Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 29, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | TRACON Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001394319 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2021 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding | 19,445,903 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | TCON | |
Entity Shell Company | false | |
Entity File Number | 001-36818 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 34-2037594 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Address, Address Line One | 4350 La Jolla Village Drive | |
Entity Address, Address Line Two | Suite 800 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92122 | |
City Area Code | 858 | |
Local Phone Number | 550-0780 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 29,901 | $ 32,131 |
Short-term investments | 3,999 | |
Prepaid and other assets | 1,241 | 784 |
Total current assets | 31,142 | 36,914 |
Property and equipment, net | 49 | 16 |
Other assets | 1,617 | 508 |
Total assets | 32,808 | 37,438 |
Current liabilities: | ||
Accounts payable and accrued expenses | 9,527 | 6,235 |
Accrued compensation and related expenses | 1,128 | 1,590 |
Long-term debt, current portion | 2,079 | 2,718 |
Total current liabilities | 12,734 | 10,543 |
Other long-term liabilities | 1,211 | 432 |
Long-term debt, less current portion | 1,391 | |
Commitments and contingencies (Note 4) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, authorized shares — 10,000,000 at September 30, 2021 and December 31, 2020; issued and outstanding shares — none | ||
Common stock, $0.001 par value; authorized shares — 40,000,000 at September 30, 2021 and December 31, 2020; issued and outstanding shares — 19,430,369 and 15,478,787 at September 30, 2021 and December 31, 2020, respectively | 19 | 15 |
Additional paid-in capital | 218,908 | 204,166 |
Accumulated deficit | (200,064) | (179,109) |
Total stockholders’ equity | 18,863 | 25,072 |
Total liabilities and stockholders’ equity | $ 32,808 | $ 37,438 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 40,000,000 | 40,000,000 |
Common stock, shares issued | 19,430,369 | 15,478,787 |
Common stock, shares outstanding | 19,430,369 | 15,478,787 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
License revenue | $ 346 | |||
Type Of Revenue Extensible List | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||||
Research and development | $ 2,730 | $ 1,785 | $ 8,082 | $ 6,001 |
General and administrative | 4,151 | 2,063 | 12,948 | 6,045 |
Total operating expenses | 6,881 | 3,848 | 21,030 | 12,046 |
Loss from operations | (6,881) | (3,848) | (20,684) | (12,046) |
Other expense: | ||||
Interest expense, net | (69) | (141) | (269) | (412) |
Other expense, net | (2) | (3) | (2) | (6) |
Total other expense | (71) | (144) | (271) | (418) |
Net loss | $ (6,952) | $ (3,992) | $ (20,955) | $ (12,464) |
Net loss per share, basic and diluted | $ (0.38) | $ (0.38) | $ (1.27) | $ (1.69) |
Weighted-average shares outstanding, basic and diluted | 18,533,772 | 10,509,220 | 16,514,652 | 7,366,888 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2019 | $ 2,698 | $ 4 | $ 165,028 | $ (162,334) |
Balance (in Shares) at Dec. 31, 2019 | 4,051,187 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Stock-based compensation expense | 267 | 267 | ||
Issuance of common stock under equity plans | (6) | (6) | ||
Issuance of common stock under equity plans (in shares) | 2,078 | |||
Issuances of common stock, net of offering costs | 3,720 | $ 1 | 3,719 | |
Issuances of common stock, net of offering costs (in shares) | 1,344,673 | |||
Issuance of common stock in exchange for services | 126 | 126 | ||
Issuance of common stock in exchange for services (in shares) | 100,000 | |||
Net loss | (4,021) | (4,021) | ||
Balance at Mar. 31, 2020 | 2,784 | $ 5 | 169,134 | (166,355) |
Balance (in Shares) at Mar. 31, 2020 | 5,497,938 | |||
Balance at Dec. 31, 2019 | 2,698 | $ 4 | 165,028 | (162,334) |
Balance (in Shares) at Dec. 31, 2019 | 4,051,187 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (12,464) | |||
Balance at Sep. 30, 2020 | 15,486 | $ 14 | 190,270 | (174,798) |
Balance (in Shares) at Sep. 30, 2020 | 13,682,653 | |||
Balance at Mar. 31, 2020 | 2,784 | $ 5 | 169,134 | (166,355) |
Balance (in Shares) at Mar. 31, 2020 | 5,497,938 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Stock-based compensation expense | 263 | 263 | ||
Issuance of common stock under equity plans | 5 | 5 | ||
Issuance of common stock under equity plans (in shares) | 2,450 | |||
Issuances of common stock, net of offering costs | 4,402 | $ 3 | 4,399 | |
Issuances of common stock, net of offering costs (in shares) | 2,273,427 | |||
Net loss | (4,451) | (4,451) | ||
Balance at Jun. 30, 2020 | 3,003 | $ 8 | 173,801 | (170,806) |
Balance (in Shares) at Jun. 30, 2020 | 7,773,815 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Stock-based compensation expense | 240 | 240 | ||
Issuances of common stock and warrants, net of offering costs | 16,235 | $ 6 | 16,229 | |
Issuances of Common Stock and Warrants Net of Offering Costs (in shares) | 5,908,838 | |||
Net loss | (3,992) | (3,992) | ||
Balance at Sep. 30, 2020 | 15,486 | $ 14 | 190,270 | (174,798) |
Balance (in Shares) at Sep. 30, 2020 | 13,682,653 | |||
Balance at Dec. 31, 2020 | 25,072 | $ 15 | 204,166 | (179,109) |
Balance (in Shares) at Dec. 31, 2020 | 15,478,787 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Stock-based compensation expense | 343 | 343 | ||
Issuance of common stock under equity plans | 14 | 14 | ||
Issuance of common stock under equity plans (in shares) | 2,024 | |||
Issuances of common stock, net of offering costs | (8) | (8) | ||
Net loss | (5,064) | (5,064) | ||
Balance at Mar. 31, 2021 | 20,357 | $ 15 | 204,515 | (184,173) |
Balance (in Shares) at Mar. 31, 2021 | 15,480,811 | |||
Balance at Dec. 31, 2020 | 25,072 | $ 15 | 204,166 | (179,109) |
Balance (in Shares) at Dec. 31, 2020 | 15,478,787 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (20,955) | |||
Balance at Sep. 30, 2021 | 18,863 | $ 19 | 218,908 | (200,064) |
Balance (in Shares) at Sep. 30, 2021 | 19,430,369 | |||
Balance at Mar. 31, 2021 | 20,357 | $ 15 | 204,515 | (184,173) |
Balance (in Shares) at Mar. 31, 2021 | 15,480,811 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Stock-based compensation expense | 417 | 417 | ||
Issuance of common stock under equity plans | 80 | $ 1 | 79 | |
Issuance of common stock under equity plans (in shares) | 21,153 | |||
Net loss | (8,939) | (8,939) | ||
Balance at Jun. 30, 2021 | 11,915 | $ 16 | 205,011 | (193,112) |
Balance (in Shares) at Jun. 30, 2021 | 15,501,964 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Stock-based compensation expense | 501 | 501 | ||
Issuance of common stock under equity plans | 7 | 7 | ||
Issuance of common stock under equity plans (in shares) | 1,703 | |||
Issuances of common stock, net of offering costs | 13,392 | $ 3 | 13,389 | |
Issuances of common stock, net of offering costs (in shares) | 3,926,702 | |||
Net loss | (6,952) | (6,952) | ||
Balance at Sep. 30, 2021 | $ 18,863 | $ 19 | $ 218,908 | $ (200,064) |
Balance (in Shares) at Sep. 30, 2021 | 19,430,369 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (20,955) | $ (12,464) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,261 | 770 |
Common stock issued for services | 126 | |
Depreciation and amortization | 10 | 10 |
Noncash interest | 52 | 99 |
Amortization of debt discount | 18 | 34 |
Amortization of premium/discount on short-term investments | (1) | |
Equity ownership license revenue | (246) | |
Lease asset amortization and liability accretion, net | (41) | (17) |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | (457) | (154) |
Accounts payable and accrued expenses | 3,364 | (1,545) |
Accrued compensation and related expenses | (462) | (275) |
Net cash used in operating activities | (17,457) | (13,416) |
Cash flows from investing activities | ||
Purchase of property and equipment | (39) | |
Proceeds from the maturity of available-for-sale short-term investments | 4,000 | |
Net cash provided by investing activities | 3,961 | |
Cash flows from financing activities | ||
Repayment of long-term debt | (2,100) | (933) |
Proceeds from sale of common stock and warrants, net of offering costs | 13,265 | 24,389 |
Proceeds from issuance of common stock under equity plans, net of tax withholdings | 101 | (1) |
Net cash provided by financing activities | 11,266 | 23,455 |
Change in cash and cash equivalents | (2,230) | 10,039 |
Cash and cash equivalents at beginning of period | 32,131 | 16,412 |
Cash and cash equivalents at end of period | $ 29,901 | $ 26,451 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Organization And Accounting Policies [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization and Business TRACON Pharmaceuticals, Inc. (TRACON or the Company) was incorporated in the state of Delaware on October 28, 2004. TRACON is a biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, and utilizes its cost efficient, contract research organization (CRO) independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, TRACON Pharma Limited and TRACON Pharma International Limited, which were formed in September 2015 and January 2019, respectively, and are currently inactive. All significant intercompany accounts and transactions have been eliminated. Basis of Presentation As of September 30, 2021, the Company has devoted substantially all its efforts to product development, raising capital, and building infrastructure and has not realized revenues from its planned principal operations. The Company has incurred operating losses since inception. As of September 30, 2021, the Company had an accumulated deficit of $200.1 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it continues the development and commercialization of its product candidates and works to develop additional product candidates through research and development programs. As of September 30, 2021, the Company had cash and cash equivalents of $29.9 million. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will be sufficient to fund the Company’s obligations for a period in excess of one year from the date of issuance of these financial statements. The Company plans to continue to fund its losses from operations through its existing cash and cash equivalents, as well as through future equity offerings, debt financings, other third-party funding, and potential licensing or collaboration arrangements. In July 2021, the Company completed an underwritten public offering of 3,926,702 shares of its common stock at an offering price of $3.82 per share. The Company received net proceeds of approximately $13.4 million, after deducting underwriting discounts, commissions and offering-related expenses. In addition, the Company may fund its losses from operations through the common stock purchase agreement the Company entered into with Aspire Capital in October 2019, as amended in April 2020, for the purchase of up to $15.0 million of the Company’s common stock over the 30 month period of the purchase agreement, $5.4 million of which remained available for sale as of September 30, 2021 and/or the Capital on Demand TM Unaudited Interim Financial Information The unaudited condensed consolidated financial statements as of September 30, 2021, and for the three and nine months ended September 30, 2021 and 2020, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and with accounting principles generally accepted in the United States (GAAP) applicable to interim financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year or future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020, included in its Annual Report on Form 10-K filed with the SEC on February 25, 2021. Risks and Uncertainties COVID-19, a novel strain of coronavirus, has become a global pandemic and has spread to over 100 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. The Company has experienced temporary closures of its offices in light of state and local orders and most of its employees continue to work remotely. In addition, the Company’s employees have not been able to conduct normal business travel, in particular as part of business development activities or in-person monitoring of clinical trial sites. Potential further impacts to the Company’s business include, but are not limited to, additional closures of its facilities or those of its vendors, continued disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing clinical trials, third-party manufacturing supply and other operations, the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the U.S. Food and Drug Administration or other regulatory authorities, and the Company’s ability to raise capital and conduct business development activities. Use of Estimates The Company’s condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). The preparation of the Company’s condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenue, and expenses. The most significant estimates in the Company’s financial statements relate to expenses incurred for clinical trials. 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. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the date of this filing. Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these investments. Cash and cash equivalents include cash in readily available checking and money market funds. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. Revenue Recognition To date, substantially all the Company’s revenue has been derived from license agreements. The terms of these arrangements included payments to the Company for the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. I n accordance with Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers , the Company performs the following five steps in determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of these agreements: (i) identification of the contract(s) with a customer; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including any constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as, the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services transferred to the customer. Once a contract is determined to be within the scope of Accounting Standards Codification 606, Revenue from Contracts with Customers, at contract inception, the Company assesses the goods or services promised within the contract to determine those that are performance obligations and assesses whether each promised good is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promised goods or services, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development, commercialization, and regulatory milestone payments, the Company evaluates whether the achievement of the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. Performance milestone payments represent a form of variable consideration. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Achievement of milestones that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable until the approvals are achieved. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis and the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achieving such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations at the outset of the arrangement. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its out-licensing arrangements. The Company receives payments from its collaborators based on billing schedules established in each contract. Up-front and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under its collaboration arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Clinical Trial Expense Accruals As part of the process of preparing the Company’s financial statements, the Company is required to estimate expenses resulting from its obligations under contracts with vendors, clinical sites, and consultants in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by recording those expenses in the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through discussion with the clinical sites and applicable personnel and outside service providers as to the progress or state of consummation of trials. During a clinical trial, the Company adjusts the clinical expense recognition if actual results differ from its estimates. The Company makes estimates of accrued expenses as of each balance sheet date based on the facts and circumstances known at that time. The Company’s clinical trial accruals are dependent upon accurate reporting by clinical sites and other third-party vendors. Although the Company does not expect its estimates to differ materially from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low for any particular period. For the three and nine months ended September 30, 2021 and 2020, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. Net loss and comprehensive loss were the same for all periods presented. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average shares of common stock outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted average number of shares of common stock outstanding that are subject to repurchase. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): September 30, 2021 2020 Warrants to purchase common stock 4,810,409 4,991,599 Common stock options and restricted stock units 1,295,808 622,552 ESPP shares 10,757 2,929 6,116,974 5,617,080 |
Investments and Fair Value Meas
Investments and Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Investments and Fair Value Measurements | 2. Investments and Fair Value Measurements At September 30, 2021, the Company had no short-term investments and at December 31, 2020, the Company’s short-term investments consisted of U.S. treasury securities. The Company classifies all investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to implement management strategies. These investments are carried at amortized cost which approximates fair value. A decline in the market value of any short-term investment below cost that is determined to be other-than-temporary will result in a revaluation of its carrying amount to fair value. The impairment is charged to earnings and a new cost basis for the security is established. No such impairment charges were recorded for any period presented. Realized gains and losses from the sale of short-term investments, if any, are determined on a specific identification basis. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income or expense on the consolidated statements of operations. Realized and unrealized gains and losses during the periods presented were immaterial. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method and are included in interest income on the consolidated statements of operations. Interest and dividends on securities classified as available-for-sale are included in interest income on the consolidated statements of operations. The carrying amounts of cash and cash equivalents, prepaid and other assets, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. Based on the borrowing rates currently available to the Company for loans with similar terms, which is considered a Level 2 input, the Company believes that the fair value of long-term debt approximates its carrying value. The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. Cash equivalents, which are classified as equity securities, and short-term investments, which are classified as available-for-sale securities, consisted of the following (in thousands): September 30, 2021 December 31, 2020 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds included in cash equivalents $ 5,003 $ — $ — $ 5,003 $ 1,002 $ — $ — $ 1,002 U.S. treasury securities included in short-term investments — — — — 3,999 — — 3,999 Equity securities included in other assets (1) 246 — — 246 — — — — $ 5,249 $ — $ — $ 5,249 $ 5,001 $ — $ — $ 5,001 (1) The Company’s equity securities included in other assets consisted of its investment in a privately held company. The Company recognizes its private company equity securities at cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. No such impairments or changes were noted for any period presented. The fair values of the Company’s assets and liabilities, which are measured at fair value on a recurring basis, were determined using the following inputs (in thousands): Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets Other Significant for Identical Observable Unobservable Assets Inputs Inputs Total (Level 1) (Level 2) (Level 3) At September 30, 2021 Money market funds $ 5,003 $ — $ 5,003 $ — At December 31, 2020 Money market funds and U.S. treasury securities $ 5,001 $ — $ 5,001 $ — |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 3 . Long-Term Debt Long-term debt and unamortized debt discount balances were as follows (in thousands): September 30, December 31, 2021 2020 Long-term debt $ 2,100 $ 4,200 Less debt discount, net of current portion — (9 ) Long-term debt, net of debt discount 2,100 4,191 Less current portion of long-term debt (2,100 ) (2,800 ) Long-term debt, net of current portion $ — $ 1,391 Current portion of long-term debt $ 2,100 $ 2,800 Current portion of debt discount (21 ) (82 ) Current portion of long-term debt, net $ 2,079 $ 2,718 In May 2018, the Company entered into a third amendment to its Amended and Restated Loan and Security Agreement with Silicon Valley Bank (the 2018 Amended SVB Loan) under which the Company borrowed $7.0 million, all of which was immediately used to repay the Company’s existing loan with SVB (the 2017 Amended SVB Loan). In accordance with the terms of the 2017 Amended SVB Loan, the Company paid a final payment of $0.3 million associated with the payoff of the 2017 Amended SVB Loan. The transaction was accounted for as a debt modification. The 2018 