IN8BIO INC
For the period ended Dec 31, 2023. Filed Mar 14, 2024.
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FY2023 · Filed Mar 14, 2024
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Notes to Financial Statements
- ORGANIZATION AND NATURE OF OPERATIONS
Organization and Business
IN8bio, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. The Company’s lead product candidate, INB-400, is currently in a company-sponsored Phase 2 clinical trial in which autologous, genetically modified gamma-delta T cells will be assessed in newly diagnosed glioblastoma, or GBM, patients at centers across the United States. In addition, the Company has two programs in Phase 1 clinical trials: INB-200, for the treatment of patients with newly diagnosed GBM, and INB-100, for the treatment of patients with hematologic malignancies that are undergoing hematopoietic stem cell transplantation ("HSCT"). In addition, the Company’s DeltEx platform has yielded a broad portfolio of preclinical programs, including INB-300 and INB-500, focused on addressing AML and other solid and hematological tumor types.
Incysus, Inc. (“Incysus”) was a corporation formed in the State of Delaware on November 23, 2015 and Incysus, Ltd. was incorporated in Bermuda on February 8, 2016. Incysus was the wholly owned United States subsidiary of Incysus, Ltd. On May 7, 2018, Incysus, Ltd. reincorporated in the United States in a domestication transaction (the “Domestication”) in which Incysus, Ltd. converted into a newly formed Delaware corporation, Incysus Therapeutics, Inc. (“Incysus Therapeutics”). On July 24, 2019, Incysus Therapeutics merged with Incysus. Incysus Therapeutics subsequently changed its name to IN8bio, Inc. in August 2020. Following the Domestication in May 2018 and the merging of Incysus Therapeutics and Incysus in July 2019, the Company does not have any subsidiaries to consolidate. The Company is headquartered in New York, New York.
Liquidity and Going Concern
To date, the Company has funded its operations primarily with proceeds from various public and private offerings of its common, preferred stock and sale of warrants. The Company has incurred recurring losses and negative operating cash flows since its inception, including net losses of$30.0 million and$28.5 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company had an accumulated deficit of$91.2 million.
The Company has not yet generated product sales and as a result has experienced operating losses since inception. The Company expects to incur additional losses in the future as it advances its product candidates through clinical trials, seeks to expand its product candidate portfolio through developing additional product candidates, grows its clinical, regulatory and quality capabilities, and incurs costs associated with operating as a public company. Based on the Company’s business strategy, its existing cash of$21.3 million as of December 31, 2023 will only fund the Company’s projected operating expenses and capital expenditure requirements into January 2025. Accordingly, there is substantial doubt about the Company’s ability to continue to operate as a going concern for a period of twelve months from the date of issuance of these financial statements. To continue to fund the operations of the Company beyond this time period, management has developed plans, which primarily consist of raising additional capital through some combination of equity and/or debt offerings, including through ATM offerings and private placements of securities, and identifying strategic collaborations, licensing or other arrangements to support development of the Company’s product candidates. In addition, pursuant to the private placement completed in December 2023 (see Note 7 and Note 8), the Company may receive an additional $14.8 million in aggregate proceeds if the holders of the series A ordinary warrants exercise their warrants pursuant to the mandatory exercise feature, which is triggered upon the Company's public announcement of INB-100 data for the ten currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months of long-term follow-up for each patient, along with certain stock price and trading volume requirements. Further, if not otherwise redeemed by the Company, the Company may also receive aggregate proceeds of $17.7 million from the exercise of its outstanding series B ordinary warrants issued in the December 2023 private placement. There is no assurance, however, that the Company will receive any additional proceeds from the private placement or that any additional financing or any revenue-generating collaboration will be available when needed, that management of the Company will be able to obtain financing or enter into a collaboration on terms acceptable to the Company, or that any additional financing or revenue generated through third party collaborations will be sufficient to fund our operations through this time period. If additional capital is not available, the Company will have to significantly delay, scale back or discontinue research and development programs or future commercialization efforts. The actual amount of cash that the Company will need to operate is subject to many factors. The accompanying financial statements have been prepared on the basis that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.
- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”).
