MeiraGTx Reports Third Quarter 2018 Financial Results and Provides Corporate Update
November 08, 2018
“The third quarter was very productive for
Corporate Highlights
NIH exclusive license: On
Phase 2 Parkinson’s Disease program: On
Clinical Development Highlights
AAV-CNGB3: Treated two additional pediatric patients in the extension phase of the Phase 1/2 study, bringing the total number of patients treated to 16 (11 adults and five pediatrics). The Company anticipates completing dosing the pediatric extension phase in 2018.
AAV-RPGR: Completed dose escalation phase of the Phase 1/2 study, bringing the total number treated to 10 patients. The Company expects to initiate dosing in the pediatric extension phase of the study in 2018.
AAV-RPE65: Dosing in the Phase 1/2 clinical study was completed in the second quarter of 2018. A total of nine adults were treated in three escalating dose cohorts. Six pediatric patients were treated in the pediatric extension arm of the study.
AAV-CNGA3: cGMP manufacturing of clinical material is ongoing in our manufacturing facility. We anticipate release in the next few months with the initiation of the treatment study in early 2019.
Regulatory Highlights
FDA Rare Pediatric Disease Designation for Achromatopsia Treatment (AAV-CNGA3): On
FDA Fast Track Designation for Achromatopsia Treatment (AAV-CNGB3): On
FDA Orphan Drug Designation for Achromatopsia Treatment (AAV-CNGA3): On
Third Quarter 2018 Financial Results
Comparison of Three Months Ended
General and administrative expenses were
Research and development expenses for the three months ended September 30, 2018 were
Foreign currency loss was $0.7 million for the three months ended September 30, 2018 compared to a gain of $0.4 million for the three months ended September 30, 2017. The increase of
Net loss for the three months ended
About MeiraGTx
For more information, please visit www.meiragtx.com
Forward-Looking Statements
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 product pipeline, anticipated product benefits, goals and strategic priorities, product candidate development, growth expectations or targets and pre-clinical and clinical data, 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, continue operating as a going concern, successfully execute strategic priorities, bring product candidates to market, build-out the manufacturing facility 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:
Investors@meiragtx.com
Media:
(212) 267-6722
cpascale@w2ogroup.com
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
September 30, | December 31, | ||||||||
2018 | 2017 | ||||||||
(unaudited) | |||||||||
ASSETS | |||||||||
CURRENT ASSETS: | |||||||||
Cash | $ | 88,560,634 | $ | 8,548,638 | |||||
Prepaid expenses | 2,029,327 | 1,961,243 | |||||||
Other current assets | 716,737 | 965,233 | |||||||
Total Current Assets | 91,306,698 | 11,475,114 | |||||||
Property and equipment, net | 13,624,968 | 14,255,729 | |||||||
Security deposits | 180,870 | - | |||||||
Restricted cash | 123,376 | 123,376 | |||||||
TOTAL ASSETS | $ | 105,235,912 | $ | 25,854,219 | |||||
LIABILITIES, CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) | |||||||||
CURRENT LIABILITIES: | |||||||||
Accounts payable | $ | 2,415,667 | $ | 7,055,380 | |||||
Accrued expenses | 6,042,290 | 9,332,944 | |||||||
Note payable | — | 1,442,009 | |||||||
Warrant liability | — | 2,679,633 | |||||||
Capitalized lease obligation - current portion | 29,284 | 30,850 | |||||||
Due to Kadmon | — | 861,030 | |||||||
Total Current Liabilities | 8,487,241 | 21,401,846 | |||||||
Capitalized lease obligation | 12,092 | 34,298 | |||||||
Deferred rent | 210,993 | 266,290 | |||||||
Asset retirement obligation | 181,515 | 178,419 | |||||||
TOTAL LIABILITIES | 8,891,841 | 21,880,853 | |||||||
COMMITMENTS | |||||||||
CONVERTIBLE PREFERRED C SHARES | |||||||||
Convertible Preferred C Shares 0 and 5,005,935 outstanding at September 30, 2018 and December 31, 2017, respectively (liquidation preference of $52,455,700 at December 31, 2017) |
— | 51,338,631 | |||||||
SHAREHOLDERS' EQUITY (DEFICIT): | |||||||||
Ordinary Shares, $0.00003881 nominal value, 1,288,327,750 authorized 27,184,132 issued and outstanding at September 30, 2018 8,826,190 issued and 8,714,563 issued and outstanding at December 31, 2017 |
1,055 | 342 | |||||||
Capital in excess of nominal value | 223,868,465 | 20,080,713 | |||||||
Accumulated other comprehensive loss | (292,477 | ) | (2,022,477 | ) | |||||
Accumulated deficit | (127,232,972 | ) | (65,423,843 | ) | |||||
Total Shareholders' Equity (Deficit) | 96,344,071 | (47,365,265 | ) | ||||||
TOTAL LIABILITIES, CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) | $ | 105,235,912 | $ | 25,854,219 | |||||
See Notes to Condensed Consolidated Financial Statements | |||||||||
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, | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Operating expenses: | |||||||||||||||||
General and administrative | $ | 6,629,052 | $ | 2,374,527 | $ | 35,129,120 | $ | 6,744,963 | |||||||||
Research and development | 8,109,160 | 6,388,227 | 22,827,176 | 16,575,129 | |||||||||||||
Total operating expenses | 14,738,212 | 8,762,754 | 57,956,296 | 23,320,092 | |||||||||||||
Loss from operations | (14,738,212 | ) | (8,762,754 | ) | (57,956,296 | ) | (23,320,092 | ) | |||||||||
Other non-operating income (expense): | |||||||||||||||||
Other income | - | — | 83,075 | — | |||||||||||||
Foreign currency (loss) gain | (677,488 | ) | 391,521 | (2,425,488 | ) | 990,395 | |||||||||||
Change in fair value of warrant liability | - | — | (1,514,775 | ) | — | ||||||||||||
Interest income | 264 | 2,915 | 50,926 | 21,295 | |||||||||||||
Interest expense | (9,508 | ) | (72,736 | ) | (46,571 | ) | (131,756 | ) | |||||||||
Net loss | (15,424,944 | ) | (8,441,054 | ) | (61,809,129 | ) | (22,440,158 | ) | |||||||||
Comprehensive income (loss): | |||||||||||||||||
Foreign currency translation | 508,758 | (348,338 | ) | 1,730,000 | (824,252 | ) | |||||||||||
Total comprehensive loss | $ | (14,916,186 | ) | $ | (8,789,392 | ) | $ | (60,079,129 | ) | $ | (23,264,410 | ) | |||||
Net loss | $ | (15,424,944 | ) | $ | (8,441,054 | ) | $ | (61,809,129 | ) | $ | (22,440,158 | ) | |||||
Accretion on convertible preferred C shares and warrants | - | (191,758 | ) | (1,806,512 | ) | (244,920 | ) | ||||||||||
Adjusted net loss | $ | (15,424,944 | ) | $ | (8,632,812 | ) | $ | (63,615,641 | ) | $ | (22,685,078 | ) | |||||
Basic and diluted net loss per ordinary share | $ | (0.59 | ) | $ | (1.00 | ) | $ | (3.89 | ) | $ | (2.66 | ) | |||||
Weighted-average number of ordinary shares outstanding | 26,340,450 | 8,607,832 | 16,355,849 | 8,536,447 | |||||||||||||
See Notes to Condensed Consolidated Financial Statements | |||||||||||||||||
Source: MeiraGTx