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
third quarter ended December 31, 2022
Recent Highlights
- The Company
anticipates receiving clarifying guidance from the Food and Drug
Administration (FDA) on its proposed phase 3 study design for
GTX-104 through a written Type C meeting in the first calendar
quarter of 2023. The Company expects that favorable FDA guidance
would allow Acasti to initiate the Phase 3 safety study and begin
recruiting clinical sites and enrolling patients. The Company
expects the study to take about 18 months to complete once the
first patient is enrolled, and if the trial is successful, the
Company expects that it will be the final clinical step required to
seek FDA approval under the 505(b)(2) regulatory pathway.
- Preliminary
topline results of the pharmacokinetic (PK) bridging study for
GTX-102 announced in December 2022 met all primary outcome
measures. The objectives of the study were to evaluate the
bioavailability, pharmacokinetics, and safety of GTX-102, a novel,
concentrated oral-mucosal metered spray of betamethasone in healthy
volunteers, and to compare the PK profile to an intramuscular
injection of betamethasone, the reference drug, which is approved
in the U.S. Acasti’s new and patented formulation of betamethasone
is intended to improve the neurological symptoms of Ataxia
Telangiectasia (A-T) in a pediatric population for which there are
currently no FDA-approved therapies. The Company expects that the
next step in the proposed 505(b)(2) regulatory pathway for GTX-102
will be a Phase 3 safety and efficacy study in children with A-T,
which could be initiated following a Type B meeting with the
FDA.
- Preliminary
topline results announced in December 2022 for the Company’s
single-dose PK study to evaluate the relative bioavailability of
GTX-101 compared to the reference listed drug in the U.S.,
bupivacaine subcutaneous injectable, met all primary outcome
measures for the study. The Company anticipates receiving the final
clinical study report in the first half of calendar 2023. This PK
study was the next step in the Company’s proposed 505(b)(2)
regulatory pathway for GTX-101 and it provided important
information on the dose and dosing frequency in humans for future
clinical studies.
- The Company
finished the second fiscal quarter ended December 31, 2022, with
$31.3 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 into calendar
Q2 of 2024 allowing for the advancement of GTX-104 well into Phase
3 and advancing GTX-102 and GTX-101 to additional important
milestones.
Management Discussion
Jan D’Alvise, Chief Executive Officer of Acasti,
said “Significant progress was made over the past few months on all
three of our clinical programs. We ended calendar 2022 in a very
strong fashion with the completion of two successful clinical
trials, and we announced important pharmacokinetic study results
for both GTX-101 and GTX-102 in late December. In both cases, the
preliminary topline results met all outcome measures. These
positive results allow us to advance both programs to the next
stage of clinical development in 2023. We expect 2023 to be very
exciting for Acasti with two of our drug candidates ready to enter
Phase 3. We look forward to receiving clarifying guidance from the
FDA in calendar Q1 2023 on the Phase 3 study design for our lead
program, GTX-104, a novel formulation of nimodipine for continuous
IV infusion in patients suffering from subarachnoid hemorrhage. We
are hopeful that this FDA feedback will confirm our 505(b)(2)
regulatory strategy and allow us to finalize the study protocol,
paving the way for the initiation of our Phase 3 safety study later
this year.”
Program Updates
GTX-104: GTX-104 is a clinical
stage, novel formulation of nimodipine to be administered via
continuous IV infusion for treating aSAH patients. Subarachnoid
hemorrhage (SAH) is bleeding over the surface of the brain in the
subarachnoid space between the brain and the skull, which contains
blood vessels that supply the brain. A primary cause of such
bleeding is rupture of an aneurysm (aSAH). The Company anticipates
receiving clarifying guidance from the FDA on its proposed phase 3
study design for GTX-104 in the form of a written Type C meeting in
the first calendar quarter of 2023. The Company expects that
favorable FDA guidance would allow the Company to initiate the
Phase 3 safety study and begin recruiting clinical sites and
enrolling patients. Once the first patient is enrolled, the Company
expects the study to take about 18 months to complete, and if the
trial is successful, the Company expects that it will be the final
clinical step required to seek FDA approval under the 505(b)(2)
regulatory pathway.
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 PK bridging study as
planned in fiscal Q2 2022 to evaluate the comparative
bioavailability, pharmacokinetics, and safety of GTX-102, compared
to an intramuscular injection (IM) of betamethasone and to an oral
solution of betamethasone, in 48 healthy subjects. On December 28,
2022, the Company reported that the topline results of this study
met all primary outcome measures.
Results showed that GTX-102 betamethasone blood
concentrations were highly predictable and consistent based on AUC
and Cmax, indicating good linearity and dose-proportionality.
