MGTX MeiraGTx Holdings plc

13.53
+0.44  (+3%)
Previous Close 13.09
Open 13.29
52 Week Low 8.82
52 Week High 22.32
Market Cap $505,520,253
Shares 37,362,916
Float 34,357,186
Enterprise Value $314,962,555
Volume 188,478
Av. Daily Volume 124,073
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Upcoming Catalysts

Drug Stage Catalyst Date
AAV-AQP1
Xerostomia
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
MGC018
Solid Tumors
Phase 1/2
Phase 1/2
Phase 1/2 presentation at ASCO May 29, 2020.
AAV-RPGR
X-Linked Retinitis Pigmentosa
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing. Phase 3 trial planned.
AAV-CNGB3
Achromatopsia
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing.
AAV-RPE65
RPE65-Deficiency
Phase 1/2
Phase 1/2
Data presented at AAO October 12, 2019.
AAV-CNGA3
Achromatopsia
Phase 1/2
Phase 1/2
Phase 1/2 trial initiation announced August 7, 2019.

Latest News

  1. - 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 Ireland

    LONDON and NEW YORK, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the second quarter ended June 30, 2020 and provided an update on recent clinical development and business progress, including the Company's new cGMP viral vector manufacturing and plasmid production facilities in Shannon, Ireland.

    "The first half of 2020 has been marked by notable achievements for MeiraGTx, including the…

    - 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 Ireland

    LONDON and NEW YORK, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the second quarter ended June 30, 2020 and provided an update on recent clinical development and business progress, including the Company's new cGMP viral vector manufacturing and plasmid production facilities in Shannon, Ireland.

    "The first half of 2020 has been marked by notable achievements for MeiraGTx, including the recent presentation of positive clinical data on our investigational therapy for people with the severe inherited retinal disease X-linked retinitis pigmentosa, which demonstrate that AAV-RPGR treatment improved vision and support advancing the program into a pivotal trial," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx.

    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 Dr. Forbes. "We look forward to working with the local community in Shannon, Ireland as we establish our second cGMP viral vector manufacturing facility and our cGMP plasmid production facility. We expect our plasmid production facility to be operational by the end of 2020, and our second viral vector manufacturing facility to be operational by the end of 2021."

    As of June 30, 2020, MeiraGTx had cash and cash equivalents of $194.8 million. In addition, the Company expects approximately $24.4 million in receivables from development partner Janssen in the next 90 days. MeiraGTx believes this capital will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

    Recent Clinical Development and Corporate Updates

    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, MeiraGTx continues 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.
    • MeiraGTx anticipates 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 London cGMP facility. MeiraGTx expects to file an Investigational New Drug (IND) application in early 2021 following the release of the clinical material.

    Manufacturing and Supply Chain

    • MeiraGTx has selected Shannon, Ireland as 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. MeiraGTx expects 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

    • MeiraGTx appointed Robert K. Zeldin, M.D. as Chief Medical Officer. In this role, Dr. Zeldin oversees the development of MeiraGTx's six clinical stage gene therapy programs.

    For more information related to our clinical trials, please visit www.clinicaltrials.gov

    Financial Results

    License revenue was $2.5 million for the quarter ended June 30, 2020, compared to $2.0 million for the quarter ended June 30, 2019. The increase represents increased amortization of the $100.0 million upfront payment that the Company received in March 2019 from its collaboration agreement with Janssen.

    Research and development expenses were $16.2 million for the quarter ended June 30, 2020, compared to $9.8 million for the quarter ended June 30, 2019. The increase of $6.4 million was primarily due to an increase for the non-cash acquisition costs of Emrys Bio, Inc. and increases in costs related to the manufacture of material for clinical trials, payroll and payroll related costs and share-based compensation, which was partially offset by an increase in research funding provided under our collaboration agreement with Janssen and a decrease in costs related to our clinical trials.

    General and administrative expenses were $11.5 million for the quarter ended June 30, 2020, compared to $13.4 million for the quarter ended June 30, 2019. The decrease of $1.9 million was primarily due to decreases in payroll and payroll related costs, which was partially offset by increases in rent and facilities costs, insurance costs and consulting fees.

