MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $0.19 per share, beating the Zacks Consensus Estimate of a loss of $0.6 per share. This compares to a loss of $0.5 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +131.67%. A quarter ago, it was expected that this company would post a loss of $0.5 per share when it actually produced a loss of $0.62, delivering a surprise of -24%.Over the last four quarters, the c ...

Exhibit 99.1 MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports Fourth Quarter and Full Year 2025 Financial and Operational Results LONDON and NEW YORK, March 26, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the fourth quarter and full-year ended December 31, 2025, ...

FDA granted Breakthrough Therapy Designation for AAV2-hAQP1 for the treatment of Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tractMeiraGTx to hold a program update and present long-term data for AAV2-hAQP1 program for the treatment of Grade 2/3 Radiation-Induced Xerostomia on Thursday, April 16th, 2026 LONDON and NEW YORK, March 26, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines co ...

MeiraGTx (NasdaqGS:MGTX) Conference March 25, 2026 11:00 AM ET Company ParticipantsAlexandria Forbes - President and CEOLisa Walter - VP of Biotech Equity ResearchLisa WalterGood morning, everyone. I'm Lisa Walter, Biotech Analyst here at RBC Capital Markets. Thanks for joining us at RBC's Ophthalmology Conference. This session, we have Alexandria Forbes, President and Chief Executive Officer of MeiraGTx. Zandy, thanks so much for joining us today. How are you doing?Alexandria ForbesWell, I'm doing very wel ...

Core Insights - MeiraGTx Holdings PLC reported a quarterly loss of $0.62 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.50, marking an earnings surprise of -24.00% [1] - The company generated revenues of $0.41 million for the quarter ended September 2025, significantly missing the Zacks Consensus Estimate by 89.95%, and down from $10.91 million in the same quarter last year [2] - The stock has increased by approximately 42.2% since the beginning of the year, outperforming the S&P 500's gain of 16.5% [3] Financial Performance - Over the last four quarters, MeiraGTx has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.54 on revenues of $4.55 million, and for the current fiscal year, it is -$1.11 on revenues of $41.42 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which MeiraGTx belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5] Future Outlook - The company's earnings outlook will be crucial for investors, particularly in light of management's commentary during the earnings call [4] - The estimate revisions trend for MeiraGTx was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6]

