Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 02, 2022 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Current Fiscal Year End Date | --12-31 | |
Document Transition Report | false | |
Entity File Number | 001-39580 | |
Entity Registrant Name | Immunome, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0694340 | |
Entity Address, Address Line One | 665 Stockton Drive | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | Exton | |
Entity Address State Or Province | PA | |
Entity Address, Postal Zip Code | 19341 | |
City Area Code | 610 | |
Local Phone Number | 321-3700 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Trading Symbol | IMNM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,127,385 | |
Entity Central Index Key | 0001472012 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 34,649,000 | $ 49,229,000 |
Prepaid expenses and other current assets | 2,949,000 | 7,409,000 |
Total current assets | 37,598,000 | 56,638,000 |
Property and equipment, net | 807,000 | 855,000 |
Operating right-of-use asset, net | 182,000 | |
Restricted cash | 100,000 | 100,000 |
Deferred offering costs | 332,000 | 332,000 |
Total assets | 39,019,000 | 57,925,000 |
Current liabilities: | ||
Accounts payable | 5,259,000 | 3,077,000 |
Accrued expenses and other current liabilities | 3,359,000 | 6,651,000 |
Total current liabilities | 8,618,000 | 9,728,000 |
Other long-term liabilities | 124,000 | 12,000 |
Total liabilities | 8,742,000 | 9,740,000 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at June 30, 2022 and December 31, 2021, respectively | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 12,127,385 and 12,110,373 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1,000 | 1,000 |
Additional paid-in capital | 129,958,000 | 127,289,000 |
Accumulated deficit | (99,682,000) | (79,105,000) |
Total stockholders' equity | 30,277,000 | 48,185,000 |
Total liabilities and stockholders' equity | $ 39,019,000 | $ 57,925,000 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Condensed Balance Sheets | ||
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 12,127,385 | 12,110,373 |
Common stock, shares outstanding (in shares) | 12,127,385 | 12,110,373 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 5,717 | $ 3,233 | $ 13,795 | $ 5,212 |
General and administrative | 3,209 | 2,507 | 6,785 | 4,425 |
Total operating expenses | 8,926 | 5,740 | 20,580 | 9,637 |
Loss from operations | (8,926) | (5,740) | (20,580) | (9,637) |
Other income (expenses): | ||||
Other income | 500 | 500 | ||
Interest income (expense), net | 2 | (1) | 3 | (2) |
Net loss | $ (8,924) | $ (5,241) | $ (20,577) | $ (9,139) |
Per share information: | ||||
Net loss per share of common stock, Basic | $ (0.74) | $ (0.46) | $ (1.70) | $ (0.83) |
Net loss per share of common stock, Diluted | $ (0.74) | $ (0.46) | $ (1.70) | $ (0.83) |
Weighted-average common shares outstanding, Basic | 12,127,385 | 11,456,991 | 12,125,156 | 11,051,185 |
Weighted-average common shares outstanding, Diluted | 12,127,385 | 11,456,991 | 12,125,156 | 11,051,185 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common stock. | Additional paid-in capital | Accumulated deficit | Total |
Balance at Dec. 31, 2020 | $ 1 | $ 95,738 | $ (54,394) | $ 41,345 |
Balance (shares) at Dec. 31, 2020 | 10,634,245 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Sale of common stock and common stock warrants | 26,404 | 26,404 | ||
Sale of common stock and common stock warrants, shares | 1,000,000 | |||
Share-based compensation expense | 1,074 | 1,074 | ||
Exercise of common stock warrants | 906 | 906 | ||
Exercise of common stock warrants (shares) | 146,017 | |||
Exercise of stock options | 27 | 27 | ||
Exercise of stock options (shares) | 32,530 | |||
Net loss | (9,139) | (9,139) | ||
Balance at Jun. 30, 2021 | $ 1 | 124,149 | (63,533) | 60,617 |
Balance (shares) at Jun. 30, 2021 | 11,812,792 | |||
Balance at Mar. 31, 2021 | $ 1 | 96,174 | (58,292) | 37,883 |
Balance (shares) at Mar. 31, 2021 | 10,660,181 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Sale of common stock and common stock warrants | 26,404 | 26,404 | ||
Sale of common stock and common stock warrants, shares | 1,000,000 | |||
Share-based compensation expense | 749 | 749 | ||
Exercise of common stock warrants | 801 | 801 | ||
Exercise of common stock warrants (shares) | 134,351 | |||
Exercise of stock options | 21 | 21 | ||
Exercise of stock options (shares) | 18,260 | |||
Net loss | (5,241) | (5,241) | ||
Balance at Jun. 30, 2021 | $ 1 | 124,149 | (63,533) | 60,617 |
Balance (shares) at Jun. 30, 2021 | 11,812,792 | |||
Balance at Dec. 31, 2021 | $ 1 | 127,289 | (79,105) | 48,185 |
Balance (shares) at Dec. 31, 2021 | 12,110,373 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense | 2,637 | 2,637 | ||
Exercise of stock options | 32 | 32 | ||
Exercise of stock options (shares) | 17,012 | |||
Net loss | (20,577) | (20,577) | ||
Balance at Jun. 30, 2022 | $ 1 | 129,958 | (99,682) | 30,277 |
Balance (shares) at Jun. 30, 2022 | 12,127,385 | |||
Balance at Mar. 31, 2022 | $ 1 | 128,631 | (90,758) | 37,874 |
Balance (shares) at Mar. 31, 2022 | 12,127,385 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense | 1,327 | 1,327 | ||
Net loss | (8,924) | (8,924) | ||
Balance at Jun. 30, 2022 | $ 1 | $ 129,958 | $ (99,682) | $ 30,277 |
Balance (shares) at Jun. 30, 2022 | 12,127,385 |
Condensed Statements of Chang_2
Condensed Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Condensed Statements of Changes in Stockholders' Equity | ||
Common stock and common stock warrants offering costs | $ 596 | $ 596 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (20,577) | $ (9,139) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 224 | 351 |
Amortization of right-of-use asset | 33 | |
Share-based compensation | 2,637 | 1,074 |
Deferred rent | (12) | (3) |
Forgiveness of PPP Loan | (500) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 4,460 | 142 |
Accounts payable | 2,182 | 486 |
Accrued expenses and other current liabilities | (3,342) | 313 |
Other long-term liabilities | (41) | |
Net cash used in operating activities | (14,436) | (7,276) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (176) | (39) |
Net cash used in investing activities | (176) | (39) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock and common stock warrants | 27,000 | |
Payment from issuance costs related to the sale of common stock and common stock warrants | (486) | |
Proceeds from exercise of stock options | 32 | 27 |
Proceeds from exercise of common stock warrants | 906 | |
Payment of equipment loan payable | (69) | |
Net cash provided by financing activities | 32 | 27,378 |
Net increase (decrease) in cash and cash equivalents and restricted cash | (14,580) | 20,063 |
Cash and cash equivalents and restricted cash at beginning of period | 49,329 | 39,866 |
Cash and cash equivalents and restricted cash at end of period | 34,749 | 59,929 |
Supplemental disclosures of cash flow information: | ||
Operating lease right-of-use asset and lease liability recorded upon adoption of ASC 842 | $ 215 | |
Offering costs included in accounts payable | 110 | |
Purchases of property plant and equipment included in accounts payable | $ 7 |
Nature of the business and basi
Nature of the business and basis of presentation | 6 Months Ended |
Jun. 30, 2022 | |
Nature of the business and basis of presentation | |
