Immuneering Corporation (IMRX) Q3 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call highlights significant financial improvement, strong survival data for atebimetinib, and strategic partnerships with Eli Lilly and Regeneron, suggesting a positive outlook. Despite some vague management responses, the overall sentiment remains optimistic due to the promising clinical results and financial health.

Key Financial Performance

Cash and Cash Equivalents $227.6 million as of September 30, 2025, compared with $36.1 million as of December 31, 2024. This significant increase was due to three successful offerings in August and September, including a $25 million private placement, a $175 million underwritten offering of Class A common stock, and a $25 million private placement of Class A common stock to Sanofi.

Overall Survival Rate 86% overall survival at 9 months in 34 first-line pancreatic cancer patients treated with atebimetinib plus modified gemcitabine/nab-paclitaxel, with a 9-month median follow-up. This is a significant improvement compared to the standard of care, which reports approximately 47% overall survival in 9 months. The improvement is attributed to the effectiveness of atebimetinib in combination with chemotherapy.

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Operating Highlights

Atebimetinib in combination with FOLFIRINOX: Demonstrated remarkable outcomes in first-line pancreatic cancer patients, including unconfirmed complete responses and improved quality of life.

Atebimetinib in combination with gemcitabine/nab-paclitaxel: Reported extraordinary overall survival data with 86% survival at 9 months in 34 first-line pancreatic cancer patients.

Strategic investment from Sanofi: Secured $25 million investment as part of $225 million cumulative financing, extending cash runway into 2029.

Clinical supply agreements: Established agreements with Eli Lilly and Regeneron to evaluate atebimetinib in combination with other therapies, potentially expanding its market opportunity beyond pancreatic cancer.

Cash position: Improved significantly to $227.6 million as of September 30, 2025, compared to $36.1 million at the end of 2024.

Regulatory and trial preparations: Preparing for pivotal Phase III trial of atebimetinib in combination with gemcitabine/nab-paclitaxel in mid-2026.

Patent exclusivity: Granted U.S. composition of matter patent for atebimetinib, providing exclusivity into 2042 with potential extensions to 2044.

Pipeline expansion: Focused on demonstrating atebimetinib's combinability across various tumor types, including lung cancer, to broaden its application.

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Risk or Challenges

Regulatory Feedback and Approvals: The company is awaiting feedback from regulatory agencies for its pivotal trial of atebimetinib in combination with gemcitabine and nab-paclitaxel. Delays or unfavorable feedback could impact the trial timeline and strategic plans.

Clinical Trial Risks: The success of the Phase III trial of atebimetinib in combination with gemcitabine and nab-paclitaxel is critical. Any failure to achieve desired outcomes or unexpected adverse events could jeopardize the drug's approval and market potential.

Financial Sustainability: While the company has extended its cash runway into 2029, its operations are heavily reliant on the success of atebimetinib. Any setbacks in clinical trials or regulatory approvals could strain financial resources.

Market Competition: The oncology market is highly competitive, with numerous companies developing treatments for pancreatic and other cancers. Atebimetinib must demonstrate clear advantages in efficacy, safety, and tolerability to secure a competitive position.

Supply Chain and Partnerships: The company has entered into agreements with Eli Lilly and Regeneron for combination trials. Any disruptions in these partnerships or supply chain issues could delay trials and impact strategic objectives.

Patient Recruitment and Retention: The success of ongoing and future trials depends on the ability to recruit and retain suitable patients. Challenges in this area could delay trial timelines and data readouts.

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Guidance & Outlook

Phase III trial of atebimetinib in combination with gemcitabine and nab-paclitaxel: The company plans to begin dosing patients in mid-2026, pending regulatory feedback. This trial is focused on first-line pancreatic cancer patients.

Updated survival data for atebimetinib plus modified gemcitabine nab-paclitaxel: The company plans to report updated survival data in the first half of 2026, potentially at a major medical meeting.

Circulating tumor DNA data: Updated data on acquired alterations is expected to be announced in the second quarter of 2026 at a major scientific meeting.

Trial of atebimetinib in combination with Libtayo: The first patient is expected to be dosed in the second half of 2026. This trial focuses on non-small cell lung cancer.

Regulatory feedback: Feedback from regulatory agencies is expected in the fourth quarter of 2025 to prepare for the pivotal trial of atebimetinib in combination with gemcitabine and nab-paclitaxel.

Atebimetinib's market expansion: The company is exploring atebimetinib's combinability across various tumor types, including advanced lung cancer, potentially expanding its market opportunity.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:Are there opportunities for atebimetinib (atebi) in the adjuvant setting for PDAC based on new case studies and its clean safety profile?

A:The top priority is the first-line setting and the combination of atebimetinib with modified gemcitabine nab-paclitaxel, which showed 86% overall survival at 9 months. While adjuvant opportunities are being considered, no decisions have been made yet.

Q:Would you consider combining atebimetinib with 5-FU-based regimens given the new case studies and clean safety profile?

A:This is being considered, but the top priority remains the combination of atebimetinib with modified gemcitabine nab-paclitaxel in first-line pancreatic cancer due to its exciting overall survival data. The new case studies validate the potential for greater optionality in the future.

Q:Where does atebimetinib fit into the competitive landscape in PDAC?

A:Atebimetinib shows extraordinary overall survival data in the first-line setting, with 86% overall survival at 9 months, a 39-point separation from the standard of care. The company believes it is the front-runner in first-line pancreatic cancer due to its survival data and tolerability.

Q:Are there plans to share full data from the FOLFIRINOX combination cohort in the near term?

A:There are no current plans to share full data from the FOLFIRINOX combination cohort as the top priority remains first-line pancreatic cancer in combination with gemcitabine and nab-paclitaxel. However, the data shared so far validates the potential of combining with FOLFIRINOX.

Q:What are the plans for the study with Regeneron Libtayo and the collaboration with Lilly?

A:The study with Regeneron Libtayo in lung cancer is planned to dose the first patient in the second half of 2026. The collaboration with Lilly is more recent, and no guidance on timing has been provided yet. The two studies address different patient populations, with broad potential for atebimetinib combinations.

Q:What is the company funded for with its cash runway extending to 2029?

A:The company is funded to conduct the Phase III trial, studies in lung cancer, and advance its preclinical pipeline, including developing deep cyclic inhibitors against various oncology targets.

Q:What type of patients would be best suited for the combination of atebimetinib with FOLFIRI instead of gem/nab-pac?

A:Atebimetinib could help a broad set of first-line pancreatic cancer patients without the need for genetic testing. Its ability to block a wide variety of mutations in the MAP kinase pathway makes it suitable for many patients.

Q:How does the safety profile of atebimetinib translate into the durability of benefit?

A:Atebimetinib's ability to block resistance mechanisms and its pulsatile mechanism contribute to durability. It effectively blocks the MAP kinase pathway, making it hard for tumors to adapt, and its design mitigates resistance while maintaining tolerability.

Q:Review of Unclear Management Responses

A:Management avoided providing direct answers or clear guidance on the timing for sharing full data from the FOLFIRINOX combination cohort and the collaboration with Lilly. They also used vague language when discussing potential future opportunities for atebimetinib in the adjuvant setting and combinations with 5-FU-based regimens.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

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