Financial Performance - The company reported net losses of $50.5 million for Q3 2025, compared to $39.3 million for Q3 2024, and $129.3 million for the nine months ended September 30, 2025, compared to $108.4 million for the same period in 2024[145]. - Net loss for the three months ended September 30, 2025, was $50.5 million, an increase of $11.2 million from a net loss of $39.3 million in 2024[196]. - Cash used in operating activities was $93.0 million for the nine months ended September 30, 2025, compared to $81.2 million in 2024, reflecting an increase in net loss from $108.4 million to $129.3 million[226][227]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances preclinical and clinical development, necessitating additional capital[221]. Cash and Financing - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $17.1 million, with an additional $2.8 million in receivables from Johnson & Johnson Innovative Medicine[144]. - As of September 30, 2025, the company had $17.1 million in cash, cash equivalents, and restricted cash, with a net decrease of $89.1 million during the nine months[225]. - Net cash provided by financing activities was $6.9 million for the nine months ended September 30, 2025, compared to $50.3 million in 2024, indicating a significant decrease in financing[229][230]. - The company anticipates needing additional capital to fund operations and may raise funds through equity offerings, debt financing, or strategic collaborations[147]. - The company estimates it can fund operations into the second half of 2027 based on current cash and anticipated payments, excluding potential near-term cash from milestone achievements[223]. Operating Expenses - The total operating expenses for Q3 2025 were $46.5 million, down from $51.0 million in Q3 2024, while for the nine-month periods, expenses were $138.5 million in 2025 compared to $144.6 million in 2024[146]. - Total operating expenses for the three months ended September 30, 2025, were $46.5 million, a decrease of $4.5 million from $50.9 million in 2024[196]. - Total operating expenses for the nine months ended September 30, 2025, were $138.5 million, a decrease of $6.1 million from $144.6 million in 2024[208]. Research and Development - Research and development expenses increased to $32.5 million for the three months ended September 30, 2025, up by $6.3 million from $26.2 million in 2024, primarily due to increased manufacturing costs[203]. - Research and development expenses for the nine months ended September 30, 2025, were $98.8 million, an increase of $3.3 million from $95.5 million in 2024, primarily due to higher costs in the AAV-GAD program and other ocular diseases[216]. - The company expects to incur increased research and development costs, particularly for AAV-hAQP1 and AAV-GAD, with some costs offset by funding from Hologen[184]. Collaborations and Agreements - The company has received approximately $632.2 million from equity securities sales, $75.0 million from debt issuance, and $130.0 million from the Collaboration Agreement with Johnson & Johnson Innovative Medicine[144]. - A strategic collaboration with Hologen Limited includes an upfront cash payment of $200 million and potential additional funding of up to $230 million[154]. - MeiraGTx entered into a strategic collaboration with Lilly, receiving an upfront payment of $75 million and potential milestone payments exceeding $400 million for the development of genetic medicines in ophthalmology[168]. - Hologen has made $28.0 million in payments towards the upfront payment and an additional $22.0 million in Q4 2025[154]. - Hologen has an exclusive option to purchase additional shares in MeiraGTx Manufacturing, potentially increasing its ownership to 40% within 12 months[164]. - The joint venture Hologen Neuro AI Ltd will be funded with a $200 million upfront payment and up to $230 million in additional funding from Hologen for the AAV-GAD program targeting Parkinson's disease[174]. Clinical Developments - AAV2-hAQP1 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, with a Phase 2 study currently enrolling participants[174]. - AAV-GAD for Parkinson's disease has received RMAT designation, with positive data from three clinical studies supporting its development[174]. - The Phase 3 LUMEOS trial for botaretigene sparoparvovec (bota-vec) has received Fast Track and orphan drug designations from the FDA, with potential revenue of up to $285 million upon first commercial sales[176]. - The company is progressing its first riboswitch program for metabolic disease, with IND-enabling discussions ongoing with regulatory agencies[176]. Currency and Interest - Foreign currency loss was $1.6 million for the three months ended September 30, 2025, compared to a gain of $3.5 million in 2024, reflecting a $5.1 million change due to currency fluctuations[204]. - Foreign currency gain was $10.8 million for the nine months ended September 30, 2025, compared to $2.6 million in 2024, reflecting an increase of $8.1 million due to the weakening of the U.S. dollar against the pound sterling and euro[217]. - Interest income decreased to $0.2 million for the three months ended September 30, 2025, down by $1.0 million from $1.2 million in 2024, attributed to lower interest rates and cash balances[205]. - Interest income decreased to $1.5 million for the nine months ended September 30, 2025, down from $3.1 million in 2024, a decline of $1.6 million attributed to lower interest rates and cash balances[219]. - Interest expense for the three months ended September 30, 2025, was $3.1 million, a decrease of $0.3 million from $3.4 million in 2024, primarily due to lower interest rates[206]. - Interest expense decreased to $9.1 million for the nine months ended September 30, 2025, from $9.9 million in 2024, a reduction of $0.7 million due to lower interest rates[220]. - A hypothetical 1% increase in the SOFR would increase annual interest expense by approximately $0.8 million, given the current outstanding balance of $75.0 million[234].

Financial Performance - MeiraGTx reported cash and cash equivalents of approximately $17.1 million as of September 30, 2025, down from $105.7 million as of December 31, 2024[18]. - Service revenue decreased to $0.4 million for Q3 2025, compared to $10.9 million for Q3 2024, a decline of $10.5 million[18]. - For the three months ended September 30, 2025, total revenue was $410,000, a decrease of 96.2% compared to $10.91 million for the same period in 2024[31]. - Net loss attributable to ordinary shareholders for the quarter ended September 30, 2025, was $50.5 million, or $0.62 per share, compared to a net loss of $39.3 million, or $0.55 per share for the same quarter in 2024[26]. - Cash and cash equivalents decreased to $14.8 million as of September 30, 2025, down from $103.7 million as of December 31, 2024[33]. - Total current liabilities increased to $152.9 million as of September 30, 2025, compared to $60.8 million as of December 31, 2024[33]. - The company reported a foreign currency loss of $1.6 million for the three months ended September 30, 2025, compared to a gain of $3.5 million for the same period in 2024, reflecting a change of $5.1 million[24]. - Interest income decreased to $0.2 million for the three months ended September 30, 2025, down from $1.2 million in the same period in 2024, a decline of 83.3%[24]. - Interest expense decreased to $3.1 million for the three months ended September 30, 2025, compared to $3.4 million for the same period in 2024, a reduction of 8.8%[25]. Research and Development - Research and development expenses increased to $32.5 million for Q3 2025, up from $26.2 million in Q3 2024, reflecting higher manufacturing costs and clinical program expenses[22]. - Research and development expenses for the three months ended September 30, 2025, were $32.5 million, an increase of 24.0% from $26.2 million in the same period in 2024[31]. - The pivotal Phase 2 study of AAV-hAQP1 for radiation-induced xerostomia is on track for target enrollment by the end of 2025, with potential BLA filing in early 2027[3]. - The company anticipates initiating a Phase 3 study for AAV-GAD in Parkinson's disease in the coming months, following positive data from previous studies[11]. - The BBS10 program for a rare pediatric ophthalmology condition has been awarded Rare Pediatric Disease Designation, with the first patient treated during the quarter[4]. - MeiraGTx has completed optimization of its riboswitch program for leptin delivery, demonstrating durability and efficacy in a mouse model over more than a year[5]. Strategic Collaborations and Future Prospects - MeiraGTx entered a strategic collaboration with Eli Lilly, receiving an upfront payment of $75 million and potential milestone payments exceeding $400 million[7]. - The company is eligible to receive up to $285 million upon the first commercial sales of botaretigene sparoparvovec in the US and EU[14]. Manufacturing and Technology - The company has developed a novel technology for in vivo delivery of biologic therapeutics using oral small molecules, focusing on metabolic peptides and CAR-T therapies[27]. - MeiraGTx has built comprehensive manufacturing capabilities with five facilities globally, including two licensed for GMP viral vector production[27].

