Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2019 | |
Document and Entity Information | |
Document Type | POS AM |
Amendment Flag | true |
Amendment description | Humanigen, Inc., a Delaware corporation (the “Company”), filed a Registration Statement on Form S-1 on November 20, 2019, which was declared effective on December 2, 2019 (as amended and supplemented, the “Registration Statement”). This Post-Effective Amendment No. 1 to Form S-1 is being filed in order to update the prospectus forming a part of the Registration Statement based on information disclosed in the Company’s Annual Report on Form 10-K initially filed with the Securities and Exchange Commission on March 16, 2020. |
Document Period End Date | Dec. 31, 2019 |
Entity Registrant Name | HUMANIGEN, INC |
Entity Central Index Key | 0001293310 |
Entity Filer Category | Non-accelerated Filer |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 143 | $ 814 |
Prepaid expenses and other current assets | 309 | 485 |
Total current assets | 452 | 1,299 |
Restricted cash | 71 | 71 |
Total assets | 523 | 1,370 |
Current liabilities: | ||
Accounts payable | 5,046 | 2,856 |
Accrued expenses | 3,308 | 3,129 |
Advance notes | 2,113 | 807 |
Convertible notes - current | 2,033 | |
Notes payable to vendors | 1,094 | 1,471 |
Total current liabilities | 13,594 | 8,263 |
Convertible notes - non current | 1,247 | 1,217 |
Total liabilities | 14,841 | 9,480 |
Stockholders' deficit: | ||
Common stock, $0.001 par value: 225,000,000 shares authorized at December 31, 2019 and December 31, 2018; 114,034,451 and 109,897,526 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 114 | 110 |
Additional paid-in capital | 270,463 | 266,381 |
Accumulated deficit | (284,895) | (274,601) |
Total stockholders' deficit | (14,318) | (8,110) |
Total liabilities and stockholders' deficit | $ 523 | $ 1,370 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 114,034,451 | 109,897,526 |
Common stock, shares outstanding | 114,034,451 | 109,897,526 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 2,616 | $ 2,219 |
General and administrative | 6,328 | 9,112 |
Total operating expenses | 8,944 | 11,331 |
Loss from operations | (8,944) | (11,331) |
Other expense: | ||
Interest expense | (1,349) | (852) |
Other income (expense), net | (1) | 324 |
Reorganization items, net | (145) | |
Net loss | (10,294) | (12,004) |
Other comprehensive income | ||
Comprehensive loss | $ (10,294) | $ (12,004) |
Basic and diluted net loss per common share | $ (0.09) | $ (0.13) |
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 111,806,251 | 94,756,375 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balances at Dec. 31, 2017 | $ 15 | $ 238,246 | $ (262,597) | $ (24,336) |
Balances (in shares) at Dec. 31, 2017 | 14,946,712 | |||
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 | $ 19 | 2,762 | 2,781 | |
Issuance of common stock (in shares) | 18,653,320 | |||
Issuance of common stock in connection with financing agreement | ||||
Issuance of common stock in connection with financing agreement (in shares) | 30,000 | |||
Beneficial conversion feature of Advance Notes | 271 | 271 | ||
Beneficial conversion feature of Convertible Notes | 1,465 | 1,465 | ||
Issuance of stock options for payment of accrued compensation | 303 | 303 | ||
Issuance of common stock in lieu of cash compensation | 85 | 85 | ||
Issuance of common stock in lieu of cash compensation (in shares) | 151,407 | |||
Issuance of common stock in exchange for services | 81 | 81 | ||
Issuance of common stock in exchange for services (in shares) | 108,333 | |||
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 | 109,897,526 | |||
Issuance of common stock | $ 1 | 185 | 186 | |
Issuance of common stock (in shares) | 500,000 | |||
Issuance of common stock in connection with financing agreement | $ 1 | (1) | ||
Issuance of common stock in connection with financing agreement (in shares) | 706,592 | |||
Beneficial conversion feature of Advance Notes | ||||
Beneficial conversion feature of Convertible Notes | 143 | |||
Issuance of stock options for payment of accrued compensation | 207 | 207 | ||
Issuance of common stock for payment of accrued compensation | 137 | 137 | ||
Issuance of common stock for payment of accrued compensation (in shares) | 152,223 | |||
Issuance of common stock in lieu of cash compensation | 137 | |||
Issuance of common stock in exchange for services | 83 | 83 | ||
Issuance of common stock in exchange for services (in shares) | 109,863 | |||
Issuance of common stock upon note conversions | $ 2 | 979 | 981 | |
Issuance of common stock upon note conversions (in shares) | 2,179,622 | |||
Convertible note beneficial conversion feature | 143 | 143 | ||
Exercise of common stock options | 324 | 324 | ||
Exercise of common stock options (in shares) | 488,625 | |||
Stock-based compensation expense | 2,025 | 2,025 | ||
Comprehensive loss | (10,294) | (10,294) | ||
Balances at Dec. 31, 2019 | $ 114 | $ 270,463 | $ (284,895) | $ (14,318) |
Balances (in shares) at Dec. 31, 2019 | 114,034,451 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | ||
Net loss | $ (10,294) | $ (12,004) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 19 | |
Noncash interest expense | 1,295 | 819 |
Stock based compensation expense | 2,025 | 4,812 |
Issuance of common stock for payment of accrued compensation | 137 | 85 |
Issuance of common stock in exchange for services | 83 | 81 |
Gain on disposal of assets | (276) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 176 | 328 |
Accounts payable | 2,190 | (198) |
Accrued expenses | 387 | 125 |
Net cash used in operating activities | (4,001) | (6,209) |
Financing activities: | ||
Net proceeds from issuance of common stock | 185 | 2,781 |
Net proceeds from term loan | 50 | |
Proceeds from exercise of stock options | 325 | |
Net proceeds from issuance of Convertible notes | 1,275 | 2,500 |
Net proceeds from issuance of Advance notes | 2,050 | 925 |
Payments on notes payable to vendors | (505) | |
Net cash provided by financing activities | 3,330 | 6,256 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (671) | 47 |
Cash, cash equivalents and restricted cash, beginning of period | 885 | 838 |
Cash, cash equivalents and restricted cash, end of period | 214 | 885 |
Supplemental cash flow disclosure: | ||
Cash paid for interest | 13 | 8 |
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 |
Beneficial conversion feature of Advance notes | 271 | |
Beneficial conversion feature of Convertible notes | 143 | 1,465 |
Issuance of stock options in lieu of cash compensation | 207 | 303 |
Issuance of common stock for payment of accrued compensation | 137 | 85 |
Issuance of common stock in exchange for services | $ 83 | $ 81 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Description of the Business Humanigen, Inc. (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 clinical-stage biopharmaceutical company. During 2019, the Company completed its transformation into a clinical stage biopharmaceutical company, Yescarta®” Kymriah® (“Kymriah” or “Kymriah®”) The Company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, T-cell engaging, and immunotherapy treatments to break the efficacy/toxicity linkage, including the prevention and/or treatment of graft-versus-host disease (“GvHD”) while preserving graft-versus-leukemia (“GvL”) benefits in patients undergoing allogeneic HSCT. In this context, GvHD is akin to CRS, or cytokine storm and the Company believe the mechanism to be driven by GM-CSF levels. The recent coronavirus pandemic which is due to the SARS-CoV-2 virus and leads to the condition referred to as COVID-19, is characterized in the later and sometimes fatal stages by lung dysfunction which is triggered by CRS, or cytokine storm. Recent publications point to GM-CSF being a key cytokine, with elevated levels especially in those patients who transition to the Intensive Care Unit (ICU).The Company has established several partnerships with leading institutions to advance its innovative pipeline and is in active discussion with several government and commercial organizations. The Company believes that it has a dominant intellectual property position in the area of GM-CSF neutralization through multiple approaches and mechanisms, as they pertain to CAR-T, GvHD and multiple other oncology/transplantation, inflammation, fibrosis and autoimmune conditions which may be driven by GM-CSF. The Company has also advanced its preclinical next-generation cell and gene therapies for the treatment of cancers via its novel human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) neutralization and gene-knockout platforms. As a leader in GM-CSF pathway science, the Company believes that it has the ability to transform prevention of CRS in SARS-CoV-2 infection. The virus associated with the current COVID-19 pandemic, SARS-Cov-2, is one of a group of several betacoronaviruses, which includes the viruses responsible for Severe Acute Respiratory Syndrome (SARS-CoV) and Middle East Respiratory Syndrome (MERS-CoV). These viruses infect predominantly the lower lung and cause fatal pneumonia. Other coronaviruses infect the upper respiratory tract and cause some cases of the common cold. The clinical course of COVID-19 can be mistaken for influenza infection – patients in both cases often suffer from aches and pains throughout the body, fever, cough and general malaise. COVID-19 is not typically associated with a productive cough – rather it tends to be a dry cough – and sneezing is less