imrx-20250331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________________________________________

FORM 10-Q

_________________________________________________

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _____________ to

Commission File Number: 001-40675

_________________________________________________

Immuneering Corporation

(Exact name of registrant as specified in its charter)

_________________________________________________


Delaware			26-1976972
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification Number)

245 Main St.
Second Floor
Cambridge, MA			02142
(Address of Principal Executive Offices)			(Zip Code)

(617) 500-8080

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

_________________________________________________

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading symbol

Name of 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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of April 28, 2025 the registrant had 35,985,702 shares of Class A common stock, $0.001 par value per share, issued and outstanding and 0 shares of Class B common stock, $0.001 par value per share, issued and outstanding.

Table of Contents

TABLE OF CONTENTS


		Page
Part I	Financial Information	7

Item 1.	Financial Statements	7

	Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 (Unaudited)	7

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2025 and 2024 (Unaudited)	8

	Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024 (Unaudited)	9

	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (Unaudited)	10

	Notes to Condensed Consolidated Financial Statements (Unaudited)	11

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	32

Item 4.	Controls and Procedures	32

Part II	Other Information	33

Item 1.	Legal Proceedings	33

Item 1A.	Risk Factors	33

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	90

Item 3.	Defaults Upon Senior Securities	90

Item 4.	Mine Safety Disclosures	90

Item 5.	Other Information	90

Item 6.	Exhibits	91

Signatures		92

Table of Contents

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements including within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this Quarterly Report on Form 10-Q, including without limitation statements regarding our plans to develop, manufacture and commercialize our product candidates (including whether as potential monotherapies or in combination with other therapeutic agents), the design, timing, disclosure of data, or outcome of our ongoing or planned preclinical studies or clinical trials involving IMM-1-104, any of our other pipeline product candidates and any future product candidates, the clinical utility of our product candidates when administered alone or in combination with other therapeutic agents, the filing with, and approval by, regulatory authorities of our product candidates, the sufficiency of funds to operate the business of the Company and related expected cash runway, our ability to continue as a going concern and our plans regarding raising additional capital, are forward-looking statements.

The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from those projected in the forward-looking statements, including, but not limited to, those described in the sections of this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These risks and uncertainties include, but are not limited to:

•our limited operating history;

•our history of operating losses;

•our ability to continue as a going concern for a period of at least one year from the date of issuance of the financial statements appearing within this Quarterly Report on Form 10-Q and our future capital needs;

•our ability to raise the substantial additional capital that will be required to finance our operations;

•the difficulty of obtaining regulatory approval for any of our current or future product candidates;

•our ability to submit an Investigational New Drug application (“IND”), or IND amendments or comparable documents in foreign jurisdictions in order to commence clinical trials on the timelines we expect;

•our limited experience in designing and conducting clinical trials;

•the timing of the initiation, progress and potential results of our ongoing and planned preclinical studies and clinical trials and our research programs, including our Phase 1/2a clinical trial of IMM-1-104;

•our ability to successfully complete our clinical trials, including our Phase 1/2a clinical trial of IMM-1-104;

•the risk of substantial delays in completing, if at all, the development and commercialization of our current or future product candidates;

•risks related to adverse events, toxicities or other undesirable side effects caused by our current or future product candidates;

•the risk of delays or difficulties in the enrollment and/or maintenance of patients in clinical trials;

•our substantial reliance on the successful development of our current and future product candidates, as well as our platform, including our proprietary technologies;

•risks related to competition in our industry;

Table of Contents

•the market opportunity for our product candidates, if approved;

•risks related to manufacturing;

•risks related to our reliance on third parties;

•risks related to our intellectual property;

•risks related to ongoing and future pandemics, or other widespread adverse health events; and

•other important risk factors that could affect the outcome of the events set forth in these statements and that could affect our operating results and financial condition described in Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Unless otherwise stated or the context requires otherwise, references to “Immuneering,” the “Company,” “we,” “us,” and “our,” refer to Immuneering Corporation and its subsidiaries.

Table of Contents

Risk Factors Summary

We are subject to numerous risks and uncertainties, including those further described below in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q, that represent challenges that we face in connection with the successful implementation of our strategy and the growth of our business. In particular, the following are principal factors that may offset our competitive strengths or have a negative effect on our business strategy, which could materially adversely affect our business, financial conditions, results of operations, future growth prospects, or cause a decline in the price of our common stock:

•We are a clinical-stage oncology company with a limited operating history in developing pharmaceutical products, have not completed any clinical trials and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.

•We have incurred significant net losses for the past several years and we expect to continue to incur significant net losses for the foreseeable future and may never obtain profitability.

•We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.

•We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.

•The regulatory approval processes of the U.S. Food and Drug Administration ("FDA") and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable with respect to outcomes. If we are ultimately unable to obtain regulatory approval for our product candidates, or to obtain regulatory approval to treat the indications we seek to treat with our product candidates, we will be unable to generate product revenue or the level of planned product revenue and our business will be substantially harmed.

•We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

•The outcome of preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities.

