Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 16, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-12584 | ||
Entity Registrant Name | Synthetic Biologics, Inc. | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Tax Identification Number | 13-3808303 | ||
Entity Address, Address Line One | 9605 Medical Center Drive, Ste. 270 | ||
Entity Address, City or Town | Rockville | ||
Entity Address, Country | MD | ||
Entity Address, Postal Zip Code | 20850 | ||
City Area Code | 301 | ||
Local Phone Number | 417-4364 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | SYN | ||
Security Exchange Name | NYSE | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 158,437,840 | ||
Entity Central Index Key | 0000894158 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 79.2 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | BDO USA, LLP | ||
Auditor Firm ID | 243 | ||
Auditor Location | Potomac, Maryland |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets | ||
Cash and cash equivalents | $ 67,325 | $ 6,227 |
Prepaid expenses and other current assets | 1,533 | 1,707 |
Total Current Assets | 68,858 | 7,934 |
Property and equipment, net | 101 | 174 |
Right of use asset | 1,383 | 279 |
Deposits and other assets | 23 | 23 |
Total Assets | 70,365 | 8,410 |
Current Liabilities: | ||
Accounts payable | 524 | 886 |
Accrued expenses | 1,928 | 925 |
Accrued employee benefits | 978 | 868 |
Lease liability | 124 | 287 |
Total Current Liabilities | 3,554 | 2,966 |
Lease liability - long term | 1,403 | 186 |
Total Liabilities | 4,957 | 3,152 |
Commitments and Contingencies | ||
Series A Preferred Stock, $0.001 par value; 10,000,000 shares authorized; 0 and 120,000 issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 0 | 12,798 |
Stockholders' Equity (Deficit): | ||
Series B Preferred Stock, $1,000 par value; 10,000,000 shares authorized, 0 issued and outstanding and 3,973 issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 0 | 2,477 |
Common stock, $0.001 par value; 200,000,000 shares authorized, 132,044,866 issued and 132,042,538 outstanding at September 30, 2021 and 29,252,253 issued and 29,249,925 outstanding at December 31, 2020 | 132 | 29 |
Additional paid-in capital | 336,560 | 240,821 |
Accumulated deficit | (271,284) | (248,094) |
Total Synthetic Biologics, Inc. and Subsidiaries Equity (Deficit) | 65,408 | (4,767) |
Non-controlling interest | (2,773) | |
Total Stockholders' Equity (Deficit) | 65,408 | (7,540) |
Total Liabilities and Stockholders' Equity | $ 70,365 | $ 8,410 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Consolidated Balance Sheets | ||
Temporary Equity, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Temporary Equity, Shares Authorized | 10,000,000 | 10,000,000 |
Temporary Equity, Shares Issued | 0 | 120,000 |
Temporary Equity, Shares Outstanding | 0 | 120,000 |
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | $ 1,000 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 3,973 |
Preferred Stock, Shares Outstanding | 0 | 3,973 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, Shares Authorized | 200,000,000 | 200,000,000 |
Common stock, Shares Issued | 132,044,866 | 29,252,253 |
Common stock, Shares Outstanding | 132,042,538 | 29,249,925 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Costs and Expenses: | ||
General and administrative | $ 6,474 | $ 5,029 |
Research and development | 7,800 | 5,131 |
Total Operating Costs and Expenses | 14,274 | 10,160 |
Loss from Operations | (14,274) | (10,160) |
Other Income : | ||
Interest income | 6 | 44 |
Total Other Income | 6 | 44 |
Net Loss | (14,268) | (10,116) |
Net Loss Attributable to Non-controlling Interest | (1) | (73) |
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | (14,267) | (10,043) |
Effect of Series A Preferred Stock Price adjustment | (7,402) | 0 |
Effect of Warrant exercise price adjustment | 0 | (880) |
Net Loss Attributable to Common Stockholders | $ (23,189) | $ (12,557) |
Net Loss Per Share - Basic | $ (0.19) | $ (0.66) |
Net Loss Per Share - Dilutive | $ (0.19) | $ (0.66) |
Weighted average number of shares outstanding during the period - basic | 121,875,042 | 19,011,362 |
Weighted average number of shares outstanding during the period - dilutive | 121,875,042 | 19,011,362 |
Series A Preferred Stock [Member] | ||
Other Income : | ||
Preferred Stock Dividends, Income Statement Impact | $ (24) | $ (254) |
Effect of Series A Preferred Stock Price adjustment | (7,402) | 0 |
Effect of Warrant exercise price adjustment | (1,000) | |
Series B Preferred Stock [Member] | ||
Other Income : | ||
Preferred Stock Dividends, Income Statement Impact | (1,496) | (1,380) |
Preferred Stock [Member] | Series B Preferred Stock [Member] | ||
Other Income : | ||
Net Loss | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders (Deficit) Equity - USD ($) $ in Thousands | Common StockSeries B Preferred | Common StockSeries A Preferred Stock [Member] | Common Stock | APICSeries B Preferred | APICSeries A Preferred Stock [Member] | APIC | Accumulated DeficitSeries B Preferred | Accumulated DeficitSeries A Preferred Stock [Member] | Accumulated Deficit | Non-Controlling InterestAccumulated Non-Controlling Stockholders'Series B Preferred | Non-Controlling InterestAccumulated Non-Controlling Stockholders'Series A Preferred Stock [Member] | Non-Controlling InterestAccumulated Non-Controlling Stockholders' | Preferred Stock [Member]Series B Preferred | Preferred Stock [Member]Series A Preferred Stock [Member] | Series B Preferred | Series A Preferred Stock [Member] | Total |
Stock-based compensation | $ 0 | $ 350 | $ 0 | $ 0 | $ 0 | $ 350 | |||||||||||
Stock issued under "at-the-market" offering | $ 9 | 3,350 | 0 | 0 | 0 | 3,359 | |||||||||||
Stock issued under "at-the-market" offering (in shares) | 9,256,535 | ||||||||||||||||
Series A Preferred Stock Dividends | $ 0 | 0 | 254 | 0 | 0 | 254 | |||||||||||
Issuance of SYN Biomics Stock | 0 | 0 | 0 | 178 | 0 | 178 | |||||||||||
Effect of Warrant exercise price adjustment | 0 | 880 | (880) | 0 | 0 | 0 | |||||||||||
Conversion of Series B Preferred Stock to Common | $ 3 | 3,661 | (1,380) | 0 | $ (2,284) | 0 | |||||||||||
Conversion of Series B Preferred Stock to Common (in shares) | 3,186,960 | (3,665) | |||||||||||||||
Net Loss | $ 0 | 0 | (10,043) | (73) | $ 0 | (10,116) | |||||||||||
Non-controlling interest | (73) | ||||||||||||||||
Balance at Dec. 31, 2020 | 29 | 240,821 | (248,094) | (2,773) | 2,477 | (7,540) | |||||||||||
Balance at Dec. 31, 2019 | $ 17 | 232,580 | (235,537) | (2,878) | $ 4,761 | (1,057) | |||||||||||
Balance (in shares) at Dec. 31, 2020 | 29,249,925 | 3,973 | |||||||||||||||
Balance (in shares) at Dec. 31, 2019 | 16,806,430 | 7,638 | |||||||||||||||
Stock-based compensation | $ 0 | 416 | 0 | 0 | $ 0 | 416 | |||||||||||
Stock issued under "at-the-market" offering | $ 79 | 65,881 | 0 | 0 | 0 | 65,960 | |||||||||||
Stock issued under "at-the-market" offering (in shares) | 78,685,315 | ||||||||||||||||
Series A Preferred Stock Dividends | $ 0 | 0 | 24 | 0 | 0 | 24 | |||||||||||
Conversion of Series B Preferred Stock to Common | $ 3 | $ 3,971 | $ (1,497) | $ 0 | $ (2,477) | $ 0 | |||||||||||
Conversion of Series B Preferred Stock to Common (in shares) | 3,454,783 | (3,973) | |||||||||||||||
Net Loss | 0 | 0 | (14,267) | (1) | $ 0 | (14,268) | |||||||||||
Reversal of noncontrolling interest due to return of Syn Biomics shares | 0 | (2,774) | 0 | 2,774 | 0 | 0 | |||||||||||
Warrants Exercised | $ 12 | 8,030 | 0 | 0 | 0 | 8,042 | |||||||||||
Warrants Exercised (In shares) | 11,655,747 | ||||||||||||||||
Effect of Series A Preferred Stock price adjustment | $ 0 | 7,402 | (7,402) | 0 | 0 | 0 | |||||||||||
Conversion of Series A Preferred Stock to Common | $ 9 | $ 12,813 | $ 0 | $ 0 | $ 0 | $ 12,822 | |||||||||||
Conversion of Series A Preferred Stock to Common (in shares) | 8,996,768 | ||||||||||||||||
Non-controlling interest | (1) | ||||||||||||||||
Balance at Dec. 31, 2021 | 132 | 336,560 | (271,284) | 0 | 0 | 65,408 | |||||||||||
Balance at Dec. 31, 2020 | $ 29 | $ 240,821 | $ (248,094) | $ (2,773) | $ 2,477 | $ (7,540) | |||||||||||
Balance (in shares) at Dec. 31, 2021 | 132,042,538 | ||||||||||||||||
Balance (in shares) at Dec. 31, 2020 | 29,249,925 | 3,973 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (14,268,000) | $ (10,116,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 416,000 | 350,000 |
Subsidiary stock issuances to vendor | 0 | 178,000 |
Depreciation | 87,000 | 201,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 174,000 | (326,000) |
Right of use asset | 166,000 | 141,000 |
Accounts payable | (363,000) | (1,429,000) |
Accrued expenses | 1,004,000 | (851,000) |
Accrued employee benefits | 110,000 | (67,000) |
Lease liability | (216,000) | (249,000) |
Net Cash Used in Operating Activities | (12,890,000) | (12,168,000) |
Cash Flows from Investing Activities | ||
Purchases of property and equipment | (14,000) | (9,000) |
Net Cash Used in Investing Activities | (14,000) | (9,000) |
Cash Flows from Financing Activities | ||
Proceeds from "at the market" stock issuance | 65,960,000 | 3,359,000 |
Proceeds from issuance of common stock for warrant exercises | 8,042,000 | 0 |
Net Cash Provided by Financing Activities | 74,002,000 | 3,359,000 |
Net increase (decrease) in cash and cash equivalents | 61,098,000 | (8,818,000) |
Cash and cash equivalents at beginning of year | 6,227,000 | 15,045,000 |
Cash and cash equivalents at end of year | 67,325,000 | 6,227,000 |
NONCASH FINANCING ACTIVITIES: | ||
Preferred stock price adjustment | 7,402,000 | 0 |
Return of SYN Biomics Stock | 2,774,000 | 0 |
Deemed dividends for accretion of Series B Preferred Stock discount | 1,496,000 | 1,380,000 |
Right of use assets from operating lease | 1,270,000 | 0 |
In-kind dividends paid in preferred stock | 24,000 | 254,000 |
Effect of Warrant exercise price adjustment | 0 | 880,000 |
Series A Preferred Stock [Member] | ||
NONCASH FINANCING ACTIVITIES: | ||
Conversion of Stock | 12,822,000 | 0 |
Preferred stock price adjustment | 7,402,000 | 0 |
Effect of Warrant exercise price adjustment | 1,000,000 | |
Series B Preferred Stock [Member] | ||
NONCASH FINANCING ACTIVITIES: | ||
Conversion of Stock | 2,477,000 | 2,284,000 |
Series B Preferred Stock [Member] | Preferred Stock [Member] | ||
Cash Flows from Operating Activities: | ||
Net loss | $ 0 | $ 0 |
Organization, Nature of Operati
Organization, Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Nature of Operations and Basis of Presentation | |
Organization, Nature of Operations and Basis of Presentation | 1. Organization and Nature of Operations and Basis of Presentation Description of Business Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a diversified clinical-stage company operating in one segment currently developing therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company’s lead clinical development candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage, (b) Clostridioides difficile The Company was also developing SYN-010 to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). On September 30, 2020, Cedars Sinai Medical Center (CSMC) (the Company’s SYN-010 clinical development partner) informed the Company that it agreed to discontinue the ongoing Phase 2b investigator-sponsored clinical study of SYN-010 IBS-C patients. Based on the results of a planned interim futility analysis, it was concluded that although SYN-010 was well tolerated, it was unlikely to meet its primary endpoint by the time enrollment is completed. Corporate Structure and Basis of Presentation As of December 31, 2021, the Company had eight subsidiaries, Pipex Therapeutics, Inc. (“Pipex Therapeutics”), Effective Pharmaceuticals, Inc. (“EPI”), Solovax, Inc. (“Solovax”), CD4 Biosciences, Inc. (“CD4”), Epitope Pharmaceuticals, Inc. (“Epitope”), Healthmine, Inc. (“Healthmine”), Putney Drug Corp. (“Putney”) and Synthetic Biomics, Inc. (“SYN Biomics”). Pipex Therapeutics, EPI, Healthmine and Putney are wholly owned, and Solovax, CD4, Epitope and SYN Biomics are majority-owned. For financial reporting purposes, the outstanding common stock of the Company is that of Synthetic Biologics, Inc. All statements of operations, (deficit) equity and cash flows for each of the entities are presented as consolidated. All subsidiaries were formed under the laws of the State of Delaware on January 8, 2001, except for EPI, which was incorporated in Delaware on December 12, 2000, Epitope which was incorporated in Delaware in January 2002, Putney which was incorporated in Delaware in November 2006, Healthmine which was incorporated in Delaware in December 2007 and SYN Biomics which was incorporated in Nevada in December 2013. Liquidity As of December 31, 2021, the Company has a significant accumulated deficit, and with the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, the Company has experienced significant losses and incurred negative cash flows since inception. The Company expects to continue incurring losses for the foreseeable future, with the recognition of revenue being contingent on successful phase 3 clinical trials and requisite approvals by the FDA or foreign equivalents. Historically, the Company has financed its operations primarily through public and private sales of its common stock and a private placement of its preferred stock, and it expects to continue to seek to obtain required capital in a similar manner. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including planned product development efforts, clinical trials and research and discovery efforts. 1. Organization and Nature of Operations and Basis of Presentation – (continued) Cash and cash equivalents totaled approximately $67.3 million as of December 31, 2021, which includes the net proceeds of approximately $66 million from sales of its Common Stock in “at-the-market” (ATM) equity offerings during 2021 and cash proceeds of approximately $8.0 million through the exercise of a portion of the October 2018 warrants. With these additional sources of liquidity , |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation All intercompany transactions and accounts have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the estimated useful lives for property and equipment, fair value of warrants, preferred stock and stock options granted for services or compensation, respectively, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses. Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates. Non-controlling Interest The Company’s non-controlling interest represents the minority stockholder’s ownership interest related to the Company’s subsidiary, SYN Biomics. The Company reports its non-controlling interest in subsidiaries as a separate component of equity in the Consolidated Balance Sheets and reports both net loss attributable to the non-controlling interest and net loss attributable to the Company’s common stockholders on the face of the Consolidated Statements of Operations. On September 5, 2018, the Company entered into an agreement with the minority stockholder for an investigator-sponsored Phase 2 clinical study of SYN-010. Prior to this agreement and IRB approval in December 2018, the Company’s equity interest in SYN Biomics was 88.5% and the non-controlling stockholder’s interest was 11.5%. In consideration of the support, the Company issued additional shares of stock to the minority stockholder, resulting in the Company’s equity interest in SYN Biomics being 83.0% and the non-controlling stockholder’s interest is 17.0%. During 2021, the minority stockholder returned its shares of SYN Bionics to the Company for no consideration. The Company's interest in SYN Biomics is now 100%. This is reflected in the Consolidated Statements of Equity (Deficit). Risks and Uncertainties The Company’s operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. These conditions may not only limit the Company’s access to capital, but also make it difficult for its customers, its vendors and its ability to accurately forecast and plan future business activities. 