0001104659-19-059538.txt : 20191104 0001104659-19-059538.hdr.sgml : 20191104 20191104163637 ACCESSION NUMBER: 0001104659-19-059538 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 60 CONFORMED PERIOD OF REPORT: 20190930 FILED AS OF DATE: 20191104 DATE AS OF CHANGE: 20191104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Synthetic Biologics, Inc. CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133808303 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-12584 FILM NUMBER: 191190343 BUSINESS ADDRESS: STREET 1: 9605 MEDICAL CENTER DRIVE STREET 2: SUITE 270 CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: (734) 332-7800 MAIL ADDRESS: STREET 1: 9605 MEDICAL CENTER DRIVE STREET 2: SUITE 270 CITY: ROCKVILLE STATE: MD ZIP: 20850 FORMER COMPANY: FORMER CONFORMED NAME: ADEONA PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20081027 FORMER COMPANY: FORMER CONFORMED NAME: PIPEX PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20061214 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC DATE OF NAME CHANGE: 19970730 10-Q 1 tm1919613-1_10q.htm FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2019

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934

For the transition period from ____________ to ____________

Commission File Number: 001-12584

SYNTHETIC BIOLOGICS, INC.

(Exact name of Registrant as Specified in Its Charter)

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)

(301) 417-4364

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

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

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer, “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ¨ No x

As of October 31, 2019, the registrant had 16,806,430 shares of common stock, $0.001 par value per share, outstanding.

SYNTHETIC BIOLOGICS, INC.

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In particular, statements contained in this Quarterly Report on Form 10-Q, including but not limited to, statements regarding the timing of our clinical trials, the development and commercialization of our pipeline products, the sufficiency of our cash, our ability to finance our operations and business initiatives and obtain funding for such activities and the timing of any such financing, our future results of operations and financial position, business strategy and plan prospects, or costs and objectives of management for future research, development or operations, are forward-looking statements. These forward-looking statements relate to our future plans, objectives, expectations and intentions and may be identified by words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “seeks,” “goals,” “estimates,” “predicts,” “potential” and “continue” or similar words. Readers are cautioned that these forward-looking statements are based on our current beliefs, expectations and assumptions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A. “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, and those identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission (the “SEC”) on February 27, 2019, as amended by the Form 10-K/A (Amendment No. 1) for the year ended December 31, 2018 filed with the SEC on April 1, 2019 (“2018 Form 10-K”). Therefore, actual results may differ materially and adversely from those expressed, projected or implied in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.

NOTE REGARDING COMPANY REFERENCES

Throughout this Quarterly Report on Form 10-Q, “Synthetic Biologics,” the “Company,” “we,” “us” and “our” refer to Synthetic Biologics, Inc.

NOTE REGARDING TRADEMARKS

All trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.

SYNTHETIC BIOLOGICS, INC.

FORM 10-Q

TABLE OF CONTENTS

		Page
	PART I. FINANCIAL INFORMATION	3

Item 1.	Financial Statements (Unaudited)	3

	Condensed Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018	3
	Condensed Consolidated Statements of Operations for the Three and Nine Months ended September 30, 2019 and 2018	4
	Condensed Consolidated Statements of Stockholders Equity for the Three and Nine Months ended September 30, 2019 and 2018	5
	Condensed Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2019 and 2018	6
	Notes to Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4.	Controls and Procedures	29

	PART II. OTHER INFORMATION	29

Item 1.	Legal Proceedings	29
Item 1A.	Risk Factors	29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	30

SIGNATURES		31

PART I–FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)

Synthetic Biologics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands except share and per share amounts)

	September 30, 2019			December 31, 2018
Assets

Current Assets
Cash and cash equivalents	$	18,650		$	28,918
Prepaid expenses and other current assets		1,193			593
Total Current Assets		19,843			29,511

Property and equipment, net		425			607

Right of Use Asset		451			-

Deposits and other assets		23			23

Total Assets	$	20,742		$	30,141

Liabilities and Stockholders' Equity

Current Liabilities:
Accounts payable	$	2,452		$	1,034
Accrued expenses		2,321			919
Accrued employee benefits		619			1,332
Deferred rent		-			99
Lease liability		241			-
Total Current Liabilities		5,633			3,384

Long term deferred rent		-			302
Lease liability - Long term		539			-

Total Liabilities		6,172			3,686
Series A convertible preferred stock, $0.001 par value; 10,000,000 shares authorized; 120,000 issued and outstanding		12,481			12,296
Stockholders' Equity:
Series B Convertible Preferred stock, $1,000 par value; 10,000,000 shares authorized, 7,638 issued and outstanding and 9,161 issued and outstanding		4,822			5,760
Common stock, $0.001 par value; 200,000,000 shares authorized, 16,808,758 issued and 16,806,430 outstanding and 15,484,411 issued and 15,482,083 outstanding		17			15
Additional paid-in capital		232,485			230,754
Accumulated deficit		(232,394	)		(219,461	)
Total Synthetic Biologics, Inc. and Subsidiaries Equity		4,930			17,068
Non-controlling interest		(2,841	)		(2,909	)
Total Stockholders' Equity		2,089			14,159

Total Liabilities and Stockholders' Equity	$	20,742		$	30,141

See accompanying notes to unaudited condensed consolidated financial statements.

Synthetic Biologics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(In thousands except share and per share amounts)

(Unaudited)

	For the three months ended September 30,						For the nine months ended September 30,
	2019			2018			2019			2018
Operating Costs and Expenses:
General and administrative	$	1,098		$	1,474		$	3,297		$	4,525
Research and development		4,144			2,846			9,156			9,788
Total Operating Costs and Expenses		5,242			4,320			12,453			14,313

Loss from Operations		(5,242	)		(4,320	)		(12,453	)		(14,313	)

Other Income:
Change in fair value of warrant liability		-			626			-			4,064
Interest income		92			5			217			20
Total Other Income		92			631			217			4,084

Net Loss		(5,150	)		(3,689	)		(12,236	)		(10,229	)

Net Loss Attributable to Non-controlling Interest		(30	)		(9	)		(73	)		(35	)

Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries	$	(5,120	)	$	(3,680	)	$	(12,163	)	$	(10,194	)
Series A Preferred Stock Dividends		(63	)		(61	)		(185	)		(181	)
Series B Preferred Stock Dividends		(70	)		-			(585	)		-

Net Loss Attributable to Common Stockholders	$	(5,253	)	$	(3,741	)	$	(12,934	)	$	(10,375	)

Net Loss Per Share - Basic and Dilutive	$	(0.31	)	$	(0.93	)	$	(0.79	)	$	(2.73	)

Weighted average number of shares outstanding during the period - Basic and Dilutive		16,805,257			4,028,304			16,313,326			3,802,812

See accompanying notes to unaudited condensed consolidated financial statements.

Synthetic Biologics, Inc. and Subsidiaries

Consolidated Statements of Stockholders Equity

(In thousands, except share amounts)

	Common Stock $0.001 Par Value				Series B Preferred
	Shares		Amount		Shares			Amount			APIC			Accumulated Deficit			Non-Controlling Interest			Total Stockholders' Equity

Balance at December 31, 2018		15,482,083	$	15		9,161		$	5,760		$	230,754		$	(219,461	)	$	(2,909	)	$	14,159

Stock-based compensation		-		-		-			-			64			-			-			64
Series A Preferred Stock Dividends ($0.01 per share)		-		-		-			-			-			(61	)		-			(61	)
Issuance of SYN Biomics Stock		-		-		-			-			(36	)		-			53			17
Conversion of Series B Preferred Stock to Common ($0.03 per share)		900,869		1		(1,036	)		(638	)		1,035			(398	)		-			-
Net loss		-		-		-			-			-			(3,512	)		-			(3,512	)
Non-controlling interest		-		-		-			-			-			-			(16	)		(16	)

Balance at March 31, 2019		16,382,952	$	16		8,125		$	5,122		$	231,817		$	(223,432	)	$	(2,872	)	$	10,651

Stock-based compensation		-		-		-			-			91			-			-			91
Series A Preferred Stock Dividends ($0.01 per share)		-		-		-			-			-			(61	)		-			(61	)
Issuance of SYN Biomics Stock		-		-		-			-			-			-			45			45
Conversion of Series B Preferred Stock to Common ($0.03 per share)		262,608		1		(302	)		(187	)		303			(117	)		-			-
Net loss		-		-		-			-			-			(3,531	)		-			(3,531	)
Non-controlling interest		-		-		-			-			-			-			(27	)		(27	)

Balance at June 30, 2019		16,645,560	$	17		7,823		$	4,935		$	232,211		$	(227,141	)	$	(2,854	)	$	7,168

Stock-based compensation		-		-		-			-			91			-			-			91
Series A Preferred Stock Dividends ($0.01 per share)		-		-		-			-			-			(63	)		-			(63	)
Issuance of SYN Biomics Stock		-		-		-			-			-			-			43			43
Conversion of Series B Preferred Stock to Common ($0.03 per share)		160,870		-		(185	)		(113	)		183			(70	)		-			-
Net loss		-		-		-			-			-			(5,120	)		-			(5,120	)
Non-controlling interest		-		-		-			-			-			-			(30	)		(30	)

Balance at September 30, 2019		16,806,430	$	17		7,638		$	4,822		$	232,485		$	(232,394	)	$	(2,841	)	$	2,089

	Common Stock $0.001 Par Value				Series B Preferred
	Shares		Amount		Shares		Amount		APIC		Accumulated Deficit			Non-Controlling Interest			Total Stockholders' (Deficit)

Balance at December 31, 2017		3,671,014	$	4		-	$	-	$	192,670	$	(194,170	)	$	(1,914	)	$	(3,410	)

Stock-based compensation		-		-		-		-		676		-			-			676
Fair Value of Warrants issued		-		-		-		-		9		-			-			9
Series A Preferred Stock Dividends ($0.02 per share)		-		-		-		-		-		(59	)		-			(59	)
Net loss		-		-		-		-		-		(2,316	)		-			(2,316	)
Non-controlling interest		-		-		-		-		-		-			(9	)		(9	)

Balance at March 31, 2018		3,671,014	$	4		-	$	-	$	193,355	$	(196,545	)	$	(1,923	)	$	(5,109	)


Stock-based compensation		-		-		-		-		557		-			-			557
Series A Preferred Stock Dividends ($0.02 per share)		-		-		-		-		-		(61	)		-			(61	)
Stock issued under "at-the-market" offering		49,490				-		-		400		-			-			400
Net loss		-		-		-		-		-		(4,198	)		-			(4,198	)
Non-controlling interest		-		-		-		-		-		-			(16	)		(16	)

Balance at June 30, 2018		3,720,504	$	4		-	$	-	$	194,312	$	(200,804	)	$	(1,939	)	$	(8,427	)

Stock-based compensation		-		-		-		-		475		-			-			475
Series A Preferred Stock Dividends ($0.02 per share)		-		-		-		-		-		(61	)		-			(61	)
Stock issued under "at-the-market" offering		1,628,498		1		-		-		6,020		-			-			6,021
Net loss		-		-		-		-		-		(3,680	)		-			(3,680	)
Non-controlling interest		-		-		-		-		-		-			(9	)		(9	)

Balance at September 30, 2018		5,349,002	$	5		-	$	-	$	200,807	$	(204,545	)	$	(1,948	)	$	(5,681	)

Synthetic Biologics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

	For the Nine Months Ended September 30,
	2019			2018
Cash Flows From Operating Activities:
Net loss	$	(12,236	)	$	(10,229	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		246			1,708
Subsidiary stock issued to consultant		104			-
Warrant issued to consultant		-			9
Change in fair value of warrant liabilities		-			(4,064	)
Depreciation and amortization		182			207
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(600	)		268
Right of use asset		86			-
Accounts payable		1,419			(1,141	)
Accrued expenses		1,403			(41	)
Accrued employee benefits		(713	)		(640	)
Lease liability		(159	)		-
Deferred rent		-			(66	)
Net Cash Used In Operating Activities		(10,268	)		(13,989	)

Net Cash Used In Investing Activities		-			-

Cash Flows From Financing Activities:
Proceeds from issuance ATM offering, net of issuance costs		-			6,422
Net Cash Provided By Financing Activities		-			6,422

Net decrease in cash		(10,268	)		(7,567	)

Cash and cash equivalents at beginning of period		28,918			17,116
Cash and cash equivalents at end of period	$	18,650		$	9,549

Noncash Financing Activities:
Right of use asset from operating lease	$	538		$	-
Conversion of Series B Preferred Stock	$	938		$	-
Deemed dividends for beneficial conversion features	$	585		$	-
In-kind dividends paid in preferred stock	$	185		$	181

See accompanying notes to unaudited condensed consolidated financial statements.