Core Insights - MeiraGTx Holdings plc announced its financial and operational results for Q3 2025, highlighting significant advancements in its gene therapy programs and strategic collaborations, particularly with Eli Lilly in ophthalmology [1][2][3] Financial Performance - As of September 30, 2025, the company reported cash and cash equivalents of approximately $14.8 million, a decrease from $105.7 million as of December 31, 2024 [13] - Service revenue for Q3 2025 was $0.4 million, down from $10.9 million in Q3 2024, primarily due to decreased activity related to the asset purchase agreement with Johnson & Johnson [14] - General and administrative expenses increased to $13.6 million in Q3 2025 from $12.7 million in Q3 2024, attributed to higher rent, consulting fees, and share-based compensation [16] - Research and development expenses rose to $32.5 million in Q3 2025 from $26.2 million in Q3 2024, driven by increased manufacturing costs and clinical program activities [17] - The net loss attributable to ordinary shareholders for Q3 2025 was $50.5 million, or $0.62 per share, compared to a net loss of $39.3 million, or $0.55 per share, in Q3 2024 [21] Strategic Collaborations - The company entered a strategic collaboration with Eli Lilly, granting exclusive rights to its AAV-AIPL1 program for treating Leber congenital amaurosis 4 (LCA4), along with access to other gene therapy technologies [2][3][8] - Under the collaboration, MeiraGTx will receive an upfront payment of $75 million and is eligible for over $400 million in milestone payments, along with tiered royalties on licensed products [8] Clinical Development - The pivotal Phase 2 study of AAV-hAQP1 for radiation-induced xerostomia is on track for target enrollment by the end of 2025, with potential BLA filing expected in early 2027 [2][8] - A Phase 3 study for AAV-GAD in Parkinson's disease is anticipated to start soon, following positive data from previous studies [2][8] - The company has optimized its riboswitch program for delivering native human leptin, addressing a significant unmet need in leptin deficiency treatment [2][8] Recent Developments - MeiraGTx has developed a second Specials program in the UK for treating BBS10-associated retinal dystrophy, which has received Rare Pediatric Disease Designation from the FDA [2][3] - The company is forming a joint venture with Hologen AI, which includes a $200 million upfront payment and additional funding for developing the AAV-GAD program [11][12]

Core Insights - The article discusses the potential for MeiraGTx Holdings plc (MGTX) to file for Biologics License Applications (BLA) in the near term, which could significantly enhance shareholder value [2]. Company Overview - MeiraGTx Holdings plc is highlighted as a company in the biotech sector with a focus on developing innovative gene therapies [2]. Analyst Background - The analysis is provided by Terry Chrisomalis, who has extensive experience in the biotech field and runs the Biotech Analysis Central service, which offers in-depth analyses of various pharmaceutical companies [2].

Core Insights - The article discusses the potential for MeiraGTx Holdings plc (MGTX) to file for Biologics License Applications (BLA) in the near term, which could significantly enhance shareholder value [2]. Company Overview - MeiraGTx Holdings plc is highlighted as a company with upcoming BLA filings that may act as catalysts for its stock performance [2]. Analyst Background - The analysis is provided by Terry Chrisomalis, who has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which offers in-depth analyses of pharmaceutical companies [2].