MeiraGTx(US:MGTX)2019-05-14 12:10Financial 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]