MGTX

GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in chronic Graft versus Host Disease (cGvHD) patients who had failed at least two prior lines of therapy. GV101's 24-week bORR exceeds published 6-month bORRs for all existing, approved steroid-refractory cGvHD therapies. Failure-free survival (FFS) was 83.9% at 24 weeks and reached 89.4% at 400 mg (78.6% at 200 mg); this FFS also exceeds published 6-month FFS probabilities for all approved steroid-refractory cGvHD therapies. Complete responses were observed in all but one organ system (only one participant had lower GI involvement). Favorable safety profile with no evidence of hematopoietic toxicity and no increased incidence of infections. The single Grade ≥3 adverse event occurring in ≥5% of participants was benign bilirubin elevation without transaminase elevation. This laboratory abnormality is related to reversible enzymatic (UGT1A1) and transporter (OATP1B3) inhibition by GV101. NEW YORK, Aug. 26, 2026 /PRNewswire/ -- Graviton BioScience Corporation, a privately held, clinical-stage biotechnology company, announced the publication of peer-reviewed data from a multicenter Phase Ib/II multi-dose, open-label clinical trial evaluating the safety, tolerability, and efficacy of GV101 in patients with moderate to severe chronic Graft versus Host Disease (cGvHD). The data, published in Signal Transduction and Targeted Therapy, a Springer Nature Portfolio journal, provide efficacy and findings from the 60 enrolled patients, 30 at 200 mg and 30 at 400 mg, who had previously received one to five prior systemic therapies for cGvHD. Key efficacy results: At 24-weeks, GV101 yielded a bORR of 86.2% (95% CI: 68.3 to 96.1) at 400 mg and 67.9% (95% CI: 47.6 to 84.1) at 200 mg; FFS was 89.4% at 400 mg and 78.6% at 200 mg. Median FFS was not met at the time of analysis. OS was 96.6% at 400 mg and 100% at 200 mg; a single participant died, attributed to COVID-19 pneumonia. Median time to first response was 30.0 days (range 28-115 days) at 400 mg and 44.5 days (range 28-284 days) at 200 mg, consistent with a rapid onset. Median duration of response was not met at the time of analysis. Complete responses were observed in all organ systems except lower GI (only 1 participant had lower GI involvement). By 24-weeks, notable organ response rates included liver (52.6%), esophagus (50.0%), and upper gastrointestinal tract (50.0%); pulmonary response rate based on the 2014 NIH Consensus Criteria lung symptom score was 23.7% (95% CI: 11.4 to 40.2). Safety: AEs occurring in ≥20% of patients included transient bilirubin elevation (81.7%) and headache (23.3%). GV101-induced bilirubin elevations are benign, related to UGT1A1 inhibition (unconjugated) and OATP1B3 inhibition (conjugated), were generally transient and not associated with elevations in liver transaminases. Grade ≥3 TRAEs (reported in ≥5% of total patients) included only laboratory events: unconjugated bilirubin elevation (n = 10; 16.7%), total bilirubin elevation (n = 9; 15.0%), and conjugated bilirubin elevation (n = 3; 5.0%). There was no grade ≥3 leukopenia, thrombocytopenia, or anemia, and only one grade 3 neutropenia. There were no CMV infections. Next: Graviton is currently in Phase III RCT planning for GV101 in cGvHD and plans to carry the high dose forward. About Chronic Graft versus Host Disease cGvHD is a rare, serious and potentially fatal complication of allogeneic stem cell transplantation that affects about 18,700 people in the US and has a global incidence of about 53,000 new cases per year. In cGvHD, donor immune cells attack healthy tissues and organs in the transplant recipient. The disease is characterized by persistent immune dysregulation, inflammation, and fibrosis that can affect multiple organ systems, significantly impair quality of life, and cause death. Despite advances in treatment, many patients experience inadequate responses, disease recurrence, and intolerable AEs. There is significant unmet need for an effective early-stage therapy that targets the key drivers of cGvHD, fibrosis and immune dysregulation, whilst preserving immune function. About GV101 GV101 is a clinical-stage, best-in-class selective inhibitor of Rho/Rho-associated coiled-coil containing protein kinase 2 (ROCK2). ROCK2 is a key regulator of multiple cellular pathways involved in inflammation, fibrosis, metabolism, and gene expression. GV101 has been evaluated in preclinical and clinical studies and is being developed for multiple potential indications. About Graviton BioScience Corporation Graviton BioScience Corporation is a clinical-stage drug discovery and development company dedicated to engineering and developing best-in-class therapeutics for treating metabolic, CNS, inflammatory, fibrotic, and other disease indications. Graviton has developed a portfolio of selective ROCK2 inhibitors among other safe, innovative, and novel therapies for patients with fibrotic, autoimmune, and CNS diseases. GV101 is in clinical studies, with additional assets advancing through the pipeline. Leading the Company is Dr. Samuel Waksal, the founder and former Chairman and CEO of Kadmon Pharmaceuticals (acquired by Sanofi). Dr. Waksal is also the founder and former CEO of ImClone Systems (acquired by Eli Lilly) and a founder of MeiraGTx (NASDAQ: MGTX). Forward-Looking Statements This press release contains forward-looking statements regarding Graviton's development plans, regulatory strategy, and potential future clinical applications for its selective ROCK2 inhibitors. Such statements are subject to risks and uncertainties, including, but not limited to, biological, clinical, regulatory, financial, and operational risks. Actual results may differ materially. Graviton BioScience Contact Melanie Glickman Senior Associate, Operations [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/graviton-bioscience-corporation-announces-publication-of-positive-ph1b-trial-results-for-gv101-tdi01-in-chronic-graft-versus-host-disease-in-signal-transduction-and-targeted-therapy-by-beijing-tide-pharmaceutical-302860706.html

Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 and reported positive three-year data from Phase 1 AQUAx clinical trial evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia Completed the acquisition of all interests and rights to botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) from Johnson & Johnson* (J&J) for $25 million Strengthened balance sheet with $100 million equity financing concurrent with the bota-vec acquisition Secured up to $400 million strategic investment from Oberland Capital, with up to $375 million in non-dilutive capital to support development and commercialization of AAV2-hAQP1 and bota-vec Anticipate submission of global regulatory filings for approval of bota-vec in 2026 and potential BLA filing for AAV2-hAQP1 in mid-2027 LONDON and NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the second quarter ended June 30, 2026, and provided a corporate update. “During the second quarter of 2026, we made tremendous progress towards transforming MeiraGTx into a commercial company,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “We acquired bota-vec from J&J and started working on the global filings for this product and establishing the market access and commercial infrastructure ahead of the potential first commercial launch in 2027. In addition, we made meaningful progress with our wholly owned AAV2-hAQP1 program for a significant unmet need, radiation induced xerostomia (RIX).  We were awarded Breakthrough Therapy Designation in March 2026 based on very strong 3-year data from our Phase 1 AQUAx clinical study (n=24), indicating strong durable responses in late-stage RIX patients. We completed enrollment in our pivotal Phase 2 AQUAx2 clinical study of AAV2-hAQP1 in RIX in the second quarter and are now working expeditiously to submit regulatory filings for bota-vec this year and preparing for AAV2-hAQP1 filings mid next year.” Dr. Forbes continued, “We are engaging high quality market access and commercial teams as we build our internal infrastructure to expedite potential launches of these first in class disease modifying therapies. We are particularly excited to be joined by two senior leaders previously with J&J, Penny Fleck as our Chief Development Officer, who has two decades of experience leading research and development at Takeda Pharmaceuticals, Johnson & Johnson Innovative Medicine, and ONL Therapeutics, including running the bota-vec program at J&J, and more recently, John Knighton as Executive Vice President of Global Manufacturing and Supply Chain. John has over 30 years of experience in biologic manufacturing and previously served as the Head of Cell & Gene Therapy API at Janssen Pharmaceuticals, Inc., supporting the successful launch of CARVYKTI®. Together, Penny and John provide extensive experience and expertise in achieving marketing approvals and successful commercial launches of many pharmaceutical products, and will be instrumental as we transition the Company into one that is well prepared for the potential launches of two products over the next two years.” Dr. Forbes added, “We also remain very excited about our Riboswitch platform. Following discussion with the FDA, we are finalizing the requirements for clinical development and progressing to first in human studies with our Ribo-Leptin program. We anticipate following