Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 01, 2020 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | Checkpoint Therapeutics, Inc. | |
Entity Central Index Key | 0001651407 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Small Business | true | |
Trading Symbol | CKPT | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Common Shares [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 48,059,006 | |
Class A Common Shares [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 7,000,000 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 21,481 | $ 26,077 |
Prepaid expenses and other assets | 753 | 863 |
Other receivables - related party | 972 | 26 |
Total current assets | 23,206 | 26,966 |
Total Assets | 23,206 | 26,966 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 5,839 | 7,257 |
Accounts payable and accrued expenses - related party | 1,149 | 862 |
Total current liabilities | 6,988 | 8,119 |
Total Liabilities | 6,988 | 8,119 |
Stockholders' Equity | ||
Common Stock Value | 5 | 5 |
Common stock issuable, 1,459,305 shares as of March 31, 2020 and December 31, 2019 | 2,510 | 2,510 |
Additional paid-in capital | 137,094 | 136,442 |
Accumulated deficit | (123,392) | (120,111) |
Total Stockholders' Equity | 16,218 | 18,847 |
Total Liabilities and Stockholders' Equity | 23,206 | 26,966 |
Class A Common Shares [Member] | ||
Stockholders' Equity | ||
Common Stock Value | 1 | 1 |
Total Stockholders' Equity | $ 1 | $ 1 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 60,000,000 | 60,000,000 |
Common Stock, Shares, Issued | 48,038,506 | 47,004,764 |
Common Stock, Shares, Outstanding | 48,038,506 | 47,004,764 |
Common Stock, Shares Subscribed but Unissued | 1,459,305 | 1,459,305 |
Class A Common Shares [Member] | ||
Common Stock, Shares, Issued | 7,000,000 | 7,000,000 |
Common Stock, Shares, Outstanding | 7,000,000 | 7,000,000 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Condensed Statements of Operations | ||
Revenue - related party | $ 972 | $ 352 |
Operating expenses: | ||
Research and development | 2,635 | 4,581 |
General and administrative | 1,678 | 1,703 |
Total operating expenses | 4,313 | 6,284 |
Loss from operations | (3,341) | (5,932) |
Other income | ||
Interest income | 60 | 42 |
Total other income | 60 | 42 |
Net Loss | $ (3,281) | $ (5,890) |
Loss per Share: | ||
Basic and diluted net loss per common share outstanding | $ (0.06) | $ (0.18) |
Basic and diluted weighted average number of common shares outstanding | 50,875,476 | 32,243,796 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) | Common Shares [Member] | Common Stock Issuable [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Class A Common Shares [Member] | Total |
Balances at Dec. 31, 2018 | $ 3,000 | $ 1,748,000 | $ 105,451,000 | $ (95,397,000) | $ 1,000 | $ 11,806,000 |
Balances (in Shares) at Dec. 31, 2018 | 27,076,154 | 7,000,000 | ||||
Issuance of common shares, net of offering costs - At-the-market offering | $ 0 | 0 | 355,000 | 0 | $ 0 | 355,000 |
Issuance of common shares, net of offering costs - At-the-market offering (in Shares) | 90,269 | 0 | ||||
Stock-based compensation expense | $ 0 | 0 | 798,000 | 0 | $ 0 | 798,000 |
Stock-based compensation expense (in Shares) | 713,000 | 0 | ||||
Issuance of common shares - Founders Agreement | $ 0 | (1,748,000) | 1,757,000 | 0 | $ 0 | 9,000 |
Issuance of common shares - Founders Agreement (in Shares) | 962,682 | 0 | ||||
Exercise of warrants | $ 0 | 0 | 0 | 0 | $ 0 | 0 |
Exercise of warrants (in Shares) | 39,651 | 0 | ||||
Net loss | $ 0 | 0 | 0 | (5,890,000) | $ 0 | (5,890,000) |
Balances at Mar. 31, 2019 | $ 3,000 | 0 | 108,361,000 | (101,287,000) | $ 1,000 | 7,078,000 |
Balances (in Shares) at Mar. 31, 2019 | 28,881,756 | 7,000,000 | ||||
Balances at Dec. 31, 2019 | $ 5,000 | 2,510,000 | 136,442,000 | (120,111,000) | $ 1,000 | 18,847,000 |
Balances (in Shares) at Dec. 31, 2019 | 47,004,764 | 7,000,000 | ||||
Stock-based compensation expense | $ 0 | 0 | 639,000 | 0 | $ 0 | 639,000 |
Stock-based compensation expense (in Shares) | 931,000 | 0 | ||||
Exercise of warrants | $ 0 | 0 | 13,000 | 0 | $ 0 | 13,000 |
Exercise of warrants (in Shares) | 102,742 | 0 | ||||
Net loss | $ 0 | 0 | 0 | (3,281,000) | $ 0 | (3,281,000) |
Balances at Mar. 31, 2020 | $ 5,000 | $ 2,510,000 | $ 137,094,000 | $ (123,392,000) | $ 1,000 | $ 16,218,000 |
Balances (in Shares) at Mar. 31, 2020 | 48,038,506 | 7,000,000 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (3,281) | $ (5,890) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 639 | 798 |
Issuance of common shares - Founders Agreement | 0 | 9 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 110 | 308 |
Other receivables - related party | (946) | 1,455 |
Accounts payable and accrued expenses | (1,062) | (4,883) |
Net cash used in operating activities | (4,540) | (8,203) |
Cash Flows from Financing Activities: | ||
Issuance of common shares - At-the-market offering | 0 | 365 |
Offering costs for the issuance of common shares - At-the-market offering | 0 | (10) |
Offering costs for the issuance of common shares - Public offering | (69) | 0 |
Proceeds from the exercise of warrants | 13 | 0 |
Net cash (used in) provided by financing activities | (56) | 355 |
Net decrease in cash and cash equivalents | (4,596) | (7,848) |
Cash and cash equivalents at beginning of period | 26,077 | 21,995 |
Cash and cash equivalents at end of period | 21,481 | 14,147 |
Supplemental disclosure of noncash investing and financing activities: | ||
Issuance of common shares - Founders Agreement | $ 0 | $ 1,748 |
Organization and Description of
Organization and Description of Business Operations | 3 Months Ended |
Mar. 31, 2020 | |
Organization and Description of Business Operations | |
Organization and Description of Business Operations | Note 1 - Organization and Description of Business Operations Checkpoint Therapeutics, Inc. (the “Company” or “Checkpoint”) was incorporated in Delaware on November 10, 2014. Checkpoint is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. The Company may acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. The Company may also enter into collaboration agreements with third and related parties including sponsored research agreements to develop these technologies for liquid tumors while retaining the rights in solid tumors. The Company is a majority-controlled subsidiary of Fortress Biotech, Inc. (“Fortress”). The Company's common stock is listed on the NASDAQ Capital Market and trades under the symbol “CKPT.” Liquidity and Capital Resources The Company has incurred substantial operating losses since its inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of March 31, 2020, the Company had an accumulated deficit of $123.4 million. The Company expects to continue to use the proceeds from previous financing transactions primarily for general corporate purposes, which may include financing the Company's growth, developing new or existing product candidates, and funding capital expenditures, acquisitions and investments. The Company currently anticipates that its cash and cash equivalents balances at March 31, 2020 will be sufficient to fund its anticipated operating cash requirements for at least one year from the date of this Quarterly Report on Form 10‑Q. The Company will be required to expend significant funds in order to advance the development of its product candidates. The