Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 02, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | CYTRX CORP | |
Entity Central Index Key | 0000799698 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity's Reporting Status Current | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 33,637,501 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2019 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 8,491,265 | $ 21,373,273 |
Short-term investments | 10,023,850 | |
Receivables | 4,789 | 148,527 |
Prepaid expenses and other current assets | 1,410,277 | 913,162 |
Current assets held for sale | 81,182 | |
Total current assets | 19,930,181 | 22,516,144 |
Equipment and furnishings, net | 23,071 | 44,326 |
Other assets | 10,119 | 40,642 |
Non-current assets held for sale | 324,853 | |
Total assets | 19,963,371 | 22,925,965 |
Current liabilities: | ||
Accounts payable | 2,194,276 | 1,234,762 |
Accrued expenses and other current liabilities | 936,105 | 726,191 |
Current liabilities of discontinued operations | 1,272 | 602,713 |
Total liabilities | 3,131,653 | 2,563,666 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred Stock, value | ||
Common stock, $0.001 par value, 41,666,667 shares authorized; 33,637,501 shares issued and outstanding at September 30, 2019 and December 31, 2018 | 33,637 | 33,637 |
Additional paid-in capital | 477,834,188 | 477,192,747 |
Accumulated deficit | (461,036,107) | (456,864,085) |
Total stockholders' equity | 16,831,718 | 20,362,299 |
Total liabilities and stockholders' equity | 19,963,371 | 22,925,965 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred Stock, value |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Preferred stock, stated value | $ 1,000 | $ 1,000 |
Preferred stock, shares authorized | 650 | 650 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 41,666,667 | 41,666,667 |
Common stock, shares issued | 33,637,501 | 33,637,501 |
Common stock, shares outstanding | 33,637,501 | 33,637,501 |
Series A Junior Participating Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 833,334 | |
Preferred stock, additional shares authorized | 4,167 | |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue: | ||||
Licensing revenue | $ 250,000 | $ 250,000 | ||
Expenses: | ||||
Research and development | 374 | (485) | 1,430 | 577,843 |
General and administrative | 1,546,213 | 2,360,996 | 4,814,436 | 6,514,107 |
Total operating expenses | 1,546,587 | 2,360,511 | 4,815,866 | 7,091,950 |
Loss before other income (expense) | (1,546,587) | (2,110,511) | (4,815,866) | (6,841,950) |
Other income (loss): | ||||
Interest income | 91,403 | 93,391 | 283,808 | 269,299 |
Interest expense | (363,086) | (1,715,733) | ||
Other income (loss), net | (35,598) | (1,502) | (37,919) | (13,230) |
Gain on warrant derivative liabilities | 527,025 | |||
Net loss from continuing operations | (1,490,782) | (2,381,708) | (4,569,977) | (7,774,589) |
Gain (loss) from discontinued operations | 19,243 | (909,336) | 397,955 | (2,601,614) |
Net loss | $ (1,471,539) | $ (3,291,044) | $ (4,172,022) | $ (10,376,203) |
Basic and diluted loss per share | ||||
Continuing operations | $ (0.04) | $ (0.07) | $ (0.14) | $ (0.26) |
Discontinued operations | (0.03) | 0.01 | (0.08) | |
Total basic and diluted loss per share | $ (0.04) | $ (0.10) | $ (0.13) | $ (0.34) |
Basic and diluted weighted-average shares outstanding | 33,249,904 | 32,991,506 | 33,249,904 | 30,242,788 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (4,172,022) | $ (10,376,203) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 15,824 | 23,819 |
Stock-based compensation expense | 644,113 | 1,278,105 |
Fair value adjustment on warrant liabilities | (527,025) | |
Amortization of loan cost and discount | 1,157,817 | |
Loss on retirement of fixed assets | 5,432 | |
Gain on disposal from discontinued operations | (186,691) | |
Stock compensation from discontinued operations | (2,672) | 89,105 |
Depreciation from discontinued operations | 384,051 | |
Changes in assets and liabilities: | ||
Receivables | 143,738 | 1,557,584 |
Prepaid expenses and other current assets | (497,040) | 665,323 |
Other assets | 30,523 | |
Current assets held for sale | 92,508 | 88,941 |
Accounts payable | 959,514 | (1,464,496) |
Current liabilities held for sale | (601,441) | 195,042 |
Accrued expenses and other current liabilities | 209,914 | (688,224) |
Net cash used in operations | (3,358,300) | (7,616,161) |
Cash flows from investing activities: | ||
Purchase of short-term investments | (10,023,850) | |
Sale of fixed assets held for sale | 500,142 | |
Purchases of equipment and furnishings | (11,478) | |
Net cash used in investing activities | (9,523,708) | (11,478) |
Cash flows from financing activities: | ||
Proceeds from public offering | 6,512,151 | |
Loan end fee payment | (1,771,250) | |
Payment of principal on term loan | (9,986,362) | |
Net cash provided by (used in) financing activities | (5,245,461) | |
Net decrease in cash and cash equivalents | (12,882,008) | (12,873,100) |
Cash and cash equivalents at beginning of period | 21,373,273 | 37,497,691 |
Cash and cash equivalents at end of period | 8,491,265 | 24,624,591 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the period for interest | 647,308 | |
Cash paid for income taxes | $ 800 | $ 800 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($) | Series B Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 28,037 | $ 468,969,445 | $ (450,852,427) | $ 18,145,055 | |
Balance, shares at Dec. 31, 2017 | 28,037,501 | ||||
Cumulative affect of adopting ASC 606 Adoption | 6,701,950 | 6,701,950 | |||
Issuance of stock options/restricted stock and warrants for compensation and services | 481,311 | 481,311 | |||
Net loss | (4,075,574) | (4,075,574) | |||
Balance at Mar. 31, 2018 | $ 28,037 | 469,450,756 | (448,226,051) | 21,252,742 | |
Balance, shares at Mar. 31, 2018 | 28,037,501 | ||||
Balance at Dec. 31, 2017 | $ 28,037 | 468,969,445 | (450,852,427) | 18,145,055 | |
Balance, shares at Dec. 31, 2017 | 28,037,501 | ||||
Net loss | (10,376,203) | ||||
Balance at Sep. 30, 2018 | $ 33,637 | 476,843,206 | (454,526,680) | 22,350,163 | |
Balance, shares at Sep. 30, 2018 | 33,637,501 | ||||
Balance at Mar. 31, 2018 | $ 28,037 | 469,450,756 | (448,226,051) | 21,252,742 | |
Balance, shares at Mar. 31, 2018 | 28,037,501 | ||||
Stock issued in connection with a public offering | $ 5,600 | 6,506,551 | $ 6,512,151 | ||
Stock issued in connection with a public offering, shares | 5,600,000 | ||||
Issuance of stock options/restricted stock and warrants for compensation and services | 453,199 | $ 453,199 | |||
Net loss | (3,009,588) | (3,009,588) | |||
Balance at Jun. 30, 2018 | $ 33,637 | 476,410,506 | (451,235,639) | 25,208,504 | |