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods presented. Such estimates and assumptions are used for, but are not limited to, the accrual of research and development expenses, deferred tax assets and liabilities and related valuation allowance, stock-based compensation, the useful lives of property and equipment and the valuation of warrants. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Concentration of Credit Risk
Financial instruments that potentially expose the Company to significant concentrations of credit risk consist primarily of cash. All of the Company’s cash and restricted cash is deposited in accounts with major financial institutions. Such deposits are in excess of the federally insured limits.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Depreciation and amortization of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. Significant replacements and improvements are capitalized, while maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to expense as incurred. The estimated useful lives of the Company’s respective assets are as follows:
| Estimated Useful Life | |
| Furniture | 5 years |
|---|---|
| Machinery and equipment | 3-5 years |
| Software | 3 years |
| Leasehold improvements | The shorter of the useful life of the leasehold improvement or the remaining term of the lease |
Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated and amortized in accordance with the above guidelines once placed into service. Upon retirement or disposal of property and equipment, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any gain or loss is reflected in the statements of operations.
Impairment of Long-Lived Assets
Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset 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 future undiscounted cash flows expected to be generated by the asset. Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. There wereno impairments recorded for the years ended December 31,2023 and 2022.
Research and Development Costs
Research and development costs are generally expensed as incurred and consist primarily of salaries and benefits, stock-based compensation expense, lab supplies and facility costs, as well as fees paid to nonemployees and entities that conduct certain research and development activities on the Company’s behalf and expenses incurred in connection with license agreements. Non-refundable advance payments for goods or services that will be used for rendered or future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability.
The Company analyzes the progress of clinical trials, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. The Company makes significant judgments and estimates in determining the accrued balance and expense in each accounting period. As actual costs become known, the Company adjusts the accrued estimates. Although the Company does not expect the estimates to be materially different from amounts actually incurred, the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment may vary from the Company’s estimates and could result in the Company reporting amounts that are too high or too low in any particular period. The Company’s research and development costs are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers.
Leases
The Company accounts for its lease obligations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2016-02, Leases(Topic 842) (“ASU 2016-02” or “ASC 842”). At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease liabilities, as applicable.
Operating and finance lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company will adjust the right-of-use assets for straight-line rent expense and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement date.
The Company recognizes rent expense related to our operating leases on a straight-line basis over the lease term. The Company will adjust the operating right-of-use assets for straight-line rent expense and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement date. For finance leases, our right-of-use assets are amortized on a straight-line basis over the earlier of the useful life of the right-of-use asset or the end of the lease term with rent expense recorded to operating expenses. The Company will adjust the lease liability to reflect lease payments made during the period and interest incurred on the lease liability using the effective interest method.
In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components.
Entities may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only.
Modification to existing lease agreements, including changes to the lease term or payment amounts, are reviewed to determine whether they result in a sperate contract. For modifications that do not result in a separate contract, management reviews the lease classification and re-measures the related right-of-use assets and lease liabilities at the effective date of the modification.
Fair Value of Financial Instruments
The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be disclosed at fair value in the financial statements. Fair value is the price at which an asset could be exchanged, or a liability transferred (an exit price) in an orderly transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or inputs are not available, valuation models are applied.
The Company’s financial instruments include cash and restricted cash, and accounts payable. The carrying amounts of cash, restricted cash, and accounts payable approximate fair value due to the short-term nature of these instruments.
Income Taxes
The Company uses the asset-and-liability method for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and tax bases of assets and liabilities and operating loss and tax credit carryforwards. These are measured using the enacted tax rates that are expected to be in effect when the differences reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to an amount that, in the opinion of management, is more likely than not to be realized.
The calculation of the income tax expense involves the use of estimates, assumptions and judgments while taking into account current tax laws and our interpretation of current and possible outcomes of future tax audits. In addition, our policy for accounting for uncertainty in income taxes requires the evaluation of tax positions taken or expected to be taken in the course of the preparation of tax returns to determine whether the tax positions are "more-likely-than-not" of being sustained by the applicable tax authority. Tax positions not deemed to meet the more-likely-than-not threshold would be recorded as a tax expense in the current year. Reevaluation of tax positions considers factors such as changes in facts or circumstances, changes in or interpretations of tax law, effectively settled issues under audit or expiration of statute of limitation and new audit activity. The Company classifies interest and penalty expense related to uncertain tax positions as a component of operating expenses on the statements of operations. As of December 31, 2023, the Company had no accrued interest or penalties.
Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require application of significant judgment. The Company is subject to U.S. federal and various state and local jurisdictions. Due to the Company’s net operating loss carryforwards, the Company may be subject to examination by authorities for all previously filed income tax returns.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019 and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The Company evaluated the impact of the CARES Act. At present, the Company does not expect that the NOL carryback provision or other provisions of the CARES Act has resulted or will result in a material tax benefit to the Company.