Company's estimate as to how long it expects its existing cash to be able to continue to fund its operations is based on assumptions that may prove to be wrong, and it could use its available capital resources sooner than it currently expects. Further, changing circumstances, some of which may be beyond its control, could cause the Company to consume capital faster than it currently anticipates, and it may need to seek additional funds sooner than planned. Accordingly, the Company will be required to obtain further funding through equity offerings, debt financings, collaborations and licensing arrangements or other sources. Further financing may not be available to it on acceptable terms, or at all. The Company's failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategy and may be forced to curtail or cease operations. In addition to the foregoing, based on the Company's current assessment, the Company does not expect any material impact on its long-term development timeline and its liquidity due to the worldwide spread of the coronavirus ("COVID-19”).However, the Company is continuing to assess the effect on its operations by monitoring the spread of COVID-19, as well as the effect of the COVID-19 pandemic on the Company's clients, vendors, and business partners, and the actions implemented to combat the virus throughout the world. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Significant Accounting Policies | |
Significant Accounting Policies | Note 2 - Significant Accounting Policies Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10‑Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company's audited financial statements and notes thereto for the year ended December 31, 2019, which were included in the Company's Form 10‑K, and filed with the SEC on March 11, 2020. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents. Other Receivables - Related Party Other receivables consist of amounts due to the Company from TG Therapeutics, Inc. (“TGTX”), a related party, and are recorded at the invoiced amount. Research and Development Costs Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services on the Company's behalf will be expensed as services are rendered or when the milestone is achieved. Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, costs associated with regulatory filings, laboratory costs and other supplies. In accordance with Accounting Standards Codification (“ASC”) 730‑10‑25‑1, Research and Development , costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. Such licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and have no alternative future use. Annual Equity Fee Under the Founder's Agreement with Checkpoint dated March 17, 2015, and amended and restated on July 11, 2016, Fortress is entitled to an annual equity fee on each anniversary of the Agreement equal to 2.5% of fully diluted outstanding equity, payable in Checkpoint common shares (“Annual Equity Fee”). The Annual Equity Fee was part of the consideration payable for formation of the Company, identification of certain assets, including the license contributed to Checkpoint by Fortress (see Note 4). The Company records the Annual Equity Fee in connection with the Founders Agreement with Fortress as contingent consideration. Contingent consideration is recorded when probable and reasonably estimable. The Company's future share prices and shares outstanding cannot be estimated prior to the issuance of the Annual Equity Fee due to the nature of its assets and the Company's stage of development. Due to these uncertainties, the Company has concluded that it is unable to reasonably estimate the contingent consideration until shares are actually issued on January 1 of each year. Pursuant to the Founders Agreement, the Company was to issue 1,459,305 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully-diluted outstanding equity of Checkpoint on January 1, 2020. The Company did not have enough unreserved authorized shares under its Certificate of Incorporation on January 1, 2020 to issue the shares for the Annual Equity Fee, therefore, in December 2019, Fortress and Checkpoint mutually agreed to defer the issuance until such time as the Checkpoint Charter has been amended in order to increase the number of authorized that may be issued thereunder. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2020 prior to the issuance of the December 31, 2019 financial statements, the Company recorded approximately $2.5 million in research and development expense and a credit to Common shares issuable - Founders Agreement during the year ended December 31, 2019. Stock-Based Compensation Expenses The Company expenses stock-based compensation over the requisite service period based on the estimated grant-date fair value of the awards and forfeiture rates. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The assumptions used in calculating the fair value of stock-based awards represent management's best estimates and involve inherent uncertainties and the application of management's judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the Condensed Statements of Operations based upon the underlying individual's role at the Company. Fair Value Measurement The Company follows the accounting guidance in ASC 820 for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, 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 at the measurement date. 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 a liability. The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Revenue from Contracts with Customers The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: · Step 1: Identify the contract with the customer · Step 2: Identify the performance obligations in the contract · Step 3: Determine the transaction price · Step 4: Allocate the transaction price to the performance obligations in the contract · Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: · The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). · The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. When determining the transaction price, an entity must consider the effects of all of the following: · Variable consideration · Constraining estimates of variable consideration · The existence of a significant financing component in the contract · Noncash consideration · Consideration payable to a customer Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. Revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property is recognized only when (or as) the later of the following events occurs: a. The subsequent sale or usage occurs. b. The performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Incremental contract costs are expensed when incurred when the amortization period of the asset that would have been recognized is one year or less; otherwise, incremental contract costs are recognized as an asset and amortized over time as services are provided to a customer. Income Taxes In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act ("CARES Act") was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer's social security payments, net operating loss utilization and carryback periods and modifications to the net interest deduction limitations. At this time, the Company does not believe that the CARES Act will have a material impact on its income tax provision for 2020. The Company will continue