LAVAL, Québec,
June 23,
2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or
the "Company") (Nasdaq: ACST), a late-stage, biopharma company
advancing GTX-104, its novel formulation of nimodipine that
addresses the high unmet medical needs for a rare disease,
aneurysmal subarachnoid hemorrhage (aSAH), today announced
financial and operational results for the fiscal year ended
March 31, 2023.
Recent Highlights
- United States Food and Drug Administration (FDA) has confirmed
the 505(b)(2) regulatory pathway for GTX-104 and that the
GTX-104-002 PK study may have met the criteria for a scientific
bridge.
- Successfully submitted GTX-104 Pivotal Phase 3 Safety Study
protocol Investigational New Drug (IND) amendment to the FDA with
the expectation that a first patient will be dosed in the second
half of calendar 2023.
- Implemented strategic transformation of operating model to an
agile biopharma reflecting its operational focus on GTX-104. In
alignment with the new operating model, Acasti has brought on a
small and highly experienced new management team with deep subject
matter knowledge and direct, hands-on clinical trial experience in
aSAH.
- Significant extension of the Company's cash runway which is
expected to be sufficient to fund the Company through calendar Q2
2025 and the achievement of critical value inflection milestones,
including a potential New Drug Application (NDA) filing for
GTX-104.
- Evaluation of strategic alternatives to maximize value of
de-prioritized pipeline assets (GTX-102 and GTX-101).
- The Company finished the fiscal year ended March 31, 2023, with $27.9
million in cash, cash equivalents and short-term
investments.
Management Discussion
Prashant Kohli, Chief Executive
Officer of Acasti, said, "After receiving positive clarifying
feedback from the FDA on the proposed Phase 3 Safety Study for
GTX-104 whereby they concurred with the suitability of the
505(b)(2) regulatory pathway and that Acasti's GTX-104-002 PK study
may have met the criteria for a scientific bridge, we moved swiftly
to submit the full protocol for our pivotal Phase 3 Safety Study in
May 2023. Further, we implemented a
strategic realignment plan to maximize shareholder value, including
a strategic transformation of Acasti's operating model to that of
an agile biopharma company which we believe allows our cash runway
to be sufficient to achieve a potential NDA filing for GTX-104 in
2025. Our new, highly motivated, and energized organization is
entirely focused on achieving critical value inflection milestones
in the quarters and years to come."
FY 2023 Financial Results
The Company's consolidated financial statements have been
prepared in accordance with generally accepted accounting
principles in the United States of
America and are presented in U.S. dollars.
Research and development expenses, net of government assistance
for the twelve months ended March 31,
2023, totaled $9.9 million
compared to $5.6 million for the
twelve months ended March 31, 2022.
Our research and development during the year ended March 31, 2023 was focused primarily on three
clinical development programs GTX-104, GTX-102, and GTX-101 drug
candidates. Due to the strategic realignment announced on
April 4, 2023, the Company will focus
its future research and development expenses exclusively on
GTX-104. Future development of GTX-102 and GTX-101 will depend on
additional dedicated funding or the signing of a strategic
partnership. Research and development expenses during the year
ended March 31, 2022, related to the
completion of our TRILOGY Phase 3 clinical program for our former
drug candidate CaPre, as well as the initiation and progression of
development work related to GTX-104, GTX-102 and GTX-101.
General and administrative expenses for the twelve months ended
March 31, 2023 were $7.6 million compared to $9.3 million for the twelve months ended
March 31, 2022. The decrease was
primarily a result of decreased legal, tax, accounting and other
professional fees related to the Grace merger for the year ended
March 31, 2022. Due to the strategic
realignment announced on April 4,
2023, the Company is over time discontinuing its operations
in Canada and has proceeded to lay
off substantially all its workforce, allowing Acasti's new
management team to rebuild a leaner organization in the United States.
As a result of the strategic realignment plan announced on
April 4, 2023 to prioritize resources
to GTX-104, and away from GTX-101 and GTX-102, the company incurred
an impairment of intangible assets of $28.7
million, and an impairment of goodwill of $4.8 million, for the period ended March 31, 2023.
Loss from operating activities for the twelve months ended
March 31, 2023 was $52.1 million compared to a loss of $15.6 million for the twelve months ended
March 31, 2022. The change is
primarily a result of the combined $33.5
million impairments to intangible assets and goodwill
mentioned.
For the twelve months ended March 31,
2022, a financial gain of $5.1
million resulted mostly due to the decrease in the fair
value of the derivative warrant liabilities.
Net loss and total comprehensive loss for the twelve months
ended March 31, 2023 was $(42.4) million, or $(0.95) loss per share, compared to a net loss of
$(9.8) million, or $(0.27) income per share, for the twelve months
ended March 31, 2022. The change is
primarily a result of the combined $33.5
million impairments to intangible assets and goodwill
mentioned.
Cash, cash equivalents and short-term investments totaled
$27.9 million as of March 31, 2023, compared to $43.7 million in cash, cash equivalents and
short-term investments as of March 31,
2022. Based on management's current projections, current
cash, cash equivalents and short-term investments are expected to
be sufficient to fund the Company through calendar Q2 2025,
facilitating achievement of critical value inflection milestones,
including a potential New Drug Application (NDA) filing for
GTX-104.
About Acasti
Acasti is a late-stage biopharma company with drug candidates
addressing rare and orphan diseases. Acasti's novel drug delivery
technologies have the potential to improve the performance of
currently marketed drugs by achieving faster onset of action,
enhanced efficacy, reduced side effects, and more convenient drug
delivery. Acasti's lead clinical assets have each been granted
Orphan Drug Designation by the FDA, which provides seven years of
marketing exclusivity post-launch in the
United States, and additional intellectual property
protection with over 40 granted and pending patents. Acasti's lead
clinical asset, GTX-104, is an intravenous infusion targeting
aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and
life-threatening medical emergency in which bleeding occurs over
the surface of the brain in the subarachnoid space between the
brain and skull.
