On November 13, 2024 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, reported financial results for the third quarter ended September 30, 2024, and provided business updates (Press release, Immuneering, NOV 13, 2024, View Source [SID1234648247]).

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"We were extremely pleased to share positive initial response data in September for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in pancreatic cancer as part of the ongoing Phase 2a clinical trial," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "While still early, it is highly encouraging to already see responses – including a complete response – as well as impressive disease control, both at levels that would represent a meaningful improvement over the existing standard of care. If these results continue, we believe we will have a clear path forward for clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer. Importantly, our recent Fast Track and Orphan Drug designations from the FDA may help advance development of this potentially important new therapy for the treatment of pancreatic cancer. With enrollment progressing well in our Phase 2a arms, we expect to share further data by year end and we look forward to providing updates on our progress at that time."

Corporate Highlights

FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer: In October 2024, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to IMM-1-104 in the treatment of pancreatic cancer.
Positive Initial Phase 2a Data Including Complete and Partial Responses with IMM-1-104 in Combination with Chemotherapy in First-Line Pancreatic Cancer Patients: In September 2024, Immuneering announced positive initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of its ongoing Phase 2a clinical trial. If the early trends with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel continue, management believes there is a clear path forward for clinical development of IMM-1-104 in pancreatic cancer, which has the potential to improve the prognosis for a drastically underserved patient population.
FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer: In July 2024, the FDA granted Fast Track designation for IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC).
Near-Term Milestone Expectations

IMM-1-104

Initial data from at least one additional arm of the Phase 2a portion of the Company’s Phase 1/2a trial is expected by year end.
IMM-6-415

Initial PK, PD and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial is expected by year end.
Third Quarter 2024 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2024 were $50.7 million, compared with $85.7 million as of December 31, 2023. The September 30, 2024 figure includes $4.2 million of net proceeds from the Company’s ATM facility.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were $11.3 million, compared with $10.1 million for the third quarter of 2023. The increase in R&D expenses was primarily attributable to higher clinical costs related to the Company’s lead program and increased personnel to support ongoing research and development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2024 were $4.0 million, compared with $3.9 million for the third quarter of 2023. The increase in G&A expenses was primarily attributable to an increase in the Company’s stock-based compensation costs and employee-related costs in connection with general and administrative functions.

Net Loss: Net loss attributable to common stockholders was $14.6 million, or $0.49 per share, for the third quarter ended September 30, 2024, compared to $12.6 million, or $0.43 per share, for the third quarter ended September 30, 2023.

2024 Financial Guidance

Based on cash, cash equivalents and marketable securities as of September 30, 2024, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into the fourth quarter of 2025.