to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows. Net Loss per Share Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Since dividends are declared, paid and set aside among the holders of shares of common stock and Class A common stock pro-rata on an as-if-converted basis, the two-class method of computing net loss per share is not required. Diluted net loss per share does not reflect the effect of shares of common stock to be issued upon the exercise of stock options and warrants, as their inclusion would be anti-dilutive. The following table summarizes potentially dilutive securities outstanding at March 31, 2020 and 2019, that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive: March 31, 2020 2019 Warrants 4,104,705 4,241,321 Stock options 200,000 110,000 Unvested restricted stock 3,999,525 3,551,459 Total 8,304,230 7,902,780 Recently Issued Accounting Standards In December 2019, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2019-12, " Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” ("ASU 2019-12"), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its financial statements and related disclosures. Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018‑13, “ Fair Value Measurement (Topic 820), - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement ,” which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of the update. The Company adopted ASU No. 2018-13 as of January 1, 2020. The adoption of this update did not have a material impact on the Company’s condensed financial statements. |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2020 | |
License Agreements | |
License Agreements | Note 3 - License Agreements Dana-Farber Cancer Institute In March 2015, the Company entered into an exclusive license agreement with Dana-Farber Cancer Institute (“Dana Farber”) to develop a portfolio of fully human immuno-oncology targeted antibodies. Dana-Farber is eligible to receive payments of up to an aggregate of approximately $21.5 million for each licensed product upon the Company's successful achievement of certain clinical development, regulatory and first commercial sale milestones. In addition, Dana-Farber is eligible to receive up to an aggregate of $60.0 million upon the Company’s successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales. Following the second anniversary of the effective date of the license agreement, Dana-Farber receives an annual license maintenance fee of $50,000, which is creditable against milestone payments or royalties due to Dana-Farber. The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1, GITR and CAIX. In connection with the license agreement with Dana-Farber, the Company entered into a collaboration agreement with TGTX, which was amended and restated in June 2019, to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies, while the Company retains the right to develop and commercialize these antibodies in solid tumors. Michael Weiss, Chairman of the Board of Directors of Checkpoint and Fortress’ Executive Vice Chairman, Strategic Development, is also the Executive Chairman, President and Chief Executive Officer and a stockholder of TGTX. Under the terms of the original collaboration agreement, TGTX paid the Company $0.5 million, representing an upfront licensing fee. Upon the signing of the amended and restated collaboration agreement in June 2019, TGTX paid the Company an additional $1.0 million upfront licensing fee. The Company is eligible to receive substantive potential milestone payments for the anti-PD-L1 program of up to an aggregate of approximately $27.6 million upon TGTX's successful achievement of certain clinical development, regulatory and first commercial sale milestones. This is comprised of up to approximately $8.4 million upon TGTX’s successful completion of clinical development milestones, and up to approximately $19.2 million upon regulatory filings and first commercial sales in specified territories. The Company is also eligible to receive substantive potential milestone payments for the anti-GITR antibody program of up to an aggregate of approximately $21.5 million upon TGTX’s successful achievement of certain clinical development, regulatory and first commercial sale milestones. This is comprised of up to approximately $7.0 million upon TGTX’s successful completion of clinical development milestones, and up to approximately $14.5 million upon first commercial sales in specified territories. In addition, the Company is eligible to receive up to an aggregate of $60.0 million upon TGTX’s successful achievement of certain sales milestones based on aggregate net sales for both programs, in addition to royalty payments based on a tiered low double-digit percentage of net sales. Following the second anniversary of the effective date of the agreement, the Company receives an annual license maintenance fee, which is creditable against milestone payments or royalties due to the Company. TGTX also pays the Company for its out-of-pocket costs of material used by TGTX for their development activities. For the three months ended March 31, 2020 and 2019, the Company recognized approximately $954,000, including a milestone of $925,000 upon the 12 th patient dosed in a phase 1 clinical trial for the anti-PD-L1 antibody cosibelimab (formerly referred to as CK-301) during March 2020, and $341,000, respectively, in revenue related to the collaboration agreement in the Condensed Statements of Operations. Adimab, LLC In October 2015, Fortress entered into a collaboration agreement with Adimab , LLC ("Adimab") to discover and optimize antibodies using their proprietary core technology platform. Under this agreement, Adimab optimized cosibelimab, the Company's anti-PD-L1 antibody which it originally licensed from Dana-Farber. In January 2019, Fortress transferred the rights to the optimized antibody to the Company, and Checkpoint entered into a collaboration agreement directly with Adimab on the same day. Under the terms of the agreement, Adimab is eligible to receive payments up to an aggregate of approximately $7.1 million upon the Company's successful achievement of certain clinical development and regulatory milestones, of which $4.8 million are due upon various filings for regulatory approvals to commercialize the product. In addition, Adimab is eligible to receive royalty payments based on a tiered low single digit percentage of net sales. NeuPharma, Inc. In March 2015, Fortress entered into an exclusive license agreement with NeuPharma , Inc. ("NeuPharma") to develop and commercialize novel irreversible, 3rd generation EGFR inhibitors, including CK‑101, on a worldwide basis other than certain Asian countries. On the same date, Fortress assigned all of its right and interest in the EGFR inhibitors to the Company. Under the terms of the license agreement NeuPharma is eligible to receive payments of up to an aggregate of approximately $40.0 million upon the Company's successful achievement of certain clinical development and regulatory milestones in up to three indications, of which $22.5 million are due upon various regulatory approvals to commercialize the products. In addition, NeuPharma is eligible to receive payments of up to an aggregate of $40.0 million upon the Company's successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered mid to high-single digit percentage of net sales. Jubilant Biosys Limited In May 2016, the Company