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IGMS STOCK ALERT: Levi & Korsinsky Notifies IGM Biosciences, Inc. Investors of an Ongoing Investigation ...

Strategic Updates and Restructuring - The company announced a strategic update to halt further development of imvotamab and IGM-2644, resulting in an approximately 73% reduction in force to preserve cash[6] - The company is unable to estimate the costs and charges associated with the 2025 Restructuring at this time and will file an amendment once determined[7] Evaluation of Strategic Alternatives - The company is evaluating internal options and potential strategic alternatives to maximize shareholder value[8]

Strategic Update - The company has decided to halt further development of imvotamab (CD20 x CD3) and IGM-2644 (CD38 x CD3) due to insufficient B cell depletion in Phase 1b studies for rheumatoid arthritis and systemic lupus erythematosus [1][2] - The decision to discontinue these programs is based on strategic considerations and the inability to meet the high bar for success in autoimmune disease treatment [2] Workforce Reduction - The company is implementing a significant workforce reduction of approximately 73% to preserve cash [2] - This reduction is part of the company's broader strategy to maximize shareholder value while evaluating internal options and potential strategic alternatives [2] Financial Position - As of December 31, 2024, the company reported cash and investments of approximately $183.8 million (unaudited) [1][2] - The company is taking immediate steps to preserve cash, including the workforce reduction, as it evaluates strategic alternatives [2] Company Overview - IGM Biosciences is a biotechnology company focused on developing and delivering medicines for autoimmune and inflammatory diseases [3] - The company has an exclusive worldwide collaboration agreement with Sanofi to develop IgM antibody agonists targeting immunology and inflammation [3]

Earnings Performance - IGM Biosciences reported a quarterly loss of $1.01 per share, missing the Zacks Consensus Estimate of a loss of $0.82, representing an earnings surprise of -23.17% [1] - The company's loss per share improved slightly from $1.04 a year ago [1] - In the previous quarter, the company posted a loss of $0.79 per share, significantly missing the expected earnings of $0.03 per share, resulting in a surprise of -2,733.33% [1] - Over the last four quarters, the company has surpassed consensus EPS estimates two times [2] Revenue Performance - IGM Biosciences reported revenues of $0.52 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 123.38% [2] - This represents a slight increase from year-ago revenues of $0.51 million [2] - The company has topped consensus revenue estimates just once over the last four quarters [2] Stock Performance and Market Comparison - IGM Biosciences shares have gained approximately 72.9% since the beginning of the year, significantly outperforming the S&P 500's gain of 25.2% [3] - The stock's immediate price movement will largely depend on management's commentary during the earnings call [3] Earnings Outlook and Estimate Revisions - The current consensus EPS estimate for the coming quarter is -$0.75 on $0.17 million in revenues [7] - For the current fiscal year, the consensus EPS estimate is -$3.17 on $2.05 million in revenues [7] - The estimate revisions trend for IGM Biosciences is mixed, resulting in a Zacks Rank 3 (Hold) [6] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions [5] Industry Context - IGM Biosciences operates in the Zacks Medical - Biomedical and Genetics industry, which is currently in the top 35% of the 250 plus Zacks industries [8] - The top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8] Peer Comparison - Cyclo Therapeutics, Inc (CYTH), another company in the same industry, is expected to report a quarterly loss of $0.17 per share, representing a year-over-year improvement of +41.4% [9] - Cyclo Therapeutics' revenues are expected to be $0.31 million, down 38% from the year-ago quarter [9]

Financial Performance - Cash and investments as of September 30, 2024 were $218.8 million, compared to $337.7 million as of December 31, 2023[6] - Collaboration revenue for the third quarter of 2024 was $0.5 million, unchanged from the third quarter of 2023[6] - Research and Development (R&D) expenses for the third quarter of 2024 were $46.1 million, compared to $54.8 million for the third quarter of 2023[6] - General and Administrative (G&A) expenses for the third quarter of 2024 were $18.8 million, compared to $12.5 million for the third quarter of 2023[6] - Net loss for the third quarter of 2024 was $61.4 million, or a loss of $1.01 per share, compared to a net loss of $62.0 million, or a loss of $1.04 per share, for the third quarter of 2023[6] - The Company expects full year 2024 GAAP operating expenses of $215 million to $225 million, including estimated non-cash stock-based compensation expense of approximately $40 million[7] - The Company expects to end 2024 with a balance of approximately $180 million in cash and investments, enabling it to fund operations into 2027[7] Clinical Development and Milestones - Initial clinical data for imvotamab in rheumatoid arthritis, systemic lupus erythematosus, and myositis is expected by mid-2025[3] - IGM-2644 is expected to enter a clinical study for generalized myasthenia gravis by the end of 2024[4] - The Company has successfully completed the third dose cohort in its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis[3]

