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Metagenomi (MGX) Reports Q1 Loss, Misses Revenue Estimates
ZACKS· 2025-05-13 22:40
Core Insights - Metagenomi reported a quarterly loss of $0.68 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.62, marking an earnings surprise of -9.68% [1] - The company's revenues for the quarter were $4.13 million, missing the Zacks Consensus Estimate by 52.83%, and down from $11.16 million a year ago [2] - Metagenomi's stock has declined approximately 57.1% since the beginning of the year, contrasting with the S&P 500's decline of only -0.6% [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 -$0.54 on revenues of $8.75 million, and for the current fiscal year, it is -$2.41 on revenues of $38.87 million [7] Industry Context - The Medical - Drugs industry, to which Metagenomi belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Metagenomi's stock performance [5] Future Outlook - The company's earnings outlook will be crucial for determining the stock's immediate price movement, with management's commentary on the earnings call being particularly important [3][4] - The estimate revisions trend for Metagenomi is currently mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6]
Metagenomi(MGX) - 2025 Q1 - Quarterly Report
2025-05-13 20:40
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements for Q1 2025 reflect a net loss of $25.0 million, a decrease in total assets, and reduced collaboration revenue, balanced by lower operating expenses [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $297.9 million, primarily due to a reduction in marketable securities, while total liabilities also decreased, resulting in stockholders' equity of $212.7 million Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $29,195 | $27,386 | | Available-for-sale marketable securities | $196,775 | $220,921 | | Total current assets | $233,195 | $257,960 | | Total assets | $297,866 | $324,599 | | **Liabilities & Equity** | | | | Total current liabilities | $39,893 | $37,309 | | Total liabilities | $85,208 | $89,742 | | Total stockholders' equity | $212,658 | $234,857 | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2025, collaboration revenue significantly decreased to $4.1 million, while research and development and general and administrative expenses also fell, resulting in a net loss of $25.0 million Condensed Statement of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $4,127 | $11,159 | | Research and development | $25,142 | $31,439 | | General and administrative | $6,805 | $8,752 | | Loss from operations | ($27,820) | ($29,032) | | Net loss | ($25,039) | ($25,148) | | Net loss per share, basic and diluted | ($0.68) | ($1.19) | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $22.8 million in Q1 2025, while investing activities provided $24.7 million, leading to a net increase in cash, cash equivalents, and restricted cash of $1.8 million Condensed Statement of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($22,842) | ($29,850) | | Net cash provided by (used in) investing activities | $24,728 | ($94,732) | | Net cash provided by (used in) financing activities | ($77) | $86,537 | | Net increase (decrease) in cash | $1,809 | ($38,045) | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes to the financial statements confirm $226.0 million in liquidity, detail ongoing collaborations with Ionis and Affini-T, the termination of the Moderna agreement, a pending class action lawsuit, and the establishment of a $75.0 million ATM program - Management believes that existing cash, cash equivalents, and available-for-sale marketable securities of **$226.0 million** as of March 31, 2025, will be sufficient to fund its current operating plan for at least the next 12 months[38](index=38&type=chunk)[142](index=142&type=chunk) - The collaboration agreement with Moderna was mutually terminated on April 26, 2024, resulting in Metagenomi regaining full rights to its base editing and RNA-mediated integration systems[60](index=60&type=chunk) - Under the Ionis agreement, the company recognized **$4.0 million** in revenue for Q1 2025, with approximately **$36.8 million** in remaining performance obligations expected over the next three years[81](index=81&type=chunk) - A class action lawsuit was filed against the company in September 2024, alleging misleading statements in its IPO registration materials concerning the Moderna collaboration, with the outcome currently unpredictable[83](index=83&type=chunk)[161](index=161&type=chunk) - In March 2025, the company established an At-The-Market (ATM) sales agreement to sell up to **$75.0 million** of its common stock, with no shares sold as of March 31, 2025[89](index=89&type=chunk)[119](index=119&type=chunk)[138](index=138&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights the company's precision gene editing platform, progress on lead program MGX-001, ongoing collaborations, a **$7.0 million** decrease in Q1 2025 collaboration revenue, reduced operating expenses, and **$226.0 million** in liquidity expected to fund operations for at least 12 months [Overview](index=27&type=section&id=Overview) Metagenomi, a precision gene editing company, is advancing its lead program MGX-001 for