entered into a license agreement with Jubilant Biosys Limited (“Jubilant”), whereby the Company obtained an exclusive, worldwide license to Jubilant's family of patents covering compounds that inhibit BET proteins such as BRD4, including CK‑103. Under the terms of the license agreement Jubilant is eligible to receive payments up to an aggregate of approximately $89.0 million upon the Company's successful achievement of certain clinical development and regulatory milestones, of which $59.5 million are due upon various regulatory approvals to commercialize the products. In addition, Jubilant is eligible to receive payments up to an aggregate of $89.0 million upon the Company's successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales. In connection with the license agreement with Jubilant, the Company entered into a sublicense agreement with TGTX, a related party, to develop and commercialize the compounds licensed in the field of hematological malignancies, while the Company retains the right to develop and commercialize these compounds in the field of solid tumors. Under the terms of the sublicense agreement the Company is eligible to receive substantive potential milestone payments up to an aggregate of approximately $87.2 million upon TGTX's successful achievement of clinical development and regulatory milestones. This is comprised of up to approximately $25.5 million upon TGTX's successful completion of three clinical development milestones for two licensed products, and up to approximately $61.7 million upon the achievement of five regulatory approvals and first commercial sales in specified territories for two licensed products. In addition, the Company is eligible to receive potential milestone payments up to an aggregate of $89.0 million upon TGTX's successful achievement of certain sales milestones based on aggregate net sales by TGTX, for two licensed products, in addition to royalty payments based on a mid-single digit percentage of net sales by TGTX. TGTX also pays the Company 50% of IND enabling costs and patent expenses. For the three months ended March 31, 2020 and 2019, the Company recognized approximately $18,000 and $11,000, respectively, in revenue related to the sublicense agreement in the Condensed Statements of Operations. The collaborations with TGTX each contain single material performance obligations under Topic 606, which is the granting of a license that is functional intellectual property. The Company's performance obligation was satisfied at the point in time when TGTX had the ability to use and benefit from the right to use the intellectual property. The performance obligations of the original agreements were satisfied prior to the adoption of Topic 606. The performance obligation of the amendment to the collaboration agreement was satisfied in June 2019. The milestone payments are based on successful achievement of clinical development, regulatory, and sales milestones. Because these payments are contingent on the occurrence of a future event, they represent variable consideration and are constrained and included in the transaction price only when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The sales-based royalty payments are recognized as revenue when the subsequent sales occur. The Company also receives variable consideration for certain research and development, out-of-pocket material costs and patent maintenance related activities that are dependent upon the Company's actual expenditures under the collaborations and are constrained and included in the transaction price only when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Revenue is recognized approximately when the amounts become due because it relates to an already satisfied performance obligation. For the three months ended March 31, 2020, the Company recognized the achievement of a clinical development milestone under its collaboration agreement with TGTX based upon their dosing of a 12 th patient in a phase 1 clinical trial of cosibelimab. |
Related Party Agreements
Related Party Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Agreements | |
Related Party Agreements | Note 4 - Related Party Agreements Founders Agreement and Management Services Agreement with Fortress Effective March 17, 2015, the Company entered into a Founders Agreement with Fortress, which was amended and restated on July 11, 2016 (the “Founders Agreement”). The Founders Agreement provides, that in exchange for the time and capital expended in the formation of Checkpoint and the identification of specific assets the acquisition of which resulted in the formation of a viable emerging growth life science company, the Company assumed $2.8 million in debt that Fortress accumulated under a promissory note through National Securities Corporation for expenses and costs of forming Checkpoint, and the Company shall also: (i) issue annually to Fortress, on the anniversary date of the Founders Agreement, shares of common stock equal to two and one-half percent (2.5%) of the fully-diluted outstanding equity of Checkpoint at the time of issuance; (ii) pay an equity fee in shares of common stock, payable within five (5) business days of the closing of any equity or debt financing for Checkpoint or any of its respective subsidiaries that occurs after the effective date of the Founders Agreement and ending on the date when Fortress no longer has majority voting control in Checkpoint's voting equity, equal to two and one-half percent (2.5%) of the gross amount of any such equity or debt financing; and (iii) pay a cash fee equal to four and one half percent (4.5%) of Checkpoint's annual net sales, payable on an annual basis, within ninety (90) days of the end of each calendar year. In the event of a change in control (as it is defined in the Founders Agreement), Checkpoint will pay a one-time change in control fee equal to five times (5x) the product of (i) monthly net sales for the twelve (12) months immediately preceding the change in control and (ii) four and one-half percent (4.5%). The Founders Agreement has a term of fifteen years, after which it automatically renews for one-year periods unless Fortress gives the Company notice of termination. The Founders Agreement will also automatically terminate upon a change of control. In October 2017, the Founder's Agreement was further amended to change the issuance date of the Annual Equity Fee from the anniversary date of the Agreement to January 1 of each year beginning in 2018. Effective March 17, 2015, the Company entered into a Management Services Agreement (the “MSA”) with Fortress. Pursuant to the terms of the MSA, for a period of five (5) years, Fortress will render advisory and consulting services to the Company. Services provided under the MSA may include, without limitation, (i) advice and assistance concerning any and all aspects of Checkpoint's operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of the Company with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”). The Company is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Fortress, provided those services are offered at market prices. However, the Company is not obligated to take or act upon any advice rendered from Fortress and Fortress shall not be liable for any of the Company's actions or inactions based upon their advice. Fortress and its affiliates, including all members of its Board of Directors, have