Warrants
The Company accounts for issued warrants as either liability or equity in accordance with ASC Topic 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC Topic 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, warrants are accounted for as liability if they are mandatorily redeemable and they require settlement in cash or other assets, or a variable number of shares. If warrants do not meet the criteria to be accounted for as liability under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be accounted for as liability or equity. Under ASC 815-40, contracts that may require settlement for cash are accounted for as a liability, regardless of the probability of the occurrence of the triggering event. If warrants do not meet the criteria to be accounted for as a liability under ASC 815-40, in order to conclude warrants should be accounted for as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are accounted for as equity under ASC 815-40 or other applicable U.S. GAAP. Warrants that meet the criteria to be accounted for as equity are recorded at fair value on the issuance date with no changes in fair value recognized after the issuance date. Warrants that meet the criteria to be accounted for as equity will be recorded within additional paid-in capital. After all relevant assessments, the Company concludes whether the warrants are accounted for as liability or equity. Refer to Note 8 for information regarding the warrants issued.
Stock-Based Compensation
The Company measures all stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The stock-based compensation expense is accounted for in the statements of operations based on the awards’ grant date fair values. The Company accounts for forfeitures as they occur by reversing any expense recognized for unvested awards.
The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company uses the simplified method as allowed by the Securities and Exchange Commission ("SEC") Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to bezero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock.
Capitalized Software
The Company capitalizes the application development phase costs of internal use software in accordance with Accounting Standards Codification (“ASC”) 350-40, Intangibles-Goodwill and Other-Internal Use Software. Capitalized costs will be amortized on a straight-line basis over the estimated useful life of the asset upon completion.
Recently Issued Accounting Standards Updates
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosure. This standard requires disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the entity's CODM. The amendments in this update also expand the interim segment disclosure requirements. All disclosure requirements under this standard are also required for public entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this update are required to be applied on a retrospective basis. The Company is currently evaluating the potential impact that this new standard will have on the Company’s financial statements and related disclosures.
- PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consist of the following (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Prepaid research and development | $2,283 | $2,562 |
| Prepaid insurance | 790 | 1,258 |
| Other | 270 | 232 |
| Prepaid expenses and other current assets | $3,343 | $4,052 |
- PROPERTY AND EQUIPMENT, NET
Property and equipment, net consist of the following (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Machinery and equipment | $379 | $358 |
| Furniture and fixtures | 370 | 335 |
| Software | 126 | 126 |
| Leasehold improvements | 3,922 | 3,899 |
| Less accumulated depreciation and amortization | (1,283) | (321) |
| Property and equipment, net | $3,514 | $4,397 |
Depreciation and amortization expense was$1.0 and$0.1 million for the years ended December 31, 2023 and 2022, respectively.
- CONSTRUCTION IN PROGRESS
Construction in progress consists of the following (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Furniture | $— | $29 |
| Internal use software not yet in service | 182 | — |
| Construction in progress | $182 | $29 |
- ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses and other current liabilities consist of the following (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Accrued clinical trials | $598 | $253 |
| Accrued compensation | 1,673 | 1,460 |
| Accrued legal | 306 | 211 |
| Accrued other | 378 | 418 |
| Total accrued expenses and other current liabilities | $2,955 | $2,342 |
- stockholders' equity
The Company’s authorized capital stock consists of 500,000,000 shares, all with a par value of $0.0001 per share, of which 490,000,000 shares are designated as common stock and 10,000,000 shares are designated as preferred stock.
Equity Offering
On August 16, 2022, the Company completed an underwritten public offering of 5,394,737 shares of its common stock at a public offering price of $1.90 per share, for net proceeds of approximately $9.0 million, after deducting underwriting discounts, commissions and offering expenses. On August 19, 2022, the underwriter partially exercised their option to purchase an additional 268,949 shares at the public offering price of $1.90 per share, resulting in additional net proceeds of approximately $0.4 million, after deducting underwriting discounts, commissions and offering expenses, increasing the aggregate net proceeds from the offering to approximately $9.4 million.
ATM Facility
In November 2022, the Company filed a shelf registration statement on Form S-3 (File No. 333-268288) (the “Shelf Registration Statement”) with the SEC, which permits the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $200.0 million of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, of which $50.0 million of common stock may be issued and sold pursuant to an at-the-market offering program (“ATM”). The Company entered into a Controlled Equity Offering SMsales agreement, (the "Sales Agreement") with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”) and Truist Securities, Inc. (“Truist”) under which Cantor Fitzgerald and Truist agreed to act as sales agents to sell shares of the Company’s common stock, from time to time, through the ATM program. On March 8, 2024, the Company delivered a termination notice to Truist, removing them as a sales agent under the ATM program. Such termination became effective on March 14, 2024.
