MeiraGTx: pioneering an in-gene-ious approach to medical treatment

MeiraGTx?("Meira") is on a mission to transform how we view and treat disease. From common ailments, such as obesity and diabetes, to rare genetic disorders, Meira is pioneering a novel medical approach using gene therapy.?

Instead of injecting the body with a synthetic substance that bypasses bodily production cycles, Meira’s gene therapy techniques trigger the body to naturally produce what would otherwise be artificially injected. By providing a “message” to the body to instruct it to create what it needs, Meira's treatments invert the generally accepted orientation of medical intervention.?

The?Curation Collective?recently welcomed Meira’s CEO and co-founder Zandy Forbes, and COO, CFO, and co-founder Richard Giroux to the club for an eye-opening hour of discussion.?

Founded in 2015 and publicly listed in 2018, Meira has three core functions: a late-stage (staggeringly full) drugs development?pipeline, end-to-end?manufacturing facilities?even the largest pharma conglomerates would be proud of, and innovation in next-generation biotech such as?gene regulation.?

Clinical pipeline??

The company is focusing on disorders that require small, non-invasive local doses of gene therapy, such as eye diseases, Parkinson’s and xerostomia – a condition inhibiting the salivary glands afflicting patients that have undergone cancer treatment. They have six ongoing development programmes, and over the last eight years, every programme has advanced to the next stage.?

One treatment in the pipeline is the retinal drug?AAV-RPGR, designed to remedy the most common form of X-linked retinitis pigmentosa (XLRP), a genetic disease causing blindness in men. In phase two of development, AAV-RPGR showed promising results: the data demonstrated a statistically significant improvement in retinal sensitivity and vision-guided mobility.?

Unique manufacturing??

Meira has commercially ready, end-to-end?manufacturing?resources with two facilities totalling over 180,000 sq. ft. They also have an in-house facility that makes the “plasmid” needed to produce genetic medicines and a licensing facility for drug approval. Bringing this all in-house has helped ease supply chain constraints that have plagued other pharma and biotech companies like Novo Nordisk.??

Additionally, Meira has effectively implemented AI into their gene therapy research, enabling them to treat diseases at a lower cost and with greater effectiveness. Coincidentally, the Curation Collective will be further exploring?AI in drug development?on a call with?E-Therapeutics?in September.??

Technological innovation?

In what would make a compelling tagline, Meira has “invented a way of controlling any gene, in any context, using a pill,” according to Zandy. What's more, it is cheaper and more effective than current medicines in treating a range of ailments.?

Zandy also discussed a new drug in development for Parkinson’s. By administering a small dose of the gene, a one-time treatment provides relief from Parkinson’s motor symptoms. Meira has conducted phase two testing, becoming the first gene therapy study to display?a clinical benefit over a control.?A final stage three study is scheduled for completion in 2024.?

Partnerships & financials?

Meira has a global eye disease treatment partnership with?Johnson & Johnson?that places them in an enviable position in what Zandy described as an “unusually good deal” due to high demand from other big pharma companies. While Meira manufactures the treatments using its unique production facilities, Johnson & Johnson incurs 100% of all development costs. Phase three testing is underway for the first co-developed treatments, with Meira hoping for approval from the FDA in 2024. The terms of the partnership let Meira take 20% of generated revenue and have allowed them to?transition “from a small gene therapy company to a commercial manufacturer.”?

Richard mentioned that Meira has a cash runway into Q2 2025 following their recent raise of $60m from a private investment in public equity ("PIPE") at a 9%?premium?to the share price from just the top 5 investors. Meira initially aimed to raise only $30-40m, but investor enthusiasm meant they exceeded expectations.?

Consensus mixed

From the start of 2022 to July 2023, Meira’s stock price has fallen by around 70%. Indeed, analysts are somewhat uncertain about Meira’s future trajectory. While there is?consensus?that per-share losses will creep up next year and downgrades are predicted for near-term revenues (although they are still expected to outperform industry competitors), there are considerable discrepancies in future price targets with some bearish analysts predicting?$18 per share and?bullish ones looking at $47 per share.?

Despite the near-term scepticism, a promising pipeline of drugs, along with extensive manufacturing capabilities and investment in next-gen biotech research, sets a solid platform for the company to grow. Once new treatments gain approval and enter the market, Meira will hopefully begin to justify the excitement felt among investors.?