Immuneering (IMRX) - 2024 Q1 - Quarterly Results

Q1 2024 Earnings Release Overview Highlights and CEO Commentary Immuneering reported positive top-line Phase 1 results for IMM-1-104 in RAS-mutant solid tumors, demonstrating tumor shrinkage potential and good tolerability, with the CEO anticipating a data-rich 2024 - IMM-1-104 Phase 1 results reported positive top-line data from the first stage of the Phase 1/2a clinical trial in RAS-mutant solid tumors[1] - The Deep Cyclic Inhibition mechanism aims to attack cancer cells while protecting healthy cells, enabling well-tolerated tumor shrinkage[2] - Preliminary data for multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 Phase 1/2a study are expected in 2024[1][2] Clinical Development and Corporate Updates Corporate Highlights Immuneering achieved significant milestones, including positive IMM-1-104 Phase 1 results, initiation of Phase 2a trials for IMM-1-104 and IMM-6-415, a new board appointment, and FDA Fast Track designation for IMM-1-104 in pancreatic cancer - IMM-1-104 demonstrated synergy with chemotherapy in pancreatic cancer models, supporting the ongoing Phase 2a trial[3] - IMM-1-104 Phase 1 top-line results showed good tolerability with potential for a differentiated safety profile[3] - 100% acquired RAS mutation inhibition observed in evaluable patients[4] - Over half of patients at 320mg or 240mg QD doses showed target lesion regression, with a best individual lesion regression of -35.7% and best RECIST Sum of Longest Diameters (SLD) of -18.9% (both at 320mg dose)[3][4] - Recommended Phase 2 Dose (RP2D) is 320mg QD, supported by tolerability, PK/PD, ctDNA results, and preliminary anti-tumor activity[4] - Clinical trial progress includes the first patient dosed in the IMM-1-104 Phase 2a clinical trial, comprising three monotherapy and two combination therapy cohorts[7] - The first patient has been dosed in the IMM-6-415 Phase 1/2a trial for RAF or RAS-mutant advanced solid tumors; IMM-6-415 is a Deep Cyclic Inhibitor with a shorter half-life than IMM-1-104, designed for twice-daily oral dosing[7] - Dr. Thomas J. Schall, former Chairman, CEO, and Founder of ChemoCentryx, was appointed to the Board of Directors[7] - IMM-1-104 received FDA Fast Track designation for treating patients with pancreatic ductal adenocarcinoma (PDAC) who have failed first-line therapy[7] Near-Term Milestone Expectations Immuneering anticipates significant clinical data releases in 2024 for its lead candidates, including preliminary data from multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 - Preliminary data from multiple cohorts of the IMM-1-104 Phase 2a portion are expected in 2024[5] - Initial pharmacokinetic (PK), pharmacodynamic (PD), and safety data for IMM-6-415 are anticipated in 2024[6] Financial Performance and Outlook First Quarter 2024 Financial Highlights Immuneering's cash decreased to $71.3 million by March 31, 2024, with increased R&D expenses, decreased G&A expenses, and a slight rise in net loss to $14.3 million Cash Position | Metric | March 31, 2024 | December 31, 2023 | | :------------------------------------ | :--------------- | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $71.3 million | $85.7 million | Operating Expenses (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Year-over-Year Change | | :-------------------------------- | :---------- | :---------- | :-------------------- | | Research and Development Expenses | $11.2 million | $10.2 million | +$1.0 million | | General and Administrative Expenses | $4.1 million | $4.5 million | -$0.4 million | Net Loss | Metric | Q1 2024 | Q1 2023 | Year-over-Year Change | | :------------------------------------ | :---------- | :---------- | :-------------------- | | Net Loss Attributable to Common Stockholders | $14.3 million | $13.6 million | +$0.7 million | | Net Loss Per Share (Basic and Diluted) | $0.49 | $0.51 | -$0.02 | 2024 Financial Guidance Based on current cash and operational plans, Immuneering expects its cash resources to fund operations into the second half of 2025 - Cash flow is projected to be sufficient to support operations into the second half of 2025[10] Company Profile About Immuneering Corporation Immuneering is a clinical-stage oncology company developing universal RAS/RAF drugs using Deep Cyclic Inhibition to selectively target cancer cells, with lead candidates IMM-1-104 and IMM-6-415 in Phase 1/2a trials - Company mission is to develop and commercialize universal RAS/RAF drugs