this first clinical study of the Riboswitch technology with a second program in neuropathic pain which is supported by very strong animal data. In each case, a precise dose of the therapeutic gene product is produced in vivo based on an oral small molecule daily pill. We are eager to progress this powerful novel technology through clinical development to address conditions that cannot be readily addressed using any of the current therapeutic modalities available.” *Janssen Pharmaceuticals, Inc., a Johnson & Johnson company Second Quarter 2026 Highlights Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-Linked Retinitis Pigmentosa (XLRP): In May 2026, MeiraGTx completed the acquisition of full rights and interests in bota-vec from J&J for a one-time $25 million upfront cash payment, with J&J eligible to receive a one-time regulatory and commercial milestone tied to U.S. approval and U.S. sales performance, plus potential mid-teens royalty on global net sales beginning in mid-2029. XLRP is a rare inherited retinal disease with early onset and progressive degeneration to complete blindness by the third decade of life, with no currently approved treatment options. There are more than 20,000 XLRP-RPGR patients in the U.S. and EU alone. The Phase 3 LUMEOS study was a global, randomized study (n=95) in which all patients were treated bilaterally. Data highlight the potential of bota-vec to improve vision, and the safety profile was as expected and manageable, with no new safety signals and an improved inflammatory profile relative to the Phase 1/2 study. As the commercial manufacturer of bota-vec, MeiraGTx has completed process performance qualification (PPQ) and holds a commercial license for its London, U.K. manufacturing facility and a commercial license for its QC facility in Shannon, Ireland. Bota-vec has been granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA), and in the EU has received Priority Medicines, or PRIME, advanced therapy medicinal product, or ATMP, and Orphan Drug Designations from the local regulatory authorities. AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia: In March 2026, the FDA granted BTD to AAV2-hAQP1 for the treatment of grade 2 and grade 3 radiation-induced xerostomia, supported by three-year data from the 24-patient Phase 1 AQUAx study. In April 2026, MeiraGTx reported positive three-year data from its Phase 1 AQUAx clinical trial (n=24) evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia. Results demonstrated sustained, clinically meaningful improvements in both patient-reported outcomes and objective measures of salivary flow, with durable effects maintained from 12 months through 36 months post-treatment. AAV2-hAQP1 continued to be safe and well-tolerated at each dose tested. The results were presented on April 16, 2026 and a replay is available on the Investors page of the Company’s website at investors.meiragtx.com. The pivotal Phase 2 AQUAx2 study (NCT05926765), a randomized, double-blind, placebo-controlled study at 30 sites in the U.S., Canada, and the U.K. completed enrollment in the second quarter of 2026 and remains on track for a 12-month pivotal data readout in the second quarter of 2027, which, if positive, would support a BLA filing and potential approval targeted for the end of 2027, with U.S. launch in 2028. Up to $400 Million Strategic Investment from Oberland Capital: In June 2026, MeiraGTx entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $400 million, including up to $375 million in non-dilutive capital in exchange for low single-digit capped royalties on certain products and up to $25 million in equity investment. Following regulatory approval, Oberland Capital is entitled to receive low single-digit capped royalties on the net sales of each of AAV2-hAQP1 (RIX), bota-vec (XLRP), and AAV-AIPL1 (LCA4). Royalty payments are capped at a multiple of the amounts funded. The initial $135 million funded comprised $125 million in cash and a $10 million equity investment. Additional capital is available at the Company's option: $50 million tied to positive AAV2-hAQP1 data readouts in 2027 from the Phase 2 AQUAx2 study; $50 million tied to bota-vec regulatory approval in 2027; and $50 million tied to AAV2-hAQP1 regulatory approval in 2028. A further $100 million is available upon mutual agreement for new products or business development, and Oberland Capital has the right to purchase an additional $15 million in equity. The agreement includes flexible provisions for a potential change of control, including the Company’s ability to buy back the entire funded royalty note at any time by paying certain specified amounts. AAV-GAD for the Treatment of Parkinson’s Disease: FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV-GAD for the treatment of Parkinson’s disease not adequately controlled with medication in 2025. This RMAT was awarded based on data demonstrating statistically significant efficacy in 2 double-blind sham-surgery controlled studies, a Phase 2 study (n=45), and a Phase 1/2 clinical bridging study (n=14) following the successful Phase 1 dose escalation study (n=14). This application also included the use of novel AI developed by our JV partner, Hologen, which demonstrated potential disease modification resulting from treatment. The Company is currently engaging with clinical trial sites globally and expects to initiate the Phase 3 study of AAV-GAD in the coming months. AAV-AIPL1 for LCA4: MeiraGTx entered into a strategic collaboration with Eli Lilly and Company (Lilly), granting Lilly worldwide exclusive rights to meduretgene parvec, or medu-vec (formerly referred to as AAV-AIPL1) for the treatment of Leber congenial amaurosis 4 (LCA4). Under the terms of the agreement, Lilly also received worldwide exclusive access rights to MeiraGTx’s innovative gene therapy technologies for use in ophthalmology with certain targets designated by Lilly, including novel intravitreal capsids developed in-house at MeiraGTx and bespoke promoters including AI-generated cell specific promoters. MeiraGTx also granted Lilly certain rights to its proprietary riboswitch technology for use in gene editing in the eye. MeiraGTx received an upfront payment of $75 million and is eligible to receive over $400 million in total milestone payments. MeiraGTx is also eligible to receive tiered royalties on licensed products. Riboswitch Gene Regulation Technology Platform for in vivo Delivery: The Company’s Riboswitch technology is a broadly applicable platform that provides a precise dose of any biologic therapeutic encoded by a transgene in response to a daily oral pill. We have demonstrated that the platform is gene agnostic and can be incorporated into any sequence delivered by lentivirus, AAV, CRISPR or LNPs providing a powerful mechanism for precisely controlling the level and timing of the production of biologic therapeutics in the body. This enables the native form of the therapeutic protein to be delivered by controlled in vivo production driven by a safe daily pill. This provides more physiological activity of the therapeutic compared to synthetic or stabilized injectable forms of the molecule, often providing improved efficacy and safety. MeiraGTx is advancing its first riboswitch program, native human leptin (Ribo-Leptin), toward the clinic in metabolic disease, and is in discussion with the FDA and is finalizing the package to open the Ribo-Leptin IND. The Company is also conducting IND-enabling studies for a second riboswitch-regulated program for neuropathic pain. Corporate and Leadership Updates In May 2026, MeiraGTx appointed Penny Fleck as Chief Development Officer. Ms. Fleck brings more than 20 years of experience from Johnson & Johnson and Takeda, leading development across numerous assets, including multiple global regulatory approvals. While Global Head of Specialty Ophthalmology at J&J, she worked closely with MeiraGTx on the development of bota-vec. In July 2026, MeiraGTx appointed John Knighton as Executive Vice President of Global Manufacturing and Supply Chain. Mr. Knighton brings more than 30 years of experience from J&J and GlaxoSmithKline. Most recently, John served as Vice President, Cell & Gene Therapy API Development at Janssen Pharmaceuticals, Inc. leading a diverse team of managers, scientists, and engineers who manufactured for the approval and successful commercialization of CARVYKTI® (a personalized CAR T-cell immunotherapy used to treat adult patients with relapsed or refractory multiple myeloma). As of June 30, 2026, MeiraGTx had cash and cash equivalents of approximately $143.2 million as well as $5.6 million in accounts receivables, $24.4 million in unbilled receivables and $14.3 million in tax incentive receivables. Together with the second purchase of $25.0 million of royalty notes and $10.0 million proceeds from the sale of the Company’s ordinary shares under the agreements with Oberland Capital in July 2026, and the additional $95.0 million upfront payment due from Hologen and associated reimbursements, the Company believes that it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second half of 2028. This estimate does not include the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the royalty note purchase agreement with Oberland Capital. Financial Results Cash, cash equivalents and restricted cash were $145.4 million as of June 30, 2026, compared to $34.4 million