fair value of derivative warrants liability reclassified to equity
-
10,691
F- 26
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
18.
Income taxes:
Reconciliation of effective tax rate:
March 31,
2021
March 31,
2020
$
$
Loss before income taxes
(19,678)
(25,513
)
Basic combined Canadian statutory income tax rate 1
26.50%
26.58
%
Computed income tax recovery
(5,105)
(6,781
)
Increase resulting from:
Non-deductible stock-based compensation
311
519
Non-deductible change in fair value of warrants
643
205
Change in valuation allowance
4,162
6,004
Other – Foreign exchange
(11)
20
Other
-
33
Total tax (recovery) expense
-
-
1 The Canadian combined statutory income tax rate has decreased
due to a reduction in the provincial statutory income tax rate.
At March 31, 2021 and 2020, the net deferred tax assets have not been recognized
in these financial statements. A valuation allowance is recognized to reduce the deferred tax assets as it is more likely than not that
a tax benefit will not be realized.
Net deferred income tax assets as of March 31, 2021, and 2020 were comprised
of the following:
March 31, 2021
March 31, 2020
$
$
Deferred tax assets
Tax losses carried forward
28,643
22,052
Research and development expenses
5,424
4,544
Property, plan and equipment
933
324
Intangible assets
-
1
Financing expenses
1,167
998
Tax credit carry forwards
2,968
2,468
Other temporary differences
86
76
Deferred tax assets
39,221-
30,463
Deferred tax liabilities
Tax basis of unsecured convertible debentures in excess of carrying
value
-
-
Deferred tax liabilities
-
-
Valuation allowance
(39,221)
(30,463
)
Net deferred tax assets
-
-
F- 27
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
18.
Income taxes (continued):
As at March 31, 2021, the amounts and expiry dates of tax attributes and
temporary differences, which are available to reduce future years’ taxable income, were as follows:
March
31, 2021
Federal
Provincial
$
$
Tax losses carried forward
2028
568
568
2029
1,296
1,290
2030
1,649
1,642
2031
1,800
1,784
2032
1,476
1,453
2033
2,864
2,864
2034
3,658
3,549
2035
4,374
4,374
2036
6,435
6,337
2037
398
394
2038
13,803
13,748
2039
32,252
32,209
2040
23,451
23,315
2041
14,279
14,279
108,303
107,808
Research and development expenses, without time limitation
19,905
21,203
Tax credit carry forwards
2,968
-
Other deductible temporary differences, without time limitation
8,249
-
Unrecognized tax benefits
The following table summarizes the activity related to our gross unrecognized
tax benefits for the years ended March 31, 2021 and 2020:
March 31,
2021
March 31,
2020
$
$
Beginning of year:
Increase (decrease) resulting from:
Positions taken in the current year
-
164
Change in valuation allowance
-
(164
)
End of year
-
-
The Corporation does not expect a significant change to the amount of unrecognized
tax benefits over the next 12 months. However, any adjustments arising from certain ongoing examinations by tax authorities could alter
the timing or amount of taxable income or deductions, of the allocation of income among tax jurisdictions, and these adjustments could
differ from the amount accrued. The Corporation’s federal and provincial income tax returns filed for all years remain subject to
examination by the taxation authorities.
F- 28
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
19.
Financial instruments:
(a)
Concentration of credit risk:
Financial instruments that potentially subject the Corporation to a concentration of credit risk consist primarily
of cash and cash equivalents and investments. Cash and cash equivalents and investments are all invested in accordance with the Corporation’s
Investment Policy with the primary objective being the preservation of capital and the maintenance of liquidity, which is managed by dealing
only with highly rated Canadian institutions. The carrying amount of financial assets, as disclosed in the statements of financial position,
represents the Corporation’s credit exposure at the reporting date.
