MGX

Remains on track to submit investigational new drug (IND) application in 4Q 2026 for the global clinical program of MGX-001 for the treatment of hemophilia A $120.7 million in cash, cash equivalents, and available-for-sale marketable securities as of June 30, 2026, with runway anticipated to support operations through 4Q 2027 EMERYVILLE, Calif., Aug. 10, 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 reported financial results for the second quarter ended June 30, 2026, and provided business updates. “During the second quarter, we continued to execute against our strategic priorities while advancing toward our planned regulatory submissions for our MGX-001 program in hemophilia A later this year,” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi Therapeutics. “As we prepare to enter the clinic, we are engaging with leading hemophilia investigators and key opinion leaders to establish a strong foundation for our first-in-human study. We believe our differentiated genome editing platform positions us to pursue durable genetic medicines, and we remain focused on disciplined execution as we move toward our upcoming regulatory and clinical milestones.” Second Quarter 2026 Updates MGX-001 - Hemophilia A Program IND-enabling studies for MGX-001 are expected to be complete by the end of the third quarter of 2026, including GLP toxicity. The Company remains on track to submit an IND application in the fourth quarter of 2026 for the global clinical program, and subject to regulatory clearance, initiate clinical trials in 2027. Two Metagenomi scientific posters received Top Poster Awards at the 2026 International Society on Thrombosis and Haemostasias (ISTH) Congress in Paris, France, including one highlighting extensive non-human primate preclinical data supporting MGX-001. MGX-001 - Large Gene Integration System for Protein Replacement via Gene Insertion The Company continues to evaluate disease indications which have the potential to be treated by protein replacement via gene insertion. Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $120.7 million as of June 30, 2026. R&D Expenses: Research and development (R&D) expenses were $22.5 million for the quarter ended June 30, 2026, compared to $22.5 million for the comparable period in 2025. G&A Expenses: General and administrative (G&A) expenses were $6.0 million for the quarter ended June 30, 2026, compared to $7.0 million for the comparable period in 2025. About Metagenomi Therapeutics Metagenomi Therapeutics, Inc. is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel CRISPR gene-editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, insertion and correction. MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile with best-in-class treatment potential, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children, potentially enabling a new standard of care for the treatment of hemophilia A. The Company is also currently pursuing indications leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co/. Cautionary Note Regarding Forward‐​Looking Statements This press release contains ​“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as​ “anticipate,” ​“believe,” “could,” “estimate,” ​“expect,” ​“goal,” ​“intend,” ​“look forward to,” ​“may,” ​“plan,” ​“potential,” ​“predict,” ​“project,” ​“should,” ​“will,” ​“would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001 including the preclinical profile with best-in-class treatment potential and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in ​“Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Investor Contact: Brian Ritchie LifeSci Advisors [email protected]

Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.91 per share, beating the Zacks Consensus Estimate of $0.66 per share. This compares to earnings of $0.85 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +37.88%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $0.7 per share when it actually produced earnings of $0.42, delivering a surprise of -40%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Amphastar, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $183.9 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.08%. This compares to year-ago revenues of $174.41 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amphastar shares have lost about 24.4% since the beginning of the year versus the S&P 500's gain of 12.8%. While Amphastar has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amphastar was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.79 on $195.49 million in revenues for the coming quarter and $2.63 on $739.38 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Generic Drugs is currently in the bottom 12% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Metagenomi Therapeutics (MGX), has yet to report results for the quarter ended June 2026. This genetic medicines company is expected to post quarterly loss of $0.63 per share in its upcoming report, which represents a year-over-year change of -16.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Metagenomi Therapeutics' revenues are expected to be $1.25 million, down 85.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amphastar Pharmaceuticals, Inc. (AMPH) : Free Stock Analysis Report Metagenomi Therapeutics, Inc. (MGX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

