MeiraGTx Holdings plc
8.93-0.33 (-3.56%)
Oct 29, 4:00:01 PM EDT · NasdaqGS · MGTX · USD
Key Stats
Market Cap
718.40MP/E (TTM)
-Basic EPS (TTM)
-2.03Dividend Yield
0%Recent Filings
10-Q
Q2 FY2025 results
MeiraGTx's Q2 FY2025 results show service revenue from related-party PPQ activities surging 1,209% y/y to $3.7M, while operating loss narrowed 2.4% y/y to $44.8M amid tighter R&D spend on manufacturing and xerostomia programs, offset by ramped AAV-GAD Parkinson's efforts. Net loss improved 20.2% y/y to $38.8M, or $(0.48) diluted EPS on 80.6M shares, reconciling to YTD $(0.99) EPS with no anti-dilution effects. Cash dipped to $32.2M from $103.7M at year-end, with $80.8M used in operations and $2.5M capex yielding negative FCF; $75M debt at 14.3% due August 2026 remains covenant-compliant, bolstered by $23M Hologen deposits toward a $200M upfront closing Q3 2025 for neuro and manufacturing JV. The Hologen deal, granting 30% ownership in a $230M-funded Parkinson's entity, sharpens pipeline focus. Yet competition in gene therapy could erode market share for late-stage assets like AAV-GAD.
8-K
Q2 loss narrows, pipeline advances
MeiraGTx reported Q2 2025 results, narrowing net loss to $38.8 million from $48.6 million year-over-year, while cash dipped to $32.2 million amid advancing late-stage gene therapies. Key wins include FDA alignment on Phase 2 AQUAx2 for radiation-induced xerostomia, targeting BLA data in late 2026, and RMAT designation for AAV-GAD in Parkinson's, bolstered by Hologen collaboration yielding $23 million upfront. Regulatory progress accelerates BLA/MAA filings for AAV-AIPL1 in LCA4 by Q4 2025. Cash runway extends to 2027, but debt repayment looms.
8-K
UK FDI clearance for Hologen deals
MeiraGTx Holdings plc secured UK foreign direct investment clearances for its March 9, 2025, transactions with Hologen Limited, paving the way for a July 2025 close. This approval clears a key regulatory hurdle, enabling the deals to proceed amid ongoing biotech uncertainties. Forward-looking statements highlight risks like execution delays. Investors eye potential funding boosts.
8-K
AGM elects director, ratifies auditors
MeiraGTx Holdings plc held its annual general meeting on June 12, 2025, with 74.2% of ordinary shares represented. Shareholders elected Thomas E. Shenk, Ph.D., as Class I director until 2028, despite 9 million withheld votes. They ratified Ernst & Young LLP as auditors for 2025, with 45.4 million for and 13.9 million against. Routine governance holds steady.
8-K
Hologen AI collaboration announced
MeiraGTx announced a strategic collaboration with Hologen AI, securing $200 million upfront cash and forming Hologen Neuro AI Ltd with $230 million committed to accelerate Phase 3 development of AAV-GAD for Parkinson's disease, where it just earned FDA RMAT designation based on positive data from three studies showing motor benefits and brain circuitry changes. The deal bolsters the balance sheet to fund operations into 2027 while advancing BLA paths for xerostomia and LCA4 programs. Momentum builds fast.
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