Nature of the business and basis of presentation | IMMUNOME, INC. Notes to Condensed Financial Statements (Unaudited) 1. Nature of the business and basis of presentation Organization Immunome, Inc. (“the Company” or “Immunome”) was incorporated as a Pennsylvania corporation on March 2, 2006 and was converted to a Delaware corporation on December 2, 2015. The Company is a biopharmaceutical company utilizing our proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics designed to change the way diseases are currently being treated. The Company’s primary focus areas are oncology and infectious disease, including COVID-19. Since its inception, the Company has devoted substantially all its resources to research and development, raising capital, building its management team and extending 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, risks associated with the successful research, development and manufacturing of product candidates, uncertain results of preclinical and clinical testing, development of new technological innovations and products by competitors, dependence on key personnel and third-party vendors, protection of proprietary technology, compliance with government regulations, regulatory approval of product candidates and the ability to secure additional capital to fund operations. Liquidity The Company has incurred net losses since inception, including net losses of $20.6 million and $9.1 million for the six months ended June 30, 2022 and 2021, respectively, and it expects to generate losses from operations and negative operating cash flows for the foreseeable future primarily due to research and development costs for its potential product candidates. As of June 30, 2022, the Company had an accumulated deficit of $99.7 million. On October 1, 2021 the Company entered into an Open Market Sale Agreement (“ATM Agreement”) with Jefferies Group LLC, which provides that, upon the terms and subject to the conditions and limitations in the ATM Agreement, the Company may elect, from time to time, to offer and sell shares of common stock under the registration statement having an aggregate offering price of up to $75.0 million through Jefferies Group LLC acting as sales agent. The Company has not yet sold any shares under the ATM Agreement. The Company had cash and cash equivalents of $34.6 million at June 30, 2022. The Company expects that its cash will enable it to fund its operating expenses and capital expenditure requirements for at least 12 months from the filing date of this Quarterly Report on Form 10-Q; however; more funding will be necessary beyond this point to fund additional research and development, clinical development and operations in order to pursue the Company’s 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 (or enter into these collaborations sooner than it might otherwise have intended to do); consider other various strategic alternatives, including a merger or sale of the Company; or reduce or cease operations. If the Company engages in collaborations, it may receive lower consideration upon commercialization of such products or technologies than if it had not entered into such arrangements or if it entered into such arrangements at later stages in the research and 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 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, there has not been a significant impact to the Company’s operations or financial statements to date. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2022 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 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”). Unaudited interim results These unaudited condensed financial statements and accompanying notes should be read in conjunction with the Company’s annual financial statements and the notes thereto included in the Company’s Form 10-K filed with the Securities and Exchange Commission on March 28, 2022. The accompanying condensed financial statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 are unaudited but include all adjustments that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2021 have been derived from the audited financial statements as of that date. 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 condensed financial statements include, but are not limited to, the expected volatility used to estimate fair value of stock options and accrued research and development expenses. Estimates and assumptions are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from these estimates. Segment and geographic information Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer. The Company views its operations as and manages its business in one operating segment operating exclusively in the United States. Fair value of financial instruments ASC Topic 820, Fair Value Measurement 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 value requires more judgement. Accordingly, the degree of judgement exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Cash and cash equivalents are Level 1 assets as of June 30, 2022 and December 31, 2021. Restricted cash Restricted cash represents collateral provided for a letter of credit issued as a security deposit in connection with the Company’s lease of its corporate facilities. This lease expires in 2024 at which time the cash will be released from restriction. Restricted cash was $100,000 at both June 30, 2022 and 2021, respectively. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash reported in the Company’s condensed balance sheets to the total of the amount presented in the condensed statements of cash flows: (in thousands) June 30, 2022 June 30, 2021 Cash and cash equivalents $ 34,649 $ 59,829 Restricted cash 100 100 $ 34,749 $ 59,929 Equity issuance costs The Company capitalizes costs that are directly associated with the ATM Agreement until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. Ongoing costs that are directly associated with the ATM Agreement are expensed as incurred. Deferred offering costs were $0.3 million and $0.3 million as of June 30, 2022 and December 31, 2021, respectively, on the condensed balance sheet. Government assistance programs The Company accounts for amounts received under its U.S. Department of Defense (“DoD”) expense reimbursement contract as contra-research and development expenses in the condensed statements of operations. The Company accounts for the employee retention credit received under the U.S. Department of Treasury Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) as contra-expense to personnel related costs within research and development and general and administrative expenses in the condensed statements of operations. 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 and clinical development expenses, including manufacture and testing of clinical supplies, consulting and other contracted services. Additionally, under the terms of the license agreements described in Note 7, the Company is obligated to make future payments should certain development and regulatory milestones be achieved. Costs for certain research and development activities are recognized based on the terms of the individual arrangements, which may differ from the timing of receipt of invoices and payment of invoices and are reflected in the financial statements as a prepaid or accrued expense. Net loss per share 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 outstanding as of June 30, 2022 and 2021 have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: June 30, 2022 2021 Stock options (1) 2,532,644 2,016,036 Common stock warrants (1) 1,303,112 1,362,181 3,835,756 3,378,217 (1) Represents common stock equivalents. 