Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2019 | |
Document and Entity Information | |
Entity Registrant Name | HUMANIGEN, INC |
Entity Central Index Key | 0001293310 |
Document Type | S-1 |
Document Period End Date | Sep. 30, 2019 |
Amendment Flag | false |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | |||
Cash and cash equivalents | $ 157 | $ 814 | $ 737 |
Prepaid expenses and other current assets | 366 | 485 | 813 |
Total current assets | 523 | 1,299 | 1,550 |
Property and equipment, net | 19 | ||
Restricted cash | 71 | 71 | 101 |
Total assets | 594 | 1,370 | 1,670 |
Current liabilities: | |||
Accounts payable | 3,932 | 2,856 | 3,330 |
Accrued expenses | 3,525 | 3,129 | 3,307 |
Advance notes | 1,730 | 807 | |
Term loans payable | 18,018 | ||
Notes payable to vendors | 1,067 | 1,471 | |
Total current liabilities | 10,254 | 8,263 | 24,655 |
Convertible notes | 3,006 | 1,217 | |
Notes payable to vendors | 1,351 | ||
Total liabilities | 13,260 | 9,480 | 26,006 |
Stockholders' deficit: | |||
Common stock, $0.001 par value: 225,000,000 and 85,000,000 shares authorized at September 30, 2019, December 31, 2018 and December 31, 2017, respectively; 112,780,386, 109,897,526 and 14,946,712 shares issued and outstanding at September 30, 2019, December 31, 2018 and December 31, 2017, respectively | 113 | 110 | 15 |
Additional paid-in capital | 270,090 | 266,381 | 238,246 |
Accumulated deficit | (282,869) | (274,601) | (262,597) |
Total stockholders' deficit | (12,666) | (8,110) | (24,336) |
Total liabilities and stockholders' deficit | $ 594 | $ 1,370 | $ 1,670 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | |||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 | 85,000,000 |
Common stock, shares issued | 112,780,386 | 109,897,526 | 14,946,712 |
Common stock, shares outstanding | 112,780,386 | 109,897,526 | 14,946,712 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | ||||||
Research and development | $ 549 | $ 535 | $ 2,142 | $ 1,808 | $ 2,219 | $ 11,165 |
General and administrative | 1,497 | 1,804 | 5,122 | 7,793 | 9,112 | 7,866 |
Total operating expenses | 2,046 | 2,339 | 7,264 | 9,601 | 11,331 | 19,031 |
Loss from operations | (2,046) | (2,339) | (7,264) | (9,601) | (11,331) | (19,031) |
Other income (expense): | ||||||
Interest expense | (343) | (116) | (1,003) | (542) | (852) | (3,056) |
Other income (expense), net | 319 | (1) | 318 | 324 | 431 | |
Reorganization items, net | (40) | (106) | (145) | (331) | ||
Net loss | (2,389) | (2,176) | (8,268) | (9,931) | (12,004) | (21,987) |
Other comprehensive income | ||||||
Comprehensive loss | $ (2,389) | $ (2,176) | $ (8,268) | $ (9,931) | $ (12,004) | $ (21,987) |
Basic and diluted net loss per common share | $ (0.02) | $ (0.02) | $ (0.07) | $ (0.11) | $ (0.13) | $ (1.47) |
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 112,766,614 | 109,766,974 | 111,303,918 | 89,655,878 | 94,756,375 | 14,975,370 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities: | ||||
Net loss | $ (8,268) | $ (9,931) | $ (12,004) | $ (21,987) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 19 | 19 | 48 | |
Noncash interest expense | 961 | 512 | 819 | 3,037 |
Stock based compensation expense | 1,877 | 4,170 | 4,812 | 2,115 |
Change in fair value of warrants issued in connection with acquisition of licenses | (97) | |||
Issuance of common stock for payment of accrued compensation | 120 | 85 | 85 | |
Issuance of common stock in exchange for services | 71 | 67 | 81 | 12 |
Gain on forgiveness of accrued legal fees | (275) | |||
Gain on disposal of assets | (276) | |||
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other assets | 119 | 308 | 328 | 831 |
Accounts payable | 1,076 | (159) | (198) | (520) |
Accrued expenses | 592 | 219 | 125 | 2,571 |
Liabilities subject to compromise | (259) | |||
Net cash used in operating activities | (3,452) | (4,985) | (6,209) | (14,249) |
Investing activities: | ||||
Changes in restricted cash | 30 | |||
Net cash provided by investing activities | 30 | |||
Financing activities: | ||||
Net proceeds from issuance of common stock | 2,781 | 2,781 | ||
Net proceeds from Term loan | 50 | 50 | 12,080 | |
Net proceeds of stock option exercise | 325 | |||
Net proceeds from issuance of Convertible notes | 1,275 | 2,500 | 2,500 | |
Net proceeds from issuance of Advance notes | 1,700 | 925 | 925 | |
Payments on notes payable to vendors | (505) | |||
Net cash provided by financing activities | 2,795 | 6,256 | 6,256 | 12,080 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (657) | 1,301 | 47 | (2,169) |
Cash, cash equivalents and restricted cash, beginning of period | 885 | 737 | 737 | 3,007 |
Cash, cash equivalents and restricted cash, end of period | 228 | 2,038 | 885 | 737 |
Supplemental cash flow disclosure: | ||||
Cash paid for interest | 8 | 6 | 8 | 6 |
Supplemental disclosure of non-cash investing and financing activities: | ||||
Conversion of notes payable and related accrued interest and fees to common stock | 981 | 18,432 | 18,432 | |
Change in fair value of warrants issued in connection with acquisition of licenses | (97) | |||
Beneficial conversion feature of Advance notes | 271 | 271 | ||
Beneficial conversion feature of Convertible notes | 143 | 1,465 | 1,465 | |
Issuance of stock options in lieu of cash compensation | 195 | 303 | 303 | |
Issuance of common stock for payment of accrued compensation | 120 | 85 | ||
Issuance of common stock in exchange for services | $ 71 | $ 67 | 81 | 12 |
Issuance of common stock in lieu of cash compensation | $ 85 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity Deficit - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balances at Dec. 31, 2016 | $ 15 | $ 236,216 | $ (240,610) | $ (4,379) |
Balances (in shares) at Dec. 31, 2016 | 14,977,397 | |||
Issuance of stock options for payment of accrued compensation | ||||
Issuance of stock in connection with financing agreement | $ 9,315 | 12 | 12 | |
Return of shares of stock by advisor | (40,000) | |||
Beneficial conversion feature of Advance Notes | ||||
Convertible note beneficial conversion feature | ||||
Write down in fair value of warrants | (97) | (97) | ||
Issuance of common stock in lieu of cash compensation | ||||
Issuance of common stock upon note conversions | ||||
Stock-based compensation expense | 2,115 | 2,115 | ||
Comprehensive loss | (21,987) | (21,987) | ||
Balances at Dec. 31, 2017 | $ 15 | 238,246 | (262,597) | (24,336) |
Balances (in shares) at Dec. 31, 2017 | 14,946,712 | |||
Issuance of stock options for payment of accrued compensation | 303 | 303 | ||
Issuance of common stock in exchange for services | 51 | 51 | ||
Issuance of common stock in exchange for services, shares | 88,333 | |||
Conversion of notes payable and related accrued interest and fees to common stock | $ 76 | 18,356 | 18,432 | |
Conversion of notes payable and related accrued interest and fees to common stock (in shares) | 76,007,754 | |||
Issuance of common stock for services | 51 | 51 | ||
Issuance of common stock for services (in shares) | 88,333 | |||
Issuance of common stock | $ 19 | 2,762 | 2,781 | |
Issuance of common stock (in shares) | 18,653,320 | |||
Beneficial conversion feature of Advance Notes | 271 | |||
Convertible note beneficial conversion feature | 1,465 | |||
Issuance of common stock in lieu of cash compensation | 85 | |||
Issuance of common stock upon note conversions | 18,432 | |||
Stock-based compensation expense | 3,455 | 3,455 | ||
Comprehensive loss | (7,755) | (9,931) | ||
Balances at Sep. 30, 2018 | $ 110 | 265,725 | (272,528) | (6,693) |
Balances (in shares) at Sep. 30, 2018 | 109,872,526 | |||
Balances at Dec. 31, 2017 | $ 15 | 238,246 | (262,597) | (24,336) |
Balances (in shares) at Dec. 31, 2017 | 14,946,712 | |||
Issuance of stock options for payment of accrued compensation | 303 | 303 | ||
Issuance of common stock in exchange for services | 113,333 | 81 | 81 | |
Conversion of notes payable and related accrued interest and fees to common stock | $ 76 | 18,356 | 18,432 | |
Conversion of notes payable and related accrued interest and fees to common stock (in shares) | 76,007,754 | |||
Issuance of common stock, net of issuance costs | $ 19 | 2,762 | 2,781 | |
Issuance of common stock, net of issuance costs (in shares) | 18,653,320 | |||
Beneficial conversion feature of Advance Notes | 271 | 271 | ||
Convertible note beneficial conversion feature | 1,465 | 1,465 | ||
Write down in fair value of warrants | ||||
Issuance of common stock in lieu of cash compensation | 151,407 | 85 | 85 | |
Issuance of common stock upon note conversions | 18,432 | |||
Stock-based compensation expense | 4,812 | 4,812 | ||
Comprehensive loss | (12,004) | (12,004) | ||
Balances at Dec. 31, 2018 | $ 110 | 266,381 | (274,601) | (8,110) |
Balances (in shares) at Dec. 31, 2018 | 109,872,526 | |||
Balances at Jun. 30, 2018 | $ 110 | 263,173 | (270,352) | (7,069) |
Balances (in shares) at Jun. 30, 2018 | 109,696,119 | |||
Issuance of common stock for payment of accrued compensation | 85 | 85 | ||
Issuance of common stock for payment of accrued compensation, shares | 151,407 | |||
Issuance of common stock in exchange for services | 16 | 16 | ||
Issuance of common stock in exchange for services, shares | 25,000 | |||
Beneficial conversion feature of Advance Notes | 271 | 271 | ||
Convertible note beneficial conversion feature | 1,465 | 1,465 | ||
Stock-based compensation expense | 715 | 715 | ||
Comprehensive loss | (2,176) | (2,176) | ||
Balances at Sep. 30, 2018 | $ 110 | 265,725 | (272,528) | (6,693) |
Balances (in shares) at Sep. 30, 2018 | 109,872,526 | |||
Balances at Dec. 31, 2018 | $ 110 | 266,381 | (274,601) | (8,110) |
Balances (in shares) at Dec. 31, 2018 | 109,872,526 | |||
Issuance of stock options for payment of accrued compensation | 195 | 195 | ||
Issuance of common stock for payment of accrued compensation | 90 | 90 | ||
Issuance of common stock for payment of accrued compensation, shares | 93,358 | |||
Issuance of common stock in exchange for services | 68 | 68 | ||
Issuance of common stock in exchange for services, shares | 82,432 | |||
Beneficial conversion feature of Advance Notes | ||||
Convertible note beneficial conversion feature | 143 | 143 | ||
Issuance of common stock in lieu of cash compensation | 120 | |||
Issuance of common stock upon note conversions | $ 2 | 979 | 981 | |
Issuance of common stock upon note conversions, shares | 2,179,622 | |||
Exercise of common stock options | $ 1 | 324 | $ 325 | |
Exercise of common stock options, shares | 488,625 | 488,625 | ||
Stock-based compensation expense | 1,426 | $ 1,426 | ||
Comprehensive loss | (5,879) | (8,268) | ||
Balances at Sep. 30, 2019 | $ 113 | 270,090 | (282,869) | (12,666) |
Balances (in shares) at Sep. 30, 2019 | 112,780,386 | |||
Balances at Jun. 30, 2019 | $ 113 | 269,606 | (280,480) | (10,761) |
Balances (in shares) at Jun. 30, 2019 | 112,741,563 | |||
Issuance of common stock for payment of accrued compensation | 30 | 30 | ||
Issuance of common stock for payment of accrued compensation, shares | 35,294 | |||
Issuance of common stock in exchange for services | 3 | 3 | ||
Issuance of common stock in exchange for services, shares | 3,529 | |||
Stock-based compensation expense | 451 | 451 | ||
Comprehensive loss | (2,389) | (2,389) | ||
Balances at Sep. 30, 2019 | $ 113 | $ 270,090 | $ (282,869) | $ (12,666) |
Balances (in shares) at Sep. 30, 2019 | 112,780,386 |
Nature of Operations
Nature of Operations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Nature of Operations | 1. Nature of Operations Description of the Business The Company was incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc. Effective August 7, 2017, the Company changed its legal name to Humanigen, Inc. During February 2018, the Company completed the restructuring transactions announced in December 2017 and furthered its transformation into a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies to enhance T-cell engaging therapies for various oncology indications, potentially making these treatments safer, more effective and more efficiently administered. The Company has sharpened its focus to develop novel cell therapies leveraging its understanding of a potentially key pathway which includes its antibody and gene-editing assets. The Company is a clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, human granulocyte-macrophage colony-stimulating factor The Company believes that its GM-CSF neutralization and gene-editing CAR-T platform technologies have the potential to reduce the inflammatory cascade associated with serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. Clinical correlative analysis and pre-clinical in-vivo The Company believes that its GM-CSF pathway science, assets and expertise create two technology platforms to assist in the development of next-generation CAR-T therapies. Lenzilumab, the Company’s proprietary Humaneered® anti-GM-CSF immunotherapy, has the potential to be used in combination with any United States Food and Drug Administration (“FDA”)-approved or development stage T-cell therapies, including CAR-T therapy, as well as in combination with other cell therapies such as allogeneic hematopoietic stem cell transplant (“HSCT”), to make these treatments safer and more effective. In addition, the Company’s GM-CSF knockout gene-editing CAR-T platform has the potential to create next-generation CAR-T therapies that may inherently avoid any efficacy/toxicity linkage, thereby potentially preserving the benefits of the CAR-T therapy while reducing or altogether avoiding its serious and potentially life-threatening side-effects. The Company’s immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, its proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite Pharmaceuticals, Inc., a Gilead company (“Kite”), was recently announced to evaluate the use of lenzilumab with Yescarta®, axicabtagene ciloleucel (“Yescarta” or “ Yescarta®” Lenzilumab Lenzilumab, the Company’s lead product candidate, is a clinical-stage monoclonal antibody (“mAb”) that neutralizes human GM-CSF and has the potential to prevent or reduce certain serious side-effects associated with CAR-T therapy and improve upon the efficacy of CAR-T therapy. Pre-clinical data generated by the Mayo Clinic (the “Mayo Clinic”) in collaboration with the Company, indicates that the use of lenzilumab in combination with CAR-T therapy may also enhance the proliferation and improve the efficacy of the CAR-T therapy. This may also result in durable, or longer term, responses. The Company is continuing to advance the development of lenzilumab in combination with CAR-T therapy through a non-exclusive clinical collaboration with Kite, entered into on May 30, 2019, pursuant to which the Company and Kite will conduct a multi-center Phase 1b/2 study of lenzilumab with Kite’s Yescarta in patients with relapsed or refractory B-cell lymphoma, including diffuse large B-cell lymphoma (“DLBCL”) (the “Study”). The primary objective of the Study is to determine the effect of lenzilumab on the safety of Yescarta. Kite’s Yescarta is one of two CAR-T therapies that have been approved by the FDA, is currently the CAR-T therapy market leader and the Company’s collaboration with Kite is currently the only clinical collaboration with the potential to improve both the safety and efficacy of CAR-T therapy. The Company also plans to measure other potentially beneficial effects on efficacy and healthcare resource utilization. In addition, lenzilumab’s success in preventing serious and potentially life-threatening side-effects could offer economic benefits to medical system payers in the United States and abroad by making the CAR-T therapy capable of being administered, and follow-up care subsequently monitored and managed, potentially on an out-patient basis in certain patients and circumstances. In turn, the Company believes that delivering such provider and payer benefits might accelerate the use of the CAR-T therapy itself, and thereby permit the Company to generate further revenues from sales of lenzilumab. In addition to CAR-T therapy, the Company is committed to advancing its diverse platform for GM-CSF axis suppression for a broad range of other T-cell engaging therapies, including both autologous and allogeneic next generation CAR-T therapies, bi-specific antibody therapies, as well as other cell-based immunotherapies in development, including allogeneic HSCT, with its current and future partners. In July 2019, the Company entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich (“UZH”). Under the Zurich Agreement, the Company has in-licensed certain technologies that it believes may be used to prevent or treat GvHD, thereby expanding its development platform to include improving the safety and effectiveness of allogeneic HSCT, a potentially curative therapy for patients with hematological cancers. There are currently no FDA-approved agents for the prevention of GvHD, nor treatment of GvHD in patients identified as high risk by certain biomarkers. The Company believes that GM-CSF neutralization with lenzilumab has the potential to prevent or treat GvHD without compromising, and potentially improving, the beneficial graft-versus-leukemia (“GvL”) effect in patients undergoing allogeneic HSCT, thereby making allogeneic HSCT safer. The Company aims to position lenzilumab as a “must have” companion product to any allogeneic HSCT and as a part of the standard pre-conditioning that all patients receiving allogeneic HSCT should receive or as an early treatment option in patients identified as high risk for GvHD. Given the Company’s focus on developing lenzilumab in the treatment of rare cancers, the Company believes that it has the opportunity to benefit from various regulatory incentives, such as orphan drug exclusivity, breakthrough therapy designation, fast track designation, priority review and accelerated approval. GM-CSF Gene Knockout The Company is advancing its GM-CSF knockout gene-editing CAR-T platform through an exclusive worldwide license agreement (the “Mayo Agreement”) that it entered into in June 2019 with the Mayo Foundation for Medical Education and Research (“Mayo Foundation”). Under the Mayo Agreement, the Company has in-licensed certain technologies that it believes may be used to create CAR-T cells lacking GM-CSF Preclinical data indicate that GM-CSF gene knockout CAR-T cells show improved overall survival compared to wild type CAR-T cells in addition to the expected benefits of reduced serious side-effects associated with CAR-T therapy. The Company is establishing a platform of next-generation combinatorial gene knockout CAR-T cells that have potential to be applied across both autologous and allogeneic approaches and is also investigating multiple CAR-T cell designs using precise dual and triple gene editing to significantly enhance the anti-tumor activity while simultaneously preventing CAR-T therapy induced toxicities. Through targeted gene expression and modulating cytokine activation signaling, the Company may be able to increase the proportion of younger and fitter T-cells produced during expansion, increase the proliferative potential, and inhibit activation induced cell death, thereby improving the cancer killing activity of its engineered CAR-T cells thereby making them more effective and safer in the treatment of cancers. The Company plans to continue development of this technology in combination approaches that could add to the observed efficacy benefits of current generation CAR-T products. In addition, the Company anticipates that its GM-CSF knockout gene-editing CAR-T platform may be a future backbone for controlling the serious side-effects that hamper CAR-T therapy that lead to serious and sometimes fatal outcomes for patients as a result of the CAR-T therapy itself. EphA3-CAR: Targeting Tumor Stroma and Tumor Vasculature The Company is working to generate its own pipeline of CAR-T therapies including an EphA3-CAR-T based on the ifabotuzumab v-region and backbone. Ifabotuzumab is a Humaneered anti-Eph Type-A receptor 3(“EphA3”) monoclonal antibody. Ifabotuzumab has the potential to kill tumor cells by targeting tumor stroma that protects them and the vasculature that feeds them. This unique combination of activities as a backbone of a CAR-T therapy may provide the potential to generate durable responses in a range of solid tumors by targeting the tissues that surround, protect, and nourish a growing cancer. By developing an EphA3-CAR-T using ifabotuzumab as the backbone, the Company may have the ability to target the tumor, tumor stroma, and tumor vasculature in a novel manner. The Company is collaborating with the Mayo Clinic and plans to move to clinical testing with an anti-EphA3 construct for a range of cancer types after completing Investigational New Drug (“IND”) enabling work. EMR1-CAR: Targeting Eosinophils The Company’s EMR1-CAR-T product is based on the HGEN005 (anti-EMR1 Humaneered monoclonal antibody) backbone and targets the epidermal growth factor-like module containing mucin-like hormone receptor 1 (“EMR1”). The Company’s EMR1-CAR-T based on the HGEN005 backbone is another approach in its growing platform of CAR-T therapies. The Company believes that because of its high selectivity, EMR1-CAR-T has significant potential to treat serious eosinophil diseases. In pre-clinical work, HGEN005’s anti-EMR1 activity resulted in dramatically enhanced killing of eosinophils from normal and eosinophilic donors and also induced a rapid and sustained depletion of eosinophils in a non-human primate model without any clinically significant adverse events. The Company has engaged with National Institutes of Health (“NIH”) to discuss expanding the initial work they have conducted utilizing HGEN005 and discussions are underway with a leading center in the U.S. to perform the IND enabling testing in eosinophilic leukemia, an orphan condition with significant unmet need, as well as several other potential partners, although there is no assurance that the Company will reach any agreements for these next steps. Liquidity and Going Concern The Company has incurred significant losses since its inception in March 2000 and had an accumulated deficit of $ 282.9 9.7 The Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2019 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The ability of the Company to meet its total liabilities of $ 13. Basis of Presentation The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results of operations and cash flows for the periods presented. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The December 31, 2018 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2019, or for any other future annual or interim period. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s 2018 Form 10-K. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in determining the valuation of the fair value-based measurement of stock-based compensation, accruals and warrant valuations. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements. | 1. Organization and Description of Business Description of the Business The Company was incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc. Effective August 7, 2017, the Company changed its legal name to Humanigen, Inc. During February 2018, the Company completed the restructuring transactions announced in December 2017 and furthered its transformation into a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for various oncology indications and to enhance T-cell therapies, potentially making these treatments safer, more effective and more efficiently administered. The Company’s primary focus is on preventing the serious and potentially life-threatening side-effects associated with chimeric antigen receptor T-cell, also known as CAR-T, therapy, and in making those therapies more effective, efficient and cost-effective. Identifying, treating and managing severe side-effects consumes significant hospital resources and additional costs that we believe have impeded the pace of adoption of these promising and highly effective treatments as the standard of care for certain hematologic cancers. The side effects may also hamper the expansion of CAR-T to earlier line use beyond the relapsed or refractory setting in hematologic cancers and the utility of CAR-T in solid tumors, both of which represent significant growth drivers for the overall CAR-T marketplace. Lenzilumab, the Company’s lead product candidate, is a novel Humaneered ® The Company continues to advance the development of lenzilumab through clinical trials that it expects will serve as the basis for registration in close collaboration with some of the leading and most experienced centers in the CAR-T field. The Company is also exploring partnerships with established CAR-T companies, who may have strong vested interest in the development and commercialization of lenzilumab. By succeeding in its efforts to develop lenzilumab, the Company aims to position lenzilumab as an essential companion product to any CAR-T therapy and a necessary part of the standard pre-conditioning drug regimen that all patients receiving CAR-T currently receive, which includes cyclophosphamide and fludarabine. In addition, lenzilumab’s success in preventing serious, potentially life-threatening side-effects will lead to substantial reductions in hospital in-patient and intensive care unit (ICU) admissions and duration of ICU stays. Use of lenzilumab alongside CAR-T therapy could result in potential efficacy improvements which could offer significant economic benefits to the healthcare system as a whole, including for hospitals, providers, patients and payers in the United States and abroad. These benefits, coupled with the potential to make CAR-T therapy capable of being administered on an out-patient basis, with follow-up care also monitored and managed in an out-patient setting, may improve access to and reimbursement of CAR-T therapy and would be expected to substantially improve, further expanding CAR-T uptake and utilization. In turn, the Company believes that delivering such payer benefits will also accelerate the use of lenzilumab, permitting us to generate further revenues from lenzilumab. The Company also believes it has the opportunity to benefit from various FDA regulatory incentives, such as orphan drug exclusivity, breakthrough therapy designation, fast track designation and accelerated approval. Lenzilumab is a recombinant monoclonal antibody (mAb) that neutralizes soluble granulocyte-macrophage colony-stimulating factor (GM-CSF) a critical cytokine in the inflammatory cascade associated with serious and potentially life-threatening CAR-T-related side effects and in the growth of certain hematologic malignancies, solid tumors and other serious conditions. There is extensive evidence linking GM-CSF expression to serious and potentially life-threatening side-effects in CAR-T therapy. The Company’s focus for lenzilumab development is investigating its potential to improve efficacy of CAR-T and to prevent or ameliorate CAR-T-related NT and CRS. Following CAR-T administration GM-CSF initiates a signaling cascade of inflammation that results in the trafficking and recruitment of myeloid cells to the tumor site. These myeloid cells then produce key downstream cytokines known to be associated with development of NT and CRS, perpetuating the inflammatory cascade. Peer-reviewed publications in leading journals by well-recognized experts have shown that GM-CSF is a biomarker present in patients who suffer serious NT as a side-effect of CAR-T therapy. Pre-clinical work has demonstrated lenzilumab’s effectiveness in preventing or ameliorating NT and CRS associated with CAR-T therapy. Pre-clinical animal data also shows that there may be an increase in CAR-T cell expansion when CAR-T is combined with lenzilumab, which potentially could translate into improved CAR-T efficacy. In addition, the Company has completed enrollment of patients in a Phase I clinical trial for chronic myelomonocytic leukemia (CMML), to identify the recommended Phase II dose (RPTD) of lenzilumab and to assess lenzilumab’s safety, pharmacokinetics, and other measures. Fifteen patients in the 200, 400 and 600 mg dose cohorts of the CMML trial have been enrolled and the trial is fully enrolled. Ifabotuzumab is an anti-Eph Type-A receptor 3 (EphA3) mAb that has the potential to offer a novel approach to treating solid tumors, hematologic malignancies and serious pulmonary conditions. Anti-EphA3 as a CAR construct may also be useful in the treatment of a range of cancers. EphA3 is aberrantly expressed on the surface of tumor cells and stroma cells in certain cancers. The Company has completed the Phase I dose escalation portion of a Phase I/II clinical trial in ifabotuzumab in multiple hematologic malignancies for which the preliminary results were published in the journal Leukemia Research HGEN005 is a pre-clinical stage anti-human epidermal growth factor-like module containing mucin-like hormone receptor 1 (EMR1) mAb. EMR1 is a therapeutic target for eosinophilic disorders. Eosinophils are a type of white blood cell. If too many are produced in the body, chronic inflammation and tissue and organ damage may result. Analysis of blood and bone marrow shows that surface expression of EMR1 is restricted to mature eosinophils and correlated with eosinophilia. Tissue eosinophils also express EMR1. In pre-clinical work, the Company has demonstrated that eosinophil killing is enhanced in the presence of HGEN005 and immune effector cells. A major limitation of current eosinophil targeted therapies is incomplete depletion of tissue eosinophils and/or lack of cell selectivity, which may mean that HGEN005 could offer promise in a range of eosinophil-driven diseases, such as eosinophilic asthma, eosinophilic esophagitis and eosinophilic granulomatosis with polyangiitis. The Company is considering developing a series of CAR constructs based on HGEN005 and may take or partner these constructs, if developed, into pre-clinical testing. The Company’s monoclonal antibody portfolio was developed with its proprietary, patent-protected Humaneered ® Liquidity and Going Concern The Company has incurred significant losses since its inception in March 2000 and had an accumulated deficit of $274.6 million as of December 31, 2018. At December 31, 2018, the Company had a working capital deficit of $7.0 million. On February 27, 2018, the Company issued 91,815,517 shares of common stock in exchange for the extinguishment of all term loans, related fees and accrued interest and received $1.5 million in cash proceeds. See Note 10 for a more detailed discussion of these restructuring transactions. On March 12, 2018, the Company issued 2,445,557 shares of common stock for proceeds of $1.1 million to accredited investors. On June 4, 2018, the Company issued 400,000 shares of common stock for proceeds of $0.2 million to an accredited investor. In June, July and August of 2018, the Company received aggregate proceeds of $0.9 million from advances made to the Company (the “Advance Notes”) by four different lenders including Dr. Cameron Durrant, the Company’s Chairman and Chief Executive Officer; Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder; and Ronald Barliant, a director of the Company. Commencing September 19, 2018, the Company delivered a series of convertible promissory notes (the “Notes”) evidencing an aggregate of $2.5 million of loans made to the Company by six different lenders, including an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder. See Note 7 for further description of the Advance Notes and the Notes. To date, none of the Company’s product candidates has been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses to continue for the foreseeable future. The Company will require additional financing in order to meet its anticipated cash flow needs during the next twelve months. As a result, the Company will continue to require additional capital through equity offerings, debt financing and/or payments under new or existing licensing or collaboration agreements. If sufficient funds are not available on acceptable terms when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, could materially harm its business, financial condition and results of operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Condensed Consolidated Financial Statements for the twelve months ended December 31, 2018 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The ability of the Company to meet its total liabilities of $9.5 million at December 31, 2018 and to continue as a going concern is dependent upon the availability of future funding. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. |
Chapter 11 Filing
Chapter 11 Filing | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Financial Statement Presentation While in Chapter 11 [Abstract] | ||
Chapter 11 Filing | 2. Chapter 11 Filing On December 29, 2015, the Company filed a voluntary petition for bankruptcy protection under Chapter 11 of the U.S. Bankruptcy Code. The filing was made in the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) (Case No. 15-12628 (LSS) (the “Bankruptcy Case”). The Company’s Plan of Reorganization filed with the Bankruptcy Court (the “Plan”) became effective June 30, 2016 and the Company emerged from its Chapter 11 bankruptcy proceedings. The reconciliation of certain proofs of claim filed against the Company in the Bankruptcy Case, including certain General Unsecured Claims, Convenience Class Claims and Other Subordinated Claims, is complete. As a result of its examination of the claims, the Company asked the Bankruptcy Court to disallow, reduce, reclassify, subordinate or otherwise adjudicate certain claims the Company believes are subject to objection or otherwise improper. On July 11, 2018, the Company filed an objection to the remaining claims. By objection, the Company sought to disallow in their entirety the remaining claims totaling approximately $0.5 million. On September 17, 2018 the Bankruptcy Court issued a Final Decree and Order to close the Bankruptcy Case and terminate the remaining claims and noticing services. For the three and nine months ended September 30, 2019 and 2018, Reorganization items, net consisted of the following charges related to the bankruptcy proceedings: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Legal fees $ - $ 32 $ - $ 85 Professional fees - 8 - 21 Total reorganization items, net $ - $ 40 $ - $ 106 There were no cash payments for reorganization for the three and nine months ended September 30, 2019. Cash payments for reorganization items totaled $0.1 million and $0.2 million for the three and nine months ended September 30, 2018, respectively. | 2. Chapter 11 Filing On December 29, 2015, the Company filed a voluntary petition for bankruptcy protection under Chapter 11 of the U.S. Bankruptcy Code. The filing was made in the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) (Case No. 15-12628 (LSS) (the “Bankruptcy Case”). Plan of Reorganization On May 9, 2016, the Company filed with the Bankruptcy Court a Plan of Reorganization and related amended disclosure statement (the “Plan”) pursuant to Chapter 11 of the Bankruptcy Code. On June 16, 2016, the Bankruptcy Court entered an order confirming the Plan. The Plan became effective on June 30, 2016 (the “Effective Date”) and the Company emerged from its Chapter 11 bankruptcy proceedings. Bankruptcy Claims Administration The reconciliation of certain proofs of claim filed against the Company in the Bankruptcy Case, including certain General Unsecured Claims, Convenience Class Claims and Other Subordinated Claims, is complete. As a result of its examination of the claims, the Company asked the Bankruptcy Court to disallow, reduce, reclassify, subordinate or otherwise adjudicate certain claims the Company believes are subject to objection or otherwise improper. On July 11, 2018, the Company filed an objection to the remaining claims. By objection, the Company sought to disallow in their entirety the remaining claims totaling approximately $0.5 million. On September 17, 2018 the Bankruptcy Court issued a Final Decree and Order to close the Bankruptcy Case and terminate the remaining claims and noticing services. Financial Reporting in Reorganization The Company applied Financial Accounting Standards Board (FASB) Accounting Standards Codification (“ASC”) 852, Reorganizations For the twelve months ended December 31, 2017, the Company wrote off approximately $0.2 million in claims that had been reduced or for which a settlement had been reached at a lower amount than had been previously accrued. Remaining amounts were paid based on terms of the Plan. For the years ended December 31, 2018 and 2017, Reorganization items, net consisted of the following charges: Year ended December 31, 2018 2017 Legal fees $ 119 $ 297 Professional fees 26 34 Total reorganization items, net $ 145 $ 331 Cash payments for reorganization items totaled $0.2 million and $0.9 million for the years ended December 31, 2018 and 2017, respectively. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies since those previously disclosed in the 2018 Form 10-K. In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-18 requires the inclusion of restricted cash with cash and cash equivalents when reconciling the beginning-of-the period and end-of-period total amounts shown on the statement of cash flows. The Company adopted the standard effective January 1, 2018. As a result of the adoption, the Company will no longer present the change within restricted cash in the consolidated statements of cash flows. See below for the composition of cash, cash equivalents and restricted cash shown on the statements of cash flow: September 30, 2019 2018 Cash and cash equivalents $ 157 $ 2,038 Restricted cash 71 71 Total cash, cash equivalents and restricted cash as shown on statement of cash flows $ 228 $ 2,109 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The FASB subsequently issued ASU No. 2018-10 and 2018-11 in July 2018, which provide clarifications and improvements to ASU 2016-02 (collectively, the “new lease standard”). ASU No. 2018-11 provides the optional transition method which allows companies to apply the new lease standard at the adoption date instead of at the earliest comparative period presented and continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. The new lease standard requires lessees to present a right-of-use asset and a corresponding lease liability on the balance sheet. Additional footnote disclosures related to leases is also required. On January 1, 2019, the Company adopted the new lease standard using the optional transition method and certain other practical expedients. Under the practical expedient package elected, the Company is not required to reassess whether expired or existing contracts are or contain a lease; and is not required to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases. The new lease standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right of use assets or lease liabilities, and this includes not recognizing right of use assets or lease liabilities for existing short-term leases of those assets in transition. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets. See Note 4 for a description of the Company’s current leases and their treatment under the new lease standard. | 3. Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all adjustments necessary for the presentation of the Company’s consolidated financial position, results of operations and cash flows for the periods presented. The Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the fair value-based measurement of stock-based compensation, accruals, liabilities subject to compromise, convertible notes and warrants. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Consolidated Financial Statements. Concentration of Credit Risk Cash, cash equivalents, and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk in the event of a default by the related financial institution holding the securities, to the extent of the value recorded in the balance sheet. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments with lower credit risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. Fair Value of Financial Instruments The fair value of financial instruments reflects the amounts that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable, and the third is considered unobservable, as follows: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 2—Inputs other than those included in Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets (marketable securities) that are measured at fair value, and the classification by level of input within the fair value hierarchy: Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 Fair Value Measurements as of December 31, 2017 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 101 $ — $ — $ 101 Total assets measured at fair value $ 101 $ — — $ 101 The estimated fair value of the Term Loans payable, Notes payable to vendors, Advance notes and Convertible notes as of December 31, 2018 and 2017, based upon current market rates for similar borrowings, as measured using Level 3 inputs, approximate the carrying amounts as presented in the Consolidated Balance Sheets. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing and demand money market accounts. Restricted Cash Restricted cash at December 31, 2018 of $0.07 million related to a standby letters of credit in the amount of $0.05 million issued in connection with certain insurance policy coverage maintained by the Company and restricted cash related to a credit card facility in the amount of $0.02 million. Restricted cash at December 31, 2017 of $0.1 million related to a standby letters of credit in the amount of $0.05 million issued in connection with certain insurance policy coverage maintained by the Company and restricted cash related to a credit card facility in the amount of $0.05 million. Property and Equipment, Net Property and equipment is stated at cost, less accumulated depreciation and amortization, and depreciated over the estimated useful lives of the respective assets of three years using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the useful lives or the non-cancelable term of the related lease. Maintenance and repair costs are charged as expense in the Statements of Operations and Comprehensive Loss as incurred. Long-Lived Assets The Company evaluates the carrying value of its long-lived assets, including intangible assets, whenever events or changes in circumstances indicate that the carrying value of the asset may be impaired. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset, including disposition, are less than the carrying value of the asset. To date, the Company has not recorded any impairment charges on its long-lived assets. Debt Issue Costs Debt issuance costs related to a recognized debt liability are presented on the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts and are amortized to interest expense over the term of the related debt on the effective interest method. Research and Development Expenses Development costs incurred in the research and development of new product candidates are expensed as incurred, including expenses that may or may not be reimbursed under research and development collaboration arrangements. Research and development costs include, but are not limited to, salaries, benefits, stock-based compensation, laboratory supplies, allocated overhead, fees for professional service providers and costs associated with product development efforts, including preclinical studies and clinical trials. The Company estimates pre-clinical study and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. The Company records upfront and milestone payments made to third parties under licensing arrangements as an expense. Upfront payments are recorded when incurred and milestone payments are recorded when the specific milestone has been achieved. Research and Development Services Internal and external research and development costs incurred in connection with collaboration agreements are recognized as revenue in the same period as the costs are incurred and are presented on a gross basis when the Company acts as a principal, has the discretion to choose suppliers, bears credit risk, and performs at least part of the services. Revenue Recognition The Company’s revenue to date has been generated primarily through license agreements and research and development collaboration agreements. The Company had no revenues for the years ending December 31, 2017 and 2018. Commencing January 1, 2018, the Company recognizes revenue in accordance with ASC 606. The core principle of ASC 606 is that an entity should recognize revenue to depict the transfer of promised goods and/or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and/or services. To determine the appropriate amount of revenue to be recognized for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following steps: (i) identify the contract(s) with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) each performance obligation is satisfied. Revenue under technology licenses and collaborative agreements typically consists of nonrefundable and/or guaranteed license fees, collaborative research funding, and various milestone and future product royalty or profit-sharing payments. These agreements are generally referred to as “multiple element arrangements”. The Company applies the accounting standard on revenue recognition for multiple element arrangements. The fair value of deliverables under the arrangement may be derived using a best estimate of selling price if vendor specific objective evidence and third-party evidence is not available. Deliverables under the arrangement will be separate units of accounting if a delivered item has value to the customer on a standalone basis and if the arrangement includes a general right of return for the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the Company’s control. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license has standalone value from any undelivered performance obligations and that value can be determined. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the fair value of the undelivered performance obligations can be determined, then these obligations would be accounted for separately. If the license is not considered to have standalone value, then the license and other undelivered performance obligations would be accounted for as a single unit of accounting. In this case, the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed or deferred indefinitely until the undelivered performance obligation is determined. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized. Revenue is recognized using a proportional performance or straight-line method. The proportional performance method is used when the level of effort required to complete performance obligations under an arrangement can be reasonably estimated. The amount of revenue recognized under the proportional performance method is determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of milestones, by the ratio of the level of effort performed to date to the estimated total level of effort required to complete performance obligations under the arrangement. If the Company cannot reasonably estimate the level of effort to complete performance obligations under an arrangement, the Company recognizes revenue under the arrangement on a straight-line basis over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. The Company’s collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales performance-based milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company’s revenue calculation. Typically, these milestones are not considered probable at the inception of the collaboration. As such, milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is achieved during the performance period, then the Company will only recognize revenue to the extent of the proportional performance achieved at that date, or the proportion of the straight-line basis achieved at that date, and the remainder will be recorded as deferred revenue to be amortized over the remaining performance period. If the milestone is achieved after the performance period has completed and all performance obligations have been delivered, then the Company will recognize the milestone payment as Revenue in its entirety in the period the milestone was achieved. Stock-Based Compensation Expense The Company measures employee and director stock-based compensation expense for stock awards at the grant date, based on the fair value-based measurement of the award, and the expense is recorded over the related service period, generally the vesting period, net of estimated forfeitures. The Company calculates the fair value-based measurement of stock options using the Black-Scholes valuation model and the single-option method and recognizes expense using the straight-line attribution approach. The Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC 505, Equity Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock.. Income Taxes The Company accounts for income taxes under an asset-and-liability approach. Deferred income taxes reflect the impact of temporary differences between assets and liabilities recognized for tax and financial reporting purposes measured by applying enacted tax rates and laws that will be in effect when the differences are expected to reverse, net operating loss carryforwards and tax credits. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is more likely than not to be realized. The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for income taxes. Comprehensive Loss Comprehensive loss represents net loss adjusted for the change during the periods presented in unrealized gains and losses on available-for-sale securities less reclassification adjustments for realized gains or losses included in net loss. The unrealized gains or losses are reported on the Consolidated Statements of Operations and Comprehensive Loss. Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, stock options, restricted stock units and common stock warrants are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The Company’s potential dilutive securities, which include stock options, restricted stock units and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per common share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented. The following shares subject to outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share as the effect of including such securities would be antidilutive: Year Ended December 31, 2018 2017 Options to purchase common stock 15,409,357 2,448,383 Warrants to purchase common stock 331,193 331,193 15,740,550 2,779,576 Segment Reporting The Company determines its segment reporting based upon the way the business is organized for making operating decisions and assessing performance. The Company operates in only one segment, which is related to the development of pharmaceutical products. Recent Accounting Pronouncements Until December 31, 2018, the Company qualified as an “emerging growth company” (“EGC”) pursuant to the provisions of the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and elected to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act which permits EGCs to defer compliance with new or revised accounting standards until non-issuers are required to comply with such standards. A registrant with EGC status loses its eligibility as an EGC five years after its common equity initial public offering, December 31, 2018 for the Company. Accordingly, the Company is required to adopt new accounting standards on the same timeline as other public companies effective January 1, 2018. In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, "Revenue from Contracts with Customers (Topic 606)." ASU 2014-09 completes the joint effort by the FASB and International Accounting Standards Board to improve financial reporting by creating common revenue recognition guidance for U.S. GAAP and International Financial Reporting Standards. ASU 2014-09 applies to all companies that enter into contracts with customers to transfer goods or services. The Company adopted the standard effective January 1, 2018. As the Company had no revenues in 2017 or 2018, ASU 2014-09 had no material impact upon adoption. On January 1, 2018, the Company adopted ASU 2016-09, “Stock Compensation – Improvements to Employee Share-Based Payment Accounting”. This new accounting standard simplifies accounting for share-based payment transactions, including income tax consequences and the classification of the tax impact on the statement of cash flows. ASU 2016-09 had no material impact upon adoption. In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-18 requires the inclusion of restricted cash with cash and cash equivalents when reconciling the beginning-of-the period and end-of-period total amounts shown on the statement of cash flows. The Company adopted the standard effective January 1, 2018. As a result of the adoption, the Company will no longer present the change within restricted cash in the consolidated statements of cash flows. See below for the composition of cash, cash equivalents and restricted cash shown on the statements of cash flow: Twelve Months Ended 2018 2017 Cash and cash equivalents $ 814 $ 737 Restricted cash 71 101 Total cash, cash equivalents and restricted cash as shown on statement of cash flows $ 885 $ 838 In July 2017, the FASB issued ASU No. 2017-11, “Earnings Per Share (Topic 260), Distinguishing Equity from Liabilities (Topic 480) and Derivatives and Hedging (Topic 815)”, which addresses the complexity of accounting for certain financial instruments with down round features and finalizes pending guidance related to mandatorily redeemable noncontrolling interests. Under ASU 2017-11, when determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. ASU 2017-11 becomes effective for annual reporting periods beginning after December 15, 2018, including interim periods thereafter; early adoption is permitted, including adoption in an interim period. The Company early adopted this standard utilizing the modified retrospective method. Since the Company didn’t have any financial instruments with a down round feature as of January 1, 2018, the beginning of the year of adoption, the adoption of this standard did not have an impact on the Company’s consolidated financial statements and related disclosures. In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”, which requires lessees to recognize on the balance sheet a right-of use asset, representing its right to use the underlying asset for the lease term, and a lease liability for all leases with terms greater than 12 months. The guidance also requires qualitative and quantitative disclosures designed to assess the amount, timing, and uncertainty of cash flows arising from leases. The standard requires the use of a modified retrospective transition approach, which includes a number of optional practical expedients that entities may elect to apply. The Company will be required to comply with the guidance for annual reporting periods beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2018. Early application is permitted. The Company is currently evaluating the requirements of ASU 2016-02 and has not yet determined its impact on the consolidated financial statements and related disclosures. In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting”. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees and is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The Company does not expect the adoption of ASU 2018-07 to have a material impact on it’s consolidated financial statements and related disclosures. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606”. ASU 2018-18 makes targeted improvements for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in Topic 808 was aligned with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The amendments in this Update should be applied retrospectively to the date of initial application of Topic 606. The Company is currently evaluating the requirements of ASU 2018-18 and has not yet determined its impact on the Company’s consolidated financial statements and related disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s consolidated financial statement presentation or disclosures. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 4. Leases The Company leases an office-space under a month-to-month lease for $1,000 per month. Management has determined the lease term to be less than 12 months, including renewals, and therefore has not recorded a right-of-use asset and corresponding liability under the short-term lease recognition exemption. Lease costs for the three and nine months ended September 30, 2019 totaled approximately $3,400 and $9,800, respectively and are included in the Consolidated Statements of Operations and Comprehensive Loss. As described in Note 3, the Company has elected to adopt the transitional practical expedients, and was not required to reassess whether any existing or expired contracts contained embedded leases. The Company has not entered into any contracts during the 2019 fiscal year that contain an embedded lease. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 4. Investments At December 31, 2018, the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows: Gross Gross Amortized Unrealized Unrealized Cost Gains Losses Fair Value Money market funds $ 71 $ — $ — $ 71 Total investments $ 71 $ — $ — $ 71 Reported as: Cash and cash equivalents $ — Restricted cash 71 Total investments $ 71 At December 31, 2017 the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows: Gross Gross Amortized Unrealized Unrealized Cost Gains Losses Fair Value Money market funds $ 101 $ — $ — $ 101 Total investments $ 101 $ — $ — $ 101 Reported as: Cash and cash equivalents $ - Restricted cash, long-term 101 Total investments $ 101 |
Potentially Dilutive Securities
Potentially Dilutive Securities | 9 Months Ended |
Sep. 30, 2019 | |
Potentially Dilutive Securities | |
Potentially Dilutive Securities | 5. Potentially Dilutive Securities The Company’s potentially dilutive securities, which include stock options, restricted stock units and warrants, have been excluded from the computation of diluted net loss per common share as the effect of including those securities would be to reduce the net loss per common share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in each period presented. The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share: As of September 30, 2019 2018 Options to purchase common stock 15,139,374 15,551,023 Warrants to purchase common stock 331,193 331,193 15,470,567 15,882,216 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment consists of the following: December 31, 2018 2017 Computer equipment and software $ 216 $ 216 Accumulated depreciation and amortization (216 ) (197 ) Property and equipment, net $ - $ 19 Depreciation and amortization expense for the years ended December 31, 2018 and December 31, 2017 was $0.02 million and $0.05 million, respectively. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 6. Fair Value of Financial Instruments Cash, accounts payable and accrued liabilities are carried at cost, which approximates fair value given their short-term nature. Marketable securities and cash equivalents are carried at fair value. The Company has money market funds of approximately $71,000 at September 30, 2019 and December 31, 2018 that are reported as restricted cash on the balance sheet. The amortized cost of these funds equals their fair value as there were no unrealized gains or losses at September 30, 2019 or December 31, 2018. The fair value of financial instruments reflects the amounts that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable, and the third is considered unobservable, as follows: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs other than those included in Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy: Fair Value Measurements as of September 30, 2019 (in thousands) Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — $ — $ 71 Fair Value Measurements as of December 31, 2018 (in thousands) Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — $ — $ 71 |
Debt
Debt | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Disclosure Text Block [Abstract] | ||
Debt | 7. Debt Notes Payable to Vendors On June 30, 2016, the Company issued promissory notes in an aggregate principal amount of approximately $1.2 million to certain claimants in accordance with the Plan. The notes are unsecured, bear interest at 10% per annum and became due and payable in full, including principal and accrued interest on June 30, 2019. In July and August, 2019, following the receipt of proceeds from the 2019 Bridge Notes, the Company used approximately $0.5 million of the proceeds to retire a portion of these notes, including accrued interest. After giving effect to these payments, the aggregate principal amount and accrued but unpaid interest on these notes approximates $1.1 million as of September 30, 2019. As of September 30, 2019 and December 31, 2018, the Company has accrued $0.4 million and $0.3 million in interest related to these promissory notes, respectively. The outstanding principal amount and accrued but unpaid interest on these notes is currently payable to the respective holders without demand, notice or declaration, and the holders, without demand or notice of any kind, may exercise any and all other rights and remedies available to them under the notes, the Plan, at law or in equity. We do not have sufficient funds to repay the principal and accrued but unpaid interest on these notes in their entirety. See Part II, Item 1A. “Risk Factors” for more information. Advance Notes In June, July and August, 2018 the Company received an aggregate of $0.9 million of proceeds from advances made to the Company (the “Advance Notes”) by four different lenders including Dr. Cameron Durrant, the Company’s Chairman and Chief Executive Officer; Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder; and Ronald Barliant, a director of the Company (collectively the “Lenders”). The Advance Notes accrued interest at a rate of 7% per year, compounded annually. In accordance with their terms, on May 30, 2019, in connection with the Company’s announcement of the Collaboration Agreement with Kite, the lenders converted the amounts due under the Advance Notes into the Company’s common stock at the conversion price of $0.45 per share. The Company issued a total of 2,179,622 shares of common stock in connection with the conversion. 2018 Convertible Notes Commencing September 19, 2018, the Company delivered a series of convertible promissory notes (the “2018 Notes”) evidencing an aggregate of $2.5 million of loans made to the Company by six different lenders, including an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder. The 2018 Notes bear interest at a rate of 7% per annum and will mature on the earliest of (i) twenty-four months from the date the 2018 Notes were signed, (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company used the proceeds from the 2018 Notes for working capital. The 2018 Notes are convertible into equity securities in the Company in three different scenarios: If the Company sells its equity securities on or before the date of repayment of the 2018 Notes in any financing transaction that results in gross proceeds to the Company of at least $10 million (a “Qualified Financing”), the 2018 Notes will be converted into either (i) such equity securities as the noteholder would acquire if the principal and accrued but unpaid interest thereon (the “Conversion Amount”) were invested directly in the financing on the same terms and conditions as given to the financing investors in the Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes). If the Company sells its equity securities on or before the date of repayment of the 2018 Notes in any financing transaction that results in gross proceeds to the Company of less than $10 million (a “Non-Qualified Financing”), the noteholders may convert their remaining 2018 Notes into either (i) such equity securities as the noteholder would acquire if the Conversion Amount were invested directly in the financing on the same terms and conditions as given to the financing investors in the Non-Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes). The 2018 Notes may convert in the event the Company enters into or publicly announces its intention to consummate a Liquidation Event. Immediately prior to the completion of any such Liquidation Event, in lieu of receiving payment in cash, noteholders may convert the Conversion Amount into common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes). 2019 Convertible Notes Commencing on April 23, 2019, the Company delivered a series of convertible promissory notes (the “2019 Notes”) evidencing an aggregate of $1.3 million of loans made to the Company. The 2019 Notes bear interest at a rate of 7.5% per annum and will mature on the earliest of (i) twenty-four months from the date the 2019 Notes are signed (the “Stated Maturity Date”), (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company used the proceeds from the 2019 Notes for working capital. The 2019 Notes are convertible into equity securities in the Company in four different scenarios: If the Company sells its equity securities on or before the Stated Maturity Date in any financing transaction that results in gross proceeds to the Company of at least $10.0 million (a “Qualified Financing”) or the Company consummates a reverse merger or similar transaction, the 2019 Notes will be converted into either (i) (a) in the case of a Qualified Financing, such equity securities as the noteholder would acquire if the principal and accrued but unpaid interest thereon together with such additional amount of interest as would have been paid on the 2019 Notes if held to the Stated Maturity Date (the “Conversion Amount”) were invested directly in the financing on the same terms and conditions (including price) as given to the financing investors in the Qualified Financing or (b) in the case of a reverse merger, common stock at the same price per share paid by the buyer in such transaction (which in a stock for stock transaction, shall be based on the price per share used by the parties for purposes of setting the applicable exchange ration), or (ii) common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes). If the Company sells its equity securities on or before the date of repayment of the 2019 Notes in any financing transaction that results in gross proceeds to the Company of less than $ 10.0 million (a “Non-Qualified Financing”), the noteholders may convert their remaining Convertible Notes into either (i) such equity securities as the noteholder would acquire if the Conversion Amount were invested directly in the financing on the same terms and conditions (including price) as given to the financing investors in the Non-Qualified Financing, or (ii) common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes). The 2019 Notes may convert in the event the Company enters into or publicly announces its intention to consummate a Liquidation Event. Immediately prior to the completion of any such Liquidation Event, in lieu of receiving payment in cash, noteholders may convert the Conversion Amount into common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes). In addition, upon the six-month anniversary of the date the 2019 Notes are signed or such earlier time as the Company publicly announces that it has entered into a definitive arrangement with an unaffiliated third party (a “Strategic Partner”) pursuant to which, among other things, such Strategic Partner may agree to collaborate with the Company in conducting a clinical study to assess the efficacy of the Company’s lenzilumab monoclonal antibody in reducing adverse effects from neurotoxicity and cytokine release syndrome when used as a companion therapy in certain CAR-T cell therapies, noteholders may convert any portion of the outstanding principal amount of the 2019 Notes, together with (a) any unpaid and accrued interest on such principal amount to the date the noteholder’s notice of the noteholder’s intention to convert is received by the Company (the “Notice Date”), and (b) such additional amount of interest as would have been paid on such principal amount from the Notice Date to the Stated Maturity Date, into common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes). The Company’s announcement of the Collaboration Agreement with Kite satisfied this requirement and accordingly, the 2019 Notes are convertible into common stock on the above terms. The Advance Notes, the 2018 Notes and the 2019 Notes have an optional voluntary conversion feature in which the holder could convert the notes in the Company’s common stock at maturity at a conversion rate of $0.45 per share for the Advance Notes and the 2018 Notes and at a conversion rate of $1.25 for the 2019 Notes. The intrinsic value of this beneficial conversion feature was $1.8 million upon the issuance of the Advance Notes, the 2018 Notes and the 2019 Notes and was recorded as additional paid-in capital and as a debt discount which is accreted to interest expense over the term of the Advance Notes and Notes. Interest expense includes debt discount amortization of $0.2 million and $0.6 million for the three and nine month periods ended September 30, 2019. The Company evaluated the embedded features within the Advance Notes, the 2018 Notes and the 2019 Notes to determine if the embedded features are required to be bifurcated and recognized as derivative instruments. The Company determined that the Advance Notes, the 2018 Notes and the 2019 Notes contain contingent beneficial conversion features (“CBCF”) that allow or require the holder to convert the Advance Notes, the 2018 Notes and the 2019 Notes, as applicable, to Company common stock at a conversion rate of $0.45 per share for the Advance Notes and the 2018 Notes and $1.25 for the 2019 Notes, but did not contain embedded features requiring bifurcation and recognition as derivative instruments. Upon the occurrence of a CBCF that results in conversion of the Advance Notes, the 2018 Notes or the 2019 Notes to Company common stock, the remaining unamortized discount will be charged to interest expense. Upon conversion of the Advance Notes on May 30, 2019, the remaining unamortized discount was charged to interest expense. The remaining debt discount will be amortized over 12 and 19 months for the 2018 Notes and the 2019 Notes, respectively. 