Acasti Announces Corporate Name Change to Grace Therapeutics, Inc.
Acasti Pharma announced its corporate name change to Grace Therapeutics, effective October 28, 2024, when it will begin trading on Nasdaq under the symbol 'GRCE'. The name change reflects the company's connection to Grace Therapeutics, which developed GTx-104 before merging with Acasti in 2021. The company has fully enrolled its STRIVE-ON trial for GTx-104, a novel injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), with data readout expected in early 2025 and NDA submission planned for first half 2025. Recent corporate developments include restructuring to a biopharma model, management team rebuilding, pipeline prioritization, legacy asset divestment, and re-domiciling to Delaware.
Acasti Pharma ha annunciato il cambiamento del proprio nome aziendale in Grace Therapeutics, con effetto dal 28 ottobre 2024, quando inizierà a quotarsi su Nasdaq con il simbolo 'GRCE'. Il cambiamento di nome riflette il legame dell'azienda con Grace Therapeutics, che ha sviluppato GTx-104 prima di fondersi con Acasti nel 2021. L'azienda ha completato l'arruolamento del suo studio STRIVE-ON per GTx-104, una nuova formulazione iniettabile di nimodipina per emorragia subaracnoidea aneurismatica (aSAH), con i risultati attesi all'inizio del 2025 e la presentazione della NDA pianificata per la prima metà del 2025. Gli sviluppi aziendali recenti includono la ristrutturazione verso un modello biopharma, la ricostruzione del team di management, la prioritizzazione della pipeline, la dismissione di asset legacy e il trasferimento della sede legale nel Delaware.
Acasti Pharma anunció su cambio de nombre corporativo a Grace Therapeutics, efectivo el 28 de octubre de 2024, cuando comenzará a cotizar en Nasdaq bajo el símbolo 'GRCE'. El cambio de nombre refleja la conexión de la empresa con Grace Therapeutics, que desarrolló GTx-104 antes de fusionarse con Acasti en 2021. La compañía ha completado la inscripción de su ensayo STRIVE-ON para GTx-104, una nueva formulación inyectable de nimodipina para la hemorragia subaracnoidea aneurismática (aSAH), con la lectura de datos esperada para principios de 2025 y la presentación de la NDA planificada para la primera mitad de 2025. Los recientes desarrollos corporativos incluyen la reestructuración a un modelo biofarmacéutico, la reconstrucción del equipo de gestión, la priorización de la cartera, la desinversión de activos heredados y el cambio de sede a Delaware.
Acasti Pharma는 2024년 10월 28일부터 Grace Therapeutics로 회사 이름을 변경한다고 발표했습니다. 이때부터 나스닥에서 기호 'GRCE'로 거래를 시작합니다. 이름 변경은 Acasti와 2021년에 합병하기 전에 GTx-104를 개발한 Grace Therapeutics와의 관계를 반영합니다. 이 회사는 GTx-104를 위한 STRIVE-ON 임상시험의 전체 모집을 완료했으며, 이는 동맥류성 지주모세포 출혈(aSAH)을 위한 새로운 주사형 니모디핀 제형입니다. 데이터 해석은 2025년 초에 예상되며, NDA 제출은 2025년 상반기로 계획되어 있습니다. 최근의 기업 활동에는 생명공학 모델로의 재구성, 경영팀 재편성, 파이프라인 우선순위 설정, 레거시 자산 매각, 델라웨어로의 본사 이전 등이 포함됩니다.
Acasti Pharma a annoncé son changement de nom en Grace Therapeutics, effectif le 28 octobre 2024, date à laquelle elle commencera à se négocier sur le Nasdaq sous le symbole 'GRCE'. Ce changement de nom reflète le lien de l'entreprise avec Grace Therapeutics, qui a développé GTx-104 avant de fusionner avec Acasti en 2021. L'entreprise a entièrement recruté pour son essai STRIVE-ON pour GTx-104, une nouvelle formulation injectable de nimodipine pour l'hémorragie sous-arachnoïdienne aneurismale (aSAH), avec une divulgation des données attendue au début de 2025 et une soumission de NDA prévue pour le premier semestre 2025. Les développements récents de l'entreprise incluent la restructuration vers un modèle biopharmaceutique, la reconstruction de l'équipe de direction, la priorisation de la pipeline, la cession d'actifs hérités et le transfert de son siège à Delaware.