Financial Performance and Losses - Net losses for the nine months ended September 30, 2024 and 2023 were $159.1 million and $185.7 million, respectively, with an accumulated deficit of $980.4 million as of September 30, 2024[76] - The company expects to continue incurring significant expenses and operating losses, with fluctuating R&D and general administrative expenses as it advances clinical programs and expands its pipeline[76][82][83] - Net cash used in operating activities was $118.2 million for the nine months ended September 30, 2024, compared to $144.2 million in the same period in 2023[96] Collaboration Revenue and Agreements - Collaboration revenue for the three months ended September 30, 2024 and 2023 was $0.5 million, solely from the Sanofi Agreement[86] - The Sanofi Agreement was refocused on immunology targets, with the company eligible to receive up to $1.065 billion in milestones per target and tiered royalties on global net sales[79] - Collaboration revenue increased to $2.3 million for the nine months ended September 30, 2024, up by $0.8 million from $1.5 million in the same period in 2023, driven by a cumulative catch-up adjustment related to the Sanofi Refocusing[89] Research and Development Expenses - Research and development expenses decreased by $8.6 million to $46.1 million for the three months ended September 30, 2024, driven by lower personnel and program expenses[87] - Clinical stage direct program expenses decreased by $2.6 million due to the wind down of deprioritized clinical programs, including imvotamab in oncology[87] - Preclinical stage program expenses decreased by $2.1 million due to reduced research activities and professional services[87] - Research and development expenses decreased to $131.9 million for the nine months ended September 30, 2024, down by $29.4 million from $161.3 million in 2023, primarily due to lower personnel and program expenses[91] - Clinical stage direct program expenses decreased by $7.5 million, driven by the wind down of deprioritized clinical programs, partially offset by the advancement of Phase 1 clinical trials for imvotamab in autoimmune diseases[91] - Preclinical stage program expenses decreased by $9.4 million, primarily due to reduced research activities and professional services following the 2023 Restructuring[91] Personnel and Restructuring Costs - Personnel-related expenses decreased by $3.9 million primarily due to the 2023 Restructuring, partially offset by one-time expenses from the 2024 Restructuring[87] - Personnel-related expenses decreased by $13.7 million, primarily due to the 2023 Restructuring, partially offset by one-time expenses from the 2024 Restructuring[91] - General and administrative expenses increased to $18.8 million for Q3 2024, up by $6.3 million from $12.5 million in Q3 2023, primarily due to higher stock-based compensation from the 2024 Restructuring[88] Strategic Pivot and Cash Runway - The company announced a strategic pivot to focus exclusively on autoimmunity in September 2024, extending its cash runway through workforce reduction and reduced R&D spending on oncology candidates[79] - Cash, cash equivalents, and marketable securities totaled $218.8 million as of September 30, 2024, with an accumulated deficit of $980.4 million[92] Interest Income and Other Expenses - Interest income decreased to $3.0 million for Q3 2024, down by $2.1 million from $5.0 million in Q3 2023, due to lower invested capital[88] - Depreciation and facilities expenses increased by $1.2 million, primarily due to additional equipment and infrastructure[91] Future Commitments and Contingencies - Future minimum lease commitments for offices and facilities in Mountain View, California, and Doylestown, Pennsylvania, total $58.2 million as of September 30, 2024[99] - Potential future milestone and royalty payments for product candidates in development stages could reach up to $361.9 million, contingent on achieving specific milestones[99] Accounting and Reporting - No off-balance sheet arrangements were reported during the periods presented[100] - The company's financial statements are prepared in accordance with U.S. GAAP, requiring significant estimates and assumptions[102] - No material changes to critical accounting policies were reported during the nine months ended September 30, 2024[102] - The company is classified as a "smaller reporting company" and is not required to provide market risk disclosures under Item 305 of Regulation S-K[104] Third-Party Service Providers - The company plans to use third-party service providers, including CROs and CMOs, for preclinical and clinical development and manufacturing[78]

