Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and
TSX-V: ACST), a late-stage, specialty pharma company advancing
three clinical stage drug candidates addressing rare and orphan
diseases, today announced financial and operational results for the
second quarter ended September 30, 2022.
Recent Highlights
- The Company
expects to receive guidance from the Food and Drug Administration
(FDA) on its proposed phase 3 study design for GTX-104 in the form
of a Type C meeting by the end of 2022 or early in the first
calendar quarter of 2023. This FDA guidance should allow the
Company to initiate the Phase 3 safety study and begin enrolling
the first patients as planned in the first half of 2023. The study
is expected to take about 18 months to complete and is expected to
be the final clinical step required to seek approval under the
505(b)(2) regulatory pathway.
- The
pharmacokinetic (PK) bridging study for GTX-102 was initiated on
September 13, 2022. The Company expects to report topline results
on schedule before the end of calendar 2022. Assuming the PK
bridging study meets its primary endpoint, the next development
step is to conduct a Phase 3 safety and efficacy trial in
Ataxia-Telangiectasia (A-T) patients. The Company plans to request
a Type B meeting with the FDA following the completion of the PK
study to confirm the Phase 3 study design, and assuming the PK
bridging study meets its primary endpoint, the Phase 3 safety study
is expected to be initiated in the second half of 2023. If both
studies meet their primary endpoints, a new drug application (NDA)
filing for GTX-102 under Section 505(b)(2) is expected to
follow.
- The single dose
PK study of GTX-101, was initiated on July 26, 2022, in healthy
human volunteers. This PK study is the next step in the Company’s
proposed 505(b)(2) regulatory pathway for GTX-101. The PK study is
expected to be completed by the end of calendar 2022 as planned and
will provide important information on the dosing strength and
frequency which will be used for additional clinical studies of
GTX-101.
- The Company
finished the second fiscal quarter ended September 30, 2022, with
$34.9 million in cash, cash equivalents and short-term investments.
Management continues to believe that based on current projections,
the Company has sufficient capital to fund operations through at
least March 2024, allowing for the advancement of GTX-104 well into
Phase 3 and advancing GTX-102 and GTX-101 to key value inflection
points.
Management Discussion
Jan D’Alvise, Chief Executive Officer of Acasti
said, “We remain focused on advancing our three clinical programs,
and I’m pleased to report that significant progress was made during
the second fiscal quarter. Importantly, we remain on track to
initiate and enroll the first patients in our Phase 3 safety study
for GTX-104 in the first half of calendar 2023. GTX-104, our most
advanced clinical candidate, is a novel aqueous formulation of
nimodipine intended to be administered via continuous IV infusion
for the treatment of hospitalized and critically ill patients
suffering from Subarachnoid Hemorrhage (SAH). The study is expected
to be the final clinical step required to seek market approval
under the 505(b)(2) regulatory pathway.”
“During the last quarter, we initiated two PK
bridging studies as planned, one for GTX-102, our novel,
concentrated oral-mucosal spray of betamethasone intended to
improve the symptoms of A-T, a neurodegenerative genetic disorder
that effects young children; and one for GTX-101, our novel
non-narcotic, topical bio-adhesive, film-forming bupivacaine spray
designed to treat Postherpetic Neuralgia (PHN), the severe and
often debilitating nerve pain that can persist following a shingles
infection. The GTX-102 PK study is the next step in the proposed
505(b)(2) regulatory pathway and is expected to be completed with
top line results reported before year end. The GTX-101 single dose
PK study is expected to also be completed with topline results
reported by the end of calendar 2022 and will provide important
information on the dose and dosing frequency for additional
clinical studies of GTX-101.”
“We are excited about the excellent progress we
are making to deliver innovative new treatments to thousands of
patients who currently lack effective therapies, and we look
forward to reporting on the near-term milestones expected to be
reached in the next couple months for each of our programs.”
Program Updates
GTX-104: GTX-104 is a clinical
stage, novel formulation of nimodipine for continuous IV infusion
in SAH patients. In May 2022, the Company announced that the top
line results from its PK bridging study for GTX-104 had met all its
planned study endpoints. The primary objective of the study was to
evaluate the relative bioavailability of GTX-104 compared to oral
nimodipine in healthy adult male and female subjects, while the
secondary objective was to assess its safety and tolerability. The
results showed statistically no difference in maximum and total
exposure between GTX-104 and the oral formulation of nimodipine,
and no serious adverse events were observed. This result means that
GTX-104 can be considered essentially bioequivalent to oral
nimodipine. Importantly, the inter- and intra-subject variability
was also much lower for GTX-104 as compared with oral
nimodipine.