to treat a broad patient population, with an initial focus on universal RAS therapies[11] - Mechanism of action involves Deep Cyclic Inhibition of the MAPK pathway, designed to impact cancer cells while sparing healthy cells[11] - Key product candidates include IMM-1-104, an oral, once-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS mutations[11] - IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS or RAF mutations[11] Legal and Investor Information Forward-Looking Statements This section contains forward-looking statements regarding Immuneering's product development, clinical trials, and financial projections, subject to inherent risks and uncertainties - All statements not concerning historical facts are considered forward-looking, including plans for developing, manufacturing, and commercializing product candidates, potential of IMM-1-104 and IMM-6-415, clinical trial design and implementation, translation of preclinical data, potential benefits and efficacy of candidates, and timing of IMM-1-104 Phase 2a and IMM-6-415 preliminary data[12] - Key risks include those inherent in oncology drug development, such as target discovery, validation, lead identification, and optimization[13] - Significant losses incurred, no current profitability, and potential future unprofitability; anticipated cash flow; and the need for additional funding[13] - Unproven therapeutic interventions; ability to address regulatory issues and uncertainties related to regulatory filings, review, and approval[13] - Long, expensive, and uncertain clinical drug development process, including potential delays or failure to obtain regulatory approval[14] - Reliance on third parties and collaborators for clinical trials, manufacturing, and commercialization of product candidates if approved[14] - Failure to compete successfully with other pharmaceutical companies; protecting proprietary technology and trade secret confidentiality; potential third-party intellectual property infringement lawsuits or claims, or challenges to intellectual property ownership; patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst coverage or reports[14] - Any forward-looking statements represent management's estimates as of the press release date, with no obligation to update them unless legally required, even if subsequent events change company views[15] Contacts Contact information is provided for media and investor inquiries - Media Contact: Gina Nugent, gina@nugentcommunications.com[16] - Investor Contact: Laurence Watts, 619-916-7620, laurence@newstreetir.com[16] Condensed Consolidated Financial Statements Condensed Consolidated Statements of Operations and Comprehensive Loss This section presents the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, detailing operating expenses, loss, other income, net loss, and loss per share Condensed Consolidated Statements of Operations and Comprehensive Loss | | Three Months Ended March 31 | | | :---------------------------------------------------- | :----------- | :----------- | | | 2024 | 2023 | | Operating expenses: | | | | Research and development expenses | $11,202,414 | $10,210,926 | | General and administrative expenses | $4,116,019 | $4,461,331 | | Amortization of intangible assets | $7,317 | $7,317 | | Total operating expenses | $15,325,750 | $14,679,574 | | Operating loss | $(15,325,750) | $(14,679,574) | | Other income (expense): | | | | Interest income | $804,884 | $831,274 | | Other income, net | $213,037 | $244,129 | | Net loss | $(14,307,829) | $(13,604,171) | | Net loss attributable to common stockholders per share, basic and diluted | $(0.49) | $(0.51) | | Weighted-average common shares outstanding, basic and diluted | 29,370,357 | 26,442,216 | | Other comprehensive loss: | | | | Unrealized gain (loss) on marketable securities | $(306) | $30,626 | | Comprehensive loss | $(14,308,135) | $(13,573,545) | Condensed Consolidated Balance Sheets This section provides the unaudited condensed consolidated balance sheets as of March 31, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets | | March 31, 2024 | | December 31, 2023 | | 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Immuneering has released its Q1 2024 financial results, highlighting clinical advancements and financial standing. The company's lead candidate, IMM-1-104, showed positive Phase 1 results in RAS-mutant solid tumors, demonstrating tumor shrinkage and good tolerability. This progress, alongside the initiation of Phase 2a trials