Press Release: Grace Therapeutics Announces Second Fiscal Quarter 2025 Financial Results, Provides Business Update

Dow Jones
2024-11-13

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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