Immuneering (US:IMRX)2025-08-13 20:25Financial Performance - Net loss for the six months ended June 30, 2025, was $29.48 million, compared to a net loss of $28.39 million for the same period in 2024, indicating an increase in loss of about 3.8%[21] - The Company incurred a net loss of $29.5 million for the six months ended June 30, 2025, with an accumulated deficit of $253.8 million as of the same date[36] - The company reported a net loss of approximately $29.5 million for the six months ended June 30, 2025, and approximately $61.0 million for the year ended December 31, 2024[109] - The company recognized a net loss of $14,433,881 for the three months ended June 30, 2025, compared to a net loss of $14,079,927 for the same period in 2024[92] - The basic and diluted net loss per share for the three months ended June 30, 2025, was $(0.40), compared to $(0.47) for the same period in 2024, reflecting a 14.9% improvement[67] - The company expects to continue incurring significant net losses for the foreseeable future, with no revenue generated from product sales to date[176] Cash and Liquidity - Cash and cash equivalents decreased from $36.14 million at the beginning of the period to $26.36 million at the end of the period, a reduction of approximately 27%[26] - As of June 30, 2025, the Company had approximately $26.1 million in cash equivalents, down from $35.9 million as of December 31, 2024[56][59] - As of June 30, 2025, the company had approximately $26.4 million in cash and cash equivalents[109] - Existing cash and cash equivalents as of June 30, 2025, are expected to fund development activities into 2026, but additional capital will be needed thereafter[148] - The company anticipates that its existing cash and cash equivalents will fund operations into 2026, but significant reductions in spending may be necessary if additional funding is not secured[158] - As of June 30, 2025, the company had $26.4 million in cash and cash equivalents, which may not be sufficient to support operations for at least one year from the issuance of the financial statements[181] Share Issuance and Capital Raising - The company issued 4,836,804 shares of common stock under an at-the-market offering, raising approximately $13.67 million net of issuance costs[23] - The Company completed an underwritten follow-on equity offering on April 20, 2023, raising net proceeds of $28.2 million from the sale of 2,727,273 shares at an offering price of $11.00 per share[34] - The company sold 4,836,804 shares under its ATM Program at an average price of $2.95, generating gross proceeds of $14.2 million during the six months ended June 30, 2025[33] - The company sold 4,836,804 shares of common stock under the ATM Program for aggregate gross proceeds of $14.2 million during the six months ended June 30, 2025[145] - The company may need to raise additional capital through public or private equity offerings, which could dilute existing stockholders[187] Research and Development - The company is developing its lead product candidate, atebimetinib, which is currently in a Phase 1/2a clinical trial targeting advanced solid tumors with RAS or RAF mutations[28] - Research and development expenses for the three months ended June 30, 2025, were $10.45 million, slightly down from $10.65 million in the same period of 2024, a decrease of about 1.8%[21] - Research and development expenses for the six months ended June 30, 2025, increased by approximately $0.1 million, or 0.3%, to approximately $21.9 million compared to the same period in 2024[137] - Direct research and development expenses for atebimetinib (IMM-1-104) increased by $1.4 million, or 35.8%, to $5.2 million for the three months ended June 30, 2025[131] - The company plans to initiate a registrational trial for atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026, pending regulatory feedback[102] Regulatory and Clinical Trials - The FDA cleared the IND application for the product candidate IMM-6-415 in December 2023, with dosing commencing in a Phase 1/2a clinical trial in March 2024[103] - The company paused further patient enrollment in the IMM-6-415 trial in February 2025 to evaluate data from the 120 mg dose level[104] - The company is conducting an ongoing Phase 1/2a clinical trial for its product candidate atebimetinib for the treatment of advanced solid tumors[176] - The company expects to provide updated overall survival and progression-free survival data from the Phase 2a trial in the third quarter of 2025[102] - The company entered into a clinical supply agreement with Regeneron Pharmaceuticals for atebimetinib in combination with Libtayo in February 2025[99] Going Concern and Financial Risks - The Company has incurred recurring losses since inception and has substantial doubt about its ability to continue as a going concern for a period of one year from the issuance date of the financial statements[37] - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern, necessitating additional funding to support operations[182] - The company raised substantial doubt about its ability to continue as a going concern for at least one year from the issuance date of the financial statements[150][176] - The company expects to continue generating operating losses and will require additional funding through various means to remain operational[37] - The company may face challenges in obtaining additional funding due to macroeconomic conditions, which could adversely affect its financial condition[187] Operating Expenses - Total operating expenses for the six months ended June 30, 2025, were $30.24 million, nearly unchanged from $30.24 million in the same period of 2024[21] - Total operating expenses for the three months ended June 30, 2025, were $14.757 million, a decrease of 1.0% compared to $14.913 million for the same period in 2024[130] - General and administrative expenses increased by approximately $42 thousand, or 1.0%, to approximately $4.3 million for the three months ended June 30, 2025, compared to approximately $4.3 million for the same period in 2024[132] Interest Income - The company reported interest income of $324,013 for the three months ended June 30, 2025, down from $826,104 in the same period of 2024, a decrease of approximately 60%[21] - Interest income for the three months ended June 30, 2025, was $324,000, a decrease of 60.8% from $826,000 in 2024[130] - Interest income decreased by approximately $0.5 million for the three months ended June 30, 2025, primarily due to lower interest rates and a lower total cash balance[134] Asset Management - Total assets decreased from $52.71 million on December 31, 2024, to $40.06 million on June 30, 2025, representing a decline of approximately 24%[19] - As of June 30, 2025, the net property and equipment amounted to $964,138, a decrease of 14.1% from $1,122,865 as of December 31, 2024[60] - Total accrued expenses as of June 30, 2025, were $4,514,960, a decrease of 9.2% from $4,973,129 as of December 31, 2024[61] Stock-Based Compensation - Stock-based compensation expense for the six months ended June 30, 2025, was $3.22 million, compared to $3.14 million in the same period of 2024, an increase of about 2.6%[26] - The company recognized stock-based compensation expense of $1,524,943 during the three months ended June 30, 2025, a decrease of 8.2% from $1,661,749 in the same period of 2024[79] - The total incremental non-cash stock-based compensation expense due to option repricing was $0.6 million, with $0.2 million recognized during the three months ended June 30, 2025[76] Future Outlook - The company expects to continue incurring significant losses, with future net losses depending on the growth rate of expenses and revenue generation capabilities[177] - The company plans to mitigate funding risks by raising additional capital through equity or debt financings and potential collaborations[158] - The company anticipates significant commercialization expenses if any product candidates receive marketing approval[183] - The company may face significant delays in obtaining marketing approvals, which could harm the commercial prospects of its product candidates[210]