Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 01, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Moleculin Biotech, Inc. | ||
Entity Central Index Key | 1,659,617 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Shell Company | false | ||
Entity Ex Transition Period | false | ||
Entity Public Float | $ 38,692,158 | ||
Trading Symbol | MBRX | ||
Entity Common Stock, Shares Outstanding | 28,528,663 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 7,134 | $ 7,714 |
Prepaid expenses and other | 840 | 588 |
Total current assets | 7,974 | 8,302 |
Furniture and equipment, net of accumulated depreciation of $93 and $21, respectively | 463 | 33 |
Intangible assets | 11,148 | 11,148 |
Total Assets | 19,585 | 19,483 |
Current Liabilities: | ||
Accounts payable | 1,246 | 810 |
Accrued expenses and other current liabilities | 2,302 | 902 |
Deferred compensation - related party | 150 | 0 |
Warrant liability - current | 180 | 503 |
Total current liabilities | 3,878 | 2,215 |
Long-term deferred compensation – related party | 0 | 150 |
Deferred rent - long-term | 107 | 0 |
Warrant liability - long-term | 1,328 | 0 |
Total Liabilities | 5,313 | 2,365 |
Commitments and contingencies (Note 8) | ||
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 authorized, no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 75,000,000 authorized, 28,528,663 and 21,469,109 shares outstanding at December 31, 2018 and December 31, 2017, respectively | 29 | 21 |
Additional paid-in capital | 40,564 | 31,577 |
Accumulated other comprehensive income | 35 | 0 |
Accumulated deficit | (26,356) | (14,480) |
Total stockholders' equity | 14,272 | 17,118 |
Total liabilities and stockholders' equity | $ 19,585 | $ 19,483 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation, furniture and equipment | $ 93 | $ 21 |
Preferred stock, par or stated value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock, par or stated value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 75,000,000 | 75,000,000 |
Common Stock, Shares, Issued | 28,528,663 | 21,469,109 |
Common Stock, Shares, Outstanding | 28,528,663 | 21,469,109 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Revenue | $ 0 | $ 0 |
Operating expenses: | ||
Research and development | 9,728 | 4,545 |
General and administrative | 5,229 | 4,090 |
Depreciation | 68 | 18 |
Total operating expenses | 15,025 | 8,653 |
Loss from operations | (15,025) | (8,653) |
Other income (expense): | ||
Gain (loss) from change in fair value of warrant liability | 3,185 | (2,548) |
Gain from settlement of liability | 0 | 149 |
Gain from expiration of warrants | 0 | 1,238 |
Other (expense) income | (40) | 9 |
Interest income (expense), net | 4 | 0 |
Net loss | $ (11,876) | $ (9,805) |
Net loss per common share - basic and diluted (in dollars per share) | $ (0.46) | $ (0.53) |
Weighted average common shares outstanding, basic and diluted | 25,904,170 | 18,569,193 |
Other comprehensive income (loss): | ||
Foreign currency translation | $ 35 | $ 0 |
Comprehensive loss | $ (11,841) | $ (9,805) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (11,876) | $ (9,805) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 68 | 18 |
Stock-based compensation | 1,140 | 707 |
Deferred compensation - related party | 0 | 62 |
Change in fair value of warrant liability | (3,185) | 2,548 |
Gain in settlement of liability | 0 | (149) |
Gain from expiration of warrants | 0 | (1,238) |
Loss on foreign currency transactions | 40 | 0 |
Other | 0 | (9) |
Changes in operating assets and liabilities: | ||
Prepaid expenses | (252) | (364) |
Accounts payable | 436 | 411 |
Accrued expenses and other current liabilities | 1,400 | 495 |
Other long-term liabilities | 26 | 0 |
Net cash used in operating activities | (12,203) | (7,324) |
Cash flows from investing activities: | ||
Purchase of fixed assets | (417) | (28) |
Net cash used in investing activities | (417) | (28) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 5 | 0 |
Proceeds from exercise of warrants | 15 | 3,988 |
Proceeds from sale of common stock, net of cash stock issuance costs | 12,025 | 6,071 |
Net cash provided by financing activities | 12,045 | 10,059 |
Effect of exchange rate changes on cash and cash equivalents | (5) | 0 |
Net change in cash and cash equivalents | (580) | 2,707 |
Cash and cash equivalents, at beginning of year | 7,714 | 5,007 |
Cash and cash equivalents, at end of year | 7,134 | 7,714 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 5 | 3 |
Cash paid for income taxes | 0 | 0 |
Non-cash investing and financing activities: | ||
Purchases of property and equipment in accounts payable and accrued liabilities | 23 | 0 |
Leasehold improvements paid by landlord | 82 | 0 |
Common stock issued for conversion of debt | 0 | 302 |
Warrants issued for services provided | 0 | 104 |
Common stock issued for services provided | $ 0 | $ 89 |
Statements of Stockholders_ Equ
Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In-Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | February 2018 Issuance | February 2018 IssuanceCommon Stock | February 2018 IssuanceAdditional Paid-In-Capital | June 2018 Issuance | June 2018 IssuanceCommon Stock | June 2018 IssuanceAdditional Paid-In-Capital | Q4 2018 Issuance | Q4 2018 IssuanceCommon Stock | Q4 2018 IssuanceAdditional Paid-In-Capital |
Beginning balance (in shares) at Dec. 31, 2016 | 12,164,852 | |||||||||||||
Beginning balance at Dec. 31, 2016 | $ 14,960 | $ 12 | $ 19,623 | $ (4,675) | $ 0 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Issued for cash - sale of units (in shares) | 3,710,000 | |||||||||||||
Issued for cash - sale of units | 317 | $ 4 | 313 | |||||||||||
Warrants exercised, net of issuance costs of $73 (in shares) | 2,728,434 | |||||||||||||
Warrants exercised | 8,903 | $ 3 | 8,900 | |||||||||||
Issued for cash - sale of common stock (in shares) | 776,016 | |||||||||||||
Issued for cash - sale of common stock | 1,645 | 1,645 | ||||||||||||
Stock-based compensation | 707 | 707 | ||||||||||||
Issued for convertible debt (in shares) | 2,010,640 | |||||||||||||
Issued for convertible debt | 302 | $ 2 | 300 | |||||||||||
Stock granted for services (in shares) | 79,167 | |||||||||||||
Stock granted for services | $ 89 | 89 | ||||||||||||
Stock options exercised (in shares) | 0 | |||||||||||||
Net loss | $ (9,805) | (9,805) | ||||||||||||
Ending balances (in shares) at Dec. 31, 2017 | 21,469,109 | |||||||||||||
Ending balance at Dec. 31, 2017 | 17,118 | $ 21 | 31,577 | (14,480) | 0 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Warrants exercised, net of issuance costs of $73 (in shares) | 9,752 | |||||||||||||
Warrants exercised | 15 | 15 | ||||||||||||
Issued for cash - sale of common stock (in shares) | 4,290,000 | 1,092,636 | 1,642,166 | |||||||||||
Issued for cash - sale of common stock | $ 5,122 | $ 5 | $ 5,117 | $ 958 | $ 957 | $ 1,756 | $ 2 | $ 1,754 | ||||||
Stock-based compensation | 1,140 | 1,140 | ||||||||||||
Stock granted for services | $ 0 | |||||||||||||
Stock options exercised (in shares) | 25,000 | 25,000 | ||||||||||||
Stock options exercised | $ 4 | 4 | ||||||||||||
Net loss | (11,876) | (11,876) | ||||||||||||
Cumulative translation adjustment | 35 | 35 | ||||||||||||
Ending balances (in shares) at Dec. 31, 2018 | 28,528,663 | |||||||||||||
Ending balance at Dec. 31, 2018 | $ 14,272 | $ 29 | $ 40,564 | $ (26,356) | $ 35 |
Statements of Stockholders_ E_2
Statements of Stockholders’ Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock warrants exercised, issuance costs | $ 73 | |
Stock issuance costs, stock offering | $ 166 | |
February 2018 Issuance | Common Stock | ||
Stock issuance costs | $ 809 | |
June 2018 Issuance | Common Stock | ||
Stock issuance costs | 232 | |
Q4 2018 Issuance | Common Stock | ||
Stock issuance costs | $ 42 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015, with its focus on the treatment of highly resistant cancers via the development of its oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, which we refer to as MD Anderson. MBI formed Moleculin Australia Pty. Ltd., (MAPL), a wholly-owned subsidiary in June 2018, to begin preclinical development in Australia for WP1732, an analog of WP1066. This may enable the Company to enjoy the benefits of certain research and development tax credits in Australia. Core Technologies - MBI has three core technologies with six drug candidates, all of which are based on discoveries made at MD Anderson. These core technologies are 1) Annamycin, 2) its Immune/Transcription Modulators portfolio and 3) its Metabolism/Glycosylation Inhibitor portfolio. The Company’s clinical stage drugs are Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, or AML and WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer and AML. Subsequent to December 31, 2018, WP1220 was approved for a clinical trial in Poland for the treatment of a form of skin cancer, cutaneous T-cell lymphoma (CTCL). WP1220 is part its Immune/Transcription Modulators portfolio. MBI is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as Metabolism/Glycosylation Inhibitors. With the approval of the Polish clinical trial in January 2019 for WP1220 for the treatment of a type of skin cancer, the Company now has three drugs in four clinical trials. The Company believes Annamycin is a "Next Generation Anthracycline" since it is designed to avoid multidrug resistance mechanisms and to affect little to no cardiotoxicity. Annamycin is currently in two Phase I/II clinical trials, and preliminary clinical data suggests that it may have the potential to become the first therapy suitable for the majority of relapsed or refractory AML patients. WP1066 is one of several Immune/Transcription Modulators that appear capable of stimulating immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs) while also inhibiting key oncogenic transcription factors, including p-STAT3, c-Myc and HIF-1α. These transcription factors are widely sought targets that may also play a role in the inability of immune checkpoint inhibitors to affect more resistant tumors. The Company is also developing new prodrugs to exploit the potential uses of inhibitors of glycolysis. Its lead Metabolism/Glycosylation Inhibitor compound, WP1122, provides an opportunity to cut off the fuel supply of tumors by taking advantage of their overdependence on glucose as compared with healthy cells. New research also points to the potential for the glucose decoy (2-DG) within WP1122 to be capable of enhancing the usefulness of checkpoint inhibitors. Drug Candidates - Within the Company's core technologies, it currently has six drug candidates representing three substantially different approaches to treating cancer. Annamycin, is a chemotherapy designed to inhibit the replication of DNA of rapidly dividing cells and is the Company's most mature drug candidate. Annamycin had been in clinical trials pursuant to an investigational new drug application or IND that had been filed with the U.S. Food and Drug Administration, or FDA. Due to a lack of development activity by a prior drug developer, this IND was terminated. To permit the renewed investigation of Annamycin, the Company resubmitted a new IND for a Phase I/II trial for the treatment of relapsed or refractory AML in August 2017, which the FDA allowed to go into effect in September 2017. The Company has trials open in the US and Poland and is actively recruiting in both countries. The Company has five other drug development projects: • WP1066 has an approved physician-sponsored clinical trial open for enrollment and dosing patients for the treatment of brain tumors and is also being evaluated for potential treatment of pediatric brain tumors, as well as AML and pancreatic cancer, • WP1220, an analog of WP1066, is being studied for the topical treatment of CTCL and MBI filed a Clinical Trial Application ("CTA") in Poland which was approved in January 2019, • WP1732, another analog of WP1066, that the Company believes is particularly well suited for intravenous administration, is being evaluated for potential treatment of AML, pancreatic and other cancers, and MBI has begun pre-clinical work which it expects to generate sufficient data for an IND filing in 2019, and • WP1122 and WP1234 are being evaluated for their potential to treat brain tumors and pancreatic cancer via their ability to inhibit glycolysis. Clinical Trials - The Company believes that patient recruitment for its Annamycin clinical trial in the US has been slow due to the high number of competitive clinical trials, combined with the FDA’s requirement to set the initial dose level relatively low in comparison with previous Annamycin clinical trials. Additionally, the Company believes that patient recruitment for its clinical trial in Poland will be more successful than in the US due to a comparatively lower number of competitive clinical trials and the protocol there being approved to start at a significantly higher dose than in the US with fewer enrollment screening limitations. On May 1, 2018, the Company engaged another contract research organization ("CRO") to evaluate additional countries for the expansion of its AML clinical trial, specifically Australia and several Western European countries to provide additional clinical sites to improve access to patients for MBI's trial. This evaluation is ongoing. In July 2018, the physician-sponsored WP1066 Phase I clinical trial for the treatment of glioblastoma opened for recruitment and began treating patients in September 2018. In September 2017, the Company engaged a CRO to prepare for a proof-of-concept clinical trial in Poland to study its drug candidate WP1220, a part of the WP1066 portfolio, for the treatment of CTCL. The Company filed a CTA in Poland for this use, which was approved subsequent to December 31, 2018, and gave the Company its third drug in its fourth clinical trial. Licenses - The Company has been granted royalty-bearing, worldwide, exclusive licenses for the patent and technology rights related to all of MBI's drug technologies, as these intellectual property rights are owned in part or entirely by MD Anderson. The Annamycin drug substance is no longer covered by any existing patent protection, however, the Company intends to submit patent applications for formulation, synthetic process and reconstitution related to MBI's Annamycin drug product candidate, although there is no assurance that the Company will be successful in obtaining such patent protection. Such technology is also licensed from MD Anderson. Independently from potential patent protection, MBI has received Orphan Drug designation (ODD) from the FDA for Annamycin for the treatment of AML and, subsequent to December 31, 2018, for WP1066 for the treatment of glioblastoma. ODD may provide tax and other benefits during product development, and if either product is approved, may lead to a grant of seven-year market exclusivity. Under that exclusivity, which runs from the date of the approval of the New Drug Application (NDA) in the United States, the FDA generally (there are important exceptions) could not approve another for the designated indication. The Company also intends to apply for similar status in the European Union (EU) where market exclusivity could extend to 10 years from the date of Marketing Authorization Application (MAA) approval. Separately, the FDA may also grant market exclusivity of 5 years for newly approved new chemical entities (which the Company believes Annamycin would be one), but there can be no assurance that such exclusivity will be granted. Moleculin, LLC - Prior to MBI's initial public offering, the Company acquired Moleculin, LLC which was merged with and into MBI. Moleculin, LLC was the holder of a license agreement with MD Anderson covering technology referred to as the WP1066 Portfolio, which is focused on the modulation of key oncogenic transcription factors. |
Basis of presentation, principl