Synthetic Biologics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company’s lead 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-010 which is intended 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). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases.

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 2018 Form 10-K. The interim results for the three and nine months ended September 30, 2019 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.

Liquidity

As of September 30, 2019, the Company has a significant accumulated deficit and with the exception of the three months ended June 30, 2010 and December 31, 2017, the Company has experienced significant losses and incurred negative cash flows since inception. The Company expects to continue incurring losses for the foreseeable future, with the recognition of revenue being contingent on successful phase 3 clinical trials and requisite approvals by the FDA. Historically, the Company has financed its operations primarily through public and private sales of its common stock and a private placement of its preferred stock, and it expects to continue to seek to obtain required capital in a similar manner. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including planned product development efforts, clinical trials and research and discovery efforts.

Cash and cash equivalents totaled approximately $18.7 million as of September 30, 2019, which includes the net proceeds of approximately $16.7 million from the sale of securities in October 2018 (the Offering) and net proceeds of approximately $12.2 million from sales of the Company’s Common Stock, $0.001 par value (the “Common Stock”) in “at-the-market” (ATM) equity offerings during 2018. With $17.6 million in cash available in early November 2019, the Company believes these resources will be sufficient to fund its operations through at least the end of the fourth quarter of 2020. Management believes its plan, which includes the further development of SYN-020 and additional testing of SYN-004 (ribaxamase) and SYN-010, will allow the Company to meet its financial obligations, further advance key products, and maintain the Company’s planned operations for at least one year from the issuance date of these consolidated financial statements, while not sacrificing the strategic direction of the Company. If necessary, the Company may attempt to utilize the ATM or seek to raise additional capital on the open market, neither of which is guaranteed. Use of the ATM is limited by certain restrictions and management’s plan does not rely on additional capital from either of these sources. If the Company is not able to obtain additional capital (which is not assured at this time), the Company’s long term business plan may not be accomplished and the Company may be forced to cease certain development activities. More specifically, the completion of a Phase 3 clinical trial will require significant financing or a significant partnership.

Reverse Stock Split

On August 10, 2018, the Company effected a one for thirty-five reverse stock split (the “Reverse Stock Split”) of its authorized, issued and outstanding common stock. Unless otherwise noted, all references to share amounts in these financial statements reflect the Reverse Stock Split.

Every thirty-five shares of issued and outstanding Common Stock were automatically combined into one issued and outstanding share of Common Stock, without any change in the par value per share of Common Stock. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the Reverse Stock Split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital.

The Reverse Stock Split affected all issued and outstanding shares of Common Stock, as well as Common Stock underlying stock options, warrants and convertible instruments outstanding immediately prior to the effectiveness of the Reverse Stock Split. The Reverse Stock Split reduced the total number of shares of Common Stock outstanding at the time of the Reverse Stock Split from approximately 128.5 million to approximately 3.7 million.

Recent Accounting Pronouncements and Developments

In February 2016, the FASB issued Accounting Standards Codification (“ASC”) 842, Leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the balance sheet and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective transition approach and provides for certain practical expedients. The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition approach wherein we applied the guidance to each lease that had commenced as of January 1, 2019 (the beginning of effective date) with a cumulative effect adjustment as of that date. The prior comparative period was not adjusted under this method and the Company has provided the required disclosures under ASC 840, Leases for the comparative period to which ASC 840 is applied. The Company has have also elected to adopt the following package of practical expedients:

	·	the Company did not reassess if any expired or existing contracts are or contain leases.
	·	the Company did not reassess the initial direct costs for existing leases.
	·	the Company did not reassess the classification of any expired or existing leases.

Additionally, the Company made ongoing accounting policy elections whereby it (i) did not recognize right of use (“ROU”) assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) does not combine lease and non-lease elements of its operating leases. The determination of whether an arrangement contains a lease and the classification of a lease, if applicable, is made at lease commencement.

Upon adoption of the new guidance on January 1, 2019, the Company recorded a ROU asset of approximately $537,000 (net of taxes and existing deferred rent liability) and recognized a lease liability of approximately $939,000.

2. Fair Value of Financial Instruments

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, included in Level 1 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 $98,000 as of September 30, 2019 and December 31, 2018 that are measured using Level 1 inputs.

The Company uses Monte Carlo simulations to estimate the fair value of its stock warrants. In using this model, the fair value is determined by applying Level 3 inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the warrant liability and the change in estimated fair value could be materially different.

3. Selected Balance Sheet Information

Prepaid expenses and other current assets (in thousands)

	September 30, 2019		December 31, 2018
Prepaid manufacturing expenses	$	1,001	$	-
Prepaid consulting, subscriptions and other expenses		123		132
Prepaid insurance		65		419
Other receivable		4		-
Prepaid conferences, travel		-		42

Total	$	1,193	$	593

Property and equipment, net (in thousands)

	September 30, 2019			December 31, 2018
Computers and office equipment	$	852		$	852
Leasehold improvements		439			439
Software		11			11

		1,302			1,302
Less: accumulated depreciation and amortization		(877	)		(695	)

Total	$	425		$	607

Accrued expenses (in thousands)

	September 30, 2019		December 31, 2018
Accrued manufacturing costs	$	1,283	$	83
Accrued clinical consulting services		709		674
Accrued vendor payments		323		150
Other accrued expenses		6		12

Total	$	2,321	$	919

Accrued employee benefits (in thousands)

	September 30, 2019		December 31, 2018
Accrued bonus expense	$	524	$	907
Accrued vacation expense		95		118
Accrued severance		-		307

Total	$	619	$	1,332

4. 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 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, 2019, there were 8,959 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 Common Stock reserved for issuance under the 2010 Stock Plan from 85,714 to 171,429. On May 15, 2015, 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 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 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 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 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 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, 2019, there were 794,618 options issued and outstanding under the 2010 Stock Plan.

In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. 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, 2019 and 2018. The assumptions used for the awards during the year ended December 31, 2018 are as follows:

Exercise price	$	0.69
Expected dividends		0	%
Expected volatility		86	%
Risk-free interest rate		2.75	%
Expected life of option		4 years

Expected dividends —The Company has never declared or paid dividends on the Common Stock and has no plans to do so in the foreseeable future.

Expected volatility—Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period.

Risk-free interest rate—The assumed risk-free rate used is a zero coupon U.S. Treasury security with a maturity that approximates the expected term of the option.

Expected life of the option—The period of time that the options granted are expected to remain unexercised. Options granted during 2018 have a maximum term of seven years. The Company estimates the expected life of the option based on the weighted average life between the dates that options become fully vested and the maximum life of options granted.

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;
	·	half vesting immediately and remaining over three years;
	·	in full on one-year anniversary date of grant date;
	·	quarterly over three years;
	·	annually over three years;
	·	one-third immediate vesting and remaining annually over two years;
	·	one-half immediate vesting and remaining over nine months;
	·	one quarter immediate vesting and remaining over three years;
	·	one quarter immediate vesting and remaining over 33 months; and
	·	monthly over three years.

A summary of stock option activity for the nine months ended September 30, 2019 and the year ended December 31, 2018 is as follows:

	Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in years)		Aggregate Intrinsic Value

Balance - December 31, 2017		359,076		$	53.93		4.60	$	1,800

Granted		671,500		$	0.69
Expired		(78,667	)	$	67.02
Forfeited		(12,927	)	$	23.72
Balance - December 31, 2018		938,982		$	15.18		6.19	$	-

Expired		(68,173	)	$	64.76
Forfeited		(67,232	)	$	5.95

Balance - September 30, 2019 - outstanding		803,577		$	11.74		5.64	$	-

Balance - September 30, 2019 - exercisable		330,470		$	26.77		4.89	$	-

Grant date fair value of options granted - September 30, 2019				$	-

Weighted average grant date fair value - September 30, 2019				$	-

Grant date fair value of options granted - December 31, 2018				$	301,000

Weighted average grant date fair value - December 31, 2018				$	0.45

Stock-based compensation expense included in operating expenses related to stock options issued to employees and consultants for the three months ended September 30, 2019 and 2018 was $90,000 and $475,000 respectively, and $246,000 and $1.7 million for the nine months ended September 30, 2019 and 2018, respectively.

As of September 30, 2019, total unrecognized stock-based compensation expense related to stock options was $305,000, which is expected to be expensed through June 2021.

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, 2019 and 2018.

5. 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 the 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.

The assumptions used by the Company are summarized in the following table:

	Issuance Date
Closing stock price	$	0.88
Expected dividends		0	%
Expected volatility		90	%
Risk free interest rate		3.01	%
Expected life of warrant (years)		5.00

On November 18, 2016, the Company completed a public offering of 714,286 shares of Common Stock in combination with accompanying warrants to purchase an aggregate of 1,428,571 shares of the Common Stock. The stock and warrants were sold in combination, with two warrants for each share of Common Stock sold, a Series A warrant and a Series B warrant, each representing the right to purchase one share of Common Stock. The purchase price for each share of Common Stock and accompanying warrants was $35.00. The shares of Common Stock were immediately separable from the warrants and were issued separately. The 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 were each exercisable 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 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, 2019, the fair value of the warrant liability was $100. At September 30, 2018, the fair value of the warrant liability was $19,000, which resulted in non-cash income of $605,000 and $3.6 million for the three and nine months ended September 30, 2018, respectively. The warrants were valued on the date of grant and on each remeasurement period using Monte Carlo simulations.

The assumptions used by the Company are summarized in the following table:

	Series A
	December 31, 2018			November 18, 2016
Closing stock price	$	0.56		$	31.15
Expected dividends		0	%		0	%
Expected volatility		92.5	%		85	%
Risk free interest rate		2.50	%		1.58	%
Expected life of warrant		1.9 years			4.0 years

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 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, have an exercise price of $61.25 per share and a life of five years. The warrants vested immediately and expired on October 10, 2019.

The warrants issued in conjunction with the registered direct offering in October 2014 included a provision that if the Company were to enter into a certain transaction, as defined in the agreement, the warrants would be purchased from the holder at a premium. Accordingly, the Company recorded the warrants as a liability at their estimated fair value on the issuance date, which was $7.4 million, and changes in estimated fair value are being recorded as non-cash income or expense in the Company’s Consolidated Statements of Operations at each subsequent period. At September 30, 2019, the fair value of the warrant liability was zero. At September 30, 2018, the fair value of the warrant liability was $200, which resulted in non-cash income of $21,000 and $415,000 for the three and nine months ended September 30, 2018, respectively. The warrants were valued on the date of grant using the Black-Scholes valuation model which approximates the value derived using Monte Carlo simulations. The assumptions used by the Company are summarized in the following table:

	December 31, 2018			October 10, 2014
Closing stock price	$	0.56		$	61.25
Expected dividends		0	%		0	%
Expected volatility		110	%		95	%
Risk free interest rate		2.60	%		1.39	%
Expected life of warrant		.79 years			5.0 years

The following table summarizes the estimated fair value of the warrant liability (in thousands):

Balance at December 31, 2017	$	4,083
Change in fair value of warrant liability		(4,083	)
Balance at December 31, 2018		-
Change in fair value of warrant liability		-
Balance at September 30, 2019	$	-

A summary of all warrant activity for the Company for the nine months ended September 30, 2019 and the year ended December 31, 2018 is as follows:

	Number of Warrants		Weighted Average Exercise Price

Balance at December 31, 2017		915,138	$	52.50
Granted		18,000,713		1.38
Exercised		-		-
Forfeited		-		-
Balance at December 31, 2018		18,915,851		3.85
Granted		-		-
Exercised		-		-
Forfeited		-		-
Balance at September 30, 2019		18,915,851	$	3.85

On December 26, 2017, the Company entered into a consulting agreement for advisory services for a period of six months. As compensation for such services, the consultant was paid an upfront payment, is paid a monthly fee, and on January 24, 2018 was issued a warrant exercisable for 714 shares of the 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.

