Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Current assets: | ||
| Cash and cash equivalents | $ 40,035 | $ 42,044 |
| Prepaid expenses and other current assets | 376 | 476 |
| Total current assets | 40,411 | 42,520 |
| Other assets | 893 | 786 |
| Total assets | 41,304 | 43,306 |
| Current liabilities: | ||
| Accounts payable | 576 | 946 |
| Accrued liabilities | 680 | 812 |
| Total current liabilities | 1,256 | 1,758 |
| Commitments and contingencies (Note 4) | ||
| Stockholders’ equity | ||
| Common stock, $0.001 par value: 200,000,000 shares authorized as of March 31, 2022 (unaudited) and December 31, 2021; 14,761,261 and 14,754,447 shares issued and outstanding at March 31, 2022 (unaudited) and December 31, 2021, respectively | 15 | 15 |
| Additional paid-in capital | 115,765 | 114,698 |
| Accumulated deficit | (75,732) | (73,165) |
| Total stockholders’ equity | 40,048 | 41,548 |
| Total liabilities, convertible preferred stock and stockholders’ equity | $ 41,304 | $ 43,306 |
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Common stock, par value | $ 0.001 | $ 0.001 |
| Common stock, shares authorized | 200,000,000 | 200,000,000 |
| Common stock, shares issued | 14,761,261 | 14,754,447 |
| Common stock, shares outstanding | 14,761,261 | 14,754,447 |
| Series A Convertible Preferred Stock | ||
| Convertible preferred stock, par value | $ 0.001 | $ 0.001 |
| Convertible preferred stock, shares authorized | 10,000,000 | 10,000,000 |
| Convertible preferred stock, shares issued | 0 | 0 |
| Convertible preferred stock, shares outstanding | 0 | 0 |
| Convertible preferred stock, liquidation preference | $ 0 | $ 0 |
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
| Operating expenses: | ||
| Research and development | $ 693 | $ 3,322 |
| General and administrative | 1,821 | 1,419 |
| Total operating expenses | 2,514 | 4,741 |
| Loss from operations | (2,514) | (4,741) |
| Other expenses, net | (53) | (63) |
| Net loss | $ (2,567) | $ (4,804) |
| Net loss per share - basic and diluted | $ (0.17) | $ (0.36) |
| Weighted average shares outstanding, basic and diluted | 14,759,806 | 13,252,921 |
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
| Cash flows from operating activities: | ||
| Net loss | $ (2,567) | $ (4,804) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation expense | 14 | |
| Stock based compensation expense | 1,055 | 495 |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses and other assets | 39 | 154 |
| Accounts payable | (370) | (34) |
| Accrued liabilities | (132) | 145 |
| Net cash used in operating activities | (1,975) | (4,030) |
| Cash flows from financing activities: | ||
| Proceeds from exercise of stock options and ESPP | 12 | 27 |
| Payment of deferred financing costs | (46) | |
| Net cash (used in) provided by financing activities | (34) | 27 |
| Net decrease in cash and cash equivalents | (2,009) | (4,003) |
| Cash and cash equivalents — beginning of period | 42,044 | 58,765 |
| Cash and cash equivalents — end of period | $ 40,035 | $ 54,762 |
Organization and Description of Business |
3 Months Ended |
|---|---|
Mar. 31, 2022 | |
| Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
| Organization and Description of Business |
1. Organization and Description of Business
Forte Biosciences, Inc. (www.fortebiorx.com), together with its subsidiaries, referred to herein as the “Company”, is a biopharmaceutical company that had been focused on developing a topical live biotherapeutic for the treatment of inflammatory skin diseases with an initial focus on atopic dermatitis (“AD”). On September 2, 2021, the Company announced that the clinical trial of FB-401 for the treatment of AD failed to achieve statistical significance in its primary endpoint. Following the announcement of the FB-401 trial results, the Company ceased further development of FB-401. Following the announcement of FB-401 trial results, the Company conducted an extensive process to evaluate strategic alternatives. Following that process, the Company decided to focus on developing its FB-102 program which the Company believes has potentially broad application for autoimmune diseases such as alopecia areata, graft-vs-host disease and vitiligo. FB-102 is currently in preclinical development. The Company entered into a business combination (“Merger”) between Forte Subsidiary, Inc. (“Forte Subsidiary”) a private entity, and Tocagen, Inc. (“Tocagen”), a publicly traded biotechnology company. The Merger closed on June 15, 2020, in which Telluride Merger Sub, Inc., a wholly-owned subsidiary of Tocagen, merged with and into Forte Subsidiary, with Forte Subsidiary surviving the Merger as a wholly-owned subsidiary of Tocagen. Immediately prior to the closing of the Merger, the shares of Tocagen common stock were adjusted with a reverse split ratio of ‑for‑15. At the closing of the Merger, each share of Forte Subsidiary common stock outstanding immediately prior to the Merger was converted into the right to receive approximately 3.1624 shares of Tocagen common stock (before giving effect to the reverse split). All share and per share amounts have been retrospectively adjusted to give effect to the exchange of Forte Subsidiary common stock and the reverse split of Tocagen common stock. The par value per share of our capital stock was not adjusted as a result of the stock split. Immediately prior to the closing of the Merger, Tocagen changed its name to Forte Biosciences, Inc. The Company’s common stock is traded on the Nasdaq stock exchange under the ticker symbol “FBRX.” Immediately following the Merger, the former Forte Subsidiary and Tocagen security holders owned approximately 84.7% and 15.3% of the number of shares of the Company’s common stock, respectively.