Balance, shares at Jun. 30, 2018 | 33,637,501 | ||||
Issuance of stock options/restricted stock and warrants for compensation and services | 432,700 | 432,700 | |||
Net loss | (3,291,041) | (3,291,044) | |||
Balance at Sep. 30, 2018 | $ 33,637 | 476,843,206 | (454,526,680) | 22,350,163 | |
Balance, shares at Sep. 30, 2018 | 33,637,501 | ||||
Balance at Dec. 31, 2018 | $ 33,637 | 477,192,747 | (456,864,085) | 20,362,299 | |
Balance, shares at Dec. 31, 2018 | 33,637,501 | ||||
Issuance of stock options/warrants for compensation and services | $ 210,502 | $ 210,502 | |||
Issuance of stock options/warrants for compensation and services, shares | |||||
Net loss | $ (1,425,988) | $ (1,425,988) | |||
Balance at Mar. 31, 2019 | $ 33,637 | 477,403,249 | (458,290,073) | 19,146,813 | |
Balance, shares at Mar. 31, 2019 | 33,637,501 | ||||
Balance at Dec. 31, 2018 | $ 33,637 | 477,192,747 | (456,864,085) | 20,362,299 | |
Balance, shares at Dec. 31, 2018 | 33,637,501 | ||||
Net loss | (4,172,022) | ||||
Balance at Sep. 30, 2019 | $ 33,637 | 477,834,188 | (461,036,107) | 16,831,718 | |
Balance, shares at Sep. 30, 2019 | 33,637,501 | ||||
Balance at Mar. 31, 2019 | $ 33,637 | 477,403,249 | (458,290,073) | 19,146,813 | |
Balance, shares at Mar. 31, 2019 | 33,637,501 | ||||
Issuance of stock options/restricted stock and warrants for compensation and services | 214,706 | 214,706 | |||
Net loss | (1,274,495) | (1,274,495) | |||
Balance at Jun. 30, 2019 | $ 33,637 | $ 477,617,955 | $ (459,564,568) | $ 18,087,024 | |
Balance, shares at Jun. 30, 2019 | 33,637,501 | ||||
Issuance of stock options/warrants for compensation and services | $ 216,233 | $ 216,233 | |||
Issuance of stock options/warrants for compensation and services, shares | |||||
Net loss | $ (1,471,539) | $ (1,471,539) | |||
Balance at Sep. 30, 2019 | $ 33,637 | $ 477,834,188 | $ (461,036,107) | $ 16,831,718 | |
Balance, shares at Sep. 30, 2019 | 33,637,501 |
Description of Company and Basi
Description of Company and Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Company and Basis of Presentation | 1. Description of Company and Basis of Presentation CytRx Corporation (“CytRx”) is a biopharmaceutical research and development company specializing in oncology and rare diseases. The Company’s focus has been on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies to enhance the accumulation and release of cytotoxic anti-cancer agents at the tumor. During 2017, CytRx’s discovery laboratory, located in Freiburg, Germany, synthesized and tested over 75 rationally designed drug conjugates with highly potent payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR-7 through LADR-10) were selected based on in vitro On June 1, 2018, CytRx launched Centurion BioPharma Corporation (“Centurion”), a private wholly owned subsidiary, and transferred all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. The Management Services Agreement may be terminated by either party at any time. Centurion is focused on the development of personalized medicine for solid tumor treatment. On December 21, 2018, CytRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany would no longer be needed and, accordingly, the lab was closed at the end of January 2019. LADR Drug Discovery Platform and Centurion Centurion’s LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining expertise in linker chemistry and albumin biology to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor. Centurion has created a “toolbox” of linker technologies that are designed to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional chemotherapies) by controlling the release of the drug payloads and improving drug-like properties. Centurion’s efforts were focused on two classes of ultra-high potency albumin-binding drug conjugates. These drug conjugates combine the proprietary LADR™ linkers with novel derivatives of the auristatin and maytansinoid drug classes. These payloads historically have required a targeting antibody for successful administration to humans. These drug conjugates eliminate the need for a targeting antibody and provide a small molecule therapeutic option with potential broader applicability. Centurion’s novel companion diagnostic, ACDx™ (albumin companion diagnostic), was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR lead assets. CytRx and Centurion have been working on identifying partnership opportunities for LADR™ ultra-high potency drug conjugates and its albumin companion diagnostic. However, no partnerships or any source of financing has become available after twenty-one months of effort. Aldoxorubicin Until July 2017, the Company was focused on the research and clinical development of aldoxorubicin, their modified version of the widely-used chemotherapeutic agent, doxorubicin. Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without several of the major dose-limiting toxicities seen with administration of doxorubicin alone. On July 27, 2017, the Company entered into an exclusive worldwide license with ImmunityBio, Inc. (formerly known as NantCell, Inc. (“ImmunityBio”)), granting to ImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and our company is no longer directly working on development of aldoxorubicin. As part of the license, ImmunityBio made a strategic investment of $13 million in CytRx common stock at $6.60 per share (adjusted to reflect our 2017 reverse stock split), a premium of 92% to the market price on that date. The Company also issued ImmunityBio a warrant to purchase up to 500,000 shares of common stock at $6.60, which expired on January 26, 2019. The Company is entitled to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones. The Company is also entitled to receive ascending double-digit royalties for net sales for orphan indications such as soft tissue sarcomas and mid to high single digit royalties for other indications. Molecular Chaperone Assets In 2011, CytRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, to Orphazyme A/S (formerly Orphazyme ApS) in exchange for a one-time, upfront payment and the right to receive up to a total of $120 million (USD) in milestone payments upon the achievement of certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol. Orphazyme is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx received a milestone payment of $250,000 in September 2018. Orphazyme has highlighted positive Phase2/3 clinical trial data in patients with NPC and has announced they remain on track to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2020. In such event, CytRx will be entitled to a milestone payment of $4 million upon EMA approval and $6 million upon FDA approval, along with royalties and potential additional milestones. The accompanying condensed consolidated financial statements at September 30, 2019 and for the three-month and nine-month periods ended September 30, 2019 and 2018, respectively, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2018 have been derived from our audited financial statements as of that date. The condensed consolidated financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2018. |