been contractually exempt from fiduciary duties to the Company relating to corporate opportunities. In consideration for the Services, the Company will pay Fortress an annual consulting fee of $0.5 million (the “Annual Consulting Fee”), payable in advance in equal quarterly installments on the first business day of each calendar quarter in each year, provided, however, that such Annual Consulting Fee shall be increased to $1.0 million for each calendar year in which the Company has net assets in excess of $100 million at the beginning of the calendar year. For the three months ended March 31, 2020 and 2019, the Company recognized $125,000 in expense on its Condensed Statements of Operations related to the MSA. Caribe BioAdvisors, LLC In December 2016, the Company entered into an advisory agreement effective January 1, 2017 with Caribe BioAdvisors, LLC (“Caribe”), owned by Michael Weiss, to provide the advisory services of Mr. Weiss as Chairman of the Board. Pursuant to the agreement, Caribe will be paid an annual cash fee of $60,000, in addition to any and all annual equity incentive grants paid to members of the board. For the three months ended March 31, 2020 and 2019, the Company recognized $28,000 and $24,000, respectively, in expense in its Condensed Statements of Operations related to the advisory agreement, including $13,000 and $9,000, respectively, in expense related to annual equity incentive grants. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 5 - Commitments and Contingencies Leases The Company is not a party to any leases for office space or equipment. License Agreements The Company has undertaken to make contingent milestone payments to the licensors of its portfolio of product candidates. In addition, the Company would pay royalties to such licensors based on a percentage of net sales of each product candidate following regulatory marketing approval (See Note 3). Litigation The Company recognizes a liability for a contingency when it is probable that liability has been incurred and when the amount of loss can be reasonably estimated. When a range of probable loss can be estimated, the Company accrues the most likely amount of such loss, and if such amount is not determinable, then the Company accrues the minimum of the range of probable loss. As of March 31, 2020, and December 31, 2019, there was no litigation against the Company. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity | |
Stockholders' Equity | Note 6 - Stockholders' Equity Common Stock The Company is authorized to issue 60,000,000 common shares with a par value of $0.0001 per share, of which 7,000,000 shares are designated as “Class A common stock.” As of March 31, 2020, and December 31, 2019, there were 7,000,000 shares of Class A common stock issued and outstanding to Fortress. Dividends are to be distributed pro-rata to the Class A and common stockholders. The holders of common stock are entitled to one vote per share of common stock held. The Class A common stockholders are entitled to a number of votes per share equal to 1.1 times a fraction, the numerator of which is the sum of the shares of outstanding common stock and the denominator of which is the number of shares of Class A common stock. Accordingly, the holder of shares of Class A common stock will be able to control or significantly influence all matters requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combination transactions. Each share of Class A common stock is convertible, at the option of the holder thereof, into one (1) fully paid and non-assessable share of common stock subject to adjustment for stock splits and combinations. In November 2017, the Company filed a shelf registration statement on Form S‑3 (the "S‑3"), which was declared effective in December 2017. Under the S‑3, the Company may sell up to a total of $100 million of its securities. In connection with the S‑3, the Company entered into an At-the-Market Issuance Sales Agreement (the "ATM") with Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC (each an "Agent" and collectively, the "Agents"), relating to the sale of shares of common stock. Under the ATM, the Company pays the Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. Pursuant to the Founders Agreement, the Company was to issue 1,459,305 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully-diluted outstanding equity of Checkpoint on January 1, 2020. The Company did not have enough unreserved authorized shares under its Certificate of Incorporation on January 1, 2020 to issue the shares for the Annual Equity Fee, therefore, in December 2019, Fortress and Checkpoint mutually agreed to defer the issuance until such time as the Checkpoint Charter has been amended in order to increase the number of authorized that may be issued thereunder (see Notes 2 and 4). The S‑3 is currently the Company's only active shelf registration statement. Subsequent to the offerings noted above, approximately $41.4 million of securities remain available for sale under the S‑3. The Company may offer the securities under the S‑3 from time to time in response to market conditions or other circumstances if it believes such a plan of financing is in the best interests of its stockholders. The Company believes that the S‑3 provides it with the flexibility to raise additional capital to finance its operations as needed. Equity Incentive Plan The Company has in effect the Amended and Restated 2015 Incentive Plan (“2015 Incentive Plan'). The 2015 Incentive Plan was adopted in March 2015 by our stockholders. Under the 2015 Incentive Plan, the compensation committee of the Company's board of directors is authorized to grant stock-based awards to directors, officers, employees and consultants. An amendment to the 2015 Incentive Plan was approved by stockholders in June 2017 to increase the shares available for issuance to 5,000,000 shares. The plan expires 10 years from the effective date of the amendment and limits the term of each option to no more than 10 years from the date of grant. As of March 31, 2020, 494,805 shares are available for issuance under the 2015 Incentive Plan. Restricted Stock Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting. The following table summarizes restricted stock award activity for the three months ended March 31, 2020: Weighted Average Number of Grant Date Fair Shares Value Nonvested at December 31, 2019 3,303,839 $ 4.29 Granted 931,000 2.43 Vested (235,314) 3.08 Nonvested at March 31, 2020 3,999,525 $ 3.93 As of March 31, 2020, there was $4.4 million of total unrecognized compensation cost related to non-vested restricted stock, which is expected to be recognized over a weighted-average period of 1.4 years. This amount does not include, as of March 31, 2020, 333,334 shares of restricted stock outstanding which are performance-based and vest upon achievement of certain corporate milestones. The expense is recognized over the vesting period of the award. Stock-based compensation for milestone awards will be measured and recorded if and when it is probable that the milestone will be achieved. Stock Options The following table summarizes stock option award activity for the three months ended March 31, 2020: Weighted Average Remaining Weighted Average Contractual Life Stock Options Exercise Price (in years) Outstanding as of December 31, 2019 160,000 $ 3.64 8.56 Granted 40,000 1.94 Outstanding