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MeiraGTx Holdings plc (Nasdaq: MGTX) is a vertically integrated, clinical-stage gene therapy company with a focus on transforming the lives of patients through innovative genetic medicines. Based in London and New York, MeiraGTx pioneers gene therapies for a range of acquired and inherited disorders. The company's research spans serious neurodegenerative diseases such as Alzheimer's, Parkinson's, and ALS, as well as ocular diseases like inherited blindness and age-related macular degeneration. Additionally, MeiraGTx is developing treatments for xerostomia, a debilitating side effect of head and neck cancer radiation therapies.
MeiraGTx's product pipeline includes several advanced-stage clinical trials and preclinical research programs aimed at addressing significant unmet medical needs. Key pipeline products include AAV-CNGB3, AAV-CNGA3, and AAV-RPGR. These therapies target eye disorders, central nervous system conditions, and salivary gland dysfunctions.
The company has gained notable recognition and strategic investments from major pharmaceutical entities. Recently, Sanofi made a $30 million strategic investment in MeiraGTx, validating its Riboswitch gene regulation technology and xerostomia program. This investment underscores the broad potential of MeiraGTx's platform, which supports the development of breakthrough medicines for neurodegenerative and immune-mediated diseases.
MeiraGTx is also advancing its gene therapy manufacturing capabilities, with facilities in the United States, the United Kingdom, and the European Union. The company boasts state-of-the-art viral vector design and optimization, as well as a transformative gene regulation platform technology that allows precise, dose-responsive control of gene expression through oral small molecules.
Financially, MeiraGTx is well-positioned with a robust cash balance, strategic partnerships, and a strong pipeline of potential milestone payments. The company recently reported a $50 million milestone payment from Janssen Pharmaceuticals following the initiation of an extension study for the Phase 3 LUMEOS clinical trial for botaretigene sparoparvovec (bota-vec) for X-linked retinitis pigmentosa.
With a dedicated management team and a comprehensive end-to-end manufacturing infrastructure, MeiraGTx is poised to bring innovative genetic therapies to market, addressing both rare and prevalent diseases. For more information, visit www.meiragtx.com.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced a term loan agreement with Perceptive Advisors for up to $100 million, including $75 million immediately available. This minimally dilutive capital, collateralized by manufacturing facilities in London and Shannon, extends the company’s cash runway to Q4 2024. The loan has a 10% interest rate and a maturity date of August 2, 2026. The funds will be used for the development of clinical products and other corporate purposes. The company retains value through its pipeline and manufacturing capabilities, supporting growth in gene therapy.
MeiraGTx Holdings (MGTX) announced positive results from its Phase 1/2 MGT009 clinical study of botaretigene sparoparvovec, an investigational gene therapy for X-linked retinitis pigmentosa (XLRP). The therapy demonstrated a favorable safety profile and significant improvements in retinal function, visual function, and functional vision compared to an untreated control group at six months. The results indicate potential for life-changing impact on patients with XLRP, a condition currently lacking approved treatments. The company is preparing for its Phase 3 Lumeos study while actively enrolling patients.
MeiraGTx Holdings plc (MGTX) reported its Q1 2022 financial results, revealing a license revenue increase to $5.6 million, up from $4.6 million in Q1 2021, mainly due to Janssen collaborations. R&D expenses rose to $23.1 million, reflecting growth in clinical trial costs. The net loss attributable to shareholders was $31 million, compared to $23.6 million a year prior. The company continues to progress its Phase 3 Lumeos trial for X-linked Retinitis Pigmentosa and recently completed the AQUAx study for radiation-induced xerostomia. MeiraGTx maintains a cash reserve of approximately $114 million.
MeiraGTx Holdings announced new clinical data from its Phase 1/2 trial of botaretigene sparoparvovec aimed at treating X-linked Retinitis Pigmentosa (XLRP) at the ARVO 2022 Annual Meeting. Results suggest localized improvements in retinal sensitivity up to 12 months post-treatment. The data indicates that the gene therapy could restore photoreceptor function, with results extending beyond the delivery site. MeiraGTx collaborates with Janssen Pharmaceuticals on this gene therapy, further demonstrating progress in developing treatments for inherited retinal diseases.
MeiraGTx Holdings (NASDAQ:MGTX) has appointed Dr. Debra Yu to its Board of Directors. Dr. Yu brings over 30 years of healthcare experience, previously serving as President and Chief Strategy Officer of LianBio. Her background includes senior positions in business development at Pfizer and venture capital firms. CEO Alexandria Forbes highlighted that Dr. Yu's expertise will provide valuable insights as MeiraGTx, a gene therapy company, continues to expand its operations and product pipeline focusing on ocular, neurodegenerative diseases, and xerostomia.
MeiraGTx Holdings plc (NASDAQ:MGTX) announced participation in several key conferences. Alexandria Forbes, Ph.D. will present at:
- Chardan's 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit on April 25, 2022
- Mass General Brigham World Medical Innovation Forum on May 4, 2022
- BofA Securities 2022 Healthcare Conference on May 10, 2022
- 2022 RBC Capital Markets Global Healthcare Conference on May 18, 2022
Webcasts will be available on the company's Investor page.
MeiraGTx Holdings plc (MGTX) reported key advancements in its clinical pipeline, including the initiation of Phase 3 trials for botaretigene sparoparvovec in collaboration with Janssen Pharmaceuticals, resulting in a $30 million milestone payment. The company also shared positive preliminary results from the Phase 1 AQUAx trial for AAV-hAQP1, aimed at treating radiation-induced xerostomia, where 6 of 7 patients showed symptom improvement. As of December 31, 2021, MeiraGTx had cash reserves of $137.7 million, ensuring operational funding through mid-2023. However, net losses increased to $79.6 million.
MeiraGTx has announced the receipt of a $30 million milestone payment from Janssen Pharmaceuticals for achieving a clinical milestone in the Phase 3 Lumeos trial of botaretigene sparoparvovec (AAV-RPGR), an investigational gene therapy targeting X-linked retinitis pigmentosa (XLRP). The trial is now actively dosing patients, and the company is also eligible for additional milestone payments related to other gene therapy programs in collaboration with Janssen. XLRP is a severe retinal disease, and this therapy aims to improve vision outcomes for patients.
On December 15, 2021, MeiraGTx Holdings plc (NASDAQ: MGTX) will conduct a virtual R&D Day showcasing its innovative gene regulation platforms. The event, led by CEO Alexandria Forbes, will cover topics such as promoter engineering and synthetic riboswitch technology. Participants can register for the event online and access a live webcast, with a replay available on the company's investor page. MeiraGTx aims to transform gene therapy with its proprietary platforms that promise precise gene expression control, targeting ocular, neurodegenerative diseases, and xerostomia.
MeiraGTx Holdings (MGTX) reported promising preliminary data from its Phase 1 AQUAx trial of AAV-hAQP1, aimed at treating grade 2/3 radiation-induced xerostomia (RIX). The results indicate that 6 out of 7 participants showed clinically meaningful improvement in xerostomia symptoms at 90 days. One participant maintained improvement at 24 months. AAV-hAQP1 demonstrated good safety and tolerability. The company plans to initiate a Phase 2 study in late 2022. RIX affects about 170,000 patients in the U.S., revealing a significant unmet medical need.
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