Foreign Currency Remeasurement
Foreign Currency Remeasurement | 9 Months Ended |
Sep. 30, 2019 | |
Foreign Currency [Abstract] | |
Foreign Currency Remeasurement | 2. Foreign Currency Remeasurement The U.S. dollar has been determined to be the functional currency for the net assets of our German operations. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a loss of approximately $16,800 and $8,400, respectively, for the three-month and nine-month periods ended September 30, 2019 and a loss of approximately $1,300 and $7,600, respectively, for the three and nine-month periods ended September 30, 2018, respectively. The Company does not engage in currency hedging transactions. |
Recently Adopted Accounting Pro
Recently Adopted Accounting Pronouncement | 9 Months Ended |
Sep. 30, 2019 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Recently Adopted Accounting Pronouncement | 3. Recently Adopted Accounting Pronouncement On January 1, 2019, CytRx adopted Accounting Standards Update (“ASU”) No. 2016-02, “Leases (Topic 842),” which requires the recognition of right-of-use (“ROU”) assets and lease liabilities on the consolidated balance sheet. This ASU retains a distinction between finance leases and operating leases, and the classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the current accounting literature. Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount , timing, and uncertainty of cash flows arising from leases. We elected the available practical expedients on adoption. Adoption of the new standard resulted in total lease liabilities of $310,000 and ROU assets of $290,000 as of January 1, 2019. At September 30, 2019, the total lease liabilities were $140,000 and the ROU assets were $131,000. On January 1, 2018 CytRx adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers The guidance provides for a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization of certain contract costs, consideration of the time value of money in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. Under the new standard the ImmunityBio Licensing Agreement, which was determined to be a functional license agreement, as the underlying intellectual property had standalone functionality, was recognizable in 2017 when ImmunityBio obtained the right to use the intellectual property. The subsequent Reimbursement Agreement was determined to be a contract modification that introduced variable contra revenue for the Company’s reimbursement obligations. In accordance with ASC 606, management estimated its obligations under the Reimbursement Agreement to be $3.2 million which is recognized as a contract liability at the time of revenue recognition. These costs were previously recognized as research and development expense in 2017 in accordance with prior accounting standards. This contract liability was reduced to $50,000 and $9,000, respectively, as of December 31, 2018 and September 30, 2019 as a result of costs incurred under the Reimbursement Agreement and is included within accrued expenses and other current liabilities on the condensed balance sheet as of September 30, 2019. Under prior revenue recognition standards, no revenue was recognized in 2017 under the ImmunityBio Licensing Agreement as a result of revenue recognition criteria not being met, resulting in a deferred revenue balance of $6.9 million as of December 31, 2017. |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2019 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | 4. Discontinued Operations On December 21, 2018, the Company announced that its pre-clinical lab operations had successfully completed its objectives – namely, it has developed four lead compounds, LADR 7, LADR-8, LADR-9 and LADR 10 along with a companion diagnostic (ACDx). Accordingly, the Company terminated the contracts of all its employees at this location. The Company terminated its lease in Freiburg Germany on April 30, 2019 with no penalty. The Company sold its analytical equipment in March 2019 and wrote down these assets by $7,000. On April 30, 2019 the Company also sold its German office furniture and German leasehold improvements for $0.3 million, realizing a gain on sale of $0.2 million. The net book value of the assets held for sale is $0 at September 30, 2019 and $0.4 million at December 31, 2018. The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations. As of September 30, 2019 December 31, 2018 Current assets held for sale $ — $ 81,182 Equipment and furnishings, net — $ 313,425 Deposit — 11,401 Non-current assets held for sale $ — $ 324,826 Accounts payable $ 1,272 $ 323,736 Accrued expenses and other current liabilities — 278,977 Current liabilities of discontinued operations $ 1,272 $ 602,713 Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ (58 ) $ 753,174 $ (171,432 ) $ 2,135,840 Loss on impairment of equipment and furnishings — — 7,100 — Employee stock option expense — 28,683 (2,672 ) 89,105 Gain on sale of assets held for sale — (192,791 ) — Other (income) loss (19,185 ) (861 ) (38,160 ) (7,382 ) Depreciation expense — 128,340 — 384,051 Loss (gain) from discontinued operations $ (19,243 ) $ 909,336 $ (397,955 ) $ 2,601,614 |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss Per Common Share | 5. Basic and Diluted Net Loss Per Common Share Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, totaled 2.6 million shares for each of the three-month and nine-month periods ended September 30, 2019, and 3.5 million shares for each of the three-month and nine-month periods ended September 30, 2018. |
Warrant Liabilities
Warrant Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Warrant Liabilities [Abstract] | |
