- Patient Enrollment in Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 On-Track for Potential NDA Submission in 1H Calendar 2025
- Projected Cash Runway into
Second Calendar Quarter 2026
"During the past year 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),” said
2024 Corporate Highlights
- Overview of 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, presented as a poster at the 2024
International Stroke Conference - Enrollment of STRIVE-ON trial on track for potential NDA submission to FDA anticipated in the first half of calendar 2025
- Conducted a meeting of STRIVE-ON trial investigators in
April 2024 ; the in-person/virtual meeting provided an excellent opportunity to energize the principal investigators from all sites, engage in an interactive discussion about the trial inclusion/exclusion criteria, and to review key procedures to ensure quality data collection - In
October 2023 hosted a Key Opinion Leader Event GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH) - Completed
$7.5 million private placement equity financing led byADAR1 Partners, LP inSeptember 2023 - Presented a pharmacokinetic comparison of GTX-104 with oral nimodipine at the 2023
Neurocritical Care Society annual meeting inAugust 2023 .
Fiscal Year 2024 Financial Results
The Company reported a net loss of
Research and development expenses for the year ended
General and administrative expenses were
At
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 the Acasti Asset Portfolio
GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion 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
GTX-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTX-102 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may out-license or sell our GTX-102 drug candidate.
GTX-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (“PHN”). GTX-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTX-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTX-101 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may out-license or sell our GTX-101 drug candidate.
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: www.acasti.com.
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---
Consolidated Balance Sheets | ||||||||
(Expressed in thousands except share data) | $ | $ | ||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | 23,005 | 27,875 | ||||||
Short-term investments | — | 15 | ||||||
Receivables | 722 | 802 | ||||||
Prepaid expenses | 283 | 598 | ||||||
Total current assets | 24,010 | 29,290 | ||||||
Operating lease right of use asset | — | 463 | ||||||
Equipment, net | 24 | 104 | ||||||
Intangible assets | 41,128 | 41,128 | ||||||
8,138 | 8,138 | |||||||
Total assets | 73,300 | 79,123 | ||||||
Liabilities and Shareholders’ equity | ||||||||
Current liabilities: | ||||||||
Trade and other payables | 1,684 | 3,336 | ||||||
Operating lease liability | — | 75 | ||||||
Total current liabilities | 1,684 | 3,411 | ||||||
Derivative warrant liabilities | 4,359 | — | ||||||
Operating lease liability | — | 410 | ||||||
Deferred tax liability | 5,514 | 7,347 | ||||||
Total liabilities | 11,557 | 11,168 | ||||||
Commitments and contingencies | ||||||||
Shareholders’ equity: | ||||||||
Class A common shares, no par value per share; unlimited shares authorized; 9,399,404 and 7,435,533 shares issued and outstanding as of respectively | 261,038 | 258,294 | ||||||
Class B, C, D and E common shares, no par value per share; unlimited shares authorized; none issued and outstanding | — | — | ||||||
Additional paid-in capital | 17,862 | 13,965 | ||||||
Accumulated other comprehensive loss | (6,038 | ) | (6,038 | ) | ||||
Accumulated deficit | (211,119 | ) | (198,266 | ) | ||||
Total shareholders' equity | 61,743 | 67,955 | ||||||
Total liabilities and shareholders’ equity | 73,300 | 79,123 |
Consolidated Statements of Operations and Comprehensive Loss | ||||||||
Year ended 2024 | Year ended 2023 | |||||||
(Expressed in thousands, except share and per data) | $ | $ | ||||||
Operating expenses | ||||||||
Research and development expenses, net of government assistance | (4,683 | ) | (9,972 | ) | ||||
General and administrative expenses | (6,432 | ) | (7,614 | ) | ||||
Sales and marketing | (252 | ) | (661 | ) | ||||
Restructuring cost | (1,485 | ) | — | |||||
Impairment of intangible assets | — | (28,682 | ) | |||||
Impairment of goodwill | — | (4,826 | ) | |||||
Impairment of assets held for sale | — | (400 | ) | |||||
Loss from operating activities | (12,852 | ) | (52,155 | ) | ||||
Foreign exchange loss | (16 | ) | (72 | ) | ||||
Change in fair value of derivative warrant liabilities | (2,728 | ) | 10 | |||||
Interest income and other expense, net | 911 | 246 | ||||||
Total other income (expense), net | (1,833 | ) | 184 | |||||
Loss before income tax benefit | (14,685 | ) | (51,971 | ) | ||||
Income tax benefit | 1,832 | 9,542 | ||||||
Net loss and total comprehensive loss | (12,853 | ) | (42,429 | ) | ||||
Basic and diluted loss per share | (1.35 | ) | (5.71 | ) | ||||
Weighted average number of shares outstanding | 9,529,123 | 7,435,472 |
Source:
2024 GlobeNewswire, Inc., source