Every material Form 8-K Grace Therapeutics, Inc. has filed with the SEC since July 28, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Grace Therapeutics reported a net loss of $15.8 million, or $0.91 per share, for the three months ended June 30, 2026, up from $3.4 million, or $0.21 per share, a year earlier. The increase was mainly due to a $13.5 million impairment of in-process research and development tied to GTx-101 and GTx-102, which the company deprioritized in favor of GTx-104. The company also said cash and cash equivalents were $22.2 million as of August 11, 2026, and that existing cash is expected to last through the end of calendar 2028.
Net loss of $15.8 million, or $0.91 per share, versus $3.4 million, or $0.21 per share, in the same period of 2025
$13.5 million impairment of IPR&D for GTx-101 and GTx-102; no impairment was recorded for GTx-104 in the quarter
Cash and cash equivalents of $22.2 million as of August 11, 2026, with cash runway expected through the end of calendar 2028
Company announced a $10 million private placement and said it is pursuing a dual-source manufacturing strategy for the GTx-104 NDA resubmission
Grace Therapeutics sold 4,761,904 shares of common stock at $2.10 per share in a private placement to institutional and accredited investors, for approximately $10 million in gross proceeds before placement agent fees and expenses. The offering closed on August 6, 2026. The company expects the proceeds, with existing cash, to extend its cash runway to the end of calendar 2028, but the new shares add to the outstanding share count and the company has agreed to register them for resale.
4,761,904 shares sold at $2.10 per share, for approximately $10 million in gross proceeds
Offering closed August 6, 2026; Craig-Hallum Capital Group LLC acted as placement agent
Company expects cash runway to extend to the end of calendar 2028; proceeds will support manufacturing and regulatory work for GTx-104
Company agreed to register the resale of the shares and generally may not issue more shares or file a registration statement for 90 days after closing, subject to exceptions
Grace Therapeutics announced it received the FDA's official minutes from a Type A meeting on the April 23, 2026 Complete Response Letter for GTx-104. The company says the FDA cited facility-level cGMP issues at its contract manufacturer and additional leachables and excipient data, and it is adding a second, U.S.-based contract manufacturer as a backup route to resubmission. The filing gives no resubmission date, so the timing of a possible approval remains open.
FDA Type A meeting minutes received; CRL issued April 23, 2026 for GTx-104 new drug application
FDA did not identify clinical safety or efficacy deficiencies and did not request additional clinical data
Company is pursuing a dual-source manufacturing strategy with a second U.S.-based contract manufacturer; no single resubmission path has been designated
Corporate presentation updated July 28, 2026 to reflect the path to NDA resubmission
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