2019 Bridge Notes On June 28, 2019, the Company issued three short-term, secured bridge notes (the “2019 Bridge Notes”) evidencing an aggregate of $1.7 million of loans made to the Company by three parties: Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder, lent $750,000; Nomis Bay LTD, the Company’s second largest stockholder, lent $750,000; and Cameron Durrant, M.D., MBA, the Company’s Chief Executive Officer and Chairman of the Board of Directors, lent $200,000. The proceeds from the 2019 Bridge Notes were used to satisfy a portion of the unsecured obligations incurred in connection with the Company’s emergence from bankruptcy in 2016 and for working capital and general corporate purposes. Of the $1.7 million in proceeds received, $950,000 was received on June 28, 2019 and was recorded as Advance notes in the Condensed Consolidated Balance Sheet as of June 30, 2019. The remaining proceeds of $750,000 were received July 1, 2019 and recorded accordingly. The 2019 Bridge Notes bear interest at a rate of 7.0% per annum and had an original maturity date of October 1, 2019. On October 8, 2019, the Company and the lenders agreed to extend the maturity date of the 2019 Bridge Notes from October 1, 2019 until December 31, 2019 and to waive any prior default up to and including the date of the amendment. No other changes to the terms of the 2019 Bridge Notes were made in connection with the extension of the maturity date. The 2019 Bridge Notes may become due and payable at such earlier time as the Company raises more than $3,000,000 in a bona fide financing transaction or upon a change in control. The 2019 Bridge Notes are secured by liens of substantially all of the Company’s assets. Upon an event of default, which events include, but are not limited to, (1) the Company failing to timely pay any monetary obligation under the 2019 Bridge Notes; (2) the Company failing to pay its debts generally as they become due and (3) the Company commencing any proceeding relating to the Company under any bankruptcy reorganization, arrangement, insolvency, readjustment of debt, dissolution or liquidation or similar laws of any jurisdiction now or hereafter in effect, the interest payable on the 2019 Bridge Notes increases to 10.0% per annum. Further, upon certain events of default, all payments and obligations due and owed under the 2019 Bridge Notes shall immediately become due and payable without demand and without notice to the Company. | 7. Debt Notes Payable to Vendors On June 30, 2016, the Company issued promissory notes in an aggregate principal amount of approximately $1.2 million to certain claimants in accordance with the Plan. The notes are unsecured, bear interest at 10% per annum and are due and payable in full, including principal and accrued interest on June 30, 2019. As of December 31, 2018 and 2017, the Company has accrued $0.3 million and $0.2 million in interest related to these promissory notes, respectively. Term Loans Term Loans consisted of the following at December 31, 2017: Original Principal Amount Accrued Interest Loan Balance Fees Balance Due December 2016 Loan $ 3,315 $ 324 $ 3,639 $ 153 $ 3,792 March 2017 Loan 5,978 452 6,430 275 6,705 July 2017 Loan 5,435 249 5,684 250 5,934 Bridge Loan 1,500 6 1,506 - 1,506 Claims Advances Loan 80 1 81 - 81 Totals $ 16,308 $ 1,032 $ 17,340 $ 678 $ 18,018 On December 21, 2016, the Company entered into a Credit and Security Agreement, as amended on March 21, 2017 and on July 8, 2017 (as amended, the “Credit Agreement”), with Black Horse Capital Master Fund Ltd. (“BHCMF”) as administrative agent and lender, and lenders Black Horse Capital LP (“BHC”), Cheval Holdings, Ltd. (“Cheval”) and Nomis Bay, Ltd. (“Nomis Bay”) (collectively the “Lenders”). The Credit Agreement provided for the December 2016 Loan, the March 2017 Loan and the July 2017 Loan (the “Term Loans”). In accordance with the terms of the Credit Agreement, the Company used the proceeds of the Credit Agreement for general working capital, the payment of certain fees and expenses owed to BHCMF and the Lenders and other costs incurred in the ordinary course of business. Dr. Chappell, one of the Company’s former directors, is an affiliate of each of BHCMF, BHC and Cheval. The Term Loans bore interest at 9% and were subject to certain customary representations, warranties and covenants, as set forth in the Credit Agreement. On December 1, 2017, the Term Loans matured and began bearing interest at the default rate of 14%. The Company’s obligations under the Credit Agreement are secured by a first priority interest in all of the Company’s real and personal property, subject only to certain carve outs and permitted liens, as set forth in the agreement. On December 21, 2017, the Company obtained a $1.5 million bridge loan (the "Bridge Loan") from Cheval. The Bridge Loan bears interest at 14% and is treated as a secured loan under the Credit Agreement. On February 27, 2018, the Term Loans and the Bridge Loan along with all related fees and accrued interest, were extinguished in connection with the restructuring transactions described in Note 10. Advance Notes In June, July and August, 2018, the Company received an aggregate of $0.9 million of proceeds from advances made to the Company (the “Advance Notes”) by four different lenders including Dr. Cameron Durrant, the Company’s Chairman and Chief Executive Officer; Cheval, an affiliate of BHC, the Company’s controlling stockholder; Ronald Barliant, a director of the Company; and an unrelated third party (collectively the “Advance Note Lenders”). The Advance Notes accrue interest at a rate of 7% per annum, compounded annually. The intention of the parties is that the amounts due under the Advance Notes will be converted automatically into the same type and class of securities as may be sold by the Company in a future financing transaction with an aggregate sales price of at least $5 million (a “Qualifying Financing”). The Advance Notes generally are not convertible at the option of the Advance Note Lenders into the Company’s common stock until June 21, 2019 (the “Expiration Date”); however, if prior to completing a Qualifying Financing, the Company experiences a change of control or makes a public announcement that it has entered into a collaboration arrangement with a strategic partner relating to clinical studies of lenzilumab in connection with certain CAR-T therapies in a transaction that would not otherwise constitute a Qualifying Financing, the Advance Note Lenders may elect to convert the amounts due under the Advance Notes into the Company’s common stock at a conversion price of $0.45 per share. Additionally, if neither a Qualifying Financing nor a change of control has occurred by the Expiration Date, then at any time from and after the Expiration Date the Advance Note Lenders may, at their option, convert the Advance Notes, plus any accrued and unpaid interest, into a number of shares of the Company’s common stock at the lesser of (i) the volume weighted average sales price per share over the 20 most recent trading days prior to the conversion or (ii) $0.45 per share. Convertible Notes Commencing September 19, 2018, the Company delivered a series of convertible promissory notes (the “Notes”) evidencing an aggregate of $2.5 million of loans made to the Company by six different lenders, including an affiliate of BHC. The Notes bear interest at a rate of 7% per annum and will mature on the earliest of (i) twenty-four months from the date the Notes are signed, (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company plans to use the proceeds from the Notes for working capital. The Notes are convertible into equity securities in the Company in three different scenarios: If the Company sells its equity securities on or before the date of repayment of the Notes in any financing transaction that results in gross proceeds to the Company of at least $10 million (a “Qualified Financing”), the Notes will be converted into either (i) such equity securities as the noteholder would acquire if the principal and accrued but unpaid interest thereon (the “Conversion Amount”) were invested directly in the financing on the same terms and conditions as given to the financing investors in the Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes). If the Company sells its equity securities on or before the date of repayment of the Notes in any financing transaction that results in gross proceeds to the Company of less than $10 million (a “Non-Qualified Financing”), the noteholders may elect to convert their remaining Notes into either (i) such equity securities as the noteholder would acquire if the Conversion Amount were invested directly in the financing on the same terms and conditions as given to the financing investors in the Non-Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes). The Notes may convert in the event the Company enters into or publicly announces its intention to consummate a Liquidation Event. Immediately prior to the completion of any such Liquidation Event, in lieu of receiving payment in cash, noteholders may convert the Conversion Amount into common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes). The Advance Notes and Notes have an optional voluntary conversion feature in which the holder could convert the notes in the Company’s common stock at maturity at a conversion rate of $0.45 per share. The intrinsic value of this beneficial conversion feature was $1.7 million upon the issuance of the Advance Notes and Notes and was recorded as additional paid-in capital and as a debt discount which is accreted to interest expense over the term of the Advance Notes and Notes. Interest expense includes debt discount amortization of $0.3 million for the year ended December 31, 2018. The Company evaluated the embedded features within the Advance Notes and Notes to determine if the embedded features are required to be bifurcated and recognized as derivative instruments. The Company determined that the Advance Notes and the Notes contain contingent beneficial conversion features (“CBCF”) that allow or require the holder to convert the Advance Notes and Notes to Company common stock at a conversion rate of $0.45 per share, but did not contain embedded features requiring bifurcation and recognition as derivative instruments. Upon the occurrence of a CBCF that results in conversion of the Advance Notes or Notes to Company common stock, the remaining unamortized discount will be charged to interest expense. |
Warrants to Purchase Common Sto
Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Warrants to Purchase Common Stock | |
Warrants to Purchase Common Stock | 8. Warrants to Purchase Common Stock On June 19, 2013, the Company issued a warrant to purchase up to an aggregate of 6,193 shares of common stock and an exercise price of $96.88 per share. The warrant expires on the tenth anniversary of its issuance date. On December 4, 2015, the Company issued a warrant to purchase up to an aggregate of 125,000 shares of common stock at an exercise price of $29.32 per share. The warrant expires on the fifth anniversary of its issuance. On June 30, 2016, in connection with the MDC Agreement described in Note 6, the Company issued to Savant a five year warrant (the “Savant Warrant”) to purchase 200,000 shares of the Company’s Common Stock, at an exercise price of $2.25 per share, subject to adjustment. The Savant Warrant is exercisable for 25% of the shares immediately and exercisable for the remaining shares upon reaching certain regulatory related milestones. In addition, pursuant to the MDC Agreement, the Company has granted Savant certain “piggyback” registration rights for the shares issuable under the Savant Warrant. The Company determined the initial fair value of the Savant Warrant to be approximately $0.7 million as of June 30, 2016. The Company reevaluated the performance conditions and expected vesting of the Warrant quarterly during 2017 and 2018 and recorded a reduction of expense of approximately $0.1 million during the year ended December 31, 2017. The expense reduction was due to a decline in the fair value, which reduction is included in Research and development expenses in the accompanying Condensed Consolidated Statement of Operations and Comprehensive Loss. Specifically, as a result of the FDA granting accelerated and conditional approval of a benznidazole therapy manufactured by the Chemo Group (“Chemo”) for the treatment of Chagas disease and awarding Chemo a neglected tropical disease PRV, the Company re-evaluated the final two vesting milestones and concluded that the probability of achievement of these milestones had decreased to 0%. The Company will continue to reevaluate the performance conditions and expected vesting of the Savant Warrant on a quarterly basis until all performance conditions have been met or the warrants expire. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Commitments and Contingencies | 8. Commitments and Contingencies Contractual Obligations and Commitments As of September 30, 2019, other than the debt issuances described in Note 7 and the license agreements described in Note 10, there were no material changes to the Company’s contractual obligations from those set forth in the 2018 Form 10-K. Guarantees and Indemnifications The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented. | 9. Commitments and Contingencies Operating Leases The Company leased office space in Brisbane, California under an operating lease agreement that expired in September 2018. In May 2018, the Company entered into a month-to-month lease for office space in Burlingame, California. As of December 31, 2018, the Company had no future minimum lease payments Rent expense was $0.2 million and $0.3 million for the years ended December 31, 2018 and December 31, 2017, respectively. Indemnification The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | ||
Stockholders' Equity | 9. Stockholders’ Equity Restructuring Transactions As further described in the Company’s Form 10-K for the year ended December 31, 2018, on February 27, 2018, the Company completed a comprehensive restructuring of its outstanding indebtedness of approximately $18.4 million under a series of term loans (the “Term Loans”) with two lender groups, including affiliates of Black Horse Capital, L.P. and raised incremental new capital from Cheval Holdings, Ltd. At the closing of the restructuring, the Company: (i) in exchange for the satisfaction and extinguishment of the entire balance of the Company’s Term Loans and related accrued interest totaling $18.4 million, (a) issued an aggregate of 59,786,848 shares of Common Stock (the “New Lender Shares”), and (b) transferred and assigned to a joint venture controlled by one of the term loan lenders, all of the assets of the Company related to benznidazole (the “Benz Assets”), the Company’s former drug candidate; and (ii) issued to Cheval an aggregate of 32,028,669 shares of Common Stock for total consideration of $3.0 million. The conversion of the outstanding debt for Common Stock at closing of the restructuring was accounted for as a decrease to Long-term debt and an increase to Common stock and Additional paid-in capital in the amount of the liabilities outstanding at the time of conversion. In connection with the transfer of the Benz Assets to the joint venture, the joint venture partner paid certain amounts incurred by the Company after December 21, 2017 and prior to February 27, 2018 in investigating certain causes of action and claims related to or in connection with the Benz Assets. In addition, upon exercise of its rights under the terms of the joint venture, the joint venture partner assumed certain legal fees and expenses owed by the Company to its litigation counsel totaling $0.3 million. Since the Benz Assets had no carrying value on the Company’s Condensed Consolidated Balance Sheet, the Company’s initial investment in the joint venture was recorded at $0. Equity Financings On March 12, 2018, the Company issued 2,445,557 shares of its common stock for total proceeds of $1.1 million to accredited investors. On June 4, 2018, the Company issued 400,000 shares of its common stock for total proceeds of $0.2 million to an accredited investor. 2012 Equity Incentive Plan Under the Company’s 2012 Equity Incentive Plan, the Company may grant shares, stock units, stock appreciation rights, performance cash awards and/or options to employees, directors, consultants, and other service providers. For options, the per share exercise price may not be less than the fair market value of a Company common share on the date of grant. Awards generally vest and become exercisable over three to four years and expire 10 years from the date of grant. Options generally become exercisable as they vest following the date of grant. On March 9, 2018, the Board of Directors of the Company approved an amendment to the Company’s 2012 Equity Incentive Plan (the “Equity Plan”) to increase the number of shares of the Company’s common stock authorized for issuance under the Equity Plan by 16,050,000 shares, and to increase the annual maximum aggregate number of shares subject to stock option awards that may be granted to any one person under the Equity Plan during a calendar year to 7,500,000. A summary of stock option activity for the nine months ended September 30, 2019 under all of the Company’s options plans is as follows: Options Weighted Outstanding at January 1, 2019 15,409,357 $ 0.95 Granted 728,610 1.10 Exercised (488,625 ) 0.67 Cancelled (forfeited) (509,923 ) 0.62 Cancelled (expired) (45 ) 9.68 Outstanding at September 30, 2019 15,139,374 $ 0.97 The weighted average fair value of options granted during the nine months ended September 30, 2019 was $1.10 per share. The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the nine months ended , 2019: Nine months ended Exercise price $0.84 - $1.30 Market value $0.84 - $1.30 Risk-free rate 2.49% - 2.59% Expected term 6 years Expected volatility 99.1% - 99.3% Dividend yield - Stock-Based Compensation The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss as follows: Three months ended Nine months ended 2019 2018 2019 2018 General and administrative $ 419 $ 715 $ 1,813 $ 3,969 Research and development 32 - 64 201 Total stock-based compensation $ 451 $ 715 $ 1,877 $ 4,170 At September 30, 2019, the Company had $1.0 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 1.7 years. | 10. Stockholders’ Equity Restructuring Transactions On December 1, 2017, the Company’s obligations matured under the Credit and Security Agreement dated December 21, 2016, as amended on March 21, 2017 and on July 8, 2017 (the “Term Loan Credit Agreement”) with BHCMF, as administrative agent and lender, BHC, as a lender, Cheval, as a lender (collectively with BHCMF and BHC, the Black Horse Entities) and Nomis Bay LTD, as a lender (Nomis and, together with the Black Horse Entities, the Term Loan Lenders). On December 21, 2017, the Company entered into a Securities Purchase and Loan Satisfaction Agreement (the Purchase Agreement) and a Forbearance and Loan Modification Agreement (the “Forbearance Agreement” and, together with the Purchase Agreement, the “Restructuring Agreements”), each with the Term Loan Lenders, in connection with a series of transactions providing for, among other things, the satisfaction and extinguishment of the Company’s outstanding obligations under the Term Loan Credit Agreement and the infusion of $3.0 million of new capital. As of February 27, 2018, the date the Restructuring Transactions were completed, the aggregate amount of our obligations under the Term Loan Credit Agreement, including the Bridge Loan, the Claims Advances extended by Nomis Bay (each as discussed below) and all accrued interest and fees, approximated $18.4 million (the “Term Loans”). On February 27, 2018 (the “Restructuring Effective Date”), the Restructuring Transactions were completed in accordance with the Restructuring Agreements. As a result, on the Restructuring Effective Date, the Company: (i) in exchange for the satisfaction and extinguishment of the entire $18.4 million balance of the Term Loans, including the Bridge Loan, the Claims Advances extended by Nomis Bay (each as discussed below) and all accrued interest and fees, (a) issued to the Term Loan Lenders an aggregate of 59,786,848 shares of its common stock (the “New Lender Shares”), and (b) transferred and assigned to Madison Joint Venture LLC owned 70% by Nomis Bay and 30% by the Company (Madison), all of the Company’s assets related to benznidazole (the Benz Assets), the Company’s former drug candidate, capable of being so assigned; and (ii) issued to Cheval an aggregate of 32,028,669 shares of common stock (the “New Black Horse Shares” and, collectively with the New Lender Shares, the “New Common Shares”) for total consideration of $3.0 million (collectively, the “Restructuring Transactions”), $1.5 million of which the Company received on December 22, 2017 in the form of a bridge loan (the “Bridge Loan”). On the Restructuring Effective Date, the aggregate amount of the Term Loans that were deemed to be satisfied and extinguished (i) previously owed to the Black Horse