as of June 30, 2025. Service revenue was $11.9 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The increase of $11.9 million was due to revenue recognized for the contract manufacturing services provided to Lilly under the Lilly collaboration agreement and related agreements. Service revenue – related party was $104.9 million for the three months ended June 30, 2026, compared to $3.7 million for the three months ended June 30, 2025. The increase of $101.2 million was due to the release of deferred revenue from the termination of the original asset purchase agreement and supply agreement with J&J and the development and transition services provided to Reogen Limited (Reogen), formerly known as Hologen Neuro AI Limited, under the Hologen collaboration agreement and related agreements, which was partially offset by decreased activity of PPQ services under the original asset purchase agreement and related agreements with J&J as the work was substantially completed in the first half of 2025. License revenue – related party was $204.6 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The increase of $204.6 million was due to revenue recognized for the licenses granted to Reogen for the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device. Cost of service revenue was $1.4 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $1.4 million was due to costs incurred during the three months ended June 30, 2026 in connection with contract manufacturing services provided to Lilly under the Lilly collaboration agreement and related agreements. Cost of service revenue – related party was $5.8 million for the three months ended June 30, 2026 compared to $2.7 million for the three months ended June 30, 2025. The increase of $3.1 million was due to costs incurred during the period related to the development and transition services provided to Reogen under the Hologen collaboration agreement and related agreements, partially offset by the decreased activity of PPQ services due to the termination of the original asset purchase agreement and related agreements with J&J during the second quarter of 2026. General and administrative expenses were $12.0 million for the three months ended June 30, 2026, compared to $12.3 million for the three months ended June 30, 2025. The decrease of $0.3 million was primarily due to decreases in legal fees and share-based compensation expense due to vesting in prior periods. These decreases were partially offset by increases in business development expenses and personnel costs. Research and development expenses were $57.8 million for the three months ended June 30, 2026, compared to $33.5 million for the three months ended June 30, 2025. The increase of $24.3 million was primarily due to the reacquisition of bota-vec from J&J under the asset purchase agreement. Costs related to the AAV2-hAQP1 clinical program increased due to the manufacturing of clinical trial batch material during the three months ended June 30, 2026 and higher clinical trial related spend. In addition, other research and development expenses increased due to employee and employee-related costs, facilities costs and other general research and development costs. These increases were partially offset by decreases in the Company’s AAV-GAD program due to a higher cost of clinical trial material batches being manufactured during the three months ended June 30, 2025. Manufacturing costs decreased due to higher manufacturing batch costs being allocated to the clinical programs during the three months ended June 30, 2026 and costs associated with the Company’s preclinical programs decreased primarily related to the gene regulation program due to the completion of certain preclinical studies in 2025. Foreign currency loss was $1.5 million for the three months ended June 30, 2026 compared to a gain of $8.6 million for the three months ended June 30, 2025. The change of $10.1 million was primarily due to the weakening of the U.S. dollar against the pound sterling and euro as it relates to the valuation of the Company’s intercompany payables and receivables. Interest income was $0.7 million for the three months ended June 30, 2026 compared to $0.4 million for the three months ended June 30, 2025. The increase of $0.3 million was due to higher cash balances in interest bearing accounts during 2026 offset by lower interest rates. Interest expense was $3.5 million for the three months ended June 30, 2026 compared to $3.0 million for the three months ended June 30, 2025. The increase of $0.5 million was primarily due to the transaction cost related to the issuance of the royalty note under the agreement with Oberland Capital, which is measured at fair value, and the write-off of unamortized deferred financing cost due to the termination of the Notes Purchase Agreement with Perceptive Credit Holdings III, LP, which is offset by a lower interest rate. Loss on derivative liability was $5.2 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $5.2 million was due to the initial measurement of the derivative liability associated with the right granted under the securities purchase agreement with Oberland Capital. Loss on equity method investee was $71.9 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The loss primarily reflects the Company’s proportionate share of Reogen’s expenses associated with the acquired in-process research and development assets relating to the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device, as well as Reogen’s ongoing research and development activities. Income tax expense was $2.4 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $2.4 million was primarily driven by taxable income generated from strategic collaboration and other non-recurring transactions, partially offset by valuation allowances and losses in jurisdictions where no tax benefit was recognized. Net income attributable to ordinary shareholders for the quarter ended June 30, 2026 was $160.7 million, or $1.76 basic and $1.71 diluted net income per ordinary share, compared to a net loss attributable to ordinary shareholders of $38.8 million, or $0.48 basic and diluted net loss per ordinary share for the quarter ended June 30, 2025. For more information related to our clinical trials, please visit www.clinicaltrials.gov About MeiraGTx MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline with four late-stage clinical programs. Each of these programs use local delivery of small doses resulting in disease modifying effects in both inherited and more common diseases, in the eye, radiation-induced xerostomia, and Parkinson’s disease. MeiraGTx uses its innovative technology in optimization of capsids, promoters and novel translational control elements to develop best in class, potent, safe viral vectors. MeiraGTx’s broad pipeline is supported by end-to-end in-house manufacturing. MeiraGTx has built the most comprehensive manufacturing capabilities in the industry, including two that are licensed for GMP viral vector production and a GMP QC facility with clinical and commercial licensure. In addition, MeiraGTx has developed a proprietary manufacturing platform process over 10 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, MeiraGTx has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation technology allows precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on the regulated in vivo delivery of metabolic peptides, including GLP-1, GIP, Glucagon, Amylin, PYY and Leptin, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally PNS targets addressing long term intractable pain. MeiraGTx has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.For more information, please visit www.meiragtx.com Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated milestones regarding our pre-clinical and clinical data, reporting of such data and the timing of results of data and regulatory matters, statements regarding our collaborations and statements regarding our future obligations under the agreement with Oberland Capital, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate,” “eligible” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic transactions or priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug or rare pediatric disease designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of pandemics, epidemics or outbreaks of infectious diseases on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contacts Investors:[email protected] or Media:Jordyn TemperatoLifeSci [email protected]

MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $1.71 per share, beating the Zacks Consensus Estimate of a loss of $0.39 per share. This compares to a loss of $0.48 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +538.46%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.57, delivering a surprise of -32.56%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. MeiraGTx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $321.43 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 20,637.68%. This compares to year-ago revenues of $3.69 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MeiraGTx shares have added about 63% since the beginning of the year versus the S&P 500's gain of 13.2%. While MeiraGTx has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MeiraGTx was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.50 on $1.55 million in revenues for the coming quarter and -$1.69 on $3.39 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Sol-Gel Technologies Ltd. (SLGL), another stock in the broader Zacks Medical sector, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $2.31 per share in its upcoming report, which represents a year-over-year change of -155.4%. The consensus EPS estimate for the quarter has been revised 1.3% higher over the last 30 days to the current level. Sol-Gel Technologies Ltd.'s revenues are expected to be $0.15 million, down 99.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report Sol-Gel Technologies Ltd. (SLGL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Pacira (PCRX) came out with quarterly earnings of $0.73 per share, beating the Zacks Consensus Estimate of $0.64 per share. This compares to earnings of $0.74 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +14.06%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $0.61 per share when it actually produced earnings of $0.6, delivering a surprise of -1.64%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Pacira, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $192.4 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.01%. This compares to year-ago revenues of $181.1 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Pacira shares have added about 4% since the beginning of the year versus the S&P 500's gain of 11%. While Pacira has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Pacira was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.80 on $190.57 million in revenues for the coming quarter and $2.83 on $767.68 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, MeiraGTx Holdings PLC (MGTX), is yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.39 per share in its upcoming report, which represents a year-over-year change of +18.8%. The consensus EPS estimate for the quarter has been revised 2% higher over the last 30 days to the current level. MeiraGTx Holdings PLC's revenues are expected to be $1.55 million, down 58% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pacira BioSciences, Inc. (PCRX) : Free Stock Analysis Report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

MeiraGTx Holdings plc (NASDAQ:MGTX) missed earnings with its latest first-quarter results, disappointing overly-optimistic forecasters. Statutory earnings fell substantially short of expectations, with revenues of US$293k missing forecasts by 98%. Losses exploded, with a per-share loss of US$0.57 some 46% below prior forecasts. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on MeiraGTx Holdings after the latest results. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Taking into account the latest results, the seven analysts covering MeiraGTx Holdings provided consensus estimates of US$49.5m revenue in 2026, which would reflect a substantial 38% decline over the past 12 months. Per-share losses are expected to explode, reaching US$1.65 per share. Before this latest report, the consensus had been expecting revenues of US$50.4m and US$1.94 per share in losses. Although the revenue estimates have not really changed MeiraGTx Holdings'future looks a little different to the past, with a cut to the loss per share forecasts in particular. Check out our latest analysis for MeiraGTx Holdings The average price target held steady at US$28.25, seeming to indicate that business is performing in line with expectations. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. The most optimistic MeiraGTx Holdings analyst has a price target of US$50.00 per share, while the most pessimistic values it at US$19.00. We would probably assign less value to the analyst forecasts in this situation, because such a wide range of estimates could imply that the future of this business is difficult to value accurately. As a result it might not be a great idea to make decisions based on the consensus price target, which is after all just an average of this wide range of estimates. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. These estimates imply that revenue is expected to slow, with a forecast annualised decline of 47% by the end of 2026. This indicates a significant reduction from annual growth of 19% over the last five years. By contrast, our data suggests that other companies (with analyst coverage) in the same industry are forecast to see their revenue grow 22% annually for the foreseeable future. So although its revenues are forecast to shrink, this cloud does not come with a silver lining - MeiraGTx Holdings is expected to lag the wider industry. The most important thing to take away is that the analysts reconfirmed their loss per share estimates for next year. Fortunately, the analysts also reconfirmed their revenue estimates, suggesting that it's tracking in line with expectations. Although our data does suggest that MeiraGTx Holdings' revenue is expected to perform worse than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that in mind, we wouldn't be too quick to come to a conclusion on MeiraGTx Holdings. Long-term earnings power is much more important than next year's profits. We have forecasts for MeiraGTx Holdings going out to 2028, and you can see them free on our platform here. Even so, be aware that MeiraGTx Holdings is showing 3 warning signs in our investment analysis , and 1 of those is concerning... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 Reported positive three-year data from the Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 late radiation-induced xerostomia Entered into an asset purchase agreement with Johnson & Johnson* (J&J) to acquire all interests in botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) Strengthened balance sheet with $100 million financing LONDON and NEW YORK, May 14, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the first quarter ended March 31, 2026, and provided a corporate update. “Our achievements in the first few months of 2026 have materially strengthened MeiraGTx – we are now in a position to file for potential approval and launch two wholly-owned therapies in the next 2 years,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “The compelling three-year durability data from our AAV2-hAQP1 Phase 1 study continue to demonstrate disease-modifying benefit following a simple one-time treatment of patients with moderate to severe persistent radiation-induced xerostomia, an otherwise debilitating life-long condition. The recent receipt of Breakthrough Therapy Designation for this program reinforces the strength of the data and the potential for an expedited development and regulatory pathway.” Dr. Forbes continued, “We are very excited to have re-acquired bota-vec for the treatment of X-linked retinitis pigmentosa (XLRP). This is a highly strategic addition to our pipeline, given our long-term experience developing this drug while partnered with J&J, our deep expertise in ophthalmology, and our long-standing relationships with the inherited retinal disease patient community and KOL networks globally. Data from the Phase 3 LUMEOS study of bota-vec highlight the potential of this therapy to improve vision and significantly change the lives of those suffering with this otherwise inexorably degenerative disease. We are now working expeditiously to complete regulatory submissions in the U.S., EU, UK and Japan.” “To that end, I am extremely pleased to announce that Penny Fleck has joined MeiraGTx as Chief Development Officer,” said Dr. Forbes. “Penny brings tremendous experience from her 20+ years at J&J and Takeda leading development of many assets, including multiple global regulatory approvals. Importantly, while at J&J as Global Head of Specialty Ophthalmology, Penny worked closely with MeiraGTx on the development of bota-vec, from the licensing of the drug by J&J through Phase 3. Her extensive experience and broad expertise across drug development will help us achieve the potential approvals of bota-vec and AAV2-hAQP1, as well as progress our early stage programs such as Ribo-Leptin into the clinic and through development. Stuart Naylor, Ph.D. will be taking on a new role with the Company as Chief Scientific Officer, Ophthalmology. Stuart is a founder of MeiraGTx and led the incorporation of the UCL ophthalmology assets into the Company, including AAV-RPGR. He has experience with this therapy from pre-clinical through Phase 3 and he will be focusing his efforts on obtaining global regulatory approval of bota-vec as well as advancing our ophthalmology product candidates at all stages of development.” *Janssen Pharmaceuticals, Inc., a Johnson & Johnson company First Quarter 2026 Highlights Strategic Acquisition of Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-linked Retinitis Pigmentosa (XLRP): MeiraGTx entered into an asset purchase agreement with Johnson & Johnson in April 2026 to acquire full rights to bota-vec, a late-stage therapy for the treatment of X-linked retinitis pigmentosa (XLRP). MeiraGTx paid J&J a one-time $25 million upfront cash consideration, and J&J is eligible to receive a one-time regulatory and commercial milestone tied to U.S. approval and U.S. sales performance of bota-vec, as well as a mid-teens royalty on global net sales starting in mid-2029. The Company plans to rapidly advance the program toward global regulatory filings in the U.S., Europe, UK and Japan, leveraging its prior involvement in the program’s development and its