Full Press Release Details
Immuneering Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates
First patient dosed in Phase 1/2a clinical trial of IMM-1-104 in advanced solid tumors with any RAS mutation
Provides debut guidance for IMM-1-104 program: initial Phase 1 PK and safety data expected in mid-2023, initial Phase 1 PD modeling and additional PK and safety data expected in 2H 2023, recommended phase 2 dose and additional safety data expected in mid-2024
Continued progress in oncology pipeline - on track to file IND for IMM-6-415 in Q4 2023
Cash runway extended into Q4 2024; sharpened focus on oncology pipeline and suspension of discovery-stage neuroscience programs
Conference call and webcast today at 4:30 p.m. ET.
CAMBRIDGE, Mass., March 6, 2023 -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided recent business updates.
"2022 was a year of important progress towards our goal of creating impactful new medicines for cancer patients," said Ben Zeskind, Ph.D., MBA, Co-founder, and Chief Executive Officer of Immuneering. "IMM-1-104, the first and only MAPK pathway inhibitor with the potential for universal-RAS activity, entered the clinic as we dosed the first patient in our Phase 1/2a clinical trial in November, enrolling patients with advanced solid tumors harboring RAS mutations. With a unique and counterintuitive mechanism of deep cyclic inhibition, IMM-1-104 was designed to limit toxicity and maximize therapeutic activity by selectively targeting cancer cells based on their increased need for sustained MAPK pathway signaling, while sparing healthy cells which are less dependent on continuous pathway signaling. IMM-1-104 is being evaluated as an oral, once-daily monotherapy. Our goal is to provide newer and better treatment options for patients with tumors driven by any mutation in KRAS, NRAS, or HRAS."
Dr. Zeskind continued: "We are very pleased with the progress of our trial, which enables us today to provide debut guidance on when investors can expect to see initial data from our ongoing IMM-1-104 Phase 1/2a clinical trial. Currently, we plan to share (1) initial Phase 1 pharmacokinetic (PK)
and safety data in mid-2023, followed by (2) initial Phase 1 pharmacodynamic (PD) modeling and additional PK and safety data in the second half of 2023 and (3) the announcement of a recommended Phase 2 dose and additional safety data in mid-2024. We also plan to provide additional trial updates on a periodic basis. Because observing a unique PK profile in humans is a fundamental aspect of our counterintuitive deep cyclic inhibition mechanism, we believe these initial readouts could provide particularly impactful early validation for our approach and the potential universal-RAS activity of IMM-1-104. With our clinical trial rapidly advancing and continued progress accelerating IMM-6-415 toward an IND filing later this year, we have also taken the opportunity to sharpen our focus exclusively to oncology, by suspending our neuroscience programs. This change as well as other non-core adjustments extend our projected cash runway by an additional quarter, into Q4 2024."
Corporate Highlights
Near-Term Milestone Expectations
Fourth Quarter and Full Year 2022 Financial Highlights
2023 Financial Guidance
Immuneering will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on March 6, 2023, to discuss the results and provide a business and pipeline update. To access the call by phone, please use this registration link, and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. After the live webcast, the event will be archived for 90 days in the Investor Relations section of Immuneering's website at Events & Presentations.
About Immuneering Corporation
Immuneering is a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The company aims to achieve universal activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering's lead product candidate, IMM-1-104, is in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations. The company's development pipeline also includes IMM-6-415, our universal-MAPK inhibitor, as well as several early-stage programs. For more information, please visit www.immuneering.com.
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, current operating plans and cash runway, the treatment potential of IMM-1-104 and IMM-6-415, including estimates of the patient population that may ultimately benefit from treatment, statements regarding the design, enrollment and conduct of the Phase 1/2a clinical trial for IMM-1-104, the timing of initial Phase 1 PK and safety data, initial PD modeling data and additional PK and safety data, additional trial updates, recommended phase 2 dose and additional safety data, the ability of initial readouts to validate the company's therapeutic approach, the timing of submission of the IND for 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 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-K 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.