hemophilia A towards 2026 regulatory submissions, progressing collaborations with Ionis and Affini-T, and recently completed an IPO and established an ATM program - The lead program, MGX-001 for hemophilia A, is a knock-in therapy targeting IND/CTA submissions in **2026** following pre-IND meetings in H2 **2025**[103](index=103&type=chunk)[107](index=107&type=chunk) - The collaboration with Ionis has achieved in vivo rodent proof-of-concept for all four Wave 1 genetic targets in cardiometabolic diseases, with one to two development candidates planned for nomination in **2025**[109](index=109&type=chunk) - The collaboration with Affini-T for ex vivo cell therapy applications is progressing, triggering a **$0.3 million** payment to Metagenomi upon an option exercise on April 14, 2025[110](index=110&type=chunk) - The company completed its IPO on February 13, 2024, raising net proceeds of approximately **$80.7 million**[118](index=118&type=chunk)[88](index=88&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Collaboration revenue decreased by **$7.0 million** in Q1 2025 due to the Ionis agreement and Moderna termination, while R&D and G&A expenses also fell, resulting in a stable net loss of **$25.0 million** Collaboration Revenue Breakdown (in thousands) | Collaborator | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Ionis | $3,974 | $8,065 | ($4,091) | | Moderna | $0 | $2,795 | ($2,795) | | Affini-T | $153 | $299 | ($146) | | **Total** | **$4,127** | **$11,159** | **($7,032)** | Research and Development Expense Breakdown (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Employee-related expenses | $9,381 | $10,641 | ($1,260) | | R&D supplies and services | $7,441 | $9,698 | ($2,257) | | Stock-based compensation | $1,280 | $3,998 | ($2,718) | | **Total R&D Expense** | **$25,142** | **$31,439** | **($6,297)** | - General and administrative expenses decreased by **$1.9 million** year-over-year, primarily due to a **$1.3 million** decrease in professional services and consulting costs[135](index=135&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$226.0 million** in liquidity, expected to fund operations for at least 12 months, with past funding from preferred stock, collaborations, and IPO proceeds, and future plans for additional capital via an ATM program and other sources - As of March 31, 2025, the company had **$226.0 million** in cash, cash equivalents and available-for-sale marketable securities, estimated to be sufficient to fund operations for at least the next 12 months[142](index=142&type=chunk)[177](index=177&type=chunk) - Primary sources of liquidity include sales of redeemable convertible preferred units (**~$351.7 million**), net proceeds from the February 2024 IPO (**~$80.7 million**), and upfront payments from collaboration agreements (**~$120.0 million**)[137](index=137&type=chunk) - Net cash used in operating activities decreased to **$22.8 million** in Q1 2025 from **$29.9 million** in Q1 2024[144](index=144&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - The company will require substantial additional funding to support its continuing operations, including advancing its portfolio, conducting clinical trials, and potential commercialization[139](index=139&type=chunk)[176](index=176&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Metagenomi is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Metagenomi is not required to provide quantitative and qualitative disclosures about market risk[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[157](index=157&type=chunk) - No material changes were made to the company's internal control over financial reporting during the first quarter of 2025[158](index=158&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a securities class action lawsuit filed September 26, 2024, alleging misleading statements in its IPO registration materials regarding the Moderna collaboration, with the outcome currently unpredictable - A class action lawsuit was filed against the company, certain officers, and directors on September 26, 2024, alleging violations of the Securities Act related to disclosures about the Moderna collaboration in its IPO filings[83](index=83&type=chunk)[431](index=431&type=chunk) - The company cannot currently predict the outcome of the lawsuit or estimate a range of possible loss[83](index=83&type=chunk)[432](index=432&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces extensive risks including a history of losses and need for funding, early-stage development challenges, reliance on third parties, significant regulatory hurdles, and substantial intellectual property litigation risks in the rapidly evolving genome editing field [Risks Related to Financial Position and Need for Capital](index=43&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Capital) The company has a history of significant losses, including a **$25.0 million** net loss in Q1 2025 and an accumulated deficit of **$248.0 million**, necessitating substantial additional funding for future operations and raising concerns about long-term viability - The company has incurred significant losses since inception, with a net loss of **$25.0 million** for Q1 2025 and an accumulated deficit of **$248.0 