Entities, including the Bridge Loan and all accrued interest and fees, approximated $9.9 million, and (ii) previously owed to Nomis Bay, including certain advances previously extended to the Company by Nomis Bay totaling $0.1 million (the “Claims Advances”) and all accrued interest and fees, approximated $8.5 million. In addition, on the Restructuring Effective Date, (i) each of the Term Loan Credit Agreement, all promissory notes issued thereunder and the Intellectual Property Security Agreement, dated as of December 21, 2016, by and between the Company and the Term Loan Lenders, were terminated and are of no further force or effect, and (ii) all security interests of the Black Horse Entities and Nomis Bay in the Company’s assets were released. Although the Term Loans were satisfied and extinguished, if Madison elected to keep the Benz Assets after the Restructuring Effective Date, Nomis Bay would be obligated to pay or cause Madison to pay $0.3 million in legal fees and expenses owed by the Company to its litigation counsel, which remain unpaid in Accounts payable at December 31, 2017. On August 23, 2018 Madison elected to keep the Benz Assets and these amount were paid by Madison to the Company’s litigation counsel. Upon completion of the Restructuring Transactions, Nomis Bay held 33,573,530 of the Company’s common stock, or approximately 31.4% of its outstanding common stock, and the Black Horse Entities collectively held 66,870,851 shares of the Company’s common stock, or approximately 62.6% of its outstanding common stock. Accordingly, the completion of the Restructuring Transactions on the Restructuring Effective Date resulted in a change in control of the Company, as the Black Horse Entities and their affiliates owning more than a majority of its outstanding common stock. Dr. Dale Chappell, a member of the Company’s board of directors from June 30, 2016 until November 10, 2017, controls the Black Horse Entities and accordingly, will be able to exert control over matters of the Company and will be able to determine all matters of the Company requiring stockholder approval. Other Common Stock Transactions Equity Financings On March 12, 2018, the Company issued 2,445,557 shares of its common stock for total proceeds of $1.1 million to accredited investors. On June 4, 2018, the Company issued 400,000 shares of its common stock for total proceeds of $0.2 million to an accredited investor. In February 2018, the Company amended and restated its certificate of incorporation to increase the authorized common stock to 225,000,000 shares and authorize 25,000,000 shares of preferred stock. The Company had reserved the following shares of common stock for issuance as of December 31, 2018: Warrants to purchase common stock 331,193 Options: Outstanding under the 2012 Equity Incentive Plan 15,408,997 Outstanding under the 2001 Equity Incentive Plan 360 Available for future grants under the 2012 Equity Incentive Plan 4,189,056 Total common stock reserved for future issuance 19,929,606 2012 Equity Incentive Plan Under the Company’s 2012 Equity Incentive Plan, the Company may grant shares, stock units, stock appreciation rights, performance cash awards and/or options to employees, directors, consultants, and other service providers. For options, the per share exercise price may not be less than the fair market value of a Company common share on the date of grant. Awards generally vest and become exercisable over three to four years and expire 10 years from the date of grant. Options generally become exercisable as they vest following the date of grant. In general, to the extent that awards under the 2012 Plan are forfeited or lapse without the issuance of shares, those shares will again become available for awards. The 2012 Plan will continue in effect for 10 years from its adoption date, unless the Company’s board of directors decides to terminate the plan earlier. On September 13, 2016, the Board of Directors of the Company approved an amendment to the Company’s 2012 Equity Incentive Plan to increase the number of shares of the Company’s common stock available for issuance under the Plan by 3,000,000 shares and to increase the annual maximum aggregate number of shares subject to stock option awards that may be granted to any one person under the Plan from 125,000 to 1,100,000. On March 9, 2018, the Board of Directors of the Company approved an amendment to the Company’s 2012 Equity Incentive Plan (the “Equity Plan”) to increase the number of shares of the Company’s common stock authorized for issuance under the Equity Plan by 16,050,000 shares, and to increase the annual maximum aggregate number of shares subject to stock option awards that may be granted to any one person under the Equity Plan during a calendar year to 7,500,000. As of December 31, 2018, there were 4,189,056 shares available for grant under the 2012 Equity Incentive Plan. 2001 Equity Incentive Plan Under the Company’s 2001 Stock Plan (the “2001 Plan”), the Company was able to grant shares and/or options to purchase up to 426,030 shares of common stock to employees, directors, consultants, and other service providers. In connection with the 2012 Plan taking effect, the 2001 Plan was terminated in August 2012. However, the awards under the 2001 Plan outstanding as of the termination of the 2001 Plan continued to be governed by their existing terms. Stock Option Activity The following table summarizes stock option activity for the years ended December 31, 2018: Number of Weighted Weighted- Aggregate Outstanding at January 1, 2017 1,835,835 $ 19.29 Granted 765,000 3.38 Cancelled (forfeited) (152,365 ) 5.86 Cancelled (expired) (87 ) 18.38 Outstanding at December 31, 2017 2,448,383 $ 4.15 Granted 13,575,038 0.66 Cancelled (forfeited) (572,935 ) 3.20 Cancelled (expired) (41,129 ) 37.82 Outstanding at December 31, 2018 15,409,357 $ 0.95 9.0 $ 576 Options vested and expected to vest 15,356,965 $ 0.95 9.0 $ 574 Exercisable 10,283,026 $ 1.01 9.0 $ 379 (1) The weighted average price per share is determined using exercise price per share for stock options. (2) The aggregate intrinsic value is calculated as the difference between the exercise price of the option and the fair value of the Company’s common stock for in-the-money options at December 31, 2018. The stock options outstanding and exercisable by exercise price at December 31, 2018 are as follows: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Number Weighted- Weighted- Number Weighted- $0.33 - $0.67 13,725,038 9.19 $ 0.66 8,922,798 $ 0.66 $1.91 - $3.30 370,000 8.10 2.97 361,666 2.97 $3.38 - $3.38 1,263,022 7.71 3.38 947,265 3.38 $3.40 - $4.72 50,625 7.77 3.40 50,625 3.40 $8.24 - $17.36 360 1.78 12.53 360 12.53 $42.88 - $48.00 312 4.76 45.17 312 45.17 15,409,357 9.04 $ 0.95 10,283,026 $ 1.01 The total fair value of options vested for the years ended December 31, 2018 and 2017 was $4.8 million and $2.1 million, respectively. Stock-Based Compensation The Company’s stock-based compensation expense for stock options is estimated at the grant date based on the award’s fair value as calculated by the Black-Scholes option pricing model and is recognized as expense over the requisite service period. The Black-Scholes option pricing model requires various highly judgmental assumptions including expected volatility and expected term. The expected volatility is based on the historical stock volatilities of several of the Company’s publicly listed peers over a period equal to the expected terms of the options as the Company does not have a sufficient trading history to use the volatility of its own common stock. To estimate the expected term, the Company has opted to use the simplified method, which is the use of the midpoint of the vesting term and the contractual term. If any of the assumptions used in the Black-Scholes option pricing model changes significantly, stock-based compensation expense may differ materially in the future from that recorded in the current period. In addition, the Company is required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. The Company estimates the forfeiture rate based on historical experience and its expectations regarding future pre-vesting termination behavior of employees. The Company reviews its estimate of the expected forfeiture rate annually, and stock-based compensation expense is adjusted accordingly. The weighted-average fair value-based measurement of stock options granted under the Company’s stock plans in the years ended December 31, 2018 and 2017 was $0.47 and $1.54 per share, respectively. The fair value- based measurement of stock options granted under the Company’s stock plans was estimated at the date of grant using the Black-Scholes model with the following assumptions: Year Ended December 31, 2018 2017 Expected term 5-6 years 5-6 years Expected volatility 93% - 97% 83% - 88% Risk-free interest rate 2.7 - 2.8% 1.8 - 2.1% Expected dividend yield 0% 0% Total expense for stock option grants recognized was as follows: Year Ended December 31, 2018 2017 General and administrative $ 4,611 $ 1,753 Research and development 201 362 $ 4,812 $ 2,115 At December 31, 2018, the Company had $2.8 million of total unrecognized compensation expense, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 1.4 years. |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License and Collaboration Agreements | 10. License and Collaboration Agreements Kite Agreement On May 30, 2019, the Company entered into a collaboration agreement (the “Kite Agreement”) with Kite Pharmaceuticals, Inc., pursuant to which the Company and Kite will conduct a multi-center Phase 1b/2 study of lenzilumab with Kite’s Yescarta in patients with relapsed or refractory B-cell lymphoma, including diffuse large B-cell lymphoma (“DLBCL”). The primary objective of the Study is to determine the effect of lenzilumab on the safety of Yescarta. Pursuant to the Kite Agreement, the Company shall supply Lenz to the collaboration for use in the study and will contribute up to approximately $8.0 million towards the out-of-pocket costs of the study. Mayo Agreement On June 19, 2019 the Company entered into an exclusive worldwide license agreement (the “Mayo Agreement”) with the Mayo Foundation for Medical Education and Research (“Mayo”) for certain technologies used to create CAR-T cells lacking GM-CSF expression through various gene-editing tools including CRISPR-Cas9 (GM-CSF knock-out). The license covers various patent applications and know-how developed by Mayo in collaboration with the Company. These licensed technologies complement and broaden the Company’s position in the GM-CSF neutralization space and expand the Company’s discovery platform aimed at improving CAR-T to include gene-edited CAR-T cells. Pursuant to the Mayo Agreement, the Company will pay $200,000 to Mayo within six months of the effective date, or upon completion of a qualified financing, whichever is earlier. The Mayo Agreement also requires the payment of milestones and royalties upon the achievement of certain regulatory and commercialization milestones. The Company accrued the initial payment in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of September 30, 2019. Zurich Agreement On July 19, 2019 the Company entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich (“UZH”) for technology used to prevent or treat Graft versus Host Disease (“GvHD”) through GM-CSF neutralization. The Zurich Agreement covers various patent applications filed by UZH which complement and broaden the Company’s position in the application of GM-CSF and expands the Company’s development platform to include improving allogeneic Hematopoietic Stem Cell Transplantation (“HSCT”). Pursuant to the Zurich Agreement, the Company paid $100,000 to UZH in July 2019. The Zurich Agreement also requires the payment of milestones and royalties upon the achievement of certain regulatory and commercialization milestones. The license payment of $100,000 was recorded as expense in Research and development in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss as of September 30, 2019. |
Savant Arrangements
Savant Arrangements | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Savant Arrangements | ||
Savant Arrangements | 11. Savant Arrangements On June 30, 2016 the Company and Savant Neglected Diseases, LLC (“Savant”) entered into an Agreement for the Manufacture, Development and Commercialization of Benznidazole for Human Use (the “MDC Agreement”), pursuant to which the Company acquired certain worldwide rights relating to benznidazole (the “Compound”). In addition, on the Effective Date the Company and Savant also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company granted Savant a continuing senior security interest in the assets and rights acquired by the Company pursuant to the MDC Agreement and certain future assets developed from those acquired assets. On the Effective Date, the Company issued to Savant a five year warrant (the “Warrant”) to purchase 200,000 shares of the Company’s Common Stock, at an exercise price of $2.25 per share, subject to adjustment. The Warrant is exercisable for 25% of the shares immediately and exercisable for the remaining shares upon reaching certain regulatory related milestones. As of September 30, 2019 the number of shares for which the Warrant is currently exercisable totals 100,000 shares at an exercise price of $2.25 per share. As a result of the FDA granting accelerated and conditional approval of a benznidazole therapy manufactured by a competitor for the treatment of Chagas disease and awarding such competitor a neglected tropical disease PRV in August 2017, the Company ceased development of benznidazole and re-evaluated the final two vesting milestones and concluded that the probability of achievement of these milestones had decreased to 0%. In July 2017, the Company commenced litigation against Savant alleging that Savant breached the MDC Agreement and seeking a declaratory judgement. Savant has asserted counterclaims for breaches of contract under the MDC Agreement and the Security Agreement. The dispute primarily concerns the Company’s right under the MDC Agreement to offset certain costs incurred by the Company in excess of the agreed upon budget against payments due Savant. See Note 12, below, for more information regarding the Savant litigation. The aggregate cost overages as of June 30, 2017 that the Company asserts are Savant’s responsibility total approximately $3.4 million, net of a $0.5 million deductible. The Company asserts that it is entitled to offset $2.0 million in milestone payments due Savant against the cost overages, such that as of June 30, 2017, Savant owed the Company approximately $1.4 million. As of June 30, 2019, the cost overages totaled $4.1 million such that Savant owed the Company approximately $2.1 million in cost overages. Such cost overages have been charged to Research and development expense as incurred. Recovery of such cost overages, if any, will be recorded as a reduction of Research and development expense in the period received. The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of September 30, 2019 and December 31, 2018. | 6. Savant Arrangements On February 29, 2016, the Company entered into a binding letter of intent (the “LOI”) with Savant Neglected Diseases, LLC (“Savant”). The LOI provided that the Company would acquire certain worldwide rights relating to benznidazole from Savant. On June 30, 2016, the Company and Savant entered into an Agreement for the Manufacture, Development and Commercialization of Benznidazole for Human Use (the “MDC Agreement”), pursuant to which the Company acquired certain worldwide rights relating to benznidazole. The MDC Agreement consummates the transactions contemplated by the LOI. In addition, on the June 30, 2016, the Company and Savant also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company granted Savant a continuing senior security interest in the assets and rights acquired by the Company pursuant to the MDC Agreement and certain future assets developed from those acquired assets. On June 30, 2016, in connection with the MDC Agreement, the Company issued to Savant a five year warrant to purchase 200,000 shares of the Company’s Common Stock, at an exercise price of $2.25 per share, subject to adjustment. See Note 8. On May 26, 2017, the Company submitted its benznidazole Investigational New Drug Application (“IND”) to the Food and Drug Administration (“FDA”) which became effective on June 26, 2017. The Company recorded expense of $1.0 million during the year ended December 31, 2017 as Research and development expense related to the milestone achievement associated with the IND being declared effective. On July 10, 2017, FDA notified the Company that it granted Orphan Drug Designation to benznidazole for the treatment of Chagas disease. The Company recorded expense of $1.0 million during the year ended December 31, 2017 as Research and development expense related to the milestone achievement associated with Orphan Drug Designation. The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of December 31, 2017 and 2018. In July 2017, the Company commenced litigation against Savant alleging that Savant breached the MDC Agreement and seeking a declaratory judgement. Savant has asserted counterclaims for breaches of contract under the MDC Agreement and the Security Agreement. See Note 13. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes No provision for federal income taxes has been recorded for the years ended December 31, 2018 and 2017 due to net losses and the valuation allowance established. Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carryovers and the temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets are as follows: December 31, 2018 2017 Deferred tax assets: Net operating losses $ 47,877 $ 45,791 Research and other credits 2,178 2,178 Stock based compensation 2,682 1,585 In-process research and development 1,314 1,375 Other 708 676 Total deferred tax assets 54,759 51,605 Valuation allowance (54,759 ) (51,605 ) Net deferred tax assets $ - $ - A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 2018 and 2017 is as follows: Year Ended December 31, 2018 2017 Statutory rate 21.0 % 34.0 % Valuation allowance (26.4 )% 57.6 % Nondeductible stock compensation 0.1 % (0.1 )% Deferred tax expense from enacted rate reduction - % (98.7 )% Other 5.3 % 7.2 % Effective tax rate - % - % On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act tax reform legislation. This legislation makes significant change in U.S. tax law including a reduction in the corporate tax rates, changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduced the U.S. corporate tax rate from the current rate of 35% to 21%. As a result of the enacted law, the Company was required to revalue deferred tax assets and liabilities at the 21% rate as of December 31, 2017. This revaluation resulted in additional income tax expense of $21.6 million, a corresponding reduction in the net deferred tax asset, an additional income tax benefit of $21.6 million, and a corresponding reduction in the valuation allowance on net deferred tax assets. The other provisions of the Tax Cuts and Jobs Act did not have a material impact on the 2017 or 2018 consolidated financial statements. Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $3.2 million during 2018 and decreased by $12.6 million during 2017. At December 31, 2018, the Company had federal net operating loss carryforwards of approximately $166.2 million, which expire in the years 2021 through 2037, and state net operating loss carryforwards of approximately $163.9 million, which expire in the years 2018 through 2038. The Company also has federal net operating loss carryforwards generated in 2018 of $7.3 million that have no expiration date as a result of the December 22, 2017 tax law changes discussed above. At December 31, 2018, the Company had federal research and development credit carryforwards of approximately $1.3 million, which expire in the years 2022 through 2035 and state research and development credit carryforwards of approximately $2.2 million. The state research and development credit carryforwards can be carried forward indefinitely. During 2013, the Company completed a Section 382 study in accordance with the Internal Revenue Code of 1986, as amended, and similar state provisions. The study concluded that the Company has experienced several ownership changes since inception. This causes the Company's utilization of its net operating loss and tax credit carryforwards to be subject to substantial annual limitations. These results are reflected in the above carryforward amounts and deferred tax assets. The Company's ability to utilize its net operating loss and tax credit carryforwards are further limited as a result of subsequent ownership changes. All such limitations could result in the expiration of carryforwards before they are utilized. An ownership change may have occurred during 2015, 2016, 2017 and 2018, or all four years and in connection with the Restructuring Transactions described in Note 10. As a result, tax attributes such as net operating losses and research and development credits may be subject to further limitation. ASC 740 requires that the Company recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Balance at December 31, 2016 $ 1,127 Additions based on tax positions related to prior year (67 ) Additions based on tax positions related to current year - Balance at December 31, 2017 1,060 Additions based on tax positions related to prior year - Additions based on tax positions related to current year - Balance at December 31, 2018 $ 1,060 There were no interest or penalties related to unrecognized tax benefits. Substantially all of the unrecognized tax benefit, if recognized to offset future taxable income would affect the Company’s tax rate. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly increase or decrease within the next 12 months. Because of net operating loss carryforwards, substantially all of the Company’s tax years remain open to federal tax and state tax examination. The Company files income tax returns in the U.S. federal jurisdiction and California. Federal and California corporation income tax returns beginning with the 2001 tax year remain subject to examination by the Internal Revenue Service and the California Franchise Tax Board, respectively. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | 12. Employee Benefit Plan The Company has established a 401(k) tax-deferred savings plan (the “401(k) Plan”), which permits participants to make contributions by salary deduction pursuant to Section 401(k) of the Internal Revenue Code. The Company is responsible for administrative costs of the 401(k) Plan. The Company may, at its discretion, make matching contributions to the 401(k) Plan. No employer contributions have been made to date. |
Litigation
Litigation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Litigation [Abstract] | ||