Stock Performance - IGM Biosciences shares ended the last trading session 11.6% higher at $17.68, driven by higher-than-average trading volume [1] - The stock has gained 65.2% over the past four weeks [1] - Allogene Therapeutics shares closed 4.4% higher at $2.88 in the last trading session and have returned 4.2% over the past month [4] Financial Results and Estimates - IGM Biosciences announced robust financial results for Q2 2024 [2] - The company is expected to post a quarterly loss of $0.82 per share, representing a year-over-year improvement of +21.2% [3] - Revenues are expected to be $0.27 million, down 47.1% from the year-ago quarter [3] - The consensus EPS estimate for IGM Biosciences has been revised 0.9% lower over the last 30 days [4] - Allogene Therapeutics' consensus EPS estimate for the upcoming report has changed +0.5% over the past month to -$0.34, representing a year-over-year improvement of +8.1% [5] Pipeline and Industry - IGM Biosciences has a promising pipeline of Immunoglobin M antibody-based candidates for treating cancer, autoimmune, and inflammatory diseases [2] - Both IGM Biosciences and Allogene Therapeutics belong to the Zacks Medical - Biomedical and Genetics industry [4] - Both companies currently carry a Zacks Rank of 3 (Hold) [4][5]

Zacks Rating Upgrade - IGM Biosciences upgraded to Zacks Rank 2 (Buy) due to upward trend in earnings estimates, a key driver of stock prices [1] - Zacks rating system tracks consensus EPS estimates from analysts for current and future years to assess earnings outlook [2] - Rating upgrades reflect positive earnings outlook, potentially leading to buying pressure and stock price increase [4] Earnings Estimate Revisions - Changes in earnings estimates strongly correlate with near-term stock price movements, influenced by institutional investors' valuation models [5] - Rising earnings estimates and rating upgrade indicate improvement in IGM Biosciences' underlying business [6] - Empirical research shows strong correlation between earnings estimate revisions and stock movements, making tracking revisions rewarding [7] Zacks Rank System - Zacks Rank system classifies stocks into 5 groups based on 4 earnings estimate factors, with Zacks Rank 1 stocks averaging +25% annual return since 1988 [8] - Zacks system maintains balanced 'buy' and 'sell' ratings, with only top 5% of stocks receiving 'Strong Buy' and next 15% receiving 'Buy' ratings [10] - IGM Biosciences' Zacks Rank 2 places it in top 20% of Zacks-covered stocks, indicating superior earnings estimate revisions and potential for market-beating returns [11] IGM Biosciences Earnings Outlook - IGM Biosciences expected to earn -$2 44 per share for fiscal year ending December 2024, representing 48 2% year-over-year change [9] - Zacks Consensus Estimate for IGM Biosciences increased 1 1% over past three months, reflecting steady upward revisions by analysts [9]

Earnings Performance - IGM Biosciences reported a quarterly loss of $0.79 per share, significantly missing the Zacks Consensus Estimate of a $0.03 loss, representing an earnings surprise of -2,733.33% [1] - The company's loss per share improved from $1.43 a year ago [1] - Over the last four quarters, the company has surpassed consensus EPS estimates three times [2] Revenue Performance - IGM Biosciences posted revenues of $1.25 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 97.58% [2] - This compares to year-ago revenues of $0.45 million [2] - The company has not been able to beat consensus revenue estimates over the last four quarters [2] Stock Performance - IGM Biosciences shares have added about 6.9% since the beginning of the year, underperforming the S&P 500's gain of 13.9% [3] - The stock's immediate price movement will depend on management's commentary on the earnings call [3] Earnings Outlook - The current consensus EPS estimate is -$0.84 on $0.5 million in revenues for the coming quarter [7] - For the current fiscal year, the consensus EPS estimate is -$2.31 on $53.23 million in revenues [7] - The estimate revisions trend for IGM Biosciences is mixed, translating into a Zacks Rank 3 (Hold) [6] Industry Context - IGM Biosciences belongs to the Zacks Medical - Biomedical and Genetics industry, which is currently in the top 29% of the 250 plus Zacks industries [8] - The top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8] Peer Comparison - Oculis Holding AG (OCS), another company in the same industry, is expected to post a quarterly loss of $0.41 per share, representing a year-over-year change of +2.4% [9] - Oculis Holding AG's revenues are expected to be $0.28 million, unchanged compared to the year-ago quarter [10]