for IMM-1-104 and IMM-6-415, and FDA Fast Track designation for IMM-1-104 in pancreatic cancer, underscores Immuneering's commitment to advancing its Deep Cyclic Inhibition platform. Financially, the company reported a decrease in cash and equivalents, with a net loss of $14.3 million for the quarter, but projects sufficient cash to fund operations into the second half of 2025. Q1 2024 Earnings Release Overview Highlights and CEO Commentary Immuneering reported positive top-line Phase 1 results for IMM-1-104 in RAS-mutant solid tumors, demonstrating tumor shrinkage potential and good tolerability, with the CEO anticipating a data-rich 2024 - IMM-1-104 Phase 1 results reported positive top-line data from the first stage of the Phase 1/2a clinical trial in RAS-mutant solid tumors[1] - The Deep Cyclic Inhibition mechanism aims to attack cancer cells while protecting healthy cells, enabling well-tolerated tumor shrinkage[2] - Preliminary data for multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 Phase 1/2a study are expected in 2024[1][2] Clinical Development and Corporate Updates Corporate Highlights Immuneering achieved significant milestones, including positive IMM-1-104 Phase 1 results, initiation of Phase 2a trials for IMM-1-104 and IMM-6-415, a new board appointment, and FDA Fast Track designation for IMM-1-104 in pancreatic cancer - IMM-1-104 demonstrated synergy with chemotherapy in pancreatic cancer models, supporting the ongoing Phase 2a trial[3] - IMM-1-104 Phase 1 top-line results showed good tolerability with potential for a differentiated safety profile[3] - 100% acquired RAS mutation inhibition observed in evaluable patients[4] - Over half of patients at 320mg or 240mg QD doses showed target lesion regression, with a best individual lesion regression of -35.7% and best RECIST Sum of Longest Diameters (SLD) of -18.9% (both at 320mg dose)[3][4] - Recommended Phase 2 Dose (RP2D) is 320mg QD, supported by tolerability, PK/PD, ctDNA results, and preliminary anti-tumor activity[4] - Clinical trial progress includes the first patient dosed in the IMM-1-104 Phase 2a clinical trial, comprising three monotherapy and two combination therapy cohorts[7] - The first patient has been dosed in the IMM-6-415 Phase 1/2a trial for RAF or RAS-mutant advanced solid tumors; IMM-6-415 is a Deep Cyclic Inhibitor with a shorter half-life than IMM-1-104, designed for twice-daily oral dosing[7] - Dr. Thomas J. Schall, former Chairman, CEO, and Founder of ChemoCentryx, was appointed to the Board of Directors[7] - IMM-1-104 received FDA Fast Track designation for treating patients with pancreatic ductal adenocarcinoma (PDAC) who have failed first-line therapy[7] Near-Term Milestone Expectations Immuneering anticipates significant clinical data releases in 2024 for its lead candidates, including preliminary data from multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 - Preliminary data from multiple cohorts of the IMM-1-104 Phase 2a portion are expected in 2024[5] - Initial pharmacokinetic (PK), pharmacodynamic (PD), and safety data for IMM-6-415 are anticipated in 2024[6] Financial Performance and Outlook First Quarter 2024 Financial Highlights Immuneering's cash decreased to $71.3 million by March 31, 2024, with increased R&D expenses, decreased G&A expenses, and a slight rise in net loss to $14.3 million Cash Position | Metric | March 31, 2024 | December 31, 2023 | | :------------------------------------ | :--------------- | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $71.3 million | $85.7 million | Operating Expenses (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Year-over-Year Change | | :-------------------------------- | :---------- | :---------- | :-------------------- | | Research and Development Expenses | $11.2 million | $10.2 million | +$1.0 million | | General and Administrative Expenses | $4.1 million | $4.5 million | -$0.4 million | Net Loss | Metric | Q1 2024 | Q1 2023 | Year-over-Year Change | | :------------------------------------ | :---------- | :---------- | :-------------------- | | Net Loss Attributable to Common Stockholders | $14.3 million | $13.6 million | +$0.7 million | | Net Loss Per Share (Basic and Diluted) | $0.49 | $0.51 | -$0.02 | 2024 Financial Guidance Based on current cash and operational plans, Immuneering expects its cash resources to fund operations into the second half of 2025 - Cash flow is projected to be sufficient to support operations into the second half of 2025[10] Company