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MeiraGTx Holdings plc: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 12 November 2026: press release. Guidance figures: 3 new, 4 kept. The quarter’s numbers.

Key takeaways

  • Net loss of $51.3 million: Net loss attributable to ordinary shareholders was $51.3 million, or $0.53 basic and diluted per share, against a net loss of $50.5 million, or $0.62, a year earlier. Source
  • EMA submission planned for December: The company said the bota-vec MAA dossier is complete and awaiting submission, with the BLA expected to follow early next year. Source
  • AQUAx2 readout set for mid-2027: The pivotal Phase 2 AQUAx2 study completed enrollment in the second quarter of 2026, with a 12-month readout set for mid-2027. Source
  • Lilly paid $75 million upfront: Lilly holds worldwide exclusive rights to AAV-AIPL1 for LCA4. The company received a $75 million upfront and is eligible for over $400 million in milestones plus royalties. Source
  • Clinical and batch costs drove R&D: The R&D increase was driven mainly by clinical trial activity and batch manufacturing for the AAV2-hAQP1 program, plus bota-vec costs after the Q2 reacquisition. Source
  • Runway into second half of 2028: The company said the current cash, with the Hologen upfront and reimbursements, is sufficient into the second half of 2028 for operating and capital needs. Source

“We are pleased to report that we have now completed much of the work towards submission of full global regulatory filings with the EMA and FDA for bota-vec for the treatment of XLRP.”

Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx

Guidance

AreaPeriodFigureAgainst last quarter
Regulatory filing, bota-vec (EMA) SourceDecember 2026December 2026Kept
Regulatory filing, bota-vec (FDA) Sourcefirst quarter of 2027first quarter of 2027New
Commercial launch, bota-vec Sourcelate 2027late 2027Kept
Clinical readout, AAV2-hAQP1 (AQUAx2) Sourcemid-2027mid-2027Kept
Regulatory approval, AAV2-hAQP1 (U.S.) Source2028potential U.S. approval in 2028
Phase 3 study start, AAV-GAD (Reogen JV) Sourcefirst quarter of 2027first quarter of 2027New
Clinical study start, lead riboswitch small molecule SourceDecember 2026December 2026New
Cash runway Sourceinto the second half of 2028into the second half of 2028Kept

What changed from last quarter

  • New guidance: A first quarter 2027 date for the bota-vec full BLA submission to the FDA was given. Source
  • New guidance: A December 2026 start date was given for the SAD/MAD study of the lead riboswitch small molecule. Source
  • New guidance: A first quarter 2027 start was given for the Phase 3 AAV-GAD study, replacing the earlier wording of coming months. Source
  • New: Alan M. Sebulsky was appointed to the Board of Directors in September 2026. Source
  • New: The company named dry AMD and Geographic Atrophy as programs where it is advancing two novel targets. Source
  • Guidance kept: The cash runway estimate into the second half of 2028 is the same as in the prior release. Source

Quarterly results and net loss

  • Net loss of $51.3 million: Net loss attributable to ordinary shareholders was $51.3 million, or $0.53 basic and diluted per share, against a net loss of $50.5 million, or $0.62, a year earlier. Source
  • Related-party service revenue rose: Service revenue from related parties was $3.2 million, up from $0.4 million a year earlier, within total revenue of $4.8 million. Source
  • Income tax expense of $0.6 million: Income tax expense was $0.6 million, which the company attributed to changes in assumptions used to estimate the annual effective tax rate for the full year. Source

Service and collaboration revenue

  • Lilly manufacturing revenue started: Service revenue of $1.6 million came from contract manufacturing and support services for Lilly under the AAV-AIPL1 program, with nil in the prior-year quarter. Source
  • Reogen services drove related-party revenue: Related-party service revenue increased $2.8 million, mainly from development and transition services for Reogen, compared with PPQ services for J&J in 2025. Source
  • Related-party service costs rose: Cost of service revenue, related party, was $2.8 million, up $2.5 million, reflecting costs of the Reogen development and transition services. Source

“We are actively preparing for our pivotal Phase 2 AQUAx2 12-month data readout for the treatment of radiation-induced xerostomia in mid-2027.”

Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx

Bota-vec filings and launch preparation

  • EMA submission planned for December: The company said the bota-vec MAA dossier is complete and awaiting submission, with the BLA expected to follow early next year. Source
  • Manufacturing qualification completed: The company reported completing process performance qualification at its London facility, with Module 3 of the MAA complete. Source
  • LUMEOS study design described: The Phase 3 LUMEOS study enrolled 95 patients in a global, randomized design, with all patients treated bilaterally. Source

AAV2-hAQP1 radiation xerostomia program

  • AQUAx2 readout set for mid-2027: The pivotal Phase 2 AQUAx2 study completed enrollment in the second quarter of 2026, with a 12-month readout set for mid-2027. Source
  • Breakthrough designation granted in March: The FDA granted Breakthrough Therapy Designation for AAV2-hAQP1 in March 2026, based on three-year data from 24 Phase 1 AQUAx patients. Source
  • Potency assay poster at ESGCT: An October 2026 ESGCT poster described a plate-reader potency assay for AAV-AQP1, being validated to ICH Q2(R2) for quality control release and future commercial licensing. Source

“In parallel with these filings, we have been preparing our market access and commercial teams ahead of the anticipated launch of our first commercial product, bota-vec, in late 2027.”

Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx

Lilly, Reogen and partnered programs

  • Lilly paid $75 million upfront: Lilly holds worldwide exclusive rights to AAV-AIPL1 for LCA4. The company received a $75 million upfront and is eligible for over $400 million in milestones plus royalties. Source
  • AAV-GAD RMAT designation granted: The FDA granted RMAT designation for AAV-GAD in Parkinson’s disease in 2025, based on two double-blind sham-surgery controlled studies. Source
  • AI analyses supported RMAT filing: The RMAT application included AI analyses from the JV partner Hologen that showed potential disease modification resulting from treatment. Source

Riboswitch platform and new programs

  • Riboswitch works across vector types: The company says its riboswitch platform is gene agnostic and can be built into lentivirus, AAV, CRISPR or LNP delivery. Source
  • Ribo-Leptin prioritized for IND: The company prioritized Ribo-Leptin, followed by a neuropathic pain program, for planned first-in-human IND submissions using vector and small molecule. Source
  • Dry AMD programs advancing two targets: The company is advancing two novel targets in its dry AMD and Geographic Atrophy programs, using AI-designed intravitreal capsids and promoters. Source

Operating expenses and R&D

  • R&D expense rose to $39.3 million: Research and development expense was $39.3 million, compared with $32.5 million a year earlier. Source
  • Clinical and batch costs drove R&D: The R&D increase was driven mainly by clinical trial activity and batch manufacturing for the AAV2-hAQP1 program, plus bota-vec costs after the Q2 reacquisition. Source
  • G&A fell on lower legal and facilities: G&A expense fell $1.6 million, mainly on lower legal, facilities and consulting fees and cost allocated to service revenue, partly offset by personnel costs. Source

Cash, balance sheet and runway

  • Cash of $184.7 million: Cash and cash equivalents were $184.7 million at September 30, 2026, up from $65.9 million at December 31, 2025. Restricted cash brings the total to $186.8 million. Source
  • Runway into second half of 2028: The company said the current cash, with the Hologen upfront and reimbursements, is sufficient into the second half of 2028 for operating and capital needs. Source
  • Lilly milestones excluded from runway: The runway estimate excludes $135.0 million of potential near-term Lilly milestone cash and any later Oberland Capital royalty-note tranches. Source
  • Financial costs moved to a gain: Financial related costs were a gain of $1.6 million, mainly from fair-value change on royalty notes and lower interest after the Perceptive agreement ended. Source

Leadership and board changes

  • Knighton named manufacturing head: John Knighton was appointed Executive Vice President of Global Manufacturing and Supply Chain in July 2026. Source
  • Knighton brings CARVYKTI manufacturing experience: Knighton previously led Cell and Gene Therapy API development at Janssen, supporting manufacturing for CARVYKTI approval and commercialization. Source
  • Sebulsky joins board: Alan M. Sebulsky was appointed to the Board of Directors in September 2026. Source
  • Sebulsky investment and finance background: Sebulsky has over 40 years in public company investment, financial strategy and board leadership, most recently at Adage Capital Management. Source

Coming up, as management said on 12 November 2026

  • EMA submission of bota-vec MAA: The company intends to submit the bota-vec MAA to the EMA in December 2026, subject to EMA confirmation of the submission date. Source
  • Full BLA to FDA in 2027: The company anticipates the full BLA for bota-vec will be submitted to the FDA in the first quarter of 2027. Source
  • ObesityWeek oral presentation November 16: Oral presentation at ObesityWeek on the AAV-BDNF program for MC4R/BDNF genetic obesity, 8:30 to 9:30 AM ET at National Harbor, Maryland. Source
  • Riboswitch SAD/MAD study starts: A SAD/MAD study of the lead small molecule is expected to start in December 2026, with data to inform dose selection for next year. Source
  • Reogen Phase 3 AAV-GAD start: The Reogen joint venture intends to start a Phase 3 study of AAV-GAD in the first quarter of 2027. Source
  • Bota-vec commercial launch: The company is preparing for the anticipated launch of bota-vec in late 2027. Source

Figures management reported

FigureReported
R&D spend Source$39.3 million, three months ended September 30, 2026
Pivotal trial readout SourceAQUAx2 12-month readout, mid-2027
Pipeline milestones SourceMAA to EMA December 2026; BLA to FDA first quarter 2027

Risks management discussed

  • Operational: Scheduled maintenance raised manufacturing costs in the quarter, which the company said was fully offset by lower preclinical ocular program costs. Source
  • Financial: The company recorded a $3.9 million loss from its share of Reogen’s research and development expenses under the equity method. Source
  • Regulatory: The timing of the MAA submission depends on EMA confirmation of the submission date. Source
  • External: Exchange-rate movements on intercompany balances affected results; the company reported a de minimis foreign currency loss this quarter. Source

Earlier plans management reported on

  • On track: Management said the AQUAx2 readout remains on track for mid-2027. Source
  • Met: The company said enrollment in the pivotal AQUAx2 study completed in the second quarter of 2026. Source
  • Met: The company said it has completed process performance qualification with Module 3 of the MAA complete. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.