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 Interim 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 Interim Chief Financial Officer have concluded that, as of the end of December 31, 2020, our disclosure controls and procedures are not designed at a reasonable assurance level and are not effective due to the material weaknesses described below.
Management’s Report on Internal Control Over Financial Reporting
This Annual Report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of our independent registered public accounting firm due to a transition period established by rules of the SEC for newly public companies.
Discussion of Material Weaknesses
In connection with our preparation and the audits of our financial statements as of and for the years ended December 31, 2020 and 2019, we identified material weaknesses as defined under the Exchange Act and by the Public Company Accounting Oversight Board (United States) in our internal control over financial reporting. The material weaknesses relate to the design of our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis.
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.
Remediation Activities
We are currently in the process of remediating the material weaknesses and have taken and will continue to take steps that we believe will address the underlying causes of the material weaknesses. The remediation efforts include (i) implementing a monthly financial statement close process that includes formal review of financial statement account balances and journal entries, (ii) creating a disclosure committee consisting of key executives and accounting personnel who review the Company’s financial statements and related disclosures and (iii) actively recruiting for open positions and anticipate hiring additional qualified accounting and financial reporting personnel in 2021. While significant progress has been made to enhance our internal control over financial reporting, we are still in the process of implementing, documenting and testing these processes, procedures and controls. We will continue to devote significant
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time and attention to these remediation efforts. However, the material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
Notwithstanding the material weaknesses, management has concluded that the financial statements included elsewhere in this Annual Report present fairly, in all material respects, our financial position, results of operations and cash flows in conformity with GAAP.
Changes in Internal Control Over Financial Reporting
Other than as described above under “Remediation Activities,” there was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(f) of the Exchange Act that occurred during the quarter ended December 31, 2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
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 2021 annual meeting of stockholders.
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 2021 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 2021 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 2021 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 2021 annual meeting of stockholders.
Part IV
Item 15. Exhibits and Financial Statement Schedules
(a)(1) Financial Statements
See Index to the Consolidated Financial Statements on page 105 of this Annual Report.
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(a)(2) Financial Statement Schedules
None, as all information required in these schedules is included in the Notes to the Consolidated Financial Statements.
(a)(3) Exhibits
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Immunome, Inc.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
106
Balance Sheets as of December 31, 2020 and 2019
107
Statements of Operations for the years ended December 31, 2020 and 2019
108
Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2020 and 2019
109
Statements of Cash Flows for the years ended December 31, 2020 and 2019
110
Notes to Financial Statements
111
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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, 2020 and 2019, the related statements of operations, changes in convertible preferred stock and stockholders’ equity (deficit), and cash flows, for each of the two years ended December 31, 2020 and 2019 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, 2020 and 2019, and the results of its operations and its cash flows for each of the two years ended December 31, 2020 and 2019, 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 25, 2021
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,
2020
2019
Assets
Current assets:
Cash
$
39,766
$
2,543
Prepaid expenses and other current assets
3,128
579
Total current assets
42,894
3,122
Property and equipment, net
1,531
1,700
Restricted cash
100
100
Other assets
—
138
Total assets
$
44,525
$
5,060
Liabilities, convertible preferred stock, and stockholders’ equity (deficit)
Current liabilities:
Current portion of capital lease obligations
$
—
$
239
Current portion of long-term debt
366
—
Current portion of equipment loan payable
113
212
Accounts payable
1,187
548
Accrued expenses and other current liabilities
1,372
666
Total current liabilities
3,038
1,665
Equipment loan payable, net of current portion
—
113
Long-term debt, net of current portion
134
—
Deferred rent
8
18
Total liabilities
3,180
1,796
Commitments and contingencies (Note 10)
Series A convertible preferred stock, $ 0.0001 par value; No shares authorized, issued or outstanding at December 31, 2020; 30,000,000 shares authorized and 4,443,259 shares issued and outstanding at December 31, 2019 (liquidation value of $ 39,990 at December 31, 2019)
—
38,894
Stockholders’ equity (deficit):
Common stock, $ 0.0001 par value; 200,000,000 and 50,000,000 shares authorized at December 31, 2020 and 2019, respectively; 10,634,245 shares issued and outstanding at December 31, 2020 and 1,099,270 shares issued and outstanding at December 31, 2019
1
—
Additional paid-in capital
95,738
927
Accumulated deficit
( 54,394 )
( 36,557 )
Total stockholders’ equity (deficit)
41,345
( 35,630 )