Basis of presentation, principles of consolidation and significant accounting policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation, principles of consolidation and significant accounting policies | Basis of presentation, principles of consolidation and significant accounting policies Basis of Presentation - The accompanying consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for financial information, and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Acquisition – We acquired Moleculin, LLC (“Moleculin”) on May 2, 2016, and, going forward our consolidated financial statements include the operations of Moleculin, LLC. We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that assets acquired, and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of acquired in-process research and development (“IPR&D”) be recorded on the balance sheet. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired will be recorded as goodwill. The Company obtained input from third-parties regarding its tangible and intangible assets and other information necessary to measure the fair value of the assets acquired and liabilities assumed in connection with the acquisition of Moleculin, LLC. Principles of consolidation - The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the United States. In accordance with FASB ASC Topic 280, Segment Reporting, we view our operations and manage our business as principally one segment. As a result, the financial information disclosed herein represents all of the material financial information related to our principal operating segment. Use of Estimates - The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, accrued expenses and taxes. Going Concern - These consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary financing to continue operations and the attainment of profitable operations. As of December 31, 2018, the Company has incurred a consolidated accumulated deficit of $26.4 million since inception and had not yet generated any revenue from operations. Additionally, management anticipates that its consolidated cash on hand as of December 31, 2018 plus the additional cash generated from its equity offering subsequent to year-end, discussed further within these notes to the financial statements, is sufficient to fund its planned operations into but not beyond the near term. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. These consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. Management cannot be certain that such events or a combination thereof can be achieved. Cash and Cash Equivalents - The Company considers all highly liquid accounts with original maturities of three months or less at the date of acquisition to be cash equivalents. Periodically in the ordinary course of business, the Company may carry cash balances at financial institutions in excess of the insured limits of $250,000. Property and equipment - Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows: Leasehold improvement Shorter of estimated useful lives or the term of the lease Computer equipment 2 years Software 3 years Machinery and equipment 5 years Furniture and office equipment 7 years Intangible assets - Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. If an intangible asset is identified as an in-process research & development asset, then no amortization will occur until the development is complete. If the associated research and development effort is abandoned, the related assets will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. We evaluate the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. No impairments of intangible assets have been identified during any of the periods presented. Intangible assets are tested for impairment on an annual basis, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach. Rent and Deferred rent - The Company recognizes rent expense for leases with increasing annual rents on a straight-line basis over the term of the lease. The amount of rent expense in excess of cash payments is classified as deferred rent. Any lease incentives received are deferred and amortized over the term of the lease. Fair Value of Financial instruments - Our financial instruments consist primarily of account payables, accrued expenses and a warrant liability. The carrying amount of accounts payables and accrued expenses approximates their fair value because of the short-term maturity of such. We have categorized our assets and liabilities that are valued at fair value on a recurring basis into three-level fair value hierarchy in accordance with GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the balance sheets at fair value are categorized based on a hierarchy of inputs as follows: Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities. Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 – Unobservable inputs for the asset or liability. The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of our warrant liability discussed in Note 5. The following table provides the financial assets and liabilities reported at fair value and measured on a recurring basis at December 31, 2018 and December 31, 2017, respectively. (in thousands): Description Liabilities Measured at Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Other Unobservable Inputs (Level 3) Fair value of warrant liability: December 31, 2018 $ 1,508 $ — $ — $ 1,508 December 31, 2017 $ 503 $ — $ — $ 503 The following table provides a summary of changes in fair value associated with the Level 3 liabilities for the years ended December 31, 2017 and 2018 (in thousands): Warrant Liability – Current Warrant Liability – Long-Term Warrant Liability – Total December 31, 2016 $ — $ — $ — Issuance of warrants 2,453 1,690 4,143 Reclass of liability from long-term to current 1,846 (1,846) — Change in fair value - net 2,643 (95) 2,548 Exercise of warrants (5,201) 251 (4,950) Expiration of warrants (1,238) — (1,238) December 31, 2017 503 — 503 Issuance of warrants — 4,203 4,203 Change in fair value - net (310) (2,875) (3,185) Exercise of warrants (13) — (13) December 31, 2018 $ 180 $ 1,328 $ 1,508 The above table of Level 3 liabilities begins with the initial valuation given the warrant issuances that occurred in 2017 and adjusts the balances for changes that occurred during the year. The ending balance of the Level 3 financial instrument presented above represent our best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized "through an" immediate settlement of the instruments. Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of reported assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740-10 which prescribes a recognition threshold and measurement attribute for financial statement disclosure of tax positions taken, or expected to be taken, on its tax return. The Company evaluates and records any uncertain tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in which it operates. Translation of Foreign Currencies - The functional currency for our foreign subsidiary is the local currency. For our non-U.S. Subsidiary that transacts in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign currency rates for the period. Adjustments resulting from the translation of the financial statements of our foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity. Stock-based Compensation - Stock-based compensation expense includes the estimated fair value of equity awards vested or expected to vest during the reporting period. The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and modifications to existing stock options, to be recognized in the consolidated statements of operations based on their fair values. The Company uses the Black-Scholes option pricing model to determine the fair value of options granted. The awards are subject to service vesting conditions. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to non-employees with service-based vesting conditions is recognized based on the then-current fair value at each financial reporting date prior to the measurement date over the associated service period of the award, which is generally the vesting term. Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. As of December 31, 2018, the Company’s potentially dilutive shares, which were not included in the calculation of net loss per share, included options to purchase 2,794,000 common shares and warrants to purchase 3,784,515 common shares. As of December 31, 2017, the Company's potentially dilutive shares, which were not included in the calculation of net loss per share, included options to purchase 1,345,000 common shares and warrants to purchase 677,576 common shares. Research and Development Costs - Research and development costs are expensed as incurred. Subsequent Events - The Company’s management reviewed all material events through the date these consolidated financial statements were issued for subsequent event disclosure consideration as described in Note 9. Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standard Update ("ASU") 2014-9, Revenue from Contracts with Customers (Topic 606), which will replace numerous requirements in U.S. GAAP, including industry-specific requirements, and provide companies with a single revenue recognition model for recognizing revenue from contracts with customers. The core principle of the new standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB approved a proposal to defer the effective date of the guidance until annual and interim reporting periods beginning after December 15, 2018. The Company is currently evaluating the impact that this standard will have on its consolidated financial statements at the time the Company starts to generate revenue or enters into other contractual arrangements, which the Company does not expect in the near term. This topic is not applicable until after 2018. In January 2016, the FASB issued ASU No. 2016-1, Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-1”). ASU 2016-1 affects the accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements of financial instruments. ASU 2016-1 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements. In February 2016, the FASB issued Topic 842, Leases, by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new leasing standards generally requires lessees to recognize operating and financing lease liabilities and corresponding right-of-use assets on the consolidated balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leasing arrangements. We will adopt the new standard effective January 1, 2019 and will not restate comparative periods. Presentation of leases within the consolidated statements of operations and consolidated statements of cash flows will be generally consistent with the current lease accounting guidance. We will elect the package of practical expedients permitted under the transition guidance and as such, the adoption of this ASU will not change the classification of any of our leases. We will elect to combine lease and non-lease components, elect not to record leases with an initial term of 12 months or less on the balance sheet and recognize the associated lease payments in the consolidated statements of operations on a straight-line basis over the lease term. We estimate that approximately $0.2 million will be recognized as total right-of-use asset and a lease liability on our consolidated balance sheet as of January 1, 2019. Otherwise, we do not expect the new standard to have a material impact on our consolidated financial statements. In March 2016, the FASB issued ASU 2016-9, Compensation-Stock Compensation (Topic 718): Improvements to Employee-Share-Based Accounting. The new guidance changes the accounting and simplifies various aspects of the accounting for share-based payments to employees. The guidance allows for a policy election to account for forfeitures as they occur or based on an estimated number of awards that are expected to vest. MBI assumes no forfeiture since it has limited history. ASU 2016-9 is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The adoption of this standard on January 1, 2017, did not have a significant impact on the Company’s consolidated financial statements. In August 2016, the FASB issued ASU, Statement of Cash Flows (Topic 230). This ASU applies to all entities that are required to present a statement of cash flows under Topic 230. The amendments provide guidance on eight specific cash flow issues and includes clarification on how these items should be classified in the statement of cash flows and is designed to help eliminate diversity in practice as to where items are classified in the cash flow statement. Furthermore, in November 2016, the FASB issued additional guidance on this Topic that requires amounts generally described as restricted cash and restricted cash equivalents to be included with cash and cash equivalents when reconciling the statement of cash flows. This ASU is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with earlier application permitted for all entities. The adoption of this standard on January 1, 2018 did not have a significant impact on the Company's consolidated financial statements. In January 2017, the FASB issued ASU 2017-01 "Business Combinations (Topic 805)," which provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This screen reduces the number of transactions that need to be further evaluated. If the screen is not met, the amendments in this update (1) require that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments in this update also narrow the definition of the term "output" so that the term is consistent with how outputs are described in Topic 606. Public business entities are required to apply the amendments in this update to annual periods beginning after December 15, 2017, including interim periods within those periods. The Company will evaluate the effect of the update at the time of any future acquisition or disposal. In May 2017, the FASB issued ASU 2017-09 "Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting." This update clarifies the existing definition of the term "modification," which is currently defined as "a change in any of the terms or conditions of a share-based payment award." The update requires entities to account for modifications of share-based payment awards unless the (1) fair value, (2) vesting conditions and (3) classification as an equity instrument or a liability instrument of the modified award are the same as of the original award before modification. Public business entities are required to adopt the amendments in this update for fiscal years and interim periods beginning after December 15, 2017, with early adoption permitted. The adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718) Improvements to Non-employee Share-Based Payment Accounting ("ASU 2018-07"). ASU 2018-07 affects all entities that enter into share-based payment transactions for acquiring goods and services from non-employees. The amendments in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The amendments in this ASU are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption permitted, but no earlier than an entity's adoption date of Topic 606. The adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) ("ASU 2018-13"). ASU 2018-13 modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits. The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of this Update. The Company is currently evaluating the impact that this standard will have, if any, on its financial statements. The Company does not believe that any other recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets The Acquisition of Moleculin, LLC On May 2, 2016, Moleculin, LLC, a Texas limited liability company, was merged with and into the Company. As a result of the merger, the Company issued to the holders of Moleculin equity interests an aggregate of 999,931 shares of the Company’s common stock valued at $6.0 million, based on the estimated acquisition-date fair value of our common stock of $6.00 per share, equal to the IPO price announced in our prospectus filed on that date. Prior to the Company’s acquisition of Moleculin, the Company had loaned $0.1 to Moleculin which was treated as part of the consideration