Immunome Inc 8-K, filed Aug 5, 2022
Immunome Inc. (IMNM)
About this 8-K
Immunome Inc filed this 8-K on August 5, 2022.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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| Item 2.02 | Results of Operations and Financial Condition. |
On August 5, 2022, Immunome, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2022. A copy of the press release is furnished herewith as Exhibit 99.1.
The information furnished in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release dated August 5, 2022 (furnished herewith) | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| IMMUNOME, INC. | ||
| By: | /s/ Purnanand D. Sarma | |
| Purnanand D. Sarma, Ph.D. | ||
| President and Chief Executive Officer | ||
| Dated: August 5, 2022 |
Exhibit 99.1
Immunome Reports Second Quarter 2022 Financial Results
Exton, PA – August 5, 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 second quarter ended June 30, 2022 and provided a corporate update.
“The second quarter marked our transition into a clinical stage company, as we continue to dose patients in our Phase 1b study of our COVID-19 antibody cocktail, IMM-BCP-01,” stated Purnanand Sarma, Ph.D., President and CEO of Immunome. “We also presented data in the second quarter that demonstrated the retention of neutralizing activity against the BA.4/.5, and BA.2.12.1 subvariants of SARS CoV-2. We look forward to reporting topline results from our Phase 1b study of IMM-BCP-01 in the second half of this year.”
Dr. Sarma continued, “additionally, we continue to make strides with our lead oncology candidate, IMM-ONC-01. Through an extensive profiling assessment of IL-38 mRNA using a database1 of over 60 cancer subtypes, we concluded that IL-38 is overexpressed in multiple cancers of high clinical unmet need. We are excited to continue advancing IMM-ONC-01 towards IND submission, as we believe IL-38 represents a promising target in multiple tumor types.
Highlights
| · | IMM-BCP-01 Retains Neutralizing Activity Against Prevalent Omicron Subvariants, BA.4/.5 and BA.2.12.1 In July 2022, Immunome announced that its antibody cocktail retained activity against the BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing. Data recently published in the peer-reviewed journal Science Immunology provides a mechanistic basis for how IMM20253 binding, which is conserved across all variants to date including Omicron and its sub-lineages, neutralized SARS-CoV-2. |
| · | Initiation of Phase 1b Study of IMM-BCP-01 for the Treatment of COVID-19. In June 2022, Immunome announced the first patient had been enrolled in a clinical trial of IMM-BCP-01, a three-antibody cocktail for the treatment of SARS-CoV-2. Immunome currently expects to announce topline data in the second half of this year. |
| · | Research & Development Update on Lead Oncology Candidate Targeting IL-38. In May of 2022, Immunome announced updates to the ongoing development of its lead oncology program, IMM-ONC-01, specifically on mRNA expression profiling and collaboration with Fox Chase Cancer Center. |
1 Tempus RealWorld Data
Financial Highlights
| · | Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2022 were $5.7 million. | |
| · | General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2022 were $3.2 million. | |
| · | Net loss: Net loss for the three months ended 2022 was $8.9 million. | |
| · | Cash and cash equivalents: As of June 30, 2022, cash and cash equivalents totaled $34.6 million. |
The investigational work related to IMM-BCP-01 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).
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 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.
IMMUNOME, INC.
Condensed Balance Sheets
(In thousands, except share data)
(unaudited)
| June 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 34,649 | $ | 49,229 | ||||
| Prepaid expenses and other current assets | 2,949 | 7,409 | ||||||
| Total current assets | 37,598 | 56,638 | ||||||
| Property and equipment, net | 807 | 855 | ||||||
| Operating right-of-use asset, net | 182 | — | ||||||
| Restricted cash | 100 | 100 | ||||||
| Deferred offering costs | 332 | 332 | ||||||
| Total assets | $ | 39,019 | $ | 57,925 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,259 | $ | 3,077 | ||||
| Accrued expenses and other current liabilities | 3,359 | 6,651 | ||||||
| Total current liabilities | 8,618 | 9,728 | ||||||
| Other long-term liabilities | 124 | 12 | ||||||
| Total liabilities | 8,742 | 9,740 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at June 30, 2022 and December 31, 2021, respectively | — | — | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 12,127,385 and 12,110,373 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 129,958 | 127,289 | ||||||
| Accumulated deficit | (99,682 | ) | (79,105 | ) | ||||
| Total stockholders’ equity | 30,277 | 48,185 | ||||||
| Total liabilities and stockholders’ equity | $ | 39,019 | $ | 57,925 | ||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
IMMUNOME, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,717 | $ | 3,233 | $ | 13,795 | $ | 5,212 | ||||||||
| General and administrative | 3,209 | 2,507 | 6,785 | 4,425 | ||||||||||||
| Total operating expenses | 8,926 | 5,740 | 20,580 | 9,637 | ||||||||||||
| Loss from operations | (8,926 | ) | (5,740 | ) | (20,580 | ) | (9,637 | ) | ||||||||
| Other income | ¾ | 500 | ¾ | 500 | ||||||||||||
| Interest income (expense), net | 2 | (1 | ) | 3 | (2 | ) | ||||||||||
| Net loss | $ | (8,924 | ) | $ | (5,241 | ) | $ | (20,577 | ) | $ | (9,139 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.74 | ) | $ | (0.46 | ) | $ | (1.70 | ) | $ | (0.83 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 12,127,385 | 11,456,991 | 12,125,156 | 11,051,185 | ||||||||||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
Immunome Contact
Corleen Roche
Chief Financial Officer
Immunome, Inc.
investors@immunome.com
Investor Contact
Laurence Watts
Managing Director
Gilmartin, LLC
laurence@gilmartinir.com