Grace Therapeutics Announces First Quarter 2026 Financial Results, Provides Business Update
Grace Therapeutics (NASDAQ:GRCE) has submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The NDA is supported by successful Phase 3 STRIVE-ON safety trial results, which met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.
For Q1 2026, Grace reported a net loss of $3.4 million ($0.21 per share), compared to $2.6 million loss in Q1 2025. The company's cash position stands at $20.0 million, with potential additional proceeds of $22.6 million from warrant exercises. The company has secured Orphan Drug Designation for GTx-104, providing 7 years of marketing exclusivity upon FDA approval.
Grace Therapeutics (NASDAQ:GRCE) ha presentato alla FDA una New Drug Application (NDA) per GTx-104, una nuova formulazione iniettabile di nimodipina destinata al trattamento dell'emorragia subaracnoidea aneurismatica (aSAH). L'NDA è supportata dai risultati positivi dello studio di fase 3 STRIVE-ON sulla sicurezza, che ha raggiunto l'endpoint primario e ha mostrato benefici clinici rispetto alla nimodipina somministrata per via orale.
Per il Q1 2026 Grace ha registrato una perdita netta di $3.4 million ($0.21 per azione), rispetto a una perdita di $2.6 million nel Q1 2025. La società dispone di $20.0 million di liquidità e potrebbe ottenere ulteriori $22.6 million dall'esercizio di warrant. GTx-104 ha ottenuto lo status di farmaco orfano, che garantisce 7 anni di esclusiva commerciale in caso di approvazione FDA.
Grace Therapeutics (NASDAQ:GRCE) ha presentado una New Drug Application (NDA) ante la FDA para GTx-104, una nueva formulación inyectable de nimodipina para el tratamiento de la hemorragia subaracnoidea aneurismática (aSAH). La NDA se apoya en los resultados positivos del ensayo de seguridad de fase 3 STRIVE-ON, que cumplió su endpoint primario y mostró beneficios clínicos frente a la nimodipina oral.
En el primer trimestre de 2026, Grace reportó una pérdida neta de $3.4 million ($0.21 por acción), frente a una pérdida de $2.6 million en el Q1 2025. La compañía cuenta con $20.0 million en efectivo y podría recibir adicionalmente $22.6 million por el ejercicio de warrants. GTx-104 ha obtenido la Designación de Medicamento Huérfano, que otorga 7 años de exclusividad comercial tras la aprobación de la FDA.
Grace Therapeutics (NASDAQ:GRCE)는 GTx-104에 대해 FDA에 신약허가신청(NDA)을 제출했습니다. GTx-104는 동맥류성 지주막하출혈(aSAH) 치료를 위한 새로운 니모디핀 주사 제형입니다. 이 NDA는 1차 평가변수를 달성하고 경구 니모디핀 대비 임상적 이점을 입증한 3상 STRIVE-ON 안전성 시험의 성공적인 결과를 근거로 하고 있습니다.
2026년 1분기 기준 Grace는 $3.4 million ($0.21 주당)의 순손실을 기록했으며, 이는 2025년 1분기의 $2.6 million 손실과 비교됩니다. 회사의 현금 보유액은 $20.0 million이고, 워런트 행사로 추가로 $22.6 million을 확보할 가능성이 있습니다. GTx-104는 희귀의약품(Orphan Drug) 지정도 받아 FDA 승인 시 7년간의 마케팅 독점권을 갖게 됩니다.
Grace Therapeutics (NASDAQ:GRCE) a soumis une New Drug Application (NDA) à la FDA pour GTx-104, une nouvelle formulation injectable de nimodipine destinée au traitement de l'hémorragie sous-arachnoïdienne anévrismale (aSAH). La NDA s'appuie sur les résultats positifs de l'essai de sécurité de phase 3 STRIVE-ON, qui a atteint son critère principal et a montré des bénéfices cliniques par rapport à la nimodipine orale.
Pour le T1 2026, Grace a déclaré une perte nette de $3.4 million ($0.21 par action), contre une perte de $2.6 million au T1 2025. La trésorerie de la société s'élève à $20.0 million et des recettes supplémentaires potentielles de $22.6 million pourraient provenir de l'exercice de bons de souscription. GTx-104 a obtenu la désignation de médicament orphelin, offrant 7 ans d'exclusivité commerciale en cas d'approbation par la FDA.
Grace Therapeutics (NASDAQ:GRCE) hat bei der FDA eine New Drug Application (NDA) für GTx-104 eingereicht, eine neuartige injizierbare Formulierung von Nimodipin zur Behandlung der aneurysmatischen Subarachnoidalblutung (aSAH). Die NDA stützt sich auf erfolgreiche Ergebnisse der Phase-3-Sicherheitsstudie STRIVE-ON, die ihren primären Endpunkt erreichte und klinische Vorteile gegenüber oralem Nimodipin zeigte.