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 three and six months ended June 30, 2022 and 2021. Leases Effective January 1, 2022, the Company adopted ASU No. 2016-02, Leases At the inception of an arrangement, the Company determines whether an arrangement contains a lease based on facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Typically, lessees are required to recognize leases with a term greater than one year on the balance sheet as an operating or finance lease liability and right-of-use asset. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. The Company has elected the practical expedient to not to recognize leases with a term of 12 months or less. The Company does not have any financing leases as of June 30, 2022. Operating lease liabilities and their corresponding right-of-use assets are recorded based on their present value of lease payments over the remaining lease term. Options to extend the lease term are included in the Company’s assessment of the lease term only if there is a reasonable assessment that the Company will renew. Leases are discounted to its present value using either the interest rate implicit in the Company’s lease or its incremental borrowing rate, which reflects the fixed rate in which the Company could borrow on a collateralized basis the amount of lease payments in the same currency, for a similar term, in a similar economic environment. Recently adopted accounting standards On January 1, 2022, the Company adopted ASC 842, which establishes ASC 842 and supersedes the lease accounting guidance under ASC 840. The standard generally requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use (ROU) assets on the balance sheet and provide enhanced disclosures on the amount, timing, and uncertainty of cash flows arising from lease arrangements. The Company adopted ASC 842 using the modified retrospective approach. The Company elected the package of practical expedients available for existing contracts, which allowed the Company to carry forward our historical assessments of lease identification, lease classification, and initial direct costs. The Company also elected a policy to not apply the recognition requirements of ASC 842 for short-term leases with a term of 12 months of less. As of January 1, 2022, the effective date, the Company identified one operating lease arrangement relating to the Company’s headquarters facility and one short-term lease relating to laboratory equipment. The adoption of ASC 842 resulted in a recognition of an ROU asset and lease Recently issued accounting pronouncements In November 2021, the FASB issued ASU Topic 832, Disclosures by Business Entities about Government Assistance |
Government assistance programs
Government assistance programs | 6 Months Ended |
Jun. 30, 2022 | |
Government assistance programs | |
Government assistance programs | 3. Government assistance programs DoD expense reimbursement contract In July 2020, the Company entered into an Other Transaction Authority for Prototype Agreement (the “OTA Agreement”) with the DoD to fund the Company’s efforts in developing an antibody cocktail therapeutic to treat COVID-19. The amount of funding originally made available to the Company under this expense reimbursement contract was $13.3 million. In May 2021, the Company and the DoD amended the OTA Agreement, pursuant to which the DoD award was increased from $13.3 million to $17.6 million. The Company recorded contra-research and development expense related to the OTA Agreement of $0.01 million and $0.6 million for the three and six months ended June 30, 2022, respectively, in the condensed statements of operations. The Company recorded contra-research and development expense related to the OTA Agreement of $4.1 million and $8.1 million for the three and six months ended June 30, 2021, respectively, in the condensed statements of operations. The Company had an expense reimbursement receivable balance of $0.2 million and $2.7 million due from the DoD in prepaid expenses and other current assets as of June 30, 2022 and December 31, 2021, respectively, in the accompanying condensed balance sheets. Costs that have been reimbursed by the DoD but not yet expensed by the Company are recorded as a deferred research obligation liability for the period. The Company has a deferred research obligation liability of $0.01 million and $2.0 million as of June 30, 2022 and December 31, 2021, respectively. This amount is included in accrued expenses and other liabilities in the accompanying condensed balance sheets. DoD reimbursable services that have been performed but not yet billed are recorded as an unbilled receivable in prepaid expenses and other current assets in the accompanying condensed balance sheets. The Company had an unbilled receivable from the DoD of $0 and $1.6 million as of June 30, 2022 and December 31, 2021, respectively. As of June 30, 2022, the Company has received $17.4 million in expense reimbursement from the DoD under the OTA Agreement. U.S. Department of Treasury CARES Act employee retention credit Under the CARES Act, the Company met eligibility criteria for a $0.8 million refundable employee retention credit. The Company recorded contra-expense to personnel related costs within research and development expense of $0.6 million and contra-general administrative expense of $0.2 million for the three and six months ended June 30, 2022, respectively, in the condensed statements of operations. No such amounts were recognized for the three and six months ended June 30, 2021. The Company had an employee retention credit receivable balance due from the U.S. Department of Treasury of $0.8 million and $0 in prepaid expenses and other current assets as of June 30, 2022 and December 31, 2021, respectively, in the accompanying condensed balance sheets. |
Prepaid expenses and other asse
Prepaid expenses and other assets | 6 Months Ended |
Jun. 30, 2022 | |
Prepaid expenses and other assets | |
Prepaid expenses and other assets | 4. Prepaid expenses and other assets Prepaid expenses and other assets consisted of the following: (in thousands) June 30, 2022 December 31, 2021 CARES Act employee retention credit receivable $ 847 $ — Prepaid insurance 830 2,019 Research and development advance payments 501 586 Other prepaids and short-term deposits 528 492 Reimbursement receivable from DoD 243 2,674 Unbilled reimbursement receivable from DoD — 1,638 $ 2,949 $ 7,409 |
Accrued expenses and other liab
Accrued expenses and other liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Accrued expenses and other liabilities | |
Accrued expenses and other liabilities | 5. Accrued expenses and other liabilities Accrued expenses and other liabilities consisted of the following: (in thousands) June 30, 2022 December 31, 2021 Research and development $ 2,205 $ 2,840 Compensation and related benefits 932 1,246 Professional fees 134 227 Short-term operating lease liability and other liabilities 66 317 Deferred research obligations 22 2,021 $ 3,359 $ 6,651 |
Long-term debt
Long-term debt | 6 Months Ended |
Jun. 30, 2022 | |
Long-term debt | |