Amended SVB Loan provides for interest to be paid at a rate of 9.0 30 months six months June 2022 At maturity (or earlier prepayment), the Company is required to make a final payment equal to 4.0% The 2018 Amended SVB Loan is collateralized by substantially all of the Company’s assets, other than the Company’s intellectual property, and contains customary conditions of borrowing, events of default and covenants, including covenants that restrict the Company’s ability to dispose of assets, merge with or acquire other entities, incur indebtedness and make distributions to holders of the Company’s capital stock. Should an event of default occur, including the occurrence of a material adverse change, the Company could be liable for immediate repayment of all obligations under the 2018 Amended SVB Loan. As of September 30, 2021, In connection with the 2018 Amended SVB Loan, the Company issued SVB a warrant to purchase 5,363 shares of its common stock at an exercise price of $26.10 per share. The warrant is fully exercisable and expires on May 3, 2025. The fair value of the warrant and the final payment related to the 2018 Amended SVB Loan were recorded as debt discounts and are being amortized to interest expense using the effective interest method over the term of the debt, in addition to the remaining unamortized discounts related to the 2017 Amended SVB Loan. At September 30, 2021, the Company had the following exercisable outstanding warrants for the purchase of common stock issued in connection with the Company’s loan agreements with SVB: Expiration Number of shares Exercise price May 13, 2022 1,841 $ 108.60 November 14, 2023 through June 4, 2024 3,874 $ 77.40 January 25, 2024 4,669 $ 51.40 May 3, 2025 5,363 $ 26.10 15,747 As of September 30, 2021, f uture minimum principal and interest payments under the 2018 Amended SVB Loan, including the final payment, are as follows (in thousands): Remaining 2021 $ 742 2022 1,717 2,459 Less interest and final payment (359 ) Long-term debt $ 2,100 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 4 . Commitments and Contingencies License Agreements The Company has entered into various license agreements pursuant to which the Company acquired licenses to certain intellectual property. The agreements generally required an upfront license fee and, in some cases, reimbursement of patent costs. Additionally, under each agreement, the Company may be required to pay annual maintenance fees, royalties, milestone payments and sublicensing fees. Each of the license agreements is generally cancelable by the Company, given appropriate prior written notice. At September 30, 2021, potential future milestone payments under these agreements totaled an aggregate of $9.6 million. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | 5. Stockholders’ Equity Sales of Common Stock In July 2021, the Company completed an underwritten public offering of 3,926,702 shares of its common stock at an offering price of $3.82 per share. The Company received net proceeds of approximately $13.4 million, after deducting underwriting discounts, commissions and offering-related expenses. In December 2020, the Company issued and sold 1,612,844 shares of its common stock at an average purchase price of $8.84 per share for net proceeds of $13.6 million in two registered direct offerings with certain institutional investors. In August 2020, the Company issued and sold 2,633,838 shares of its common stock at an average purchase price of $1.66 per share and warrants to purchase 3,429,696 shares of its common stock at an average purchase price of $1.64 per warrant share with an exercise price of $0.01 per share (the Pre-Funded Warrants) for net proceeds of approximately $10.0 million in a private placement with multiple accredited institutional health care focused funds. In accordance with their terms, the Pre-Funded Warrants may not be exercised if the holder’s ownership of the Company’s common stock would exceed 19.99% of the Company’s total shares outstanding following such exercise. The Pre-Funded Warrants were recorded as a component of stockholders’ equity within additional paid-in capital on the consolidated balance sheets. In October 2019, the Company entered into a Common Stock Purchase Agreement , which was amended in April 2020 (the 2019 Purchase Agreement), with Aspire Capital which provides that, upon the terms and subject to the conditions and limitations set forth in the 2019 Purchase Agreement, Aspire Capital is committed to purchase up to an aggregate of $15.0 million of shares of the Company’s common stock solely at the Company’s request from time to time during the 30 month period of the agreement and at prices based on the market price at the time of each sale. In consideration for entering into the 2019 Purchase Agreement and concurrently with the execution of the 2019 Purchase Agreement, the Company issued 142,658 shares of its common stock to Aspire Capital. As of September 30, 2021 At-The-Market Issuance Sales Agreement In December 2020, the Company entered into a Capital on Demand TM Equity Plan Activity During the three months ended September 30, 2021, t he Company issued 1,703 shares of common stock upon the exercise of outstanding stock options, no shares of common stock upon the vesting of restricted stock units, and no shares of common stock in connection with the employee stock purchase plan (the ESPP). During the nine months ended September 30, 2021, the Company issued shares of common stock upon the exercise of outstanding stock options, no shares of common stock upon the vesting of restricted stock units, and 21,153 shares of common stock in connection with the ESPP. During the year ended December 31, 2020, the Company issued no shares of common stock upon the exercise of outstanding stock options, 2,078 shares of common stock upon the vesting of restricted stock units, net of shares withheld to settle the employees’ minimum statutory tax obligations for income and other related employment taxes, and 4,550 shares of common stock in connection with the ESPP. Common Stock Warrants As of September 30, 2021 , the Company had the following outstanding warrants for the purchase of common stock: Expiration Number of shares Exercise price May 13, 2022 1,841 $ 108.60 November 14, 2023 through June 4, 2024 3,874 $ 77.40 January 25, 2024 4,669 $ 51.40 March 27, 2024 1,369,602 $ 27.00 March 27, 2025 176,554 $ 0.10 May 3, 2025 5,363 $ 26.10 August 27, 2027 1,889,513 $ 0.01 August 31, 2027 1,358,993 $ 0.01 4,810,409 During the three and nine months ended September 30, 2021, no warrants were exercised. During the year ended December 31, 2020, 181,190 Pre-Funded Warrants were exercised for net proceeds of $2,000. Stock-Based Compensation Expense The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Risk-free interest rate 0.9% — 0.8% 1.2% Expected volatility 89% — 90% 86% Expected term (in years) 6.3 — 6.2 6.2 Expected dividend yield — — — — Stock compensation expense for the ESPP was immaterial for the three and nine months ended September 30, 2021 and 2020. The allocation of stock-based compensation expense was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development $ 176 $ 81 $ 447 $ 293 General and administrative 325 159 814 477 $ 501 $ 240 $ 1,261 $ 770 |
Licenses and Collaborations
Licenses and Collaborations | 9 Months Ended |
Sep. 30, 2021 | |
Collaborations Disclosure [Abstract] | |
Licenses and Collaborations | 6. Licenses and Collaborations 3D Medicines and Alphamab In December 2019, the Company, 3D Medicines Co., Ltd. (3D Medicines), and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (Alphamab) entered into a collaboration and clinical trial agreement (the Envafolimab Collaboration Agreement) for the development of envafolimab, also known as KN035, an investigational PD-L1 single-domain antibody (sdAb), or nanobody, administered by subcutaneous injection, for the treatment of sarcoma in North America. No consideration was exchanged in the Envafolimab Collaboration Agreement. Given no consideration was exchanged, no value was assigned to the Envafolimab Collaboration Agreement in the accompanying consolidated balance sheets. Pursuant to the Envafolimab Collaboration Agreement, the Company was granted an exclusive license to develop and commercialize envafolimab for the treatment of sarcoma in North America. The Company is responsible for conducting, and will bear the costs of Phase 1, Phase 2, and Phase 3 or post-approval clinical trials in North America for envafolimab in the indications of refractory and first line treatment of sarcoma. 3D Medicines and Alphamab are responsible for conducting, and will bear the costs of, investigational new drug (IND)-enabling studies (other than those specific to the sarcoma indication) and the preparation of chemistry, manufacturing and controls (CMC) activities sections of an IND application for envafolimab. 3D Medicines and Alphamab have agreed to manufacture and supply, or to arrange for a third-party manufacturer to manufacture and supply, envafolimab to the Company at pre-negotiated prices that vary based on clinical or commercial use. 3D Medicines and Alphamab retained the right to develop envafolimab in all territories outside of North America as well as within North America for all indications other than sarcoma. The Company will be responsible for commercializing envafolimab for sarcoma in North America, including booking of sales revenue, unless (a) envafolimab is first approved in North America for an indication other than sarcoma and launched in North America, or (b) envafolimab is first approved in North America for sarcoma and subsequently approved in North America for an additional non-orphan indication and sold commercially by 3D Medicines and/or Alphamab, or a licensee, in which case 3D Medicines and Alphamab will be responsible for commercializing envafolimab for sarcoma in North America, including booking of sales revenue. If 3D Medicines and Alphamab become responsible for commercialization under the Envafolimab Collaboration Agreement, the Company has the option to co-market envafolimab for sarcoma in North America. In the event that envafolimab is first approved in North America for sarcoma and within three years of the commercial launch of envafolimab in North America for sarcoma 3D Medicines and Alphamab replace the Company as the party responsible for commercialization, and the Company elects and 3D Medicines and Alphamab agree for the Company to not co-market envafolimab for sarcoma in North America, then 3D Medicine and Alphamab will be required to compensate the Company for its costs associated with preparing for and conducting commercial activities. If the Company has the responsibility for commercialization under the Envafolimab Collaboration Agreement, the Company will owe 3D Medicines and Alphamab tiered double digit royalties on net sales of envafolimab for sarcoma in North America ranging from the teens to mid-double digits. If 3D Medicines and Alphamab have responsibility for commercialization under the Envafolimab Collaboration Agreement, the Company will be entitled to (a) escalating double digit royalties on net sales of envafolimab for sarcoma in North America ranging from the teens to mid-double digits if the Company has chosen to not co-market envafolimab in sarcoma or (b) a 50% royalty on net sales of envafolimab for sarcoma in North America if the Company has chosen to co-market envafolimab in sarcoma. Payment obligations under the Envafolimab Collaboration Agreement continue on a country-by-country basis until the last to expire licensed patent covering envafolimab expires. 