Under current SEC regulations, if at any time the Company's public float is less than $75.0 million, and for so long as the Company's public float remains less than $75.0 million, the amount the Company can raise through primary public offerings of securities in any 12-month period using shelf registration statements is limited to an aggregate of one-third of the Company's public float, which is referred to as the baby shelf rules. As of December 31, 2023, the Company's calculated public float was less than $75.0 million. During the years ended December 31, 2023 and 2022, the Company sold an aggregate of 7,492,580 and 43,000 shares, respectively, of its common stock under the ATM, resulting in net proceeds of approximately$14.4 and $0.1 million, respectively, after deducting underwriting discounts.
Private Placement
On December 11, 2023, the Company entered into a Securities Purchase Agreement (the "Purchase Agreement"), with multiple investors (the “Private Placement”), pursuant to which the Company issued and sold an aggregate of 11,823,829 units
(the“Units”) comprised of (A) (1) one share of common stock, par value $0.0001 per share (the "Shares"), or (2) one pre-funded warrant to purchase one share of common stock (the “Pre-Funded Warrants”) and, in each case, (B) one Series A ordinary warrant to purchase one share of common stock (the “Series A Warrants”) and (C) one Series B ordinary warrant to purchase one share of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Common Stock Warrants”). In connection with the Private Placement, the Company issued an aggregate of 11,249,588 shares of common stock,574,241 Pre-Funded Warrants,11,823,829 Series A Warrants and 11,823,829 Series B Warrants. The Units were sold at a purchase price of $1.22 per Unit, for an aggregate initial net proceeds of $13.5 million, after deducting fees and expenses. The closing of the Private Placement occurred on December 13, 2023.
- warrants
In December 2023, the Private Placement was completed and the Company issued 574,241 Pre-Funded Warrants,11,823,829 Series A Warrants and 11,823,829 Series B Warrants. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and are exercisable until the Pre-Funded Warrant is exercised in full. In lieu of making the cash payment otherwise contemplated to be made to the Company upon exercise of a Pre-Funded Warrant in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the Pre-Funded Warrants terms. The Pre-Funded Warrants meet the criteria for permanent equity classification. As of December 31, 2023,574,241 Pre-Funded Warrants were considered issued and outstanding.
The Series A Warrants have an exercise price of $1.25 per share. The Series A Warrants are exercisable immediately and will expire on June 13, 2025. The Company has the option to cause the Series A Warrants to be exercised at a strike price of $1.25 per share upon the Company’s public announcement of INB-100 clinical data for the ten currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months, along with certain stock price and trading volume requirements. The Series A Warrants meet the criteria for permanent equity classification. As of December 31, 2023,11,823,829 Series A Warrants were considered issued and outstanding.
The Series B Warrants have an exercise price of $1.50 per share. The Series B Warrants are exercisable immediately and will expire on December 13, 2028. The Series B Warrants allow the Company to redeem such warrants at a price of $0.01 per Series B Warrant upon the Company’s public announcement of its INB-100 data for all enrolled patients covering a period of at least 22 months, along with certain stock price and trading volume requirements. Holders of Class B Warrants may choose to exercise such warrants at a purchase price of $1.50 per share prior to such redemption. The Series B Warrants meet the criteria for permanent equity classification. As of December 31, 2023,11,823,829 Series B Warrants were considered issued and outstanding.
- STOCK-BASED COMPENSATION
2018 Equity Incentive Plan
On May 7, 2018, the Company established and adopted the 2018 Equity Incentive Plan (the “2018 Plan”) providing for the granting of stock awards for employees, directors and consultants to purchase shares of the Company’s common stock. Upon the effectiveness of the 2020 Plan (as defined below), the 2018 Plan was terminated and no further issuances were made under the 2018 Plan, although it continues to govern the terms of any equity grants that remain outstanding under the 2018 Plan.
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the Company's board of directors (the "Board of Directors") and the Company’s stockholders and became effective on July 29, 2021. The number of shares initially reserved for issuance under the 2020 Plan was 4,200,000, which automatically increases on January 1 of each year for a period often years, beginning on January 1, 2022 and continuing through January 1, 2031, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the immediately preceding year, or a lesser number of shares determined by the Board of Directors no later than the last day of the immediately preceding year. Pursuant to the terms of the 2020 Plan, the number of shares available under the 2020 Plan was increased by 1,227,257 shares effective January 1, 2023. Upon the effectiveness of the 2023 Plan (as defined below), the 2020 Plan was terminated and no further issuances were made under the 2020 Plan, although it continues to govern the terms of any equity grants that remain outstanding under the 2020 Plan.