    Foreign currency loss was $0.4 million for the quarter ended June 30, 2020, compared to a gain of $0.3 million for the quarter ended June 30, 2019. The increase in the loss of $0.7 million was primarily due to a strengthening of the U.S. dollar against the pound sterling during the three months ended June 30, 2020.

    Net loss attributable to ordinary shareholders for the quarter ended June 30, 2020 was $25.4 million, or $0.69 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $20.8 million, or $0.63 basic and diluted net loss per ordinary share for the quarter ended June 30, 2019.

    Cash and cash equivalents were $194.8 million for the quarter ended June 30, 2020, compared to $204.4 million as of June 30, 2019.

    About MeiraGTx

    MeiraGTx (NASDAQ:MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx's initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

    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 June 30, 2020, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts

    Investors:

    MeiraGTx

    Elizabeth Broder

    (646) 860-7983

    or

    Media:

    W2O pure

    Christiana Pascale

    (212) 257-6722



    MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)

           
      June 30,  December 31, 
        2020

     2019

           
    ASSETS      
           
    CURRENT ASSETS:      
    Cash and cash equivalents $194,811,181  $227,233,384 
    Accounts receivable - related party  24,432,392   23,337,377 
    Prepaid expenses  7,318,772   4,464,085 
    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 
    Security deposits  705,515   951,138 
    In-process research and development  774,727   777,655 
    Restricted cash     123,376 
    Other assets  194,318   195,053 
    Right-of-use assets  25,920,174   29,002,448 
    TOTAL ASSETS $290,611,376  $323,887,646 
           
    LIABILITIES AND SHAREHOLDERS' EQUITY      
    CURRENT LIABILITIES:      
    Accounts payable $3,089,350  $3,759,339 
    Accrued expenses  18,491,860   18,083,757 
    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 
    Lease obligations  18,555,378   21,504,340 
    Asset retirement obligations  1,682,515   1,654,755 
    Deferred income tax liability  194,318   195,053 
    TOTAL LIABILITIES  117,845,862   133,085,545 
           
    COMMITMENTS      
           
    SHAREHOLDERS' EQUITY:      
    Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 37,362,416 and 36,791,906 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively  1,451   1,429 
    Capital in excess of par value  414,229,672   395,630,666 
    Accumulated other comprehensive income (loss)  2,669,474   (1,794,042)
    Accumulated deficit  (244,135,083)  (203,035,952)
    Total Shareholders' Equity  172,765,514   190,802,101 
    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $290,611,376  $323,887,646 





    MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (unaudited)

                 
      For the Three-

    Month Periods Ended June 30,
     For the Six-

    Month Periods Ended June 30,
      2020 2019 2020 2019
                 
    License revenue - related party $2,473,705  $1,981,676  $6,683,281  $2,766,636 
                 
    Operating expenses:            
    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 
    Interest income  193,604   39,726   982,975   39,726 
    Interest expense  (34,045)  (9,454)  (68,011)  (19,028)
    Loss before income taxes  (25,417,934)  (20,913,802)  (41,099,131)  (38,895,720)
    Benefit for income taxes     91,390      91,390 
    Net loss  (25,417,934)  (20,822,412)  (41,099,131)  (38,804,330)
    Other comprehensive income:            
    Foreign currency translation gain, net of tax of $0, for the three-month and six-month periods ended June 30, 2020, and $91,390 for the three-month and six-month periods ended June 30, 2019  517,592   1,579,882   4,463,516   446,199 
    Total comprehensive loss $(24,900,342) $(19,242,530) $(36,635,615) $(38,358,131)
    Net loss $(25,417,934) $(20,822,412) $(41,099,131) $(38,804,330)
    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 

     

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  2. LONDON and NEW YORK, Aug. 05, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the appointment of Robert K. Zeldin, M.D. as chief medical officer (CMO).

    A clinical immunologist by training, Dr. Zeldin brings more than 20 years of clinical, regulatory and industry experience to MeiraGTx, ranging from early-stage clinical development through Biologics License Application (BLA) filing and commercialization.

    "Dr. Zeldin is an experienced drug developer with a distinguished track record in the design and implementation of successful clinical development strategies," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "As we…

    LONDON and NEW YORK, Aug. 05, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the appointment of Robert K. Zeldin, M.D. as chief medical officer (CMO).