GTX-102 betamethasone blood concentrations were within the same
range of exposure as IM betamethasone, based on AUC. Acasti is
proposing that this IM formulation will serve as a bridge for
GTX-102 for the 505(b)(2) regulatory pathway. GTX-102 betamethasone
blood concentrations were also within the same range of exposure as
the oral solution (OS), based on AUC. This OS formulation is not
available in the US and was used in a published clinical trial
conducted in Europe (Zannolli, et.al.), and may serve as a
comparator for further clinical development. Furthermore,
statistically there was no significant difference (p>0.05)
between GTX-102 administered at a fast rate (each spray immediately
following the preceding one) vs. a slow rate (1 spray/minute), as
indicated by Cmax and AUC. The Company believes this finding is
important because being able to use the fast or the slow rate of
administration may provide greater flexibility for patients and
caregivers. The Cmax of GTX-102 was within the same range of
exposure as the OS, but the Cmax for the IM formulation was lower
than both GTX-102 and the OS, as well as what has been reported
previously for the IM in the literature. It is important to note
that achieving bioequivalence with the IM was not an objective of
this study, nor was it expected. Finally, no serious adverse events
(AE) were reported, and the most frequent drug-related AE was mild
headache (4 cases).
Based on this data, Acasti will work with its
clinical experts and the FDA to determine the optimal final dosing
regimen for GTX-102 to incorporate into its Phase 3 study design.
Based on previous discussions with the FDA, the Company plans to
conduct a confirmatory Phase 3 safety and efficacy trial in A-T
patients, and plan to seek clarifying guidance from the FDA on the
study design at a Type B meeting. The Company expects the Phase 3
study to be initiated following the Type B meeting. If both studies
meet their primary endpoints, a Pre-NDA meeting with the FDA and an
NDA filing under Section 505(b)(2) would follow.
GTX-101: GTX-101 is a
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 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
to approval.
On July 26, 2022, the Company initiated its
single dose PK study to evaluate the relative bioavailability of
GTX-101 compared to the reference listed drug, bupivacaine, in 48
healthy subjects. Topline results from this study were reported on
December 23, 2022, and the results met all primary outcome
measures.
The median Tmax of bupivacaine in plasma
following GTX-101 single-dose topical applications ranged between
18 to 24 hours depending on dose, while the median Tmax following
the subcutaneous injection of 10 mg of bupivacaine was only 23
minutes. This result suggests that bupivacaine delivered by GTX-101
remains in the skin for a long period of time, potentially inducing
a prolonged analgesic effect in the sprayed area. The exposure to
bupivacaine based on Cmax and AUC following GTX-101 topical
application as a single-dose increased with increasing dose.
The systemic exposure to bupivacaine following a
200mg dose of GTX-101 was approximately 29-fold less than a single
subcutaneous dose of 10mg of bupivacaine based on Cmax and
approximately 6-fold less than a single subcutaneous dose of 10mg
of bupivacaine based on AUC. The Company expects these results will
correspond to an increased safety margin for GTX-101 with regards
to toxicity risk. Mean half-life (T half) following GTX-101
single-dose topical applications ranged between 24 to 37 hours
depending on dose, suggesting a slow elimination and potentially
long duration of effect, while mean Tmax following the subcutaneous
injection of 10 mg of bupivacaine was only 8 hours.
There were only two AEs determined to be related
to the study drug by the investigator for each of GTX-101 and the
bupivacaine subcutaneous injection. Following GTX-101 topical
application, headache (1 event = 3%) and numbness (1 event = 3%) at
the sprayed area; following bupivacaine subcutaneous injection,
dizziness (1 event = 8%) and nausea (1 event = 8%).
The Company plans to follow this successful PK
study with a multiple ascending dose study in 2023. Results from
these non-clinical and clinical studies are required before the
initiation of the Company’s Phase 2 program in PHN patients.
Q3 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 three months ended December 31, 2022,
totaled $2.5 million compared to $2.2 million for the three months
ended December 31, 2021. Our research and development during the
quarter ended December 31, 2022, was focused primarily on our
clinical development programs for our GTX-104, GTX-102, and GTX-101
drug candidates.
General and administrative expenses for the
three months ended December 31, 2022 were $1.6 million compared to
$1.8 million for the three months ended December 31, 2021. This
decrease was a result of decreased legal, tax, accounting and other
professional fees that had been incurred in connection with our
acquisition of Grace Therapeutics Inc. in August 2021.
Loss from operating activities for the three
months ended December 31, 2022 was $4.2 million compared to a loss
of $4.5 million for the three months ended December 31, 2021.
For the three months ended December 31, 2022 a
financial gain of $0.8 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 December 31, 2022 was $(3.9) million, or $(0.09)
loss per share, compared to a net loss of $(3.8) million, or
$(0.09) income per share, for the three months ended December 31,
2021.