established manufacturing readiness. Bota-vec for the Treatment of X-linked Retinitis Pigmentosa (XLRP): XLRP is a rare inherited retinal disease with early onset and progressive degeneration to complete blindness in the third decade of life. There are currently no treatment options. There are >20,000 XLRP-RPGR patients in the U.S. and EU. The Phase 3 LUMEOS study was a global randomized study (n=95). All patients were treated bilaterally. Data from the Phase 3 LUMEOS trial of bota-vec for the treatment of XLRP was presented at the Foundation Fighting Blindness 2025 Retinal Therapeutics Innovation Summit. Safety profile of bota-vec was as expected and manageable, with no new safety signals in the Phase 3 study with improved inflammatory profile compared to the Phase 1/2 study. As the commercial manufacturer of bota-vec, MeiraGTx has successfully completed process performance qualification (PPQ). The Company has a commercial license from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its London manufacturing facility, as well as a commercial license for the Company’s QC facility in Shannon, Ireland where release and stability assays for the product are conducted. MeiraGTx is now working to complete regulatory submissions in the U.S., EU, UK and Japan. The U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug Designations to bota-vec, and the regulatory authorities in the EU have granted Priority Medicines, or PRIME, advanced therapy medicinal product, or ATMP, and Orphan Drug Designations to bota-vec. Clinical and Technology Programs AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia: In April 2026, MeiraGTx reported positive three-year data from its Phase 1 AQUAx clinical trial (n=24) evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia. Results demonstrated sustained, clinically meaningful improvements in both patient-reported outcomes and objective measures of salivary flow, with durable effects maintained from 12 months through 36 months post-treatment. AAV2-hAQP1 continued to be safe and well-tolerated at each dose tested. The results were presented on April 16, and a replay is available on the Investors page of the Company’s website at investors.meiragtx.com. These findings provide strong clinical validation of the Company’s salivary gland gene therapy platform and support continued advancement of this treatment not only in the pivotal AQUAx2 study, but also development in additional conditions where dry mouth is a significant patient burden. The Phase 2 AQUAx2 (NCT05926765) randomized, double-blind, placebo-controlled study at 30 sites in the U.S., Canada and the U.K. is closing this month with the 12-month pivotal data readout on track for the second quarter of 2027 which, if positive, would support a BLA filing and potential approval targeted for the end of 2027, with U.S. launch early in 2028. FDA Breakthrough Therapy Designation (BTD) for AAV2-hAQP1: The U.S. Food and Drug Administration granted BTD to AAV2-hAQP1 for the treatment of grade 2 and grade 3 radiation-induced xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract in March 2026. The designation was supported by 3-year data from the 24 patient Phase 1 AQUAx study in long term moderate to severe radiation induced xerostomia. BTD is for serious or life-threatening conditions and enables enhanced engagement with the FDA and potential for priority review. AAV-GAD for the Treatment of Parkinson’s Disease: FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV-GAD for the treatment of Parkinson’s disease not adequately controlled with medication in 2025. This RMAT was awarded based on data demonstrating statistically significant efficacy in 2 double-blind sham-surgery controlled studies, a Phase 2 study (n=45), and a Phase 1/2 clinical bridging study (n=14) following the successful Phase 1 dose escalation study (n=14). This application also included the use of novel AI developed by our JV partner, Hologen, which demonstrated potential disease modification resulting from treatment. The Company is currently engaging with clinical trial sites globally and expects to initiate the Phase 3 study of AAV-GAD in the coming months. AAV-AIPL1 for LCA4: MeiraGTx entered into a strategic collaboration with Lilly, granting Lilly worldwide exclusive rights to meduretgene parvec, or medu-vec (formerly referred to as AAV-AIPL1) program for Leber congenial amaurosis 4 (LCA4). Under the terms of the agreement, Lilly also received worldwide exclusive access rights to MeiraGTx’s innovative gene therapy technologies for use in ophthalmology with certain targets designated by Lilly, including novel intravitreal capsids developed in-house at MeiraGTx and bespoke promoters including AI-generated cell specific promoters. MeiraGTx also granted Lilly certain rights to its proprietary riboswitch technology for use in gene editing in the eye. MeiraGTx received an upfront payment of $75 million and is eligible to receive over $400 million in total milestone payments. MeiraGTx is also eligible to receive tiered royalties on licensed products. Riboswitch Gene Regulation Technology Platform for in vivo Delivery: The Company’s Riboswitch technology is a powerful platform that transforms the potential of biologic therapeutics by providing a broadly applicable mechanism for the precise dosing of any protein, hormone or peptide that is encoded by DNA via in vivo production in direct dose response to bespoke oral small molecule inducers. MeiraGTx is progressing its first riboswitch program into the clinic in metabolic disease with native human leptin (Ribo-Leptin). The Company is in iterative discussion with the FDA to open a Ribo-Leptin IND later this year. The Company is also in IND enabling studies for a second riboswitch regulated vector for neuropathic pain. Strengthened Balance Sheet with $100 Million Financing: In April 2026, MeiraGTx announced the pricing of an underwritten offering of 11,111,111 of its ordinary shares at an offering price of $9.00 per share, generating gross proceeds of approximately $100 million. As of March 31, 2026, MeiraGTx had cash and cash equivalents of approximately $71.5 million. Based on the cash and cash equivalents and tax incentive receivable of $14.7 million, together with the approximately $100.0 million gross proceeds from the public equity offering in the second quarter of 2026 and the remaining $95.0 million upfront payment due from Hologen and associated reimbursements, the Company estimates that such funds will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2028, including the $25.0 million upfront cash payment to J&J for the reacquisition of bota-vec and the repayment of its debt obligation to Perceptive Credit Holdings III, LP of $25.0 million (due in June 2026) and $50.0 million (due in July 2027). For more information related to our clinical trials, please visit www.clinicaltrials.gov Financial Results Cash, cash equivalents and restricted cash were $73.8 million as of March 31, 2026, compared to $68.2 million as of December 31, 2025. Service revenue was $0.3 million for the three months ended March 31, 2026, compared to $1.9 million for the three months ended March 31, 2025. The decrease of $1.6 million was due to decreased activity of PPQ services under the original asset purchase agreement with J&J as the work was substantially completed in the first half of 2025. Cost of service revenue was $0.2 million for the three months ended March 31, 2026, compared to $1.4 million for the three months ended March 31, 2025. The decrease of $1.2 million was due to decreased activity of PPQ services under the original asset purchase agreement with J&J as the work was substantially completed in the first half of 2025. General and administrative expenses were $8.9 million for the three months ended March 31, 2026, compared to $9.3 million for the three months ended March 31, 2025. The decrease of $0.4 million was primarily due to lower personnel related costs, including a decrease in payroll expense primarily due to lower bonus accruals, as well as a decrease in share-based compensation expense due to vesting in prior periods and a decrease in facilities costs. These decreases were partially offset by an increase in professional services costs. In addition, the three months ended March 31, 2025 included a release of asset retirement obligation provisions related to U.S. office and laboratory leases, which did not recur during the three months ended March 31, 2026. Research and development expenses were $32.0 million for the three months ended March 31, 2026, compared to $32.8 million for the three months ended March 31, 2025. The decrease of $0.8 million was primarily due to decreases in other ocular diseases and AAV2-hAQP1 clinical programs, as there were no clinical trial material batches manufactured during the three months ended March 31, 2026 and overall lower clinical trial-related spend for AAV-GAD and AAV2-hAPQ1. In addition, costs associated with our preclinical programs for gene regulation and neurodegenerative diseases decreased compared to the prior year, primarily due to the completion of certain preclinical studies in 2025. These decreases were partially offset by an increase in manufacturing costs as there was no clinical trial material batch costs to allocate to our clinical programs as no batches were produced during the three months ended March 31, 2026, as