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MeiraGTx(MGTX) - 2022 Q3 - Quarterly Report
2022-11-10 21:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION MeiraGTx Holdings plc 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 September 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 (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 (State or othe ...
MeiraGTx Holdings (MGTX) Investor Presentation - Slideshow
2022-10-05 17:46
CONFIDENTIAL Corporate Presentation October 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 ...
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
Financial Position - As of December 31, 2021, the company had cash and cash equivalents of $137.7 million, a decrease from $209.5 million as of December 31, 2020[651]. - Total current assets decreased to $183.2 million in 2021 from $272.6 million in 2020[661]. - The company reported an accumulated deficit of $340.6 million as of December 31, 2021, compared to $261.0 million in 2020, indicating ongoing financial losses[661]. - Total liabilities increased to $134.8 million in 2021 from $125.1 million in 2020[661]. - The net loss for 2021 was $79.6 million, compared to a net loss of $58.0 million in 2020, reflecting a 37% increase in losses[663]. - The company reported a basic and diluted net loss per ordinary share of $1.80 for 2021, compared to $1.54 in 2020[663]. - Cash and cash equivalents at the end of 2021 were $137.7 million, down from $209.5 million at the end of 2020, indicating a decrease of 34%[666]. - The accumulated deficit as of December 31, 2021, totaled $340.6 million, indicating significant ongoing financial challenges[672]. - The company used $10.5 million in cash flows from operations during 2021, with no assurance of generating positive cash flows in the future[672]. Revenue and Expenses - License revenue from related parties increased to $37.7 million in 2021, up from $15.6 million in 2020, representing a growth of 142%[663]. - Total operating expenses rose to $110.9 million in 2021, compared to $78.1 million in 2020, marking an increase of 42%[663]. - The Company recorded reductions to research and development expenses of $5.4 million and $5.3 million for the years ended December 31, 2021 and 2020, respectively, related to UK tax incentive programs[684]. - The Company recognized collaboration revenue of $37.7 million and $15.6 million for the years ended December 31, 2021 and 2020, respectively, related to license revenue[812]. - The Company recorded a total lease cost of $6.98 million for the year ended December 31, 2021, compared to $4.66 million for 2020[832]. Acquisitions and Collaborations - MeiraGTx Holdings acquired Bullseye Therapeutics, Inc. on October 4, 2021, to enhance its capabilities in retinal drug delivery[668]. - The company acquired Bullseye Therapeutics, Inc. for a total consideration of $1.5 million, which included 80,276 ordinary shares and $0.5 million in assumed liabilities[751]. - The acquisition of Bullseye resulted in an immediate charge of $1.5 million to research and development expense due to the lack of alternative use for the acquired in-process research and development[752]. - The company acquired Emrys Bio Inc. for a total consideration of $7.7 million, which included 580,000 ordinary shares[758]. - The acquisition of Emrys also resulted in an immediate charge of $7.7 million to research and development expense[759]. - The Company entered into a Collaboration Agreement with Janssen Pharmaceuticals, receiving a non-refundable upfront fee of $100 million for gene therapy development[800]. - The Company is eligible to receive up to $340 million in additional development and commercialization milestones from Janssen, with the first milestone payment of $30 million received in December 2021[805]. - Janssen will cover 100% of clinical and commercialization costs for the products developed under the Collaboration Agreement, with the Company receiving royalties on net sales[806]. Research and Development - The company has six programs in clinical development and a broad pipeline of preclinical and research programs, focusing on ocular and neurodegenerative diseases[667]. - Research and development costs are incurred with Janssen responsible for up to 100% of the costs, which are recorded as research and development expenses[737]. - The company recognized research and development expenses of $0.01 million related to its share of Visiogene's losses during the year ended December 31, 2021[765]. - The company accounted for the Visiogene License Agreement and Unit Agreement as a basket transaction, expensing $1.0 million as acquired in-process research and development[764]. Tax and Regulatory Matters - The Company recorded deferred tax assets of $100.3 million as of December 31, 2021, up from $61.5 million in 2020, primarily due to increased net operating loss carryforwards[794]. - The UK corporation tax rate is set to increase from 19% to 25% effective April 1, 2023, impacting future accounting periods[795]. - The company recorded unrecognized tax positions of $0.7 million and $0.5 million as of December 31, 2021 and 2020, respectively[742]. Asset Management - The company's non-current assets increased to $136.9 million in 2021 from $91.1 million in 2020, with significant growth in the European Union[748]. - Property, plant and equipment, net increased to $75.86 million in 2021 from $44.04 million in 2020, representing a 72% growth[767]. - Intangible assets decreased to $1.79 million in 2021 from $2.12 million in 2020, reflecting a 15.6% decline due to accumulated amortization[770]. - The balance of asset retirement obligations increased from $1,814,000 in 2021 to $2,081,000 in 2022, reflecting a growth of 14.7%[708]. - The company utilizes an estimated discount rate of 8% for calculating asset retirement obligations, which may significantly impact future measurements[706]. Market and Competitive Environment - The company anticipates continued losses for the foreseeable future and may never achieve profitability[17]. - The company is heavily dependent on the success of its Most Advanced Product Candidates, which are still in development[17]. - The company faces significant competition in a rapidly changing technological environment, which may impact its financial condition[17]. - The company has proprietary technology licensed from others, and losing these licenses could hinder product development[24]. COVID-19 Impact - The Company continues to monitor the impact of the COVID-19 pandemic on its financial condition and operations, with uncertainties affecting future predictions[676]. - The Company has made estimates regarding the impact of the COVID-19 pandemic within its consolidated financial statements, which may change in future periods[681].
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 ...