Prior to the Merger, Forte Subsidiary was incorporated as Forte Biosciences, Inc. under the laws of the State of Delaware on May 3, 2017 as a privately-held company. Forte Biosciences, Inc. was renamed Forte Subsidiary, Inc. in connection with the Merger.
On February 12, 2021, the Company incorporated Forte Biosciences Emerald Limited in Dublin, Ireland, for the purpose of potentially undertaking clinical trials in the European Union. This subsidiary was dissolved on April 1, 2022.
Liquidity and Risks
The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The condensed consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred losses and negative cash flows from operations. As of March 31, 2022, the Company had an accumulated deficit of $75.7 million. The Company used $2.0 million of cash in operating activities during the three months ended March 31, 2022. Management expects to continue to incur additional losses in the foreseeable future as the Company focuses its development efforts on advancing FB-102 through preclinical studies and clinical trials. The Company had cash and cash equivalents of approximately $40.0 million as of March 31, 2022. The Company’s cash and cash equivalents are held at financial institutions and exceed federally insured limits. The Company believes that its existing cash and cash equivalents will be sufficient to allow the Company to fund its operations for at least 12 months from the filing date of this Form 10-Q. The Company will continue to need to raise additional capital or obtain financing from other sources. Management may fund future operations through the sale of equity and debt financings and may also seek additional capital through arrangements with strategic partners or other sources. There can be no assurance that additional funding will be available on terms acceptable to the Company, if at all. If the Company is unable to raise additional funding to meet its working capital needs in the future, it may be forced to delay or reduce the scope of its research and development programs and/or limit or cease its operations. There are numerous risks and uncertainties associated with pharmaceutical development and the Company is unable to predict the timing or amount of increased expenses on the development of future product candidates or when or if it will start to generate revenues. Even if the Company does generate revenues, it may not be able to achieve or maintain profitability. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then it may be unable to continue its operations at planned levels and may be forced to reduce its operations. The pandemic caused by outbreaks of new strains of coronaviruses, or COVID-19 and its variants, has resulted, and may continue to result, in significant national and global economic disruption and may adversely affect the Company’s operations. The Company is actively monitoring the impact of COVID-19 and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. However, the full extent, consequences, and duration of the COVID-19 pandemic and the resulting impact on the Company cannot currently be predicted. The Company will continue to evaluate the impact that these events could have on its operations, financial position, results of operations and cash flows during the remainder of 2022. |
Summary of Significant Accounting Policies |
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company should be read in conjunction with its audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2021 included in the Company’s Form 10-K as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 31, 2022. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), as found in the Accounting Standards Codification (“ASC”), the Accounting Standards Update (“ASU”), of the Financial Accounting Standards Board (“FASB”), and the rules and regulations of the US Securities and Exchange Commission (“SEC”). The Merger was accounted for as a reverse asset acquisition, as more fully described in Note 1. Forte Subsidiary was deemed to be the acquirer for accounting purposes and Tocagen was the accounting acquiree. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position, the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period. Principles of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Forte Subsidiary, Inc and Forte Biosciences Emerald Limited. All intercompany accounts and transactions have been eliminated in the preparation of the condensed consolidated financial statements. Cash and Cash Equivalents Cash and cash equivalents include money market funds and deposits with commercial banks. Cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. There is a three-level hierarchy that prioritizes the inputs used in determining fair value by their reliability and preferred use as follows:
To the extent that a valuation is based on models or inputs that are less observable, or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized within 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. There have been no significant changes to the valuation methods utilized by the Company during the periods presented. There have been no transfers between Level 1, Level 2, and Level 3 in any periods presented. The carrying amounts of financial instruments consisting of cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities included in the Company’s financial statements, are reasonable estimates of fair value, primarily due to their short maturities. The Company had $34.9 million in money market funds as of March 31, 2022 and December 31, 2021, which are classified within Level 1. Money market funds are valued at the closing price reported by the fund sponsor from an actively traded exchange. Money market funds were included as cash and cash equivalents in the condensed consolidated balance sheets at March 31, 2022 and December 31, 2021. Use of Estimates The preparation of the Company’s condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. Significant management estimates that affect the reported amounts of assets, liabilities and expenses include stock-based compensation expense, accruals and deferred tax assets. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and benefits of research and development personnel, costs related to research activities, preclinical studies, clinical trials and drug manufacturing. Non-refundable advance payments for goods or services that will be used in future research and development activities are deferred and capitalized and are only expensed when the goods have been received or when the service has been performed rather than when the payment is made.