Warrant Liabilities | 6. Warrant Liabilities Liabilities measured at fair value on a recurring basis include warrant liabilities resulting from our equity financings. In accordance with ASC 815-40 , Derivatives and Hedging – Contracts in Entity’s Own Equity Equity-Based Payments to Non-Employees Nine Months Ended September 30, 2019 2018 Risk-free interest rate — 1.77 % Expected dividend yield — 0 % Expected lives — 0.05 Expected volatility — 50.2 % Warrants classified as liabilities (in shares) — 2,834,246 Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. The dividend yield assumption of zero is based upon the fact that we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each warrant classified as a derivative is equal to the U.S. Treasury rates in effect at September 30 of each year presented. The expected lives are based on the remaining contractual lives of the related warrants at the valuation date. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 7. Leases The Company determines whether an arrangement is, or contains, a lease at inception. Prior to 2019, the company generally accounted for operating lease payments by charging them to expense as incurred. Beginning in 2019, operating leases that have commenced are included in other assets, other accrued expenses and other long-term liabilities in the consolidated balance sheet. Classification of operating lease liabilities as either current or noncurrent is based on the expected timing of payments due under the company’s obligations. Because most of the company’s leases do not provide an implicit rate, the company estimates incremental borrowing rates based on the information available at the commencement date in determining the present value of lease payments. The company uses the implicit rate when readily determinable. Lease terms may include the effect of options to extend or terminate the lease when it is reasonably certain that the company will exercise that option. We lease office space related primarily to the administrative activities and at September 30, 2019, the remaining term of these leases are less than 12 months. See Note 3. Leases with lease terms of twelve-months or less are expensed on a straight-line basis over the lease term and are not recorded in the Condensed Consolidated Balance Sheet. In addition, we elected the hindsight practical expedient to determine the lease term for existing leases. In our application of hindsight, we evaluated the Freiburg lease and determined the term would be less than 12 months. As of September 30, 2019, balance of the right-of-use assets was approximately $131,000, and balance of the total lease liabilities was approximately $140,000. The remaining term of the leases were less than 12 months and as such, balances of the right-of-use assets and lease liabilities were included in prepaid expenses and other current assets, and accrued expenses and other current liabilities, respectively, on the accompanying condensed consolidated balance sheet. The components of rent expense and supplemental cash flow information related to leases for the period are as follows: Nine Months Ended Lease Cost Operating lease cost (included in General and Administrative expenses in the Company’s unaudited condensed consolidated statements of operations) $ 205,520 Other information Cash paid for amounts included in the measurement of lease liabilities for nine months ended September 30, 2019 $ 211,749 Weighted average remaining lease term – operating leases (in years) 0.88 Average discount rate 5.5 % |
Stock Based Compensation
Stock Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock Based Compensation | 8 Stock Based Compensation We have a 2000 Long-Term Incentive Plan, which expired on August 6, 2010. As of September 30, 2019, there were 10,452 shares subject to outstanding stock options under this plan. No further shares are available for future grant under this plan. We also have a 2008 Stock Incentive Plan. As of September 30, 2019, there were approximately 2.4 million shares subject to outstanding stock options and approximately 0.8 million shares outstanding related to restricted stock grants. This plan expired on November 20, 2018 and thus no further shares are available for future grant under this plan. We follow ASC 718, Compensation-Stock Compensation, For stock options and stock warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50. Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period, the value of these options, as calculated using the Black-Scholes option-pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. As a result, the amount of the future compensation expense is subject to adjustment until the common stock options are fully vested. The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in our Condensed Consolidated Statements of Operations: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development — employee $ — $ 28,683 $ (2,672 ) $ 89,105 General and administrative — employee 216,234 243,673 644,113 799,832 Total employee stock-based compensation $ 216,234 $ 272,356 $ 641,441 $ 888,937 Research and development — non-employee $ — $ — $ — $ — General and administrative — non-employee $ — 19,517 — 60,384 Total non-employee stock-based compensation $ — $ 19,517 $ — $ 60,384 No options were granted during the nine-month period ended September 30, 2019 as compared to 1,667 stock options at an exercise price of $1.89 during the comparative September 30, 2018 period. The fair value of the stock options was estimated using the Black-Scholes option-pricing model, based on the following assumptions: Nine Months Ended September 30, 2019 Nine Months Ended September 30, 2018 Risk-free interest rate — 2.42 % Expected volatility — 91.6 % Expected lives (years) — 6 Expected dividend yield — 0.00 % Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. We use historical information to compute expected lives. In the nine-month period ended September 30, 2018, the contractual term of the options granted was ten years. The dividend yield assumption of zero is based upon the fact we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each grant and issuance is equal to the U.S. Treasury rates in effect at the time of the grant and issuance for instruments with a similar expected life. On January 1, 2017, the Company adopted ASU 2016-09 and made a policy election to recognize forfeitures as they occur. The adoption of ASU 2016-09 did not have a material impact to the Company’s financial condition or results of operations. No amounts relating to stock-based compensation have been capitalized. The Company recorded stock compensation expense on vested options of $75,407 and $226,225, respectively, for the three and nine-month periods ended September 30, 2019, as compared to $272,356 and $888,937, respectively, for the three and nine-month periods ended September 30, 2018. As of September 30, 2019, there remained approximately $0.2 million of unrecognized compensation expense related to unvested stock options granted to current and former employees, directors, to be recognized as expense over a weighted-average period of 0.51 years. Presented below is our stock option activity: Nine Months Ended September 30, 2019 Number of Options (Employees) Number of Options (Non-Employees) Total