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IMMUNEERING CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended December 31 | Twelve Months Ended December 31 | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenue | $ | 456 | $ | 189,591 | $ | 316,952 | $ | 2,079,961 | ||||
| Cost of revenue | - | 206,221 | 158,122 | 1,153,073 | ||||||||
| Gross profit | 456 | (16,630) | 158,830 | 926,888 | ||||||||
| Operating expenses | ||||||||||||
| Research and development | 9,871,761 | 7,950,488 | 36,267,116 | 26,540,959 | ||||||||
| General and administrative | 4,106,385 | 3,148,637 | 15,606,529 | 8,271,998 | ||||||||
| Amortization of intangible asset | 7,317 | - | 30,053 | - | ||||||||
| Total operating expenses | 13,985,463 | 11,099,125 | 51,903,698 | 34,812,957 | ||||||||
| Loss from operations | (13,985,007) | (11,115,755) | (51,744,868) | (33,886,069) | ||||||||
| Other income (expense) | ||||||||||||
| Interest income | 516,167 | 142,885 | 1,014,456 | 169,899 | ||||||||
| Other income (expense) | 223,278 | (118,974) | 216,844 | (127,063) | ||||||||
| Loss before income taxes | (13,245,562) | (11,091,844) | (50,513,568) | (33,843,233) | ||||||||
| Income tax benefit | - | 307,485 | - | 307,485 | ||||||||
| Net loss | $ | (13,245,562) | $ | (10,784,359) | $ | (50,513,568) | $ | (33,535,748) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | (0.50) | (0.42) | (1.91) | (2.46) | ||||||||
| Weighted-average common shares outstanding, basic and diluted | 26,406,933 | 25,977,246 | 26,386,864 | 13,612,677 | ||||||||
| Other comprehensive loss: | ||||||||||||
| Unrealized losses from marketable securities | 112,353 | (44,258) | 18,889 | (49,009) | ||||||||
| Comprehensive Loss | $ | (13,133,209) | $ | (10,828,617) | $ | (50,494,679) | $ | (33,584,757) |
IMMUNEERING CORPORATION
CONSOLIDATED BALANCE SHEETS
| December 31, 2022 | December 31, 2021 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 72,636,886 | $ | 74,888,145 | ||
| Marketable securities, current | 32,887,970 | 74,311,203 | ||||
| Accounts receivable | 12,417 | 246,040 | ||||
| Prepaids and other current assets | 3,209,536 | 2,888,608 | ||||
| Total current assets | 108,746,809 | 152,333,996 | ||||
| Marketable securities, non-current | - | 996,560 | ||||
| Property and equipment, net | 1,369,608 | 807,223 | ||||
| Goodwill | 6,690,431 | 6,701,726 | ||||
| Intangible asset | 408,947 | 439,000 | ||||
| Right-of-use assets, net | 4,407,785 | 5,324,198 | ||||
| Other assets | 743,703 | 102,129 | ||||
| Total assets | $ | 122,367,283 | $ | 166,704,832 | ||
| Liabilities, convertible preferred stock and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 3,154,557 | $ | 1,394,340 | ||
| Accrued expenses | 4,500,993 | 3,965,447 | ||||
| Other liabilities, current | 19,796 | - | ||||
| Lease liabilities, current | 378,723 | 274,039 | ||||
| Total current liabilities | 8,054,069 | 5,633,826 | ||||
| Long-term liabilities: | ||||||
| Lease liabilities, non-current | 4,462,959 | 5,090,897 | ||||
| Total liabilities | 12,517,028 | 10,724,723 | ||||
| Commitments and contingencies (Note 13) | ||||||
| Stockholders' equity: | ||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2022 and December 31, 2021; No shares issued or outstanding | - | - | ||||
| Class A common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2022 and December 31, 2021; 26,418,732 and 26,320,199 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 26,419 | 26,320 | ||||
| Class B common stock, $0.001 par value, 20,000,000 shares authorized at December 31, 2022 and December 31, 2021; 0 shares issued and outstanding at December 31, 2022 and December 31, 2021 | - | - | ||||
| Additional paid-in capital | 219,640,912 | 215,276,186 | ||||
| Accumulated other comprehensive loss | (30,120) | (49,009) | ||||
| Accumulated deficit | (109,786,956) | (59,273,388) | ||||
| Total stockholders' equity | 109,850,255 | 155,980,109 | ||||
| Total liabilities, convertible preferred stock and stockholders' equity | $ | 122,367,283 | $ | 166,704,832 |