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)
$
44,525
$
5,060
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,
2020
2019
Operating expenses:
Research and development
$
7,486
$
8,823
General and administrative
4,775
1,525
Total operating expenses
12,261
10,348
Loss from operations
( 12,261 )
( 10,348 )
Other expenses:
Change in fair value of warrant liability
( 5,538 )
—
Interest expense, net
( 38 )
( 96 )
Total other expenses
( 5,576 )
( 96 )
Net loss
$
( 17,837 )
$
( 10,444 )
Per share information:
Net loss per share of common stock, basic and diluted
$
( 5.26 )
$
( 9.55 )
Weighted-average common shares outstanding, basic and diluted
3,389,592
1,093,959
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, 2019
3,108,776
$
27,513
1,087,821
$
—
$
908
$
( 26,113 )
$
( 25,205 )
Issuance of Series A convertible preferred stock upon conversion of debt
821,657
6,800
—
—
—
—
—
Sale of Series A convertible preferred stock, net of $ 35 of issuance costs
512,826
4,581
—
—
—
—
—
Share-based compensation expense
—
—
—
—
14
—
14
Exercise of stock options
—
—
11,449
—
5
—
5
Net loss
—
—
—
—
—
( 10,444 )
( 10,444 )
Balance at December 31, 2019
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
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,
2020
2019
Cash flows from operating activities:
Net loss
$
( 17,837 )
$
( 10,444 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
755
615
Share-based compensation
621
14
Change in fair value of warrant liability
5,538
—
Deferred rent
( 2 )
3
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 2,411 )
( 53 )
Accounts payable
504
75
Accrued expenses and other current liabilities
698
190
Net cash used in operating activities
( 12,134 )
( 9,600 )
Cash flows from investing activities:
Purchases of property and equipment
( 586 )
( 233 )
Net cash used in investing activities
( 586 )
( 233 )
Cash flows from financing activities:
Proceeds from convertible promissory notes
—
6,800
Proceeds from exercise of stock options
20
5
Proceeds from long-term debt
500
—
Proceeds from the sale of common stock in connection with IPO
44,850
—
Payment of IPO costs
( 5,973 )
—
Proceeds from the sale of Series A convertible preferred stock
11,046
4,616
Payment of Series A convertible preferred stock issuance costs
( 49 )
( 35 )
Payment of equipment loan payable
( 212 )
( 225 )
Payment of capital lease obligations
( 239 )
( 387 )
Net cash provided by (used in) financing activities
49,943
10,774
Net increase (decrease) in cash and restricted cash
37,223
941
Cash and restricted cash at beginning of year
2,643
1,702
Cash and restricted cash at end of year
$
39,866
$
2,643
Supplemental disclosures of cash flow information:
Cash paid for interest
$
29
$
106
Supplemental disclosures of non-cash investing and financing activities:
Conversion of Series A convertible preferred stock upon IPO
$
48,369
$
—
IPO costs included in accounts payable
$
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
$
—
Issuance of Series A convertible preferred stock upon conversion of convertible promissory notes
$
—
$
6,800
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 biotechnology company focused on identifying novel cancer immunotherapies utilizing a patented process to immortalize human B cells.
Since its inception, the Company has devoted substantially all of 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 biotechnology industry including, but not limited to; technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenues from product sales.
Liquidity
The Company has incurred net losses since inception, including net losses of $ 17.8 million and $ 10.4 million for the years ended December 31, 2020 and 2019, 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, 2020 and 2019, the Company had an accumulated deficit of $ 54.4 million and $ 36.6 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.
The Company expects that its cash as of December 31, 2020 will be sufficient to fund its operations through the second fiscal quarter of 2022. 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, 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
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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).
Reverse stock split
The Company’s board of directors approved a one-for- six reverse stock split of its issued and outstanding common stock, stock options, convertible preferred stock and convertible preferred stock warrants legally effective as of September 22, 2020. Accordingly, all convertible preferred shares and common stock shares, common stock warrants, per share amounts, and additional paid-in capital amounts for all periods presented in the accompanying financial statements and notes thereto have been retroactively adjusted, where applicable, to reflect the reverse stock split.
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 in connection with share-based compensation arrangements and the fair value of the warrant liability. Actual results could differ from these estimates.
Cash
Cash consists 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. There are no cash equivalents as of December 31, 2020 and 2019.
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 2022 at which time the cash will be released from restriction. Restricted cash was $ 100,000 at both December 31, 2020 and 2019. For purposes of the cash flow statements, this restricted cash is combined with cash at December 31, 2020 and 2019.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and restricted cash. 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.
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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, 2020 and 2019.
Equity issuance costs
The Company capitalized incremental legal, professional, accounting and other third-party fees that were directly associated with the IPO as other noncurrent assets until the IPO was consummated. After consummation of the IPO in October 2020, these costs were recorded in stockholders’ deficit as a reduction of additional paid-in-capital generated as a result of the IPO. As of December 31, 2020, there were no deferred offering costs.