Drug manufacturing and clinical trial costs are a component of research and development expenses. The Company expenses costs for its drug manufacturing activities performed by Contract Manufacturing Organizations (“CMOs”), preclinical and clinical trial costs performed by Contract Research Organizations (“CROs”) and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the percentage of completion and therefore the expense to be incurred. Comprehensive Loss Comprehensive loss includes net loss and other comprehensive income (loss) for the period. The Company did not have other comprehensive income (loss) items such as unrealized gains and losses. Comprehensive loss was equal to net loss for the three months ended March 31, 2022 and 2021. Net Loss Per Share Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding during the period in accordance with the treasury stock method. The following number of unexercised stock options, warrants and restricted stock units, which are common stock equivalents, have been excluded from the diluted net loss calculation as their effect would have been anti-dilutive for all periods presented:
Recently Issued Accounting Standards Not Yet Adopted From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of a specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations. In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in an Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings per share computation. The amendments in ASU 2020-06 are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but not earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements and does not expect the adoption of this amended guidance to have a material impact on the Company’s consolidated financial statements. |
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Balance Sheet Components |
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| Balance Sheet Related Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance Sheet Components |
3. Balance Sheet Components Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets as of March 31, 2022 and December 31, 2021 consist of the following (in thousands):
Other Assets Other assets as of March 31, 2022 and December 31, 2021 consist of the following (in thousands).
Accrued Liabilities Accrued liabilities as of March 31, 2022 and December 31, 2021 consist of the following (in thousands):
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Commitments and Contingencies |
3 Months Ended |
|---|---|
Mar. 31, 2022 | |
| Commitments And Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies |
4. Commitments and Contingencies Concentrations of Credit Risk Bank accounts in the United States are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. The Company’s cash accounts significantly exceed FDIC limits. Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, and employees for certain events and occurrences while the officer, or director is, or was, serving at the Company’s request in such capacity. License to Patented Technology In December 2017, the Company entered into an exclusive license agreement with the Department of Health and Human Services (“DHHS”). Under the agreement, the DHHS granted the Company an exclusive, sublicensable, worldwide license to certain patent rights under which the Company may develop and commercialize pharmaceutical and biological compositions comprising Gram-negative bacteria for the topical treatment of dermatological diseases and conditions (the “DHHS License”). Under the DHHS License, the Company is obligated to meet certain development benchmarks within certain time periods. If the Company is unable to meet any of these development benchmarks, the DHHS could terminate the license. In addition, the DHHS may terminate or modify the DHHS License in the event of a material breach or upon certain insolvency events that remain uncured following a 90 day written notice of such material breach or insolvency event. The DHHS also has the right to require the Company to grant mandatory sublicenses to patent rights licensed from the DHHS to product candidates covered by other DHHS licenses under certain specified circumstances, including if it is necessary to meet health and safety needs or to meet requirements for public use as specified by federal regulations that the Company is not reasonably satisfying. Under the DHHS License, as amended in May 2020, the Company was obligated to pay the DHHS a minimum annual payment of $100,000 beginning January 1, 2021. The Company is required to reimburse the DHHS for certain patent-related expenses and may also be obligated to make payments to the DHHS based upon achieving specified development and regulatory milestones for the first licensed product. Such development milestone payments are the completion of patient enrollment in a phase 3 clinical trial and the completion of a phase 3 clinical trial demonstrating a statistically significant efficacy benefit. The regulatory milestones are the receipt of the first FDA approval and the first non-USA regulatory agency approval. In addition, to the extent licensed products are approved for commercial sale, the Company is also obligated to pay the DHHS royalties based on net sales of licensed products sold by the Company and if applicable, its sublicensees. No milestones have been met as of March 31, 2022. The Company