Number Weighted-Average Exercise Price Outstanding at January 1, 2019 2,190,835 365,000 2,555,835 $ 10.69 Granted — — — $ — Exercised, Forfeited or Expired (181,837 ) — (181,837 ) $ 10.66 Outstanding at September 30, 2019 2,008,998 365,000 2,373,998 $ 10.69 Options exercisable at September 30, 2019 1,857,291 365,000 2,222,291 $ 11.29 The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2019: Range of Total Number of Options Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price Total Number of Options Exercisable Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price $ 0.77 - $5.00 1,123,449 7.84 $ 2.13 971,743 7.81 $ 2.16 $ 5.01 – $11.00 165,834 3.19 $ 10.98 165,834 3.19 $ 10.98 $ 11.01 – $15.00 623,193 5.54 $ 13.89 623,193 5.54 $ 13.89 $ 15.01 – $98.28 461,523 3.96 $ 27.09 461,523 3.96 $ 27.09 2,373,998 6.16 $ 10.69 2,222,291 6.03 $ 11.29 There was no aggregate intrinsic value to the outstanding options and vested options as of September 30, 2019. There were 193,196 and 693,196 warrants outstanding at September 30, 2019 and December 31, 2018, respectively at a weighted-average exercise price of $8.60 and $7.16, respectively. Restricted Stock No restricted stock was granted in 2019 and 2018. In December 2017, the Company granted to our Chairman and Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $679,000. In December 2016, the Company granted to our Chairman and Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years. The fair value of the restricted stock is based on the market price of the Company’s shares on the grant date less the par value received as consideration. The fair value of the restricted stock on the grant date was $1,000,000 The Company recorded an employee stock-based compensation expense for restricted stock of $140,827 and $417,889 respectively, for the three and nine-month periods ended September 30, 2019 as compared to $140,827 and $417,889 respectively, for the three and nine-month periods ended September 30, 2018. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 9. Fair Value Measurements Assets and liabilities recorded at fair value on the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows: Level 1 – quoted prices in active markets for identical assets or liabilities. Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date. Level 3 – significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date. The following table summarizes fair value measurements by level at September 30, 2019 for assets and liabilities measured at fair value on a recurring basis: (In thousands) Level I Level II Level III Total Cash equivalents $ 6,519 $ — $ — $ 6,519 Short-term investments 10,024 — — $ 10,024 The following table summarizes fair value measurements by level at December 31, 2018 for assets and liabilities measured at fair value on a recurring basis: (In thousands) Level I Level II Level III Total Cash equivalents $ 19,731 $ — $ — $ 19,731 We consider carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments. Our non-financial assets are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 9 Months Ended |
Sep. 30, 2019 | |
Liquidity and Capital Resources [Abstract] | |
Liquidity and Capital Resources | 10 Liquidity and Capital Resources At September 30, 2019, the Company had cash and cash equivalents and short-term investments of approximately $18.5 million. Management believes that our current cash and cash equivalents will be sufficient to fund our operations for the foreseeable future. The estimate is based, in part, upon our currently projected expenditures for the remainder of 2019 and the first ten months of 2020 of approximately $5.0 million. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these projections. While these projections represent the Company’s current expected expenditures, the Company has the ability to reduce the amounts as needed to manage its liquidity needs while still advancing its corporate objectives. The Company will ultimately be required to obtain additional funding in order to execute its long-term business plans, although it does not currently have commitments from any third parties to provide it with long term debt, capital or non-dilutive up-front payments from a potential strategic partner. The Company cannot assure that additional funding will be available on favorable terms, or at all. If the Company fails to obtain additional funding when needed, it may not be able to execute its business plans and its business may suffer, which would have a material adverse effect on its financial position, results of operations and cash flows. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes At December 31, 2018, we had federal and state net operating loss carryforwards as of $310.6 million and $235.6 million, respectively, available to offset against future taxable income, which expire in 2019 through 2038, of which $237.9 million and $235.6 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and contingencies Commitments We have an agreement with Vergell Medical (formerly KTB Tumorforschungs GmbH, or KTB) (“Vergell”) for the Company’s exclusive license of patent rights held by Vergell for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to Vergell in the aggregate of $7.5 million upon meeting clinical and regulatory milestones up to and including the product’s second final marketing approval. We also have agreed to pay: ● commercially reasonable royalties based on a percentage of net sales (as defined in the agreement); ● a percentage of non-royalty sub-licensing income (as defined in the agreement); and ● milestones of $1 million for each additional final marketing approval that we obtain. In the event that we must pay a third party in order to exercise our right to the intellectual property under the agreement, we will deduct a percentage of those payments from the royalties due Vergell, up to an agreed upon cap. Contingencies We applied the disclosure provisions of ASC 460, Guarantees During 2018, the Company successfully resolved various shareholder derivative actions and a class action lawsuit that were pending against it. The Company has directors’ and officers’ liability insurance, which would be utilized in the defense of any such matters. The Company may from time to time be subject to third-party claims or proceedings, include those claiming that we are infringing the proprietary rights of others or that we owe royalty, milestone or other payments to third parties. The Company evaluates developments in legal proceedings and other matters on a quarterly basis. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Discontinued Operations | The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations. As of September 30, 2019 December 31, 2018 Current assets held for sale $ — $ 81,182 Equipment and furnishings, net — $ 313,425 Deposit — 11,401 Non-current assets held for sale $ — $ 324,826 Accounts payable $ 1,272 $ 323,736 Accrued expenses and other current liabilities — 278,977 Current liabilities of discontinued operations $ 1,272 $ 602,713 Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ (58 ) $ 753,174 $ (171,432 ) $ 2,135,840 Loss on impairment of equipment and furnishings — — 7,100 — Employee stock option expense — 28,683 (2,672 ) 89,105 Gain on sale of assets held for sale — (192,791 ) — Other (income) loss (19,185 ) (861 ) (38,160 ) (7,382 ) Depreciation expense — 128,340 — 384,051 Loss (gain) from discontinued operations $ (19,243 ) $ 909,336 $ (397,955 ) $ 2,601,614 |