    A clinical immunologist by training, Dr. Zeldin brings more than 20 years of clinical, regulatory and industry experience to MeiraGTx, ranging from early-stage clinical development through Biologics License Application (BLA) filing and commercialization.

    "Dr. Zeldin is an experienced drug developer with a distinguished track record in the design and implementation of successful clinical development strategies," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "As we advance the MeiraGTx pipeline into late-stage development we are delighted to add Dr. Zeldin to our senior management team."

    Prior to joining MeiraGTx, Dr. Zeldin was CMO of Immunovant. Previously, he was CMO of Acceleron Pharma where he was instrumental in the preparation of the BLA for luspatercept which has been approved in the U.S. and Europe for the treatment of anemia associated with myelodysplastic syndromes and anemia associated with beta thalassemia. Prior to Acceleron, he was CMO of Belgium-based Ablynx NV, where he directed the Phase 3 development program and regulatory filings of caplacizumab, which has been approved for the treatment of thrombotic thrombocytopenic purpura in the U.S. and Europe. Dr. Zeldin also served as Senior Vice President and Head of Global Clinical Development at Stallergenes SA and Vice President and U.S. Medical Franchise Head – Respiratory and Dermatology at Novartis Pharmaceuticals. Earlier in his career, Dr. Zeldin spent seven years at Merck in increasingly strategic roles in worldwide regulatory affairs and clinical development. Prior to his work in industry, Dr. Zeldin served as a Medical Officer at the U.S. Food & Drug Administration (FDA) Center for Biologics Evaluation and Research. He also spent several years in clinical practice.

    "I look forward to working with MeiraGTx to bring innovative gene therapy treatments to patients with severe diseases who today have no treatment options," said Dr. Zeldin. "I am excited to join the MeiraGTx team at this important juncture as we prepare to initiate the Company's first pivotal trial."

    Dr. Zeldin holds a B.A. with honors from the Johns Hopkins University and a M.D. from Tufts University School of Medicine. His postdoctoral training included Residency in Internal Medicine at the University Health Center of Pittsburgh and Fellowship in Allergy and Clinical Immunology at the Johns Hopkins University School of Medicine.

    About MeiraGTx

    MeiraGTx (NASDAQ:MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx's initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

    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 March 31, 2020, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts



    Investors:

    MeiraGTx

    Elizabeth Broder

    (646) 860-7983

    or

    Media:

    W2O pure

    Christiana Pascale

    (212) 257-6722

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  3. • Data being presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting 

    • Significant improvements demonstrated after treatment in Phase 1/2 clinical trial 

    • Based on encouraging safety and efficacy profile, MeiraGTx and Janssen expect to progress AAV-RPGR into Phase 3 Lumeos clinical trial  

    • MeiraGTx to host investor conference call on Friday, July 17 at 8:00 a.m. ET     

    LONDON and NEW YORK, July 17, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced six-month data from the ongoing Phase 1/2 clinical trial (NCT03252847) of AAV-RPGR, an investigational gene therapy in development for the treatment of patients with…

    • Data being presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting 

    • Significant improvements demonstrated after treatment in Phase 1/2 clinical trial 

    • Based on encouraging safety and efficacy profile, MeiraGTx and Janssen expect to progress AAV-RPGR into Phase 3 Lumeos clinical trial  

    • MeiraGTx to host investor conference call on Friday, July 17 at 8:00 a.m. ET     

    LONDON and NEW YORK, July 17, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced six-month data from the ongoing Phase 1/2 clinical trial (NCT03252847) of AAV-RPGR, an investigational gene therapy in development for the treatment of patients with X-linked retinitis pigmentosa (XLRP) with genetically confirmed variants in the RPGR gene. Significant improvement in vision was demonstrated in the dose escalation phase of the trial and AAV-RPGR was found to be generally well tolerated. These initial results from the trial are being presented as a late-breaker oral presentation at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting.

    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.

    The ongoing Phase 1/2 MGT009 clinical trial consists of three phases: dose-escalation, dose-confirmation, and dose-expansion. In the dose-escalation phase (n=10), adults were administered low, intermediate, or high dose AAV-RPGR. Each patient was treated with subretinal delivery of AAV-RPGR in the eye that was more affected at baseline. The patient's other eye served as an untreated control. The primary endpoint of the trial is safety, with secondary endpoints assessing changes in visual function at pre-specified timepoints post-treatment. Baseline values were determined in triplicate. 