paid to acquire Moleculin. As additional consideration payable to the Moleculin unit holders, we agreed pursuant to the merger agreement that if drugs for dermatology indications are successfully developed by us using any of the Existing IP Assets, then the Moleculin, LLC unit holders, in the aggregate, will be entitled to receive a 2.5% royalty on the net revenues generated by such drugs. Any such net revenues would include a deduction for license fees or royalty obligations payable to MD Anderson for such Existing IP Assets. The merger agreement defined “Existing IP Assets” to mean all intellectual property, licensed by us and Moleculin as of the time of the merger, including, without limitation, the intellectual property licensed from MD Anderson under the Patent and Technology License Agreement entered into by and between IntertechBio Corporation and MD Anderson dated April 2, 2012, as amended, and the Patent and Technology License Agreement dated June 21, 2010, as amended, between MD Anderson and Moleculin, LLC, but excluding any intellectual property relating to Annamycin. The right to receive the contingent royalty payments described herein is limited to drugs developed only for dermatology indications and does not include drugs developed for any other indications. We have no obligation of any nature to pursue the development of any drugs for dermatology indications. Our acquisition of Moleculin, LLC, occurring prior to our IPO offering, provided us with the rights to the license agreement that Moleculin, LLC had with MD Anderson covering the WP1066 Portfolio. However, Moleculin, LLC had previously granted Houston Pharmaceuticals, Inc. (“HPI”), a related party, an option, which could be exercised at any time, to obtain an exclusive sub-license to develop the WP1066 Portfolio in all non-dermatological fields. Moleculin, LLC had previously pursued development of the WP1066 Portfolio for treatment of psoriasis, however, psoriasis related clinical trials had been terminated. Because WP1066 has shown significant activity against a wide range of tumors, Moleculin, LLC’s focus prior to the acquisition included the development of drugs for cancer treatment. However, the exclusive sub-license option held by HPI precluded Moleculin, LLC from pursuing drug development related to non-skin cancers, in addition to potentially creating significant intellectual property, clinical and commercialization risks associated with drug development for skin cancers. Re-acquisition of the HPI option was therefore essential for the values of both the WP1066 Portfolio and Moleculin, LLC. Additionally, the merger agreement contained mutual representations and warranties between the parties. Pursuant to the merger agreement, we agreed for a period of six party or threatened to be made a party to any threatened, pending or completed proceeding or claim by reason of the fact that he or she was a director or officer of the Moleculin, LLC prior to the effective time of the merger and arising out of actions or omissions of the indemnified party in any such capacity occurring at or prior to the effective time of the merger against any losses or damages reasonably incurred in connection with any claim. To our knowledge, no such proceeding or claim exists or has been threatened on the date hereof. In connection with the acquisition of Moleculin, LLC, we also negotiated on behalf of Moleculin, LLC two agreements with HPI. Under the first agreement, HPI’s option to obtain the aforementioned exclusive sublicense was terminated in exchange for a payment of $100,000 and the issuance of 629,000 shares of our common stock, valued at $6 per share. Under the second agreement (HPI Out-Licensing Agreement), HPI has received a non-exclusive technology rights and development sublicense under which it may continue its ongoing work to develop the WP1066 Portfolio related to treatment of non-skin cancer. The Company expenses such costs as incurred as research and development expense, commencing after the IPO offering in exchange for HPI allowing us to access any data, information or know-how resulting from the research and development conducted by HPI. As of December 31, 2018, notwithstanding our obligation to make the foregoing payments, the HPI Out-Licensing Agreement does not obligate HPI to conduct any specific research or to meet any milestones. Pursuant to the HPI Out-Licensing Agreement, we have the right within three three The termination of the HPI option was completed on behalf of Moleculin, LLC, which was required to enable the sale of Moleculin, LLC by materializing the value of its most significant asset and was non-cancelable by either party. Further, the HPI option termination price was determined simultaneously with the acquisition on May 2, 2016 as our IPO price was established at that time. Accordingly, we concluded that this transaction was primarily for the benefit of Moleculin, LLC and its former owners, resulting in control of the underlying intellectual property and thereby increasing the value of Moleculin, LLC intangible assets immediately prior to the closing of its acquisition by us. Intangible assets consisted of the following at December 31, 2018 and December 31, 2017 (in thousands): December 31, 2018 2017 Intangibles acquired from Moleculin, LLC $ 11,148 $ 11,148 |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued expenses and other current liabilities | Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following components (in thousands): December 31, 2018 2017 Accrued license fees and sponsored research agreements $ 1,147 $ 260 Accrued drug manufacturing costs 400 — Accrued payroll 342 250 Accrued clinical testing 95 320 Accrued legal and professional fees 91 50 Accrued other 227 22 Total accrued expenses and other current liabilities $ 2,302 $ 902 |
Warrant Liability
Warrant Liability | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Warrant Liability | Warrant Liability The basis of value of the warrant liability is fair value, which is defined pursuant to Accounting Standards Codification (“ASC”) 820 to be “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date”. The Company used the Black-Scholes option pricing model (“BSM”) to determine the fair value of the Series A and Series B Warrants from the February 2017 Issuance, described below, along with the warrants issued in the February 2018 Issuance and June 2018 Issuance. The Company used a Monte Carlo simulation (“MCM”) with regard to the Series C Warrants from the February 2017 Issuance because of the path dependent vesting terms of the contract. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the warrants and is calculated by using the average daily historical stock prices through the day preceding the issuance date. Estimated volatility is a measure of the amount by which its stock price is expected to fluctuate each year during the expected life of the warrants. Where appropriate, the Company used the historical volatility of peer entities due to the lack of sufficient historical data of its stock price. June 2018 Issuance of Warrants On June 22, 2018, the Company entered into a definitive agreement with institutional investors for a registered direct offering of securities for the sale of 1,092,636 shares of its common stock, at a purchase price of $2.105 per share. Concurrently with the sale of the common shares, pursuant to the agreement, the Company also sold warrants to purchase 710,212 shares of common stock. The total number of warrants issued were 742,991, which includes the Roth Warrants below. The Company sold the common shares and warrants for aggregate gross proceeds of approximately $2.3 million. Subject to certain beneficial ownership limitations, the warrants will be initially exercisable on the six five The Company also entered into a placement agent agreement (the “Placement Agency Agreement”) with Roth Capital Partners, LLC (“Roth”), pursuant to which Roth agreed to serve as exclusive placement agent for the issuance and sale of the common shares and warrants. The Company paid Roth an aggregate fee equal to 6.5% of the gross proceeds received from the sale of the securities in the transactions. Pursuant to the Placement Agency Agreement, the Company also issued Roth warrants to purchase up to 3% of the aggregate number of shares of common stock sold in the transactions (the “Roth Warrants”) or 32,779 shares. The Roth Warrants have substantially the same terms as the investor warrants described above, except that the Roth Warrants will expire on June 21, 2023 and have an exercise price of $2.3155 per share. The Roth Warrants and the shares issuable upon exercise of the Roth Warrants will be issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and in reliance on similar exemptions under applicable state laws. The Company also reimbursed Roth for its expenses of $50,000. The Company agreed to give Roth a nine six six The assumptions used in the BSM model for the June 2018 Warrants are as follows: Year Ended December 31, 2018 2017 Risk-free interest rate 2.5 % to 2.51% N/A Volatility 75 % to 80% N/A Expected life (years) 4.47 to 4.98 N/A Dividend yield —% N/A A summary of the Company's June 2018 Warrant activity and related information follows: Description Number of Range of Weighted Weighted Average Balance as of January 1, 2018 — — — — — Granted 742,991 $ 2.02 to $ 2.32 $ 2.03 4.97 Exercised — — — — — Expired — — — — — Balance as of December 31, 2018 742,991 $ 2.02 to $ 2.32 $ 2.03 4.97 Vested and exercisable at December 31, 2018 742,991 $ 2.02 to $ 2.32 $ 2.03 4.97 February 2018 Issuance of Warrants On February 16, 2018, the Company entered into a Securities Purchase Agreement with certain institutional investors for the sale of 4,290,000 shares of its common stock, at a purchase price of $2.10 per share. Concurrently with the sale of the common shares, pursuant to the Purchase Agreement, the Company also sold warrants to purchase 2,145,000 shares of common stock. The total number of warrants issued were 2,273,700 which includes the Roth Warrants below. The Company sold the common shares and warrants for aggregate gross proceeds of approximately $9.0 million. Subject to certain beneficial ownership limitations, the warrants became exercisable on the six five The warrants and the shares issuable upon exercise of the warrants were sold without registration under the Securities Act of 1933 ("Securities Act") in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable state laws. The Company also entered into a placement agent agreement with Roth, pursuant to which Roth agreed to serve as exclusive placement agent for the issuance and sale of the common shares and warrants. The Company paid Roth an aggregate fee equal to 6.5% of the gross proceeds received from the sale of the securities in the transactions. Pursuant to the Placement Agency Agreement, the Company also issued Roth warrants to purchase up to 3% of the aggregate number of shares of common stock sold in the transactions (the “Roth Warrants”) or 128,700 shares. The Roth Warrants have substantially the same terms as the investor warrants described above, except that the Roth Warrants will expire on February 15, 2023. The Roth Warrants and the shares issuable upon exercise of the Roth Warrants will be issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and in reliance on similar exemptions under applicable state laws. The Company also reimbursed Roth for its expenses of $75,000 The Company agreed to give Roth a nine six The assumptions used in the BSM model for the February 2018 Warrants are as follows: Year Ended December 31, 2018 2017 Risk-free interest rate 2.49 % to 2.50% N/A Volatility 75.0 % to 77.5% N/A Expected life (years) 4.13 to 4.63 N/A Dividend yield —% N/A A summary of the Company's February 2018 Warrant activity and related information follows: Description Number of Range of Weighted Weighted Average Balance at January 1, 2018 — — — — Granted 2,273,700 $ 2.80 $2.80 4.64 Exercised — — — — Expired — — — — Balance at December 31, 2018 2,273,700 $ 2.80 $2.80 4.64 Vested and Exercisable at December 31, 2018 2,273,700 $ 2.80 $2.80 4.64 February 2017 Issuance of Warrants On February 9, 2017, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC, as representative of the several underwriters identified therein (collectively, the “Underwriters”), pursuant to which we sold in a registered public offering (the “Offering”), 3,710,000 units, priced at a public offering price of $1.35 per unit (the closing price that day was $1.50), with each unit consisting of: (i) one share of common stock, (ii) a five five Under the terms of the Underwriting Agreement, we granted the Underwriters a 45-day option to purchase an additional 556,500 shares of common stock and/or an additional 556,500 warrant combination (comprised of an aggregate of 278,250 Series A warrants, 556,500 Series B warrants and 278,250 Series C warrants), in any combinations thereof, from us to cover over-allotments at the public offering price per share of $1.349 and public offering price per warrant combination of $.001, respectively, less the underwriting discounts and commissions. Upon the closing of the Offering, the Underwriters exercised the over-allotment option with respect to $278,100 warrant combinations. We received approximately $4.5 million in net proceeds from the Offering, after deducting underwriting discounts and commissions and estimated offering expenses. The assumptions used in the BSM and MCM models for the February 2017 Warrants are as follows: Year Ended December 31, 2018 2017 Risk-free interest rate 2.46% 1.68 % to 1.86% Volatility 75.0% 80.0 % to 160.11% Expected life (years) 3.12 0.5 to 5.00 Dividend yield —% —% A summary of our February 2017 Warrant activity and related information follows: Description Number of Shares Under Warrant Range of Warrant Price per Share Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Balance at December 31, 2017 419,772 $ 1.50 $ 1.46 4.38 Granted — — Exercised (9,752) $ 1.50 $ 1.50 Expired — — Balance at December 31, 2018 410,020 $ 1.50 $ 1.50 3.13 Vested and Exercisable - December 31, 2018 410,020 $ 1.50 $ 1.50 3.13 |
Equity
Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Equity | Equity We are authorized to issue 5,000,000 shares of preferred stock and 75,000,000 shares of common stock. Preferred Stock Our certificate of incorporation authorizes the board to issue these shares in one or more series, to determine the designations and the powers, preferences and relative, participating, optional or other special rights and the qualifications, limitations and restrictions thereof, including the dividend rights, conversion or exchange rights, voting rights (including the number of votes per share), redemption rights and terms, liquidation preferences, sinking fund provisions and the number of shares constituting the series. As of December 31, 2018, there was no issued preferred stock. Common Stock Lincoln Park Transaction On October 4, 2018, 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 ("Lincoln Park"). Pursuant to the terms of the Purchase Agreement, Lincoln Park has agreed to purchase from us up to $20.0 million of our common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement. Pursuant to the terms of the Registration Rights Agreement, we filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, at the time we signed the Purchase Agreement and the Registration Rights Agreement, we issued 243,013 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the Purchase Agreement and may issue an additional 121,507 commitment shares pro-rata when and if Lincoln Park purchases (at the Company's discretion) the $20.0 million aggregate commitment. The commitment shares were valued at $337,788, recorded as an addition to equity for the issuance of common stock and treated as a reduction to equity as a cost of capital to be raised under the Purchase Agreement. During the fourth quarter, the Company issued 1,399,153 shares to Lincoln Park which included 10,918 commitment shares for $1.8 million. Settlement of a Liability In January 2017, the Company issued 79,167 shares of common stock to a consultant in full settlement for prior services rendered to the Company. Settlement occurred February 21, 2017 with the issuance of the shares, resulting in a gain on settlement of $0.15 million recorded in gain in settlement of liability on the Statements of Operations. Follow-On Public Offering In February 2017, the Company completed a public offering and sold 3,710,000 shares of the Company’s common stock. The offering price per unit was $1.35. The Company received net cash proceeds of $4.5 million after deducting underwriting discounts, commissions and direct offering expenses payable by us. See Note 5 above regarding Warrant issuances related to our February 2017 public offering. At Market Issuance Sales Agreement (ATM) On September 15, 2017, the Company entered into an At Market Issuance Sales Agreement (the “Agreement” or “ATM”) with Roth Capital Partners, LLC and National Securities Corporation (collectively, the “Agents”). Pursuant to the terms of the Agreement, the Company may sell from time to time through the Agents shares of the Company's common stock with an aggregate sales price of up to $13.0 million. Any sales of Shares pursuant to the Agreement will be made under the Company's effective shelf registration statement on Form S-3 (File No. 333-219434) which became effective on August 21, 2017 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the “SEC”) on September 15, 2017. Under the Agreement, the Company may sell Shares through an Agent by any method that is deemed an at the market offering as defined in Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”). Sales of the shares may be made at market prices prevailing at the time of sale, subject to such other terms as may be agreed upon at the time of sale, including a minimum sales price that may be stipulated by the Company's Board of Directors or a duly authorized committee thereof. The Company or the Agents, under certain circumstances and upon notice to the other, may suspend the offering of the shares under the Agreement. The offering of the shares pursuant to the Agreement will terminate upon the sale of shares in an aggregate offering amount equal to $13.0 million, or sooner if either the Company or the Agents terminate the Agreement pursuant to its terms. The Company agreed to pay a commission to the Agents of 3.0% of the gross proceeds of the sale of the shares sold under the Agreement and to reimburse the Agents for certain expenses. The Company has also provided the Agents with customary indemnification rights. The Company is not obligated to make any sales of Common Stock under the Agreement. As of December 2017, the Company had sold 776,016 shares of common stock from $2.05 to $2.71 per share with gross proceeds of $1.6 million under this Agreement. During the year ended December 31, 2018, the Company did not sell any shares under this ATM Agreement. Consulting Agreement In 2017, the Company entered into a consulting agreement for its investor relations operations. The consulting agreement initially covered a period of twelve five Adoption of 2015 Stock Plan On December 5, 2015, the Board of Directors of the Company approved the Company’s 2015 Stock Plan, which was amended on April 22, 2016 and April 6, 2018. The expiration date of the plan is December 5, 2025 and the total number of underlying shares of the Company’s common stock available for grant to employees, directors and consultants under the plan is 4,500,000 shares. The awards under the 2015 Stock Plan can be in the form of stock options, stock awards or stock unit awards. On June 6, 2018, the stockholders approved an amendment to the 2015 Plan to, among other things, increase the number of shares of common stock authorized for issuance under the 2015 Plan by 2,000,000 shares. Stock option activity for the years ended December 31, 2018 and 2017 is as follows: Number of Shares Weighted Average Grant Date Fair Value Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding, December 31, 2017 1,345,000 $ 1.93 $ 3.50 9.07 $ 83,000 Granted 1,479,000 $ 1.32 $ 1.79 Granted - Exercised (25,000) $ 0.13 $ 0.20 Canceled (5,000) $ 1.75 $ 2.49 Outstanding, December 31, 2018 2,794,000 $ 1.78 $ 2.61 9.43 $ 21,200 Exercisable, December 31, 2018 512,500 $ 2.61 $ 3.51 8.00 $ 21,000 The fair value of the option grants has been estimated, with the following weighted-average assumptions: Year Ended December 31, 2018 2017 Risk-free interest rate 0.95 % to 2.24% 1.83 % to 1.95% Volatility 70.18% to 89.11% 80% Expected life (years) 5.0 to 6.25 5.0 to 6.25 Expected dividend yield —% —% Stock-based compensation expense is as follows (in thousands): Year Ended December 31, 2018 2017 General and administrative $ 976 $ 684 Research and development 164 23 Total $ 1,140 $ 707 In 2018, the Company granted each of the two members of its science advisory board options in the aggregate to purchase 10,000 shares of the Company’s common stock with a weighted average exercise price of $1.46 per share, a term of 10 years, and a vesting period of 4 years. Options granted during 2018 have an aggregated fair value of $1.9 million that was calculated using the Black-Scholes option-pricing model. At December 31, 2018, total compensation cost not yet recognized was $3.2 million and the weighted average period over which this amount is expected to be recognized is 2.8 years. The aggregate fair value of options vesting in the years ended December 31, 2018 and 2017 was $1.9 million and $3.1 million, respectively. No options were exercised in 2017. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option valuation model that uses the assumptions noted in the above paragraph and table. The expected term of the options was computed using the “plain vanilla” method as prescribed by the Securities and Exchange Commission Staff Accounting Bulletin 107 because we do not have sufficient data regarding employee exercise behavior to estimate the expected term. The volatility was determined by referring to the average historical volatility of a peer group of public companies because we do not have sufficient trading history to determine our historical volatility. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The provision for income taxes consists of the following components (in thousands): Year Ended December 31, 2018 2017 Current expense (benefit): Federal $ — $ — State — — Current income tax expense $ — $ — Deferred expense (benefit): Federal $ — $ — State — — Deferred income tax expense $ — $ — Net deferred taxes $ — $ — The following summarizes activity related to the Company’s valuation allowance (in thousands): Year Ended December 31, 2018 2017 Valuation allowance at beginning of period $ 2,561 $ 1,397 Income tax benefit 3,294 1,164 Release of valuation allowance — — Valuation allowance at end of period $ 5,855 $ 2,561 A reconciliation of the income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands): Year Ended December 31, 2018 2017 Amount Percent Amount Percent Federal tax benefit at statutory rate $ 2,494 21.00 % $ 3,334 34.00 % State tax benefit net of federal 18 .15 % (117) (1.20) % Foreign rate differential 43 0.36 % — — % IPO costs (112) (.94) % (76) (.77) % Stock warrant costs 669 5.63 % (395) (4.03) % Other permanent differences (8) (.07) % (9) (.09) % Permanent PTR items 190 1.60 % — — % Change in deferred tax rate due to tax reform — — % (1,562) (15.93) % Other — — % (11) (.11) % Increase in valuation allowance (3,294) (27.73) % (1,164) (11.87) % Total tax (expense) benefit $ — — % $ — — % The principal components of the Company’s deferred tax assets and liabilities consist of the following (in thousands): Year Ended December 31, 2018 2017 Deferred tax assets: Start-up costs $ 1,962 $ 1,105 Federal net operating loss carryforwards 3,153 1,275 State tax loss carryforwards 21 9 Foreign net operating loss carryforwards 182 — Tax credit carryforward 190 — Interest limitation 1 — Deferred compensation 418 176 Total deferred tax assets $ 5,927 $ 2,565 Less valuation allowance (5,855) (2,561) Net deferred tax assets $ 72 $ 4 Deferred tax liabilities: Fixed assets (72) (4) Total deferred tax liabilities $ (72) $ (4) Net deferred taxes $ — $ — The Company has incurred net operating losses since inception. As of December 31, 2018, the Company had total federal operating loss carry forwards of approximately $15.1 million. Of this, $6.1 million will expire commencing in 2037, with the rest having no set expiration date. The value of these carryforwards depends on the Company’s ability to generate taxable income. Additionally, because federal tax laws limit the time during which the net operating loss carryforwards may be applied against future taxes, if the Company fails to generate taxable income prior to the expiration dates of the carry forwards the Company may not be able to fully utilize the net operating loss carryforwards to reduce future income taxes. Under the new tax laws, net operating loss carry forwards will not expire beginning for losses generated in the 2018 tax year. However, these net operating losses will only be able to offset 80% of future taxable income. Finally, the Company has not undertaken a detailed analysis of the application of IRC Section 382 with respect to limitations on the utilization of net operating loss carryforwards and other deferred tax assets. However, the Company believes that this matter is not material to the overall tax position within the financial statements due to the full valuation allowance against the net operating losses and the lack of utilization of the net operating losses during tax years open under statute. The Company conducts business in various locations and, as a result, files income tax returns in the United States Federal jurisdiction and in multiple state jurisdictions. As of December 31, 2018, the Company had state operating losses of approximately $13.3 million which expire commencing in 2038. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. Management has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. The Company has cumulative losses and there is no assurance of future taxable income, therefore, valuation allowances have been recorded to fully offset the deferred tax asset at December 31, 2018. Management has determined that it is more likely than not that the Company will not recognize the benefits of its federal and state deferred tax assets, and as a result, a valuation allowance of $5.9 million and $2.56 million has been established at December 31, 2018 and 2017, respectively. The change in the valuation allowance for the year ended December 31, 2018 was primarily due to additional operating losses and capitalized research costs. The Company may be eligible to claim research and development tax credits in the future, but has not conducted a study to date. The Company participates in significant Research and Development Activities, and expects to receive a benefit from both a federal and foreign Research and Development Tax Credit. Currently, we have not recognized the tax credit for the 2018 tax year and will wait for completion of the full study for the federal credit. The company has recognized the federal Research and Development tax credit claimed on the 2017 tax return, for approximately $0.2 million. While the company is fully reserved, we expect a reserve of 20% for this credit claimed. The company has a liability for unrecognized tax benefits of $38,000 (excluding accrued interest and penalties) as of December 31, 2018. A reconciliation of the beginning and ending unrecognized tax benefits excluding interest and penalties is as follows (in thousands): Year Ended December 31, 2018 2017 Balance, beginning of year $ — $ — Additions for tax positions related to the current year — — Additions for tax positions related to prior years 38 — Reductions due to lapse of statutes of limitations — — Decreases related to settlements with tax authorities — — Balance, end of year $ 38 $ — The Company also participates in significant research and development activities in Australia. The Australian government provides a refundable tax credit based on whether the business and the activities it is conducting are eligible. While the Company was not pre-approved for this credit, approval for the year ended December 31, 2018 is expected. The amount of benefit is estimated to be around A$0.4 million. This will not be booked until approval has been received. Although the Company believes its recorded assets and liabilities are reasonable, tax regulations are subject to interpretation and tax litigation is inherently uncertain; therefore, the Company’s assessments can involve both a series of complex judgments about future events and rely heavily on estimates and assumptions. Although the Company believes that the estimates and assumptions supporting its assessments are reasonable, the final determination of tax audit settlements and any related litigation could be materially different from that which is reflected in historical income tax provisions and recorded assets and liabilities. If the Company were to settle an audit or a matter under litigation, it could have a material effect on the income tax provision, net income, or cash flows in the period or periods for which that determination is made. Any accruals for tax contingencies are provided for in accordance with U.S. GAAP . The Company does not believe that its tax positions will significantly change due to any settlement and/or expiration of statutes of limitations prior to December 31, 2018. On December 22, 2017, Staff Accounting Bulletin No. 118 ("SAB 118") was issued to address the application of US GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. The deferred tax expense recorded in connection with the remeasurement of deferred tax assets was a provisional amount and a reasonable estimate at December 31, 2017 based upon the best information that was available. The accounting with respect to the implementation of the Tax Act is now complete with no change from the amounts reported at December 31, 2017. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Lease Obligations Payable On March 22, 2018, the Company entered into a Lease Agreement (the “Lease”) with IPX Memorial Drive Investors, LLC (the “Landlord”) in Houston, Texas which is being used for corporate office space and headquarters. The term of the Lease began in August 2018 and will continue for an initial term of 66 months, which may be renewed for an additional 5 years. The Company is required to remit base monthly rent of approximately $4,300 which will increase at an average approximate rate of 3% each year. Rent expense is being recognized on a straight-line basis over the life of the lease and the difference between rent expense and rent paid is being recorded as deferred rent. The Company is responsible for certain charges incurred by the Landlord. Rent expense also includes lab space, which is on a month-to-month lease. Rent expense was $54,000 and $29,000 for the years ended December 31, 2018 and 2017, respectively. Minimum aggregate future lease commitments at December 31, 2018 are as follows (in thousands): Year Ended Minimum Lease Payments 2019 $ 48 2020 53 2021 54 2022 55 2023 56 Thereafter 5 Total minimum lease payments $ 271 MD Anderson Under agreements associated with Annamycin, the WP1122 Portfolio, and the WP1066 Portfolio, which includes WP1732, all described below, the Company is responsible for certain license, milestone and royalty payments over the course of the agreements. Annual license fees can cost as high as $0.1 million depending upon the anniversary. Milestone payments for the commencement of phase II and phase III clinical trials can cost as high as $0.5 million. Other milestone payments for submission of an NDA to the FDA and receipt of first marketing approval for sale of a license product can be as high as $0.6 million. Royalty payments can range in the single digits as a percent of net sales on drug products or flat fees as high as $0.6 million, depending upon certain terms and conditions. Not all of these payments are applicable to every drug. Total expenses under these agreements were $0.3 million and $0.2 million for the years ended December 31, 2018 and 2017, respectively. On June 29, 2017, the Company entered into an agreement with MD Anderson licensing certain technology related to the method of preparing Liposomal Annamycin. WP1122 Portfolio The rights and obligations to an April 2012 Patent and Technology License Agreement entered into by and between IntertechBio and MD Anderson (the “IntertechBio Agreement”) have been assigned to MBI. Therefore, MBI has obtained a royalty-bearing, worldwide, exclusive license to intellectual property, including patent rights, related to our WP1122 Portfolio and to our drug product candidate, WP1122. WP1066 Portfolio The rights and obligations to a June 2010 Patent and Technology License Agreement entered into by and between Moleculin LLC and MD Anderson (the “Moleculin Agreement”) have been assigned MBI. Therefore, MBI has obtained a royalty-bearing, worldwide, exclusive license to intellectual property rights, including patent rights, related to our WP1066 drug product candidate. In consideration, we must make payments to MD Anderson including an up-front payment, milestone payments and minimum annual royalty payments for sales of products developed under the license agreement. Annual Maintenance fee payments will no longer be due upon marketing approval in any country of a licensed product. One-time milestone payments are due upon commencement of the first Phase III study for a licensed product within the United States, Europe, China or Japan; upon submission of the first NDA for a licensed product in the United States; and upon receipt of the first marketing approval for sale of a licensed product in the United States. The rights the Company has obtained pursuant to the assignment of the Moleculin Agreement are made subject to the rights of the U.S. government to the extent that the technology covered by the licensed intellectual property was developed under a funding agreement between MD Anderson and the U.S. government. MBI entered into an out-licensing agreement with Houston Pharmaceuticals, Inc. (“HPI”), pursuant to which we have granted certain intellectual property rights to HPI, including rights covering the potential drug candidate, WP1066 (“HPI Out-Licensing Agreement”). Under the HPI Out-Licensing Agreement we must make quarterly payments totaling $0.75 million for the first twelve quarters following the effective date of the HPI Out-Licensing Agreement, or May 2, 2016, in consideration for the right to development data related to the development of licensed products. Notwithstanding our obligation to make the foregoing payments, the HPI Out-Licensing Agreement does not obligate HPI to conduct any research or to meet any milestones. Upon payment in the amount of $1.0 million to HPI within three years of the effective date of the HPI Out-Licensing Agreement we will regain all rights to the licensed subject matter and rights to any and all development data and any regulatory submissions including any IND, NDA or ANDA related to the licensed subject matter and can end the license without any other obligation other than the aforementioned quarterly payments. In the event that MBI does not exercise our rights to the licensed subject matter within three years of the effective date of the HPI Out-Licensing Agreement, the license granted to HPI shall convert to an exclusive license upon HPI’s written notice and we shall be obligated to transfer all existing data relating to licensed subject matter including any development data and any IND to HPI. During the year, management concluded that it was more likely than not that the Company will pay in the near term the HPI Repurchase Payment. The $1.0 million accrual for this payment is recorded on the balance sheet as a liability as of December 31, 2018 under "Accrued expenses and other liabilities" and expensed under "Research and development" during the period. License fees expensed related to HPI and the accrual for the HPI Repurchase Payment were $1.3 million and $0.2 million respectively, for the year ended December 31, 2018 and 2017. In February 2018, we entered into a license agreement with MD Anderson covering a new group of molecules recently discovered in connection with research it has been sponsoring there called WP1732, a part of the WP1066 Portfolio. Sponsored Research Agreements with MD Anderson On January 9, 2017, MBI amended our Sponsored Laboratory Study Agreement with MD Anderson whereby we paid $0.3 million in 2017, and the agreement was extended to October 31, 2018. On December 4, 2017, MBI extended this Agreement until October 31, 2019 for total payment amount of $0.35 million spread over that period of time. Of this amount, $0.24 million was paid in the first quarter of 2018 and the final payment of $0.11 million was paid in the third quarter of 2018. On September 25, 2018, we extended this Agreement until October 31, 2020 for total payment amount of $0.4 million spread over that period of time. Of this amount, $0.27 million was paid in the fourth quarter of 2018, and the final payment of $0.13 million was paid in 2019. The expenses recognized under the MD Anderson agreement with regards to the Sponsored Laboratory Study were $0.4 million and $0.2 million for the years ended December 31, 2018 and 2017, respectively. Other Licenses In 2015, we obtained the rights and obligations for certain patent and technology development and license agreements with Dermin Sp. Zoo ("Dermin"). In connection with such agreements, certain intellectual property rights related to Annamycin, our WP1122 portfolio, and our WP1066 portfolio have been licensed to Dermin and Dermin has been granted a royalty-bearing, exclusive license to manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of human therapeutics under the licensed intellectual property. With respect to Annamycin, the license is limited to the countries of Poland, Ukraine, Czech Republic, Hungary, Romania, Slovakia, Belarus, Lithuania, Latvia, Estonia, Netherlands, Turkey, Belgium, Switzerland, Austria, Sweden, Greece, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland, Kazakhstan, Russian Federation, Uzbekistan, Georgia, Armenia, Azerbaijan and Germany; provided that we have the right to remove Germany from the list of covered territories with a $0.5 million payment. With respect to WP1122, the license is limited to the countries of Belarus, Russia, Kazakhstan, Uzbekistan, Turkmenistan, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Ukraine. With respect to WP1066, the license is limited to the countries of Belarus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Ukraine. In each case, Dermin will pay a royalty for the sale of any licensed product in the licensed territories and will pay all out-of-pocket expenses incurred in filing, prosecuting and maintaining the licensed patents for which the license has been granted in the licensed territories. Dermin also agreed to provide a percentage of certain consideration that Dermin receives pursuant to sublicense agreements. Employment Agreements The Company has agreements with nine employees to provide certain benefits in the event of termination where the base salary and certain other benefits would aggregate approximately $1.2 million using the rate of compensation in effect at December 31, 2018. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events In addition to the subsequent events discussed elsewhere in these notes, see below for a discussion of our subsequent events occurring after December 31, 2018. Summary of WPD Agreement On February 19, 2019, we sublicensed certain intellectual property rights, including rights to Annamycin, our WP1122 portfolio, and our WP1066 portfolio to WPD Pharmaceuticals (“ WPD ”) (the “WPD Agreement”). WPD is affiliated with Dr. Waldemar Priebe, our founder and largest shareholder. Under the WPD Agreement, we granted WPD a royalty-bearing, exclusive license to research, develop, manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of human therapeutics under the licensed intellectual property in the countries of Germany, Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova, Romania, Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary, Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland (“licensed territories”), provided that we have the right to buyback Germany from the licensed territories by making a payment $0.5 million, or by issuing 235,850 shares of our common stock. In consideration for entering into the WPD Agreement, WPD agreed that it must use Commercially Reasonable Development Efforts to develop and commercialize products in the licensed territories. For purposes of the WPD Agreement, the term “Commercially Reasonable Development Efforts” means the expenditure by or on behalf of WPD or any of its affiliates of at least: (i) $2.0 million during the first two two Prior to approval of the WPD Agreement, our board of directors received a fairness opinion from Roth Capital Partners, LLC that stated that it was their opinion that the consideration we will receive from WPD pursuant to the WPD Agreement is fair, from a financial point of view, to us. Summary of Animal Life Sciences Agreement On February 19, 2019, we sublicensed certain intellectual property rights, including rights to Annamycin, our WP1122 portfolio, and our WP1066 portfolio in the field of non-human animals to Animal Life Sciences, LLC (“ALI”) (the “ALI Agreement”). ALI is affiliated with Dr. Waldemar Priebe, our founder and largest shareholder. Under the ALI Agreement, we granted ALI a worldwide royalty-bearing, exclusive license to research, develop, manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of non-human animals under the licensed intellectual property. During the term of the ALI Agreement, to the extent we are required to make any payments to MD Anderson pursuant to our license agreements with MD Anderson, whether a milestone or royalty payment, as a result of the research and development or sale of a sublicensed product, ALI shall be required to advance or reimburse us such payments. In further consideration for the rights granted by us to ALI under the ALI Agreement, ALI agreed to pay us a royalty percentage at a rate equal to the royalty rate we owe MD Anderson under our license agreements with MD Anderson plus an additional royalty equal to 5.0%of net sales of any sublicensed products. As additional consideration, ALI issued us a 10.0% ownership interest in ALI. With certain exceptions, the ALI Agreement will remain in full force and effect until the expiration of the last patent within the sublicensed patents. Sale of Shares to Lincoln Park During February 2019, the Company sold 600,000 shares to Lincoln Park for an aggregate purchase price of $0.9 million and 5,367 commitment shares. |
Basis of presentation, princi_2
Basis of presentation, principles of consolidation and significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Acquisition | Acquisition – We acquired Moleculin, LLC (“Moleculin”) on May 2, 2016, and, going forward our consolidated financial statements include the operations of Moleculin, LLC. We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that assets acquired, and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of acquired in-process research and development (“IPR&D”) be recorded on the balance sheet. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired will be recorded as goodwill. The Company obtained input from third-parties regarding its tangible and intangible assets and other information necessary to measure the fair value of the assets acquired and liabilities assumed in connection with the acquisition of Moleculin, LLC. |
Use of Estimates | Use of Estimates - The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, accrued expenses and taxes. |
Going Concern | Going Concern - These consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary financing to continue operations and the attainment of profitable operations. As of December 31, 2018, the Company has incurred a consolidated accumulated deficit of $26.4 million since inception and had not yet generated any revenue from operations. Additionally, management anticipates that its consolidated cash on hand as of December 31, 2018 plus the additional cash generated from its equity offering subsequent to year-end, discussed further within these notes to the financial statements, is sufficient to fund its planned operations into but not beyond the near term. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. These consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. Management cannot be certain that such events or a combination thereof can be achieved. |
Cash and Cash Equivalents | Cash and Cash Equivalents - The Company considers all highly liquid accounts with original maturities of three months or less at the date of acquisition to be cash equivalents. Periodically in the ordinary course of business, the Company may carry cash balances at financial institutions in excess of the insured limits of $250,000. |
Property and equipment | Property and equipment - Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows: Leasehold improvement Shorter of estimated useful lives or the term of the lease Computer equipment 2 years Software 3 years Machinery and equipment 5 years Furniture and office equipment 7 years |
Intangible assets | Intangible assets - Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. If an intangible asset is identified as an in-process research & development asset, then no amortization will occur until the development is complete. If the associated research and development effort is abandoned, the related assets will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. We evaluate the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. No impairments of intangible assets have been identified during any of the periods presented. Intangible assets are tested for impairment on an annual basis, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach. |
Rent and Deferred Rent | Rent and Deferred rent - The Company recognizes rent expense for leases with increasing annual rents on a straight-line basis over the term of the lease. The amount of rent expense in excess of cash payments is classified as deferred rent. Any lease incentives received are deferred and amortized over the term of the lease. |
Fair Value of Financial Instruments | Fair Value of Financial instruments - Our financial instruments consist primarily of account payables, accrued expenses and a warrant liability. The carrying amount of accounts payables and accrued expenses approximates their fair value because of the short-term maturity of such. We have categorized our assets and liabilities that are valued at fair value on a recurring basis into three-level fair value hierarchy in accordance with GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the balance sheets at fair value are categorized based on a hierarchy of inputs as follows: Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities. Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 – Unobservable inputs for the asset or liability. |
Income Taxes | Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of reported assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740-10 which prescribes a recognition threshold and measurement attribute for financial statement disclosure of tax positions taken, or expected to be taken, on its tax return. The Company evaluates and records any uncertain tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in which it operates. |
