Full Press Release Details
Immunome Reports Fourth Quarter and Full Year 2021 Financial Results
Receives Safe-to-Proceed Notification from U.S. FDA for IMM-BCP-01 Investigational New Drug Application
Continues to Progress IMM-BCP-01 Towards Phase 1b Clinical Trial -
Progress on Oncology Pipeline, Including Lead Program Targeting IL-38, a Novel Innate Immunome Checkpoint -
Exton, PA - March 28,
2022 - Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover
and develop first-in-class antibody therapeutics, today reported financial results for the fourth quarter ended December 31, 2021 and
provided a corporate update.
"There remains a clear
need for safe and efficacious antibody treatments against COVID-19, especially those less susceptible to mutational drift. We believe
our three-antibody cocktail, IMM-BCP-01, has strong potential to address that unmet need. We are pleased the FDA has given us a safe-to-proceed
notification and lifted the clinical hold for our Investigational New Drug (IND) application," stated Purnanand Sarma, Ph.D., President
and CEO of Immunome.
"Additionally, we continue
to progress IMM-ONC-01, our novel, IL-38-targeting innate immune checkpoint inhibitor, towards an IND submission in the second half of
2022," Sarma continued. "Our preclinical work is ongoing, and we have analyzed IL-38 expression across nearly 60 tumor subtypes
and we have confirmed a high frequency of expression in difficult to treat cancers, such as head and neck squamous cell carcinoma, gastroesophageal
squamous carcinoma, and squamous lung carcinoma."
Fourth Quarter and Subsequent
This investigational work was
funded by the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).
Financial Highlights
Immunome is a biopharmaceutical company that utilizes its proprietary
human memory B cell platform to discover and develop first-in-class antibody therapeutics that are designed to change the way diseases
are treated. The company's initial focus is developing therapeutics to treat oncology and infectious diseases, including COVID-19.
Immunome's proprietary discovery engine identifies novel therapeutic antibodies and their targets by leveraging the highly educated
components of the immune system, memory B cells, from patients whose bodies have learned to fight off their disease. For more information,
please visit www.immunome.com.
Forward-Looking Statements
This press release includes certain disclosures that contain
"forward-looking statements" intended to qualify for the "safe harbor" from liability established by the
Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding
Immunome's beliefs and expectations regarding the advancement of its platform and programs, execution of its regulatory,
research, clinical and strategic plans and anticipated upcoming milestones for its platform and programs, including expectations
regarding, among other things, the timing and results of its preclinical studies and clinical trials, clinical plans, general
regulatory actions, the translation of preclinical data into clinical safety and efficacy, the therapeutic potential and benefits of
our product candidates, the possible need and demand for its product candidates and other statements that are not historical fact.
Forward-looking statements may be identified by the words "anticipate," "believe," "estimate,"
"expect," "intend," "plan," "project," "suggest," "may,"
"will," "could," "should," "seek," "potential" and similar expressions.
Forward-looking statements are based on Immunome'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, those
risks and uncertainties associated with: the impact of the COVID-19 pandemic on Immunome's business, operations, strategy,
goals and anticipated milestones; the fact that research and development data are subject to differing interpretations and
assessments; Immunome's ability to execute on its strategy, including with respect to its R&D efforts, IND submissions and
other regulatory filings, timing of these filings and the timing and nature of governmental authority feedback regarding the same,
initiation and completion of any clinical studies, confirmatory testing and other anticipated milestones as and when anticipated;
the effectiveness of Immunome's product candidates, including the possibility that further preclinical data and any clinical
trial data may be inconsistent with the data used for advancing the product candidates and that further variants of concern could
emerge; Immunome's ability to fund operations and raise capital; Immunome's reliance on vendors; the competitive
landscape; and the additional risks and uncertainties set forth more fully under the caption "Risk Factors" in
Immunome's Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) on March 28, 2022,
and elsewhere in Immunome's other filings and reports with the SEC. Forward-looking statements contained in this announcement
are made as of this date, and Immunome undertakes no duty to publicly update or revise any forward looking statements, whether as a
result of new information, future events or otherwise, except as may be required under applicable law. In this press release, we may
discuss our current and potential future product candidates that have not yet undergone clinical trials or been approved for
marketing by the U.S. Food and Drug Administration or other governmental authority, including expectations about their therapeutic
potential and benefits thereof. No representation is made as to the safety or effectiveness of these current or potential future
product candidates for the use for which such product candidates are being studied.
(in thousands, except share and per share amounts)
| December 31, | |||||||||
| 2021 | 2020 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 49,229 | $ | 39,766 | |||||
| Prepaid expenses and other current assets | 7,409 | 3,128 | |||||||
| Total current assets | 56,638 | 42,894 | |||||||
| Property and equipment, net | 855 | 1,531 | |||||||
| Restricted cash | 100 | 100 | |||||||
| Deferred offering costs | 332 | - | |||||||
| Total assets | $ | 57,925 | $ | 44,525 | |||||
| Liabilities, convertible preferred stock, and stockholders' equity (deficit) | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 3,077 | $ | 1 ,187 | |||||
| Accrued expenses and other current liabilities | 6,651 | 1,372 | |||||||
| Current portion of long-term debt | - | 366 | |||||||
| Current portion of equipment loan payable | - | 113 | |||||||
| Total current liabilities | 9,728 | 3,038 | |||||||
| Equipment loan payable, net of current portion | - | ||||||||
| Long-term debt, net of current portion | - | 134 | |||||||
| Deferred rent | 12 | 8 | |||||||
| Total liabilities | 9,740 | 3,180 | |||||||
| Commitments and contingencies (Note 8) | |||||||||
| Stockholders' equity (deficit): | |||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or | |||||||||
| outstanding at December 31, 2021 and December 31, 2020 | - | - | |||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 12,110,373 shares issued | |||||||||
| and outstanding at December 31, 2021 and 10,634,245 shares issued and outstanding at | |||||||||
| December 31, 2020 | 1 | 1 | |||||||
| Additional paid-in capital | 127,289 | 95,738 | |||||||
| Accumulated deficit | (79,105 | ) | (54,394 | ) | |||||
| Total stockholders' equity (deficit) | 48,185 | 41,345 | |||||||
| Total liabilities, convertible preferred stock, and stockholders' equity (deficit) | $ | 57,925 | $ | 44,525 |
Statements of operations
except share and per share amounts)
| Year ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 14,110 | $ | 7,486 | ||||
| General and administrative | 11,094 | 4,775 | ||||||
| Total operating expenses | 25,204 | 12,261 | ||||||
| Loss from operations | (25,204 | ) | (12,261 | ) | ||||
| Other income (expenses): | ||||||||
| Change in fair value of warrant liability | - | (5,538 | ) | |||||
| Other income | 503 | - | ||||||
| Interest expense, net | (10 | ) | (38 | ) | ||||
| Total other expenses | 493 | (5,576 | ) | |||||
| Net loss | $ | (24,711 | ) | $ | (17,837 | ) | ||
| Per share information: | ||||||||
| Net loss per common share, basic and diluted | $ | (2.14 | ) | $ | (5.26 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 11,538,668 | 3,389,592 |
Chief Financial Officer
LifeSci Communications