terminated the license agreement with DHHS effective April 2, 2022. The Company incurred $25,000 in minimum royalty expenses for each of the three months ended March 31, 2022 and 2021. Lease Agreements In April 2019, the Company entered into a lease agreement for certain office and laboratory space in Torrance, California. The lease agreement is cancellable by the Company at any time with a 30-day notice. In June 2021, the Company entered into a lease agreement for additional office space at a separate location for an initial lease of 6 months after which the lease term will be month-to-month. Total rent expense for all locations for the three months ended March 31, 2022 was $3,000. The Company recorded a net rent credit of $14,000 for the three months ended March 31, 2021 as a result of a refund for operating expense adjustments. Clinical Supply Agreements The Company had entered into various agreements with CMOs for the manufacture of clinical trial materials and CROs for clinical trial services. These agreements provide the terms and conditions under which the CMOs and CROs will formulate, fill, inspect, package, label and test the Company’s drug product candidate, FB-401. The Company has scaled back its clinical and manufacturing operations in order to conserve cash as a result of the FB-401 clinical trial not meeting its primary endpoint. The estimated remaining commitments as of March 31, 2022 under these agreements were approximately $290 thousand. |
Equity |
3 Months Ended |
|---|---|
Mar. 31, 2022 | |
| Equity [Abstract] | |
| Equity |
5. Equity Series A Convertible Preferred Stock On November 27, 2018, the Company entered into a preferred stock purchase agreement with certain investors and issued 1,738,759 shares of Series A convertible preferred stock for net proceeds of $5.7 million, including $0.7 million from the conversion of convertible notes and accrued interest. In addition, on January 2, 2019, the Company completed a second round of the Series A preferred stock financing and issued 1,438,985 shares at $3.41 per share for net proceeds of $4.9 million. All outstanding shares of Series A convertible preferred stock were converted into shares of common stock on a one for one ratio in connection with the closing of the Merger on June 15, 2020. Common Stock In connection with the Merger, the Company issued 3,804,817 shares of its common stock and warrants to purchase 2,752,546 shares (the “Concurrent Financing Warrants”) of the Company’s common stock at an exercise price of $10.56 per share, for net proceeds of $19.4 million. In addition, on June 16, 2020, the Company issued an additional 411,112 shares of common stock for net proceeds of $4.6 million. Warrants to purchase 4,434 shares of the Company’s common stock at an exercise price of $140.25 per share which were previously issued by Tocagen, survived the Merger and remained outstanding as of March 31, 2022. In June 2021, the Company filed a shelf registration statement on Form S-3 that went effective in June 2021 which will allow the Company to raise up to $300 million in additional capital. The Company incurred $106.4 thousand in offering costs related to this shelf registration statement which is recorded in Other Assets in the condensed consolidated balance sheet as of March 31, 2022. The Company has not issued any securities under the new shelf registration statement as of the filing date of this Form 10-Q. On November 2, 2020, the Company completed a public offering of 1,614,035 shares of its common stock at $28.50 per share, which includes the over-allotment option exercised by the underwriters to purchase an additional 210,526 shares. Total net proceeds were $42.7 million after deducting underwriting discounts and other offering expenses of approximately $3.3 million. In February 2021, Concurrent Financing Warrants to purchase 978,858 shares of common stock were exercised on a cashless basis resulting in 673,463 shares being issued. In June 2021, Concurrent Financing Warrants to purchase 760,572 shares of common stock were exercised on a cashless basis resulting in 560,402 shares being issued. In September 2021, Concurrent Financing Warrants to purchase 1,013,116 shares of common stock were exercised on a cashless basis resulting in 655,409 shares being issued. As of March 31, 2022, no Concurrent Financing Warrants were outstanding. On March 31, 2022, the Company entered into an “at-the-market” equity offering program (“ATM Facility”) whereby the Company may from time to time offer and sell shares of its common stock up to an aggregate offering price of $25.0 million during the term of the ATM Facility. The Company has also filed a prospectus supplement relating to the offer and sale of the shares pursuant to the ATM Facility covering sales of up to $7,000,000 of shares of common stock. The Company is not obligated to sell any shares under the ATM Facility. The ATM Facility may be terminated at any time upon ten days’ prior notice, or at any time in certain circumstances, including the occurrence of a material adverse effect on the Company. The Company has agreed to pay the sales agent a commission equal to 3.0% of the gross proceeds from the sales of shares under the ATM Facility and has agreed to provide the sales agent with customary indemnification and contribution rights. The Company incurred $156 thousand in offering costs related to the ATM facility which is recorded in Other Assets in the condensed consolidated balance sheet for the period ended March 31, 2022. The Company has not issued any shares of common stock under the ATM Facility through the filing date of this Form 10-Q. |
