Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of December 31, 2021, our disclosure controls and procedures were effective as of December 31, 2021 to ensure the timely disclosure of required information in our SEC filings.
Management’s Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal control over financial reporting. The Company’s internal control over financial reporting is a process designed, as defined in Rule 13a-15(f) under the Exchange Act, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. The Company’s internal control over financial reporting is supported by written policies and procedures that:
- Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the Company’s assets;
- Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of the Company’s management and directors; and
- Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the consolidated financial statements.
In connection with the preparation of the Company’s annual financial statements, management of the Company has undertaken an assessment of the effectiveness of the Company’s internal control over financial reporting based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Management’s assessment included an evaluation of the design of the Company’s internal control over financial reporting and testing of the operational effectiveness of the Company’s internal control over financial reporting. Based on this assessment, management has concluded that the Company’s internal control over financial reporting was effective as of December 31, 2021.
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Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements prepared for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f)) under the Exchange Act) that occurred during the year ended December 31, 2021, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting, except as follows:
Material Weakness Remediation
As previously reported, management recognized that the Company had material weaknesses in its internal control over financial reporting as of December 31, 2020. The material weaknesses that we identified related to the lack of review of journal entries, lack of timely and effective review of financial statement account balances and our lack of maintaining a sufficient complement of personnel commensurate with our accounting and reporting requirements.
Management determined that the deficiencies could have potentially resulted in a material misstatement of the financial statements in a future annual or interim period that would not be prevented or detected. Therefore, the deficiencies constituted material weaknesses in internal control.
We initiated several steps to evaluate and implement measures designed to improve our internal control over financial reporting in order to remediate the control deficiencies noted above. These steps include hiring a Chief Financial Officer, a Corporate Controller, and a Finance Manager who are responsible for the preparation and review of the Company’s financial statements and related disclosures. In addition, we enhanced our reporting process thereby reducing the risk of undetected errors by (i) implementing a monthly financial statement close process that includes formal review of financial statement account balances and journal entries, and (ii) creating a disclosure committee consisting of key executives and accounting personnel who review the Company’s financial statements and related disclosures on a quarterly basis.
As a result of these efforts, the Company determined that the material weaknesses were remediated and our internal control over financial reporting was effective as of December 31, 2021.
Item 9B. Other Information
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
PART III
Item 10. Directors, Executive Officers, and Corporate Governance
The information required by Item 10 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
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Item 11. Executive Compensation
The information required by Item 11 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by Item 12 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by Item 13 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
Item 14. Principal Accountant’s Fees and Services
The information required by Item 14 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
Part IV
Item 15. Exhibits and Financial Statement Schedules
(a)(1) Financial Statements
See Index to the Financial Statements on page 90 of this Annual Report.
(a)(2) Financial Statement Schedules
None, as all information required in these schedules is included in the Notes to the Financial Statements.
(a)(3) Exhibits
See Exhibit Index or Page 111 of this Annual Report.
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Immunome, Inc.
INDEX TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 )
91
Balance Sheets as of December 31, 2021 and 2020
92
Statements of Operations for the years ended December 31, 2021 and 2020
93
Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2021 and 2020
94
Statements of Cash Flows for the years ended December 31, 2021 and 2020
95
Notes to Financial Statements
96
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Report of independent registered public accounting firm
To the Stockholders and the Board of Directors of Immunome, Inc.
Opinion on the financial statements
We have audited the accompanying balance sheets of Immunome, Inc. (the “Company”) as of December 31, 2021 and 2020, the related statements of operations, changes in convertible preferred stock and stockholders’ equity (deficit), and cash flows, for each of the two years in the period ended December 31, 2021 and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Basis for opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte & Touche LLP
Philadelphia, Pennsylvania
March 28, 2022
We have served as the Company’s auditor since 2019.
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Immunome, Inc.
Balance sheets
(in thousands, except share and per share amounts)
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
49,229
$
39,766
Prepaid expenses and other current assets
7,409
3,128
Total current assets
56,638
42,894
Property and equipment, net
855
1,531
Restricted cash
100
100
Deferred offering costs
332
-
Total assets
$
57,925
$
44,525
Liabilities, convertible preferred stock, and stockholders’ equity (deficit)
Current liabilities:
Accounts payable
$
3,077
$
1,187
Accrued expenses and other current liabilities
6,651
1,372
Current portion of long-term debt
—
366
Current portion of equipment loan payable
—
113
Total current liabilities
9,728
3,038
Equipment loan payable, net of current portion
-
Long-term debt, net of current portion
—
134
Deferred rent
12
8
Total liabilities
9,740
3,180
Commitments and contingencies (Note 8)
Stockholders’ equity (deficit):
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2021 and December 31, 2020
—
—
Common stock, $ 0.0001 par value; 200,000,000 shares authorized; 12,110,373 shares issued and outstanding at December 31, 2021 and 10,634,245 shares issued and outstanding at December 31, 2020
1
1
Additional paid-in capital
127,289
95,738
Accumulated deficit
( 79,105 )
( 54,394 )
Total stockholders’ equity (deficit)
48,185
41,345
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)
$
57,925
$
44,525
The accompanying notes are an integral part of these financial statements.
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Immunome, Inc.
Statements of operations
(in thousands, except share and per share amounts)
Year ended December 31,
2021
2020
Operating expenses:
Research and development
$
14,110
$
7,486
General and administrative
11,094
4,775
Total operating expenses
25,204
12,261
Loss from operations
( 25,204 )
( 12,261 )
Other income (expenses):
Change in fair value of warrant liability
—
( 5,538 )
Other income
503
—
Interest expense, net
( 10 )
( 38 )
Total other expenses
493
( 5,576 )
Net loss
$
( 24,711 )
$
( 17,837 )
Per share information:
Net loss per common share, basic and diluted
$
( 2.14 )
$
( 5.26 )
Weighted-average common shares outstanding, basic and diluted
11,538,668
3,389,592
The accompanying notes are an integral part of these financial statements.
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Immunome Inc.
