Grace Therapeutics — Second Quarter 2027 Earnings Summary

Financial Performance:

• Reported a net loss of $2.1 million ($0.11 per share) for the three months ended September 30, 2026, compared to a net loss of $0.9 million ($0.06 per share) for the same period in 2025.
• Total research and development expenses were $0.9 million for the three months ended September 30, 2026, an increase of $0.3 million from $0.6 million in the prior year period.
• General and administrative expenses were $1.4 million for the three months ended September 30, 2026, a decrease of $0.6 million from $2.0 million in the prior year period.
• Cash and cash equivalents totaled $21.3 million as of September 30, 2026, an increase of $4.3 million from $17.0 million at March 31, 2026.
• Cash used in operations was approximately $5.0 million for the six months ended September 30, 2026.
• Total assets were $57.7 million as of September 30, 2026, down from $66.7 million at March 31, 2026, primarily due to a reduction in intangible assets from $41.1 million to $27.6 million.
• Total liabilities were $2.2 million as of September 30, 2026, compared to $2.8 million at March 31, 2026.
• Stockholders' equity decreased to $55.5 million as of September 30, 2026, from $63.9 million at March 31, 2026.

Guidance and Future Outlook:

• The company expects its existing cash and cash equivalents to sustain planned operations, including activities to address FDA Complete Response Letter (CRL) items, through the end of calendar 2028.
• The company is executing a plan to address CMC and non-clinical data items identified in the FDA CRL to prepare for the resubmission of the New Drug Application (NDA) for GTx-104.
• The timing of the NDA resubmission will depend on whichever manufacturing site (current or dual-source) reaches readiness first.
• Reinspection timing for the current contract manufacturer depends on the facility's readiness and FDA scheduling.

Business Segments and Product Lines:

• GTx-104, an injectable formulation of nimodipine for IV infusion in aSAH patients, has completed a Phase 3 clinical trial.
• The company initiated a dual-source manufacturing strategy, including technology transfer to a second U.S.-based contract manufacturer starting with analytical method transfer.
• Required non-clinical studies identified in the CRL have been initiated.
• The current contract manufacturer has submitted a corrective action plan to the FDA, which the company believes is being executed.
• GTx-104 has been administered to over 200 patients and healthy volunteers and holds FDA Orphan Drug Designation.

Market and Competitive Landscape:

• Aneurysmal Subarachnoid Hemorrhage (aSAH) accounts for approximately 5% of all strokes, affecting an estimated 42,500 U.S. hospital-treated patients annually.
• GTx-104 aims to address unmet medical needs by potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients.
• The drug delivery technology offers potential benefits including lower food effects, reduced drug-to-drug interactions, elimination of dosing errors, and better management of hypotension.

Risks and Challenges:

• The NDA resubmission is contingent on successfully addressing all items cited in the FDA CRL, with risks of review delays.
• Approval is contingent on the current contract manufacturer regaining compliance and generating required leachables data, or the second manufacturer completing technology transfer, manufacturing registration batches, and passing pre-approval inspection.
• The FDA will not approve the NDA while the current facility remains in an unacceptable compliance status.
• The company may require additional capital, which may not be available on acceptable terms.
• Risks include the timing and success of regulatory resubmission, intellectual property protection, and potential legislative or regulatory changes.

Management Commentary and Tone:

• CEO Prashant Kohli stated that the FDA did not identify clinical safety or efficacy deficiencies in the CRL and did not request additional clinical data.
• Management expressed confidence that the dual-source manufacturing strategy is progressing to address potential remediation issues.
• The tone indicates a focus on executing the plan to resolve CRL items and achieve NDA resubmission milestones.

Other Key Points:

• Completed a $10 million private placement financing in August 2026 with institutional and accredited investors, resulting in net proceeds of $9.2 million.
• Net proceeds are intended to support manufacturing and regulatory work to advance GTx-104.
• Received FDA meeting minutes from a Type A Meeting held to discuss the CRL issued on April 23, 2026.
• The company has 52 granted and pending patents related to GTx-104.
• Common stock outstanding increased to 21,035,930 shares as of September 30, 2026, from 16,024,026 shares as of March 31, 2026.