MGX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-11

• We are an in vivo genome editing company capitalizing on our proprietary technologies to create curative genetic medicines for patients. We were founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel CRI…

• In the fourth quarter of 2025, we completed a pre-IND meeting for the development of MGX-001. We remain on track for regulatory submission to advance a global clinical program, including an investigational new drug application (“IND”) in the fourth quarter of 2026, and subject to regulatory clearanc…

• MGX-001 Large Gene Integration System for Protein Replacement via Gene Insertion

• Leveraging the MGX-001 site-specific genome integration system, we are pursuing disease indications which have the potential to be treated by protein replacement via gene insertion. In late 2025, we demonstrated the curative potential of the MGX-001 large gene integration system in a secreted protei…

• In November 2022, we entered into a Collaboration and License Agreement with Ionis Pharmaceuticals, Inc. (“Ionis”) to research, develop and commercialize investigational medicines using our genome editing technologies. We are currently in Wave 1 of our collaboration with Ionis focused on four diseas…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We are an in vivo genome editing company capitalizing on our proprietary technologies to create curative genetic medicines for patients. We were founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel edi…

• We plan to advance MGX-001 into clinical development, conduct pre-IND regulatory meetings by the end of 2025, submit investigational new drug (“IND”) and clinical trial application (“CTA”) submissions in the fourth quarter of 2026, and initiate clinical trials in 2027.

• Leveraging the MGX-001 site-specific genome integration approach, we are advancing additional wholly owned therapeutic candidates targeting secreted protein deficiencies with the goal of achieving targeted and durable protein replacement. We plan to demonstrate NHP proof-of-concept for our lead secr…

• In November 2022, we entered into a Collaboration and License Agreement with Ionis Pharmaceuticals, Inc. (“Ionis”) to research, develop and commercialize investigational medicines using our genome editing technologies. Wave 1 of the collaboration is comprised of four cardiometabolic targets includin…

• In partnership with Ionis, we plan to nominate a development candidate from the Wave 1 targets in 2025. In 2026, we plan to initiate IND-enabling activities for the development candidate nominated in 2025 and nominate additional development candidates from the remaining Wave 1 targets.

Text added vs the prior filing · source: 10-Q · 2026-05-11

• The summary risk factors described above should be read together with the text of the full risk factors below in this section titled “Risk Factors” in Part II, Item 1A. and the other information set forth in this Quarterly Report on Form 10-Q, as well as in other documents that we file with the U.S.…

• As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. In March 2025, we filed a Shelf Registration Statement on Form S-3 (File No. 333-285867) with the U.S. Securities and Exchange Commission, which was declared effective on Mar…

• The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely a…

• original marketing application for any potential product candidates for which we have received rare pediatric disease designation. The FDA may determine that a marketing application for any such product candidates, if approved, does not meet the eligibility criteria for a PRV. The FDA is currently a…

• In addition, the One Big Beautiful Bill Act of 2025 (“OBBBA”) imposed significant reductions in Medicaid funding, additional work requirements for Medicaid recipients, and more frequent reenrollment requirements. These changes are expected to place substantial pressure on state Medicaid budgets, red…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We are currently, and may in the future be, subject to securities litigation, which is expensive and could divert management attention. Such lawsuits could result in substantial damages, divert management’s time and attention from our business, and have a material adverse effect on our financial pos…

• The impacts of cyber-attacks and data privacy breaches on our business.

• The summary risk factors described above should be read together with the text of the full risk factors below in this section titled “Risk Factors” in Part II, Item 1A. and the other information set forth in this Quarterly Report on Form 10-Q, as well as in other documents that we file with the U.S.…

• As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Our Shelf Registration Statement was declared effective on March 25, 2025, and permits us to sell from time to time up to $250.0 million of shares of our common stock and oth…

• The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely a…

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Brian C. Thomas, Ph. D., founder and member of our Board of Directors, entered into a pre-arranged stock trading plan on February 10, 2026. Dr. Thomas’s trading plan provides for the sale of up to 110,000 shares of our common stock between May 1, 2026 (subject to compliance with applicable laws rela…

• During the quarter ended March 31, 2026, no other director or “officer” of the Company, as defined in Rule 16a-1(f) under the Exchange Act, adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• During the quarter ended September 30, 2025, no director or “officer” of the Company, as defined in Rule 16a-1(f) under the Exchange Act, adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

• On November 5, 2025, Brian C. Thomas, Ph.D. resigned from his position as the Company’s Chief Executive Officer and Chairman (the “Chair”) of the board of directors of the Company (the “Board”) effective as of November 6, 2025. Dr. Thomas will remain on the Board as a director. On November 5, 2025, …

• In connection with Dr. Thomas’s resignation as Chief Executive Officer, the Company and Dr. Thomas entered into a transition agreement (the “Transition Agreement”). In accordance with the terms of the Transition Agreement, Dr. Thomas shall receive one hundred sixty-five thousand dollars ($166,500.00…

• Appointment of Chief Executive Officer and Grant of Equity Awards

• On November 5, 2025, the Board appointed Jian Irish, Ph.D., M.B.A, the Company’s current President and Chief Operating Officer, as President and Chief Executive Officer and principal executive officer of the Company, effective as of November 6, 2025.