Full Press Release Details
Immuneering Reports Second Quarter 2022 Financial Results and Recent Business Highlights
IND filing for IMM-1-104, which has displayed broad preclinical pan-KRAS/NRAS activity, expected this quarter; Enrollment of first patient in planned Phase 1/2a clinical trial expected in Q4 2022
IND filing for IMM-6-415, designed to sensitize resistant tumors to select immunotherapies, expected in 2023
Cash, cash equivalents and marketable securities of $128.1M is expected to provide cash runway into Q3 2024
CAMBRIDGE, Mass., August 10, 2022- Immuneering Corporation (NASDAQ: IMRX), a biopharmaceutical company using translational bioinformatics to advance a pipeline of product candidates designed to benefit large populations of patients with cancer and other diseases, today reported financial results for the second quarter ended June 30, 2022 and provided recent business highlights.
"We believe IMM-1-104 has great potential to benefit the many cancer patients with tumors driven by KRAS or NRAS mutations," said Ben Zeskind, Ph.D., MBA, chief executive officer of Immuneering Corporation. "We are thrilled to be gearing up to file our IND for IMM-1-104, which remains on track to be filed this quarter, and we expect to enroll the first patient in our planned Phase 1 clinical trial in the fourth quarter of 2022. To date, we have generated strong preclinical results across a broad range of animal tumor models including KRAS-G12C, KRAS-G12D, KRAS-G12S, KRAS-G12V, NRAS-Q61R, and BRAF-V600E mutations. This compelling preclinical data package demonstrates IMM-1-104's potential as a third generation MEK inhibitor to have broad activity that is independent of the specific mutation activating the MAPK pathway."
Corporate Highlights
Key Development Highlights
Second Quarter 2022 Financial Highlights
2022 Financial Guidance
About Immuneering Corporation
Immuneering aims to improve patient outcomes by advancing a pipeline of product candidates designed to benefit large populations of patients with cancer and other diseases, developed using its translational bioinformatics platform. 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-KRAS/NRAS activity that selectively impacts cancer cells to a greater extent than healthy cells. IMM-1-104 is designed to be a highly selective dual-MEK inhibitor that further disrupts KSR to modulate 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, moderate level of signaling sufficient 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 evaluating its MEK-io product candidate, IMM-6-415, in IND-enabling studies, and has five other oncology programs in the discovery stage that are designed to target components of the MAPK or mTOR pathway, as well as two discovery stage 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 sufficiency of Immuneering's cash, cash equivalents and marketable securities, its full year GAAP operating expenses for 2022, the treatment potential of IMM-1-104 and IMM-6-415, the timing of
submission of the IND and commencement of clinical trials for IMM-1-104 and IMM-6-415, 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 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
Rebecca Kusko, Ph.D.
Immuneering Corporation
S.A. Noonan Communications
IMMUNEERING CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenue | $ | 94,419 | $ | 660,040 | $ | 278,117 | $ | 1,408,240 | ||||
| Cost of revenue | 47,933 | 318,601 | 138,778 | 727,763 | ||||||||
| Gross profit | 46,486 | 341,439 | 139,339 | 680,477 | ||||||||
| Operating expenses | ||||||||||||
| Research and development | 7,981,075 | 6,991,965 | 17,031,517 | 12,382,985 | ||||||||
| General and administrative | 3,704,143 | 1,340,398 | 7,664,112 | 2,524,422 | ||||||||
| Amortization of intangible asset | 7,317 | - | 15,420 | - | ||||||||
| Total operating expenses | 11,692,535 | 8,332,363 | 24,711,049 | 14,907,407 | ||||||||
| Loss from operations | (11,646,049) | (7,990,924) | (24,571,710) | (14,226,930) | ||||||||
| Other income (expense) | ||||||||||||
| Interest income | 142,799 | 3,259 | 275,304 | 9,614 | ||||||||
| Other expense | (24,053) | - | (127,271) | - | ||||||||
| Net loss | $ | (11,527,303) | $ | (7,987,665) | $ | (24,423,677) | $ | (14,217,316) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.44) | $ | (1.61) | $ | (0.93) | $ | (2.87) | ||||
| Weighted-average common shares outstanding, basic and diluted | 26,386,343 | 4,954,553 | 26,372,787 | 4,952,352 | ||||||||
| Other comprehensive loss: | ||||||||||||
| Unrealized losses from marketable securities | (14,166) | - | (132,552) | - | ||||||||
| Comprehensive Loss | $ | (11,541,469) | $ | (7,987,665) | $ | (24,556,229) | $ | (14,217,316) |
IMMUNEERING CORPORATION
CONSOLIDATED BALANCE SHEETS
| June 30, 2022 | December 31, 2021 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 87,937,479 | $ | 74,888,145 | ||
| Marketable securities, current | 40,163,875 | 74,311,203 | ||||
| Accounts receivable | 178,425 | 246,040 | ||||
| Prepaids and other current assets | 890,409 | 2,888,608 | ||||
| Total current assets | 129,170,188 | 152,333,996 | ||||
| Marketable securities, non-current | - | 996,560 | ||||
| Property and equipment, net | 985,007 | 807,223 | ||||
| Goodwill | 6,690,431 | 6,701,726 | ||||
| Intangible asset | 423,580 | 439,000 | ||||
| Right-of-use assets, net | 4,691,157 | 5,324,198 | ||||
| Other assets | 89,579 | 102,129 | ||||
| Total assets | $ | 142,049,942 | $ | 166,704,832 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,240,241 | $ | 1,394,340 | ||
| Accrued expenses | 2,226,687 | 3,965,447 | ||||
| Other liabilities, current | 47,213 | - | ||||
| Lease liabilities, current | 286,374 | 274,039 | ||||
| Total current liabilities | 3,800,515 | 5,633,826 | ||||
| Long-term liabilities: | ||||||
| Other liabilities, non-current | 9,898 | - | ||||
| Lease liabilities, non-current | 4,644,683 | 5,090,897 | ||||
| Total liabilities | 8,455,096 | 10,724,723 | ||||
| Commitments and contingencies (Note 12) | ||||||
| Stockholders' equity: | ||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2022 and December 31, 2021, respectively; 0 shares issued or outstanding at June 30, 2022 and December 31, 2021 | - | - | ||||
| Class A common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 26,392,299 and 26,320,199 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 26,392 | 26,320 | ||||
| Class B common stock, $0.001 par value, 20,000,000 shares authorized at June 30, 2022 and December 31, 2021; 0 shares issued and outstanding at June 30, 2022 and December 31, 2021 | - | - | ||||
| Additional paid-in capital | 217,447,080 | 215,276,186 | ||||
| Accumulated other comprehensive loss | (181,561) | (49,009) | ||||
| Accumulated deficit | (83,697,065) | (59,273,388) | ||||
| Total stockholders' equity | 133,594,846 | 155,980,109 | ||||
| Total liabilities and stockholders' equity | $ | 142,049,942 | $ | 166,704,832 |