Long-term debt | 6. Long-term debt On April 30, 2020, the Company entered into a loan agreement with Silicon Valley Bank as the lender (“Lender”) for a loan in an aggregate principal amount of $0.5 million (“PPP Loan”) pursuant to the Paycheck Protection Program (“PPP”) under the CARES Act and implemented by the U.S. Small Business Administration (“SBA”). The Company used the proceeds of the PPP Loan for payroll and other qualifying expenses. The entire PPP Loan was forgiven on May 21, 2021 and recognized as other income in the condensed statements of operations. |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and contingencies | |
Commitments and contingencies | 7. Commitments and contingencies Employment agreements The Company entered into employment agreements (the “Employment Agreements”) with certain 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 respective Employment Agreements (subject to the payment of severance upon certain terminations) and provide for annual pay adjustments and bonuses at the discretion of the Board of Directors. Employee benefit plan The Company maintains a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company assumes all administrative costs of the 401(k) Plan and makes matching contributions as defined in the 401(k) Plan document. The Company made matching contributions of $0.1 million to the 401(k) Plan for each of the three and six months ended June 30, 2022 and 2021, respectively. Legal proceedings The Company is not a party to any material 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. License Agreements The Company entered into various license agreements to further discover, develop and commercialize certain technologies and treatments. The Company may need to pay developmental and regulatory milestone payments of up to approximately $2.6 million. In addition, the Company may need to pay royalty rates on net product sales and certain commercial milestone payments of up to approximately $1.5 million, if any. The Company recorded $0.1 million milestone payments during the three and six months ended June 30, 2022, respectively, in research and development expenses in the condensed statements of operations. No such costs were recorded during the three and six months ended June 30, 2021, respectively. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases | |
Leases | 8. Leases Effective January 1, 2022, the Company adopted ASC 842 using the modified retrospective approach by applying the new standard to all leases existing on the adoption date. The results for reporting periods beginning after January 1, 2022 are presented in accordance with ASC 842, while prior period amounts are not adjusted and continue to be reported under the accounting standards that were in effect prior to January 1, 2022. The Company elected the practical expedient to recognize short-term leases under ASC 840. In May 2017, the Company entered into a 62-month office and laboratory space lease commencing on July 1, 2017 for approximately 11,000 square feet of space in Exton, Pennsylvania. The Company has an option to extend the lease for up to two additional five-year terms. In December 2021, the Company extended the lease for an additional eighteen-month term ending in March 2024. Beginning July 2021, the Company leased laboratory equipment on a month-to-month basis. In April 2022, the Company terminated the agreement through exercising the option to purchase the leased laboratory equipment under the lease agreement. Supplemental balance sheet information related to leases as of June 30, 2022 was as follows (in thousands): Operating leases: Operating lease right-of-use assets $ 182 Operating lease liability $ 64 Operating lease liability, net of current portion 124 Total operating lease liability $ 188 Operating lease liability and operating lease liability, net of current portion is included in accrued expenses and other current liabilities and other long-term liabilities, respectively, in the accompanying condensed balance sheets. Supplemental lease expense related to leases was as follows: Lease Cost (in thousands) Statements of Operations Classification Three Months Ended June 30, 2022 Six Months Ended June 30, 2022 Operating lease cost General and administrative $ 60 121 Short-term lease cost General and administrative - 53 Total lease expense $ 60 174 Under ASC 840, rent expense was $0.1 million for each of the three and six months ended June 30, 2021, respectively. Other information related to the operating lease where the Company is the lessee was as follows: Six Months Ended June 30, 2022 Weighted-average remaining lease term (in years) 1.75 Weighted-average discount rate 9.0% Supplemental cash flow information related to the operating lease was as follows (in thousands): Six Months Ended June 30, 2022 Cash paid for operating lease liability $ 114 As of June 30, 2022, minimum rental commitments under the operating lease were as follows (in thousands): Years ending December 31, Amount 2022 (represents remaining six months in 2022) $ 120 2023 246 2024 63 Total lease payments 429 Less imputed interest (241) Present value of lease liability $ 188 |
Common stock
Common stock | 6 Months Ended |
Jun. 30, 2022 | |
Common stock | |
Common stock | 9. Common 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 holders of a majority in interest of the Company’s stockholders entitled to vote thereon, the holders of common stock shall be entitled to receive dividends out of legally available funds. In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of common stock are entitled to share ratably in the remaining assets of the Company available for distribution. On April 28, 2021, the Company sold 1,000,000 units, each unit comprising one share of the Company’s common stock and one Series B Warrant (each, a “Series B Warrant”) to purchase one-half of a share of common stock. The units were issued in a private placement at a price of $27.00 per unit for gross proceeds of $27.0 million. The Series B Warrants are equity-classified, exercisable at any time, have an exercise price of $45.00 per share and will terminate at three years from the date of issuance. The fair value of the warrants on the date of issuance was $6.0 million. The fair value of the warrants was estimated using a Black-Scholes Option Pricing Model. The significant assumptions used in preparing the option pricing model for valuing the Company's warrants to purchase shares of common stock as of April 28, 2021 included (i) volatility of 82.7%, (ii) risk free interest rate of 0.35%, (iii) strike price of $45.00 per share, (iv) fair value of common stock of $28.70 per share, and (v) expected life of three years. The Series B Warrants are callable by the Company in certain circumstances. Warrants to acquire shares of common stock At June 30, 2022, common stock warrants outstanding were as follows: Warrants Exercise Price per Share Expiration Date 803,112 $ 9.00 June 2, 2023 500,000 $ 45.00 April 28, 2024 During the six months ended June 30, 2022, no warrants were exercised. During the six months ended June 30, 2021, 100,695 warrants were exercised, and the Company received proceeds of $0.9 million and 100,695 shares of the Company’s common stock were issued. Additionally, 72,320 warrants were cashless exercised during the six months ended June 30, 2021 and 45,322 shares of the Company’s common stock were issued. |
Share-based compensation
Share-based compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-based compensation | |