The assumptions used by the Company are summarized in the following table:

	Issuance Date
Closing stock price	$	18.55
Expected dividends		0	%
Expected volatility		85	%
Risk free interest rate		2.42	%
Expected life of warrant (years)		4.92

A summary of all outstanding and exercisable warrants as of September 30, 2019 is as follows:

Exercise Price		Warrants Outstanding		Warrants Exercisable		Weighted Average Remaining Contractual Life
$	1.38		17,999,999		17,999,999		4.04 years
	18.20		714		714		3.24 years
	50.05		714,286		714,286		1.14 years
	61.25		200,852		200,852		0.03 years
$	3.85		18,915,851		18,915,851		3.88 years

6. Net Loss per Share

Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Included in net loss is the Series A preferred dividend from preferred shares issuance of $63,000 and $185,000 for the three and nine months ended September 30, 2019 and $61,000 and $181,000 for the three and nine months ended September 30, 2018, respectively. Net loss for the three and nine months ended September 30, 2019 also includes the Series B deemed dividend of $71,000 and $585,000. The deemed dividend relates to the discount provided to preferred stockholders upon conversion of their preferred stock to common shares and is subtracted from net loss (see Note 8). 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 potentially 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. The number of options and warrants for the purchase of Common Stock that were excluded from the computations of net loss per common share for the three and nine months ended September 30, 2019 were 803,577 and 18,915,851, respectively, and for the three and nine months and ended September 30, 2018 were 347,765 and 915,852, respectively.

The following tables set forth the computation of diluted net loss per weighted average number of shares outstanding attributable to Synthetic Biologics, Inc. and Subsidiaries for the three and nine months ended September 30, 2019 and 2018 (in thousands except share and per share amounts):

	Three months ended September 30, 2019								Nine months ended September 30, 2019
	Net loss (Numerator)			Shares (Denominator)		Per Share Amount			Net Loss (Numerator)			Shares (Denominator)		Per Share Amount
Net loss - Basic	$	(5,253	)		16,805,257	$	(0.31	)	$	(12,934	)		16,313,326	$	(0.79	)

Dilutive shares related to warrants		-			-		-			-			-		-

Net loss - Dilutive	$	(5,253	)		16,805,257	$	(0.31	)	$	(12,934	)		16,313,326	$	(0.79	)

	Three months ended September 30, 2018								Nine months ended September 30, 2018
	Net loss (Numerator)			Shares (Denominator)		Per Share Amount			Net Loss (Numerator)			Shares (Denominator)		Per Share Amount
Net loss - Basic	$	(3,741	)		4,028,304	$	(0.93	)	$	(10,375	)		3,802,812	$	(2.73	)

Dilutive shares related to warrants		-			-		-			-			-		-

Net loss - Dilutive	$	(3,741	)		4,028,304	$	(0.93	)	$	(10,375	)		3,802,812	$	(2.73	)

7. Non-controlling Interest

The Company’s non-controlling interest is accounted for under ASC 810, Consolidation, 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 (the ‘Stock Purchase Agreement”) with Cedars-Sinai Medical Center (CSMC) for an investigator-sponsored Phase 2b clinical study of SYN-010 to be co-funded by the Company and CSMC (the “Study”). The Study will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN-010 is designed to reduce methane production by certain microorganisms (M. smithii) in 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 will 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 50,000 shares of Common Stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary SYN Biomics, Inc. (“Synbiomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of 7,480,000 shares of common stock of SYN Biomics, representing 17% of the issued and outstanding shares of SYN Biomics’ common stock. The services rendered are recorded to research and development expense in proportion with the progress of the study and are based overall on the fair value of the shares ($285,000) as determined at the date of IRB approval. During 2019, research and development expense recorded related to this transaction approximated $108,000 and $318,000 for the three and nine months ended September 30, 2019, respectively.

The Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of the 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.

8. Common and Preferred Stock

Series B Preferred Stock

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 is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Common Stock. The exercise price of the Warrants is subject to adjustment in the event of certain dilutive issuances. During the three and nine months ended September 30, 2019, 185 and 1,523 shares of Series B Preferred Stock, respectively, have been converted resulting in the recognition of $71,000 and $585,000 of unamortized discount from the conversion, respectively. As of September 30, 2019, 8,085 shares of Series B Preferred Stock have been converted resulting in the recognition of $3.1 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 Stock 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 is less than the fair value of the underlying Common Stock at the date of issuance, there is a beneficial conversion feature (“BCF”) at the issuance date. Because the Series B Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the 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 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.

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 (i) redeemable based on contingent events outside of the Company’s control, and (ii) convertible immediately and from time to time. Since the effective conversion price of the Series A Preferred Stock was 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 retained earnings as a “deemed dividend” and impacts earnings per share. 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, 2019, the Company accrued dividends of $63,000 and $185,000, respectively. During the three and nine months ended September 30, 2018, the Company accrued dividends of $62,000 and $182,000, 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 FBR, Inc.), which enables the Company to offer and sell shares of the 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 Common Stock sold on the Company’s behalf. For the year ended December 31, 2018, the Company sold through the B. Riley FBR Sales Agreement an aggregate of 3.5 million shares of the Common Stock, and received net proceeds of approximately $12.2 million. For the three and nine months ending September 30, 2018, the Company sold through the B. Riley FBR Sales Agreement an aggregate of 1.6 and 1.7 million shares of the Common Stock, and received net proceeds of approximately $6.0 million and $6.4 million. The Company has not sold any shares of common stock during 2019 through the B. Riley FBR Sales Agreement.

9. 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 will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN-010 is designed to reduce methane production by certain microorganisms (M. smithii) in 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: (i) issued to CSMC 50,000 shares of Common Stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary Synthetic Biomics, Inc. (“SYN Biomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of 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.

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, 2019 and 2018, the Company did not owe and did not pay CSMC for milestone payments related this license agreement.

10. Commitments and Contingencies

Leases

All of the Company’s existing leases as of September 30, 2019 are classified as operating leases. As of September 30, 2019, 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. 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 the general and administrative expenses in the condensed consolidated statements of operations, and for the three and nine months ended September 30, 2019 approximated $50,000 and $151,000, respectively. During the same period, operating cash flows used for operating leases approximated $75,000 and $224,000, respectively. During 2019, there were no ROU assets exchanged for operating lease obligations. The initial non-cash addition of ROU assets due to adoption of ASC 842 was $538,000.

A maturity analysis of our operating leases as of September 30, 2019 is as follows (amounts in thousands of dollars):

Future undiscounted cash flows:
2019	$	77
2020		309
2021		321
2022		192
Total	$	899

Discount factor	$	(119	)
Lease liability	$	780
Amount due within 12 months	$	(241	)
Non-current lease liability	$	539

As of December 31, 2018, the Company’s future minimum lease payments were as follows (in thousands):

	2019		2020		2021		2022		Total
Operating Lease	$	300	$	309	$	321	$	192	$	1,122

Total	$	300	$	309	$	321	$	192	$	1,122

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q, and our audited consolidated financial statements and notes thereto for the year ended December 31, 2018 included in our 2018 Form 10-K. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Our actual results and the timing of events could differ materially from those expressed or implied by the forward-looking statements due to important factors and risks including, but not limited to, those set forth below under “Risk Factors” and elsewhere herein, and those identified under Part I, Item 1A of our 2018 Form 10-K. All share and per share numbers set forth in this Management’s Discussion and Analysis of Financial Conditions and Results of Operations reflect the one-for-thirty five reverse stock split effected August 10, 2018.

Overview

We are a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to treat gastrointestinal (GI) diseases in areas of high unmet need. Our lead 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 microbiome damage, Clostridioides difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR), and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010 which is intended 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). We are also advancing SYN-020, an early-stage oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases.

Our Product Pipeline:

aGVHD acute graft-vs-host disease; AMR antimicrobial resistance; bIAP bovine intestinal alkaline phosphatase; CDI Clostridioides difficile infection; CIC chronic idiopathic constipation; HCT hematopoietic cell transplant patients; IBS-C irritable bowel syndrome with constipation; VRE vancomycin resistant enterococci.

¹Additional products with preclinical proof-of-concept include SYN-006 (carbapenemase) being designed to prevent aGVHD and infection by carbapenem resistant enterococci and SYN-007 (ribaxamase) DR being designed to prevent antibiotic associated diarrhea with oral β-lactam antibiotics. ²Dependent on funding/partnership.

*Based on management’s current beliefs and expectations.

Summary of Clinical and Preclinical Programs

Therapeutic Area	Product Candidate	Current Status

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 adult allogeneic HCT recipients (Q3 2019) · Anticipate initiation of proposed Phase 1b/2a clinical trial to be conducted by Washington University in adult allogeneic HCT recipients in Q1 2020

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) · Commenced enrollment in the Phase 2b investigator-sponsored clinical study of SYN-010 conducted by CSMC (Q1 2019) · Anticipate a data readout from investigator-sponsored Phase 2b clinical study (1H 2020)

Prevention of CDI, overgrowth of pathogenic organisms and AMR (Degrade IV carbapenem antibiotics)	SYN-006 (oral enzyme)	· Identified P2A as a potent carbapenemase that is stable in the GI tract · Manufactured a formulated research lot for oral delivery (2017) · Demonstrated microbiome protection in a pig model of ertapenem administration (Q1 2018)

Prevention of CDI, overgrowth of pathogenic organisms and AMR (Degrade oral beta-lactam antibiotics)	SYN-007 (oral enzyme)	· Preclinical work ongoing to expand the utility of SYN-004 (ribaxamase) for use with oral beta-lactam antibiotics · Reported supportive data from a second canine animal model demonstrating that when co-administered with oral amoxicillin and oral Augmentin, oral SYN-007 did not interfere with systemic absorption of antibiotics but did diminish microbiome damage associated with these antibiotics (Q2 2018)

Preserve gut barrier, treat local GI inflammation, and restore gut microbiome

SYN-020
(oral IAP enzyme)

· Generated high expressing manufacturing cell lines for intestinal alkaline phosphatase (IAP) (1H 2017)

· Identified basic Drug Supply manufacturing process and potential tablet formulation (2H 2017)

· Identified potential clinical indications with unmet medical need including enterocolitis associated with radiation therapy for cancer (Q1 2019)

· Completed pre-IND (Investigational New Drug) meeting with the FDA to clarify requirements for IND-enabling toxicology studies and manufacturing requirements (Q2 2019)

· Anticipate IND filing (Q1 2020)

Prevention and treatment of pertussis

SYN-005
(monoclonal antibody
therapies)

· Reported supportive preclinical data demonstrating that an extended half-life version of hu1B7, a component of SYN-005, provided protection from pertussis for five weeks in a neonatal non-human primate study (Q4 2017)

· Collaborations with Intrexon, Inc. and UT Austin

Recent Developments

Our Microbiome-Focused Pipeline

Our SYN-004 (ribaxamase) and SYN-010 clinical programs are focused on the gut microbiome, which is home to billions of microbes and composed of a natural balance of both “good” beneficial species and potentially “bad” pathogenic species. When the natural balance or normal function of these microbial species is disrupted, a person’s health can be compromised. All of our programs are supported by our growing intellectual property portfolio. We are maintaining and building our patent portfolio through: filing new patent applications; prosecuting existing applications; and licensing and acquiring new patents and patent applications. Our plan remains focused on the advancement of our two lead clinical programs. We continue to actively manage resources in preparation for the clinical advancement of our two lead microbiome-focused clinical programs, SYN-004 (ribaxamase) and SYN-010, as well as our pre-IND program SYN-020, including our pursuit of opportunities that will allow us to establish the clinical infrastructure and financial resources necessary to successfully initiate and complete this plan.

