Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 06, 2020 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2020 | |
Entity Registrant Name | Synthetic Biologics, Inc. | |
Title of 12(b) Security | Common Stock | |
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 | 19,993,390 | |
Entity Central Index Key | 0000894158 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Trading Symbol | SYN |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash and cash equivalents | $ 6,005 | $ 15,045 |
Prepaid expenses and other current assets | 657 | 1,381 |
Total Current Assets | 6,662 | 16,426 |
Property and equipment, net | 202 | 367 |
Right of use asset | 316 | 419 |
Deposits and other assets | 23 | 23 |
Total Assets | 7,203 | 17,235 |
Current Liabilities: | ||
Accounts payable | 992 | 2,315 |
Accrued expenses | 988 | 1,776 |
Accrued employee benefits | 752 | 935 |
Lease liability | 278 | 249 |
Total Current Liabilities | 3,010 | 5,275 |
Lease liability - Long term | 261 | 473 |
Total Liabilities | 3,271 | 5,748 |
Series A convertible preferred stock, $0.001 par value; 10,000,000 shares authorized; 120,000 issued and outstanding | 12,733 | 12,544 |
Stockholders' Deficit: | ||
Series B convertible preferred stock, $1,000 par value; 10,000,000 shares authorized, 4,146 issued and outstanding and 7,638 issued and outstanding | 2,584 | 4,761 |
Common Stock, $0.001 par value; 200,000,000 shares authorized, 19,845,283 and 16,808,758 issued and 19,842,955 and 16,806,430 outstanding | 20 | 17 |
Additional paid-in capital | 236,320 | 232,580 |
Accumulated deficit | (244,975) | (235,537) |
Total Synthetic Biologics, Inc. and Subsidiaries Deficit | (6,051) | 1,821 |
Non-controlling interest | (2,750) | (2,878) |
Total Stockholders' Deficit | (8,801) | (1,057) |
Total Liabilities and Stockholders' Deficit | $ 7,203 | $ 17,235 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Condensed 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 | 120,000 | 120,000 |
Temporary Equity, Shares Outstanding | 120,000 | 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 | 4,146 | 7,638 |
Preferred Stock, Shares Outstanding | 4,146 | 7,638 |
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 | 19,845,283 | 16,808,758 |
Common stock, Shares Outstanding | 19,842,955 | 16,806,430 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating Costs and Expenses: | ||||
General and administrative | $ 1,197,000 | $ 1,098,000 | $ 3,876,000 | $ 3,297,000 |
Research and development | 914,000 | 4,144,000 | 4,152,000 | 9,156,000 |
Total Operating Costs and Expenses | 2,111,000 | 5,242,000 | 8,028,000 | 12,453,000 |
Loss from Operations | (2,111,000) | (5,242,000) | (8,028,000) | (12,453,000) |
Other Income : | ||||
Interest income | 0 | 92,000 | 44,000 | 217,000 |
Total Other Income | 0 | 92,000 | 44,000 | 217,000 |
Net Loss | (2,111,000) | (5,150,000) | (7,984,000) | (12,236,000) |
Net Loss Attributable to Non-controlling Interest | (8,000) | (30,000) | (50,000) | (73,000) |
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | (2,103,000) | (5,120,000) | (7,934,000) | (12,163,000) |
Preferred Stock Dividends, Income Statement Impact | (185,000) | |||
Net Loss Attributable to Common Stockholders | $ (2,686,000) | $ (5,253,000) | $ (9,438,000) | $ (12,934,000) |
Net Loss Per Share - Basic and Dilutive | $ (0.14) | $ (0.31) | $ (0.52) | $ (0.79) |
Weighted average number of shares outstanding during the period - Basic and Dilutive | 19,398,339 | 16,805,257 | 18,302,585 | 16,313,326 |
Series A Preferred Stock [Member] | ||||
Other Income : | ||||
Preferred Stock Dividends, Income Statement Impact | $ (64,000) | $ (63,000) | $ (189,000) | $ (185,000) |
Series B Preferred Stock [Member] | ||||
Other Income : | ||||
Net Loss Attributable to Non-controlling Interest | 0 | 0 | ||
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | 0 | 0 | ||
Preferred Stock Dividends, Income Statement Impact | $ (519,000) | $ (70,000) | $ (1,315,000) | $ (585,000) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders Equity (Deficit) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Noncontrolling Interest [Member] | Series B Preferred Stock [Member] | Total |
Balance at Dec. 31, 2018 | $ 15 | $ 230,754 | $ (219,461) | $ (2,909) | $ 5,760 | $ 14,159 |
Balance (in shares) at Dec. 31, 2018 | 15,482,083 | 9,161 | ||||
Stock-based compensation | $ 0 | 64 | 0 | 0 | $ 0 | 64 |
Series A Preferred Stock Dividends | 0 | 0 | (61) | 0 | 0 | (61) |
Issuance of SYN Biomics Stock | $ 0 | (36) | 0 | 53 | $ 0 | 17 |
Conversion of Series B Preferred Stock to Common (in shares) | 900,869 | (1,036) | ||||
Conversion of Series B Preferred Stock to Common | $ 1 | 1,035 | (398) | 0 | $ (638) | 0 |
Net loss | 0 | 0 | (3,512) | 0 | 0 | (3,512) |
Non-controlling interest | 0 | 0 | 0 | (16) | 0 | (16) |
Balance at Mar. 31, 2019 | $ 16 | 231,817 | (223,432) | (2,872) | $ 5,122 | 10,651 |
Balance (in shares) at Mar. 31, 2019 | 16,382,952 | 8,125 | ||||
Balance at Dec. 31, 2018 | $ 15 | 230,754 | (219,461) | (2,909) | $ 5,760 | 14,159 |
Balance (in shares) at Dec. 31, 2018 | 15,482,083 | 9,161 | ||||
Net loss | (12,163) | |||||
Non-controlling interest | (73) | |||||
Balance at Sep. 30, 2019 | $ 17 | 232,485 | (232,394) | (2,854) | $ 4,822 | 2,089 |
Balance (in shares) at Sep. 30, 2019 | 16,806,430 | 7,638 | ||||
Balance at Mar. 31, 2019 | $ 16 | 231,817 | (223,432) | (2,872) | $ 5,122 | 10,651 |
Balance (in shares) at Mar. 31, 2019 | 16,382,952 | 8,125 | ||||
Stock-based compensation | $ 0 | 91 | 0 | 0 | $ 0 | 91 |
Series A Preferred Stock Dividends | 0 | 0 | (61) | 0 | 0 | (61) |
Issuance of SYN Biomics Stock | $ 0 | 0 | 0 | 45 | $ 0 | 45 |
Conversion of Series B Preferred Stock to Common (in shares) | 262,608 | (302) | ||||
Conversion of Series B Preferred Stock to Common | $ 1 | 303 | (117) | 0 | $ (187) | 0 |
Net loss | 0 | 0 | (3,531) | 0 | 0 | (3,531) |
Non-controlling interest | 0 | 0 | 0 | (27) | 0 | (27) |
Balance at Jun. 30, 2019 | $ 17 | 232,211 | (227,141) | (2,854) | $ 4,935 | 7,168 |
Balance (in shares) at Jun. 30, 2019 | 16,645,560 | 7,823 | ||||
Stock-based compensation | $ 0 | 91 | 0 | 0 | $ 0 | 91 |
Series A Preferred Stock Dividends | 0 | 0 | (63) | 0 | 0 | (63) |
Issuance of SYN Biomics Stock | $ 0 | 0 | 0 | 43 | $ 0 | 43 |
Conversion of Series B Preferred Stock to Common (in shares) | 160,870 | (185) | ||||
Conversion of Series B Preferred Stock to Common | $ 0 | 183 | (70) | 0 | $ (113) | 0 |
Net loss | 0 | 0 | (5,120) | 0 | 0 | (5,120) |
Non-controlling interest | 0 | 0 | 0 | (30) | 0 | (30) |
Balance at Sep. 30, 2019 | $ 17 | 232,485 | (232,394) | (2,854) | $ 4,822 | 2,089 |
Balance (in shares) at Sep. 30, 2019 | 16,806,430 | 7,638 | ||||
Balance at Dec. 31, 2019 | $ 17 | 232,580 | (235,537) | (2,878) | $ 4,761 | (1,057) |
Balance (in shares) at Dec. 31, 2019 | 16,806,430 | 7,638 | ||||
Stock-based compensation | $ 0 | 83 | 0 | 0 | $ 0 | 83 |
Series A Preferred Stock Dividends | 0 | 0 | (62) | 0 | 0 | (62) |
Issuance of SYN Biomics Stock | $ 0 | 0 | 0 | 26 | $ 0 | 26 |
Conversion of Series B Preferred Stock to Common (in shares) | 933,045 | (1,073) | ||||
Conversion of Series B Preferred Stock to Common | $ 1 | 1,072 | (404) | 0 | $ (669) | 0 |
Net loss | 0 | 0 | (2,964) | 0 | 0 | (2,964) |
Non-controlling interest | 0 | 0 | 0 | (26) | 0 | (26) |
Balance at Mar. 31, 2020 | $ 18 | 233,735 | (238,967) | (2,878) | $ 4,092 | (4,000) |
Balance (in shares) at Mar. 31, 2020 | 17,739,475 | 6,565 | ||||
Balance at Dec. 31, 2019 | $ 17 | 232,580 | (235,537) | (2,878) | $ 4,761 | (1,057) |
Balance (in shares) at Dec. 31, 2019 | 16,806,430 | 7,638 | ||||
Net loss | (7,934) | |||||
Non-controlling interest | (50) | |||||
Balance at Sep. 30, 2020 | $ 20 | 236,320 | (244,975) | (2,750) | $ 2,584 | (8,801) |
Balance (in shares) at Sep. 30, 2020 | 19,842,955 | 4,146 | ||||
Balance at Mar. 31, 2020 | $ 18 | 233,735 | (238,967) | (2,878) | $ 4,092 | (4,000) |
Balance (in shares) at Mar. 31, 2020 | 17,739,475 | 6,565 | ||||
Stock-based compensation | $ 0 | 86 | 0 | 0 | $ 0 | 86 |
Series A Preferred Stock Dividends | 0 | 0 | (63) | 0 | 0 | (63) |
Issuance of SYN Biomics Stock | $ 0 | 0 | 0 | 10 | $ 0 | 10 |
Conversion of Series B Preferred Stock to Common (in shares) | 904,349 | (1,040) | ||||
Conversion of Series B Preferred Stock to Common | $ 1 | 1,039 | (392) | 0 | $ (648) | 0 |
Net loss | 0 | 0 | (2,867) | 0 | 0 | (2,867) |
Non-controlling interest | 0 | 0 | 0 | (16) | 0 | (16) |
Balance at Jun. 30, 2020 | $ 19 | 234,860 | (242,289) | (2,884) | $ 3,444 | (6,850) |
Balance (in shares) at Jun. 30, 2020 | 18,643,824 | 5,525 | ||||
Stock-based compensation | $ 0 | 82 | 0 | 0 | $ 0 | 82 |