Stock-based Compensation | Stock-based Compensation - Stock-based compensation expense includes the estimated fair value of equity awards vested or expected to vest during the reporting period. The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and modifications to existing stock options, to be recognized in the consolidated statements of operations based on their fair values. The Company uses the Black-Scholes option pricing model to determine the fair value of options granted. The awards are subject to service vesting conditions. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to non-employees with service-based vesting conditions is recognized based on the then-current fair value at each financial reporting date prior to the measurement date over the associated service period of the award, which is generally the vesting term. |
Loss Per Common Share | Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. |
Research and Development Costs | Research and Development Costs - Research and development costs are expensed as incurred. |
Subsequent Events | Subsequent Events - The Company’s management reviewed all material events through the date these consolidated financial statements were issued for subsequent event disclosure consideration as described in Note 9. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standard Update ("ASU") 2014-9, Revenue from Contracts with Customers (Topic 606), which will replace numerous requirements in U.S. GAAP, including industry-specific requirements, and provide companies with a single revenue recognition model for recognizing revenue from contracts with customers. The core principle of the new standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB approved a proposal to defer the effective date of the guidance until annual and interim reporting periods beginning after December 15, 2018. The Company is currently evaluating the impact that this standard will have on its consolidated financial statements at the time the Company starts to generate revenue or enters into other contractual arrangements, which the Company does not expect in the near term. This topic is not applicable until after 2018. In January 2016, the FASB issued ASU No. 2016-1, Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-1”). ASU 2016-1 affects the accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements of financial instruments. ASU 2016-1 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements. In February 2016, the FASB issued Topic 842, Leases, by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new leasing standards generally requires lessees to recognize operating and financing lease liabilities and corresponding right-of-use assets on the consolidated balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leasing arrangements. We will adopt the new standard effective January 1, 2019 and will not restate comparative periods. Presentation of leases within the consolidated statements of operations and consolidated statements of cash flows will be generally consistent with the current lease accounting guidance. We will elect the package of practical expedients permitted under the transition guidance and as such, the adoption of this ASU will not change the classification of any of our leases. We will elect to combine lease and non-lease components, elect not to record leases with an initial term of 12 months or less on the balance sheet and recognize the associated lease payments in the consolidated statements of operations on a straight-line basis over the lease term. We estimate that approximately $0.2 million will be recognized as total right-of-use asset and a lease liability on our consolidated balance sheet as of January 1, 2019. Otherwise, we do not expect the new standard to have a material impact on our consolidated financial statements. In March 2016, the FASB issued ASU 2016-9, Compensation-Stock Compensation (Topic 718): Improvements to Employee-Share-Based Accounting. The new guidance changes the accounting and simplifies various aspects of the accounting for share-based payments to employees. The guidance allows for a policy election to account for forfeitures as they occur or based on an estimated number of awards that are expected to vest. MBI assumes no forfeiture since it has limited history. ASU 2016-9 is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The adoption of this standard on January 1, 2017, did not have a significant impact on the Company’s consolidated financial statements. In August 2016, the FASB issued ASU, Statement of Cash Flows (Topic 230). This ASU applies to all entities that are required to present a statement of cash flows under Topic 230. The amendments provide guidance on eight specific cash flow issues and includes clarification on how these items should be classified in the statement of cash flows and is designed to help eliminate diversity in practice as to where items are classified in the cash flow statement. Furthermore, in November 2016, the FASB issued additional guidance on this Topic that requires amounts generally described as restricted cash and restricted cash equivalents to be included with cash and cash equivalents when reconciling the statement of cash flows. This ASU is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with earlier application permitted for all entities. The adoption of this standard on January 1, 2018 did not have a significant impact on the Company's consolidated financial statements. In January 2017, the FASB issued ASU 2017-01 "Business Combinations (Topic 805)," which provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This screen reduces the number of transactions that need to be further evaluated. If the screen is not met, the amendments in this update (1) require that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments in this update also narrow the definition of the term "output" so that the term is consistent with how outputs are described in Topic 606. Public business entities are required to apply the amendments in this update to annual periods beginning after December 15, 2017, including interim periods within those periods. The Company will evaluate the effect of the update at the time of any future acquisition or disposal. In May 2017, the FASB issued ASU 2017-09 "Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting." This update clarifies the existing definition of the term "modification," which is currently defined as "a change in any of the terms or conditions of a share-based payment award." The update requires entities to account for modifications of share-based payment awards unless the (1) fair value, (2) vesting conditions and (3) classification as an equity instrument or a liability instrument of the modified award are the same as of the original award before modification. Public business entities are required to adopt the amendments in this update for fiscal years and interim periods beginning after December 15, 2017, with early adoption permitted. The adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718) Improvements to Non-employee Share-Based Payment Accounting ("ASU 2018-07"). ASU 2018-07 affects all entities that enter into share-based payment transactions for acquiring goods and services from non-employees. The amendments in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The amendments in this ASU are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption permitted, but no earlier than an entity's adoption date of Topic 606. The adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) ("ASU 2018-13"). ASU 2018-13 modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits. The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of this Update. The Company is currently evaluating the impact that this standard will have, if any, on its financial statements. The Company does not believe that any other recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements. |
Basis of presentation, princi_3
Basis of presentation, principles of consolidation and significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Property Plant And Equipment Useful life | Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows: Leasehold improvement Shorter of estimated useful lives or the term of the lease Computer equipment 2 years Software 3 years Machinery and equipment 5 years Furniture and office equipment 7 years |
Fair Value Measurements, Recurring and Nonrecurring | The following table provides the financial assets and liabilities reported at fair value and measured on a recurring basis at December 31, 2018 and December 31, 2017, respectively. (in thousands): Description Liabilities Measured at Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Other Unobservable Inputs (Level 3) Fair value of warrant liability: December 31, 2018 $ 1,508 $ — $ — $ 1,508 December 31, 2017 $ 503 $ — $ — $ 503 The following table provides a summary of changes in fair value associated with the Level 3 liabilities for the years ended December 31, 2017 and 2018 (in thousands): Warrant Liability – Current Warrant Liability – Long-Term Warrant Liability – Total December 31, 2016 $ — $ — $ — Issuance of warrants 2,453 1,690 4,143 Reclass of liability from long-term to current 1,846 (1,846) — Change in fair value - net 2,643 (95) 2,548 Exercise of warrants (5,201) 251 (4,950) Expiration of warrants (1,238) — (1,238) December 31, 2017 503 — 503 Issuance of warrants — 4,203 4,203 Change in fair value - net (310) (2,875) (3,185) Exercise of warrants (13) — (13) December 31, 2018 $ 180 $ 1,328 $ 1,508 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following at December 31, 2018 and December 31, 2017 (in thousands): December 31, 2018 2017 Intangibles acquired from Moleculin, LLC $ 11,148 $ 11,148 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued expenses and Other Liabilities | Accrued expenses and other current liabilities consist of the following components (in thousands): December 31, 2018 2017 Accrued license fees and sponsored research agreements $ 1,147 $ 260 Accrued drug manufacturing costs 400 — Accrued payroll 342 250 Accrued clinical testing 95 320 Accrued legal and professional fees 91 50 Accrued other 227 22 Total accrued expenses and other current liabilities $ 2,302 $ 902 |
Warrant Liability (Tables)
Warrant Liability (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Warrant Activity | A summary of our February 2017 Warrant activity and related information follows: Description Number of Shares Under Warrant Range of Warrant Price per Share Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Balance at December 31, 2017 419,772 $ 1.50 $ 1.46 4.38 Granted — — Exercised (9,752) $ 1.50 $ 1.50 Expired — — Balance at December 31, 2018 410,020 $ 1.50 $ 1.50 3.13 Vested and Exercisable - December 31, 2018 410,020 $ 1.50 $ 1.50 3.13 |
Schedule of Assumptions Used | The fair value of the option grants has been estimated, with the following weighted-average assumptions: Year Ended December 31, 2018 2017 Risk-free interest rate 0.95 % to 2.24% 1.83 % to 1.95% Volatility 70.18% to 89.11% 80% Expected life (years) 5.0 to 6.25 5.0 to 6.25 Expected dividend yield —% —% |
February 2017 Issuance | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Assumptions Used | The assumptions used in the BSM and MCM models for the February 2017 Warrants are as follows: Year Ended December 31, 2018 2017 Risk-free interest rate 2.46% 1.68 % to 1.86% Volatility 75.0% 80.0 % to 160.11% Expected life (years) 3.12 0.5 to 5.00 Dividend yield —% —% |
Equity (Tables)
Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Summary of Option Activities | Stock option activity for the years ended December 31, 2018 and 2017 is as follows: Number of Shares Weighted Average Grant Date Fair Value Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding, December 31, 2017 1,345,000 $ 1.93 $ 3.50 9.07 $ 83,000 Granted 1,479,000 $ 1.32 $ 1.79 Granted - Exercised (25,000) $ 0.13 $ 0.20 Canceled (5,000) $ 1.75 $ 2.49 Outstanding, December 31, 2018 2,794,000 $ 1.78 $ 2.61 9.43 $ 21,200 Exercisable, December 31, 2018 512,500 $ 2.61 $ 3.51 8.00 $ 21,000 |
Schedule of Assumptions Used | The fair value of the option grants has been estimated, with the following weighted-average assumptions: Year Ended December 31, 2018 2017 Risk-free interest rate 0.95 % to 2.24% 1.83 % to 1.95% Volatility 70.18% to 89.11% 80% Expected life (years) 5.0 to 6.25 5.0 to 6.25 Expected dividend yield —% —% |
Components of Share-Based Compensation | Stock-based compensation expense is as follows (in thousands): Year Ended December 31, 2018 2017 General and administrative $ 976 $ 684 Research and development 164 23 Total $ 1,140 $ 707 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The provision for income taxes consists of the following components (in thousands): Year Ended December 31, 2018 2017 Current expense (benefit): Federal $ — $ — State — — Current income tax expense $ — $ — Deferred expense (benefit): Federal $ — $ — State — — Deferred income tax expense $ — $ — Net deferred taxes $ — $ — |
Summary of Valuation Allowance | The following summarizes activity related to the Company’s valuation allowance (in thousands): Year Ended December 31, 2018 2017 Valuation allowance at beginning of period $ 2,561 $ 1,397 Income tax benefit 3,294 1,164 Release of valuation allowance — — Valuation allowance at end of period $ 5,855 $ 2,561 |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands): Year Ended December 31, 2018 2017 Amount Percent Amount Percent Federal tax benefit at statutory rate $ 2,494 21.00 % $ 3,334 34.00 % State tax benefit net of federal 18 .15 % (117) (1.20) % Foreign rate differential 43 0.36 % — — % IPO costs (112) (.94) % (76) (.77) % Stock warrant costs 669 5.63 % (395) (4.03) % Other permanent differences (8) (.07) % (9) (.09) % Permanent PTR items 190 1.60 % — — % Change in deferred tax rate due to tax reform — — % (1,562) (15.93) % Other — — % (11) (.11) % Increase in valuation allowance (3,294) (27.73) % (1,164) (11.87) % Total tax (expense) benefit $ — — % $ — — % |
Schedule of Deferred Tax Assets and Liabilities | The principal components of the Company’s deferred tax assets and liabilities consist of the following (in thousands): Year Ended December 31, 2018 2017 Deferred tax assets: Start-up costs $ 1,962 $ 1,105 Federal net operating loss carryforwards 3,153 1,275 State tax loss carryforwards 21 9 Foreign net operating loss carryforwards 182 — Tax credit carryforward 190 — Interest limitation 1 — Deferred compensation 418 176 Total deferred tax assets $ 5,927 $ 2,565 Less valuation allowance (5,855) (2,561) Net deferred tax assets $ 72 $ 4 Deferred tax liabilities: Fixed assets (72) (4) Total deferred tax liabilities $ (72) $ (4) Net deferred taxes $ — $ — |
Summary of Unrecognized Tax Benefits | A reconciliation of the beginning and ending unrecognized tax benefits excluding interest and penalties is as follows (in thousands): Year Ended December 31, 2018 2017 Balance, beginning of year $ — $ — Additions for tax positions related to the current year — — Additions for tax positions related to prior years 38 — Reductions due to lapse of statutes of limitations — — Decreases related to settlements with tax authorities — — Balance, end of year $ 38 $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Minimum aggregate future lease commitments at December 31, 2018 are as follows (in thousands): Year Ended Minimum Lease Payments 2019 $ 48 2020 53 2021 54 2022 55 2023 56 Thereafter 5 Total minimum lease payments $ 271 |
Nature of Business and Liquidit
Nature of Business and Liquidity (Details) | 12 Months Ended | |
Dec. 31, 2018technologyprojectcandidate | Feb. 21, 2019drugclinicalTrial | |
Subsequent Event [Line Items] | ||
Number of drug technologies | technology | 3 | |
Number of drug candidates | candidate | 6 | |
Number of other drug development projects | project | 5 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Number of drugs in clinical trials | drug | 3 | |
Number of clinical trials | clinicalTrial | 4 |
Basis of presentation, princi_4
Basis of presentation, principles of consolidation and significant accounting policies - Narrative (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018USD ($)segmentshares | Dec. 31, 2017USD ($)shares | Jan. 01, 2019USD ($) | |
