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):
September 7, 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) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
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 Stock Market LLC |
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 8.01 | Other Events**.** |
|---|
On September 7, 2021, Immunome, Inc. (the “Company”) issued a press release announcing that its three antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Lambda and Delta Plus variants in pre-clinical pseudovirus testing. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated into this Item 8.01 by reference.
Cautionary Statement Regarding Forward-Looking Information
This current report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than those of historical fact in this current report on Form 8-K are forward-looking statements. Forward-looking statements may be identified by terminology such as “believe,” “anticipate,” “plan,” “may,” “intend,” “will,” “should,” “expect,” “estimate,” “potential” and “continue” and similar expressions, including the negative of these words, but not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, express or implied statements regarding the Company’s beliefs and expectations regarding the advancement of its COVID-19 therapeutic antibody programs, execution of its regulatory, clinical and strategic plans, anticipated upcoming milestones for IMM-BCP-01, including expectations regarding therapeutic potential and benefits thereof. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions applicable to Immunome and our industry in general 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 the Company’s business, operations, strategy, goals and anticipated milestones; the Company’s ability to execute on its strategy 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 of clinical studies and other anticipated milestones as and when anticipated; the effectiveness of the Company’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; the Company’s ability to fund operations; the Company’s reliance on vendors; the competitive landscape; and the additional risks and uncertainties set forth more fully under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) on March 25, 2021, and elsewhere in the Company’s filings and reports with the SEC. These risks, uncertainties and other factors may cause our actual results to differ materially and adversely from what is contained in (or may be implied from) any forward-looking statements. Forward-looking statements speak as of the date they are made, and the Company undertakes no obligation to update them except as may be required under applicable law.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit <br><br>No. | Description |
|---|---|
| 99.1 | Press Release dated September 7, 2021 |
| 104 | The cover page of 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/<br>Purnanand D. Sarma |
| Purnanand D. Sarma, Ph.D.<br><br> <br>President and Chief Executive Officer |
Dated: September 8, 2021
Exhibit99.1
ImmunomeAntibody Cocktail (IMM-BCP-01) Neutralizes SARS-CoV-2 Lambda and Delta Plus Variants in Pre-clinical Testing
-IMM-BCP-01 already shown to neutralize all other Center for Disease Control (CDC) variants of concern in pre-clinical testing -
Exton,PA – September 7, 2021 – Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced today that its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against SARS-CoV-2 Lambda (C.37) and Delta AY.1/2 (Delta Plus) variants, in pre-clinical testing conducted by Immunome on lentiviral-based pseudovirus. IMM-BCP-01 consists of three antibodies that bind to non-overlapping regions of the spike protein and show combinatorial activity against multiple strains of SARS-CoV-2.
“IMM-BCP-01 continues to demonstrate its broad neutralizing activity against emerging SARS-CoV-2 variants in preclinical testing, most recently against the Lambda and Delta plus variants. While the Delta lineage is the dominant strain in the U.S., the Lambda variant is rapidly spreading through South America, and is a designated variant of interest by World Health Organization (WHO). IMM-BCP-01 was designed to be resistant to SARS-CoV-2 variants, and we are delighted that our approach continues to be supported by our preclinical data,” said Purnanand Sarma, PhD, President & CEO of Immunome. “These results give us further confidence that IMM-BCP-01 will be critical in the ongoing fight against SARS-CoV-2. IMM-BCP-01 has already been shown to neutralize all other current Center for Disease Control (CDC) variants of concern in pre-clinical testing.”
This project was funded by the U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPEO-CBRN Medical), in collaboration with the Defense Health Agency (DHA).
AboutImmunome
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-LookingStatements
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 COVID-19 therapeutic antibody programs, execution of its regulatory, clinical and strategic plans, anticipated upcoming milestones for IMM-BCP-01, including expectations regarding therapeutic potential and benefits thereof. 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 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 of 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.
ImmunomeContact
Corleen Roche
Chief Financial Officer
Immunome, Inc.
investors@immunome.com
InvestorContact
Laurence Watts
Managing Director
Gilmartin, LLC
laurence@gilmartinir.com
ImmunomeMedia Contact
Megan McGrath or Nick Chang
MacDougall
781-235-3060
mmcgrath@macbiocom.com or nchang@macbiocom.com