million** as of March 31, 2025[166](index=166&type=chunk) - Substantial additional funding is required for operations, and failure to raise capital could force delays or termination of R&D programs and commercialization efforts[176](index=176&type=chunk) - The company's short operating history and early stage of development make it difficult to assess its future viability and performance[182](index=182&type=chunk)[183](index=183&type=chunk) [Risks Related to Business, Technology, and Industry](index=49&type=section&id=Risks%20Related%20to%20Business%2C%20Technology%2C%20and%20Industry) The company faces significant business risks including early-stage development with no clinical candidates, challenges with novel genome editing technology, complex manufacturing, intense competition, and potential negative public perception of gene editing and AI use - The company is in a very early development stage with no product candidates in IND-enabling studies or clinical trials, and commercialization is many years away, if ever[187](index=187&type=chunk) - The novel nature of genome editing technology presents additional risks, including changing regulatory guidance, potential for off-target effects, and immunological reactions[191](index=191&type=chunk)[192](index=192&type=chunk) - Manufacturing genetic therapies is complex and difficult, potentially leading to production problems, lot failures, or insufficient supply that could delay development programs[216](index=216&type=chunk) - The company faces significant competition from numerous companies in the rapidly evolving genome editing field, including those with more advanced or effective therapies and greater financial resources[221](index=221&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk) - The use of artificial intelligence (AI) in the company's platform introduces risks related to inaccuracy, bias, IP infringement, and an uncertain legal landscape, potentially leading to reputational harm and legal liability[254](index=254&type=chunk)[255](index=255&type=chunk) [Risks Related to Third Party Relationships](index=88&type=section&id=Risks%20Related%20to%20Third%20Party%20Relationships) The company's reliance on third-party collaborations and CMOs for research, development, and manufacturing creates risks including conflicting priorities, non-performance, agreement termination, and supply chain disruptions, which could significantly impair its programs - Conflicts with collaborators or strategic partners could lead them to act in a manner adverse to the company, such as developing competing products or withdrawing support for programs[320](index=320&type=chunk)[321](index=321&type=chunk) - The success of collaborations with partners like Ionis and Affini-T is not guaranteed and depends on the collaborator's efforts, resources, and strategic focus, over which Metagenomi has limited control[322](index=322&type=chunk)[323](index=323&type=chunk) - The company relies on third-party CMOs for manufacturing materials like gRNA and DNA templates, which creates risks related to regulatory compliance (cGMP), quality assurance, and potential supply disruptions[338](index=338&type=chunk)[339](index=339&type=chunk) - Reliance on third parties for conducting clinical trials (CROs) and research reduces direct control over these activities and their timelines, and any failure by these parties to perform could harm development programs[333](index=333&type=chunk)[335](index=335&type=chunk) [Risks Related to Our Intellectual Property](index=100&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success hinges on its intellectual property, facing risks from a competitive and litigious genome editing patent landscape, potential patent invalidation or infringement claims, and challenges in protecting trade secrets, all of which could impede product commercialization - Commercial success depends on protecting proprietary technology, but the scope of patent protection may not be broad enough to prevent competitors from developing similar products[358](index=358&type=chunk)[361](index=361&type=chunk) - The patent landscape for biotechnology is uncertain, and patents may be challenged and invalidated, making it difficult and costly to ensure IP protection[366](index=366&type=chunk)[374](index=374&type=chunk)[375](index=375&type=chunk) - The company may be sued for infringing third-party IP rights, which could be costly, time-consuming, and prevent or delay the development and commercialization of its genome editing systems[404](index=404&type=chunk)[405](index=405&type=chunk) - The field of CRISPR-based technology is subject to extensive patent filings and complex litigation, with multiple third-party patent portfolios potentially relevant to the company's work[407](index=407&type=chunk)[408](index=408&type=chunk) - The company relies on trade secrets, which are difficult to protect, and unauthorized disclosure by employees, collaborators, or contractors could impair its competitive position[415](index=415&type=chunk)[416](index=416&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=127&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered equity sales in Q1 2025 and confirmed no material change in the planned use of **$80.7 million** net proceeds from its February 2024 IPO - The company closed its IPO on February 13, 2024, receiving net proceeds of approximately **$80.7 million** after **$13.0 million** in costs[464](index=464&type=chunk)[465](index=465&type=chunk) - There has been no material change in the planned use of the net proceeds from the IPO as described in the final prospectus[466](index=466&type=chunk) [Item 3. Defaults Upon Senior Securities](index=127&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - The company reports no defaults upon senior securities[467](index=467&type=chunk) [Item 4. Mine Safety Disclosures](index=127&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[468](index=468&type=chunk) [Item 5. Other Information](index=127&type=section&id=Item%205.