Statements of changes in convertible preferred stock and stockholders’ equity (deficit )
(in thousands, except share amounts)
Convertible preferred stock
Stockholders’ equity (deficit)
Series A
Common stock
Additional
paid-in
Accumulated
Shares
Amount
Shares
Amount
capital
deficit
Total
Balance at January 1, 2020
4,443,259
$
38,894
1,099,270
$
—
$
927
$
( 36,557 )
$
( 35,630 )
Sale of Series A convertible preferred stock and warrants with a fair value of $ 1,522 , net of $ 49 of issuance costs
1,226,925
9,475
—
—
—
—
Conversion of Series A convertible preferred stock upon IPO
( 5,670,184 )
( 48,369 )
5,670,184
1
48,368
—
48,369
Conversion of liability-classified warrants upon IPO
—
—
—
—
7,060
—
7,060
Sale of common stock in connection with IPO, net of $ 6,108 of issuance costs
—
—
3,737,500
—
38,742
—
38,742
Share-based compensation expense
—
—
—
—
621
—
621
Exercise of stock options
—
—
127,291
—
20
—
20
Net loss
—
—
—
—
—
( 17,837 )
( 17,837 )
Balance at December 31, 2020
—
—
10,634,245
1
95,738
( 54,394 )
41,345
Sale of common stock and common stock warrants, net of $ 559 in offering costs
—
—
1,014,115
—
26,666
—
26,666
Share-based compensation expense
—
—
—
—
3,448
—
3,448
Exercise of common stock warrants
—
—
200,979
—
1,338
—
1,338
Exercise of stock options and vesting of restricted stock
—
—
261,034
—
99
—
99
Net loss
—
—
—
—
—
( 24,711 )
( 24,711 )
Balance at December 31, 2021
—
$
—
12,110,373
$
1
$
127,289
$
( 79,105 )
$
48,185
The accompanying notes are an integral part of these financial statements.
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Immunome Inc.
Statements of cash flows
(in thousands)
Year ended December 31,
2021
2020
Cash flows from operating activities:
Net loss
$
( 24,711 )
$
( 17,837 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
755
755
Share-based compensation
3,448
621
Change in fair value of warrant liability
—
5,538
Deferred rent
4
( 2 )
Forgiveness of PPP Loan
( 500 )
—
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 4,281 )
( 2,411 )
Accounts payable
1,780
504
Accrued expenses and other current liabilities
5,279
698
Net cash used in operating activities
( 18,226 )
( 12,134 )
Cash flows from investing activities:
Purchases of property and equipment
( 79 )
( 586 )
Net cash used in investing activities
( 79 )
( 586 )
Cash flows from financing activities:
Proceeds from exercise of stock options
99
20
Proceeds from exercise of common stock warrants
1,338
—
Proceeds from long-term debt
—
500
Proceeds from sale of common stock and common stock warrants
27,225
44,850
Payment of issuance costs related to the sale of common stock and common stock warrants
( 559 )
( 5,973 )
Proceeds from the sale of Series A convertible preferred stock
—
11,046
Payment of Series A convertible preferred stock issuance costs
—
( 49 )
Payment of equipment loan payable
( 113 )
( 212 )
Payment of capital lease obligations
—
( 239 )
Payment of offering costs
( 222 )
—
Net cash provided by financing activities
27,768
49,943
Net increase in cash and cash equivalents and restricted cash
9,463
37,223
Cash and cash equivalents and restricted cash at beginning of year
39,866
2,643
Cash and cash equivalents and restricted cash at end of year
$
49,329
$
39,866
Supplemental disclosures of cash flow information:
Cash paid for interest
$
14
$
29
Supplemental disclosures of non-cash investing and financing activities:
Conversion of Series A convertible preferred stock upon IPO
$
—
$
48,369
Offering costs included in accounts payable
$
110
$
135
Fair value of liability-classified warrants issued in connection with Series A convertible preferred stock
$
—
$
1,522
Conversion of liability-classified warrants upon IPO
$
—
$
7,060
The accompanying notes are an integral part of these financial statements.
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Immunome, Inc.
Notes to financial statements
1. Nature of the business and basis of presentation
Organization
Immunome, Inc. (the Company or Immunome) was incorporated as a Pennsylvania corporation on March 2, 2006 and was converted to a Delaware corporation on December 2, 2015. The Company is a biopharmaceutical company utilizing our proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics designed to change the way diseases are currently being treated. The Company’s primary focus areas are oncology and infectious disease, including COVID-19.
Since its inception, the Company has devoted substantially all its resources to research and development, raising capital, building its management team and building its intellectual property portfolio. The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry including, but not limited to, risks associated with the successful research, development and manufacturing of product candidates, uncertain results of preclinical and clinical testing, development by competitors of new technological innovations, dependence on key personnel and third-party vendors, protection of proprietary technology, compliance with government regulations, regulatory approval of product candidates and the ability to secure additional capital to fund operations.
Liquidity
The Company has incurred net losses since inception, including net losses of $ 24.7 million and $ 17.8 million for the years ended December 31, 2021 and 2020, respectively, and it expects to generate losses from operations for the foreseeable future primarily due to research and development costs for its potential product candidates. As of December 31, 2021 and 2020, the Company had an accumulated deficit of $ 79.1 million and $ 54.4 million, respectively. The Company expects to generate operating losses and negative operating cash flows for the foreseeable future.
On October 6, 2020, the Company closed its IPO, in which the Company issued and sold 3,250,000 shares of its common stock at a public offering price of $ 12.00 per share. On October 13, 2020, the underwriters exercised their option to purchase an additional 487,500 shares of the Company’s common stock at a purchase price of $ 12.00 per share. The Company received net proceeds of $ 41.7 million after deducting underwriting discounts and commissions of $ 3.1 million but before deducting other offering expenses. On April 28, 2021, the Company sold 1,000,000 units, each consisting of one share of the Company’s common stock and one warrant to purchase one-half a share of common stock in a private placement at a price of $ 27.00 per unit for net proceeds of $ 26.4 million. The Company filed a shelf registration statement on Form S-3, which was declared effective by the SEC on October 14, 2021, pursuant to which the Company may issue from time-to-time securities with an aggregate price of up to $ 200.0 million. On October 1, 2021 the Company entered into a new Open Market Sale Agreement (“ATM Agreement”) with Jefferies Group LLC, which provides that, upon the terms and subject to the conditions and limitations in the ATM Agreement, the Company may elect, from time to time, to offer and sell shares of common stock under the registration statement having an aggregate offering price of up to $ 75.0 million through Jefferies Group LLC acting as sales agent. The Company has not yet sold any shares under the ATM Agreement.
The Company expects that its cash as of December 31, 2021 will be sufficient to fund its operations for at least 12 months from the filing date of this Annual Report on Form 10-K. Beyond that date, the Company will need additional financing to support its continuing operations and pursue its growth strategy.
