IMRX 8-K
Immuneering Corp (IMRX)
8-K
2025-08-13
For: 2025-08-13
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Added on
April 07, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
__________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 13, 2025
__________________________________
(Exact name of Registrant as Specified in Its Charter)
__________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of principal executive offices) (Zip Code)
(617 ) 500-8080
(Registrant’s telephone number, include area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On August 13, 2025, Immuneering Corporation (the “Company”) announced its financial results for the quarter ended June 30, 2025 and provided operational updates. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).
The information in this Item 2.02 of this Current Report, including Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
The following exhibits relate to Item 2.02, which shall be deemed to be furnished, and not filed:
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| IMMUNEERING CORPORATION | ||||||||
Date: August 13, 2025 | By: | /s/ Benjamin J. Zeskind | ||||||
| Name: Benjamin J. Zeskind, Ph.D. | ||||||||
| Title: Co-Founder, President, Chief Executive Officer and Director (Principal Executive Officer) | ||||||||
Exhibit 99.1
Immuneering Reports Second Quarter 2025 Financial Results and Provides Business Updates
- Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance -
- Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance -
- Exceptional 94% overall survival (OS) observed at 6 months in ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N = 34) -
- Newly issued U.S. composition of matter patent for atebimetinib expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension -
- Request for End of Phase 2 meeting has been submitted to the FDA;
pivotal trial expected to initiate in 2026 -
pivotal trial expected to initiate in 2026 -
CAMBRIDGE, Mass., August 13, 2025 - Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today reported financial results for the second quarter ended June 30, 2025, and provided several business updates.
“We are excited to announce updated OS and PFS data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the coming weeks. Last quarter we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our exceptional 6-month overall survival data in first-line pancreatic cancer patients is generating strong interest from leading pharmaceutical companies and top-tier investors, and we look forward to sharing the latest results.”
“We are busy preparing for our Phase 3 pivotal trial, and have now submitted our end of phase 2 meeting request to FDA. In addition, the granting of our composition of matter patent for atebimetinib by the United States Patent and Trademark Office (USPTO) was an important milestone for our company. We expect the long patent runway we are forging for atebimetinib will support our efforts to maximize its therapeutic potential across multiple indications” Zeskind concluded.
Corporate Highlights
•Reported Positive Overall Survival Data for Atebimetinib from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients: In June, Immuneering shared exceptional data from its ongoing Phase 2a trial of atebimetinib in combination with modified mGnP in first-line pancreatic cancer. The company reported that 94% OS and 72% PFS were observed at 6 months (n=34; patients treated at the 320 mg once-daily dose of atebimetinib), with median OS and PFS not yet reached. A markedly favorable tolerability profile was also observed. All results were reported using a data cutoff date of May 26, 2025. Subject to regulatory feedback, the company plans to initiate a pivotal trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026.
•Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the company was granted a composition of matter patent for atebimetinib by the USPTO, which is expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension. The patent is the first granted in the U.S. for a deep cyclic inhibitor, a once-daily pill that aims to drive longer-lasting benefit by outpacing resistance mechanisms that cause cancer drugs to stop working. Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into 2044.
•Third-Line Pancreatic Cancer Patient Passes 18-month Mark on Atebimetinib Monotherapy: Today, Immuneering is providing an update on a pancreatic cancer patient in the third-line setting who has received atebimetinib monotherapy for more than 18 months as a participant in the company’s Phase 1 trial and who remains on treatment. The patient – who previously experienced disease progression on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on atebimetinib monotherapy at 240 mg once daily and has maintained a partial response, including a 34% reduction in target lesions (RECIST sum of longest diameters) for a confirmed partial response, and a 96% reduction in peak CA 19-9 levels. Treatment continued to be well tolerated by the patient, with a ~16% weight gain observed.
Near-Term Milestone Expectations
Immuneering is planning for several near-term milestones related to atebimetinib, including to:
•Announce updated OS and PFS data from first-line pancreatic cancer patients (n = 34) treated with atebimetinib + mGnP in Q3 2025
•Receive regulatory feedback on pivotal study plans in Q4 2025
•Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
•Initiate additional atebimetinib clinical trial combination arms in 2026
Second Quarter 2025 Financial Highlights
Cash Position: Cash and cash equivalents as of June 30, 2025 were $26.4 million, compared with $36.1 million as of December 31, 2024.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2025 were $10.5 million, compared with $10.7 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily attributable to decreases in spend for preclinical programs, decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, offset by higher clinical costs related to the Company’s lead atebimetinib program.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2025 were $4.3 million, compared with $4.3 million for the quarter ended June 30, 2024. The second quarter of 2025 costs were consistent with the comparable prior period.
Net Loss: Net loss attributable to common stockholders was $14.4 million, or $0.40 per share, for the quarter ended June 30, 2025, compared to $14.1 million, or $0.47 per share, for the quarter ended June 30, 2024.
