8-K
Immunome Inc. (IMNM)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 12, 2021
Immunome, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39580 | 77-0694340 |
|---|---|---|
| (state or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
| 665 Stockton Drive, Suite 300 Exton, Pennsylvania | 19341 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (610) 321-3700
Not applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange<br> on which registered |
|---|---|---|
| Common Stock, $0.0001 par value per share | IMNM | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 | Results of Operations and Financial Condition. |
|---|
On May 12, 2021, Immunome, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2021. 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. |
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(d) Exhibits.
| Exhibit <br><br>No. | Description |
|---|---|
| 99.1 | Press Release dated May 12, 2021 (furnished herewith) |
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
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.<br><br> <br>President and Chief Executive Officer |
Dated: May 12, 2021
Exhibit 99.1
Immunome Reports First Quarter 2021 FinancialResults
- IMM-BCP-01: Selected antibody cocktail demonstratingneutralization of CDC SARS-CoV-2 “variants of concern” in preclinical testing, progressing towards IND filing -
- IMM-ONC-01: Advanced proprietary antibodyagainst IL-38, a novel innate immune checkpoint, into IND-enabling studies -
- Dennis Giesing, Ph.D. appointed as Chief DevelopmentOfficer and Corleen Roche appointed as Chief Financial Officer -
- Raised $27 million in gross proceeds in aprivate placement -
Exton,Pa., May 12, 2021 – Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell discovery engine platform to discover and develop first-in-class antibody therapeutics, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.
First Quarter and Subsequent Highlights
| · | IMM-BCP-001: In February 2021, Immunome announced that it discovered antibodies capable<br>of neutralizing multiple SARS-CoV-2 variants, including the South African Variant, in pseudovirus testing. In April 2021, the company<br>announced antibody selection for its IMM-BCP-01 cocktail and shared data showing that IMM-BCP-01 neutralizes CDC SARS-CoV-2 "Variants<br>of Concern" in preclinical testing. The cocktail was efficacious in Syrian hamsters infected with SARS-CoV-2 (USA-WA1/2020) in both<br>prophylactic and treatment schedules. Further, the cocktail neutralized South Africa and UK variants in live virus testing and Brazil<br>and California variants in pseudovirus testing. An Investigational New Drug (IND) filing for IMM-BCP-001 is planned for late 2Q/early<br>3Q 2021. |
|---|---|
| · | IMM-ONC-001: In March 2021, Immunome announced its proprietary antibody against IL-38<br>advanced into IND-enabling studies. Based on Immunome’s research findings, IL-38 functions as a novel innate immune checkpoint<br>that inhibits infiltration and pro-inflammatory activity of innate immune cells. The company’s analysis also suggests that IL-38<br>is over-expressed in certain tumors and is potentially linked to reduced infiltration of innate immune cells. Immunome anticipates filing<br>an IND for this product candidate in 2H 2021. |
| --- | --- |
| · | Appointed Dr. Dennis Giesing as Chief Development Officer and Corleen Roche as Chief FinancialOfficer. In March 2021, the company announced the appointment of Dennis Giesing, Ph.D. to the role of Chief Development Officer.<br>Dr. Giesing brings more than 35 years of pharmaceutical industry experience to Immunome and will be responsible for driving Immunome’s<br>programs into clinical development. In April 2021, Immunome announced that it appointed Corleen Roche as its Chief Financial<br>Officer. Ms. Roche is a highly accomplished CFO with over 30 years of industry experience to lead the company’s finance and<br>corporate strategy functions. |
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| · | Completed a $27 million private placement. In April 2021, the company announced a private<br>placement of its common stock for gross proceeds to Immunome of approximately $27 million, before deducting placement agent commissions<br>and other offering expenses. The company currently expects the proceeds from this private placement, together with its cash on hand, will<br>be sufficient to fund its operations through fiscal year 2022. |
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“I am thrilled with the significant progress that Immunome has made in the development of our product pipeline,” said Purnanand Sarma, Ph.D., President and CEO of Immunome. “We are excited to welcome Dr. Giesing and Ms. Roche to the Immunome team as we move towards becoming a clinical stage biopharmaceutical company.”
