Nature of operations |
3 Months Ended |
|---|---|
Jun. 30, 2026 | |
| Nature of operations [Abstract] | |
| Nature of operations |
1. Nature of operations
General
Grace Therapeutics, Inc. (formerly known as Acasti Pharma Inc.) (“Acasti Delaware” or the “Company”), is a Delaware corporation that, as further described below, previously existed under the laws of the Province of Québec, Canada (“Acasti Québec”), before changing its jurisdiction on October 1, 2024 to the Province of British Columbia, Canada (“Acasti British Columbia”). On October 7, 2024, Acasti British Columbia changed its jurisdiction to the State of Delaware in the United States of America. Effective October 28, 2024, the Company changed its corporate name to Grace Therapeutics, Inc.
Liquidity and Financial Condition
The Company has incurred operating losses and negative cash flows from operations in each period since its inception. The Company expects to incur significant expenses and continued operating losses for the foreseeable future.
In
May 2023, the Company implemented a strategic realignment plan to enhance
shareholder value that resulted in the Company engaging a new management team,
streamlining its research and development activities, and greatly reducing its
workforce. Following the realignment, the Company is a smaller, more focused
organization, based in the United States, and concentrated on its development
of its lead product candidate GTx-104. In June 2026, following continued
evaluation of strategic priorities and focus on GTx-104, the Company impaired
the $13,533 capitalized carrying value of GTx-102 and GTx-101 in process
research and development (“IPR&D”), which is recorded within operating
expenses in the condensed consolidated statements of loss and comprehensive
loss for the three months ended June 30, 2026. In August 2026, the Company
completed a private placement of Company common stock, par value $0.0001 per
share (“Common Stock”) with certain institutional and accredited
investors. Net proceeds to the Company were approximately $9,100. Refer to Note 12, Subsequent Events for additional
information. As of August 11, 2026, cash and cash equivalents were $22,231. The
Company plans to use its cash and cash equivalents towards resolving the items
cited in the FDA’s CRL, working capital and other general corporate purposes.
The Company believes its existing cash and cash equivalents will be sufficient
to sustain planned operations, including the activities to address the items
cited in the CRL, through at least 12 months from the issuance date of these
unaudited condensed financial statements. The
Company will require additional capital to fund its daily operating needs. The
Company does not expect to generate revenue from product sales unless and until
it successfully completes drug development and obtains regulatory approval,
which is subject to significant uncertainty. To date, the Company has financed
its operations primarily through public offerings and private placements of its
common equity, warrants and convertible debt and the proceeds from warrant
exercises and research tax credits. Until such time that the
Company can generate significant revenue from drug product sales, if ever, it
will require additional financing, which is expected to be sourced from a
combination of public or private equity or debt financing or other non-dilutive
sources, which may include fees, milestone payments and royalties from
collaborations with third parties. Arrangements with collaborators or others
may require the Company to relinquish certain rights related to its
technologies or drug product candidates. Adequate additional financing may not
be available to the Company on acceptable terms, or at all. The Company’s
inability to raise capital as and when needed could have a negative impact on
its financial condition and its ability to pursue its business strategy. The
Company plans to raise additional capital in order to maintain adequate
liquidity. Negative results from studies or trials, if any, the timing and
ability to receive FDA approval for marketing the
Company’s drug candidates or depressed prices of the Company’s
stock could impact the Company’s ability to raise additional financing. Raising
additional equity capital is subject to market conditions that are not within
the Company’s control. If the Company is unable to raise additional funds, the
Company may not be able to realize its assets and discharge its liabilities in
the normal course of business.
The Company remains subject to risks similar to other development stage companies in the biopharmaceutical industry, including compliance with government regulations, protection of proprietary technology, dependence on third-party contractors and consultants and potential product liability, among others. Please refer to the risk factors included in Part 1, Item 1A of the Company’s Annual Report on Form 10-K for the year ended March 31, 2026, filed with the SEC on June 18, 2026 (the “Annual Report”).
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