Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Apr. 08, 2019 | Jun. 30, 2018 | |
Document And Entity Information | |||
Entity Registrant Name | Adhera Therapeutics, Inc. | ||
Entity Central Index Key | 0000737207 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | false | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 4,200,000 | ||
Entity Common Stock, Shares Outstanding | 10,761,684 | ||
Trading Symbol | ATRX | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash | $ 3,918,290 | $ 106,378 |
Accounts receivable, net of allowance | 48,289 | |
Inventory | 241,458 | |
Prepaid expenses and other assets | 469,142 | 18,565 |
Total current assets | 4,677,179 | 124,943 |
Furniture and fixtures, net of depreciation | 71,774 | |
Intangible assets, net of amortization | 391,892 | 2,555,974 |
Goodwill | 3,502,829 | |
Total noncurrent assets | 463,666 | 6,058,803 |
Total assets | 5,140,845 | 6,183,746 |
Current liabilities | ||
Accounts payable | 270,138 | 1,033,353 |
Due to related party | 27,977 | 730,629 |
Warrant liability to related party | 605,889 | |
Accrued expenses | 851,870 | 1,139,369 |
Accrued dividends | 1,064,141 | |
Accrued fee payable | 320,000 | |
Notes payable | 444,223 | |
Notes payable - related parties | 1,462,040 | |
Total current liabilities | 2,214,126 | 5,735,503 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity | ||
Common stock, $0.006 par value; 180,000,000 shares authorized, 10,761,684, and 10,521,278 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 64,570 | 63,127 |
Additional paid-in capital | 28,709,916 | 8,413,823 |
Accumulated deficit | (25,847,805) | (8,028,707) |
Total stockholders' equity | 2,926,719 | 448,243 |
Total liabilities and stockholders' equity | 5,140,845 | 6,183,746 |
Series C Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 100,000 shares authorized | ||
Series D Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 100,000 shares authorized | ||
Series E Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 100,000 shares authorized | 35 | |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 100,000 shares authorized | $ 3 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 100,000 | 100,000 |
Common stock, par value | $ 0.006 | $ 0.006 |
Common stock, shares authorized | 180,000,000 | 180,000,000 |
Common stock, shares issued | 10,761,684 | 10,521,278 |
Common stock, shares outstanding | 10,761,684 | 10,521,278 |
Series C Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 1,200 | 1,200 |
Preferred stock, liquidation preference value | $ 5,100 | $ 5,100 |
Preferred stock, shares issued | 100 | 750 |
Preferred stock, shares outstanding | 100 | 750 |
Series D Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 220 | 220 |
Preferred stock, liquidation preference value | $ 300 | $ 300 |
Preferred stock, shares issued | 40 | 60 |
Preferred stock, shares outstanding | 40 | 60 |
Series E Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 3,500 | 3,500 |
Preferred stock, liquidation preference value | $ 5,000 | $ 5,000 |
Preferred stock, shares issued | 3,488 | 0 |
Preferred stock, shares outstanding | 3,488 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 2,200 | 2,200 |
Preferred stock, liquidation preference value | $ 5,000 | $ 5,000 |
Preferred stock, shares issued | 381 | 0 |
Preferred stock, shares outstanding | 381 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Net sales | $ 76,186 | |
Cost of sales | 458,708 | |
Gross loss | (382,522) | |
Operating expenses | ||
Sales, marketing and commercial operations | 3,635,904 | |
Research and development | 240,982 | 907,493 |
General and administrative | 6,029,318 | 4,732,221 |
Amortization | 330,396 | 450,903 |
Goodwill and intangible assets impairment | 5,175,716 | |
Total operating expenses | 15,412,316 | 6,090,617 |
Loss from operations | (15,794,838) | (6,090,617) |
Other expense | ||
Interest expense | (36,729) | (78,890) |
Loss on settlement | (810,219) | |
Amortization of debt discount | (113,171) | (49,041) |
Total other expense, net | (960,119) | (127,931) |
Loss before provision for income taxes | (16,754,957) | (6,218,548) |
Provision for income taxes | 800 | |
Net loss | (16,754,957) | (6,219,348) |
Preferred Stock Dividends | (1,064,141) | |
Net Loss Applicable to Common Stockholders | $ (17,819,098) | $ (6,219,348) |
Net loss per share - Common Stockholders | $ (1.64) | $ (0.63) |
Weighted average shares outstanding | 10,838,731 | 9,836,109 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Series E Preferred Stock [Member] | Series F Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Additional Paid-In Capital - Warrants [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 53,863 | $ 5,115,983 | $ (1,951,082) | $ 3,218,764 | |||
Balance, shares at Dec. 31, 2016 | 8,977,138 | ||||||
Retrospective adjustment of adoption of new accounting standard | 141,723 | 141,723 | |||||
Sale of common stock to related party | $ 517 | 249,483 | 250,000 | ||||
Sale of common stock to related party, shares | 86,207 | ||||||
Common stock issued for services | $ 3,180 | 1,400,977 | 1,404,157 | ||||
Common stock issued for services, shares | 530,058 | ||||||
Common stock issued to settle accounts payable and accrued liabilities | $ 3,734 | 972,980 | 976,714 | ||||
Common stock issued to settle accounts payable and accrued liabilities, shares | 622,296 | ||||||
Return of common stock against settlement of note receivable | $ (52) | (31,352) | (31,404) | ||||
Return of common stock against settlement of note receivable, shares | (8,725) | ||||||
Restricted stock issued to officers | $ 420 | 245,580 | 246,000 | ||||
Restricted stock issued to officers, shares | 70,000 | ||||||
Share based compensation | 178,784 | 178,784 | |||||
Warrants issued with convertible debt as loan fee | 112,210 | 112,210 | |||||
Exercise of warrants for common stock | $ 366 | 170,277 | 170,643 | ||||
Exercise of warrants for common stock, shares | 60,944 | ||||||
Conversion of Series C Preferred to common stock | $ 1,080 | (1,080) | |||||
Conversion of Series C Preferred to common stock, shares | 180,000 | ||||||
Effects of rounding due to reverse split | $ 19 | (19) | |||||
Effects of rounding due to reverse split, shares | 3,360 | ||||||
Net loss | (6,219,348) | (6,219,348) | |||||
Balance at Dec. 31, 2017 | $ 63,127 | 8,413,823 | (8,028,707) | 448,243 | |||
Balance, shares at Dec. 31, 2017 | 10,521,278 | ||||||
Conversion of Series C Preferred to common stock | $ 2,600 | (2,600) | |||||
Conversion of Series C Preferred to common stock, shares | 433,334 | ||||||
Issuance of Series E Preferred Stock, net of fees | $ 28 | 12,247,297 | 12,247,325 | ||||
Issuance of Series E Preferred Stock, net of fees, shares | 2,812 | ||||||
Warrants issued with Series E Preferred Stock | (31,106,896) | 31,106,896 | |||||
Issuance of Series F Preferred Stock, net of fees | $ 3 | 1,644,215 | 1,644,218 | ||||
Issuance of Series F Preferred Stock, net of fees, shares | 381 | ||||||
Warrants issued with Series F Preferred Stock | (1,492,464) | 1,492,464 | |||||
Issuance of Series E Preferred for debt and accounts payable | $ 7 | 3,437,728 | 3,437,735 | ||||
Issuance of Series E Preferred for debt and accounts payable, shares | 687 | ||||||
Conversion of Series D Preferred stock for common stock | $ 150 | (150) | |||||
Conversion of Series D Preferred stock for common stock, shares | 25,000 | ||||||
Conversion of Series E Preferred stock for common stock | $ 120 | (120) | |||||
Conversion of Series E Preferred stock for common stock, shares | (2) | 20,000 | |||||
Warrants issued for settlement of liability | 1,494,469 | 1,494,469 | |||||
Shares issued for settlement of litigation | $ 1,261 | 248,739 | 250,000 | ||||
Shares issued for settlement of litigation, shares | 210,084 | ||||||
Shares issued for License Agreement | $ 312 | 74,688 | 75,000 | ||||
Shares issued for License Agreement, shares | 51,988 | ||||||
Accrued dividend | (1,064,141) | (1,064,141) | |||||
Share based compensation | 1,445,138 | 1,445,138 | |||||
Cancellation of Series E Preferred Stock | (46,311) | (46,311) | |||||
Cancellation of Series E Preferred Stock, shares | (9) | ||||||
Repurchase of common stock for settlement, related party | $ (3,000) | (247,000) | (250,000) | ||||
Repurchase of common stock for settlement, related party, shares | (500,000) | ||||||
Net loss | (16,754,957) | (16,754,957) | |||||
Balance at Dec. 31, 2018 | $ 35 | $ 3 | $ 64,570 | $ (5,383,913) | $ 34,093,829 | $ (25,847,805) | $ 2,926,719 |
Balance, shares at Dec. 31, 2018 | 3,488 | 381 | 10,761,684 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash Flows Used in Operating Activities: | ||
Net loss | $ (16,754,957) | $ (6,219,348) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share based compensation | 1,445,138 | 424,784 |
Common shares issued to third party for services | 1,404,157 | |
Loss on note settlement with issuance of preferred shares | 375,000 | |
Common shares issued to license agreement | 75,000 | |
Goodwill and intangible assets impairment | 5,175,716 | |
Amortization of intangibles | 330,396 | 450,903 |
Amortization of debt discount | 113,171 | 49,041 |
Depreciation | 2,590 | |
Non-cash interest expense | 36,729 | |
Loss on settlement | 810,219 | |
Bad debt expense | 68,072 | |
Impairment of inventory | 123,711 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (116,361) | |
Inventory | (204,369) | |
Prepaid expenses and other assets | (450,577) | 161,164 |
Accounts payable | (703,154) | 425,339 |
Accrued expenses | 131,837 | 837,714 |
Accrued fee payable | (320,000) | |
Due to related party | 185,928 | 1,205,561 |
Net Cash Used in Operating Activities | (9,611,433) | (1,260,685) |
Cash Flows Used in Investing Activities: | ||
Purchase of furniture and fixtures | (74,364) | |
Purchase of intangible assets | (375,000) | |
Net Cash Used in Investing Activities | (74,364) | (375,000) |
Cash Flows Provided By Financing Activities: | ||
Proceeds from sale of preferred stock, net offering expenses | 13,891,543 | |
Proceeds from sale of common stock to related party | 250,000 | |
Proceeds from notes payable due to related party | 500,000 | |
Repurchase of common stock for settlement, related party | (250,000) | |
Proceeds from convertible notes due to related parties, net | 790,073 | |
Proceeds from exercise of warrants for common stock | 170,643 | |
Payments for notes payable | (143,834) | (24,000) |
Loan fees | (50,000) | |
Net Cash Provided by Financing Activities | 13,497,709 | 1,636,716 |
Net increase in cash | 3,811,912 | 1,031 |
Cash - Beginning of Period | 106,378 | 105,347 |
Cash - End of Period | 3,918,290 | 106,378 |
Supplementary Cash Flow Information: | ||
Income taxes paid | 800 | |
Non-cash Investing and Financing Activities: | ||
Issuance of warrants for liabilities, related party | 1,494,469 | |
Common stock issued for settlement of accrued expenses | 976,714 | |
Return of common stock for other assets | 31,404 | |
Adjustment to goodwill | 55,247 | |
Assumption of liabilities for acquisition of assets | 320,000 | |
Warrants issued with convertible debt as loan fee | 112,210 | |
Non-cash retrospective adjustment | 141,723 | |
Preferred share settlement of debt and accrued liabilities | 3,437,735 | |
Issuance of warrants | 32,599,360 | |
Accrued dividends | 1,064,141 | |
Cancellation of Series E Preferred Stock | 46,311 | |
Goodwill reclassified to inventory | 160,800 | |
Shares issued for settlement of litigation | $ 250,000 |
Organization and Business Opera
Organization and Business Operations | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business Operations | NOTE 1 – ORGANIZATION AND BUSINESS OPERATIONS Adhera Therapeutics, Inc. (formerly known as Marina Biotech, Inc.) and its wholly-owned subsidiaries, MDRNA Research, Inc. (“MDRNA”), Cequent Pharmaceuticals, Inc. (“Cequent”), Atossa Healthcare, Inc. (“Atossa”), and IThenaPharma, Inc. (“IThena”) (collectively “Adhera,” the “Company,” “we,” “our,” or “us”) is an emerging specialty pharmaceutical company that leverages innovative distribution models and technologies to improve the quality of care for patients in the United States suffering from chronic and acute diseases. We are focused on fixed dose combination (“FDC”) therapies in hypertension, with plans to expand the portfolio of drugs we commercialize to include other therapeutic areas. Our mission is to provide effective and patient centric treatment for hypertension and resistant hypertension while actively seeking additional assets that can be commercialized through our proprietary Total Care System (“TCS”). At the core of our TCS system is DyrctAxess, our patented technology platform. DyrctAxess is designed to offer enhanced efficiency, control and access to the information necessary to empower patients, physicians and manufacturers to achieve optimal care. We began marketing Prestalia ® ® ® We have discontinued all significant clinical development and are evaluating disposition options for all of our development assets, including: (i) our next generation celecoxib program drug candidates for the treatment of acute and chronic pain, IT-102 and IT-103; (ii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (“FAP”); (iii) CEQ508 combined with IT-103 to treat Colorectal Cancer; (iv) CEQ608 and CEQ609, an oral delivery of IL-6Ra tkRNAi against irritable bowel disease (IBD) gene targets, which could significantly reduce colon length and abolish the IL-6Rα message in proximal ileum; (v) Claudin-2 strains which (CEQ631 and CEQ632) significantly reduce Claudin-2 mRNA expression and protein levels in the colon as well as attenuation of the disease phenotype and enhance survival; (vi) MIP3a therapeutic strains CEQ631 and CEQ632 which also resulted in a significant reduction in sum pathology scores and reduction in MIP3a mRNA expression. We plan to license or divest these development assets since they no longer align with our focus on the treatment of hypertension. As our strategy is to be a commercial pharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, with a focus on developing our technology and TCS. We intend to create value through the continued commercialization of our FDA-approved product, Prestalia, while continuing to develop and leverage our TCS to further strengthen our commercial presence. On November 15, 2016, Adhera entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among IThenaPharma, Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Adhera (“Merger Sub”), and a representative of the stockholders of IThena (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). In the second quarter of 2018, we raised approximately $12.2 million, net of fees and expenses, from a private placement of our newly created Series E Convertible Preferred Stock. In July and November 2018, we raised approximately $1.7 million net of fees and expenses, from a private placement of our newly created Series F Convertible Preferred Stock. The use of funds from the raise was used for the commercialization of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and other general corporate requirements. We plan to license or divest our other pharmaceutical assets and halt any other development programs, since they no longer align with our focus on the treatment of hypertension. Change of Company Name and OTC Markets Symbol On October 4, 2018, we filed a Certificate of Amendment to our Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to change the name of our company from “Marina Biotech, Inc.” to “Adhera Therapeutics, Inc.” The change of name was effective October 9, 2018. Following the name change from Marina Biotech, Inc. to Adhera Therapeutics, Inc., our common stock, par value $0.006 per share, began trading on the OTCQB tier of the OTC Markets under the symbol “ATRX”. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The summary of significant accounting policies presented below is designed to assist in understanding the Company’s financial statements. Such financial statements and accompanying notes are the representations of Company’s management, who is responsible for their integrity and objectivity. Principles of Consolidation The consolidated financial statements include the accounts of Adhera Therapeutics, Inc. and the wholly-owned subsidiaries, IThena, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions. Reverse Stock Split In August 2017, we filed a Certificate of Amendment of our Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse split of our issued and outstanding shares of common stock. Our common stock commenced trading on the OTCQB tier of the OTC Markets on a split-adjusted basis on Thursday, August 3, 2017. Unless indicated otherwise, all share and per share information included in these financial statements and Notes to the Consolidated Financial Statements give effect to the reverse split. Going Concern and Management’s Liquidity Plans The accompanying consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At December 31, 2018, we had a significant accumulated deficit of approximately $26 million and working capital of approximately $2.5 million. For the year ended December 31, 2018, we had a loss from operations of approximately $15.8 million and negative cash flows from operations of approximately $9.6 million. Our operating activities consume the majority of our cash resources. We anticipate that we will continue to incur operating losses as we execute our commercialization plans for Prestalia, as well as strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from operations, at least into the near future. We have previously funded, and plan to continue funding, our losses primarily through the sale of common and preferred stock, combined with or without warrants, the sale of notes, cash generated from the out-licensing or sale of our licensed assets and, to a lesser extent, equipment financing facilities and secured loans. However, we cannot be certain that we will be able to obtain such funds required for our operations at terms acceptable to us or at all. In April and May 2018, we raised approximately $12.2 million net proceeds from a private placement of shares of our Series E Convertible Preferred Stock and warrants to purchase shares of our common stock. Further, in July 2018, we raised an additional $1.4 million net proceeds from the private placement of our Series F Convertible Preferred Stock. On November 9, 2018, we sold 73 shares of our Series F Preferred Stock for total net proceeds of approximately $0.31 million. For our assessment as of December 31, 2018, we have considered the amount raised and we will continue to reassess our ability to address the going concern. We will continue to attempt to obtain future financing or engage in strategic transactions which may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional equity or debt financing, or whether such actions would generate the expected liquidity as currently planned. Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include valuation allowance for accounts receivable and deferred income tax assets, legal contingencies and fair value of financial instruments. Actual results could differ materially from such estimates under different assumptions or circumstances. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. There are no cash equivalents as of December 31, 2018 or 2017. The Company deposits its cash with major financial institutions and may at times exceed the federally insured limit. At December 31, 2018, the Company had a cash balance of approximately $3.7 million in excess of the federal insurance limit. Fair Value of Financial Instruments We consider the fair value of cash, accounts payable, due to related parties, notes payable, notes payable to related parties, accounts receivable and accrued liabilities not to be materially different from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3: Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use. Our cash is subject to fair value measurement and is determined by Level 1 inputs. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. There were no liabilities measured at fair value as of December 31, 2018 or 2017. Goodwill and Intangible Assets The Company periodically reviews the carrying value of intangible assets, including goodwill, to determine whether impairment may exist. Goodwill and certain intangible assets are assessed annually, or when certain triggering events occur, for impairment using fair value measurement techniques. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. Specifically, goodwill impairment is determined using a two-step process. The first step of the goodwill impairment test is used to identify potential impairment by comparing the fair value of a reporting unit with its carrying amount, including goodwill. The Company uses level 3 inputs and a discounted cash flow methodology to estimate the fair value of a reporting unit. A discounted cash flow analysis requires one to make various judgmental assumptions including assumptions about future cash flows, growth rates, and discount rates. The assumptions about future cash flows and growth rates are based on the Company’s budget and long-term plans. Discount rate assumptions are based on an assessment of the risk inherent in the respective reporting units. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired and the second step of the impairment test is unnecessary. If the carrying amount of a reporting unit exceeds its fair value, the second step of the goodwill impairment test is performed to measure the amount of impairment loss, if any. The second step of the goodwill impairment test compares the implied fair value of the reporting unit’s goodwill with the carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination. That is, the fair value of the reporting unit is allocated to all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination and the fair value of the reporting unit was the purchase price paid to acquire the reporting unit. On September 30, 2018, the Company determined that goodwill was impaired and, as a result, a loss on impairment of $3,502,831 was recognized for the year ended December 31, 2018. The impairment determination was primarily a result of the decision to divest of assets that no longer align with the Company’s strategic objectives. There was no such loss on impairment for the year ended December 31, 2017. Impairment of Long-Lived Assets We review all of our long-lived assets for impairment indicators throughout the year and perform detailed testing whenever impairment indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets, at least annually, at December 31. When necessary, we record charges for impairments. Specifically: ● For finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and ● For indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair value, if any. On September 30, 2018, the Company determined that the intangible asset from the merger was impaired and, as a result, a loss on impairment of $1,291,200 was recognized for the year ended December 31, 2018. The impairment determination was primarily a result of the decision to divest of assets that no longer align with the Company’s strategic objectives. There was no such loss on impairment for the year ended December 31, 2017. On December 31, 2018, the Company determined that a portion of the remaining intangible asset balance was impaired, resulting in an additional loss on impairment of $381,685, and a total impairment of approximately $1,672,885 for the year ended December 31, 2018. Revenue Recognition The Company has adopted the new revenue recognition guidelines in accordance with ASC 606, Revenue from Contracts with Customers The Company sells its medicines primarily to wholesale distributors and specialty pharmacy providers. These customers subsequently resell the Company’s medicines to health care patients. In addition, the Company enters into arrangements with health care providers and payers that provide for government-mandated or privately-negotiated discounts and allowances related to the Company’s medicines. Revenue is recognized when performance obligations under the terms of a contract with a customer are satisfied. The majority of the Company’s contracts have a single performance obligation to transfer medicines. Accordingly, revenues from medicine sales are recognized when the customer obtains control of the Company’s medicines, which occurs at a point in time, typically upon delivery to the customer. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring medicines and is generally based upon a list or fixed price less allowances for medicine returns, rebates and discounts. The Company sells its medicines to wholesale pharmaceutical distributors and pharmacies under agreements with payment terms typically less than 90 days. During the year ended December 31, 2018, management determined certain costs related to the sales of Prestalia, specifically, costs associated with free product, should be classified as cost of goods sold and not revenue reductions. For the year ended December 31, 2018, the Company recognized approximately $59,000 for such items. Consistent with the accounting during the third quarter of 2018, the Company recorded an estimate of unrealized revenue reductions, and the related liability, for bottles sold to pharmacies but not yet prescribed. Medicine Sales Discounts and Allowances The nature of the Company’s contracts gives rise to variable consideration because of allowances for medicine returns, rebates and discounts. Allowances for medicine returns, rebates and discounts are recorded at the time of sale to wholesale pharmaceutical distributors and pharmacies. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future. The Company’s adjustments to gross sales are discussed further below. Distribution Service Fees The Company includes distribution service fees paid to its wholesalers for distribution and inventory management services as a reduction to revenue. The Company calculates accrued distribution service fee estimates using the most likely amount method. The Company accrues estimated distribution fees based on contractually determined amounts, typically as a percentage of revenue. Accrued distribution service fees are included in “accrued expenses” on the consolidated balance sheet. Patient Access Programs The Company offers discounts to patients under which the patient receives a discount on his or her prescription. In circumstances when a patient’s prescription is rejected by a third-party payer, the Company will pay for the full cost of the prescription. The Company reimburses pharmacies for this discount directly or through third-party vendors. The Company reduces gross sales by the amount of actual co-pay and other patient assistance in the period based on the invoices received. The Company also records an accrual to reduce gross sales for estimated co-pay and other patient assistance on units sold to distributors or pharmacies that have not yet been prescribed/dispensed to a patient. The Company calculates accrued co-pay and other patient assistance fee estimates using the expected value method. The estimate is based on contract prices, estimated percentages of medicine that will be prescribed to qualified patients, average assistance paid based on reporting from the third-party vendors and estimated levels of inventory in the distribution channel. Accrued co-pay and other patient assistance fees are included in “accrued expenses” on the consolidated balance sheet. Patient assistance programs include both co-pay assistance and fully bought down prescriptions. Sales Returns Consistent with industry practice, the Company maintains a return policy that allows customers to return medicines within a specified period prior to and subsequent to the medicine expiration date. Generally, medicines may be returned for a period beginning six months prior to its expiration date and up to one year after its expiration date. The right of return expires on the earlier of one year after the medicine expiration date or the time that the medicine is dispensed to the patient. The majority of medicine returns result from medicine dating, which falls within the range set by the Company’s policy and are settled through the issuance of a credit to the customer. The Company calculates sales returns using the expected value method. The estimate of the provision for returns is based upon industry experience. This period is known to the Company based on the shelf life of medicines at the time of shipment. The Company records sales returns in “accrued expenses” and as a reduction of revenue. Shipping Fees The Company includes fees incurred by pharmacies for shipping medicines to patients as a reduction to revenue. The Company calculates accrued shipping fee estimates using the expected value method. The Company records accrued shipping fees in “accrued expenses” on the consolidated balance sheet. Customers Concentration The Company sells its prescription drug (Prestalia) directly to specialty contracted retail pharmacies and indirectly through wholesalers. For the year ended December 31, 2018, the Company’s three largest customers accounted for approximately 37%, 32%, and 17%, respectively, of the Company’s total gross sales. The Company works with a third-party pharmacy network manager to attract, retain, and manage the Company’s pharmacy customers and distribution channels. Approximately 68% of 2018 gross sales were made to customers associated with or related to the Company’s third-party pharmacy network manager. The Company had no significant sales for the year ended December 31, 2017. Licensing Agreements In terms of licensing agreements entered into by the Company, they typically include payment of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services; and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. During the year ended December 31, 2018, Adhera entered into a Licensing Agreement, whereby Adhera granted exclusive rights to the Company’s DiLA 2 2 Recently Issued Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). Under the provisions of ASU 2014-09, entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange for goods and services provided. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017. The Company adopted the provisions of this standard effective January 1, 2018. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU No. 2016-02”). Under ASU No. 2016-02, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. For leases with a term of twelve months or less, the lessee is permitted to make an accounting policy election not to recognize lease assets and lease liabilities by class of underlying assets. ASU No. 2016-02 becomes effective for the Company beginning in the first quarter of 2019. The guidance can be applied using either a modified retrospective approach at the beginning of the earliest period presented, or at the beginning of the period in which it is adopted. The Company will adopt this standard in the first quarter of 2019, using a modified retrospective approach at the adoption date through a cumulative-effect adjustment to retained earnings. The Company does not expect the adoption will have a material impact on its consolidated statement of operations. However, the new standard requires the Company to establish approximately $250,000 of liabilities and corresponding right-of-use assets of approximately $242,000 on its consolidated balance sheet for operating leases on rented office properties that existed as of the January 1, 2019, adoption date. The Company also expects to elect to not recognize lease assets and liabilities for leases with a term of twelve months or less. Net Income (Loss) per Common Share Basic net income (loss) per common share (after giving effect of the one for ten reverse stock split) is computed by dividing the net income (loss) by the weighted average number of common shares outstanding during the period, excluding any unvested restricted stock awards. Diluted net income (loss) per share includes the effect of common stock equivalents (stock options, unvested restricted stock, and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. Net income (loss) is adjusted for the dilutive effect of the change in fair value liability for price adjustable warrants, if applicable. The following number of shares have been excluded from diluted net (loss) since such inclusion would be anti-dilutive: Year Ended December 31, 2018 2017 Stock options outstanding 5,613,057 745,707 Warrants 36,267,329 2,559,612 Shares to be issued upon conversion of notes payable - 319,617 Restricted common stock - - Series E Preferred Stock 34,880,000 - Series F Preferred Stock 3,810,000 - Total 80,570,386 3,624,936 Stock-Based Compensation The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the statements of operations. For stock options issued to employees and members of the board of directors for their services, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets, including tax loss and credit carry forwards, and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company accounts for income taxes using the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts, using currently enacted tax rates. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | NOTE 3 – INVENTORY Inventory consists of raw material and finished goods stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. The Company reviews the composition of inventory at each reporting period in order to identify obsolete, slow-moving, quantities in excess of expected demand, or otherwise non-saleable items. Inventory consisted of the following as of December 31, 2018 and 2017: Year Ended December 31, 2018 2017 Raw Materials $ 147,139 $ - Finished Goods 94,319 - Inventory, Net $ 241,458 $ - During the years ended December 31, 2018 and 2017, the Company recorded a related charge to cost of goods sold for obsolete inventory of $123,711 and $0, respectively. |
Prepaid and Other Assets