Profile About Immuneering Corporation Immuneering is a clinical-stage oncology company developing universal RAS/RAF drugs using Deep Cyclic Inhibition to selectively target cancer cells, with lead candidates IMM-1-104 and IMM-6-415 in Phase 1/2a trials - Company mission is to develop and commercialize universal RAS/RAF drugs to treat a broad patient population, with an initial focus on universal RAS therapies[11] - Mechanism of action involves Deep Cyclic Inhibition of the MAPK pathway, designed to impact cancer cells while sparing healthy cells[11] - Key product candidates include IMM-1-104, an oral, once-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS mutations[11] - IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS or RAF mutations[11] Legal and Investor Information Forward-Looking Statements This section contains forward-looking statements regarding Immuneering's product development, clinical trials, and financial projections, subject to inherent risks and uncertainties - All statements not concerning historical facts are considered forward-looking, including plans for developing, manufacturing, and commercializing product candidates, potential of IMM-1-104 and IMM-6-415, clinical trial design and implementation, translation of preclinical data, potential benefits and efficacy of candidates, and timing of IMM-1-104 Phase 2a and IMM-6-415 preliminary data[12] - Key risks include those inherent in oncology drug development, such as target discovery, validation, lead identification, and optimization[13] - Significant losses incurred, no current profitability, and potential future unprofitability; anticipated cash flow; and the need for additional funding[13] - Unproven therapeutic interventions; ability to address regulatory issues and uncertainties related to regulatory filings, review, and approval[13] - Long, expensive, and uncertain clinical drug development process, including potential delays or failure to obtain regulatory approval[14] - Reliance on third parties and collaborators for clinical trials, manufacturing, and commercialization of product candidates if approved[14] - Failure to compete successfully with other pharmaceutical companies; protecting proprietary technology and trade secret confidentiality; potential third-party intellectual property infringement lawsuits or claims, or challenges to intellectual property ownership; patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst coverage or reports[14] - Any forward-looking statements represent management's estimates as of the press release date, with no obligation to update them unless legally required, even if subsequent events change company views[15] Contacts Contact information is provided for media and investor inquiries - Media Contact: Gina Nugent, gina@nugentcommunications.com[16] - Investor Contact: Laurence Watts, 619-916-7620, laurence@newstreetir.com[16] Condensed Consolidated Financial Statements Condensed Consolidated Statements of Operations and Comprehensive Loss This section presents the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, detailing operating expenses, loss, other income, net loss, and loss per share Condensed Consolidated Statements of Operations and Comprehensive Loss | | Three Months Ended March 31 | | | :---------------------------------------------------- | :----------- | :----------- | | | 2024 | 2023 | | Operating expenses: | | | | Research and development expenses | $11,202,414 | $10,210,926 | | General and administrative expenses | $4,116,019 | $4,461,331 | | Amortization of intangible assets | $7,317 | $7,317 | | Total operating expenses | $15,325,750 | $14,679,574 | | Operating loss | $(15,325,750) | $(14,679,574) | | Other income (expense): | | | | Interest income | $804,884 | $831,274 | | Other income, net | $213,037 | $244,129 | | Net loss | $(14,307,829) | $(13,604,171) | | Net loss attributable to common stockholders per share, basic and diluted | $(0.49) | $(0.51) | | Weighted-average common shares outstanding, basic and diluted | 29,370,357 | 26,442,216 | | Other comprehensive loss: | | | | Unrealized gain (loss) on marketable securities | $(306) | $30,626 | | Comprehensive loss | $(14,308,135) | $(13,573,545) | Condensed Consolidated Balance Sheets This section provides the unaudited condensed consolidated balance sheets as of March 31, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets | | March 31, 2024 | | December 31, 2023 | | 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