Recruiting has Commenced for Phase 1/2a Clinical Trial of IMM-1-104 in Advanced Solid Tumors with RAS Mutations (NCT05585320), with the First Patient Expected to be Dosed this Quarter
Shares Promising Preclinical Data on Second Program IMM-6-415 at the 37th Annual Meeting of SITC, Demonstrating Preclinical Single Agent Activity in RAF and RAS Mutant Tumors and Enhancement of PD1 and CTLA4 Checkpoint Blockade
Cash, Cash Equivalents and Marketable Securities of $117.2M is Expected to Provide Cash Runway into Q3 2024
CAMBRIDGE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company that aims to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events, today reported financial results for the third quarter ended September 30, 2022, and provided recent business highlights.
“The third quarter was a turning point for Immuneering as we submitted and cleared our first IND. Our Phase 1/2a trial for IMM-1-104 is now recruiting in what we believe is the first all-comers RAS clinical trial conducted to date,” said Ben Zeskind, Chief Executive Officer of Immuneering Corporation. “Cancer patients need new treatment options, regardless of the specific mutations in KRAS, NRAS, or HRAS that might be driving their tumors. IMM-1-104 has shown pan-RAS activity in preclinical studies with good tolerability. The conventional wisdom has been that a pan-RAS approach makes it difficult to avoid hitting wild-type RAS in healthy cells, but IMM-1-104’s novel deep cyclic inhibition mechanism aims to focus the therapeutic activity against RAS-driven malignant cells with the goal of largely sparing healthy cells.”
Dr. Zeskind continued, “Today, we also shared promising preclinical data on our second program IMM-6-415 at the 37th Annual Meeting of SITC. IMM-6-415 is designed to target RAF and RAS mutant tumors as monotherapy and enhance therapeutic activity in select drug-drug combinations, including checkpoint inhibitors. We are very encouraged by this data and look forward to completing ongoing IND-enabling studies and expect to submit an IND for IMM-6-415 in Q4 2023.”
Corporate Highlights
Key Development Highlights
Third Quarter 2022 Financial Highlights
2022 Financial Guidance
About Immuneering Corporation
Immuneering aims to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events. Immuneering has more than a decade of experience applying translational bioinformatics to generate insights into drug mechanism of action and patient treatment response. Building on this experience, Immuneering’s disease-agnostic discovery platform enables the company to create product candidates based on 1) biological insights that are both counterintuitive and deeply rooted in data, and 2) novel chemistry. Immuneering’s lead product candidate, IMM-1-104, aims to achieve pan-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells. IMM-1-104 is designed to be a highly selective third generation dual MEK inhibitor that modulates the signaling dynamics of the MAPK pathway by driving deep cyclic inhibition that deprives tumor cells of the sustained proliferative signaling required for rapid growth, while providing a cadenced, normalized level of signaling designed to spare healthy cells. IMM-1-104 is being developed to treat advanced solid tumors in patients harboring RAS mutations, and is translationally guided by Immuneering’s proprietary, human-aligned 3D tumor modeling platform combined with patient-aligned bioinformatics. In addition to IMM-1-104, Immuneering is currently evaluating IMM-6-415 in IND-enabling studies. The earlier Immuneering drug discovery pipeline includes five additional oncology programs as well as two neuroscience programs.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding Immuneering’s expectations regarding the treatment potential of IMM-1-104 and IMM-6-415, the timing of enrollment and dosing of the first patient in the Phase 1/2a clinical trial for IMM-1-104, the design, enrollment criteria and conduct of the Phase 1/2a clinical trial, the timing of submission of the IND and commencement of clinical trials for IMM-6-415, that the Phase 1/2a trial of IMM-1-104 is believed to be the first all-comers RAS trial conducted to date, statements regarding Immuneering’s financial guidance and Immuneering’s ability to advance its pipeline and further diversify its portfolio and make progress towards its longstanding goal of creating better medicines for cancer patients. Forward-looking statements are based on Immuneering’s 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 research and 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 Immuneering’s 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 Corporation
