EMERYVILLE, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Metagenomi Therapeutics, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today announced that Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of the Company, will participate in a fireside chat at the 46th Annual TD Cowen Healthcare Conference, being held in Boston, MA, on Monday, March 2, 2026 at 11:10 a.m. ET. The fires ...

Core Viewpoint - MGX Resources faced operational interruptions due to a significant rockfall at Koolan Island, leading to a suspension of mining and a shift in focus towards cash flow generation through alternative means [2]. Group 1: Financial Performance - The financial performance for the December quarter exceeded original expectations, driven by the adjustment of operations to monetize lower-grade stockpile material [3]. - Processing and shipping of low-grade stockpile material is projected to continue until late in the June 2026 quarter [3]. Group 2: Strategic Initiatives - MGX Resources is nearing the completion of the acquisition of the Central Tanami Gold Project, which will facilitate diversification into the precious metals sector [3].

Core Insights - The company has rebranded to Metagenomi Therapeutics, Inc. to reflect its strategic focus on advancing its lead program in hemophilia A and other promising technologies [1][2] - The MGX-001 program has shown curative factor VIII (FVIII) activity in non-human primates, with plans for IND/CTA submissions by the end of 2026 and a first-in-human study anticipated in 2027 [2][4] - The company expects its cash runway to extend through the fourth quarter of 2027, supporting its ongoing development efforts [2][12] Pipeline Advancements - MGX-001 has demonstrated durable FVIII activity over a 19-month study in non-human primates, with no off-target editing detected [6][10] - The company is exploring the potential of the MGX-001 system for treating other secreted protein deficiencies, including Antithrombin (AT-III) deficiency [7][10] - Recent strategic prioritization has strengthened the company's balance sheet and focused its pipeline on high-value therapeutic programs [12] Corporate Updates - The company appointed Jian Irish, Ph.D., M.B.A., as Chief Executive Officer, emphasizing a commitment to delivering curative genetic medicines [12] - Metagenomi Therapeutics aims to leverage its proprietary gene-editing technologies to expand its pipeline and address various genetic disorders [9][10]

Core Insights - Metagenomi, Inc. is set to present new preclinical data on APOC3 at the upcoming Nature Conference, highlighting its collaboration with Ionis Pharmaceuticals [1][2] - The company focuses on developing curative genetic medicines through proprietary genome editing technologies, aiming to address various genetic mutations [2] - Metagenomi's lead program, MGX-001, shows a promising preclinical profile for treating hemophilia A, potentially offering lifelong protection from bleeding events [3] Company Overview - Metagenomi is an in vivo genome editing company that utilizes metagenomics to develop novel editing tools for correcting genetic mutations [2] - The company aims to expand its pipeline by leveraging its genetic editing capabilities for site-specific deletion, integration, and correction [2] Product Development - MGX-001 is designed to provide a one-time treatment for hemophilia A, demonstrating competitive potential against existing treatment options [3] - The company is also exploring treatments for other secreted protein deficiencies and cardiometabolic diseases using its genome integration system [3]