2. Summary of Significant Accounting Policies – (continued) Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less. Property and Equipment Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table. Asset Description Estimated Useful Life Office equipment and furniture 3 – 5 years Leasehold improvements and fixtures Lesser of estimated useful life or lease term Depreciation and amortization expense was approximately $87,000 and $201,000 for the years ended December 31, 2021 and 2020, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts with any gain or loss reported in the consolidated statement of operations. Repairs and maintenance are charged to expense as incurred. The Company reviews property and equipment for impairment to determine if assets are impaired due to obsolescence. As a result of this review, there was no impairment recognized for the years ended December 31, 2021 and 2020. Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value. Loss per Share Basic net loss per share is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. Net loss attributable to common stockholders for the year ended December 31, 2021 includes the effect of the Series A preferred stock price adjustment of $7.4 million, the accretion of the Series B preferred discount of $1.5 million on converted shares and Series A preferred stock accrued dividends of $0.1 million. Net loss attributable to common stockholders for the year ended December 31, 2020 excludes net loss attributable to non-controlling interest of $0.1 million and includes the accretion of Series B preferred discount of $1.4 million on converted shares, the effect of warrant exercise adjustment of $1.0 million and Series A preferred stock accrued dividends of $0.3 million. The number of shares of common stock underlying Series A Preferred shares convertible to common stock that were excluded from the computation of the net loss per common share for the year ended December 31, 2020 was 678,258. The number of shares of common stock underlying Series B Preferred shares convertible to common stock that was excluded from the computation of net loss per common share and for the year ended December 31, 2020 was 3,454,783. The number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share for the year ended December 31, 2021 were 6,255,275 and 6,344,966, respectively, and for the year ended December 31, 2020 were 3,997,418 and 18,000,713, respectively, because their effect is anti-dilutive. 2. Summary of Significant Accounting Policies – (continued) Research and Development Costs The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related employee costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of our product candidates. Research and development expenses include external contract research organization (“CRO”) services. The Company makes payments to the CROs based on agreed upon terms and may include payments in advance of study services. The Company reviews and accrues CRO expenses based on services performed and relies on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. At December 31, 2021 and 2020, the Company has accrued CRO expenses of $0.7 million, that are included in accrued expenses. The Company has prepaid CRO costs at December 31, 2021 and 2020 of $0.5 million that are included in prepaid expenses. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) 820, Fair Value Measurement ● Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; ● Level 2 inputs: Inputs, other than quoted prices, that are observable either directly or indirectly; and ● Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy. The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these instruments. Cash and cash equivalents include money market accounts of $193,000 and $114,000 as of December 31, 2021 and 2020, respectively, that are measured using Level 1 inputs. The Company uses Monte Carlo simulations to estimate the fair value of the warrants. In using this model, the fair value is determined by applying Level 3 inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the warrant liability and the change in estimated fair value could be materially different. In 2021 and 2020, the Monte Carlo simulations were not used as the value of the warrants was deemed to be minimal based on the historical fair value of the warrants and the Company’s current stock price. 2. Summary of Significant Accounting Policies – (continued) Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using the Black-Scholes option pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the Consolidated Statements of Operations, depending on the nature of the services provided. Derivative Instruments The warrants issued in conjunction with the public offering of the Company’s securities in November 2016 include a provision that if the Company were to enter into a certain transaction, as defined in the warrant agreement, the warrants would be purchased from the holder for cash. The provisions of these warrants preclude equity accounting treatment under ASC 815, Derivatives and Hedging. Income Taxes The Company recognizes deferred tax assets and liabilities based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized. Management assesses the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2021 and 2020, the Company did not record any liabilities for uncertain tax positions. Recent Accounting Pronouncements and Developments In August 2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity (subtopic 815-40) Accounting for Convertible Instruments and Contracts in an Entity's Own Equity In October 2021, the FASB issued Accounting Standards Update 2021-08 that address the accounting for Contract Assets and Liabilities from Contracts with Customers in a business combination (“ASU 2021-08”), with an effective date for SYN of January 1,2 2024 (earlier adoption permitted). ASU 2021-08 provides that existing contract assets and liabilities (including deferred costs to obtain and deferred revenue) are measured in a business combination under the measurement and recognition requirements of ASC 606. ASU 2021-08 should generally “result in an acquirer recognizing and measuring the acquired contract assets and liabilities consistent with how they were recognized and measured in the acquiree’s financial statements.” The Company is currently assessing the impact of ASU 2021-08 on its consolidated financial statements. |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 12 Months Ended |
Dec. 31, 2021 | |
Selected Balance Sheet Information | |
Selected Balance Sheet Information | 3. Selected Balance Sheet Information PREPAID EXPENSES AND OTHER CURRENT ASSETS (in thousands): December 31, December 31, 2021 2020 Prepaid insurance $ 803 $ 639 Prepaid clinical research organizations 458 470 Prepaid consulting, subscriptions and other expenses 272 90 Stock sales receivable — 469 Prepaid manufacturing expenses — 39 Total $ 1,533 $ 1,707 Prepaid CRO expense is classified as a current asset. The Company makes payments to the CROs based on agreed upon terms that include payments in advance of study services. PROPERTY AND EQUIPMENT (in thousands) December 31, December 31, 2021 2020 Computers and office equipment $ 827 $ 813 Leasehold improvements 94 439 Software 11 11 932 1,263 Less: accumulated depreciation and amortization (831) (1,089) Total $ 101 $ 174 ACCRUED EXPENSES (in thousands) December 31, December 31, 2021 2020 Accrued vendor payments $ 1,028 $ 225 Accrued clinical consulting services 696 700 Accrued manufacturing costs 204 — Total $ 1,928 $ 925 ACCRUED EMPLOYEE BENEFITS (in thousands) December 31, December 31, 2021 2020 Accrued bonus expense $ 886 $ 724 Accrued vacation expense 92 144 Total $ 978 $ 868 |
Stock-Based Compensation and Wa
Stock-Based Compensation and Warrants | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation and Warrants | |
Stock-Based Compensation and Warrants | 4. Stock-Based Compensation and Warrants Stock Incentive Plan On March 20, 2007, the Company’s Board of Directors approved the 2007 Stock Incentive Plan (the “2007 Stock Plan”) for the issuance of up to 71,429 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. This plan was approved by the stockholders on November 2, 2007. The exercise price of stock options under the 2007 Stock Plan was determined by the compensation committee of the Board of Directors and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2007 plan shall not exceed 7,143. Options become exercisable over various periods from the date of grant, and generally expire ten years after the grant date. As of December 31, 2021, there were 5,145 options issued and outstanding under the 2007 Stock Plan. There are no shares available to be issued under this plan. On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to 85,714 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. From time to time the number of shares authorized for options was increased such that 4,000,000 million were authorized as of September 30, 2021. The exercise price of stock options under the 2010 Stock Plan is determined by the compensation committee of the Board of Directors and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. Options become exercisable over various periods from the date of grant and expire between five and ten years after the grant date. As of December 31, 2021, there were 2,450,130 options issued and outstanding under the 2010 Stock Plan. There are no shares available to be issued under this plan. On September 17, 2020, the stockholders approved and adopted the 2020 Stock Incentive Plan ("2020 Stock Plan") for the issuance of up to 4,000,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. As of December 31, 2021, there were 3,800,000 options issued and outstanding under the 2010 Stock Plan. In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. Stock forfeitures are recognized as incurred. There is no deferred compensation recorded upon initial grant date. Instead, the fair value of the stock-based payment is recognized over the stated vesting period. The Company has applied fair value accounting for all stock-based payment awards since inception. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option pricing model. The assumptions used for the years ended December 31, 2021 and 2020 are as follows: Year ended December 31, 2021 2020 Exercise price $ 0.33 $ 0.42 Expected dividends 0 % 0 % Expected volatility 92 % 88 % Risk free interest rate 1.12 % 0.31 % Expected life of option (years) 4.3 4.3 Expected dividends — 4. Stock-Based Compensation and Warrants – (continued) Expected volatility Risk-free interest rate Expected life of the option The Company records stock-based compensation based upon the stated vesting provisions in the related agreements. The vesting provisions for these agreements have various terms as follows: ● immediate vesting, ● in full on one-year anniversary date of grant date, ● half vesting immediately and remaining over three years, ● quarterly over three years, ● annually over three years, ● one-third immediate vesting and remaining annually over two years, ● one-half immediate vesting and remaining over nine months, ● one-quarter immediate vesting and remaining over three years, ● one-quarter immediate vesting and remaining over 33 months, ● monthly over one year, and ● monthly over three years. During the years ended December 31, 2021 and 2020, the Company granted 2,260,000 and 1,540,000 options to employees and directors having an approximate fair value of $0.5 million and $0.4 million based upon the Black-Scholes option pricing model, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to employees for the years ended December 31, 2021 and 2020 was $204,000 and $213,000, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the years ended December 31, 2021 and 2020 was $212,000 and $137,000, respectively. 4. Stock-Based Compensation and Warrants – (continued) A summary of stock option activity for the years ended December 31, 2021 and 2020 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2019 2,502,012 $ 3.62 6.51 years $ 153,353 Granted 1,540,000 0.42 Exercised — — Expired (14,944) 17.57 Forfeited (29,650) 0.55 Balance - December 31, 2020 3,997,418 2.35 6.09 years — Granted 2,260,000 0.33 Exercised — — Expired (2,143) 45.15 Forfeited — — Balance -December 31, 2021 - outstanding 6,255,275 $ 1.61 5.58 years $ — Balance - December 31, 2021 - exercisable 2,786,934 $ 3.16 4.44 years $ — Grant date fair value of options granted - December 31, 2021 $ 501,000 Weighted average grant date fair value - December 31, 2021 $ 0.22 Grant date fair value of options granted - December 31, 2020 $ 412,000 Weighted average grant date fair value - December 31, 2020 $ 0.27 The options outstanding and exercisable at December 31, 2021 are as follows: Options Outstanding Options Exercisable Weighted Weighted Weighted Average Weighted Average Average Remaining Average Remaining Range of Exercise Contractual Exercise Contractual Exercise Price Options Price Life Options Price Life $ 0.00 – $40.00 6,189,257 $ 0.75 6 years 2,720,916 $ 1.25 4 years 41.00 – $70.00 6,221 52.07 2 years 6,221 52.07 2 years 71.00 – $102.00 59,797 85.19 2 years 59,797 85.19 2 years As of December 31, 2021, total unrecognized stock-based compensation expense related to stock options was $771,000, which is expected to be expensed through February 2024. The FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from operating activities. Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options. The Company did not record any excess tax benefits in 2021 or 2020. Cash received from option exercises under the Company’s stock-based compensation plans for the years ended December 31, 2021 and 2020 was zero. 4. Stock-Based Compensation and Warrants – (continued) Stock Warrants On October 15, 2018, the Company closed its underwritten public offering pursuant to which it received gross proceeds of approximately $18.6 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company and sold an aggregate of (i) 2,520,000 Class A Units (the “Class A Units”), with each Class A Unit consisting of one share of common stock, and one five-year warrant to purchase one share of common stock at an initial exercise price of $1.38 per share, which subsequently was reduced to $0.69 per share (each a “Warrant” and collectively, the “Warrants”), with each Class A Unit to be offered to the public at a public offering price of $1.15, and (ii) 15,723 Class B Units (the “Class B Units”, and together with the Class A Units, the “Units”), with each Class B Unit offered to the public at a public offering price of $1,000 per Class B Unit and consisting of one share of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), with a stated value of $1,000 and convertible into shares of common stock at the stated value divided by a conversion price of $1.15 per share, with all shares of Series B Preferred Stock convertible into an aggregate of 13,672,173 shares of common stock, and issued with an aggregate of 13,672,173 Warrants. On November 16, 2020, the exercise price of the Warrants was reduced from $1.38 per Warrant per full share of the Company’s common stock, $0.001 par value per share (the “Common Stock”), to $0.69 per Warrant per full share of common stock in accordance with the anti-dilution terms of the Warrant. The reduction was the result of the issuance of shares of common stock by the Company through its “at the market offering” facility. The effect of the change in the exercise price of the warrants as a result of the triggering of the down round protection clause in the Warrants was recorded as a deemed dividend of $0.9 million during the year ended December 31, 2020, which reduces the income available to common stockholders. In addition, pursuant to the underwriting agreement that the Company had entered into with A.G.P./Alliance Global Partners (the “Underwriters”), as representative of the underwriters, the Company granted the Underwriters a 45 day option (the “Over-allotment Option”) to purchase up to an additional 2,428,825 shares of common stock and/or additional Warrants to purchase an additional 2,428,825 shares of common stock. The Underwriters partially exercised the Over-allotment Option by electing to purchase from the Company additional Warrants to purchase 1,807,826 shares of common stock. If, at the time of exercise, there is no effective registration statement registering, or no current prospectus available for, the issuance of the shares of common stock to the holder, then the Warrants may only be exercised through a cashless exercise. No fractional shares of common stock will be issued in connection with the exercise of a Warrant. In lieu of fractional shares, the holder will receive an amount in cash equal to the fractional amount multiplied by the fair market value of any such fractional shares. The Company has concluded that the Warrants are required to be equity classified. The Warrants were valued on the date of grant using Monte Carlo simulations. During the year ended December 31, 2021, 11,655,747 warrants were exercised for cash proceeds of $8.0 million. There were no warrants exercised during the year ended December 31, 2020. On November 18, 2016, the Company completed a public offering of 714,286 shares of common stock in combination with accompanying warrants to purchase an aggregate of 1,428,571 shares of the common stock. The stock and warrants were sold in combination, with two warrants for each share of common stock sold, a Series A warrant and a Series B warrant, each representing the right to purchase one share of common stock. The purchase price for each share of common stock and accompanying warrants was $35.00. The shares of common stock were immediately separable from the warrants and were issued separately. The initial per share exercise price of the Series A warrants is $50.05 and the per share exercise price of the Series B warrants is $60.20, each subject to adjustment as specified in the warrant agreements. The Series A and Series B warrants could be exercised at any time on or after the date of issuance. The Series A warrants were exercisable until the four-year anniversary of the issuance date and expired November 16, 2020. The Series B warrants expired December 31, 2017 and none were exercised prior to expiration. The warrants included a provision, that if the Company were to enter into a certain transaction, as defined in the agreement, the warrants would be purchased from the holder for cash. Accordingly, the Company recorded the warrants as a liability at their estimated fair value on the issuance date of $15.7 million and changes in estimated fair value were recorded as non-cash income or expense in the Company’s Statement of Operations at each subsequent period. At December 31, 2019, the fair value of the warrant liability was $100. The warrants were valued on the date of grant and on each remeasurement period. 4. Stock-Based Compensation and Warrants – (continued) A summary of all warrant activity for the Company for the years ended December 31, 2021 and 2020 is as follows: Number of Weighted Average Warrants Exercise Price Balance at December 31,2019 18,714,999 $ 3.24 Granted — — Exercised — — Forfeited (714,286) 50.05 Balance at December 31,2020 18,000,713 0.69 Granted — — Exercised (11,655,747) — Forfeited — 0.69 Balance at December 31,2021 6,344,966 $ 0.69 On December 26, 2017, the Company entered into a consulting agreement for advisory services for a period of six months. As compensation for such services, the consultant was paid an upfront payment, is paid a monthly fee and on January 24, 2018 was issued a warrant exercisable for 714 shares of the Company’s common stock on the date of issue. The warrant is equity classified and the fair value of the warrant approximated $9,000 and was measured using the Black-Scholes option pricing model. A summary of all outstanding and exercisable warrants as of December 31, 2021 is as follows: Weighted Average Warrants Warrants Remaining Exercise Price Outstanding Exercisable Contractual Life $ 0.69 6,344,252 6,344,252 0.99 years 18.20 714 714 1.78 years $ 0.69 6,344,966 6,344,966 1.78 years |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 5. Stockholders’ Equity Series B Preferred Stock On October 15, 2018, the Company closed its underwritten public offering pursuant to which it received gross proceeds of approximately $18.6 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company and sold an aggregate of (i) 2,520,000 Class A Units, with each Class A Unit offered to the public at a public offering price of $1.15, and (ii) 15,723 Class B Units, with each Class B Unit offered to the public at a public offering price of $1,000 per Class B Unit and consisting of one share of the Company’s Series B Preferred Stock, with a stated value of $1,000 and convertible into shares of common stock at the stated value divided by a conversion price of $1.15 per share, with all shares of Series B Preferred Stock convertible into an aggregate of 13,672,173 shares of common stock, and issued with an aggregate of 13,672,173 October 2018 Warrants. Since the above units are equity instruments, the proceeds were allocated on a relative fair value basis which created the Series B Preferred Stock discount. In addition, pursuant to the Underwriting Agreement that the Company entered into with the Underwriters on October 10, 2018, the Company granted the Underwriters a 45 day option (the “Over-allotment Option”) to purchase up to an additional 2,428,825 shares of common stock and/or additional warrants to purchase an additional 2,428,825 shares of common stock. Each Warrant is exercisable for one share of common stock. The Underwriters partially exercised the Over-allotment Option by electing to purchase from the Company additional Warrants to purchase 1,807,826 shares of common stock. 5. Stockholders’ Equity – (continued) The conversion price of the Series B Preferred Stock and exercise price of the October 2018 Warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the common stock. The exercise price of the Warrants is subject to adjustment in the event of certain dilutive issuances. On November 16, 2020, the exercise price of the Warrants was reduced from $1.38 per Warrant per full share of common stock to $0.69 per Warrant per full share of common stock. The reduction was the result of the issuance of shares of common stock by the Company through its “at the market offering” facility. The effect of the change in the exercise price of the warrants as a result of the triggering of the down round protection clause in the Warrants was recorded as a deemed dividend in accumulated deficit of $0.9 million, which reduces the income available to common stockholders for the year ended December 31, 2020. The October 2018 Warrants are immediately exercisable at a price of $0.69 per share of common stock (which was 120% of the public offering price of the Class A Units) and will expire on October 15, 2023. If, at the time of exercise, there is no effective registration statement registering, or no current prospectus available for, the issuance of the shares of common stock to the holder, then the October 2018 warrants may only be exercised through a cashless exercise. No fractional shares of common stock will be issued in connection with the exercise of any October 2018 warrants. In lieu of fractional shares, the holder will receive an amount in cash equal to the fractional amount multiplied by the fair market value of any such fractional shares. Since the effective conversion price of the Series B Preferred Stock is less than the fair value of the underlying common stock at the date of issuance, there is a beneficial conversion feature (“BCF”) at the issuance date. Because the Series B Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the years ended December 31, 2021 and 2020, 3,973 and 3,665 shares, respectively, were converted resulting in the recognition of deemed dividends of $1.5 million and $1.4 million, respectively, for the amortization of the Series B Preferred Stock discount upon conversion. Series A Preferred Stock On September 11, 2017, the Company entered into a share purchase agreement (the “Purchase Agreement”) with an investor (the “Investor”), pursuant to which the Company offered and sold in a private placement 120,000 shares of its Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”) for an aggregate purchase price of $12 million, or $100 per share. The Series A Preferred Stock ranks senior to the shares of the Company’s common stock, and any other class or series of stock issued by the Company with respect to dividend rights, redemption rights and rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company. Holders of Series A Preferred Stock are entitled to a cumulative dividend at the rate of 2.0% per annum, payable quarterly in arrears, as set forth in the Certificate of Designation of Series A Preferred Stock classifying the Series A Preferred Stock. The Series A Preferred Stock is convertible at the option of the holders at any time into shares of common stock at an initial conversion price of $0.54 per share which was increased to $18.90 after taking into account the 2018 reverse stock split, subject to certain customary anti-dilution adjustments, and was decreased to $1.50 on January 27, 2021, as described below. Any conversion of Series A Preferred Stock may be settled by the Company in shares of common stock only. The holder’s ability to convert the Series A Preferred Stock into common stock is subject to(i) a 19.99% blocker provision to comply with NYSE American Listing Rules, (ii) if so elected by the Investor, a 4.99% blocker provision that will prohibit beneficial ownership of more than 4.99% of the outstanding shares of the Company’s common stock or voting power at any time, and (iii) applicable regulatory restrictions. 5. Stockholders’ Equity – (continued) In the event of any liquidation, dissolution or winding-up of the Company, holders of the Series A Preferred Stock are entitled to a preference on liquidation equal to the greater of (i) an amount per share equal to the stated value plus any accrued and unpaid dividends on such share of Series A Preferred Stock (the “Accreted Value”), and (ii) the amount such holders would receive in such liquidation if they converted their shares of Series A Preferred Stock (based on the Accreted Value and without regard to any conversion limitation) into shares of the common stock immediately prior to any such liquidation, dissolution or winding-up (the greater of (i) and (ii), is referred to as the “Liquidation Value”). Except as otherwise required by law, the holders of Series A Preferred Stock have no voting rights, other than customary protections against adverse amendments and issuance of pari passu On or at any time after (i) the VWAP (as defined in the Certificate of Designation) for at least 20 trading days in any 30 trading day period is greater than $70.00, subject to adjustment in the case of stock split, stock dividends or the like the Company has the right, after providing notice not less than 6 months prior to the redemption date, to redeem, in whole or in part, on a pro rata basis from all holders thereof based on the number of shares of Series A Preferred Stock then held, the outstanding Series A Preferred Stock, for cash, at a redemption price per share of Series A Preferred Stock of $7,875.00, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Convertible Preferred Stock or (ii) the five year anniversary of the issue date, the Company shall have the right to redeem, in whole or in part, on a pro rata basis from all holders thereof based on the number of shares of Series A Convertible Preferred Stock then held, the outstanding Series A Preferred Stock, for cash, at a redemption price per share equal to the Liquidation Value. The Series A Preferred Stock was classified as temporary equity due to the shares being redeemable based on contingent events outside of the Company’s control. Since the effective conversion price of the Series A Preferred Stock is less than the fair value of the underlying common stock at the date of issuance, there is BCF at the issuance date. Because the Series A Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the year ended December 31, 2017, the Company recorded a discount of $6.9 million. Because the Series A Preferred Stock is not currently redeemable, the discount arising from issuance costs was allocated to temporary equity and will not be accreted until such time that redemption becomes probable. The stated dividend rate of 2% per annum is cumulative and the Company accrues the dividend on a quarterly basis (in effect accreting the dividend regardless of declaration because the dividend is cumulative). During the years ended December 31, 2021 and 2020, the Company accrued dividends of $24,000 and $254,000, respectively. On January 27, 2021, the Company filed an amendment to the Certificate of Designation for the Series A Preferred Stock to (i) lower the stated Conversion Price through September 30, 2021 and (ii) remove their change in control put. The Amendment to the Certificate of Designation for the Series A Convertible Preferred Stock (the “Certificate of Amendment”) that was filed with the Secretary of State of the State of Nevada adjusted the conversion price from $18.90 per share to $1.50 per share and removed the redemption upon change of control. The Company received notice from the holder of the Series A Preferred Stock that it was increasing the Maximum Percentage as defined in the “Certificate of Designation” from 4.99% to 9.99%, such increase to be effective 61 days from the date thereof. The holder of the Series A Preferred Stock converted all of its shares of Series A Preferred Stock and there are no remaining shares of the Series A Convertible Preferred stock outstanding. During January and February 2021, the Company issued 8,996,768 shares of its common stock upon the conversion effected on such date by the holder of 120,000 shares of its Series A Convertible Preferred Stock. The fair value of the consideration issued to the holder to induce conversion was accounted for as a deemed dividend and increased net loss available to common shareholders for purposes of calculating loss per share. The Company estimated the fair value of the inducement consideration of $7.4 million and as a result recorded a corresponding deemed dividend of $7.4 million during the year ended December 31, 2021. 5. Stockholders’ Equity – (continued) B. Riley Securities Sales Agreement On August 5, 2016, the Company entered into the B. Riley FBR Sales Agreement with FBR Capital Markets & Co. (now known as B. Riley Securities), which enables the Company to offer and sell shares of the common stock from time to time through B. Riley Securities, Inc. as the Company’s sales agent. Sales of common stock under the B. Riley Securities Sales Agreement are made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act. B. Riley Securities, Inc. is entitled to receive a commission rate of up to 3.0% of gross sales in connection with the sale of the common stock sold on the Company’s behalf. For the year ended December 31, 2020, the Company sold through the B. Riley Securities Sales Agreement an aggregate of 9.3 million shares of common stock and received net proceeds of approximately $3.4 million. On February 9, 2021, the Company entered into an amended and restated sales agreement with B. Riley Securities, Inc. (“B. Riley”) and A.G.P./Alliance Global Partners (“AGP”) in order to include AGP as an additional sales agent for the Company’s “at the market offering” program (the “Amended and Restated Sales Agreement”). During the year ended December 31, 2021, the Company sold through the At Market Issuance Sales Agreement and the Amended and Restated Sales Agreement approximately 78.7 million shares of the Company’s common stock and received net proceeds of approximately $66.0 million. |