3D Medicines and Alphamab retain the right to reacquire the rights to envafolimab for sarcoma in North America in connection with an arm’s length sale to a third party, provided that the sale may not occur prior to completion of a pivotal trial of envafolimab in sarcoma without the Company’s written consent and the parties must negotiate in good faith and agree to fair compensation to be paid to the Company for the value of and opportunity represented by the required rights. Each party agreed that during the term of the Envafolimab Collaboration Agreement, it would not develop or license from any third party a monospecific inhibitor to PD-L1 or PD-1 in sarcoma. The term of the Envafolimab Collaboration Agreement continues until the later of the date the parties cease further development and commercialization of envafolimab for sarcoma in North America or the expiration of all payment obligations. The Envafolimab Collaboration Agreement may be terminated earlier by a party in the event of an uncured material breach by the other party or bankruptcy of the other party, or for safety reasons related to envafolimab. In the event the Company elects, or a joint steering committee determines, to cease further development or commercialization of envafolimab, or if the Company fails to use commercially reasonable efforts to develop (including progress in clinical trials) and commercialize envafolimab and does not cure such failure within a specified time period, then the Company’s rights and obligations under the Envafolimab Collaboration Agreement will revert to 3D Medicines and Alphamab. I-Mab In November 2018, the Company and I-Mab Biopharma (I-Mab) entered into separate strategic collaboration and clinical trial agreements (the I-Mab Collaboration Agreements) for the development of programs for multiple immuno-oncology product candidates, including I-Mab’s proprietary CD73 antibody TJ004309 (the TJ004309 Agreement) as well as up to five proprietary bispecific antibodies currently under development by I-Mab (the Bispecific Agreement). No consideration was exchanged in the I-Mab Collaboration Agreements. Given the early preclinical stage of development of these assets as of the agreement date, no value was assigned to the I-Mab Collaboration Agreements in the accompanying consolidated balance sheets. TJ004309 Agreement Pursuant to the TJ004309 Agreement, the Company and I-Mab are collaborating on developing the TJ004309 antibody, with the Company bearing the costs of filing an IND and for Phase 1 clinical trials, with the parties sharing costs equally for Phase 2 clinical trials, and with the Company and I-Mab bearing 40% and 60%, respectively, of the costs for pivotal clinical trials. I-Mab will be responsible for the cost of certain non-clinical activities, the drug supply of TJ004309, and any reference drugs used in the clinical trials. Each of the parties also agreed for a specified period of time to not develop or license to or from a third party any monoclonal antibody targeting CD73 or any other biologic for certain indications that a joint steering committee (JSC), as set up under the TJ004309 Agreement, selects for TJ004309 development. In the event that I-Mab out-licenses the rights to TJ004309 to a third party, the Company would be entitled to receive escalating portions of royalty and non-royalty consideration received by I-Mab with respect to certain territories outside of Greater China. In the event that I-Mab commercializes TJ004309, the Company would be entitled to receive a royalty percentage on net sales by I-Mab in North America ranging from the mid-single digits to low double digits, and in the EU and Japan in the mid-single digits. The portions of certain third party royalty and non-royalty consideration and the royalty from net sales by I-Mab to which the Company would be entitled will escalate based on the phase of development and relevant clinical trial obligations the Company completes under the TJ004309 Agreement, ranging from a high-single digit to a mid-teen percentage of non-royalty consideration as well as a double digit percentage of royalty consideration. In March 2020 , I-Mab issued a press release announcing a strategic partnership with Kalbe Genexine Biologics (KG Bio), whereby KG Bio received what the press release described as a right of first negotiation outside North America for TJ004309 for up to The TJ004309 TJ004309 TJ004309 TJ004309 Bispecific Agreement Pursuant to the Bispecific Agreement, the Company and I-Mab may mutually select through a joint steering committee (JSC) up to five of I-Mab’s bispecific antibody product candidates within a five-year For each product candidate selected by the JSC for development under the Bispecific Agreement, I-Mab will be responsible and bear the costs for IND-enabling studies and establishing manufacturing for the product candidate, while the Company will be responsible for and bear the costs of filing an IND and conducting Phase 1 and Phase 2 clinical trials, and the Company will be responsible for and will share equally with I-Mab in the costs of conducting Phase 3 or pivotal clinical trials, in each case within North America. Subject to I-Mab’s right to co-promote an approved product candidate, the Company will be responsible for commercializing any approved product candidates in North America and will share profits and losses equally with I-Mab in North America. The Company would also be entitled to tiered low single digit royalties on net sales of product candidates in the EU and Japan. At any time prior to completing the first pivotal clinical trial for a product candidate or if I-Mab ceases to support development costs or pay its portion of Phase 3 clinical trial costs for a product candidate or the JSC decides to cease development over the Company’s objections after initiating Phase 3 clinical trials, the Company will have an option to obtain an exclusive license to such product candidate in all territories except Greater China and Korea, and any other territories in which I-Mab previously licensed rights to a third party subject to the Company’s right of first refusal for any licenses I-Mab may grant to third-parties. If the Company exercises the option, it would assume sole responsibility for developing and commercializing the product candidate in the licensed territory, and in lieu of profit or loss sharing with I-Mab with respect to such product candidate, the Company would owe I-Mab pre-specified upfront and milestone payments and royalties on net sales, with the payments and royalties escalating depending on the phase of development the product candidate reached at the time the Company obtained the exclusive license as follows: (i) if before IND-enabling studies and the preparation of the CMC activities of the collaborative product, the Company would owe I-Mab a one-time upfront payment of $10.0 million, development and regulatory based milestone payments totaling up to $90.0 million that begin upon completion of a pivotal trial, sales milestones totaling up to $250.0 million, and royalties in the mid-single digits on annual net sales; (ii) if after IND submission but before completion of a Phase 1a clinical trial of the collaborative product, the Company would owe I-Mab a one-time upfront payment of $25.0 million, development and regulatory based milestone payments totaling up to $125.0 million that begin upon completion of a pivotal trial, sales milestones totaling up to $250.0 million, and royalties in the high single digits on annual net sales; (iii) if after completion of a Phase 1a clinical trial but before completion of Phase 2 proof of concept clinical trial for the collaborative product, the Company would owe I-Mab a one-time upfront payment of $50.0 million, development and regulatory based milestone payments totaling up to $250.0 million that begin upon completion of a pivotal trial, sales milestones totaling up to $250.0 million, and royalties in the low double digits on annual net sales; and (iv) if after completion of Phase 2 proof of concept clinical trial and before completion of pivotal trial for the collaborative product, the Company would owe I-Mab a one-time upfront payment of $80.0 million, development and regulatory based milestone payments totaling up to $420.0 million that begin upon completion of a pivotal trial, sales milestones totaling up to $250.0 million, and royalties in the high-teen double digits on annual net sales. Each party agreed that for a specified period of time, it would not develop or license to or from any third party any bispecific monoclonal antibody targeting the same two biological targets as those of any selected product candidates under the Bispecific Agreement. If development of any selected product candidates is terminated by a decision of the JSC, all rights to the product candidate will revert to I-Mab, subject to the Company’s right to obtain an exclusive license in certain circumstances. If development is terminated after submission of an IND and prior to initiating Phase 3 clinical trials or after initiating Phase 3 clinical trials and with the Company’s concurrence, the Company would be entitled to tiered low single digit royalties on net sales of the product candidate in North America, the EU, and Japan. The Bispecific Agreement may be terminated by either party in the event of an uncured material breach by the other party, bankruptcy of the other party, or with respect to any selected product candidate, for safety reasons related to that product candidate. In March 2020, the Company learned that I-Mab had entered into two license and collaboration agreements with ABL Bio in July 2018 (ABL Bio License 1 and ABL Bio License 2). Under ABL Bio License 1, I-Mab granted to ABL Bio exclusive, worldwide (excluding Greater China), royalty-bearing rights to develop and commercialize a bispecific antibody (the BsAb) using certain monoclonal antibody sequences. Under ABL License 2, I-Mab and ABL agreed to collaborate to develop three PD-L1-based bispecific antibodies by using ABL Bio’s proprietary bispecific antibody technology and commercialize