Immuneering (IMRX) - 2023 Q4 - Annual Results

Immuneering Fourth Quarter and Full Year 2023 Financial Results and Business Updates Corporate Highlights and Business Updates Immuneering reported significant progress in its clinical programs during 2023 and early 2024, including upcoming topline data for IMM-1-104 and initiation of IMM-6-415 dosing IMM-1-104 Program Updates The IMM-1-104 program is rapidly advancing with expected Phase 1 topline data, expanded Phase 2a trials, and FDA Fast Track designation - Topline data from the Phase 1 portion of the Phase 1/2a trial is anticipated in March 2024, which will include data on tolerability, recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and initial clinical activity[1][4] - The Phase 2a portion of the trial was expanded to include 5 arms, evaluating IMM-1-104 as a monotherapy in approximately 90 patients across pancreatic cancer (PDAC), melanoma, and non-small cell lung cancer (NSCLC), and in combination therapy for approximately 60 PDAC patients[4][5] - In February 2024, the U.S. FDA granted Fast Track Designation for IMM-1-104 for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment[1][5] - In June 2023, the company completed dose escalation for the Phase 1 portion, observing that doses up to 320 mg once daily were tolerated with no dose-limiting toxicities[5] IMM-6-415 Program Updates Immuneering is initiating the IMM-6-415 Phase 1/2a trial in March 2024, supported by promising preclinical data in MAPK-driven tumors - The first patient in the Phase 1/2a clinical trial of IMM-6-415 is expected to be dosed in March 2024[1][5] - The Phase 1 portion will evaluate safety, tolerability, PK, and PD to identify a candidate for the recommended Phase 2 dose (RP2D), potentially enrolling up to 60 patients. The Phase 2a dose expansion is planned for approximately 180 patients[5] - Preclinical data presented in October 2023 demonstrated high sensitivity in various MAPK-driven tumors and showed that IMM-6-415 in combination with encorafenib drove deeper regressions than the combination of binimetinib plus encorafenib in animal models[5] Near-Term Milestone Expectations The company anticipates key milestones in 2024, including topline data for IMM-1-104 and first patient dosing for IMM-6-415 - IMM-1-104: - Topline data from Phase 1 portion expected in March 2024 - First patient in Phase 2a portion expected to be dosed in March 2024 - Initial data from multiple Phase 2a arms expected in 2024[7] - IMM-6-415: - First patient in the Phase 1 portion of the Phase 1/2a trial expected to be dosed in March 2024[7] Fourth Quarter and Full Year 2023 Financial Highlights Immuneering's 2023 financial results show decreased cash, increased expenses, and a higher net loss, despite a $30 million offering - In April 2023, the company raised $30 million ($28.2 million net proceeds) through an underwritten offering of its Class A common stock[9] Cash, Cash Equivalents, and Marketable Securities | Metric | Dec 31, 2023 (in millions) | Dec 31, 2022 (in millions) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $85.7 | $105.5 | Operating Expenses | Expense Category | Q4 2023 (in millions) | Q4 2022 (in millions) | Full Year 2023 (in millions) | Full Year 2022 (in millions) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $11.9 | $9.9 | $41.6 | $36.3 | | G&A Expenses | $4.4 | $4.1 | $16.8 | $15.6 | Net Loss and Per Share Data | Metric | Q4 2023 (in millions) | Q4 2022 (in millions) | Full Year 2023 (in millions) | Full Year 2022 (in millions) | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $15.1 | $13.2 | $53.5 | $50.5 | | Net Loss Per Share ($) | $0.52 | $0.50 | $1.88 | $1.91 | 2024 Financial Guidance Immuneering projects its current financial resources will fund operations into the second half of 2025 - The company expects its cash runway to be sufficient to fund operations into the second half of 2025[11] Financial Statements The consolidated financial statements detail Immuneering's financial position, showing a net loss and changes in assets and equity Consolidated Statements of Operations and Comprehensive Loss Immuneering's 2023 operations show no revenue, increased expenses, and a net loss of $53.5 million, or $1.88 per share Consolidated Statements of Operations and Comprehensive Loss | (in thousands, except per share data) | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $317 | | Total operating expenses | $58,413 | $51,904 | | Loss from operations | ($58,413) | ($51,745) | | Net loss | ($53,472) | ($50,514) | | Net loss per share | ($1.88) | ($1.91) | Consolidated Balance Sheets Immuneering's balance sheet as of December 31, 2023, shows decreased total assets and stockholders' equity, primarily due to reduced cash Consolidated Balance Sheets | (in thousands) | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $59,406 | $72,637 | | Marketable securities, current | $26,260 | $32,888 | | Total current assets | $89,084 | $108,747 | | Total assets | $102,585 | $122,367 | | Liabilities & Equity | | | | Total current liabilities | $7,846 | $8,054 | | Total liabilities | $12,008 | $12,517 | | Total stockholders' equity | $90,576 | $109,850 |