If the Company cannot obtain the necessary funding, it will need to delay, scale back or eliminate some or all of its research and development programs or enter into collaborations with third parties to commercialize potential products or technologies that it might otherwise seek to develop or commercialize independently; consider other various strategic alternatives, including a merger or sale of the Company; or cease operations. If the Company engages in collaborations, it may receive lower consideration upon commercialization of such products than if it had not entered into such arrangements or if it entered into such arrangements at later stages in the product development process. Additionally,
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volatility in the capital markets and general economic conditions in the United States may be a significant obstacle to raising the required funds.
Operations of the Company are subject to certain risks and uncertainties including various internal and external factors that will affect whether and when the Company’s product candidates become approved drugs and how significant their market share will be, some of which are outside of the Company’s control. The length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of the drug approval process will materially affect the Company’s financial condition and future operations. On March 11, 2020, the World Health Organization characterized the novel COVID-19 virus as a global pandemic. Although there is significant uncertainty as to the likely effects this disease may have in the future, to date, there has not yet been a significant impact to the Company’s operations or financial statements.
2. Summary of significant accounting policies
Basis of presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted (GAAP) in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB).
Use of estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the fair value of the Company’s common stock prior to its IPO, in connection with share-based compensation arrangements, the expected volatility used to estimate fair value of common stock, services performed but not billed relating to research and development contracts, and services performed on research and development advanced payments. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from these estimates.
Segment and geographic information
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker (CODM), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer. The Company views its operations as and manages its business in one operating segment operating exclusively in the United States.
Cash and Cash Equivalents
Cash and cash equivalents consist of standard checking accounts and a money market account. The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents.
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Restricted cash
Restricted cash represents collateral provided for a letter of credit issued as a security deposit in connection with the Company’s lease of its corporate facilities. This lease expires in 2024; at which time, the cash will be released from restriction. Restricted cash was $ 100,000 at both December 31, 2021 and 2020. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash reported in the Company’s balance sheets to the total of the amount presented in the statements of cash flows:
(in thousands)
December 31, 2021
December 31, 2020
Cash and cash equivalents
$
49,229
$
39,766
Restricted cash
100
100
$
49,329
$
39,866
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high credit quality, and the Company has not experienced any losses on these deposits.
Property and equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows:
Asset category
Estimates useful life
Lab equipment
5 years
Leasehold improvements
Lesser of lease term or 5 years
Computer equipment
3 years
Office equipment
5 years
Furniture and fixtures
5 years
Expenditures for repairs and maintenance of assets are charged to expense as incurred, while major betterments are capitalized. Upon retirement or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts and any resulting gain or loss is included in the statements of operations.
Impairment of long-lived assets
The Company evaluates its long-lived assets, which consist primarily of property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. There were no impairment losses recognized during the years ended December 31, 2021 and 2020.
Equity issuance costs
The Company capitalizes costs that are directly associated with in-process equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed.
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As of December 31, 2021, there was $ 0.3 million of deferred offering costs in connection with the Company’s shelf registration statement, and there were no deferred offering costs as of December 31, 2020.
Government contract funding
The Company accounts for amounts received under its U.S. Department of Defense (DoD) expense reimbursement contract as contra-research and development expenses in the statements of operations.
Warrant liability
The Company issued warrants to purchase shares of Series A convertible preferred stock in connection with the June 2020 Series A convertible preferred stock sale. The warrants were initially classified as a liability on the balance sheet at September 30, 2020 as the underlying Series A convertible preferred stock was contingently redeemable and outside of the Company’s control (see Note 10, Common stock and convertible preferred stock). The fair value of the warrants on the date of issuance was recorded as a reduction of the carrying value of the Series A convertible preferred stock and as a long-term liability in the balance sheets. The warrants were subsequently remeasured to fair value at each balance sheet date with changes in the fair value of the warrants recognized as other income or expense in the statements of operations. The change in fair value of the warrants during the year ended December 31, 2020 was $ 5.5 million. Upon completion of the IPO on October 6, 2020, the warrants became exercisable for shares of the Company’s common stock and were reclassified to additional paid-in capital upon the consummation of the IPO.
The Company used the Black-Scholes option pricing model, which incorporated assumptions and estimates, to value the Series A convertible preferred stock warrants until the conversion of the Series A Preferred to stockholders’ equity in October 2020. Estimates and assumptions impacting the fair value measurement of the warrants included the fair value per share of the underlying Series A convertible preferred stock, the remaining contractual term of the warrants, risk-free interest rate, expected dividend yield and expected volatility of the price of the underlying Series A convertible preferred stock. The Company historically determined the fair value per share of the underlying Series A convertible preferred stock by taking into consideration the most recent sales of its Series A convertible preferred stock, results obtained from third party valuations and additional factors that were deemed relevant. The Company historically had been a private company and lacked company-specific historical and implied volatility information of its stock. Therefore, it estimated the expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining contractual term of the warrants at the time. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. Expected dividend yield was determined based upon the Company’s history of not paying cash dividends and its expectation that it will not pay any cash dividends in the foreseeable future.
Research and development costs
Research and development costs are charged to expense as incurred. Research and development costs consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation and amortization, preclinical expenses, consulting and other contracted services. Additionally, under the terms of the license agreements, the Company is obligated to make future payments should certain development and regulatory milestones be achieved. No such costs have been incurred for the years ended December 31, 2021 and 2020. Costs for certain research and development activities are recognized based on the terms of the individual arrangements, which may differ from the timing of receipt of invoices and payment of invoices, and are reflected in the financial statements as a prepaid or accrued expense.
Share-based compensation
The Company’s share-based compensation program allows for grants of stock options and restricted stock awards. Grants are awarded to employees and non-employees, including directors.
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The Company accounts for its share-based compensation awards granted to employees and nonemployees based on the estimated fair value on the date of grant and recognized compensation expense of those awards over the requisite service period, which is the vesting period of the respective award. The Company accounts for forfeitures as they occur. For share-based awards with service-based vesting conditions, the Company recognized compensation expense on a straight-line basis over the service period. The Company classified share-based compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company estimates the fair value of options granted using the Black-Scholes option pricing model for stock option grants to both employees and non-employees.
The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to the lack of Company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and biopharmaceutical industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company uses the simplified method to calculate the expected term for options granted to employees and non-employees whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the options due to its lack of sufficient historical data. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock.
