Grace Therapeutics, Inc. 8K

Grace Therapeutics reported a larger quarterly net loss driven by impairment of non‑core programs, raised $10 million in private financing, and outlined its dual‑source manufacturing and regulatory plan to resubmit the NDA for lead asset GTx‑104 while projecting cash runway through year‑end 2028.

Grace Therapeutics, Inc. reported its first quarter 2027 financial results and provided a business update, highlighting a $10 million private placement financing, continued remediation and dual‑source manufacturing efforts to address chemistry, manufacturing and controls and non‑clinical issues cited in the FDA’s April 23, 2026 Complete Response Letter for its lead asset GTx‑104, and receipt of Type A meeting minutes confirming no clinical safety or efficacy deficiencies. For the quarter ended June 30, 2026, the company recorded a net loss of $15.8 million, driven largely by a $13.5 million impairment of in‑process R&D related to deprioritized programs GTx‑101 and GTx‑102, while research and development and general and administrative expenses declined year over year. Management reaffirmed that its existing cash and cash equivalents of $22.2 million as of August 11, 2026, together with the recent financing, are expected to fund operations, including completion of required non‑clinical studies and NDA resubmission activities for GTx‑104, through the end of calendar 2028.

Filing Facts

CIK

1444192

Ticker

-

Form

8K

Source Type

sec

Accession

0001140361-26-032644

Alert Tier

7