Immunome Inc 8-K, filed May 20, 2021
Immunome Inc. (IMNM)
About this 8-K
Immunome Inc filed this 8-K on May 20, 2021, reporting on events of May 19, 2021.
Items reported
- Item 1.01: Entered into a material agreement
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Item 1.01 Entry into a Material Definitive Agreement.
On May 19, 2021, Immunome, Inc. (the “Company”) entered into a Modification of Contract (the “Modification of Contract”), with 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, that, among other things, increases the award amount under the Other Transaction Authority for Prototype Agreement by $4.3 million from $13.3 million to $17.6 million, for the continued development of an antibody cocktail (IMM-BCP-01) to combat SARS-CoV-2 and its variants.
The foregoing description of the Modification of Contract is qualified in its entirety by reference to the full text of the Modification of Contract, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 8.01 Other Events.
On May 20, 2021, the Company issued a press release announcing the $4.3 million increase awarded 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). A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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: May 20, 2021
Exhibit 10.1
 |
EXCEPT ION TO SF 30 30-105-04 ST ANDARD FORM 30 (Rev. 10-83) APPROVED BY OIRM 11-84 Prescribed by GSA FAR (48 CFR) 53.243 |
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SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGES
SECTION SF 30 - BLOCK 14 CONTINUATION PAGE
The following have been added by
full text:
P00002
| A. | The purpose of this modification is as follows: |
| a. | CLIN 0001 is hereby increased by $4,297,626.00, From $13,300,971.00, to $17,598,597.00. |
| b. | CLIN 000103 is hereby added to incorporate $4,297,626.00 of funding. |
| c. | The total funded amount of this agreement is hereby increased from $4,297,626.00, From $13,300,971.00, to $17,598,597.00. |
| d. | Proposal titled “DoD Reforecast – 2021-04 (2021-05-13) DOD Summary” is hereby incorporated by reference to Appendix A of the agreement. |
| e. | The completion date for CLIN 0001 is hereby extended from [***] to [***]. |
| B. | The parties hereby agree that changes effected by this modification constitute both the consideration and the equitable adjustment due under any clause of this agreement resulting from the incorporation of the changes identified in paragraph A. |
| C. | All other terms and conditions remain the same and in full force and effect. |
SECTION A - SOLICITATION/CONTRACT FORM
The total cost of this contract was increased by $4,297,626.00 from $13,300,971.00 to $17,598,597.00.
SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0001
The estimated/max cost has increased by $4,297,626.00 from $12,913,564.00 to $17,211,190.00.
The total cost of this line item has increased by $4,297,626.00 from $13,300,971.00 to $17,598,597.00.
SUBCLIN 000103 is added as follows:
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| ITEM NO | SUPPLIES/SERVICES | QUANTITY | UNIT | UNIT PRICE | AMOUNT |
| 000103 | $0.00 |
FY 21 Funding FFP
PURCHASE REQUEST NUMBER: 0011518049-0006
| NET AMT | $0.00 | ||||
| ACRN AA | $4,297,626.00 | ||||
| CIN: GFEBS001151804900012 |
SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for SUBCLIN 000103:
| INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
| N/A | N/A | N/A | N/A |
SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule item for CLIN 0001 has been changed from:
| DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | DODAAC / CAGE |
| [***] | N/A FOB: Destination |
To:
| DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | DODAAC / CAGE |
| [***] | N/A FOB: Destination |
SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by $4,297,626.00 from $13,300,971.00 to $17,598,597.00.
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SUBCLIN 000103:
Funding on SUBCLIN 000103 is initiated as follows:
ACRN: [***]
CIN: [***]
Acctng Data: [***]
Increase: $4,297,626.00
Total: $4,297,626.00
Cost Code: [***]
(End of Summary of Changes)
APPENDIX A
[***]
Exhibit 99.1
Immunome Announces Additional $4.3 Million Award by DOD following Positive Preclinical Testing Results on COVID-19 Variants of Concern
- Additional $4.3 million in funding brings total DOD funding to $17.6 million.
- Antibody cocktail (IMM-BCP-01) is a combination of three antibodies that bind to complementary, non-overlapping regions of the SARS-CoV-2 spike protein.
- Neutralizes South Africa (B.1.351) and UK (B.1.1.7) in live virus testing and Brazil (P.1) and California (B.1.429, also containing B.1.427 mutations) in pseudovirus testing, all of which are CDC-designated “Variants of Concern.”
- Binds to several mutations, including E484Q and L452R, which are associated with the India variant (B.1.617) in mechanistic testing.
Exton, Pa., May 20, 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 announced a $4.3 million increase awarded 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), for the continued development of an antibody cocktail (IMM-BCP-01) to combat SARS-CoV-2 and its variants. The additional capital comes less than a year after an initial DOD award of $13.3 million, bringing the total commitment to Immunome to $17.6 million. The additional funding is to support expansion of the clinical study following feedback from the FDA. Immunome is continuing efforts towards an IND filing for IMM-BCP-01 in late 2Q/early 3Q 2021.
IMM-BCP-01 contains three monoclonal antibodies that bind to non-overlapping regions of the spike protein with picomolar affinity. The antibodies exhibit combinatorial effects in vitro against multiple SARS-CoV-2 variants, including those exhibiting both increased transmission in the United States and resistance to current antibody therapeutics and vaccines.
“We are thrilled to have secured additional funding from the Department of Defense,” said Purnanand Sarma, Ph.D., President and CEO of Immunome. “We are grateful to the DOD for their continued support and we are eager to move our antibody cocktail into the clinic.”
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; 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.
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