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segments | segment | 1 | ||
Accumulated deficit | $ (26,356) | $ (14,480) | |
Computer equipment | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment assets acquired, useful life | 2 years | ||
Software Equipment | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment assets acquired, useful life | 3 years | ||
Machinery and Equipment | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment assets acquired, useful life | 5 years | ||
Office furniture and equipment | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment assets acquired, useful life | 7 years | ||
Warrant | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive shares excluded from computation of earnings per share (in shares) | shares | 3,784,515 | 677,576 | |
Employee Stock Option | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive shares excluded from computation of earnings per share (in shares) | shares | 2,794,000 | 1,345,000 | |
Subsequent Event | Accounting Standards Update 2016-02 | Scenario, Forecast | |||
Description Of Business And Summary Of Significant Accounting Policies [Line Items] | |||
Right-of-use asset | $ 200 | ||
Lease liability | $ 200 |
Basis of presentation, princi_5
Basis of presentation, principles of consolidation and significant accounting policies - Fair Value of Warrant Liability (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of warrant liability | $ 503 | $ 1,508 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of warrant liability | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of warrant liability | 0 | 0 |
Significant Other Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of warrant liability | $ 503 | $ 1,508 |
Basis of presentation, princi_6
Basis of presentation, principles of consolidation and significant accounting policies - Fair Value Measurements (Details) - Significant Other Unobservable Inputs (Level 3) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Warrant Liability – Current | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 503 | $ 0 |
Issuances of warrants | 0 | 2,453 |
Reclass of liability from long-term to current | 1,846 | |
Change in fair value - net | (310) | 2,643 |
Transfer in and out (exercise of warrants) | (13) | (5,201) |
Expiration of warrants | (1,238) | |
Ending balance | 180 | 503 |
Warrant Liability – Long-Term | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 0 | 0 |
Issuances of warrants | 4,203 | 1,690 |
Reclass of liability from long-term to current | (1,846) | |
Change in fair value - net | (2,875) | (95) |
Transfer in and out (exercise of warrants) | 0 | 251 |
Expiration of warrants | 0 | |
Ending balance | 1,328 | 0 |
Warrant Liability – Total | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 503 | 0 |
Issuances of warrants | 4,203 | 4,143 |
Reclass of liability from long-term to current | 0 | |
Change in fair value - net | (3,185) | 2,548 |
Transfer in and out (exercise of warrants) | (13) | (4,950) |
Expiration of warrants | (1,238) | |
Ending balance | $ 1,508 | $ 503 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) | May 02, 2016USD ($)agreement$ / sharesshares | Dec. 31, 2017shares | Dec. 31, 2018USD ($) | Jun. 22, 2018$ / shares |
Indefinite-lived Intangible Assets [Line Items] | ||||
Indemnification period granted to former officers (in years) | 6 years | |||
Number of agreements with HPI | agreement | 2 | |||
Shares issued, price per share (in dollars per share) | $ / shares | $ 2.105 | |||
Licensing agreement term | 3 years | |||
Moleculin LLC | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Price per share of common stock issued (in dollars per share) | $ / shares | $ 6 | |||
Loan to Moleculin | $ 100,000 | |||
Royalty on net revenues (as a percent) | 2.50% | |||
Moleculin LLC | License Agreement | Houston Pharmaceuticals, Inc | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Accrued license agreement payment | $ 100,000 | |||
Shares of common stock issued | shares | 629,000 | |||
Shares issued, price per share (in dollars per share) | $ / shares | $ 6 | |||
Moleculin LLC | Out-Lincense Agreement | Houston Pharmaceuticals, Inc | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Licensing agreement term | 3 years | |||
Licensing arrangements reserve | $ 1,000,000 | |||
Licensing arrangements consideration payable | $ 750,000 | |||
Common Stock | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Shares of common stock issued | shares | 776,016 | |||
Common Stock | Moleculin LLC | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Business acquisition, equity interest issued (in shares) | shares | 999,931 | |||
Business acquisition, value of equity interest issued | $ 6,000,000 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other Intangible Assets | ||
Business Combination Segment Allocation [Line Items] | ||
Intangibles acquired from Moleculin, LLC | $ 11,148 | $ 11,148 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Accrued license fees and sponsored research agreements | $ 1,147 | $ 260 |
Accrued drug manufacturing costs | 400 | 0 |
Accrued payroll | 342 | 250 |
Accrued clinical testing | 95 | 320 |
Accrued legal and professional fees | 91 | 50 |
Accrued other | 227 | 22 |
Total accrued expenses and other current liabilities | $ 2,302 | $ 902 |
Warrant Liability - Narrative (
Warrant Liability - Narrative (Details) - USD ($) | Jun. 22, 2018 | Feb. 16, 2018 | Feb. 09, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock issued for cash, IPO | 3,710,000 | ||||
Shares issued, price per share (in dollars per share) | $ 2.105 | ||||
Gross proceeds received from sale of shares and warrants | $ 9,000,000 | ||||
Exercisable period, subject to beneficial ownership limitations | 6 months | ||||
Warrants, exercise price (in dollars per share) | $ 2.80 | ||||
Warrant term | 5 years | ||||
Right of first refusal period (in months) | 9 months | ||||
Tail fee period (in months) | 6 months | ||||
Additional shares available for purchase | 1,479,000 | ||||
Proceeds from issuance, IPO | $ 12,025,000 | $ 6,071,000 | |||
Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares issued, price per share (in dollars per share) | $ 1.35 | ||||
Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares issued, price per share (in dollars per share) | $ 1.50 | ||||
Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 1 | ||||
Series A Warrant | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrant term | 5 years | ||||
Class of warrants aggregate amounts (in shares) | 278,250 | ||||
Series A Warrant | Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 0.50 | ||||
Series B Warrant | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants, exercise price (in dollars per share) | $ 1.35 | ||||
Warrant term | 90 days | ||||
Class of warrants aggregate amounts (in shares) | 556,500 | ||||
Series B Warrant | Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 1 | ||||
Series C Warrant | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrant term | 5 years | ||||
Class of warrants aggregate amounts (in shares) | 278,250 | ||||
Series C Warrant | Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 0.50 | ||||
Series A and Series C Warrants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants, exercise price (in dollars per share) | $ 1.50 | ||||
Underwriting Agreement | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants, exercise price (in dollars per share) | $ 0.001 | ||||
Additional shares available for purchase | 556,500 | ||||
Price per share of common stock issued (in dollars per share) | $ 1.349 | ||||
Warrants exercised | $ 278,100 | ||||
Proceeds from issuance, IPO | $ 4,500,000 | ||||
June 2018 Registered Direct Offering | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock issued for cash, IPO | 1,092,636 | ||||
Gross proceeds received from sale of shares and warrants | $ 2,300,000 | ||||
Exercisable period, subject to beneficial ownership limitations | 6 months | ||||
Warrants, exercise price (in dollars per share) | $ 2.02 | ||||
Warrant term | 5 years | ||||
June 2018 Registered Direct Offering | Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 710,212 | ||||
June 2018 Registered Direct Offering | Warrant | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 742,991 | ||||
Placement Agency Agreement | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Commission payment to agents (as a percent) | 6.50% | 6.50% | |||
Warrants granted to purchase common stock, percentage | 3.00% | 3.00% | |||
Reimbursement of expenses | $ 50,000 | $ 75,000 | |||
Right of first refusal period (in months) | 9 months | ||||
Tail fee period (in months) | 6 months | ||||
Roth Warrants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock offered for each warrant (in shares) | 32,779 | ||||
Warrants, exercise price (in dollars per share) | $ 2.3155 | ||||
Class of warrants aggregate amounts (in shares) | 128,700 | ||||
Securities Purchase Agreement | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Class of warrants aggregate amounts (in shares) | 2,273,700 | ||||
Securities Purchase Agreement | Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares of common stock sold | 4,290,000 | ||||
Purchase price (in dollars per share) | $ 2.10 | ||||
Class of warrants aggregate amounts (in shares) | 2,145,000 |
Warrant Liability - Schedule of
Warrant Liability - Schedule of Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield (as a percent) | 0.00% | 0.00% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years | 5 years |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years 3 months | 6 years 3 months |
June 2018 Issuance | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield (as a percent) | 0.00% | |
June 2018 Issuance | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.50% | |
Volatility (as a percent) | 75.00% | |
Expected life (in years) | 4 years 5 months 19 days | |
June 2018 Issuance | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.51% | |
Volatility (as a percent) | 80.00% | |
Expected life (in years) | 4 years 11 months 23 days | |
February 2018 Issuance | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield (as a percent) | 0.00% | |
February 2018 Issuance | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.49% | |
Volatility (as a percent) | 75.00% | |
Expected life (in years) | 4 years 1 month 17 days | |
February 2018 Issuance | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.50% | |
Volatility (as a percent) | 77.50% | |
Expected life (in years) | 4 years 7 months 17 days | |
February 2017 Issuance | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.46% | |
Volatility (as a percent) | 75.00% | |
Expected life (in years) | 3 years 1 month 13 days | |
Dividend yield (as a percent) | 0.00% | |
February 2017 Issuance | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.68% | |
Volatility (as a percent) | 80.00% | |
Expected life (in years) | 6 months | |
February 2017 Issuance | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.86% | |
Volatility (as a percent) | 160.11% | |
Expected life (in years) | 5 years |
Warrant Liability - Schedule _2
Warrant Liability - Schedule of Warrant Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted Average Exercise Price | ||
Granted (in dollars per share) | $ 0 | |
Expired (in dollars per share) | $ 0 | |
June 2018 Issuance | ||
Number of Shares Under Warrant | ||
Granted (in shares) | 742,991 | |
Ending balance (in shares) | 742,991 | |
Number of shares under warrant, vested and exercisable at December 31, 2018 | 742,991 | |
Weighted Average Exercise Price | ||
Granted (in dollars per share) | $ 2.03 | |
Ending balance (in dollars per share) | 2.03 | |
Weighted Average Exercise Price, vested and exercisable (in dollars per share) | $ 2.03 | |
Weighted Average Remaining Contractual Life (Years) | ||
Beginning of period | 4 years 11 months 19 days | |
Granted | 4 years 11 months 19 days | |
End of period | 4 years 11 months 19 days | |
Vested and Exercisable | 4 years 11 months 19 days | |
June 2018 Issuance | Minimum | ||
Number of Shares Under Warrant | ||
Range of warrant price per share, granted (in dollars per share) | $ 2.02 | |
Range of warrant price per share, outstanding at end of period (in dollars per share) | 2.02 | |
Range of warrant price per share, vested and exercisable at December 31, 2017 (in dollars per share) | 2.02 | |
June 2018 Issuance | Maximum | ||
Number of Shares Under Warrant | ||
Range of warrant price per share, granted (in dollars per share) | 2.32 | |
Range of warrant price per share, outstanding at end of period (in dollars per share) | 2.32 | |
Range of warrant price per share, vested and exercisable at December 31, 2017 (in dollars per share) | $ 2.32 | |
February 2018 Issuance | ||
Number of Shares Under Warrant | ||
Granted (in shares) | 2,273,700 | |
Ending balance (in shares) | 2,273,700 | |
Number of shares under warrant, vested and exercisable at December 31, 2018 | 2,273,700 | |
Range of warrant price per share, granted (in dollars per share) | $ 2.80 | |
Range of warrant price per share, outstanding at end of period (in dollars per share) | 2.80 | |
Range of warrant price per share, vested and exercisable at December 31, 2017 (in dollars per share) | 2.80 | |
Weighted Average Exercise Price | ||
Granted (in dollars per share) | 2.80 | |
Ending balance (in dollars per share) | 2.80 | |
Weighted Average Exercise Price, vested and exercisable (in dollars per share) | $ 2.80 | |
Weighted Average Remaining Contractual Life (Years) | ||
Beginning of period | 4 years 7 months 20 days | |
Granted | 4 years 7 months 20 days | |
End of period | 4 years 7 months 20 days | |
Vested and Exercisable | 4 years 7 months 20 days | |
February 2017 Issuance | ||
Number of Shares Under Warrant | ||
Beginning balance (in shares) | 419,772 | |
Granted (in shares) | 0 | |
Exercised (in shares) | (9,572) | |
Expired (in shares) | 0 | |
Ending balance (in shares) | 410,200 | 419,772 |
Number of shares under warrant, vested and exercisable at December 31, 2018 | 410,200 | |
Range of warrant price per share, outstanding at beginning of period (in dollars per share) | $ 1.50 | |
Range of warrant price per share, granted (in dollars per share) | 0 | |
Range of warrant price per share, exercised (in dollars per share) | 1.50 | |
Range of warrant price per share, expired (in dollars per share) | 0 | |
Range of warrant price per share, outstanding at end of period (in dollars per share) | 1.50 | $ 1.50 |
Range of warrant price per share, vested and exercisable at December 31, 2017 (in dollars per share) | 1.50 | |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | 1.46 | |
Exercised (in dollars per share) | 1.50 | |
Ending balance (in dollars per share) | 1.50 | $ 1.46 |
Weighted Average Exercise Price, vested and exercisable (in dollars per share) | $ 1.50 | |
Weighted Average Remaining Contractual Life (Years) | ||
Beginning of period | 3 years 1 month 17 days | 4 years 4 months 17 days |
End of period | 3 years 1 month 17 days | 4 years 4 months 17 days |
Vested and Exercisable | 3 years 1 month 17 days |
Equity - Narrative (Details)
Equity - Narrative (Details) | Oct. 04, 2018USD ($)shares | Apr. 30, 2018$ / sharesshares | Sep. 15, 2017USD ($) | Jul. 29, 2017warrant$ / sharesshares | Feb. 21, 2017USD ($) | Apr. 30, 2018USD ($)$ / sharesshares | Feb. 28, 2017USD ($)$ / sharesshares | Jan. 31, 2017shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016shares | Jun. 22, 2018$ / shares | Jun. 06, 2018shares | Feb. 16, 2018$ / shares | Feb. 09, 2017$ / shares | May 02, 2016shares | Apr. 22, 2016shares |
Class of Stock [Line Items] | ||||||||||||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | ||||||||||||||
Common stock, shares authorized | 75,000,000 | 75,000,000 | 75,000,000 | 75,000,000 | ||||||||||||||
Preferred stock, shares issued | 0 | 0 | 0 | |||||||||||||||
Issued for cash - sale of common stock | $ | $ 1,645,000 | |||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 2.105 | |||||||||||||||||
