Form 8-K
8-K — Immuneering Corp
Accession: 0001790340-26-000095
Filed: 2026-10-29
Period: 2026-10-29
CIK: 0001790340
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — imrx-20261029.htm (Primary)
EX-99.1 (imrx-20261029xexx991.htm)
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8-K
8-K (Primary)
Filename: imrx-20261029.htm · Sequence: 1
imrx-20261029
0001790340FALSE00017903402026-10-292026-10-29
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): October 29, 2026
__________________________________
Immuneering Corporation
(Exact name of Registrant as Specified in Its Charter)
__________________________________
Delaware 001-40675 26-1976972
(State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.)
245 Main St.
Second Floor
Cambridge, MA 02142
(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
Class A common stock, par value $0.001 per share IMRX The Nasdaq Global Market
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 October 29, 2026, Immuneering Corporation (the “Company”) announced its financial results for the quarter ended September 30, 2026 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
Press Release issued on October 29, 2026
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: October 29, 2026
By: /s/ Benjamin J. Zeskind
Name: Benjamin J. Zeskind, Ph.D.
Title: Co-Founder, President, Chief Executive Officer and Director (Principal Executive Officer)
EX-99.1
EX-99.1
Filename: imrx-20261029xexx991.htm · Sequence: 2
Document
Exhibit 99.1
Immuneering Reports Third Quarter 2026 Financial Results and Provides Business Updates
- Phase 2 pancreatic cancer follow-up extended as patients on atebimetinib combinations live longer than projected -
- Updated Phase 2 atebimetinib + mGnP pancreatic cancer data (N=55) expected in the first half of 2027 -
- Phase 3 MAPKeeper 301 enrollment ahead of schedule; enrollment target expanding from 510 to 570 patients; potential to accelerate current mid-2028 topline data guidance -
NEW YORK, NY, October 29, 2026 - Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the third quarter ended September 30, 2026, and provided business updates.
“We are thrilled to share that follow-up in our Phase 2 trial in first-line pancreatic cancer is being extended because patients are living longer than projected. We now plan to provide an update on topline data from the atebimetinib + mGnP arm of that trial in the first half of 2027. We are also excited to report that enrollment in our pivotal Phase 3 MAPKeeper 301 trial is ahead of schedule. This strong momentum enables us to expand the enrollment target and potentially accelerate our expected mid-2028 topline data readout. We have updated our cash runway guidance to the fourth quarter of 2028 to reflect our Phase 2 extension, accelerated and expanded Phase 3 enrollment, and commercial readiness activities,” said Ben Zeskind, Ph.D., CEO of Immuneering. “We are seeing growing recognition within the medical community of atebimetinib’s differentiated mechanism of action as demonstrated by the strong engagement with our presentations at recent medical meetings, including the 2026 AACR Conference on Pancreatic Cancer and ESMO Congress 2026. The 17.3 months median overall survival with excellent tolerability that we reported at ASCO is unprecedented among agents targeting this pathway, and we are excited to share updated clinical data in the first half of 2027.”
Corporate Highlights
•Phase 2 Pancreatic Cancer Trial Extended; Topline Data Update Expected in 1H 2027. The Company plans to share further data from the mGnP arm of its Phase 2 PDAC trial (N = 55) in 1H 2027. Follow-up has been extended as patients are living longer than projected.
•Phase 3 MAPKeeper 301 Enrollment Updated. Enrollment is ahead of schedule for Immuneering’s Phase 3 MAPKeeper 301 trial, enabling the Company to expand the trial to approximately 570 patients and potentially accelerate its current mid-2028 topline data readout guidance.
•Publication in Cancer Research Detailed Atebimetinib’s Unique Attributes as the First/Only Third Generation MEK Inhibitor, Including Broad, Durable Preclinical Activity and Favorable Tolerability Across RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition In October, atebimetinib was featured on the cover of Cancer Research in a paper entitled “Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF Bypass” and also described in a spotlight commentary entitled “MEKing Room: On the Quest for New Sources of Therapeutic Index in RAS/MAPK-Driven Cancers” both highlighting the Company’s publication in the same issue, which included data showing broad antitumor activity across KRAS-, NRAS-, and BRAF-mutant models, including colorectal, lung, and melanoma, by counteracting the RAF-mediated bypass signaling that has constrained other MEK inhibitors.
•Presented Data at the 2026 AACR Conference on Pancreatic Cancer Supporting Atebimetinib’s Mechanisms Designed to Extend Survival in Pancreatic Cancer. In September, the Company presented data showing that stable or increased weight was twice as common among pancreatic cancer patients in an atebimetinib + mGnP trial, compared to those in a benchmark study, and that patients with stable or increased weight at three months had significantly longer overall survival than patients who lost weight at three months.
•Presented MAPKeeper 301 Trial Design at ESMO Congress 2026. In October, Immuneering presented the design for its pivotal Phase 3 trial evaluating atebimetinib in combination with modified gemcitabine/nab-paclitaxel versus standard-of-care chemotherapy in first-line metastatic pancreatic cancer at ESMO.
Near-Term Milestone Expectations
Immuneering is planning for several near-term anticipated milestones, including:
•4Q 2026 (SITC): Preclinical data for atebimetinib in combination with anti-PD-1 in lung cancer to be shared at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
•4Q 2026: Dose the first patient in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in lung cancer, with a preliminary data readout expected in late-2027.
•1H 2027: Updated 1L PDAC Phase 2 atebimetinib + mGnP data (N=55).
