- New leadership team singularly focused on executing GTX-104 strategy
- Announced alignment with the
U.S. Food and Drug Administration (FDA) for Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 with first patient expected to be dosed prior to the end of 2023 - Cash and cash equivalents as of quarter end were
$21.6 million ; company reiterates projected cash runway to Q2 2025, beyond potential submission of GTX-104 New Drug Application (NDA) - Abstract of pharmacokinetic comparison of GTX-104 with oral nimodipine accepted for presentation at 2023
Neurocritical Care Society (NCS) annual meeting
"During our first quarter we made substantial progress executing on the strategic vision we laid out in April, moving with full speed to prioritize development of GTX-104, streamline our operations, extend our cash runway to fully fund the clinical development of GTX-104, and strengthen our leadership team with industry leaders in our sector," said
Recent Corporate Highlights
- Implemented strategic realignment plan that extends projected cash runway through calendar Q2 2025
- Prioritized resources to biggest value driver – GTX-104.
- Significant extension of the Company's cash runway facilitates the achievement of critical value inflection milestones, including a potential NDA filing for GTX-104.
- Evaluation of strategic alternatives to maximize value of de-prioritized pipeline assets (GTX-102 and GTX-101) including out-licensing or sale.
- Announced alignment with FDA on the STRIVE-ON trial protocol.
- The STRIVE-ON trial will be a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH. Key trial design features include:
- Approximately 100 patients will be enrolled at an estimated 25 hospitals in the
U.S. - The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups.
- GTX-104 will be administered as a continuous IV infusion of 0.15 mg/hour, and a 30-minute IV bolus of 4 mg every 4 hours. Oral nimodipine will be administered as 60 mg (two 30 mg capsules) every 4 hours.
- Both groups will receive their assigned GTX-104 or oral nimodipine for up to 21 consecutive days and will be evaluated from commencement of patient treatment through a 90-day follow-up period.
- Approximately 100 patients will be enrolled at an estimated 25 hospitals in the
- The FDA also provided guidance for a potential GTX-104 NDA submission.
- GTX-104 has been administered to over 150 healthy subjects to date and has a well- established safety profile.
- The STRIVE-ON trial will be a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH. Key trial design features include:
- Announced selection of
WuXi as CRO to conduct the STRIVE-ON trial of GTX-104 in aSAH patients; Acasti andWuXi continue preparatory work in advance of Acasti's recent alignment with the FDA on the protocol for the STRIVE-ON trial. - Abstract of pharmacokinetic comparison of GTX-104 with oral nimodipine accepted for presentation as a poster at the 2023
Neurocritical Care Society (NCS) annual meeting.- The poster is titled GTX-104, Novel IV Formulation of Nimodipine to Treat Subarachnoid Hemorrhage: A Pharmacokinetic Comparison with Oral Nimodipine.
- Enhanced senior leadership team with the appointments of Dr.
R. Loch Macdonald , MD, PhD, (Chief Medical Officer),Carrie D'Andrea (VP Clinical Operations), andAmresh Kumar , PhD (VP Program Management). - Announced expansion of
Scientific Advisory Board (SAB) to include:- Distinguished physicians and key opinion leaders
W. Taylor Kimberly , MD, PhD,Alejandro A. Rabinstein , MD and Sherry H-Y. Chou, MD - Acasti’s
SAB now possesses clinical expertise in neurosurgery and neurocritical care from leading academic medical centers across the country.
- Distinguished physicians and key opinion leaders
First Quarter 2024 Financial Results
The Company's consolidated financial statements have been prepared in accordance with generally accepted accounting principles in
- Net loss for the three months ended
June 30, 2023 , was$4.0 million , or$0.54 per share compared to$4.5 million , or$0.61 per share, for the three months endedJune 30, 2022 . - Research and development expenses before depreciation, amortization and stock-based compensation expenses for the three months ended
June 30, 2023 totaled$1.1 million compared to$2.3 million for the three months endedJune 30, 2022 . The net decrease was mainly attributable to the restructuring to align our organizational and management cost structure to prioritize resources to GTX-104 and reduce losses to improve cash flow and extend available cash resources. - General and administrative expenses totaled
$1.7 million before stock-based compensation and depreciation expense for the three months endedJune 30, 2023 , an increase of$0.1 million from$1.6 million for the three months endedJune 30, 2022 . The increase was primarily a result of an increase in legal, tax, accounting and other professional fees. - Restructuring cost for the three months ended
June 30, 2023 , totaled$1.5 million primarily consisting of employee severance costs. OnMay 8, 2023 , the Company communicated its decision to terminate a substantial amount of its workforce as part of a plan that intended to align the Company’s organizational and management cost structure to prioritize resources to GTX-104 and reduce losses to improve cash flow and extend available cash resources. - Cash and cash equivalents as of
June 30, 2023 , totaled$21.6 million , a decrease of$6.2 million compared to cash and cash equivalents totaling$27.8 million atMarch 31, 2023 , primarily due to ongoing research and development activities, and funding the restructuring expense. - As of
June 30, 2023 , the Company had 7,435,533 common shares issued and outstanding.
About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH 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 the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in
About GTX-104
GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous infusion (IV) in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion.
GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in
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
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
For more information, please contact:
Acasti Contact:
Chief Executive Officer
Tel: 450-686-4555
Email:info@acastipharma.com
www.acasti.com
Investor Relations:
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
---tables to follow---
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(Unaudited)
Three months ended | ||||||
2022 | ||||||
(Expressed in thousands of share data) | Notes | $ | $ | |||
Operating expenses | ||||||
Research and development expenses, net of government assistance | 6 | (1,095 | ) | (2,590 | ) | |
General and administrative expenses | (1,763 | ) | (1,919 | ) | ||
Sales and marketing | (111 | ) | (221 | ) | ||
Restructuring cost | 15 | (1,485 | ) | — | ||
Loss from operating activities | (4,454 | ) | (4,730 | ) | ||
Foreign exchange gain (loss) | 8 | (78 | ) | |||
Change in fair value of warrant liabilities | — | 10 | ||||
Interest income and other expense | 134 | 32 | ||||
Total other income (loss), net | 142 | (36 | ) | |||
Loss before income tax recovery | (4,312 | ) | (4,766 | ) | ||
Income tax recovery | 289 | 242 | ||||
Net loss and total comprehensive loss | (4,023 | ) | (4,524 | ) | ||
Basic and diluted loss per share | 11 | (0.54 | ) | (0.61 | ) | |
Weighted average number of shares outstanding | 7,435,533 | 7,388,065 |
See accompanying notes to unaudited interim financial statements
Condensed Consolidated Interim Balance Sheet
(Unaudited)
2023 | ||||||
(Expressed in thousands of | Notes | $ | $ | |||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | 21,633 | 27,875 | ||||
Short-term investments | 5 | 15 | 15 | |||
Receivables | 4 | 837 | 802 | |||
Prepaid expenses | 1,127 | 598 | ||||
Total current assets | 23,612 | 29,290 | ||||
Operating lease right of use asset | 71 | 463 | ||||
Equipment | 84 | 104 | ||||
Intangible assets | 41,128 | 41,128 | ||||
8,138 | 8,138 | |||||
Total assets | 73,033 | 79,123 | ||||
Liabilities and Shareholders’ equity | ||||||
Current liabilities: | ||||||
Trade and other payables | 7 | 1,886 | 3,336 | |||
Operating lease liability | 8 | 80 | 75 | |||
Total current liabilities | 1,966 | 3,411 | ||||
Operating lease liability | — | 410 | ||||
Deferred tax liability | 7,057 | 7,347 | ||||
Total liabilities | 9,023 | 11,168 | ||||
Shareholders’ equity: | ||||||
Common shares, no par value per share; unlimited shares authorized as of shares issued and outstanding as of 31, 2023 | 9(a) | 258,294 | 258,294 | |||
Additional paid-in capital | 14,043 | 13,965 | ||||
Accumulated other comprehensive loss | (6,038 | ) | (6,038 | ) | ||
Accumulated deficit | (202,289 | ) | (198,266 | ) | ||
Total shareholders' equity | 64,010 | 67,955 | ||||
Commitments and contingencies | 14 | |||||
Total liabilities and shareholders’ equity | 73,033 | 79,123 |
See accompanying notes to unaudited interim financial statements.
Source:
2023 GlobeNewswire, Inc., source