Prepaid and Other Assets | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid and Other Assets | NOTE 4 – PREPAID AND OTHER ASSETS Prepaid expenses and other assets at December 31, 2018 and December 31, 2017 included prepaid insurance of $179,145 and $0, respectively, and deposits with third-party co-pay program managers of $158,000 and $0, respectively. The deposits with co-pay program managers are used to fund patient’s insurance co-pay support, for a specified period of time, with any unused amounts refunded to the Company. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | NOTE 5 - INTANGIBLE ASSETS Acquisition of Prestalia & DyrctAxess In June 2017, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Symplmed Pharmaceuticals LLC (“Symplmed”) pursuant to which we purchased from Symplmed, for aggregate consideration of approximately $620,000 (consisting of $300,000 in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $320,000), Symplmed’s assets relating to a single-pill FDC of perindopril arginine and amlodipine besylate known as Prestalia® (“Prestalia”), that has been approved by the FDA for the treatment of hypertension. In addition, as part of the transactions contemplated by the Purchase Agreement: (i) Symplmed agreed to transfer to us, not later than 150 days following the closing date, the New Drug Applications for the approval of Prestalia as a new drug by the FDA; and (ii) Symplmed assigned to us all of its rights and obligations under that certain Amended and Restated License and Commercialization Agreement by and between Symplmed and Les Laboratoires Servier (“Servier”) dated January 2012, pursuant to which Symplmed has an exclusive license from Servier to manufacture, have manufactured, develop, promote, market, distribute and sell Prestalia in the U.S. (and its territories and possessions) in consideration of regulatory and sales-based milestone payments and royalty payments based on net sales. Management has determined that this acquisition was deemed an asset purchase under FASB ASC 805. The purchase price of $620,000 was allocated based on a preliminary estimate of the fair value of the assets acquired and was included in intangible assets as of December 31, 2017. During the year ended December 31, 2018, the allocation of the purchase price was finalized which resulted in $160,800 of the price being allocated to raw materials received from Symplmed, and the remaining $459,200 being allocated to intangible assets. Further, we hired a Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective in June 2017. We also agreed in such offer letter to issue 60,000 restricted shares of our common stock under our 2014 Long-Term Incentive Plan to our Chief Commercial Officer, with all of such shares vesting on the six (6) month anniversary of the date of grant. These shares were fully vested on December 31, 2017. This Chief Commercial Officer resigned in January 2019. In furtherance of the acquisition and commercialization of Prestalia, in July 2017 we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also known as Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care for $75,000 in cash. Intangible Asset Summary The following table summarizes the balances as of December 31, 2018 of the identifiable intangible assets acquired, their useful life, and annual amortization, prior to impairment: Net Book Value December 31, 2018 Remaining Estimated Annual Amortization Expense Intangible asset - Prestalia 324,705 5.00 94,177 Intangible asset - DyrctAxess 67,187 12.59 5,357 Total $ 391,892 $ 99,534 On September 30, 2018, the Company determined that the intangible asset from the Merger was impaired and, as a result, a loss on impairment of approximately $1,291,200. On December 31, 2018, the Company determined that the remaining balance was impaired, resulting in an additional loss on impairment of $381,685, and a total impairment of $1,672,885 for the year ended December 31, 2018. Amortization expense was $330,396 and $450,903 for the year ended December 31, 2018 and 2017, respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 6 - Related Party Transactions Due to Related Party The Company and other related entities have had a commonality of ownership and/or management control, and as a result, the reported operating results and /or financial position of the Company could significantly differ from what would have been obtained if such entities were autonomous. The Company had a Master Services Agreement (“MSA”) with Autotelic Inc., a related party that is partly-owned by one of the Company’s former Board members, namely Vuong Trieu, Ph.D., effective November 15, 2016. Autotelic Inc. currently owns less than 5% of the Company. The MSA stated that Autotelic Inc. will provide business functions and services to the Company and allowed Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA included personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The MSA required a 90-day written termination notice in the event either party requires to terminate such services. We and Autotelic Inc. agreed to terminate the MSA effective October 31, 2018. Dr. Trieu resigned as a director of our company effective October 1, 2018. During the period commencing November 15, 2016 (the “Effective Date”) and ending on the date that the Company had completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10 million (the “Equity Financing Date”), the Company paid Autotelic the following compensation: cash in an amount equal to the actual labor cost (paid on a monthly basis), plus 100% markup in warrants for shares of the Company’s common stock with a strike price equal to the fair market value of the Company’s common stock at the time said warrants were issued. The Company also paid Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share was calculated based on the Black-Scholes model. After the Equity Financing Date, the Company paid Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided services and 20% mark up of provided services by third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations (“CMO”), FDA regulatory process, Contract Research Organizations (“CRO”) and Chemistry and Manufacturing Controls (“CMC”). In accordance with the MSA, Autotelic Inc. billed the Company for personnel and service expenses Autotelic Inc. incurred on behalf of the Company. For the year ended December 31, 2018 and 2017, Autotelic Inc. billed a total of $795,228 and $791,889, respectively, including personnel costs of $531,794 and $558,098, respectively. An unpaid balance of $4,392 and $730,629 is included in due to related party in the accompanying balance sheet as of December 31, 2018 and 2017, respectively. In April 2018, and in connection with the closing of our private placement on that date, we entered into a Compromise and Settlement Agreement with Autotelic Inc. pursuant to which we agreed to issue to Autotelic Inc. an aggregate of 162.59 shares of Series E Preferred Stock to settle accounts payable of $812,967 and Warrants to purchase up to 1,345,040 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount of approximately $739,772, and other liabilities, owed to Autotelic Inc. as of March 31, 2018 pursuant to the MSA. The securities that were issued to Autotelic Inc., which were issued upon the closing described above, have the same terms and conditions as the securities that were issued to investors in the offering (See Note 6). The warrants have a five-year term, an initial exercise price of $0.55, and have a fair value of $1,494,469 resulting in a loss on settlement of debt of $754,697, which is included in the loss on settlement in the consolidated statements of operations. Resignation and Appointment of Officer and Directors On April 27, 2018, our Board of Directors (the “Board”) increased the size of the entire Board from five (5) directors to seven (7) directors, and it appointed each of Erik Emerson and Tim Boris to fill the vacancies created thereby. In May 2018, each of Philip C. Ranker and Philippe P. Calais, Ph.D. resigned as members of the Board, and all committees thereof, effective immediately. In connection with their resignations: (i) each of Mr. Ranker and Dr. Calais released us from all claims arising prior to the date of his resignation; (ii) we granted to Mr. Ranker fully-vested options to purchase up to 200,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock; and (iii) we granted to Dr. Calais fully-vested options to purchase up to 80,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. The foregoing options are exercisable for a period of five years from the grant date. In May 2018, the Board accepted the resignation of Joseph W. Ramelli, our Chief Executive Officer, whereby Mr. Ramelli resigned as an officer of our company, and as a director and/or officer of any and all subsidiaries of our company, effective immediately, to pursue other opportunities. In connection with his resignation, Mr. Ramelli released us from all claims arising prior to the date of his resignation and affirmed his obligations to be bound by the restrictive covenants contained in the employment agreement between Mr. Ramelli and our company dated February 2, 2017, and we: (i) agreed to make severance payments to Mr. Ramelli in the amount of $60,000 to be paid over a six (6) month period; and (ii) granted to Mr. Ramelli fully-vested options, exercisable for a period of five years from the grant date, to purchase up to 100,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. In May 2018, the Board appointed Vuong Trieu, a director of the Company and former Executive Chairman, to serve as our Interim Chief Executive Officer, to replace Mr. Ramelli, effective with Mr. Ramelli’s departure. In his capacity as Interim Chief Executive Officer, Dr. Trieu received a salary in the amount of $20,000 per month. On June 18, 2018, the Board appointed Robert C. Moscato, Jr., to serve as our Chief Executive Officer effective immediately. In connection with the appointment of Mr. Moscato as Chief Executive Officer, Dr. Trieu resigned as Interim Chief Executive Officer, and also from his position as Executive Chairman of our company, effective immediately. On June 18, 2018, the Board appointed Uli Hacksell, Ph.D.to serve as a member of the Board, and as Chairman of the Board, effective July 1, 2018. Dr. Hacksell agreed to devote half of his business time to Adhera. On June 28, 2018, the Board appointed Mr. Moscato to serve as a member of the Board, effective July 1, 2018. On September 24, 2018, we entered into an employment agreement with R. Eric Teague pursuant to which Mr. Teague began serving as our Chief Financial Officer. In connection with the appointment of Mr. Teague as our Chief Financial Officer, Amit Shah, our prior Chief Financial Officer, resigned from such position, effective September 24, 2018. Mr. Teague, Mr. Moscato, and Mr. Emerson resigned subsequent to December 31, 2018 (See Note 13 - Subsequent Events). Issuance of Preferred Stock and Warrants to Directors In April 2018, and in connection with the closing of our private placement on that date, we entered into Compromise and Settlement Agreements with four of the then current members of our Board of Directors and one former member of our Board of Directors pursuant to which we agreed to issue to such directors an aggregate of 58.25 shares of Series E Preferred Stock and Warrants to purchase up to 436,875 shares of common stock to satisfy accrued and unpaid fees owed to such directors for service as members of the Board of Directors during the period ending on December 31, 2017 in the aggregate amount of approximately $291,250. The securities that were issued to the directors, which were issued upon the closing of our private placement described above, have the same terms and conditions as the securities that were issued to investors in the offering. Additionally, we paid an aggregate of $95,000 to assist in tax liabilities arising from these transactions. Omnibus Settlement Agreement with Vuong Trieu, Ph.D. and Affiliated Entities On October 1, 2018, we entered into an Omnibus Settlement Agreement (the “Settlement Agreement”) with Vuong Trieu, Ph.D., our former interim Chief Executive Officer, Executive Chairman and Chairman of the Board, Autotelic Inc., Autotelic LLC, Autotelic BIO, Oncotelic, Inc. and LipoMedics, Inc. At the same time, and in connection therewith, we also entered into an Agreement and Release with each of Dr. Trieu and Falguni Trieu (the “Individual Releases”) and entered into an Agreement and Release with each of Autotelic Inc., Autotelic LLC, Autotelic BIO, Oncotelic, Inc. and LipoMedics, Inc. (collectively, the “Entity Releases”). We also delivered a release (the “Company Release”) to Dr. Trieu, Ms. Trieu, Autotelic Inc., Autotelic LLC, Autotelic BIO, Oncotelic, Inc. and LipoMedics, Inc. Pursuant to the Settlement Agreement, we agreed to make a payment to Dr. Trieu in the amount of $10,000 in consideration for Dr. Trieu entering into the Individual Releases between Dr. Trieu and our company. Dr. Trieu also agreed to sell, and we agreed to purchase, from Dr. Trieu for cancellation an aggregate of 500,000 shares of our common stock in consideration of an aggregate purchase price of $250,000. Additionally, each of Dr. Trieu, Autotelic Inc., Autotelic LLC, Oncotelic, Inc. and LipoMedics, Inc. agreed to certain restrictions on sale, transfer or assignment of our common stock. Furthermore: (i) we and Autotelic Inc. agreed that the Master Services Agreement, dated as of November 15, 2016, by and between our company and Autotelic Inc., shall be terminated as of October 1, 2018; (ii) we and Autotelic BIO agreed that the Term Sheet, entered into as of January 11, 2018, by and between our company and Autotelic BIO, shall be terminated immediately; (iii) we and Oncotelic, Inc. confirmed that the License Agreement, dated July 17, 2017, by and between our company and Oncotelic Inc. was terminated effective May 15, 2018; and (iv) we and Lipomedics, Inc. agreed that the License Agreement, dated as of February 6, 2016, by and between our company and Lipomedics, Inc. would remain in effect. Under the Settlement Agreement, we and Autotelic LLC agreed with respect to the License Agreement, dated as of November 15, 2016, by and between our company and Autotelic LLC, that such License Agreement shall continue, provided that Autotelic LLC shall be licensee and have a license to, without representation or warranty, nasal apomorphine and nasal scopolamine and related intellectual property in addition to nasal insulin, and Autotelic LLC shall not be a licensee or have a license to Familial Adenomatous Polyposis or CEQ508 and related intellectual property. Pursuant to the Individual Releases, each of Dr. Trieu and Ms. Trieu, our former Director of Business Development and the spouse of Dr. Trieu, agreed to release us from all claims arising prior to the date of the Release Agreements. Pursuant to the Entity Releases, each of Autotelic Inc., Autotelic LLC, Autotelic BIO, Oncotelic, Inc. and LipoMedics, Inc. agreed to release us from all claims arising prior to the date of the applicable Entity Release. Pursuant to the Company Release, we agreed to release each of Dr. Trieu, Ms. Trieu, Autotelic Inc., Autotelic LLC, Autotelic BIO, Oncotelic, Inc. and LipoMedics, Inc. from all claims arising prior to the date of the Company Release. Transactions with BioMauris, LLC/Erik Emerson During the year ended December 31, 2018, we paid a total of $572,381 for services provided by BioMauris, LLC, of which Erik Emerson, our former Chief Commercial Officer and a current director of Adhera, is Executive Chairman. A total of $23,585 was due BioMauris, LLC as of December 31, 2018. In addition, during the year ended December 31, 2018, we paid a total to BioMauris, LLC of $62,576 related to Acutus Medical, which entity owns an equity interest in BioMauris, LLC. Transactions Involving Robert Moscato During the year ended December 31, 2018, we paid a total of $15,983 to an entity owned and operated by the wife of Robert Moscato, our former CEO, which entity rendered interior design services to our company. |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Notes Payable | Note 7 - Notes Payable Following is a breakdown of notes payable as of December 31, 2018 and 2017: December 31, 2018 December 31, 2017 Notes payable $ - $ 97,523 Convertible notes payable - 346,700 Total notes payable $ - $ 444,223 Notes payable - related parties - $ 93,662 Convertible notes payable - related parties (net of debt discount of $0 and $113,170 as of December 31, 2018 and December 31, 2017, respectively) - 1,368,378 Total notes payable - related parties $ - $ 1,462,040 Note Payable - Service Provider In December 2016, we entered into an Agreement and Promissory Note with a law firm for past services performed totaling $121,523. The note called for monthly payments of $6,000 per month, beginning with an initial payment on March 31, 2017. The note was unsecured and non-interest bearing. The note was paid in full in May 2018. The balance due on the note was $0 and $97,523 as of December 31, 2018 and 2017, respectively. Note Purchase Agreement and Amendment In July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with the holders (such holders, the “June 2016 Noteholders”) of the promissory notes that we issued in June 2016 to Noteholders (the “2016 Notes”) with respect to the 2016 Notes and the warrants to purchase shares of our common stock that are held by the June 2016 Noteholders and that were originally issued pursuant to a certain Note and Warrant Purchase Agreement dated as of February 10, 2012 by and among Adhera, MDRNA, Cequent and the purchasers identified on the signature pages thereto (as amended from time to time), to, among other things, extend the maturity date of the 2016 Notes to December 31, 2017, to provide for the issuance of consideration securities at a cost of $375,000 (“Consideration Securities”) and to extend the price protection applicable to certain of the warrants held by the June 2016 Noteholders with respect to dilutive offerings afforded thereunder to February 10, 2020. Refer to our Form 10-Q for the six months ended June 30, 2017 for a more detailed discussion and additional terms for the 2016 Notes. In April 2018, and in connection with the closing of our private placement on that date, we issued to the June 2016 Noteholders an aggregate of 71.46 shares of Series E Preferred Stock and Warrants to purchase up to 535,950 shares of common stock as a result of the conversion of the 2016 Notes. As a result of the conversion of the 2016 Notes and the issuance of the securities to the June 2016 Noteholders, the entire unpaid principal balance of the 2016 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding. In addition, in April 2018, and in connection with the closing of our private placement on that date, we issued to the June 2016 Noteholders an aggregate of 75 shares of Series E Preferred Stock and Warrants to purchase up to 562,500 shares of common stock in full and complete satisfaction of our obligations to issue $375,000 worth of Consideration Securities to the June 2016 Noteholders pursuant to the Amendment Agreement. As of December 31, 2018 and 2017, the accrued interest expense on the 2016 Notes amounted to $0 and $46,700, respectively, with a total balance of principal and interest of $0 and $346,700, respectively. 