Stock-Based Compensation |
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| Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-Based Compensation |
6. Stock-Based Compensation Equity Plans In December 2018, Forte Subsidiary adopted the 2018 Equity Incentive Plan (the “2018 Incentive Plan”). The terms and conditions of stock-based awards were defined at the sole discretion of the Forte Subsidiary’s Board of Directors. Service-based awards vesting over a defined period of service and performance-based awards that vest upon the achievement of defined conditions have been issued under the 2018 Incentive Plan. Service-based awards generally vest over a period, with the first 25% of such awards vesting following twelve months of continued employment or service with the remaining awards vesting monthly in equal installments over the following thirty-six months. Stock options granted under the 2018 Incentive Plan expire ten years from the date of grant and the exercise price must be at least equal to the fair market value of common stock on the grant date. In connection with the Merger, all outstanding options under the 2018 Incentive Plan were exchanged into options to purchase common stock of Tocagen, which changed its name to Forte Biosciences Inc. upon the closing of the Merger. Subsequent to the Merger, the 2018 Incentive Plan was frozen and no more stock-based awards will be granted from that plan. In connection with the Merger, the Company assumed Tocagen’s 2017 Equity Incentive Plan, which was effective on April 12, 2017, was subsequently amended on September 30, 2018 and further amended on February 12, 2019 (the “2017 Plan”). Immediately upon closing of the Merger, 61,406 restricted stock awards and stock options to purchase 26,968 shares of common stock granted under the 2017 Plan prior to the Merger became fully vested in consideration for pre-merger services provided to Tocagen. On July 26, 2020, the Company adopted the 2020 Inducement Equity Incentive Plan (the “2020 Inducement Plan”) and reserved 500,000 shares for future grants under the 2020 Inducement Plan. As of March 31, 2022, there were 365,000 options available for issuance under the 2020 Inducement Plan. In May 2021, the 2017 Plan was terminated and replaced by the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan had an initial reserve of 1,000,000 shares available for grant. The 2021 Plan provides for the grant of incentive stock options (“ISOs”), non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants of the Company and its affiliates. Subsequent to the Merger, service-based awards generally vested over a period, with the first 25% of such awards vesting following twelve months of continued employment or service with the remaining awards vesting monthly in equal installments over the following thirty-six months. For certain service-based awards to the board of directors, vesting occurs in thirty-six equal monthly installments over a period for initial grants and in twelve equal monthly installments over a period for subsequent grants. As of March 31, 2022, there were 25,902 options available for issuance under the 2021 Plan. Stock Options The risk-free interest rate valuation assumption for options is based on the U.S. Treasury yield curve rate at the date of grant with a maturity approximating the expected term of the option. The expected term assumption for options granted to employees is determined using the simplified method that represents the average of the contractual term of the option and the weighted average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term. Due to the Company’s limited trading of its common stock and lack of company-specific historical or implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies in the life sciences industry whose shares are publicly traded. The Company selects the peer group based on comparable characteristics, including development stage, product pipeline, and enterprise value. The Company computes historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until sufficient amount of historical information regarding the volatility of its own stock price become available. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. Prior to the Merger, the fair value per share was determined by the Company’s Board of Directors, as of the date of each grant based on independent third-party valuations, taking into consideration various objective and subjective factors. Subsequent to the Merger, the fair value per share is the closing stock price on the option grant date. The weighted average grant-date fair value of stock options granted in the three months ended March 31, 2022 and 2021 was $0.96 and $22.89, respectively. The weighted-average assumptions used to value these stock options using the Black-Scholes option-pricing model were as follows.
The table below summarizes the stock option activity during the three months ended March 31, 2022:
The aggregate intrinsic value of options at March 31, 2022 is based on the Company’s fair value of its stock price on that date of $1.46 per share.