Warrant Liabilities (Tables)
Warrant Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Warrant Liabilities [Abstract] | |
Schedule of Weighted-average Assumptions | The following reflects the weighted-average assumptions for each of the nine-month periods indicated: Nine Months Ended September 30, 2019 2018 Risk-free interest rate — 1.77 % Expected dividend yield — 0 % Expected lives — 0.05 Expected volatility — 50.2 % Warrants classified as liabilities (in shares) — 2,834,246 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases | The components of rent expense and supplemental cash flow information related to leases for the period are as follows: Nine Months Ended Lease Cost Operating lease cost (included in General and Administrative expenses in the Company’s unaudited condensed consolidated statements of operations) $ 205,520 Other information Cash paid for amounts included in the measurement of lease liabilities for nine months ended September 30, 2019 $ 211,749 Weighted average remaining lease term – operating leases (in years) 0.88 Average discount rate 5.5 % |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Total Stock-based Compensation Expense from Stock Options, Restricted Stock and Warrants | The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in our Condensed Consolidated Statements of Operations: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development — employee $ — $ 28,683 $ (2,672 ) $ 89,105 General and administrative — employee 216,234 243,673 644,113 799,832 Total employee stock-based compensation $ 216,234 $ 272,356 $ 641,441 $ 888,937 Research and development — non-employee $ — $ — $ — $ — General and administrative — non-employee $ — 19,517 — 60,384 Total non-employee stock-based compensation $ — $ 19,517 $ — $ 60,384 |
Schedule of Share-based Payment Award, Fair Value of the Stock Options Granted, Assumptions | The fair value of the stock options was estimated using the Black-Scholes option-pricing model, based on the following assumptions: Nine Months Ended September 30, 2019 Nine Months Ended September 30, 2018 Risk-free interest rate — 2.42 % Expected volatility — 91.6 % Expected lives (years) — 6 Expected dividend yield — 0.00 % |
Schedule of Share-based Compensation, Stock Options, Activity | Presented below is our stock option activity: Nine Months Ended September 30, 2019 Number of Options (Employees) Number of Options (Non-Employees) Total Number Weighted-Average Exercise Price Outstanding at January 1, 2019 2,190,835 365,000 2,555,835 $ 10.69 Granted — — — $ — Exercised, Forfeited or Expired (181,837 ) — (181,837 ) $ 10.66 Outstanding at September 30, 2019 2,008,998 365,000 2,373,998 $ 10.69 Options exercisable at September 30, 2019 1,857,291 365,000 2,222,291 $ 11.29 |
Schedule of Outstanding Stock Options | The following table summarizes significant ranges of outstanding stock options under our plans at September 30, 2019: Range of Total Number of Options Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price Total Number of Options Exercisable Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price $ 0.77 - $5.00 1,123,449 7.84 $ 2.13 971,743 7.81 $ 2.16 $ 5.01 – $11.00 165,834 3.19 $ 10.98 165,834 3.19 $ 10.98 $ 11.01 – $15.00 623,193 5.54 $ 13.89 623,193 5.54 $ 13.89 $ 15.01 – $98.28 461,523 3.96 $ 27.09 461,523 3.96 $ 27.09 2,373,998 6.16 $ 10.69 2,222,291 6.03 $ 11.29 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Measurements by Level for Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table summarizes fair value measurements by level at September 30, 2019 for assets and liabilities measured at fair value on a recurring basis: (In thousands) Level I Level II Level III Total Cash equivalents $ 6,519 $ — $ — $ 6,519 Short-term investments 10,024 — — $ 10,024 The following table summarizes fair value measurements by level at December 31, 2018 for assets and liabilities measured at fair value on a recurring basis: (In thousands) Level I Level II Level III Total Cash equivalents $ 19,731 $ — $ — $ 19,731 |
Description of Company and Ba_2
Description of Company and Basis of Presentation (Details Narrative) - USD ($) | Jul. 27, 2017 | Sep. 30, 2018 | Sep. 30, 2019 | Dec. 31, 2011 | Jun. 01, 2018 |
Cash investment | $ 13,000,000 | ||||
Investment in common stock per share | $ 6.60 | ||||
Common stock market price premium percentage | 92.00% | ||||
Number of warrants issued to purchase shares of common stock | 500,000 | ||||
Warrants exercise price per share | $ 6.60 | ||||
Warrant expiration | Jan. 26, 2019 | ||||
Milestone payments receivable | $ 343,000,000 | $ 250,000 | |||
EMA [Member] | |||||
Payments for milestone | $ 4,000,000 | ||||
FDA [Member] | |||||
Payments for milestone | $ 6,000,000 | ||||
Management Services Agreement [Member] | |||||
Service charge, percentage | 5.00% | ||||
Orphazyme A/S [Member] | |||||
Milestone payments receivable | $ 120,000,000 |
Foreign Currency Remeasurement
Foreign Currency Remeasurement (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Foreign Currency [Abstract] | ||||
Foreign currency transaction loss, recognized | $ 16,800 | $ 1,300 | $ 8,400 | $ 7,600 |
Recently Adopted Accounting P_2
Recently Adopted Accounting Pronouncement (Details Narrative) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2017 | Sep. 30, 2019 | Jan. 02, 2019 | Dec. 31, 2018 | Jan. 02, 2018 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
ROU assets | $ 131,000 | ||||
Nant Cell Licensing Agreement [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Deferred revenue | $ 6,900,000 | ||||
Difference Between Revenue Guidance In Effect Before and After Topic 606 [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Contract liability | 9,000 | $ 50,000 | |||
Accounting Standards Update 2016-02 [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Total lease liabilities | 140,000 | $ 310,000 | |||
ROU assets | $ 131,000 | $ 290,000 | |||