In determining the exercise prices for options granted, the Company has considered the estimated fair value of the common stock as of the measurement date. Prior to the IPO, the estimated fair value of the common stock had been determined at each grant date based upon a variety of factors, including the illiquid nature of the common stock, the effect of the rights and preferences of the preferred stockholders, and the prospects of a liquidity event. Among other factors were the Company’s financial position and historical financial performance, the status of technological developments within the Company’s research, the composition and ability of the current research and management team, an evaluation or benchmark of the Company’s competition, and the current business climate in the marketplace. Significant changes to the key assumptions underlying the factors used could have resulted in different fair values of common stock at each valuation date. Following the closing of the IPO, the fair value of common stock was the closing price of the Company's common stock on the Nasdaq Global Market as reported on the date of the grant.
Patent costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the accompanying statements of operations.
Rent expense
The Company’s real estate operating lease provides for scheduled annual rent increases throughout the lease term. The Company recognizes the effects of the scheduled rent increases on a straight-line basis over the full term of the lease.
Income taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of
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the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes.
Fair value of financial instruments
ASC Topic 820, Fair Value Measurement (ASC 820), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the assets or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the price that would be received to sell an asset or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tiered value hierarchy that distinguishes between the following:
● Level 1: Quoted market prices in active markets for identical assets or liabilities.
● Level 2: Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves.
● Level 3: Unobservable inputs for the asset or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk).
To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgement. Accordingly, the degree of judgement exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Cash and cash equivalents are Level 1 assets for the years ended December 31, 2021 and 2020.
Net loss per share
The Company follows the two-class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.
Basic net loss per share of common stock is computed by dividing the net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share of common stock is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share of common stock is computed by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents.
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The following potentially dilutive securities as of December 31, 2021 and 2020 have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:
Year ended December 31,
2021
2020
Stock options (1)
2,005,756
1,472,840
Common stock warrants (1)
1,303,112
1,035,196
3,308,868
2,508,036
(1) Represents common stock equivalents
Prior to its conversion, the Company’s Series A convertible preferred stock contractually entitled the holders of such shares to participate in dividends but did not contractually require the holders of such shares to participate in losses of the Company. Accordingly, in periods in which the Company reported a net loss, such losses were not allocated to participating securities. In periods in which the Company reports a net loss per share of common stock, diluted net loss per share of common stock is the same as basic net loss per share of common stock since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss per share of common stock for the years ended December 31, 2021 and 2020.
Recent accounting pronouncements
The Jumpstart Our Business Startups Act of 2012 permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. As an emerging growth company, the Company has elected to take advantage of this extended transition period.
In February 2016, the FASB issued ASC Topic 842, Leases, (Topic 842). This standard requires all entities that lease assets with terms of more than 12 months to capitalize the assets and related liabilities on the balance sheet. As the Company has elected to use the extended transition period for complying with new or revised accounting standards as available under the JOBS Act, the standard is effective for the Company beginning January 1, 2022, with early adoption permitted. The Company expects to adopt ASC 842 effective January 1, 2022 using the modified retrospective approach. The Company expects to elect the package of practical expedients available for existing contracts, which will allow us to carry forward our historical assessments of lease identification, lease classification, and initial direct costs. The Company also expects to elect a policy to not apply the recognition requirements of ASC 842 for short-term leases. The Company expects to recognize a right-of-use asset and lease liability of $ 0.2 million, respectively, on January 1, 2022 , which is related to our facility operating lease (Note 8).
In November 2021, the FASB issued ASU Topic 832, Disclosures by Business Entities about Government Assistance (“Topic 832”). This standard requires disclosures about transactions with a government that have been accounted for by analogizing to a grant or contribution accounting model to increase transparency about the types of transactions, the accounting for the transactions, and the effect of the transactions on an entity’s financial statements. The effective date of Topic 832 is for financial statements issued for annual periods beginning after December, 15 2021. The Company is currently evaluating the effect Topic 832 will have on its consolidated financial statements and related disclosures.
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3. Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following:
December 31,
(in thousands)
2021
2020
Reimbursement receivable from DoD
$
2,674
$
850
Prepaid insurance
2,019
1,767
Unbilled reimbursement receivable from DoD
1,638
—
Research and development advance payments
586
—
Other prepaids and short term deposits
492
511
$
7,409
$
3,128
4. Property and equipment, net
Property and equipment consisted of the following:
December 31,
(in thousands)
2021
2020
Lab equipment
$
3,513
$
3,506
Leasehold improvements
193
185
Computer equipment
156
96
Office equipment and furniture and fixtures
22
18
3,884
3,805
Less accumulated depreciation and amortization
( 3,029 )
( 2,274 )
Property and equipment, net
$
855
$
1,531
Depreciation and amortization expense was $ 0.8 million for the years ended December 31, 2021 and December 31, 2020, respectively. There were no assets under capital leases as of December 31, 2021 and 2020.
5. DoD expense reimbursement contract
In July 2020, the Company entered into an Other Transaction Authority for Prototype Agreement (the OTA Agreement) with the DoD to fund the Company’s efforts in developing an antibody cocktail therapeutic to treat COVID-19. The amount of funding being made available to the Company under this expense reimbursement contract was $ 13.3 million. In May 2021, the Company and the DoD amended the OTA Agreement, pursuant to which the DoD award was increased from $ 13.3 million to $ 17.6 million. Under the agreement, the DoD shall pay the Company, upon submission of proper invoices, within 30 calendar days of receipt of request for payment.
The Company recorded contra-research and development expense of $ 15.2 million and $ 1.7 million for the years ended December 31, 2021 and 2020, respectively, in the statements of operations. The Company had an expense reimbursement receivable balance of $ 2.7 million and $ 0.9 million due from the DoD in prepaid expenses and other current assets for the years ended December 31, 2021 and 2020, respectively, on the balance sheet.
Costs that have been reimbursed by the DoD but not yet expensed by the Company are recorded as a deferred research obligation liability for the period. The Company has a deferred research obligation liability of $ 2.0 million and $ 0 million for the years ended December 31, 2021 and 2020, respectively. This amount is included in accrued expenses and other liabilities in the accompanying balance sheet. DoD reimbursable services that have been performed but not yet billed are recorded as an unbilled receivable in prepaid expenses and other current assets on the balance sheet. The Company had an unbilled receivable from the DoD of $ 1.6 million and $ 0 million for the years ended December 31, 2021 and 2020, respectively.
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As of December 31, 2021, the Company has the potential for $ 0.2 million of expense reimbursement under the OTA Agreement.