Restricted Stock Unit Awards
There were no restricted stock units granted during the three months ended March 31, 2022. The Company made a change in accounting estimate in the three months ended March 31, 2022 related to the vesting of performance-based restricted stock units. As a result of this change in accounting estimate, $158 thousand dollar of expense that had been previously recognized in 2021 was reversed in three months ended March 31, 2022. Restricted stock unit awards outstanding as of March 31, 2022 were as follows:
2017 Employee Stock Purchase Plan In May 2021, the Company’s board of directors reactivated the Company’s 2017 Employee Stock Purchase Plan (“ESPP”) which had previously been suspended. The ESPP allows eligible employees to withhold up to 15% of their earnings to purchase shares of the Company’s common stock at a price per share equal to the lower of (i) 85% of the fair market value of a share of the Company’s common stock on the first date of an offering or (ii) 85% of the fair market value of a share of the Company’s common stock on the date of purchase. The Company had 170,978 shares available for future issuance under the ESPP as of March 31, 2022. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year through January 1, 2027, by the lesser of (a) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (b) 300,000 shares, or (c) a number determined by the Company’s board of directors that is less than (a) and (b). The Company issued 5,716 shares under the ESPP during the three months ended March 31, 2022. The ESPP is considered a compensatory plan and the Company did not record stock-based compensation expense for the three months ended March 31, 2022 or 2021. Stock-Based Compensation Expense Stock-based compensation expenses included in the Company’s condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021 were (in thousands):
As of March 31, 2022, there was unrecognized stock-based compensation expense related to stock options with service conditions of $8.7 million, which is expected to be recognized over a weighted-average period of 1.42 years. Total unrecognized stock-based compensation expenses related to stock options and restricted stock units with performance conditions were approximately $392,000. |
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Related Party Transactions |
3 Months Ended |
|---|---|
Mar. 31, 2022 | |
| Related Party Transactions [Abstract] | |
| Related Party Transactions |
7. Related Party Transactions One member of the Company’s board of directors received cash payments of $5,000 for scientific consulting services during the three months ended March 31, 2022. There were no related party transactions during the three months ended March 31, 2021. |
Summary of Significant Accounting Policies (Policies) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Presentation |
Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company should be read in conjunction with its audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2021 included in the Company’s Form 10-K as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 31, 2022. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), as found in the Accounting Standards Codification (“ASC”), the Accounting Standards Update (“ASU”), of the Financial Accounting Standards Board (“FASB”), and the rules and regulations of the US Securities and Exchange Commission (“SEC”). The Merger was accounted for as a reverse asset acquisition, as more fully described in Note 1. Forte Subsidiary was deemed to be the acquirer for accounting purposes and Tocagen was the accounting acquiree. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position, the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period. |
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| Principles of Consolidation |
Principles of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Forte Subsidiary, Inc and Forte Biosciences Emerald Limited. All intercompany accounts and transactions have been eliminated in the preparation of the condensed consolidated financial statements. |
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| Cash and Cash Equivalents |
Cash and Cash Equivalents Cash and cash equivalents include money market funds and deposits with commercial banks. Cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase. |
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| Fair Value of Financial Instruments |
Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. There is a three-level hierarchy that prioritizes the inputs used in determining fair value by their reliability and preferred use as follows:
To the extent that a valuation is based on models or inputs that are less observable, or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized within 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. There have been no significant changes to the valuation methods utilized by the Company during the periods presented. There have been no transfers between Level 1, Level 2, and Level 3 in any periods presented. The carrying amounts of financial instruments consisting of cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities included in the Company’s financial statements, are reasonable estimates of fair value, primarily due to their short maturities. The Company had $34.9 million in money market funds as of March 31, 2022 and December 31, 2021, which are classified within Level 1. Money market funds are valued at the closing price reported by the fund sponsor from an actively traded exchange. Money market funds were included as cash and cash equivalents in the condensed consolidated balance sheets at March 31, 2022 and December 31, 2021. |
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| Use of Estimates |
Use of Estimates The preparation of the Company’s condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. Significant management estimates that affect the reported amounts of assets, liabilities and expenses include stock-based compensation expense, accruals and deferred tax assets. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
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| Research and Development Costs |
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and benefits of research and development personnel, costs related to research activities, preclinical studies, clinical trials and drug manufacturing. Non-refundable advance payments for goods or services that will be used in future research and development activities are deferred and capitalized and are only expensed when the goods have been received or when the service has been performed rather than when the payment is made.