Amended and Restated 2023 Equity Incentive Plan
The Amended and Restated 2023 Equity Incentive Plan (the “2023 Plan”) was approved by the Board of Directors and the Company’s stockholders and became effective on June 15, 2023. The Board of Directors, or a committee thereof, is authorized to administer the 2023 Plan. The 2023 Plan provides for the grant of Incentive Stock Options (“ISO”) within the meaning of Section 422 of the Internal Revenue Code (“IRC”) as amended, to employees, and for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to the Company’s employees, directors and consultants and any Company affiliates’ employees and consultants. The number of shares initially reserved for issuance under the 2023 Plan was 7,400,000, which automatically increases on January 1 of each year for a period often years, beginning on January 1, 2024 and continuing through January 1, 2033, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the immediately preceding year, or a lesser number of shares determined by the Board of Directors no later than the last day of the immediately preceding year. The maximum number of shares of common stock that may be issued upon the exercise of ISOs under the 2023 Plan is 41,000,000 shares. As of December 31, 2023,6,753,724 shares were available for grant pursuant to the 2023 Plan. Pursuant to the terms of the 2023 Plan, the number of shares available under the 2023 Plan was increased by 2,164,366 shares effective January 1, 2024.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the Board of Directors and the Company’s stockholders and became effective on July 29, 2021. A total of 200,000 shares of common stock were initially reserved for issuance under this plan, which automatically increases on January 1 of each year by the lesser of (i)1% of the outstanding number of shares of common stock on the immediately preceding December 31; and (ii)400,000, or such lesser number of shares as determined by our Board of Directors. The Board of Directors acted not to increase the number of shares of common stock reserved for future issuance under the ESPP as of January 1,2023. As of December 31, 2023, no shares of common stock had been issued under the 2020 ESPP and 387,812 shares remained available for future issuance under the 2020 ESPP. The Board of Directors or designated committee has not set an offering period. Pursuant to the terms of the 2020 ESPP, the number of shares available under the 2020 ESPP was increased by 400,000 shares effective January 1, 2024.
Stock Option Activity
The following is a summary of the stock option award activity during the year ended December 31, 2023:
| Numberof StockOptions | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm(in years) | AggregateIntrinsicValue(in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2022 | 4,003,294 | $4.90 | 8.28 | $860 |
| Granted | 2,997,075 | 1.57 | ||
| Exercised | — | — | ||
| Forfeited | (304,436) | 2.36 | ||
| Outstanding at December 31, 2023 | 6,695,933 | $3.52 | 8.32 | $361 |
| Exercisable at December 31, 2023 | 2,546,509 | $5.12 | 7.45 | $49 |
| Options expected to vest as of December 31, 2023 | 4,149,424 | $2.54 | 8.86 | $312 |
The weighted-average grant date fair value of options granted during the years ended December 31, 2023 and 2022 was $1.57 and $2.85, respectively. The aggregate intrinsic value is calculated as the difference between the exercise price and the market price of the Company’s common stock at December 31, 2023.
Stock-Based Compensation Expense
For the years ended December 31, 2023 and 2022, the Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock options. The following table presents the assumptions and the Company’s methodology for developing each of the assumptions used:
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Volatility | 91.91% - 100.95% | 86.91% - 89.16% |
| Expected life (years) | 5.27 - 6.08 | 5.27 - 6.08 |
| Risk-free interest rate | 3.58% - 4.17% | 1.99% - 4.31% |
| Dividend rate | — | — |
Volatility—The Company estimates the expected volatility of its common stock at the date of grant based on the historical volatility of comparable public companies over the expected term.
Expected life—The expected term represents the period that the Company’s stock option grants are expected to be outstanding. The expected term of the options granted to employees and non-employee directors by the Company has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option.
Risk-free interest rate—The risk-free rate for periods within the estimated life of the stock award is based on the U.S. Treasury yield curve in effect at the time of grant.
Dividend rate—The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future.
Stock-based compensation expense was recorded in the following line items in the statements of operations for the years ended December 31,2023 and 2022 (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development | $1,891 | $1,404 |
| General and administrative | 2,479 | 2,063 |
| Total stock-based compensation expense | $4,370 | $3,467 |
No related tax benefits from stock-based compensation expense were recognized for the years ended December 31,2023 and 2022. As of December 31, 2023, there was$7.7 million in unrecognized stock-based compensation expense, which is expected to be recognized over a weighted-average period of 2.39 years.
