XML 12 R1.htm IDEA: XBRL DOCUMENT

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	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

XML 13 R2.htm IDEA: XBRL DOCUMENT

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

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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

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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)

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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

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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-Subparagraph (SX 210.4-08(g)(1)(ii))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 830
-SubTopic 30
-Section 50
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=6450520&loc=d3e32583-110901

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 718
-SubTopic 10
-Section 65
-Paragraph 15
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=121322162&loc=SL121327923-165333

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 65
-Paragraph 8
-Subparagraph (d)(2)

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 65
-Paragraph 8
-Subparagraph (d)(3)

+ Details

XML 17 R6.htm IDEA: XBRL DOCUMENT

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

XML 18 R7.htm IDEA: XBRL DOCUMENT

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.

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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.

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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.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

XML 21 R10.htm IDEA: XBRL DOCUMENT

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

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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	$	3.62	5.79 years	$	96,106

Balance - September 30, 2020 - exercisable	747,781	$	10.80	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.

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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

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Net Loss per Share	9 Months Ended
Net Loss per Share	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.

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Non-controlling Interest	9 Months Ended
Non-controlling Interest	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.

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Common and Preferred Stock	9 Months Ended
Common and Preferred Stock	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.

XML 27 R16.htm IDEA: XBRL DOCUMENT

Related Party Transactions	9 Months Ended
Related Party Transactions	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.

XML 28 R17.htm IDEA: XBRL DOCUMENT

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.

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Subsequent Events	9 Months Ended
Subsequent Events	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.

XML 30 R19.htm IDEA: XBRL DOCUMENT

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

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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	$	3.62	5.79 years	$	96,106

Balance - September 30, 2020 - exercisable	747,781	$	10.80	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

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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

XML 33 R22.htm IDEA: XBRL DOCUMENT

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

XML 34 R23.htm IDEA: XBRL DOCUMENT

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

XML 35 R24.htm IDEA: XBRL DOCUMENT

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

XML 36 R25.htm IDEA: XBRL DOCUMENT

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

XML 37 R26.htm IDEA: XBRL DOCUMENT

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

XML 38 R27.htm IDEA: XBRL DOCUMENT

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

XML 39 R28.htm IDEA: XBRL DOCUMENT

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

XML 40 R29.htm IDEA: XBRL DOCUMENT

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	0.00	0.42
Weighted Average Exercise Price, Exercised	0.00	0.00
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	$ 0.00	$ 0.27

XML 41 R30.htm IDEA: XBRL DOCUMENT

Stock-Based Compensation - Additional Information (Details) - USD ($)				1 Months Ended				3 Months Ended		9 Months Ended
	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

XML 42 R31.htm IDEA: XBRL DOCUMENT

Stock Warrants - Additional Information (Details) - USD ($)					1 Months Ended	9 Months Ended
	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	$ 35.00
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

XML 43 R32.htm IDEA: XBRL DOCUMENT

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

XML 44 R33.htm IDEA: XBRL DOCUMENT

Stock warrants - Summary of all outstanding and exercisable warrants (Details)	9 Months Ended
	Sep. 30, 2020 $ / shares shares
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

XML 45 R34.htm IDEA: XBRL DOCUMENT

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

XML 46 R35.htm IDEA: XBRL DOCUMENT

Non-controlling Interest (Details) - USD ($)		3 Months Ended		9 Months Ended
Non-controlling Interest (Details) - USD ($)	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%

XML 47 R36.htm IDEA: XBRL DOCUMENT

Common and Preferred Stock (Details)					1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended
Common and Preferred Stock (Details)	Oct. 15, 2018 USD ($) $ / shares shares	Oct. 10, 2018 shares	Sep. 11, 2017 USD ($) D $ / shares shares	Aug. 05, 2016 USD ($)	Oct. 31, 2018 $ / shares	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 30, 2019 USD ($) shares	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 30, 2019 USD ($) shares	Dec. 31, 2019 $ / shares	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)
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			$ 70.00
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