On track for regulatory submission of MGX-001 to advance global clinical program, including investigational new drug application (“IND”) in 4Q 2026 Publication in Nature Structural & Molecular Biology highlights potential of MG119-28, a proprietary compact CRISPR nuclease with enhanced genome editing efficiency $140.2 million in cash, cash equivalents, and available-for-sale marketable securities as of March 31, 2026, with runway anticipated to support operations through 4Q 2027 EMERYVILLE, Calif., May 11, 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 reported financial results for the first quarter ended March 31, 2026, and provided business updates. “We remain diligently focused on advancing our core genome-editing technologies, led by our MGX-001 program for hemophilia A, which remains on track for regulatory submission in the fourth quarter of this year and first-in-human studies in 2027,” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi Therapeutics. “The promise of our novel technology, most recently highlighted by a Nature publication, in addition to the encouraging preclinical data and continued IND-enabling execution, gives us confidence in our goal to provide patients an option for one-time, curative treatments, beginning with hemophilia A.” First Quarter 2026 and Subsequent Updates MGX-001 – Hemophilia A Program On track for regulatory submission of MGX-001 to advance global clinical program, including an IND in the fourth quarter of 2026, and subject to regulatory clearance, initiate clinical trials in 2027. During the first quarter, Kapil Saxena, MD joined the Company to spearhead the clinical development program for MGX-001. Prior to joining the Company, Dr. Saxena held leadership positions in clinical development at Autolus, Daiichi Sankyo and Bayer. Prior to joining industry, Dr. Saxena was a practicing hematologist and director of hemophilia treatment centers in Boston and Oklahoma. MGX-001 Large Gene Integration System for Protein Replacement via Gene Insertion Following the demonstration of in vivo proof-of-concept in NHPs via the MGX-001 site-specific genome integration system, the Company is pursuing disease indications which have the potential to be treated by protein replacement via gene insertion. Platform Technology Updates Publication in Nature Structural & Molecular Biology highlights the discovery and detailed characterization of MG119-28, a compact CRISPR nuclease with superior editing efficiency relative to previously identified compact nucleases from the Cas12f class. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $140.2 million as of March 31, 2026. R&D Expenses: Research and development (R&D) expenses were $19.3 million for the quarter ended March 31, 2026, compared to $25.1 million for the comparable period in 2025. G&A Expenses: General and administrative (G&A) expenses were $6.5 million for the quarter ended March 31, 2026, compared to $6.8 million for the comparable period in 2025. About Metagenomi Therapeutics Metagenomi Therapeutics, Inc. is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel CRISPR gene-editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, insertion and correction. MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile with best-in-class treatment potential, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children, potentially enabling a new standard of care for the treatment of hemophilia A. The Company is also currently pursuing indications leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co/. Cautionary Note Regarding Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001 including the preclinical profile with best-in-class treatment potential and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Investor Contact: Stephen Jasper Gilmartin Group [email protected]

Completed pre-IND meeting following MGX-001 preclinical data demonstrating curative FVIII activity in non-human primates (NHPs) and remains on track for global regulatory submission including investigational new drug application (“IND”) in 4Q 2026 Announced corporate name change to Metagenomi Therapeutics, Inc. to reflect Company’s strategic evolution $160.8 million in cash, cash equivalents and available-for-sale marketable securities as of December 31, 2025 with runway anticipated to support operations through 4Q 2027 EMERYVILLE, Calif., March 05, 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 reported financial results for the full year ended December 31, 2025, and provided business updates. “2025 was a pivotal year for Metagenomi as we sharpened our strategic focus, advanced our core genome-editing technologies, and continued to demonstrate the breadth and durability of our technology across multiple therapeutic areas,” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of the Company. “Over the year, we made meaningful progress across our pipeline and collaborations, which reinforce the versatility of our signature technologies and our ability to engineer differentiated genome-editing solutions tailored to specific disease contexts. With our corporate rebranding, we are entering 2026 with a clearer identity and mission centered on unlocking the full potential of precision genetic medicines.” Fourth Quarter 2025 Updates MGX-001 - Hemophilia A Program Announced preclinical data from MGX-001 hemophilia A program that demonstrated curative FVIII activity in NHPs for a therapy with best-in-class treatment potential supporting advancement into clinical development. Completed a pre-IND meeting for MGX-001 and remain on track for regulatory submission to advance global clinical program, including an IND in the fourth quarter of 2026, and subject to regulatory clearance, initiate clinical trials in 2027. Secreted Protein Deficiencies Demonstrated in vivo proof-of-concept in NHPs for Antithrombin (AT-III) Deficiency evidencing the potential to expand the MGX-001 site-specific genome