Preferred stock
The Company had classified the Series A Preferred as temporary equity in the accompanying balance sheet at December 31, 2019 because it became redeemable due to certain deemed liquidation events, as defined in the Company’s articles of incorporation, that were outside of the Company’s control. The Company accreted the Series A Preferred to redemption when such deemed liquidation events were probable. No accretion has been recognized during the years ended December 31, 2020 and 2019 as redemption was not probable. The Series A Preferred converted into common stock in connection with the IPO (see Note 1) and was reclassified to stockholders’ equity in October 2020.
Government contract funding
The Company accounts for amounts received under its U.S. Department of Defense 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 is contingently redeemable and outside of the Company’s control (see Note 12, 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
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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 in October 2020 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 (see Note 10, 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, 2020 and 2019. Costs for certain research and development activities are recognized based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, 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.
The Company accounts for its share-based compensation in using the fair value method and all share-based payments to employees, non-employees and directors, are recognized as expense in the statements of operations based on their fair values. 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 Company’s share-based compensation awards are subject to service-based vesting conditions. Compensation expense related to awards to employees, directors and non-employees with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term.
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 life science industry focus. The historical volatility is calculated based on a period of time commensurate with 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
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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.
Prior to the adoption of Compensation — Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (ASU 2018-07), the measurement date for non-employee awards was generally the date the services are completed, resulting in financial reporting period adjustments to share-based compensation during the vesting terms for changes in the fair value of the awards. After the adoption of ASU 2018-07 on January 1, 2018, the measurement date for non-employee awards is the date of grant without changes in the fair value of the award.
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 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
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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.
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.
The following potentially dilutive securities 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,
2020
2019
Stock options (1)
1,472,840
583,622
Common stock warrants (1)
1,035,196
—
Convertible preferred stock (1)
—
4,443,260
2,508,036
5,026,882
(1) Represents common stock equivalents
The Company’s Series A Preferred had 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 reports 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, 2020 and 2019.
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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.
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 ASU No. 2016-02, Leases (ASC 842) which requires a lessee to record a right-of-use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. 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 is currently evaluating the expected impact that the standard could have on its financial statements and related disclosures.
3. Fair value measurement
A reconciliation of the change in the fair value of the warrant liability for the year ended December 31, 2020 is as follows (in thousands).
Fair Value
Measurements
Using Significant
Unobservable
Inputs
(Level 3)
Balance, December 31, 2019
$
—
Issuance of warrants on June 2, 2020
1,522
Change in fair value of warrant liability
5,538
Reclass of warrant liability to additional paid-in capital upon IPO
( 7,060 )
Warrant liability, December 31, 2020
$
—
A summary of the inputs used in the Black-Scholes pricing model to fair value the warrants are disclosed in Note 12.
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4. Property and equipment, net
Property and equipment consisted of the following:
December 31,
(in thousands)
2020
2019
Lab equipment
$
3,506
$
2,942
Leasehold improvements
185
184
Computer equipment
96
76
Office equipment and furniture and fixtures
18
17
3,805
3,219
Less accumulated depreciation and amortization
( 2,274 )
( 1,519 )
Property and equipment, net
$
1,531
$
1,700
Depreciation and amortization expense for the years ended December 31, 2020 and 2019 was $ 0.8 million and $ 0.6 million , respectively. There were no assets under capital leases as of December 31, 2020. At December 31, 2019, the Company had $ 1.1 million of laboratory equipment under capital leases.
5. Department of Defense (DoD) expense reimbursement contract
In July 2020, the Company entered into an Other Transaction Authority for Prototype Agreement (the DoD Agreement) with the DoD to fund the Company’s efforts in developing Biosynthetic Convalescent Plasma (BCP) to treat COVID-19. Under the DoD Agreement, the Company intends to develop BCP for use in the U.S. military population and the U.S. population as a whole, subject to approval by the U.S. Food and Drug Administration (FDA). The amount of funding being made available to the Company under this expense reimbursement contract is $ 13.3 million which, based on the Company’s anticipated expenditures, is expected to be received through mid-2021. The Company recorded contra-research and development expense of $ 1.7 million for the year ended December 31, 2020 in the statements of operations. As of December 31, 2020, the Company had an expense reimbursement receivable balance of $ 0.9 million due from the DoD in prepaid expenses and other current assets on the balance sheet.