them in their respective territories, which, collectively, include China, Hong Kong, Macau, Taiwan and South Korea, and other territories throughout the rest of the world if both parties agree to do so in such other territories during the performance of the agreement. On April 8, 2020, the Company issued a notice of dispute regarding possible breach of the Bispecific Agreement related to I-Mab having previously entered into ABL License 1 and ABL License 2 . The dispute is before an ICC arbitration tribunal seated in New York City and will be arbitrated under New York law with the hearing set for February 2022. The Company cannot currently estimate the likely outcome of the dispute under the Bispecific Agreement. Until the dispute is concluded, the Company may be unable to provide a timeline as to when or if it will file an IND for a bispecific antibody under the Bispecific Agreement. Janssen In September 2016, the Company entered into a license and option agreement with Janssen (the License and Option Agreement) under which Janssen granted the Company a license to technology and intellectual property to develop, manufacture and commercialize two compounds: a small molecule inhibitor of androgen receptor and androgen receptor mutations (the AR Mutant Program or TRC253) which is intended for the treatment of men with prostate cancer, and an inhibitor of NF-kB inducing kinase (the NIK Program or TRC694). Following completion of the pre-clinical development of TRC694, the Company determined the compound did not warrant further development and, in February 2019, issued written notice to terminate the License and Option Agreement with respect to the NIK Program and returned TRC694 and all rights thereto to Janssen. Following completion of the TRC253 Phase 1/2 trial, the Company determined commercialization of TRC253 in prostate cancer in the United States was not viable and, in May 2021, issued written notice to terminate the License and Option Agreement with respect to the AR Mutant Program and returned TRC253 and all rights thereto to Janssen. No consideration was exchanged for these assets on the acquisition date. Given the early preclinical stage of development of these assets and the low likelihood of success of development through regulatory approval on the acquisition date, no value was previously assigned to these assets in the accompanying consolidated balance sheets. Enviro and Kairos In May 2021, the Company entered into a license and supply agreement with Enviro Therapeutics Inc. (Enviro) and Kairos Pharma, Ltd. (Kairos) under which the Company granted to Enviro access to inactive IND filings for TRC105 in the United States, ownership of existing supplies of TRC105 drug product, and assignment of the Company’s patent rights to CD105 technologies, which includes the TRC105 antibody. In consideration of the transfer and assignment, the Company received a one-time, non-refundable, non-creditable upfront payment in the amount of $0.1 million and equity ownership in Enviro, subject to certain specified reductions. In addition, the Company received anti-dilution protection of its equity ownership in Enviro, subject to certain specified reductions, and is eligible to receive up to a total of $1.0 million in milestone payments upon the achievement of specified financing events, and a single-digit royalty on worldwide net sales of TRC105. Under the terms of the agreement, Enviro has sole responsibility for funding, developing, seeking regulatory approval for and commercializing TRC105 product candidates. Enviro has the right to grant sublicenses to affiliates and third-party collaborators and in the event Enviro sublicenses any of its rights under the agreement, Enviro would be obligated to pay the Company a single-digit percentage of all consideration received under such sublicense. The Company assessed this agreement and identified multiple promised goods and services, which included at contract inception: (1) assignment of patent rights to CD105 technologies, (2) access to inactive IND filings for TRC105 in the United States, and (3) transfer of ownership of TRC105 drug product. All performance obligations were satisfied by June 30, 2021, which completed the Company’s obligations under the terms of the agreement. The transaction price included the $0.1 million upfront payment and equity in Enviro valued at $0.2 million, all of which had been fully recognized as revenue as of June 30, 2021. The value of the Company’s equity ownership in Enviro was estimated based on the fair value of observable market prices. The remaining $1.0 million of potential financing milestone payments were not considered probable at contract inception or at September 30, 2021 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Leases | 7 . Leases The Company’s operating lease obligations relate to its corporate headquarters as the Company leases its office space under a non-cancelable operating lease. The Company amended its lease in August 2021 extending the lease term to April 2027. The lease is subject to base lease payments and additional charges for common area maintenance and other costs and includes certain lease incentives and tenant improvement allowances. Operating lease expense was $0.1 million and $0.3 million for the three and nine months ended September 30, 2021, respectively, and $0.1 million and $0.3 million for the three and nine months ended September 30, 2020, respectively. As of September 30, 2021 Supplemental cash flow information related to operating leases was as follows (in thousands): Nine Months Ended September 30, 2021 2020 Cash paid within operating cash flows $ 344 $ 330 ROU assets recognized in exchange for new lease obligations $ 1,117 $ — Supplemental balance sheet information related to operating leases was as follows (in thousands, except lease term and discount rate): September 30, 2021 2020 Reported as: Other assets (ROU asset) $ 1,371 $ 595 Accounts payable and accrued expenses (lease liability) $ 182 $ 402 Other long-term liabilities (lease liability) 1,211 263 Total lease liabilities $ 1,393 $ 665 Weighted average remaining lease term 5.6 1.6 Weighted average discount rate 11.3% 11.3% As of September 30, 2021 Remaining 2021 $ 117 2022 285 2023 320 2024 334 2025 349 2026 365 Thereafter 123 Total lease payments 1,893 Less imputed interest (500 ) Total operating lease liabilities $ 1,393 Under the terms of the lease agreement, the Company provided the lessor with an irrevocable letter of credit in the amount of $175,000. The lessor is entitled to draw on the letter of credit in the event of any default by the Company under the terms of the lease. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 8 . Subsequent Events Eucure and Biocytogen Collaborative Development and Commercialization Agreement On October 8, 2021, the Company, Eucure (Beijing) Biopharma Co., Ltd. (Eucure) and Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen), Eucure’s controlling affiliate, entered into a collaborative development and commercialization agreement (the YH001 Collaboration Agreement) for the development of YH001, a monospecific investigational CTLA-4 antibody. Pursuant to the YH001 Collaboration Agreement, the Company was granted an exclusive (including with respect to Eucure and its affiliates), nontransferable, license to develop and commercialize YH001 in North America for the treatment, through administration of YH001 by intravenous or subcutaneous means, of multiple human indications, including sarcoma, microsatellite stable colorectal cancer, renal cell carcinoma (RCC), and K-ras positive non-small cell lung cancer (collectively, the Initial Indications) or one or more of bladder cancer, endometrial cancer, and melanoma as substitute indications, which may be substituted for Initial Indications at the Company’s discretion (each upon such substitution, a Substitute Indication). The Company is responsible for, and will bear the costs of, preparing and filing all regulatory submissions and conducting any Phase 1, Phase 2, Phase 3, or post-approval clinical trials in North America for YH001 in the Initial Indications and potentially the Substitute Indications, while Eucure is responsible for conducting, and will bear the costs of, the preparation of chemistry, manufacturing and controls activities for YH001. Eucure has agreed to manufacture and supply, or to arrange for a third party manufacturer to manufacture and supply, YH001 to the Company for clinical trials pursuant to the terms of a clinical supply and quality agreement to be separately negotiated. During a specified period, the Company has the option, subject to Eucure’s prior written approval, to expand the license to include the development and commercialization of YH001 for the treatment, through administration by intravenous or subcutaneous means, of all human and veterinary therapeutic indications in North America for a payment to Eucure in the low single digit millions. The Company will be responsible for commercializing YH001 in North America, including booking of sales revenue in the Initial and Substitute Indications. The Company will owe Eucure escalating double digit royalties on net sales of YH001 in North America ranging from the mid-twenties to mid-double digits; provided that until the end of the first full calendar year following the first commercial sale of YH001, royalties will range from the lower double digits to the mid-double digits. If sales of YH001 exceed a pre-determined sales threshold in the first full year of sales following first commercial sale, the Company will owe a milestone to Eucure in the high single digit millions. Payment obligations under the YH001 Collaboration Agreement continue on a country-by-country basis until the latest of (i) expiration of the last to expire licensed patent covering YH001, (ii) expiration of marketing or regulatory exclusivity covering YH001 and (iii) 10 years from the first commercial sale of YH001 in such country in North America. Eucure has agreed to manufacture and supply, or to arrange for a third party manufacturer to manufacture and supply, YH001 to the Company at cost plus a low double digit markup for commercial sales pursuant to the terms of a commercial supply and quality agreement to be separately negotiated. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Organization And Accounting Policies [Abstract] | |
Organization and Business | Organization and Business TRACON Pharmaceuticals, Inc. (TRACON or the Company) was incorporated in the state of Delaware on October 28, 2004. TRACON is a biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, and utilizes its cost efficient, contract research organization (CRO) independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, TRACON Pharma Limited and TRACON Pharma International Limited, which were formed in September 2015 and January 2019, respectively, and are currently inactive. All significant intercompany accounts and transactions have been eliminated. |