XML 48 R37.htm IDEA: XBRL DOCUMENT

Related Party Transactions (Details) - USD ($)	9 Months Ended
Related Party Transactions (Details) - USD ($)	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%

XML 49 R38.htm IDEA: XBRL DOCUMENT

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

XML 50 R39.htm IDEA: XBRL DOCUMENT

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

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M% 7\NFRUB6D<=1HN/^9!@D6& N&$M U6OWY'LWV&4_O/ M_P]02P$"% ,4 " 0B&I11=U*=M/3 !I=A $ @ $ M 6XM,C R,# Y,S N>'-D4$L! A0#% M @ $(AJ43UMH=4B"P 59( !0 ( !NN( '-Y;BTR,#(P M,#DS,%]C86PN>&UL4$L! A0#% @ $(AJ4=+/FO*^(@ 3U$" !0 M ( !#NX '-Y;BTR,#(P,#DS,%]D968N>&UL4$L! A0#% @ M$(AJ4; !(]\H3@ 5Y $ !0 ( !_A ! '-Y;BTR,#(P,#DS M,%]L86(N>&UL4$L! A0#% @ $(AJ4?:>1D@Z-P O@4$ !0 M ( !6%\! '-Y;BTR,#(P,#DS,%]P&UL4$L%!@ & 8 A $ ' ,26 0 $! end

Nevada	13-3808303
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)

9605 Medical Center Drive, Suite 270
Rockville, MD	20850
(Address of Principal Executive Offices)	(Zip Code)

		Page
	PART I. FINANCIAL INFORMATION	3

Item 1.	Financial Statements (Unaudited)	3

	Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019	3
	Condensed Consolidated Statements of Operations for the Three and Nine Months ended September 30, 2020 and 2019	4
	Condensed Consolidated Statements of Stockholders’ (Deficit) Equity for the Nine Months ended September 30, 2020 and 2019	5
	Condensed Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2020 and 2019	6
	Notes to Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	35
Item 4.	Controls and Procedures	35

	PART II. OTHER INFORMATION	35

Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	35
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	38
Item 3.	Defaults Upon Senior Securities	39
Item 4.	Mine Safety Disclosures	39
Item 5.	Other Information	39
Item 6.	Exhibits	39

SIGNATURES		40

Therapeutic Area	Product Candidate	Developments & Milestones

Prevention of microbiome damage, CDI, overgrowth of pathogenic organisms, AMR, and aGVHD in allogeneic HCT recipients (Degrade IV beta-lactam antibiotics)	SYN-004 (ribaxamase) (oral enzyme)	· Announced outcomes from End of Phase 2 meeting, including FDA-proposed criteria for Phase 3 clinical efficacy and safety which, if achieved, may support submission for marketing approval on the basis of a single Phase 3 clinical trial (Q4 2018) · Anticipate initiation of the Phase 3 clinical program proposed by the FDA for the prevention of CDI only after securing additional potential funding via a strategic partnership · Clarified market/potential partner needs and identified potential additional indications in specialty patient populations such as allogeneic hematopoietic cell transplant patients · Announced clinical trial agreement (CTA) with Washington University School of Medicine to conduct a Phase 1b/2a clinical trial to evaluate safety, tolerability and pharmacokinetics in up to 36 evaluable adult allogeneic HCT recipients (Q3 2019) · Received official meeting minutes from FDA Type-C meeting held on December 2, 2019 to discuss development in allogeneic HCT recipients who are administered IV beta-lactam antibiotics in response to fever (Q1 2020) · Received written notification from the FDA informing the Company that the FDA determined the Phase 1b/2a clinical program in adult allogeneic hematopoietic cell transplant (HCT) recipients may proceed per the submitted clinical program protocol (Q3 2020) · Proposed Phase 1b/2a clinical trial to be conducted by Washington University in adult allogeneic HCT is anticipated to commence during Q1 2021, subject to COVID-19 global pandemic