Drug manufacturing and clinical trial costs are a component of research and development expenses. The Company expenses costs for its drug manufacturing activities performed by Contract Manufacturing Organizations (“CMOs”), preclinical and clinical trial costs performed by Contract Research Organizations (“CROs”) and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the percentage of completion and therefore the expense to be incurred. |
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| Comprehensive Loss |
Comprehensive Loss Comprehensive loss includes net loss and other comprehensive income (loss) for the period. The Company did not have other comprehensive income (loss) items such as unrealized gains and losses. Comprehensive loss was equal to net loss for the three months ended March 31, 2022 and 2021. |
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| Net Loss Per Share |
Net Loss Per Share Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding during the period in accordance with the treasury stock method. The following number of unexercised stock options, warrants and restricted stock units, which are common stock equivalents, have been excluded from the diluted net loss calculation as their effect would have been anti-dilutive for all periods presented:
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| Recently Issued Accounting Standards Not Yet Adopted |
Recently Issued Accounting Standards Not Yet Adopted From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of a specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations. In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in an Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings per share computation. The amendments in ASU 2020-06 are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but not earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements and does not expect the adoption of this amended guidance to have a material impact on the Company’s consolidated financial statements. |
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Summary of Significant Accounting Policies (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Calculation | The following number of unexercised stock options, warrants and restricted stock units, which are common stock equivalents, have been excluded from the diluted net loss calculation as their effect would have been anti-dilutive for all periods presented:
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Balance Sheet Components (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance Sheet Related Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets as of March 31, 2022 and December 31, 2021 consist of the following (in thousands):
|
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| Schedule of Other Assets |
Other assets as of March 31, 2022 and December 31, 2021 consist of the following (in thousands).
|
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| Components of Accrued Liabilities |
Accrued liabilities as of March 31, 2022 and December 31, 2021 consist of the following (in thousands):
|
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Stock-Based Compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Weighted-Average Assumptions Used to Value Stock Options | The weighted-average assumptions used to value these stock options using the Black-Scholes option-pricing model were as follows.
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| Summary of Stock Option Activity | The table below summarizes the stock option activity during the three months ended March 31, 2022:
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| Summary of Restricted Stock Unit Award Transactions |
Restricted stock unit awards outstanding as of March 31, 2022 were as follows:
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| Summary of Stock-Based Compensation Expenses |
Stock-based compensation expenses included in the Company’s condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021 were (in thousands):
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Organization and Description of Business - Additional Information (Details) $ in Thousands |
3 Months Ended | ||
|---|---|---|---|
|
Mar. 31, 2022
USD ($)
shares
|
Mar. 31, 2021
USD ($)
|
Dec. 31, 2021
USD ($)
|
|
| Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
| Accumulated deficit | $ 75,732 | $ 73,165 | |
| Cash used in operating activities | (1,975) | $ (4,030) | |
| Cash and cash equivalents | $ 40,035 | $ 42,044 | |
| Tocagen, Inc. | |||
| Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
| Right to receive shares for each common stock outstanding | shares | 3.1624 | ||
| Reverse stock split, description | 1‑for‑15 | ||
| Reverse split ratio | 0.06667 | ||
| Common stock ownership percentage | 15.30% | ||
| Forte Subsidiary, Inc. | |||
| Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
| Common stock ownership percentage | 84.70% | ||
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) |
3 Months Ended | ||
|---|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
Dec. 31, 2021 |
|
| Schedule Of Significant Accounting Policies [Line Items] | |||
| Transfers between fair value hierarchy levels | $ 0 | ||
| Other comprehensive income (loss) | 0 | $ 0 | |
| Level 1 | |||