common. A nasal or throat swab can be used to test for SARS-CoV-2 infection, and blood tests can be run to check for viral titers. Travel to areas where COVID-19 appears to have a large number of cases and exposure to people who are known to have suffered from the condition or carriers of SARS-CoV-2 also increases the clinical suspicion of possible infection. Data generated during the SARS and MERS outbreaks point to cytokine storm as a phase of the illness which is characterized by an immune hyperactive phase, which then can progress to lung dysfunction and death. The natural history of SARS infection shows viral load actually decreases as patients enter the second phase. Recent data from China and the subject of a pre-publication titled “Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus”, supports the hypothesis that cytokine storm-induced immune mechanisms have contributed to patient mortality with the current pandemic strain of coronavirus. The severe clinical features associated with some COVID-19 infections result from an inflammation-induced lung injury requiring Intensive Care Unit (ICU) care and mechanical ventilation. This lung injury is a result of a cytokine storm resulting from a hyper-reactive immune response. The lung injury that leads to death is not directly related to the virus, but appears to be a result of a hyper-reactive immune response to the virus triggering a cytokine storm that can continue even after viral titers begin to fall. The authors of the study assessed samples from patients with severe pneumonia resulting from COVID-19 infection to identify whether inflammatory factors such as GM-CSF, G-CSF, IL-6, MCP-1, MIP 1 alpha, IFN-gamma and TNF-alpha were implicated. The authors noted that steroid treatment in such cases has been disappointing in terms of outcome, but suggested that a monoclonal antibody that targets GM-CSF may prevent or curb the hyper-active immune response caused by COVID-19 in this setting. The Company believes that the authors’ findings are worthy of further investigation, suggesting that to reduce or eradicate ICU care and prevent deaths from COVID-19 infection, an intervention may be needed to prevent cytokine storm. Separate publications confirm that cytokine storm is characterized by surge of high levels of circulating inflammatory cytokines, and is an overreaction of the immune system under the conditions, such as CAR-T therapy and patients infected with SARS-CoV-2. These recent studies revealed that high levels of GM-CSF, along with a few other cytokines, are critically associated with severe clinical complications in COVID-19 patients. High concentration of GM-CSF was found in the plasma of severe and critically ill patients, which account for approximately 20% of all patients, especially in those requiring intensive care. Lenzilumab has been shown to prevent cytokine storm in animal models and this work has been published in peer reviewed journals. Patients are expected to be enrolled soon in a clinical study to determine lenzilumab’s effect on cytokine storm associated with the hyper-active immune response associated with CAR-T therapy in collaboration with Kite Pharma. The Company believes these new data suggest that GM-CSF may be a critical triggering cytokine in the increased mortality in the current coronavirus pandemic. A potential program in COVID-19 to prevent cytokine storm is complementary to the programs in CAR-T and GvHD, which are also focused on preventing or reducing cytokine storm in those disease states. As a leader in GM-CSF pathway science, the Company believes that it has the ability to transform chimeric antigen receptor T-cell (“CAR-T”) therapy and a broad range of other T-cell engaging therapies, including both autologous and allogeneic cell transplantation. There is a direct correlation between the efficacy of CAR-T therapy and the incidence of life-threatening toxicities (referred to as the efficacy/toxicity linkage). 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 preclinical 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 U.S. FDA-approved or development stage T-cell therapies, including CAR-T therapy, as well as in combination with other cell therapies such as hematopoietic stem cell therapy (“HSCT”), to make these treatments safer and more effective. The Company has utilized a precision medicine approach and personalized the development of lenzilumab based on specific genetic mutations or biomarkers at baseline. The Company recently reported on a Phase I study of lenzilumab as monotherapy in refractory chronic myelomonocytic leukemia (CMML) and is now planning a potential Phase II study of lenzilumab in combination with azacitidine (current standard therapy) in newly diagnosed CMML patients with certain genetic mutations. The Company is also planning a potential Phase II/III study focused on early intervention with lenzilumab in patients at high risk for acute Graft versus Host Disease (GvHD) based on specific biomarkers. The Company has also reported on a Phase II study in severe asthma utilizing lenzilumab, which showed a statistically significant improvement in efficacy and favorable safety profile in patients with eosinophilic asthma, 21 of whom received lenzilumab vs. 20 patients who received placebo. 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 lead product candidate. A clinical collaboration with Kite was recently announced to evaluate the use of lenzilumab with Yescarta in a multicenter clinical trial (ZUMA-19) in adults with relapsed or refractory large B-cell lymphoma. The Company is also creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. This includes developing its own portfolio of proprietary first-in-class EphA3-CAR-Ts for various solid cancers and EMR1-CAR-Ts for various eosinophilic disorders. Lenzilumab Lenzilumab neutralizes human GM-CSF and has the potential to prevent or reduce certain serious side-effects associated with CAR-T therapy (CRS and neurotoxicity) and improve upon the efficacy of CAR-T therapy. ® There are currently no products approved by the FDA for the prevention of CRS/cytokine storm associated with COVID-19. Also there are currently no products approved by the FDA for the prevention of CAR-T therapy-related side effects, nor are there any approved therapies for the treatment of CAR-T therapty related NT. The Company is continuing to advance the development of lenzilumab in combination with CAR-T therapy through a non-exclusive clinical collaboration with Kite, pursuant to which we are conducting a multi-center Phase Ib/II study (the “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 has been designated the nomenclature ‘ZUMA-19’, consistent with the other Kite CAR-T studies, which also receive a ‘ZUMA’ designation. The primary objective of ZUMA-19 is to determine the effect of lenzilumab on the safety and efficacy of Yescarta. Kite’s Yescarta is one of two CAR-T therapies that have been approved by the FDA and is the CAR-T therapy market leader, and our collaboration with Kite is currently the only clinical collaboration which is now enrolling patients 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 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 us to generate further revenues from sales of lenzilumab. In addition to COVID-19 and 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 our current and future partners. In July 2019, the Company entered into the “Zurich Agreement” with the University of Zurich, Switzerland (“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. Several recent papers have been published which support this approach, including in Science Translational Medicine in November 2018 and in ‘blood advances’ in October 2019. The Company aims to position lenzilumab as a necessary 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 its interest in developing lenzilumab to prevent CRS/cytokine storm in COVID-19 as well as in the treatment of rare cancers and other orphan conditions such as GvHD, 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 the Mayo Agreement that it entered into in June 2019 with the 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 indicates that GM-CSF gene knockout CAR-T cells show improved overall survival in animals 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 fitter T-cells produced during expansion, increase their proliferative potential, and inhibit activation-induced cell death, thereby improving the cancer killing activity of our engineered CAR-T cells thereby making them more effective and safer in the treatment of cancers. Initial data were published in an abstract that was presented at the December 2019 American Society of Hematology (ASH) meeting and also won an ASH Abstract Achievement award. 