    At six months, significant improvement in retinal sensitivity was demonstrated in patients treated with low and intermediate dose AAV-RPGR. Improvement was evident at first post-treatment perimetry assessments at three months, with improvements generally sustained or increased at six months. Significant differences were observed in retinal sensitivity between treated and untreated eyes over time. Based on the robust safety and efficacy signals observed in the dose escalation portion of the study, the low and intermediate doses were selected for use in the ongoing randomized, controlled dose-expansion phase of the trial.

    "XLRP is characterized by early-onset visual field loss, with most patients progressing to blindness and associated loss of independence by young adulthood," said Michel Michaelides1, BSc MB BS MD(Res) FRCOphth FACS, MGT009 trial investigator, Consultant Ophthalmologist, Moorfields Eye Hospital and Professor of Ophthalmology, University College London. "Six-month data demonstrate AAV-RPGR may improve visual function in XLRP patients. Initial data also suggest treatment with AAV-RPGR has the potential to stabilize or slow progressive vision loss. These results support AAV-RPGR as an important advancement in the treatment of XLRP, for which there is no currently available therapeutic option." 

    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.

    "We are pleased to share these encouraging initial results from our XLRP gene therapy trial and look forward to advancing this program into a Phase 3 trial," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "These early data suggest AAV-RPGR has the potential to address some of the key functional manifestations of this severe disease for which there is no currently available therapy. I'd like to thank the investigators, patients and families who dedicate their time to our clinical trials and who continue to support us in our efforts to develop therapies that have the potential to make a meaningful difference and improve the lives of people with serious diseases."

    Data Summary:

    Data obtained to date suggest AAV-RPGR is generally well-tolerated. Most adverse events (AEs) were related to the surgical delivery procedure, were transient and resolved without intervention. There were no dose-limiting events. Inflammatory responses to therapy were observed in two out of three patients in the high dose cohort, which may have been associated with decreased activity of AAV-RPGR in these patients. Inflammation was effectively managed with an extended steroid protocol.               

    Six-month data from the dose escalation portion of the study (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).

    • Significant differences in mean retinal sensitivity were observed between treated eyes and untreated eyes in the intermediate dose cohort: 1.02 dB (90% CI: 0.75, 1.31)
    • Significant differences were observed in central visual field progression rate (V30) between treated eyes and untreated eyes in both the low2, 1.10 dB-sr/year (90% CI: 0.10, 2.10) and intermediate, 1.26 dB-sr/year (90% CI: 0.65, 1.86), dose cohorts.
    • Efficacy signals were observed at first post-treatment assessments at three months, with improvements generally sustained or increased at six months.             

    Perimetry is a sensitive standard-of-care measure of retinal function that reproducibly determines retinal sensitivity both cross-sectionally and longitudinally, thereby accurately defining disease progression over time.

    ASRS Presentation Information:

    Late-Breaker Presentation

    Title: AAV-RPGR Gene Therapy for RPGR-Associated X-Linked Retinitis Pigmentosa: 6-month Results From a Phase 1/2 Clinical Trial

    Presenter: Michel Michaelides, UCL Institute of Ophthalmology; Moorfields Eye Hospital

    Date: Oral presentation available to ASRS meeting attendees on the virtual meeting site as of July 17, 2020; live Q&A session to take place July 25, 2020

    Session: Hereditary Retinal Diseases Symposium

    Time: 11:55 a.m. – 12:10 p.m. ET

    Conference Call Information:

    MeiraGTx will host a conference call and webcast to review Professor Michaelides' ASRS presentation on July 17, 2020 at 8:00 a.m. ET. The webcast can be accessed by visiting the Investors page of the Company's website at https://investors.meiragtx.com/events-presentations. Alternatively, please call 1 (866) 796-1272 (U.S.) or 1 (409) 937-8924 (International) to listen to the conference call. The conference ID number for the call is 4669817. A replay of the webcast and accompanying presentation materials will be available on the Company's website for 30 days following the conference call.