6. Accrued expenses
Accrued expenses consisted of the following:
December 31,
(in thousands)
2020
2019
Compensation and related benefits
$
845
$
426
Professional fees, contractors and other
527
240
$
1,372
$
666
7 . Convertible promissory notes
From January 2019 through July 2019, the Company issued $ 6.8 million of non-interest bearing convertible promissory notes to several existing Series A Preferred shareholders and new investors. The notes were to mature on February 2, 2020, if not converted or otherwise settled prior to maturity. Upon completion of a qualified equity financing event, as defined in the note agreement, the notes were to automatically convert into shares of the stock sold in such a qualified financing and at a price equal to 80 % of the subscription price. In the event that the Company were to sell additional shares of Series A Preferred prior to a qualified financing event, the notes were to automatically convert into shares of Series A Preferred at a discount to the $ 9.00 per share subscription price. The discount was equal to 1 % for each month that has lapsed from the initial note issuance date to the date in which the extended sale of Series A Preferred is consummated.
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In November 2019, the Company completed the sale of its Series A Preferred and the notes automatically converted into 821,657 shares of Series A Preferred. The effective conversion price of the notes was less than the fair value of the Series A Preferred and therefore, no beneficial conversion feature was recorded for the discount.
The Company accounted for the conversion upon a qualified financing event as a bifurcated redemption feature as settlement under this feature would be in a variable number of shares and at a substantial discount. At issuance and over the term of the note, the Company determined the probability of settlement pursuant to the qualified financing event to be remote. As such, the estimated fair value of the redemption feature was de minimis.
8. Equipment loan payables
The Company entered into various equipment financing agreements (the Agreements) to purchase laboratory equipment. The Agreements provide for 36 to 38 monthly payments ranging from $ 1,000 to $ 8,000 . Interest rates for the Agreements range from 9.03 % to 12.08 %, and interest expense related to the equipment financing agreements was $ 21,000 and $ 46,000 for the years ended December 31, 2020 and 2019, respectively.
Future payments for the Company’s Agreements are as follows (in thousands):
Year ending December 31,
Amount
2021
$
117
Total
117
Less amounts representing interest
( 4 )
Total equipment loan payable
$
113
9. 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 (the Loan) pursuant to the Paycheck Protection Program (“PPP”) under the Coronavirus Aid, Relief, and Economic Security (CARES) Act and implemented by the U.S. Small Business Administration (“SBA”). The Company is using the proceeds of the Loan for payroll and other qualifying expenses. The Company may apply for forgiveness of amounts due under the Loan, with the amount of potential loan forgiveness to be calculated in accordance with the requirements of the PPP based on payroll costs, any mortgage interest payments, any covered rent payments and any covered utilities payments during the 8 or 24-week period after the origination date of the Loan. The Loan matures in two years and bears interest at a rate of 1 % per year, with all payments deferred through the six-month anniversary of the date of the Loan or until a conclusion has been reached as to whether the Loan will be forgiven. In January 2021, the Company applied to the SBA for forgiveness and is awaiting a decision. While the Company believes that its use of the Loan proceeds will meet the conditions of forgiveness of the Loan, it cannot be assured that actions taken could cause the Company to be ineligible for forgiveness of the Loan, in whole or in part. Proceeds received are recorded as long-term debt. In the event the debt is forgiven in a future period, the Company will recognize a gain on extinguishment in the statement of operations. Interest expense for the year ended December 31, 2020 was de minimis.
Years ending December 31,
Amount
2021
$
366
2022
134
Total
500
Less current portion of long-term debt
( 366 )
Long-term debt, net of current portion
$
134
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10. 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 two additional five-year terms. 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 $ 16,000 and $ 18,000 as of December 31, 2020 and 2019, 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 expires 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
2021
$
349
2022
153
$
502
Rent expense for the years ended December 31, 2020 and 2019 was $ 0.4 million and $ 0.3 million, respectively.
Capital leases
During 2016 and 2017, the Company entered into multiple capital leases (the leases) for laboratory equipment. All of the leases expired during 2020. Interest expense related to the leases was $ 7,000 and $ 60,000 for the years ended December 31, 2020 and 2019, respectively.
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 $ 74,000 and $ 61,000 to the 401(k) Plan for the years ended December 31, 2020 and 2019, 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.
