Full Press Release Details
Immuneering Reports Third Quarter 2021 Financial Results and Recent Business Highlights
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., November 9, 2021- 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
Key Development Highlights
Third Quarter 2021 Financial Highlights
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. Immuneering's 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. Immuneering's 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 Immuneering's expectations regarding the sufficiency of Immuneering's 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 Immuneering's ability to advance its pipeline and further diversify its portfolio. 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 undertakes no duty to update such information except as required under applicable law.
Rebecca Kusko, Ph.D.
Immuneering Corporation
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 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 expenses | ||||||||||||
| Research and development | 6,207,486 | 4,069,037 | 18,590,471 | 10,113,291 | ||||||||
| General and administrative | 2,598,940 | 698,760 | 5,123,361 | 1,972,171 | ||||||||
| Total operating expenses | 8,806,426 | 4,767,797 | 23,713,832 | 12,085,462 | ||||||||
| Loss from operations | (8,543,384) | (4,400,229) | (22,770,314) | (11,246,099) | ||||||||
| 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 per share attributable to common stockholders, basic and diluted | $ | (0.47) | $ | (0.89) | $ | (2.41) | $ | (2.26) | ||||
| Weighted-average common shares outstanding, basic and diluted | 18,286,352 | 4,950,129 | 9,445,862 | 4,950,129 | ||||||||
| Other comprehensive loss: | ||||||||||||
| Unrealized losses from marketable securities | (4,751) | - | (4,751) | - | ||||||||
| Comprehensive Loss | $ | (8,538,824) | $ | (4,399,079) | $ | (22,756,140) | $ | (11,203,961) |
IMMUNEERING CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2021 | December 31, 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 assets | 3,361,471 | 140,958 | ||||
| Total current assets | 153,310,816 | 37,731,219 | ||||
| Marketable securities, non-current | 10,098,616 | - | ||||
| Property 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, Convertible Preferred Stock and Stockholders' Deficit | ||||||
| Current 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, $0.001 par value, 0 and 6,032,183 shares authorized at September 30, 2021 and December 31, 2020, 0 and 3,619,292 shares issued and outstanding at September 30, 2021 and December 31, 2020 | - | 36,983,910 | ||||
| Series A preferred stock, $0.001 par value, 0 and 2,495,933 shares authorized at September 30, 2021 and December 31, 2020, 0 and 2,495,933 shares issued and outstanding at September 30, 2021 and December 31, 2020 | - | 21,119,940 | ||||
| Total convertible preferred stock | - | 58,103,850 | ||||
| Stockholders' deficit: | ||||||
| Preferred stock, $0.001 par value; 10,000,000 and 0 shares authorized at September 30, 2021 and December 31, 2020, respectively; No shares issued or outstanding | - | - | ||||
| Class A common stock, $0.001 par value, 200,000,000 and 22,026,200 shares authorized at September 30, 2021 and December 31, 2020 respectively; 25,938,064 and 4,950,129 shares issued and outstanding at September 30, 2021 and December 31, 2020 | 25,938 | 4,950 | ||||
| Class B common stock, $0.001 par value, 20,000,000 and 6,032,183 shares authorized at September 30, 2021 and December 31, 2020 respectively; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020 | - | - | ||||
| Additional paid-in capital | 206,761,467 | 3,251,240 | ||||
| Accumulated other comprehensive loss | (4,751) | - | ||||
| Accumulated deficit | (48,489,029) | (25,737,640) | ||||
| Total stockholders' equity (deficit) | 158,293,625 | (22,481,450) | ||||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 164,042,391 | $ | 38,423,018 |