- LICENSE AGREEMENTS
Emory University, Children’s Healthcare of Atlanta, Inc. and UAB Research Foundation
In June 2016, the Company entered into an exclusive license agreement with Emory University, Children’s Healthcare of Atlanta, Inc. and UAB Research Foundation ("UABRF"), as amended from time to time (the “Emory License Agreement”). The Emory License Agreement was amended in October 2017 and July 2020. Under the Emory License Agreement, the Company obtained an exclusive worldwide license under certain immunotherapy related patents and know-how related to gamma-delta T cells developed by Emory University, Children’s Healthcare of Atlanta, Inc. and UABRF’s affiliate, the University of Alabama at Birmingham, to develop, make, have made, use, sell, import and otherwise commercialize products that are covered by such patents or otherwise incorporate or use the licensed technology. Such exclusive license is subject to certain rights retained by these institutions and also the U.S. government.
In consideration of the license granted under the Emory License Agreement, the Company paid Emory University a nominal upfront payment. In addition, the Company is required to pay Emory University development milestones totaling up to an aggregate of $1.4 million, low-single-digit to mid-single-digit tiered running royalties on the net sales of the licensed products, including an annual minimum royalty beginning on a specified period after the first sale of a licensed product, and a share of certain payments that the Company may receive from sublicenses. In addition, in the event no milestone payments have been paid in certain years, the Company will be required to pay an annual license maintenance fee. The Emory License Agreement also requires the Company to reimburse Emory University for the cost of the prosecution and maintenance of the licensed patents.
Pursuantto the Emory License Agreement, the Company is required to use its best efforts to develop, manufacture and commercialize the licensed product and is obligated to meet certain specified deadlines in the development of the licensed products.
The term of the Emory License Agreement will continue until 15 years after the first commercial sale of licensed product, or the expiration of the relevant licensed patents, whichever is later. The Company may terminate the Emory License Agreement at will at any time upon prior written notice to Emory University. Emory University has the right to terminate the Emory License Agreement if the Company materially breaches the agreement (including failure to meet diligence obligations) and fails to cure such breach within a specified cure period, if the Company becomes bankrupt or insolvent or decides to cease development and commercialization of the licensed product, or if the Company challenges the validity or enforceability of any licensed patents.
Exclusive License Agreement with UABRF
In March 2016, the Company entered into an exclusive license agreement with UABRF, as amended from time to time (the “UABRF License Agreement”). The Company amended the UABRF License Agreement in December 2016, January 2017, June 2017 and November 2018. Under the UABRF License Agreement, the Company obtained an exclusive worldwide license under certain immunotherapy-related patents related to the use of gamma-delta T cells, certain CAR-T cells and combination treatments for cellular therapies developed by the University of Alabama at Birmingham and owned by UABRF to develop, make, have made, use, sell, import and otherwise commercialize products that are covered by such patents. Such exclusive license is subject to certain rights retained by UABRF and also the U.S. government.
In consideration of the license granted under the UABRF License Agreement, the Company paid UABRF a nominal upfront payment and issued 91,250 shares of common stock to UABRF, which were subject to certain antidilution rights.
In addition, the Company is required to pay UABRF development milestones totaling up to an aggregate of $1.4 million, lump-sum royalties on cumulative net sales totaling up to an aggregate of $22.5 million, mid-single-digit running royalties on net sales of the licensed products, low-single-digit running royalties on net sales of the licensed products, and a share of certain non-royalty income that the Company may receive, including from any sublicenses. The UABRF License Agreement also requires the Company to reimburse UABRF for the cost of the prosecution and maintenance of the licensed patents.
Pursuant to the UABRF License Agreement, the Company is required to use good faith reasonable commercial efforts to develop, manufacture and commercialize the licensed product.
The term of the UABRF License Agreement will continue until the expiration of the licensed patents. The Company may terminate the UABRF License Agreement at will at any time upon prior written notice to UABRF. UABRF has the right to terminate the UABRF License Agreement if the Company materially breaches the agreement and fails to cure such breach within a specified cure period, if the Company fails to diligently undertake development and commercialization activities as set forth in the development and commercialization plan, if the Company underreports its payment obligations or underpays by more than a specified threshold, if the Company challenges the validity or enforceability of any licensed patents, or if the Company becomes bankrupt or insolvent.