Litigation | 12. Litigation Savant Litigation On July 10, 2017, the Company filed a complaint against Savant Neglected Diseases, LLC (“Savant”) in the Superior Court for the State of Delaware, New Castle County (the “Delaware Court”). KaloBios Pharmaceuticals, Inc. v. Savant Neglected Diseases, LLC On July 12, 2017, Savant removed the case to the Bankruptcy Court, claiming that the action is related to or arises under the Bankruptcy Case from which we emerged in July 2016. On July 27, 2017, Savant filed an Answer and Counterclaims. Savant’s filing alleges breaches of contracts under the MDC Agreement and the Security Agreement, claiming that the Company breached its obligations to pay the milestone payments and other related representations and obligations. On August 1, 2017, the Company moved to remand the case back to the Delaware Court (the “Motion to Remand”). On August 2, 2017, Savant sent a foreclosure notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the “TRO”) and Preliminary Injunction in the Bankruptcy Court on August 4, 2017. Savant responded on August 7, 2017. On August 7, 2017, the Bankruptcy Court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies under the MDC Agreement or the Security Agreement. The parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court. On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO, ordering that any request to dissolve the TRO be made to the Delaware Court. On February 13, 2018 Savant made a letter request to the Delaware Superior Court to dissolve the TRO. Also on February 13, 2018, the Company filed its Answer and Affirmative defenses to Savant’s Counterclaims. On February 15, 2018 the Company filed a letter opposition to Savant’s request to dissolve the TRO and requesting a status conference. A hearing on Savant’s request to dissolve the TRO was held before the Delaware Superior Court on March 19, 2018. The Delaware Superior Court denied Savant’s request to dissolve the TRO and the TRO remains in effect. On April 11, 2018, the Company advised the Delaware Superior Court that it would meet and confer with Savant regarding a proposed case management order and date for trial. On April 26, 2018 the Delaware Superior Court so-ordered a proposed case management order submitted by the Company and Savant. The schedule in the case management order was modified by stipulation on August 24, 2018. On April 8, 2019, the Company moved to compel Savant to produce documents in response to the Company’s document requests. The parties thereafter agreed to a discovery schedule through June 30, 2019, which the Superior Court so-ordered, and the parties produced documents to each other. On June 4, 2019, Savant filed a complaint against the Company and Madison Joint Venture LLC (“Madison”) in the Delaware Court of Chancery (the “Chancery Action”) seeking to “recover as damages that amounts owed to it under the MDC Agreement, and to reclaim Savant’s intellectual property,” among other things. Savant also requested leave to move to dismiss the Company’s complaint on the grounds that the Company’s transfer of assets to Madison was champertous. On June 10, 2019, the Company requested by letter that the Superior Court hold a contempt hearing because the Chancery Action violated the TRO entered by the Bankruptcy Court, the terms of which have been extended by stipulation of the parties. On June 18, 2019, the Superior Court held a telephonic status conference. The parties agreed that the Chancery Action should be consolidated with the Superior Court action, after which the Superior Court would address the parties’ motions. On July 22, 2019, the Company moved for contempt against Savant. Savant filed its opposition on July 29, 2019. On August 12, 2019, the Superior Court denied the Company’s motion for contempt. On July 23, 2019, Savant moved for summary judgment on the issue of champerty. The Company filed its response and cross-motion for summary judgment on August 27, 2019. Savant filed its reply on September 10, 2019 and the Company filed its cross-reply on September 20, 2019. The motion is fully briefed, but no argument date has been set. On July 26, 2019, the Company moved to modify the previously agreed-upon discovery schedule to extend discovery through December 31, 2019, which the Court granted. On July 30, 2019, the Company filed a motion to dismiss Savant’s Chancery Court complaint. Savant filed an amended complaint on September 4, 2019, and the Company filed its opening brief in support of its motion to dismiss on October 11, 2019. Savant’s opposition is due on November 22, 2019, and the Company’s reply is due on December 11, 2019. On August 19, 2019, Savant moved to dismiss the Company’s amended Superior Court complaint. On September 27, 2019, the Company filed an opposition to Savant’s motion and, in the alternative, requested leave to file a second amended complaint against Savant. Savant consented to the filing of the second amended complaint and withdrew their motion to dismiss. | 13. Litigation Savant Litigation On July 10, 2017, the Company filed a complaint against Savant Neglected Diseases, LLC (“Savant”) in the Superior Court for the State of Delaware, New Castle County (the “Delaware Court”). KaloBios Pharmaceuticals, Inc. v. Savant Neglected Diseases, LLC On July 12, 2017, Savant removed the case to the United States District Court for the District of Delaware, claiming that the action is related to or arises under the bankruptcy court case from which we emerged in July 2016. In re KaloBios Pharmaceuticals, Inc. On August 2, 2017, Savant sent a foreclosure notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the “TRO”) and Preliminary Injunction in the bankruptcy court on August 4, 2017. Savant responded on August 7, 2017. On August 7, 2017, the bankruptcy court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies under the MDC Agreement or the Security Agreement. The parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court. On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO, ordering that any request to dissolve the TRO be made to the Delaware Superior Court. On February 13, 2018 Savant made a letter request to the Delaware Superior Court to dissolve the TRO. Also on February 13, 2018, Humanigen filed its Answer and Affirmative defenses to Savant’s Counterclaims. On February 15, 2018 Humanigen filed a letter opposition to Savant’s request to dissolve the TRO and requesting a status conference. A hearing on Savant’s request to dissolve the TRO was held before the Delaware Superior Court on March 19, 2018. The Delaware Superior Court denied Savant’s request to dissolve the TRO and the TRO remains in effect. On April 11, 2018, Humanigen advised the Delaware Superior Court that it would meet and confer with Savant regarding a proposed case management order and date for trial. On April 26, 2018 the Delaware Superior Court so-ordered a proposed case management order submitted by the Company and Savant. The schedule in the case management order was modified by stipulation on August 24, 2018. The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying balance sheet as of December 31, 2017 and 2018. Recovery of the cost overages from Savant, if any, will be recorded in the period received. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions On December 21, 2017, the Company entered into a Purchase Agreement and a Forbearance Agreement as more fully described in Note 10, with certain lenders and investors who were deemed to be affiliates of the Company. In June, July and August, 2018 the Company received an aggregate of $0.9 million of proceeds from advances made to it by four different lenders including Dr. Cameron Durrant, our Chairman and Chief Executive Officer; Cheval, an affiliate of BHC, the Company’s controlling stockholder; and Ronald Barliant, a director of the Company. See Note 7. Commencing September 19, 2018, the Company delivered a series of convertible promissory notes evidencing an aggregate of $2.5 million of loans made to the Company by six different lenders, including an affiliate of BHC, the Company’s controlling stockholder. See Note 7. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events On October 8, 2019, the Company and the lenders agreed to extend the maturity date of the 2019 Bridge Notes from October 1, 2019 until December 31, 2019 and to waive any prior default up to and including the date of the amendment. See Note 7 for more information. On November 8, 2019, the Company entered into a Purchase Agreement (the “Purchase Agreement”) under which the Company may sell up to $20.0 million of shares of its common stock, par value $0.001 per share, to Lincoln Park Capital Fund, LLC (“Lincoln Park”) over a 36-month period, including the 706,592 shares of common stock we issued to Lincoln Park in November 2019 as compensation for its commitment to enter into the Purchase Agreement. On November 12, 2019, the Company made two short-term, secured bridge notes evidencing an aggregate of $350,000 of loans made to the Company by two parties: Cheval, an affiliate of BCH, our controlling stockholder; and Cameron Durrant, M.D., MBA, our Chief Executive Officer and Chairman of the Board of Directors. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all adjustments necessary for the presentation of the Company’s consolidated financial position, results of operations and cash flows for the periods presented. The Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the fair value-based measurement of stock-based compensation, accruals, liabilities subject to compromise, convertible notes and warrants. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Consolidated Financial Statements. |
Concentration of Credit Risk | Concentration of Credit Risk Cash, cash equivalents, and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk in the event of a default by the related financial institution holding the securities, to the extent of the value recorded in the balance sheet. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments with lower credit risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The fair value of financial instruments reflects the amounts that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable, and the third is considered unobservable, as follows: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 2—Inputs other than those included in Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets (marketable securities) that are measured at fair value, and the classification by level of input within the fair value hierarchy: Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 Fair Value Measurements as of December 31, 2017 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 101 $ — $ — $ 101 Total assets measured at fair value $ 101 $ — — $ 101 The estimated fair value of the Term Loans payable, Notes payable to vendors, Advance notes and Convertible notes as of December 31, 2018 and 2017, based upon current market rates for similar borrowings, as measured using Level 3 inputs, approximate the carrying amounts as presented in the Consolidated Balance Sheets. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing and demand money market accounts. |
Restricted Cash | Restricted Cash Restricted cash at December 31, 2018 of $0.07 million related to a standby letters of credit in the amount of $0.05 million issued in connection with certain insurance policy coverage maintained by the Company and restricted cash related to a credit card facility in the amount of $0.02 million. Restricted cash at December 31, 2017 of $0.1 million related to a standby letters of credit in the amount of $0.05 million issued in connection with certain insurance policy coverage maintained by the Company and restricted cash related to a credit card facility in the amount of $0.05 million. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment is stated at cost, less accumulated depreciation and amortization, and depreciated over the estimated useful lives of the respective assets of three years using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the useful lives or the non-cancelable term of the related lease. Maintenance and repair costs are charged as expense in the Statements of Operations and Comprehensive Loss as incurred. |
Long-Lived Assets | Long-Lived Assets The Company evaluates the carrying value of its long-lived assets, including intangible assets, whenever events or changes in circumstances indicate that the carrying value of the asset may be impaired. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset, including disposition, are less than the carrying value of the asset. To date, the Company has not recorded any impairment charges on its long-lived assets. |
Debt Issue Costs | Debt Issue Costs Debt issuance costs related to a recognized debt liability are presented on the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts and are amortized to interest expense over the term of the related debt on the effective interest method. |
Research and Development Expenses | Research and Development Expenses Development costs incurred in the research and development of new product candidates are expensed as incurred, including expenses that may or may not be reimbursed under research and development collaboration arrangements. Research and development costs include, but are not limited to, salaries, benefits, stock-based compensation, laboratory supplies, allocated overhead, fees for professional service providers and costs associated with product development efforts, including preclinical studies and clinical trials. The Company estimates pre-clinical study and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. The Company records upfront and milestone payments made to third parties under licensing arrangements as an expense. Upfront payments are recorded when incurred and milestone payments are recorded when the specific milestone has been achieved. |
Research and Development Services | Research and Development Services Internal and external research and development costs incurred in connection with collaboration agreements are recognized as revenue in the same period as the costs are incurred and are presented on a gross basis when the Company acts as a principal, has the discretion to choose suppliers, bears credit risk, and performs at least part of the services. |
Revenue Recognition | Revenue Recognition The Company’s revenue to date has been generated primarily through license agreements and research and development collaboration agreements. The Company had no revenues for the years ending December 31, 2017 and 2018. Commencing January 1, 2018, the Company recognizes revenue in accordance with ASC 606. The core principle of ASC 606 is that an entity should recognize revenue to depict the transfer of promised goods and/or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and/or services. To determine the appropriate amount of revenue to be recognized for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following steps: (i) identify the contract(s) with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) each performance obligation is satisfied. Revenue under technology licenses and collaborative agreements typically consists of nonrefundable and/or guaranteed license fees, collaborative research funding, and various milestone and future product royalty or profit-sharing payments. These agreements are generally referred to as “multiple element arrangements”. The Company applies the accounting standard on revenue recognition for multiple element arrangements. The fair value of deliverables under the arrangement may be derived using a best estimate of selling price if vendor specific objective evidence and third-party evidence is not available. Deliverables under the arrangement will be separate units of accounting if a delivered item has value to the customer on a standalone basis and if the arrangement includes a general right of return for the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the Company’s control. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license has standalone value from any undelivered performance obligations and that value can be determined. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the fair value of the undelivered performance obligations can be determined, then these obligations would be accounted for separately. If the license is not considered to have standalone value, then the license and other undelivered performance obligations would be accounted for as a single unit of accounting. In this case, the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed or deferred indefinitely until the undelivered performance obligation is determined. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized. Revenue is recognized using a proportional performance or straight-line method. The proportional performance method is used when the level of effort required to complete performance obligations under an arrangement can be reasonably estimated. The amount of revenue recognized under the proportional performance method is determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of milestones, by the ratio of the level of effort performed to date to the estimated total level of effort required to complete performance obligations under the arrangement. If the Company cannot reasonably estimate the level of effort to complete performance obligations under an arrangement, the Company recognizes revenue under the arrangement on a straight-line basis over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. The Company’s collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales performance-based milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company’s revenue calculation. Typically, these milestones are not considered probable at the inception of the collaboration. As such, milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is achieved during the performance period, then the Company will only recognize revenue to the extent of the proportional performance achieved at that date, or the proportion of the straight-line basis achieved at that date, and the remainder will be recorded as deferred revenue to be amortized over the remaining performance period. If the milestone is achieved after the performance period has completed and all performance obligations have been delivered, then the Company will recognize the milestone payment as Revenue in its entirety in the period the milestone was achieved. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company measures employee and director stock-based compensation expense for stock awards at the grant date, based on the fair value-based measurement of the award, and the expense is recorded over the related service period, generally the vesting period, net of estimated forfeitures. The Company calculates the fair value-based measurement of stock options using the Black-Scholes valuation model and the single-option method and recognizes expense using the straight-line attribution approach. The Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC 505, Equity Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock.. |
Income Taxes | Income Taxes The Company accounts for income taxes under an asset-and-liability approach. Deferred income taxes reflect the impact of temporary differences between assets and liabilities recognized for tax and financial reporting purposes measured by applying enacted tax rates and laws that will be in effect when the differences are expected to reverse, net operating loss carryforwards and tax credits. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is more likely than not to be realized. The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for income taxes. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss represents net loss adjusted for the change during the periods presented in unrealized gains and losses on available-for-sale securities less reclassification adjustments for realized gains or losses included in net loss. The unrealized gains or losses are reported on the Consolidated Statements of Operations and Comprehensive Loss. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, stock options, restricted stock units and common stock warrants are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The Company’s potential dilutive securities, which include stock options, restricted stock units and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per common share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented. The following shares subject to outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share as the effect of including such securities would be antidilutive: Year Ended December 31, 2018 2017 Options to purchase common stock 15,409,357 2,448,383 Warrants to purchase common stock 331,193 331,193 15,740,550 2,779,576 |
