MeiraGTx Reports Full Year 2019 Financial Results
March 11, 2020
LONDON and NEW YORK,
“During 2019, the
Recent Clinical Development Highlights and Anticipated 2020 Milestones
AAV-AQP1 for the treatment of Grade 2/3 Radiation-Induced Xerostomia:
MeiraGTxcontinues to activate clinical trial sites in the Company’s recently initiated Phase 1/2 AQUAx study, with patients now being enrolled at three of five expected study sites. Dosing in the first cohort was completed in the first quarter of 2020.
- The Company’s single center Phase 1 dose-finding study of AAV-AQP1 also continues to enroll patients at the
National Institutes of Health(NIH). Enrollment in the fourth dose escalation cohort is now ongoing. MeiraGTxexpects to report preliminary data from the AQUAx clinical trial in the second half of 2020.
Janssen-partnered investigational gene therapies for the treatment of inherited retinal diseases:
- In 2019,
MeiraGTxand Janssen Pharmaceuticals, Inc.(Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, entered into a worldwide collaboration and license agreement to develop, manufacture and commercialize gene therapies for inherited retinal diseases, including MeiraGTx’s ongoing Phase 1/2 studies of AAV-RPGR for X-linked retinitis pigmentosa (XLRP) and AAV-CNGB3 and AAV-CNGA3 for achromatopsia (ACHM).
- In the first quarter of 2020, the
European Medicines Agency(EMA) granted Priority Medicines (PRIME) and Advanced Therapy Medicinal Product (ATMP) designations to AAV-RPGR. PRIME designation was granted based on clinical data from the ongoing Phase 1/2 trial. To be awarded PRIME, a medicine must demonstrate potential to benefit patients with unmet medical needs based on early clinical data. MeiraGTxexpects to engage with global regulatory authorities in 2020 with the goal of optimizing and accelerating the development of AAV-RPGR. MeiraGTxexpects to report data from the ongoing clinical trial of AAV-RPGR in 2020. MeiraGTxcontinues to advance the Company’s ongoing Phase 1/2 studies of AAV-CNGB3 and AAV-CNGA3 for the treatment of ACHM associated with mutations in the CNGB3 and CNGA3 genes.
AAV-GAD for the treatment of Parkinson’s Disease:
MeiraGTxanticipates that the Company will file an Investigational New Drug application (IND) in the second half of 2020.
AAV-RPE65 for the treatment of RPE65-Associated Retinal Dystrophy:
- In 2019,
MeiraGTxpresented data from a Phase 1/2 clinical trial which demonstrated that, in addition to meeting its primary endpoint of safety, AAV-RPE65 demonstrated statistically significant improvement across several assessments of visual function. MeiraGTxexpects to meet with global regulatory authorities in 2020 to determine the regulatory pathway for AAV-RPE65.
For more information related to our clinical trials, please visit www.clinicaltrials.gov
Recent Corporate Development Highlights and Anticipated 2020 Milestones
Second Viral Vector Manufacturing Facility and Plasmid Production Facility
MeiraGTxhas completed feasibility studies for a second cGMP viral vector manufacturing facility and a cGMP plasmid production facility.
- The Company anticipates that its plasmid production facility will be operational by the end of 2020 and expects to initiate construction of its viral vector facility in mid-2020.
Expanding Clinical, Regulatory, Manufacturing, MSAT and Preclinical Development Teams
MeiraGTxcontinues to substantially increase key personnel across functional areas to support the Company’s broad pipeline of optimized investigational gene therapies. The MeiraGTxteam now includes more than 155 full-time employees.
Cash and cash equivalents were
Research and development expenses were
General and administrative expenses were
Foreign currency gain was
Net loss attributable to ordinary shareholders for the year ended
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 2020 milestones regarding our pre-clinical and clinical data and reporting of such data and the timing of results of 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, 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 FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|For the Year Ended
|License revenue - related party||$||13,291,956||$||—|
|General and administrative||$||46,684,297||$||44,483,938|
|Research and development||24,875,659||33,620,223|
|Total operating expenses||71,559,956||78,104,161|
|Loss from operations||(58,268,000||)||(78,104,161||)|
|Other non-operating income (expense):|
|Foreign currency gain (loss)||3,199,774||(3,824,383||)|
|Change in fair value of warrant liability||—||(1,514,775||)|
|Loss before income taxes||(54,746,235||)||(83,340,265||)|
|Benefit for income taxes||—||474,391|
|Other comprehensive (loss) income:|
|Foreign currency translation, net of tax of
|Total comprehensive loss||$||(56,833,943||)||$||(80,549,731||)|
|Accretion on convertible preferred C shares and warrants||—||(1,806,512||)|
|Net loss attributable to ordinary shareholders||$||(54,746,235||)||$||(84,672,386||)|
|Basic and diluted adjusted net loss per ordinary share||$||(1.65||)||$||(4.47||)|
|Weighted-average number of ordinary shares outstanding||33,161,860||18,948,520|
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||227,233,384||$||68,080,175|
|Accounts receivable - related party||23,337,377||—|
|Tax incentive receivable||11,974,437||3,416,932|
|Other current assets||1,970,585||1,217,173|
|Total Current Assets||268,979,868||74,652,065|
|Property and equipment, net||23,858,108||22,014,237|
|In-process research and development||777,655||—|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Lease obligations, current||1,674,210||27,199|
|Deferred revenue - related party, current||25,678,515||—|
|Other current liabilities||—||437,053|
|Total Current Liabilities||49,195,821||15,498,810|
|Deferred revenue - related party||60,535,576||—|
|Asset retirement obligations||1,654,755||128,119|
|Deferred income tax liability||195,053||—|
36,791,906 issued and outstanding at
27,386,632 issued and outstanding at
|Capital in excess of par value||395,630,666||229,054,460|
|Accumulated other comprehensive (loss) income||(1,794,042||)||293,666|
|Total Shareholders' Equity||190,802,101||81,059,473|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||323,887,646||$||96,894,763|