rkusko@immuneering.com
617-500-8080
Investor Contact:
Susan A. Noonan
S.A. Noonan Communications
susan@sanoonan.com
917-513-5303
IMMUNEERING CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue | $ | 38,380 | $ | 482,130 | $ | 316,497 | $ | 1,890,370 | ||||||||
Cost of revenue | 19,343 | 219,088 | 158,122 | 946,852 | ||||||||||||
Gross profit | 19,037 | 263,042 | 158,375 | 943,518 | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development | 9,363,838 | 6,207,486 | 26,395,355 | 18,590,471 | ||||||||||||
General and administrative | 3,836,032 | 2,598,940 | 11,500,144 | 5,123,361 | ||||||||||||
Amortization of intangible asset | 7,317 | — | 22,737 | — | ||||||||||||
Total operating expenses | 13,207,187 | 8,806,426 | 37,918,236 | 23,713,832 | ||||||||||||
Loss from operations | (13,188,150 | ) | (8,543,384 | ) | (37,759,861 | ) | (22,770,314 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Interest income | 222,985 | 17,400 | 498,288 | 27,014 | ||||||||||||
Other income (expense) | 120,835 | (8,089 | ) | (6,434 | ) | (8,089 | ) | |||||||||
Net loss | $ | (12,844,330 | ) | $ | (8,534,073 | ) | $ | (37,268,007 | ) | $ | (22,751,389 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.49 | ) | $ | (0.47 | ) | $ | (1.41 | ) | $ | (2.41 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 26,394,490 | 18,286,352 | 26,380,101 | 9,445,862 | ||||||||||||
Other comprehensive loss: | ||||||||||||||||
Unrealized gains/(losses) from marketable securities | 39,088 | (4,751 | ) | (93,464 | ) | (4,751 | ) | |||||||||
Comprehensive Loss | $ | (12,805,242 | ) | $ | (8,538,824 | ) | $ | (37,361,471 | ) | $ | (22,756,140 | ) |
IMMUNEERING CORPORATION
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, 2022 | December 31, 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 76,417,850 | $ | 74,888,145 | ||||
Marketable securities, current | 40,779,440 | 74,311,203 | ||||||
Accounts receivable | 70,180 | 246,040 | ||||||
Prepaids and other current assets | 2,757,220 | 2,888,608 | ||||||
Total current assets | 120,024,690 | 152,333,996 | ||||||
Marketable securities, non-current | — | 996,560 | ||||||
Property and equipment, net | 1,310,067 | 807,223 | ||||||
Goodwill | 6,690,431 | 6,701,726 | ||||||
Intangible asset | 416,263 | 439,000 | ||||||
Right-of-use assets, net | 4,512,883 | 5,324,198 | ||||||
Other assets | 737,293 | 102,129 | ||||||
Total assets | $ | 133,691,627 | $ | 166,704,832 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,338,380 | $ | 1,394,340 | ||||
Accrued expenses | 4,564,136 | 3,965,447 | ||||||
Other liabilities, current | 44,562 | — | ||||||
Lease liabilities, current | 308,694 | 274,039 | ||||||
Total current liabilities | 7,255,772 | 5,633,826 | ||||||
Long-term liabilities: | ||||||||
Lease liabilities, non-current | 4,542,653 | 5,090,897 | ||||||
Total liabilities | 11,798,425 | 10,724,723 | ||||||
Commitments and contingencies (Note 12) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2022 and December 31, 2021; 0 shares issued or outstanding at September 30, 2022 and December 31, 2021 | — | — | ||||||
Class A common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 26,404,732 and 26,320,199 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 26,405 | 26,320 | ||||||
Class B common stock, $0.001 par value, 20,000,000 shares authorized at September 30, 2022 and December 31, 2021; 0 shares issued and outstanding at September 30, 2022 and December 31, 2021 | — | — | ||||||
Additional paid-in capital | 218,550,665 | 215,276,186 | ||||||
Accumulated other comprehensive loss | (142,473 | ) | (49,009 | ) | ||||
Accumulated deficit | (96,541,395 | ) | (59,273,388 | ) | ||||
Total stockholders’ equity | 121,893,202 | 155,980,109 | ||||||
Total liabilities and stockholders’ equity | $ | 133,691,627 | $ | 166,704,832 |
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