GlobeNewswire Inc | Nov 9, 2021 06:30AM EST

November 09, 2021

Successfully completed upsized initial public offering raising $129.4 million in gross proceeds, providing runway into 2024

Company expects to file IND for IMM-1-104 in Q1 2022

CAMBRIDGE, Mass., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company advancing a robust pipeline of oncology and neuroscience product candidates that are designed to uniquely disrupt cellular signaling dynamics, today reported financial results for the third quarter ended September 30, 2021 and provided recent business highlights.

We made notable progress in the third quarter, including completing our IPO, and are well-funded to support the continued development of our robust pipeline of oncology and neuroscience drug programs. In the near term, we anticipate filing our Investigational New Drug (IND) application for IMM-1-104, our dual-MEK inhibitor, targeting RAS mutant tumors, in the first quarter of 2022, said Ben Zeskind, Ph.D., MBA, chief executive officer of Immuneering Corporation.

Corporate Highlights

-- IMM-1-104 Preclinical Data Presented at EORTC 2021: Immuneering presented data from three posters showcasing IMM-1-104 at the recent AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics that took place virtually from October 7-10, 2021. The study authors concluded that IMM-1-104 displayed broad activity across a wide range of animal tumor models with diverse RAS and RAF mutations including KRAS-G12C, KRAS-G12D, KRAS-G12S, NRAS-Q61R, and BRAF-V600E. In addition, IMM-1-104 prompted tumor regressions similar to sotorasib in a KRAS-G12C mutant pancreatic xenograft model (MIA PaCa-2) and led to deeper durable tumor regressions in combination with sotorasib when compared to either drug alone. Transcriptomic data that was presented confirmed IMM-1-104s deep cyclic inhibition by demonstrating strong MAPK pathway inhibition at two hours post-treatment, with a near complete release at 12 hours post-treatment. Through its short half-life, IMM-1-104 observes an encouraging tolerability profile across animal models that may provide differentiation from FDA-approved MEK inhibitors. A replay of all three presentations can be accessed at: www.immuneering.com/publications. -- Company Held Its First Key Opinion Leader Event: Immuneering held its first key opinion leader event titled Better Medicines for MEK, RAS and Beyond Through Signaling Dynamics on October 12, 2021 where participating key experts reviewed the RAS mutant tumor treatment landscape and noted the need for development of therapies outside of the KRAS-G12C mutant tumor setting. A replay of the event can be accessed at: https://ir.immuneering.com/news-events/events-presentations. -- Completed Initial Public Offering: On August 3, 2021, Immuneering announced the closing of its upsized initial public offering of 8,625,000 shares of Class A common stock, including the full exercise by the underwriters of their overallotment option to purchase 1,125,000 shares of Class A common stock, at a public offering price of $15.00 per share, for total gross proceeds of approximately $129.4 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Immuneering. -- Strengthened Leadership Team and Board of Directors: Immuneering strengthened its management team with the appointment of Michael Bookman as the companys General Counsel and Secretary in July 2021. Immuneering also appointed Ann Berman to its board of directors in July 2021.

Key Development Highlights

-- IMM-1-104 IND submission expected in Q1 2022: Immuneering expects to file the IND for IMM-1-104 in Q1 2022 and expects to initiate its Phase 1 trial evaluating IMM-1-104 in 1H 2022. IMM-1-104 is a highly selective dual-MEK inhibitor that has been designed to overcome MAPK-feedback loops and exhibits deep cyclic inhibition through its targeted potency and short half-life. As a result, Immuneering believes IMM-1-104 has the potential to become an important new treatment option for advanced solid tumors in patients with a broad spectrum of mutations in genes, such as KRAS and NRAS, that activate the MAPK pathway.

Third Quarter 2021 Financial Highlights

-- Cash Position: Cash and cash equivalents and marketable securities as of September 30, 2021 were $159.6 million, compared with $37.1 million as of December31, 2020. -- Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $6.2 million, compared with $4.1 million for the third quarter of 2020. The increase in R&D expenses was primarily attributable to higher preclinical costs related to the Companys lead programs and increased personnel to support ongoing research and development activities. -- General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2021 were $2.6 million, compared with $0.7 million for the same period of 2020. The increase in G&A expenses was primarily attributable to an increase in headcount in our general and administrative functions to support the Companys business and to costs related to preparing for the Companys initial public offering. -- Net Loss: Net loss attributable to common stockholders was $8.5 million, or $0.47 per share, for the quarter ended September30, 2021, compared to $4.4 million, or $0.89 per share, for the quarter ended September 30, 2020.

About Immuneering Corporation

Immuneering is a biopharmaceutical company with an emerging pipeline focused on improving patient outcomes across a spectrum of debilitating oncologic and neurologic diseases by applying its deep knowledge of translational bioinformatics to every stage of the drug development process. Immuneering has more than a decade of experience in translational bioinformatics and generating insights into drug mechanisms of action and patient treatment responses. Building on this experience, Immuneering has developed a disease-agnostic platform that enables the company to utilize human data, novel biology and chemistry, and translational planning to create and advance its wholly owned pipeline. Immuneerings current development programs in oncology are focused on providing potential treatments for patients with solid tumors caused by mutations of oncologic signaling pathways, including the MAPK pathway. Immuneerings lead product candidate, IMM-1-104, is designed to be a highly selective dual-MEK inhibitor that further disrupts KSR for the treatment of advanced solid tumors in patients harboring RAS mutant tumors. Additionally, Immuneering has six other oncology programs in the discovery stage that are designed to target either the MAPK or mTOR pathway, and two neuroscience programs in the discovery stage.

