– IMM-BCP-01 Progressing Towards IND Filing –
EXTON, Pa.–(BUSINESS WIRE)–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 third quarter ended September 30, 2021 and provided a corporate update.
“We made significant progress in advancing our three-antibody cocktail to combat SARS-CoV-2, IMM-BCP-01, reporting additional activity against emerging variants, Lambda and Delta Plus. We now have demonstrated compelling neutralizing activity of IMM-BCP-01 in all of the variants of concern, as identified by the CDC, and look forward to submitting our IND this quarter and reporting topline data in the first half of 2022,” commented Purnanand Sarma, Ph.D., President and CEO of Immunome. “We continue to advance IMM-ONC-01, our novel innate immune checkpoint that targets IL-38, towards an IND submission that we expect in early 2022.”
Third Quarter and Subsequent Highlights
- Demonstrated Potent Neutralization Activity of IMM-BCP-01 Against SARS-CoV-2 Lambda and Delta Plus Variants. In September 2021, Immunome announced that its three-antibody cocktail (IMM-BCP-01) has demonstrated robust neutralizing activity against SARS-CoV-2 Lambda (C.37) and Delta AY.1/2 (Delta Plus) variants. Furthermore, IMM-BCP-01 has been shown to neutralize all of the Centers for Disease Control (CDC) variants of concern in preclinical testing*.
- Presented Data on Anti-IL38 Antibody Program at AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. In October 2021, Immunome presented an oral presentation of its anti-IL-38 monoclonal antibody that demonstrated the mAb inhibits tumor growth in two different murine syngeneic tumor models and induces protection following implantation of secondary tumors. Additionally, Immunome’s mAb binds to human IL-38 while inhibiting binding to its putative receptors, IL1RAPL1 and IL-36R, as well as inhibiting IL-38-mediated suppression of myeloid cell activity in vitro.
- Submitted Preclinical Research of IMM-BCP-01 Against SARS-CoV-2 for Publication in bioRxiv. In October 2021, Immunome announced its submission of a preprint manuscript on its preclinical findings of its antibody cocktail, IMM-BCP-01, to bioRxiv. The manuscript detailed IMM-BCP-01’s potent activation of phagocytosis and complement fixation, which is known to be a component of in vivo treatment efficacy, as well as potent efficacy in pseudovirus neutralization against the Delta variant of SARS-CoV-2*.
* Immunome received funding from 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), for these studies. (Contract number: W911QY-20-9-0019)
Financial Highlights
- Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2021 were $4.5 million.
- General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2021 were $3.2 million.
- Net loss: Net loss for the three months ended September 30, 2021 was $7.7 million.
- Cash and cash equivalents: As of ended September 30, 2021, cash and cash equivalents totaled $56.3 million.
About Immunome
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 oncology and COVID-19 therapeutic antibody programs, execution of its regulatory, clinical and strategic plans and anticipated upcoming milestones for IMM-BCP-01 and IMM-ONC-01. 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, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether the data will be published in a scientific journal and, if so, when and with what modifications; 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 governmental authority feedback regarding the same, initiation and completion of any clinical studies 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; Immunome’s ability to fund operations; 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 25, 2021, and elsewhere in Immunome’s 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.
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IMMUNOME, INC. |
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Condensed Statements of Operations |
||||||||||||||||
|
(Unaudited; In thousands, except share and per share data) |
||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ |
4,513 |
|
$ |
1,644 |
|
$ |
9,725 |
|
$ |
5,651 |
|
||||
| General and administrative |
3,210 |
|
1,174 |
|
7,635 |
|
2,537 |
|
||||||||
| Total operating expenses |
7,723 |
|
2,818 |
|
17,360 |
|
8,188 |
|
||||||||
| Loss from operations |
(7,723 |
) |
(2,818 |
) |
(17,360 |
) |
(8,188 |
) |
||||||||
| Change in fair value of warrant liability |
— |
|
(5,549 |
) |
— |
|
(5,549 |
) |
||||||||
| Other income |
6 |
|
— |
|
506 |
|
— |
|
||||||||
| Interest expense, net |
(3 |
) |
(10 |
) |
(5 |
) |
(27 |
) |
||||||||
| Net loss | $ |
(7,720 |
) |
$ |
(8,377 |
) |
$ |
(16,859 |
) |
$ |
(13,764 |
) |
||||
| Per share information: | ||||||||||||||||
| Net loss per share of common stock, basic and diluted | $ |
(0.65 |
) |
$ |
(7.52 |
) |
$ |
(1.49 |
) |
$ |
(12.44 |
) |
||||
| Weighted-average common shares outstanding, basic and diluted |
11,934,491 |
|
1,114,427 |
|
11,348,856 |
|
1,106,039 |
|
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IMMUNOME, INC. |
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|
Condensed Balance Sheets |
||||||||
|
(Unaudited; In thousands, except share data) |
||||||||
| September 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ |
56,243 |
|
$ |
39,766 |
|
||
| Prepaid expenses and other current assets |
4,947 |
|
3,128 |
|
||||
| Total current assets |
61,190 |
|
42,894 |
|
||||
| Property and equipment, net |
961 |
|
1,531 |
|
||||
| Restricted cash |
100 |
|
100 |
|
||||
| Deferred offering costs |
307 |
|
— |
|
||||
| Total assets | $ |
62,558 |
|
$ |
44,525 |
|
||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
3,277 |
|
$ |
1,187 |
|
||
| Accrued expenses and other current liabilities |
4,472 |
|
1,372 |
|
||||
| Equipment loan payable |
16 |
|
113 |
|
||||
| Current portion of long-term debt |
— |
|
366 |
|
||||
| Total current liabilities |
7,765 |
|
3,038 |
|
||||
| Long-term debt, net of current portion |
— |
|
134 |
|
||||
| Deferred rent |
— |
|
8 |
|
||||
| Total liabilities |
7,765 |
|
3,180 |
|
||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 12,093,333 and 10,634,245 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively |
1 |
|
1 |
|
||||
| Additional paid-in capital |
126,045 |
|
95,738 |
|
||||
| Accumulated deficit |
(71,253 |
) |
(54,394 |
) |
||||
| Total stockholders’ equity |
54,793 |
|
41,345 |
|
||||
| Total liabilities and stockholders’ equity | $ |
62,558 |
|
$ |
44,525 |
|
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Contacts
Immunome Contact
Corleen Roche
Chief Financial Officer
Immunome, Inc.
investors@immunome.com
Investor Contact
Laurence Watts
Managing Director
Gilmartin, LLC
laurence@gilmartinir.com