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 has begun 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-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 IND-enabling work. The Company has published initial data from its Phase I study in an abstract that was accepted for the November 2019 Society of Neuro-Oncology (SNO) meeting, showing data in glioblastoma multiforme, a form of brain cancer. EMR1-CAR: Targeting Eosinophils The Company’s EMR1-CAR-T product is based on the HGEN005 (anti-EMR1 Humaneered monoclonal antibody) backbone and targets EMR1. Our EMR1-CAR-T based on the HGEN005 backbone is another approach in our 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 preclinical 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 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 with several other potential partners, although there is no assurance that it 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 $284.9 million as of December 31, 2019. At December 31, 2019, the Company had a working capital deficit of $13.1 million. During March, April and May of 2019, the Company received aggregate proceeds of $324,000 from the exercise of stock options by our Chairman and Chief Executive Officer and two other members of our Board of Directors. Commencing on April 23, 2019, the Company delivered a series of convertible promissory notes (the “2019 Convertible Notes”) evidencing an aggregate of $1.3 million of loans made to the Company by eleven different lenders. See Note 6 for further description of the 2019 Convertible Notes. On June 28, 2019, the Company received aggregate proceeds of $1.7 million from bridge loans made to the Company (the “June Bridge Notes”) by three 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 Nomis Bay LTD, our second largest shareholder. See Note 6 for further description of the June Bridge Notes. On November 12, 2019, the Company received aggregate proceeds of $350,000 from bridge loans made to the Company (the “November Bridge Notes”) by two parties, including Dr. Cameron Durrant, the Company’s Chairman and Chief Executive Officer and Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder. See Note 6 for further description of the November Bridge Notes. During the month of December 2019, the Company received aggregate proceeds of approximately $186,000 from the issuance of common stock to Lincoln Park Capital under the Purchase Agreement. See Note 9 for further description of the Purchase Agreement. 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 Consolidated Financial Statements for the twelve months ended December 31, 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 $14.8 million at December 31, 2019 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 | 12 Months Ended |
Dec. 31, 2019 | |
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 U.S. 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 years ended December 31, 2019 and 2018, Reorganization items, net consisted of the following charges: Year Ended December 31, 2019 2018 Legal fees $ - $ 119 Professional fees - 26 Total reorganization items, net $ - $ 145 Cash payments for reorganization items totaled $0.2 million for the year ended December 31, 2018. There were no payments for reorganization items for the year ended December 31, 2019. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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, 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, 2019 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 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 The estimated fair value of the Advance notes, Notes payable to vendors, Bridge notes and Convertible notes as of December 31, 2019 and 2018, 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, 2019 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, 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. 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 preclinical 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, 2019 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. Leases 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. The Company sub-leases office-space under a short-term lease for $300 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 years ended December 31, 2019 and 2018 totaled approximately $10,700 and $204,800, respectively and are included in the Consolidated Statements of Operations and Comprehensive Loss. Because the Company has elected to adopt the transitional practical expedients, Management 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. Stock-Based Compensation Expense The Company measures 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. 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, 2019 2018 Options to purchase common stock 15,881,721 15,409,357 Warrants to purchase common stock 331,193 331,193 16,212,914 15,740,550 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, or December 31, 2018 for the Company. Accordingly, the Company was required to adopt new accounting standards on the same timeline as other public companies effective January 1, 2018. 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: Year Ended December 31, 2019 2018 Cash and cash equivalents $ 143 $ 814 Restricted cash 71 71 Total cash, cash equivalents and restricted cash as shown on statement of $ 214 $ 885 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 adopted the standard effective January 1, 2019. The adoption of this standard did not have a material impact on the Company’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. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 4. Investments At December 31, 2019, 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, 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, long-term 71 Total investments $ 71 |
Savant Arrangements
Savant Arrangements | 12 Months Ended |
Dec. 31, 2019 | |
Savant Arrangements | |
Savant Arrangements | 5. 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 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 7. 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, 2019 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 12 below for more information regarding the Savant litigation. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Text Block [Abstract] | |
Debt | 6. 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 December 31, 2019. As of December 31, 2019 and December 31, 2018, the Company has accrued $0.3 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. The Company does not have sufficient funds to repay the principal and accrued but unpaid interest on these notes in their entirety. 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 was that the amounts due under the Advance Notes would 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 were 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 experienced a change of control or made a public announcement that it had 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 could 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 had occurred by the Expiration Date, then at any time from and after the Expiration Date the Advance Note Lenders could, 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. In accordance with their terms, on May 30, 2019, in connection with the Company’s announcement of the Kite Agreement, 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. Convertible Notes 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 Kite Agreement 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 $1.9 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 $0.8 million and $0.3 million for the years ended December 31, 2019 and 2018, respectively. Total interest expense for the Advance Notes, the 2018 Notes and the 2019 Notes for the years ended December 31, 2019 and 2018, excluding the debt discount amortization was $0.3 and $0.1 million, respectively. 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 9 and 16 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 “June 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 June 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 June 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 June 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. On December 30, 2019, the Company and the lenders agreed to extend the maturity date of the June Bridge Notes from December 31, 2019 until March 31, 2020. No other changes to the terms of the June Bridge Notes were made in connection with the extension of the maturity date. The June 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 June Bridge Notes are secured by liens of substantially all of the Company’s assets. On November 12, 2019, he Company issued two short-term, secured bridge notes (the “November Bridge Notes” and together with the June Bridge Notes, the “2019 Bridge Notes”) evidencing an aggregate of $350,000 of loans made to the Company by two parties: Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., our controlling stockholder, lent $250,000; and Cameron Durrant, M.D., MBA, our Chief Executive Officer and Chairman of our Board of Directors, lent $100,000 The November Bridge Notes rank on par with the June Bridge Notes, and possess other terms and conditions substantially consistent with those notes. The November Bridge Notes bear interest at a rate of 7.0% per annum and had an original maturity date of December 31, 2019. On December 30, 2019, the Company and the lenders agreed to extend the maturity date of the November Bridge Notes from December 31, 2019 until March 31, 2020. No other changes to the terms of the November Bridge Notes were made in connection with the extension of the maturity date. The November 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 November Bridge Notes also are secured by a lien of substantially all of the Company’s assets. Upon an event of default, which events include, but are not limited to, (1) the Company’s failure to timely pay any monetary obligation under the 2019 Bridge Notes; (2) our failure to pay our debts generally as they become due and (3) our 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. Total interest expense for the 2019 Bridge Notes for the year ended December 31, 2019 was $0.1 million. As of December 31, 2019, the maturities of the debt of the Company by year is as follows: Total 2020 2021 Principal payments on Notes payable to vendors $ 774 $ 774 $ - Interest payments on Notes payable to vendors 320 320 - Principal payments on 2019 Bridge notes 2,050 2,050 - Interest payments on 2019 Bridge notes 63 63 - Principal payments on Convertible notes 3,775 2,500 1,275 Interest payments on Convertible notes 290 224 66 Gross debt before unamortized discount 7,272 5,931 1,341 Unamortized debt discount on convertible debt (785 ) (691 ) (94 ) Total Debt $ 6,487 $ 5,240 $ 1,247 |