Series A Preferred Stock Dividends | 0 | 0 | (64) | 0 | 0 | (64) |
Issuance of SYN Biomics Stock | $ 0 | 0 | 0 | 142 | $ 0 | 142 |
Conversion of Series B Preferred Stock to Common (in shares) | 1,199,131 | (1,379) | ||||
Conversion of Series B Preferred Stock to Common | $ 1 | 1,378 | (519) | 0 | $ (860) | 0 |
Net loss | 0 | 0 | (2,103) | 0 | 0 | (2,103) |
Non-controlling interest | 0 | 0 | 0 | (8) | 0 | (8) |
Balance at Sep. 30, 2020 | $ 20 | $ 236,320 | $ (244,975) | $ (2,750) | $ 2,584 | $ (8,801) |
Balance (in shares) at Sep. 30, 2020 | 19,842,955 | 4,146 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (7,984) | $ (12,236) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 251 | 246 |
Subsidiary stock issued to vendor | 178 | 104 |
Depreciation | 169 | 182 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 724 | (600) |
Right of use asset | 103 | 86 |
Accounts payable | (1,324) | 1,419 |
Accrued expenses | (788) | 1,403 |
Accrued employee benefits | (182) | (713) |
Lease liability | (183) | (159) |
Net Cash Used In Operating Activities | (9,036) | (10,268) |
Cash Flows From Investing Activities: | ||
Purchases of property and equipment | (4) | 0 |
Net Cash Used In Investing Activities | (4) | 0 |
Cash Flows From Financing Activities: | ||
Net Cash From Financing Activities | 0 | 0 |
Net decrease in cash and cash equivalents | (9,040) | (10,268) |
Cash and cash equivalents at beginning of period | 15,045 | 28,918 |
Cash and cash equivalents at end of period | 6,005 | 18,650 |
Noncash Financing Activities: | ||
Deemed dividends for accretion of Series B Preferred Stock discount | 1,315 | 585 |
In-kind dividends paid in preferred stock | 189 | 185 |
Right of use asset from operating lease | 0 | 538 |
Series B Preferred Stock [Member] | ||
Noncash Financing Activities: | ||
Conversion of Series B Preferred Stock | $ 2,177 | $ 938 |
Organization, Nature of Operati
Organization, Nature of Operations and Basis of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Nature of Operations and Basis of Presentation | |
Organization, Nature of Operations and Basis of Presentation | 1. Organization, Nature of Operations and Basis of Presentation Description of Business Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a diversified clinical-stage company 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 infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance (AMR) and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. 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’s (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. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by Accounting Principles Generally Accepted in the United States of America (“U.S. GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements include all adjustments, comprised of normal recurring adjustments, considered necessary by management to fairly state the Company’s results of operations, financial position and cash flows. The operating results for the interim periods are not necessarily indicative of results that may be expected for any other interim period or for the full year. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s 2019 Form 10‑K. The interim results for the three and nine months ended September 30, 2020 are not necessarily indicative of results for the full year. The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which requires the use of estimates, judgments and assumptions that affect the amounts of assets and liabilities at the reporting date and the amounts of revenue and expenses in the periods presented. The Company believes that the accounting estimates employed are appropriate and the resulting balances are reasonable; however, due to the inherent uncertainties in making estimates, actual results may differ from the original estimates, requiring adjustments to these balances in future periods. Recent Accounting Pronouncements and Developments In August 2020, the FASB issued Accounting Standards Update 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. This ASU amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related EPS guidance for both Subtopics. The ASU will be effective for annual reporting periods after December 15, 2023 and interim periods within those annual periods and early adoption is permitted in annual reporting periods ending after December 15, 2020. The Company is currently assessing the impact of ASU 2020-06 on our consolidated financial statements. On January 30, 2020, the World Health Organization (WHO) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the COVID-19 outbreak or “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. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (CARES Act) was enacted. The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States’ economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions include removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. The Company has assessed the impact of the CARES Act and, based upon our initial assessment, we do not believe that it will have a significant effect on our financial position, results of operations or cash flows. The Company continues to evaluate its impact as new information becomes available. Impairment of Long-Lived Assets Long-lived assets include property, equipment and right-of-use assets. In accordance with Accounting Standards Codification (“ASC”) 360 - Property, Plant and Equipment (“ASC 360”), management reviews the Company’s recorded long-lived assets for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable. The Company determines the extent to which an asset may be impaired based upon its expectation of the asset’s future usability as well as whether there is reasonable assurance that the future cash flows associated with the asset will be in excess of its carrying amount. If the total of the expected undiscounted future cash flows is less than the carrying amount of the asset, a loss is recognized for the difference between fair value and the carrying value of the asset. During the quarter ending March 31, 2020 the Company identified COVID-19 as a triggering event and performed a qualitative assessment of the fair value of its long-lived assets. The results from this analysis determined that it is still more likely than not that the fair value of its long-lived assets remain higher than the carrying value of these assets. As a result, no impairment charges were recorded during the three and nine months ended September 30, 2020. |
Going Concern
Going Concern | 9 Months Ended |
Sep. 30, 2020 | |
Going Concern | |
Going Concern | 2. Going Concern The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company continues to incur losses and, as of September 30, 2020, the Company had an accumulated deficit of approximately $245 million. Since inception, the Company has financed its activities primarily from the proceeds from the issuance of equity securities. The Company does not have sufficient capital to fund its operations for the next twelve months following the issuance date of its Quarterly Report on Form 10-Q. The Company’s ability to continue as a going concern, address its capital needs, and execute the required clinical trials, is therefore dependent upon the Company’s ability to obtain capital through the issuance of debt and/or additional equity offerings. The Company is actively pursuing additional equity or debt financing in the form of either a private placement or a public offering and the Company continues ongoing discussions with strategic institutional investors and investment banks with respect to such possible offerings. Included in these options is utilizing the “at-the-market” Issuance Sales Agreement (the “FBR Sales Agreement”) that the Company entered into with B. Riley Securities (formerly FBR Capital Markets & Co.) in August 2016. Nonetheless, there can be no assurance that such capital will be available in sufficient amounts or on terms acceptable to the Company when and if needed or that the Company will meet the requirements for use of the FBR Sales Agreement. If the Company is unable to obtain additional financing in sufficient amounts or on acceptable terms under such circumstances, the Company’s operating results and prospects will be adversely affected. These factors individually and collectively, including the Company’s dependence on its ability to raise additional capital to fund its operations for the next twelve months following the issuance date of these financial statements raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should the Company be unable to continue as a going