well as a lower allocation of costs to cost of service revenue reflecting PPQ services provided under the original asset purchase agreement and related agreements being substantially completed during the first half of 2025. Foreign currency loss was $2.8 million for the three months ended March 31, 2026, compared to a gain of $3.7 million for the three months ended March 31, 2025. The change of $6.5 million was primarily due to the strengthening of the U.S. dollar against the pound sterling and euro as it relates to the valuation of our intercompany payables and receivables. Interest income was $0.2 million for the three months ended March 31, 2026, compared to $1.0 million for the three months ended March 31, 2025. The decrease of $0.8 million was due to lower interest rates and cash balances held in interest bearing accounts during 2026. Interest expense was $2.8 million for the three months ended March 31, 2026 compared to $3.0 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily due to a lower interest rate in connection with the debt financing. Net loss attributable to ordinary shareholders for the quarter ended March 31, 2026, was $46.3 million, or $0.57 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $40.0 million, or $0.51 basic and diluted net loss per ordinary share for the quarter ended March 31, 2025. About MeiraGTx MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline with four late-stage clinical programs. Each of these programs use local delivery of small doses resulting in disease modifying effects in both inherited and more common diseases, in the eye, Parkinson’s disease and radiation-induced xerostomia. MeiraGTx uses its innovative technology in optimization of capsids, promoters and novel translational control elements to develop best in class, potent, safe viral vectors. MeiraGTx’s broad pipeline is supported by end-to-end in-house manufacturing. MeiraGTx has built the most comprehensive manufacturing capabilities in the industry, with 5 facilities globally, including two that are licensed for GMP viral vector production and a GMP QC facility with clinical and commercial licensure. In addition, MeiraGTx has developed a proprietary manufacturing platform process over 9 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, MeiraGTx has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation technology allows precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on the regulated in vivo delivery of metabolic peptides, including GLP-1, GIP, Glucagon, Amylin, PYY and Leptin, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally PNS targets addressing long term intractable pain. MeiraGTx has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high. For more information, please visit www.meiragtx.com Forward Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated milestones regarding our pre-clinical and clinical data, reporting of such data and the timing of results of data and regulatory matters, statements regarding our collaborations, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate,” “eligible” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic transactions or priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug or rare pediatric disease designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of pandemics, epidemics or outbreaks of infectious diseases on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contacts Investors: MeiraGTx [email protected] or Media: Jordyn Temperato LifeSci Communications [email protected]

The market expects Alector (ALEC) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotechnology company is expected to post quarterly loss of $0.35 per share in its upcoming report, which represents a year-over-year change of +14.6%. Revenues are expected to be $3 million, down 18.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 7.96% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Alector, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -18.57%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that Alector will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Alector would post a loss of$0.39 per share when it actually produced a loss of -$0.34, delivering a surprise of +12.82%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Alector doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, MeiraGTx Holdings PLC (MGTX), is soon expected to post loss of $0.43 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of +15.7%. This quarter's revenue is expected to be $1.55 million, down 19.7% from the year-ago quarter. The consensus EPS estimate for MeiraGTx has been revised 6.5% higher over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -48.84%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that MeiraGTx will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alector, Inc. (ALEC) : Free Stock Analysis Report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects MeiraGTx Holdings PLC (MGTX) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.43 per share in its upcoming report, which represents a year-over-year change of +15.7%. Revenues are expected to be $1.55 million, down 19.7% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 6.45% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For MeiraGTx, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -48.84%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that MeiraGTx will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that MeiraGTx would post a loss of$0.6 per share when it actually produced earnings of $0.19, delivering a surprise of +131.67%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. MeiraGTx doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Kura Oncology (KURA), is soon expected to post loss of $0.88 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of -33.3%. Revenues for the quarter are expected to be $15.06 million, up 6.7% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Kura Oncology has remained unchanged. Nevertheless, the company now has an Earnings ESP of +14.45%, reflecting a higher Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Kura Oncology will most likely beat the consensus EPS estimate. The company could not beat consensus EPS estimates in any of the last four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report Kura Oncology, Inc. (KURA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 company has surpassed consensus EPS estimates two times. MeiraGTx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $75.36 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 3,027.14%. This compares to year-ago revenues of $21.39 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MeiraGTx shares have lost about 4.2% since the beginning of the year versus the S&P 500's decline of 3.7%. While MeiraGTx has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MeiraGTx was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.59 on $3.41 million in revenues for the coming quarter and -$1.11 on $167.86 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, BioHarvest Sciences Inc. (BHST), is yet to report results for the quarter ended December 2025. The results are expected to be released on March 31. This company is expected to post quarterly loss of $0.11 per share in its upcoming report, which represents a year-over-year change of +35.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. BioHarvest Sciences Inc.'s revenues are expected to be $9.34 million, up 28.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report BioHarvest Sciences Inc. (BHST) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 tract MeiraGTx 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 company, today announced financial and operational results for the fourth quarter and full-year ended December 31, 2025, and provided a corporate update. “We are delighted to have been awarded Breakthrough Designation for our AAV2-hAQP1 treatment for Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “This Breakthrough application was supported by 3-year data from the Phase 1 dose escalation study. On April 16th, we will be providing an AAV2-hAQP1 program update with information about the commercial opportunity for this therapy, as well as presenting the 3-year data. We have also had huge enthusiasm about our Phase 2 AQUAx2 study in the RIX community, amongst physicians and patients.” “In 2025 we executed two important strategic collaborations bringing immediate non-dilutive financing into the company, as well as potential significant near-term financial milestones. We signed a collaboration with Eli Lilly and Company (Lilly) focused on our AAV-AIPL1 program for the treatment of LCA4, one of the most severe forms of inherited retinopathies. In addition to AAV-AIPL1, Lilly gained exclusive rights to two preclinical ocular programs as well as our intravitreal capsids, bespoke promoters and certain rights to our riboswitch platform in the eye. Lilly is working with global regulatory agencies to expeditiously gain approval of AAV-AIPL1 and to provide access to this life changing therapy for LCA4 to children globally.” Dr. Forbes continued, “Earlier in the year, we entered into a strategic collaboration with Hologen Limited, a world-leader in the development of multi-modal generative AI foundation models which were built specifically to remove noise from clinical data and to allow the real