6. Accrued expenses and other liabilities
Accrued expenses and other liabilities consisted of the following:
December 31,
(in thousands)
2021
2020
Research and development
$
2,840
$
9
Deferred research obligations
2,021
—
Compensation and related benefits
1,246
845
Professional fees
227
417
Other
317
101
$
6,651
$
1,372
7. Long-term debt
On April 30, 2020, the Company entered into a loan agreement with Silicon Valley Bank as the lender (Lender) for a loan in an aggregate principal amount of $ 0.5 million (PPP Loan) pursuant to the Paycheck Protection Program (PPP) under the Coronavirus Aid, Relief, and Economic Security Act and implemented by the U.S. Small Business Administration. The Company used the proceeds of the PPP Loan for payroll and other qualifying expenses. The entire PPP Loan was forgiven on May 21, 2021 and recognized as other income in the statement of operations.
8. Commitments and contingencies
Operating leases
In May 2017, the Company entered into a 62-month office and laboratory space lease commencing on July 1, 2017 for approximately 11,000 square feet of space in Exton, Pennsylvania. The Company has an option to extend the lease for up to two additional five-year terms. In December 2021, the Company extended the lease for an additional eighteen-month term. The lease is subject to fixed rate escalation increases and the landlord waived the Company’s rent obligation for the first two months of the lease. Deferred rent is de minimis as of December 31, 2021 and 2020, respectively, and is being amortized as a reduction in rent expense over the term of the lease. The Company recognizes rent expense on a straight-line basis over the expected lease term.
In August 2020, the Company entered into a one-year operating lease for laboratory equipment that expired in July 2021 and has fixed monthly payments of $ 18,000 .
Future minimum lease payments for the Company’s operating leases are as follows (in thousands):
Years ending December 31,
Amount
2022
$
257
2023
246
2024
63
$
566
Rent expense for the years ended December 31, 2021 and 2020 was $ 0.5 million and $ 0.4 million, respectively.
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Employment agreements
The Company entered into offer letter agreements (the Employment Agreements) with key personnel providing for compensation and severance in certain circumstances, as defined in the respective Employment Agreements. The Employment Agreements may be terminated by either the Company or the employees in accordance with the Employment Agreements and provide for annual pay increases and bonuses at the discretion of the Board of Directors.
Employee benefit plan
The Company maintains a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the 401(k) Plan). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company assumes all administrative costs of the 401(k) Plan and makes matching contributions as defined in the 401(k) Plan document. The Company made matching contributions of $ 0.1 million to the 401(k) Plan for the years ended December 31, 2021 and 2020, respectively.
Legal proceedings
The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies.
9. Licensing arrangements
The Company has entered into various licensing agreements to further discover, develop and commercialize certain technologies and treatments. The Company may need to pay developmental and regulatory milestone payments up to approximately $ 2.6 million. In addition, the Company may need to pay royalty rates on net product sales and certain commercial milestone payments up to approximately $ 1.5 million, if any.
2021 Patent License Agreement
In June 2021, the Company entered into an exclusive worldwide patent license agreement with several Philadelphia based universities and hospitals (the Licensors) to further discover, develop and commercialize human antibodies, identified using Immunome’s human hybridoma technology, for the treatment of diseases associated with the formation of bacterial biofilms. The Licensors are eligible to receive up to $ 1.5 million in regulatory and developmental milestone payments and up to $ 0.7 million in commercial milestone payments. In addition, the Licensors are eligible to receive low single digit royalty rates for net product sales, which are subject to adjustment in the event the Company sublicenses the approved technology. Beginning in June 2022, the Company is subject to annual minimum payments to the Licensors of $ 20,000 , which increases to $ 30,000 annually in June 2023 and thereafter.
For the year ended December 31, 2021, the Company recorded a $ 0.1 million non-refundable license initiation fee that covers the attorney’s fees and all other charges associated with the preparation, filing, prosecution, and maintenance of the Patent Rights. This non-refundable license initiation fee was recorded as an operating expense on the income statement.
10. Common stock and convertible preferred stock
Common stock
The holders of common stock are entitled to one vote for each share of common stock. Subject to the approval of the majority of shareholders, the holders of common stock shall be entitled to receive dividends out of funds legally available. In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the
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holders of common stock shall be entitled to share ratably in the remaining assets of the Company available for distribution.
On October 14, 2021, the Company filed a shelf registration statement on Form S-3, which was declared effective by the SEC, pursuant to which the Company may issue from time-to-time securities with an aggregate price of up to $ 200.0 million. On October 1, 2021 the Company entered into a new Open Market Sale Agreement ("ATM Agreement”) with Jefferies LLC, which provides that, upon the terms and subject to the conditions and limitations in the ATM Agreement, the Company may elect, from time to time, to offer and sell shares of common stock under the registration statement having an aggregate offering price of up to $ 75.0 million through Jefferies acting as sales agent. The Company has not yet sold any shares under the ATM Agreement. The Company has not yet sold any shares under the ATM Agreement.
On August 4, 2021, the Company entered into a consulting agreement that included a cash retainer and an equity grant. In addition, the consultant purchased 14,115 shares of common stock from the Company for $ 15.94 per share.
On April 28, 2021, the Company sold 1,000,000 units, each unit comprising one share of the Company’s common stock and one Series B Warrant (each, a Series B Warrant) to purchase one-half a share of common stock. The units were issued in a private placement at a price of $ 27.00 per unit for gross proceeds of $ 27.0 million. The Series B Warrants are equity-classified, exercisable at any time, have an exercise price of $ 45.00 per share and will terminate at three years from the date of issuance. The fair value of the warrants on the date of issuance was $ 6.0 million. The fair value of the warrants was estimated using a Black-Scholes Option Pricing Model. The significant assumptions used in preparing the option pricing model for valuing the Company's warrants to purchase shares of common stock as of April 28, 2021 included (i) volatility of 82.7 %, (ii) risk free interest rate of 0.35 %, (iii) strike price of $ 45.00 per share, (iv) fair value of common stock of $ 28.70 per share, and (v) expected life of three years. The Series B Warrants are callable by the Company in certain circumstances.
On October 6, 2020, the Company closed the IPO in which the Company issued and sold 3,737,500 shares of its common stock at a public offering price of $ 12.00 per share, including 487,500 shares of the Company’s common stock sold pursuant to the underwriters’ option to purchase additional shares. The Company received net proceeds of $ 41.7 million after deducting underwriting discounts and commissions of $ 3.1 million but before deducting other offering expenses. The Company’s common stock is listed on the Nasdaq Capital Market under the trading symbol “IMNM.” On October 6, 2020, the Company filed an amended and restated certificate of incorporation to, among other things, increase the number of shares of common stock, $ 0.0001 par value per share, authorized for issuance to 200,000,000 and authorize the Company’s Board of Directors to issue up to 10,000,000 shares of “blank check” preferred stock, $ 0.0001 par value per share.