concern. In January 2020, the World Health Organization declared a global pandemic for the novel strain of coronavirus, COVID-19. Since then, COVID-19 has spread to the United States and countries worldwide. As COVID-19 continues to spread around the globe, the Company has experienced disruptions that impact our business and clinical trials, including the temporary halt of the enrollment of new patients in its SYN-010 Phase 2b clinical study during the quarter ended June 30, 2020 and the postponement of clinical site initiation for its SYN-004 Phase 1b/2a clinical study. While the Company has experienced limited financial impact at this time, given the global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic, the Company’s business, financial condition, results of operations and growth prospects could be materially adversely affected, including its ability to raise capital. To maximize patient participation and safeguard the trials integrity and patient safety, initiation of the Company’s Phase 1b/2a clinical study of SYN-004 to be conducted by Washington University in Allogeneic HCT Recipients is deferred until Q1 2021, pandemic conditions permitting. At September 30, 2020, the Company had cash and cash equivalents of approximately $6.0 million. Management has been able to extend its cash runway since its clinical development partners CSMC and Washington University continued to limit non-essential activities during the third quarter, which included the SYN-010 Phase 2b clinical study and SYN-004 Phase 1b/2a clinical study. The Company anticipates its current cash will allow it to cover overhead costs, manufacturing costs for clinical supply and limited research efforts, including funding requirements to initiate its planned Phase 1b/2a clinical study of SYN-004 in allogeneic HCT recipients and Phase 1-enabling assay development and manufacturing of drug supply in support of the planned Phase 1 single ascending dose (SAD) study of SYN-020 intestinal alkaline phosphatase (IAP). The Company does not anticipate any additional expense related to the Phase 1b/2a SYN-004 (ribaxamase) clinical trial until the trial is cleared for commencement by Washington University (expected Q1 2021). Commencement of the FDA-agreed Phase 3 clinical trial of SYN-004 for the prevention of C. difficile infection in the future is subject to the Company’s successful pursuit of opportunities that will allow it to establish the clinical infrastructure and financial resources necessary to successfully initiate and complete its plan. The Company will be required to obtain additional funding in order to continue the development of its current product candidates beyond its planned Phase 1b/2a clinical study of SYN-004 in allogeneic HCT recipients, its planned Phase 1 SAD study of SYN-020 IAP in healthy volunteers, and to continue to fund operations at the current cash expenditure levels. Currently, the Company does not have commitments from any third parties to provide it with capital. If the Company fails to obtain additional funding for its clinical trials, it will not be able to fully execute its business plan as planned and will be forced to cease certain development activities until funding is received. Further, on September 30, 2020, the Company and CSMC 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, it was also concluded that SYN-010 is unlikely to meet its primary endpoint by the time enrollment is completed. The Company anticipates additional reductions in clinical development expense during the remainder of 2020 as a result of the discontinuation of this clinical program. The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond its control. These factors include the following: · the progress of its research activities; · the number and scope of its research programs; · the ability to recruit patients for clinical studies in a timely manner; · the progress of its preclinical and clinical development activities; · the progress of the development efforts of parties with whom the Company has entered into research and development agreements and amount of funding received from partners and collaborators; · its ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements; · its ability to achieve milestones under licensing arrangements; · the costs associated with manufacturing-related services to produce material for use in clinical trials; · the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; · the costs and timing of regulatory approvals; and · the ability to commence or complete clinical trials due to the ongoing impact of the COVID-19 global pandemic. The Company has based its estimates of funding requirements on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater amounts than it currently anticipates. If the Company raises funds by selling additional shares of Common Stock or other securities convertible into Common Stock, the ownership interest of the existing stockholders will be diluted. If the Company is not able to obtain financing when needed, it may be unable to carry out its business plan. As a result, the Company may have to significantly limit its operations and its business, financial condition and results of operations would be materially harmed. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC 820, Fair Value Measurement , defines fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows: · 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, other current assets, 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 $114,000 as of September 30, 2020 and $98,000 as of December 31, 2019 that are measured using Level 1 inputs. |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 9 Months Ended |
Sep. 30, 2020 | |
Selected Balance Sheet Information | |
Selected Balance Sheet Information | 4. Selected Balance Sheet Information Prepaid expenses and other current assets (in thousands) September 30, December 31, 2020 2019 Prepaid clinical research organizations $ 471 $ 48 Prepaid consulting, subscriptions and other expenses 74 134 Prepaid insurances 73 549 Prepaid manufacturing expenses 39 622 Prepaid conferences, travel and other expenses — 25 Other receivables — 3 Total $ 657 $ 1,381 Amounts prepaid to clinical research organizations (CROs) were classified as current assets. The Company makes payments to the CROs based on agreed upon terms that include payments in advance of study services. Property and equipment, net (in thousands) September 30, December 31, 2020 2019 Computers and office equipment $ 808 $ 804 Leasehold improvements 439 439 Software 11 11 1,258 1,254 Less: accumulated depreciation and amortization (1,056) (887) Total $ 202 $ 367 Accrued expenses (in thousands) September 30, December 31, 2020 2019 Accrued clinical consulting services $ 660 $ 684 Accrued vendor payments 309 456 Accrued manufacturing costs 18 635 Other accrued expenses 1 1 Total $ 988 $ 1,776 Accrued employee benefits (in thousands) September 30, December 31, 2020 2019 Accrued bonus expense $ 594 $ 858 Accrued vacation expense 158 77 Total $ 752 $ 935 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Stock-Based Compensation | 5 . Stock-Based Compensation Stock Incentive Plans 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 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. 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 September 30, 2020, there were 7,052 options issued and outstanding under the 2007 Stock 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. On October 22, 2013, the stockholders approved and adopted an amendment to the Company’s 2010 Stock Plan to increase the number of shares of the Company’s Common Stock reserved for issuance under the Plan from 85,714 to 171,429. On May 15, 2015, the stockholders approved and adopted an amendment to the Company’s 2010 Stock Plan to increase the number of shares of the Company’s Common Stock reserved for issuance under the Plan from 171,429 to 228,572. On August 25, 2016, the stockholders approved and adopted an amendment to the 2010 Stock Plan to increase the number of shares of the Company’s Common Stock reserved for issuance under the 2010 Stock Plan from 228,572 to 400,000. On September 7, 2017, the stockholders approved and adopted an amendment to the 2010 Stock Plan to increase the number of shares of the Company’s Common Stock reserved for issuance under the 2010 Stock Plan from 400,000 to 500,000. On September 24, 2018, the stockholders approved and adopted an amendment to the 2010 Stock Plan to increase the number of shares of the Company’s Common Stock reserved for issuance under the 2010 Stock Plan from 500,000 to 1,000,000. On September 5, 2019, the stockholders approved and adopted an amendment to the 2010 Stock Plan to increase the number of shares of the Common Stock reserved for issuance under the 2010 Stock Plan from 1,000,000 to 4,000,000. 