Share-based compensation | 10. Share-based compensation In July 2008, the Board of Directors adopted the 2008 Equity Incentive Plan (the “2008 Plan”) which provided for the grant of qualified incentive stock options and non-qualified stock options, restricted stock or other awards to the Company’s employees, officers, directors, advisors, and outside consultants for the issuance or purchase of shares of the Company’s common stock. The 2008 Plan was replaced in July 2018 with the 2018 Equity Incentive Plan (2018 Plan and collectively with the 2008 Plan, the “Prior Plans”). At the time that the 2008 Plan was terminated, there were 388,748 shares available for grant that were transferred to the 2018 Plan. On September 24, 2020, the 2018 Plan was terminated and replaced with the 2020 Equity Incentive Plan (the “2020 Plan”). Additionally, the number of shares of our common stock reserved for issuance under the 2020 Plan will automatically increase on January 1 of each year, beginning on January 1, 2021 and continuing through and including January 1, 2030, by 4% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s Board of Directors. As of June 30, 2022, there were 1,313,412 shares available for future issuance under the 2020 Plan. The Company also adopted the 2020 Employee Stock Purchase Plan (“ESPP”) 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. The maximum number of shares of common stock that may be issued under the ESPP will not exceed 125,000 shares of common stock, plus the number of shares of common stock that are automatically added on January 1 of each calendar year for a period of up to ten years, commencing on the first January 1 following the year in which an IPO occurs and ending on, and including, January 1, 2030, in an amount equal to the lesser of (i) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, and (ii) 1,000,000 shares of common stock. No shares of common stock have been issued under the ESPP as of June 30, 2022. The 2020 Plan and the ESPP are administered by the Board of Directors subject to the Board’s right to delegate to a committee. The exercise prices, vesting and other restrictions are determined at the discretion of the Board of Directors. Stock options awarded under the Prior Plans and the 2020 Plan generally expire 10 years after the grant date unless the Board of Directors sets a shorter term. Vesting periods for awards under the Prior Plans and the 2020 Plan are determined at the discretion of the Board of Directors. Stock options granted to employees, officers, members of the Board of Directors and consultants of the Company typically vest over one Share-based compensation expense recorded as research and development and general and administrative expenses in the condensed statements of operations is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 462 $ 368 $ 907 $ 522 General and administrative 865 381 1,730 552 $ 1,327 $ 749 $ 2,637 $ 1,074 Unrecognized compensation cost related to unvested options was $12.1 million as of June 30, 2022 and will be recognized over an estimated weighted average period of 3.5 years. Stock options The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were: Six Months Ended June 30, 2022 2021 Expected volatility 85.6 % 83.1 % Risk-free interest rate 2.7 % 1.1 % Expected term (in years) 5.97 6.04 Expected dividend yield — — Fair value of common stock $ 3.64 $ 25.60 A summary of option activity under the Plans and 2020 Plan during the six months ended June 30, 2022 is as follows: Weighted Weighted average average remaining Number of exercise price contractual shares per share term (years) Outstanding at January 1, 2022 2,005,756 $ 11.26 8.50 Granted 543,900 3.64 9.90 Forfeited — — — Exercised (17,012) 1.87 7.86 Outstanding at June 30, 2022 2,532,644 9.69 8.41 Exercisable at June 30, 2022 980,061 7.84 7.59 Vested or expected to vest at June 30, 2022 2,532,644 9.69 8.41 The weighted-average grant date fair value per share of stock options granted during the six months ended June 30, 2022 and 2021 was $2.65 and $18.00, respectively. The aggregate intrinsic value of stock options exercised during the six months ended June 30, 2022 was $0.1 million. The aggregate intrinsic value of stock options outstanding at June 30, 2022 is $1.8 million. |
Related party transactions
Related party transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related party transactions | |
Related party transactions | 11. Related party transactions License agreements The Company has entered into license agreements with certain stockholders of the Company. Expenses with these related parties were de minimis for the three and six months ended June 30, 2022 and 2021, respectively. In addition, amounts owed to these related parties were de minimis as of June 30, 2022 and December 31, 2021. Broadband services agreement In November 2015, the Company entered into a management services agreement (the “Broadband MSA”) with BCM Advisory Partners LLC and Broadband Capital Partners LLC (collectively “Broadband Capital”). Certain directors of the Company are principals of Broadband Capital. Under the Broadband MSA, the Company engages Broadband Capital as a consultant for advice in connection with senior management matters related to the Company’s business, administration and policies in exchange for a cash fee to Broadband Capital of $20,000 per month. The Broadband MSA was amended and/or restated in July 2016, January 2017, June 2018, March 2020 and August 2020. In June 2021, the Company extended the Broadband MSA to continue through June 2022. The Company recorded $0.1 million during each of the three and six months ended June 30, 2022 and 2021, respectively, related to the Broadband MSA, which is included in general and administrative expenses in the condensed statements of operations. Amounts due to Broadband Capital were $0.1 million and $0 as of June 30, 2022 and December 31, 2021, respectively. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Summary of significant accounting policies | |
Basis of presentation | 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”). |
Unaudited interim results | Unaudited interim results These unaudited condensed financial statements and accompanying notes should be read in conjunction with the Company’s annual financial statements and the notes thereto included in the Company’s Form 10-K filed with the Securities and Exchange Commission on March 28, 2022. The accompanying condensed financial statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 are unaudited but include all adjustments that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2021 have been derived from the audited financial statements as of that date. |
Use of estimates | 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 condensed financial statements include, but are not limited to, the expected volatility used to estimate fair value of stock options and accrued research and development expenses. Estimates and assumptions are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from these estimates. |
Segment and geographic information | 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. |
Fair value of financial instruments | Fair value of financial instruments ASC Topic 820, Fair Value Measurement 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 value requires more judgement. Accordingly, the degree of judgement exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Cash and cash equivalents are Level 1 assets as of June 30, 2022 and December 31, 2021. |