Series A convertible preferred stock
Prior to the IPO, all of the Company’s convertible preferred stock was classified outside of stockholders’ equity (deficit) because the shares contained certain redemption features that were not solely within the control of the Company. At the time of issuance, the redeemable convertible preferred stock was recorded at its issuance price, less issuance costs.
In connection with the IPO, all of the Series A Preferred converted into 5,670,184 shares of common stock and all of the outstanding warrants to purchase convertible preferred stock converted into warrants to purchase common stock.
Warrants to acquire shares of common stock
At December 31, 2021 common stock warrants outstanding were as follows:
Warrants
Exercise Price per Share
Expiration Date
803,112
$ 9.00
June 2, 2023
500,000
$ 45.00
April 28, 2024
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For the year ended December 31, 2021, 148,653 warrants exercisable for $ 9.00 per share were exercised, and the Company received proceeds of $ 1.3 million and 148,653 shares of the Company’s common stock were issued. Additionally, 83,431 warrants were exercisable for $ 9.00 per share were exercised in cashless transactions for the year ended December 31, 2021 and 52,326 shares of the Company’s common stock were issued.
11. Share-based compensation
In July 2008, the Board of Directors adopted the 2008 Equity Incentive Plan ("the 2008 Plan”) which provided for the grant of qualified incentive stock options and non-qualified stock options, restricted stock or other awards to the Company’s employees, officers, directors, advisors, and outside consultants for the issuance or purchase of shares of the Company’s common stock. The 2008 Plan was replaced in July 2018 with the 2018 Equity Incentive Plan (the 2018 Plan and collectively with the 2008 Plan, the Plans). At the time that the 2008 Plan was terminated, there were 388,748 shares available for grant that were transferred to the 2018 Plan. On September 24, 2020, the 2018 Plan was terminated and replaced with the 2020 Equity Incentive Plan (2020 Plan). Additionally, the number of shares of our common stock reserved for issuance under the 2020 Plan will automatically increase on January 1 of each year, beginning on January 1, 2021 and continuing through and including January 1, 2030, by 4 % of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s Board of Directors. As of December 31, 2021, there were 1,372,897 shares available for future issuance under the 2020 Plan.
The Company also adopted the 2020 Employee Stock Purchase Plan (ESPP Plan) on September 18, 2020 which provides for the grant of purchase rights to purchase shares of the Company’s common stock to eligible employees, as defined by the ESPP Plan. The maximum number of shares of common stock that may be issued under the ESPP Plan will not exceed 125,000 shares of common stock, plus the number of shares of common stock that are automatically added on January 1 of each calendar year for a period of up to ten years , commencing on the first January 1 following the year in which an IPO occurs and ending on, and including, January 1, 2030, in an amount equal to the lesser of (i) 1 % of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, and (ii) 1,000,000 shares of common stock. No shares of common stock have been issued under the ESPP Plan as of December 31, 2021.
The 2020 Plan and the ESPP Plan are administered by the Board of Directors subject to the Board’s right to delegate to a committee. The exercise prices, vesting and other restrictions are determined at the discretion of the Board of Directors. Stock options awarded under the Plans and the 2020 Plan generally expire 10 years after the grant date unless the Board of Directors sets a shorter term. Vesting periods for awards under the Plans and the 2020 Plan are determined at the discretion of the Board of Directors. Stock options granted to employees, officers, members of the Board of Directors and consultants of the Company typically vest over one to four years . Certain options provide for accelerated vesting if there is a change in control, as defined in the Plans and the 2020 Plan.
Share-based compensation expense recorded as research and development and general and administrative expenses in the statements of operations is as follows (in thousands):
Year Ended December 31,
In thousands)
2021
2020
General and administrative
$
2,071
$
441
Research and development
1,377
180
$
3,448
$
621
Unrecognized compensation cost related to unvested options was $ 13.3 million as of December 31, 2021 and will be recognized over an estimated weighted average period of 3.4 years.
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Stock options
The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were:
Year ended December 31,
2021
2020
Expected volatility
83.0
%
83.0
%
Risk-free interest rate
1.0
%
0.6
%
Expected term (in years)
6.0
6.1
Expected dividend yield
—
—
Fair value of common stock
$
23.04
$
5.30
A summary of option activity under the Plans and the 2020 Plan during the year ended December 31, 2021 is as follows:
Weighted
Weighted
average
average
remaining
Number of
exercise price
contractual
shares
per share
term (years)
Outstanding at January 1, 2021
1,472,840
$
3.14
8.51
Granted
803,481
$
23.04
9.25
Forfeited
( 23,031 )
$
19.88
—
Exercised
( 247,534 )
$
0.40
5.21
Outstanding at December 31, 2021
2,005,756
$
11.26
8.50
Exercisable at December 31, 2021
659,478
$
3.14
7.60
Vested or expected to vest at December 31, 2021
2,005,756
$
11.26
8.50
The weighted-average grant date fair value per share of stock options granted during the years ended December 31, 2021 and 2020 was $ 16.49 and $ 3.71 , respectively. The aggregate intrinsic value of stock options exercised during the year ended December 31, 2021 and 2020 was $ 4.0 million and $ 1.2 million, respectively. The aggregate intrinsic value of stock options outstanding at December 31, 2021 and 2020 is $ 11.3 million and $ 10.1 million, respectively.
In August 2020, the Company granted a total of 92,169 stock options to two of its officers, which option awards included both performance-based and service-based vesting conditions. These option awards were subsequently modified in September 2020 to eliminate the performance-based criteria. As a result of the modification, only service-based vesting conditions remained. All other terms and conditions of these option awards remain unchanged. Since the performance condition was not considered probable of being achieved prior to the modification, no share-based compensation expense was recorded prior to the modification. At the time of the modification, the fair value of these options awards was recalculated at $ 8.69 per option.
Restricted Stock Awards
During August 2021, the Company granted 13,500 fully vested shares of common stock to a consultant in exchange for various strategic and advisory services. The Company recorded stock-based compensation expense of $ 0.2 million for the year ended December 31, 2021 related to shares granted. No such transaction occurred for the year ended December 31, 2020. As of December 31, 2021, there was no unvested portion of the restricted stock award as all shares were fully vested upon grant.