Core Insights - Several small-cap biotech and healthcare stocks experienced significant gains in after-hours trading on November 28, 2025, despite a lack of new news [1] Company Summaries - **BioAtla Inc. (BCAB)**: Shares surged 13.94% to $1.03 after closing at $0.9040, up 6.27%. The increase may be linked to financing agreements announced on November 21, including a $7.5 million advance and a Standby Equity Purchase Agreement allowing for the sale of up to $15 million in common stock at a 3% discount [2] - **Metagenomi Inc. (MGX)**: Stock rose 5.71% to $1.85 after a 3.55% gain to $1.75 during regular trading. The movement appears driven by investor sentiment or technical factors, with no new corporate updates [3] - **PAVmed Inc. (PAVM)**: Advanced 5.72% to $0.3900, recovering from a slight decline earlier in the day. The company reported a GAAP net loss of $6.3 million, or $(0.29) per share, with revenue dropping sharply to $5,000 from $996,000 year-over-year [4] - **Precision BioSciences, Inc. (DTIL)**: Gained 2.94% to $5.60, building on a 6.46% rise to $5.44. The company is set to present Phase 1 data from its ELIMINATE-B trial at the Hep-DART 2025 meeting, which may be boosting investor optimism [5] - **Reviva Pharmaceuticals Holdings, Inc. (RVPH)**: Edged up 2.04% to $0.57 after a 7.66% gain to $0.5625. The company narrowed its quarterly net loss to $4.0 million, or $0.06 per share, compared to $8.4 million, or $0.25 per share, in the prior year [6] - **Sonnet BioTherapeutics Holdings, Inc. (SONN)**: Rose 5.11% to $3.91, recovering from a 10.47% decline earlier in the day. The company adjourned a special meeting to allow more time for voting on a proposed combination with Hyperliquid Strategies Inc. and Rorschach I LLC, with over 95% of shares voting in favor [7] - **Entero Therapeutics, Inc. (ENTO)**: Gained 3.68% to $3.10 after a 5.28% rise to $2.99. The company announced a rebranding to GridAI Technologies Corp., effective December 1, 2025, following its acquisition of GRID AI Corp. The new ticker symbol "GRDX" will debut on the Nasdaq Capital Market [8]

Summary of Metagenomi Conference Call Company Overview - **Company**: Metagenomi (NasdaqGS:MGX) - **Industry**: In vivo genome editing and genetic medicines - **Focus**: Developing curative genetic medicines leveraging metagenomics and AI technologies [2][3] Core Points and Arguments - **Technological Advancements**: Metagenomi has developed over 20,000 signature gene editing systems that enhance editing precision and expand genome targeting beyond CRISPR-Cas9 [3] - **Lead Program - MGX001**: - Targeting hemophilia A through site-specific gene integration in the albumin gene - Anticipated pre-IND meeting with the FDA later this year and IND CTA filing in Q4 2026 [4][20] - Demonstrated curative factor VIII activity in non-human primates, with dose-dependent efficacy observed [5][6] - Potential to provide a one-time curative therapy, significantly reducing treatment burden and costs for patients [10][19] Market Insights - **Hemophilia A Statistics**: - Approximately 26,500 patients in the U.S. and 500,000 globally - Current treatment costs range from $565,000 to $750,000 annually, totaling $18 million to $24 million over a lifetime [8][10] - **Current Treatment Challenges**: Existing therapies involve frequent infusions and high costs, leading to compliance issues [9][10] Competitive Advantages - **MGX001's Mechanism**: - A two-component system using AAV for gene delivery and LMP for gene editing - Aims to enable endogenous production of factor VIII, contrasting with bispecific factor VIII mimetics [11][19] - **Safety Profile**: - No off-target editing observed, with a robust safety margin established in preclinical studies [6][18] Future Directions - **Expansion Plans**: Exploring opportunities in neuromuscular and liver diseases, alongside ongoing collaborations with Ionis Pharmaceuticals for cardiometabolic indications [5][21] - **Regulatory Milestones**: Plans to file IND and CTA in Q4 2026, with clinical trials expected to start in 2027 [20][23] Additional Important Content - **Patient Advocacy**: Strong patient advocacy network is crucial for education and clinical trial enrollment [19] - **Collaboration with Ionis**: Focused on cardiometabolic targets, with plans to announce additional collaboration targets later this year [21][22] Conclusion - Metagenomi is positioned to make significant advancements in the treatment of hemophilia A and potentially other genetic disorders through innovative gene editing technologies, with a clear path towards clinical development and regulatory approval [23]