Warrants to Purchase Common Sto
Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2019 | |
Warrants to Purchase Common Stock | |
Warrants to Purchase Common Stock | 7. 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. As of December 31, 2019, these warrants were fully vested. 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. As of December 31, 2019, these warrants were fully vested. On June 30, 2016, in connection with the MDC Agreement described in Note 5, 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%. As of December 31, 2019, 100,000 of these warrants were fully vested and 100,000 were not vested. 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 | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. 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. The Company terminated the lease on November 19, 2019 and entered into a sub-lease agreement for space in the same building in Burlingame, California. The sub-lease initial term expires on March 31, 2020 and is renewable for additional terms by mutual agreement. As of December 31, 2019, the Company had no significant future minimum lease payments. Rent expense was $0.01 million and $0.2 million for the years ended December 31, 2019 and December 31, 2018, 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 | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 9. 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 remained unpaid in Accounts payable at December 31, 2017. On August 23, 2018 Madison elected to keep the Benz Assets and these amounts 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. Lincoln Park Capital Purchase Agreement On November 8, 2019, the Company entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right to sell to LPC up to $20,000,000 in shares of the Company’s common stock, $0.001 par value per share (the “Common Stock”), subject to certain limitations and conditions set forth in the Purchase Agreement. Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 100,000 shares of Common Stock, with such amounts increasing based on certain threshold prices but not to exceed $750,000 in total proceeds on any purchase date. The purchase price of shares of Common Stock pursuant to the Purchase Agreement will be based on the market prices of the Common Stock at the time of such purchases as set forth in the Purchase Agreement. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 36-month period expiring in December 2022. In connection with the signing of the Purchase Agreement on November 8, 2019, the Company issued 706,592 shares of its common stock to LPC. The issuance of the shares were recorded as debt issuance costs in Common stock and Additional paid-in capital with no net effect on Stockholders’ deficit. In addition to regular purchases, as described above, the Company may also direct LPC to purchase additional amounts as accelerated purchases if the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 4.99% of the Common Stock then outstanding. LPC represented to the Company, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the “Securities Act”)), and the Company sold the securities to LPC pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of, and Regulation D under, the Securities Act. The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any “event of default” under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other sale of shares to LPC until such event of default is cured. Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. In consideration for entering in the Purchase Agreement, the Company has agreed to pay to LPC a commitment fee in shares of Common Stock. The Company will not receive any cash proceeds from the issuance of these shares. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes. On November 20, 2019, the Company filed a registration statement on Form S-1. The registration statement was declared effective on December 2, 2019 and the Company filed a final prospectus on December 4, 2019. 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 authorized 25,000,000 shares of preferred stock. During the month of December 2019, the Company issued 500,000 shares of its common stock for aggregate proceeds of $0.2 million under the Purchase Agreement. The Company has reserved the following shares of common stock for issuance as of December 31, 2019: Warrants to purchase common stock 331,193 Options: Outstanding under the 2012 Equity Incentive Plan 15,881,406 Outstanding under the 2001 Equity Incentive Plan 315 Available for future grants under the 2012 Equity Incentive Plan 3,050,799 Shares reserved under the 2019 LPC Purchase Agreement 14,500,000 Total common stock reserved for future issuance 33,763,713 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, 2019, there were 3,050,799 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, 2019 and 2018: Number of Weighted Weighted- Aggregate Outstanding at January 1, 2018 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 Granted 1,470,957 0.78 Exercised (488,625 ) 0.67 Cancelled (forfeited) (509,923 ) 0.62 Cancelled (expired) (45 ) 9.68 Outstanding at December 31, 2019 15,881,721 $ 0.95 8.2 $ 49 Options vested and expected to vest 15,827,723 $ 0.95 8.2 $ 49 Exercisable 13,661,670 $ 0.99 8.0 $ 22 (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, 2019. The stock options outstanding and exercisable by exercise price at December 31, 2019 are as follows: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Number of Weighted- Weighted- Number of Weighted- $0.33 - $0.67 13,442,367 8.28 $ 0.65 11,533,358 $ 0.66 $0.84 - $1.30 755,080 9.15 $ 1.09 445,705 $ 0.94 $1.91 - $3.30 370,000 7.10 $ 2.97 368,333 $ 2.97 $3.38 - $3.38 1,263,022 6.71 $ 3.38 1,263,022 $ 3.38 $3.40 - $4.72 50,625 6.77 $ 3.40 50,625 $ 3.40 $8.24 - $17.36 315 1.02 $ 12.94 315 $ 12.94 $42.88 - $48.00 312 3.76 $ 45.17 312 $ 45.17 15,881,721 8.17 $ 0.95 13,661,670 $ 0.99 The total fair value of options vested for the years ended December 31, 2019 and 2018 was $2.0 million and $4.8 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, 2019 and 2018 was $0.79 and $0.47 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, 2019 2018 Expected term 5 - 6 years 5 - 6 years Expected volatility 96% - 99% 93% - 97% Risk-free interest rate 1.74% - 2.59% 2.7% - 2.8% Expected dividend yield 0% 0% Total expense for stock option grants recognized was as follows: Year ended December 31, 2019 2018 General and administrative $ 1,928 $ 4,611 Research and development 97 201 Total stock-based compensation $ 2,025 $ 4,812 At December 31, 2019, the Company had $1.0 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes No provision for federal income taxes has been recorded for the years ended December 31, 2019 and 2018 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: As of December 31, 2019 2018 Deferred tax assets: Net operating losses $ 50,144 $ 47,877 Research and other credits 2,178 2,178 Stock based compensation 3,001 2,682 In-Process research and development 1,253 1,314 Other 854 708 Total deferred tax assets 57,430 54,759 Valuation allowance (57,430 ) (54,759 ) Net deferred tax assets $ - $ - A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 Statutory rate 21.0 % 21.0 % Valuation allowance (26.0 )% (26.4 )% Nondeductible stock compensation (0.3 )% 0.1 % Other 5.3 % 5.3 % Effective tax rate - % - % 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 $2.7 million during 2019 and increased by $3.2 million during 2018. At December 31, 2019, 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 $172 million, which expire in the years 2028 through 2039. The Company also has federal net operating loss carryforwards generated in 2018 and 2019 of $15.4 million that have no expiration date as a result of the December 22, 2017 Tax Cuts and Jobs Act tax reform legislation. At December 31, 2019, 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, 2018 and 2019, or all five years and in connection with the Restructuring Transactions described in Note 9. 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, 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 Additions based on tax positions related to prior year - Additions based on tax positions related to current year - Balance at December 31, 2019 $ 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, California and Florida. 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, 2019 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | 11. 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 | 12 Months Ended |
Dec. 31, 2019 | |
Litigation [Abstract] | |