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 September 30, 2020, there were 2,453,273 options issued and outstanding under the 2010 Stock 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 September 30, 2020, there were no options issued and outstanding under the 2020 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 as compensation expense 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 is estimated on the date of grant using the Black-Scholes option pricing model. There were no options granted during the three and nine months ended September 30, 2020 and 2019. 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 the six-month anniversary of grant date; · in full on one-year anniversary of grant date; · quarterly over three years; · annually over three years; · one-third immediate vesting and remaining annually over two years; and · monthly over three years. A summary of stock option activity for the nine months ended September 30, 2020 and the year ended December 31, 2019 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2018 938,982 $ 15.18 6.19 years $ — Granted 1,725,000 0.42 Exercised — — Expired (94,738) 58.25 Forfeited (67,232) 5.95 Balance - December 31, 2019 2,502,012 3.62 6.51 years 153,353 Granted — — Exercised — — Expired (12,037) 10.89 Forfeited (29,650) 0.55 Balance - September 30, 2020 - outstanding 2,460,325 $ 5.79 years $ 96,106 Balance - September 30, 2020 - exercisable 747,781 $ 5.14 years $ 13,196 Grant date fair value of options granted - nine months ended September 30, 2020 $ — Weighted average grant date fair value - nine months ended September 30, 2020 $ — Grant date fair value of options granted - year ended December 31, 2019 $ 470,000 Weighted average grant date fair value - year ended December 31, 2019 $ 0.27 Stock-based compensation expense included in general and administrative expenses relating to stock options issued to employees for the three and nine months ended September 30, 2020 was $41,000 and $120,000, respectively, and $59,000 and $165,000 for the three and nine months ended September 30, 2019, respectively. Stock-based compensation expense included in research and development expenses relating to stock options issued to employees for the three and nine months ended September 30, 2020 was $14,000 and $45,000, respectively, and $22,000 and $52,000 for the three and nine months ended September 30, 2019, respectively. Stock-based compensation expense included in general and administrative expenses relating to stock options issued to consultants for the three and nine months ended September 30, 2020 was $26,000 and $79,000, respectively, and $9,000 and $28,000 for the three and nine months ended September 30, 2019, respectively. Stock-based compensation expense included in research and development expenses relating to stock options issued to consultants for the three and nine months ended September 30, 2020 was $1,000 and $7,000, respectively, and $1,000 for the three and nine months ended September 30, 2019. As of September 30, 2020, total unrecognized stock-based compensation expense related to stock options was $406,000, which is expected to be expensed through August 2022. 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 during the three and nine months ended September 30, 2020 and 2019. |
Stock Warrants
Stock Warrants | 9 Months Ended |
Sep. 30, 2020 | |
Stock Warrants | |
Stock Warrants | 6 . 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 exercise price of $1.38 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 . 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. The Warrants are immediately exercisable at a price of $1.38 per share of Common Stock (which is 120% of the public offering price of the Class A Units) and 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 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. 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 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 may be exercised at any time on or after the date of issuance. The Series A warrants are exercisable until the four-year anniversary of the issuance date. The Series B warrants expired on December 31, 2017 and none were exercised prior to expiration. The warrants include 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 are being recorded as non-cash income or expense in the Company’s Condensed Consolidated Statements of Operations at each subsequent period. At September 30, 2020 and September 30, 2019, the fair value of the warrant liability was nominal.In 2020 and 2019, the Monte Carlo simulations were not used as the value of the warrants were deemed to be minimal based on the historical fair value of the warrants and the Company’s current stock price. On October 10, 2014, the Company raised net proceeds of $19.1 million through the sale of 14,059,616 units at a price of $1.47 per unit to certain institutional investors in a registered direct offering. Each unit consisted of one share of the Company's Common Stock and a warrant to purchase 0.50 shares of Common Stock. The warrants, exercisable for an aggregate of 200,852 shares of Common Stock, had an exercise price of $61.25 per share and a life of five years. The warrants vested immediately and expired on October 10, 2019. A summary of all warrant activity for the Company for the nine months ended September 30, 2020 and the year ended December 31, 2019 is as follows: Number of Weighted Average Warrants Exercise Price Balance at December 31, 2018 18,915,851 $ 3.85 Granted — — Exercised — — Forfeited (200,852) 61.25 Balance at December 31, 2019 18,714,999 3.24 Granted — — Exercised — — Forfeited — — Balance at September 30, 2020 18,714,999 $ 3.24 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, was 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 issuance. The warrant is equity classified and the fair value of the warrant approximated $9,000 on the date of grant and was measured using the Black-Scholes option pricing model. This entire expense was recorded in the quarter ended March 31, 2018. A summary of all outstanding and exercisable warrants as of September 30, 2020 is as follows: Weighted Average Warrants Warrants Remaining Exercise Price Outstanding Exercisable Contractual Life $ 1.38 17,999,999 17,999,999 3.03 years 18.20 714 714 2.24 years 50.05 714,286 714,286 0.13 years $ 3.24 18,714,999 18,714,999 2.92 years |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2020 | |
Net Loss per Share | |
Net Loss per Share | 7 . Net Loss per Share Basic net loss per share is computed by dividing net loss 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 three and nine months ended September 30, 2020 excludes net loss attributable to non-controlling interest of $0.1 million and includes the accretion of Series B preferred discount of $0.5 million and $1.3 million, respectively, on converted shares and Series A preferred stock accrued dividends of $0.1 million and $0.2 million, respectively. Net loss attributable to common stockholders for the three and nine months ended September 30, 2019 excludes net loss attributable to non-controlling interest of $0.1 million and includes the accretion of Series B preferred discount of $0.1 million and $0.6 million, respectively, on converted shares and Series A preferred stock accrued dividends of $0.1 million and $0.2 million, respectively. The number of shares of common stock underlying Series B Preferred shares convertible to common stock that were excluded from the computations of net loss per common share for the three and nine months ended September 30, 2020 and 2019 were 3,605,217 and 6,641,739, respectively. The number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share and for the three and nine months ended September 30, 2020 were 2,460,325 and 18,714,999, respectively, and for the three and nine months ended September 30, 2019 were 803,577 and 18,915,851, respectively, because their effect is anti-dilutive. |
Non-controlling Interest
Non-controlling Interest | 9 Months Ended |
Sep. 30, 2020 | |
Non-controlling Interest | |