The Company believes that because of its better
absorption profile and more consistent blood levels, GTX-104 may
provide physicians with a more reliable and effective treatment for
patients with SAH. This feature could be a key competitive
advantage, as GTX-104 could help to reduce the incidence of
hypotensive events and vasospasm, which require immediate and
costly intervention and can lead to worse outcomes for the
patient.
The Company has submitted the PK bridging study
data and a proposed phase 3 safety study design to the FDA and
requested a Type C meeting to get the agency’s feedback and
guidance. The Company expects to receive that guidance by the end
of 2022 or early in the first calendar quarter of 2023. This FDA
guidance should allow the Company to initiate the Phase 3 safety
study and enroll the first patient in the first half of 2023. The
Phase 3 safety study is expected to be the final step required to
seek regulatory approval under the 505(b)(2) regulatory pathway
before submitting an NDA to the FDA for GTX-104 for the treatment
of SAH patients.
GTX-102: GTX-102 is a novel,
concentrated oral-mucosal spray of betamethasone intended to
improve the neurological symptoms of A-T, for which there are
currently no FDA-approved therapies. GTX-102 is comprised of a
proprietary formulation of the gluco-corticosteroid betamethasone
that can be sprayed conveniently over the tongue of the A-T
patient.
The Company initiated its planned PK bridging
study as planned in fiscal Q2 to evaluate the comparative
bioavailability, pharmacokinetics, and safety of its oral
betamethasone spray, GTX-102, compared to an intramuscular
injection of betamethasone and to an oral solution of
betamethasone, in 48 healthy subjects. The First Subject, First
Dose was administered on September 13, 2022. This PK study is the
next step in the proposed 505(b)(2) regulatory pathway for GTX-102
and is expected to be completed with top line results reported
before the end of calendar year 2022.
GTX-101: GTX-101 is a
non-narcotic, topical bio-adhesive film-forming bupivacaine spray
designed to treat PHN, the severe and often debilitating nerve pain
that can persist following a shingles infection. The data from a
single dose Phase 1 clinical trial for GTX-101 along with
regulatory guidance from the FDA’s Division of Anesthesiology has
informed the design of additional preclinical toxicology studies,
and a proposed clinical and regulatory pathway for approval.
On July 26, 2022, the Company initiated its PK
bridging study to evaluate the relative bioavailability of GTX-101
compared to the reference listed drug bupivacaine in 48 healthy
subjects. The PK study is the next step in the Company’s proposed
505(b)(2) regulatory pathway for GTX-101. The PK study is expected
to be completed with topline results reported by the end of
calendar 2022 as planned. These results will provide important
information on the dosing strength and frequency for additional
planned clinical studies of GTX-101.
Q2 2023 Financial Results (U.S.
Dollars)
The Company’s consolidated financial statements
have been prepared in accordance with generally accepted accounting
principles in the United States of America.
Research and development expenses, net of
government assistance for the three months ended September 30,
2022, totaled $3.3 million compared to $0.6 million for the three
months ended September 30, 2021. Our research and development
during the quarter ended September 30, 2022, was focused primarily
on our clinical development programs for GTX-104, GTX-102, and
GTX-101 drug candidates.
General and administrative expenses for the
three months ended September 30, 2022, were $1.6 million compared
to $2.9 million for the three months ended September 30, 2021. This
decrease was a result of decreased legal, tax, accounting and other
professional fees that had been incurred in connection with the
Grace acquisition. The decrease in professional fees was partly
offset by an increase in salaries and benefits due to the
reinstated accruals for our employee incentive bonus program.
Loss from operating activities for the three
months ended September 30, 2022, was $5.1 million compared to a
loss of $3.6 million for the three months ended September 30, 2021.
For the three months ended September 30, 2021, a financial gain of
$4.5 million resulted mostly due to the decrease in the fair value
of the derivative warrant liabilities.
Net loss and total comprehensive loss for the
three months ended September 30, 2022, was $4.9 million, or $0.11
loss per share, compared to a net income of $1.0 million, or $0.03
income per share, for the three months ended September 30,
2021.