| Schedule Of Significant Accounting Policies [Line Items] | |||
| Money market funds, at carrying value | $ 34,900,000 | $ 34,900,000 | |
Summary of Significant Accounting Policies - Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Calculation (Details) - shares |
3 Months Ended | |
|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
| Anti-dilutive securities excluded from diluted net loss calculation | 2,187,855 | 2,917,963 |
| Options | ||
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
| Anti-dilutive securities excluded from diluted net loss calculation | 1,924,570 | 1,119,841 |
| Warrants | ||
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
| Anti-dilutive securities excluded from diluted net loss calculation | 4,434 | 1,778,122 |
| Restricted Stock Units | ||
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
| Anti-dilutive securities excluded from diluted net loss calculation | 258,851 | 20,000 |
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Balance Sheet Related Disclosures [Abstract] | ||
| Prepaid insurance | $ 287 | $ 387 |
| Other | 89 | 89 |
| Total Prepaid Expenses and Other Current Assets | $ 376 | $ 476 |
Balance Sheet Components - Schedule of Other Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Balance Sheet Related Disclosures [Abstract] | ||
| Prepaid insurance | $ 618 | $ 667 |
| Prepaid offering costs | 262 | 106 |
| Other | 13 | 13 |
| Total Other Assets | $ 893 | $ 786 |
Balance Sheet Components - Components of Accrued Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|
| Balance Sheet Related Disclosures [Abstract] | ||
| Accrued legal and professional fees | $ 180 | $ 75 |
| Accrued compensation | 359 | 681 |
| Accrued manufacturing and clinical expenses | 40 | |
| Other | 141 | 16 |
| Total Accrued Liabilities | $ 680 | $ 812 |
Commitments and Contingencies - Additional Information (Details) - USD ($) |
3 Months Ended | ||
|---|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
Jan. 01, 2021 |
|
| Commitments And Contingencies [Line Items] | |||
| FDIC insured amount | $ 250,000 | ||
| Rent expenses | $ 3,000 | ||
| Initial lease term | 6 months | ||
| Rent Credit Due to Refund for Operating Expense Adjustments | $ 14,000 | ||
| Contractual Obligation | $ 290,000 | ||
| DHHS | |||
| Commitments And Contingencies [Line Items] | |||
| Minimum annual payment | $ 100,000 | ||
| DHHS | Minimum | |||
| Commitments And Contingencies [Line Items] | |||
| Royalty expenses | $ 25,000 | $ 25,000 | |
Stock-Based Compensation - Summary of Weighted-Average Assumptions Used to Value Stock Options (Details) - $ / shares |
3 Months Ended | |
|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
| Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
| Fair value of common stock | $ 1.58 | $ 36.94 |
| Risk-free interest rate | 1.75% | 0.66% |
| Dividend yield | 0.00% | 0.00% |
| Expected term of options (years) | 5 years 10 months 24 days | 6 years 29 days |
| Volatility | 66.89% | 70.00% |
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended |
|---|---|---|
Mar. 31, 2022 |
Dec. 31, 2021 |
|
| Number of Shares Outstanding | ||
| Outstanding, Beginning | 1,281,396 | |
| Granted | 695,000 | |
| Exercised | (1,098) | |
| Cancelled/Forfeited | (50,728) | |
| Outstanding, Ending | 1,924,570 | 1,281,396 |
| Vested and expected to vest | 1,924,570 | |
| Exercisable | 287,029 | |
| Weighted-Average Exercise Price | ||
| Outstanding, Beginning | $ 18.18 | |
| Granted | 1.63 | |
| Exercised | 1.06 | |
| Cancelled/Forfeited | 25.61 | |
| Outstanding, Ending | 12.02 | $ 18.18 |
| Vested and expected to vest | 12.02 | |
| Exercisable | $ 21.33 | |
| Weighted-Average Remaining Contractual Term (Years) | ||
| Outstanding | 8 years 7 months 13 days | 7 years 11 months 8 days |
| Vested and expected to vest | 8 years 7 months 13 days | |
| Exercisable | 8 years 4 months 6 days | |
| Aggregate Intrinsic Value | ||
| Outstanding | $ 304 | |
| Vested and expected to vest | 304 | |
| Exercisable | $ 21 |
Stock-Based Compensation - Summary of Restricted Stock Unit Award Transactions (Details) - Restricted Stock Units (RSUs) |
3 Months Ended |
|---|---|
|
Mar. 31, 2022
$ / shares
shares
| |
| Shares | |
| Outstanding at December 31, 2021 | 258,851 |
| Stock awards granted | 0 |
| Outstanding at March 31, 2022 | 258,851 |
| Weighted Avg Grant Date Fair Value | |
| Outstanding at December 31, 2021 | $ / shares | $ 3.36 |
| Outstanding at March 31, 2022 | $ / shares | $ 3.36 |
Stock-Based Compensation - Summary of Stock-Based Compensation Expenses (Details) - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
| Stock-based compensation expense | $ 1,055 | $ 495 |
| Research and Developments Expenses | ||
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
| Stock-based compensation expense | 286 | 304 |
| General and Administrative | ||
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
| Stock-based compensation expense | $ 769 | $ 191 |
Related Party Transactions - Additional Information (Details) - USD ($) |
3 Months Ended | |
|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
| Director | ||
| Related Party Transaction [Line Items] | ||
| Payments for scientific consulting services | $ 5,000 | |
| Director One | ||
| Related Party Transaction [Line Items] | ||
| Accounts payable | $ 0 |