Clinical and Pre-Clinical Update

SYN-004 (ribaxamase) — Prevention of antibiotic-mediated microbiome damage, C. difficile infections (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host disease (aGVHD) in allogeneic HCT recipients

In August 2019, we entered into a Clinical Trial Agreement (CTA) with Washington University School of Medicine (“Washington University”) to conduct a Phase 1b/2a clinical trial. The proposed Phase 1b/2a single-center, randomized, double-blinded, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and pharmacokinetics of oral SYN-004 (ribaxamase) in up to 36 adult allogeneic HCT recipients. Under the terms of this agreement, Synthetic Biologics will serve as the sponsor of the study and supply SYN-004 (ribaxamase). Dr. Erik R. Dubberke, Professor of Medicine and Clinical Director, Transplant Infectious Diseases at Washington University will serve as the principal investigator of the trial in collaboration with his Washington University colleague Dr. Mark A. Schroeder, Associate Professor of Medicine, Division of Oncology, Bone Marrow Transplantation and Leukemia.

The goal of this proposed study is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever. Study participants will be enrolled into three sequential cohorts administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo. Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee, which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic. The study will also evaluate potential protective effects of SYN-004 on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allogeneic HCT recipients. During the fourth quarter, we intend to hold a Type-C meeting with FDA to solidify the clinical protocol parameters for this program with the intention of commencing enrollment during the first quarter of 2020, contingent upon agreement with the FDA and approval of the clinical study protocol by the Washington University School of Medicine’s Institutional Review Board (IRB). We anticipate that subsequent potential Phase 2/3 pivotal trial(s) in this patient population may consist of as many as 500 patients.

SYN-010 — Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)

On September 5, 2018, we entered into an agreement with CSMC for an investigator-sponsored Phase 2b clinical study of SYN-010 to be co-funded by us and CSMC (the “Study”).

The Study will further evaluate the efficacy and safety of SYN-010. The data from this study will provide additional insights into potential SYN-010 clinical efficacy, including dose response and microbiome effects, ideally solidifying existing clinical outcomes data, and potentially simplifying and reducing costs for future Phase 3 clinical development. We believe the successful completion of the Study will allow us to re-engage with prospective partners, both domestically and abroad, who found the results from our previously completed Phase 2a study compelling and have indicated their interest in reviewing a more robust clinical data set.

The Phase 2b study is being conducted out of the Medically Associated Science and Technology (MAST) Program at CSMC and is a 12-week, placebo-controlled, double-blind, randomized clinical trial to evaluate two dose strengths of oral SYN-010 21 mg and 42 mg in approximately 150 patients diagnosed with IBS-C.

The primary objective for the Study is to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo. Exploratory outcomes include adequate relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires. Enrollment in this study commenced in January 2019 and remains ongoing. After consulting with the investigators at Cedars-Sinai Medical Center, the study sponsor, enrollment is expected to extend beyond our previously anticipated timeline in order to accommodate the higher than anticipated screen-fail rates for patients who presented at screening with breath-methane levels below the protocol-required ten parts-per-million. In order to ensure the possibility of generating a meaningful data set of the highest quality, we are discussing with CSMC the opportunity for a data read out in the first half of 2020.

SYN-020 — Oral Intestinal Alkaline Phosphatase

SYN-020 is a quality-controlled, recombinant version of Intestinal Alkaline Phosphatase (IAP) formulated for oral delivery. The published literature indicates that IAP functions to diminish GI inflammation, tighten the gut barrier to diminish “leaky gut,” and promote a healthy microbiome. Based on these known mechanisms as well as our own supporting animal model data, we are developing SYN-020 to mitigate the intestinal damage caused by radiation therapy that is routinely used to treat pelvic cancers. A key hurdle to commercialization has been the high cost of IAP manufacture. We believe we have developed technologies to traverse this hurdle and are currently advancing a SYN-020 product candidate through preclinical development and towards clinical trials. During the second quarter of 2019, we completed a pre-IND meeting with the FDA where we discussed nonclinical and clinical strategies and clarified requirements for IND-enabling toxicology studies to evaluate safety and pharmacokinetics of SYN-020 in healthy volunteers. As a result of these activities, we anticipate filing an IND for this program during the first quarter of 2020.

Intellectual Property

All of our programs are supported by growing patent estates that we either own or exclusively license. Each potential product has issued patents that provide protection. In total, we have over 110 U.S. and foreign patents and over 100 U.S. and foreign patents pending. The SYN-004 (ribaxamase) program is supported by IP that is assigned to Synthetic Biologics, namely U.S. patents and foreign patents (in most major markets, e.g. Europe (including Germany, Great Britain and France), Japan, China and Canada, among others) and U.S. and foreign patents pending in most major markets, e.g. Europe (including Germany, Great Britain and France), Japan, China and Canada, among others). For instance, U.S. Patent Nos. 8,894,994 and 9,587,234, which include claims to compositions of matter and pharmaceutical compositions of beta-lactamases, including SYN-004 (ribaxamase), have patent terms to at least 2031. Further, U.S. Patent 9,301,995 and 9,301,996, both of which will expire in 2031, cover various uses of beta-lactamases, including SYN-004 (ribaxamase), in protecting the microbiome, and U.S. Patent Nos. 9,290,754, 9,376,673, 9,404,103, 9,464,280, and 9,695,409 which will expire in at least 2035, covers further beta-lactamase compositions of matter related to SYN-004 (ribaxamase). The SYN-010 program is supported by IP that is exclusively licensed to (and, in some cases co-owned by) Synthetic Biologics, namely U.S. patents and foreign patents (in most major markets, e.g. Europe (including Germany, Great Britain and France), and Canada, among others) and U.S. and foreign patents pending in most major markets, e.g. Europe (including Germany, Great Britain and France), Japan, China and Canada, among others). For instance, U.S. Patent No. 9,192,618, which expires in at least 2023, includes claims that cover use of statins, including SYN-010, for the treatment of IBS-C. U.S. Patent No. 9,289,418, which expires in at least 2033, includes claims that cover the use of a variety of compounds, including the active agent of SYN-010, to treat constipation in certain screened patients. U.S. Patent No. 9,744,208 covers methods of use of the active agent of SYN-010 for the treatment of constipation until at least 2034. U.S. Patent No. 9,956,292 includes claims related to composition of matter of anti-methanogenic compositions that find use in treating IBS-C and will expire in at least 2035. Further, recently granted U.S. Patent No. 10,328,151, covers the composition of matter of the SYN-010 clinical agent and recently allowed U.S. Patent Application No. 15/810,891 covers methods of treating IBS-C with a statin, inclusive of SYN-010, in a selected patient population.

Our goal is to (i) obtain, maintain, and enforce patent protection for our products, formulations, processes, methods, and other proprietary technologies, (ii) preserve our trade secrets, and (iii) operate without infringing on the proprietary rights of other parties worldwide. We seek, where appropriate, the broadest intellectual property protection for product candidates, proprietary information, and proprietary technology through a combination of contractual arrangements and patents.

Critical Accounting Policies

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 reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses in the periods presented. We believe that the accounting estimates employed are appropriate and resulting balances are reasonable; however, due to inherent uncertainties in making estimates, actual results may differ from the original estimates, requiring adjustments to these balances in future periods. The critical accounting estimates that affect the condensed consolidated financial statements and the judgments and assumptions used are consistent with those described under Part II, Item 7 of our 2018 Form 10-K.

Results of Operations

Three Months Ended September 30, 2019 and 2018

General and Administrative Expenses

General and administrative expenses decreased by approximately 26% to $1.1 million for the three months ended September 30, 2019 from $1.5 million for the three months ended September 30, 2018. This decrease is primarily due to decreased stock-based compensation expense related to forfeitures and decreased option grants, along with the reduction of investor relations and consulting costs. The charge related to stock-based compensation expense was $68,000 for the three months ended September 30, 2019, compared to $186,000 the three months ended September 30, 2018.

Research and Development Expenses

Research and development expenses increased by approximately 46% to $4.1 million for the three months ended September 30, 2019 from $2.8 million for the three months ended September 30, 2018. This increase is primarily the result of higher manufacturing and pre IND-enabling toxicology study costs for SYN-020 and the cost incurred to co-fund the investigator-sponsored Phase 2b clinical study of SYN-010. Research and development expenses also include a charge relating to stock-based compensation expense of $22,000 for the three months ended September 30, 2019, compared to $289,000 for the three months ended September 30, 2018.

The following table sets forth our research and development expenses directly related to our therapeutic areas for the three months ended September 30, 2019 and 2018. These direct expenses were external costs associated with preclinical studies and clinical trials. Indirect research and development expenses related to employee costs, facilities, stock-based compensation and research and development support services that are not directly allocated to specific drug candidates.

Therapeutic Areas	September 30, 2019		September 30, 2018
SYN-010	$	174	$	76
Ribaxamase		73		56
Other therapeutic areas		7		3

Total direct costs		254		135
Total indirect costs		3,890		2,711

Total Research and Development Expenses	$	4,144	$	2,846

Other Income

Other income was $92,000 for the three months ended September 30, 2019, compared to other income of $631,000 for the three months ended September 30, 2018. Other income for the three months ended September 30, 2019 is primarily comprised of interest income while the three months ended September 30, 2018 is comprised of non-cash income of $626,000 from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price.

Net Loss Attributable to Common Stockholders

Our net loss attributable to common stockholders was $5.3 million, or $0.31 per basic and dilutive common share for the three months ended September 30, 2019, compared to a net loss of $3.7 million, or $0.93 per basic common share and dilutive common share for the three months ended September 30, 2018. The net loss was primarily attributed to the loss from operations described above.

Nine Months Ended September 30, 2019 and 2018

General and Administrative Expenses

General and administrative expenses decreased by approximately 27% to $3.3 million for the nine months ended September 30, 2019, from $4.5 million for the nine months ended September 30, 2018. This decrease is primarily due to decreased stock-based compensation expense related to forfeitures and decreased option grants, along with the reduction of investor relations, consulting, registration, and legal costs. The charge related to stock-based compensation expense was $193,000 for the nine months ended September 30, 2019, compared to $800,000 the nine months ended September 30, 2018.

Research and Development Expenses

Research and development expenses decreased by 6% to $9.2 million for the nine months ended September 30, 2019, from $9.8 million for the nine months ended September 30, 2018. This decrease is primarily the result of lower SYN-004 (ribaxamase) indirect program costs for the nine months ended September 30, 2019, including salary and related expense reductions resulting from the 2018 restructuring and the fact that no clinical trial activity for SYN-004 (ribaxamase) was ongoing during the nine months ended September 30, 2019, offset by an increase in manufacturing and pre IND-enabling toxicology study costs for SYN-020. The research and development costs incurred during the nine months ended September 30, 2019 were primarily related to the investigator-sponsored Phase 2b clinical study of SYN-010 and manufacturing cost for SYN-020. Research and development expenses also include a charge relating to stock-based compensation expense of $53,000 for the nine months ended September 30, 2019, compared to $909,000 for the nine months ended September 30, 2018.

The following table sets forth our research and development expenses directly related to our therapeutic areas for the nine months ended September 30, 2019 and 2018. These direct expenses were external costs associated with preclinical studies and clinical trials. Indirect research and development expenses related to employee costs, facilities, stock-based compensation and research and development support services that are not directly allocated to specific drug candidates.

Therapeutic Areas	September 30, 2019		September 30, 2018
SYN-010	$	426	$	305
SYN-004 (ribaxamase)		185		281
Other therapeutic areas		23		1
Total direct costs		634		587
Total indirect costs		8,522		9,201

Total Research and Development Expenses	$	9,156	$	9,788

Other Income

Other income was $217,000 for the nine months ended September 30, 2019, compared to other income of $4.1 million for the nine months ended September 30, 2018. Other income for the nine months ended September 30, 2019 is primarily due to interest income while the nine months ended September 30, 2018 is comprised of non-cash income of $4.0 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price.

Net Loss Attributable to Common Stockholders

Our net loss attributable to common stockholders was $12.9 million, or $0.79 per basic and dilutive common share for the nine months ended September 30, 2019, compared to a net loss of $10.4 million, or $2.73 per basic common share and dilutive common share for the nine months ended September 30, 2018. The net loss was primarily attributed to the loss from operations described above.

Liquidity and Capital Resources

With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have experienced significant losses since inception, incurred negative cash flows from operations, and have a significant accumulated deficit. We have incurred an accumulated deficit of $232.4 million as of September 30, 2019 and expect to continue to incur losses in the foreseeable future.