(b)
Foreign currency risk:
The Corporation is exposed to the financial risk related to the fluctuation
of foreign exchange rates and the degrees of volatility of those rates. Foreign currency risk is limited to the portion of the Corporation's
business transactions denominated in currencies other than the Corporations functional currency of the Canadian dollar. Fluctuations related
to foreign exchange rates could cause unforeseen fluctuations in the Corporation's operating results. The Corporation does not use derivative instruments to hedge exposure to foreign exchange risk.
The fluctuation of the U.S. dollar in relation to the Canadian dollar and other foreign currencies will consequently have an impact upon
the Corporation’s net loss.
The operating results and financial position of the Corporation
are reported in U.S. dollars (reporting currency) in the Corporation’s financial statements.
(c)
Liquidity risk:
Liquidity risk is the risk that the Corporation will encounter difficulty in meeting the obligations associated with its
financial liabilities that are settled by delivering cash or another financial asset.
The Corporation manages liquidity risk through the management of its capital structure and financial leverage. It also manages liquidity
risk by continuously monitoring actual and projected cash flows. The Board of Directors reviews and approves the Corporation's operating
budgets, and reviews material transactions outside the normal course of business. Refer to Note 2 – Basis of Presentation.
The Corporation’s financial liabilities obligations include trade
and other payables, which fall due within the next 12 months in addition to the warrant derivatives that fall due beyond 12 months and
are likely to be settled by the Corporation’s equity.
F- 29
Acasti pharma inc.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
20.
Commitments
(a)
Take or pay contract :
On October 25, 2019, the Corporation signed a supply agreement with Aker
Biomarine Antartic AS (“Aker”), to purchase raw krill oil product for a committed volume of commercial starting material for
CaPre for a total value of $3.1 million (take or pay). The delivery of the products must be completed by October 31, 2021. As at March
31, 2021, the remaining balance of the commitment with Aker amounts to $2.8 million. There are no termination provisions within the supply
agreement. Management is currently assessing whether they can recover value from the raw krill oil product and given the uncertainty of
recoverability, there is a risk that the Corporation may have a loss on this contract in the near term.
(b)
Success fees
On September 23, 2020 the Corporation engaged Oppenheimer & Co., Inc.,
as its financial advisor to assist in the formal process to explore and evaluate strategic alternatives to enhance shareholder value.
This arrangement includes fees of $1.2 million to be paid by the Corporation based on the success of a strategic outcome.
(c)
Retention agreements
In October 2020 in connection with its strategic review process, the Corporation
entered into retention incentive agreements with the Chief Executive Officer (CEO) and Chief Operating Officer (COO).
The Retention Agreements provide that the Corporation will pay the CEO
an employment retention incentive of $100 provided that the CEO remains employed with the Corporation until the earlier of April 30, 2021
or the closing of a merger or like transaction with a third party.
In addition, the Retention Agreements also provide that the Corporation
will pay each of the CEO and COO an amount of up to $125 in the event that certain milestones are met in relation to the monetization
by the Corporation of its assets.
21.
Subsequent events
Definitive Agreement to Acquire Grace Therapeutics, Inc.
On May 7, 2021, the Corporation announced it has
entered into a definitive agreement to acquire Grace Therapeutics, Inc., a privately held emerging biopharmaceutical company focused on
developing innovative drug delivery technologies for the treatment of rare and orphan diseases. Subject to the completion of the Proposed
Transaction, Acasti will acquire Grace and its pipeline of drug candidates. The Proposed Transaction has been approved by the boards of
directors of both companies and is supported by Grace’s shareholders through voting and lock-up agreements with the Company. The
transaction remains subject to approval of Acasti stockholders, as well as applicable stock exchanges.
NASDAQ Communication
On May 17, 2021 it was announced that, on May
11, 2021, the Corporation received notice from the Nasdaq Listing Qualifications Department (the “Staff”) indicating that,
based upon the Corporation’s non-compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a) (the “Rule”)
as of May 10, 2021, the Corporation’s securities were subject to delisting unless the Corporation timely requests a hearing before
the Nasdaq Hearings Panel (the “Panel”). The Corporation has requested and was granted a hearing, which will stay any further
action by Nasdaq pending the conclusion of the hearing process.
F-30
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