Litigation | 12. Litigation Savant Litigation On July 10, 2017, the Company filed a complaint against 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. 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. On August 9, 2017, the parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court, which the Bankruptcy Court signed that same day (the “Stipulated Order”). On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO and the Stipulated Order. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO and Stipulated Order, ordering that any request to dissolve the TRO and Stipulated Order be made to the Delaware Court. On February 13, 2018 Savant made a letter request to the Delaware Court to dissolve the TRO and Stipulated Order. 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 Stipulated Order and requesting a status conference. A hearing on Savant’s request to dissolve the TRO and Stipulated Order was held before the Delaware Court on March 19, 2018. The Delaware Court denied Savant’s request to dissolve the TRO and Stipulated order, which remain in effect. On April 11, 2018, the Company advised the Delaware 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 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 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, and is scheduled for argument on February 3, 2020. On July 26, 2019, the Company moved to modify the previously agreed-upon discovery schedule to extend discovery through December 31, 2019, which the Superior Court granted. In a subsequent order, the discovery schedule was extended until the end of March 2020. On July 30, 2019, the Company filed a motion to dismiss Savant’s Chancery Action. 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. That motion is fully briefed and scheduled for argument on February 3, 2020. 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. Savant filed a partial motion to dismiss against a co-defendant on October 30, 2019. That motion is fully briefed and is scheduled for argument on February 3, 2020. At the February 3, 2020 hearing, the Court reserved judgment on the parties’ reciprocal motions. On November 18, 2019, the Court granted Savant’s Motion to Schedule a Preliminary Injunction hearing concerning the August 2017 TRO and Stipulated Order that are still in effect. A briefing schedule has been set and the hearing is scheduled for March 25, 2020. The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying balance sheet as of December 31, 2019 and 2018. Recovery of the cost overages from Savant, if any, will be recorded in the period received. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License and Collaboration Agreements | 13. License and Collaboration Agreements Kite Agreement On May 30, 2019, the Company entered into the Kite Agreement, pursuant to which the Company and Kite will conduct a multi-center Phase Ib/II study of lenzilumab with Kite’s Yescarta in patients with relapsed or refractory B-cell lymphoma, including 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 will supply lenzilumab 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 was required to pay $200,000 to Mayo within six months of the effective date, or upon completion of a qualified financing, whichever is earlier. The Company did not pay the initial payment as of the due date and will incur interest on the unpaid balance at the prime rate plus 2%. 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 Consolidated Balance Sheet as of December 31, 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 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 Consolidated Statements of Operations and Comprehensive Loss for the year ended December 31, 2019. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions The Restructuring Transactions were completed on February 27, 2018. See Note 9. In June, July and August, 2018 the Company received an aggregate of $0.9 million of proceeds from advance notes 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 6 for a further discussion of the Advance Notes. 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 6 for a further discussion of the 2018 Notes. On June 28, 2019, the Company issued three short-term, secured bridge notes evidencing an aggregate of $1.7 million of loans made to the Company by three parties including Dr. Cameron Durrant, our Chairman and Chief Executive Officer and Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., our controlling stockholder. See Note 6 for a further discussion of the 2019 Bridge Notes. On November 12, 2019, the Company issued two short-term, secured bridge notes (the “November Bridge Notes” and together with the June Bridge Notes, the “2019 Bridge Notes”) evidencing an aggregate of $350,000 of loans made to the Company by two parties, including Dr. Cameron Durrant, our Chairman and Chief Executive Officer and Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., our controlling stockholder. See Note 6 for a further discussion of the 2019 Bridge Notes. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events In March 2020 (the “Issuance Date”), we delivered a series of convertible redeemable promissory notes (the “Notes”) evidencing loans with an aggregate principal amount of $448,333.33 made to us. The Notes bear interest at a rate of 7.0% per annum and will mature on March 13, 2021 and March 19, 2021, respectively. The Notes contain an original issue discount of $33,000 and $18,833.33, respectively. We plan to use the proceeds from the Notes for working capital. Beginning on the 6th month anniversary of the Issuance Date, unless earlier redeemed by us, the holder is entitled, at its option, to convert all or any amount of the principal amount of the Notes then outstanding, together with the accrued and unpaid interest on such portion of the Notes proposed to be converted, into shares of our common stock (the "Common Stock") at a conversion price equal to $.25 per share (the “Fixed Price”). After the 9 month anniversary of the Issuance Date, the conversion price shall be equal to the lower of (i) the Fixed Price or (ii) 68% of the lowest of either the trading price or closing bid of the Common Stock, for the ten prior trading days including the day upon which a Notice of Conversion is received (the “Variable Conversion Price”). In the event our Common Stock has a closing price equal to $0.30 or less for 5 consecutive days prior to the 9 month anniversary of the Issuance Date, then, beginning on the 6 month anniversary of the Issuance Date, the holder may elect in its Notice of Conversion to use the lower of the Fixed Price or the Variable Conversion Price set forth above. Commencing on the 6 month anniversary of the Issuance Date, we will have the right, but not the obligation, to elect to make fixed monthly amortizing payments to the holder in the amount of $25,000. If we elect to make such payments, the holder shall not be entitled to convert all or any amount of the principal amount of the Notes then outstanding if and for so long as we are current in respect of the amortizing payments. The Notes may be redeemed by us at any time before the 270 th The Notes contain customary default and remedies provisions for convertible note financings of this nature. The Notes were issued in reliance upon the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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, 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, 2019 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 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 The estimated fair value of the Advance notes, Notes payable to vendors, Bridge notes and Convertible notes as of December 31, 2019 and 2018, 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, 2019 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, 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. |
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 preclinical 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, 2019 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. |
Leases | Leases 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. The Company sub-leases office-space under a short-term lease for $300 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 years ended December 31, 2019 and 2018 totaled approximately $10,700 and $204,800, respectively and are included in the Consolidated Statements of Operations and Comprehensive Loss. Because the Company has elected to adopt the transitional practical expedients, Management 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. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company measures 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. |
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, 2019 2018 Options to purchase common stock 15,881,721 15,409,357 Warrants to purchase common stock 331,193 331,193 16,212,914 15,740,550 |
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, or December 31, 2018 for the Company. Accordingly, the Company was required to adopt new accounting standards on the same timeline as other public companies effective January 1, 2018. 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: Year Ended December 31, 2019 2018 Cash and cash equivalents $ 143 $ 814 Restricted cash 71 71 Total cash, cash equivalents and restricted cash as shown on statement of $ 214 $ 885 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 adopted the standard effective January 1, 2019. The adoption of this standard did not have a material impact on the Company’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. |
Chapter 11 Filing (Tables)
Chapter 11 Filing (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Chapter 11Filing Tables Abstract | |