as of March 31, 2020 200,000 $ 3.30 8.63 Upon the exercise of stock options, the Company will issue new shares of its common stock. Warrants A summary of warrant activities for the three months ended March 31, 2020 is presented below: Weighted Average Remaining Weighted Average Contractual Life Warrants Exercise Price (in years) Outstanding as of December 31, 2019 4,207,447 $ 6.81 1.25 Exercised (102,742) 0.13 Outstanding as of March 31, 2020 4,104,705 $ 6.98 0.65 Upon the exercise of warrants, the Company will issue new shares of its common stock. During the three months ended March 31, 2020, the Company issued 102,742 common shares and received $13,000. Stock-Based Compensation The following table summarizes stock-based compensation expense for the three months ended March 31, 2020 and 2019 ($ in thousands): For the three months ended March 31, 2020 2019 Research and development $ 144 $ 196 General and administrative 495 602 Total stock-based compensation expense $ 639 $ 798 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | Note 7 - Accounts Payable and Accrued Expenses At March 31, 2020 and December 31, 2019, accounts payable and accrued expenses consisted of the following ($ in thousands): March 31, December 31, 2020 2019 Accounts payable $ 2,314 $ 3,079 Accrued compensation 122 414 Research and development 3,088 3,496 Other 315 268 Accounts payable and accrued expenses - related party 1,149 862 Total accounts payable and accrued expenses $ 6,988 $ 8,119 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10‑Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company's audited financial statements and notes thereto for the year ended December 31, 2019, which were included in the Company's Form 10‑K, and filed with the SEC on March 11, 2020. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents. |
Other Receivables - Related Party | Other Receivables - Related Party Other receivables consist of amounts due to the Company from TG Therapeutics, Inc. (“TGTX”), a related party, and are recorded at the invoiced amount. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services on the Company's behalf will be expensed as services are rendered or when the milestone is achieved. Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, costs associated with regulatory filings, laboratory costs and other supplies. In accordance with Accounting Standards Codification (“ASC”) 730‑10‑25‑1, Research and Development , costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. Such licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and have no alternative future use. |
Annual Equity Fee | Annual Equity Fee Under the Founder's Agreement with Checkpoint dated March 17, 2015, and amended and restated on July 11, 2016, Fortress is entitled to an annual equity fee on each anniversary of the Agreement equal to 2.5% of fully diluted outstanding equity, payable in Checkpoint common shares (“Annual Equity Fee”). The Annual Equity Fee was part of the consideration payable for formation of the Company, identification of certain assets, including the license contributed to Checkpoint by Fortress (see Note 4). The Company records the Annual Equity Fee in connection with the Founders Agreement with Fortress as contingent consideration. Contingent consideration is recorded when probable and reasonably estimable. The Company's future share prices and shares outstanding cannot be estimated prior to the issuance of the Annual Equity Fee due to the nature of its assets and the Company's stage of development. Due to these uncertainties, the Company has concluded that it is unable to reasonably estimate the contingent consideration until shares are actually issued on January 1 of each year. Pursuant to the Founders Agreement, the Company was to issue 1,459,305 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully-diluted outstanding equity of Checkpoint on January 1, 2020. The Company did not have enough unreserved authorized shares under its Certificate of Incorporation on January 1, 2020 to issue the shares for the Annual Equity Fee, therefore, in December 2019, Fortress and Checkpoint mutually agreed to defer the issuance until such time as the Checkpoint Charter has been amended in order to increase the number of authorized that may be issued thereunder. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2020 prior to the issuance of the December 31, 2019 financial statements, the Company recorded approximately $2.5 million in research and development expense and a credit to Common shares issuable - Founders Agreement during the year ended December 31, 2019. |
Stock-Based Compensation Expenses | Stock-Based Compensation Expenses The Company expenses stock-based compensation over the requisite service period based on the estimated grant-date fair value of the awards and forfeiture rates. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The assumptions used in calculating the fair value of stock-based awards represent management's best estimates and involve inherent uncertainties and the application of management's judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the Condensed Statements of Operations based upon the underlying individual's role at the Company. |
Fair Value Measurement | Fair Value Measurement The Company follows the accounting guidance in ASC 820 for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, 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 at the measurement date. 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 a liability. The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: · Step 1: Identify the contract with the customer · Step 2: Identify the performance obligations in the contract · Step 3: Determine the transaction price · Step 4: Allocate the transaction price to the performance obligations in the contract · Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: · The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). · The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. When determining the transaction price, an entity must consider the effects of all of the following: · Variable consideration · Constraining estimates of variable consideration · The existence of a significant financing component in the contract · Noncash consideration · Consideration payable to a customer Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. Revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property is recognized only when (or as) the later of the following events occurs: a. The subsequent sale or usage occurs. b. The performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Incremental contract costs are expensed when incurred when the amortization period of the asset that would have been recognized is one year or less; otherwise, incremental contract costs are recognized as an asset and amortized over time as services are provided to a customer. |
Income Taxes | Income Taxes In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act ("CARES Act") was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer's social security payments, net operating loss utilization and carryback periods and modifications to the net interest deduction limitations. At this time, the Company does not believe that the CARES Act will have a material impact on its income tax provision for 2020. The Company will continue to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows. |