Cash, cash equivalents and short-term
investments totaled $34.9 million as of September 30, 2022,
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 is expected to fund our lead asset
GTX-104 well into phase 3, and GTX-102 and GTX-101 to additional
important milestones.
Acasti is also pleased to announce
that Vimal Kavuru, an independent Director, was appointed as
Chairman of the Company.
Financing Activities
As previously disclosed, Acasti entered into an
amended and restated ATM sales agreement on June 29, 2020 (the
“Sales Agreement”) with B. Riley FBR Inc., Oppenheimer & Co.
Inc. and H.C. Wainwright & Co., LLC (collectively, the
“Agents”), to implement an “at-the market” equity offering program
under which Acasti may issue and sell from time to time its common
shares having an aggregate offering price of up to $75 million
through the Agents (the “ATM Program”). Pursuant to the ATM
Program, as required pursuant to the policies of the TSX Venture
Exchange (“TSXV”), since the last distributions reported on August
11, 2022, Acasti issued an aggregate of 118,638 common shares (the
“ATM Shares”) over the NASDAQ Stock Market for aggregate gross
proceeds to the Company of US $112,705. The ATM Shares were sold at
prevailing market prices averaging US $0.93 per share. No
securities were sold through the facilities of the TSXV or, to the
knowledge of the Company, in Canada. The ATM Shares were sold
pursuant to a U.S. registration statement on Form S-3 (No.
333-239538) as made effective on July 7, 2020, as well as the Sales
Agreement. Pursuant to the Sales Agreement, a cash commission of
3.0% on the aggregate gross proceeds raised was paid to the Agents
in connection with their services. The recent ATM sales have been
made in the month of August 2022. As a result of the recent ATM
sales since June 2022, Acasti has a total of 44,612,831 common
shares issued and outstanding as of November 11, 2022.
Conference Call Details
Acasti will host a conference call on Monday,
November 14, 2022, at 1:00 PM Eastern Time to discuss the Company’s
corporate progress and other developments, as well as financial
results for its quarter ended September 30, 2022.
The conference call will be available via
telephone by dialing toll free 844-836-8745 for U.S. callers or +1
412-317-6797 for international callers. A webcast of the call may
be accessed at https://app.webinar.net/KP8QXdZzj5R or on the
Company’s Investor Relations section of its website:
https://www.acastipharma.com/investors/.
A webcast replay will be available on the
Investors News/Events section of the Company’s website
(https://www.acastipharma.com/investors/). A telephone replay of
the call will be available approximately one hour following the
call, through November 21, 2022, and can be accessed by dialing
877-344-7529 for U.S. callers or +1 412-317-0088 for international
callers and entering replay access code: 8826640.
About Acasti
Acasti is a specialty pharma company advancing
three clinical stage drug candidates addressing rare and orphan
diseases. Acasti’s novel drug candidates 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—all which could help to increase
treatment compliance and improve patient outcomes.
Acasti’s three lead clinical assets have each
been granted Orphan Drug Designation by the FDA, which provides the
assets with seven years of marketing exclusivity post-launch in the
United States, and have additional intellectual property protection
with over 40 granted and pending patents. Acasti’s lead clinical
assets target underserved orphan diseases: (i) GTX-104, an
intravenous infusion targeting Subarachnoid Hemorrhage (SAH), 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; (ii) GTX-102, an oral mucosal spray
targeting Ataxia-telangiectasia (A-T), a progressive,
neurodegenerative genetic disease that primarily affects children,
causing severe disability, and for which no treatment currently
exists; and (iii) GTX-101, a topical spray targeting Postherpetic
Neuralgia (PHN), a persistent and often debilitating neuropathic
pain caused by nerve damage from the varicella zoster virus
(shingles), which may persist for months and even years. 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 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 and Acasti’s other pre-clinical and clinical trials for
GTX-102 and GTX-101; (ii) regulatory requirements or developments
and the outcome of meetings with the FDA; (iii) changes to clinical
trial designs and regulatory pathways; (iv) legislative,
regulatory, political and economic developments; and (v) actual
costs associated with Acasti’s clinical trials as compared to
management’s current expectations. 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. Neither NASDAQ,
the TSXV nor its Regulation Services Provider (as that term is
defined in the policies of the TSXV) accepts responsibility for the
adequacy or accuracy of this release.
