For more information, please visit: www.gracetx.com
Forward-Looking Statements
Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes, " "belief," "expects," "intends," "anticipates," "estimates", "potential, " "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company's anticipated cash runway, the timing of the Company's planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial and the timing of data readouts from the STRIVE-ON trial, GTx-104's commercial prospects; the size of the addressable market for GTx-104, the Company's beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Grace Therapeutics' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Grace Therapeutics' clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2024, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024 and other documents that have been and will be filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.
For more information, please contact:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
---tables to follow---
GRACE THERAPEUTICS, INC. Condensed
Consolidated Balance Sheets
(Unaudited)
September 30, March 31,
2024 2024
(Expressed in thousands except share
data) $ $
------------------------------------ ------------- ---------
Assets
Current assets:
Cash and cash equivalents 15,155 23,005
Short-term investments 15 --
Receivables 415 722
Prepaid expenses 477 283
-------------------------------------- ------------- ---------
Total current assets 16,062 24,010
Equipment, net 21 24
Intangible assets 41,128 41,128
Goodwill 8,138 8,138
-------------------------------------- ------------- ---------
Total assets 65,349 73,300
-------------------------------------- ------------- ---------
Liabilities and shareholders' equity
Current liabilities:
Trade and other payables 2,674 1,684
-------------------------------------- ------------- ---------
Total current liabilities 2,674 1,684
Derivative warrant liabilities 2,603 4,359
Deferred tax liability 3,938 5,514
-------------------------------------- ------------- ---------
Total liabilities 9,215 11,557
-------------------------------------- ------------- ---------
Commitments and contingencies
Shareholders' equity:
Class A common shares, no par value
per share; unlimited shares
authorized; 10,139,861 and 9,399,404
shares issued and outstanding as of
September 30, 2024 and March 31,
2024, respectively 261,038 261,038
Class B, C, D and E common shares,
no par value per share; unlimited
shares authorized; none issued and
outstanding -- --
Additional paid-in capital 18,302 17,862
Accumulated other comprehensive loss (6,038) (6,038)
Accumulated deficit (217,168) (211,119)
-------------------------------------- ------------- ---------
Total shareholders' equity 56,134 61,743
Total liabilities and shareholders'
equity 65,349 73,300
-------------------------------------- ------------- ---------
GRACE
THERAPEUTICS,
INC. Condensed
Consolidated
Statements of
Loss and
Comprehensive
Loss
(Unaudited)
----------------------- ----------------------
Three months ended Six months ended
----------------------- ----------------------
September September September September
30, 2024 30, 2023 30, 2024 30, 2023
(Expressed in
thousands,
except share
and per share
data) $ $ $ $
--------------- ---------- --------- ---------- ---------
Operating
expenses
Research and
development
expenses, net of
government
assistance (2,976) (460) (5,684) (1,555)
General and
administrative (1,855) (1,632) (4,109) (3,506)
Restructuring
cost -- -- -- (1,485)
----------------- ---------- --------- ---------- ---------
Loss from
operating
activities (4,831) (2,092) (9,793) (6,546)
Foreign exchange
gain (loss) 13 (13) 5 (5)
Change in fair
value of
derivative
warrant
liabilities 362 (1,826) 1,756 (1,826)
Interest and
other income,
net 172 212 407 346
----------------- ---------- --------- ---------- ---------
Total other
income
(expenses), net 547 (1,627) 2,168 (1,485)
----------------- ---------- --------- ---------- ---------
Loss before
income tax
benefit (4,284) (3,719) (7,625) (8,031)
Income tax
benefit 852 446 1,576 735
Net loss and
total
comprehensive
loss (3,432) (3,273) (6,049) (7,296)
----------------- ---------- --------- ---------- ---------
Basic and diluted
loss per share (0.30) (0.43) (0.53) (0.97)
Weighted average
number of shares
outstanding 11,506,234 7,552,677 11,506,234 7,494,425
----------------- ---------- --------- ---------- -
(MORE TO FOLLOW) Dow Jones Newswires
November 13, 2024 08:00 ET (13:00 GMT)
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