Net Loss per Share | Net Loss per Share Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Since dividends are declared, paid and set aside among the holders of shares of common stock and Class A common stock pro-rata on an as-if-converted basis, the two-class method of computing net loss per share is not required. Diluted net loss per share does not reflect the effect of shares of common stock to be issued upon the exercise of stock options and warrants, as their inclusion would be anti-dilutive. The following table summarizes potentially dilutive securities outstanding at March 31, 2020 and 2019, that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive: March 31, 2020 2019 Warrants 4,104,705 4,241,321 Stock options 200,000 110,000 Unvested restricted stock 3,999,525 3,551,459 Total 8,304,230 7,902,780 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In December 2019, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2019-12, " Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” ("ASU 2019-12"), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its financial statements and related disclosures. Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018‑13, “ Fair Value Measurement (Topic 820), - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement ,” which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of the update. The Company adopted ASU No. 2018-13 as of January 1, 2020. The adoption of this update did not have a material impact on the Company’s condensed financial statements. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Significant Accounting Policies | |
Schedule of potentially dilutive securities outstanding, that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | The following table summarizes potentially dilutive securities outstanding at March 31, 2020 and 2019, that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive: March 31, 2020 2019 Warrants 4,104,705 4,241,321 Stock options 200,000 110,000 Unvested restricted stock 3,999,525 3,551,459 Total 8,304,230 7,902,780 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity | |
Summary of restricted stock award activity | The following table summarizes restricted stock award activity for the three months ended March 31, 2020: Weighted Average Number of Grant Date Fair Shares Value Nonvested at December 31, 2019 3,303,839 $ 4.29 Granted 931,000 2.43 Vested (235,314) 3.08 Nonvested at March 31, 2020 3,999,525 $ 3.93 |
Summary of stock option award activity | The following table summarizes stock option award activity for the three months ended March 31, 2020: Weighted Average Remaining Weighted Average Contractual Life Stock Options Exercise Price (in years) Outstanding as of December 31, 2019 160,000 $ 3.64 8.56 Granted 40,000 1.94 Outstanding as of March 31, 2020 200,000 $ 3.30 8.63 |
Summary of warrant activities | A summary of warrant activities for the three months ended March 31, 2020 is presented below: Weighted Average Remaining Weighted Average Contractual Life Warrants Exercise Price (in years) Outstanding as of December 31, 2019 4,207,447 $ 6.81 1.25 Exercised (102,742) 0.13 Outstanding as of March 31, 2020 4,104,705 $ 6.98 0.65 |
Summary of stock-based compensation expense | The following table summarizes stock-based compensation expense for the three months ended March 31, 2020 and 2019 ($ in thousands): For the three months ended March 31, 2020 2019 Research and development $ 144 $ 196 General and administrative 495 602 Total stock-based compensation expense $ 639 $ 798 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | At March 31, 2020 and December 31, 2019, accounts payable and accrued expenses consisted of the following ($ in thousands): March 31, December 31, 2020 2019 Accounts payable $ 2,314 $ 3,079 Accrued compensation 122 414 Research and development 3,088 3,496 Other 315 268 Accounts payable and accrued expenses - related party 1,149 862 Total accounts payable and accrued expenses $ 6,988 $ 8,119 |
Organization and Description _2
Organization and Description of Business Operations - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Organization and Description of Business Operations | ||
Retained Earnings (Accumulated Deficit) | $ (123,392) | $ (120,111) |
Significant Accounting Polici_4
Significant Accounting Policies - Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 8,304,230 | 7,902,780 |
Warrants (Note 6) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,104,705 | 4,241,321 |
Stock options (Note 6) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 200,000 | 110,000 |
Unvested restricted stock (Note 6) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,999,525 | 3,551,459 |
Significant Accounting Polici_5
Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Millions | Jan. 01, 2020 | Dec. 31, 2019 | Mar. 17, 2015 |
Equity Method Investment, Annual Equity Fee, Percentage | 2.50% | ||
Fortress Biotech, Inc [Member] | |||
Equity Method Investment, Annual Equity Fee, Percentage | 2.50% | ||
Stock Issued During Period, Shares, New Issues | 1,459,305 | ||
Research and development [Member] | |||
Stock Issued During Period, Value, Issued for Services | $ 2.5 |
License Agreements (Details)
License Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Jun. 30, 2019 | Mar. 31, 2015 | Mar. 31, 2020 | Mar. 31, 2019 | |
Neupharma [Member] | Additional Sales Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | $ 40,000,000 | |||
Neupharma [Member] | Clinical and Development Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | 40,000,000 | |||
Neupharma [Member] | Regulatory Approvals To Commercialize The Products [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | 22,500,000 | |||
Dana-Farber [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maintenance Fee | 50,000 | |||
Dana-Farber [Member] | First Commercial Sale Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 27,600,000 | |||
Maximum Potential Milestone Payments | 21,500,000 | |||
Dana-Farber [Member] | Additional Sales Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 60,000,000 | |||
Maximum Potential Milestone Payments | 60,000,000 | |||
Dana-Farber [Member] | Commercial Sales In Specified Territories [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 21,500,000 | |||
Jubilant Biosys Ltd [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 18,000 | $ 11,000 | ||
Research and Development Cost, Shared Percentage | 50.00% | |||
Jubilant Biosys Ltd [Member] | Clinical and Development Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | $ 89,000,000 | |||
Jubilant Biosys Ltd [Member] | Regulatory Approvals To Commercialize The Products [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | 59,500,000 | |||
Jubilant Biosys Ltd [Member] | Five Regulatory Approvals And First Commercial Sales [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 61,700,000 | |||
Jubilant Biosys Ltd [Member] | Sale Millstone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 89,000,000 | |||
Maximum Potential Milestone Payments | 89,000,000 | |||
Jubilant Biosys Ltd [Member] | Clinical Development and Regulatory Milestones [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 87,200,000 | |||
Adimab LLC [Member] | Clinical and Development Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | 7,100,000 | |||
Adimab LLC [Member] | Regulatory Approvals To Commercialize The Products [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | 4,800,000 | |||