Non-controlling Interest | 8 . Non-controlling Interest The Company’s non-controlling interest is accounted for under ASC 810, Consolidation (“ASC 810”), and represents the minority shareholder’s ownership interest related to the Company’s subsidiary, Synthetic Biomics, Inc. (“SYN Biomics”). In accordance with ASC 810, 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 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 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 was designed to reduce methane production by certain microorganisms ( M. smithii ) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). After the 2018 transaction with CSMC, the Company's equity interest in SYN Biomics was 83% and the non-controlling stockholder's interest is 17%. As of September 30, 2020 , the accumulated net loss attributable to the non-controlling interest is $2.8 million. In consideration of the support provided by CSMC for the Study, the Company agreed to pay $441,000 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 fifty thousand (50,000) shares of common stock of the Company; and (ii) transferred to CSMC an additional two million four hundred twenty thousand (2,420,000) shares of common stock of its subsidiary SYN Biomics, Inc. (“Synbiomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of seven million four hundred eighty thousand (7,480,000) shares of common stock of SYN Biomics, representing seventeen percent (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 based overall on the fair value of the shares ($285,000) as determined at the date of IRB approval. During the three and nine months ended September 30, 2020, research and development expense recorded related to this transaction approximated $134,000 and $225,000, respectively. During the three and nine months ended September 30, 2019, research and development expense recorded related to this transaction approximated $108,000 and $318,000, respectively. On September 30, 2020, CSMC 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, it was also concluded that SYN-010 is unlikely to meet its primary endpoint by the time enrollment is completed. As a result, the Company anticipates additional reductions in clinical development expense during the remainder of 2020 resulting from the discontinuation of this clinical program. The 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 the Company's 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. |
Common and Preferred Stock
Common and Preferred Stock | 9 Months Ended |
Sep. 30, 2020 | |
Common and Preferred Stock | |
Common and Preferred Stock | 9 . Common and Preferred Stock 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. The Units were offered by the Company pursuant to a registration statement on Form S‑1 (File No. 333‑227400), as amended, filed with the SEC, which was declared effective by the SEC on October 10, 2018. The conversion price of the Series B Preferred Stock and exercise price of the October 2018 Warrants are 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. During the three and nine months ended September 30, 2020, 1,379 and 3,492 Series B shares, respectively, have been converted into common stock resulting in the recognition of $519,000 and $1,315,000, respectively, of unamortized discount from the conversion. During the three and nine months ended September 30, 2019, 185 and 1,523 Series B shares, respectively, have been converted into common stock resulting in the recognition of $71,000 and $585,000, respectively, of unamortized discount from the conversion. As of September 30, 2020, 11,577 shares have been converted resulting in the recognition of $4.4 million of unamortized discount. This is recorded as a deemed dividend in accumulated deficit. The October 2018 Warrants are immediately exercisable at a price of $1.38 per share of common stock (which is 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. The Company may not effect, and the holder will not be entitled to, exercise any Warrants or conversion of the Series B Preferred Stock, which, upon giving effect to such exercise, would cause (i) the aggregate number of shares of Common Stock beneficially owned by the holder (together with its affiliates) to exceed 4.99% (or, at the election of the holder, 9.99%) of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of the Company’s securities beneficially owned by the holder (together with its affiliates) to exceed 4.99% (or, at the election of the holder, 9.99%) of the combined voting power of all of the Company’s securities then outstanding immediately after giving effect to the exercise or conversion, as such percentage ownership is determined in accordance with the terms of the October 2018 Warrants or Series B Preferred Stock. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99% upon at least 61 days’ prior notice from the holder to the Company. The holders of the Series B Preferred will participate, on an as-if-converted-to-common stock basis, in any dividends to the holders of common stock. Upon a defined Fundamental Transaction, the holders of the Series B Preferred Stock are entitled to the same consideration as are holders of Common Stock. The Series B Preferred Stock ranks junior to existing Series A Preferred Stock but on parity with common stock. Liquidation preference is equal to an amount pari passu with the common stock on an as converted basis (i.e., there is no preference to common stock). Since the effective conversion price of the Series B Preferred Stock was less than the fair value of the underlying common stock at the date of issuance, there was a beneficial conversion feature (“BCF”) at the issuance date. Because the Series B Preferred Stock had no stated maturity or redemption date and was 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, 2018, the Company recorded a discount of $9.1 million and immediately amortized the discount to record the deemed dividend. 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 upon 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. 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 $18.90 per share, subject to certain customary anti-dilution adjustments. Any conversion of Series A Preferred Stock may be settled by the Company in shares of common stock only. 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, 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 issuance date, the Company has 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 (as defined in the Certificate of Designations). The Series A Preferred Stock is 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 a beneficial conversion feature (“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 three and nine months ended September 30, 2020, the Company accrued dividends of $64,000 and $189,000, respectively. During the three and nine months ended September 30, 2019, the Company accrued dividends of $63,000 and $185,000, respectively. Once the dividend is declared, the Company will reclassify the declared amount from temporary equity to a dividends payable liability. When the redemption of the Series A Preferred Stock becomes probable, the temporary equity will be accreted to redemption value as a deemed dividend. B. Riley FBR 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 Company's common stock with an aggregate sales price of up to $40.0 million from time to time through B. Riley FBR, Inc. as the Company’s sales agent. Sales of common stock under the B. Riley FBR 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 FBR, Inc. is entitled to receive a commission rate of up to 3.0% of gross sales in connection with the sale of the Company's common stock sold on the Company’s behalf. The Company has not sold any shares during 2020 and 2019 through the B. Riley FBR Sales Agreement. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions | |
Related Party Transactions | 10 . Related Party Transactions On September 5, 2018, the Company entered into an agreement with 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 was intended 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 was designed to reduce methane production by certain microorganisms ( M. smithii ) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In consideration of the support provided by CSMC for the Study, 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) to: (i) issued to CSMC fifty thousand (50,000) shares of common stock of the Company; and (ii) transferred to CSMC an additional two million four hundred twenty thousand (2,420,000) shares of common stock of its subsidiary Synthetic Biomics, Inc. (“SYN Biomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of seven million four hundred eighty thousand (7,480,000) shares of common stock of SYN Biomics, representing seventeen percent (17%) of the issued and outstanding shares of SYN Biomics’ common stock. The 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 the Company’s 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 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 is unlikely to meet its primary endpoint by the time enrollment is completed. The Company anticipates additional reductions in clinical development expense during the remainder of 2020 and an acceleration of expense recognition of $141,000 as a result of the discontinuation of this clinical program. In December 2013, through the Company’s subsidiary, Synthetic Biomics, Inc., the Company entered into a worldwide exclusive license agreement with CSMC and acquired the rights to develop products for therapeutic and prophylactic treatments of acute and chronic diseases, including the development of SYN-010 to target IBS-C. The Company licensed from CSMC a portfolio of intellectual property comprised of several U.S. and foreign patents and pending patent applications for various fields of use, including IBS-C, obesity and diabetes. An investigational team led by Mark Pimentel, M.D. at CSMC discovered that these products may reduce the production of methane gas by certain GI microorganisms. During the three and nine months ended September 30, 2020 and 2019, the Company did not owe and did not pay CSMC for milestone payments related this license agreement. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 11. Commitments and Contingencies Leases All of the Company’s existing leases as of September 30, 2020 are classified as operating leases. As of September 30, 2020, the Company has one material operating lease for facilities with a remaining term expiring in 2022. The existing lease has fair value renewal options, none of which are considered certain of being exercised or included in the minimum lease term. The discount rate used in the calculation of the lease liability was 9.9%. The rates implicit within the Company’s leases are generally not determinable, therefore, the Company’s incremental borrowing rate is used to determine the present value of lease payments. The determination of the Company’s incremental borrowing rate requires judgment. Because the Company currently has no outstanding debt, the incremental borrowing rate for each lease is primarily based on publicly-available information for companies within the same industry and with similar credit profiles. The rate is then adjusted for the impact of collateralization, the lease term and other specific terms included in the Company’s lease arrangements. The incremental borrowing rate is determined at lease commencement, or as of January 1, 2019 for operating leases in existence upon adoption of ASC 842, Leases (ASC 842). The incremental borrowing rate is subsequently reassessed upon a modification to the lease arrangement. ROU assets are subsequently assessed for impairment in accordance with the Company’s accounting policy for long-lived assets. Operating lease costs are presented as part of general and administrative expenses in the condensed consolidated statements of operations, and for the three and nine months ended September 30, 2020 approximated $50,000 and $151,000, respectively, and for three and nine months ended September 30, 2019 approximated $50,000 and $151,000, respectively. For the three and nine months ended September 30, 2020, operating cash flows used for operating leases approximated $77,000 and $231,000, respectively, and for three and nine months ended September 30, 2019 approximated $75,000 and $224,000, respectively. A maturity analysis of our operating leases as of September 30, 2020 is as follows (amounts in thousands of dollars) : Future undiscounted cash flow for the years ending December 31: 2020 $ 79 2021 321 2022 192 Total 592 Discount factor (53) Lease liability 539 Amount due within 12 months (278) Lease liability – long term $ 261 Risks and Uncertainties On January 30, 2020, the World Health Organization (WHO) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the COVID-19 outbreak) 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. As the COVID-19 continued to spread around the globe, the Company experienced disruptions that impact its business and clinical trials, including halting 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, 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. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Events 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 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. 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. The patent rights previously licensed to the Company covering the use of SYN-010 will remain the property of CSMC. |
Selected Balance Sheet Inform_2
Selected Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Selected Balance Sheet Information | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets (in thousands) September 30, December 31, 2020 2019 Prepaid clinical research organizations $ 471 $ 48 Prepaid consulting, subscriptions and other expenses 74 134 Prepaid insurances 73 549 Prepaid manufacturing expenses 39 622 Prepaid conferences, travel and other expenses — 25 Other receivables — 3 Total $ 657 $ 1,381 |
Schedule of property, plant and equipment, net | Property and equipment, net (in thousands) September 30, December 31, 2020 2019 Computers and office equipment $ 808 $ 804 Leasehold improvements 439 439 Software 11 11 1,258 1,254 Less: accumulated depreciation and amortization (1,056) (887) Total $ 202 $ 367 |
Schedule of accrued expenses | Accrued expenses (in thousands) September 30, December 31, 2020 2019 Accrued clinical consulting services $ 660 $ 684 Accrued vendor payments 309 456 Accrued manufacturing costs 18 635 Other accrued expenses 1 1 Total $ 988 $ 1,776 |
Schedule of accrued employee benefits | September 30, December 31, 2020 2019 Accrued clinical consulting services $ 660 $ 684 Accrued vendor payments 309 456 Accrued manufacturing costs 18 635 Other accrued expenses 1 1 Total $ 988 $ 1,776 Accrued employee benefits (in thousands) September 30, December 31, 2020 2019 Accrued bonus expense $ 594 $ 858 Accrued vacation expense 158 77 Total $ 752 $ 935 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Summary of stock option activity | A summary of stock option activity for the nine months ended September 30, 2020 and the year ended December 31, 2019 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2018 938,982 $ 15.18 6.19 years $ — Granted 1,725,000 0.42 Exercised — — Expired (94,738) 58.25 Forfeited (67,232) 5.95 Balance - December 31, 2019 2,502,012 3.62 6.51 years 153,353 Granted — — Exercised — — Expired (12,037) 10.89 Forfeited (29,650) 0.55 Balance - September 30, 2020 - outstanding 2,460,325 $ 5.79 years $ 96,106 Balance - September 30, 2020 - exercisable 747,781 $ 5.14 years $ 13,196 Grant date fair value of options granted - nine months ended September 30, 2020 $ — Weighted average grant date fair value - nine months ended September 30, 2020 $ — Grant date fair value of options granted - year ended December 31, 2019 $ 470,000 Weighted average grant date fair value - year ended December 31, 2019 $ 0.27 |
Stock Warrants (Tables)
Stock Warrants (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stock Warrants | |
Summary of all warrant activity | A summary of all warrant activity for the Company for the nine months ended September 30, 2020 and the year ended December 31, 2019 is as follows: Number of Weighted Average Warrants Exercise Price Balance at December 31, 2018 18,915,851 $ 3.85 Granted — — Exercised — — Forfeited (200,852) 61.25 Balance at December 31, 2019 18,714,999 3.24 Granted — — Exercised — — Forfeited — — Balance at September 30, 2020 18,714,999 $ 3.24 |
Summary of all outstanding and exercisable warrants | A summary of all outstanding and exercisable warrants as of September 30, 2020 is as follows: Weighted Average Warrants Warrants Remaining Exercise Price Outstanding Exercisable Contractual Life $ 1.38 17,999,999 17,999,999 3.03 years 18.20 714 714 2.24 years 50.05 714,286 714,286 0.13 years $ 3.24 18,714,999 18,714,999 2.92 years |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies | |
Schedule of maturity analysis of operating leases | Future undiscounted cash flow for the years ending December 31: 2020 $ 79 2021 321 2022 192 Total 592 Discount factor (53) Lease liability 539 Amount due within 12 months (278) Lease liability – long term $ 261 |
Going Concern (Details)
Going Concern (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Going Concern | ||||
Accumulated deficit | $ (244,975) | $ (235,537) | ||