Non-controlling Interest
Non-controlling Interest | 12 Months Ended |
Dec. 31, 2021 | |
Non-controlling Interest | |
Non-controlling Interest | 6. Non-controlling Interest On September 5, 2018, the Company entered into an agreement (the ‘Stock Purchase Agreement”) with Cedars-Sinai Medical Center (CSMC) for an investigator-sponsored Phase 2b clinical study of SYN-010 to be co-funded by the Company and CSMC (the “Study”). The Study will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN-010 is designed to reduce methane production by certain microorganisms ( M. smithii In consideration of the support provided by CSMC for the Study, the Company paid $328,000 to support the Study and the Company entered into a Stock Purchase Agreement with CSMC pursuant to which the Company, upon the approval of the Study protocol by the Institutional Review Board (“IRB”) : (i) issued to CSMC 50,000 shares of common stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary SYN Biomics, Inc. (“SYN Biomics”) owned by the Company, such that after such issuance CSMC owned an aggregate of 7,480,000 shares of common stock of SYN Biomics, representing 17% of the issued and outstanding shares of SYN Biomics’ common stock. The services rendered are recorded to research and development expense in proportion with the progress of the study and are based overall on the fair value of the shares ($285,000) as determined at the date of IRB approval. During the years ended December 31, 2021 and 2020, research and development expense recorded related to this transaction approximated $1,000 and $225,000, respectively. The Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of Common Stock, with the rate of exchange based upon the relative contribution of the valuation of SYN Biomics to the public market valuation of the Company at the time of each exchange. The Stock Purchase Agreement also provides for tag-along rights in the event of the sale by the Company of its shares of SYN Biomics. On September 30, 2020, CSMC Medically Associated Science and Technology Program (MAST) formally agreed to discontinue the ongoing Phase 2b investigator-sponsored clinical study of SYN-010 following the results of a planned interim futility analysis. Although it was concluded that SYN-010 was well tolerated, SYN-010 was unlikely to meet its primary endpoint by the time enrollment is completed. 6. Non-controlling Interest – (continued) On November 9, 2020, the Company and its subsidiary, Synthetic Biomics, Inc. and CSMC mutually agreed to terminate the exclusive license agreement dated December 5, 2013 and all amendments thereto and the clinical trial agreement relating to SYN-010. The determination to terminate the SYN-010 license agreement was agreed to following the completion of a planned interim futility analysis of the Phase 2b investigator-sponsored clinical trial of SYN-010. On September 30, 2020, CSMC (the Company’s SYN-010 clinical development partner) informed the Company that it discontinued the ongoing Phase 2b investigator-sponsored clinical study of SYN-010 IBS-C patients. During 2021, CSMC returned its shares of SYN Biomics to the Company. The Company’s interest in SYN Biomics is now 100%. This is reflected in the Consolidated Statements of Equity (Deficit). The Company’s non-controlling interest is accounted for under ASC 810, Consolidation As of December 31, 2020, the accumulated net loss attributable to the non-controlling interest was $2.8 million and includes $73,000 of prior year losses attributable to minority stockholders including the reversal of Dr. Pimentel’s 2015 losses of $505,000 associated with the exchange of his shares of common stock in SYN Biomics for shares of the Company’s common stock. During 2021, the minority stockholder returned its shares of SYN Biomics to the Company for no consideration. The Company’s interest in SYN Biomics is now 100%. |
License, Collaborative and Empl
License, Collaborative and Employment Agreements and Commitments | 12 Months Ended |
Dec. 31, 2021 | |
License, Collaborative and Employment Agreements and Commitments | |
License, Collaborative and Employment Agreements and Commitments | 7. License, Collaborative and Employment Agreements and Commitments License and Collaborative Agreements As described below, the Company has entered into several license and collaborative agreements for the right to use research, technology and patents. Some of these license and collaborative agreements may contain milestones. The specific timing of such milestones cannot be predicted and is dependent on future developments as well as regulatory actions which cannot be predicted with certainty (including actions which may never occur). Further, under the terms of certain licensing agreements, the Company may have the obligation to pay certain milestones contingent upon the achievement of specific levels of sales. Due to the long-range nature of such commercial milestone amounts, they are neither probable at this time nor predictable and consequently are not included in this disclosure. Washington University School of Medicine in St. Louis Clinical Trial Agreement In August 7, 2019, the Company entered into a clinical trial agreement (“CTA”) with Washington University School of Medicine in St. Louis (“Washington University”) to conduct a Phase 1b/2a single-center, randomized, double-blinded, placebo-controlled clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of oral SYN-004 (ribaxamase) in up to 36 adult allogeneic hematopoietic cell transplant (HCT) recipients (the “Study”). Under the terms of the CTA, the Company will serve as the sponsor of the Study and supply SYN-004 (ribaxamase), as well as compensate Washington University for all research services to be provided in connection with the Study which is estimated to cost approximately $3,200,000. The CTA continues in effect until completion of all obligations under the CTA. Either party may terminate the CTA prior to completion of its obligations (i) if authorization of the study is withdrawn by the FDA; (ii) if the emergence of any adverse reaction or side effect with SYN-004 (ribaxamase) administered in the Study is of such magnitude or incidence in the opinion of either party to support termination; or (iii) upon a breach of the terms of the CTA if the breaching party fails to cure the breach within 30 days after receipt of notice. The Company has the right to terminate the CTA (i) effective immediately if Washington University fails to perform the study in accordance with the terms of the protocol, the CTA or applicable laws or regulations or if Washington University or the principal investigator become debarred or (ii) upon 14 days written notice and Washington University has the right to terminate the CTA upon 14 days notice if the principal investigator becomes unable to perform or complete the Study and the parties have not, prior to the expiration of such fourteen (14) day period, agreed to an alternative principal investigator. 7. License, Collaborative and Employment Agreements and Commitments – (continued) Cedars-Sinai Medical Center (“CSMC”) Agreement On December 5, 2013, the Company, through its newly formed, majority owned subsidiary, SYN Biomics, entered into a worldwide exclusive License Agreement with CSMC for the development of new treatment approaches to target non-bacterial intestinal microorganism life forms known as archaea that are associated with intestinal methane production and chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes. As part of the terms of the License Agreement, the Company issued 9,569 unregistered shares of the Company’s common stock to CSMC, paid $150,000 for the initial license fee and $220,000 for patent reimbursement fees. The License Agreement also provides that, commencing on the second anniversary of the License Agreement, SYN Biomics will pay an annual maintenance fee, which payment shall be creditable against annual royalty payments owed under the License Agreement. In addition to royalty payments which are a percentage of net sales of license and technology products, SYN Biomics is obligated to pay CSMC a percentage of any non-royalty sublicense revenues, as well as additional consideration upon the achievement of milestones (the first two of which are payable in cash or unregistered shares of Company stock at the Company’s option). The License Agreement provided for termination: (i) automatically if SYN Biomics enters into a liquidating bankruptcy or other specified bankruptcy event or if the performance of any term, covenant, condition or provision of the License Agreement will jeopardize the licensure of CSMC, its participation in certain reimbursement programs, its full accreditation by the Joint Commission of Accreditation of Healthcare Organizations or any similar state organizations, its tax exempt status or is deemed illegal; (ii) upon 30 days notice from CSMC if SYN Biomics fails to make a payment or use commercially reasonable efforts to exploit the patent rights; (iii) upon 60 days notice from CSMC if SYN Biomics fails to cure any breach or default of any material obligations under the License Agreement; or (iv) upon 90 days notice from SYN Biomics if CSMC fails to cure any breach or default of any material obligations under the License Agreement. SYN Biomics also has the right to terminate the License Agreement without cause upon six months notice to CSMC; however, upon such termination, SYN Biomics is obligated to pay a termination fee with the amount of such fee reduced: (i) if such termination occurs after an Investigational New Drug submission to the FDA but prior to completion of a Phase 2 clinical trial, (ii) reduced further if such termination occurs after completion of Phase 2 clinical trial but prior to completion of a Phase 3 clinical trial; and (iii) reduced to zero if such termination occurs after completion of a Phase 3 clinical trial. On September 5, 2018, the Company entered into an agreement with CSMC for an investigator-sponsored Phase 2 clinical study of SYN-010 to be co-funded by the Company and CSMC (the “Study”). The Study was to provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN-010 is designed to reduce methane production by certain microorganisms ( M. smithii University of Texas Austin Agreement On December 19, 2012, the Company entered into a License Agreement with University of Texas Austin (“UT”) Austin for the exclusive license of the right to use, develop, manufacture, market and commercialize certain research and patents related to pertussis antibodies. The License Agreement provides that UT Austin is entitled to payment of past patent expenses, an annual payment of $50,000 per year commencing on the effective date through December 31, 2014, a $25,000 payment on December 31, 2015 and milestone payments of $50,000 upon commencement of Phase 1 clinical trials, $100,000 upon commencement of Phase 3 clinical trials, $250,000 upon NDA submission in the U.S., $100,000 upon European Medicines Agency approval and $100,000 upon regulatory approval in an Asian country. In addition, UT Austin is entitled to a running royalty upon net sales. The License Agreement terminates upon the expiration of the patent rights; provided, however that the License Agreement is subject to early termination by the Company in its discretion and by UT Austin for a breach of the License Agreement by the Company. 7. License, Collaborative and Employment Agreements and Commitments – (continued) In connection with the License Agreement, the Company and UT Austin also entered into a Sponsored Research Agreement pursuant to which UT Austin will perform certain research work related to pertussis. The Sponsored Research Agreement may be renewed annually, in the sole discretion of the Company, after the first year for two additional one year terms with a fixed fee for the first year of $303,287. The Sponsored Research Agreement was renewed for the second and third years for a fixed fee of $316,438 and $328,758 respectively, all payable in quarterly installments. The Sponsored Research Agreement expires January 17, 2023; provided, however, the Sponsored Research Agreement is subject to early termination upon the written agreement of the parties, a default in the material obligations under the Research Agreement which remain uncured for 60 days after receipt of notice, automatically upon the Company’s bankruptcy or insolvency and by the Company in its sole discretion at any time after the one year anniversary of the date of execution thereof upon no less than 90 days’ notice. Prev ABR LLC (“Prev”) Agreement On November 28, 2012, the Company entered into an agreement (“Prev Agreement”) to acquire the C. diff program assets of Prev, including the pre-Investigational New Drug (IND) package, Phase 1 and Phase 2 clinical data, manufacturing process data and all issued and pending U.S. and international patents. Upon execution and closing of the Prev Agreement, the Company paid Prev cash payments of $235,000 and issued 17,858 unregistered shares of its common stock to Prev. As set forth in the Prev Agreement, Prev may be entitled to receive additional consideration upon the achievement of certain milestones, including: (i) commencement of an IND; (ii) commencement of a Phase 1 clinical trial; (iii) commencement of a Phase 2 clinical trial; (iv) commencement of a Phase 3 clinical trial; (v) filing a Biologic License Application (BLA) in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) approval of a BLA in the U.S. and for territories outside the U.S. With exception of the first milestone payment, the remaining milestones are payable 50% in cash and 50% in our stock, however, at Prev’s option the entire milestone may be payable in shares of the Company’s stock. As of December 31, 2015, the first three milestones have been met, and at Prev’s option, Prev elected to receive 18,724 shares of the Company’s common stock. Currently, assets licensed under this agreement are used in the Company’s Phase 1b/2a Clinical Study in Allogeneic HCT Recipients. No milestones were achieved or such payments were made during the years ended December 31, 2021 and 2020. Employment Agreements On December 6, 2018, the Company entered into a three-year employment agreement with Steven A. Shallcross, (the “Employment Agreement”), to serve as the Chief Executive Officer and to continue to serve as the Chief Financial Officer of the Company. The Employment Agreement has a stated term of three years but may be terminated earlier pursuant to its terms. If Mr. Shallcross’ employment is terminated for any reason, he or his estate as the case may be, will be entitled to receive the accrued base salary, vacation pay, expense reimbursement and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”); provided, however, that if his employment is terminated (i) by the Company without Cause or by Mr. Shallcross for Good Reason (as each is defined in the Employment Agreement) then in addition to paying the Accrued Obligations, (a) the Company will continue to pay his then current base salary and continue to provide benefits at least equal to those that were provided at the time of termination for a period of twelve (12) months and (b) he shall have the right to exercise any vested equity awards until the earlier of six (6) months after termination or the remaining term of the awards; or (ii) by reason of his death or Disability (as defined in the Employment Agreement), then in addition to paying the Accrued Obligations, Mr. Shallcross would have the right to exercise any vested options until the earlier of six (6) months after termination or the remaining term of the awards. In such event, if Mr. Shallcross commenced employment with another employer and becomes eligible to receive medical or other welfare benefits under another employer-provided plan, the medical and other welfare benefits to be provided by the Company as described herein would terminate. On December 30, 2020, the Board of Directors of the Company awarded Steven A. Shallcross (i) a cash bonus equal to 62% of his prior base salary and (ii) an option to purchase 450,000 shares of the Company’s common stock. On December 23, 2020, the Board of the Company awarded Steven A. Shallcross (i) a cash bonus equal to 62.5% of his prior base salary and (ii) an option to purchase 450,000 shares of the Company’s common stock. On December 23, 2021, the Board of Directors of the Company awarded Steven A. Shallcross (i) a cash bonus equal to approximately 62.5% of his current base salary, and (ii) an option to purchase 650,000 shares of the Company’s common stock. 