%20Other%20Information) The company reported no other material information for the quarter, confirming no director or officer adopted or terminated a Rule 10b5-1 trading arrangement - During the quarter ended March 31, 2025, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement[470](index=470&type=chunk) [Item 6. Exhibits](index=128&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including required certifications by the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents
Metagenomi(MGX) - 2025 Q1 - Quarterly Results
2025-05-13 20:35
Financial Performance - As of March 31, 2025, Metagenomi reported cash, cash equivalents, and available-for-sale marketable securities of $226.0 million, expected to support operations into 2027[1][9] - Research and development (R&D) expenses for Q1 2025 were $25.1 million, a decrease from $31.4 million in the same period of 2024, representing a reduction of approximately 20.5%[9][10] - General and administrative (G&A) expenses for Q1 2025 were $6.8 million, down from $8.8 million in Q1 2024, indicating a decrease of approximately 22.7%[10] - Collaboration revenue for Q1 2025 was reported at $4.1 million, a significant decrease from $11.2 million in Q1 2024[20] - The net loss for Q1 2025 was $25.0 million, slightly improved from a net loss of $25.1 million in Q1 2024[20] Research and Development - The nonhuman primate (NHP) study for the Hemophilia A program showed FVIII activity levels of 80%, 10%, and 32% in three animals at the 19-month mark, correlating with gene integration frequencies of 5.3%, 0.89%, and 2.5% respectively[3] - The mean FVIII activity during months 12-19 post lipid nanoparticle dosing was 75%, with individual results of 8% and 29% for two of the animals[3] - The company plans to leverage findings from the NHP study to inform the strategy for the MGX-001 program moving forward[2] Technological Advancements - Metagenomi's AI-driven metagenomics platform has analyzed over 7.4 billion proteins, enhancing its gene editing capabilities[13] - The company anticipates additional advancements in its compact CRISPR-associated transposase (CAST) systems for clinical applications in 2025[7]
Metagenomi Reports Business Updates and First Quarter 2025 Financial Results
Globenewswire· 2025-05-13 20:30
- Nonhuman primate (NHP) study in hemophilia A demonstrated therapeutically relevant factor VIII (FVIII) activity with durable response through approximately 19 months with an encouraging safety profile - Well capitalized with $226.0 million in cash, cash equivalents and available-for-sale marketable securities as of March 31, 2025 with runway anticipated to support operations into 2027 EMERYVILLE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX), a precision genetic medicines company ...
Metagenomi to Present at Upcoming Scientific Meetings
Globenewswire· 2025-05-02 11:00
Core Insights - Metagenomi, Inc. is set to present at two significant scientific meetings, showcasing its advancements in gene editing technologies [1][2] - The company utilizes an AI-driven metagenomics platform to develop curative therapeutics, aiming to correct genetic mutations across the genome [3] Presentation Details - At TIDES USA 2025, Metagenomi will deliver an oral presentation titled "AI-Guided Metagenomic Discovery of Compact CRISPR Systems for In Vivo Therapeutic Genome Editing" on May 22, 2025 [2] - The company will also present three posters at the ASGCT 2025 Annual Meeting, focusing on various aspects of in vivo genome editing and CRISPR systems on May 13, 2025 [2] Company Overview - Metagenomi is dedicated to developing precision genetic medicines, leveraging four billion years of microbial evolution to create novel genome editing tools [3] - The company's toolbox includes programmable nucleases, base editors, and advanced integration systems, positioning it to address a wide range of genetic mutations [3]
Metagenomi(MGX) - 2024 Q4 - Annual Results
2025-03-17 20:06
Exhibit 99.1 Metagenomi Reports Business Updates and Full Year 2024 Financial Results Hemophilia A presentation at American Society of Hematology (ASH) 66th Annual Meeting demonstrated sustained Factor VIII (FVIII) activity in nonhuman primate (NHP) study for more than 16 months Leveraged hemophilia A albumin platform to achieve in vivo proof-of-concept in multiple secreted protein deficiencies to support wholly-owned follow-on program Progressed four Wave 1 Ionis targets to lead optimization with plans to ...