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11. Licensing arrangements
2009 license agreement
In June 2009, the Company entered into and subsequently amended a license agreement (the 2009 License Agreement) with two research institutions (the 2009 Licensors) for certain base editing technology pursuant to which the Company received an exclusive, worldwide, sublicensable, royalty-bearing license under specified patent rights to develop and commercialize licensed products and a nonexclusive, worldwide, sublicensable, royalty-bearing license under certain patent rights to research and develop licensed products. The Company agreed to use commercially reasonable efforts to develop licensed products in accordance with the development plan, to introduce any licensed products that gain regulatory approval into the commercial market, to market licensed products that have gained regulatory approval following such introduction into the market, and to make licensed products that have gained regulatory approval reasonably available to the public. The license term extends until the later of the expiration of (i) the last to expire licensed patent covering a licensed product, (ii) the period of exclusivity associated with a licensed product or (iii) a certain period after the first commercial sale of a licensed product, unless terminated earlier by either party under certain provisions. The 2009 License Agreement was subsequently amended in December 2009, March 2013, August 2017 and July 2020.
The Company agreed to pay to the 2009 Licensors an annual license maintenance fee in the mid five figures. The Company is responsible for the payment of certain patent prosecution and maintenance costs incurred by the 2009 Licensors related to licensed patents. To the extent achieved, the Company is obligated to pay $ 0.7 million in the aggregate for certain development, regulatory and commercial milestones and $ 0.3 million for each product or derivative that the Company discovers using the licensed product or processes. To the extent there are sales of a licensed product, the Company is required to pay low single digit royalties on net sales. If the Company sublicenses its rights to develop or commercialize a licensed product under the 2009 License Agreement to a third party and the Company receives non-royalty sublicense income, then the 2009 Licensors are entitled to a percentage of such consideration, ranging from the high single digits to low double digits depending on the date in which such sublicense agreement is executed and the stage of development of the Company’s licensed products at such time.
The Company concluded that the licensing rights acquired from the 2009 Licensors did not meet the accounting definition of a business as inputs, but no processes or outputs were acquired with the license. As the inputs that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As of the date of the 2009 License Agreement, the assets acquired had no alternative future use as the assets had not reached a stage of technological feasibility. As a result, all share-based and cash payment obligations have been recorded as research and development expense in the statements of operations.
The Company is monitoring the development and regulatory milestone payments for this arrangement on an ongoing basis. The achievement of these milestone payments was not considered probable as of the acquisition date through December 31, 2020, as such, no expense has been recorded for these milestones for the years ended December 31, 2020 and 2019. To the extent products are commercialized under the 2009 License Agreement, the Company will accrue royalty expense and sublicense nonroyalty payments, as applicable, for the amount it is obligated to pay, with adjustments as sales are made.
2012 license agreement
In June 2012, the Company entered into a license agreement (the 2012 License Agreement) with a medical institution (the 2012 Licensor) for certain patent rights, know-how, and materials pursuant to which the Company received an exclusive, worldwide, sublicensable (with certain restrictions), royalty-bearing license under specified patent rights to develop and commercialize licensed products. The Company agreed to use commercially reasonable efforts to develop licensed products in accordance with the development plan, to introduce any licensed products that gain regulatory approval into the commercial market, to market licensed products that have gained regulatory approval following such introduction into the market, and to make licensed products that have gained regulatory approval reasonably available to the public. The license term extends until the last patent or patent application has expired or been abandoned or unless terminated earlier by either party under certain provisions. The 2012 License Agreement was
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amended in October 2017 to change the terms of the royalty and milestone payments and was further amended in July 2020.
The Company is responsible for the payment of certain patent prosecution and maintenance costs incurred by the 2012 Licensor related to licensed patents. To the extent achieved, the Company is obligated to pay up to an aggregate of $ 1.0 million in product development and regulatory approval milestones. To the extent there are sales of a licensed product, the Company is required to pay low single digit royalties on net sales. If the Company sublicenses its rights to develop or commercialize a licensed product under the 2012 License Agreement to a third party and the Company receives non-royalty sublicense income, then the 2012 Licensor is entitled to a percentage of such consideration.
The Company concluded that the licensing rights acquired from the 2012 Licensor did not meet the accounting definition of a business as inputs, but no processes or outputs were acquired with the license. As the inputs that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As of the date of the 2012 License Agreement, the assets acquired had no alternative future use as the assets had not reached a stage of technological feasibility.
The Company is monitoring the development and regulatory milestone payments for this arrangement on an ongoing basis. The achievement of these milestone payments was not considered probable as of the acquisition date through December 31, 2020, and as such, no expense has been recorded for these milestones for the years ended December 31, 2020 and 2019. To the extent products are commercialized under the 2012 License Agreement, the Company will accrue royalty expense and sublicense nonroyalty payments, as applicable, for the amount it is obligated to pay, with adjustments as sales are made.