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12. Income taxes
A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows:
Year ended
December 31,
2021
2020
Federal tax benefit at statutory rate
21.0
%
21.0
%
State tax, net of federal benefit
8.0
5.8
Research and development credits
2.4
0.9
Permanent differences
0.3
( 6.8 )
Change in valuation allowance
( 31.7 )
( 20.9 )
—
%
—
%
The components of the Company’s deferred taxes are as follows (in thousands):
December 31,
(in thousands)
2021
2020
Deferred tax assets:
Net operating loss carryforwards
$
19,925
$
13,693
Research and development credits
2,157
1,560
Share-based compensation
886
82
Accrued bonus
331
201
Amortization
1
2
Gross deferred tax assets
23,300
15,538
Less: valuation allowance
( 23,255 )
( 15,435 )
Net deferred tax asset
45
103
Deferred tax liability
Depreciation
( 45 )
( 103 )
Total deferred tax liabilities
$
—
$
—
The Company had no income tax expense due to the operating loss incurred for the years ended December 31, 2021 and 2020. Management has evaluated the positive and negative evidence bearing upon the realizability of the Company’s net deferred tax assets and has determined that it is more likely than not that the Company will not recognize the benefits of the net deferred tax assets. As a result, the Company has recorded a full valuation allowance at December 31, 2021 and 2020. The valuation allowance increased by $ 7.8 million and $ 3.7 million in 2021 and 2020, respectively, due to the increase in deferred tax assets, primarily due to net operating loss carryforwards, and research and development tax credits, and deductible accrued expenses.
Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the Internal Revenue Code, certain substantial changes in the Company’s ownership, including a sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss and other attributes including research and development credit carry forwards which could be used annually to offset future taxable income. Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company has not currently completed an evaluation of ownership changes through December 31, 2021 to assess whether utilization of the Company’s net operating loss or research and development credit carryforwards would be subject to an annual limitation under Sections 382 and 383. To the extent an ownership change occurs in the future, the net operating loss and credit carryforwards may be subject to limitation. Further, until a study is completed and any limitation is known, no amounts
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are being presented as an uncertain tax position. As a result, the Company is not able to estimate the effect of the change in control, if any, on the Company’s ability to utilize net operating loss and research and development credit carryforwards in the future. The Company has not yet conducted a study of its research and development credit carryforwards. This study may result in an increase or decrease to the Company’s credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s credits, and if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. As a result, there would be no impact to the Company’s financial statements.
As of December 31, 2021, the Company had $ 68.8 million of federal and $ 69.2 million of state net operating loss carryforwards. As of December 31, 2020, the Company had $ 47.3 million of federal and $ 47.7 million of state net operating loss carryforwards. If not utilized, the federal and state net operating loss carryforwards expire starting in 2027. Included in the federal net operating loss carryforwards are $ 51.8 million of net operating loss generated from 2018 to 2021 that will not expire and are limited to offset 80 % of our taxable income for years beginning after December 31, 2020. Certain federal and state net operating loss carryforwards expire at various dates through 2040. As of December 31, 2021, we had cumulative federal R&D tax credits of $ 2.0 million. These tax credit carryforwards will expire at various dates through 2040.
As of December 31, 2021 and 2020, the Company had no uncertain tax positions. The Company recognizes both interest and penalties associated with unrecognized tax benefits as a component of income tax expense. The Company has no t recorded any interest or penalties for unrecognized tax benefits since its inception.
The Company filed income tax returns in the United States and Pennsylvania in all tax years since inception. The tax years 2016 and beyond remain open to examination by these jurisdictions. Carryforward attributes generated in all years since inception remain subject to adjustment. The Company is not currently under examination by the Internal Revenue Service or any other jurisdiction for these years.
13. Related party transactions
License agreements
The Company has entered into license agreements with shareholders of the Company (see Note 9, Licensing Arrangements). Expenses with these related parties during the years ended December 31, 2021 and 2020 were approximately $ 0.4 million and $ 0.1 million, respectively. Amounts owed to these related parties were approximately $ 0.1 million and $ 0 as of December 31, 2021 and 2020, respectively.
Broadband services agreement
In November 2015, the Company entered into a management services agreement (MSA) with BCM Advisory Partners LLC and Broadband Capital Partners LLC (collectively Broadband Capital). Certain directors of the Company are principals of Broadband Capital. Under the Broadband MSA, the Company engages Broadband Capital as a consultant for advice in connection with senior management matters related to the Company’s business, administration and policies in exchange for a cash fee to Broadband Capital of $ 20,000 per month. The Broadband MSA was amended and/or restated in July 2016, January 2017, June 2018, March 2020 and August 2020. In June 2021, the Company extended the Broadband MSA to continue through June 2022. The Company recorded $ 0.2 million and $ 0.2 million during the years ended December 31, 2021 and 2020, respectively, related to the Broadband MSA, which is included in general and administrative expenses in the statements of operations. There were no amounts due to Broadband Capital as of December 31, 2021 and 2020.
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EXHIBIT INDEX
Exhibit
Number
Description
3.1
Amended and Restated Certificate of Incorporation of Immunome, Inc. (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed October 6, 2020).
3.2
Amended and Restated Bylaws of Immunome, Inc. (incorporated by reference to Exhibit 3.2 to our Current Report on Form 8-K filed October 6, 2020).
4.1
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.2 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020).
4.2
Amended and Restated Investors’ Rights Agreement by and among the registrant and certain of its stockholders, dated as of June 2, 2020 (incorporated by reference to Exhibit 4.1 to our Registration Statement on Form S-1 filed on September 9, 2020).
4.3
Form of 2020 Series A Preferred Stock Warrant (incorporated by reference to Exhibit 4.3 to our Registration Statement on Form S-1 filed on September 9, 2020).
4.4
Form of Amendment to 2020 Series A Preferred Stock Warrants (incorporated by reference to Exhibit 4.4 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020).
4.5
Form of Series B Warrant (incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed on April 26, 2021).
4.6*
Description of Securities
10.1
Form of Indemnification Agreement between the registrant and its directors and officers (incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.2#
Amended and Restated 2008 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.3#
Form of Incentive Stock Option and Option Agreement for the Amended and Restated 2008 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.3 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.4#
Amended and Restated 2018 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.5#
Form of Incentive Stock Option and Option Agreement for the Amended and Restated 2018 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.5 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.6#
2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.6 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020).
10.7#
Forms of Stock Option Grant Notice, Option Agreement, RSU Award Grant Notice and Notice of Exercise for the 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020).