Segment Reporting | Segment Reporting The Company determines its segment reporting based upon the way the business is organized for making operating decisions and assessing performance. The Company operates in only one segment, which is related to the development of pharmaceutical products. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Until December 31, 2018, the Company qualified as an “emerging growth company” (“EGC”) pursuant to the provisions of the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and elected to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act which permits EGCs to defer compliance with new or revised accounting standards until non-issuers are required to comply with such standards. A registrant with EGC status loses its eligibility as an EGC five years after its common equity initial public offering, December 31, 2018 for the Company. Accordingly, the Company is required to adopt new accounting standards on the same timeline as other public companies effective January 1, 2018. In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, "Revenue from Contracts with Customers (Topic 606)." ASU 2014-09 completes the joint effort by the FASB and International Accounting Standards Board to improve financial reporting by creating common revenue recognition guidance for U.S. GAAP and International Financial Reporting Standards. ASU 2014-09 applies to all companies that enter into contracts with customers to transfer goods or services. The Company adopted the standard effective January 1, 2018. As the Company had no revenues in 2017 or 2018, ASU 2014-09 had no material impact upon adoption. On January 1, 2018, the Company adopted ASU 2016-09, “Stock Compensation – Improvements to Employee Share-Based Payment Accounting”. This new accounting standard simplifies accounting for share-based payment transactions, including income tax consequences and the classification of the tax impact on the statement of cash flows. ASU 2016-09 had no material impact upon adoption. In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-18 requires the inclusion of restricted cash with cash and cash equivalents when reconciling the beginning-of-the period and end-of-period total amounts shown on the statement of cash flows. The Company adopted the standard effective January 1, 2018. As a result of the adoption, the Company will no longer present the change within restricted cash in the consolidated statements of cash flows. See below for the composition of cash, cash equivalents and restricted cash shown on the statements of cash flow: Twelve Months Ended 2018 2017 Cash and cash equivalents $ 814 $ 737 Restricted cash 71 101 Total cash, cash equivalents and restricted cash as shown on statement of cash flows $ 885 $ 838 In July 2017, the FASB issued ASU No. 2017-11, “Earnings Per Share (Topic 260), Distinguishing Equity from Liabilities (Topic 480) and Derivatives and Hedging (Topic 815)”, which addresses the complexity of accounting for certain financial instruments with down round features and finalizes pending guidance related to mandatorily redeemable noncontrolling interests. Under ASU 2017-11, when determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. ASU 2017-11 becomes effective for annual reporting periods beginning after December 15, 2018, including interim periods thereafter; early adoption is permitted, including adoption in an interim period. The Company early adopted this standard utilizing the modified retrospective method. Since the Company didn’t have any financial instruments with a down round feature as of January 1, 2018, the beginning of the year of adoption, the adoption of this standard did not have an impact on the Company’s consolidated financial statements and related disclosures. In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”, which requires lessees to recognize on the balance sheet a right-of use asset, representing its right to use the underlying asset for the lease term, and a lease liability for all leases with terms greater than 12 months. The guidance also requires qualitative and quantitative disclosures designed to assess the amount, timing, and uncertainty of cash flows arising from leases. The standard requires the use of a modified retrospective transition approach, which includes a number of optional practical expedients that entities may elect to apply. The Company will be required to comply with the guidance for annual reporting periods beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2018. Early application is permitted. The Company is currently evaluating the requirements of ASU 2016-02 and has not yet determined its impact on the Company’s consolidated financial statements and related disclosures. In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting”. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees and is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The Company does not expect the adoption of ASU 2018-07 to have a material impact on it’s consolidated financial statements and related disclosures. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606”. ASU 2018-18 makes targeted improvements for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in Topic 808 was aligned with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The amendments in this Update should be applied retrospectively to the date of initial application of Topic 606. The Company is currently evaluating the requirements of ASU 2018-18 and has not yet determined its impact on the Company’s consolidated financial statements and related disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s consolidated financial statement presentation or disclosures. |
Chapter 11 Filing (Tables)
Chapter 11 Filing (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Chapter 11Filing Tables Abstract | ||
Schedule of Reorganization Items, Net | For the three and nine months ended September 30, 2019 and 2018, Reorganization items, net consisted of the following charges related to the bankruptcy proceedings: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Legal fees $ - $ 32 $ - $ 85 Professional fees - 8 - 21 Total reorganization items, net $ - $ 40 $ - $ 106 | For the years ended December 31, 2018 and 2017, Reorganization items, net consisted of the following charges: Year ended December 31, 2018 2017 Legal fees $ 119 $ 297 Professional fees 26 34 Total reorganization items, net $ 145 $ 331 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Schedule of fair value of financial assets and liabilities measured at fair value and classification by level of input | Fair Value Measurements as of September 30, 2019 (in thousands) Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — $ — $ 71 Fair Value Measurements as of December 31, 2018 (in thousands) Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — $ — $ 71 | The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets (marketable securities) that are measured at fair value, and the classification by level of input within the fair value hierarchy: Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 Fair Value Measurements as of December 31, 2017 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 101 $ — $ — $ 101 Total assets measured at fair value $ 101 $ — — $ 101 |
Schedule of antidilutive securities excluded from computations of diluted net loss per common share | The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share: As of September 30, 2019 2018 Options to purchase common stock 15,139,374 15,551,023 Warrants to purchase common stock 331,193 331,193 15,470,567 15,882,216 | The following shares subject to outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share as the effect of including such securities would be antidilutive: Year Ended December 31, 2018 2017 Options to purchase common stock 15,409,357 2,448,383 Warrants to purchase common stock 331,193 331,193 15,740,550 2,779,576 |
Schedule of composition of cash, cash equivalents and restricted cash | September 30, 2019 2018 Cash and cash equivalents $ 157 $ 2,038 Restricted cash 71 71 Total cash, cash equivalents and restricted cash as shown on statement of cash flows $ 228 $ 2,109 | See below for the composition of cash, cash equivalents and restricted cash shown on the statements of cash flow: Twelve Months Ended 2018 2017 Cash and cash equivalents $ 814 $ 737 Restricted cash 71 101 Total cash, cash equivalents and restricted cash as shown on statement of cash flows $ 885 $ 838 |
Potentially Dilutive Securiti_2
Potentially Dilutive Securities (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Potentially Dilutive Securities Tables | ||
Potentially Dilutive Securities Excluded From Computation of Diluted Net Loss Per Common Share | The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share: As of September 30, 2019 2018 Options to purchase common stock 15,139,374 15,551,023 Warrants to purchase common stock 331,193 331,193 15,470,567 15,882,216 | The following shares subject to outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share as the effect of including such securities would be antidilutive: Year Ended December 31, 2018 2017 Options to purchase common stock 15,409,357 2,448,383 Warrants to purchase common stock 331,193 331,193 15,740,550 2,779,576 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Schedule of fair value of financial assets and liabilities measured at fair value and classification by level of input | Fair Value Measurements as of September 30, 2019 (in thousands) Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — $ — $ 71 Fair Value Measurements as of December 31, 2018 (in thousands) Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — $ — $ 71 | The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets (marketable securities) that are measured at fair value, and the classification by level of input within the fair value hierarchy: Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 Fair Value Measurements as of December 31, 2017 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 101 $ — $ — $ 101 Total assets measured at fair value $ 101 $ — — $ 101 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of amortized cost and fair value of investments, with gross unrealized gains and losses | At December 31, 2018, the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows: Gross Gross Amortized Unrealized Unrealized Cost Gains Losses Fair Value Money market funds $ 71 $ — $ — $ 71 Total investments $ 71 $ — $ — $ 71 Reported as: Cash and cash equivalents $ — Restricted cash 71 Total investments $ 71 At December 31, 2017 the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows: Gross Gross Amortized Unrealized Unrealized Cost Gains Losses Fair Value Money market funds $ 101 $ — $ — $ 101 Total investments $ 101 $ — $ — $ 101 Reported as: Cash and cash equivalents $ - Restricted cash, long-term 101 Total investments $ 101 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | Property and equipment consists of the following: December 31, 2018 2017 Computer equipment and software $ 216 $ 216 Accumulated depreciation and amortization (216 ) (197 ) Property and equipment, net $ - $ 19 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Text Block [Abstract] | |
Schedule of term Loans consisted | Term Loans consisted of the following at December 31, 2017: Original Principal Amount Accrued Interest Loan Balance Fees Balance Due December 2016 Loan $ 3,315 $ 324 $ 3,639 $ 153 $ 3,792 March 2017 Loan 5,978 452 6,430 275 6,705 July 2017 Loan 5,435 249 5,684 250 5,934 Bridge Loan 1,500 6 1,506 - 1,506 Claims Advances Loan 80 1 81 - 81 Totals $ 16,308 $ 1,032 $ 17,340 $ 678 $ 18,018 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | ||
Schedule of shares of common stock reserved for issuance | The Company had reserved the following shares of common stock for issuance as of December 31, 2018: Warrants to purchase common stock 331,193 Options: Outstanding under the 2012 Equity Incentive Plan 15,408,997 Outstanding under the 2001 Equity Incentive Plan 360 Available for future grants under the 2012 Equity Incentive Plan 4,189,056 Total common stock reserved for future issuance 19,929,606 | |
Summary of stock option activity | A summary of stock option activity for the nine months ended September 30, 2019 under all of the Company’s options plans is as follows: Options Weighted Outstanding at January 1, 2019 15,409,357 $ 0.95 Granted 728,610 1.10 Exercised (488,625 ) 0.67 Cancelled (forfeited) (509,923 ) 0.62 Cancelled (expired) (45 ) 9.68 Outstanding at September 30, 2019 15,139,374 $ 0.97 | The following table summarizes stock option activity for the years ended December 31, 2018: Number of Weighted Weighted- Aggregate Outstanding at January 1, 2017 1,835,835 $ 19.29 Granted 765,000 3.38 Cancelled (forfeited) (152,365 ) 5.86 Cancelled (expired) (87 ) 18.38 Outstanding at December 31, 2017 2,448,383 $ 4.15 Granted 13,575,038 0.66 Cancelled (forfeited) (572,935 ) 3.20 Cancelled (expired) (41,129 ) 37.82 Outstanding at December 31, 2018 15,409,357 $ 0.95 9.0 $ 576 Options vested and expected to vest 15,356,965 $ 0.95 9.0 $ 574 Exercisable 10,283,026 $ 1.01 9.0 $ 379 (1) The weighted average price per share is determined using exercise price per share for stock options. (2) The aggregate intrinsic value is calculated as the difference between the exercise price of the option and the fair value of the Company’s common stock for in-the-money options at December 31, 2018. |
Schedule of stock options outstanding and exercisable by exercise price | The stock options outstanding and exercisable by exercise price at December 31, 2018 are as follows: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Number Weighted- Weighted- Number Weighted- $0.33 - $0.67 13,725,038 9.19 $ 0.66 8,922,798 $ 0.66 $1.91 - $3.30 370,000 8.10 2.97 361,666 2.97 $3.38 - $3.38 1,263,022 7.71 3.38 947,265 3.38 $3.40 - $4.72 50,625 7.77 3.40 50,625 3.40 $8.24 - $17.36 360 1.78 12.53 360 12.53 $42.88 - $48.00 312 4.76 45.17 312 45.17 15,409,357 9.04 $ 0.95 10,283,026 $ 1.01 | |
Schedule of fair value-based measurement of stock options granted under the entity's stock plans estimated using Black-Scholes model | The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the nine months ended , 2019: Nine months ended Exercise price $0.84 - $1.30 Market value $0.84 - $1.30 Risk-free rate 2.49% - 2.59% Expected term 6 years Expected volatility 99.1% - 99.3% Dividend yield - | The fair value- based measurement of stock options granted under the Company’s stock plans was estimated at the date of grant using the Black-Scholes model with the following assumptions: Year Ended December 31, 2018 2017 Expected term 5-6 years 5-6 years Expected volatility 93% - 97% 83% - 88% Risk-free interest rate 2.7 - 2.8% 1.8 - 2.1% Expected dividend yield 0% 0% |
Schedule of total stock-based compensation expense recognized | The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss as follows: Three months ended Nine months ended 2019 2018 2019 2018 General and administrative $ 419 $ 715 $ 1,813 $ 3,969 Research and development 32 - 64 201 Total stock-based compensation $ 451 $ 715 $ 1,877 $ 4,170 | Total expense for stock option grants recognized was as follows: Year Ended December 31, 2018 2017 General and administrative $ 4,611 $ 1,753 Research and development 201 362 $ 4,812 $ 2,115 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of significant components of deferred tax assets | Significant components of the Company's deferred tax assets are as follows: December 31, 2018 2017 Deferred tax assets: Net operating losses $ 47,877 $ 45,791 Research and other credits 2,178 2,178 Stock based compensation 2,682 1,585 In-process research and development 1,314 1,375 Other 708 676 Total deferred tax assets 54,759 51,605 Valuation allowance (54,759 ) (51,605 ) Net deferred tax assets $ - $ - |
Schedule of reconciliation of the statutory tax rates and the effective tax rates | A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 2018 and 2017 is as follows: Year Ended December 31, 2018 2017 Statutory rate 21.0 % 34.0 % Valuation allowance (26.4 )% 57.6 % Nondeductible stock compensation 0.1 % (0.1 )% Deferred tax expense from enacted rate reduction - % (98.7 )% Other 5.3 % 7.2 % Effective tax rate - % - % |
Reconciliation of beginning and ending amount of unrecognized tax benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Balance at December 31, 2016 $ 1,127 Additions based on tax positions related to prior year (67 ) Additions based on tax positions related to current year - Balance at December 31, 2017 1,060 Additions based on tax positions related to prior year - Additions based on tax positions related to current year - Balance at December 31, 2018 $ 1,060 |
Nature of Operations (Details)
Nature of Operations (Details) $ in Thousands | Jun. 04, 2018USD ($)shares | Mar. 12, 2018USD ($)shares | Sep. 30, 2019USD ($)itemshares | Sep. 19, 2018USD ($) | Feb. 27, 2018USD ($)shares | Aug. 31, 2018USD ($) | Sep. 30, 2019USD ($)shares | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($)itemshares | Dec. 31, 2017USD ($)shares |
Accumulated deficit | $ 282,869 | $ 282,869 | $ 274,601 | $ 262,597 | ||||||
Number of product candidates approved for sale | item | 0 | 0 | ||||||||
Total liabilities | $ 13,260 | 13,260 | $ 9,480 | $ 26,006 | ||||||
Working capital deficit | $ 9,700 | $ 9,700 | $ 7,000 | |||||||
Common share issued | shares | 400,000 | 2,445,557 | 112,780,386 | 91,815,517 | 112,780,386 | 109,897,526 | 14,946,712 | |||
Cash proceeds from issuance of common stock | $ 1,500 | |||||||||
Proceeds from issuance of common stock | $ 200 | $ 1,100 | $ 2,781 | $ 2,781 | ||||||
Proceeds from advance notes | $ 900 | $ 1,700 | $ 925 | $ 925 | ||||||
Convertible Promissory Note [Member] | ||||||||||
Proceeds from advance notes | $ 2,500 |
Chapter 11 Filing (Narrative) (
Chapter 11 Filing (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 11, 2018 | |
Cash payment for reorganization items | $ 0 | $ 100 | $ 0 | $ 200 | $ 200 | $ 900 | |
Financial Reporting In Reorganization [Member] | |||||||
Write off claim reduce in settlement | $ 200 | ||||||
Subject To Review By Bankruptcy Court [Member] | |||||||
Disallowed bankruptcy claims, amount | $ 500 |
Chapter 11 Filing (Reorganizati
Chapter 11 Filing (Reorganization Items, Net) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Chapter 11 Filing Reorganization Items Net | ||||||
Legal fees | $ 32 | $ 85 | $ 119 | $ 297 | ||
Professional fees | 8 | 21 | 26 | 34 | ||
Total reorganization items, net | $ 40 | $ 106 | $ 145 | $ 331 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)itemshares | Dec. 31, 2017USD ($) | |
Accounting Policies [Abstract] | ||
Restricted cash current, standby letters of credit | $ 70 | $ 100 |
Issuance of letters of credit for insurance policy coverage | 50 | 50 |
Restricted cash related credit card facility | $ 20 | $ 50 |
Property and equipment, estimated useful lives | 3 years | |
Issuance of warrant to purchase shares of common stock | shares | 331,193 | |
Number of operating segments | item | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Fair Value of Financial Instruments) (Details) - Fair Value Measurements Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Estimate Of Fair Value Fair Value Disclosure [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | $ 71 | $ 71 | $ 101 |
Money Market Funds [Member] | Estimate Of Fair Value Fair Value Disclosure [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | 71 | 71 | 101 |
Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | 71 | 71 | 101 |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | 71 | 71 | 101 |
Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Potentially Dilutive Securities) (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computations of diluted net loss per common share | 15,470,567 | 15,882,216 | 15,740,550 | 2,779,576 |
Options to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computations of diluted net loss per common share | 15,139,374 | 15,551,023 | 15,409,357 | 2,448,383 |
Warrants to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computations of diluted net loss per common share | 331,193 | 331,193 | 331,193 | 331,193 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (composition of cash, cash equivalents and restricted cash) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 157 | $ 814 | $ 2,038 | $ 737 |
Restricted cash | 71 | 71 | 71 | 101 |
Total cash, cash equivalents and restricted cash as shown on statement of cash flows | $ 228 | $ 885 | $ 2,109 | $ 838 |
Leases (Details)
Leases (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Leases [Abstract] | ||
Monthly lease | $ 1,000 | |
Lease costs | $ 3,400 | $ 9,800 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 71 | $ 101 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 71 | 101 |
Cash And Cash Equivalents [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | ||
Restricted Cash [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 71 | 101 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 71 | 101 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | $ 71 | $ 101 |
Potentially Dilutive Securiti_3
Potentially Dilutive Securities (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computations of diluted net loss per common share | 15,470,567 | 15,882,216 | 15,740,550 | 2,779,576 |
Options to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computations of diluted net loss per common share | 15,139,374 | 15,551,023 | 15,409,357 | 2,448,383 |
Warrants to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computations of diluted net loss per common share | 331,193 | 331,193 | 331,193 | 331,193 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation and amortization | $ (216) | $ (197) |
Property and equipment, net | 19 | |
Computer equipment and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 216 | $ 216 |
Property and Equipment (Narrati
Property and Equipment (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 20 | $ 50 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Fair Value of Financial Assets) (Details) - Fair Value Measurements Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | $ 71 | $ 71 | $ 101 |
Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | 71 | 71 | 101 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | |||
Estimate Of Fair Value Fair Value Disclosure [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | 71 | 71 | 101 |
Estimate Of Fair Value Fair Value Disclosure [Member] | Money Market Funds [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Total assets measured at fair value | $ 71 | $ 71 | $ 101 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 02, 2019 | May 30, 2019 | Sep. 19, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Aug. 31, 2018 | Jun. 28, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 21, 2016 | Apr. 23, 2019 | Dec. 21, 2017 | Dec. 04, 2017 | Jun. 30, 2016 |
Debt Instrument [Line Items] | ||||||||||||||||
Notes payable to vendors | $ 1,351 | |||||||||||||||
Accrued interest | 1,032 | |||||||||||||||
Debt instrument amount | $ 5,000 | |||||||||||||||
Proceeds from advance notes | $ 900 | $ 1,700 | $ 925 | 925 | ||||||||||||
Percentage of accrued interest | 7.00% | |||||||||||||||
Common stock conversion price | $ 0.45 | $ 0.45 | ||||||||||||||
Intrinsic value of this beneficial conversion feature | $ 1,465 | 143 | 1,465 | 1,465 | ||||||||||||
Proceeds from convertible debt | 1,275 | 2,500 | 2,500 | |||||||||||||
Issuance of common stock upon note conversions shares | 2,179,622 | |||||||||||||||
Interest Expense | $ 343 | $ 116 | $ 1,003 | $ 542 | $ 852 | 3,056 | ||||||||||
2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Term loan interest rate | 7.00% | |||||||||||||||
Debt instrument amount | $ 1,700 | |||||||||||||||
Proceeds from advance notes | $ 750 | |||||||||||||||
Maturity Date | Oct. 1, 2019 | |||||||||||||||
2019 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Term loan interest rate | 7.50% | |||||||||||||||
Debt instrument amount | $ 1,300 | |||||||||||||||
Convertible Promissory Note [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from advance notes | $ 2,500 | |||||||||||||||
Proceeds from convertible debt | $ 10,000 | |||||||||||||||
Convertible Promissory Note [Member] | Black Horse Capital LP [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Term loan interest rate | 7.00% | |||||||||||||||
Debt instrument amount | $ 2,500 | |||||||||||||||
Credit Agreement Term Loan [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Interest rate | 14.00% | |||||||||||||||
Credit Agreement [Member] | Bridge Loan [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Interest rate | 14.00% | |||||||||||||||
Debt instrument amount | $ 1,500 | |||||||||||||||
Advance Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from advance notes | $ 1,700 | |||||||||||||||
Common stock conversion price | $ 0.45 | |||||||||||||||
Intrinsic value of this beneficial conversion feature | $ 1,700 | |||||||||||||||
Debt discount amortization | 300 | |||||||||||||||