- INCOME TAXES
For the years ended December 31,2023 and 2022, the tax provision (benefit) consisted of (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Current provision (benefit): | ||
| Federal | $— | $— |
| State | — | — |
| Total | — | — |
| Deferred provision (benefit) | ||
| Federal | (6,084) | (5,967) |
| State | 343 | 1,455 |
| Total | (5,741) | (4,512) |
| Change in valuation allowance | 5,741 | 4,512 |
| Income tax provision (benefit) | $— | $— |
The items accounting for the difference between income taxes computed at the federal statutory rate and the Company’s effective tax rate for the years ended December 31,2023 and 2022 were as follows:
| December 31,2023 | December 31,2022 | |
|---|---|---|
| U.S. Federal statutory rate | 21.0% | 21.0% |
| State taxes, net of federal benefit | 0.0 | 0.0 |
| Stock-based compensation | (1.0) | (0.6) |
| Other permanent differences | (0.0) | 0.0 |
| True up adjustments | (1.0) | (4.0) |
| Change in valuation allowance | (19.0%) | (16.4%) |
| Income tax provision (benefit) | 0.0% | 0.0% |
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial statement purposes and the amounts used for income tax purposes.
Components of the Company’s net deferred tax assets (liabilities) balance are as follows at December 31,2023 and 2022 (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Deferred tax assets: | ||
| Stock-based compensation | $1,628 | $920 |
| Net operating loss carryforwards and alternative minimum tax credits | 12,708 | 9,737 |
| Lease liabilities | 1,027 | 1,234 |
| Reserves and accruals | 352 | 307 |
| Intangibles and fixed assets | 4,953 | 2,940 |
| Total deferred tax assets | 20,668 | 15,137 |
| Deferred tax liabilities: | ||
| ROU assets | (1,024) | (1,233) |
| Total deferred tax liabilities | (1,024) | (1,233) |
| Valuation allowance | (19,644) | (13,903) |
| Deferred tax assets (liabilities), net | $— | $— |
As of December 31, 2023, the Company had federal net operating loss carryforwards of approximately $52.4 million, which do not expire. As of December 31, 2023, the Company had state net operating loss carryforwards of approximately $18.3 million which will begin to expire in 2038.
The Company has evaluated both positive and negative evidences and determined that negative evidence outweighed the positive evidence and that a full valuation allowance on its net deferred tax assets will be maintained. The net change in the valuation allowance for the year ended December 31, 2023 was an increase of $5.7 million.
IRC Section 382 imposes limitations on the use of net operating loss carryovers when the stock ownership of one or more 5% shareholders (shareholders owning 5% or more of the Company’s outstanding capital stock) has increased on a cumulative basis by more than 50 percentage points. Accordingly, there is a risk of an ownership change that could trigger a limitation of the use of the loss carryover. The Company has undertaken a formal IRC Section 382 study up until December 31, 2023. Management concluded that the Company has undergone a more than 50% ownership change defined under IRS Section 382(a) on December 13, 2023; all the attributes disclosed in this footnotes reflect the conclusion of that study. However, subsequent ownership changes may further limit the Company's ability in the future to utilize its NOLs and other tax carryforwards.
The Tax Cuts and Jobs Act contained a provision which requires the capitalization of Section 174 costs incurred in years beginning on or after January 1, 2022. Section 174 costs are expenditures which represent research and development costs that are incident to the development or improvement of a product, process, formula, invention, computer software, or technique. This provision changes the treatment of Section 174 costs such that the expenditures are no longer allowed as an immediate deduction but rather must be capitalized and amortized. We have included the impact of this provision, which results in an increase in deferred tax assets of approximately $2.7 million for the year ended December 31, 2023.
In the ordinary course of business, the Company’s income tax returns are subject to examination by various taxing authorities. Such examinations may result in future tax and interest assessment by these taxing authorities. Accordingly, the Company believes that it is more likely than not that it will realize the benefits of tax positions it has taken in its tax returns or for the amount of any tax benefit that exceeds the cumulative probability threshold in accordance with FASB ASC 740. Differences between the estimated and actual amounts determined upon ultimate resolution, individually or in the aggregate, are not expected to have a material adverse effect on the Company’s financial position. The Company believes its tax positions are highly certain of being upheld upon examination. The Company is subject to the U.S. federal and state income taxes with varying statutes of limitations. Tax years from 2018 forward remaining open to examination due to the carryover of net operating losses or tax credits.
- NET LOSS PER SHARE
Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for the periods presented since the effects of potentially dilutive securities are antidilutive given the net loss of the Company.