Für Q1 2026 meldete Grace einen Nettoverlust von $3.4 million ($0.21 je Aktie), verglichen mit einem Verlust von $2.6 million im Q1 2025. Das Unternehmen verfügt über $20.0 million an Zahlungsmitteln und könnte zusätzliche Erlöse in Höhe von $22.6 million aus der Ausübung von Warrants erzielen. GTx-104 hat die Orphan-Drug-Zulassung erhalten, die bei FDA-Zulassung sieben Jahre Marktexklusivität gewährt.
- Successful completion and submission of NDA for GTx-104 with positive Phase 3 STRIVE-ON trial results
- Secured Orphan Drug Designation providing 7 years of marketing exclusivity
- Strong cash position of $20.0M with potential additional $22.6M from warrant exercises
- Reduced R&D expenses by $1.8M due to trial completion
- Cash runway extended through Q2 2027 if warrants are exercised
- Increased net loss to $3.4M from $2.6M year-over-year
- Cash decreased by $2.1M from previous quarter
- Warrant exercise proceeds are uncertain and dependent on FDA acceptance/approval
Insights
Grace Therapeutics has submitted an NDA for GTx-104, showing clinical benefits in aSAH treatment while managing costs during regulatory phase.
Grace Therapeutics has reached a pivotal milestone with the submission of its New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine targeting aneurysmal Subarachnoid Hemorrhage (aSAH). This achievement represents the culmination of over a decade of research and potentially addresses a therapeutic area that has seen no meaningful innovation in nearly 40 years.
The NDA is supported by positive data from the Phase 3 STRIVE-ON safety trial, which not only met its primary endpoint but demonstrated clinical benefits compared to oral nimodipine. The company has secured Orphan Drug Designation, which would provide seven years of marketing exclusivity upon approval, complemented by patent protections.
Financially, the company reported a net loss of
With
The progress toward potential commercialization of GTx-104, coupled with careful cash management during the regulatory review phase, positions Grace at a critical inflection point. The acceptance of the NDA by the FDA, expected within 60 days, will be the next significant milestone to watch.
Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for GTx-104 Seeking Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH)
NDA Supported by Data from Phase 3 STRIVE-ON Safety Trial, which Met Primary Endpoint and Provided Evidence of Clinical Benefit Compared to Orally Administered Nimodipine
PRINCETON, N.J., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced the financial results and business highlights for the quarter ended June 30, 2025.
“During our first quarter of 2026 we continued to execute on our clinical and corporate goals, led by the submission of our NDA to the FDA for GTx-104 for the treatment of aSAH,” said Prashant Kohli, CEO of Grace Therapeutics. “Our NDA for GTx-104 was a significant milestone for the Company and built on more than a decade of painstaking research and innovation. Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provided evidence of improved clinical outcomes in aSAH patients treated with GTx-104 as well as potential medical and pharmacoeconomic benefits of GTx-104 in the treatment of aSAH. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe the STRIVE-ON trial results point to a very promising role for GTx-104 as a potential breakthrough for the care of aSAH patients. We are hopeful the FDA will accept our NDA for formal review, and look forward to continued engagement with the FDA during the review process.”
First Quarter 2026 Corporate Highlights
- Submission to the FDA of the Company’s NDA for GTx-104. The application included a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine.
- Submission of the NDA has the potential to trigger the exercise of up to
$7.6 million in warrants issued as part of a private placement the Company completed in September 2023. Under the terms of the September 2023 private placement, each warrant is exercisable for one share of common stock at an exercise price of$3.00 3 per share. These warrants are immediately exercisable and will expire on the earlier of (i) the 60th day after the date of the acceptance by the FDA of an NDA for the Company's product candidate GTx-104 or (ii) September 25, 2028.
- The FDA typically has a 60-day period to determine if the Company’s NDA is complete and acceptable for filing. Grace has obtained Orphan Drug Designation from the FDA for GTx-104, which generally provides seven years of marketing exclusivity in United States upon FDA approval of the NDA. Additionally, the Company believes that its U.S. and international patent estate will provide additional marketing exclusivity for GTx-104.
First Quarter 2026 Financial Results
The Company reported a net loss of
Total research and development expenses were approximately
General and administrative expenses were approximately
Cash Runway
As of June 30, 2025, cash and cash equivalents were
The private placement the Company completed in February 2025 included common warrants exercisable for shares of common stock (or pre-funded warrants in lieu thereof) at an exercise price of
The private placement the Company completed in September 2023 included common warrants exercisable for shares of common stock at an exercise price of
While the Company believes that current cash and cash equivalents provide cash runway through at least the next twelve months, the runway could extend into the second quarter of calendar 2027 if all of the common warrants issued in connection with the Company’s February 2025 and September 2023 private placements are exercised at the election of the investors.
