Grace Therapeutics, Inc.

Acasti reported no revenue, as it remains a clinical-stage company. Research and development expenses, net of government assistance, were $2.5 million for the three months ended December 31, 2022, versus $2.2 million a year earlier. General and administrative expense was $1.6 million, down from $1.8 million year over year. Loss from operating activities was $4.2 million versus $4.5 million last year, and net loss was $3.9 million, or $0.09 per share, compared with $3.8 million, or $0.09 per share, in the prior-year quarter. Cash, cash equivalents and short-term investments were $31.3 million at quarter-end, down from $34.9 million at September 30, 2022. Management said that, based on current projections, the company has sufficient capital to fund operations into calendar Q2 2024. Looking ahead, Acasti expects FDA clarifying guidance on GTX-104 before the end of calendar Q1, then hopes to finalize the protocol and start the Phase 3 safety study later in 2023. GTX-102 is also expected to move toward a Type B FDA meeting and Phase 3 startup in the second half of 2023, subject to the final clinical report and FDA input.

Jan D’Alvise struck an upbeat tone, saying the company made significant progress across all three clinical programs and ended the quarter strongly. She highlighted two successful PK readouts in December and framed 2023 as potentially the company’s most exciting year, with two drug candidates expected to enter Phase 3. She also stressed the company’s focus on reformulating marketed drugs for orphan indications via 505(b)(2), describing it as a shorter, less risky, and less costly regulatory path.

Brian Ford emphasized the company’s early-stage profile and noted that it still generates no revenue and has no cost of goods sold. He reported R&D expense of $2.5 million, G&A of $1.6 million, operating loss of $4.2 million, and net loss of $3.9 million, or $0.09 per share. He also pointed to $31.3 million in cash, cash equivalents and short-term investments at December 31, 2022, and reiterated the view that this is enough to fund operations into calendar Q2 2024 and support GTX-104 well into Phase 3 plus GTX-102 and GTX-101 through key milestones.

Analysts focused on timing, FDA interaction, and commercial preparation. For GTX-102, management said it expects the final clinical report in the first half of 2023, a draft protocol and FDA Type B meeting later this year, and startup activity in the second half of 2023. For GTX-104, Jan said Acasti has not yet had the FDA meeting and is waiting on guidance about eligibility for 505(b)(2), dosing, patient count, and how to define hypotensive events; she added that the FDA is short-staffed and timing has been slower than hoped. On commercial readiness for GTX-104, Prashant Kohli said the company is building relationships with key opinion leaders, high-volume neurocritical care centers, and potential early adopters, and plans to support launch with publications and pharmacoeconomic data. On GTX-101, Pierre Lemieux said the final report is expected in May and that some pharmacodynamic information may be shared later, but the study was primarily designed around PK, not PD.