7. License, Collaborative and Employment Agreements and Commitments – (continued) Operating Lease The Company’s existing lease as of December 31, 2021 is classified as an operating lease. As of December 31, 2021, the Company has one operating lease for facilities with a remaining term expiring in 2027. During the quarter ended June 30, 2021, the Company renewed its facility lease by entering into a Second Lease Amendment which extends the lease term for 63 months beginning on September 1, 2022 and ending on December 31, 2027 at stated rental rates and including a 3 month rent abatement. The Second Amendment also has options for a Tenant Improvement Allowance and a Second Extension Term. The Second Amendment also gives the Company the right to expand their space by giving notice to the landlord before December 31, 2021. The Company did not give notice to expand the space during 2021. The Second Extension Term is offered at market rates and there is no economic incentive for the lessee, therefore the Company has determined that it is not part of the original lease term. There is an option in this Second Amendment to Lease for the Company to borrow funds for tenant improvements subject to an 8.5% interest rate. Operating lease costs are presented as part of general and administrative expenses in the condensed consolidated statements of operations, and for the years ended December 31, 2021 and 2020 approximated $280,000 and $209,000, respectively. For the years ended December 31, 2021 and 2020, operating cash flows used for operating leases approximated $321,000 and $309,000, respectively, and the right of use assets exchanged for operating the lease obligation was $1.3 million. The day one non-cash addition of right of use assets due to adoption of ASC 842 was $538,000. A maturity analysis of our operating leases as of December 31, 2021 is as follows (amounts in thousands of dollars) Future undiscounted cash flow for the years ending December 31, 2022 247 2023 327 2024 337 2025 347 2026 357 2027 368 Total 1,983 Discount factor (456) Lease liability 1,527 Lease liability - current (124) Lease liability - long term $ 1,403 Consulting Fees In November 2017, the Company engaged a regulatory consultant to assist in the Company’s efforts to prepare, file and obtain FDA approval for ribaxamase. The term of the engagement is on a monthly basis, provided that either party may terminate the agreement at any time by providing the other party a six-month notice period. The Company was obligated to pay the consultant a monthly retainer in addition to success fee payments of up to an aggregate of $4,500,000 for attainment of certain regulatory milestones. The achievement of the milestones is not probable at this time. Risks and Uncertainties On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of COVID-19 and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. 7. License, Collaborative and Employment Agreements and Commitments – (continued) As COVID-19 continued to spread around the globe, the Company experienced disruptions that impacted its business and clinical trials, including the postponement of clinical site initiation of the Phase 1b/2a clinical trial of SYN-004. The extent to which the COVID-19 pandemic impacts the Company’s business, the clinical development of SYN-004 (ribaxamase) and SYN-020, the business of the Company’s suppliers and other commercial partners, the Company’s corporate development objectives and the value of and market for the Company’s common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, especially in light of the new variants, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company's business, financial condition, results of operations and growth prospects. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties which the Company faces. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | 8. Income Taxes There was no income tax expense for the years ended December 31, 2021 and 2020 due to the Company’s net losses. The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2021 and 2020. For 2021, the “expected” tax expense is computed by applying the Federal corporate statutory tax rate of 21% and a net, after Federal benefit state tax rate of 6.46% (state blended rate was 8.18%) to loss before taxes. For 2020, the “expected” tax expense is computed by applying the Federal corporate statutory tax rate of 21% and a net, after Federal benefit state tax rate of 6.45% (state blended rate was 8.17.%) to loss before taxes. These results are as follows (in thousands): 2021 2020 Computed “expected” tax-benefit - Federal $ (3,045) $ (2,124) Computed “expected” tax-benefit - State (931) (616) Adjustment of “expected” tax-benefit to actual — — Meals, entertainment and other — — Non-deductible stock-based compensation 32 32 State Tax Rate Adjustment 932 (1,221) Federal and state NOL Adjustment — — Change in valuation allowance 3,012 3,929 $ — $ — The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2021 and 2020 are as follows ( in thousands 2021 2020 Deferred tax assets: Stock issued for services $ 1,504 $ 1,428 Accrued compensation 27 42 Stock issued for acquisition of program 1,462 1,436 Stock issued for license agreement 1,363 1,574 Stock issued for milestone payment 236 262 Amortizable License Fee 4 5 Net operating loss carry-forward 16,884 12,540 Total gross deferred tax assets 21,480 17,287 Less: valuation allowance (21,480) (17,287) Total net deferred tax assets $ — $ — 8. Income Taxes – (continued) At December 31, 2021, the Company has a gross Federal net operating loss carry-forward of approximately $58.3 million available to offset future taxable income. The Company’s pre-2018 net operating losses expire on various dates through 2037. In addition, it was determined that the utilization of gross Federal net operating losses of approximately $198.8 million was limited by $155.6 million. due to change of control ownership changes that occurred under Section 382 of the Internal Revenue Code. State NOL’s are also limited by Section 382 of the Internal Revenue Code and were limited accordingly. In 2020, the Company completed an Internal Revenue Code Section 382 analysis of its historical net operating loss carry-forward amount. As a result, the prior year net operating loss carry-forward of $188.6 million was limited by $155.6 million. The decrease in the prior year net operating loss is attributable to change of control ownership shifts which were determined for the years 2013 and 2018 which caused the reduction in the value of the historical net operating loss carry-forward amounts. An updated section 382 analysis was performed in 2021 to identify if any additional ownership shifts occurred in the current year. It was determined that an ownership shift occurred on January 20, 2021. The result of the updated 2021 analysis produced an IRC 382 limit due to the 2021 ownership shift. However, all previously limited net operating losses remain available for use in future periods. The Company’s pre-2018 net operating losses expire on various dates through 2037 while the net operating loss carry-forward originating in the 2018 year and later carry-forward indefinitely and are subject to additional limitations based on taxable income. In December 2019, the FASB issued ASU 20109-12, “Income Taxes Topic 740-Simplifying the Accounting for Income Taxes” (“ASU 2019-12”), which intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application of Topic 740. This guidance is effective for fiscal years beginning after December 15, 2020, including interim periods therein, and early adoption is permitted. The Company adopted ASU 2019-12 in the current period. The valuation allowance at December 31, 2021 was approximately $21.5 million. The net change in valuation allowance during the year ended December 31, 2021, was an increase of approximately $4.2 million primarily due to increases in gross federal and state deferred tax assets in 2021. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on consideration of these items, management has determined that enough uncertainty exists relative to the realization of the deferred income tax asset balances to warrant the application of a full valuation allowance as of December 31, 2021. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events | |
Subsequent Events | 9. Subsequent Events On January 3, 2022, the Company entered into a three-year employment agreement with Steven A. Shallcross (the “Employment Agreement”), who has served as the Company’s Chief Executive Officer since December 6, 2018 and as the Company’s Chief Financial Officer since June 1, 2015, to continue to serve as the Chief Executive Officer and Chief Financial Officer of the Company. The Employment Agreement replaced the prior employment agreement with the Company that Mr. Shallcross entered into on December 6, 2018, as amended December 5, 2019. Pursuant to the Employment Agreement, Mr. Shallcross is entitled to an annual base salary of $585,000 and an annual cash performance bonus of up to fifty percent (50%) of his annual base salary as well as discretionary annual equity awards pursuant to the Company’s incentive plans. The annual bonus will be based upon the assessment of the Board of Mr. Shallcross’s performance. The Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Shallcross and non-solicitation and non-competition provisions. On March 10, 2022, the Company completed the acquisition of all the outstanding shares of VCN (the “VCN Shares”) from the shareholders of VCN. VCN is a private, clinical-stage biopharmaceutical company developing new oncolytic adenoviruses for the treatment of cancer. VCN’s lead product candidate, VCN-01, is being studied in clinical trials for pancreatic cancer and retinoblastoma. VCN-01 is designed to be administered systemically, intratumorally or intravitreally, either as a monotherapy or in combination with standard of care, to treat a wide variety of cancer indications. VCN-01 is designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment, Degrading the tumor stroma has been shown to improve access to the tumor by the virus and additional therapies such as chemo- and immuno-therapies. Importantly, degrading the stroma exposes tumor antigens, turning “cold” tumors “hot” and enabling a sustained anti-tumor immune response. VCN has the rights to four exclusive patents for proprietary technologies, as well as technologies developed in collaboration with the Virotherapy Group of the Catalan Institute of Oncology (ICO-IDIBELL), with a number of additional patents pending. As consideration for the purchase of the VCN Shares, the Comany paid $4,700,000 to Grifols Innovation and New Technologies Limited the owner of approximately 86% of the equity of VCN, and issued to the remaining sellers and certain key employees and consultants of VCN the closing Shares, representing 19.99% of the outstanding shares of the Company’s common stock on December 14, 2021, the date of the Purchase Agreement. In addition to the consideration described above, under the terms of the Purchase Agreement, the Company assumed up to $2,400,000 of existing liabilities of VCN and has agreed to make cash payments to Grifols upon the achievement of certain clinical and commercialization milestones, as described below. In connection with the Acquisition, prior to the closing the Company loaned VCN $425,000 to help finance the costs of certain of VCN’s research and development activities and, at the Closing, VCN and Grifols entered into a sublease agreement for the sublease by VCN of the laboratory and office space currently occupied by it as well as a transitional services agreement. As a Purchase Agreement post-Closing covenant, Synthetic has agreed to commit to fund VCN’s research and development programs, including but not limited to VCN01 PDAC phase 2 trial, VCN01 RB pivotal trial and necessary G&A within a budgetary plan of approximately $27.8 million. Milestone Payments US$3MM upon VCN-01 US IND Safe to Proceed pancreatic ductal adenocarcinoma (“PDAC”, or other first indication) US$2.75MM upon VCN-01 US IND Safe to Proceed – retinoblastoma (“RB”, or other second indication) US$3.25MM upon VCN-01 US first patient dosed– PDAC (or other first indication) after receipt of VCN-01 US IND Safe to Proceed for PDAC being informed US$3.25MM upon VCN-01 US first patient dosed – RB (or other second indication) after receipt of VCN-01 US IND Safe to Proceed for RB being informed US$6MM upon VCN-01 US Phase 2 trial meets the primary endpoint or if a Phase 2 trial is not conducted and only a Phase 3 trial is conducted then upon a Phase 3 being initiated – PDAC (or other first indication) US$8MM upon VCN-01 Pivotal Trial meeting the primary endpoint or upon BLA Submission – RB (or other second indication) US$12MM upon VCN-01 US Phase 3 trial meeting the primary endpoint or upon BLA Submission – PDAC (or other first indication) US$16MM upon VCN-01 BLA Approval – PDAC (or other first indication) US$16MM upon VCN-01 BLA Approval – RB (or other second indication) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Principles of Consolidation | Principles of Consolidation All intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the estimated useful lives for property and equipment, fair value of warrants, preferred stock and stock options granted for services or compensation, respectively, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses. Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates. |