Our cash and cash equivalents totaled $18.7 million as of September 30, 2019, a decrease of $10.3 million from December 31, 2018. During the three and nine months ended September 30, 2019, the primary use of cash was for working capital requirements and operating activities which resulted in a net loss attributable to Synthetic Biologics, Inc. and its Subsidiaries of $5.1 million and $12.2 million for the three and nine months ended September 30, 2019, respectively. With the 17.6 million of cash available in early November 2019, we believe these resources will be sufficient to fund our operations through at least the end of the fourth quarter of 2020.

To date, we have financed our operations primarily through public and private sales of our securities, and we expect to continue to seek to obtain our required capital in a similar manner. During the year ended December 31, 2018, our only sources of funding were from our public offering that closed in October 2018 in which we received net proceeds of approximately $16.7 million and sales of 3.5 million shares of our Common Stock in our at-the-market offering program through the FBR Sales Agreement pursuant to which we received net proceeds of approximately $12.2 million. The FBR Sales Agreement enables us to offer and sell shares of our Common Stock from time to time through B. Riley FBR, Inc. as our sales agent, with aggregate sales of up to $40.0 million, of which $19.9 million remains available subject to certain conditions and requirements. Sales of Common Stock under the 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 our common stock sold on our behalf. No shares of our Common Stock were sold through the FBR Sales Agreement during 2019.

There can be no assurance that we will be able to continue to raise funds through the sale of shares of Common Stock through the FBR Sales Agreement. If we raise funds by selling additional shares of Common Stock or other securities convertible into Common Stock, the ownership interest of our existing stockholders will be diluted. If we are not able to obtain funding for future clinical trials when needed, we will be unable to carry out our business plan and we will be forced to delay the initiation of future clinical trials until such time as we obtain adequate financing.

We have spent, and expect to continue to spend, a substantial amount of funds in connection with implementing our business strategy, including our planned product development efforts, preparation for our planned clinical trials, performance of clinical trials and our research and discovery efforts. With the cash available in early November 2019, we believe these resources will be sufficient to fund our operations through at least the end of the fourth quarter of 2020, including the anticipated completion of the ongoing Phase 2b investigator-sponsored clinical study of SYN-010, a potential Phase 1b/2a clinical study of SYN-004 (ribaxamase) in a specialty population for the prevention of aGVHD in allogeneic HCT recipients, as well as our preclinical activities and planned development of SYN-020.

Although our cash and cash equivalents are expected to be sufficient for us to fund the foregoing, our cash and cash equivalents will not be sufficient to enable us to meet our long-term expected plans, including initiation or completion of future registrational studies for SYN-010, the Phase 3 clinical program of SYN-004 (ribaxamase) for prevention of CDI, or later-stage clinical trials of SYN-020. Therefore, we do not intend to commence future registrational studies of SYN-010, our Phase 3 clinical program of SYN-004 (ribaxamase) for prevention of CDI or later-stage clinical trials of SYN-020 until we are confident that we have funding necessary to complete such trials. In addition, following the completion of our ongoing Phase 2b clinical study of SYN-010, our planned potential Phase 1b/2a clinical study of SYN-004 (ribaxamase) and development of SYN-020, we anticipate needing to obtain additional funds for future clinical trials. We do not currently have commitments from any third parties to provide us with capital and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all. Potential sources of financing that we are pursuing include strategic relationships, public or private sales of our equity (including through the FBR Sales Agreement) or debt and other sources. We cannot assure that we will meet the requirements for use of the FBR Sales Agreement especially in light of the fact that we are currently limited by rules of the SEC as to the number of shares of Common Stock that we can sell pursuant to the FBR Sales Agreement due to the market value of our common stock held by non-affiliates. Additionally, we may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. If we are unable to obtain additional capital (which is not assured at this time), our long-term business plan may not be accomplished and we may be forced to cease certain development activities. More specifically, the completion of future Phase 3 and/or registrational clinical studies will require significant financing or a significant partnership.

We do not have any committed sources of financing for future clinical trials at this time.

Off-Balance Sheet Arrangements

During the three and nine months ended September 30, 2019, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Contractual Obligations

Leases

At the inception of a contract we determine if the arrangement is, or contains, a lease. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term.

We have made certain accounting policy elections whereby we (i) do not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less), and (ii) combine lease and non-lease elements of our operating leases. ROU assets are included in other noncurrent assets and lease liabilities are included in other current and non-current liabilities in our condensed consolidated balance sheets. As of September 30, 2019, we did not have any material finance leases.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

The primary objective of our investment activities is to preserve our capital to fund operations. We also seek to maximize income from our investments without assuming significant risk. Our exposure to market risk is confined to our cash and cash equivalents. As of September 30, 2019, our cash and cash equivalents consisted primarily of money market securities. We do not engage in any hedging activities against changes in interest rates. Due to the short-term duration of our investment portfolio and the low risk profile of our investments, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a sudden change in market interest rates or credit conditions on our securities portfolio. We may, however, require additional financing to fund future obligations and no assurance can be given that the terms of future sources of financing will not expose us to material market risk.

ITEM 4. CONTROLS AND PROCEDURES.

(a) Evaluation of Disclosure Controls and Procedures

The Company has adopted and maintains disclosure controls and procedures (as defined Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized and reported within the time periods specified in the rules of the SEC. The Company’s disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. As required under Exchange Act Rule 13a-15, the Company’s management, including the Chief Executive Officer (principal executive officer), who also serves as the Chief Financial Officer (principal financial officer), after evaluating the effectiveness of our disclosure controls and procedures as of September 30, 2019, the end of the period covered by this Quarterly Report on Form 10-Q, has concluded that based on such evaluation, the Company’s disclosure controls and procedures are effective as of September 30, 2019 to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

(b) Changes in Internal Control over Financial Reporting

There have not been any changes in our internal controls over financial reporting during the three months ended September 30, 2019 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II–OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

From time to time we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

ITEM 1A. RISK FACTORS.

The following information updates, and should be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in our 2018 Form 10-K. Except as disclosed below, there have been no material changes from the risk factors disclosed in our 2018 Form 10-K.

RISKS RELATING TO OUR BUSINESS

We will need to raise additional capital to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate our development programs or commercialization efforts.

During the three and nine months ended September 30, 2019, our operating activities used net cash of approximately $3.0 million and $10.3 million, respectively, and our cash and cash equivalents were $18.7 million as of September 30, 2019. With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have experienced significant losses since inception and have a significant accumulated deficit. As of September 30, 2019, our accumulated deficit totaled approximately $232.4 million on a consolidated basis. We expect to incur additional operating losses in the future and therefore expect our cumulative losses to increase. With the exception of the quarter ended September 30, 2010, and limited laboratory revenues from Adeona Clinical Laboratory, which we sold in March 2012, we have generated very minimal revenues. We do not expect to derive revenue from any source in the near future until we or our potential partners successfully commercialize our products. We expect our expenses to increase in connection with our anticipated activities, particularly as we continue research and development, initiate and conduct clinical trials, and seek marketing approval for our product candidates. Until such time as we receive approval from the FDA and other regulatory authorities for our product candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products. For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings, cash on hand, licensing and collaboration fees and grants, if any.

We will need to raise additional capital to fund our operations and meet our current timelines and we cannot be certain that funding will be available on acceptable terms on a timely basis, or at all. Based on our current plans, our cash and cash equivalents, including the proceeds of our recent public offering, will not be sufficient to complete our planned Phase 3 clinical trial for SYN-004, our planned Phase 3 clinical trial for SYN-010 or late-stage clinical trials of SYN-020, which are expected to require significant cash expenditures. In addition, based on the anticipated significant cost of a Phase 3 clinical program in a broad indication for SYN-004, we expect it will not be feasible for us to initiate and complete this trial at this time without a partner given the capital constraints tied to our current market cap and share price. In addition, based on the anticipated cost of our planned Phase 3 clinical trial for SYN-010, we expect that we may also reach the same determination regarding the feasibility of initiating and completing the trial without a partner given the capital constraints tied to our current market cap and share price at such time. Following the completion of our ongoing Phase 2b clinical study of SYN-010, our planned potential Phase 1a/2b clinical study of SYN-004 (ribaxamase) and anticipated Phase 1 clinical study of SYN-020, we anticipate needing to obtain additional funds for future clinical trials. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business and also have a dilutive effect on our stockholders. A failure otherwise to secure additional funds when needed in the future whether through an equity or debt financing or a sufficient amount of capital without a strategic partnership could result in us being unable to complete planned preclinical and clinical trials or obtain approval of our product candidates from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities. Our ability to raise capital through the sale of securities is currently limited by the rules of the SEC and NYSE American that place limits on the number and dollar amount of securities that may be sold. There can be no assurances that we will be able to raise the funds needed, especially in light of the fact that our ability to sell securities registered on our registration statement on Form S-3 will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more. We also may be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

We did not sell any equity securities during the quarter ended September 30, 2019 in transactions that were not registered under the Securities Act.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

Not applicable.

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5. OTHER INFORMATION.

Not applicable

ITEM 6. EXHIBITS

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	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 4, 2019

EXHIBIT INDEX

Exhibit Number		Exhibit Title
10.1		Clinical Trial Agreement between Washington University School of Medicine in St Louis and Synthetic Biologics, Inc. dated August 7, 2019 (incorporated by reference to the current report on Form 8-K (file no. 001-12584) filed with the Securities and Exchange Commission on August 8, 2019.

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*

*Filed herewith.

EX-31.1 2 tm19196131_ex31-1.htm EXHIBIT 31.1

EXHIBIT 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER

PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Steven A. Shallcross, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Synthetic Biologics, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its condensed consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 4, 2019	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)

EX-32.1 3 tm19196131_ex32-1.htm EXHIBIT 32.1

EXHIBIT 32.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFCIER 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

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Synthetic Biologics, Inc. (the “Registrant”) hereby certifies, to such officer’s knowledge, that:

(1)	the accompanying Quarterly Report on Form 10-Q of the Registrant for the quarter ended September 30, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(2)	the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

Date: November 4, 2019

	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)

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

Sep. 05, 2018

Sep. 30, 2019

Jun. 30, 2019

Mar. 31, 2019

Sep. 30, 2018

Jun. 30, 2018

Mar. 31, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Noncontrolling Interest [Line Items]

Net Loss Attributable to Non-controlling Interest $ (30,000) $ (27,000) $ (16,000) $ (9,000) $ (16,000) $ (9,000) $ (73,000) $ (35,000)

Stockholders' Equity Attributable to Noncontrolling Interest (2,841,000) (2,841,000) $ (2,909,000)

Related Party Transaction, Expenses from Transactions with Related Party $ 441,000

Research and Development Expense $ 4,144,000 $ 2,846,000 $ 9,156,000 $ 9,788,000

Cedarssinai Medical Center [Member]

Noncontrolling Interest [Line Items]

Number Of Common Stock To Be Issued 50,000 50,000 50,000

Research and Development Expense $ 108,000 $ 318,000

Fair Value Of Shares Issued $ 285,000

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Net Loss per Share (Tables)
9 Months Ended

Sep. 30, 2019

Net Loss per Share

Schedule of computation of diluted net loss per weighted average number of shares outstanding

The following tables set forth the computation of diluted net loss per weighted average number of shares outstanding attributable to Synthetic Biologics, Inc. and Subsidiaries for the three and nine months ended September 30, 2019 and 2018 (in thousands except share and per share amounts):



Three months ended September 30, 2019



Nine months ended September 30, 2019

Net loss

Shares

Per Share

Net Loss

Shares

Per Share

(Numerator)

(Denominator)

Amount

(Numerator)

(Denominator)

Amount

Net loss - Basic

$

(5,253)

16,805,257

$

(0.31)

$

(12,934)

16,313,326

$

(0.79)

Dilutive shares related to warrants

—

—

—

—

—

—

Net loss - Dilutive

$

(5,253)

16,805,257

$

(0.31)

$

(12,934)

16,313,326

$

(0.79)



Three months ended September 30, 2018



Nine months ended September 30, 2018

Net loss

Shares

Per Share

Net Loss

Shares

Per Share

(Numerator)

(Denominator)

Amount

(Numerator)

(Denominator)

Amount

Net loss - Basic

$

(3,741)

4,028,304

$

(0.93)

$

(10,375)

3,802,812

$

(2.73)

Dilutive shares related to warrants

—

—

—

—

—

—

Net loss - Dilutive

$

(3,741)

4,028,304

$

(0.93)

$

(10,375)

3,802,812

$

(2.73)

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Selected Balance Sheet Information - Schedule of prepaid expenses and other current assets (Details) - USD ($)
$ in Thousands

Sep. 30, 2019

Dec. 31, 2018

Selected Balance Sheet Information

Prepaid manufacturing expense $ 1,001 $ 0

Prepaid consulting, subscriptions and other expenses 123 132

Prepaid insurance 65 419

Other receivable 4 0

Prepaid conferences, travel 0 42

Total $ 1,193 $ 593

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Net Loss per Share
9 Months Ended

Sep. 30, 2019

Net Loss per Share

Net Loss per Share

6. Net Loss per Share

Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Included in net loss is the Series A preferred dividend from preferred shares issuance of $63,000 and $185,000 for the three and nine months ended September 30, 2019 and $61,000 and $181,000 for the three and nine months ended September 30, 2018, respectively. Net loss for the three and nine months ended September 30, 2019 also includes the Series B deemed dividend of $71,000 and $585,000. The deemed dividend relates to the discount provided to preferred stockholders upon conversion of their preferred stock to common shares and is subtracted from net loss (see Note 8). 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 potentially 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. The number of options and warrants for the purchase of Common Stock that were excluded from the computations of net loss per common share for the three and nine months ended September 30, 2019 were 803,577 and 18,915,851, respectively, and for the three and nine months and ended September 30, 2018 were 347,765 and 915,852, respectively.

