Grace Therapeutics’ Storied History Grace Therapeutics was originally founded in 2002 in the province of Québec, Canada, under the name Acasti Pharma Inc. The company’s initial focus was on developing pharmaceutical products for cardiovascular diseases and neurological disorders. In its early years, Acasti Pharma concentrated on developing CaPre, a prescription omega-3 fatty acid for the treatment of hypertriglyceridemia. The company conducted several clinical trials to evaluate the efficacy and safety of CaPre. However, in 2021, Acasti Pharma decided to discontinue the development of this product candidate.
A significant turning point came in 2021 when Acasti Pharma merged with Grace Therapeutics, a privately-held company developing GTX-104. This strategic move marked a significant shift in the company’s direction, as it doubled down on its efforts to advance GTX-104 for the treatment of aSAH. The merger necessitated a restructuring of the company, including a reduction in workforce to align its organizational and management cost structure with the new focus on GTX-104. While this restructuring resulted in one-time costs, it allowed the company to conserve resources and extend its cash runway.
aSAH is a rare condition that affects approximately 50,000 patients per year in the United States, with an additional 60,000 cases in the European Union and 150,000 cases in China. Despite the availability of oral nimodipine, the current standard of care, Grace Therapeutics recognized the significant limitations of this therapy and set out to develop a more effective and convenient solution.
GTX-104: A Novel Approach to Treating aSAH GTX-104 is a clinical-stage, novel, injectable formulation of nimodipine designed for intravenous (IV) infusion in aSAH patients. The unique nanoparticle technology of GTX-104 facilitates the aqueous formulation of the otherwise insoluble nimodipine, allowing for a safe, standard peripheral IV infusion. This approach addresses several key limitations of the oral nimodipine formulation, including poor bioavailability, high variability in blood levels, and the need for administration via nasogastric tube in unconscious or dysphagic patients.
GTX-104 uses a unique nanoparticle technology to solubilize nimodipine for a safe, standard peripheral IV infusion. This formulation aims to provide better control of blood pressure, improved management of hypotension, and 100% bioavailability compared to the oral form of nimodipine. GTX-104 also has the potential to eliminate food effects and reduce inter- and intra-subject variability in drug exposure. The company believes GTX-104 could provide a more convenient mode of administration and reduce nursing burden compared to the oral nimodipine capsules or oral liquid solution.
Pivotal Phase 3 STRIVE-ON Trial In 2023, Grace Therapeutics announced the alignment with the FDA on the pivotal Phase 3 STRIVE-ON (Safety, Tolerability, Randomized, IV and Oral Nimodipine) trial for GTX-104. This prospective, open-label, randomized trial is designed to evaluate the safety and tolerability of GTX-104 compared to oral nimodipine in approximately 100 aSAH patients. The primary endpoint is safety, measured as the incidence of adverse events, including hypotension, between the two groups.
Enrollment in the STRIVE-ON trial has been progressing well, with the company announcing the completion of enrollment in September 2024. Grace Therapeutics anticipates reporting data from the trial in the first quarter of 2025 and plans to submit a New Drug Application (NDA) to the FDA in the first half of 2025, assuming positive results.
Financial Strength and Outlook As of September 30, 2024, Grace Therapeutics reported cash and cash equivalents of $15.1 million, which the company believes will be sufficient to fund its operations into the second calendar quarter of 2026. This runway extends well beyond the anticipated NDA submission for GTX-104, providing the company with the financial flexibility to navigate the regulatory review process and, if approved, prepare for the potential commercialization of its lead candidate.
During the six months ended September 30, 2024, Grace Therapeutics reported a net loss of $6.0 million, compared to a net loss of $7.3 million in the same period of the prior year. The decrease in net loss was primarily due to a $3.6 million difference in the change in fair value of derivative warrant liabilities, an $841,000 increase in the company’s income tax benefit, and a $1.5 million decrease in restructuring costs, partially offset by a $4.1 million increase in research and development expenses and a $603,000 increase in general and administrative expenses.
For the most recent quarter ended September 30, 2024, Grace Therapeutics reported no revenue and a net loss of $2.62 million. The company’s operating cash flow (OCF) for the quarter was negative $3.60 million, which was also its free cash flow (FCF) as there were no capital expenditures reported.
Research and development expenses for the three and six months ended September 30, 2024, were $2.98 million and $5.68 million, respectively, primarily related to the GTX-104 clinical program. General and administrative expenses for the same periods were $1.85 million and $4.11 million.
Liquidity Grace Therapeutics’ liquidity position appears stable, with the reported cash and cash equivalents of $15.1 million expected to fund operations into the second calendar quarter of 2026. This provides a significant runway for the company to advance its lead candidate, GTX-104, through the regulatory process and potentially to commercialization. However, the company may need to consider additional financing options to support long-term growth and potential commercialization efforts beyond this timeframe.
Product Portfolio In addition to GTX-104, Grace Therapeutics has two other clinical-stage drug candidates in its portfolio:
GTX-101: A topical, bio-adhesive film-forming bupivacaine spray being developed for the treatment of Postherpetic Neuralgia (PHN), the severe nerve pain that can persist after a shingles infection. The company has conducted several Phase 1 trials in healthy volunteers to assess the PK, safety, and tolerability of GTX-101. The results suggest that bupivacaine delivered via the GTX-101 topical spray is well absorbed through the skin while maintaining low systemic exposure.
While Grace Therapeutics has prioritized the development of GTX-104, the company plans to collaborate with experts to design a Phase 3 trial protocol for GTX-102 and seek FDA alignment on the development path forward, contingent on securing additional funding or a strategic partnership. Similarly, the company may pursue additional clinical trials or seek a strategic partnership to advance the GTX-101 program.
Risks and Potential Headwinds While Grace Therapeutics’ progress with GTX-104 is promising, the company faces several risks and potential headwinds. The successful completion of the STRIVE-ON trial and the subsequent regulatory approval of GTX-104 are critical to the company’s future success. Any delays or setbacks in the clinical development or regulatory approval process could significantly impact Grace Therapeutics’ timeline and financial position.
Additionally, the company may need to raise additional capital to fund its operations beyond the second calendar quarter of 2026, as well as potential commercialization efforts for GTX-104. The ability to secure additional financing on favorable terms is crucial for Grace Therapeutics to realize its full potential.
The company’s focus on rare diseases and orphan drug designations may present both opportunities and challenges. While these designations can provide market exclusivity and other benefits, the small patient populations may limit revenue potential and require specialized marketing strategies.
Conclusion Grace Therapeutics’ transformation from Acasti Pharma to a laser-focused, late-stage biopharma company advancing GTX-104 for the treatment of aSAH is a testament to the company’s resilience and strategic vision. The successful completion of the STRIVE-ON trial and the potential approval of GTX-104 could be a game-changer for aSAH patients, addressing significant unmet medical needs and improving clinical outcomes.
The company’s decision to prioritize GTX-104 while maintaining potential for its other drug candidates demonstrates a balanced approach to pipeline management. This strategy allows Grace Therapeutics to concentrate its resources on the most advanced program while retaining optionality for future growth.
As Grace Therapeutics navigates the regulatory landscape and prepares for potential commercialization, its story has the potential to evolve from one of “confusion to infusion” in the rare disease treatment space. The company’s focus on addressing unmet medical needs in niche markets, combined with its innovative drug delivery technologies, positions it uniquely in the biopharmaceutical landscape. However, success will depend on the company’s ability to execute its clinical development plans, secure regulatory approvals, and effectively commercialize its products in a competitive market environment.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.