Proceeds from issuance, IPO | $ | $ 12,025,000 | $ 6,071,000 | ||||||||||||||||
Warrants, exercise price (in dollars per share) | $ / shares | $ 2.80 | |||||||||||||||||
Quarterly payments for consulting agreement | $ | $ 20,000 | |||||||||||||||||
Additional shares available for purchase | 1,479,000 | |||||||||||||||||
Options issued, exercise price (in dollars per share) | $ / shares | $ 1.79 | |||||||||||||||||
Shares granted, contractual term | 9 years 5 months 4 days | 9 years 25 days | ||||||||||||||||
Aggregate fair value of options granted | $ | $ 1,900,000 | |||||||||||||||||
Unrecognized compensation cost, net of estimated forfeitures | $ | $ 3,200,000 | $ 3,200,000 | ||||||||||||||||
Compensation cost recognized, weighted average period (in years) | 2 years 9 months 18 days | |||||||||||||||||
Aggregate fair value of options | $ | $ 1,900,000 | $ 3,100,000 | ||||||||||||||||
Number of shares, exercised | 25,000 | 0 | 0 | |||||||||||||||
Maximum | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 1.50 | |||||||||||||||||
Minimum | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 1.35 | |||||||||||||||||
GSK Consulting Agreement Warrant One | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants to purchase common stock | 100,000 | |||||||||||||||||
Warrants, exercise price (in dollars per share) | $ / shares | $ 2.41 | |||||||||||||||||
Number of warrants issued | warrant | 2 | |||||||||||||||||
GSK Consulting Agreement Warrant Two | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants to purchase common stock | 50,000 | |||||||||||||||||
Warrants, exercise price (in dollars per share) | $ / shares | $ 3 | |||||||||||||||||
Consulting Agreement Warrant Three | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants to purchase common stock | 100,000 | 100,000 | ||||||||||||||||
Warrants, exercise price (in dollars per share) | $ / shares | $ 3 | $ 3 | ||||||||||||||||
Warrants exercisable period | 3 years | |||||||||||||||||
The Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Agreement period | 12 months | |||||||||||||||||
Warrant vesting period (in months) | 12 months | |||||||||||||||||
Expiration period of warrants | 5 years | |||||||||||||||||
Stock compensation expense for non-employee consulting agreement | $ | $ 113,273 | $ 104,000 | ||||||||||||||||
Lincoln Park | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Maximum amount of common stock to be sold in transaction | $ | $ 20,000,000 | |||||||||||||||||
Issued for cash - sale of common stock (in shares) | 1,399,153 | |||||||||||||||||
Lincoln Park | Commitment Shares | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Issued for cash - sale of common stock (in shares) | 121,507 | 10,918 | ||||||||||||||||
Issued for cash - sale of common stock | $ | $ 337,788 | $ 1,800,000 | ||||||||||||||||
IPO | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of units issued | 3,710,000 | |||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 1.35 | |||||||||||||||||
Proceeds from issuance, IPO | $ | $ 4,500,000 | |||||||||||||||||
At Market Issuance Sales Agreement | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Commission payment to agents (as a percent) | 3.00% | |||||||||||||||||
Proceeds from issuance of common stock | $ | $ 1,600,000 | |||||||||||||||||
2015 Stock Plan | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Total number of underlying shares under 2015 Stock Plan | 2,000,000 | 4,500,000 | ||||||||||||||||
Science Advisory Board Member | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Additional shares available for purchase | 10,000,000,000 | |||||||||||||||||
Options issued, exercise price (in dollars per share) | $ / shares | $ 1,460,000 | |||||||||||||||||
Shares granted, contractual term | 10 years | |||||||||||||||||
Options issued, vesting period (in years) | 4 years | |||||||||||||||||
Common Stock | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Issued for cash - sale of common stock (in shares) | 776,016 | |||||||||||||||||
Shares of common stock issued for services | 79,167 | |||||||||||||||||
Number of shares, exercised | 25,000 | |||||||||||||||||
Common Stock | Lincoln Park | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Issued for cash - sale of common stock (in shares) | 243,013 | |||||||||||||||||
Common Stock | At Market Issuance Sales Agreement | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares of common stock sold | 776,016 | |||||||||||||||||
Common Stock | At Market Issuance Sales Agreement | Maximum | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 2.71 | |||||||||||||||||
Common Stock | At Market Issuance Sales Agreement | Minimum | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 2.05 | |||||||||||||||||
Common Stock | Roth Capital Partners, LLC and National Securities Corporation | At Market Issuance Sales Agreement | Maximum | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Aggregate price of shares issued | $ | $ 13,000,000 | |||||||||||||||||
Former Science Advisory Board | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares of common stock issued for services | 79,167 | |||||||||||||||||
Gain on settlement of liability | $ | $ 150,000 |
Equity - Summary of Option Acti
Equity - Summary of Option Activities (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Number of shares outstanding, beginning balance | 1,345,000 | ||
Number of shares, granted | 1,479,000 | ||
Number of shares, exercised | (25,000) | 0 | 0 |
Number of shares, cancelled | (5,000) | ||
Number of shares outstanding, ending balance | 2,794,000 | 1,345,000 | |
Number of shares exercisable, end of period | 512,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Weighted average grant date fair value, outstanding, beginning of period (in dollars per share) | $ 1.93 | ||
Weighted average grant date fair value, granted (in dollars per share) | 1.32 | ||
Weighted average grant date fair value, exercised (in dollars per share) | 0.13 | ||
Weighted average grant date fair value, cancelled (in dollars per share) | 1.75 | ||
Weighted average grant date fair value, outstanding, end of period (in dollars per share) | 1.82 | $ 1.93 | |
Weighted average grant date fair value, exercisable (in dollars per share) | 2.61 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Weighted average exercise price, outstanding, beginning of period (in dollars per share) | 3.5 | ||
Weighted average exercise price, granted (in dollars per share) | 1.79 | ||
Weighted average exercise price, exercises (in dollars per share) | 0.2 | ||
Weighted average exercise price, cancelled (in dollars per share) | 2.49 | ||
Weighted average exercise price, outstanding, end of period (in dollars per share) | 2.61 | $ 3.5 | |
Weighted average exercise price, exercisable (in dollars per share) | $ 3.51 | ||
Weighted average remaining contractual term outstanding (in years) | 9 years 5 months 4 days | 9 years 25 days | |
Weighted average remaining contractual term exercisable (in years) | 8 years | ||
Aggregate intrinsic value, outstanding balance | $ 21,200 | $ 83,000 | |
Aggregate intrinsic value, exercisable | $ 21,000 |
Equity - Schedule of Assumption
Equity - Schedule of Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Class of Warrant or Right [Line Items] | ||
Risk-free interest rate, minimum (as a percent) | 0.95% | 1.83% |
Risk-free interest rate, maximum (as a percent) | 2.24% | 1.95% |
Volatility (as a percent) | 80.00% | |
Expected dividend yield (as a percent) | 0.00% | 0.00% |
Minimum | ||
Class of Warrant or Right [Line Items] | ||
Volatility (as a percent) | 70.18% | |
Expected life (in years) | 5 years | 5 years |
Maximum | ||
Class of Warrant or Right [Line Items] | ||
Volatility (as a percent) | 89.11% | |
Expected life (in years) | 6 years 3 months | 6 years 3 months |
Equity - Schedule of Stock base
Equity - Schedule of Stock based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Class of Stock [Line Items] | ||
Stock-based compensation | $ 1,140 | $ 707 |
General and administrative | ||
Class of Stock [Line Items] | ||
Stock-based compensation | 976 | 684 |
Research and development | ||
Class of Stock [Line Items] | ||
Stock-based compensation | $ 164 | $ 23 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current expense (benefit): | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Current income tax expense | 0 | 0 |
Deferred expense (benefit): | ||
Federal | 0 | 0 |
State | 0 | 0 |
Deferred income tax expense | 0 | 0 |
Net deferred taxes | $ 0 | $ 0 |
Income Taxes - Summary of Valua
Income Taxes - Summary of Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Valuation allowance at beginning of period | $ 2,561 | $ 1,397 |
Income tax benefit | 3,294 | 1,164 |
Release of valuation allowance | 0 | 0 |
Valuation allowance at end of period | $ 5,855 | $ 2,561 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | ||
Federal tax benefit at statutory rate | $ (2,494) | $ (3,334) |
State tax benefit net of federal | (18) | 117 |
Foreign rate differential | 43 | 0 |
IPO costs | 112 | 76 |
Stock warrant costs | (669) | 395 |
Other permanent differences | 8 | 9 |
Permanent PTR items | 190 | 0 |
Change in deferred tax rate due to tax reform | 0 | 1,562 |
Other | 0 | 11 |
Increase in valuation allowance | 3,294 | 1,164 |
Total tax (expense) benefit | $ 0 | $ 0 |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||
Federal Tax Benefit at Statutory Rate (percentage) | 21.00% | 34.00% |
State Tax Benefit Net of Federal (percentage) | (0.15%) | 1.20% |
Foreign rate differential (percentage) | 0.36% | 0.00% |
IPO Costs (percentage) | 0.94% | 0.77% |
Stock Warrant Costs (percentage) | (5.63%) | 4.03% |
Other Permanent Differences (percentage) | 0.07% | 0.09% |
Permanent PTR Items (percentage) | 1.60% | 0.00% |
Change in Deferred Tax Rate due to Tax Reform (percentage) | 0.00% | 15.93% |
Other (percentage) | 0.00% | 0.11% |
Increase in Valuation Allowance (percentage) | 27.73% | 11.87% |
Total Tax (Expense) / Benefit (percentage) | 0.00% | 0.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | |||
Start-up costs | $ 1,962 | $ 1,105 | |
Federal net operating loss carryforwards | 3,153 | 1,275 | |
State tax loss carryforwards | 21 | 9 | |
Foreign net operating loss carryforwards | 182 | 0 | |
Tax credit carryforward | 190 | 0 | |
Interest limitation | 1 | 0 | |
Deferred compensation | 418 | 176 | |
Total deferred tax assets | 5,927 | 2,565 | |
Less valuation allowance | (5,855) | (2,561) | $ (1,397) |
Net deferred tax assets | 72 | 4 | |
Deferred tax liabilities: | |||
Fixed assets | (72) | (4) | |
Total deferred tax liabilities | (72) | (4) | |
Net deferred taxes | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 15,100,000 | ||
Operating loss carryforwards, subject to expiration | 6,100,000 | ||
Deferred tax assets, valuation allowance | $ 2,561,000 | 5,855,000 | $ 1,397,000 |
Research and development tax credit claimed | 200,000 | ||
Unrecognized tax benefits | 0 | 38,000 | $ 0 |
Tax Act, income tax expense | $ 0 | ||
State and Local Jurisdiction | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 13,300,000 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance, beginning of year | $ 0 | $ 0 |
Additions for tax positions related to the current year | 0 | 0 |
Additions for tax positions related to prior years | 38 | 0 |
Reductions due to lapse of statutes of limitations | 0 | 0 |
Decreases related to settlements with tax authorities | 0 | 0 |
Balance, end of year | $ 38 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) | Sep. 25, 2018USD ($) | Mar. 22, 2018USD ($) | Dec. 04, 2017USD ($) | Jan. 09, 2017USD ($) | May 02, 2016USD ($) | Feb. 21, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)employee | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) |
Loss Contingencies [Line Items] | ||||||||||||
Rent expense | $ 54,000 | $ 29,000 | ||||||||||
Payments to HPI over three-year period | $ 750,000 | |||||||||||
Payments for research and development agreement | $ 1,000,000 | 1,000,000 | ||||||||||
Licensing agreement term | 3 years | |||||||||||
Research and development expense | $ 9,728,000 | 4,545,000 | ||||||||||
Employee agreement, termination benefits, number of employees | employee | 9 | |||||||||||
Termination benefits provided to key employees, aggregate amount | $ 1,200,000 | |||||||||||
Maximum | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Payments for royalties | 600,000 | |||||||||||
MD Anderson | Maximum | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
License agreement annual license fee | 100,000 | |||||||||||
MD Anderson | Commencement of Phase II and Phase III Clinical Trials | Maximum | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Milestone payment liabilities | $ 500,000 | 500,000 | ||||||||||
MD Anderson | Submission Of NDA And Receipt Of First Marketing Approval For Sale Of A Licensed Product | Maximum | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Milestone payment liabilities | 600,000 | 600,000 | ||||||||||
MD Anderson | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Payments for research and development agreement | $ 400,000 | $ 350,000 | $ 300,000 | $ 270,000 | $ 110,000 | $ 240,000 | ||||||
Research and development expense | 400,000 | 200,000 | ||||||||||
MD Anderson | Subsequent Event | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Payments for research and development agreement | $ 130,000 | |||||||||||
Dermin | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Licensed technology future payment to remove country | $ 500,000 | |||||||||||
Lease Agreement For Corporate Office Space | IPX Memorial Drive Investors, LLC | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
Lease agreement, initial term | 66 months | |||||||||||
Lease renewal term | 5 years | |||||||||||
Base monthly rent | $ 4,300 | |||||||||||
Annual increase in rent expense (as a percent) | 3.00% | |||||||||||
License | MD Anderson | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
License fees | 300,000 | 200,000 | ||||||||||
License | Houston Pharmaceuticals, Inc | ||||||||||||
Loss Contingencies [Line Items] | ||||||||||||
License fees | $ 1,300,000 | $ 200,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,019 | $ 48 |
2,020 | 53 |
2,021 | 54 |
2,022 | 55 |
2,023 | 56 |
Thereafter | 5 |
Total minimum lease payments | $ 271 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Feb. 19, 2019 | Feb. 15, 2019 | Feb. 16, 2018 | Feb. 28, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Subsequent Event [Line Items] | ||||||
Research and development expense | $ 9,728,000 | $ 4,545,000 | ||||
Gross proceeds received from sale of shares and warrants | $ 9,000,000 | |||||
Subsequent Event | WPD Pharmaceuticals | ||||||
Subsequent Event [Line Items] | ||||||
Licensed technology future payment to remove country | $ 500,000 | |||||
Licensed technology, payment to remove country, shares | 235,850 | |||||
Subsequent Event | Animal Life Sciences, LLC | ||||||
Subsequent Event [Line Items] | ||||||
Royalty agreement, percentage of net sales of sublicensed products | 5.00% | |||||
Royalty agreement, equity interests acquired In transaction, percent | 10.00% | |||||
Subsequent Event | Lincoln Park | ||||||
Subsequent Event [Line Items] | ||||||
Gross proceeds received from sale of shares and warrants | $ 900,000 | |||||
Subsequent Event | Common Stock | Lincoln Park | ||||||
Subsequent Event [Line Items] | ||||||
Shares of common stock sold | 600,000 | |||||
Subsequent Event | Commitment Shares | Lincoln Park | ||||||
Subsequent Event [Line Items] | ||||||
Shares of common stock sold | 5,367 | |||||
Commercially reasonable development effect period one | WPD Pharmaceuticals | Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Research and development expense | $ 2,000,000 | |||||
Commercially reasonable development efforts, period | 2 years | |||||
Commercially reasonable development effect period two | WPD Pharmaceuticals | Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Research and development expense | $ 1,000,000 | |||||
Commercially reasonable development efforts, period | 2 years |