Non-controlling Interest | Non-controlling Interest The Company’s non-controlling interest represents the minority stockholder’s ownership interest related to the Company’s subsidiary, SYN Biomics. The Company reports its non-controlling interest in subsidiaries as a separate component of equity in the Consolidated Balance Sheets and reports both net loss attributable to the non-controlling interest and net loss attributable to the Company’s common stockholders on the face of the Consolidated Statements of Operations. On September 5, 2018, the Company entered into an agreement with the minority stockholder for an investigator-sponsored Phase 2 clinical study of SYN-010. Prior to this agreement and IRB approval in December 2018, the Company’s equity interest in SYN Biomics was 88.5% and the non-controlling stockholder’s interest was 11.5%. In consideration of the support, the Company issued additional shares of stock to the minority stockholder, resulting in the Company’s equity interest in SYN Biomics being 83.0% and the non-controlling stockholder’s interest is 17.0%. During 2021, the minority stockholder returned its shares of SYN Bionics to the Company for no consideration. The Company's interest in SYN Biomics is now 100%. This is reflected in the Consolidated Statements of Equity (Deficit). |
Risks and Uncertainties | Risks and Uncertainties The Company’s operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. These conditions may not only limit the Company’s access to capital, but also make it difficult for its customers, its vendors and its ability to accurately forecast and plan future business activities. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less. |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table. Asset Description Estimated Useful Life Office equipment and furniture 3 – 5 years Leasehold improvements and fixtures Lesser of estimated useful life or lease term Depreciation and amortization expense was approximately $87,000 and $201,000 for the years ended December 31, 2021 and 2020, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts with any gain or loss reported in the consolidated statement of operations. Repairs and maintenance are charged to expense as incurred. The Company reviews property and equipment for impairment to determine if assets are impaired due to obsolescence. As a result of this review, there was no impairment recognized for the years ended December 31, 2021 and 2020. |
Long-Lived Assets | Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value. |
Loss per Share | Loss per Share Basic net loss per share is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. Net loss attributable to common stockholders for the year ended December 31, 2021 includes the effect of the Series A preferred stock price adjustment of $7.4 million, the accretion of the Series B preferred discount of $1.5 million on converted shares and Series A preferred stock accrued dividends of $0.1 million. Net loss attributable to common stockholders for the year ended December 31, 2020 excludes net loss attributable to non-controlling interest of $0.1 million and includes the accretion of Series B preferred discount of $1.4 million on converted shares, the effect of warrant exercise adjustment of $1.0 million and Series A preferred stock accrued dividends of $0.3 million. The number of shares of common stock underlying Series A Preferred shares convertible to common stock that were excluded from the computation of the net loss per common share for the year ended December 31, 2020 was 678,258. The number of shares of common stock underlying Series B Preferred shares convertible to common stock that was excluded from the computation of net loss per common share and for the year ended December 31, 2020 was 3,454,783. The number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share for the year ended December 31, 2021 were 6,255,275 and 6,344,966, respectively, and for the year ended December 31, 2020 were 3,997,418 and 18,000,713, respectively, because their effect is anti-dilutive. |
Research and Development Costs | Research and Development Costs The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related employee costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of our product candidates. Research and development expenses include external contract research organization (“CRO”) services. The Company makes payments to the CROs based on agreed upon terms and may include payments in advance of study services. The Company reviews and accrues CRO expenses based on services performed and relies on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. At December 31, 2021 and 2020, the Company has accrued CRO expenses of $0.7 million, that are included in accrued expenses. The Company has prepaid CRO costs at December 31, 2021 and 2020 of $0.5 million that are included in prepaid expenses. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) 820, Fair Value Measurement ● Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; ● Level 2 inputs: Inputs, other than quoted prices, that are observable either directly or indirectly; and ● Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy. The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these instruments. Cash and cash equivalents include money market accounts of $193,000 and $114,000 as of December 31, 2021 and 2020, respectively, that are measured using Level 1 inputs. The Company uses Monte Carlo simulations to estimate the fair value of the warrants. In using this model, the fair value is determined by applying Level 3 inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the warrant liability and the change in estimated fair value could be materially different. In 2021 and 2020, the Monte Carlo simulations were not used as the value of the warrants was deemed to be minimal based on the historical fair value of the warrants and the Company’s current stock price. |
Stock-Based Payment Arrangements | Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using the Black-Scholes option pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the Consolidated Statements of Operations, depending on the nature of the services provided. |
Derivative Instruments | Derivative Instruments The warrants issued in conjunction with the public offering of the Company’s securities in November 2016 include a provision that if the Company were to enter into a certain transaction, as defined in the warrant agreement, the warrants would be purchased from the holder for cash. The provisions of these warrants preclude equity accounting treatment under ASC 815, Derivatives and Hedging. |
Income Taxes | Income Taxes The Company recognizes deferred tax assets and liabilities based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized. Management assesses the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2021 and 2020, the Company did not record any liabilities for uncertain tax positions. |
Recent Accounting Pronouncements and Developments | Recent Accounting Pronouncements and Developments In August 2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity (subtopic 815-40) Accounting for Convertible Instruments and Contracts in an Entity's Own Equity In October 2021, the FASB issued Accounting Standards Update 2021-08 that address the accounting for Contract Assets and Liabilities from Contracts with Customers in a business combination (“ASU 2021-08”), with an effective date for SYN of January 1,2 2024 (earlier adoption permitted). ASU 2021-08 provides that existing contract assets and liabilities (including deferred costs to obtain and deferred revenue) are measured in a business combination under the measurement and recognition requirements of ASC 606. ASU 2021-08 should generally “result in an acquirer recognizing and measuring the acquired contract assets and liabilities consistent with how they were recognized and measured in the acquiree’s financial statements.” The Company is currently assessing the impact of ASU 2021-08 on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Schedule of Estimated Useful Life | Asset Description Estimated Useful Life Office equipment and furniture 3 – 5 years Leasehold improvements and fixtures Lesser of estimated useful life or lease term |
Selected Balance Sheet Inform_2
Selected Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Selected Balance Sheet Information | |
Schedule of prepaid expenses and other current assets | PREPAID EXPENSES AND OTHER CURRENT ASSETS (in thousands): December 31, December 31, 2021 2020 Prepaid insurance $ 803 $ 639 Prepaid clinical research organizations 458 470 Prepaid consulting, subscriptions and other expenses 272 90 Stock sales receivable — 469 Prepaid manufacturing expenses — 39 Total $ 1,533 $ 1,707 |
Schedule of property, plant and equipment, net | PROPERTY AND EQUIPMENT (in thousands) December 31, December 31, 2021 2020 Computers and office equipment $ 827 $ 813 Leasehold improvements 94 439 Software 11 11 932 1,263 Less: accumulated depreciation and amortization (831) (1,089) Total $ 101 $ 174 |
Schedule of accrued expenses | ACCRUED EXPENSES (in thousands) December 31, December 31, 2021 2020 Accrued vendor payments $ 1,028 $ 225 Accrued clinical consulting services 696 700 Accrued manufacturing costs 204 — Total $ 1,928 $ 925 |
Schedule of accrued employee benefits | ACCRUED EMPLOYEE BENEFITS (in thousands) December 31, December 31, 2021 2020 Accrued bonus expense $ 886 $ 724 Accrued vacation expense 92 144 Total $ 978 $ 868 |
Stock-Based Compensation and _2
Stock-Based Compensation and Warrants (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation and Warrants | |
Schedule of assumptions used for awards | Year ended December 31, 2021 2020 Exercise price $ 0.33 $ 0.42 Expected dividends 0 % 0 % Expected volatility 92 % 88 % Risk free interest rate 1.12 % 0.31 % Expected life of option (years) 4.3 4.3 |
Summary of stock option activity | A summary of stock option activity for the years ended December 31, 2021 and 2020 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2019 2,502,012 $ 3.62 6.51 years $ 153,353 Granted 1,540,000 0.42 Exercised — — Expired (14,944) 17.57 Forfeited (29,650) 0.55 Balance - December 31, 2020 3,997,418 2.35 6.09 years — Granted 2,260,000 0.33 Exercised — — Expired (2,143) 45.15 Forfeited — — Balance -December 31, 2021 - outstanding 6,255,275 $ 1.61 5.58 years $ — Balance - December 31, 2021 - exercisable 2,786,934 $ 3.16 4.44 years $ — Grant date fair value of options granted - December 31, 2021 $ 501,000 Weighted average grant date fair value - December 31, 2021 $ 0.22 Grant date fair value of options granted - December 31, 2020 $ 412,000 Weighted average grant date fair value - December 31, 2020 $ 0.27 |
Schedule of options outstanding and exercisable | The options outstanding and exercisable at December 31, 2021 are as follows: Options Outstanding Options Exercisable Weighted Weighted Weighted Average Weighted Average Average Remaining Average Remaining Range of Exercise Contractual Exercise Contractual Exercise Price Options Price Life Options Price Life $ 0.00 – $40.00 6,189,257 $ 0.75 6 years 2,720,916 $ 1.25 4 years 41.00 – $70.00 6,221 52.07 2 years 6,221 52.07 2 years 71.00 – $102.00 59,797 85.19 2 years 59,797 85.19 2 years |
Summary of all warrant activity | A summary of all warrant activity for the Company for the years ended December 31, 2021 and 2020 is as follows: Number of Weighted Average Warrants Exercise Price Balance at December 31,2019 18,714,999 $ 3.24 Granted — — Exercised — — Forfeited (714,286) 50.05 Balance at December 31,2020 18,000,713 0.69 Granted — — Exercised (11,655,747) — Forfeited — 0.69 Balance at December 31,2021 6,344,966 $ 0.69 |
Summary of all outstanding and exercisable warrants | Weighted Average Warrants Warrants Remaining Exercise Price Outstanding Exercisable Contractual Life $ 0.69 6,344,252 6,344,252 0.99 years 18.20 714 714 1.78 years $ 0.69 6,344,966 6,344,966 1.78 years |
License, Collaborative and Em_2
License, Collaborative and Employment Agreements and Commitments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
License, Collaborative and Employment Agreements and Commitments | |
Schedule of maturity analysis of operating leases | A maturity analysis of our operating leases as of December 31, 2021 is as follows (amounts in thousands of dollars) Future undiscounted cash flow for the years ending December 31, 2022 247 2023 327 2024 337 2025 347 2026 357 2027 368 Total 1,983 Discount factor (456) Lease liability 1,527 Lease liability - current (124) Lease liability - long term $ 1,403 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of Components of Income Tax Expense (Benefit) | The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2021 and 2020. For 2021, the “expected” tax expense is computed by applying the Federal corporate statutory tax rate of 21% and a net, after Federal benefit state tax rate of 6.46% (state blended rate was 8.18%) to loss before taxes. For 2020, the “expected” tax expense is computed by applying the Federal corporate statutory tax rate of 21% and a net, after Federal benefit state tax rate of 6.45% (state blended rate was 8.17.%) to loss before taxes. These results are as follows (in thousands): 2021 2020 Computed “expected” tax-benefit - Federal $ (3,045) $ (2,124) Computed “expected” tax-benefit - State (931) (616) Adjustment of “expected” tax-benefit to actual — — Meals, entertainment and other — — Non-deductible stock-based compensation 32 32 State Tax Rate Adjustment 932 (1,221) Federal and state NOL Adjustment — — Change in valuation allowance 3,012 3,929 $ — $ — |
Schedule of Deferred Tax Assets and Liabilities | The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2021 and 2020 are as follows ( in thousands 2021 2020 Deferred tax assets: Stock issued for services $ 1,504 $ 1,428 Accrued compensation 27 42 Stock issued for acquisition of program 1,462 1,436 Stock issued for license agreement 1,363 1,574 Stock issued for milestone payment 236 262 Amortizable License Fee 4 5 Net operating loss carry-forward 16,884 12,540 Total gross deferred tax assets 21,480 17,287 Less: valuation allowance (21,480) (17,287) Total net deferred tax assets $ — $ — |
Organization, Nature of Opera_2
Organization, Nature of Operations and Basis of Presentation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Organization, Nature of Operations and Basis of Presentation | ||
Cash and cash equivalents | $ 67,325,000 | $ 6,227,000 |
Proceeds from issuance ATM offering, net of issuance costs | 66,000,000 | |
Cash proceeds from exercise of warrants | $ 8,042,000 | $ 0 |
Number of Operating Segments | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Property and equipment (Details) - Office Equipment And Furniture | 12 Months Ended |
Dec. 31, 2021 | |
Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | Nov. 16, 2020 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Sep. 05, 2018 |
Summary of Significant Accounting Policies [Line Items] | ||||||
Depreciation, Depletion and Amortization | $ 87,000 | $ 201,000 | ||||
Cash and Cash Equivalents, at Carrying Value. | $ 6,227,000 | $ 67,325,000 | 6,227,000 | |||
Equity Method Investment, Ownership Percentage | 83.00% | |||||
Accrued Liabilities | $ 700,000 | |||||
Prepaid Expense | 500,000 | 500,000 | 500,000 | |||
