• |
Announced Phase 3 STRIVE-ON safety trial met primary endpoint.
|
• |
NDA submission to the FDA is anticipated in the first half of calendar year 2025.
|
•
|
Announced private placement financing of up to approximately $30.0 million in potential total gross proceeds, consisting of initial upfront funding of approximately $15.0 million and the potential to
receive up to an additional approximately $15.0 million upon cash exercise of accompanying warrants at the election of the investors; the financing was led by Nantahala Capital and ADAR1 Partners, LP, and includes participation from
new and existing healthcare-focused institutional investors, including Stonepine Capital Management, among others.The net proceeds of the initial upfront funding were approximately $13.8 million, after deducting fees and expenses.
|
• |
Hosted a virtual key opinion leader (KOL) event on November 20, 2024 featuring Abhishek Ray, MD (University Hospitals) and Andrew
Webb, PharmD, BCCCP (Massachusetts General Hospital), who discussed the high unmet medical need and current treatment landscape for patients suffering from aSAH. For the replay, click here.
|
• |
Received written responses to its End of Phase 1 meeting in GTx-102 where the FDA made recommendations on the path toward an NDA.
The FDA provided guidance on the design of a single pivotal efficacy and safety trial, including the neurological assessment scale for the primary endpoint, that could, with appropriate confirmatory evidence, support an NDA.
|
December 31, 2024
|
March 31, 2024
|
|||||||
(Expressed in thousands except share data)
|
|
$ |
|
$ |
||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
11,055
|
23,005
|
||||||
Receivables
|
301
|
722
|
||||||
Prepaid expenses
|
583
|
283
|
||||||
Total current assets
|
11,939
|
24,010
|
||||||
Equipment, net
|
19
|
24
|
||||||
Intangible assets
|
41,128
|
41,128
|
||||||
Goodwill
|
8,138
|
8,138
|
||||||
Total assets
|
61,224
|
73,300
|
||||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Trade and other payables
|
1,971
|
1,684
|
||||||
Total current liabilities
|
1,971
|
1,684
|
||||||
Derivative warrant liabilities
|
3,781
|
4,359
|
||||||
Deferred tax liability
|
3,333
|
5,514
|
||||||
Total liabilities
|
9,085
|
11,557
|
||||||
Commitments and contingencies (Note 10)
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.0001 par value per share; 10,000,000 authorized; none issued and outstanding
|
—
|
—
|
||||||
Common stock, $0.0001 par value per share; 100,000,000 authorized; 10,139,861 and 9,399,404 shares issued and outstanding as of December
31, 2024 and March 31, 2024, respectively
|
1
|
1
|
||||||
Additional paid-in capital
|
279,499
|
278,899
|
||||||
Accumulated other comprehensive loss
|
(6,038
|
)
|
(6,038
|
)
|
||||
Accumulated deficit
|
(221,323
|
)
|
(211,119
|
)
|
||||
Total stockholders' equity
|
52,139
|
61,743
|
||||||
Total liabilities and stockholders’ equity
|
61,224
|
73,300
|
Three months ended
|
Nine months ended
|
|||||||||||||||
December 31, 2024
|
December 31, 2023
|
December 31, 2024
|
December 31, 2023
|
|||||||||||||
(Expressed in thousands, except share and per share data)
|
|
$ |
|
$ |
$ |
|
$ |
|||||||||
Operating expenses
|
||||||||||||||||
Research and development expenses, net of government assistance
|
(2,194
|
)
|
(1,443
|
)
|
(7,877
|
)
|
(2,998
|
)
|
||||||||
General and administrative expenses
|
(1,510
|
)
|
(1,600
|
)
|
(5,619
|
)
|
(5,106
|
)
|
||||||||
Restructuring cost
|
—
|
—
|
—
|
(1,485
|
)
|
|||||||||||
Loss from operating activities
|
(3,704
|
)
|
(3,043
|
)
|
(13,496
|
)
|
(9,589
|
)
|
||||||||
Foreign exchange (loss) gain
|
(16
|
)
|
3
|
(11
|
)
|
(2
|
)
|
|||||||||
Change in fair value of derivative warrant liabilities
|
(1,178
|
)
|
125
|
578
|
(1,701
|
)
|
||||||||||
Interest and other income, net
|
138
|
316
|
544
|
662
|
||||||||||||
Total other income (expenses), net
|
(1,056
|
)
|
444
|
1,111
|
(1,041
|
)
|
||||||||||
Loss before income tax benefit
|
(4,760
|
)
|
(2,599
|
)
|
(12,385
|
)
|
(10,630
|
)
|
||||||||
Income tax benefit
|
605
|
208
|
2,181
|
943
|
||||||||||||
Net loss and total comprehensive loss
|
(4,155
|
)
|
(2,391
|
)
|
(10,204
|
)
|
(9,687
|
)
|
||||||||
Basic and diluted loss per share
|
(0.36
|
)
|
(0.21
|
)
|
(0.89
|
)
|
(1.09
|
)
|
||||||||
Weighted-average number of shares outstanding
|
11,506,234
|
11,506,257
|
11,506,234
|
8,874,872
|