•Mid-2027: Begin IND-enabling studies for our next DCI product candidate program.
•Late-2027: Preliminary data readout expected from Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in lung cancer.
•Mid-2028: Topline data readout from the MAPKeeper 301 trial.
Third Quarter 2026 Financial Highlights
Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2026 were $166.1 million, compared with $217.0 million as of December 31, 2025.
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $20.7 million, compared with $10.9 million for the third quarter of 2025. 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 2026 were $5.1 million, compared with $4.5 million for the third quarter of 2025. 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 $24.2 million, or $0.37 per share, for the third quarter ended September 30, 2026, compared to $15.0 million, or $0.38 per share, for the third quarter ended September 30, 2025.
Financial Guidance
Based on cash, cash equivalents and marketable securities as of September 30, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into the fourth quarter of 2028. The updated cash runway reflects the Phase 2 trial extension, accelerated and expanded Phase 3 enrollment, and commercial readiness activities.
About Immuneering Corporation
Immuneering is a late-stage clinical oncology company dedicated to keeping cancer patients alive and helping them thrive, with an initial focus on patients with RAS, RAF, and other MAPK-driven cancers. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications. The Company is conducting a global randomized pivotal trial, MAPKeeper 301, evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and preclinical 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: 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 and its potential to deliver overall survival with both durability and tolerability; expansion of the enrollment target enabling the Company to maintain or potentially accelerate the timing of the Phase 3 topline readout of the MAPKeeper 301 trial in mid-2028; the timing of a data update in the Phase 2a atebimetinib + mGnP trial in first-line pancreatic cancer; the timing of dosing and preliminary readout of the planned Phase 2 lung cancer trial; the timing of beginning IND-enabling studies in a second DCI program; our operating plans and anticipated cash runway, and the potential ability of the three design mechanisms of atebimetinib to shrink tumors durably, improve overall survival and overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients.
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: we are a late-stage clinical oncology company with a limited operating history and have not completed any registrational clinical trials; we have incurred significant losses, are not currently profitable and may never become profitable; limitations on our cash runway and potential increases in expenditures; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and changing regulatory standards, and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including the uncertainty of whether positive preclinical or early clinical efficacy and safety results are confirmed in later-stage trials, potential delays in activation of trial sites or enrollment of trial participants, 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 period ended September 30, 2026, 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.
Investor Contact:
Laurence Watts
New Street Investor Relations
laurence@newstreetir.com
Media Contact:
David Caouette
dcaouette@immuneering.com
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2026 2025 2026 2025
Operating expenses
Research and development $ 20,721,243 $ 10,867,983 $ 45,363,112 $ 32,793,835
General and administrative 5,059,459 4,505,406 14,738,398 12,807,465
Amortization of intangible asset 7,317 7,317 21,950 21,950
Total operating expenses 25,788,019 15,380,706 60,123,460 45,623,250
Loss from operations (25,788,019) (15,380,706) (60,123,460) (45,623,250)
Other income (expense)
Interest income 1,204,598 415,831 3,647,786 1,178,362
Other income, net 390,838 — 1,551,769 —
Net loss $ (24,192,583) $ (14,964,875) $ (54,923,905) $ (44,444,888)
Net loss per share attributable to common stockholders, basic and diluted $ (0.37) $ (0.38) $ (0.85) $ (1.20)
Weighted-average common shares outstanding, basic and diluted 64,714,194 39,670,095 64,690,275 37,077,041
Other comprehensive loss:
Unrealized loss from marketable securities (142,913) — (630,485) —
Comprehensive Loss $ (24,335,496) $ (14,964,875) $ (55,554,390) $ (44,444,888)
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, 2026 December 31, 2025
Assets
Current assets:
Cash and cash equivalents $ 58,226,805 $ 128,645,025
Marketable securities 87,178,645 44,186,244
Prepaids and other current assets 5,305,154 3,414,685
Total current assets 150,710,604 176,245,954
Marketable securities, non-current 20,712,253 44,183,186
Property and equipment, net 808,952 938,481
Goodwill 6,690,431 6,690,431
Intangible asset, net 299,197 321,147
Right-of-use assets 3,039,783 3,322,249
Other assets 299,827 283,562
Total assets $ 182,561,047 $ 231,985,010
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 2,758,219 $ 1,542,737
Accrued expenses 7,498,137 7,842,367
Other liabilities 89,419 291,513
Lease liabilities 445,496 397,104
Total current liabilities 10,791,271 10,073,721
Long-term liabilities:
Lease liabilities, net of current portion 3,089,079 3,427,321
Total liabilities 13,880,350 13,501,042
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2026 and December 31, 2025; 0 shares issued or outstanding at September 30, 2026 and December 31, 2025
— —
Class A common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2026 and December 31, 2025; 64,763,155 and 64,648,230 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively
64,763 64,648
Class B common stock, $0.001 par value, 20,000,000 shares authorized at September 30, 2026 and December 31, 2025; 0 shares issued and outstanding at September 30, 2026 and December 31, 2025
— —
Additional paid-in capital 504,409,076 498,658,072
Accumulated other comprehensive income (loss) (549,153) 81,332
Accumulated deficit (335,243,989) (280,320,084)
Total stockholders' equity 168,680,697 218,483,968
Total liabilities and stockholders' equity $ 182,561,047 $ 231,985,010
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Oct. 29, 2026
Cover [Abstract]
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration