Metagenomi Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and available-for-sale marketable securities totaled $101.7 million as of September 30, 2026, down from $160.8 million as of December 31, 2025.
• Collaboration revenue was $2.2 million for the three months ended September 30, 2026, compared to $8.7 million in the same period in 2025; for the nine months ended September 30, 2026, revenue was $3.2 million versus $21.3 million in 2025.
• Research and development expenses were $17.5 million for the quarter ended September 30, 2026, a decrease from $25.3 million in the comparable 2025 period; for the nine months ended September 30, 2026, R&D expenses were $59.3 million compared to $72.9 million in 2025.
• General and administrative expenses were $6.9 million for the quarter ended September 30, 2026, including a $1.2 million one-time net litigation settlement expense, compared to $6.2 million in the comparable 2025 period; for the nine months ended September 30, 2026, G&A expenses were $19.4 million versus $20.0 million in 2025.
• Net loss was $21.1 million ($0.56 per share) for the three months ended September 30, 2026, compared to a net loss of $20.4 million ($0.55 per share) in the same period in 2025; for the nine months ended September 30, 2026, net loss was $71.7 million ($1.90 per share) compared to $65.3 million ($1.76 per share) in 2025.
• Total operating expenses were $24.4 million for the quarter ended September 30, 2026, compared to $31.5 million in 2025; for the nine months ended September 30, 2026, total operating expenses were $78.8 million compared to $92.9 million in 2025.
• Interest income was $1.0 million for the quarter ended September 30, 2026, compared to $2.2 million in 2025; for the nine months ended September 30, 2026, interest income was $3.8 million compared to $7.6 million in 2025.
• Total liabilities were $64.2 million as of September 30, 2026, compared to $62.5 million as of December 31, 2025.
• Total stockholders' equity was $93.2 million as of September 30, 2026, compared to $158.6 million as of December 31, 2025.

Guidance and Future Outlook:

• The Company plans to initiate the INTEGR8 global clinical trial in the first half of 2027.
• Initial clinical data, including safety, tolerability, and FVIII functional activity data, is expected to be provided in the second half of 2027.
• The Company anticipates its cash runway will support operations into 2028.
• The Company intends to expand the INTEGR8 trial to hemophilia treatment centers beyond the U.S., subject to clinical clearances in additional jurisdictions.

Business Segments and Product Lines:

• The U.S. FDA cleared the Investigational New Drug (IND) application for MGX-001, the Company's lead program for the treatment of hemophilia A.
• MGX-001 is a one-time genome editing treatment designed to deliver durable, endogenous Factor VIII (FVIII) activity by site-specifically integrating the FVIII gene into the albumin gene intron.
• The INTEGR8 trial is a global, multi-center, open-label, single-arm, dose escalation followed by dose expansion Phase 1/2 trial in adult patients with moderately severe to severe hemophilia A.
• Additional preclinical data for MGX-001, including efficacy and safety results, will be presented at the 68th American Society of Hematology (ASH) Annual Meeting on December 14, 2026.
• The Company is evaluating additional disease indications for protein deficiency diseases using the same site-specific large gene integration technology at the albumin locus.
• The Company is pursuing partnered assets targeting cardiometabolic diseases.

Market and Competitive Landscape:

• Hemophilia A affects approximately 25,000 patients in the United States and an estimated 500,000 worldwide.
• Current standard-of-care treatments require lifelong, repeated dosing, are not curative, and carry a risk of breakthrough bleeding.
• MGX-001 represents a departure from prior approved gene therapies for hemophilia A that relied on episomal FVIII expression, aiming to provide life-long protection from bleeding events and joint damage.
• Preclinical data in non-human primates demonstrated FVIII activity in the normal physiologic range with durable expression over approximately 19 months and no detectable off-target editing.

Risks and Challenges:

• Forward-looking statements are subject to risks including the ability to obtain financing, results of research and development activities, and timing of IND submissions and clinical trials.
• Risks include potential clinical holds by the FDA or other regulatory authorities, delays in trial initiation, uncertainties in preclinical and clinical testing, and dependence on third-party suppliers.
• Additional risks include the early stage of products, the need for substantial additional funds, government regulation, patent and intellectual property matters, competition, and volatility in capital markets.

Management Commentary and Tone:

• President and CEO Jian Irish, Ph.D., M.B.A., described the FDA clearance as a "pivotal milestone" and expressed excitement about the potential for MGX-001 to provide long-term benefit to adult and pediatric patients in a landscape with no current cure for hemophilia A.
• Management highlighted that MGX-001 leverages a proprietary platform to harness the body's native albumin promoter for durable FVIII production, contrasting it with prior therapies relying on episomal expression.
• The Company believes MGX-001 has the potential to provide a new standard of care for the treatment of hemophilia A.

Other Key Points:

• The Company reported a $1.2 million one-time net litigation settlement expense included in the third quarter 2026 G&A expenses.
• The Company was founded on the science of metagenomics to discover and develop novel CRISPR gene-editing tools.
• The Company intends to continue expanding its pipeline by leveraging proprietary genetic editing capabilities in site-specific deletion, insertion, and correction.
• The Company has no revenue from product sales as it remains in the development stage.