MeiraGTx Reports Second Quarter 2020 Financial Results
August 06, 2020
- Positive initial data from Phase 1/2 clinical trial of AAV-RPGR for the treatment of XLRP recently presented
- AAV-RPGR to advance into Phase 3 Lumeos clinical trial
- Expands manufacturing capabilities with new facilities in
LONDON and NEW YORK,
“The first half of 2020 has been marked by notable achievements for
MeiraGTx and Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, are jointly developing AAV-RPGR as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases.
“As we advance and expand our clinical pipeline of potential gene therapy products, our flexible and scalable cGMP manufacturing capabilities become increasingly critical in enabling the efficient and timely development of these potential therapies,” continued
AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa
- Initial positive clinical data from MeiraGTx’s ongoing Phase 1/2 clinical study (MGT009) of AAV-RPGR were presented as a late-breaker oral presentation at the
American Society of Retina Specialists(ASRS) 2020 Virtual Annual Meeting in July 2020.
- Six-month data from the dose escalation portion of the trial (n=10) demonstrated meaningful improvement from baseline in retinal sensitivity in the low (n=3) and intermediate (n=4) dose cohorts. Importantly, these improvements were evident when assessed with two perimetry approaches (static perimetry and microperimetry) and three analysis metrics (mean retinal sensitivity, central 30° hill-of-vision volumetric measure (V30), and pointwise comparison).
- Based on the encouraging safety and efficacy data demonstrated in the MGT009 trial to date, MeiraGTx and Janssen expect to advance AAV-RPGR into the Phase 3 Lumeos clinical trial for the treatment of patients with XLRP caused by mutations in RPGR gene.
AAV-AQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia
- In response to the COVID-19 pandemic,
MeiraGTxcontinues to work closely with clinical sites to enable continuity of the Company’s ongoing AQUAx clinical trial. New patient enrollment in the trial has resumed, and patients who have been treated in the trial are continuing to undergo post-treatment follow-up assessments. MeiraGTxanticipates reporting preliminary clinical data from the AAV-AQP1 program by the end of 2020.
AAV-GAD for the Treatment of Parkinson’s Disease
- Manufacturing of AAV-GAD material is ongoing at the Company’s
LondoncGMP facility. MeiraGTxexpects to file an Investigational New Drug (IND) application in early 2021 following the release of the clinical material.
Manufacturing and Supply Chain
MeiraGTxhas selected Shannon, Irelandas the site of the Company’s second cGMP viral vector manufacturing facility and cGMP plasmid production facility. These facilities will be designed for the manufacture of commercial-grade gene therapies in a fully integrated manner supported by MeiraGTx’s global quality assurance organization. MeiraGTxexpects the Irish facilities to provide additional flexibility as well as further large-scale capacity for clinical and commercial supply of its gene therapy product candidates from first-in-man clinical trials through potential commercialization. This project is supported by the Irish Government through IDA Ireland.
- The plasmid production facility is expected to be operational by the end of 2020, and the viral vector manufacturing facility is expected to be operational by the end of 2021.
Strengthened Senior Leadership Team
MeiraGTxappointed Robert K. Zeldin, M.D. as Chief Medical Officer. In this role, Dr. Zeldinoversees the development of MeiraGTx’s six clinical stage gene therapy programs.
For more information related to our clinical trials, please visit www.clinicaltrials.gov
License revenue was
Research and development expenses were
General and administrative expenses were
Foreign currency loss was
Net loss attributable to ordinary shareholders for the quarter ended
Cash and cash equivalents were
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, including in light of the COVID-19 pandemic, 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; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; 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 Quarterly Report on Form 10-Q for the quarter ended
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||194,811,181||$||227,233,384|
|Accounts receivable - related party||24,432,392||23,337,377|
|Tax incentive receivable||6,777,863||11,974,437|
|Other current assets||1,868,559||1,970,585|
|Total Current Assets||235,208,767||268,979,868|
|Property and equipment, net||27,807,875||23,858,108|
|In-process research and development||774,727||777,655|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Lease obligations, current||2,137,788||1,674,210|
|Deferred revenue - related party, current||23,003,106||25,678,515|
|Total Current Liabilities||46,722,104||49,195,821|
|Deferred revenue - related party||50,691,547||60,535,576|
|Asset retirement obligations||1,682,515||1,654,755|
|Deferred income tax liability||194,318||195,053|
|Capital in excess of par value||414,229,672||395,630,666|
|Accumulated other comprehensive income (loss)||2,669,474||(1,794,042||)|
|Total Shareholders' Equity||172,765,514||190,802,101|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||290,611,376||$||323,887,646|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|For the Three-
Month Periods Ended June 30,
|For the Six-
Month Periods Ended June 30,
|License revenue - related party||$||2,473,705||$||1,981,676||$||6,683,281||$||2,766,636|
|General and administrative||11,497,270||13,437,171||23,303,404||21,936,646|
|Research and development||16,202,065||9,771,754||24,285,405||22,747,983|
|Total operating expenses||27,699,335||23,208,925||47,588,809||44,684,629|
|Loss from operations||(25,225,630||)||(21,227,249||)||(40,905,528||)||(41,917,993||)|
|Other non-operating income (expense):|
|Foreign currency (loss) gain||(351,863||)||283,175||(1,108,567||)||3,001,575|
|Loss before income taxes||(25,417,934||)||(20,913,802||)||(41,099,131||)||(38,895,720||)|
|Benefit for income taxes||—||91,390||—||91,390|
|Other comprehensive income:|
|Foreign currency translation gain, net of tax of
|Total comprehensive loss||$||(24,900,342||)||$||(19,242,530||)||$||(36,635,615||)||$||(38,358,131||)|
|Basic and diluted net loss per ordinary share||$||(0.69||)||$||(0.63||)||$||(1.12||)||$||(1.26||)|
|Weighted-average number of ordinary shares outstanding||36,969,682||32,827,029||36,797,316||30,814,639|