•Our current or future product candidates may cause adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could inhibit regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.

•We are early in our development efforts. Our business is substantially dependent on the successful development of our current and future product candidates. If we are unable to advance our current or future product candidates through clinical trials, obtain marketing approval to treat the indications that we seek to treat with our product candidates, and ultimately commercialize any product candidates we develop, or experience significant delays in doing so, our business will be materially harmed.

•We are substantially dependent on our platform, including our proprietary technologies, which are supported by our information technology systems. Any failure of these or other elements of our platform will materially harm our business.

•Our long-term prospects depend in part upon discovering, developing and commercializing product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.

•Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and expand our Disease Cancelling Technology ("DCT") platform and capabilities to build a pipeline of product candidates with commercial value.

•We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.

Table of Contents

•We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted.

•We substantially rely, and expect to continue to rely, on third parties, including independent clinical investigators and contract research organizations ("CROs"), to conduct certain aspects of our preclinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.

•We contract with third parties, including contract manufacturing organizations ("CMOs") and consultants, for the manufacture of our product candidates for preclinical studies and clinical trials, and expect to continue to do so for commercialization of any approved product candidate. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or drugs or be able to acquire such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

•The manufacture of drugs is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.

•If we are unable to obtain and maintain patent and/or other intellectual property protection for our product candidates and technologies, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully develop and commercialize our product candidates, products (if any) and technology may be impaired, and we may not be able to compete effectively in our market.

•Acquisitions, joint ventures or other transactions involving third parties could disrupt our business, cause dilution to our stockholders and otherwise harm our business.

Table of Contents

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

IMMUNEERING CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)


	March 31, 2025		December 31, 2024

Assets
Current assets:
Cash and cash equivalents	$	35,865,696	$	36,144,720


Prepaids and other current assets	2,340,459		3,442,849
Total current assets	38,206,155		39,587,569


Property and equipment, net	1,046,549		1,122,865
Goodwill	6,690,431		6,690,431
Intangible asset, net	343,097		350,413
Right-of-use assets, net	3,584,170		3,667,352
Other assets	810,895		1,295,783
Total assets	$	50,681,297	$	52,714,413

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	1,310,565	$	1,958,536
Accrued expenses	3,388,562		4,973,129
Other liabilities	56,531		233,665
Lease liabilities	352,521		338,438
Total current liabilities	5,108,179		7,503,768

Long-term liabilities:
Lease liabilities, net of current portion	3,730,198		3,824,419
Total liabilities	8,838,377		11,328,187
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; 0 shares issued or outstanding at March 31, 2025 and December 31, 2024	—		—
Class A common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2025 and December 31, 2024; 35,985,702 and 31,050,448 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively	35,985		31,050
Class B common stock, $0.001 par value, 20,000,000 shares authorized at March 31, 2025 and December 31, 2024; 0 shares issued and outstanding at March 31, 2025 and December 31, 2024	—		—
Additional paid-in capital	281,148,253		265,650,362

Accumulated deficit	(239,341,318)		(224,295,186)
Total stockholders' equity	41,842,920		41,386,226
Total liabilities and stockholders' equity	$	50,681,297	$	52,714,413

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

Table of Contents

IMMUNEERING CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)


	Three Months Ended March 31,
	2025		2024

Operating expenses
Research and development	$	11,471,693	$	11,202,414
General and administrative	4,005,642		4,116,019
Amortization of intangible asset	7,317		7,317
Total operating expenses	15,484,652		15,325,750
Loss from operations	(15,484,652)		(15,325,750)

Other income (expense)
Interest income	438,520		804,884
Other income, net	—		213,037
Net loss	$	(15,046,132)	$	(14,307,829)

Net loss per share attributable to common stockholders, basic and diluted	$	(0.42)	$	(0.49)
Weighted-average common shares outstanding, basic and diluted	35,529,652		29,370,357

Other comprehensive loss:
Unrealized loss from marketable securities	—		(306)
Comprehensive Loss	$	(15,046,132)	$	(14,308,135)

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

Table of Contents

IMMUNEERING CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)



	Class A Common Stock		Class B Common Stock					Additional Paid-In Capital	Accumulated Other Comprehensive Loss			Accumulated Deficit		Total Stockholders' Equity
		Shares		Par Value			Shares				Par Value

Balance at December 31, 2024			31,050,448		$	31,050		—	$	—		$	265,650,362	$	—	$	(224,295,186)	$	41,386,226

Issuance of common stock under at-the-market offering, net of issuance costs			4,836,804		4,837			—	—			13,671,830		—		—		13,676,667
Issuance of common stock through employee stock purchase plan			98,450		98			—	—			133,794		—		—		133,892
Stock-based compensation expense			—		—			—	—			1,692,267		—		—		1,692,267
Net loss			—		—			—	—			—		—		(15,046,132)		(15,046,132)

Balance at March 31, 2025			35,985,702		$	35,985		—	$	—		$	281,148,253	$	—	$	(239,341,318)	$

SEC Form 10-Q filed by Immuneering Corporation