2017 Bridge Note Financing In June 2017, we issued convertible promissory notes (the “2017 Notes”) in the aggregate principal amount of $400,000 to 10 investors pursuant to a Note Purchase Agreement (the “Note Purchase Agreement”) that we entered into with such investors (the “June 2017 Noteholders”). The 2017 Notes bear interest at a rate of five percent (5%) per annum and are due and payable at any time on or after the earlier of (i) June 1, 2018 and (ii) the occurrence of an event of default (as defined in the Note Purchase Agreement). Our then Executive Chairman and our Chief Science Officer were each investors in the 2017 Notes. As of December 31, 2018 and 2017, the accrued interest expense on the 2017 Notes amounted to $0 and $11,365, respectively, with a total balance of principal and interest of $0 and $411,365, respectively, and is included in notes payable - related parties on the accompanying balance sheet. In April 2018, and in connection with the closing of our private placement on that date, we issued to the June 2017 Noteholders an aggregate of 74.17 shares of Series E Preferred Stock and Warrants to purchase up to 505,705 shares of common stock (and also paid to such holders an aggregate of $56 thousand in cash) as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to the June 2017 Noteholders under the 2017 Notes. As a result of the conversion of the 2017 Notes and the issuance of the securities to the June 2016 Noteholders (and payment of cash), the entire unpaid principal balance of the 2017 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding. Convertible Notes Payable In July 2016, IThena issued convertible promissory notes with an aggregate principal balance of $50,000 to certain related-party investors. Borrowings under each of these convertible notes bore interest at 3% per annum and these notes mature on December 31, 2018. Upon the completion of certain funding events, IThena had the right to convert the outstanding principal amount of these notes into shares of IThena’s common stock. The notes were assumed by Autotelic Inc. on November 15, 2016 as part of its acquisition of the technology asset (IT-101). In November 2017, the Company issued a convertible promissory note with a related party (a trust affiliated with Isaac Blech, a member of our Board of Directors) for $500,000 (the “Blech Note”), with annual interest at 8%, maturing on March 31, 2018, and convertible at the price equal to any financing transaction involving the sale by the Company of its equity securities yielding aggregate gross proceeds to the Company of not less than $5 million. The note included warrants issued to the placement agent to purchase 66,667 shares of the Company’s common stock, with a 5-year term and an exercise price of $0.75. In April 2018, and in connection with the closing of our private placement on that date, we issued to the trust an aggregate of 103.18 shares of Series E Preferred Stock and Warrants to purchase up to 777,750 shares of common stock as a result of the conversion of the Blech Note in the original principal amount of $500,000. As a result of the conversion of the Blech Note and the issuance of the securities to the holder thereof, the entire unpaid principal balance of the Blech Note, and the accrued and unpaid interest thereon, has been satisfied in full, and the Blech Note is no longer outstanding. The securities that were issued to the holder of the Blech Note have the same terms and conditions as the securities that were issued to investors in the offering. The Blech Note included a debt discount of $162,210 consisting of loan costs of $50,000 and the fair value of the warrants of $112,210. Total amortization of this debt discount was $113,171 for the year ended December 31, 2018, with a remaining unamortized value of $0. Total principal and interest was $0 and $504,274 as of December 31, 2018 and 2017, respectively, and is included in notes payable - related parties on the accompanying balance sheet. Convertible Notes Payable, Dr. Trieu In connection with the Merger, Adhera entered into a Line Letter dated November 15, 2016 with Dr. Trieu for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses. Dr. Trieu has advanced the full $540,000 under the Line Letter as of December 31, 2017. The line of credit was convertible at any time into shares of the Company’s common stock at a price of $1.77 per share. In April 2018, and in connection with the closing of our private placement on that date, we issued to Dr. Trieu 114.63 shares of Series E Preferred Stock and Warrants to purchase up to 859,725 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to Dr. Trieu under the Line of Credit. As such, the Line of Credit was terminated in April 2018. Accrued interest on the Line Letter was $0 and $25,836 as of December 31, 2018 and 2017, respectively, and is included in notes payable - related parties on the accompanying consolidated balance sheets. Line Letter with Autotelic, Inc. In April 2017, the Company entered into a Line Letter with Autotelic Inc. for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses. Autotelic Inc. is a stockholder of IThenaPharma that became the holder of 525,535 shares of Adhera common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board. Autotelic Inc. was to consider requests for advances under the Line Letter until September 1, 2017. Autotelic Inc. had the right at any time for any reason in its sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissory Note issued to Autotelic Inc., and are due and payable upon demand by Autotelic, Inc. Autotelic Inc. advanced funds after September 1, 2017 but is no longer considering additional requests for advances as of December 31, 2017. In April 2018, and in connection with the closing of our private placement on that date, we issued to Autotelic Inc. 19 shares of Series E Preferred Stock and Warrants to purchase up to 142,500 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to Autotelic Inc. under the Line of Credit, of which $90,816 had been drawn down as of the date of the closing described above. As such, in April 2018, the line of credit with Autotelic Inc was terminated. The balance under the line was $0 and $93,662, respectively, including accrued interest of $0 and $2,847 as of December 31, 2018 and 2017, respectively, and is included in notes payable - related parties on the accompanying consolidated balance sheet. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | NOTE 8 - STOCKHOLDERS’ EQUITY Preferred Stock Adhera has authorized 100,000 shares of preferred stock for issuance and has designated 1,000 shares as Series B Preferred Stock (“Series B Preferred”) and 90,000 shares as Series A Junior Participating Preferred Stock (“Series A Preferred”). No shares of Series B Preferred or Series A Preferred are outstanding. In March 2014, Adhera designated 1,200 shares as Series C Convertible Preferred Stock (“Series C Preferred”). In August 2015, Adhera designated 220 shares as Series D Convertible Preferred Stock (“Series D Preferred”). In April 2018, Adhera designated 3,500 shares of Series E Convertible Preferred Stock (“Series E Preferred”). In July 2018, Adhera designated 2,200 shares of Series F Convertible Preferred Stock (“Series F Preferred”). Series C Preferred Each share of Series C Preferred has a stated value of $5,000 per share, has a $5,100 liquidation preference per share, has voting rights of 666.67 votes per share, and is convertible into shares of common stock at a conversion price of $7.50 per share. In September 2017, an investor converted 270 shares of Series C Preferred stock into 180,000 shares of our common stock. In June 2018, an investor converted 650 shares of Series C Preferred stock into 433,334 shares of our common stock. As of December 31, 2018 and December 31, 2017, 100 and 750 shares, respectively, of Series C Preferred remained outstanding. Series D Preferred In August 2015, Adhera entered into a Securities Purchase Agreement with certain investors pursuant to which Adhera sold 220 shares of Series D Preferred and warrants to purchase up to 344,000 shares of Adhera’s common stock at an initial exercise price of $4.00 per share before August 2021, for an aggregate purchase price of $1.1 million. Each share of Series D Preferred has a stated value of $5,000 per share, has a liquidation preference of $300 per share, has voting rights of 1,250 votes per share and is convertible into shares of common stock at a conversion price of $4.00 per share. The Series D Preferred is initially convertible into an aggregate of 275,000 shares of Adhera’s common stock, subject to certain limitations and adjustments, has a 5% stated dividend rate, is not redeemable and has voting rights on an as-converted basis. In May 2018, an investor converted 20 shares of Series D Preferred into 25,000 shares of common stock. As of December 31, 2018 and December 31, 2017, 40 and 60 shares, respectively, of Series D Preferred remained outstanding. Series E Convertible Preferred Stock Private Placement In April and May 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 2,812 shares of our Series E Preferred, at a purchase price of $5,000 per share of Series E Preferred. Each share of Series E Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Series E Preferred, the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series E Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Series E Preferred accrues 8% dividends per annum and are payable in cash or stock at the Company’s discretion. The Series E Preferred has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in April 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations. We received net proceeds of approximately $12.2 million from the sale of the Series E Preferred, after deducting placement agent fees and estimated expenses payable by us of approximately $2.0 million associated with such closing. We intend to use the proceeds of the offering for funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures, the repayment of certain liabilities and other general corporate purposes. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 2,958,460 shares of our common stock. In October 2018, an investor converted 2 shares of Series E Preferred into 20,000 shares of our common stock. We accrued dividends on the Series E Preferred of $974,247 for the year ended December 31, 2018. No similar dividends were accrued in 2017. Series F Convertible Preferred Share Private Placement In July 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 308 shares of our Series F Preferred, at a purchase price of $5,000 per share of Series F Preferred. Each share of Series F Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Preferred Stock, the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Series F Preferred accrues 8% dividends per annum and are payable in cash or stock at the Company’s discretion. The Series F Preferred has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in July 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations. We received proceeds of approximately $1.4 million from the sale of the Securities, after deducting placement agent fees and estimated expenses payable by us of approximately $180,000 associated with such closing. We intend to use the proceeds of the offering for funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures, the repayment of certain liabilities and other general corporate purposes. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 308,000 shares of our common stock. The Warrant has a five-year term and an exercise price of $0.55 per share. On November 9, 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 73 shares of our Series F Preferred Stock, at a purchase price of $5,000 per share of Preferred Stock. Each share of Series F Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. We received total net proceeds of approximately $0.31 million from the issuance of the securities described above, after deducting placement agent fees and estimated expenses payable by us associated with such closing. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 73,000 shares of our common stock. The Warrant has a five-year term and an exercise price of $0.55 per share. We accrued dividends on the Series F Preferred of $89,894 for the year ended December 31, 2018. No similar dividends were accrued in 2017. Stock Option Grants In July 2018, we granted our Chief Executive Officer, Robert Moscato, Jr., 1,500,000 stock options; Uli Hacksell, Ph. D., the Chairman of our Board, 1,000,000 stock options, Erik Emerson, our Chief Commercial Officer, 1,125,000 stock options, and Jay Schwartz, our SVP of Commercial Operations, 250,000 stock options. In September 2018, we granted our Chief Financial Officer, Eric Teague, 450,000 stock options. Subsequent to December 31, 2018, Mr. Moscato, Mr. Emerson, and Mr. Teague resigned (See Note 13 – Subsequent Events). All vested options held by Mr. Teague are set to expire 90 days after his resignation date and all vested options held by Mr. Moscato are set to expire 12 months after his resignation date. During the three months ended December 31, 2018, we granted an aggregate of 260,000 stock options to employees. Common Stock Our common stock currently trades on the OTCQB tier of the OTC Markets under the symbol “ATRX”. We currently have 10,761,684 shares of our common stock outstanding. Stock Issuances In addition to the common stock and preferred stock issuances described above, we issued the following shares of common stock during the year ended December 31, 2018. As discussed in Note 11, in May 2018, we issued to Novosom 51,988 shares of our common stock as additional consideration pursuant to the Asset Purchase Agreement, dated as of July 27, 2010, between our company and Novosom. Such shares were due to Novosom as a result of the receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc. in February 2017. As discussed in Note 10 in April 2018, we entered into a Stipulation of Settlement with Vaya Pharma and issued a total of 210,084 shares of our common stock with a fair value of $250,000. In May 2018, an investor converted 20 shares of Series D Preferred into 25,000 shares of common stock. In June 2018, an investor converted 650 shares of Series C Preferred stock into 433,334 shares of our common stock. In October 2018, an investor converted 2 shares of Series E convertible preferred stock into 20,000 shares of our common stock. As discussed in Note 6, on October 1, 2018, we entered into a Settlement Agreement with Vuong Trieu, Ph.D., our former interim Chief Executive Officer, Executive Chairman and Chairman of our Board of Directors, which included the Company repurchasing 500,000 shares of our common stock from Dr. Trieu for $250,000. Warrants As of December 31, 2018, there were 36,267,329 warrants outstanding, with a weighted average exercise price of $0.79 per share, and annual expirations as follows: Expiring in 2019 600,000 Expiring in 2020 1,189,079 Expiring in 2021 343,750 Expiring in 2022 66,667 Expiring in 2023 33,729,180 Expiring thereafter 338,653 36,267,329 The above includes 29,135,560 warrants issued in April and May 2018 in connection with our Series E Preferred Stock offering with a fair value of $31,106,896 and 3,238,500 warrants issued with our Series F Preferred Stock offering with a fair value of $1,492,464 which are reflected in additional paid-in capital and additional paid in capital-warrants on the accompanying consolidated statement of stockholders’ equity. The warrants have a five-year term and an initial exercise price of $0.55. There was no expense related to these warrants. Additionally, the above includes 1,345,040 warrants issued to Autotelic, Inc. in April 2018 to satisfy accrued and unpaid fees in the aggregate amount of approximately $739,772, and other liabilities, owed to Autotelic Inc. as of March 31, 2018. The warrants have a five-year term, an initial exercise price of $0.55, and have a fair value of $1,494,469 resulting in a loss on settlement of liability of $754,697. The above includes price adjustable warrants totaling 1,895,013. A total of 339,702 warrants expired during the year ended December 31, 2018. |
Stock Incentive Plans
Stock Incentive Plans | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Incentive Plans | NOTE 9 - STOCK INCENTIVE PLANS Stock Options The following table summarizes stock option activity for the year-ended December 31, 2018: Options Outstanding Shares Weighted Average Exercise Price Outstanding, December 31, 2017 745,707 $ 8.84 Options granted 4,984,000 0.66 Options expired / forfeited (116,650 ) 54.29 Outstanding, December 31, 2018 5,613,057 0.83 Exercisable, December 31, 2018 1,636,664 $ 0.93 The following table summarizes additional information on Adhera’s stock options outstanding at December 31, 2018: Options Outstanding Options Exercisable Range of Exercise Prices Number Outstanding Weighted- Average Remaining Contractual Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $0.31 - $0.98 4,965,000 8.66 $ 0.64 1,467,500 $ 0.73 $1.00 7,000 2.88 $ 1.00 7,000 $ 1.00 $1.50 - $1.80 493,207 8.68 $ 1.79 134,314 $ 1.78 $2.60 - $8.20 135,200 3.52 $ 2.77 15,200 $ 4.48 $10.70 - $22.00 12,650 0.75 $ 10.92 12,650 $ 10.92 Totals 5,613,057 8.97 $ 0.83 1,636,664 $ 0.93 Weighted-Average Exercisable Remaining Contractual Life (Years) 8.03 In January 2018, the Company granted a total of 19,000 stock options to directors and officers for services. The options have an exercise price of $1.56 and a five-year term. In May 2018, the Company granted a total of 380,000 stock options to departing directors and officers for services. The options have an exercise price of $0.98 and a five-year term. In July 2018, we granted our Chief Executive Officer, 1,500,000 stock options; Uli Hacksell, Ph.D., the Chairman of our Board, 1,000,000 stock options; and Erik Emerson, our Chief Commercial Officer, 1,125,000 stock options at an exercise prices of $0.66 per share with a 10-year term. In July 2018, we granted our SVP of Commercial Operations 250,000 stock options at an exercise price of $0.575 per share with a 10-year term. In September 2018 we granted our Chief Financial Officer 450,000 stock options at an exercise price of $0.55 per share with a 10-year term. During the three months ended December 31, 2018, we granted an aggregate of 260,000 stock options to employees at exercise prices ranging from $0.31 to $0.53 per share with a 10-year term. The options vest at a rate of one-third at the end of each annual anniversary over three years from the grant date. As of December 31, 2018, we had $1,185,627 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $1,445,138 and $178,784 for the year ended December 31, 2018 and 2017, respectively. As of December 31, 2018, the intrinsic value of options outstanding or exercisable was $0 as there were no options outstanding with an exercise price less than $0.28, the per share closing market price of our common stock at that date. |
Intellectual Property and Colla
