MeiraGTx Reports Third Quarter 2019 Financial Results
November 07, 2019
LONDON and NEW YORK,
“Over the course of the third quarter, we continued to advance our broad pipeline of investigational gene therapies,” said
Third Quarter 2019 Clinical Development Highlights
Phase 1/2 trial of AAV-RPE65 for RPE65-Associated Retinal Dystrophy: Data from the trial were presented in
Phase 1/2 AQUAx trial of AAV-AQP1 for Grade 2/3 Radiation-Induced Xerostomia:
The Company’s single center Phase 1 dose-finding study of AAV-AQP1 also continues to enroll patients at the
Janssen-partnered investigational gene therapies:
For more information related to all of our clinical trials, please visit www.clinicaltrials.gov.
Third Quarter 2019 Corporate Highlights
Expanding manufacturing capabilities: In
Third Quarter 2019 Financial Results
As of
Comparison of Three Months Ended
General and administrative expenses were
Research and development expenses for the three months ended
Foreign currency gain was $0.1 million for the three months ended
Net loss for the three months ended
About MeiraGTx
For more information, please visit www.meiragtx.com.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated 2019 milestones regarding our pre-clinical and clinical data and reporting of such data and the timing of results of data in connection with AAV-AQP1 for the treatment of patients with radiation-induced Grade 2/3 xerostomia, as well as statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “should,” “anticipate” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, acquire additional capital, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; failure of early data to predict eventual outcomes; failure to obtain
Contacts
Investors:
(646) 860-7983
Investors@meiragtx.com
or
Media:
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(212) 257-6722
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MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 253,330,623 | $ | 68,080,175 | ||||
Prepaid expenses | 6,248,981 | 1,937,785 | ||||||
Other current assets | 11,509,144 | 4,634,105 | ||||||
Total Current Assets | 271,088,748 | 74,652,065 | ||||||
Right-of-use assets | 28,801,757 | - | ||||||
Property and equipment, net | 16,899,147 | 22,014,237 | ||||||
Security deposits | 839,149 | 105,085 | ||||||
Restricted cash | 123,376 | 123,376 | ||||||
TOTAL ASSETS | $ | 317,752,177 | $ | 96,894,763 | ||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable | $ | 3,798,441 | $ | 3,042,861 | ||||
Accrued expenses | 9,346,895 | 11,991,697 | ||||||
Lease obligations, current | 2,028,689 | 27,199 | ||||||
Deferred revenue - related party, current | 24,115,777 | — | ||||||
Other current liabilities | — | 437,053 | ||||||
Total Current Liabilities | 39,289,802 | 15,498,810 | ||||||
Deferred revenue - related party | 62,837,715 | — | ||||||
Lease obligations | 20,600,077 | 7,097 | ||||||
Deferred rent | - | 201,264 | ||||||
Asset retirement obligations | 131,213 | 128,119 | ||||||
TOTAL LIABILITIES | 122,858,807 | 15,835,290 | ||||||
COMMITMENTS | ||||||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized 36,571,722 issued and outstanding at September 30, 2019 27,386,632 issued and outstanding at December 31, 2018 |
1,420 | 1,064 | ||||||
Capital in excess of par value | 390,053,479 | 229,054,460 | ||||||
Accumulated other comprehensive income | 2,393,372 | 293,666 | ||||||
Accumulated deficit | (197,554,901 | ) | (148,289,717 | ) | ||||
Total Shareholders' Equity | 194,893,370 | 81,059,473 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 317,752,177 | $ | 96,894,763 | ||||
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (unaudited)
For the Three-Month Period Ended September 30, |
For the Nine-Month Period Ended September 30, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
License revenue - related party | $ | 3,582,586 | $ | - | $ | 6,349,222 | $ | - | ||||||||
Operating expenses: | ||||||||||||||||
General and administrative | $ | 9,874,810 | $ | 6,629,052 | $ | 31,811,456 | $ | 35,129,120 | ||||||||
Research and development | 4,614,446 | 8,109,160 | 27,362,432 | 22,827,176 | ||||||||||||
Total operating expenses | 14,489,256 | 14,738,212 | 59,173,888 | 57,956,296 | ||||||||||||
Loss from operations | (10,906,670 | ) | (14,738,212 | ) | (52,824,666 | ) | (57,956,296 | ) | ||||||||
Other non-operating income (expense): | ||||||||||||||||
Foreign currency gain (loss) | 115,470 | (677,488 | ) | 3,117,047 | (2,425,488 | ) | ||||||||||
Change in fair value of warrant liability | - | - | - | (1,514,775 | ) | |||||||||||
Other income | - | - | - | 83,075 | ||||||||||||
Interest income | 959 | 264 | 40,686 | 50,926 | ||||||||||||
Interest expense | (9,283 | ) | (9,508 | ) | (28,311 | ) | (46,571 | ) | ||||||||
Loss before income taxes | (10,799,524 | ) | (15,424,944 | ) | (49,695,244 | ) | (61,809,129 | ) | ||||||||
Benefit for income taxes | 338,670 | - | 430,060 | - | ||||||||||||
Net loss | (10,460,854 | ) | (15,424,944 | ) | (49,265,184 | ) | (61,809,129 | ) | ||||||||
Other comprehensive income: | ||||||||||||||||
Foreign currency translation, net of tax of $338,670 and $0 for the three-month periods | ||||||||||||||||
ended September 30, 2019 and 2018, respectively and $430,060 and $0 for the nine-month | ||||||||||||||||
periods ended September 30, 2019 and 2018, respectively | 1,653,507 | 508,758 | 2,099,706 | 1,730,000 | ||||||||||||
Total comprehensive loss | $ | (8,807,347 | ) | $ | (14,916,186 | ) | $ | (47,165,478 | ) | $ | (60,079,129 | ) | ||||
Net loss | $ | (10,460,854 | ) | $ | (15,424,944 | ) | $ | (49,265,184 | ) | $ | (61,809,129 | ) | ||||
Accretion on convertible preferred C shares and warrants | - | - | - | (1,806,512 | ) | |||||||||||
Adjusted net loss | $ | (10,460,854 | ) | $ | (15,424,944 | ) | $ | (49,265,184 | ) | $ | (63,615,641 | ) | ||||
Basic and diluted adjusted net loss per ordinary share | $ | (0.30 | ) | $ | (0.59 | ) | $ | (1.53 | ) | $ | (3.89 | ) | ||||
Weighted-average number of ordinary shares outstanding | 34,663,623 | 26,340,450 | 32,111,733 | 16,355,849 | ||||||||||||
Source: MeiraGTx