Schedule of Reorganization Items, Net | For the years ended December 31, 2019 and 2018, Reorganization items, net consisted of the following charges: Year Ended December 31, 2019 2018 Legal fees $ - $ 119 Professional fees - 26 Total reorganization items, net $ - $ 145 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of fair value of financial assets and liabilities measured at fair value and classification by level of input | 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, 2019 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 Level 1 Level 2 Level 3 Total Investments: Money market funds $ 71 $ — $ — $ 71 Total assets measured at fair value $ 71 $ — — $ 71 |
Schedule of antidilutive securities excluded from computations of diluted net loss per common share | 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, 2019 2018 Options to purchase common stock 15,881,721 15,409,357 Warrants to purchase common stock 331,193 331,193 16,212,914 15,740,550 |
Schedule of composition of cash, cash equivalents and restricted cash | 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: Year Ended December 31, 2019 2018 Cash and cash equivalents $ 143 $ 814 Restricted cash 71 71 Total cash, cash equivalents and restricted cash as shown on statement of $ 214 $ 885 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of amortized cost and fair value of investments, with gross unrealized gains and losses | At December 31, 2019, 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, 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, long-term 71 Total investments $ 71 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Text Block [Abstract] | |
Schedule of Maturities of Debt | As of December 31, 2019, the maturities of the debt of the Company by year is as follows: Total 2020 2021 Principal payments on Notes payable to vendors $ 774 $ 774 $ - Interest payments on Notes payable to vendors 320 320 - Principal payments on 2019 Bridge notes 2,050 2,050 - Interest payments on 2019 Bridge notes 63 63 - Principal payments on Convertible notes 3,775 2,500 1,275 Interest payments on Convertible notes 290 224 66 Gross debt before unamortized discount 7,272 5,931 1,341 Unamortized debt discount on convertible debt (785 ) (691 ) (94 ) Total Debt $ 6,487 $ 5,240 $ 1,247 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Schedule of shares of common stock reserved for issuance | The Company has reserved the following shares of common stock for issuance as of December 31, 2019: Warrants to purchase common stock 331,193 Options: Outstanding under the 2012 Equity Incentive Plan 15,881,406 Outstanding under the 2001 Equity Incentive Plan 315 Available for future grants under the 2012 Equity Incentive Plan 3,050,799 Shares reserved under the 2019 LPC Purchase Agreement 14,500,000 Total common stock reserved for future issuance 33,763,713 |
Summary of stock option activity | The following table summarizes stock option activity for the years ended December 31, 2019 and 2018: Number of Weighted Weighted- Aggregate Outstanding at January 1, 2018 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 Granted 1,470,957 0.78 Exercised (488,625 ) 0.67 Cancelled (forfeited) (509,923 ) 0.62 Cancelled (expired) (45 ) 9.68 Outstanding at December 31, 2019 15,881,721 $ 0.95 8.2 $ 49 Options vested and expected to vest 15,827,723 $ 0.95 8.2 $ 49 Exercisable 13,661,670 $ 0.99 8.0 $ 22 (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, 2019. |
Schedule of stock options outstanding and exercisable by exercise price | The stock options outstanding and exercisable by exercise price at December 31, 2019 are as follows: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Number of Weighted- Weighted- Number of Weighted- $0.33 - $0.67 13,442,367 8.28 $ 0.65 11,533,358 $ 0.66 $0.84 - $1.30 755,080 9.15 $ 1.09 445,705 $ 0.94 $1.91 - $3.30 370,000 7.10 $ 2.97 368,333 $ 2.97 $3.38 - $3.38 1,263,022 6.71 $ 3.38 1,263,022 $ 3.38 $3.40 - $4.72 50,625 6.77 $ 3.40 50,625 $ 3.40 $8.24 - $17.36 315 1.02 $ 12.94 315 $ 12.94 $42.88 - $48.00 312 3.76 $ 45.17 312 $ 45.17 15,881,721 8.17 $ 0.95 13,661,670 $ 0.99 |
Schedule of fair value-based measurement of stock options granted under the entity's stock plans estimated using Black-Scholes model | The weighted-average fair value-based measurement of stock options granted under the Company’s stock plans in the years ended December 31, 2019 and 2018 was $0.79 and $0.47 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, 2019 2018 Expected term 5 - 6 years 5 - 6 years Expected volatility 96% - 99% 93% - 97% Risk-free interest rate 1.74% - 2.59% 2.7% - 2.8% Expected dividend yield 0% 0% |
Schedule of total stock-based compensation expense recognized | Total expense for stock option grants recognized was as follows: Year ended December 31, 2019 2018 General and administrative $ 1,928 $ 4,611 Research and development 97 201 Total stock-based compensation $ 2,025 $ 4,812 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of significant components of deferred tax assets | 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: As of December 31, 2019 2018 Deferred tax assets: Net operating losses $ 50,144 $ 47,877 Research and other credits 2,178 2,178 Stock based compensation 3,001 2,682 In-Process research and development 1,253 1,314 Other 854 708 Total deferred tax assets 57,430 54,759 Valuation allowance (57,430 ) (54,759 ) 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 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 Statutory rate 21.0 % 21.0 % Valuation allowance (26.0 )% (26.4 )% Nondeductible stock compensation (0.3 )% 0.1 % Other 5.3 % 5.3 % 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, 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 Additions based on tax positions related to prior year - Additions based on tax positions related to current year - Balance at December 31, 2019 $ 1,060 |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | Nov. 12, 2019 | Jun. 04, 2018 | Mar. 12, 2018 | Dec. 31, 2019 | Jun. 28, 2019 | Apr. 23, 2019 | May 31, 2019 | Aug. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Accumulated deficit | $ 284,895 | $ 284,895 | $ 274,601 | |||||||
Total liabilities | 14,841 | 14,841 | 9,480 | |||||||
Working capital deficit | 13,100 | 13,100 | ||||||||
Proceeds from issuance of exercise of stock options | 325 | |||||||||
Proceeds from issuance of common stock | $ 200 | $ 1,100 | 200 | 185 | 2,781 | |||||
Proceeds from advance notes | $ 900 | $ 2,050 | $ 925 | |||||||
Percentage of high concentration in patients | 20.00% | |||||||||
Lincoln Park Capital Purchase Agreement [Member] | ||||||||||
Proceeds from issuance of common stock | $ 186 | |||||||||
2019 Convertible Notes Payable [Member] | ||||||||||
Proceeds from advance notes | $ 1,300 | |||||||||
June Bridge Notes [Member] | ||||||||||
Proceeds from advance notes | $ 1,700 | |||||||||
Bridge Loan [Member] | ||||||||||
Proceeds from advance notes | $ 350 | |||||||||
Chairman and Chief Executive Officer and two other members of our Board of Directors [Member] | ||||||||||
Proceeds from issuance of exercise of stock options | $ 324 |
Chapter 11 Filing (Narrative) (
Chapter 11 Filing (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Jul. 11, 2018 | |
Cash payment for reorganization items | $ 0 | $ 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 | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Chapter 11 Filing Reorganization Items Net | ||
Legal fees | $ 119 | |
Professional fees | 26 | |
Total reorganization items, net | $ 145 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) | 12 Months Ended | |
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Accounting Policies [Abstract] | ||
Restricted cash current, standby letters of credit | $ 70,000 | $ 70,000 |
Issuance of letters of credit for insurance policy coverage | 50,000 | 50,000 |
Restricted cash related credit card facility | $ 20,000 | 20,000 |
Number of operating segments | 1 | |
Short-term lease amount per month | $ 300 | |
Lease costs | $ 10,700 | $ 204,800 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Fair Value of Financial Instruments) (Details) - Fair Value Measurements Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
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 |
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 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total assets measured at fair value | 71 | 71 |
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 |
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 | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computations of diluted net loss per common share | 16,212,914 | 15,740,550 |
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 |
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 | 15,881,721 | 15,409,357 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (composition of cash, cash equivalents and restricted cash) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Cash and cash equivalents | $ 143 | $ 814 |
Restricted cash | 71 | 71 |
Total cash, cash equivalents and restricted cash as shown on statement of cash flows | $ 214 | $ 885 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 71 | $ 71 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 71 | 71 |
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 | 71 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 71 | 71 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | $ 71 | $ 71 |
Savant Arrangements (Details)
Savant Arrangements (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 10, 2017 | May 26, 2017 | Jun. 30, 2016 | Dec. 31, 2019 | Dec. 31, 2018 |