Forward-Looking Statements

This press release includes certain disclosures that contain "forward-looking statements," including, without limitation, statements regarding Immuneerings expectations regarding the sufficiency of Immuneerings cash and cash equivalents and marketable securities, the treatment potential of IMM-1-104, the timing of submission of the IND and commencement of clinical trials for IMM-1-104 and Immuneerings ability to advance its pipeline and further diversify its portfolio. Forward-looking statements are based on Immuneerings current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology and neuroscience drug development, including target discovery, target validation, lead compound identification, lead compound optimization, preclinical studies and clinical trials. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in Immuneerings most recent Form 10-Q filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Immuneering undertakes no duty to update such information except as required under applicable law.

Corporate Contact:Rebecca Kusko, Ph.D.Immuneering Corporation617-500-8080rkusko@immuneering.com

Investor Contact:Anne Marie FieldsManaging DirectorRx Communications afields@rxir.com

IMMUNEERING CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended September30, Nine Months Ended September30, 2021 2020 2021 2020 Revenue $ 482,130 $ 682,570 $ 1,890,370 $ 1,646,455 Cost of revenue 219,088 315,002 946,852 807,092 Gross profit 263,042 367,568 943,518 839,363 Operating expensesResearch and 6,207,486 4,069,037 18,590,471 10,113,291 developmentGeneral and 2,598,940 698,760 5,123,361 1,972,171 administrativeTotal operating 8,806,426 4,767,797 23,713,832 12,085,462 expensesLoss from (8,543,384 ) (4,400,229 ) (22,770,314 ) (11,246,099 )operations Other income (expense)Interest income 17,400 1,150 27,014 42,138 Other expense (8,089 ) - (8,089 ) - Net loss $ (8,534,073 ) $ (4,399,079 ) $ (22,751,389 ) $ (11,203,961 ) Net loss pershareattributable tocommon $ (0.47 ) $ (0.89 ) $ (2.41 ) $ (2.26 )stockholders,basic anddilutedWeighted-averagecommon sharesoutstanding, 18,286,352 4,950,129 9,445,862 4,950,129 basic anddiluted Othercomprehensive loss:Unrealizedlosses from (4,751 ) ? (4,751 ) ? marketablesecuritiesComprehensive $ (8,538,824 ) $ (4,399,079 ) $ (22,756,140 ) $ (11,203,961 )Loss

IMMUNEERING CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

September30,2021 December31,2020 Assets Current assets: Cash and cash equivalents $ 106,927,550 $ 37,090,151 Marketable securities 42,550,420 ? Accounts receivable 471,375 500,110 Prepaids and other current 3,361,471 140,958 assetsTotal current assets 153,310,816 37,731,219 Marketable securities, 10,098,616 ? non-currentProperty and equipment, net 81,445 64,363 Right-of-use asset, net 537,181 613,103 Other assets 14,333 14,333 Total assets $ 164,042,391 $ 38,423,018 Liabilities, ConvertiblePreferred Stock and Stockholders' DeficitCurrent liabilities: Accounts payable $ 1,795,153 $ 1,480,537 Accrued expenses 3,388,853 698,992 Lease liability, current 82,795 76,322 Total current liabilities 5,266,801 2,255,851 Long-term liabilities: Lease liability, non-current 481,965 544,767 Total liabilities 5,748,766 2,800,618 Commitments and contingencies (Note 11)Convertible preferred stock: Series B preferred stock, $0.001par value, 0 and 6,032,183shares authorized at September30, 2021 and December 31, 2020, ? 36,983,910 0 and 3,619,292 shares issuedand outstanding atSeptember30,2021 andDecember31,2020Series A preferred stock, $0.001par value, 0 and 2,495,933shares authorized at September30, 2021 and December 31, 2020, ? 21,119,940 0 and 2,495,933 shares issuedand outstanding atSeptember30,2021 andDecember31,2020Total convertible preferred ? 58,103,850 stockStockholders? deficit: Preferred stock, $0.001 parvalue; 10,000,000 and 0 sharesauthorized at September 30, 2021 ? ? and December 31, 2020,respectively; No shares issuedor outstandingClass A common stock, $0.001 parvalue, 200,000,000 and22,026,200 shares authorized atSeptember 30, 2021 and December31, 2020 respectively; 25,938 4,950 25,938,064 and 4,950,129 sharesissued and outstanding atSeptember30,2021 andDecember31,2020Class B common stock, $0.001 parvalue, 20,000,000 and 6,032,183shares authorized at September30, 2021 and December 31, 2020 ? ? respectively; 0 shares issuedand outstanding atSeptember30,2021 andDecember31,2020Additional paid-in capital 206,761,467 3,251,240 Accumulated other comprehensive (4,751 ) ? lossAccumulated deficit (48,489,029 ) (25,737,640 )Total stockholders' equity 158,293,625 (22,481,450 )(deficit)Total liabilities, convertiblepreferred stock and $ 164,042,391 $ 38,423,018 stockholders' equity (deficit)