- Projected Cash Runway Extends into
Second Calendar Quarter 2026, Well Beyond Potential 1H 2025 Submission of GTX-104 New Drug Application (NDA) - Patient Enrollment in Pivotal STRIVE-ON Phase 3 Trial Continues, On Track for NDA Submission Timeline
- Poster Highlighting the STRIVE-ON Trial Presented at 2024
International Stroke Conference
"During the third quarter we continued to execute our focused strategy around our biggest value driver program GTX-104 and its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405). Having dosed the first patient in October, we’ve continued to enroll more patients and sites since that time,” said
Recent Corporate Highlights
- Announced dosing of first patient in STRIVE-ON trial, a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH.
- STRIVE-ON trial on track for potential NDA submission with the FDA anticipated to occur in the first half of calendar 2025.
- Hosted a Key Opinion Leader Event GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH)
- Overview of STRIVE-ON trial presented as a poster at the 2024
International Stroke Conference .
Third Quarter 2024 Financial Results
On
The Company reported a net loss of
- Research and development expenses for the three months ended
December 31, 2023 totaled$1.4 million compared to$2.5 million for the three months endedDecember 31, 2022 . The decrease from the prior year period was mainly attributable to the Company’s strategic realignment plan to align the organizational and management cost structure to prioritize resources to GTX-104, thereby reducing losses to improve cash flow and extend available cash resources. - General and administrative expenses were
$1.6 million for the three months endedDecember 31, 2023 , unchanged from$1.6 million for the three months endedDecember 31, 2022 .
The Company’s cash, cash equivalents and short-term investments as of
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
Condensed Consolidated Interim Balance Sheets
(Unaudited)
2023 | 2023 | |||||||
(Expressed in thousands except share data) | $ | $ | ||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | 18,545 | 27,875 | ||||||
Short-term investments | 6,569 | 15 | ||||||
Receivables | 959 | 802 | ||||||
Prepaid expenses | 811 | 598 | ||||||
Total current assets | 26,884 | 29,290 | ||||||
Operating lease right of use asset | 23 | 463 | ||||||
Equipment | 12 | 104 | ||||||
Intangible assets | 41,128 | 41,128 | ||||||
8,138 | 8,138 | |||||||
Total assets | 76,185 | 79,123 | ||||||
Liabilities and Shareholders’ equity | ||||||||
Current liabilities: | ||||||||
Trade and other payables | 1,746 | 3,336 | ||||||
Operating lease liability | 24 | 75 | ||||||
Total current liabilities | 1,770 | 3,411 | ||||||
Derivative warrant liabilities | 3,332 | — | ||||||
Operating lease liability | — | 410 | ||||||
Deferred tax liability | 6,403 | 7,347 | ||||||
Total liabilities | 11,505 | 11,168 | ||||||
Commitments and contingencies | ||||||||
Shareholders’ equity: | ||||||||
Class A common shares, no par value per share; unlimited shares authorized as of | 261,038 | 258,294 | ||||||
Class B, C, D and E common shares, no par value per share; unlimited shares authorized as of | — | — | ||||||
Additional paid-in capital | 17,633 | 13,965 | ||||||
Accumulated other comprehensive loss | (6,038 | ) | (6,038 | ) | ||||
Accumulated deficit | (207,953 | ) | (198,266 | ) | ||||
Total shareholders' equity | 64,680 | 67,955 | ||||||
Total liabilities and shareholders’ equity | 76,185 | 79,123 |
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(Unaudited)
Three months ended | Nine months ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
(Expressed in thousands, except share and per share data) | $ | $ | $ | $ | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development expenses, net of government assistance | (1,443 | ) | (2,450 | ) | (2,998 | ) | (8,332 | ) | ||||||||
General and administrative expenses | (1,570 | ) | (1,589 | ) | (4,922 | ) | (5,187 | ) | ||||||||
Sales and marketing | (30 | ) | (206 | ) | (184 | ) | (563 | ) | ||||||||
Restructuring cost | — | — | (1,485 | ) | — | |||||||||||
Loss from operating activities | (3,043 | ) | (4,245 | ) | (9,589 | ) | (14,082 | ) | ||||||||
Foreign exchange gain (loss) | 3 | 15 | (2 | ) | (75 | ) | ||||||||||
Change in fair value of derivative warrant liabilities | 125 | — | (1,701 | ) | 10 | |||||||||||
Interest income and other expense, net | 316 | 67 | 662 | 134 | ||||||||||||
Total other income (expense), net | 444 | 82 | (1,041 | ) | 69 | |||||||||||
Loss before income tax recovery | (2,599 | ) | (4,163 | ) | (10,630 | ) | (14,013 | ) | ||||||||
Income tax recovery | 208 | 274 | 943 | 671 | ||||||||||||
Net loss and total comprehensive loss | (2,391 | ) | (3,889 | ) | (9,687 | ) | (13,342 | ) | ||||||||
Basic and diluted loss per share | (0.21 | ) | (0.52 | ) | (1.09 | ) | (1.80 | ) | ||||||||
Weighted-average number of shares outstanding | 11,506,257 | 7,435,472 | 8,874,872 | 7,416,318 |
Source:
2024 GlobeNewswire, Inc., source