For more information, please contact:
Acasti Contact:
Jan D’AlviseChief Executive OfficerTel:
450-686-4555Email:info@acastipharma.com www.acastipharma.com
Investor Relations:Robert BlumLytham Partners,
LLC602-889-9700ACST@lythampartners.com
ACASTI PHARMA INC.Condensed Consolidated
Interim Balance Sheet(Unaudited)
|
September 30, 2022 |
|
|
March 31, 2022 |
|
|
(Expressed in thousands of U.S. dollars except share data) |
$ |
|
|
$ |
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
34,926 |
|
|
30,339 |
|
|
Short-term investments |
14 |
|
|
13,322 |
|
|
Receivables |
859 |
|
|
548 |
|
|
Assets held for sale |
352 |
|
|
352 |
|
|
Prepaid expenses |
1,354 |
|
|
720 |
|
|
Total current assets |
37,505 |
|
|
45,281 |
|
|
|
|
|
|
|
Right of use
asset |
510 |
|
|
315 |
|
|
Equipment |
122 |
|
|
250 |
|
|
Intangible
assets |
69,810 |
|
|
69,810 |
|
|
Goodwill |
12,964 |
|
|
12,964 |
|
|
Total assets |
120,911 |
|
|
128,620 |
|
|
|
|
|
|
|
Liabilities
and shareholders' equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Trade and other payables |
3,735 |
|
|
3,156 |
|
|
Lease liability |
70 |
|
|
104 |
|
|
Total current liabilities |
3,805 |
|
|
3,260 |
|
|
|
|
|
|
|
Derivative
warrant liabilities |
- |
|
|
10 |
|
|
Lease
liability |
450 |
|
|
191 |
|
|
Deferred tax
liability |
16,492 |
|
|
16,889 |
|
|
Total liabilities |
20,747 |
|
|
20,350 |
|
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
Common shares |
258,294 |
|
|
257,990 |
|
|
Additional paid-in capital |
13,200 |
|
|
12,154 |
|
|
Accumulated other comprehensive loss |
(6,040 |
) |
|
(6,037 |
) |
|
Accumulated deficit |
(165,290 |
) |
|
(155,837 |
) |
|
Total shareholder's equity |
100,164 |
|
|
108,270 |
|
|
|
|
|
|
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity |
120,911 |
|
|
128,620 |
|
|
|
|
|
|
|
|
|
|
|
|
ACASTI PHARMA INC.Condensed Consolidated
Interim Statements of Loss and Comprehensive Loss(Unaudited)
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six Months ended |
|
|
September 30, 2022 |
|
|
September 30, 2021 |
|
|
September 30, 2022 |
|
|
September 30, 2021 |
|
(Expressed in thousands of U.S dollars, except per share data) |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and
development expenses, net of government assistance |
(3,292 |
) |
|
(585 |
) |
|
(5,882 |
) |
|
(1,054 |
) |
General and
administrative expenses |
(1,680 |
) |
|
(2,957 |
) |
|
(3,598 |
) |
|
(5,633 |
) |
Sales and marketing expenses |
(136 |
) |
|
(25 |
) |
|
(357 |
) |
|
(25 |
) |
Loss
from operating activities |
(5,108 |
) |
|
(3,567 |
) |
|
(9,837 |
) |
|
(6,712 |
) |
Financial income (expenses) |
24 |
|
|
4,548 |
|
|
(13 |
) |
|
4,575 |
|
Income
(loss) before income tax recovery |
(5,084 |
) |
|
981 |
|
|
(9,850 |
) |
|
(2,137 |
) |
|
|
|
|
|
|
|
|
Income tax
recovery |
155 |
|
|
- |
|
|
397 |
|
|
- |
|
|
|
|
|
|
|
|
|
Net income (loss) and total comprehensive income
(loss) |
(4,929 |
) |
|
981 |
|
|
(9,453 |
) |
|
(2,137 |
) |
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
(0.11 |
) |
|
0.03 |
|
|
(0.21 |
) |
|
(0.07 |
) |
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding |
44,550,996 |
|
|
32,788,275 |
|
|
44,440,132 |
|
|
29,436,032 |
|
Acasti Pharma (TSXV:ACST)
과거 데이터 주식 차트
부터 9월(9) 2024 으로 10월(10) 2024
Acasti Pharma (TSXV:ACST)
과거 데이터 주식 차트
부터 10월(10) 2023 으로 10월(10) 2024