    About AAV-RPGR

    AAV-RPGR is an investigational gene therapy for the treatment of patients with XLRP caused by mutations in the eye specific form of the RPGR gene (RPGR ORF15). AAV-RPGR is designed to deliver functional copies of the RPGR gene to the subretinal space in order to improve and preserve visual function. MeiraGTx and development partner Janssen are currently conducting a Phase 1/2 clinical trial of AAV-RPGR in patients with XLRP with mutations in RPGR ORF15. AAV-RPGR has been granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and PRIME, ATMP and Orphan designations by the European Medicines Agency (EMA). 

    About the Phase 1/2 MGT009 Clinical Trial

    MGT009 is a multi-center, open-label Phase 1/2 trial (NCT03252847) of AAV-RPGR gene therapy for the treatment of patients with XLRP associated with disease-causing variants in the RPGR gene. MGT009 consists of three phases: dose-escalation, dose-confirmation, and dose-expansion. Each patient was treated with subretinal delivery of AAV-RPGR in the eye that was more affected at baseline. The patient's other eye served as an untreated control. In dose-escalation (n=10), adults were administered low, intermediate, or high dose AAV-RPGR. The primary endpoint was safety. Visual function was assessed at baseline, three, six, nine and 12 months with Octopus 900 full-field static perimetry and mesopic fundus-guided microperimetry (MP); mean retinal sensitivity, visual field modeling and analysis (VFMA; Hill-of-vision volumetric measure), and pointwise comparisons were examined.

    About X-Linked Retinitis Pigmentosa (XLRP)

    XLRP is the most severe form of retinitis pigmentosa (RP), a group of inherited retinal diseases characterized by progressive retinal degeneration and vision loss. In XLRP, both rods and cones function poorly, leading to degeneration of the retina and total blindness. The most frequent cause of XLRP is disease-causing variants in the RPGR gene, accounting for more than 70% of cases of XLRP, and up to 20% of all cases of RP. There are currently no approved treatments for XLRP.

    About MeiraGTx

    MeiraGTx (NASDAQ:MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx's initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

    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 the development and efficacy of AAV-RPGR, plans to advance AAV-RPGR into Phase 3 clinical trial and anticipated  milestones regarding our 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 March 31, 2020, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts

    Investors:

    MeiraGTx

    Elizabeth Broder

    (646) 860-7983

    or

    Media:

    W2O pure

    Christiana Pascale

    (212) 257-6722

    ___________________________

    1 Professor Michaelides is a scientific founder of and consultant to MeiraGTx.

    2 Excludes one subject with panuveitis in the low dose cohort 

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  4. LONDON and NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced that its 2020 Annual General Meeting of Shareholders scheduled for Tuesday, June 2, 2020 at 10:00 a.m. ET, will be conducted solely through webcast instead of a hybrid meeting (i.e., in-person and webcast). The Company has elected to hold the meeting in a virtual-only format due to the public health and safety concerns posed by the outbreak of the novel coronavirus (COVID-19), the protocols imposed by state and local governmental authorities, and to support the health and safety of its shareholders, directors, employees and the public.  Shareholders can participate via live…

    LONDON and NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced that its 2020 Annual General Meeting of Shareholders scheduled for Tuesday, June 2, 2020 at 10:00 a.m. ET, will be conducted solely through webcast instead of a hybrid meeting (i.e., in-person and webcast). The Company has elected to hold the meeting in a virtual-only format due to the public health and safety concerns posed by the outbreak of the novel coronavirus (COVID-19), the protocols imposed by state and local governmental authorities, and to support the health and safety of its shareholders, directors, employees and the public.  Shareholders can participate via live webcast and will be unable to physically attend this year's Annual Meeting.

    As described in the proxy materials for the Annual Meeting, shareholders as of the close of business on April 6, 2020, the record date, are entitled to participate in the Annual Meeting by visiting www.virtualshareholdermeeting.com/MGTX2020 and entering the 16-digit control number found on the proxy card or Notice Regarding the Availability of Proxy Materials previously received by shareholders. Shareholders may vote and ask questions during the Annual Meeting by following the instructions available on the meeting website. Guests and shareholders without their 16-digit control number may join the Annual Meeting in a listen-only mode, but they will not have the option to vote shares or ask questions during the meeting. 