Intellectual Property and Collaborative Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intellectual Property and Collaborative Agreements | Note 10 - Intellectual Property and Collaborative Agreements Novosom Agreements In July 2010, Adhera entered into an asset purchase agreement with Novosom Verwaltungs GmbH (“Novosom”), pursuant to which Adhera acquired intellectual property for Novosom’s SMARTICLES-based liposomal delivery system. In May 2018, we issued to Novosom 51,988 shares of our common stock, with a fair value of $75,000, as additional consideration pursuant to the Asset Purchase Agreement. Such shares were due to Novosom as a result of the receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc. in February 2017. Arrangements with LipoMedics In February 2017, we entered into a License Agreement (the “License Agreement”) with LipoMedics, pursuant to which, among other things, we provided to LipoMedics a license to our SMARTICLES platform for further development of Lipomedics’s proprietary phospholipid nanoparticles that can deliver protein, small molecule drugs, and peptides. On the same date, we also entered into a Stock Purchase Agreement with LipoMedics pursuant to which we issued to LipoMedics an aggregate of 86,207 shares of our common stock for a total purchase price of $250,000. Under the terms of the License Agreement, we could receive success-based milestones based on commercial sales of licensed products. In addition, if LipoMedics determines to pursue further development and commercialization of products under the License Agreement, LipoMedics agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $2.90 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which LipoMedics notifies us that it intends to pursue further development or commercialization of a licensed product. If LipoMedics breaches the License Agreement, we shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to LipoMedics specifying the breach, if LipoMedics fails to cure such material breach within such sixty (60) day period. Vuong Trieu, Ph.D. is the Chairman of the Board and Chief Operating Officer of LipoMedics. Arrangements with Oncotelic Inc. In July 2017, we entered into a License Agreement (the “License Agreement”) with Oncotelic, Inc. (“Oncotelic”) pursuant to which, among other things, we provided to Oncotelic a license to our SMARTICLES platform for the delivery of antisense DNA therapeutics, as well as a license to our conformationally restricted nucleotide (“CRN”) technology with respect to TGF-Beta. Under the terms of the License Agreement, Oncotelic also agreed to purchase 49,019 shares of our common stock for an aggregate purchase price of $0.25 million ($5.10 per share), with such purchase and sale to be made pursuant to a Stock Purchase Agreement to be entered into between us and Oncotelic within thirty (30) days following the date of the License Agreement. Oncotelic has not completed the purchase of the stock and we have not been able to reach to a definitive agreement, as such we have terminated the agreement. Agreement with Autotelic BIO On January 11, 2018, we entered into a binding agreement with Autotelic BIO (“ATB”) pursuant to which, among other things, and subject to the satisfaction of certain conditions on or prior to January 15, 2019, we shall grant to ATB a perpetual exclusive right of development and marketing of our IT-103 product candidate, which is a fixed dose combination of celecoxib and olmesartan medoxomil, at the currently approved dose/approved indications only for celecoxib for combined hypertension and arthritis only, with such right extending throughout the entire world (excluding the United States and Canada, and the territories of such countries). The grant of the license would be memorialized in a definitive license agreement to be entered into between the parties. On October 1, 2018, we and ATB agreed to terminate this arrangement. Autotelic LLC, an entity that owns approximately 22% of the issued and outstanding shares of our common stock and of which Dr. Trieu serves as Chief Executive Officer, owns approximately 19% of the issued and outstanding shares of the common stock of ATB. License of DiLA 2 On March 16, 2018, Adhera entered into a Licensing Agreement, whereby Adhera granted exclusive rights to the company’s DiLA 2 2 Asset Purchase Agreement In July 2017, Adhera entered into an Asset Purchase Agreement with Symplmed Pharmaceuticals LLC and its wholly-owned subsidiary Symplmed Technologies, LLC pursuant to which the Company purchased from the Sellers, for an aggregate purchase price of $75,000 in cash, certain specified assets of the Sellers relating to the Sellers’ patented technology platform known as DyrctAxess that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care (see Note 5). |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11 - Commitments and Contingencies Amendment to Agreement with Windlas Healthcare Private Limited On August 17, 2017, we entered into an amendment (the “Amendment”) of that certain Pharmaceutical Development Agreement dated as of March 30, 2017 by and between Windlas Healthcare Private Limited (“Windlas”) and our company (the “Development Agreement”), relating to the development by Windlas of certain pharmaceutical products to be used for conducting clinical trials or for regulatory submissions, as more fully described therein. Pursuant to the Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas’ agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the total amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). The maximum value of common stock that may be issued to Windlas pursuant to the Development Agreement (as modified by the Amendment) is $2 million. The parties also agreed that the foregoing payment arrangement would apply to any Contract Manufacturing and Supply Agreement (or similar agreement) relating to the manufacturing of commercial batches of the products covered by the Development Agreement that may be entered into between the parties. Litigation Because of the nature of our activities, we are subject to claims and/or threatened legal actions, which arise out of the normal course of business. Other than the disclosure below, as of the date of this filing, we are not aware of any pending lawsuits against us, our officers or our directors. Paragraph IV Challenge Our Prestalia product is currently involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This challenge, which is currently pending in the United States District Court for the District of Delaware (No. 1:17-cv-00276), is captioned Apotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratoires Servier. The challengers (Apotex Inc. and Apotex Corp. (“Apotex”)) have filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Prestalia and included a Paragraph (IV) certification. In the litigation, Apotex seeks a declaratory judgment that no valid claims of the two patents Symplmed listed in the FDA Orange Book as having claims covering Prestalia, U.S. Patent No. 6,696,481 and 7,846,961, will be infringed by the Apotex proposed generic version of Prestalia and that the claims of those patents are invalid. The challenge is designed to provide Apotex with an opportunity to enter the market with a generic version of Prestalia, ahead of the expiration of the patents with claims covering that product. Apotex entered into negotiations with Symplmed Pharmaceuticals, LLC (which entity sold its assets relating to Prestalia to us in June 2017, including its License and Commercialization Agreement with Les Laboratories Servier) and Les Laboratories Servier (which entity owns or controls intellectual property rights relating to pharmaceutical products containing as an active pharmaceutical ingredient perindopril in combination with other active pharmaceutical ingredients, which rights have been licensed to Symplmed Pharmaceuticals) to resolve the challenge in the second quarter of 2017, and such parties, along with us, have come to a general agreement on terms that will result in a delay to the challengers’ ability to enter the market with a generic version of Prestalia, while still providing the challenger with the right to enter the market prior to the expiration of the patent covering such product. The term sheet memorializing such terms is pending execution in a final settlement agreement. In the meantime, the District Court has entered an order extending the time for the defendants to respond to Apotex’s Complaint. Resolution of the Apotex litigation continues with alignment from all parties, including Servier, Apotex, Symplmed and Adhera. Necessary extensions have been agreed upon and final resolution is anticipated this year. We had been named on a complaint filed in New York State as a defendant in the matter entitled Vaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. Leases We have entered into a Standard Form Office Lease with ROC III Fairlead Imperial Center, LLC, as landlord, pursuant to which we lease our corporate headquarters located at 4721 Emperor Boulevard, Suite 350, Durham, North Carolina 27703 for a term of 37 months starting on October 1, 2018. Our base monthly rent for such space is currently $6,457.92, which amount will increase to $7,057 for the final month of the term. Other than the lease for our corporate headquarters, we do not own or lease any real property or facilities that are material to our current business operations. As we expand our business operations, we may seek to lease additional facilities of our own in order to support our operational and administrative needs under our current operating plan. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 12 - INCOME TAXES We have identified our federal and California state tax returns as “major” tax jurisdictions. The periods our income tax returns are subject to examination for these jurisdictions are 2014 through 2016. We believe our income tax filing positions and deductions will be sustained on audit, and we do not anticipate any adjustments that would result in a material change to our financial position. Therefore, no liabilities for uncertain income tax positions have been recorded. At December 31, 2017, we had available net operating loss carry-forwards for federal income tax reporting purposes of approximately $332 million and had available tax credit carry-forwards for federal tax reporting purposes of approximately $10.6 million, which are available to offset future taxable income. Portions of these carry-forwards will expire through 2038 if not otherwise utilized. We have not performed a formal analysis, but we believe our ability to use such net operating losses and tax credit carry-forwards is subject to annual limitations due to change of control provisions under Sections 382 and 383 of the Internal Revenue Code, which significantly impacts our ability to realize these deferred tax assets. Our net deferred tax assets, liabilities and valuation allowance as of December 31, 2018 and 2017 are summarized as follows: Year Ended December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards (a) $ 4,109,956 $ 2,075,529 Tax credit carryforwards (a) - - Depreciation and amortization 2,799,217 3,107,094 Share based compensation 435,770 297,893 Other 248,654 389,146 Total deferred tax assets 7,593,597 5,869,662 Valuation allowance (7,539,944) (5,354,880 ) Net deferred tax assets 53,653 514,782 Deferred tax liabilities: Intangible assets (53,653) (514,782 ) Net deferred tax liabilities $ - $ - (a) reflects estimated change of control limitation under Section 382 and 383 of the Internal Revenue Code as of December 31, 2016 due to reverse merger on November 15, 2016. We record a valuation allowance in the full amount of our net deferred tax assets since realization of such tax benefits has been determined by our management to be less likely than not. The valuation allowance increased $2,185,064 and $1,436,089 during 2018 and 2017, respectively. In 2018 and 2017, there was income tax expense of $0 and $800, respectively, due to IThena’s income tax due the state of California. As of the date of this filing, the Company has not filed its 2018 or 2017 federal and state corporate income tax returns. The Company expects to file these documents as soon as practicable. The Tax Cuts and Jobs Act (the Act) was enacted on December 22, 2017. The Act reduces the US federal corporate tax rate from 35% to 21% and will require the Company to re-measure certain deferred tax assets and liabilities based on the rates at which they are anticipated to reverse in the future, which is generally 21%. The Company adopted the new rate as it relates to the calculations, of deferred tax amounts as of December 31, 2017. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13 - Subsequent Events Except for the event(s) discussed below, there were no subsequent events that required recognition or disclosure. The Company evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission. Compensation Increase and Option Grant for Chief Financial Officer On January 15, 2019, the Board of Directors (the “Board”) of the Company approved an increase of the base salary to be paid to the Chief Financial Officer of the Company (our “CFO”), from $285,000 per year to $305,000 per year, effective immediately. The Board also granted to our CFO options to purchase up to an aggregate of 100,000 shares of the common stock of the Company at an exercise price of $0.32 per share, with 25,000 options being exercisable immediately and with 25,000 options vesting on each of the first, second and third anniversary of the grant date. Resignation of Chief Commercial Officer On January 15, 2019, the Board accepted the resignation of the Chief Commercial Officer of the Company (our “former CCO”), effective immediately. He will remain as a member of the Board. Simultaneous with his resignation as our CCO, the Company and our former CCO entered into a Consulting Agreement dated as of January 15, 2019 pursuant to which our former CCO agreed to provide certain consulting services regarding the Company’s FDA-approved Prestalia product for a fee of $3,000 per month. Resignation of Chief Financial Officer On March 11, 2019, our CFO submitted his resignation as our CFO and from any other positions (whether as an officer, director or otherwise) that he may hold with the Company or any of its subsidiaries, effective March 22, 2019. The Company anticipates that he will be available to assist in the transition of his ongoing activities on behalf of the Company to his successor following the effective date of his resignation. His services have been retained for the preparation and filing of this document. Resignation and Appointment of Chief Executive Officer On April 4, 2019, the Company entered into an employment agreement with our new CEO, Nancy R. Phelan, effective immediately, who was also appointed to serve as Secretary of the Company. In connection with the appointment of our new CEO and Secretary, Robert C. Moscato, Jr. resigned from such positions, and also from his position as a member of the Board of Directors of the Company effective immediately. The Employment Agreement provides for a three-year term and a base salary of $360,000 per year, which is subject to review and adjustment by the Board from time to time. Our new CEO shall be eligible for an annual discretionary cash bonus with a target of 50% of her base salary, subject to her achievement of any applicable performance targets and goals established by the Board. We granted to our new CEO options to purchase an aggregate of 1,500,000 shares of our common stock, of which 400,000 are exercisable immediately, 600,000 vest on a monthly basis over a two year period beginning on April 4, 2020, and 500,000 vest upon the achievement of certain product sales and stock price targets. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The summary of significant accounting policies presented below is designed to assist in understanding the Company’s financial statements. Such financial statements and accompanying notes are the representations of Company’s management, who is responsible for their integrity and objectivity. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of IThena, Adhera Therapeutics, Inc. and the wholly-owned subsidiaries, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions. |
Reverse Stock Split | Reverse Stock Split In August 2017, we filed a Certificate of Amendment of our Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse split of our issued and outstanding shares of common stock. Our common stock commenced trading on the OTCQB tier of the OTC Markets on a split-adjusted basis on Thursday, August 3, 2017. Unless indicated otherwise, all share and per share information included in these financial statements and Notes to the Consolidated Financial Statements give effect to the reverse split. |
Going Concern and Management's Liquidity Plans | Going Concern and Management’s Liquidity Plans The accompanying consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At December 31, 2018, we had a significant accumulated deficit of approximately $26 million and working capital of approximately $2.5 million. For the year ended December 31, 2018, we had a loss from operations of approximately $15.8 million and negative cash flows from operations of approximately $9.6 million. Our operating activities consume the majority of our cash resources. We anticipate that we will continue to incur operating losses as we execute our commercialization plans for Prestalia, as well as strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from operations, at least into the near future. We have previously funded, and plan to continue funding, our losses primarily through the sale of common and preferred stock, combined with or without warrants, the sale of notes, cash generated from the out-licensing or sale of our licensed assets and, to a lesser extent, equipment financing facilities and secured loans. However, we cannot be certain that we will be able to obtain such funds required for our operations at terms acceptable to us or at all. In April and May 2018, we raised approximately $12.2 million net proceeds from a private placement of shares of our Series E Convertible Preferred Stock and warrants to purchase shares of our common stock. Further, in July 2018, we raised an additional $1.4 million net proceeds from the private placement of our Series F Convertible Preferred Stock. On November 9, 2018, we sold 73 shares of our Series F Preferred Stock for total net proceeds of approximately $0.31 million. For our assessment as of December 31, 2018, we have considered the amount raised and we will continue to reassess our ability to address the going concern. We will continue to attempt to obtain future financing or engage in strategic transactions which may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional equity or debt financing, or whether such actions would generate the expected liquidity as currently planned. |