clinical effects of treatment to be clearly seen. The use of Hologen’s AI technology applied to MeiraGTx’s statistically significant double-blind Phase 2 data-sets has de-risked the AAV-GAD program and identified disease modifying changes in the physiology of the brain in response to treatment. We are working closely with Hologen to initiate the pivotal Phase 3 double blind sham-controlled study of AAV-GAD in Parkinson’s in the coming months at global centers of excellence in Parkinson’s disease treatment.” “We have also been successful in the further development of our Riboswitch platform. We are currently in conversation with the FDA preparing our first Riboswitch IND with our Ribo-leptin product to deliver leptin using a daily oral small molecule inducer. We have very strong long-term data in animal models demonstrating the small molecule controlled riboswitch dynamics are durable for the life of the animal – out to 19 months so far. We have also now demonstrated very encouraging data in the second Riboswitch program that we intend to take into the clinic which is in neuropathic pain.” 2025 and Recent Highlights AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia (RIX): The FDA has now 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 tract. This is in addition to the Regenerative Medicine Advanced Therapy (RMAT) designation already granted by the FDA for AAV2-hAQP1. The Company has aligned with the FDA on the clinical requirements for the Phase 2 AQUAx2 (NCT05926765) study to support a potential BLA with the primary endpoint being the change from baseline in the Xerostomia Questionnaire at 12 months following the one time treatment. The final patients are currently enrolling, and the Company anticipates data 12 months after the last patient is treated, with a potential BLA filing in the first half of 2027 and potential approval around the end of 2027 with launch in the US targeted in early 2028. MeiraGTx will be hosting a program update April 16th to discuss the commercial opportunity as well as presenting the full 3-year data from all cohorts of the Phase 1 study. AAV-GAD for the Treatment of Parkinson’s Disease: In 2025, the FDA granted RMAT designation to AAV-GAD for the treatment of Parkinson’s disease not adequately controlled with medication. This RMAT was awarded based on positive data demonstrating statistically significant efficacy in 3 clinical studies: a Phase 1 dose escalation study (n=14), a double-blind sham-surgery controlled Phase 2 study (n=45), and a double-blind sham-surgery controlled Phase 1/2 clinical bridging study (n=14). This application also included the demonstration of potential disease modification resulting from treatment in the Company’s positive Phase 2 studies. The Company is currently engaging with clinical trial sites globally and expects to initiate the Phase 3 study of AAV-GAD in the coming months. Strategic Collaboration with Hologen AI: MeiraGTx and Hologen have formed a joint venture, Hologen Neuro AI Ltd, with a $200 million upfront payment to MeiraGTx, as well as additional committed funding from Hologen into the joint venture of up to $230 million to fully fund the development of the AAV-GAD program through approval. MeiraGTx will hold a 30% ownership in the joint venture and lead all clinical development and manufacturing. Hologen Neuro AI Ltd will contribute its proprietary multi-modal generative foundation models (LMMs) to the joint venture and will enter into both clinical and commercial manufacturing supply agreements with MeiraGTx for exclusive manufacturing of AAV-GAD. As part of the Hologen collaboration, the Company also intends to move forward into the clinic this year with a locally delivered treatment for trigeminal neuralgia, one of the most severe forms of pain and intractable to treatment. Ophthalmology Programs Strategic partnership with Eli Lilly and Company on AAV-AIPL1 for LCA4 MeiraGTx entered into a strategic collaboration with Lilly, granting Lilly worldwide exclusive rights to the AAV-AIPL1 program for Leber congenial amaurosis 4 (LCA4) and access to additional ocular and gene regulation assets. Under the terms of the agreement, MeiraGTx received an upfront payment of $75 million and is eligible to receive over $400 million in total milestone payments. MeiraGTx is also eligible to receive tiered royalties on licensed products. Lilly also received worldwide exclusive access rights to MeiraGTx’s innovative gene therapy technologies for use in ophthalmology with certain targets designated by Lilly, including novel intravitreal capsids developed in-house at MeiraGTx and bespoke promoters including AI-generated cell specific promoters. MeiraGTx also granted Lilly certain rights to its proprietary riboswitch technology for use in gene editing in the eye. Botaretigene Sparoparvovec for the Treatment of X-linked Retinitis Pigmentosa (XLRP): Data from the Phase 3 LUMEOS trial of botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa was presented by Dr. Michael Clark, the primary clinical lead on the study from Johnson & Johnson Innovative Medicine, at the Foundation Fighting Blindness 2025 Retinal Therapeutics Innovation Summit on May 2nd, 2025. The FDA has granted Fast Track and orphan drug designations to bota-vec and the regulatory authorities in the EU have granted Priority Medicines, or PRIME, advanced therapy medicinal product, or ATMP, and orphan drug designations to bota-vec. Johnson & Johnson Innovative Medicine is the sponsor of this program with MeiraGTx eligible to receive up to $285 million upon the first commercial sales of bota-vec in the US and EU and manufacturing tech transfer. MeiraGTx also entered into a commercial supply agreement with Johnson & Johnson Innovative Medicine for bota-vec manufacturing. As part of this agreement, MeiraGTx has completed PPQ to support CMC sections of global regulatory filings. Following the release of the compelling Phase 3 data at their summit, the Foundation Fighting Blindness issued a public letter to Johnson & Johnson Innovative Medicine strongly supporting the filing and ultimate approval of this treatment for XLRP and stating that it had a remarkable benefit for many of the patients treated. Riboswitch Gene Regulation Technology Platform for in vivo Delivery: The Company’s Riboswitch technology is a powerful platform that transforms the potential of biologic therapeutics by providing a broadly applicable mechanism for the precise dosing of any protein, hormone or peptide that is encoded by DNA via in vivo production in direct dose response to bespoke oral small molecule inducers. AI driven target discovery is identifying a universe of peptides, hormones and proteins with important roles in homeostatic pathways regulating cardiovascular, metabolic, neurological and immunological systems that underly many of the diseases of aging. Such proteins acting in rapidly responsive systems are often short lived and hard to make into long-acting injectable analogs that retain full physiological function. The Company’s Riboswitch technology provides the only broadly applicable mechanism for precisely dosing the growing number of proteins that are currently intractable to use as therapeutics. MeiraGTx is progressing its first riboswitch program into the clinic in metabolic disease with native human leptin (Ribo-leptin). This is a significant unmet need in patients with both inherited and acquired leptin deficiency. The only currently available treatment - metreleptin - is immunogenic, which can lead to neutralizing antibodies against leptin, resulting catastrophic and even lethal metabolic consequences. The Company is in iterative discussion with the FDA to open a Ribo-leptin IND later this year. As of December 31, 2025, MeiraGTx had cash and cash equivalents of approximately $65.9 million, as well as $3.0 million in receivables due from Johnson & Johnson Innovative Medicine and $15.3 million in tax incentive receivables. Together with the $55.0 million received to date in the first quarter 2026 and $5.0 million in receivables from Hologen as well as the remaining $95.0 million from the closing of the strategic collaboration with Hologen, the Company believes that it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second half of 2027 and to repay its debt obligation of $25.0 million to Perceptive Credit Holdings III, LP (due in June 2026) and $50.0 million (due in May 2027). This estimate does not include the $135.0 million in potential near-term cash consideration from Lilly upon the achievement of certain development and regulatory approval milestones, or the $285.0 million in milestones the Company is eligible to receive under the asset purchase agreement upon first commercial sale of bota-vec in the United States and in at least one of the United Kingdom, France, Germany, Spain and Italy, for completion of the transfer of certain manufacturing technology to Johnson & Johnson Innovative Medicine and upon regulatory approval of a Johnson & Johnson Innovative Medicine-selected manufacturing facility in each of the United States and European Union for commercial manufacture of bota-vec. Financial Results Cash, cash equivalents and restricted cash were $68.2 million as of December 31, 2025, compared to $105.7 million as of December 31, 2024. Service revenue was $6.4 million for the year ended December 31, 2025, compared to $33.3 million for the year