    All shareholders are encouraged to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. The proxy card and Notice Regarding the Availability of Proxy Materials that were previously distributed will not be updated to reflect the virtual-only meeting format and may be used to vote shares in connection with the Annual Meeting. Shareholders who have previously sent in proxies, or voted via telephone or by internet, do not need to take any further action.

    About MeiraGTx
    MeiraGTx (NASDAQ:MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx's initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

    For more information, please visit www.meiragtx.com.

    Contacts

    Investors:
    MeiraGTx
    Elizabeth Broder
    (646) 860-7983

    or

    Media:
    W2O pure
    Christiana Pascale
    (212) 267-6722

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  5. LONDON and NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2020 and provided an update on recent progress.

    During the first quarter of 2020, MeiraGTx remained focused on achieving its most important priorities for patients, including advancing its inherited retinal disease programs, progressing its xerostomia program through ongoing clinical studies, preparing for the next clinical trial of AAV-GAD for Parkinson's disease and planning the buildout of its second viral vector and plasmid manufacturing facility. In response to the COVID-19 pandemic, the Company is working closely…

    LONDON and NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2020 and provided an update on recent progress.

    During the first quarter of 2020, MeiraGTx remained focused on achieving its most important priorities for patients, including advancing its inherited retinal disease programs, progressing its xerostomia program through ongoing clinical studies, preparing for the next clinical trial of AAV-GAD for Parkinson's disease and planning the buildout of its second viral vector and plasmid manufacturing facility. In response to the COVID-19 pandemic, the Company is working closely with its development partners and clinical sites to implement solutions enabling continuity of study conduct while protecting the health and safety of employees, patients and healthcare providers.

    "Our teams in the UK, U.S. and Netherlands are working tirelessly to minimize the disruption caused by the global COVID-19 pandemic and continue our mission of improving the lives of people with serious diseases," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "Thank you to the MeiraGTx team and our collaborators for their dedication and commitment to developing transformative medicines during this challenging time."

    As of March 31, 2020, MeiraGTx had cash, cash equivalents and restricted cash of approximately $211 million. The Company believes this capital will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

    Inherited Retinal Disease (IRD) Portfolio:

    • MeiraGTx remains on track to report data from the ongoing Phase 1/2 clinical trial of AAV-RPGR for the treatment of X-linked retinitis pigmentosa in 2020, and continues to engage with global regulatory authorities as anticipated to advance the Company's IRD programs.

    AAV-AQP1 for the treatment of Grade 2/3 Radiation-Induced Xerostomia:  

    • Patients who have been treated in MeiraGTx's Phase 1/2 AQUAx trial are continuing post-treatment follow-up assessments. The Company anticipates that treatment of new patients will resume in the second quarter of 2020. MeiraGTx expects to report preliminary clinical data from this trial in the second half of 2020.

    AAV-GAD for the treatment of Parkinson's Disease:

    • MeiraGTx has initiated the process for cGMP-grade AAV-GAD material and expects to file an Investigational New Drug (IND) application in late 2020 or early 2021.

    Manufacturing and Supply Chain:

    • MeiraGTx continues to anticipate that its cGMP plasmid production facility will be operational by the end of 2020, and that its second cGMP viral vector manufacturing facility will be operational in 2021.
    • The Company has not experienced COVID-19 related supply chain disruptions and does not anticipate encountering supply chain disruptions that will impact its ability to support its current manufacturing and clinical trial activities.             

    For more information related to our clinical trials, please visit www.clinicaltrials.gov

    Financial Results
    Cash, cash equivalents and restricted cash were $210.8 million as of March 31, 2020, compared to $227.4 million as of March 31, 2019.

    License revenue was $4.2 million for the quarter ended March 31, 2020, compared to $0.8 million for the quarter ended March 31, 2019. The increase represents increased amortization of the $100.0 million upfront payment that the Company received in March 2019 from its collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

    Research and development expenses were $8.1 million for the quarter ended March 31, 2020, compared to $13.0 million for the quarter ended March 31, 2019. The decrease of $4.9 million was primarily due to an increase in research funding under the Janssen collaboration agreement in the amount of $12.7 million, which was partially offset by increases in costs related to the manufacture of material for clinical trials and costs related to clinical trials.