integration system into additional curative therapies for secreted protein disorders. Cardiometabolic Indications Presented preclinical data supporting APOC3 as a new collaboration target with Ionis Pharmaceuticals (“Ionis”) at the Nature Conference, “Cracking the Code: Nucleic Acid Medicines Coming of Age.” APOC3 is a part of Wave 1 of the Ionis collaboration, which includes four targets in significant cardiometabolic indications. Completed corporate name change to Metagenomi Therapeutics, Inc. to reflect the Company’s strategic evolution focused on advancing its lead program in hemophilia A and other compelling programs and technologies that have the highest probability of success. Full Year 2025 Financial Results Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $160.8 million as of December 31, 2025. R&D Expenses: Research and development (R&D) expenses were $94.4 million for the full year ended December 31, 2025, compared to $109.2 million for the full year ended December 31, 2024. G&A Expenses: General and administrative (G&A) expenses were $26.8 million for the full year ended December 31, 2025, compared to $32.0 million for the full year ended December 31, 2024. About Metagenomi Therapeutics Metagenomi Therapeutics, Inc. is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction. MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co. Cautionary Note Regarding Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001 including the preclinical profile being potentially competitive with best-in-class treatment options and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Investor Contact: Stephen Jasper Gilmartin Group [email protected]

Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.73 per share, missing the Zacks Consensus Estimate of $0.97 per share. This compares to earnings of $0.92 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -24.49%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $0.77 per share when it actually produced earnings of $0.93, delivering a surprise of +20.78%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Amphastar, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $183.11 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 5.63%. This compares to year-ago revenues of $186.52 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amphastar shares have added about 4.4% since the beginning of the year versus the S&P 500's gain of 1.5%. While Amphastar has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amphastar was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.74 on $169.08 million in revenues for the coming quarter and $3.57 on $744.5 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Generic Drugs is currently in the bottom 34% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Metagenomi Therapeutics (MGX), is yet to report results for the quarter ended December 2025. This genetic medicines company is expected to post quarterly loss of $0.58 per share in its upcoming report, which represents a year-over-year change of +7.9%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Metagenomi Therapeutics' revenues are expected to be $8.66 million, down 9.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amphastar Pharmaceuticals, Inc. (AMPH) : Free Stock Analysis Report Metagenomi Therapeutics, Inc. (MGX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

New MGX-001 preclinical data supports advancement into clinical development; Demonstrated curative FVIII activity in non-human primates Prioritized later-stage preclinical pipeline including wholly-owned MGX-001 hemophilia A program; pre-IND meeting for MGX-001 expected in 4Q 2025 with IND/CTA submissions expected in 4Q 2026 Organizational restructuring reduced workforce by 25%; Capital allocation strategy anticipated to extend cash runway into the 4Q 2027 Jian Irish, Ph.D., M.B.A., currently President and Chief Operating Officer, appointed as Chief Executive Officer; Brian Thomas, Ph.D., former Chief Executive Officer, continuing on Board of Directors and Dr. Willard Dere serving as new Board Chair Conference call today at 4:30 p.m. ET EMERYVILLE, Calif., Nov. 11, 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 reported financial results for the quarter ended September 30, 2025, and announced a strategic evolution focusing capital on the development of its wholly-owned MGX-001 hemophilia A program and later-stage preclinical pipeline while reducing its workforce by 25%. To support the next phase of development, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer, and Brian Thomas, Ph.D., the Company’s founder and former Chief Executive Officer, will remain on the Board of Directors (the “Board”) and current Board member Dr. Willard Dere will serve as the Company’s new Board Chair. “In light of the encouraging preclinical MGX-001 hemophilia A results we reported today, we made the decision to strategically reprioritize our pipeline and discovery efforts to focus resources on driving forward our lead program for hemophilia A and pursuing programs that leverage our most advanced, signature gene-editing capabilities. These include programs addressing additional secreted protein deficiencies that deploy the site-specific genome integration system used in MGX-001, and cardiometabolic indications in collaboration with Ionis.” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi. “We are committed to our most compelling programs that have the highest probability of success, and potential to address unmet needs and create near-term value. We are capitalizing on our most advanced gene editing technologies while maintaining financial discipline to drive sustainable growth and long-term value. I am honored to share this vision with a seasoned leadership team as we enter this new phase of the Metagenomi story.” Dr. Irish continued, “As part of this initiative, we are streamlining our organization to optimize our R&D efforts and cost structure, which is anticipated to extend our cash runway into the fourth quarter of 2027. I want to express my deepest gratitude to every member of the Metagenomi team, including those who were impacted by the workforce reduction, for their invaluable contributions toward advancing our mission. In addition, I would like to thank Dr. Thomas, whose novel vision in applying metagenomics towards drug discovery led to all we have accomplished to date. I look forward to continuing to work with him and the other members of the Board and appreciate their ongoing support.” “The Board of Directors is pleased that Dr. Irish is assuming the role of CEO as Metagenomi advances toward the clinic and its next stage of development,” added Willard Dere, M.D., current director and newly appointed Board Chair. “She brings a wealth of experience having held development and global operations positions with Kite Pharma / Gilead, Sanofi and Amgen, and having played key roles in the launch of several breakthrough medicines. As a co-founder of Metagenomi, we believe this is the right time for her to step into this role.” Third Quarter 2025 Updates MGX-001 Hemophilia A Program and Other Secreted Protein Deficiencies New dose range finding data presented today from the Company’s wholly-owned MGX-001 hemophilia A program demonstrated curative factor VIII (FVIII) activity in non-human primates (NHPs) and informs a clinical dose regimen strategy for a therapy with best-in-class treatment potential. Metagenomi intends to advance MGX-001 into clinical development. On track to achieve NHP proof-of-concept data for lead secreted protein deficiency target in 2025, leveraging the MGX-001 site-specific genome integration system. Cardiometabolic Indications On track to nominate one DC from the four Wave 1 collaboration targets in 2025. Plan to initiate IND-enabling activities for nominated DC and nominate additional DCs from the remaining Wave 1 targets in 2026. Corporate Updates The Company has strategically evolved its pipeline and discovery efforts to focus on the advancement of its leading in vivo therapeutics including the MGX-001 program in hemophilia A, other secreted protein disorders leveraging the MGX-001 approach, and cardiometabolic indications in collaboration with Ionis. In line with this strategic focus, the Company deprioritized early discovery and platform research and reduced its workforce by 25%. As a result of these actions and its revised capital allocation strategy, the Company expects to extend its cash runway into the fourth quarter of 2027. In conjunction with the strategic evolution, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer. Brian Thomas, Ph.D., the Company’s former Chief Executive Officer, will continue as a member of the Board; and Willard Dere, M.D., current director, will serve as Board Chair. Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $184.1 million as of September 30, 2025, which is anticipated to support operations into the fourth quarter of 2027. R&D Expenses: Research and development (“R&D”) expenses were $25.3 million for the quarter ended September 30, 2025, as compared to $26.3 million for the comparable period in 2024. G&A Expenses: General and administrative (“G&A”) expenses were $6.2 million for the quarter ended September 30, 2025, as compared to $7.6 million for the comparable period in 2024. Conference Call Metagenomi will host a live webcast today, Tuesday, November 11, 2025, at 4:30 p.m. ET, to discuss the MGX-001 preclinical results and business updates. The live event can be accessed in the “Events” section of Metagenomi’s website at ir.metagenomi.co.The webcast will be archived and available for replay for at least 30 days after the event. About Hemophilia A Hemophilia A is the most common X-linked inherited bleeding disorder, caused by a large variety of mutations in the FVIII gene leading to a loss of functional FVIII protein. Intracranial bleeding is of greatest concern as this can lead to major morbidity and mortality. Bleeding into joints leads to cumulative joint damage and is a major cause of morbidity. Diagnosis of severe disease typically occurs in infancy due to exaggerated bleeding in response to minor injury or routine medical procedures. Prevalence is estimated to be up to 26,500 patients in the US and more than 500,000 patients globally according to the World Federation of Hemophilia, with the vast majority of patients being male. About Metagenomi Metagenomi is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction. MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001, including the preclinical profile being potentially competitive with best-in-class treatment options and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones including the nomination of development candidates, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Investor Contacts: Stephen Jasper Gilmartin Group [email protected] or Kiki Patel, PharmD Gilmartin Group [email protected]