For more information, please
visit: https://www.acastipharma.com/en.
Forward-Looking Statements
Statements in this press release that are not statements of
historical or current fact constitute "forward-looking statements"
within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995, as amended, Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, and "forward-looking information" within the meaning of
Canadian securities laws (collectively, "forward-looking
statements"). Such forward looking statements involve known and
unknown risks, uncertainties, and other factors that could cause
the actual results of Acasti to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. In addition to statements which
explicitly describe such risks and uncertainties, readers are urged
to consider statements containing the terms "believes," "belief,"
"expects," "intends," "anticipates," "estimates", "potential,"
"should," "may," "will," "plans," "continue", "targeted" or other
similar expressions to be uncertain and forward-looking. Readers
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
The forward-looking statements in this press release, including on
the Company's anticipated cash runway, are based upon Acasti's
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties, including, without limitation: (i) the success and
timing of regulatory submissions of the planned Phase 3 safety
study for GTX-104; (ii) regulatory requirements or developments and
the outcome and timing of the proposed IND application for GTX-104;
(iii) changes to clinical trial designs and regulatory pathways;
(iv) legislative, regulatory, political and economic developments;
(v) actual costs associated with Acasti's clinical trials as
compared to management's current expectations; and (vi) the
projected extension of the Company's cash runway to calendar Q2
2025. The foregoing list of important factors that could cause
actual events to differ from expectations should not be construed
as exhaustive and should be read in conjunction with statements
that are included herein and elsewhere, including the risk factors
detailed in documents that have been and are filed by Acasti from
time to time with the Securities and Exchange Commission and
Canadian securities regulators. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Acasti undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
applicable securities laws. The NASDAQ does not accept
responsibility for the adequacy or accuracy of this release.
For more information, please contact:
Acasti Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email:info@acastipharma.com
www.acasti.com
Investor Relations:
Robert
Blum
Lytham Partners, LLC
602-889-9700
ACST@lythampartners.com
ACASTI PHARMA INC.
|
|
|
|
Condensed Consolidated
Balance Sheet
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
As of
|
|
March 31,
2023
|
|
March 31,
2022
|
(Expressed in thousands of U.S. dollars except share
data)
|
$
|
|
$
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
27,875
|
|
30,339
|
Short-term
investments
|
15
|
|
13,322
|
Receivables
|
802
|
|
548
|
Assets held for
sale
|
—
|
|
352
|
Prepaid
expenses
|
598
|
|
720
|
Total current
assets
|
29,290
|
|
45,281
|
|
|
|
|
Operating lease right
of use asset
|
463
|
|
315
|
Equipment
|
104
|
|
250
|
Intangible
assets
|
41,128
|
|
69,810
|
Goodwill
|
8,138
|
|
12,964
|
Total assets
|
79,123
|
|
128,620
|
|
|
|
|
Liabilities and
Shareholders' equity
|
|
|
|
Current
liabilities:
|
|
|
|
Trade and other
payables
|
3,336
|
|
3,156
|
Operating lease
liability
|
75
|
|
104
|
Total current
liabilities
|
3,411
|
|
3,260
|
|
|
|
|
Derivative warrant
liabilities
|
—
|
|
10
|
Operating lease
liability
|
410
|
|
191
|
Deferred tax
liability
|
7,347
|
|
16,889
|
|
|
|
|
Total
liabilities
|
11,168
|
|
20,350
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
Common shares, no par
value per share; unlimited shares authorized as
of March 31, 2023 and March 31, 2022; 44,612,831 and 44,288,183
shares issued and outstanding as of March 31, 2023 and March 31,
2022,
respectively
|
258,294
|
|
257,990
|
Additional paid-in
capital
|
13,965
|
|
12,154
|
Accumulated other
comprehensive loss
|
(6,038)
|
|
(6,037)
|
Accumulated
deficit
|
(198,266)
|
|
(155,837)
|
Total shareholder's
equity
|
67,955
|
|
108,270
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
Total liabilities and
shareholders' equity
|
79,123
|
|
128,620
|
ACASTI PHARMA INC.
|
|
|
|
Condensed Consolidated
Statements of Loss and Comprehensive Loss
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Year ended
March 31, 2023
|
|
Year ended
March 31, 2022
|
(Expressed in thousands of U.S. dollars except share
and per data)
|
$
|
|
$
|
|
|
|
|
Operating Expenses
|
|
|
|
Research and
development expenses, net of government assistance
|
(9,972)
|
|
(5,559)
|
General and
administrative expenses
|
(7,614)
|
|
(9,263)
|
Sales and
marketing
|
(661)
|
|
(518)
|
Impairment of
intangible assets
|
(28,682)
|
|
—
|
Impairment of
goodwill
|
(4,826)
|
|
—
|
Impairment of assets
held for sale
|
(400)
|
|
(249)
|
Loss from operating activities
|
(52,155)
|
|
(15,589)
|
Other income
|
184
|
|
5,122
|
Loss before income tax
recovery
|
(51,971)
|
|
(10,467)
|
|
|
|
|
Income tax
recovery
|
9,542
|
|
648
|
|
|
|
|
Net loss and total comprehensive
loss
|
(42,429)
|
|
(9,819)
|
|
|
|
|
Basic and diluted loss
per share
|
(0.95)
|
|
(0.27)
|
|
|
|
|
Weighted average number of shares
outstanding
|
44,612,831
|
|
36,841,762
|
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SOURCE Acasti Pharma Inc.