Effect of Warrant exercise price adjustment | 900,000 | 0 | 880,000 | |||
Net Loss Attributable to Non-controlling Interest | $ (1,000) | $ (73,000) | ||||
Preferred Stock Shares Converted | 1.38 | 3,973 | 3,665 | |||
Right of use asset | 279,000 | $ 1,383,000 | $ 279,000 | |||
Operating Lease Liability | 287,000 | 124,000 | 287,000 | |||
Preferred stock price adjustment | 7,402,000 | $ 0 | ||||
Series A and Series B Preferred Stock [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Net Loss Attributable to Non-controlling Interest | 100,000 | |||||
Series B Preferred Stock [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,454,783 | |||||
Preferred stock accrued dividends | 1,496,000 | $ 1,380,000 | ||||
Accretion of preferred discount | $ 900,000 | 1,400,000 | 1,500,000 | $ 1,400,000 | ||
Series A Preferred Stock [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 678,258 | |||||
Preferred stock accrued dividends | 24,000 | $ 254,000 | ||||
Effect of Warrant exercise price adjustment | 1,000,000 | |||||
Accretion of Preferred Stock Deemed Dividend | 300,000 | |||||
Accretion of preferred discount | 100,000 | $ 6,900,000 | ||||
Preferred stock price adjustment | $ 7,402,000 | $ 0 | ||||
Warrant [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,344,966 | 18,000,713 | ||||
Options [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,255,275 | 3,997,418 | ||||
Money Market Accounts [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Cash and Cash Equivalents, at Carrying Value. | $ 114,000,000 | $ 193,000,000 | $ 114,000,000 | |||
SYN Biomics [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Equity Method Investment, Ownership Percentage | 100.00% | 88.50% | ||||
Noncontrolling Interest, Ownership Percentage by Parent | 11.50% | |||||
Net Loss Attributable to Non-controlling Interest | $ 2,800,000 |
Selected Balance Sheet Inform_3
Selected Balance Sheet Information - Schedule of PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Selected Balance Sheet Information | ||
Prepaid insurance | $ 803 | $ 639 |
Prepaid clinical research organizations | 458 | 470 |
Prepaid consulting, subscriptions and other expenses | 272 | 90 |
Stock sales receivable | 0 | 469 |
Prepaid manufacturing expenses | 0 | 39 |
Total | $ 1,533 | $ 1,707 |
Selected Balance Sheet Inform_4
Selected Balance Sheet Information - Schedule of PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | $ 932 | $ 1,263 |
Less: accumulated depreciation and amortization | (831) | (1,089) |
Total | 101 | 174 |
Computers and office equipment | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 827 | 813 |
Leasehold improvements | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 94 | 439 |
Software | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | $ 11 | $ 11 |
Selected Balance Sheet Inform_5
Selected Balance Sheet Information - Schedule of ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Selected Balance Sheet Information | ||
Accrued vendor payments | $ 1,028 | $ 225 |
Accrued clinical consulting services | 696 | 700 |
Accrued manufacturing costs | 204 | |
Total | $ 1,928 | $ 925 |
Selected Balance Sheet Inform_6
Selected Balance Sheet Information - Schedule of ACCRUED EMPLOYEE BENEFITS (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Selected Balance Sheet Information | ||
Accrued bonus expense | $ 886 | $ 724 |
Accrued vacation expense | 92 | 144 |
Total | $ 978 | $ 868 |
Stock-Based Compensation and _3
Stock-Based Compensation and Warrants - (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-Based Compensation and Warrants | ||
Exercise price | $ 0.33 | $ 0.42 |
Expected dividends | 0.00% | 0.00% |
Expected volatility | 92.00% | 88.00% |
Risk -free interest rate | 1.12% | 0.31% |
Expected life of option | 4 years 3 months 18 days | 4 years 3 months 18 days |
Stock-Based Compensation and _4
Stock-Based Compensation and Warrants - Summary of stock option activity (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, Exercised | 0 | ||
Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, Beginning Balance | 3,997,418 | 2,502,012 | |
Options, Granted | 2,260,000 | 1,540,000 | |
Options, Expired | (2,143) | (14,944) | |
Options, Forfeited | (29,650) | ||
Options, Ending Balance | 6,255,275 | 3,997,418 | 2,502,012 |
Options, Exercisable | 2,786,934 | ||
Weighted Average Exercise Price, Beginning Balance | $ 2.35 | $ 3.62 | |
Weighted Average Exercise Price, Granted | 0.33 | 0.42 | |
Weighted Average Exercise Price, Expired | 45.15 | 17.57 | |
Weighted Average Exercise Price, Forfeited | 0.55 | ||
Weighted Average Exercise Price, Ending Balance | 1.61 | $ 2.35 | $ 3.62 |
Weighted Average Exercise Price, Exercisable | $ 3.16 | ||
Weighted Average Remaining Contractual Life, Balance Outstanding | 5 years 6 months 29 days | 6 years 1 month 2 days | 6 years 6 months 3 days |
Weighted Average Remaining Contractual Life, Exercisable | 4 years 5 months 8 days | ||
Aggregate Intrinsic Value, Ending Balance | $ 0 | $ 0 | $ 153,353 |
Aggregate Intrinsic Value, Exercisable | 0 | ||
Grant date fair value of options granted | $ 501,000 | $ 412,000 | |
Exercise price of options granted | $ 0.22 | $ 0.27 |
Stock-Based Compensation and _5
Stock-Based Compensation and Warrants - Options outstanding and exercisable (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Range of Exercise Price 0.00-40.00 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price Lower | $ 0 |
Options Outstanding, Range of Exercise Price Upper | $ 40 |
Options Outstanding, Options | shares | 6,189,257 |
Options Outstanding, Weighted Average Exercise Price | $ 0.75 |
Options Outstanding, Weighted Average Remaining Contractual Life | 6 years |
Options Exercisable, Options | shares | 2,720,916 |
Options Exercisable, Weighted Average Exercise Price | $ 1.25 |
Options Exercisable, Weighted Average Remaining Contractual Life | 4 years |
Range of Exercise Price 41.00-70.00 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price Lower | $ 41 |
Options Outstanding, Range of Exercise Price Upper | $ 70 |
Options Outstanding, Options | shares | 6,221 |
Options Outstanding, Weighted Average Exercise Price | $ 52.07 |
Options Outstanding, Weighted Average Remaining Contractual Life | 2 years |
Options Exercisable, Options | shares | 6,221 |
Options Exercisable, Weighted Average Exercise Price | $ 52.07 |
Options Exercisable, Weighted Average Remaining Contractual Life | 2 years |
Range Of Exercise Price 71.09-102.00 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Range of Exercise Price Lower | $ 71 |
Options Outstanding, Range of Exercise Price Upper | $ 102 |
Options Outstanding, Options | shares | 59,797 |
Options Outstanding, Weighted Average Exercise Price | $ 85.19 |
Options Outstanding, Weighted Average Remaining Contractual Life | 2 years |
Options Exercisable, Options | shares | 59,797 |
Options Exercisable, Weighted Average Exercise Price | $ 85.19 |
Options Exercisable, Weighted Average Remaining Contractual Life | 2 years |
Stock-Based Compensation and _6
Stock-Based Compensation and Warrants - Stock incentive plan and other information (Details) - USD ($) | Nov. 18, 2016 | Sep. 30, 2021 | Mar. 20, 2007 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 16, 2020 | Sep. 17, 2020 | Dec. 31, 2019 | Oct. 15, 2018 | Dec. 26, 2017 | Nov. 08, 2016 | Nov. 02, 2010 |
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 771,000 | |||||||||||
Proceeds from Stock Options Exercised | 0 | $ 0 | ||||||||||
Exercise price per warrant | $ 1.38 | $ 1.38 | ||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 9,000 | |||||||||||
IPO [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Stock Issued During Period, Shares, New Issues | 714,286 | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,428,571 | |||||||||||
Shares Issued, Price Per Share | $ 35 | |||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 15,700,000 | $ 100,000,000 | ||||||||||
Series B Warrants [Member] | IPO [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Exercise price per warrant | $ 60.20 | |||||||||||
General and Administrative Expenses and Research and Development Expense [Member] | Employees [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Allocated Share-based Compensation Expense | $ 204,000 | $ 213,000 | ||||||||||
Employees And Directors [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 2,260,000 | 1,540,000 | ||||||||||
Consultant [Member] | General and Administrative Expenses and Research and Development Expense [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Allocated Share-based Compensation Expense | $ 212,000 | $ 137,000 | ||||||||||
Employees | General and Administrative Expenses and Research and Development Expense [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Allocated Share-based Compensation Expense | $ 500,000 | $ 400,000 | ||||||||||
2007 Stock Plan [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 71,429 | 5,145 | ||||||||||
2007 Stock Plan [Member] | Maximum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 7,143 | |||||||||||
2010 Stock Plan [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 3,800,000 | 85,714 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of shares authorized | 4,000,000,000,000 | |||||||||||
2010 Stock Plan [Member] | Board of Directors [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 2,450,130 | |||||||||||
2020 Stock Plan [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 4,000,000 |
Stock-Based Compensation and _7
Stock-Based Compensation and Warrants - Stock Warrants (Details) | Nov. 16, 2020USD ($)$ / sharesshares | Oct. 15, 2018USD ($)$ / sharesshares | Oct. 10, 2018shares | Nov. 18, 2016item$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Oct. 31, 2018$ / shares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Dec. 26, 2017USD ($)shares | Nov. 08, 2016shares |
Equity, Class of Treasury Stock | |||||||||||
Proceeds from "at the market" stock issuance | $ | $ 18,600,000 | ||||||||||
Exercise price per warrant | $ / shares | $ 1.38 | $ 1.38 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 1,000 | $ 1,000 | $ 1,000 | |||||||
Effect of Warrant exercise price adjustment | $ | $ 900,000 | $ 0 | $ 880,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 0 | ||||||||||
Cash proceeds from exercise of warrants | $ | $ 8,042,000 | 0 | |||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ | $ 9,000 | ||||||||||
Proceeds from Issuance of Common Stock | $ | 65,960,000 | $ 3,359,000 | |||||||||
Proceeds From Warrants Exercised | $ | $ 8,000,000 | ||||||||||
Warrants Exercised | 0 | ||||||||||
Series B Preferred Stock [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Exercise price per warrant | $ / shares | $ 0.69 | ||||||||||
Shares Issued, Price Per Share | $ / shares | 1.15 | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 1,000 | ||||||||||
Stock Issued During Period, Value, Issued for Services | $ | $ 1,000 | ||||||||||
Preferred Stock Conversion Price Per Share | $ / shares | $ 1.15 | ||||||||||
Conversion of Stock, Shares Converted | 13,672,173 | ||||||||||
Percentage of issue of the public offering | 120.00% | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 0 | ||||||||||
Common Class A [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Stock Issued During Period, Shares, New Issues | 2,520,000 | ||||||||||
Shares Issued, Price Per Share | $ / shares | $ 1.15 | ||||||||||
Common Class B [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Stock Issued During Period, Shares, New Issues | 15,723 | ||||||||||
Series A Warrants [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Number of Share sold | item | 2 | ||||||||||
Series B Warrants [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Number of Shares purchase | item | 1 | ||||||||||
IPO [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Stock Issued During Period, Shares, New Issues | 714,286 | ||||||||||
Shares Issued, Price Per Share | $ / shares | $ 35 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,428,571 | ||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ | $ 15,700,000 | $ 100,000,000 | |||||||||
IPO [Member] | Series B Warrants [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Exercise price per warrant | $ / shares | 60.20 | ||||||||||
Over-Allotment Option [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Stock Issued During Period, Shares, New Issues | 2,428,825 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,428,825 | ||||||||||
Issue of warrants to purchase common stock | 1,807,826 | ||||||||||
Over-Allotment Option [Member] | Series B Preferred Stock [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Stock Issued During Period, Shares, New Issues | 2,428,825 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,428,825 | ||||||||||
Issue of warrants to purchase common stock | 1,807,826 | ||||||||||
Underwritten Public Offering [Member] | October 2018 Warrants [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Warrant Term | 5 years | ||||||||||
Stock Warrants [Member] | IPO [Member] | Series A [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Exercise price per warrant | $ / shares | $ 50.05 | ||||||||||
Warrant [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Exercise price per warrant | $ / shares | $ 0.69 | $ 0.69 | |||||||||
Conversion of Stock, Shares Converted | 13,672,173 | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award Non Option Equity Instruments Warrants Exercisable Number | 714 | ||||||||||
Warrant [Member] | Series B Preferred Stock [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 13,672,173 | ||||||||||
Warrant [Member] | Stock Warrants [Member] | |||||||||||
Equity, Class of Treasury Stock | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 11,655,747 |
Stock-Based Compensation and _8
Stock-Based Compensation and Warrants - Summary of all warrant activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Warrants | ||
Number of Warrants, Beginning Balance | 18,000,713 | 18,714,999 |
Number of Warrants, Exercised | (11,655,747) | |
Number of Warrants, Forfeited | (714,286) | |
Number of Warrants, Ending Balance | 6,344,966 | 18,000,713 |
Weighted Average Exercise Price, Beginning Balance | $ 0.69 | $ 3.24 |
Weighted Average Exercise Price, Forfeited | 0.69 | 50.05 |
Weighted Average Exercise Price, Ending Balance | $ 0.69 | $ 0.69 |
Stock-Based Compensation and _9
Stock-Based Compensation and Warrants - Summary of all outstanding and exercisable warrants (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Exercise Price 0.69 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted Average Exercise Price | $ / shares | $ 0.69 |
Warrants Outstanding | 6,344,252 |
Warrants Exercisable | 6,344,252 |
Weighted Average Remaining Contractual Life (in years) | 11 months 26 days |
Exercise Price 18.20 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted Average Exercise Price | $ / shares | $ 18.20 |
Warrants Outstanding | 714 |
Warrants Exercisable | 714 |
Weighted Average Remaining Contractual Life (in years) | 1 year 9 months 10 days |
Exercise Price 0.69 Two [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted Average Exercise Price | $ / shares | $ 0.69 |
Warrants Outstanding | 6,344,966 |
Warrants Exercisable | 6,344,966 |
Weighted Average Remaining Contractual Life (in years) | 1 year 9 months 10 days |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Jan. 27, 2021 | Nov. 16, 2020 | Oct. 15, 2018 | Oct. 10, 2018 | Sep. 11, 2017 | Sep. 30, 2021 | Feb. 28, 2021 | Dec. 31, 2020 | Oct. 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2017 | Mar. 29, 2021 | Dec. 31, 2018 | Aug. 05, 2016 |