Financial Highlights
| · | Research and development (R&D) expenses: R&D expenses<br>for the three months ended March 31, 2021 were $2.0 million. |
|---|---|
| · | General and administrative (G&A) expenses: G&A<br>expenses for the three months ended March 31, 2021 were $1.9 million. |
| --- | --- |
| · | **Net loss:**Net loss for the three months ended 2021 was<br>$3.9 million. |
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| · | Cash and cash equivalents: As of March 31, 2021,<br>cash and cash equivalents totaled $36.3 million (excluding $27.0 million in proceeds from the private placement in April 2021). |
| --- | --- |
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 on 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 clinical and strategic plans, anticipated upcoming milestones for IMM-BCP-01 and IMM-ONC-01, including expectations regarding therapeutic potential and benefits thereof, and IND filings. Forward-looking statements may be identified by the words “anticipate,” believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “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; Immunome’s ability to execute on its strategy including with respect to the timing of its R&D efforts, IND filings, initiation of clinical studies and other anticipated milestones; the timing and effectiveness of any antibody therapeutics which may be developed by Immunome; Immunome’s ability to fund operations as anticipated; and the additional risks and uncertainties set forth more fully under the caption “Risk Factors” in Immunome’s 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.
Immunome Contact
Corleen Roche
Chief Financial Officer
Immunome, Inc.
investors@immunome.com
Investor Contact
Laurence Watts
Managing Director
Gilmartin, LLC
laurence@gilmartinir.com
Immunome Media Contact
Megan McGrath or Nick Chang
MacDougall
781-235-3060
mmcgrath@macbiocom.com or nchang@macbiocom.com
IMMUNOME, INC.
Condensed Statements of Operations
(Unaudited; In thousands, except share and pershare data)
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | |||||
| Operating expenses: | ||||||
| Research and development | $ | 1,979 | $ | 2,115 | ||
| General and administrative | 1,918 | 540 | ||||
| Total operating expenses | 3,897 | 2,655 | ||||
| Loss from operations | (3,897 | ) | (2,655 | ) | ||
| Interest expense, net | (1 | ) | (22 | ) | ||
| Net loss | $ | (3,898 | ) | $ | (2,677 | ) |
| Per share information: | ||||||
| Net loss per share of common stock, basic and diluted | $ | (0.37 | ) | $ | (2.44 | ) |
| Weighted-average common shares outstanding, basic and diluted | 10,640,870 | 1,099,270 |
IMMUNOME, INC.
Condensed Balance Sheets
(Unaudited; In thousands, except share data)
| March 31, 2021 | December 31, 2020 | |||||
|---|---|---|---|---|---|---|
| Assets | ||||||
| Current assets: | ||||||
| Cash | $ | 36,276 | $ | 39,766 | ||
| Prepaid expenses and other current assets | 4,831 | 3,128 | ||||
| Total current assets | 41,107 | 42,894 | ||||
| Property and equipment, net | 1,386 | 1,531 | ||||
| Restricted cash | 100 | 100 | ||||
| Total assets | $ | 42,593 | $ | 44,525 | ||
| Liabilities and stockholders’ equity | ||||||
| Current liabilities: | ||||||
| Current portion of long-term debt | $ | 366 | $ | 366 | ||
| Equipment loan payable | 78 | 113 | ||||
| Accounts payable | 2,958 | 1,187 | ||||
| Accrued expenses and other current liabilities | 1,169 | 1,372 | ||||
| Total current liabilities | 4,571 | 3,038 | ||||
| Long-term debt, net of current portion | 134 | 134 | ||||
| Deferred rent | 5 | 8 | ||||
| Total liabilities | 4,710 | 3,180 | ||||
| Stockholders’ equity: | ||||||
| Common stock | 1 | 1 | ||||
| Additional paid-in capital | 96,174 | 95,738 | ||||
| Accumulated deficit | (58,292 | ) | (54,394 | ) | ||
| Total stockholders’ equity | 37,883 | 41,345 | ||||
| Total liabilities and stockholders’ equity | $ | 42,593 | $ | 44,525 |