Restricted cash | Restricted cash Restricted cash represents collateral provided for a letter of credit issued as a security deposit in connection with the Company’s lease of its corporate facilities. This lease expires in 2024 at which time the cash will be released from restriction. Restricted cash was $100,000 at both June 30, 2022 and 2021, respectively. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash reported in the Company’s condensed balance sheets to the total of the amount presented in the condensed statements of cash flows: (in thousands) June 30, 2022 June 30, 2021 Cash and cash equivalents $ 34,649 $ 59,829 Restricted cash 100 100 $ 34,749 $ 59,929 |
Equity issuance costs | Equity issuance costs The Company capitalizes costs that are directly associated with the ATM Agreement until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. Ongoing costs that are directly associated with the ATM Agreement are expensed as incurred. Deferred offering costs were $0.3 million and $0.3 million as of June 30, 2022 and December 31, 2021, respectively, on the condensed balance sheet. |
Government assistance programs | Government assistance programs The Company accounts for amounts received under its U.S. Department of Defense (“DoD”) expense reimbursement contract as contra-research and development expenses in the condensed statements of operations. The Company accounts for the employee retention credit received under the U.S. Department of Treasury Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) as contra-expense to personnel related costs within research and development and general and administrative expenses in the condensed statements of operations. |
Research and development costs | 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 and clinical development expenses, including manufacture and testing of clinical supplies, consulting and other contracted services. Additionally, under the terms of the license agreements described in Note 7, the Company is obligated to make future payments should certain development and regulatory milestones be achieved. Costs for certain research and development activities are recognized based on the terms of the individual arrangements, which may differ from the timing of receipt of invoices and payment of invoices and are reflected in the financial statements as a prepaid or accrued expense. |
Net loss per share | Net loss per share 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 outstanding as of June 30, 2022 and 2021 have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: June 30, 2022 2021 Stock options (1) 2,532,644 2,016,036 Common stock warrants (1) 1,303,112 1,362,181 3,835,756 3,378,217 (1) Represents common stock equivalents. 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 three and six months ended June 30, 2022 and 2021. |
Leases | Leases Effective January 1, 2022, the Company adopted ASU No. 2016-02, Leases At the inception of an arrangement, the Company determines whether an arrangement contains a lease based on facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Typically, lessees are required to recognize leases with a term greater than one year on the balance sheet as an operating or finance lease liability and right-of-use asset. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. The Company has elected the practical expedient to not to recognize leases with a term of 12 months or less. The Company does not have any financing leases as of June 30, 2022. Operating lease liabilities and their corresponding right-of-use assets are recorded based on their present value of lease payments over the remaining lease term. Options to extend the lease term are included in the Company’s assessment of the lease term only if there is a reasonable assessment that the Company will renew. Leases are discounted to its present value using either the interest rate implicit in the Company’s lease or its incremental borrowing rate, which reflects the fixed rate in which the Company could borrow on a collateralized basis the amount of lease payments in the same currency, for a similar term, in a similar economic environment. |
Recent Accounting Pronouncements | Recently adopted accounting standards On January 1, 2022, the Company adopted ASC 842, which establishes ASC 842 and supersedes the lease accounting guidance under ASC 840. The standard generally requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use (ROU) assets on the balance sheet and provide enhanced disclosures on the amount, timing, and uncertainty of cash flows arising from lease arrangements. The Company adopted ASC 842 using the modified retrospective approach. The Company elected the package of practical expedients available for existing contracts, which allowed the Company to carry forward our historical assessments of lease identification, lease classification, and initial direct costs. The Company also elected a policy to not apply the recognition requirements of ASC 842 for short-term leases with a term of 12 months of less. As of January 1, 2022, the effective date, the Company identified one operating lease arrangement relating to the Company’s headquarters facility and one short-term lease relating to laboratory equipment. The adoption of ASC 842 resulted in a recognition of an ROU asset and lease Recently issued accounting pronouncements In November 2021, the FASB issued ASU Topic 832, Disclosures by Business Entities about Government Assistance |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Summary of significant accounting policies | |
Schedule of reconciliation of the components of cash and restricted cash reported in balance sheet | (in thousands) June 30, 2022 June 30, 2021 Cash and cash equivalents $ 34,649 $ 59,829 Restricted cash 100 100 $ 34,749 $ 59,929 |
Schedule of potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive | The following potentially dilutive securities outstanding as of June 30, 2022 and 2021 have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: June 30, 2022 2021 Stock options (1) 2,532,644 2,016,036 Common stock warrants (1) 1,303,112 1,362,181 3,835,756 3,378,217 (1) Represents common stock equivalents. |
Prepaid expenses and other as_2
Prepaid expenses and other assets (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Prepaid expenses and other assets | |
Schedule of prepaid expenses and other current assets | (in thousands) June 30, 2022 December 31, 2021 CARES Act employee retention credit receivable $ 847 $ — Prepaid insurance 830 2,019 Research and development advance payments 501 586 Other prepaids and short-term deposits 528 492 Reimbursement receivable from DoD 243 2,674 Unbilled reimbursement receivable from DoD — 1,638 $ 2,949 $ 7,409 |
Accrued expenses and other li_2
Accrued expenses and other liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accrued expenses and other liabilities | |
Schedule of accrued expenses and other liabilities | (in thousands) June 30, 2022 December 31, 2021 Research and development $ 2,205 $ 2,840 Compensation and related benefits 932 1,246 Professional fees 134 227 Short-term operating lease liability and other liabilities 66 317 Deferred research obligations 22 2,021 $ 3,359 $ 6,651 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases | |
Supplemental balance sheet information | Supplemental balance sheet information related to leases as of June 30, 2022 was as follows (in thousands): Operating leases: Operating lease right-of-use assets $ 182 Operating lease liability $ 64 Operating lease liability, net of current portion 124 Total operating lease liability $ 188 |
Supplemental lease expense | Lease Cost (in thousands) Statements of Operations Classification Three Months Ended June 30, 2022 Six Months Ended June 30, 2022 Operating lease cost General and administrative $ 60 121 Short-term lease cost General and administrative - 53 Total lease expense $ 60 174 |
Schedule of other information related to the operating lease | Six Months Ended June 30, 2022 Weighted-average remaining lease term (in years) 1.75 Weighted-average discount rate 9.0% |
Supplemental cash flow information | Supplemental cash flow information related to the operating lease was as follows (in thousands): Six Months Ended June 30, 2022 Cash paid for operating lease liability $ 114 |
Schedule of future minimum lease payments under operating lease | As of June 30, 2022, minimum rental commitments under the operating lease were as follows (in thousands): Years ending December 31, Amount 2022 (represents remaining six months in 2022) $ 120 2023 246 2024 63 Total lease payments 429 Less imputed interest (241) Present value of lease liability $ 188 |
Common stock (Tables)
Common stock (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Common stock | |
Schedule of warrants outstanding | At June 30, 2022, common stock warrants outstanding were as follows: Warrants Exercise Price per Share Expiration Date 803,112 $ 9.00 June 2, 2023 500,000 $ 45.00 April 28, 2024 |
Share-based compensation (Table
Share-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-based compensation | |
Schedule of Stock-based compensation expense | Share-based compensation expense recorded as research and development and general and administrative expenses in the condensed statements of operations is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 462 $ 368 $ 907 $ 522 General and administrative 865 381 1,730 552 $ 1,327 $ 749 $ 2,637 $ 1,074 |
Weighted average assumptions used in option-pricing | The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were: Six Months Ended June 30, 2022 2021 Expected volatility 85.6 % 83.1 % Risk-free interest rate 2.7 % 1.1 % Expected term (in years) 5.97 6.04 Expected dividend yield — — Fair value of common stock $ 3.64 $ 25.60 |
Summary of option activity | A summary of option activity under the Plans and 2020 Plan during the six months ended June 30, 2022 is as follows: Weighted Weighted average average remaining Number of exercise price contractual shares per share term (years) Outstanding at January 1, 2022 2,005,756 $ 11.26 8.50 Granted 543,900 3.64 9.90 Forfeited — — — Exercised (17,012) 1.87 7.86 Outstanding at June 30, 2022 2,532,644 9.69 8.41 Exercisable at June 30, 2022 980,061 7.84 7.59 Vested or expected to vest at June 30, 2022 2,532,644 9.69 8.41 |
Nature of the business and ba_2
Nature of the business and basis of presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Oct. 01, 2021 | |
Net loss | $ 8,924 | $ 5,241 | $ 20,577 | $ 9,139 | ||
Accumulated deficit | 99,682 | 99,682 | $ 79,105 | |||
Cash and cash equivalents | $ 34,649 | $ 59,829 | $ 34,649 | $ 59,829 | $ 49,229 | |
Open Market Sale | Maximum | ||||||
Securities aggregate price | $ 75,000 |
Summary of significant accoun_4
Summary of significant accounting policies - Narrative (Details) | 6 Months Ended | |||
Jun. 30, 2022 USD ($) segment | Jan. 01, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) | |
Summary of significant accounting policies | ||||
Number of operating segments | segment | 1 | |||
Restricted cash | $ 100,000 | $ 100,000 | $ 100,000 | |
Deferred offering costs | 300,000 | $ 300,000 | ||
Operating lease liability | $ 200,000 | |||
Operating right-of-use asset, net | $ 182,000 | $ 200,000 |
Summary of significant accoun_5
Summary of significant accounting policies - Components of cash and restricted cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Summary of significant accounting policies | ||||
Cash and cash equivalents | $ 34,649 | $ 49,229 | $ 59,829 | |
Restricted cash | 100 | 100 | ||
Cash and restricted cash | $ 34,749 | $ 49,329 | $ 59,929 | $ 39,866 |
Summary of significant accoun_6
Summary of significant accounting policies - Anti-dilutive (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 3,835,756 | 3,378,217 |
Stock options | ||
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 2,532,644 | 2,016,036 |
Common stock warrants | ||
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 1,303,112 | 1,362,181 |
Government assistance programs
Government assistance programs (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jul. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | May 31, 2021 | Mar. 27, 2020 | |
Unusual or Infrequent Item, or Both [Line Items] | ||||||||
Contra-research and development expense | $ 600,000 | $ 600,000 | ||||||
Refundable employee retention credit | $ 800,000 | |||||||
Contra General And Administrative Expense | 200,000 | |||||||
Contra expenses | $ 0 | $ 0 | ||||||
Employee retention credit receivable | 847,000 | 847,000 | $ 0 | |||||
Other Transaction Authority for Prototype Agreement | ||||||||
Unusual or Infrequent Item, or Both [Line Items] | ||||||||
Grants Receivable | $ 13,300,000 | $ 17,600,000 | ||||||
Payment period of reimbursement contract | 30 days | |||||||
Contra-research and development expense | 10,000 | $ 4,100,000 | 600,000 | $ 8,100,000 | ||||
Prepaid expenses and other current assets | 200,000 | 200,000 | 2,700,000 | |||||
Deferred research obligation liability | 10,000 | 10,000 | 2,000,000 | |||||
Grant expected to be received | 0 | 0 | $ 1,600,000 | |||||
Grants receivable current | $ 17,400,000 | $ 17,400,000 |
Prepaid expenses and other as_3
Prepaid expenses and other assets (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Prepaid expenses and other assets | ||
CARES Act employee retention credit receivable | $ 847,000 | $ 0 |
Prepaid insurance | 830,000 | 2,019,000 |
Research and development advance payments | 501,000 | 586,000 |
Other prepaids and short-term deposits | 528,000 | 492,000 |
Reimbursement receivable from DoD | 243,000 | 2,674,000 |
Unbilled reimbursement receivable from DoD | 1,638,000 | |
Prepaid expenses and other assets | $ 2,949,000 | $ 7,409,000 |
Accrued expenses and other li_3
Accrued expenses and other liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued expenses and other liabilities | ||
Research and development | $ 2,205 | $ 2,840 |
Compensation and related benefits | 932 | 1,246 |
Professional fees | 134 | 227 |
Short-term operating lease liability and other liabilities | 66 | 317 |
Deferred research obligations | 22 | 2,021 |
Accrued expenses and other liabilities | $ 3,359 | $ 6,651 |
Long-term debt (Details)
Long-term debt (Details) $ in Millions | Apr. 30, 2020 USD ($) |
Paycheck Protection Program | |
Debt Instrument [Line Items] | |
Debt amount | $ 0.5 |
Commitments and contingencies (
Commitments and contingencies (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Commitments and contingencies | ||||
Defined contribution | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 |
Product development and regulatory approval milestone payments | 2.6 | 2.6 | ||