Cash and Cash Equivalents, at Carrying Value | $ 6,005 | $ 15,045 | $ 18,650 | $ 28,918 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Details) - Money market accounts - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Cash and cash equivalents | $ 114,000 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Cash and cash equivalents | $ 98,000 |
Selected Balance Sheet Inform_3
Selected Balance Sheet Information - Schedule of prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Selected Balance Sheet Information | ||
Prepaid clinical research organizations | $ 471 | $ 48 |
Prepaid consulting, subscriptions and other expenses | 74 | 134 |
Prepaid insurances | 73 | 549 |
Prepaid manufacturing expenses | 39 | 622 |
Prepaid conferences, travel and other expenses | 0 | 25 |
Other receivables | 0 | 3 |
Total | $ 657 | $ 1,381 |
Selected Balance Sheet Inform_4
Selected Balance Sheet Information - Schedule of property, plant and equipment, net (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | $ 1,258 | $ 1,254 |
Less: accumulated depreciation and amortization | (1,056) | (887) |
Total | 202 | 367 |
Computers and office equipment [Member] | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 808 | 804 |
Leasehold Improvements [Member] | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 439 | 439 |
Software [Member] | ||
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Selected Balance Sheet Information | ||
Accrued clinical consulting services | $ 660 | $ 684 |
Accrued vendor payments | 309 | 456 |
Accrued manufacturing costs | 18 | 635 |
Other accrued expenses | 1 | 1 |
Total | $ 988 | $ 1,776 |
Selected Balance Sheet Inform_6
Selected Balance Sheet Information - Schedule of accrued employee benefits (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Selected Balance Sheet Information | ||
Accrued bonus expense | $ 594 | $ 858 |
Accrued vacation expense | 158 | 77 |
Total | $ 752 | $ 935 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of stock option activity (Details) - Stock Option [Member] - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, Beginning Balance | 2,502,012 | 938,982 | |
Options, Granted | 0 | 1,725,000 | |
Options, Exercised | 0 | 0 | |
Options, Expired | (12,037) | (94,738) | |
Options, Forfeited | (29,650) | (67,232) | |
Options, Ending Balance | 2,460,325 | 2,502,012 | 938,982 |
Options, Exercisable | 747,781 | ||
Weighted Average Exercise Price, Beginning Balance | $ 3.62 | $ 15.18 | |
Weighted Average Exercise Price, Granted | 0 | 0.42 | |
Weighted Average Exercise Price, Exercised | 0 | 0 | |
Weighted Average Exercise Price, Expired | 10.89 | 58.25 | |
Weighted Average Exercise Price, Forfeited | 0.55 | 5.95 | |
Weighted Average Exercise Price, Ending Balance | 3.62 | $ 3.62 | $ 15.18 |
Weighted Average Exercise Price, Exercisable | $ 10.80 | ||
Weighted Average Remaining Contractual Life, Balance Outstanding | 5 years 9 months 15 days | 6 years 6 months 4 days | 6 years 2 months 9 days |
Weighted Average Remaining Contractual Life, Exercisable | 5 years 1 month 21 days | ||
Aggregate Intrinsic Value, Ending Balance | $ 96,106 | $ 153,353 | $ 0 |
Aggregate Intrinsic Value, Exercisable | 13,196 | ||
Grant date fair value of options granted | $ 0 | $ 470,000 | |
Weighted average grant date fair value | $ 0 | $ 0.27 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | Sep. 05, 2019 | Sep. 07, 2017 | May 15, 2015 | Sep. 24, 2018 | Aug. 25, 2016 | Oct. 22, 2013 | Mar. 20, 2007 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 17, 2020 | Dec. 31, 2019 | Nov. 02, 2010 |
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Net of Forfeitures | 0 | 0 | 0 | 0 | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 406,000 | $ 406,000 | ||||||||||||
Temporary Equity, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||
Employees | General and Administrative Expense | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Allocated Share-based Compensation Expense | $ 41,000 | $ 59,000 | $ 120,000 | $ 165,000 | ||||||||||
Employees | Research and Development Expense | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Allocated Share-based Compensation Expense | 14,000 | 22,000 | 45,000 | 52,000 | ||||||||||
Consultants | General and Administrative Expense | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Allocated Share-based Compensation Expense | 26,000 | 9,000 | 79,000 | 28,000 | ||||||||||
Consultants | Research and Development Expense | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Allocated Share-based Compensation Expense | $ 1,000 | $ 1,000 | $ 7,000 | $ 1,000 | ||||||||||
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 | 7,052 | 7,052 | |||||||||||
2007 Stock Plan [Member] | Maximum [Member] | ||||||||||||||
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 | 2,453,273 | 2,453,273 | 85,714 | |||||||||||
2010 Stock Plan [Member] | Maximum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 4,000,000 | 500,000 | 228,572 | 1,000,000 | 400,000 | 171,429 | ||||||||
2010 Stock Plan [Member] | Minimum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 1,000,000 | 400,000 | 171,429 | 500,000 | 228,572 | 85,714 | ||||||||
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 | 0 | 0 | 4,000,000 |
Stock Warrants - Additional Inf
Stock Warrants - Additional Information (Details) - USD ($) | Oct. 15, 2018 | Oct. 15, 2018 | Oct. 10, 2018 | Oct. 10, 2014 | Nov. 18, 2016 | Sep. 30, 2020 | Dec. 31, 2019 | Oct. 31, 2018 | Dec. 26, 2017 |
Equity, Class of Treasury Stock | |||||||||
Proceeds from Issuance or Sale of Equity | $ 18,600,000 | ||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 9,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 13,672,173 | 13,672,173 | |||||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | $ 1,000 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.38 | $ 1.38 | $ 1.38 | ||||||
Class A [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Stock Issued During Period, Shares, New Issues | 2,520,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 61.25 | ||||||||
Preferred Stock Conversion Price Per Share | $ 1.15 | $ 1.15 | |||||||
Class B [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Stock Issued During Period, Shares, New Issues | 15,723 | ||||||||
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 | 13,672,173 | |||||||
Stock Issued During Period, Value, Issued for Services | $ 1,000 | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | $ 1,000 | |||||||
Conversion of Stock, Shares Converted | 13,672,173 | 11,577 | |||||||
IPO [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 15,700,000 | ||||||||
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 | ||||||||
Sale of Stock, Price Per Share | $ 1.47 | $ 35 | |||||||
IPO [Member] | Series A [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 50.05 | ||||||||
IPO [Member] | Series B [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 60.20 | ||||||||
Over-Allotment Option [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Stock Issued During Period, Shares, New Issues | 2,428,825 | 2,428,825 | |||||||
Issuance Of Warrants To Purchase Of Common Stock | 1,807,826 | 1,807,826 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,428,825 | 2,428,825 | 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 | ||||||||
Series A Warrants [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Proceeds from Issuance of Common Stock | $ 19,100,000 | ||||||||
Sale of Stock, Number of Shares Issued in Transaction | 14,059,616 | ||||||||
Issuance Of Warrants To Purchase Of Common Stock | 0.50 | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award Warrants Vested and Expected To Vest Outstanding Number | 200,852 | ||||||||
Warrant [Member] | |||||||||
Equity, Class of Treasury Stock | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award Non Option Equity Instruments Warrants Exercisable Number | 714 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 13,672,173 | 13,672,173 |
Stock Warrants - Summary of all
Stock Warrants - Summary of all warrant activity (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Stock-Based Compensation | ||
Number of Warrants, Beginning Balance | 18,714,999 | 18,915,851 |
Number of Warrants, Granted | 0 | |
Number of Warrants, Exercised | 0 | |
Number of Warrants, Forfeited | 0 | (200,852) |
Number of Warrants, Ending Balance | 18,714,999 | 18,714,999 |
Weighted Average Exercise Price, Beginning Balance | $ 3.24 | $ 3.85 |
Weighted Average Exercise Price, Granted | 0 | |
Weighted Average Exercise Price, Exercised | 0 | |
Weighted Average Exercise Price, Forfeited | 0 | 61.25 |
Weighted Average Exercise Price, Ending Balance | $ 3.24 | $ 3.24 |
Stock warrants - Summary of a_2
