Metagenomi (NasdaqGS:MGX) 2025 Conference November 20, 2025 04:30 AM ET Company ParticipantsJian Irish - CEOModeratorMorning and welcome to the Jefferies 2025 Global Healthcare Conference. It is my pleasure to now introduce Jian Irish, CEO, and Pam Wapnick, CFO of Metagenomi. Just as a reminder, this will be a 25-minute presentation. Thank you.Jian IrishOkay, good morning, everybody. Thank you very much for—very glad to be here. Jian Irish, I'm the CEO of Metagenomi. Pleasure to be here. Before we begin, pl ...

EMERYVILLE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Metagenomi, 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 Metagenomi, will be presenting at the Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025, at 9:30 a.m. GMT. A live webcast will be available in the investor sectio ...

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].

Core Insights - Metagenomi reported a quarterly loss of $0.55 per share, which was better than the Zacks Consensus Estimate of a loss of $0.60, representing an earnings surprise of +8.33% [1] - The company generated revenues of $8.66 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 6.44% and down from $11.51 million a year ago [2] - Metagenomi shares have declined approximately 40.4% year-to-date, contrasting with the S&P 500's gain of 16.2% [3] Financial Performance - Over the last four quarters, Metagenomi has surpassed consensus EPS estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.50 on revenues of $9.26 million, and for the current fiscal year, it is -$2.39 on revenues of $30.44 million [7] Market Outlook - The sustainability of Metagenomi's stock price movement will largely depend on management's commentary during the earnings call [3] - The Zacks Rank for Metagenomi is currently 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] - The Medical - Drugs industry, to which Metagenomi belongs, is currently in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Core Insights - Metagenomi, Inc. is advancing its MGX-001 hemophilia A program into clinical development following promising preclinical results demonstrating curative FVIII activity in non-human primates [1][4] - The company has undergone an organizational restructuring, reducing its workforce by 25% to optimize resources and extend its cash runway into the fourth quarter of 2027 [1][3] - Jian Irish, Ph.D., M.B.A., has been appointed as the new Chief Executive Officer, succeeding Brian Thomas, who will remain on the Board of Directors [1][2] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and available-for-sale marketable securities totaling $184.1 million, expected to support operations until the fourth quarter of 2027 [7] - Research and development expenses for the third quarter of 2025 were $25.3 million, a decrease from $26.3 million in the same period of 2024 [7] - General and administrative expenses were reported at $6.2 million for the third quarter of 2025, down from $7.6 million in the comparable period in 2024 [8] Strategic Focus - The company is prioritizing its MGX-001 hemophilia A program and other secreted protein deficiencies while deprioritizing early discovery and platform research [11][12] - Metagenomi aims to leverage its advanced gene-editing technologies to address unmet medical needs and create near-term value [3][12] - The company is also pursuing cardiometabolic indications in collaboration with Ionis, indicating a strategic expansion of its therapeutic pipeline [11][12] Upcoming Milestones - A pre-IND meeting for MGX-001 is anticipated in the fourth quarter of 2025, with IND/CTA submissions expected in the fourth quarter of 2026 [1] - The company is on track to achieve proof-of-concept data for its lead secreted protein deficiency target in 2025 [5]

Core Insights - Metagenomi's MGX-001 has shown curative factor VIII (FVIII) activity in non-human primates, indicating its potential as a best-in-class treatment for hemophilia A [1][2] - The company plans to submit investigational new drug (IND) and clinical trial application (CTA) submissions by the end of 2026, following a pre-IND regulatory meeting expected in Q4 2025 [1][2] Study Design and Results - The preclinical study involved administering a single dose of AAV containing a B-domain deleted human FVIII gene to 24 non-human primates across six dose cohorts, with doses ranging from 5.0e11 vg/kg to 4.0e13 vg/kg [2][3] - Therapeutically relevant FVIII activity was achieved in the five highest AAV doses, with average FVIII activity ranging from 49% to 81% at a fixed LNP dose of 0.6 mg/kg [4] - The treatment was well tolerated, with no significant elevation of liver enzymes observed, except for transient elevations in the highest LNP dose [4] Implications for Hemophilia A Treatment - MGX-001 represents a potential paradigm shift in hemophilia A treatment, enabling endogenous production of FVIII and potentially providing a lifelong cure [4][5] - The prevalence of hemophilia A is estimated at up to 26,500 patients in the US and over 500,000 globally, highlighting the significant market potential for effective treatments [5] Company Overview - Metagenomi is focused on in vivo genome editing to create curative genetic medicines, leveraging proprietary technologies to address genetic mutations [6][7] - The company aims to expand its pipeline by developing treatments for other secreted protein deficiencies and cardiometabolic diseases [7]

Core Viewpoint - The significant rockfall incident at Koolan Island has led to the suspension of mining activities, impacting the iron ore supply to the company, which relies on Koolan as a major supplier [1][2]. Group 1: Incident Details - On October 16, 2025, a major rockfall occurred in the main pit area of Koolan Island, affecting operations [1]. - Koolan is a key supplier of iron ore, bound by a long-term supply agreement to provide 80% of its available total production to the company until the mine permanently ceases operations [1]. Group 2: Operational Impact - Due to safety concerns regarding the stability of the affected area, MGI has deemed it unfeasible to resume mining operations at Koolan [2]. - Mining activities at Koolan have been suspended, although processing of available ore stockpiles will continue to meet scheduled shipments [2]. - The company has notified the group of delays in shipments originally scheduled for the fourth quarter of 2025 [2]. Group 3: Future Considerations - The remaining mining life of the Koolan operation was limited, with plans to conclude by September 2026 prior to the incident [2]. - The company is currently in discussions with Koolan regarding iron ore supply and assessing the overall impact of the incident on its business [2].

Core Viewpoint - Mount Gibson Iron Limited (MGI) announced a significant rockfall incident at its Koolan Island iron ore mine, leading to the suspension of mining activities in the affected area due to safety concerns and limited remaining mining life [1][2] Group 1: Incident Details - The rockfall occurred on October 16, 2025, in the main pit area of the Koolan Island operation [1] - Koolan is a major supplier of iron ore, bound by a long-term supply agreement with the group, which requires it to supply 80% of its available total production annually until the mine permanently ceases operations [1] Group 2: Operational Impact - MGI has deemed it unfeasible to remediate the affected area and resume mining operations due to the limited remaining mining life, which was originally set to conclude around September 2026 [2] - Mining activities at the Koolan operation have been suspended, although processing of available ore stockpiles will continue to meet upcoming shipment commitments [2] - The incident has led to delays in shipments originally scheduled for the fourth quarter of 2025, but all major business operations of the group remain normal [2] - The group is currently in discussions with Koolan regarding iron ore supply and assessing the overall impact of the incident on its business [2]