Treatment of IBS-C	SYN-010 (oral modified-release lovastatin lactone)	· Confirmed key elements of Pivotal Phase 2b/3 clinical trial design pursuant to consultations with FDA (Q1 2017) · Entered into agreement with CSMC for an investigator-sponsored Phase 2b clinical study of SYN-010 to evaluate SYN-010 dose response and inform Phase 3 clinical development (Q3 2018) · Patient recruitment and enrollment in the Phase 2b investigator-sponsored clinical study recommenced following a temporary halt in Q1 and Q2 due to the COVID-19 global pandemic (Q3 2020) · Announced results from a planned interim futility analysis which concluded that although SYN-010 was well-tolerated, it was unlikely to meet its primary objective by the time enrollment is completed. As a result, CSMC has agreed to discontinue the trial and will conduct a comprehensive review of the final data set and publish its findings (Q3 2020)

	•	postponement in clinical site initiation for our SYN-004 clinical study;

	•	postponement of the initiation of our SYN-020 single ascending dose (SAD) study

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	SYN	NYSE American

	September 30, 2020			December 31, 2019
Assets

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

Liabilities and Stockholders' Deficit

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

	For the three months ended September 30,						For the nine months ended September 30,
	2020			2019			2020			2019
Operating Costs and Expenses:
General and administrative	$	1,197		$	1,098		$	3,876		$	3,297
Research and development		914			4,144			4,152			9,156
Total Operating Costs and Expenses		2,111			5,242			8,028			12,453

Loss from Operations		(2,111	)		(5,242	)		(8,028	)		(12,453	)

Other Income:
Interest income		-			92			44			217
Total Other Income		-			92			44			217

Net Loss		(2,111	)		(5,150	)		(7,984	)		(12,236	)

Net Loss Attributable to Non-controlling Interest		(8	)		(30	)		(50	)		(73	)

Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries	$	(2,103	)	$	(5,120	)	$	(7,934	)	$	(12,163	)

Series A Preferred Stock Dividends		(64	)		(63	)		(189	)		(185	)
Series B Preferred Stock Dividends		(519	)		(70	)		(1,315	)		(585	)

Net Loss Attributable to Common Stockholders	$	(2,686	)	$	(5,253	)	$	(9,438	)	$	(12,933	)

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

	Common Stock				Series B Preferred
	Shares		Amount		Shares			Amount			APIC		Accumulated Deficit			Non- Controlling Interest			Total Stockholders' Equity (Deficit)
Balance at December 31, 2019		16,806,430	$	17		7,638		$	4,761		$	232,580	$	(235,537	)	$	(2,878	)	$	(1,057	)

Stock-based compensation		-		-		-			-			83		-			-			83
Series A Preferred Stock Dividends ($0.01 per share)		-		-		-			-			-		(62	)		-			(62	)
Issuance of SYN Biomics Stock		-		-		-			-					-			26			26
Conversion of Series B Preferred Stock to Common ($0.03 per share)		933,045		1		(1,073	)		(669	)		1,072		(404	)		-			-
Net loss		-		-		-			-			-		(2,964	)		-			(2,964	)
Non-controlling interest		-		-		-			-			-		-			(26	)		(26	)

Balance at March 31, 2020		17,739,475	$	18		6,565		$	4,092		$	233,735	$	(238,967	)	$	(2,878	)	$	(4,000	)

Stock-based compensation		-		-		-			-			86		-			-			86
Series A Preferred Stock Dividends ($0.01 per share)		-		-		-			-			-		(63	)		-			(63	)
Issuance of SYN Biomics Stock		-		-		-			-			-		-			10			10
Conversion of Series B Preferred Stock to Common ($0.03 per share)		904,349		1		(1,040	)		(648	)		1,039		(392	)		-			-
Net loss		-		-		-			-			-		(2,867	)		-			(2,867	)
Non-controlling interest		-		-		-			-			-		-			(16	)		(16	)