Basis of Presentation | Basis of Presentation As of September 30, 2021, the Company has devoted substantially all its efforts to product development, raising capital, and building infrastructure and has not realized revenues from its planned principal operations. The Company has incurred operating losses since inception. As of September 30, 2021, the Company had an accumulated deficit of $200.1 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it continues the development and commercialization of its product candidates and works to develop additional product candidates through research and development programs. As of September 30, 2021, the Company had cash and cash equivalents of $29.9 million. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will be sufficient to fund the Company’s obligations for a period in excess of one year from the date of issuance of these financial statements. The Company plans to continue to fund its losses from operations through its existing cash and cash equivalents, as well as through future equity offerings, debt financings, other third-party funding, and potential licensing or collaboration arrangements. In July 2021, the Company completed an underwritten public offering of 3,926,702 shares of its common stock at an offering price of $3.82 per share. The Company received net proceeds of approximately $13.4 million, after deducting underwriting discounts, commissions and offering-related expenses. In addition, the Company may fund its losses from operations through the common stock purchase agreement the Company entered into with Aspire Capital in October 2019, as amended in April 2020, for the purchase of up to $15.0 million of the Company’s common stock over the 30 month period of the purchase agreement, $5.4 million of which remained available for sale as of September 30, 2021 and/or the Capital on Demand TM Unaudited Interim Financial Information The unaudited condensed consolidated financial statements as of September 30, 2021, and for the three and nine months ended September 30, 2021 and 2020, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and with accounting principles generally accepted in the United States (GAAP) applicable to interim financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year or future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020, included in its Annual Report on Form 10-K filed with the SEC on February 25, 2021. |
Risks And Uncertainties | Risks and Uncertainties COVID-19, a novel strain of coronavirus, has become a global pandemic and has spread to over 100 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. The Company has experienced temporary closures of its offices in light of state and local orders and most of its employees continue to work remotely. In addition, the Company’s employees have not been able to conduct normal business travel, in particular as part of business development activities or in-person monitoring of clinical trial sites. Potential further impacts to the Company’s business include, but are not limited to, additional closures of its facilities or those of its vendors, continued disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing clinical trials, third-party manufacturing supply and other operations, the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the U.S. Food and Drug Administration or other regulatory authorities, and the Company’s ability to raise capital and conduct business development activities. |
Use of Estimates | Use of Estimates The Company’s condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). The preparation of the Company’s condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenue, and expenses. The most significant estimates in the Company’s financial statements relate to expenses incurred for clinical trials. 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. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the date of this filing. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these investments. Cash and cash equivalents include cash in readily available checking and money market funds. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. |
Revenue Recognition | Revenue Recognition To date, substantially all the Company’s revenue has been derived from license agreements. The terms of these arrangements included payments to the Company for the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. I n accordance with Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers , the Company performs the following five steps in determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of these agreements: (i) identification of the contract(s) with a customer; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including any constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as, the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services transferred to the customer. Once a contract is determined to be within the scope of Accounting Standards Codification 606, Revenue from Contracts with Customers, at contract inception, the Company assesses the goods or services promised within the contract to determine those that are performance obligations and assesses whether each promised good is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promised goods or services, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development, commercialization, and regulatory milestone payments, the Company evaluates whether the achievement of the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. Performance milestone payments represent a form of variable consideration. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Achievement of milestones that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable until the approvals are achieved. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis and the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achieving such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations at the outset of the arrangement. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its out-licensing arrangements. The Company receives payments from its collaborators based on billing schedules established in each contract. Up-front and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under its collaboration arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. |
Clinical Trial Expense Accruals | Clinical Trial Expense Accruals As part of the process of preparing the Company’s financial statements, the Company is required to estimate expenses resulting from its obligations under contracts with vendors, clinical sites, and consultants in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by recording those expenses in the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through discussion with the clinical sites and applicable personnel and outside service providers as to the progress or state of consummation of trials. During a clinical trial, the Company adjusts the clinical expense recognition if actual results differ from its estimates. The Company makes estimates of accrued expenses as of each balance sheet date based on the facts and circumstances known at that time. The Company’s clinical trial accruals are dependent upon accurate reporting by clinical sites and other third-party vendors. Although the Company does not expect its estimates to differ materially from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low for any particular period. For the three and nine months ended September 30, 2021 and 2020, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. Net loss and comprehensive loss were the same for all periods presented. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average shares of common stock outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted average number of shares of common stock outstanding that are subject to repurchase. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): September 30, 2021 2020 Warrants to purchase common stock 4,810,409 4,991,599 Common stock options and restricted stock units 1,295,808 622,552 ESPP shares 10,757 2,929 6,116,974 5,617,080 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization And Accounting Policies [Abstract] | |
Schedule of potentially dilutive securities not included in the calculation of diluted net loss per share | Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): September 30, 2021 2020 Warrants to purchase common stock 4,810,409 4,991,599 Common stock options and restricted stock units 1,295,808 622,552 ESPP shares 10,757 2,929 6,116,974 5,617,080 |
Investments and Fair Value Me_2
Investments and Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Available-for-sale Securities | Cash equivalents, which are classified as equity securities, and short-term investments, which are classified as available-for-sale securities, consisted of the following (in thousands): September 30, 2021 December 31, 2020 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds included in cash equivalents $ 5,003 $ — $ — $ 5,003 $ 1,002 $ — $ — $ 1,002 U.S. treasury securities included in short-term investments — — — — 3,999 — — 3,999 Equity securities included in other assets (1) 246 — — 246 — — — — $ 5,249 $ — $ — $ 5,249 $ 5,001 $ — $ — $ 5,001 (1) The Company’s equity securities included in other assets consisted of its investment in a privately held company. The Company recognizes its private company equity securities at cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. No such impairments or changes were noted for any period presented. |
Schedule of assets and liabilities measured at fair value on a recurring basis | The fair values of the Company’s assets and liabilities, which are measured at fair value on a recurring basis, were determined using the following inputs (in thousands): Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets Other Significant for Identical Observable Unobservable Assets Inputs Inputs Total (Level 1) (Level 2) (Level 3) At September 30, 2021 Money market funds $ 5,003 $ — $ 5,003 $ — At December 31, 2020 Money market funds and U.S. treasury securities $ 5,001 $ — $ 5,001 $ — |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term debt and unamortized debt discount balances | Long-term debt and unamortized debt discount balances were as follows (in thousands): September 30, December 31, 2021 2020 Long-term debt $ 2,100 $ 4,200 Less debt discount, net of current portion — (9 ) Long-term debt, net of debt discount 2,100 4,191 Less current portion of long-term debt (2,100 ) (2,800 ) Long-term debt, net of current portion $ — $ 1,391 Current portion of long-term debt $ 2,100 $ 2,800 Current portion of debt discount (21 ) (82 ) Current portion of long-term debt, net $ 2,079 $ 2,718 |