Use of Estimates | Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include valuation allowance for accounts receivable and deferred income tax assets, legal contingencies and fair value of financial instruments. Actual results could differ materially from such estimates under different assumptions or circumstances. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. There are no cash equivalents as of December 31, 2018 or 2017. The Company deposits its cash with major financial institutions and may at times exceed the federally insured limit. At December 31, 2018, the Company had a cash balance of approximately $3.7 million in excess of the federal insurance limit. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments We consider the fair value of cash, accounts payable, due to related parties, notes payable, notes payable to related parties, accounts receivable and accrued liabilities not to be materially different from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3: Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use. Our cash is subject to fair value measurement and is determined by Level 1 inputs. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. There were no liabilities measured at fair value as of December 31, 2018 or 2017. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company periodically reviews the carrying value of intangible assets, including goodwill, to determine whether impairment may exist. Goodwill and certain intangible assets are assessed annually, or when certain triggering events occur, for impairment using fair value measurement techniques. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. Specifically, goodwill impairment is determined using a two-step process. The first step of the goodwill impairment test is used to identify potential impairment by comparing the fair value of a reporting unit with its carrying amount, including goodwill. The Company uses level 3 inputs and a discounted cash flow methodology to estimate the fair value of a reporting unit. A discounted cash flow analysis requires one to make various judgmental assumptions including assumptions about future cash flows, growth rates, and discount rates. The assumptions about future cash flows and growth rates are based on the Company’s budget and long-term plans. Discount rate assumptions are based on an assessment of the risk inherent in the respective reporting units. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired and the second step of the impairment test is unnecessary. If the carrying amount of a reporting unit exceeds its fair value, the second step of the goodwill impairment test is performed to measure the amount of impairment loss, if any. The second step of the goodwill impairment test compares the implied fair value of the reporting unit’s goodwill with the carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination. That is, the fair value of the reporting unit is allocated to all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination and the fair value of the reporting unit was the purchase price paid to acquire the reporting unit. On September 30, 2018, the Company determined that goodwill was impaired and, as a result, a loss on impairment of $3,502,831 was recognized for the year ended December 31, 2018. The impairment determination was primarily a result of the decision to divest of assets that no longer align with the Company’s strategic objectives. There was no such loss on impairment for the year ended December 31, 2017. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We review all of our long-lived assets for impairment indicators throughout the year and perform detailed testing whenever impairment indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets, at least annually, at December 31. When necessary, we record charges for impairments. Specifically: ● For finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and ● For indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair value, if any. On September 30, 2018, the Company determined that the intangible asset from the merger was impaired and, as a result, a loss on impairment of $1,291,200 was recognized for the year ended December 31, 2018. The impairment determination was primarily a result of the decision to divest of assets that no longer align with the Company’s strategic objectives. There was no such loss on impairment for the year ended December 31, 2017. On December 31, 2018, the Company determined that a portion of the remaining intangible asset balance was impaired, resulting in an additional loss on impairment of $381,685, and a total impairment of approximately $1,672,885 for the year ended December 31, 2018. |
Revenue Recognition | Revenue Recognition The Company has adopted the new revenue recognition guidelines in accordance with ASC 606, Revenue from Contracts with Customers The Company sells its medicines primarily to wholesale distributors and specialty pharmacy providers. These customers subsequently resell the Company’s medicines to health care patients. In addition, the Company enters into arrangements with health care providers and payers that provide for government-mandated or privately-negotiated discounts and allowances related to the Company’s medicines. Revenue is recognized when performance obligations under the terms of a contract with a customer are satisfied. The majority of the Company’s contracts have a single performance obligation to transfer medicines. Accordingly, revenues from medicine sales are recognized when the customer obtains control of the Company’s medicines, which occurs at a point in time, typically upon delivery to the customer. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring medicines and is generally based upon a list or fixed price less allowances for medicine returns, rebates and discounts. The Company sells its medicines to wholesale pharmaceutical distributors and pharmacies under agreements with payment terms typically less than 90 days. During the year ended December 31, 2018, management determined certain costs related to the sales of Prestalia, specifically, costs associated with free product, should be classified as cost of goods sold and not revenue reductions. For the year ended December 31, 2018, the Company recognized approximately $59,000 for such items. Consistent with the accounting during the third quarter of 2018, the Company recorded an estimate of unrealized revenue reductions, and the related liability, for bottles sold to pharmacies but not yet prescribed. Medicine Sales Discounts and Allowances The nature of the Company’s contracts gives rise to variable consideration because of allowances for medicine returns, rebates and discounts. Allowances for medicine returns, rebates and discounts are recorded at the time of sale to wholesale pharmaceutical distributors and pharmacies. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future. The Company’s adjustments to gross sales are discussed further below. Distribution Service Fees The Company includes distribution service fees paid to its wholesalers for distribution and inventory management services as a reduction to revenue. The Company calculates accrued distribution service fee estimates using the most likely amount method. The Company accrues estimated distribution fees based on contractually determined amounts, typically as a percentage of revenue. Accrued distribution service fees are included in “accrued expenses” on the consolidated balance sheet. Patient Access Programs The Company offers discounts to patients under which the patient receives a discount on his or her prescription. In circumstances when a patient’s prescription is rejected by a third-party payer, the Company will pay for the full cost of the prescription. The Company reimburses pharmacies for this discount directly or through third-party vendors. The Company reduces gross sales by the amount of actual co-pay and other patient assistance in the period based on the invoices received. The Company also records an accrual to reduce gross sales for estimated co-pay and other patient assistance on units sold to distributors or pharmacies that have not yet been prescribed/dispensed to a patient. The Company calculates accrued co-pay and other patient assistance fee estimates using the expected value method. The estimate is based on contract prices, estimated percentages of medicine that will be prescribed to qualified patients, average assistance paid based on reporting from the third-party vendors and estimated levels of inventory in the distribution channel. Accrued co-pay and other patient assistance fees are included in “accrued expenses” on the consolidated balance sheet. Patient assistance programs include both co-pay assistance and fully bought down prescriptions. Sales Returns Consistent with industry practice, the Company maintains a return policy that allows customers to return medicines within a specified period prior to and subsequent to the medicine expiration date. Generally, medicines may be returned for a period beginning six months prior to its expiration date and up to one year after its expiration date. The right of return expires on the earlier of one year after the medicine expiration date or the time that the medicine is dispensed to the patient. The majority of medicine returns result from medicine dating, which falls within the range set by the Company’s policy and are settled through the issuance of a credit to the customer. The Company calculates sales returns using the expected value method. The estimate of the provision for returns is based upon industry experience. This period is known to the Company based on the shelf life of medicines at the time of shipment. The Company records sales returns in “accrued expenses” and as a reduction of revenue. Shipping Fees The Company includes fees incurred by pharmacies for shipping medicines to patients as a reduction to revenue. The Company calculates accrued shipping fee estimates using the expected value method. The Company records accrued shipping fees in “accrued expenses” on the consolidated balance sheet. Customers Concentration The Company sells its prescription drug (Prestalia) directly to specialty contracted retail pharmacies and indirectly through wholesalers. For the year ended December 31, 2018, the Company’s three largest customers accounted for approximately 37%, 32%, and 17%, respectively, of the Company’s total gross sales. The Company works with a third-party pharmacy network manager to attract, retain, and manage the Company’s pharmacy customers and distribution channels. Approximately 68% of 2018 gross sales were made to customers associated with or related to the Company’s third-party pharmacy network manager. The Company had no significant sales for the year ended December 31, 2017. Licensing Agreements In terms of licensing agreements entered into by the Company, they typically include payment of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services; and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. During the year ended December 31, 2018, Adhera entered into a Licensing Agreement, whereby Adhera granted exclusive rights to the Company’s DiLA 2 2 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). Under the provisions of ASU 2014-09, entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange for goods and services provided. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017. The Company adopted the provisions of this standard effective January 1, 2018. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU No. 2016-02”). Under ASU No. 2016-02, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. For leases with a term of twelve months or less, the lessee is permitted to make an accounting policy election not to recognize lease assets and lease liabilities by class of underlying assets. ASU No. 2016-02 becomes effective for the Company beginning in the first quarter of 2019. The guidance can be applied using either a modified retrospective approach at the beginning of the earliest period presented, or at the beginning of the period in which it is adopted. The Company will adopt this standard in the first quarter of 2019, using a modified retrospective approach at the adoption date through a cumulative-effect adjustment to retained earnings. The Company does not expect the adoption will have a material impact on its consolidated statement of operations. However, the new standard requires the Company to establish approximately $250,000 of liabilities and corresponding right-of-use assets of approximately $242,000 on its consolidated balance sheet for operating leases on rented office properties that existed as of the January 1, 2019, adoption date. The Company also expects to elect to not recognize lease assets and liabilities for leases with a term of twelve months or less. |
Net Income (Loss) Per Common Share | Net Income (Loss) per Common Share Basic net income (loss) per common share (after giving effect of the one for ten reverse stock split) is computed by dividing the net income (loss) by the weighted average number of common shares outstanding during the period, excluding any unvested restricted stock awards. Diluted net income (loss) per share includes the effect of common stock equivalents (stock options, unvested restricted stock, and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. Net income (loss) is adjusted for the dilutive effect of the change in fair value liability for price adjustable warrants, if applicable. The following number of shares have been excluded from diluted net (loss) since such inclusion would be anti-dilutive: Year Ended December 31, 2018 2017 Stock options outstanding 5,613,057 745,707 Warrants 36,267,329 2,559,612 Shares to be issued upon conversion of notes payable - 319,617 Restricted common stock - - Series E Preferred Stock 34,880,000 - Series F Preferred Stock 3,810,000 - Total 80,570,386 3,624,936 |
Stock-Based Compensation | Stock-Based Compensation The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the statements of operations. For stock options issued to employees and members of the board of directors for their services, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets, including tax loss and credit carry forwards, and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company accounts for income taxes using the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts, using currently enacted tax rates. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities | The following number of shares have been excluded from diluted net (loss) since such inclusion would be anti-dilutive: Year Ended December 31, 2018 2017 Stock options outstanding 5,613,057 745,707 Warrants 36,267,329 2,559,612 Shares to be issued upon conversion of notes payable - 319,617 Restricted common stock - - Series E Preferred Stock 34,880,000 - Series F Preferred Stock 3,810,000 - Total 80,570,386 3,624,936 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following as of December 31, 2018 and 2017: Year Ended December 31, 2018 2017 Raw Materials $ 147,139 $ - Finished Goods 94,319 - Inventory, Net $ 241,458 $ - |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The following table summarizes the balances as of December 31, 2018 of the identifiable intangible assets acquired, their useful life, and annual amortization, prior to impairment: Net Book Value December 31, 2018 Remaining Estimated Annual Amortization Expense Intangible asset - Prestalia 324,705 5.00 94,177 Intangible asset - DyrctAxess 67,187 12.59 5,357 Total $ 391,892 $ 99,534 |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Summary of Notes Payable | Following is a breakdown of notes payable as of December 31, 2018 and 2017: December 31, 2018 December 31, 2017 Notes payable $ - $ 97,523 Convertible notes payable - 346,700 Total notes payable $ - $ 444,223 Notes payable - related parties - $ 93,662 Convertible notes payable - related parties (net of debt discount of $0 and $113,170 as of December 31, 2018 and December 31, 2017, respectively) - 1,368,378 Total notes payable - related parties $ - $ 1,462,040 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Schedule of Warrant Activity | As of December 31, 2018, there were 36,267,329 warrants outstanding, with a weighted average exercise price of $0.79 per share, and annual expirations as follows: Expiring in 2019 600,000 Expiring in 2020 1,189,079 Expiring in 2021 343,750 Expiring in 2022 66,667 Expiring in 2023 33,729,180 Expiring thereafter 338,653 36,267,329 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes stock option activity for the year-ended December 31, 2018: Options Outstanding Shares Weighted Average Exercise Price Outstanding, December 31, 2017 745,707 $ 8.84 Options granted 4,984,000 0.66 Options expired / forfeited (116,650 ) 54.29 Outstanding, December 31, 2018 5,613,057 0.83 Exercisable, December 31, 2018 1,636,664 $ 0.93 |