Collaboration Agreement With TGTX [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Payment of Upfront Fees | $ 1,000,000 | |||
Revenue Recognition, Milestone Method, Revenue Recognized | 954,000 | $ 341,000 | ||
Proceeds from Upfront Fees | $ 500,000 | |||
Collaboration Agreement With TGTX [Member] | PD-L1 [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum Potential Milestone Payments | 925,000 | |||
Collaboration Agreement With TGTX [Member] | Clinical and Development Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 7,000,000 | |||
Collaboration Agreement With TGTX [Member] | Commercial Sales In Specified Territories [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 14,500,000 | |||
Collaboration Agreement With TGTX [Member] | Five Regulatory Approvals And First Commercial Sales [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 19,200,000 | |||
Collaboration Agreement With TGTX [Member] | Clinical Development and Regulatory Milestones [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | 8,400,000 | |||
Sublicense Agreement with TGTX [Member] | Clinical and Development Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Revenue Recognition Milestone Method, Payments Due | $ 25,500,000 |
Related Party Agreements (Detai
Related Party Agreements (Details) | 1 Months Ended | 3 Months Ended | ||
Dec. 31, 2016USD ($) | Mar. 17, 2015USD ($)item | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | |
Management Services Agreement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Number of period | 5 years | |||
Annual Consulting Fee | $ 500,000 | |||
Increase In Annual Consulting Fee | 1,000,000 | |||
Excess In Net Assets Value | 100,000,000 | |||
Costs and Expenses, Related Party | $ 125,000 | $ 125,000 | ||
Fortress Biotech, Inc [Member] | Founders Agreement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Long-term Debt, Gross | $ 2,800,000 | |||
Issuance of Common Stock, Percentage of Outstanding Diluted Equity | 2.50% | |||
Number of Business Days | 5 days | |||
Voting equity, Percentage of Equity or Debt Financing | 2.50% | |||
Cash Fee, Percentage of Annual Net Sales | 4.50% | |||
Cash Fees, Maximum Number of Days | 90 days | |||
Control Fees, Number of Times | item | 5 | |||
Control Fees, Monthly Net Sales | 12 months | |||
Cash Fee, Percentage of Monthly Net Sales | 4.50% | |||
Agreement Term | 15 years | |||
Caribe Bioadvisors LLC [Member] | ||||
Related Party Transaction [Line Items] | ||||
Costs and Expenses, Related Party | 28,000 | 24,000 | ||
Annual Advisory Service Fee | $ 60,000 | |||
Caribe Bioadvisors LLC [Member] | Equity Incentive Grants [Member] | ||||
Related Party Transaction [Line Items] | ||||
Costs and Expenses, Related Party | $ 13,000 | $ 9,000 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock (Details) - Unvested restricted stock (Note 6) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Nonvested Beginning Balance | shares | 3,303,839 |
Number of Shares, Granted | shares | 931,000 |
Number of Shares, Vested | shares | (235,314) |
Number of Shares, Nonvested Ending Balance | shares | 3,999,525 |
Weighted Average Exercise Price, Nonvested Beginning Balance | $ / shares | $ 4.29 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 2.43 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 3.08 |
Weighted Average Exercise Price, Nonvested Ending Balance | $ / shares | $ 3.93 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options (Details) - Options [Member] - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Options, Outstanding (Beginning) | 160,000 | |
Stock Options, Granted | 40,000 | |
Stock Options, Outstanding (Ending) | 200,000 | 160,000 |
Weighted Average Exercise Price, Outstanding (Beginning) | $ 3.64 | |
Weighted Average Exercise Price, Granted | 1.94 | |
Weighted Average Exercise Price, Outstanding (Ending) | $ 3.30 | $ 3.64 |
Weighted Average Remaining Contractual Life (in years) | 8 years 7 months 17 days | 8 years 6 months 22 days |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - Warrants (Note 6) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Warrants, Outstanding Beginning Balance | 4,207,447 | |
Warrants, Exercised | (102,742) | |
Warrants, Outstanding Ending Balance | 4,104,705 | 4,207,447 |
Weighted Average Exercise Price, Nonvested Beginning Balance | $ 6.81 | |
Weighted Average Exercise Price Exercised | 0.13 | |
Weighted Average Exercise Price, Nonvested Ending Balance | $ 6.98 | $ 6.81 |
Weighted Average Remaining Contractual Life, Outstanding (in years) | 7 months 24 days | 1 year 3 months |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 639 | $ 798 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 144 | 196 |
General and administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 495 | $ 602 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Jan. 01, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Nov. 30, 2017 | Jun. 30, 2017 | Mar. 17, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common Stock, Shares Authorized | 60,000,000 | 60,000,000 | |||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | |||||
Common Stock, Shares, Issued | 48,038,506 | 47,004,764 | |||||
Common Stock, Shares, Outstanding | 48,038,506 | 47,004,764 | |||||
Shelf Registration Statement, Maximum Authorized Securities | $ 100,000,000 | ||||||
Equity Method Investment, Annual Equity Fee, Percentage | 2.50% | ||||||
Stock Issued During Period Value Common Shares For At The Market Offering | $ 355,000 | ||||||
Stock Issued During Period, Value, Common Shares For Services | 9,000 | ||||||
Shelf Registration Statement, Remaining Authorized Securities | $ 41,400,000 | ||||||
Amount received for issuance of common stock upon exercise of warrants | 13,000 | $ 0 | |||||
Non-vested Restricted Stock [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 4,400,000 | ||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 4 months 24 days | ||||||
Performance Shares [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 333,334 | ||||||
2015 Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 5,000,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 494,805 | ||||||
Common Shares [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity Method Investment, Annual Equity Fee, Percentage | 2.50% | ||||||
Stock Issued During Period Shares Common Shares For At The Market Offering | 90,269 | ||||||
Stock Issued During Period Value Common Shares For At The Market Offering | $ 0 | ||||||
Stock Issued During Period, Value, Common Shares For Services | $ 0 | ||||||
Issuance of stock upon exercise of warrants | 102,742 | 39,651 | |||||
Amount received for issuance of common stock upon exercise of warrants | $ 0 | $ 0 | |||||
Fortress Biotech, Inc [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 1,459,305 | ||||||
Agent [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Commission rate | 3.00% | ||||||
Common Class A [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common Stock, Shares Authorized | 7,000,000 | ||||||
Common Stock, Shares, Issued | 7,000,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 2,314 | $ 3,079 |
Accrued compensation | 122 | 414 |
Research and development | 3,088 | 3,496 |
Other | 315 | 268 |
Accounts payable and accrued expenses - related party | 1,149 | 862 |
Total accounts payable and accrued expenses | $ 6,988 | $ 8,119 |