Schedule of exercisable outstanding warrants for purchase of common stock issued | At September 30, 2021, the Company had the following exercisable outstanding warrants for the purchase of common stock issued in connection with the Company’s loan agreements with SVB: Expiration Number of shares Exercise price May 13, 2022 1,841 $ 108.60 November 14, 2023 through June 4, 2024 3,874 $ 77.40 January 25, 2024 4,669 $ 51.40 May 3, 2025 5,363 $ 26.10 15,747 As of September 30, 2021 , the Company had the following outstanding warrants for the purchase of common stock: Expiration Number of shares Exercise price May 13, 2022 1,841 $ 108.60 November 14, 2023 through June 4, 2024 3,874 $ 77.40 January 25, 2024 4,669 $ 51.40 March 27, 2024 1,369,602 $ 27.00 March 27, 2025 176,554 $ 0.10 May 3, 2025 5,363 $ 26.10 August 27, 2027 1,889,513 $ 0.01 August 31, 2027 1,358,993 $ 0.01 4,810,409 |
Schedule of future minimum principal and interest payments | As of September 30, 2021, f uture minimum principal and interest payments under the 2018 Amended SVB Loan, including the final payment, are as follows (in thousands): Remaining 2021 $ 742 2022 1,717 2,459 Less interest and final payment (359 ) Long-term debt $ 2,100 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders Equity Note [Abstract] | |
Schedule of exercisable outstanding warrants for purchase of common stock issued | At September 30, 2021, the Company had the following exercisable outstanding warrants for the purchase of common stock issued in connection with the Company’s loan agreements with SVB: Expiration Number of shares Exercise price May 13, 2022 1,841 $ 108.60 November 14, 2023 through June 4, 2024 3,874 $ 77.40 January 25, 2024 4,669 $ 51.40 May 3, 2025 5,363 $ 26.10 15,747 As of September 30, 2021 , the Company had the following outstanding warrants for the purchase of common stock: Expiration Number of shares Exercise price May 13, 2022 1,841 $ 108.60 November 14, 2023 through June 4, 2024 3,874 $ 77.40 January 25, 2024 4,669 $ 51.40 March 27, 2024 1,369,602 $ 27.00 March 27, 2025 176,554 $ 0.10 May 3, 2025 5,363 $ 26.10 August 27, 2027 1,889,513 $ 0.01 August 31, 2027 1,358,993 $ 0.01 4,810,409 |
Summary of weighted-average assumptions used Black-Scholes option pricing model to determine the fair value | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Risk-free interest rate 0.9% — 0.8% 1.2% Expected volatility 89% — 90% 86% Expected term (in years) 6.3 — 6.2 6.2 Expected dividend yield — — — — |
Summary of allocation of stock-based compensation expense | The allocation of stock-based compensation expense was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development $ 176 $ 81 $ 447 $ 293 General and administrative 325 159 814 477 $ 501 $ 240 $ 1,261 $ 770 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Schedule of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases was as follows (in thousands): Nine Months Ended September 30, 2021 2020 Cash paid within operating cash flows $ 344 $ 330 ROU assets recognized in exchange for new lease obligations $ 1,117 $ — |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases was as follows (in thousands, except lease term and discount rate): September 30, 2021 2020 Reported as: Other assets (ROU asset) $ 1,371 $ 595 Accounts payable and accrued expenses (lease liability) $ 182 $ 402 Other long-term liabilities (lease liability) 1,211 263 Total lease liabilities $ 1,393 $ 665 Weighted average remaining lease term 5.6 1.6 Weighted average discount rate 11.3% 11.3% |
Schedule of Maturities of Operating Lease Liabilities | As of September 30, 2021 Remaining 2021 $ 117 2022 285 2023 320 2024 334 2025 349 2026 365 Thereafter 123 Total lease payments 1,893 Less imputed interest (500 ) Total operating lease liabilities $ 1,393 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended | ||
Jul. 31, 2021 | Oct. 31, 2019 | Sep. 30, 2021 | Dec. 31, 2020 | |
Basis of Presentation | ||||
Accumulated deficit | $ 200,064,000 | $ 179,109,000 | ||
Cash, cash equivalents and short-term investments | 29,900,000 | |||
IPO | Common Stock | ||||
Basis of Presentation | ||||
Common stock issued and sold | 3,926,702 | |||
Common stock purchase price per share | $ 3.82 | |||
Net proceeds from common stock issuance | $ 13,400,000 | |||
Jones Trading Institutional Services LLC | Capital on Demand Sales Agreement | Common Stock | ||||
Basis of Presentation | ||||
Maximum aggregate value of stock to be sold | $ 50,000,000 | $ 50,000,000 | ||
Aspire Capital | Common Stock | ||||
Basis of Presentation | ||||
Common stock issued and sold | 142,658 | 4,800,000 | ||
Net proceeds from common stock issuance | $ 9,600,000 | |||
Maximum aggregate value of common stock to be purchase | $ 15,000,000 | |||
Sale duration for common stock under purchase agreement | 30 months | |||
Remaining amount available under the purchase Agreement | $ 5,400,000 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in the Calculation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive securities | ||
Antidilutive securities | 6,116,974 | 5,617,080 |
Warrants to Purchase Common Stock | ||
Antidilutive securities | ||
Antidilutive securities | 4,810,409 | 4,991,599 |
Common Stock Options and Restricted Stock Units | ||
Antidilutive securities | ||
Antidilutive securities | 1,295,808 | 622,552 |
ESPP Shares | ||
Antidilutive securities | ||
Antidilutive securities | 10,757 | 2,929 |
Investments and Fair Value Me_3
Investments and Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2019 | Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |||
Impairment charges | $ 0 | $ 0 | |
Amount of transfers between levels | $ 0 | $ 0 |
Investments and Fair Value Me_4
Investments and Fair Value Measurements - Schedule of Available for Sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Short-Term Investments, Cash Equivalents and Fair Value Measurements | |||
Cost | $ 5,249 | $ 5,001 | |
Estimated Fair Value | 5,249 | 5,001 | |
Money market funds included in cash equivalents | |||
Short-Term Investments, Cash Equivalents and Fair Value Measurements | |||
Cost | 5,003 | 1,002 | |
Estimated Fair Value | 5,003 | 1,002 | |
U.S. treasury securities included in short-term investments | |||
Short-Term Investments, Cash Equivalents and Fair Value Measurements | |||
Cost | 3,999 | ||
Estimated Fair Value | $ 3,999 | ||
Equity securities included in other assets | |||
Short-Term Investments, Cash Equivalents and Fair Value Measurements | |||
Cost | [1] | 246 | |
Estimated Fair Value | [1] | $ 246 | |
[1] | The Company’s equity securities included in other assets consisted of its investment in a privately held company. The Company recognizes its private company equity securities at cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. No such impairments or changes were noted for any period presented. |
Investments and Fair Value Me_5
Investments and Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Recurring - Money market funds and U.S. treasury securities - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Fair value, assets | $ 5,003 | $ 5,001 |
Level 2 | ||
Assets: | ||
Fair value, assets | $ 5,003 | $ 5,001 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt and Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Long-term debt | $ 2,100 | $ 4,200 |
Less debt discount, net of current portion | (9) | |
Long-term debt, net of debt discount | 2,100 | 4,191 |
Less current portion of long-term debt | (2,100) | (2,800) |
Long-term debt, net of current portion | 1,391 | |
Current portion of long-term debt | 2,100 | 2,800 |
Current portion of debt discount | (21) | (82) |
Current portion of long-term debt, net | $ 2,079 | $ 2,718 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended |
May 31, 2018 | Sep. 30, 2021 | |
Debt Instrument [Line Items] | ||
Warrants issued | 4,810,409 | |
Silicon Valley Bank | ||
Debt Instrument [Line Items] | ||
Warrants issued | 15,747 | |
2018 SVB Loan | Silicon Valley Bank | ||
Debt Instrument [Line Items] | ||
Proceeds From Issuance Of Long Term Debt | $ 7,000,000 | |
Interest rate | 9.00% | |
Repayment Period | 30 months | |
Warrants issued | 5,363 | |
Exercise price (per share) | $ 26.10 | |
2018 SVB Loan | Silicon Valley Bank | After May 3, 2020 | ||
Debt Instrument [Line Items] | ||
Prepayment fee (as a percent) | 4.00% | |
2017 SVB Loan | Silicon Valley Bank | ||
Debt Instrument [Line Items] | ||
Final payment on payoff | $ 300,000 | |
Deferral Agreement | Silicon Valley Bank | ||
Debt Instrument [Line Items] | ||
Extension of period for interest only payments | 6 months | |
Maturity date | Jun. 30, 2022 | |
Debt Instrument Extension Of Period For Interest Only Payments Description | . In April 2020, the Company entered into a deferral agreement with SVB (the Deferral Agreement) for an interest-only payment period of six months, with a corresponding six-month extension to the maturity date to June 2022. All other key terms and conditions of the 2018 Amended SVB Loan remained unchanged and the transaction was accounted for as a debt modification |
Long-Term Debt - Schedule of Ex
Long-Term Debt - Schedule of Exercisable Outstanding Warrants for Purchase of Common Stock Issued (Details) | Sep. 30, 2021$ / sharesshares |
Debt Instrument [Line Items] | |
Warrants issued | 4,810,409 |
Silicon Valley Bank | |
Debt Instrument [Line Items] | |
Warrants issued | 15,747 |
Silicon Valley Bank | May 13, 2022 | |
Debt Instrument [Line Items] | |
Warrants issued | 1,841 |
Exercise price (per share) | $ / shares | $ 108.60 |
Silicon Valley Bank | November 14, 2023 Through June 4, 2024 | |
Debt Instrument [Line Items] | |
Warrants issued | 3,874 |
Exercise price (per share) | $ / shares | $ 77.40 |
Silicon Valley Bank | January 25, 2024 | |
Debt Instrument [Line Items] | |
Warrants issued | 4,669 |
Exercise price (per share) | $ / shares | $ 51.40 |
Silicon Valley Bank | May 3, 2025 | |
Debt Instrument [Line Items] | |
Warrants issued | 5,363 |
Exercise price (per share) | $ / shares | $ 26.10 |
Long-Term Debt - Schedule of Fu
Long-Term Debt - Schedule of Future Minimum Principal and Interest Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Long-term debt | $ 2,100 | $ 4,200 |
2018 SVB Loan | ||
Debt Instrument [Line Items] | ||
Remaining 2021 | 742 | |
2022 | 1,717 | |
Long Term Debt Including Final Payment | 2,459 | |
Less interest and final payment | (359) | |
Long-term debt | $ 2,100 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | Sep. 30, 2021USD ($) |
Research and development arrangement | |
Commitments and Contingencies | |
Potential milestone payable | $ 9.6 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jul. 31, 2021 | Dec. 31, 2020 | Aug. 30, 2020 | Oct. 31, 2019 | Sep. 30, 2018 | Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Class Of Stock [Line Items] | ||||||||
Warrants issued | 4,810,409 | 4,810,409 | ||||||
Warrants exercised | 0 | 0 | ||||||