Metagenomi Reports Business Updates and Full Year 2024 Financial Results
Globenewswire· 2025-03-17 20:05
Core Insights - Metagenomi, Inc. reported significant advancements in its hemophilia A program, demonstrating sustained Factor VIII (FVIII) activity in nonhuman primate studies for over 16 months, supporting the durability of its gene editing therapy [1][7] - The company is well-capitalized with $248.3 million in cash and equivalents as of December 31, 2024, providing a cash runway anticipated to support operations into 2027 [1][10] - Metagenomi plans to submit its first Investigational New Drug (IND) application for hemophilia A in 2026 and aims to nominate one to two development candidates from its Wave 1 Ionis collaboration programs in 2025 [2][14] Hemophilia A Program - The company has declared MGX-001 as a development candidate for hemophilia A, which includes a bioengineered FVIII construct with higher activity levels compared to the wild type [7] - An oral presentation at the American Society of Hematology (ASH) highlighted the sustained FVIII activity in nonhuman primate studies, reinforcing the potential of MGX-001 [7] - Plans are in place to release final FVIII durability and related preclinical study data in the first half of 2025 [14] Secreted Protein Deficiencies - Metagenomi has identified targets for wholly-owned therapeutic programs leveraging the gene integration approach used in MGX-001, achieving in vivo proof-of-concept in rodents across three secreted protein targets [4] - The company plans to demonstrate nonhuman primate proof-of-concept for its lead secreted protein deficiency target in 2025 and nominate a development candidate in 2026 [9] Cardiometabolic Indications - The company advanced four Wave 1 Ionis collaboration programs to lead optimization, including targets for transthyretin amyloidosis and refractory hypertension, achieving in vivo proof-of-concept in rodents [8] - Demonstrated a 95% protein knockdown in spontaneous hypertensive rats, showcasing the progress made in the collaboration [8] Financial Performance - For the full year ended December 31, 2024, Metagenomi reported research and development expenses of $109.2 million, an increase from $94.4 million in 2023 [10] - General and administrative expenses rose to $32.0 million in 2024 from $28.8 million in 2023 [11] - The net loss for 2024 was $78.1 million, compared to a net loss of $68.3 million in 2023, with a net loss per share of $2.36 [20]
Metagenomi(MGX) - 2024 Q4 - Annual Report
2025-03-17 20:01
Financial Performance - Collaboration revenue increased to $52.3 million for the year ended December 31, 2024, compared to $44.8 million in 2023, reflecting a growth of approximately 33.3%[558] - Collaboration revenue increased by $7.5 million, from $44.8 million in 2023 to $52.3 million in 2024, primarily driven by an $8.5 million increase from the Ionis Agreement[572] - The net loss for 2024 was $78.1 million, compared to a net loss of $68.3 million in 2023, reflecting an increase of $9.8 million[581] - Total operating expenses rose to $141.2 million in 2024, up $17.9 million from $123.2 million in 2023, with research and development expenses accounting for $109.2 million, an increase of $14.8 million[574] - Total other income, net, decreased by $12.9 million, from $18.3 million in 2023 to $5.3 million in 2024, primarily due to a loss of $9.2 million on long-term investments[576] - The provision for income taxes changed from an expense of $8.0 million in 2023 to a benefit of $5.5 million in 2024, reflecting a strategic tax credit carryback[577] - The company has an accumulated deficit of $223.0 million as of December 31, 2024, indicating ongoing financial challenges[581] Cash Flow and Liquidity - Cash used in operating activities was $109.1 million for 2024, consisting mainly of the net loss and changes in operating assets and liabilities[586] - As of December 31, 2024, the company had $248.3 million in cash, cash equivalents, and available-for-sale marketable securities, sufficient to fund projected operating expenses for at least the next 12 months[582] - Net cash used in operating activities for the year ended December 31, 2023 was $91.4 million, primarily due to a net loss of $68.3 million and a net reduction of $26.4 million in net operating assets and liabilities[587] - Net cash provided by investing activities for the year ended December 31, 2023 was $45.7 million, consisting of $55.5 million in net maturities of available-for-sale marketable securities, offset by $9.8 million of purchases of property and equipment[589] - Net cash provided by financing activities for the year ended December 31, 2024 was $84.0 million, attributed to net proceeds from the issuance of common stock in the IPO[590] - Net cash used in investing activities for the year ended December 31, 2024 was $88.2 million, primarily due to net purchases of available-for-sale securities of $84.7 million[588] - Net cash provided by financing activities for the year ended December 31, 2023 was $1.0 million, consisting of $4.3 million of net cash