Acasti Pharma kündigte die Umbenennung in Grace Therapeutics an, die am 28. Oktober 2024 wirksam wird, wenn die Aktie unter dem Symbol 'GRCE' an der Nasdaq gehandelt werden soll. Die Namensänderung spiegelt die Verbindung des Unternehmens zu Grace Therapeutics wider, das GTx-104 entwickelte, bevor es 2021 mit Acasti fusionierte. Das Unternehmen hat die vollständige Einschreibung für seine STRIVE-ON-Studie zu GTx-104 abgeschlossen, einer neuartigen injizierbaren Nimodipin-Formulierung zur aneurysmalen Subarachnoidalblutung (aSAH), mit Ergebnissen, die Anfang 2025 erwartet werden, und einer NDA-Einreichung, die für die erste Hälfte 2025 geplant ist. Zu den jüngsten Unternehmensentwicklungen gehören die Umstellung auf ein biopharmazeutisches Modell, der Wiederaufbau des Managementteams, die Priorisierung der Pipeline, der Verkauf von Altbeständen und die Verlagerung des Sitzes nach Delaware.
- Full enrollment completed in STRIVE-ON trial for GTx-104
- NDA submission planned for first half 2025
- Successfully restructured to more efficient biopharma model
- Strengthened balance sheet
- Re-domiciled to US, potentially increasing attractiveness to strategic partners and investors
- None.
Insights
The corporate rebranding to Grace Therapeutics represents more than just a name change - it signals important progress in the company's development of GTx-104 for aSAH treatment. Key developments include full enrollment of the STRIVE-ON trial with data expected in early 2025 and planned NDA submission in H1 2025. The timing suggests potential commercialization by 2026 if approved.
The injectable nimodipine formulation addresses critical limitations of oral nimodipine in aSAH patients who often can't swallow pills. With
Name Change Reflects Extensive Scientific and Corporate Brand Equity Previously Established under Grace Therapeutics
Grace Therapeutics will begin trading on Nasdaq under the trading symbol "GRCE" effective October 28, 2024
Virtual Key Opinion Leader Event to be held on November 20th
PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it is changing its name to Grace Therapeutics, Inc. (Grace Therapeutics). Grace Therapeutics was the name of the company developing GTx-104 prior to its merger with Acasti in 2021. Grace Therapeutics will begin trading on Nasdaq under the trading symbol “GRCE” at the open of the market on October 28, 2024 and all company branding including corporate website will be updated accordingly.
“The Grace Therapeutics brand reconnects us to our roots that are steeped in scientific innovation and highlights our transformative journey,” said Prashant Kohli, CEO of Acasti. “The breakthrough formulation of GTx-104 is the result of a decade of research by our exceptional scientific team while Grace Therapeutics was located in the pharma industry research corridor of New Jersey. We have continued to make significant progress in the clinical development plan of GTx-104, including full enrollment of the STRIVE-ON trial and anticipate a data readout in early calendar 2025 with an expected submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of calendar 2025.
“In addition to advancing GTx-104 over the past 18 months, we successfully restructured to an agile biopharma model, rebuilt the management team, prioritized the pipeline, divested legacy assets, strengthened the balance sheet, and re-domiciled to the United States as a Delaware corporation. We believe these steps offer several potential benefits, including a U.S. corporate structure that should increase the company’s attractiveness and marketability to potential strategic partners and global institutional investors. We are proud of the progress made within a relatively short timeframe and look forward to fully realizing the Company’s value under the Grace Therapeutics brand.”
The Company will host a Key Opinion Leader (KOL) event titled Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage, on November 20, 2024 at 2pm Eastern Time. To register for this debut event hosted by Grace Therapeutics, click here. A replay of the event will be available and archived for at least 180 days after the webcast.
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 the United States for GTx-104 is estimated to be about
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 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 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 the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti’s lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal 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.
For more information, please visit: www.acasti.com or www.gracetx.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 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, including statements regarding the timing of a data readout from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates 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 Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (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.
For more information, please contact:
Acasti Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email: info@acastipharma.com
www.acasti.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
FAQ
When will Acasti Pharma (ACST) change its name to Grace Therapeutics?
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Why is Acasti Pharma (ACST) changing its name to Grace Therapeutics?