2025 Financial Guidance
Based on cash and cash equivalents as of June 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.
About Immuneering Corporation
Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. The Company’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer; the treatment potential of our pipeline product candidates in other types of cancer; the plans and objectives of Company management for future operations, including with respect to the timing, planning, enrollment and execution of additional atebimetinib combination trials and a potential pivotal trial of atebimetinib in combination with mGnP; the timing for release of additional results from the Phase 2a portion of the atebimetinib trial; the timing and substance of regulatory feedback on pivotal trial plans; expectations regarding our cash runway; the expected expiration of our issued and pending patents and additional planned patent applications, including the U.S. composition of matter patent covering atebimetinib; our ability to obtain patent term extension on our U.S. composition of matter patent; and our expectations for a long patent runway we are forging for atebimetinib will support our efforts to maximize its full therapeutic potential, extending to many different cancer types and combinations.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Media Contact:
Gina Nugent
Investor Contact:
Laurence Watts
619-916-7620
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development | $ | 10,454,160 | $ | 10,651,958 | $ | 21,925,852 | $ | 21,854,372 | |||||||||||||||
| General and administrative | 4,296,417 | 4,254,473 | 8,302,059 | 8,370,493 | |||||||||||||||||||
| Amortization of intangible asset | 7,317 | 7,317 | 14,633 | 14,633 | |||||||||||||||||||
| Total operating expenses | 14,757,894 | 14,913,748 | 30,242,544 | 30,239,498 | |||||||||||||||||||
| Loss from operations | (14,757,894) | (14,913,748) | (30,242,544) | (30,239,498) | |||||||||||||||||||
| Other income (expense) | |||||||||||||||||||||||
| Interest income | 324,013 | 826,104 | 762,532 | 1,630,988 | |||||||||||||||||||
| Other income, net | — | 7,717 | — | 220,754 | |||||||||||||||||||
| Net loss | $ | (14,433,881) | $ | (14,079,927) | $ | (29,480,012) | $ | (28,387,756) | |||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.40) | $ | (0.47) | $ | (0.82) | $ | (0.96) | |||||||||||||||
| Weighted-average common shares outstanding, basic and diluted | 35,985,878 | 29,653,355 | 35,759,026 | 29,511,856 | |||||||||||||||||||
| Other comprehensive loss: | |||||||||||||||||||||||
| Unrealized loss from marketable securities | — | 1,084 | — | 778 | |||||||||||||||||||
| Comprehensive Loss | $ | (14,433,881) | $ | (14,078,843) | $ | (29,480,012) | $ | (28,386,978) | |||||||||||||||
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| June 30, 2025 | December 31, 2024 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 26,355,498 | $ | 36,144,720 | |||||||
| Prepaids and other current assets | 1,369,928 | 3,442,849 | |||||||||
| Total current assets | 27,725,426 | 39,587,569 | |||||||||
| Property and equipment, net | 964,138 | 1,122,865 | |||||||||
| Goodwill | 6,690,431 | 6,690,431 | |||||||||
| Intangible asset, net | 335,780 | 350,413 | |||||||||
| Right-of-use assets, net | 3,498,967 | 3,667,352 | |||||||||
| Other assets | 841,726 | 1,295,783 | |||||||||
| Total assets | $ | 40,056,468 | $ | 52,714,413 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 2,395,203 | $ | 1,958,536 | |||||||
| Accrued expenses | 4,514,960 | 4,973,129 | |||||||||
| Other liabilities | 209,708 | 233,665 | |||||||||
| Lease liabilities | 366,959 | 338,438 | |||||||||
| Total current liabilities | 7,486,830 | 7,503,768 | |||||||||
| Long-term liabilities: | |||||||||||
| Lease liabilities, net of current portion | 3,633,601 | 3,824,419 | |||||||||
| Total liabilities | 11,120,431 | 11,328,187 | |||||||||
| Commitments and contingencies | |||||||||||
| Stockholders’ equity: | |||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2025 and December 31, 2024; 0 shares issued or outstanding at June 30, 2025 and December 31, 2024 | — | — | |||||||||
Class A common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2025 and December 31, 2024; 35,987,306 and 31,050,448 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 35,987 | 31,050 | |||||||||
Class B common stock, $0.001 par value, 20,000,000 shares authorized at June 30, 2025 and December 31, 2024; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024 | — | — | |||||||||
| Additional paid-in capital | 282,675,249 | 265,650,362 | |||||||||
| Accumulated deficit | (253,775,199) | (224,295,186) | |||||||||
| Total stockholders' equity | 28,936,037 | 41,386,226 | |||||||||
| Total liabilities and stockholders' equity | $ | 40,056,468 | $ | 52,714,413 | |||||||