proceeds from the issuance of Series B-1 preferred redeemable convertible preferred stock[591] Research and Development - The investigational therapy for hemophilia A demonstrated durable FVIII activity levels in non-human primates over a 16.5-month period, with no significant safety findings reported[547] - The company plans to conduct pre-IND and ex-U.S. regulatory meetings in 2025 and aims to complete IND and clinical trial application filings for MGX-001 in 2026[547] - Research and development expenses are expected to increase substantially as the company continues to invest in its platform and advance clinical trials[562] General and Administrative Expenses - General and administrative expenses are anticipated to rise due to increased headcount and costs associated with being a public company[564] - General and administrative expenses increased to $32.0 million in 2024, up $3.2 million from $28.8 million in 2023, primarily due to increased stock-based compensation[575] Collaborations and Partnerships - The company has entered into collaborations with Ionis Pharmaceuticals and Affini-T Therapeutics to develop gene editing therapies for cardiometabolic diseases and cancer, respectively[548][555] - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying instead on collaboration agreements for revenue[556] Corporate Actions - The company completed its initial public offering (IPO) on February 13, 2024, issuing 6,250,000 shares at $15.00 per share, resulting in net proceeds of approximately $80.7 million after costs[552] - The Reorganization and reverse stock split were completed on January 24, 2024, and January 26, 2024, respectively, with a 1-for-1.74692 ratio for the stock split[549][551] Tax and Deferred Assets - As of December 31, 2024, the company had net operating loss carryforwards of $45.6 million for federal and $118.3 million for state income tax purposes, available to reduce future taxable income[567] - The company assesses the need for a valuation allowance against deferred tax assets based on various factors, including projected future taxable income and historical earnings experience[609] - The company recognizes tax benefits related to uncertain tax positions when it is more likely than not that a tax position will be sustained during an audit[610]
Metagenomi Announces Publication in Nature Communications on Large Gene Integration Advances Using Novel, Compact CRISPR-associated transposase (CAST) Systems
Globenewswire· 2025-03-13 10:19
Core Insights - Metagenomi has developed a novel, compact CAST system for large, targeted gene integration into the human genome, which is a significant advancement in the field of gene editing [1][2][4] - The CAST system is designed to address complex genetic diseases caused by loss of function mutations, such as Wilson's disease, cystic fibrosis, and Duchenne Muscular Dystrophy [2][4] - The technology utilizes an AI-driven metagenomics platform to facilitate the discovery and application of the CAST system in human cells [1][3] Company Developments - The compact CAST system allows for the integration of multiple gene cargoes at a known safe-harbor site in the human genome, showcasing its site-specific and programmable capabilities [3][4] - The system simplifies delivery through a single 'all-in-one' mRNA design, representing a first-in-class approach in the industry [1][4] - Future advancements in large gene integration technology are anticipated in 2025, with ongoing efforts to optimize the system for clinical applications [1][4] Industry Impact - The findings from Metagenomi's research highlight the potential of compact CAST systems to overcome limitations in large gene integration, paving the way for precision genetic medicines [4] - The technology is positioned to unlock the full potential of genome editing for patients, addressing a wide range of genetic mutations [5]
Metagenomi to Present at TD Cowen's 45th Annual Health Care Conference
Globenewswire· 2025-02-11 13:55
Core Viewpoint - Metagenomi, Inc. is actively participating in the TD Cowen's 45th Annual Health Care Conference, showcasing its commitment to developing curative therapeutics through its proprietary gene editing toolbox [1]. Company Overview - Metagenomi is a precision genetic medicines company focused on curative therapeutics using an AI-driven metagenomics platform [3]. - The company leverages four billion years of microbial evolution to discover novel editing tools capable of correcting any genetic mutation in the genome [3]. - Its genome editing toolbox includes programmable nucleases, base editors, and RNA and DNA-mediated integration systems, such as prime editing systems and CAST [3]. - Metagenomi's proprietary toolbox is designed to access the entire genome and select optimal tools for effective genome editing [3]. Event Participation - Brian C. Thomas, PhD, CEO and founder of Metagenomi, will engage in a fireside chat at the conference on March 5, 2025, from 1:10-1:40 p.m. ET in Boston [1]. - The company will also host one-on-one investor meetings during the conference [1].