Number of shares called by warrant | 331,193 | 331,193 | |||
Research and development | $ 1,000 | $ 1,000 | $ 2,616 | $ 2,219 | |
Due to Savant | $ 2,000 | $ 2,000 | |||
Savant Neglected Diseases, LLC [Member] | |||||
Number of shares called by warrant | 200,000 | ||||
Exercise price of warrant | $ 2.25 | ||||
Exercise period of warrant | 5 years |
Debt (Narrative) (Details)
Debt (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 12, 2019 | Jul. 02, 2019 | Dec. 30, 2019 | May 30, 2019 | Apr. 23, 2019 | Sep. 19, 2018 | Aug. 31, 2018 | Jun. 28, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2016 |
Debt Instrument [Line Items] | |||||||||||
Debt instrument amount | $ 5,000 | ||||||||||
Proceeds from advance notes | $ 900 | $ 2,050 | $ 925 | ||||||||
Percentage of accrued interest | 7.00% | ||||||||||
Common stock conversion price | $ 0.45 | $ 0.45 | |||||||||
Intrinsic value of this beneficial conversion feature | 143 | 1,465 | |||||||||
Proceeds from convertible debt | 1,275 | 2,500 | |||||||||
Issuance of common stock upon note conversions shares | 2,179,622 | ||||||||||
Advance Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from advance notes | $ 1,700 | ||||||||||
2019 Bridge Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Interest rate | 10.00% | ||||||||||
Term loan interest rate | 7.00% | ||||||||||
Debt instrument amount | $ 1,700 | ||||||||||
Proceeds from advance notes | $ 750 | ||||||||||
Interest expense debt | $ 100 | ||||||||||
Maturity Date | Oct. 1, 2019 | ||||||||||
2019 Bridge Notes [Member] | Bona fide financing [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from advance notes | $ 3,000 | ||||||||||
2019 Bridge Notes [Member] | November Bridge Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Interest rate | 7.00% | ||||||||||
Debt instrument amount | $ 350 | ||||||||||
Maturity Date | Dec. 31, 2019 | Mar. 31, 2020 | |||||||||
2019 Bridge Notes [Member] | November Bridge Notes [Member] | Cheval Holdings [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument amount | $ 250 | ||||||||||
2019 Bridge Notes [Member] | November Bridge Notes [Member] | Cameron Durrant [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument amount | $ 100 | ||||||||||
2019 Bridge Notes [Member] | Advance Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from advance notes | 950 | ||||||||||
2019 Bridge Notes [Member] | Nomis Bay LTD [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument amount | 750 | ||||||||||
2019 Bridge Notes [Member] | Cameron Durrant [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument amount | 750 | ||||||||||
2019 Bridge Notes [Member] | Chief Executive Officer [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt instrument amount | $ 200 | ||||||||||
2019 Bridge Notes [Member] | Bona Fide Financing Transaction [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from advance notes | 3,000 | ||||||||||
Black Horse Capital LP [Member] | Convertible Promissory Note [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Term loan interest rate | 7.00% | ||||||||||
Debt instrument amount | $ 2,500 | ||||||||||
2018 Convertible Notes Payable [Member] | Qualified Financing [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from convertible debt | $ 10,000 | ||||||||||
Conversion price | $ 0.45 | ||||||||||
2018 Convertible Notes Payable [Member] | Non Qualified Financing [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from convertible debt | $ 10,000 | ||||||||||
Conversion price | $ 0.45 | ||||||||||
2018 Convertible Notes Payable [Member] | Advance Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Common stock conversion price | $ 0.45 | ||||||||||
Intrinsic value of this beneficial conversion feature | $ 1,900 | ||||||||||
Debt discount amortization | 800 | 800 | |||||||||
Interest expense debt | $ 300 | 100 | |||||||||
Remaining Discount Amortization Period | 9 months | ||||||||||
2019 Convertible Notes Payable [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Term loan interest rate | 7.50% | ||||||||||
Debt instrument amount | $ 1,300 | ||||||||||
Proceeds from advance notes | $ 1,300 | ||||||||||
2019 Convertible Notes Payable [Member] | Qualified Financing [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from convertible debt | $ 10,000 | ||||||||||
Conversion price | $ 1.25 | ||||||||||
2019 Convertible Notes Payable [Member] | Non Qualified Financing [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from convertible debt | $ 10,000 | ||||||||||
Conversion price | $ 1.25 | ||||||||||
2019 Convertible Notes Payable [Member] | Advance Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Common stock conversion price | $ 1.25 | ||||||||||
Intrinsic value of this beneficial conversion feature | $ 1,900 | ||||||||||
Debt discount amortization | 300 | 300 | |||||||||
Interest expense debt | $ 300 | 100 | |||||||||
Remaining Discount Amortization Period | 16 months | ||||||||||
Notes Payable To Vendors [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Interest rate | 10.00% | ||||||||||
Notes payable to vendors | $ 1,200 | ||||||||||
Accrued interest | $ 300 | $ 300 | |||||||||
Notes Payable To Vendors [Member] | 2019 Bridge Notes [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Accrued interest | $ 1,100 | ||||||||||
Debt instrument amount | $ 500 |
Debt (Schedule of Maturities of
Debt (Schedule of Maturities of Debt) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | |
Total | $ 6,487 |
2020 | 5,240 |
2021 | 1,247 |
Principal payments on Notes payable to vendors [Member] | |
Debt Instrument [Line Items] | |
Total | 774 |
2020 | 774 |
2021 | |
Interest payments on Notes payable to vendors [Member] | |
Debt Instrument [Line Items] | |
Total | 320 |
2020 | 320 |
2021 | |
Principal payments on 2019 Bridge notes [Member] | |
Debt Instrument [Line Items] | |
Total | 2,050 |
2020 | 2,050 |
2021 | |
Interest payments on 2019 Bridge notes [Member] | |
Debt Instrument [Line Items] | |
Total | 63 |
2020 | 63 |
2021 | |
Principal payments on Convertible notes [Member] | |
Debt Instrument [Line Items] | |
Total | 3,775 |
2020 | 2,500 |
2021 | 1,275 |
Interest payments on Convertible notes [Member] | |
Debt Instrument [Line Items] | |
Total | 290 |
2020 | 224 |
2021 | 66 |
Gross debt before unamortized discount [Member] | |
Debt Instrument [Line Items] | |
Total | 7,272 |
2020 | 5,931 |
2021 | 1,341 |
Unamortized debt discount on convertible debt [Member] | |
Debt Instrument [Line Items] | |
Total | 785 |
2020 | 691 |
2021 | $ 94 |
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, 2019 | Dec. 31, 2018 | Dec. 04, 2015 | Jun. 19, 2013 | |
Class of Warrant or Right [Line Items] | ||||||
Issuance of warrant to purchase shares of common stock | 331,193 | 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 | ||||
Options vested | 100,000 | |||||
Options not vested | 100,000 | |||||
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 | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Other Commitments [Line Items] | ||
Rent expense | $ 10 | $ 200 |
Brisbane, California Lease [Member] | ||
Other Commitments [Line Items] | ||
Expiration date | Sep. 30, 2018 | |
Burlingame, California Lease [Member] | ||
Other Commitments [Line Items] | ||
Expiration date | Mar. 31, 2020 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - USD ($) | Jun. 04, 2018 | Mar. 12, 2018 | Dec. 31, 2019 | Feb. 27, 2018 | Dec. 22, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 08, 2019 | Feb. 28, 2018 | Dec. 21, 2017 |
Class of Stock [Line Items] | ||||||||||
Common Stock, shares authorized upon the completion of the IPO | 225,000,000 | 225,000,000 | 225,000,000 | |||||||
Stock issued | 500,000 | 500,000 | ||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||||
Common share issued | 400,000 | 2,445,557 | 114,034,451 | 114,034,451 | 109,897,526 | |||||
Total proceeds | $ 200,000 | $ 1,100,000 | $ 200,000 | $ 185,000 | $ 2,781,000 | |||||
Lincoln Park Capital Purchase Agreement [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Common stock, par value | $ 0.001 | |||||||||
Value of right to sell number of shares | $ 20,000,000 | |||||||||
Right to sell number of shares | 100,000 | |||||||||
Threshold prices but not to exceed in total proceeds | $ 750,000 | |||||||||
Percentage of beneficially owning more than common stock outstanding | 4.99% | |||||||||
Common share issued | 706,592 | |||||||||
Total proceeds | $ 186,000 | |||||||||
Common Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Common Stock, shares authorized upon the completion of the IPO | 225,000,000 | |||||||||
Preferred Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Common Stock, shares authorized upon the completion of the IPO | 25,000,000 | |||||||||
Nomis Bay [Member] | ||||||||||
Class of Stock [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 | |||||||||
Legal fees and expenses | 300,000 | |||||||||
Common stock held | $ 33,573,530 | |||||||||
Percentage of outstanding common stock | 31.40% | |||||||||
New Lender Shares [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Stock issued | 59,786,848 | |||||||||
Madison [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Percentage owned | 30.00% | |||||||||
New Black Horse Shares [Member] | ||||||||||
Class of Stock [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] | ||||||||||
Class of Stock [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 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants to purchase common stock | 331,193 | 331,193 | |||