Accounting Standards Update 2014-09 [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Contract with customer, liability, revenue recognized | $ 3,200,000 | ||||
Accounting Standards Update 2014-09 [Member] | Accumulated Deficit [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Cumulative effect adjustment | $ 6,700,000 |
Discontinued Operations (Detail
Discontinued Operations (Details Narrative) - USD ($) | Apr. 30, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Assets held for sale | $ 324,853 | ||
Freiburg Germany [Member] | |||
Written down on assets held for sale | $ 7,000 | ||
Assets held for sale | $ 0 | $ 400,000 | |
Freiburg Germany [Member] | Office Furniture and Leasehold Improvements [Member] | |||
Assets held for sale | 300,000 | ||
Gain on sale of property | $ 200,000 |
Discontinued Operations - Sched
Discontinued Operations - Schedule of Discontinued Operations (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Current assets held for sale | $ 81,182 | ||||
Non-current assets held for sale | 324,853 | ||||
Current liabilities of discontinued operations | 1,272 | 1,272 | 602,713 | ||
Loss (gain) from discontinued operations | (19,243) | $ 909,336 | (397,955) | $ 2,601,614 | |
Discontinued Operations [Member] | |||||
Current assets held for sale | 81,182 | ||||
Equipment and furnishings, net | 313,425 | ||||
Deposit | 11,401 | ||||
Non-current assets held for sale | 324,826 | ||||
Accounts payable | 1,272 | 1,272 | 323,736 | ||
Accrued expenses and other current liabilities | 278,977 | ||||
Current liabilities of discontinued operations | 1,272 | 1,272 | $ 602,713 | ||
Research and development | (58) | 753,174 | (171,432) | 2,135,840 | |
Loss on impairment of equipment and furnishings | 7,100 | ||||
Employee stock option expense | 28,683 | (2,672) | 89,105 | ||
Gain on sale of assets held for sale | (192,791) | ||||
Other (income) loss | (19,185) | (861) | (38,160) | (7,382) | |
Depreciation expense | 128,340 | 384,051 | |||
Loss (gain) from discontinued operations | $ (19,243) | $ 909,336 | $ (397,955) | $ 2,601,614 |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Common Share (Details Narrative) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Jun. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share [Abstract] | ||||
Antidilutive securities excluded from computation of earnings per share | 2,600,000 | 3,500,000 | 2,600,000 | 3,500,000 |
Warrant Liabilities (Details Na
Warrant Liabilities (Details Narrative) - USD ($) | Jul. 20, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Gain loss on warrant liabilities | $ 527,025 | ||||
Warrants [Member] | |||||
Number of warrants classified as liabilities | 2,834,246 | ||||
Gain loss on warrant liabilities | $ 0 | $ 500,000 |
Warrant Liabilities - Schedule
Warrant Liabilities - Schedule of Weighted-average Assumptions (Details) - Warrants [Member] | 9 Months Ended | |
Sep. 30, 2019shares | Sep. 30, 2018shares | |
Weighted average assumptions, expected lives | 0 years | 18 days |
Warrants classified as liabilities (in shares) | 2,834,246 | |
Risk Free Interest Rate [Member] | ||
Weighted average assumptions, input | 0 | 1.77 |
Expected Dividend Yield [Member] | ||
Weighted average assumptions, input | 0 | 0 |
Expected Volatility [Member] | ||
Weighted average assumptions, input | 0 | 50.2 |
Leases (Details Narrative)
Leases (Details Narrative) | Sep. 30, 2019USD ($) |
Right-of-use assets | $ 131,000 |
Lease liabilities | $ 140,000 |
Maximum [Member] | |
Operating lease, term of contract | 12 months |
Leases - Schedule of Rent Expen
Leases - Schedule of Rent Expense and Supplemental Cash Flow Information Related to Leases (Details) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost (included in General and Administrative expenses in the Company's unaudited condensed consolidated statements of operations) | $ 205,520 |
Cash paid for amounts included in the measurement of lease liabilities for nine months ended September 30, 2019 | $ 211,749 |
Weighted average remaining lease term - perating leases (in years) | 10 months 17 days |
Average discount rate | 5.50% |
Stock Based Compensation (Detai
Stock Based Compensation (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Dec. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Share-based compensation, shares subject to stock options | 2,373,998 | 2,373,998 | 2,555,835 | ||||
Weighted average exercise price of stock options granted | |||||||
Expected dividend yield | 0.00% | 0.00% | |||||
Stock compensation expense on vested options | $ 75,407 | $ 272,356 | $ 226,225 | $ 888,937 | |||
Warrants [Member] | |||||||
Warrants outstanding | 193,196 | 193,196 | 693,196 | ||||
Weighted-average exercise price of warrants outstanding | $ 8.60 | $ 8.60 | $ 7.16 | ||||
Current Employees [Member] | |||||||
Unrecognized compensation expense related to unvested stock options, granted | $ 200,000 | $ 200,000 | |||||
Unrecognized compensation cost, recognized as expense over a weighted-average period | 6 months 3 days | ||||||
Restricted Stock [Member] | |||||||
Restricted stock expense | $ 140,827 | $ 140,827 | $ 417,889 | $ 417,889 | |||
Stock Options [Member] | |||||||
Number of stock options granted to purchase common stock | 1,667 | ||||||
Weighted average exercise price of stock options granted | $ 1.89 | ||||||
Expected dividend yield | 0.00% | ||||||
2000 Long Term Incentive Plan [Member] | |||||||
Expiration date | Aug. 6, 2010 | ||||||
Share-based compensation, shares subject to stock options | 10,452 | 10,452 | |||||
2008 Stock Incentive Plan [Member] | |||||||
Share-based compensation, shares subject to stock options | 2,400,000 | 2,400,000 | |||||
2008 Stock Incentive Plan [Member] | Restricted Stock [Member] | |||||||
Share-based compensation, outstanding stock options | 800,000 | 800,000 | |||||
2008 Stock Incentive Plan [Member] | Restricted Stock [Member] | Chairman and Chief Executive Officer [Member] | |||||||
Share based compensation arranged by share based payment award restricted stock granted | 387,597 | 387,597 | |||||
Vesting period | 3 years | 3 years | |||||
Share based compensation of fair value of restricted stock on grant | $ 679,000 | $ 1,000,000 |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Total Stock-based Compensation Expense from Stock Options, Restricted Stock and Warrants (Details) - Stock Options, Restricted Stock and Warrants [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employees [Member] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | $ 216,234 | $ 272,356 | $ 641,441 | $ 888,937 |
Non Employees [Member] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 19,517 | 60,384 | ||