Cash, cash equivalents and short-term
investments totaled $31.3 million as of December 31, 2022, compared
to $34.9 million in cash, cash equivalents and short-term
investments as of September 30, 2022. Based on management’s current
projections, current cash, cash equivalents and short-term
investments are expected to continue to fund our lead asset GTX-104
well into Phase 3, and GTX-102 and GTX-101 to additional important
milestones.
Conference Call Details
Acasti will host a conference call on Tuesday,
February 14, 2023, 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 December 31, 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/E7mea0O2qxk 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 February 21, 2023, 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: 9403168.
About Acasti
Acasti is a specialty pharma company with drug
delivery technologies and 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—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 (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 caused by a ruptured aneurysm; (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 and timing 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)
|
December 31, 2022 |
|
March 31, 2022 |
|
(Expressed in thousands of U.S. dollars except share data) |
$ |
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
26,241 |
|
|
30,339 |
|
|
Short-term investments |
5,015 |
|
|
13,322 |
|
|
Receivables |
778 |
|
|
548 |
|
|
Assets held for sale |
352 |
|
|
352 |
|
|
Prepaid expenses |
1,042 |
|
|
720 |
|
|
Total current assets |
33,428 |
|
|
45,281 |
|
|
|
|
|
|
|
Right of use
asset |
487 |
|
|
315 |
|
|
Equipment |
112 |
|
|
250 |
|
|
Intangible
assets |
69,810 |
|
|
69,810 |
|
|
Goodwill |
12,964 |
|
|
12,964 |
|
|
Total assets |
116,801 |
|
|
128,620 |
|
|
|
|
|
|
|
Liabilities
and shareholders' equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Trade and other payables |
3,360 |
|
|
3,156 |
|
|
Lease liability |
73 |
|
|
104 |
|
|
Total current liabilities |
3,433 |
|
|
3,260 |
|
|
|
|
|
|
|
Derivative
warrant liabilities |
- |
|
|
10 |
|
|
Lease
liability |
430 |
|
|
191 |
|
|
Deferred tax
liability |
16,218 |
|
|
16,889 |
|
|
Total liabilities |
20,081 |
|
|
20,350 |
|
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
Common shares |
258,294 |
|
|
257,990 |
|
|
Additional paid-in capital |
13,643 |
|
|
12,154 |
|
|
Accumulated other comprehensive loss |
(6,038 |
) |
|
(6,037 |
) |
|
Accumulated deficit |
(169,179 |
) |
|
(155,837 |
) |
|
Total shareholder's equity |
96,720 |
|
|
108,270 |
|
|
|
|
|
|
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity |
116,801 |
|
|
128,620 |
|
|
|
|
|
|
|
ACASTI PHARMA INC.Condensed Consolidated
Interim Statements of Loss and Comprehensive Loss(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
December 31,
2022 |
|
December 31,
2021 |
|
December 31,
2022 |
|
December 31,
2021 |
(Expressed in thousands of U.S dollars, except per share data) |
|
$ |
|
$ |
|
$ |
|
$ |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development expenses, net of government
assistance |
|
(2,450 |
) |
|
(2,179 |
) |
|
(8,332 |
) |
|
(3,233 |
) |
General and
administrative expenses |
|
(1,589 |
) |
|
(1,808 |
) |
|
(5,187 |
) |
|
(7,441 |
) |
Sales and
marketing expenses |
|
(206 |
) |
|
(238 |
) |
|
(563 |
) |
|
(263 |
) |
Impairment of Other asset and prepaid |
|
- |
|
|
(249 |
) |
|
- |
|
|
(249 |
) |
Loss
from operating activities |
|
(4,245 |
) |
|
(4,474 |
) |
|
(14,082 |
) |
|
(11,186 |
) |
|
|
|
|
|
|
|
|
|
Financial income (expenses) |
|
82 |
|
|
696 |
|
|
69 |
|
|
5,271 |
|
Loss before
income tax recovery |
|
(4,163 |
) |
|
(3,778 |
) |
|
(14,013 |
) |
|
(5,915 |
) |
|
|
|
|
|
|
|
|
|
Income tax
recovery |
|
274 |
|
|
- |
|
|
671 |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Loss and total comprehensive loss) |
|
(3,889 |
) |
|
(3,778 |
) |
|
(13,342 |
) |
|
(5,915 |
) |
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
|
(0.09 |
) |
|
(0.09 |
) |
|
(0.30 |
) |
|
(0.23 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding |
|
44,612,831 |
|
|
44,288,183 |
|
|
44,497,907 |
|
|
25,785,579 |
|
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