Proceeds from Issuance or Sale of Equity | $ 18,600,000 | ||||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||||
Exercise price per warrant | 1.38 | $ 1.38 | |||||||||||||
Effect of Warrant exercise price adjustment | $ 900,000 | $ 0 | $ 880,000 | ||||||||||||
Preferred Stock, Convertible, Conversion Price, Decrease | $ 1.50 | $ 0.69 | |||||||||||||
Common stock issued upon conversion | 8,996,768 | ||||||||||||||
Preferred Stock, Shares Outstanding | 3,973 | 0 | 3,973 | ||||||||||||
Estimated fair value of inducement consideration | $ 7,400,000 | ||||||||||||||
Proceeds from Issuance of Common Stock | $ 65,960,000 | $ 3,359,000 | |||||||||||||
Preferred Stock Shares Converted | 1.38 | 3,973 | 3,665 | ||||||||||||
Proceeds from Stock Options Exercised | $ 0 | $ 0 | |||||||||||||
Stock Purchase Agreement [Member] | |||||||||||||||
Proceeds from Issuance of Common Stock | 66,000,000 | ||||||||||||||
Sale of Stock, Consideration Received on Transaction | $ 78,700,000 | ||||||||||||||
Over-Allotment Option [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 2,428,825 | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,428,825 | ||||||||||||||
Issue of warrants to purchase common stock | 1,807,826 | ||||||||||||||
Fbr Capital Markets Co [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 9,300,000 | ||||||||||||||
Brokerage Commission percentage | 3.00% | ||||||||||||||
Proceeds from Issuance of Common Stock for Exclusive Channel Collaboration Agreement | 3,400,000 | ||||||||||||||
Series A Preferred Stock [Member] | |||||||||||||||
Preferred Stock Conversion Price Per Share | $ 0.54 | ||||||||||||||
Effect of Warrant exercise price adjustment | 1,000,000 | ||||||||||||||
Preferred Stock Redemption Discount | $ 100,000 | $ 6,900,000 | |||||||||||||
Preferred Stock, Dividend Rate, Percentage | 2.00% | 2.00% | |||||||||||||
Preferred Stock, Convertible, Conversion Price, Increase | $ 18.90 | $ 18.90 | |||||||||||||
Preferred Stock, Convertible, Conversion Price, Decrease | $ 1.50 | ||||||||||||||
Convertible Preferred Stock, Terms of Conversion | (i) a 19.99% blocker provision to comply with NYSE American Listing Rules, (ii) if so elected by the Investor, a 4.99% blocker provision that will prohibit beneficial ownership of more than 4.99% of the outstanding shares of the Company’s common stock or voting power at any time, and (iii) applicable regulatory restrictions. | ||||||||||||||
Preferred stock accrued dividends | 24,000 | 254,000 | |||||||||||||
Maximum percentage | 4.99% | 9.99% | |||||||||||||
Accretion of Preferred Stock Deemed Dividend | 300,000 | ||||||||||||||
Preferred Stock, Redemption Terms | (i) the VWAP (as defined in the Certificate of Designation) for at least 20 trading days in any 30 trading day period is greater than $70.00, subject to adjustment in the case of stock split, stock dividends or the like the Company has the right, after providing notice not less than 6 months prior to the redemption date, to redeem, in whole or in part, on a pro rata basis from all holders thereof based on the number of shares of Series A Preferred Stock then held, the outstanding Series A Preferred Stock, for cash, at a redemption price per share of Series A Preferred Stock of $7,875.00, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Convertible Preferred Stock or (ii) the five year anniversary of the issue date, the Company shall have the right to redeem, in whole or in part, on a pro rata basis from all holders thereof based on the number of shares of Series A Convertible Preferred Stock then held, the outstanding Series A Preferred Stock, for cash, at a redemption price per share equal to the Liquidation Value. | ||||||||||||||
Series A Preferred Stock [Member] | Private Placement [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 120,000 | 120,000 | |||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | ||||||||||||||
Proceeds from Issuance of Convertible Preferred Stock | $ 12,000,000 | ||||||||||||||
Sale of Stock, Consideration Received Per Transaction | $ 100 | ||||||||||||||
Series B Preferred Stock [Member] | |||||||||||||||
Shares Issued, Price Per Share | $ 1.15 | ||||||||||||||
Stock Issued During Period, Value, Issued for Services | $ 1,000 | ||||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | ||||||||||||||
Preferred Stock Conversion Price Per Share | $ 1.15 | ||||||||||||||
Conversion of Stock, Shares Converted | 13,672,173 | ||||||||||||||
Exercise price per warrant | $ 0.69 | ||||||||||||||
Percentage of issue of the public offering | 120.00% | ||||||||||||||
Preferred Stock Redemption Discount | $ 900,000 | $ 1,400,000 | 1,500,000 | 1,400,000 | |||||||||||
Preferred stock accrued dividends | $ 1,496,000 | 1,380,000 | |||||||||||||
Preferred Stock Redemption Discount | $ 1,400,000 | ||||||||||||||
Investment Warrants Expiration Date1 | Oct. 15, 2023 | ||||||||||||||
Series B Preferred Stock [Member] | Over-Allotment Option [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 2,428,825 | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,428,825 | ||||||||||||||
Issue of warrants to purchase common stock | 1,807,826 | ||||||||||||||
Common Class A [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 2,520,000 | ||||||||||||||
Shares Issued, Price Per Share | $ 1.15 | ||||||||||||||
Common Class B [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 15,723 |
Non-controlling Interest (Detai
Non-controlling Interest (Details) - USD ($) | Sep. 05, 2018 | Sep. 05, 2018 | Dec. 31, 2021 | Dec. 31, 2020 |
Noncontrolling Interest | ||||
Equity Method Investment, Ownership Percentage | 83.00% | |||
Related Party Transaction, Expenses from Transactions with Related Party | $ 328,000 | |||
Research and Development Expense | $ 7,800,000 | $ 5,131,000 | ||
Fair Value Of Shares Issued | $ 285,000 | |||
Net Income (Loss) Attributable to Noncontrolling Interest | (1,000) | (73,000) | ||
Stock Purchase Agreement [Member] | ||||
Noncontrolling Interest | ||||
Research and Development Expense | $ 1,000 | 225,000 | ||
SYN Biomics [Member] | ||||
Noncontrolling Interest | ||||
Equity Method Investment, Ownership Percentage | 88.50% | 88.50% | 100.00% | |
Equity interest by parent | 11.50% | 11.50% | ||
Net Income (Loss) Attributable to Noncontrolling Interest | 2,800,000 | |||
Synthetic Biomics Inc [Member] | ||||
Noncontrolling Interest | ||||
Equity interest by parent | 17.00% | |||
Dr. Pimentels [Member] | ||||
Noncontrolling Interest | ||||
Net Income (Loss) Attributable to Noncontrolling Interest | 73,000,000,000 | |||
Dr. Pimentels [Member] | Consolidation, Eliminations | ||||
Noncontrolling Interest | ||||
Net Income (Loss) Attributable to Noncontrolling Interest | $ 505,000 | |||
Cedarssinai Medical Center [Member] | ||||
Noncontrolling Interest | ||||
Number Of Common Stock To Be Issued | 50,000 | 50,000 | ||
Number Of Common Stock To Be Held By Related Party | 7,480,000 | 7,480,000 | ||
Cedarssinai Medical Center [Member] | SYN Biomics [Member] | ||||
Noncontrolling Interest | ||||
Additional Number Of Common Stock To Be Issued | 2,420,000 | 2,420,000 | ||
Cedarssinai Medical Center [Member] | Synthetic Biomics Inc [Member] | ||||
Noncontrolling Interest | ||||
Noncontrolling Interest, Ownership Percentage by Noncontrolling Owners | 17.00% | 17.00% |
License, Collaborative and Em_3
License, Collaborative and Employment Agreements and Commitments - Maturity analysis of operating leases (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies | ||
2022 | $ 247 | |
2023 | 327 | |
2024 | 337 | |
2025 | 347 | |
2026 | 357 | |
2027 | 368 | |
Total | 1,983 | |
Discount factor | (456) | |
Lease liability | 1,527 | |
Lease liability - current | (124) | $ (287) |
Lease liability - long term | $ 1,403 | $ 186 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Lease liability - current, Lease liability - long term |
License, Collaborative and Em_4
License, Collaborative and Employment Agreements and Commitments - Additional Information (Details) - USD ($) | Dec. 23, 2021 | Dec. 30, 2020 | Dec. 23, 2020 | Aug. 07, 2019 | Sep. 05, 2018 | Dec. 05, 2013 | Nov. 30, 2017 | Dec. 19, 2012 | Dec. 19, 2012 | Nov. 28, 2012 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2015 |
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Payments for Other Fees | $ 4,500,000 | ||||||||||||
Cost of Living Adjustments Percentage | 62.50% | ||||||||||||
Fair Value Of Shares Issued | $ 285,000 | ||||||||||||
Operating Lease, Cost | $ 280,000 | $ 209,000 | |||||||||||
Operating Lease, Payments | 321,000 | 309,000 | |||||||||||
Non Cash Addition of Right of Use Assets | $ 538,000 | ||||||||||||
Operating Lease, Weighted Average Discount Rate, Percent | 8.50% | ||||||||||||
Research and Development Expense | $ 7,800,000 | 5,131,000 | |||||||||||
Cedarssinai Medical Center [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Number Of Common Stock To Be Issued | 50,000 | ||||||||||||
Number Of Common Stock To Be Held By Related Party | 7,480,000 | ||||||||||||
Cedarssinai Medical Center [Member] | SYN Biomics [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Additional Number Of Common Stock To Be Issued | 2,420,000 | ||||||||||||
Operating Lease [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Operating Lease, Cost | 1,300,000 | ||||||||||||
Licensing Agreements [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Annual payments due under license agreement | $ 50,000 | ||||||||||||
Final payment due under license agreement | 25,000 | ||||||||||||
Payments for Other Fees | $ 150,000 | ||||||||||||
Stock Issued During Period, Shares, New Issues | 9,569 | ||||||||||||
Patents [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Payments for Other Fees | $ 220,000 | ||||||||||||
Steven A. Shallcross | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Deferred Compensation Arrangement with Individual, Cash Awards Granted, Percentage | 62.00% | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 450,000 | ||||||||||||
Dr. Sliman [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Deferred Compensation Arrangement with Individual, Cash Awards Granted, Percentage | 62.50% | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 650,000 | ||||||||||||
Annual Base Salary | $ 450,000 | ||||||||||||
Prev Abr Llc [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Additional Cash Payment for License Agreement | $ 235,000 | ||||||||||||
Unregistered Shares Issued to License Agreement | 17,858 | ||||||||||||
Additional Consideration Payable | 50% in cash and 50% in our stock | ||||||||||||
Options To Be Received Common Stock Shares | 18,724 | ||||||||||||
Phase I Clinical Trials [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Milestone Payment | $ 50,000 | ||||||||||||
Phase III Clinical Trials [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Milestone Payment | 100,000 | ||||||||||||
NDA Submission In US [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Milestone Payment | 250,000 | ||||||||||||
European Medicines Agency Approval [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Milestone Payment | 100,000 | ||||||||||||
Regulatory Approval In Asian Country [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Milestone Payment | 100,000 | ||||||||||||
Stock Purchase Agreement [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Research and Development Expense | $ 1,000 | $ 225,000 | |||||||||||
Clinical Trial Agreement [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Estimated Research Costs | $ 3,200,000 | ||||||||||||
First Year [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Research Agreement Fixed Fee | 303,287 | 303,287 | |||||||||||
Second Year [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Research Agreement Fixed Fee | 316,438 | 316,438 | |||||||||||
Third Year [Member] | |||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | |||||||||||||
Research Agreement Fixed Fee | $ 328,758 | $ 328,758 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Computed "expected" tax-benefit - Federal | $ (3,045) | $ (2,124) |
Computed "expected" tax-benefit - State | (931) | (616) |
Adjustment of "expected" tax-benefit to actual | 0 | 0 |
Meals, entertainment and other | 0 | 0 |
Non-deductible stock-based compensation | 32 | 32 |
State tax rate adjustment | 932 | (1,221) |
Federal and state net operating loss adjustment | 0 | 0 |
Change in valuation allowance | 3,012 | 3,929 |
Income tax expense | $ 0 | $ 0 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Stock issued for services | $ 1,504 | $ 1,428 |
Accrued compensation | 27 | 42 |
Stock issued for acquisition of program | 1,462 | 1,436 |
Stock issued for license agreement | 1,363 | 1,574 |
Stock issued for milestone payment | 236 | 262 |
Amortizable license fee | 4 | 5 |
Net operating loss carry-forward | 16,884 | 12,540 |
Total gross deferred tax assets | 21,480 | 17,287 |
Less: valuation allowance | (21,480) | (17,287) |
Total net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax [Line Items] | ||
Effective Income Tax Rate Reconciliation, State and Local Income Taxes, Percent | 6.46% | 6.45% |
Effective Income Tax Rate Reconciliation, Change in Enacted Tax Rate, Percent | 8.18% | 8.17% |
Deferred Tax Assets, Valuation Allowance | $ 21,480 | $ 17,287 |
Deferred Tax Assets, Net of Valuation Allowance | 4,200 | |
Operating Loss Carryforwards | $ 58,300 | |
Operating Loss Carryforwards Expire Date | 2037 | |
Income Tax Expense (Benefit) | $ 0 | 0 |
Tax Year 2018 [Member] | ||
Income Tax [Line Items] | ||
Operating Loss Carryforwards | 198,800 | |
Limitation on Operating loss carryforwards | $ 155,600 | 155,600 |
Operating Loss Carryforwards Expire Date | 2037 | |
Tax Year 2020 [Member] | ||
Income Tax [Line Items] | ||
Operating Loss Carryforwards | $ 188,600 | |
Scenario, Plan [Member] | ||
Income Tax [Line Items] | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Mar. 10, 2022 | Jan. 03, 2022 | Dec. 30, 2020 |
Steven A. Shallcross | |||
Subsequent Event [Line Items] | |||
Annual cash performance bonus | 62.00% | ||
Subsequent Event | Steven A. Shallcross | |||
Subsequent Event [Line Items] | |||
Employment agreement term | 3 years | ||
Annual base salary | $ 585,000 | ||
Subsequent Event | Steven A. Shallcross | Maximum | |||
Subsequent Event [Line Items] | |||
Annual cash performance bonus | 50.00% | ||
Subsequent Event | VCN Private [Member] | |||
Subsequent Event [Line Items] | |||
Consideration purchase paid | $ 4,700,000 | ||
Existing liabilities | 2,400,000 | ||
Finance costs | 425,000 | ||
Budgetary plan | 27,800,000 | ||
Milestone payments | $ 12,000,000 | ||
Subsequent Event | VCN Private [Member] | Grifols Innovation | |||
Subsequent Event [Line Items] | |||
Business Acquisition, Percentage of Voting Interests Acquired | 86.00% | ||
Subsequent Event | VCN Private [Member] | New technologies | |||
Subsequent Event [Line Items] | |||
Business Acquisition, Percentage of Voting Interests Acquired | 19.99% | ||
Subsequent Event | VCN Private [Member] | Other First Indication [Member] | |||
Subsequent Event [Line Items] | |||
Milestone payments safe to proceed | $ 3,000,000 | ||
Milestone payments first patient dosed | 3,250,000 | ||
Milestone payments | 6,000,000 | ||
Milestone payments BLA approval | 16,000,000 | ||
Subsequent Event | VCN Private [Member] | Other Second Indication | |||
Subsequent Event [Line Items] | |||
Milestone payments safe to proceed | 2,750,000 | ||
Milestone payments first patient dosed | 3,250,000 | ||
Milestone payments | 8,000,000 | ||
Milestone payments BLA approval | $ 16,000,000 |