Summary of Additional Information on Stock Options Outstanding | The following table summarizes additional information on Adhera’s stock options outstanding at December 31, 2018: Options Outstanding Options Exercisable Range of Exercise Prices Number Outstanding Weighted- Average Remaining Contractual Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $0.31 - $0.98 4,965,000 8.66 $ 0.64 1,467,500 $ 0.73 $1.00 7,000 2.88 $ 1.00 7,000 $ 1.00 $1.50 - $1.80 493,207 8.68 $ 1.79 134,314 $ 1.78 $2.60 - $8.20 135,200 3.52 $ 2.77 15,200 $ 4.48 $10.70 - $22.00 12,650 0.75 $ 10.92 12,650 $ 10.92 Totals 5,613,057 8.97 $ 0.83 1,636,664 $ 0.93 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | Our net deferred tax assets, liabilities and valuation allowance as of December 31, 2018 and 2017 are summarized as follows: Year Ended December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards (a) $ 4,109,956 $ 2,075,529 Tax credit carryforwards (a) - - Depreciation and amortization 2,799,217 3,107,094 Share based compensation 435,770 297,893 Other 248,654 389,146 Total deferred tax assets 7,593,597 5,869,662 Valuation allowance (7,539,944) (5,354,880 ) Net deferred tax assets 53,653 514,782 Deferred tax liabilities: Intangible assets (53,653) (514,782 ) Net deferred tax liabilities $ - $ - (a) reflects estimated change of control limitation under Section 382 and 383 of the Internal Revenue Code as of December 31, 2016 due to reverse merger on November 15, 2016. |
Organization and Business Ope_2
Organization and Business Operations (Details Narrative) - USD ($) | Jul. 31, 2018 | Nov. 30, 2018 | Jul. 31, 2018 | May 31, 2018 | Apr. 30, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Common stock, par value | $ 0.006 | $ 0.006 | ||||||
Series E Convertible Preferred Stock [Member] | ||||||||
Proceeds from private placement | $ 12,200,000 | $ 12,200,000 | $ 12,200,000 | |||||
Series F Convertible Preferred Stock [Member] | ||||||||
Proceeds from private placement | $ 1,400,000 | $ 1,700,000 | $ 1,700,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | Nov. 09, 2018 | Jul. 31, 2018 | Nov. 30, 2018 | Jul. 31, 2018 | May 31, 2018 | Apr. 30, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Accumulated deficit | $ (25,847,805) | $ (8,028,707) | |||||||
Working capital | 2,500,000 | ||||||||
Loss from operations | (15,794,838) | (6,090,617) | |||||||
Negative cash flows from operations | (9,611,433) | (1,260,685) | |||||||
Proceeds from sale of shares | 250,000 | ||||||||
Cash equivalents | |||||||||
Cash balances in excess of federal insurance limit | 3,700,000 | ||||||||
Loss on impairment of goodwill | 3,502,831 | ||||||||
Loss on impairment of intangible assets | 1,291,200 | ||||||||
Additional loss on impairment of intangible assets | 381,685 | ||||||||
Impairment of intangible assets | 1,672,885 | ||||||||
Cost of sales | 458,708 | ||||||||
Accrued liabilities | 0 | $ 250,000 | |||||||
Operating lease liabilities | 250,000 | ||||||||
Operating lease, right-of-use asset | 242,000 | ||||||||
DiLA2 Delivery System [Member] | |||||||||
Upfront milestones payment | 200,000 | ||||||||
Accrued liabilities | $ 200,000 | ||||||||
Customer Concentration Risk [Member] | Customer 1 [Member] | Sales Revenue, Net [Member] | |||||||||
Customers concentration risk percentage | 37.00% | ||||||||
Customer Concentration Risk [Member] | Customer 2 [Member] | Sales Revenue, Net [Member] | |||||||||
Customers concentration risk percentage | 32.00% | ||||||||
Customer Concentration Risk [Member] | Customer 3 [Member] | Sales Revenue, Net [Member] | |||||||||
Customers concentration risk percentage | 17.00% | ||||||||
Customer Concentration Risk [Member] | Customers [Member] | Sales Revenue, Net [Member] | Third-Party [Member] | |||||||||
Customers concentration risk percentage | 68.00% | ||||||||
Free Product [Member] | |||||||||
Cost of sales | $ 59,000 | ||||||||
Series E Convertible Preferred Stock [Member] | |||||||||
Proceeds from private placement | $ 12,200,000 | $ 12,200,000 | $ 12,200,000 | ||||||
Series F Convertible Preferred Stock [Member] | |||||||||
Proceeds from private placement | $ 1,400,000 | $ 1,700,000 | $ 1,700,000 | ||||||
Series F Preferred Stock [Member] | |||||||||
Sale of stock, shares | 73 | ||||||||
Proceeds from sale of shares | $ 310,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Anti-dilutive securities | 80,570,386 | 3,624,936 |
Stock Options Outstanding [Member] | ||
Anti-dilutive securities | 5,613,057 | 745,707 |
Warrants [Member] | ||
Anti-dilutive securities | 36,267,329 | 2,559,612 |
Shares to be Issued Upon Conversion of Notes Payable [Member] | ||
Anti-dilutive securities | 319,617 | |
Restricted Common Stock [Member] | ||
Anti-dilutive securities | ||
Series E Preferred Stock [Member] | ||
Anti-dilutive securities | 34,880,000 | |
Series F Preferred Stock [Member] | ||
Anti-dilutive securities | 3,810,000 |
Inventory (Details Narrative)
Inventory (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cost of goods sold | $ 458,708 | |
Obsolete Inventory [Member] | ||
Cost of goods sold | $ 123,711 | $ 0 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw Materials | $ 147,139 | |
Finished Goods | 94,319 | |
Inventory, Net | $ 241,458 |
Prepaid and Other Assets (Detai
Prepaid and Other Assets (Details Narrative) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Prepaid insurance | $ 179,145 | $ 0 |
Third-party Co-pay Program Managers [Member] | ||
Deposits with a customer | $ 158,000 | $ 0 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 31, 2017 | |
Fair value of the assets acquired | $ 620,000 | |||
Loss on impairment | $ 1,291,200 | |||
Additional loss on impairment of intangible assets | 381,685 | |||
Impairment of intangible assets | 1,672,885 | |||
Amortization | $ 330,396 | $ 450,903 | ||
2014 Long-Term Incentive Plan [Member] | Chief Commercial Officer [Member] | ||||
Number of restricted shares of common stock | 60,000 | |||
Symplmed Pharmaceuticals LLC [Member] | Purchase Agreement [Member] | ||||
Purchase consideration | $ 620,000 | |||
Payment to acquire business | $ 300,000 | |||
Liabilities assumed | $ 320,000 | |||
Fair value of the assets acquired | 160,800 | |||
Intangible asset | $ 459,200 | |||
Symplmed Technologies, LLC [Member] | ||||
Intangible asset | $ 75,000 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Net Book Value, Intangible assets | $ 391,892 |
Annual Amortization Expense, Intangible assets | 99,534 |
Prestalia [Member] | |
Net Book Value, Intangible assets | $ 324,705 |
Estimated Useful Life, Intangible assets | 5 years |
Annual Amortization Expense, Intangible assets | $ 94,177 |
DyrctAxess [Member] | |
Net Book Value, Intangible assets | $ 67,187 |
Estimated Useful Life, Intangible assets | 12 years 7 months 2 days |
Annual Amortization Expense, Intangible assets | $ 5,357 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Oct. 02, 2018 | Dec. 31, 2017 | May 31, 2018 | Apr. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Due to related party | $ 730,629 | $ 4,392 | $ 730,629 | |||
Number of stock issued during the period, shares | 51,988 | |||||
Proceeds from notes payable due to related party | 500,000 | |||||
Loss on settlement of debt | (810,219) | |||||
Aggregate of cancellation shares, value | 46,311 | |||||
BioMauris, LLC [Member] | ||||||
Due to related party | 23,585 | |||||
Paid to related party for services | 572,381 | |||||
BioMauris, LLC [Member] | Acutus Medical [Member] | ||||||
Paid to related party for services | 62,576 | |||||
Philip C. Ranker [Member] | ||||||
Options to purchase share | 200,000 | |||||
Exercise price of common shares | $ 0.98 | |||||
Philippe P. Calais [Member] | ||||||
Options to purchase share | 80,000 | |||||
Exercise price of common shares | $ 0.98 | |||||
Joseph W. Ramelli [Member] | ||||||
Severance payments | $ 60,000 | |||||
Exercisable period | 5 years | |||||
Exercise price of common stock | $ 0.98 | |||||
Dr. Trieu [Member] | ||||||
Salary received amount per month | 20,000 | |||||
Robert Moscato [Member] | Interior Design Services [Member] | ||||||
Paid to related party for services | $ 15,983 | |||||
Warrants [Member] | ||||||
Warrant term | 5 years | |||||
Exercise price of warrants | $ 0.55 | |||||
Fair value of warrant | $ 1,494,469 | |||||
Loss on settlement of debt | $ 754,697 | |||||
Maximum [Member] | Joseph W. Ramelli [Member] | ||||||
Number of exercisable options grants | 100,000 | |||||
Series E Preferred Stock [Member] | ||||||
Aggregate of cancellation shares | 9 | |||||
Aggregate of cancellation shares, value | ||||||
Autotelic [Member] | ||||||
Billed expenses | 795,228 | 791,889 | ||||
Personnel cost | 531,794 | $ 558,098 | ||||
Master Services Agreement [Member] | ||||||
Proceeds from common or preferred stock, gross | $ 10,000,000 | |||||
Compensation description | After the Equity Financing Date, the Company paid Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided services and 20% mark up of provided services by third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations ("CMO"), FDA regulatory process, Contract Research Organizations ("CRO") and Chemistry and Manufacturing Controls ("CMC"). | |||||
Master Services Agreement [Member] | Related Party [Member] | ||||||
Service provider percentage | 20.00% | |||||
Settlement Agreement with Autotelic Inc [Member] | Maximum [Member] | ||||||
Warrants to purchase common shares | 1,345,040 | |||||
Settlement Agreement with Autotelic Inc [Member] | Series E Preferred Stock [Member] | ||||||
Number of stock issued during the period, shares | 162.59 | |||||
Proceeds from notes payable due to related party | $ 812,967 | |||||
Accrued and unpaid fees | $ 739,772 | |||||
Compromise and Settlement Agreements [Member] | Board of Directors [Member] | ||||||
Number of stock issued during the period, shares | 58.25 | |||||
Accrued and unpaid fees | $ 291,250 | |||||
Compromise and Settlement Agreements [Member] | Two Farmer Directors [Member] | ||||||
Payments Related to Tax Withholding | $ 95,000 | |||||
Compromise and Settlement Agreements [Member] | Maximum [Member] | Board of Directors [Member] | ||||||
Warrants to purchase common shares | 436,875 | |||||
Omnibus Settlement Agreement [Member] | Dr. Trieu [Member] | ||||||
Due to related party | $ 10,000 | |||||
Aggregate of cancellation shares | 500,000 | |||||
Aggregate of cancellation shares, value | $ 250,000 | |||||
Autotelic Inc. [Member] | Master Services Agreement [Member] | ||||||
Ownership interest | 5.00% |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | Mar. 31, 2017 | May 31, 2018 | Apr. 30, 2018 | Nov. 30, 2017 | Jul. 31, 2017 | Apr. 30, 2017 | Jul. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | Nov. 15, 2016 |
Number of stock issued during the period, shares | 51,988 | |||||||||||
Unamortization of debt discount | $ 0 | $ 113,170 | ||||||||||
Amortization of debt discount | 113,171 | 49,041 | ||||||||||
Line Letter [Member] | ||||||||||||
Accrued interest expenses | 0 | 25,836 | ||||||||||
Line Letter [Member] | Autotelic Inc. [Member] | ||||||||||||
Number of stock issued during the period, shares | 19 | |||||||||||
Purchase of warrants | 142,500 | |||||||||||
Line of credit maximum borrowing capacity | $ 500,000 | |||||||||||
Line of credit | 0 | 93,662 | ||||||||||
Line of credit interest | 0 | 2,847 | ||||||||||
Number of common stock issued for merger | 525,535 | |||||||||||
Line of credit bears interest rate | 5.00% | |||||||||||
Line of credit drawn down amount | $ 90,816 | |||||||||||
Dr. Trieu [Member] | Line Letter [Member] | ||||||||||||
Number of stock issued during the period, shares | 114.63 | |||||||||||
Purchase of warrants | 859,725 | |||||||||||
Debt conversion price per share | $ 1.77 | |||||||||||
Line of credit maximum borrowing capacity | $ 540,000 | |||||||||||
Line of credit | 540,000 | |||||||||||
Private Placement [Member ] | ||||||||||||
Number of stock issued during the period, shares | 71.46 | |||||||||||
Private Placement [Member ] | Maximum [Member] | ||||||||||||
Purchase of warrants | 535,950 | |||||||||||
Amendment Agreement [Member] | February 10, 2012 [Member] | ||||||||||||
Debt instrument maturity date | Dec. 31, 2017 | |||||||||||
Issuance of consideration securities | $ 375,000 | |||||||||||
Note Purchase Agreement [Member] | ||||||||||||
Notes payable | $ 56,000 | |||||||||||
Purchase of warrants | 505,705 | |||||||||||
Note Purchase Agreement [Member] | 10 Investors [Member] | ||||||||||||
Debt instrument face amount | $ 400,000 | |||||||||||
Debt instrument interest rate | 5.00% | |||||||||||
Original principal amount | $ 400,000 | |||||||||||
Note Purchase Agreement [Member] | Private Placement [Member ] | ||||||||||||
Number of stock issued during the period, shares | 74.17 | |||||||||||
Promissory Note [Member] | ||||||||||||
Debt instrument face amount | $ 121,523 | |||||||||||
Debt periodic payment | $ 6,000 | |||||||||||
Original principal amount | $ 121,523 | |||||||||||
Notes Payable [Member] | ||||||||||||
Notes payable | 0 | 97,523 | ||||||||||
June 2016 Noteholders [Member] | Private Placement [Member ] | ||||||||||||
Number of stock issued during the period, shares | 75 | |||||||||||
Obligation issued amount | $ 375,000 | |||||||||||
June 2016 Noteholders [Member] | Private Placement [Member ] | Maximum [Member] | ||||||||||||
Purchase of warrants | 562,500 | |||||||||||
Notes One [Member] | ||||||||||||
Accrued interest expenses | 0 | 46,700 | ||||||||||
Interest | 0 | 346,700 | ||||||||||
Notes Two [Member] | ||||||||||||
Accrued interest expenses | 0 | 11,365 | ||||||||||
Interest | 0 | 411,365 | ||||||||||
Convertible Promissory Notes [Member] | ||||||||||||
Debt instrument face amount | $ 50,000 | |||||||||||
Debt instrument interest rate | 8.00% | 3.00% | ||||||||||
Debt instrument maturity date | Mar. 31, 2018 | Dec. 31, 2018 | ||||||||||
Purchase of warrants | 66,667 | |||||||||||
Notes payable to related party | $ 500,000 | |||||||||||
Gross proceeds from debt | $ 5,000,000 | |||||||||||
Convertible note payable | 0 | $ 504,274 | ||||||||||
Warrants terms | 5 years | |||||||||||
Exercise price of warrants | $ 0.75 | |||||||||||
Original principal amount | $ 50,000 | |||||||||||
Unamortization of debt discount | $ 162,210 | 0 | ||||||||||
Fair value of warrants | $ 112,210 | |||||||||||
Amortization of debt discount | $ 113,171 | |||||||||||
Convertible Notes Payable [Member] | ||||||||||||
Debt instrument face amount | $ 500,000 | |||||||||||
Number of stock issued during the period, shares | 103.18 | |||||||||||
Purchase of warrants | 777,750 | |||||||||||
Original principal amount | $ 500,000 |
Notes Payable - Summary of Note
Notes Payable - Summary of Notes Payable (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Total notes payable | $ 444,223 | |
Total notes payable - related parties | 1,462,040 | |
Notes Payable [Member] | ||
Total notes payable | 97,523 | |
Convertible Notes Payable [Member] | ||
Total notes payable | 346,700 | |
Notes Payable Related Parties [Member] | ||
Total notes payable - related parties | 93,662 | |
Convertible Notes Payable Related Parties [Member] | ||
Total notes payable - related parties | $ 1,368,378 |
Notes Payable - Summary of No_2
Notes Payable - Summary of Notes Payable (Details) (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Disclosure [Abstract] | ||
Convertible notes payable - related parties net of debt discount | $ 0 | $ 113,170 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Nov. 09, 2018 | Nov. 09, 2018 | Oct. 02, 2018 | Jul. 31, 2018 | Aug. 31, 2015 | Nov. 30, 2018 | Oct. 31, 2018 | Sep. 30, 2018 | Jul. 31, 2018 | May 31, 2018 | Apr. 30, 2018 | Sep. 30, 2017 | May 31, 2018 | Dec. 31, 2018 | Jun. 30, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2014 |
Preferred stock, shares authorized | 100,000 | 100,000 | 100,000 | ||||||||||||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||||||||
Number of stock issued during the period, shares | 51,988 | ||||||||||||||||||
Sale of preferred stock | $ 13,891,543 | ||||||||||||||||||
Accrued dividends | $ 1,064,141 | ||||||||||||||||||
Stock option granted during the period | 4,984,000 | ||||||||||||||||||
Common stock, shares outstanding | 10,761,684 | 10,761,684 | 10,521,278 | ||||||||||||||||
Number shares issued, value | $ 75,000 | ||||||||||||||||||
Repurchase of common stock | $ 46,311 | ||||||||||||||||||
Loss on settlement of debt | $ (810,219) | ||||||||||||||||||
Warrants [Member] | |||||||||||||||||||
Weighted average exercise price | $ 0.79 | ||||||||||||||||||
Number of warrants expired | 339,702 | ||||||||||||||||||
Vaya Pharma LLC [Member] | |||||||||||||||||||
Number of stock issued during the period, shares | 210,084 | ||||||||||||||||||
Number shares issued, value | $ 250,000 | ||||||||||||||||||
Employee Stock Option [Member] | |||||||||||||||||||
Stock option granted during the period | 260,000 | ||||||||||||||||||
Robert Moscato Jr [Member] | |||||||||||||||||||
Stock option granted during the period | 1,500,000 | ||||||||||||||||||
Uli Hacksell [Member] | |||||||||||||||||||
Stock option granted during the period | 1,000,000 | ||||||||||||||||||
Erik Emerson [Member] | |||||||||||||||||||
Stock option granted during the period | 1,125,000 | ||||||||||||||||||
SVP of Operations [Member] | |||||||||||||||||||
Stock option granted during the period | 250,000 | ||||||||||||||||||
Eric Teague [Member] | |||||||||||||||||||
Stock option granted during the period | 450,000 | ||||||||||||||||||
Private Placement [Member ] | |||||||||||||||||||
Number of stock issued during the period, shares | 71.46 | ||||||||||||||||||
Warrants [Member] | |||||||||||||||||||
Common stock exercise price, per share | $ 0.55 | $ 0.55 | |||||||||||||||||
Warrants outstanding | 36,267,329 | 36,267,329 | |||||||||||||||||
Fair value of warrants | $ 1,494,469 | ||||||||||||||||||
Loss on settlement of debt | $ 754,697 | ||||||||||||||||||
Adjustable warrants, shares | 1,895,013 | 1,895,013 | |||||||||||||||||
Warrants [Member] | Autotelic Inc. [Member] | |||||||||||||||||||
Fair value of warrants | $ 1,494,469 | ||||||||||||||||||
Loss on settlement of debt | $ 754,697 | ||||||||||||||||||
Subscription Agreements [Member] | Private Placement [Member ] | |||||||||||||||||||
Warrants to purchase of common stock shares | 2,958,460 | 2,958,460 | |||||||||||||||||
Sale of preferred stock | $ 12,200,000 | ||||||||||||||||||
Placement agent fees and estimated expenses | $ 2,000,000 | ||||||||||||||||||
Subscription Agreements [Member] | Warrants [Member] | |||||||||||||||||||
Preferred stock, par value | $ 0.75 | $ 0.75 | |||||||||||||||||
Warrants to purchase of common stock shares | 73,000 | 73,000 | 0.75 | 0.75 | |||||||||||||||
Common stock exercise price, per share | $ 0.55 | $ 0.55 | |||||||||||||||||
Asset Purchase Agreement [Member] | Novosom Verwaltungs GmbH [Member] | |||||||||||||||||||