2019 license agreement
In June 2019, the Company entered into an exclusive license agreement (the 2019 License Agreement) with a company (the 2019 Licensor) for certain methods and apparatus for substrate handling and printing technology pursuant to which the Company received an exclusive, worldwide, sublicensable, royalty-bearing license under specified patent rights and know-how to research, develop, make, have made, use, sell, offer for sale, market, and otherwise commercialize licensed products. The Company agreed to use commercially reasonable efforts to develop licensed products in accordance with the development plan, to introduce any licensed products that gain regulatory approval into the commercial market, to market licensed products that have gained regulatory approval following such introduction into the market, and to make licensed products that have gained regulatory approval reasonably available to the public. The license term extends until the last patent or patent application has expired or been abandoned or unless terminated earlier by either party under certain provisions.
As part of the 2019 License Agreement, the Company is required to pay an exclusivity fee in the low six figures. The Company is also responsible for the payment of certain patent prosecution and maintenance costs incurred by the 2019 Licensor related to licensed patents. To the extent there are sales of a licensed product, the Company is required to pay low single digit royalties on net sales. If the Company sublicenses its rights to develop or commercialize a licensed product under the 2019 License Agreement to a third party and the Company receives non-royalty sublicense income, then the 2019 Licensor is entitled to a percentage of such consideration.
The Company concluded that the licensing rights acquired from the 2019 Licensor did not meet the accounting definition of a business as inputs, but no processes or outputs were acquired with the license. As the inputs that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As of the date of the 2019 License Agreement, the assets acquired had no alternative future use as the assets had not reached a stage of technological feasibility. As a result, all cash payment obligations have been recorded as research and development expense in the statement of operations.
The Company pays an annual exclusivity fee related to the 2019 License Agreement and recognized $ 175,000 and $ 63,000 as license fee expense in research and development for the years ended December 31, 2020 and 2019, respectively. Annual patent costs will be expensed as incurred. To the extent products are commercialized under the 2019 License Agreement, the Company will accrue royalty expense and sublicense nonroyalty payments, as applicable, for the amount it is obligated to pay, with adjustments as sales are made.
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12. 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 holders of common stock shall be entitled to share ratably in the remaining assets of the Company available for distribution.
In October 2020, the Company closed its IPO in which the Company issued and sold 3,757,500 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’ 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.
During the year ended December 31, 2019, the Company sold 512,826 shares of its Series A Preferred at $ 9.00 per share in exchange for $ 4.6 million in gross proceeds and incurred $ 35,000 of related issuance costs. In November 2019, the Company issued 821,657 shares of Series A Preferred in connection with the conversion of the promissory notes of $ 6.8 million (see Note 7, Convertible Promissory Notes). In June 2020, the Company completed the sale of an additional 1,226,925 shares of Series A Preferred at $ 9.00 per share, resulting in gross cash proceeds of $ 11.0 million. In addition to the shares of Series A Preferred, the Company issued 1,035,196 warrants to purchase shares of the Company’s Series A Preferred with a fair value of $ 1.5 million. The warrants were exercisable at any time and had an exercise price of $ 9.00 per share and were to terminate at the earlier of (i) three years from the date of issuance, (ii) upon liquidation of the Company and (iii) upon the Company’s securities trading at $ 27.00 per share for at least 10 days out of a consecutive 20 -day trading period beginning after the first anniversary of the IPO.
In connection with the Company’s sale of its Series A Preferred in 2015, a future milestone closing provision (the Future Milestone) was included requiring the Company to sell, on the same terms and conditions as the initial offering, an aggregate of $ 3.5 million of additional Series A Preferred upon achievement of certain development and strategic milestones, as defined in the purchase agreement and at $ 9.00 per share, or 388,888 shares of Series A Preferred. The Future Milestone was not achieved and the Company’s obligations under this right terminated upon completion of the Company’s IPO.
The Company determined that the future tranche right related to the Future Milestone did not meet the definition of a freestanding financial instrument as it was not legally detachable. The future tranche right was also evaluated as an embedded derivative and the Company determined it did not meet the definition of a derivative instrument for which bifurcation would be required.
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.
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Warrants to acquire shares of common stock
At December 31, 2020 there are 1,035,196 warrants outstanding to acquire shares of the Company’s common stock. The warrants were issued in connection with the June 2020 sale of the Company’s Series A convertible preferred stock and originally entitled the holders to acquire shares of the Company’s Series A Preferred. These warrants were originally liability-classified as the underlying Series A convertible preferred stock was contingently redeemable and outside of the Company’s control. The warrants had a grant date fair value of $ 1.5 million and a warrant liability was recorded in the balance sheet upon issuance. Upon completion of the IPO on October 6, 2020, the warrants became exercisable for shares of the Company’s common stock and the $ 7.1 million warrant liability was reclassified to additional paid-in capital (see Note 3).