Basic and diluted net loss per share is calculated as follows (in thousands except share and per share amounts):
| Year EndedDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Net loss | $(30,007) | $(28,521) |
| Net loss per share—basic and diluted | $(1.00) | $(1.36) |
| Weighted-average number of shares used in computing net loss per share—basic and diluted | 29,864,932 | 20,967,955 |
The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect is antidilutive:
| Year EndedDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Stock options to purchase common stock | 5,681,577 | 3,200,412 |
| Pre-Funded Warrants | 118,593 | — |
| Series A Warrants | 2,441,878 | — |
| Series B Warrants | 2,441,878 | — |
| Total | 10,683,926 | 3,200,412 |
- COMMITMENTS AND CONTINGENCIES
Intellectual Property
The Company has existing commitments to the licensors of the intellectual property which the Company has licensed. These commitments are based upon certain clinical research, regulatory, financial and sales milestones being achieved. Additionally, the Company is obligated to pay a single-digit royalty on commercial sales on a global basis of licensed products under the Emory License Agreement and the UABRF License Agreement. The royalty term is the later of 15 years from first commercial sale or expiration of the last-to-expire component of the licensed intellectual property.
Legal Proceedings
The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred costs related to such legal proceedings.
- equipment and FACILITY LEASES
The Company has historically entered into lease arrangements for its facilities. As of December 31, 2023, the Company had three operating leases with required future minimum payments. The Company determined the classification of these leases to be operating leases and recorded right-of-use assets and lease liabilities as of the effective date. The Company’s leases generally do not include termination or purchase options.
Finance Leases
The Company entered into an agreement with an equipment leasing company in 2018, which provided up to $2.5 million for equipment purchases in the form of sale and leasebacks or direct leases. As of December 31, 2023, the Company has ten active leases from the leasing company. The terms of the leases are three years and afterwards provide for either annual extensions or an outright purchase of the equipment.
The Company entered into an agreement with another equipment leasing company in the second quarter of 2023. As of December 31, 2023, the Company has one active lease from this leasing company. The terms of the lease are three years and afterwards provide for either annual extensions or an outright purchase of the equipment.
The equipment leases require two advance rental payments to be held as security deposits. The security deposits held amounted to approximately $0.3 million as of December 31,2023 and 2022, and are included in other non-current assets on the balance sheets.
Operating Leases
The Company has an operating lease for office space in Birmingham, Alabama, for a 63-month term ending in March 2026, with anoption to extend five years. Throughout the term of the lease, the Company is responsible for paying certain costs and expenses, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities.
The Company has an operating lease for office space in New York, New York, with a term that commenced on September 15, 2021, and continues through March 2027. Throughout the term of the lease, the Company is responsible for paying certain costs and expenses, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities.
The Company has identified an embedded lease within the University of Louisville Manufacturing Services Agreement, as the Company has the exclusive use of, and control over, a portion of the manufacturing facility and equipment of the facility during the contractual term of the manufacturing arrangement. The commencement date of the embedded lease was August 4, 2022 and it continues through August 2028.
The operating leases require security deposits at the inception of each lease. The security deposits amounted to approximately $0.3 million as of December 31,2023 and 2022. As of December 31, 2023, approximately$256,000 was included in restricted cash and$10,000 was included in other current assets. As of December 31, 2022, approximately $252,000 was included in restricted cash and $10,000 was included in other current assets.
The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s finance and operating leases for the years ended December 31, 2023 and 2022 (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Lease Cost | ||
| Amortization of finance right-of-use assets | $871 | $461 |
| Interest on finance lease liabilities | 138 | 53 |
| Operating lease cost | 1,151 | 731 |
| Short-term lease cost | 468 | — |
| Variable lease cost | 116 | — |
| Total lease cost | $2,744 | $1,245 |
| Other Lease Information | ||
|---|---|---|
| Cash paid for amounts included in the measurement of lease liability – finance leases | $956 | |
| Cash paid for amounts included in the measurement of lease liability – operating leases | $1,190 | |
| Weighted-average remaining lease term – finance leases | 1.96 years | |
| Weighted-average remaining lease term – operating leases | 4.27 years | |
| Weighted-average discount rate – finance leases | 9.5% | |
| Weighted-average discount rate – operating leases | 12.1% | |
The following table reconciles the undiscounted cash flows to the operating and financing lease liabilities at December 31, 2023 (in thousands):
| Financing Leases · Operating Leases | ||
|---|---|---|
| 2024 | $766 | $1,212 |
| 2025 | 501 | 1,224 |
| 2026 | 52 | 1,013 |
| 2027 | — | 767 |
| 2028 | — | 422 |
| Thereafter | — | — |
| Total lease payment | 1,319 | 4,638 |
| Less: interest | 100 | 964 |
| Total lease liabilities | 1,219 | 3,674 |
| Less: short-term lease liability | 694 | 820 |
| Long-term lease liability | $525 | $2,854 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.