    General and administrative expenses were $11.8 million for the quarter ended March 31, 2020, compared to $8.5 million for the quarter ended March 31, 2019. The increase of $3.3 million was primarily due to increases in share-based compensation, payroll and payroll related costs, insurance costs and rent and facilities costs, which was partially offset by a decrease in legal and consulting fees.

    Foreign currency loss was $0.8 million for the quarter ended March 31, 2020, compared to a gain of $2.7 million for the quarter ended March 31, 2019. The decrease of $3.5 million was primarily due to a strengthening of the U.S. dollar against the pound sterling during the quarter ended March 31, 2020.

    Net loss attributable to ordinary shareholders for the quarter ended March 31, 2020 was $15.7 million, or $0.43 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $18.0 million, or $0.62 basic and diluted net loss per ordinary share for the quarter ended March 31, 2019.  

    About MeiraGTx
    MeiraGTx (NASDAQ:MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx's initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

    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 March 31, 2020, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts


    Investors:
    MeiraGTx
    Elizabeth Broder
    (646) 860-7983

    or

    Media:
    W2O pure
    Christiana Pascale
    (212) 267-6722


    MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (unaudited)
                 
        March 31,    December 31, 
        2020   2019 
                 
    ASSETS            
                 
    CURRENT ASSETS:            
    Cash and cash equivalents   $  210,409,650     $  227,233,384  
    Restricted cash      377,598        —  
    Accounts receivable - related party      27,979,259        23,337,377  
    Prepaid expenses      3,460,056        4,464,085  
    Tax incentive receivable      6,819,851        11,974,437  
    Other current assets      1,965,752        1,970,585  
    Total Current Assets      251,012,166        268,979,868  
                 
    Property and equipment, net      25,430,812        23,858,108  
    Security deposits      709,886        951,138  
    In-process research and development      762,285        777,655  
    Restricted cash      —        123,376  
    Other assets      191,198        195,053  
    Right-of-use assets      26,561,496        29,002,448  
    TOTAL ASSETS   $  304,667,843     $  323,887,646  
                 
    LIABILITIES AND SHAREHOLDERS' EQUITY            
    CURRENT LIABILITIES:            
    Accounts payable   $  7,288,347     $  3,759,339  
    Accrued expenses      12,784,394        18,083,757  
    Lease obligations, current      1,962,363        1,674,210  
    Deferred revenue - related party, current      20,930,133        25,678,515  
    Other current liabilities      60,780        —  
    Total Current Liabilities      43,026,017        49,195,821  
                 
    Deferred revenue - related party      55,700,543        60,535,576  
    Lease obligations      19,172,729        21,504,340  
    Asset retirement obligations      1,652,570        1,654,755  
    Deferred income tax liability      191,198        195,053  
    TOTAL LIABILITIES      119,743,057        133,085,545  
                 
    COMMITMENTS            
                 
    SHAREHOLDERS' EQUITY:            
    Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 36,817,916 and 36,791,906 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively      1,430        1,429  
    Capital in excess of par value      401,488,623        395,630,666  
    Accumulated other comprehensive income (loss)      2,151,882        (1,794,042 )
    Accumulated deficit      (218,717,149 )      (203,035,952 )
    Total Shareholders' Equity      184,924,786        190,802,101  
    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY   $  304,667,843     $  323,887,646  


    MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (unaudited)
                 
        For the Three Months Ended March 31, 
        2020     2019
                 
    License revenue - related party   $  4,209,576     $  784,960  
                 
    Operating expenses:            
    General and administrative      11,806,134        8,499,475  
    Research and development      8,083,342        12,976,229  
    Total operating expenses      19,889,476        21,475,704  
    Loss from operations      (15,679,900 )      (20,690,744 )
    Other non-operating income (expense):            
    Foreign currency (loss) gain      (756,701 )      2,718,400  
    Interest income      789,370        —  
    Interest expense      (33,966 )      (9,574 )
    Net loss      (15,681,197 )      (17,981,918 )
    Other comprehensive income (loss):            
    Foreign currency translation gain (loss)      3,945,924        (1,133,683 )
    Total comprehensive loss   $  (11,735,273 )   $  (19,115,601 )
    Basic and diluted net loss per ordinary share   $  (0.43 )   $  (0.62 )
    Weighted-average number of ordinary shares outstanding      36,624,950        28,776,915  

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