Commercial milestone payments | 1.5 | 1.5 | ||
Collaborative agreement, milestone payments made | $ 0.1 | $ 0 | $ 0.1 | $ 0 |
Leases (Details)
Leases (Details) - Office and laboratory space | 1 Months Ended | |
Dec. 31, 2021 | May 31, 2017 ft² item | |
Lessee, Lease, Description [Line Items] | ||
Lease term | 62 months | |
Area | ft² | 11,000 | |
Number of extension | item | 2 | |
Period of extension | 18 months | 5 years |
Leases - Balance Sheet related
Leases - Balance Sheet related information (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Jan. 01, 2022 |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 182 | $ 200 |
Total operating lease liability | $ 200 | |
Office and laboratory space | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | 182 | |
Operating lease liability | 64 | |
Operating lease liability, net of current portion | 124 | |
Total operating lease liability | $ 188 |
Leases - Lease expense (Details
Leases - Lease expense (Details) - Office and laboratory space - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Lessee, Lease, Description [Line Items] | ||||
Total lease expense | $ 60 | $ 174 | ||
Rent expenses | $ 100 | $ 100 | ||
General, Administrative, Research and Development | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease cost | $ 60 | 121 | ||
Short-term lease cost | $ 53 |
Leases - Additional lease relat
Leases - Additional lease related information (Details) - Office and laboratory space | Jun. 30, 2022 |
Lessee, Lease, Description [Line Items] | |
Weighted-average remaining lease term | 1 year 9 months |
Weighted-average discount rate | 9% |
Leases - Cash flow information
Leases - Cash flow information (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Office and laboratory space | |
Lessee, Lease, Description [Line Items] | |
Cash paid for operating lease liability | $ 114 |
Leases - Lease maturity (Detail
Leases - Lease maturity (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Jan. 01, 2022 |
Lessee, Lease, Description [Line Items] | ||
Total operating lease liability | $ 200 | |
Office and laboratory space | ||
Lessee, Lease, Description [Line Items] | ||
2022 (represents remaining six months in 2022) | $ 120 | |
2023 | 246 | |
2024 | 63 | |
Total lease payments | 429 | |
Less imputed interest | (241) | |
Total operating lease liability | $ 188 |
Common stock (Details)
Common stock (Details) $ in Thousands | 6 Months Ended | ||
Apr. 28, 2021 USD ($) $ / shares item shares | Jun. 30, 2022 Vote | Jun. 30, 2021 USD ($) | |
Common stock voting right | Vote | 1 | ||
Number of warrants | shares | 1 | ||
Proceeds from issuance of common stock | $ | $ 906 | ||
Private offering | |||
Stock issued | shares | 1,000,000 | ||
Number of share for company's common stock | item | 1 | ||
Share price | $ 27 | ||
Proceeds from issuance of common stock | $ | $ 27,000 | ||
Exercise price | $ 45 | ||
Warrants and Rights Outstanding, Term | 3 years | ||
Fair Value of Warrants | $ | $ 6,000 | ||
Warrants and Rights Outstanding, Measurement Input | 28.70 | ||
Volatility rate | |||
Warrants and Rights Outstanding, Measurement Input | 82.7 | ||
Risk-free interest rate | |||
Warrants and Rights Outstanding, Measurement Input | 0.35 | ||
Strike price (per share) | |||
Warrants and Rights Outstanding, Measurement Input | 45 |
Common stock - Warrants (Detail
Common stock - Warrants (Details) - Warrants - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Class of Warrant or Right [Line Items] | ||
Warrants exercised, numbers | 0 | 100,695 |
Gross proceeds from issuance of warrants | $ 0.9 | |
Exercise of common stock warrants (shares) | 100,695 | |
Additional warrants exercised on cashless | 72,320 | |
Shares issued in cashless exercise | 45,322 | |
Exercise Price $9.00 | ||
Class of Warrant or Right [Line Items] | ||
Warrants outstanding | 803,112 | |
Exercise price | $ 9 | |
Exercise Price $45.00 | ||
Class of Warrant or Right [Line Items] | ||
Warrants outstanding | 500,000 | |
Exercise price | $ 45 |
Share-based compensation - Plan
Share-based compensation - Plans (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 31, 2018 | |
2018 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for grant | 388,748 | |
2020 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Threshold Percentage Of Total Number Of Common Stock Outstanding | 4% | |
Shares available for future issuance | 1,313,412 | |
Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Authorized stock options | 125,000 | |
Employee Stock Purchase Plan, Threshold Period For Which Common Stock Is Automatically Added To Arrive At Authorized Shares | 10 years | |
Percentage of outstanding capital stock | 1% | |
Number of common shares added in authorized | 1,000,000 | |
Awards granted | 0 | |
The Plans | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expiration period | 10 years | |
The Plans | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | |
The Plans | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year |
Share-based compensation - Cost
Share-based compensation - Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,327 | $ 749 | $ 2,637 | $ 1,074 |
Unrecognized compensation cost | 12,100 | $ 12,100 | ||
Recognition period | 3 years 6 months | |||
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 462 | 368 | $ 907 | 522 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 865 | $ 381 | $ 1,730 | $ 552 |
Share-based compensation - Assu
Share-based compensation - Assumptions (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based compensation | ||
Expected volatility | 85.60% | 83.10% |
Risk-free interest rate | 2.70% | 1.10% |
Expected term (in years) | 5 years 11 months 19 days | 6 years 14 days |
Fair value of common stock | $ 3.64 | $ 25.60 |
Share-based compensation - Opti
Share-based compensation - Option Activity and Restricted Stock (Details) - The Plans - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Options, Beginning balance | 2,005,756 | ||
Options, Granted | 543,900 | ||
Options, Exercised | (17,012) | ||
Options, Ending balance | 2,532,644 | 2,005,756 | |
Options, Exercisable | 980,061 | ||
Options, Vested or expected to vest | 2,532,644 | ||
Weighted Average Exercise price | |||
Beginning price | $ 11.26 | ||
Granted | 3.64 | ||
Exercised | 1.87 | ||
Ending price | 9.69 | $ 11.26 | |
Exercisable | 7.84 | ||
Vested or expected to vest | $ 9.69 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted Average Remaining Contractual Term | 8 years 4 months 28 days | 8 years 6 months | |
Weighted Average Remaining Contractual Term, Granted | 9 years 10 months 24 days | ||
Weighted Average Remaining Contractual Term, Exercised | 7 years 10 months 9 days | ||
Weighted Average Remaining Contractual Term, Exercisable | 7 years 7 months 2 days | ||
Weighted Average Remaining Contractual Term, Vested or expected to vest | 8 years 4 months 28 days | ||
Weighted average grant date fair value | $ 2.65 | $ 18 | |
Intrinsic value, exercised | $ 0.1 | ||
Intrinsic value, outstanding | $ 1.8 |
Related party transactions (Det
Related party transactions (Details) - Broadband services agreement - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Nov. 30, 2015 | |
Related Party Transaction [Line Items] | ||||||
Monthly cash fee payment | $ 20,000 | |||||
Related party transaction, expenses | $ 100,000 | $ 100,000 | $ 100,000 | $ 100,000 | ||
Due to related party | $ 100,000 | $ 100,000 | $ 0 |