Number of stock issued during the period, shares | 51,988 | ||||||||||||||||||
Settlement Agreement [Member] | Vuong Trieu, Ph.D [Member] | |||||||||||||||||||
Repurchase of common stock | $ 250,000 | ||||||||||||||||||
Repurchase of common stock, shares | 500,000 | ||||||||||||||||||
Series B Preferred Stock [Member] | |||||||||||||||||||
Preferred stock designated, shares | 1,000 | 1,000 | |||||||||||||||||
Preferred stock shares outstanding | |||||||||||||||||||
Series A Preferred Stock [Member] | |||||||||||||||||||
Preferred stock designated, shares | 90,000 | 90,000 | |||||||||||||||||
Preferred stock shares outstanding | |||||||||||||||||||
Series C Preferred Stock [Member] | |||||||||||||||||||
Preferred stock designated, shares | 1,200 | ||||||||||||||||||
Preferred stock, par value | $ 5,000 | $ 5,000 | |||||||||||||||||
Preferred stock liquidation preference per share | 5,100 | $ 5,100 | |||||||||||||||||
Preferred stock voting rights | voting rights of 666.67 votes per share | ||||||||||||||||||
Common stock at a conversion price, per share | $ 7.50 | $ 7.50 | |||||||||||||||||
Number of stock issued during the period, shares | 100 | 750 | |||||||||||||||||
Series C Preferred Stock [Member] | Investor [Member] | |||||||||||||||||||
Conversion of stock, shares converted | 270 | 650 | |||||||||||||||||
Number of stock issued during the period, shares | 180,000 | 433,334 | |||||||||||||||||
Series D Preferred Stock [Member] | |||||||||||||||||||
Preferred stock designated, shares | 220 | ||||||||||||||||||
Number of stock issued during the period, shares | 40 | 60 | |||||||||||||||||
Series D Preferred Stock [Member] | Securities Purchase Agreement [Member] | |||||||||||||||||||
Preferred stock, par value | $ 5,000 | ||||||||||||||||||
Preferred stock liquidation preference per share | $ 300 | ||||||||||||||||||
Preferred stock voting rights | voting rights of 1,250 votes per share | ||||||||||||||||||
Common stock at a conversion price, per share | $ 4 | ||||||||||||||||||
Number of stock issued during the period, shares | 275,000 | ||||||||||||||||||
Sale of stock, shares | 220 | ||||||||||||||||||
Warrants to purchase of common stock shares | 344,000 | ||||||||||||||||||
Common stock exercise price, per share | $ 4 | ||||||||||||||||||
Proceeds from exercise price of warrants to common stock | $ 1,100,000 | ||||||||||||||||||
Preferred stock stated dividend rate | 5.00% | ||||||||||||||||||
Series D Preferred Stock [Member] | Investor [Member] | |||||||||||||||||||
Conversion of stock, shares converted | 20 | ||||||||||||||||||
Number of stock issued during the period, shares | 25,000 | ||||||||||||||||||
Series E Convertible Preferred Stock [Member] | |||||||||||||||||||
Preferred stock, shares authorized | 3,500 | 3,500 | 3,500 | ||||||||||||||||
Preferred stock designated, shares | 3,500 | ||||||||||||||||||
Preferred stock shares outstanding | 3,488 | 3,488 | 0 | ||||||||||||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||||||||
Accrued dividends | $ 974,247 | ||||||||||||||||||
Proceeds from private placement | $ 12,200,000 | $ 12,200,000 | $ 12,200,000 | ||||||||||||||||
Series E Convertible Preferred Stock [Member] | Subscription Agreements [Member] | |||||||||||||||||||
Sale of stock, shares | 2,812 | ||||||||||||||||||
Preferred stock stated dividend rate | 8.00% | ||||||||||||||||||
Series E Convertible Preferred Stock [Member] | Subscription Agreements [Member] | Warrants [Member] | |||||||||||||||||||
Preferred stock, par value | $ 5,000 | $ 5,000 | |||||||||||||||||
Common stock at a conversion price, per share | $ 0.50 | $ 0.50 | |||||||||||||||||
Warrants to purchase of common stock shares | 0.75 | 0.75 | |||||||||||||||||
Common stock exercise price, per share | $ 0.55 | $ 0.55 | |||||||||||||||||
Warrant term | 5 years | 5 years | |||||||||||||||||
Series E Convertible Preferred Stock [Member] | Investor [Member] | |||||||||||||||||||
Conversion of stock, shares converted | 2 | ||||||||||||||||||
Number of stock issued during the period, shares | 20,000 | ||||||||||||||||||
Series F Convertible Preferred Stock [Member] | |||||||||||||||||||
Preferred stock, shares authorized | 2,200 | 2,200 | 2,200 | ||||||||||||||||
Preferred stock designated, shares | 2,200 | 2,200 | |||||||||||||||||
Preferred stock shares outstanding | 381 | 381 | 0 | ||||||||||||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||||||||
Accrued dividends | $ 89,894 | ||||||||||||||||||
Proceeds from private placement | $ 1,400,000 | $ 1,700,000 | $ 1,700,000 | ||||||||||||||||
Series F Convertible Preferred Stock [Member] | Subscription Agreements [Member] | |||||||||||||||||||
Preferred stock, par value | $ 5,000 | $ 5,000 | |||||||||||||||||
Common stock at a conversion price, per share | $ 0.50 | $ 0.50 | $ 0.50 | $ 0.50 | |||||||||||||||
Sale of stock, shares | 73 | 308 | |||||||||||||||||
Warrants to purchase of common stock shares | 0.75 | 0.75 | 308,000 | 308,000 | |||||||||||||||
Common stock exercise price, per share | $ 0.55 | $ 0.55 | $ 0.55 | $ 0.55 | |||||||||||||||
Preferred stock stated dividend rate | 8.00% | ||||||||||||||||||
Warrant term | 5 years | 5 years | 5 years | 5 years | |||||||||||||||
Placement agent fees and estimated expenses | $ 310,000 | $ 180,000 | |||||||||||||||||
Proceeds from private placement | $ 1,400,000 | ||||||||||||||||||
Purchase price of preferred stock | $ 5,000 | $ 5,000 | |||||||||||||||||
Weighted average exercise price | $ 0.55 | ||||||||||||||||||
Series E Preferred Stock [Member] | |||||||||||||||||||
Sale of stock, shares | |||||||||||||||||||
Repurchase of common stock | |||||||||||||||||||
Repurchase of common stock, shares | 9 | ||||||||||||||||||
Series E Preferred Stock [Member] | Warrants [Member] | |||||||||||||||||||
Warrant issued | 29,135,560 | ||||||||||||||||||
Fair value of warrants | $ 31,106,896 | ||||||||||||||||||
Series E Preferred Stock [Member] | Subscription Agreements [Member] | Private Placement [Member ] | |||||||||||||||||||
Conversion of stock, shares converted | 2 | ||||||||||||||||||
Number of stock issued during the period, shares | 20,000 | ||||||||||||||||||
Common Stock [Member] | |||||||||||||||||||
Common stock, shares outstanding | 10,761,684 | 10,761,684 | |||||||||||||||||
Series F Preferred Stock [Member] | |||||||||||||||||||
Sale of stock, shares | 73 | ||||||||||||||||||
Repurchase of common stock | |||||||||||||||||||
Repurchase of common stock, shares | |||||||||||||||||||
Series F Preferred Stock [Member] | Warrants [Member] | |||||||||||||||||||
Warrant issued | 3,238,500 | ||||||||||||||||||
Fair value of warrants | $ 1,492,464 | ||||||||||||||||||
Warrants [Member] | |||||||||||||||||||
Common stock exercise price, per share | $ 0.55 | $ 0.55 | |||||||||||||||||
Warrant term | 5 years | 5 years | |||||||||||||||||
Warrants [Member] | Autotelic Inc. [Member] | |||||||||||||||||||
Warrant issued | 1,345,040 | ||||||||||||||||||
Accrued and unpaid fees | $ 739,772 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrant Activity (Details) | 12 Months Ended |
Dec. 31, 2018shares | |
Equity [Abstract] | |
Expiring in 2019 | 600,000 |
Expiring in 2020 | 1,189,079 |
Expiring in 2021 | 343,750 |
Expiring in 2022 | 66,667 |
Expiring in 2023 | 33,729,180 |
Expiring thereafter | 338,653 |
Total | 36,267,329 |
Stock Incentive Plans (Details
Stock Incentive Plans (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Sep. 30, 2018 | Jul. 31, 2018 | May 31, 2018 | Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 31, 2017 | |
Weighted-average exercisable remaining contractual life (years) | 8 years 11 days | |||||||
Stock option granted during the period | 4,984,000 | |||||||
Stock option weighted average period term | 10 years | |||||||
Stock option unrecognized compensation expense | $ 1,185,627 | $ 1,185,627 | ||||||
Stock option expenses | 1,445,138 | $ 178,784 | ||||||
Stock option outstanding, intrinsic value | $ 0 | $ 0 | ||||||
Option outstanding | ||||||||
Stock option outstanding exercise price | $ 0.66 | $ 0.28 | $ 0.28 | |||||
Employee Stock Option [Member] | ||||||||
Stock option granted during the period | 260,000 | |||||||
Stock option weighted average period term | 10 years | |||||||
Employee Stock Option [Member] | Minimum [Member] | ||||||||
Options to purchase exercise price, per share | $ 0.31 | 0.31 | ||||||
Employee Stock Option [Member] | Maximum [Member] | ||||||||
Options to purchase exercise price, per share | $ 0.53 | $ 0.53 | ||||||
Director and Officers [Member] | ||||||||
Stock option granted during the period | 380,000 | 19,000 | ||||||
Options to purchase exercise price, per share | $ 0.98 | $ 1.56 | ||||||
Stock option weighted average period term | 5 years | 5 years | ||||||
Robert Moscato Jr [Member] | ||||||||
Stock option granted during the period | 1,500,000 | |||||||
Uli Hacksell [Member] | ||||||||
Stock option granted during the period | 1,000,000 | |||||||
Erik Emerson [Member] | ||||||||
Stock option granted during the period | 1,125,000 | |||||||
SVP of Commercial Operations [Member] | ||||||||
Stock option granted during the period | 250,000 | |||||||
Options to purchase exercise price, per share | $ 0.575 | |||||||
Stock option weighted average period term | 10 years | |||||||
Chief Financial Officer [Member] | ||||||||
Stock option granted during the period | 450,000 | |||||||
Options to purchase exercise price, per share | $ 0.55 | |||||||
Stock option weighted average period term | 10 years |
Stock Incentive Plans - Schedul
Stock Incentive Plans - Schedule of Stock Option Activity (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Options Outstanding Beginning, Shares | shares | 745,707 |
Options Outstanding, granted | shares | 4,984,000 |
Options Outstanding, expired/ forfeited | shares | (116,650) |
Options Outstanding Ending, Shares | shares | 5,613,057 |
Options Outstanding Exercisable, Shares | shares | 1,636,664 |
Options Outstanding Weighted Average Exercise Price, Beginning | $ / shares | $ 8.84 |
Options Outstanding Weighted Average Exercise Price, granted | $ / shares | 0.66 |
Options Outstanding Weighted Average Exercise Price, expired/ forfeited | $ / shares | 54.29 |
Options Outstanding Weighted Average Exercise Price, Ending | $ / shares | 0.83 |
Options Outstanding Exercisable Weighted Average Exercise Price | $ / shares | $ 0.93 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Additional Information on Stock Options Outstanding (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Options Outstanding, Shares | shares | 5,613,057 |
Options Outstanding Weighted-average Remaining Contractual Life (years) | 8 years 11 months 19 days |
Options Outstanding Weighted Average Exercise Price | $ 0.83 |
Number of Option Exercisable, Shares | shares | 1,636,664 |
Options Exercisable Weighted Average Exercise Price | $ 0.93 |
Range One [Member] | |
Range of Exercise Prices, Lower | 0.31 |
Range of Exercise Prices, Upper | $ 0.98 |
Number of Options Outstanding, Shares | shares | 4,965,000 |
Options Outstanding Weighted-average Remaining Contractual Life (years) | 8 years 7 months 28 days |
Options Outstanding Weighted Average Exercise Price | $ 0.64 |
Number of Option Exercisable, Shares | shares | 1,467,500 |
Options Exercisable Weighted Average Exercise Price | $ 0.73 |
Range Two [Member] | |
Range of Exercise Prices, Upper | $ 1 |
Number of Options Outstanding, Shares | shares | 7,000 |
Options Outstanding Weighted-average Remaining Contractual Life (years) | 2 years 10 months 17 days |
Options Outstanding Weighted Average Exercise Price | $ 1 |
Number of Option Exercisable, Shares | shares | 7,000 |
Options Exercisable Weighted Average Exercise Price | $ 1 |
Range Three [Member] | |
Range of Exercise Prices, Lower | 1.50 |
Range of Exercise Prices, Upper | $ 1.80 |
Number of Options Outstanding, Shares | shares | 493,207 |
Options Outstanding Weighted-average Remaining Contractual Life (years) | 8 years 8 months 5 days |
Options Outstanding Weighted Average Exercise Price | $ 1.79 |
Number of Option Exercisable, Shares | shares | 134,314 |
Options Exercisable Weighted Average Exercise Price | $ 1.78 |
Range Four [Member] | |
Range of Exercise Prices, Lower | 2.60 |
Range of Exercise Prices, Upper | $ 8.20 |
Number of Options Outstanding, Shares | shares | 135,200 |
Options Outstanding Weighted-average Remaining Contractual Life (years) | 3 years 6 months 7 days |
Options Outstanding Weighted Average Exercise Price | $ 2.77 |
Number of Option Exercisable, Shares | shares | 15,200 |
Options Exercisable Weighted Average Exercise Price | $ 4.48 |
Range Five [Member] | |
Range of Exercise Prices, Lower | 10.70 |
Range of Exercise Prices, Upper | $ 22 |
Number of Options Outstanding, Shares | shares | 12,650 |
Options Outstanding Weighted-average Remaining Contractual Life (years) | 9 months |
Options Outstanding Weighted Average Exercise Price | $ 10.92 |
Number of Option Exercisable, Shares | shares | 12,650 |
Options Exercisable Weighted Average Exercise Price | $ 10.92 |
Intellectual Property and Col_2
Intellectual Property and Collaborative Agreements (Details Narrative) - USD ($) | Mar. 16, 2018 | May 31, 2018 | Jul. 31, 2017 | Jun. 30, 2017 | Feb. 28, 2017 | Dec. 31, 2017 | Dec. 31, 2018 |
Sale of common stock to related party, shares | 51,988 | ||||||
Sale of common stock to related party | $ 75,000 | ||||||
Purchase price | $ 250,000 | ||||||
Accrued liabilities | $ 250,000 | $ 0 | |||||
Executive Chairman [Member] | |||||||
Ownership percentage | 22.00% | ||||||
Chief Executive Officer [Member] | |||||||
Ownership percentage | 19.00% | ||||||
License Agreement [Member] | |||||||
Sale of stock price per share | $ 5.10 | ||||||
License Agreement [Member] | Oncotelic, Inc. [Member] | |||||||
Purchase price, shares | 49,019 | ||||||
Purchase price | $ 250,000 | ||||||
License Agreement [Member] | Lipo Medics [Member] | |||||||
Sale of common stock to related party | $ 500,000 | ||||||
Number of shares issued for equity components | 86,207 | ||||||
Licensing Agreement [Member] | |||||||
Upfront payment of future consideration | $ 200,000 | ||||||
Accrued liabilities | $ 200,000 | ||||||
Purchase Agreement [Member] | Symplmed Pharmaceuticals LLC [Member] | |||||||
Purchase price | $ 75,000 | ||||||
Upfront payment of future consideration | $ 620,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
May 31, 2018 | Apr. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Issuance of common stock, value | $ 75,000 | |||
Issuance of common stock, shares | 51,988 | |||
Accrued expenses | $ 0 | $ 250,000 | ||
Operating lease term of contract | 37 months | |||
Operating lease rent increase in future | $ 7,057 | |||
Vaya Pharma, Inc. [Member] | ||||
Issuance of common stock, value | $ 250,000 | |||
Issuance of common stock, shares | 210,084 | |||
Pharmaceutical Development Agreement [Member] | ||||
Commitments, description | The Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas' agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the total amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). | |||
Cash payments percentage | 40.00% | |||
Operating lease rent expenses | $ 6,458 | |||
Pharmaceutical Development Agreement [Member] | Maximum [Member] | ||||
Issuance of common stock, value | $ 2,000,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | Dec. 22, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Net operating loss carry-forwards | $ 323,000,000 | ||
Available tax credit carry-forwards | $ 10,600,000 | ||
Net operating loss carry forwards expire period | 2038 | ||
Increase decrease in deferred tax asset, valuation allowance, amount | $ 2,185,064 | $ 1,436,089 | |
Income tax expense | $ 800 | ||
Income tax reconciliation description | The Tax Cuts and Jobs Act (the Act) was enacted on December 22, 2017. The Act reduces the US federal corporate tax rate from 35% to 21% and will require the Company to re-measure certain deferred tax assets and liabilities based on the rates at which they are anticipated to reverse in the future, which is generally 21%. | ||
Effective income tax rate percentage | 35.00% | ||
Reduced Tax Rate [Member] | |||
Effective income tax rate percentage | 21.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Net operating loss carryforwards | [1] | $ 4,109,956 | $ 2,075,529 |
Tax credit carryforwards | [1] | ||
Depreciation and amortization | 2,799,217 | 3,107,094 | |
Share based compensation | 435,770 | 297,893 | |
Other | 248,654 | 389,146 | |
Total deferred tax assets | 7,593,597 | 5,869,662 | |
Valuation allowance | (7,539,944) | (5,354,880) | |
Net deferred tax assets | 53,653 | 514,782 | |
Intangible assets | (53,653) | (514,782) | |
Net deferred tax liabilities | |||
[1] | reflects estimated change of control limitation under Section 382 and 383 of the Internal Revenue Code as of December 31, 2016 due to reverse merger on November 15, 2016. |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Apr. 04, 2019 | Jan. 15, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Stock option granted during the period | 4,984,000 | |||
Stock options exercisable | 1,636,664 | |||
Subsequent Event [Member] | Resignation and Appointment of Chief Executive Officer [Member] | ||||
Officers compensation | $ 360,000 | |||
Employment agreement term | 3 years | |||
Bonus percentage upon target fixed | 50.00% | |||
Subsequent Event [Member] | New Chief Executive Officer [Member] | ||||
Stock option granted during the period | 1,500,000 | |||
Stock options exercisable | 400,000 | |||
Number of stock options vested | 600,000 | |||
Chief Financial Officer [Member] | ||||
Officers compensation | $ 285,000 | |||
Stock option granted during the period | 450,000 | |||
Chief Financial Officer [Member] | Subsequent Event [Member] | ||||
Exercise price | $ 0.32 | |||
Stock options exercisable | 25,000 | |||
Chief Commercial Officer [Member] | Subsequent Event [Member] | Resignation of Chief Commercial Officer [Member] | ||||
Consulting fees | $ 3,000 | |||
New Chief Executive Officer [Member] | Subsequent Event [Member] | Achievement Of Certain Product Sales And Stock Price Targets [Member] | ||||
Number of stock options vested | 500,000 |