ended December 31, 2024. The decrease of $26.9 million was due to decreased activity of PPQ services under the asset purchase agreement with Johnson & Johnson Innovative Medicine as the work was substantially completed during the first half of 2025. License revenue was $75.0 million for the year ended December 31, 2025 due to the upfront license fee payment under the Lilly collaboration agreement. There was no license revenue for the year ended December 31, 2024. Cost of service revenue was $4.8 million for the year ended December 31, 2025, compared to $23.8 million for the year ended December 31, 2024. The decrease of $18.9 million was due to decreased activity of PPQ services under the asset purchase agreement with Johnson & Johnson Innovative Medicine as the work was substantially completed during the first half of 2025. General and administrative expenses were $52.9 million for the year ended December 31, 2025, compared to $54.2 million for the year ended December 31, 2024. The decrease of $1.3 million was primarily due to a decrease in professional fees, legal fees, a change in estimate of an asset retirement obligation, which were partially offset by an increase in payroll expenses and facilities costs. Research and development expenses for the year ended December 31, 2025 were $129.6 million, compared to $119.5 million for the year ended December 31, 2024. The increase of $10.1 million was primarily due to an increase in manufacturing costs due to both a lower allocation of clinical trial material batch costs to our clinical programs and a lower allocation of costs to cost of services revenue reflecting PPQ services provided under the Asset Purchase Agreement and related agreements being substantially completed during the first half of 2025. Other cost increases arose in our clinical programs for other ocular diseases and AAV-GAD, primarily due to an increase in manufactured clinical trial material batches related to these programs, and our preclinical programs for gene regulation reflecting preclinical studies initiated during the year. These increases were partially offset by a decrease in costs for our AAV-hAQP1 program due to a decrease in the number of batches of clinical trial material manufactured compared to the prior year. Foreign currency gain was $2.1 million for the year ended December 31, 2025, compared to a loss of $2.9 million for the year ended December 31, 2024. The change of $5.0 million was primarily due to the weakening of the U.S. dollar against the pound sterling and euro as it mostly relates to the valuation of our intercompany payables and receivables. Interest income was $1.8 million for the year ended December 31, 2025, compared to $4.1 million for the year ended December 31, 2024. The decrease of $2.3 million was due to lower interest rates and cash balances during 2025. Interest expense was $12.2 million for the year ended December 31, 2025, compared to $13.3 million for the year ended December 31, 2024. The decrease of $1.1 million was primarily due to a lower interest rate in connection with the debt financing. There was no gain on sale of nonfinancial assets during the year ended December 31, 2025 compared to $28.4 million for the year ended December 31, 2024. This decrease was a result of the recognition of the $50.0 million milestone allocated to the nonfinancial assets sold and assigned to Johnson & Johnson Innovative Medicine being fully recognized during 2023 and 2024. Net loss attributable to ordinary shareholders for the year ended December 31, 2025, was $114.2 million, or $1.42 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $147.8 million, or $2.12 basic and diluted net loss per ordinary share for the year ended December 31, 2024. For more information related to our clinical trials, please visit www.clinicaltrials.gov About MeiraGTx MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline with four late-stage clinical programs. Each of these programs use local delivery of small doses resulting in disease modifying effects in both inherited and more common diseases, in the eye, Parkinson’s disease and radiation-induced xerostomia. MeiraGTx uses its innovative technology in optimization of capsids, promoters and novel translational control elements to develop best in class, potent, safe viral vectors. MeiraGTx’s broad pipeline is supported by end-to-end in-house manufacturing. MeiraGTx has built the most comprehensive manufacturing capabilities in the industry, with 5 facilities globally, including two that are licensed for GMP viral vector production and a GMP QC facility with clinical and commercial licensure. In addition, MeiraGTx has developed a proprietary manufacturing platform process over 9 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, MeiraGTx has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation technology allows precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on the regulated in vivo delivery of metabolic peptides, including GLP-1, GIP, Glucagon, Amylin, PYY and Leptin, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally PNS targets addressing long term intractable pain. MeiraGTx has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high. For more information, please visit www.meiragtx.com Forward Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated milestones regarding our pre-clinical and clinical data, reporting of such data and the timing of results of data and regulatory matters, potential milestone payments and the achievement of such milestones, statements regarding our collaborations, including the anticipated timing for the closing and funding of the collaboration with Hologen, the success of the activities to be performed under the Hologen collaboration agreements and the efficacy of Hologen’s AI technology, the development of our AAV-GAD and other CNS product candidates and the development of our manufacturing technology, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate,” “eligible” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic transactions or priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug or rare pediatric disease designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of pandemics, epidemics or outbreaks of infectious diseases on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contacts Investors: MeiraGTx [email protected] or Media: Jason Braco, Ph.D. LifeSci Communications [email protected]

AnaptysBio, Inc. (ANAB) came out with quarterly earnings of $1.58 per share, beating the Zacks Consensus Estimate of $0.89 per share. This compares to a loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +78.53%. A quarter ago, it was expected that this company would post a loss of $1.06 per share when it actually produced earnings of $0.52, delivering a surprise of +149.06%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. AnaptysBio, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $108.25 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 28.47%. This compares to year-ago revenues of $43.11 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. AnaptysBio shares have added about 13.3% since the beginning of the year versus the S&P 500's gain of 0.5%. While AnaptysBio has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for AnaptysBio was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$1.10 on $29.16 million in revenues for the coming quarter and -$4.34 on $151.33 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 45% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, MeiraGTx Holdings PLC (MGTX), is yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.60 per share in its upcoming report, which represents a year-over-year change of -20%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. MeiraGTx Holdings PLC's revenues are expected to be $2.41 million, down 88.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AnaptysBio, Inc. (ANAB) : Free Stock Analysis Report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

TG Therapeutics (TGTX) came out with quarterly earnings of $0.14 per share, missing the Zacks Consensus Estimate of $0.35 per share. This compares to earnings of $0.15 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -60.45%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.24 per share when it actually produced earnings of $2.43, delivering a surprise of +912.5%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $192.57 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 0.22%. This compares to year-ago revenues of $108.18 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TG Therapeutics shares have lost about 0.5% since the beginning of the year versus the S&P 500's gain of 1.5%. While TG Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TG Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.34 on $203.41 million in revenues for the coming quarter and $1.65 on $904 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 36% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. MeiraGTx Holdings PLC (MGTX), another stock in the same industry, has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.60 per share in its upcoming report, which represents a year-over-year change of -20%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. MeiraGTx Holdings PLC's revenues are expected to be $2.41 million, down 88.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research