Total common stock reserved for future issuance | 33,763,713 | ||||
Total fair value of options vested | $ 2,000,000 | $ 4,800,000 | |||
Weighted-average fair value of options granted during the period | $ 0.79 | $ 0.47 | |||
Weighted-average period | 1 year 4 months 24 days | ||||
Unrecognized compensation expense | $ 1,000,000 | ||||
2019 LPC Purchase Agreement [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total common stock reserved for future issuance | 14,500,000 | ||||
2012 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option outstanding | 15,881,406 | ||||
Available for future grants | 7,500,000 | 3,000,000 | 3,050,799 | ||
Vesting period expiration | 10 years | ||||
Number of shares authorized to be issued under the plan | 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 | ||||
2012 Equity Incentive Plan [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
2001 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option outstanding | 315 | ||||
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 | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | ||
Number of Shares | |||
Balance at the beginning of the period (in shares) | 15,409,357 | 2,448,383 | |
Options granted (in shares) | 1,470,957 | 13,575,038 | |
Options exercised (in shares) | (488,625) | ||
Options cancelled (forfeited) (in shares) | (509,923) | (572,935) | |
Options cancelled (expired) (in shares) | (45) | (41,129) | |
Balance at the end of the period (in shares) | 15,881,721 | 15,409,357 | |
Options vested and expected to vest at the end of the period (in shares) | 15,827,723 | ||
Options exercisable (in shares) | 13,661,670 | ||
Weighted-Average Exercise Price (per share) | |||
Balance at the beginning of the period (in dollars per share) | [1] | $ 0.95 | $ 4.15 |
Options granted (in dollars per share) | [1] | 0.78 | 0.66 |
Options exercised (in dollars per share) | [1] | 0.67 | |
Options cancelled (forfeited) (in dollars per share) | [1] | 0.62 | 3.20 |
Options cancelled (expired) (in dollars per share) | [1] | 9.68 | 37.82 |
Balance at the ending of the period (in dollars per share) | [1] | 0.95 | $ 0.95 |
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] | $ 0.99 | |
Weighted-Average Remaining Contractual Term (in years) | |||
Balance at the end of the period | 8 years 2 months 12 days | ||
Options vested and expected to vest at the end of the period | 8 years 2 months 12 days | ||
Options exercisable | 8 years | ||
Aggregate Intrinsic Value (in thousands) | |||
Balance at the end of the period | [2] | $ 49 | |
Options vested and expected to vest at the end of the period | [2] | 49 | |
Options exercisable | [2] | $ 22 | |
[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, 2019. |
Stockholders' Equity (Options O
Stockholders' Equity (Options Outstanding and Exercisable By Price Range) (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Stock Options Outstanding | |
Number of Shares | shares | 15,881,721 |
Weighted Average Remaining Contractual Life | 8 years 2 months 1 day |
Weighted Average Exercise Price (in dollars per share) | $ 0.95 |
Stock Options Exercisable | |
Number of Shares | shares | 13,661,670 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 0.99 |
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 | 13,442,367 |
Weighted Average Remaining Contractual Life | 8 years 3 months 11 days |
Weighted Average Exercise Price (in dollars per share) | $ 0.65 |
Stock Options Exercisable | |
Number of Shares | shares | 11,533,358 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 0.66 |
Exercise Price Range From $0.84 - $0.1.30 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price, low end of range (in dollars per share) | 0.84 |
Exercise Price, high end of range (in dollars per share) | $ 1.30 |
Stock Options Outstanding | |
Number of Shares | shares | 755,080 |
Weighted Average Remaining Contractual Life | 9 years 1 month 24 days |
Weighted Average Exercise Price (in dollars per share) | $ 1.09 |
Stock Options Exercisable | |
Number of Shares | shares | 445,705 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 0.94 |
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 | 7 years 1 month 6 days |
Weighted Average Exercise Price (in dollars per share) | $ 2.97 |
Stock Options Exercisable | |
Number of Shares | shares | 368,333 |
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 | 6 years 8 months 16 days |
Weighted Average Exercise Price (in dollars per share) | $ 3.38 |
Stock Options Exercisable | |
Number of Shares | shares | 1,263,022 |
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 | 6 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 | 315 |
Weighted Average Remaining Contractual Life | 1 year 7 days |
Weighted Average Exercise Price (in dollars per share) | $ 12.94 |
Stock Options Exercisable | |
Number of Shares | shares | 315 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 12.94 |
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 | 3 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 (Fair Valu
Stockholders' Equity (Fair Value Assumptions) (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Expected volatility, minimum (as a percent) | 96.00% | 93.00% |
Expected volatility, maximum (as a percent) | 99.00% | 97.00% |
Risk-free interest rate, minimum (as a percent) | 1.74% | 2.70% |
Risk-free interest rate, maximum (as a percent) | 2.59% | 2.80% |
Expected dividend yield (as a percent) | 0.00% | 0.00% |
Minimum [Member] | ||
Expected term | 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 ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 2,025 | $ 4,812 |
General And Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 1,928 | 4,611 |
Research And Development Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 97 | $ 201 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Increase (decrease) in valuation allowance | $ 2.7 | $ 3.2 |
Internal Revenue Service I R S [Member] | ||
Net operating loss carryforwards | 166.2 | $ 15.4 |
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 | $ 172 | |
State And Local Jurisdiction [Member] | Research [Member] | ||
Tax credit carryforwards | $ 2.2 | |
State And Local Jurisdiction [Member] | Minimum [Member] | ||
Expiration year | Dec. 31, 2028 | |
State And Local Jurisdiction [Member] | Maximum [Member] | ||
Expiration year | Dec. 31, 2039 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating losses | $ 50,144 | $ 47,877 |
Research and other credits | 2,178 | 2,178 |
Stock based compensation | 3,001 | 2,682 |
In-Process research and development | 1,253 | 1,314 |
Other | 854 | 708 |
Total deferred tax assets | 57,430 | 54,759 |
Valuation allowance | (57,430) | (54,759) |
Net deferred tax assets |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of the Statutory Tax Rates and Effective Tax Rates) (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of the statutory tax rates and the effective tax rates | ||
Statutory rate | 21.00% | 21.00% |
Valuation allowance | (26.00%) | (26.40%) |
Nondeductible stock compensation | (0.30%) | 0.10% |
Other | 5.30% | 5.30% |
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, 2019 | Dec. 31, 2018 | |
Reconciliation of the beginning and ending amount of unrecognized tax benefits | ||
Balance at the beginning of the period | $ 1,060 | $ 1,060 |
Additions based on tax positions related to prior year | ||
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, 2019USD ($) | |
Retirement Benefits [Abstract] | |
Employer contributions | $ 0 |
Litigation (Details)
Litigation (Details) - Savant [Member] - USD ($) $ in Thousands | 1 Months Ended | ||
Jun. 30, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | |
Aggregate cost | $ 3,400 | ||
Deductible | 500 | ||
Offset payment due | 2,000 | ||
Amount owed | $ 1,400 | ||
Accrued expenses | $ 2,000 | $ 2,000 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Jul. 19, 2019 | May 30, 2019 | Dec. 31, 2019 | |
Mayo Agreement [Member] | |||
Amount paid in license agreement | $ 200 | ||
Interest rate | 2.00% | ||
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 | $ 100 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Aug. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 12, 2019 | Jun. 28, 2019 | Sep. 19, 2018 | |
Proceeds from advance notes | $ 900 | $ 2,050 | $ 925 | |||
Debt instrument amount | $ 5,000 | |||||
Convertible Promissory Note [Member] | Black Horse Capital LP [Member] | ||||||
Debt instrument amount | $ 2,500 | |||||
Issued three short-term, secured bridge notes [Member] | ||||||
Short term debt | $ 1,700 | |||||
Issued two short-term, secured bridge notes [Member] | ||||||
Short term debt | $ 350 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Mar. 13, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Subsequent Event [Line Items] | |||
Proceeds from convertible debt | $ 1,275,000 | $ 2,500,000 | |
Subsequent Event [Member] | Convertible redeemable promissory note [Member] | |||
Subsequent Event [Line Items] | |||
Proceeds from convertible debt | $ 448,333 | ||
Interest rate | 7.00% | ||
Maturity Date | Mar. 13, 2021 | ||
Debt discount | $ 33,000 | ||
Common stock conversion price | $ 0.25 | ||
Percentage of conversion price | 68.00% | ||
Common stock closing price | $ 0.30 | ||
Amount of Fixed monthly amortizing payments | $ 25,000 | ||
Subsequent Event [Member] | Convertible redeemable promissory note [Member] | Note Two [Member] | |||
Subsequent Event [Line Items] | |||
Interest rate | 7.00% | ||
Maturity Date | Mar. 19, 2021 | ||
Debt discount | $ 18,833 |