0001104659-22-059118.txt : 20220512 0001104659-22-059118.hdr.sgml : 20220512 20220512083420 ACCESSION NUMBER: 0001104659-22-059118 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220512 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220512 DATE AS OF CHANGE: 20220512 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Immunome Inc. CENTRAL INDEX KEY: 0001472012 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 770694340 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39580 FILM NUMBER: 22915852 BUSINESS ADDRESS: STREET 1: 665 STOCKTON DRIVE STREET 2: SUITE 300 CITY: EXTON STATE: PA ZIP: 19341 BUSINESS PHONE: 610-321-3700 MAIL ADDRESS: STREET 1: 665 STOCKTON DRIVE STREET 2: SUITE 300 CITY: EXTON STATE: PA ZIP: 19341 8-K 1 tm2215331d1_8k.htm FORM 8-K
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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, 2022 

 

 

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
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, 2022, Immunome, Inc. issued a press release announcing its financial results for the quarter ended March 31, 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 May 12, 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: May 12, 2022    

 

 

 

EX-99.1 2 tm2215331d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Immunome Reports First Quarter 2022 Financial Results

 

Exton, PA – May 12, 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 first quarter ended March 31, 2022 and provided a corporate update.

 

“We received FDA clearance to proceed with our Phase 1b clinical trial for our three-antibody cocktail, IMM-BCP-01, for the treatment of COVID-19 and patient recruitment efforts are underway. Based on the preclinical data, we believe this therapy can address the ongoing need for a substantial and effective COVID-19 antibody treatment, especially in light of the continued emergence of new variants,” stated Purnanand Sarma, Ph.D., President and CEO of Immunome. “Additionally, we continue to progress IMM-ONC-01, our antibody treatment targeting IL-38, an immune modulator that appears to potently suppress innate immune response, especially in the context of cancer. IL-38 is overexpressed in multiple tumor types with significant unmet need. We are targeting an IND submission in the second half of 2022 and look forward to providing updates as they arise.”

 

First Quarter and Subsequent Highlights

 

•FDA Lifts Clinical Hold on Immunome’s IMM-BCP-01 IND Application for the Treatment of COVID-19. In March 2022, Immunome announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01), for the treatment of SARS-CoV-2 (COVID-19).

 

•In Vitro Efficacy of IMM-BCP-01 Against SARS-CoV-2 Omicron Variant in Live Virus Testing. In February 2022, Immunome announced that IMM-BCP-01 demonstrated effective neutralization of the Omicron variant of COVID-19 in in vitro testing. The combination of two antibodies in Immunome’s antibody cocktail, IMM20253/IMM20184, demonstrated neutralization of the Omicron variant within 3.5-fold potency compared to a preclinical version of sotrovimab in a head-to-head test using live virus samples.

 

Financial Highlights

 

•Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2022 were $8.1 million.

 

•General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2022 were $3.6 million.

 

•Net loss: Net loss for the three months ended 2022 was $11.7 million.

 

•Cash and cash equivalents: As of March 31, 2022, cash and cash equivalents totaled $42.9 million.

 

 

 

 

This investigational work 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)

 

   March 31, 2022   December 31, 2021 
Assets          
Current assets:          
Cash and cash equivalents  $42,879   $49,229 
Prepaid expenses and other current assets   3,424    7,409 
Total current assets   46,303    56,638 
Property and equipment, net   753    855 
Operating right-of-use asset, net   190    — 
Restricted cash   100    100 
Deferred offering costs   382    332 
  Total assets  $47,728   $57,925 
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $3,890   $3,077 
Accrued expenses and other current liabilities   5,817    6,651 
Total current liabilities   9,707    9,728 
Other long-term liabilities   147    12 
   Total liabilities  $9,854   $9,740 
Commitments and contingencies (Note 6)          
Stockholders’ equity:          
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at March 31, 2022 and December 31, 2021   —    — 
Common stock, $0.0001 par value; 200,000,000 shares authorized;
12,127,385 and 12,110,373 shares issued and outstanding at March 31, 2022
and December 31, 2021, respectively
   1    1 
Additional paid-in capital   128,631    127,289 
Accumulated deficit   (90,758)   (79,105)
  Total stockholders’ equity   37,874    48,185 
Total liabilities and stockholders’ equity  $47,728   $57,925 

 

 

 

 

IMMUNOME, INC.

 

Condensed Statements of Operations 

(In thousands, except share and per share data)

 

(unaudited)

 

   Three Months Ended March 31, 
   2022   2021 
Operating expenses:          
   Research and development  $8,078   $1,979 
   General and administrative   3,576    1,918 
Total operating expenses   11,654    3,897 
Loss from operations   (11,654)   (3,897)
Interest income (expense), net   1    (1)
Net loss  $(11,653)  $(3,898)
Per share information:          
Net loss per share of common stock, basic and diluted  $(0.96)  $(0.37)
Weighted-average common shares outstanding, basic and diluted   12,122,903    10,640,870 

 

Immunome Contact

 

Corleen Roche

 

Chief Financial Officer

 

Immunome, Inc.

 

investors@immunome.com

 

Investor Contact

 

Laurence Watts Managing Director

 

Gilmartin, LLC

 

laurence@gilmartinir.com

 

 

 

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