The fair value of the warrants was estimated using a Black-Scholes pricing model with the following inputs:
June 2, 2020
October 6, 2020
Volatility rate
79.0
%
82.0
%
Risk-free interest rate
0.2
%
0.2
%
Expected term (in years)
3.0
2.7
Strike price (per share)
$
9.00
$
9.00
Fair value of Series A convertible preferred stock
$
4.44
$
12.00
13. 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 nonqualified 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 Immunome, Inc. 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. Any additional shares that become available for grant under the 2008 Plan are automatically transferred to and made available for grant under the 2018 Plan. On September 24, 2020, the Plans were terminated and replaced with the 2020 Equity Incentive Plan (the 2020 Plan). The remaining 298,277 shares available for grant under the Plans are available for issuance under the 2020 Plan and an additional 1,701,723 shares were authorized under the 2020 Plan.
The Company also adopted the 2020 Employee Stock Purchase Plan (the 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 1st 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 31st of the preceding calendar year, and (ii) 1,000,000 shares of common stock. No awards have been granted under the ESPP Plan as of December 31, 2020.
The 2020 Plan and the ESPP Plan are administered by the board of directors. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors. Stock options awarded under the Plans 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. Incentive stock options and non-statutory stock options granted to employees, officers, members of the board of directors and consultants of the Company typically vest over two 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.
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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)
2020
2019
General and administrative
$
441
$
5
Research and development
180
9
$
621
$
14
Unrecognized compensation cost related to unvested options was $ 3.6 million as of December 31, 2020 and will be recognized over an estimated weighted average period of 3.88 years.
Stock options
The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were:
Year ended December 31,
2020
2019
Expected volatility
83.0
%
73.7
%
Risk-free interest rate
0.6
%
2.5
%
Expected term (in years)
6.1
5.3
Expected dividend yield
—
—
Fair value of common stock
$
5.30
$
0.36
A summary of option activity under the Plans during the year ended December 31, 2020 is as follows:
Weighted
Weighted
average
average
remaining
Number of
exercise price
contractual
shares
per share
term (years)
Outstanding at January 1, 2020
583,622
$
0.47
6.30
Granted
1,168,618
$
4.90
Forfeited
( 152,109 )
$
8.90
Exercised
( 127,291 )
$
0.16
Outstanding at December 31, 2020
1,472,840
$
3.14
8.51
Exercisable at December 31, 2020
632,524
$
0.89
7.38
Vested or expected to vest at December 31, 2020
1,472,840
$
3.14
8.51
The weighted-average grant date fair value per share of stock options granted during the years ended December 31, 2020 and 2019 was $ 3.71 and $ 0.24 , respectively. The aggregate intrinsic value of stock options exercised during the year ended December 31, 2020 was $ 1.2 million and for the year ended December 31, 2019 was de minimis. The aggregate intrinsic value of stock options outstanding at December 31, 2020 and 2019 is $ 10.1 million and $ 0.2 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.
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14. Income taxes
A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows:
Year ended
December 31,
2020
2019
Federal tax benefit at statutory rate
21.0
%
21.0
%
State tax, net of federal benefit
5.8
7.9
Research and development credits
0.9
3.8
Permanent differences
( 6.8 )
( 0.1 )
Change in valuation allowance
( 20.9 )
( 32.6 )
—
%
—
%
The components of the Company’s deferred taxes are as follows (in thousands):
December 31,
(in thousands)
2020
2019
Deferred tax assets:
Net operating loss carryforwards
$
13,693
$
10,202
Research and development credits
1,560
1,355
Share-based compensation
82
194
Accrued bonus
201
120
Amortization
2
3
Gross deferred tax assets
15,538
11,874
Less: valuation allowance
( 15,435 )
( 11,711 )
Net deferred tax asset
103
163
Deferred tax liability
Depreciation
( 103 )
( 163 )
Total deferred tax liabilities
$
—
$
—
The Company had no income tax expense due to the operating loss incurred for the years ended December 31, 2020 and 2019. 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, 2020 and 2019. The valuation allowance increased by $ 3.7 million and $ 3.4 million in 2020 and 2019, 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, 2020 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 are being presented as an uncertain tax position. As a result, the Company is not able to estimate the effect of the change
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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, 2020, the Company had $ 47.3 million of federal and $ 47.7 million of state net operating loss carryforwards. As of December 31, 2019, the Company had $ 35.3 million of federal and $ 35.3 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 is $ 18.3 million of net operating loss generated in 2018 and 2019 that will not expire. Federal net operating loss carryforwards of $ 12.3 million and $ 10.0 million generated in 2020 and 2019, respectively, will be limited to offset 80 % of our taxable income for taxable years beginning after December 31, 2020. Certain federal and state net operating loss carryforwards expire at various dates through 2039. As of December 31, 2020, we had cumulative federal R&D tax credits of $ 1.4 million. These tax credit carryforwards will expire at various dates through 2039.