The following tables set forth the computation of diluted net loss per weighted average number of shares outstanding attributable to Synthetic Biologics, Inc. and Subsidiaries for the three and nine months ended September 30, 2019 and 2018 (in thousands except share and per share amounts):



Three months ended September 30, 2019



Nine months ended September 30, 2019

Net loss

Shares

Per Share

Net Loss

Shares

Per Share

(Numerator)

(Denominator)

Amount

(Numerator)

(Denominator)

Amount

Net loss - Basic

$

(5,253)

16,805,257

$

(0.31)

$

(12,934)

16,313,326

$

(0.79)

Dilutive shares related to warrants

—

—

—

—

—

—

Net loss - Dilutive

$

(5,253)

16,805,257

$

(0.31)

$

(12,934)

16,313,326

$

(0.79)



Three months ended September 30, 2018



Nine months ended September 30, 2018

Net loss

Shares

Per Share

Net Loss

Shares

Per Share

(Numerator)

(Denominator)

Amount

(Numerator)

(Denominator)

Amount

Net loss - Basic

$

(3,741)

4,028,304

$

(0.93)

$

(10,375)

3,802,812

$

(2.73)

Dilutive shares related to warrants

—

—

—

—

—

—

Net loss - Dilutive

$

(3,741)

4,028,304

$

(0.93)

$

(10,375)

3,802,812

$

(2.73)

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Commitments and Contingencies
9 Months Ended

Sep. 30, 2019

Commitments and Contingencies

Commitments and Contingencies

10. Commitments and Contingencies

Leases

All of the Company’s existing leases as of September 30, 2019 are classified as operating leases. As of September 30, 2019, 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. 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 the general and administrative expenses in the condensed consolidated statements of operations, and for the three and nine months ended September 30, 2019 approximated $50,000 and $151,000, respectively. During the same period, operating cash flows used for operating leases approximated $75,000 and $224,000, respectively. During 2019, there were no ROU assets exchanged for operating lease obligations. The initial non-cash addition of ROU assets due to adoption of ASC 842 was $538,000.

A maturity analysis of our operating leases as of September 30, 2019 is as follows (amounts in thousands of dollars):

Future undiscounted cash flows:





2019

$

77

2020

309

2021

321

2022

192

Total

$

899

Discount factor

$

(119)

Lease liability

$

780

Amount due within 12 months

$

(241)

Non-current lease liability

$

539

As of December 31, 2018, the Company’s future minimum lease payments were as follows (in thousands):



2019



2020



2021



2022



Total

Operating Lease

$

300

$

309

$

321

$

192

$

1,122

Total

$

300

$

309

$

321

$

192

$

1,122

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Condensed Consolidated Statements of Operations - USD ($)
3 Months Ended 9 Months Ended

Sep. 30, 2019

Sep. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Operating Costs and Expenses:

General and administrative $ 1,098,000 $ 1,474,000 $ 3,297,000 $ 4,525,000

Research and development 4,144,000 2,846,000 9,156,000 9,788,000

Total Operating Costs and Expenses 5,242,000 4,320,000 12,453,000 14,313,000

Loss from Operations (5,242,000) (4,320,000) (12,453,000) (14,313,000)

Other Income :

Change in fair value of warrant liability 0 626,000 0 4,064,000

Interest income 92,000 5,000 217,000 20,000

Total Other Income 92,000 631,000 217,000 4,084,000

Net Loss (5,150,000) (3,689,000) (12,236,000) (10,229,000)

Net Loss Attributable to Non-controlling Interest (30,000) (9,000) (73,000) (35,000)

Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries (5,120,000) (3,680,000) (12,163,000) (10,194,000)

Net Loss Attributable to Common Stockholders $ (5,253,000) $ (3,741,000) $ (12,934,000) $ (10,375,000)

Net Loss Per Share - Basic and Dilutive $ (0.31) $ (0.93) $ (0.79) $ (2.73)

Weighted average number of shares outstanding during the period - Basic and Dilutive 16,805,257 4,028,304 16,313,326 3,802,812

Series A Preferred Stock [Member]

Other Income :

Preferred Stock Dividends, Income Statement Impact $ (63,000) $ (61,000) $ (185,000) $ (181,000)

Series B Preferred Stock [Member]

Other Income :

Net Loss Attributable to Non-controlling Interest 0

Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries 0

Preferred Stock Dividends, Income Statement Impact $ (70,000) $ 0 $ (585,000) $ 0

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Sep. 30, 2019

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 leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company’s lead 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‑010 which is intended 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). The Company is also advancing SYN‑020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases.

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 2018 Form 10‑K. The interim results for the three and nine months ended September 30, 2019 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.

Liquidity

As of September 30, 2019, the Company has a significant accumulated deficit and with the exception of the three months ended June 30, 2010 and December 31, 2017, the Company has experienced significant losses and incurred negative cash flows since inception. The Company expects to continue incurring losses for the foreseeable future, with the recognition of revenue being contingent on successful phase 3 clinical trials and requisite approvals by the FDA. Historically, the Company has financed its operations primarily through public and private sales of its common stock and a private placement of its preferred stock, and it expects to continue to seek to obtain required capital in a similar manner. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including planned product development efforts, clinical trials and research and discovery efforts.

Cash and cash equivalents totaled approximately $18.7 million as of September 30, 2019, which includes the net proceeds of approximately $16.7 million from the sale of securities in October 2018 (the Offering) and net proceeds of approximately $12.2 million from sales of the Company's Common Stock , $0.001 par value (the "Common Stock") in “at-the-market” (ATM) equity offerings during 2018. With $17.6 million in cash available in early November 2019, the Company believes these resources will be sufficient to fund its operations through at least the end of the fourth quarter of 2020. Management believes its plan, which includes the further development of SYN‑020 and additional testing of SYN‑004 (ribaxamase) and SYN‑010, will allow the Company to meet its financial obligations, further advance key products, and maintain the Company’s planned operations for at least one year from the issuance date of these consolidated financial statements, while not sacrificing the strategic direction of the Company. If necessary, the Company may attempt to utilize the ATM or seek to raise additional capital on the open market, neither of which is guaranteed. Use of the ATM is limited by certain restrictions and management’s plan does not rely on additional capital from either of these sources. If the Company is not able to obtain additional capital (which is not assured at this time), the Company’s long term business plan may not be accomplished and the Company may be forced to cease certain development activities. More specifically, the completion of a Phase 3 clinical trial will require significant financing or a significant partnership.

Reverse Stock Split

On August 10, 2018, the Company effected a one for thirty-five reverse stock split (the “Reverse Stock Split”) of its authorized, issued and outstanding common stock. Unless otherwise noted, all references to share amounts in these financial statements reflect the Reverse Stock Split.

Every thirty-five shares of issued and outstanding Common Stock were automatically combined into one issued and outstanding share of Common Stock, without any change in the par value per share of Common Stock. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the Reverse Stock Split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital.

The Reverse Stock Split affected all issued and outstanding shares of Common Stock, as well as Common Stock underlying stock options, warrants and convertible instruments outstanding immediately prior to the effectiveness of the Reverse Stock Split. The Reverse Stock Split reduced the total number of shares of Common Stock outstanding at the time of the Reverse Stock Split from approximately 128.5 million to approximately 3.7 million.

Recent Accounting Pronouncements and Developments

In February 2016, the FASB issued Accounting Standards Codification (“ASC”) 842, Leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the balance sheet and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective transition approach and provides for certain practical expedients. The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition approach wherein we applied the guidance to each lease that had commenced as of January 1, 2019 (the beginning of effective date) with a cumulative effect adjustment as of that date. The prior comparative period was not adjusted under this method and the Company has provided the required disclosures under ASC 840, Leases for the comparative period to which ASC 840 is applied. The Company has have also elected to adopt the following package of practical expedients:

·

the Company did not reassess if any expired or existing contracts are or contain leases.

·

the Company did not reassess the initial direct costs for existing leases.

·

the Company did not reassess the classification of any expired or existing leases.

Additionally, the Company made ongoing accounting policy elections whereby it (i) did not recognize right of use (“ROU”) assets or lease liabilities for short-term leases (those with original terms of 12‑months or less) and (ii) does not combine lease and non-lease elements of its operating leases. The determination of whether an arrangement contains a lease and the classification of a lease, if applicable, is made at lease commencement.

Upon adoption of the new guidance on January 1, 2019, the Company recorded a ROU asset of approximately $537,000 (net of taxes and existing deferred rent liability) and recognized a lease liability of approximately $939,000.

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Net Loss per Share - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended

Sep. 30, 2019

Sep. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Series A Preferred Stock [Member]

Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]

Preferred Stock Dividends, Income Statement Impact $ 63 $ 61 $ 185 $ 181

Series B Preferred Stock [Member]

Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]

Preferred Stock Dividends, Income Statement Impact $ 70 $ 0 $ 585 $ 0

Equity Option [Member]

Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]

Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 803,577 347,765

Warrant [Member]

Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]

Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 18,915,851 915,852

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Stock Warrants
9 Months Ended

Sep. 30, 2019

Stock Warrants

Stock Warrants

5. 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 the 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.

The assumptions used by the Company are summarized in the following table:



Issuance

Date

Closing stock price

$

0.88

Expected dividends

0

%

Expected volatility

90

%

Risk free interest rate

3.01

%

Expected life of warrant (years)

5.00

On November 18, 2016, the Company completed a public offering of 714,286 shares of Common Stock in combination with accompanying warrants to purchase an aggregate of 1,428,571 shares of the Common Stock. The stock and warrants were sold in combination, with two warrants for each share of Common Stock sold, a Series A warrant and a Series B warrant, each representing the right to purchase one share of Common Stock. The purchase price for each share of Common Stock and accompanying warrants was $35.00. The shares of Common Stock were immediately separable from the warrants and were issued separately. The 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 were each exercisable 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 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, 2019, the fair value of the warrant liability was $100. At September 30, 2018, the fair value of the warrant liability was $19,000, which resulted in non-cash income of $605,000 and $3.6 million for the three and nine months ended September 30, 2018, respectively. The warrants were valued on the date of grant and on each remeasurement period using Monte Carlo simulations.

The assumptions used by the Company are summarized in the following table:



Series A

December 31,

November 18,

2018

2016

Closing stock price

$

0.56

$

31.15

Expected dividends

0

%

0

%

Expected volatility

92.5

%

85

%

Risk free interest rate

2.50

%

1.58

%

Expected life of warrant

1.9 years

4.0 years

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 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, have an exercise price of $61.25 per share and a life of five years. The warrants vested immediately and expired on October 10, 2019.