About the STRIVE-ON Trial
The STRIVE-ON trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a
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 in the brain. The result is aSAH, a relatively uncommon type of stroke that accounts for about
About the Grace Therapeutics Asset Portfolio
GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for 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 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.
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 Company received written responses to its End of Phase 1 meeting in GTx-102 where the FDA made recommendations on the path toward an NDA. The FDA provided guidance on the design of a single pivotal efficacy and safety trial, including the neurological assessment scale for the primary endpoint, that could, with appropriate confirmatory evidence, support an NDA. The further development of GTx-102 has been deprioritized in favor of focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-102.
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, which are used for the treatment of PHN, the Company believes 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 focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-101.
About Grace Therapeutics
Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ 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. Grace Therapeutic’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. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV 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.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 Grace Therapeutics 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 Company’s cash runway, the future prospects of the Company’s GTx-104 drug candidate, the timing and outcome of the Company’s NDA submission for GTx-104, the Company’s belief that the data and regulatory packages as currently structured will be sufficient for submission of such NDA, GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to the oral form of nimodipine, GTx-104’s potential to achieve medical and pharmacoeconomic benefit, GTx-104’s commercial prospects, the future prospects of the Company’s GTx-102 drug candidate, GTx-102’s potential to provide clinical benefits to decrease symptoms associated with A-T, the timing and outcomes of a Phase 3 efficacy and safety trial for GTx-102, the timing of an NDA filing for GTx-102, the future prospects of the Company’s GTX-101 drug candidate, GTX-101’s potential to be administered to PHN patients to treat the severe nerve pain associated with the disease and any future patent and other intellectual property filings made by the Company for new developments are based upon Grace Therapeutics’ 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 of the Company’s NDA application for GTx-104; (iii) changes to regulatory pathways; and (iv) legislative, regulatory, political and economic developments. 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 the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 to be filed with the Securities and Exchange Commission (“SEC”) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics 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:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
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GRACE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
| June 30, 2025 | March 31, 2025 | |||||||
| (Expressed in thousands except share data) | $ | $ | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | 20,005 | 22,133 | ||||||
| Receivables | 20 | 126 | ||||||
| Prepaid expenses | 500 | 453 | ||||||
| Total current assets | 20,525 | 22,712 | ||||||
| Equipment, net | 14 | 15 | ||||||
| Intangible assets | 41,128 | 41,128 | ||||||
| Goodwill | 8,138 | 8,138 | ||||||
| Total assets | 69,805 | 71,993 | ||||||
| Liabilities and Stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | 2,315 | 1,930 | ||||||
| Total current liabilities | 2,315 | 1,930 | ||||||
| Derivative warrant liabilities | 1,628 | 1,141 | ||||||
| Deferred tax liability | 2,312 | 2,312 | ||||||
| Total liabilities | 6,255 | 5,383 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, as of June 30, 2025 and March 31, 2025 | — | — | ||||||
| Common stock, 2025 and March 31, 2025, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 293,636 | 293,334 | ||||||
| Accumulated other comprehensive loss | (6,038 | ) | (6,038 | ) | ||||
| Accumulated deficit | (224,049 | ) | (220,687 | ) | ||||
| Total stockholders' equity | 63,550 | 66,610 | ||||||
| Total liabilities and stockholders’ equity | 69,805 | 71,993 | ||||||
GRACE THERAPEUTICS, INC.
Condensed Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
| Three months ended | ||||||||
| June 30, 2025 | June 30, 2024 | |||||||
| (Expressed in thousands, except share and per share data) | $ | $ | ||||||
| Operating expenses | ||||||||
| Research and development expenses | (955 | ) | (2,708 | ) | ||||
| General and administrative expenses | (2,135 | ) | (2,255 | ) | ||||
| Loss from operating activities | (3,090 | ) | (4,963 | ) | ||||
| Foreign exchange gain (loss) | 10 | (8 | ) | |||||
| Change in fair value of derivative warrant liabilities | (487 | ) | 1,395 | |||||
| Interest and other income, net | 205 | 235 | ||||||
| Other (expense) income, net | (272 | ) | 1,622 | |||||
| Loss before income tax benefit | (3,362 | ) | (3,341 | ) | ||||
| Income tax benefit | — | 724 | ||||||
| Net loss and total comprehensive loss | (3,362 | ) | (2,617 | ) | ||||
| Basic and diluted loss per share | (0.21 | ) | (0.24 | ) | ||||
| Weighted-average number of shares outstanding | 15,924,522 | 10,928,543 | ||||||
FAQ
What is the status of Grace Therapeutics' (GRCE) GTx-104 NDA submission?
What are Grace Therapeutics' (GRCE) Q1 2026 financial results?
What potential warrant proceeds could Grace Therapeutics (GRCE) receive?
What market exclusivity rights does Grace Therapeutics have for GTx-104?
How long is Grace Therapeutics' (GRCE) cash runway?