Research and Development Expense [Member] | Employees [Member] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 28,683 | (2,672) | 89,105 | |
Research and Development Expense [Member] | Non Employees [Member] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | ||||
General and Administrative Expense [Member] | Employees [Member] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 216,234 | 243,673 | 644,113 | 799,832 |
General and Administrative Expense [Member] | Non Employees [Member] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | $ 19,517 | $ 60,384 |
Stock Based Compensation - Sc_2
Stock Based Compensation - Schedule of Share-based Payment Award, Fair Value of the Stock Options Granted, Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Payment Arrangement [Abstract] | ||
Risk-free interest rate | 0.00% | 2.42% |
Expected volatility | 0.00% | 91.60% |
Expected lives (years) | 0 years | 6 years |
Expected dividend yield | 0.00% | 0.00% |
Stock Based Compensation - Sc_3
Stock Based Compensation - Schedule of Share-based Compensation, Stock Options, Activity (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Number of Options Outstanding at beginning of period | 2,555,835 | |
Number of Options Granted | ||
Number of Options Exercised, Forfeited or Expired | (181,837) | |
Number of Options Outstanding at end of period | 2,373,998 | |
Number of Options exercisable at end of period | 2,222,291 | |
Weighted-Average Exercise Price Options Outstanding at beginning of period | $ 10.69 | |
Weighted-Average Exercise Price Options Granted | ||
Weighted-Average Exercise Price Options Exercised, Forfeited or Expired | 10.66 | |
Weighted-Average Exercise Price Options Outstanding at end of period | 10.69 | |
Weighted-Average Exercise Price Options exercisable at end of period | $ 11.29 | |
Stock Options [Member] | ||
Weighted-Average Exercise Price Options Granted | $ 1.89 | |
Stock Options [Member] | Employees [Member] | ||
Number of Options Outstanding at beginning of period | 2,190,835 | |
Number of Options Granted | ||
Number of Options Exercised, Forfeited or Expired | (181,837) | |
Number of Options Outstanding at end of period | 2,008,998 | |
Number of Options exercisable at end of period | 1,857,291 | |
Stock Options [Member] | Non Employees [Member] | ||
Number of Options Outstanding at beginning of period | 365,000 | |
Number of Options Granted | ||
Number of Options Exercised, Forfeited or Expired | ||
Number of Options Outstanding at end of period | 365,000 | |
Number of Options exercisable at end of period | 365,000 |
Stock Based Compensation - Sc_4
Stock Based Compensation - Schedule of Outstanding Stock Options (Details) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Number of Options Outstanding | shares | 2,373,998 |
Weighted-Average Remaining Contractual Life (years) | 6 years 1 month 27 days |
Weighted-Average Exercise Price | $ 10.69 |
Number of Options Exercisable | shares | 2,222,291 |
Weighted-Average Remaining Contractual Life (years) | 6 years 11 days |
Weighted-Average Exercise Price, Options Exercisable | $ 11.29 |
Stock Options [Member] | Exercise Price Range One [Member] | |
Range of Exercise Prices, Lower Range | 0.77 |
Range of Exercise Prices, Upper Range | $ 5 |
Number of Options Outstanding | shares | 1,123,449 |
Weighted-Average Remaining Contractual Life (years) | 7 years 10 months 3 days |
Weighted-Average Exercise Price | $ 2.13 |
Number of Options Exercisable | shares | 971,743 |
Weighted-Average Remaining Contractual Life (years) | 7 years 9 months 22 days |
Weighted-Average Exercise Price, Options Exercisable | $ 2.16 |
Stock Options [Member] | Exercise Price Range Two [Member] | |
Range of Exercise Prices, Lower Range | 5.01 |
Range of Exercise Prices, Upper Range | $ 11 |
Number of Options Outstanding | shares | 165,834 |
Weighted-Average Remaining Contractual Life (years) | 3 years 2 months 8 days |
Weighted-Average Exercise Price | $ 10.98 |
Number of Options Exercisable | shares | 165,834 |
Weighted-Average Remaining Contractual Life (years) | 3 years 2 months 8 days |
Weighted-Average Exercise Price, Options Exercisable | $ 10.98 |
Stock Options [Member] | Exercise Price Range Three [Member] | |
Range of Exercise Prices, Lower Range | 11.01 |
Range of Exercise Prices, Upper Range | $ 15 |
Number of Options Outstanding | shares | 623,193 |
Weighted-Average Remaining Contractual Life (years) | 5 years 6 months 14 days |
Weighted-Average Exercise Price | $ 13.89 |
Number of Options Exercisable | shares | 623,193 |
Weighted-Average Remaining Contractual Life (years) | 5 years 6 months 14 days |
Weighted-Average Exercise Price, Options Exercisable | $ 13.89 |
Stock Options [Member] | Exercise Price Range Four [Member] | |
Range of Exercise Prices, Lower Range | 15.01 |
Range of Exercise Prices, Upper Range | $ 98.28 |
Number of Options Outstanding | shares | 461,523 |
Weighted-Average Remaining Contractual Life (years) | 3 years 11 months 15 days |
Weighted-Average Exercise Price | $ 27.09 |
Number of Options Exercisable | shares | 461,523 |
Weighted-Average Remaining Contractual Life (years) | 3 years 11 months 15 days |
Weighted-Average Exercise Price, Options Exercisable | $ 27.09 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Measurements by Level for Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Cash equivalents | $ 6,519 | $ 19,731 |
Short-term investments | 10,024 | |
Level 1 [Member] | Recurring [Member] | ||
Cash equivalents | 6,519 | 19,731 |
Short-term investments | 10,024 | |
Level 2 [Member] | Recurring [Member] | ||
Cash equivalents | ||
Short-term investments | ||
Level 3 [Member] | Recurring [Member] | ||
Cash equivalents | ||
Short-term investments |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details Narrative) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Liquidity and Capital Resources [Abstract] | |
Cash and cash equivalents and short-term investments | $ 18,500,000 |
Projected expenditures for preclinical programs | $ 5,000,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Earliest Tax Year [Member] | |
Expiration date | Dec. 31, 2019 |
Latest Tax Year [Member] | |
Expiration date | Dec. 31, 2038 |
Federal [Member] | |
Operating loss carryforwards | $ 310,600,000 |
Federal [Member] | Earliest Tax Year [Member] | |
Operating loss carryforwards | 237,900,000 |
State [Member] | |
Operating loss carryforwards | 235,600,000 |
State [Member] | Latest Tax Year [Member] | |
Operating loss carryforwards | $ 235,600,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) | Sep. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Amount of milestone payment payable | $ 7,500,000 |
Potential future milestone payments on each additional final marketing approval | $ 1,000,000 |