Core Insights - Metagenomi, Inc. is an in vivo genome editing company focused on developing curative genetic medicines using proprietary technologies [3][4] - The company will present at the Jefferies Global Healthcare Conference in London on November 20, 2025 [1] - Metagenomi's lead program, MGX-001, targets hemophilia A and has shown a competitive preclinical profile compared to existing treatments [4] Company Overview - Metagenomi specializes in metagenomics, utilizing genetic materials from the environment to create novel genome editing tools [3] - The company aims to correct various genetic mutations and is focused on high-value disease indications with clear clinical pathways [3] Product Development - MGX-001 is designed to provide lifelong protection from bleeding events in hemophilia A patients through a one-time treatment [4] - The company is also exploring treatments for secreted protein deficiencies and cardiometabolic diseases using its genome integration system [4]

Core Insights - Metagenomi, Inc. has shared new dose range finding data from its MGX-001 hemophilia A program, demonstrating curative factor VIII (FVIII) activity in non-human primates, which informs a clinical dose regimen strategy [1][2][3] Data Summary - In a preclinical study, a single dose of AAV containing a B-domain deleted human FVIII gene was administered to 24 non-human primates across six dose cohorts, with each animal receiving corticosteroids before treatment [4] - A functional cure is defined as FVIII levels of 50% to 150% of normal human levels, and therapeutically relevant levels of FVIII activity were achieved in the five highest AAV doses [4] - FVIII activity showed both AAV and LNP dose dependency, with no animal exceeding 150% of normal FVIII activity; the treatment was well tolerated, except for transient liver enzyme elevations in the highest LNP dose [5] Future Plans - The company anticipates a pre-investigational new drug regulatory meeting in Q4 2025, with submissions for investigational new drug and clinical trial applications expected in Q4 2026 [6] Strategic Focus - Metagenomi has shifted its pipeline to focus on advancing in vivo therapeutics, including the MGX-001 program for hemophilia A and other secreted protein disorders, while collaborating with Ionis Pharmaceuticals on cardiometabolic indications [7] - The company has deprioritized early discovery and platform research, resulting in a 25% workforce reduction, and expects to extend its cash runway into Q4 2027, with cash and equivalents totaling $184.1 million [8] Stock Performance - At the time of publication, Metagenomi shares were down 15.68% at $1.85 [8]