Advance Notes [Member] | 2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from advance notes | 950 | |||||||||||||||
Advance Notes [Member] | 2018 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Common stock conversion price | $ 0.45 | |||||||||||||||
Intrinsic value of this beneficial conversion feature | $ 1,800 | |||||||||||||||
Debt discount amortization | $ 200 | |||||||||||||||
Remaining Discount Amortization Period | 12 months | |||||||||||||||
Advance Notes [Member] | 2019 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Common stock conversion price | $ 1.25 | |||||||||||||||
Intrinsic value of this beneficial conversion feature | $ 1,800 | |||||||||||||||
Debt discount amortization | $ 600 | |||||||||||||||
Remaining Discount Amortization Period | 19 months | |||||||||||||||
Qualified Financing [Member] | 2018 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from convertible debt | $ 10,000 | |||||||||||||||
Conversion price | $ 0.45 | $ 0.45 | ||||||||||||||
Qualified Financing [Member] | 2019 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from convertible debt | $ 10,000 | |||||||||||||||
Conversion price | 1.25 | $ 1.25 | ||||||||||||||
Non Qualified Financing [Member] | 2018 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from convertible debt | $ 10,000 | |||||||||||||||
Conversion price | 0.45 | $ 0.45 | ||||||||||||||
Non Qualified Financing [Member] | 2019 Convertible Notes Payable [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from convertible debt | $ 10,000 | |||||||||||||||
Conversion price | $ 1.25 | $ 1.25 | ||||||||||||||
Bona Fide Financing Transaction [Member] | 2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from advance notes | $ 3,000 | |||||||||||||||
Nomis Bay LTD [Member] | 2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument amount | 750 | |||||||||||||||
Cameron Durrant [Member] | 2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument amount | 750 | |||||||||||||||
Chief Executive Officer [Member] | 2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument amount | $ 200 | |||||||||||||||
December 2016 Term Loan [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Term loan interest rate | 9.00% | |||||||||||||||
Notes Payable To Vendors [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Interest rate | 10.00% | |||||||||||||||
Notes payable to vendors | $ 1,200 | |||||||||||||||
Accrued interest | 400 | $ 300 | $ 200 | |||||||||||||
Notes Payable To Vendors [Member] | 2019 Bridge Notes [Member] | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Accrued interest | $ 1,100 | |||||||||||||||
Debt instrument amount | $ 500 |
Debt (Term Loans consisted) (De
Debt (Term Loans consisted) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Original Principal Amount | $ 16,308 | |
Accrued Interest | 1,032 | |
Loan Balance | 17,340 | |
Fees | 678 | |
Balance Due | 18,018 | |
December 2016 Loan [Member] | ||
Original Principal Amount | 3,315 | |
Accrued Interest | 324 | |
Loan Balance | 3,639 | |
Fees | 153 | |
Balance Due | 3,792 | |
March 2017 Loan [Member] | ||
Original Principal Amount | 5,978 | |
Accrued Interest | 452 | |
Loan Balance | 6,430 | |
Fees | 275 | |
Balance Due | 6,705 | |
July 2017 Loan [Member] | ||
Original Principal Amount | 5,435 | |
Accrued Interest | 249 | |
Loan Balance | 5,684 | |
Fees | 250 | |
Balance Due | 5,934 | |
Bridge Loan [Member] | ||
Original Principal Amount | 1,500 | |
Accrued Interest | 6 | |
Loan Balance | 1,506 | |
Fees | ||
Balance Due | 1,506 | |
Claims Advances Loan [Member] | ||
Original Principal Amount | 80 | |
Accrued Interest | 1 | |
Loan Balance | 81 | |
Fees | ||
Balance Due | $ 81 |
Warrants to Purchase Common S_2
Warrants to Purchase Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 06, 2015 | Jun. 19, 2013 | |
Class of Warrant or Right [Line Items] | |||||
Issuance of warrant to purchase shares of common stock | 331,193 | ||||
Reduction of expense warrant | $ 100 | ||||
Warrant [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Issuance of warrant to purchase shares of common stock | 125,000 | 6,193 | |||
Exercise price of warrants issued (in dollars per share) | $ 29.32 | $ 96.88 | |||
Savant Warrant [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Issuance of warrant to purchase shares of common stock | 200,000 | ||||
Exercise price of warrants issued (in dollars per share) | $ 2.25 | ||||
Warrants initial fair value | $ 700 | ||||
Term of issuance of warrant | 5 years | ||||
Percentage of warrant exercisable | 25.00% |
Commitments and Contingencies (
Commitments and Contingencies (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Other Commitments [Line Items] | |||
Rent expense | $ 200 | $ 300 | |
San Francisco Lease [Member] | |||
Other Commitments [Line Items] | |||
Expiration date | Sep. 30, 2017 |
Stockholders' Equity (Equity In
Stockholders' Equity (Equity Incentive Plan) (Details) - USD ($) | Jun. 04, 2018 | Mar. 12, 2018 | Mar. 09, 2018 | Sep. 13, 2016 | Feb. 27, 2018 | Dec. 22, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 21, 2017 | Dec. 27, 2018 | Feb. 28, 2018 | Sep. 30, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Common stock available for issuance | 19,929,606 | |||||||||||||
Common share issued | 400,000 | 2,445,557 | 91,815,517 | 112,780,386 | 109,897,526 | 14,946,712 | ||||||||
Total proceeds | $ 200,000 | $ 1,100,000 | $ 2,781,000 | $ 2,781,000 | ||||||||||
Authorized shares of Common Stock | 225,000,000 | 225,000,000 | 85,000,000 | |||||||||||
Common Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Authorized shares of Common Stock | 225,000,000 | |||||||||||||
Preferred Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Authorized shares of Common Stock | 25,000,000 | |||||||||||||
2012 Equity Incentive Plan [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period expiration | 10 years | 10 years | ||||||||||||
Additional shares authorized | 7,500,000 | 3,000,000 | 4,189,056 | |||||||||||
Authorized shares of Common Stock | 16,050,000 | |||||||||||||
2012 Equity Incentive Plan [Member] | Minimum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 3 years | 3 years | ||||||||||||
2012 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 4 years | 4 years | ||||||||||||
Common stock available for issuance | 125,000 | 1,100,000 | ||||||||||||
Black Horse Capital, L.P [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Term Loan | $ 18,400,000 | |||||||||||||
Stock issued | 32,028,669 | |||||||||||||
Total consideration | $ 3,000,000 | |||||||||||||
Black Horse Capital, L.P [Member] | New Lender Shares [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock issued | 59,786,848 | |||||||||||||
Benz Assets [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Legal fees | $ 300,000 | |||||||||||||
Initial investment | $ 0 | |||||||||||||
Nomis Bay [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Term Loan | $ 18,400,000 | $ 3,000,000 | ||||||||||||
Percentage owned | 70.00% | |||||||||||||
Claims advances | $ 100,000 | |||||||||||||
Accrued interest and fees | 8,500,000 | |||||||||||||
Common stock held | $ 33,573,530 | |||||||||||||
Percentage of outstanding common stock | 31.40% | |||||||||||||
New Lender Shares [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock issued | 59,786,848 | |||||||||||||
Madison [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Legal fees | $ 300,000 | |||||||||||||
Percentage owned | 30.00% | |||||||||||||
New Black Horse Shares [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Term Loan | $ 9,900,000 | |||||||||||||
Stock issued | 32,028,669 | |||||||||||||
Total consideration | $ 3,000,000 | |||||||||||||
Common stock held | $ 66,870,851 | |||||||||||||
Percentage of outstanding common stock | 62.60% | |||||||||||||
Bridge Loan [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Total consideration | $ 1,500,000 |
Stockholders' Equity (Schedule
Stockholders' Equity (Schedule of Shares of Common Stock Reserved for Issuance) (Details) - USD ($) | Mar. 09, 2018 | Sep. 13, 2016 | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Issuance of warrant to purchase shares of common stock | 331,193 | |||||
Total common stock reserved for future issuance | 19,929,606 | |||||
Total fair value of options vested | $ 4,800,000 | $ 2,100,000 | ||||
Weighted-average fair value of options granted during the period | $ 1.10 | $ 0.47 | $ 1.54 | |||
Weighted-average period | 1 year 8 months 12 days | 1 year 4 months 24 days | ||||
Unrecognized compensation expense | $ 1,000,000 | $ 2,800,000 | ||||
Authorized shares of Common Stock | 225,000,000 | 225,000,000 | 85,000,000 | |||
2012 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Option outstanding | 15,408,997 | |||||
Available for future grants | 7,500,000 | 3,000,000 | 4,189,056 | |||
Vesting period expiration | 10 years | 10 years | ||||
Authorized shares of Common Stock | 16,050,000 | |||||
2012 Equity Incentive Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Total common stock reserved for future issuance | 125,000 | 1,100,000 | ||||
Vesting period | 4 years | 4 years | ||||
2012 Equity Incentive Plan [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 3 years | 3 years | ||||
2001 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Option outstanding | 360 | |||||
2001 Stock Option Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized to be issued under the plan | 426,030 |
Stockholders' Equity (Stock Opt
Stockholders' Equity (Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||||
Number of Shares | ||||||
Balance at the beginning of the period (in shares) | 15,409,357 | 2,448,383 | 1,835,835 | |||
Options granted (in shares) | 728,610 | 13,575,038 | 765,000 | |||
Options exercised (in shares) | (488,625) | |||||
Options forfeited (in shares) | (509,923) | (572,935) | (152,365) | |||
Options expired (in shares) | (45) | (41,129) | (87) | |||
Balance at the end of the period (in shares) | 15,139,374 | 15,409,357 | 2,448,383 | |||
Options vested and expected to vest at the end of the period (in shares) | 15,356,965 | |||||
Options exercisable (in shares) | 10,283,026 | |||||
Weighted-Average Exercise Price (Per Share) | ||||||
Balance at the beginning of the period (in dollars per share) | [1] | $ 0.95 | $ 4.15 | $ 19.29 | ||
Options granted (in dollars per share) | 1.10 | 0.66 | [1] | 3.38 | [1] | |
Options exercised (in dollars per share) | 0.67 | |||||
Options forfeited (in dollars per share) | 0.62 | 3.20 | [1] | 5.86 | [1] | |
Options expired (in dollars per share) | 9.68 | 37.82 | [1] | 18.38 | [1] | |
Balance at the ending of the period (in dollars per share) | $ 0.97 | 0.95 | [1] | $ 4.15 | [1] | |
Options vested and expected to vest at the end of the period (in dollars per share) | [1] | 0.95 | ||||
Options exercisable (in dollars per share) | [1] | $ 1.01 | ||||
Weighted-Average Remaining Contractual Term (in years) | ||||||
Balance at the end of the period | 9 years | |||||
Options vested and expected to vest at the end of the period | 9 years | |||||
Options exercisable | 9 years | |||||
Aggregate Intrinsic Value (in thousands) | ||||||
Balance at the end of the period | [2] | $ 576 | ||||
Options vested and expected to vest at the end of the period | [2] | 574 | ||||
Options exercisable | [2] | $ 379 | ||||
[1] | The weighted average price per share is determined using exercise price per share for stock options. | |||||
[2] | The aggregate intrinsic value is calculated as the difference between the exercise price of the option and the fair value of the Company's common stock for in-the-money options at December 31, 2018. |
Stockholders' Equity (Options O
Stockholders' Equity (Options Outstanding and Exercisable By Price Range) (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Stock Options Outstanding | |
Number of Shares | shares | 15,409,357 |
Weighted Average Remaining Contractual Life | 9 years 15 days |
Weighted Average Exercise Price (in dollars per share) | $ 0.95 |
Stock Options Exercisable | |
Number of Shares | shares | 10,283,026 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 1.01 |
Exercise Price Range From $0.33 - $0.67 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 0.33 |
Exercise Price, high end of range (in dollars per share) | $ 0.67 |
Stock Options Outstanding | |
Number of Shares | shares | 13,725,038 |
Weighted Average Remaining Contractual Life | 9 years 2 months 8 days |
Weighted Average Exercise Price (in dollars per share) | $ 0.66 |
Stock Options Exercisable | |
Number of Shares | shares | 8,922,798 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 0.66 |
Exercise Price Range From $1.91 To $3.30 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 1.91 |
Exercise Price, high end of range (in dollars per share) | $ 3.30 |
Stock Options Outstanding | |
Number of Shares | shares | 370,000 |
Weighted Average Remaining Contractual Life | 8 years 1 month 6 days |
Weighted Average Exercise Price (in dollars per share) | $ 2.97 |
Stock Options Exercisable | |
Number of Shares | shares | 361,666 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 2.97 |
Exercise Price Range From $3.38 To $3.38 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 3.38 |
Exercise Price, high end of range (in dollars per share) | $ 3.38 |
Stock Options Outstanding | |
Number of Shares | shares | 1,263,022 |
Weighted Average Remaining Contractual Life | 7 years 8 months 16 days |
Weighted Average Exercise Price (in dollars per share) | $ 3.38 |
Stock Options Exercisable | |
Number of Shares | shares | 947,265 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 3.38 |
Exercise Price Range From $3.40 To $4.72 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 3.40 |
Exercise Price, high end of range (in dollars per share) | $ 4.72 |
Stock Options Outstanding | |
Number of Shares | shares | 50,625 |
Weighted Average Remaining Contractual Life | 7 years 9 months 7 days |
Weighted Average Exercise Price (in dollars per share) | $ 3.40 |
Stock Options Exercisable | |
Number of Shares | shares | 50,625 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 3.40 |
Exercise Price Range From $8.24 To $17.36 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 8.24 |
Exercise Price, high end of range (in dollars per share) | $ 17.36 |
Stock Options Outstanding | |
Number of Shares | shares | 360 |
Weighted Average Remaining Contractual Life | 1 year 9 months 11 days |
Weighted Average Exercise Price (in dollars per share) | $ 12.53 |
Stock Options Exercisable | |
Number of Shares | shares | 360 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 12.53 |
Exercise Price Range From $42.88 To $48.00 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 42.88 |
Exercise Price, high end of range (in dollars per share) | $ 48 |
Stock Options Outstanding | |
Number of Shares | shares | 312 |
Weighted Average Remaining Contractual Life | 4 years 9 months 3 days |
Weighted Average Exercise Price (in dollars per share) | $ 45.17 |
Stock Options Exercisable | |
Number of Shares | shares | 312 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 45.17 |
Stockholders' Equity (Weighted-
Stockholders' Equity (Weighted-Average Assumption) (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Dividend yield | 0.00% | 0.00% | |
Minimum [Member] | |||
Exercise price | $ 0.84 | ||
Market value | $ 0.84 | ||
Risk-free rate | 2.49% | ||
Expected term | 6 years | 5 years | 5 years |
Expected volatility | 99.10% | ||
Maximum [Member] | |||
Exercise price | $ 1.30 | ||
Market value | $ 1.30 | ||
Risk-free rate | 2.59% | ||
Expected term | 6 years | 6 years | |
Expected volatility | 99.30% |
Stockholders' Equity (Fair Valu
Stockholders' Equity (Fair Value Assumptions) (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Expected volatility, minimum (as a percent) | 93.00% | 83.00% | |
Expected volatility, maximum (as a percent) | 97.00% | 88.00% | |
Risk-free interest rate, minimum (as a percent) | 2.70% | 1.80% | |
Risk-free interest rate, maximum (as a percent) | 2.80% | 2.10% | |
Expected dividend yield (as a percent) | 0.00% | 0.00% | |
Minimum [Member] | |||
Expected term | 6 years | 5 years | 5 years |
Maximum [Member] | |||
Expected term | 6 years | 6 years |
Stockholders' Equity (Stock-Bas
Stockholders' Equity (Stock-Based Compensation Expense Recognized) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | $ 451,000 | $ 715,000 | $ 1,877,000 | $ 4,170,000 | $ 4,812,000 | $ 2,115,000 |
Unrecognized compensation expense | 1,000,000 | $ 1,000,000 | $ 2,800,000 | |||
Weighted average period for recognition | 1 year 8 months 12 days | 1 year 4 months 24 days | ||||
Options issued to purchase of common stock | 331,193 | |||||
Weighted average fair value of options granted | $ 1.10 | $ 0.47 | $ 1.54 | |||
General And Administrative Expense [Member] | ||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | 419,000 | 715,000 | $ 1,813,000 | 3,969,000 | $ 4,611,000 | $ 1,753,000 |
Research And Development Expense [Member] | ||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | $ 32,000 | $ 64,000 | $ 201,000 | $ 201,000 | $ 362,000 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | |
Jul. 19, 2019 | May 30, 2019 | Sep. 30, 2019 | |
Mayo Agreement [Member] | |||
Amount paid in license agreement | $ 200 | ||
Kite Agreement [Member] | |||
Amount paid in license agreement | $ 8,000 | ||
Zurich Agreement [Member] | |||
Amount paid in license agreement | $ 100 | ||
Zurich Agreement [Member] | Research And Development Expense [Member] | |||
Amount paid in license agreement | $ 1,000 |
Savant Arrangements (Details)
Savant Arrangements (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 10, 2017 | May 26, 2017 | Jun. 30, 2016 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2019 | Jun. 30, 2017 |
Number of shares called by warrant | 331,193 | ||||||||||
Milestone payments and certain other contingent payments | $ 2,000 | $ 2,000 | |||||||||
Aggregate cost overages | $ 4,100 | $ 3,400 | |||||||||
Net of duductible | 500 | ||||||||||
Due to Savant | $ 2,000 | $ 2,000 | 2,000 | $ 2,100 | 2,000 | ||||||
Research and development | $ 1,000 | $ 1,000 | $ 549 | $ 535 | $ 2,142 | $ 1,808 | $ 2,219 | $ 11,165 | |||
Savant Neglected Diseases, LLC [Member] | |||||||||||
Number of shares called by warrant | 200,000 | 100,000 | 100,000 | ||||||||
Exercise price of warrant | $ 2.25 | $ 2.25 | $ 2.25 | ||||||||
Exercise period of warrant | 5 years | ||||||||||
Due from Savant | $ 1,400 | ||||||||||
Savant Neglected Diseases, LLC [Member] | Exercisable Immediately [Member] | |||||||||||
Percentage of warrants exercisable | 25.00% |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Dec. 22, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Increase (decrease) in valuation allowance | $ 3.2 | $ 12.6 | |
Income tax expense | $ 21.6 | ||
Income tax benefit | $ 21.6 | ||
Federal Statutory Income Tax Rate | 21.00% | 34.00% | |
Minimum [Member] | |||
Federal Statutory Income Tax Rate | 21.00% | ||
Maximum [Member] | |||
Federal Statutory Income Tax Rate | 35.00% | ||
Internal Revenue Service I R S [Member] | |||
Net operating loss carryforwards | $ 166.2 | ||
Internal Revenue Service I R S [Member] | Research [Member] | |||
Tax credit carryforwards | $ 1.3 | ||
Internal Revenue Service I R S [Member] | Minimum [Member] | |||
Expiration year | Dec. 31, 2021 | ||
Internal Revenue Service I R S [Member] | Minimum [Member] | Research [Member] | |||
Expiration year | Dec. 31, 2022 | ||
Internal Revenue Service I R S [Member] | Maximum [Member] | |||
Expiration year | Dec. 31, 2037 | ||
Internal Revenue Service I R S [Member] | Maximum [Member] | Research [Member] | |||
Expiration year | Dec. 31, 2035 | ||
State And Local Jurisdiction [Member] | |||
Net operating loss carryforwards | $ 163.9 | ||
State And Local Jurisdiction [Member] | Research [Member] | |||
Tax credit carryforwards | $ 2.2 | ||
State And Local Jurisdiction [Member] | Minimum [Member] | |||
Expiration year | Dec. 31, 2018 | ||
State And Local Jurisdiction [Member] | Maximum [Member] | |||
Expiration year | Dec. 31, 2038 | ||
Federal Jurisdiction [Member] | |||
Net operating loss carryforwards | $ 7.3 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 22, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Deferred tax assets: | |||
Income Tax Expense (Benefit) | $ 21,600 | ||
Net operating losses | $ 47,877 | $ 45,791 | |
Research and other credits | 2,178 | 2,178 | |
Stock based compensation | 2,682 | 1,585 | |
In-process research and development | 1,314 | 1,375 | |
Other | 708 | 676 | |
Total deferred tax assets | 54,759 | 51,605 | |
Valuation allowance | (54,759) | (51,605) | |
Net deferred tax assets | |||
Domestic Country [Member] | |||
Deferred tax assets: | |||
Income Tax Expense (Benefit) | $ 0 | $ 0 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of the Statutory Tax Rates and Effective Tax Rates) (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of the statutory tax rates and the effective tax rates | ||
Statutory rate | 21.00% | 34.00% |
Valuation allowance | (26.40%) | 57.60% |
Nondeductible stock compensation | 0.10% | (0.10%) |
Deferred tax expense from enacted rate reduction | (98.70%) | |
Other | 5.30% | 7.20% |
Effective tax rate |
Income Taxes (Reconciliation _2
Income Taxes (Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of the beginning and ending amount of unrecognized tax benefits | ||
Balance at the beginning of the period | $ 1,060 | $ 1,127 |
Additions based on tax positions related to prior year | (67) | |
Additions based on tax positions related to current year | ||
Balance at the end of the period | $ 1,060 | $ 1,060 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Retirement Benefits [Abstract] | |
Employer contributions | $ 0 |
Litigation (Details)
Litigation (Details) - Savant Neglected Diseases, LLC [Member] - USD ($) $ in Thousands | 1 Months Ended | |
Jun. 30, 2017 | Dec. 31, 2017 | |
Aggregate cost | $ 3,400 | |
Deductible | 500 | |
Offset payment due | 2,000 | |
Amount owed | $ 1,400 | |
Accrued expense | $ 2,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 19, 2018 | Aug. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Proceeds from advance notes | $ 900 | $ 1,700 | $ 925 | $ 925 | ||
Debt instrument amount | $ 5,000 | |||||
Convertible Promissory Note [Member] | ||||||
Proceeds from advance notes | $ 2,500 | |||||
Convertible Promissory Note [Member] | Black Horse Capital LP [Member] | ||||||
Debt instrument amount | $ 2,500 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 08, 2019 | Oct. 08, 2019 | Nov. 12, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | Aug. 31, 2018 | Dec. 31, 2017 |
Par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Debt amount | $ 5,000 | ||||||
Subsequent Event [Member] | |||||||
Debt amount | $ 350 | ||||||
Subsequent Event [Member] | 2019 Bridge Notes [Member] | |||||||
Maturity date | Dec. 31, 2019 | ||||||
Subsequent Event [Member] | Lincoln Park [Member] | |||||||
Amount authorized | $ 20,000 | ||||||
Par value | $ 0.001 | ||||||
Shares issued | 706,592 |