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MeiraGTx Holdings (MGTX) Investor Presentation - Slideshow
2022-08-11 18:01
CONFIDENTIAL Corporate Presentation August 2022 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product development and anticipated milestones regarding our pre-clinical and clinical data and reporting o ...
MeiraGTx(MGTX) - 2022 Q2 - Quarterly Report
2022-08-11 12:45
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38520 MeiraGTx Holdings plc (Exact Name of Registrant as Specified in its Charter) Indicate by check mark whether the registrant ...
MeiraGTx (MGTX) Investor Presentation - Slideshow
2022-05-20 20:07
Company Overview - MeiraGTx is a vertically integrated, clinical-stage gene therapy company developing cost-effective treatments for a range of serious disorders[3] - The company has a diversified pipeline of gene therapy candidates and a platform of core viral vector engineering capabilities[3] - MeiraGTx possesses cGMP manufacturing capacity with a commercial-ready scalable process[3] - The company is developing a next-generation gene therapy riboswitch-based gene regulation platform[3] Pipeline and Programs - MeiraGTx has six ongoing clinical programs focusing on inherited retinal diseases, salivary gland disorders, and Parkinson's disease[3] - In ocular, botaretigene sparoparvovec for X-linked RP is in Phase 3, with Phase 1/2 randomized expansion cohort data to be presented in 1H 2022 and Phase 3 enrollment in 2022[5, 6] - AAV-GAD for Parkinson's disease is expected to file an IND and initiate a clinical study in 1H 2022[6] - AAV-hAQP1 for Grade 2/3 RIX (radiation-induced xerostomia) has Phase 1 dose escalation data expected by YE 2022, and a randomized, multi-dose Phase 2 trial is planned to initiate by YE 2022[6] Gene Regulation Platform - The company's proprietary technology allows precise control of gene therapy expression levels via dose response to orally delivered small molecules, with an unprecedented dynamic range of >5000[3, 22] - MeiraGTx has created a gene regulation cassette controlled by a riboswitch, offering high expression when on and low expression when off[28] - The gene regulation system can control any gene, any vector, cell therapy, and gene editing[22] Manufacturing Capabilities - MeiraGTx has a fully integrated manufacturing ecosystem, including a non-GMP vector core in Amsterdam for preclinical supply[9] - The company has flexible and scalable GMP manufacturing facilities for clinical and commercial production, including a 150,000 sq ft facility in Shannon, Ireland, and a 29,000 sq ft facility in London, UK[10] - The Shannon facility has up to 12 viral vector suites with 2x 500L bioreactors per suite, while the London facility has 2 cell suites and 3 viral vector suites[10]
MeiraGTx(MGTX) - 2022 Q1 - Quarterly Report
2022-05-12 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38520 MeiraGTx Holdings plc (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 (State or other ju ...
Corporate Presentation March 2022
2022-04-29 21:53
CONFIDENTIAL Corporate Presentation March 2022 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product development and anticipated milestones regarding our pre-clinical and clinical data and reporting of ...
MeiraGTx(MGTX) - 2021 Q4 - Annual Report
2022-03-10 21:55
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38520 MEIRAGTX HOLDINGS PLC (Exact name of registrant as specified in its charter) Cayman Islands 98-1448305 (State or other ...
MeiraGTx(MGTX) - 2021 Q3 - Quarterly Report
2021-11-10 13:40
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q Cayman Islands 98-1448305 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 450 East 29 th Street, 14 th Floor New York, NY 10016 (Address of principal executive offices) (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 O ...
MeiraGTx(MGTX) - 2021 Q2 - Quarterly Report
2021-08-11 12:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38520 MeiraGTx Holdings plc (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 (State or other jur ...
MeiraGTx(MGTX) - 2021 Q1 - Quarterly Report
2021-05-11 12:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38520 MeiraGTx Holdings plc (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 (State or other ju ...
MeiraGTx(MGTX) - 2020 Q4 - Annual Report
2021-03-11 13:48
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38520 MEIRAGTX HOLDINGS PLC (Exact name of registrant as specified in its charter) Cayman Islands 98-1448305 (State or other ...