MeiraGTx(MGTX)
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MeiraGTx(MGTX) - 2019 Q1 - Quarterly Report
2019-05-14 12:10
Financial Position - As of March 31, 2019, the company had cash and cash equivalents of $227.3 million, which is expected to fund operating expenses and capital expenditures into 2022[144] - The company had $227.3 million in cash and cash equivalents as of March 31, 2019[180] - Cash provided by operating activities was $82.2 million in Q1 2019, primarily due to the $100 million upfront payment, offset by a net loss[182] - A 10% unfavorable movement in foreign currency exchange rates would not significantly increase the company's net loss[195] Operating Results - The company reported net losses of $18.0 million for the three months ended March 31, 2019, compared to $16.4 million for the same period in 2018, resulting in an accumulated deficit of $166.3 million[140] - The company reported a net loss of $17.98 million for Q1 2019, compared to a net loss of $16.40 million in Q1 2018, reflecting an increase in losses of $1.58 million[172] - Total operating expenses for the three months ended March 31, 2019, were $21.5 million, up from $18.1 million in the same period of 2018[141] - Total operating expenses for Q1 2019 were $21.5 million, up from $18.0 million in Q1 2018, an increase of $3.4 million[172] Research and Development - Research and development expenses for Q1 2019 totaled $13.0 million, a 87.3% increase from $7.0 million in Q1 2018[175] - The company anticipates that its research and development expenses will continue to increase substantially as it initiates additional clinical trials[12] - The company expects general and administrative expenses to increase as personnel headcount rises to support research and development activities[159] - The company is focused on the progress, costs, and results of its gene therapy programs and related clinical trials[190] Collaborations and Agreements - The company received an upfront payment of $100.0 million from the Collaboration and License Agreement with Janssen Pharmaceuticals, which also includes potential milestone payments and royalties[140] - The company entered a strategic collaboration with Janssen to develop gene therapies for inherited retinal diseases, with Janssen covering 100% of clinical and commercialization costs[153] - License revenue for Q1 2019 was $0.8 million, resulting from the amortization of a $100 million upfront payment from a collaboration agreement[173] Future Outlook - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances clinical development[178] - The company expects to finance its cash needs through a combination of equity offerings, debt financings, collaboration agreements, and other third-party funding until it can generate sufficient product revenue for profitability[189] - The company plans to scale up manufacturing processes to support preclinical studies and clinical trials of its product candidates[190] Other Financial Information - General and administrative expenses decreased to $8.5 million in Q1 2019 from $11.1 million in Q1 2018, a reduction of $2.6 million[174] - Foreign currency gain increased to $2.7 million in Q1 2019 from $1.0 million in Q1 2018, an increase of $1.7 million[177] - The company has not entered into any off-balance sheet arrangements and does not hold any variable interest entities[193] - The company is classified as an emerging growth company and has elected to take advantage of an extended transition period for compliance with new accounting standards[194] - There were no material changes in the company's commitments under contractual obligations during the three months ended March 31, 2019[192] - The company may have to relinquish valuable rights to technologies or future revenue streams if it raises additional funds through third-party funding or collaboration agreements[191] Clinical Trials - AAV-RPE65 for RPE65-Deficiency achieved the primary endpoint of safety and tolerability in a Phase 1/2 trial, with 15 patients treated[149] - The company is currently enrolling patients in the randomized extension portion of the AAV-RPGR study for X-Linked Retinitis Pigmentosa, expecting to treat up to 40 additional patients[150] - AAV-GAD for Parkinson's Disease is anticipated to meet with the FDA in mid-2019 to define the clinical pathway for regulatory approval[151]
MeiraGTx(MGTX) - 2018 Q4 - Annual Report
2019-03-26 21:13
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, 2018 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 Not applicable (State or ot ...
MeiraGTx (MGTX) Presents At BIO CEO & Investor Conference - Slideshow
2019-02-11 18:17
IRAGT February 11, 2019 ◎MEIRAGTZ | 1 Forward Looking Statements 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 the success of the research to be performed under the collaboration agreement, the development ...