| • |
Submission to the FDA of the Company’s NDA for GTx-104. The application included a comprehensive data package, including positive data obtained from the Company’s Phase 3
STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine.
|
| • |
Submission of the NDA has the potential to trigger the exercise of up to $7.6 million in warrants issued as part of a private placement the Company completed in September 2023.
Under the terms of the September 2023 private placement, each warrant is exercisable for one share of common stock at an exercise price of $3.003 per share. These warrants are immediately exercisable and will expire on the earlier of (i)
the 60th day after the date of the acceptance by the FDA of an NDA for the Company's product candidate GTx-104 or (ii) September 25, 2028.
|
| • |
The FDA typically has a 60-day period to determine if the Company’s NDA is complete and acceptable for filing. Grace has obtained Orphan Drug Designation from the FDA for
GTx-104, which generally provides seven years of marketing exclusivity in United States upon FDA approval of the NDA. Additionally, the Company believes that its U.S. and international patent estate will provide additional marketing
exclusivity for GTx-104.
|




|
June 30,
2025
|
March
31, 2025
|
|||||||
|
(Expressed in thousands except share data)
|
$ | $ | ||||||
|
Assets
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
20,005
|
22,133
|
||||||
|
Receivables
|
20
|
126
|
||||||
|
Prepaid expenses
|
500
|
453
|
||||||
|
Total current assets
|
20,525
|
22,712
|
||||||
|
Equipment, net
|
14
|
15
|
||||||
|
Intangible assets
|
41,128
|
41,128
|
||||||
|
Goodwill
|
8,138
|
8,138
|
||||||
|
Total assets
|
69,805
|
71,993
|
||||||
|
Liabilities and Stockholders’ equity
|
||||||||
|
Current liabilities:
|
||||||||
|
Trade and other payables
|
2,315
|
1,930
|
||||||
|
Total current liabilities
|
2,315
|
1,930
|
||||||
|
Derivative warrant liabilities
|
1,628
|
1,141
|
||||||
|
Deferred tax liability
|
2,312
|
2,312
|
||||||
|
Total liabilities
|
6,255
|
5,383
|
||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Preferred stock, $0.0001 par value per share; 10,000,000 authorized; none issued and outstanding
as of June 30, 2025 and March 31, 2025
|
—
|
—
|
||||||
|
Common stock,
$0.0001 par value per share; 100,000,000 authorized; 13,828,562 and 13,718,106 shares issued and outstanding as of June 30,
2025 and March 31, 2025, respectively
|
1
|
1
|
||||||
|
Additional paid-in capital
|
293,636
|
293,334
|
||||||
|
Accumulated other comprehensive loss
|
(6,038
|
)
|
(6,038
|
)
|
||||
|
Accumulated deficit
|
(224,049
|
)
|
(220,687
|
)
|
||||
|
Total stockholders' equity
|
63,550
|
66,610
|
||||||
|
Total liabilities and stockholders’ equity
|
69,805
|
71,993
|
||||||

|
Three months ended
|
||||||||
|
June 30, 2025
|
June 30, 2024
|
|||||||
|
(Expressed in thousands, except share and per share data)
|
$ | $ | ||||||
|
Operating expenses
|
||||||||
|
Research and development expenses
|
(955
|
)
|
(2,708
|
)
|
||||
|
General and administrative expenses
|
(2,135
|
)
|
(2,255
|
)
|
||||
|
Loss from operating activities
|
(3,090
|
)
|
(4,963
|
)
|
||||
|
Foreign exchange gain (loss)
|
10
|
(8
|
)
|
|||||
|
Change in fair value of derivative warrant liabilities
|
(487
|
)
|
1,395
|
|||||
|
Interest and other income, net
|
205
|
235
|
||||||
|
Other (expense) income, net
|
(272
|
)
|
1,622
|
|||||
|
Loss before income tax benefit
|
(3,362
|
)
|
(3,341
|
)
|
||||
|
Income tax benefit
|
—
|
724
|
||||||
|
Net loss and total comprehensive loss
|
(3,362
|
)
|
(2,617
|
)
|
||||
|
Basic and diluted loss per share
|
(0.21
|
)
|
(0.24
|
)
|
||||
|
Weighted-average number of shares outstanding
|
15,924,522
|
10,928,543
|
||||||