Financial Performance - Collaboration revenue for Q3 2025 was $8.7 million, down 24.8% from $11.5 million in Q3 2024, and for the nine months ended September 30, 2025, it was $21.3 million, a decrease of 50.1% from $42.7 million in the same period of 2024[123] - Total operating expenses for Q3 2025 were $31.5 million, a decrease of 7.1% from $33.9 million in Q3 2024, and for the nine months ended September 30, 2025, total operating expenses were $92.9 million, down 16.3% from $111.0 million in the same period of 2024[130] - The net loss for Q3 2025 was $20.4 million, compared to a net loss of $18.8 million in Q3 2024, representing an increase of 8.8%[130] Research and Development - Research and development expenses for Q3 2025 were $25.3 million, a slight decrease of 3.7% from $26.3 million in Q3 2024, and for the nine months ended September 30, 2025, they totaled $72.9 million, down 15.2% from $86.0 million in the same period of 2024[130] - The company plans to advance MGX-001 into clinical development, with pre-IND regulatory meetings expected by the end of 2025 and clinical trials to begin in 2027[110] - The company is exploring opportunities in neuromuscular and liver disease targets, as well as partnerships for cell therapy applications[114] - The company has a collaboration with Ionis Pharmaceuticals to develop investigational medicines, with plans to nominate a development candidate from this collaboration in 2025[112] - The company has demonstrated over 90% editing efficiency with its novel Adenine Base Editors across seven genomic targets in primary T-cells, indicating strong potential for its technology platform[116] Cash Flow and Funding - As of September 30, 2025, the company had $184.1 million in cash, cash equivalents, and available-for-sale marketable securities, which is expected to fund projected operating expenses for at least the next 12 months[144] - Net cash used in operating activities for the nine months ended September 30, 2025, was $65.3 million, consisting primarily of the net loss of $65.3 million and changes in net operating assets and liabilities[147] - Net cash provided by investing activities for the nine months ended September 30, 2025, was $71.2 million, primarily due to net maturities of available-for-sale marketable securities[150] - The company expects to require additional funding to support ongoing research and development activities and to commercialize future product candidates[145] - Net cash used in financing activities for the nine months ended September 30, 2025, was $0.4 million primarily due to a payment of deferred financing costs[151] - Net cash provided by financing activities for the nine months ended September 30, 2024, was $84.0 million due to net proceeds from the issuance of common stock in the IPO, net of issuance costs paid during the period[151] Accounting and Estimates - There were no material changes to the company's critical accounting estimates or methodology used for estimates during the nine months ended September 30, 2025[156] - The preparation of financial statements requires the company to make estimates and assumptions affecting reported amounts of assets and liabilities[154] - The company evaluates estimates related to revenue recognition, stock-based compensation expense, and the valuation of deferred tax assets[155] - Actual results may differ from estimates under different assumptions or conditions, which could impact financial reporting[155] - There were no material changes outside the ordinary course of business to the company's cash requirements during the nine months ended September 30, 2025[152] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[157] - Recently issued accounting pronouncements that may impact financial position and results of operations are disclosed in the quarterly report[153] Share Issuance and Agreements - The company completed its initial public offering on February 13, 2024, issuing 6,250,000 shares at $15.00 per share, resulting in net proceeds of approximately $80.7 million[117] - The company has entered into an Open Market Sale Agreement with Jefferies LLC to issue shares with an aggregate offering price of up to $75.0 million, with no shares sold under this agreement as of September 30, 2025[118] - Collaboration revenue decreased by $2.9 million to $8.7 million for the three months ended September 30, 2025, compared to the prior year, primarily due to a $1.5 million decrease from the Affini-T Agreement and a $1.4 million decrease from the Ionis Agreement[131] - For the nine months ended September 30, 2025, collaboration revenue decreased by $21.4 million to $21.3 million, mainly due to an $18.7 million decrease from the Moderna Agreement and a $2.3 million decrease from the Affini-T Agreement[132] - Research and development expenses decreased by $1.0 million to $25.3 million for the three months ended September 30, 2025, primarily due to a $1.6 million decrease in employee-related expenses[133] - For the nine months ended September 30, 2025, research and development expenses decreased by $13.1 million to $72.9 million, primarily due to a $5.1 million decrease in employee-related expenses and a $3.9 million decrease in research supplies and services[134] - General and administrative expenses decreased by $1.4 million to $X million for the three months ended September 30, 2025, primarily due to a $0.6 million decrease in professional services and consulting costs[135] - Total other income (expense), net increased by $0.7 million for the three months ended September 30, 2025, primarily due to a higher loss from the change in fair value of long-term investments in the prior year[137]

Financial Position - Metagenomi reported a cash position of $184.1 million as of September 30, 2025, expected to support operations into Q4 2027[9]. - Collaboration revenue for Q3 2025 was $8.7 million, down from $11.5 million in Q3 2024[22]. - The net loss for Q3 2025 was $20.4 million, compared to a net loss of $18.8 million in Q3 2024[22]. Research and Development - R&D expenses for Q3 2025 were $25.3 million, a decrease from $26.3 million in Q3 2024, while G&A expenses were $6.2 million compared to $7.6 million in the same period[9][10]. - The company has prioritized the MGX-001 hemophilia A program, with new preclinical data demonstrating curative FVIII activity in non-human primates[5][3]. - Metagenomi aims to nominate one development candidate from four Wave 1 collaboration targets in 2025 and initiate IND-enabling activities in 2026[7]. - The company is on track to achieve proof-of-concept data for lead secreted protein deficiency targets in 2025[6]. Organizational Changes - The workforce has been reduced by 25% as part of an organizational restructuring to optimize R&D efforts and extend cash runway[1][13]. - Jian Irish has been appointed as CEO, succeeding Brian Thomas, who remains on the Board of Directors[2][4]. Future Plans - Metagenomi plans to submit an IND/CTA for MGX-001 in Q4 2026 following a pre-IND meeting expected in Q4 2025[1].