MeiraGTx reports 2022 EPS ($2.87), consensus ($2.74)

Reports 2022 revenue $15.9M, consensus $32.74M. "As we begin 2023, we are increasingly confident in all three of our lead clinical programs, as well as our transformative riboswitch gene regulation technology," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "In the fourth quarter of last year, we announced positive clinical data from our Phase 1 trial of AAV-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia and presented positive data at AAO demonstrating positive safety and sustained vision improvement in patients with X-linked retinitis pigmentosa who were treated with botaretigene sparoparvovec in our Phase 1/2 trial. We also presented 15 abstracts at the European Society of Gene and Cell Therapy Annual Congress highlighting just some of the data from our gene control platforms, including for the first time our riboswitch gene regulation applied to cell therapy. In addition, we began dosing patients with adeno-associated virus encoding glutamic acid decarboxylase, an investigational gene therapy for Parkinson’s disease. This year, in XLRP, we intend to complete enrollment of the pivotal Lumeos Phase 3 study and are on track for a BLA filing in 2024. In xerostomia, we intend to begin a randomized, double-blind, placebo-controlled, Phase 2 study in the second quarter, and in AAV-GAD for Parkinson’s, we anticipate completing enrollment of our current study in the second half of 2023 as we move forward with discussions with global regulators regarding a path to BLA. This progress across multiple programs and platforms is enabled by our broad end-to-end capabilities in vectorology optimization and manufacturing. In addition, in 2023, we intend to share more about our plans to use our riboswitch technology to allow gene therapy to be applied to more prevalent diseases in a cost-effective way. This has been one of our primary goals since the inception of MeiraGTx, and we are very excited to be advancing towards potentially achieving this ambition."