Presented three abstracts at American Society of Gene & Cell Therapy (“ASGCT”) demonstrating early proof-of-concept data across multiple gene editing technologies Well capitalized with $205.0 million in cash, cash equivalents and available-for-sale marketable securities as of June 30, 2025 with runway anticipated to support operations into 2027 EMERYVILLE, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today reported financial results for the quarter ended June 30, 2025, and provided business updates. “Entering the second half of the year, we continue to advance our MGX-001 wholly-owned program for hemophilia A towards pre-IND and ex-U.S. regulatory meetings in 2025, and our collaboration with Ionis in cardiometabolic indications towards nomination of development candidates in 2025,” said Brian C. Thomas, PhD, CEO and founder of Metagenomi. “Our strong balance sheet and continued focus on operational efficiency are enabling investment in both our pipeline and AI-driven metagenomics platform. At ASGCT, we showcased key advancements of our platform, including compact nucleases for extrahepatic gene editing and CRISPR-associated transposases (“CAST”) for site-specific integration of large therapeutic genes.” Second Quarter 2025 Updates MGX-001 Hemophilia A Program In May 2025, the Company reported additional long-term data from its nonhuman primate (“NHP”) study that demonstrated durable and consistent FVIII activity levels through approximately 19 months. Mean FVIII activity of months 12-19 following lipid nanoparticle dosing was 75%, 8% and 29% in animals 1001, 1002 and 1003, respectively. Emerging data relating to MGX-001 using a bioengineered FVIII construct has, to date, demonstrated FVIII activity higher than expected; the Company has commenced additional studies and may consider alternatives to this construct. Based on the current information, we plan to submit an investigational new drug (“IND”) and clinical trial application (“CTA”) in 2026. Platform Technology Updates Presented three abstracts at the ASGCT 28th Annual Meeting in May 2025 highlighting early proof-of-concept data demonstrating potentially best-in-class compact nucleases for extrahepatic gene editing; and the ability for novel CAST systems to integrate genetic cargo in primary human hepatocytes, a key milestone towards large (>10 kbp) targeted genomic integrations. In May 2025, the Company made an oral presentation at TIDES 2025 highlighting the use of AI to systematically identify and optimize efficient compact gene editing systems. Corporate Updates In August 2025, the Company appointed Laurence Reid, Ph.D., to the Board of Directors. Dr. Reid is an entrepreneur, company builder, and biotech executive, leveraging his experience as an advisor to growing biotech companies. Previously, Dr. Reid served as Chief Executive Officer of Decibel Therapeutics, Inc. (acquired by Regeneron Pharmaceuticals) and as Chief Executive Officer of Warp Drive Bio, LLC (merged with Revolution Medicines). Established a Research and Development (“R&D”) Committee within the Board of Directors. The new committee, including Willard Dere, M.D., Jian Irish, Ph.D., MBA, Laurence Reid, Ph.D. and Brian Thomas, Ph.D., will provide the Board with scientific and clinical strategy insights related to the Company’s research and development initiatives. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, and available-for-sale marketable securities were $205.0 million as of June 30, 2025, which is anticipated to support operations into 2027. R&D Expenses: R&D expenses were $22.5 million for the quarter ended June 30, 2025, as compared to $28.3 million for the comparable period in 2024. G&A Expenses: General and administrative (“G&A”) expenses were $7.0 million for the quarter ended June 30, 2025, as compared to $8.6 million for the comparable period in 2024. About Hemophilia A Hemophilia A is the most common X-linked inherited bleeding disorder, caused by a large variety of mutations in the FVIII gene leading to a loss of functional FVIII protein. Intracranial bleeding is of greatest concern as this can lead to major morbidity and mortality. Bleeding into joints leads to cumulative joint damage and is a major cause of morbidity. Diagnosis of severe disease typically occurs in infancy due to exaggerated bleeding in response to minor injury or routine medical procedures. Prevalence is estimated to be up to 26,500 patients in the US and more than 500,000 patients globally according to the World Federation of Hemophilia, with the vast majority of patients being male. About Metagenomi Metagenomi is a precision gene editing company leveraging the power of artificial intelligence and machine learning to develop the next generation of potentially curative genome editing therapeutics. Its metagenomics-derived gene editing toolbox has analyzed over 7.4 billion proteins and has the potential to target any type of genetic mutation across the entire human genome. The Company’s innovative and comprehensive platform has full spectrum gene editing, with technologies ranging from ultra-small nucleases and base editors to large gene integrations using CRISPR-associated transposase (CAST) and RNA-Mediated Integration Systems (RIGS). The Company’s lead, wholly-owned development program in Hemophilia A is a potentially curative therapy designed to provide life-long protection from bleeding events and joint damage in adults and children. The Company has additional wholly-owned assets in its pipeline for secreted protein deficiencies and partnered assets for cardiometabolic diseases. For more information, please visit https://metagenomi.co. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies, make regulatory filings such as INDs, statements concerning the potential of therapies and product candidates, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Investor Contacts: Stephen Jasper Gilmartin Group [email protected] or Kiki Patel, PharmD Gilmartin Group [email protected]