Stock warrants - Summary of all outstanding and exercisable warrants (Details) | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Exercise Price 1.38 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.38 |
Warrants Outstanding | 17,999,999 |
Warrants Exercisable | 17,999,999 |
Weighted Average Remaining Contractual Life (in years) | 3 years 11 days |
Exercise Price 18.20 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 18.20 |
Warrants Outstanding | 714 |
Warrants Exercisable | 714 |
Weighted Average Remaining Contractual Life (in years) | 2 years 2 months 27 days |
Exercise Price 50.05 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 50.05 |
Warrants Outstanding | 714,286 |
Warrants Exercisable | 714,286 |
Weighted Average Remaining Contractual Life (in years) | 1 month 17 days |
Exercise price 3.24 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 3.24 |
Warrants Outstanding | 18,714,999 |
Warrants Exercisable | 18,714,999 |
Weighted Average Remaining Contractual Life (in years) | 2 years 11 months 1 day |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Net Loss Attributable to Non-controlling Interest | $ (8,000) | $ (16,000) | $ (26,000) | $ (30,000) | $ (27,000) | $ (16,000) | $ (50,000) | $ (73,000) |
preferred stock accrued dividends | 185,000 | |||||||
Series A Preferred Stock [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
preferred stock accrued dividends | 64,000 | 63,000 | 189,000 | 185,000 | ||||
Series B Preferred Stock [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Net Loss Attributable to Non-controlling Interest | 0 | $ 0 | $ 0 | 0 | $ 0 | $ 0 | ||
Accretion of preferred discount | 500,000 | 100,000 | 1,300,000 | 600,000 | ||||
preferred stock accrued dividends | $ 519,000 | $ 70,000 | $ 1,315,000 | $ 585,000 | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,605,217 | 6,641,739 | 3,605,217 | 6,641,739 | ||||
Equity Option [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,460,325 | 803,577 | ||||||
Warrant [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 18,714,999 | 18,915,851 |
Non-controlling Interest (Detai
Non-controlling Interest (Details) - USD ($) | Sep. 05, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
Noncontrolling Interest | |||||
Related Party Transaction, Expenses from Transactions with Related Party | $ 441,000 | ||||
Research and Development Expense | $ 914,000 | $ 4,144,000 | $ 4,152,000 | $ 9,156,000 | |
SYN Biomics | |||||
Noncontrolling Interest | |||||
Equity interest by parent | 83.00% | 83.00% | |||
Accumulated net loss attributable to the non-controlling interest | $ 2,800,000 | 2,800,000 | $ 2,800,000 | 2,800,000 | |
Cedarssinai Medical Center [Member] | |||||
Noncontrolling Interest | |||||
Number Of Common Stock To Be Issued | 50,000 | 0 | 0 | ||
Research and Development Expense | $ 134,000 | $ 108,000 | $ 225,000 | $ 318,000 | |
Fair Value Of Shares Issued | $ 285,000 | ||||
Cedarssinai Medical Center [Member] | SYN Biomics | |||||
Noncontrolling Interest | |||||
Additional Number Of Common Stock To Be Issued | 2,420,000 | ||||
Number Of Common Stock To Be Held By Related Party | 7,480,000 | ||||
Noncontrolling Interest, Ownership Percentage by Noncontrolling Owners | 17.00% |
Common and Preferred Stock (Det
Common and Preferred Stock (Details) | Oct. 15, 2018USD ($)$ / sharesshares | Oct. 10, 2018shares | Sep. 11, 2017USD ($)D$ / sharesshares | Aug. 05, 2016USD ($) | Oct. 31, 2018$ / shares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($)shares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($)shares | Dec. 31, 2019$ / shares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||
preferred stock accrued dividends | $ 185,000 | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 13,672,173 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 1.38 | $ 1.38 | ||||||||||
Preferred Stock Redemption Discount | $ 9,100,000 | |||||||||||
Percentage of issue of the public offering | 120.00% | |||||||||||
Common Stock, Discount on Shares | $ 4,400,000 | $ 4,400,000 | ||||||||||
Proceeds from Issuance or Sale of Equity | $ 18,600,000 | |||||||||||
Over-Allotment Option [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 2,428,825 | 2,428,825 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 2,428,825 | 2,428,825 | ||||||||||
Fbr Capital Markets Co Member | ||||||||||||
Brokerage Commission percentage | 3.00% | |||||||||||
Stock Issued During Period, Value, New Issues | $ 40,000,000 | |||||||||||
Warrant [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 13,672,173 | |||||||||||
Series A Preferred Stock [Member] | ||||||||||||
Preferred Stock, Dividend Rate, Percentage | 2.00% | 2.00% | ||||||||||
Preferred Stock Conversion Price Per Share | $ / shares | $ 18.90 | |||||||||||
Debt Instrument, Convertible, Threshold Trading Days | D | 20 | |||||||||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | D | 30 | |||||||||||
Dividends Payable, Amount Per Share | $ / shares | $ 70 | |||||||||||
Adjustments to Additional Paid in Capital, Stock Split | $ 7,875 | |||||||||||
preferred stock accrued dividends | 64,000 | $ 63,000 | 189,000 | 185,000 | ||||||||
Preferred Stock Redemption Discount | $ 6,900,000 | |||||||||||
Series A Preferred Stock [Member] | Private Placement [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 120,000 | |||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 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] | ||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 1,000 | |||||||||||
preferred stock accrued dividends | $ 519,000 | $ 70,000 | $ 1,315,000 | $ 585,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 13,672,173 | |||||||||||
Stock Issued During Period, Value, Issued for Services | $ 1,000 | |||||||||||
Percentage Exceed Aggregate Number Of Common Stock | 4.99% | |||||||||||
Percentage Exceed Aggregate Number Of Common Stock Outstanding | 9.99% | |||||||||||
Increase Decrease in Excess of Other Percentage | 9.99% | |||||||||||
Preferred Stock Shares Converted | shares | 1,379 | 185 | 3,492 | 1,523 | ||||||||
Preferred Shares, Unamortized Discount From Conversion | $ 519,000 | $ 71,000 | $ 1,315,000 | $ 585,000 | ||||||||
Conversion of Stock, Shares Converted | shares | 13,672,173 | 11,577 | ||||||||||
Common Class A [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 2,520,000 | |||||||||||
Shares Issued, Price Per Share | $ / shares | $ 1.15 | |||||||||||
Common Class B [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 15,723 | |||||||||||
Preferred Stock Conversion Price Per Share | $ / shares | $ 1.15 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 9 Months Ended | |||||
Sep. 30, 2020 | Dec. 31, 2019 | Oct. 31, 2018 | Oct. 15, 2018 | Sep. 05, 2018 | Nov. 18, 2016 | |
Related Party Transaction | ||||||
Common Stock, Shares, Issued | 19,845,283 | 16,808,758 | ||||
Common Stock, Value, Issued | $ 20,000 | $ 17,000 | ||||
Common Stock, Par or Stated Value Per Share | $ (0.001) | $ (0.001) | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 13,672,173 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.38 | $ 1.38 | ||||
IPO [Member] | ||||||
Related Party Transaction | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,428,571 | |||||
Synthetic Biomics Inc [Member] | ||||||
Related Party Transaction | ||||||
Additional Number Of Common Stock To Be Issued | 2,420,000 | |||||
Cedarssinai Medical Center [Member] | ||||||
Related Party Transaction | ||||||
Number Of Common Stock To Be Issued | 0 | 50,000 | ||||
Acceleration of expense recognition as a result of discontinuation | $ 141,000 | |||||
Cedarssinai Medical Center [Member] | Synthetic Biomics Inc [Member] | ||||||
Related Party Transaction | ||||||
Number Of Common Stock To Be Held By Related Party | 0 | 7,480,000 | ||||
Noncontrolling Interest, Ownership Percentage by Noncontrolling Owners | 0.00% | 17.00% |
Commitments and Contingencies -
Commitments and Contingencies - Maturity analysis of operating leases (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Commitments and Contingencies | ||
2020 | $ 79 | |
2021 | 321 | |
2022 | 192 | |
Total | 592 | |
Discount factor | (53) | |
Lease liability | 539 | |
Amount due within 12 months | (278) | $ (249) |
Lease liability - Long term | $ 261 | $ 473 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Commitments and Contingencies | ||||
Operating Lease, Weighted Average Discount Rate, Percent | 9.90% | 9.90% | ||
Operating Lease, Cost | $ 50,000 | $ 50,000 | $ 151,000 | $ 151,000 |
Operating Lease, Payments | $ 77,000 | $ 75,000 | 231,000 | 224,000 |
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | $ 0 | $ 538,000 | ||
Operating Lease Expiration Year | 2022 |