As of December 31, 2020 and 2019, 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 not 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.
15. Interest expense, net
Interest expense, net consisted of the following:
Year Ended December 31,
(in thousands)
2020
2019
Capital lease obligations interest expense
$
( 18 )
$
( 60 )
Equipment loan payable interest expense
( 21 )
( 46 )
Interest income
1
10
$
( 38 )
$
( 96 )
16. Related party transactions
License agreements
The Company has entered into license agreements with shareholders of the Company (see Note 11, Licensing Arrangements). Expenses with these related parties during the years ended December 31, 2020 and 2019 were approximately $ 0.1 million and $ 0.2 million, respectively. There were no amounts owed to these related parties as of December 31, 2020 and 2019.
Convertible promissory notes
During the year ended December 31, 2019, the Company received $ 6.8 million upon issuing convertible promissory notes, of which $ 3.8 million was from several of its existing preferred stock investors. All of the convertible promissory notes were converted into shares of Series A Preferred (see Note 7, Convertible Promissory Notes).
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Broadband services agreement
During November 2015, the Company entered into a Master Services Agreement (MSA) with BCM Advisory Partners LLC, Broadband Capital Partners LLC and Broadband Advisory (collectively, Broadband) pursuant to which Broadband will provide corporate finance, strategic planning, and management recruiting services to the Company. The Company is required to pay Broadband a cash fee of $ 20,000 per month, retroactive to May 1, 2016, for Broadband’s advisory services. The Company recorded $ 0.2 million and $ 0.2 million during the years ended December 31, 2020 and 2019, respectively, related to the Broadband MSA which is included in general and administrative expenses in the statements of operations.
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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*
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#
Offer Letter Agreement by and between the registrant and Purnanand D. Sarma, dated as of May 30, 2019 (incorporated by reference to Exhibit 10.9 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.10#
Amendment to Offer Letter Agreement by and between the registrant and Purnanand D. Sarma, dated as of August 5, 2020 (incorporated by reference to Exhibit 10.10 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.11#
Amended and Restated Offer Letter Agreement by and between the registrant and Michael J. Morin, dated as of August 5, 2020 (incorporated by reference to Exhibit 10.11 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.12#
Consulting Agreement by and between the registrant and Diane Marcou, dated as of May 1, 2020 (incorporated by reference to Exhibit 10.12 to our Registration Statement on Form S-1 filed on September 9, 2020).
10.13
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).
10.14†
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).
10.15†
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).
10.16†
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).
10.17†
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) .
10.19†
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).
10.20
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).
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10.22
Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.22 to Amendment No. 1 to our Registration Statement on Form S-1/A filed on September 24, 2020).
10.23#
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)
10.24#
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)
10.25#
Separation Agreement and General Release between the Company and Richard Fitzgerald, dated December 1, 2020 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on November 30, 2020)
10.26*#
Employment Agreement between the Company and Sandra G. Stoneman effective October 19, 2020.
10.27*†
Master Services Agreement, between the Company and Abzena (San Diego) Inc dated December 14, 2020.
31.1*
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Interim 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 Interim 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, 2020, formatted in Inline XBRL (eXtensible Business Reporting Language): (1) Balance Sheets as of December 31, 2020 and 2019; (2) Statements of Operations for the years ended December 31, 2020 and 2019; (3) Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2020 and 2019; (4) Statements of Cash Flows for the years ended December 31, 2020 and 2019; and (5) Notes to Financial Statements.
104
Cover Page Interactive Data File (formatted as Inline XBRL).
*
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 25, 2021.
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 Diane Marcou, 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 25, 2021
Purnanand D. Sarma, Ph.D.
( Principal Executive Officer )
/s/ Diane Marcou
Interim Chief Financial Officer
March 25, 2021
Diane Marcou
(Principal Financial Officer and Principal Accounting Officer)
/s/ Michael Rapp
Director
March 25, 2021
Michael Rapp
/s/ Richard Baron
Director
March 25, 2021
Richard Baron
/s/ John LaMattina
Director
March 25, 2021
John LaMattina, Ph.D.
/s/ Michael Lefenfeld
Director
March 25, 2021
Michael Lefenfeld
/s/ Philip Wagenheim
Director
March 25, 2021
Philip Wagenheim
/s/ Michael Widlitz
Director
March 25, 2021
Michael Widlitz
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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.