10.8#
2020 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.8 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020).
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10.9
Consulting Agreement by and between the registrant and Michael Lefenfeld, dated as of April 15, 2020 (incorporated by reference to Exhibit 10.13 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.10†
License Agreement by and between the registrant and Arrayjet Limited, dated June 28, 2019, as amended by the Amendment to the License Agreement dated July 10, 2020 (incorporated by reference to Exhibit 10.14 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.11†
Exclusive Patent License Agreement by and between the registrant and the Massachusetts Institute of Technology as licensing agent for Whitehead Institute for Biomedical Research, dated June 25, 2009, as amended by the First Amendment to the Exclusive Patent License Agreement dated December 17, 2009, by the Second Amendment to the Exclusive Patent License Agreement Dated March 21, 2013, by the Third Amendment to the Exclusive Patent License Agreement dated August 21, 2017 and by the Fourth Amendment to the Exclusive Patent License Agreement dated July 21, 2020 (incorporated by reference to Exhibit 10.15 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.12†
Exclusive License Agreement by and between the registrant and Thomas Jefferson University, dated June 1, 2012, as amended by the First Amendment to License Agreement dated October 19, 2017 (incorporated by reference to Exhibit 10.16 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.13†
Second Amendment to License Agreement by and between the registrant and Thomas Jefferson University, dated July 28, 2020 (incorporated by reference to Exhibit 10.17 to our Form 10-Q for the quarterly period ended September 30, 2020 filed on November 16, 2020) .
10.14†
Other Transaction Authority for Prototype Agreement by and between the registrant and the Department of Defense, United States of America, dated July 3, 2020 (incorporated by reference to Exhibit 10.18 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.15
Second Amended and Restated Management Services Agreement, by and among the registrant, BCM Advisory Partners LLC and Broadband Capital Partners LLC, dated as of January 17, 2017, as amended by the Amendment to Second Amended and Restated Management Services Agreement dated June 12, 2018, the Second Amendment to Second Amended and Restated Management Services Agreement dated March 3, 2020 and the Third Amendment to Second Amended and Restated Management Services Agreement dated August 4, 2020 (incorporated by reference to Exhibit 10.19 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.16#
Amended and Restated Employment Agreement by and between the registrant and Purnanand D. Sarma, dated September 23, 2020 (incorporated by reference to Exhibit 10.23 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020)
10.17#
Amended and Restated Employment Agreement by and between the registrant and Michael J. Morin, dated September 23, 2020 (incorporated by reference to Exhibit 10.24 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020)
10.18#
Employment Agreement between the Company and Sandra G. Stoneman effective October 19, 2020. (incorporated by reference to Exhibit 10.26 to our Annual Report on Form 10-K filed on March 25, 2021).
10.19†
Master Services Agreement, between the Company and Abzena (San Diego) Inc dated December 14, 2020 (incorporated by reference to Exhibit 10.27 to our Annual Report on Form 10-K filed on March 25, 2021).
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10.20#
Employment Letter Agreement between the Company and Corleen M. Roche, effective April 19, 2021 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on April 20, 2021).
10.21
Securities Purchase Agreement by and among the Company and the Purchasers signatory thereto, dated April 26, 2021 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on April 26, 2021).
10.22
Engagement Letter, by and between the Company and Ladenburg Thalmann & Co. Inc., dated April 9, 2021, as amended by the Amendment No. 1 thereto, dated April 25, 2021 (incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed on April 26, 2021).
10.23†
Modification of Contract between the Company and the Department of Defense, United States of America, dated May 19, 2021 (portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv)) (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on May 20, 2021).
10.24
Fourth Amendment to Second Amended and Restated Management Services Agreement, dated June 1, 2021, by and between the Company and Broadband Capital Partners LLC (incorporated by reference to Exhibit 10.5 to our Quarterly Report on Form 10-Q filed on August 16, 2021).
10.25#
Second Amended and Restated Employment Agreement, dated August 1, 2021, by and between the Company and Dr. Michael J. Morin, Ph.D. (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on August 5, 2021).
10.26#
Amended and Restated Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q filed on November 15, 2021).
10.27
Open Market Sale Agreement, dated October 1, 2021, by and between Immunome, Inc. and Jefferies LLC (incorporated by reference to Exhibit 1.2 to our Registration Statement on Form S-3 filed on October 1, 2021).
10.28*#
Immunome, Inc. Annual Employee Bonus Plan.
23.1*
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
31.1*
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*
The following financial information from the Annual Report on Form 10 K of IMMUNOME, INC. for the year ended December 31, 2021, formatted in Inline XBRL (eXtensible Business Reporting Language): (1) Balance Sheets as of December 31, 2021 and 2020; (2) Statements of Operations for the years ended December 31, 2021 and 2020; (3) Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2021 and 2020; (4) Statements of Cash Flows for the years ended December 31, 2021 and 2020; and (5) Notes to Financial Statements.
104
Cover Page Interactive Data File (formatted as Inline XBRL).
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*
Filed or furnished herewith.
#
Management contracts or compensatory plans or arrangements
†
Certain portions of this exhibit (indicated by asterisks) have been omitted because they are not material and would likely cause competitive harm to Immunome, Inc. if publicly disclosed.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on March 28, 2022.
IMMUNOME, INC.
By:
/s/ Purnanand D. Sarma
Name: Purnanand D. Sarma, Ph.D.
Title: President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Purnanand D. Sarma, Ph.D. and Corleen M. Roche, and each of them, his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him in his name, place and stead, in any and all capacities, to sign this report, and file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons in the capacities and on the dates indicated on behalf of the Registrant.
Signature
Title
Date
/s/ Purnanand D. Sarma
President, Chief Executive Officer and Director
March 28, 2022
Purnanand D. Sarma, Ph.D.
( Principal Executive Officer )
/s/ Corleen M. Roche
Chief Financial Officer
March 28, 2022
Corleen M. Roche
(Principal Financial Officer)
/s/ Michael Rapp
Director
March 28, 2022
Michael Rapp
/s/ Richard Baron
Director
March 28, 2022
Richard Baron
/s/ John LaMattina
Director
March 28, 2022
John LaMattina, Ph.D.
/s/ Michael Lefenfeld
Director
March 28, 2022
Michael Lefenfeld
/s/ Philip Wagenheim
Director
March 28, 2022
Philip Wagenheim
/s/ Frank Prendergast
Director
March 28, 2022
Frank Prendergast
115
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.