Pre-Funded Warrants | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrants exercised | 181,190 | |||||||
Proceeds from warrant exercises | $ 2,000 | |||||||
Pre-Funded Warrants and Common Warrants | ||||||||
Class Of Stock [Line Items] | ||||||||
Maximum percentage of holders ownership interest in common stock after exercise | 19.99% | |||||||
Common Stock | Equity Plan Activity | ||||||||
Class Of Stock [Line Items] | ||||||||
Shares issued upon exercise of outstanding stock options | 1,703 | 3,727 | 0 | |||||
Shares issued in connection with employee stock purchase plan | 0 | 21,153 | 4,550 | |||||
Common Stock | Equity Plan Activity | Restricted Stock Units | ||||||||
Class Of Stock [Line Items] | ||||||||
Shares withheld on vesting date to settle employees minimum statutory tax obligations | 2,078 | |||||||
Shares issued upon vesting of restricted stock units | 0 | 0 | 2,078 | |||||
Common Stock | Aspire Capital | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock issued and sold | 142,658 | 4,800,000 | ||||||
Net proceeds from common stock issuance | $ 9,600,000 | |||||||
Maximum aggregate value of common stock to be purchase | $ 15,000,000 | |||||||
Sale duration for common stock under purchase agreement | 30 months | |||||||
Common Stock | IPO | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock issued and sold | 3,926,702 | |||||||
Common stock purchase price per share | $ 3.82 | |||||||
Net proceeds from common stock issuance | $ 13,400,000 | |||||||
Common Stock | Direct Offerings | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock issued and sold | 1,612,844 | |||||||
Common stock purchase price per share | $ 8.84 | $ 8.84 | ||||||
Net proceeds from common stock issuance | $ 13,600,000 | |||||||
Common Stock | Private Placement | ||||||||
Class Of Stock [Line Items] | ||||||||
Net proceeds received in private placement | $ 10,000,000 | |||||||
Common Stock | Private Placement | Pre-Funded Warrants | ||||||||
Class Of Stock [Line Items] | ||||||||
Exercise price (per share) | $ 0.01 | |||||||
Common Stock | Private Placement | Purchase Price of $1.66 Per Share | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock issued and sold | 2,633,838 | |||||||
Common stock purchase price per share | $ 1.66 | |||||||
Common Stock | Private Placement | Common Stock Purchase Price Of One Point Six Four Per Share1 | Pre-Funded Warrants | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock purchase price per share | $ 1.64 | |||||||
Warrants issued | 3,429,696 | |||||||
Common Stock | Capital on Demand Sales Agreement | Jones Trading Institutional Services LLC | ||||||||
Class Of Stock [Line Items] | ||||||||
Maximum aggregate value of stock to be sold | $ 50,000,000 | $ 50,000,000 | $ 50,000,000 | $ 50,000,000 | ||||
Percentage of gross proceeds, required to pay for common stock sold through sales agreement | 2.50% |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Outstanding Warrants for Purchase of Common Stock Issued (Details) | Sep. 30, 2021$ / sharesshares |
Class Of Stock [Line Items] | |
Warrants issued | 4,810,409 |
May 13, 2022 | |
Class Of Stock [Line Items] | |
Warrants issued | 1,841 |
Exercise price (per share) | $ / shares | $ 108.60 |
November 14, 2023 Through June 4, 2024 | |
Class Of Stock [Line Items] | |
Warrants issued | 3,874 |
Exercise price (per share) | $ / shares | $ 77.40 |
January 25, 2024 | |
Class Of Stock [Line Items] | |
Warrants issued | 4,669 |
Exercise price (per share) | $ / shares | $ 51.40 |
March 27, 2024 | |
Class Of Stock [Line Items] | |
Warrants issued | 1,369,602 |
Exercise price (per share) | $ / shares | $ 27 |
March 27, 2025 | |
Class Of Stock [Line Items] | |
Warrants issued | 176,554 |
Exercise price (per share) | $ / shares | $ 0.10 |
May 3, 2025 | |
Class Of Stock [Line Items] | |
Warrants issued | 5,363 |
Exercise price (per share) | $ / shares | $ 26.10 |
Aug 27, 2027 | |
Class Of Stock [Line Items] | |
Warrants issued | 1,889,513 |
Exercise price (per share) | $ / shares | $ 0.01 |
Aug 31, 2027 | |
Class Of Stock [Line Items] | |
Warrants issued | 1,358,993 |
Exercise price (per share) | $ / shares | $ 0.01 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Weighted-Average Assumptions Fair Value of the Employee Stock Option Grants (Details) - Stock Option | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Class Of Stock [Line Items] | |||
Risk-free interest rate | 0.90% | 0.80% | 1.20% |
Expected volatility | 89.00% | 90.00% | 86.00% |
Expected term (in years) | 6 years 3 months 18 days | 6 years 2 months 12 days | 6 years 2 months 12 days |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Allocation of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Class Of Stock [Line Items] | ||||
Stock based compensation expense | $ 501 | $ 240 | $ 1,261 | $ 770 |
Research and development | ||||
Class Of Stock [Line Items] | ||||
Stock based compensation expense | 176 | 81 | 447 | 293 |
General and administrative | ||||
Class Of Stock [Line Items] | ||||
Stock based compensation expense | $ 325 | $ 159 | $ 814 | $ 477 |
Licenses and Collaborations - A
Licenses and Collaborations - Additional Information (Details) | 1 Months Ended | 6 Months Ended | 9 Months Ended | ||
Feb. 28, 2021USD ($) | Nov. 30, 2018USD ($)antibody | Jun. 30, 2021USD ($) | Sep. 30, 2021USD ($) | Mar. 31, 2020USD ($) | |
Janssen | License and Option Agreement | NIK Program | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Consideration exchanged for assets acquired | $ 0 | ||||
Value given to assets acquired | 0 | ||||
Enviro And Kairos Pharma Ltd | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
One time upfront payment fee | 100,000 | ||||
Future potential milestone payments upon achievement of financing events | $ 1,000,000 | ||||
Bispecific Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Royalty on net sales | 50.00% | ||||
Bispecific Agreement | I-Mab | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Maximum number of proprietary bispecific antibodies under development | antibody | 5 | ||||
Number of biological targets | antibody | 2 | ||||
Bispecific Agreement | I-Mab | North America | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Maximum period of selecting candidates for development and commercialization | 5 years | ||||
Bispecific Agreement | I-Mab | Before IND | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
One time upfront payment fee | $ 10,000,000 | ||||
Development and regulatory based on milestone payments | 90,000,000 | ||||
Potential milestones payments received | 250,000,000 | ||||
Bispecific Agreement | I-Mab | After IND Before Phase 1a | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
One time upfront payment fee | 25,000,000 | ||||
Development and regulatory based on milestone payments | 125,000,000 | ||||
Potential milestones payments received | 250,000,000 | ||||
Bispecific Agreement | I-Mab | After Phase 1a and Before Phase 2 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
One time upfront payment fee | 50,000,000 | ||||
Development and regulatory based on milestone payments | 250,000,000 | ||||
Potential milestones payments received | 250,000,000 | ||||
Bispecific Agreement | I-Mab | After Phase 2 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
One time upfront payment fee | 80,000,000 | ||||
Development and regulatory based on milestone payments | 420,000,000 | ||||
Potential milestones payments received | $ 250,000,000 | ||||
Collaboration Agreements | I-Mab | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Consideration exchanged for assets acquired | $ 0 | ||||
Value given to assets acquired | 0 | ||||
TJ4309 Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Percentage of cost bearing | 40.00% | ||||
TJ4309 Agreement | I-Mab | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Percentage of cost bearing | 60.00% | ||||
Potential payments receivable | $ 340,000,000 | ||||
Termination Fee | $ 9,000,000 | ||||
Termination of agreement upon completion of clinical trial | 90 days | ||||
Additional payment | $ 35,000,000 | ||||
TJ4309 Agreement | I-Mab | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Non-royalty consideration | 35,000,000 | ||||
TJ4309 Agreement | I-Mab | First Phase Clinical Trial | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Termination Fee | 9,000,000 | ||||
TJ4309 Agreement | I-Mab | First Phase Two Clinical Trial | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Termination Fee | $ 15,000,000 | ||||
Collaborative Arrangement | Enviro And Kairos Pharma Ltd | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Upfront payment for transaction | $ 100,000 | ||||
Collaborative Arrangement | Enviro And Kairos Pharma Ltd | Development Milestones | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Single digit equity ownership | $ 200,000 | ||||
Collaborative Arrangement | Enviro And Kairos Pharma Ltd | Development And Regulatory Milestones | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Balance of potential milestone that could be received | 1,000,000 | ||||
Collaboration revenue recognized | $ 0 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Leases [Abstract] | ||||
Non-cancelable operating lease expiration term | 2021-08 | |||
Non-cancelable operating lease term to be extended | 2027-04 | |||
Operating lease expense | $ 100,000 | $ 100,000 | $ 300,000 | $ 300,000 |
Finance lease liability | 0 | 0 | ||
Operating lease liability | 0 | 0 | ||
Irrevocable letter of credit provided to lessor | $ 175,000 | $ 175,000 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Leases [Abstract] | ||
Cash paid within operating cash flows | $ 344 | $ 330 |
ROU assets recognized in exchange for new lease obligations | $ 1,117 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information Related to Operating Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Sep. 30, 2020 |
Reported as: | ||
Total lease liabilities | $ 1,393 | $ 665 |
Weighted average remaining lease term | 5 years 7 months 6 days | 1 year 7 months 6 days |
Weighted average discount rate | 11.30% | 11.30% |
Other assets (ROU asset) | ||
Reported as: | ||
Other assets (ROU asset) | $ 1,371 | $ 595 |
Accounts payable and accrued expenses (lease liability) | ||
Reported as: | ||
Total lease liabilities | 182 | 402 |
Other long-term liabilities (lease liability) | ||
Reported as: | ||
Total lease liabilities | $ 1,211 | $ 263 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Sep. 30, 2020 |
Leases [Abstract] | ||
Remaining 2021 | $ 117 | |
2022 | 285 | |
2023 | 320 | |
2024 | 334 | |
2025 | 349 | |
2026 | 365 | |
Thereafter | 123 | |
Total lease payments | 1,893 | |
Less imputed interest | (500) | |
Total operating lease liabilities | $ 1,393 | $ 665 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2021 | |
North America | Collaboration Agreement | |
Subsequent Event [Line Items] | |
Commercial Sale | 10 years |