Balance at June 30, 2020		18,643,824	$	19		5,525		$	3,444		$	234,860	$	(242,289	)	$	(2,884	)	$	(6,850	)

Stock-based compensation		-		-		-			-			82		-			-			82
Series A Preferred Stock Dividends ($0.01 per share)		-		-		-			-			-		(64	)		-			(64	)
Issuance of SYN Biomics Stock		-		-		-			-			-		-			142			142
Conversion of Series B Preferred Stock to Common ($0.03 per share)		1,199,131		1		(1,379	)		(860	)		1,378		(519	)		-			-
Net loss		-		-		-			-			-		(2,103	)		-			(2,103	)
Non-controlling interest		-		-		-			-			-		-			(8	)		(8	)

Balance at September 30, 2020		19,842,955	$	20		4,146		$	2,584		$	236,320	$	(244,975	)	$	(2,750	)	$	(8,801	)

	For the nine months ended September 30,
	2020			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
Purchase of property and equipment		(4	)		-
Net Cash Used In Investing Activities		(4	)		-

Net Cash From Financing Activities		-			-

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:
Conversion of Series B Preferred Stock	$	2,177		$	938
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	$	-		$	538

	September 30, 2020		December 31, 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

	Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life	Aggregate Intrinsic 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		$	3.62	5.79 years	$	96,106

Balance – September 30, 2020 - exercisable		747,781		$	10.80	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

	Number of Warrants			Weighted Average 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

Exercise Price		Warrants Outstanding		Warrants Exercisable		Weighted Average Remaining 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

Therapeutic Areas *(in thousands)*	September 30, 2020		September 30, 2019
SYN-004 (ribaxamase	$	76	$	73
SYN-010		45		174
SYN-005		1		7

Total direct costs		122		254
Total indirect costs		792		3,890

Total	$	914	$	4,144

Therapeutic Areas (in thousands)	September 30, 2020		September 30, 2019
SYN-010	$	293	$	426
SYN-004 (ribaxamase)		181		185
Other therapeutic areas		30		23
Total direct costs		504		634
Total indirect costs		3,648		8,522

Total	$	4,152	$	9,156

	SYNTHETIC BIOLOGICS, INC.

	By:	/s/ Steven A. Shallcross
		Steven A. Shallcross
		Chief Executive Officer, Chief Financial Officer
		(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

		Date: November 10, 2020

10.1		Termination of Exclusive License Agreement, effective November 9, 2020, by and among Cedars- Sinai Medical Center, Synthetic Biologics, Inc. and Synthetic Biomics, Inc.*

31.1		Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a)*

32.1		Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

101.INS		XBRL Instance Document*

101.SCH		XBRL Taxonomy Extension Schema*

101.CAL		XBRL Taxonomy Extension Calculation Linkbase*

101.DEF		XBRL Taxonomy Extension Definition Linkbase*

101.LAB		XBRL Taxonomy Extension Label Linkbase*

101.PRE		XBRL Taxonomy Extension Presentation Linkbase*

SYNTHETIC BIOLOGICS, INC.		SYNTHETIC BIOMICS, INC.

By:	/s/ Steve Shallcross	By:	/s/ Steve Shallcross
	Name: Steve Shallcross		Name: Steve Shallcross
	Title: Chief Executive Officer		Title: Chief Executive Officer

CEDARS-SINAI MEDICAL CENTER

By:	/s/ James D. Laur, JD
	Name: James D. Laur, JD
	Title: Vice President, Intellectual Property

Date: November 10, 2020	By:	/s/ Steven A. Shallcross
		Name: Steven A. Shallcross
		Chief Executive Officer, Chief Financial Officer
		(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

Large Accelerated Filer

Accelerated Filer

Non-accelerated Filer

Smaller Reporting Company

Emerging growth company