The warrants issued in conjunction with the registered direct offering in October 2014 included a provision that if the Company were to enter into a certain transaction, as defined in the agreement, the warrants would be purchased from the holder at a premium. Accordingly, the Company recorded the warrants as a liability at their estimated fair value on the issuance date, which was $7.4 million, and changes in estimated fair value are being recorded as non-cash income or expense in the Company’s Consolidated Statements of Operations at each subsequent period. At September 30, 2019, the fair value of the warrant liability was zero. At September 30, 2018, the fair value of the warrant liability was $200, which resulted in non-cash income of $21,000 and $415,000 for the three and nine months ended September 30, 2018, respectively. The warrants were valued on the date of grant using the Black-Scholes valuation model which approximates the value derived using Monte Carlo simulations. The assumptions used by the Company are summarized in the following table:



December 31,

October 10,

2018

2014

Closing stock price

$

0.56

$

61.25

Expected dividends

0

%

0

%

Expected volatility

110

%

95

%

Risk free interest rate

2.60

%

1.39

%

Expected life of warrant

.79

years

5.0

years

The following table summarizes the estimated fair value of the warrant liability (in thousands):

Balance at December 31, 2017



$

4,083

Change in fair value of warrant liability

(4,083)

Balance at December 31, 2018

—

Change in fair value of warrant liability

—

Balance at September 30, 2019

$

—

A summary of all warrant activity for the Company for the nine months ended September 30, 2019 and the year ended December 31, 2018 is as follows:



Number of



Weighted Average

Warrants

Exercise Price

Balance at December 31, 2017

915,138

$

52.50

Granted

18,000,713

1.38

Exercised

—

—

Forfeited

—

—

Balance at December 31, 2018

18,915,851

3.85

Granted

—

—

Exercised

—

—

Forfeited

—

—

Balance at September 30, 2019

18,915,851

$

3.85

On December 26, 2017, the Company entered into a consulting agreement for advisory services for a period of six months. As compensation for such services, the consultant was paid an upfront payment, is paid a monthly fee, and on January 24, 2018 was issued a warrant exercisable for 714 shares of the 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.

The assumptions used by the Company are summarized in the following table:



Issuance

Date

Closing stock price

$

18.55

Expected dividends

0

%

Expected volatility

85

%

Risk free interest rate

2.42

%

Expected life of warrant (years)

4.92

A summary of all outstanding and exercisable warrants as of September 30, 2019 is as follows:







Weighted Average

Warrants

Warrants

Remaining

Exercise Price

Outstanding

Exercisable

Contractual Life

$

1.38

17,999,999

17,999,999

4.04 years

18.20

714

714

3.24 years

50.05

714,286

714,286

1.14 years

61.25

200,852

200,852

0.03 years

$

3.85

18,915,851

18,915,851

3.88 years

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Related Party Transactions
9 Months Ended

Sep. 30, 2019

Related Party Transactions

Related Party Transactions

9. 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 will provide further evaluation of the efficacy and safety of SYN‑010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN‑010 is designed to reduce methane production by certain microorganisms (M. smithii) in 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: (i) issued to CSMC 50,000 shares of Common Stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary Synthetic Biomics, Inc. (“SYN Biomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of 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 Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of the 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. As of September 30, 2019, CSMC has not exercised its right to exchange its SYN Biomics shares for the Common Stock.

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, 2019 and 2018, the Company did not owe and did not pay CSMC for milestone payments related this license agreement.

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Fair Value of Financial Instruments
9 Months Ended

Sep. 30, 2019

Fair Value of Financial Instruments

Fair Value of Financial Instruments

2. Fair Value of Financial Instruments

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, included in Level 1 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 $98,000 as of September 30, 2019 and December 31, 2018 that are measured using Level 1 inputs.

The Company uses Monte Carlo simulations to estimate the fair value of its stock warrants. In using this model, the fair value is determined by applying Level 3 inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the warrant liability and the change in estimated fair value could be materially different.

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Consolidated Statements of Stockholders Equity - USD ($)

Series B Preferred Stock [Member]

Common Stock [Member]

Additional Paid-in Capital [Member]

Accumulated Deficit [Member]

Noncontrolling Interest [Member]

Total

Balance at Dec. 31, 2017 $ 4,000 $ 192,670,000 $ (194,170,000) $ (1,914,000) $ (3,410,000)

Balance (in shares) at Dec. 31, 2017 3,671,014

Stock-based compensation $ 0 $ 0 676,000 0 0 676,000

Fair Value of Warrants issued 0 0 9,000 0 0 9,000

Series A Preferred Stock Dividends 0 0 0 (59,000) 0 (59,000)

Net loss $ 0 0 0 (2,316,000) 0 (2,316,000)

Non-controlling interest 0 0 0 (9,000) (9,000)

Balance at Mar. 31, 2018 $ 4,000 193,355,000 (196,545,000) (1,923,000) (5,109,000)

Balance (in shares) at Mar. 31, 2018 3,671,014

Balance at Dec. 31, 2017 $ 4,000 192,670,000 (194,170,000) (1,914,000) (3,410,000)

Balance (in shares) at Dec. 31, 2017 3,671,014

Net loss (10,194,000)

Non-controlling interest (35,000)

Balance at Sep. 30, 2018 $ 5,000 200,807,000 (204,545,000) (1,948,000) (5,681,000)

Balance (in shares) at Sep. 30, 2018 5,349,002

Balance at Mar. 31, 2018 $ 4,000 193,355,000 (196,545,000) (1,923,000) (5,109,000)

Balance (in shares) at Mar. 31, 2018 3,671,014

Stock-based compensation 557,000 557,000

Series A Preferred Stock Dividends (61,000) (61,000)

Stock issued under "at-the-market" offering 400,000 400,000

Stock issued under "at-the-market" offering (in shares) 0 49,490

Net loss (4,198,000) (4,198,000)

Non-controlling interest (16,000) (16,000)

Balance at Jun. 30, 2018 $ 4,000 194,312,000 (200,804,000) (1,939,000) (8,427,000)

Balance (in shares) at Jun. 30, 2018 3,720,504

Stock-based compensation 475,000 475,000

Series A Preferred Stock Dividends (61,000) (61,000)

Stock issued under "at-the-market" offering $ 1,000 6,020,000 6,021,000

Stock issued under "at-the-market" offering (in shares) 1,628,498

Net loss (3,680,000) (3,680,000)

Non-controlling interest (9,000) (9,000)

Balance at Sep. 30, 2018 $ 5,000 200,807,000 (204,545,000) (1,948,000) (5,681,000)

Balance (in shares) at Sep. 30, 2018 5,349,002

Balance at Dec. 31, 2018 $ 5,760,000 $ 15,000 230,754,000 (219,461,000) (2,909,000) 14,159,000

Balance (in shares) at Dec. 31, 2018 9,161 15,482,083

Stock-based compensation $ 0 $ 0 64,000 0 0 64,000

Series A Preferred Stock Dividends 0 0 0 (61,000) 0 (61,000)

Issuance of SYN Biomics Stock 0 0 (36,000) 0 53,000 17,000

Conversion of Series B Preferred Stock to Common $ (638,000) $ 1,000 1,035,000 (398,000) 0 0

Conversion of Series B Preferred Stock to Common (in shares) (1,036) 900,869

Net loss $ 0 $ 0 0 (3,512,000) 0 (3,512,000)

Non-controlling interest 0 0 0 (16,000) (16,000)

Balance at Mar. 31, 2019 $ 5,122,000 $ 16,000 231,817,000 (223,432,000) (2,872,000) 10,651,000

Balance (in shares) at Mar. 31, 2019 8,125 16,382,952

Balance at Dec. 31, 2018 $ 5,760,000 $ 15,000 230,754,000 (219,461,000) (2,909,000) 14,159,000

Balance (in shares) at Dec. 31, 2018 9,161 15,482,083

Net loss (12,163,000)

Non-controlling interest (73,000)

Balance at Sep. 30, 2019 $ 4,822,000 $ 17,000 232,485,000 (232,394,000) (2,841,000) 2,089,000

Balance (in shares) at Sep. 30, 2019 7,638 16,806,430

Balance at Mar. 31, 2019 $ 5,122,000 $ 16,000 231,817,000 (223,432,000) (2,872,000) 10,651,000

Balance (in shares) at Mar. 31, 2019 8,125 16,382,952

Stock-based compensation $ 0 $ 0 91,000 0 0 91,000

Series A Preferred Stock Dividends 0 0 0 (61,000) 0 (61,000)

Issuance of SYN Biomics Stock 0 0 0 0 45,000 45,000

Conversion of Series B Preferred Stock to Common $ (187,000) $ 1,000 303,000 (117,000) 0 0

Conversion of Series B Preferred Stock to Common (in shares) (302) 262,608

Net loss $ 0 0 (3,531,000) 0 (3,531,000)

Non-controlling interest 0 0 0 (27,000) (27,000)

Balance at Jun. 30, 2019 $ 4,935,000 $ 17,000 232,211,000 (227,141,000) (2,854,000) 7,168,000

Balance (in shares) at Jun. 30, 2019 7,823 16,645,560

Stock-based compensation $ 0 $ 0 91,000 0 0 91,000

Series A Preferred Stock Dividends 0 0 0 (63,000) 0 (63,000)

Issuance of SYN Biomics Stock 0 0 0 0 43,000 43,000

Conversion of Series B Preferred Stock to Common $ (113,000) $ 0 183,000 (70,000) 0 0

Conversion of Series B Preferred Stock to Common (in shares) (185) 160,870

Net loss $ 0 $ 0 0 (5,120,000) 0 (5,120,000)

Non-controlling interest 0 0 0 0 (30,000) (30,000)

Balance at Sep. 30, 2019 $ 4,822,000 $ 17,000 $ 232,485,000 $ (232,394,000) $ (2,841,000) $ 2,089,000

Balance (in shares) at Sep. 30, 2019 7,638 16,806,430

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Common and Preferred Stock (Details)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended

Oct. 15, 2018

USD ($)

$ / shares

shares

Oct. 10, 2018

shares

Sep. 11, 2017

USD ($)

D

$ / shares

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Aug. 05, 2016

USD ($)

Oct. 31, 2018

USD ($)

$ / shares

Sep. 30, 2019

USD ($)

$ / shares

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USD ($)

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Sep. 30, 2019

USD ($)

$ / shares

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Sep. 30, 2018

USD ($)

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Dec. 31, 2018

USD ($)

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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%

Preferred Shares, Unamortized Discount From Conversion $ 71,000 $ 585,000

Proceeds from Issuance Initial Public Offering $ 16,700,000

Common Stock, Discount on Shares $ 3,100,000 $ 3,100,000

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

Issue of warrants to purchase common stock | shares 1,807,826

Warrant [Member]

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Fbr Capital Markets Co [Member]

Stock Issued During Period, Shares, New Issues | shares 1,600,000 1,700,000 3,500,000

Stock Issued During Period, Value, New Issues $ 40,000,000

Brokerage Commission percentage 3.00%

Proceeds from Issuance of Common Stock $ 6,000,000 $ 6,400,000 $ 12,200,000

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Preferred Stock, Par or Stated Value Per Share | $ / shares $ 0.001 $ 0.001 $ 0.001

Preferred Stock, Dividend Rate, Percentage 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 Dividends, Income Statement Impact $ 63,000 61,000 $ 185,000 181,000

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 $ 1,000 $ 1,000 $ 1,000

Preferred Stock Dividends, Income Statement Impact $ 70,000 $ 0 $ 585,000 $ 0

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 185 1,523

Conversion of Stock, Shares Converted | shares 13,672,173 8,085

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

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Stock Warrants (Tables)
9 Months Ended

Sep. 30, 2019

Stock Warrants

Summary of assumptions used by the company

The assumptions used by the Company are summarized in the following table:



Issuance

Date

Closing stock price

$

0.88

Expected dividends

0

%

Expected volatility

90

%

Risk free interest rate

3.01

%

Expected life of warrant (years)

5.00

The assumptions used by the Company are summarized in the following table:



Series A

December 31,

November 18,

2018

2016

Closing stock price

$

0.56

$

31.15

Expected dividends

0

%

0

%

Expected volatility

92.5

%

85

%

Risk free interest rate

2.50

%

1.58

%

Expected life of warrant

1.9 years

4.0 years



December 31,

October 10,

2018

2014

Closing stock price

$

0.56

$

61.25

Expected dividends

0

%

0

%

Expected volatility

110

%

95

%

Risk free interest rate

2.60

%

1.39

%

Expected life of warrant

.79

years

5.0

years

The assumptions used by the Company are summarized in the following table:



Issuance

Date

Closing stock price

$

18.55

Expected dividends

0

%

Expected volatility

85

%

Risk free interest rate

2.42

%

Expected life of warrant (years)

4.92

Summary of the estimated fair value of the warrant liability

The following table summarizes the estimated fair value of the warrant liability (in thousands):

Balance at December 31, 2017



$

4,083

Change in fair value of warrant liability

(4,083)

Balance at December 31, 2018

—

Change in fair value of warrant liability

—

Balance at September 30, 2019

$

—

Summary of all warrant activity

A summary of all warrant activity for the Company for the nine months ended September 30, 2019 and the year ended December 31, 2018 is as follows:



Number of



Weighted Average

Warrants

Exercise Price

Balance at December 31, 2017

915,138

$

52.50

Granted

18,000,713

1.38

Exercised

—

—

Forfeited

—

—

Balance at December 31, 2018

18,915,851

3.85

Granted

—

—

Exercised

—

—

Forfeited

—

—

Balance at September 30, 2019

18,915,851

$

3.85

Summary of all outstanding and exercisable warrants

A summary of all outstanding and exercisable warrants as of September 30, 2019 is as follows:







Weighted Average

Warrants

Warrants

Remaining

Exercise Price

Outstanding

Exercisable

Contractual Life

$

1.38

17,999,999

17,999,999

4.04 years

18.20

714

714

3.24 years

50.05

714,286

714,286

1.14 years

61.25

200,852

200,852

0.03 years

$

3.85

18,915,851

18,915,851

3.88 years

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Fair Value of Financial Instruments (Details) - USD ($)

Sep. 30, 2019

Dec. 31, 2018

Fair Value of Financial Instruments

Cash and cash equivalents $ 98,000 $ 98,000

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Selected Balance Sheet Information
9 Months Ended

Sep. 30, 2019

Selected Balance Sheet Information

Selected Balance Sheet Information

3. Selected Balance Sheet Information

Prepaid expenses and other current assets (in thousands)

September 30,

December 31,



2019



2018

Prepaid manufacturing expenses

$

1,001

$

—

Prepaid consulting, subscriptions and other expenses

123

132

Prepaid insurance

65

419

Other receivable

4

—

Prepaid conferences, travel

—

42

Total

$

1,193

$

593

Property and equipment, net (in thousands)



September 30,

December 31,

2019



2018

Computers and office equipment

$

852

$

852

Leasehold improvements

439

439

Software

11

11

1,302

1,302

Less: accumulated depreciation and amortization

(877)

(695)

Total

$

425

$

607

Accrued expenses (in thousands)



September 30,

December 31,

2019



2018

Accrued manufacturing costs

$

1,283

$

83

Accrued clinical consulting services

709

674

Accrued vendor payments

323

150

Other accrued expenses

6

12

Total

$

2,321

$

919

Accrued employee benefits (in thousands)



September 30,

December 31,

2019



2018

Accrued bonus expense

$

524

$

907

Accrued vacation expense

95

118

Accrued severance

—

307

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$

619

$

1,332

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Non-controlling Interest
9 Months Ended

Sep. 30, 2019

Non-controlling Interest

Non-controlling Interest

7. Non-controlling Interest

The Company’s non-controlling interest is accounted for under ASC 810, Consolidation, 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 (the 'Stock Purchase Agreement") with Cedars-Sinai Medical Center (CSMC) for an investigator-sponsored Phase 2b clinical study of SYN‑010 to be co-funded by the Company and CSMC (the “Study”). The Study will provide further evaluation of the efficacy and safety of SYN‑010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN‑010 is designed to reduce methane production by certain microorganisms (M. smithii) in 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 will 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 50,000 shares of Common Stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary SYN Biomics, Inc. (“Synbiomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of 7,480,000 shares of common stock of SYN Biomics, representing 17% of the issued and outstanding shares of SYN Biomics’ common stock. The services rendered are recorded to research and development expense in proportion with the progress of the study and are based overall on the fair value of the shares ($285,000) as determined at the date of IRB approval. During 2019, research and development expense recorded related to this transaction approximated $108,000 and $318,000 for the three and nine months ended September 30, 2019, respectively.

The Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of the 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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Selected Balance Sheet Information (Tables)
9 Months Ended

Sep. 30, 2019

Selected Balance Sheet Information

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets (in thousands)

September 30,

December 31,



2019



2018

Prepaid manufacturing expenses

$

1,001

$

—

Prepaid consulting, subscriptions and other expenses

123

132

Prepaid insurance

65

419

Other receivable

4

—

Prepaid conferences, travel

—

42

Total

$

1,193

$

593

Schedule of property, plant and equipment, net

Property and equipment, net (in thousands)



September 30,

December 31,

2019



2018

Computers and office equipment

$

852

$

852

Leasehold improvements

439

439

Software

11

11

1,302

1,302

Less: accumulated depreciation and amortization

(877)

(695)

Total

$

425

$

607

Schedule of accrued expenses

Accrued expenses (in thousands)



September 30,

December 31,

2019



2018

Accrued manufacturing costs

$

1,283

$

83

Accrued clinical consulting services

709

674

Accrued vendor payments

323

150

Other accrued expenses

6

12

Total

$

2,321

$

919

Schedule of accrued employee benefits

Accrued employee benefits (in thousands)



September 30,

December 31,

2019



2018

Accrued bonus expense

$

524

$

907

Accrued vacation expense

95

118

Accrued severance

—

307

Total

$

619

$

1,332

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Stock Warrants - Additional Information (Details) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended

Oct. 15, 2018

Oct. 10, 2018

Oct. 10, 2014

Nov. 18, 2016

Sep. 30, 2019

Sep. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Oct. 31, 2018

Dec. 26, 2017

Equity, Class of Treasury Stock [Line Items]

Proceeds from Issuance or Sale of Equity $ 18,600,000

Warrants Not Settleable in Cash, Fair Value Disclosure $ 9,000

Proceeds from Issuance of Common Stock $ 12,200,000

Class of Warrant or Right, Number of Securities Called by Warrants or Rights 13,672,173

Fair Value Adjustment of Warrants $ 0 $ (626,000) $ 0 $ (4,064,000) $ (4,083,000)

Class of Warrant or Right, Exercise Price of Warrants or Rights $ 1.38 $ 1.38

Class A [Member]

Equity, Class of Treasury Stock [Line Items]

Stock Issued During Period, Shares, New Issues 2,520,000

Class B [Member]

Equity, Class of Treasury Stock [Line Items]

Stock Issued During Period, Shares, New Issues 15,723

Preferred Stock Conversion Price Per Share $ 1.15

Series B Preferred Stock [Member]

Equity, Class of Treasury Stock [Line Items]

Class of Warrant or Right, Number of Securities Called by Warrants or Rights 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 $ 1,000 $ 1,000

Conversion of Stock, Shares Converted 13,672,173 8,085

IPO [Member]

Equity, Class of Treasury Stock [Line Items]

Warrants Not Settleable in Cash, Fair Value Disclosure $ 15,700,000 $ 100,000 19,000 $ 100,000 19,000

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

Fair Value Adjustment of Warrants 605,000 3,600,000

Sale of Stock, Price Per Share $ 1.47 $ 35.00

IPO [Member] | Series A [Member]

Equity, Class of Treasury Stock [Line Items]

Class of Warrant or Right, Exercise Price of Warrants or Rights 50.05

IPO [Member] | Series B [Member]

Equity, Class of Treasury Stock [Line Items]

Class of Warrant or Right, Exercise Price of Warrants or Rights $ 60.20

Over-Allotment Option [Member]

Equity, Class of Treasury Stock [Line Items]

Issuance Of Warrants To Purchase Of Common Stock 1,807,826

Stock Issued During Period, Shares, New Issues 2,428,825 2,428,825

Class of Warrant or Right, Number of Securities Called by Warrants or Rights 2,428,825 2,428,825

Underwritten Public Offering [Member] | October 2018 Warrants [Member]

Equity, Class of Treasury Stock [Line Items]

Warrant Term 5 years

Series A Warrants [Member]

Equity, Class of Treasury Stock [Line Items]

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, Options, Exercisable, Number 61.25

Share Based Compensation Arrangement By Share Based Payment Award Warrants Vested and Expected To Vest Outstanding Number 200,852

Fair Value of Warrant Liability $ 0 200 $ 0 200

Fair Value Adjustment of Warrants $ 7,400,000 $ 21,000 $ 415,000

Warrant [Member]

Equity, Class of Treasury Stock [Line Items]

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

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Stock Warrants - Warrant liability (Details) - $ / shares
1 Months Ended 12 Months Ended

Oct. 10, 2014

Nov. 18, 2016

Dec. 31, 2018

Fair Value Measurement Inputs and Valuation Techniques [Line Items]

Closing stock price $ 61.25 $ 0.56

Expected dividends 0.00% 0.00%

Expected volatility 95.00% 110.00%

Risk free interest rate 1.39% 2.60%

Expected life of warrant 5 years 9 months 15 days

Series A Warrants [Member]

Fair Value Measurement Inputs and Valuation Techniques [Line Items]

Closing stock price $ 31.15 $ 0.56

Expected dividends 0.00% 0.00%

Expected volatility 85.00% 92.50%

Risk free interest rate 1.58% 2.50%

Expected life of warrant 4 years 1 year 10 months 24 days

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Condensed Consolidated Statements of Cash Flows - USD ($)
9 Months Ended

Sep. 30, 2019

Sep. 30, 2018

Cash Flows From Operating Activities:

Net Loss $ (12,236,000) $ (10,229,000)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation 246,000 1,708,000

Subsidiary stock issued to consultant 104,000 0

Warrant issued to consultant 0 9,000

Change in fair value of warrant liabilities 0 (4,064,000)

Depreciation and amortization 182,000 207,000

Changes in operating assets and liabilities:

Prepaid expenses and other current assets (600,000) 268,000

Right of use asset 86,000 0

Accounts payable 1,419,000 (1,141,000)

Accrued expenses 1,403,000 (41,000)

Accrued employee benefits (713,000) (640,000)

Lease Liability (159,000) 0

Deferred rent 0 (66,000)

Net Cash Used In Operating Activities (10,268,000) (13,989,000)

Cash Flows From Investing Activities:

Net Cash Provided by (Used in) Investing Activities, Total 0 0

Cash Flows From Financing Activities:

Proceeds from issuance ATM offering, net of issuance costs 0 6,422,000

Net Cash Provided By Financing Activities 0 6,422,000

Net decrease in cash (10,268,000) (7,567,000)

Cash and cash equivalents at beginning of period 28,918,000 17,116,000

Cash and cash equivalents at end of period 18,650,000 9,549,000

Noncash Financing Activities:

Right of use asset from operating lease 538,000 0

Deemed dividends for beneficial conversion feature 585,000 0

In-kind dividends paid in preferred stock 185,000 181,000

Series B Preferred Stock [Member]

Noncash Financing Activities:

Conversion of Series B Preferred Stock $ 938,000 $ 0

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Dec. 31, 2018

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Preferred Stock, Par or Stated Value Per Share $ 0.001 $ 0.001

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Preferred Stock, Par or Stated Value Per Share $ 1,000 $ 1,000

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$ in Thousands

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Dec. 31, 2018

Commitments and Contingencies

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2020 309

2021 321

2022 192

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Lease liability 780

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Related Party Transactions (Details) - USD ($)
$ / shares in Units, $ in Thousands
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Sep. 30, 2019

Oct. 31, 2018

Oct. 15, 2018

Sep. 05, 2018

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Synthetic Biomics Inc [Member]

Related Party Transaction [Line Items]

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Cedarssinai Medical Center [Member]

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Selected Balance Sheet Information - Schedule of accrued expenses (Details) - USD ($)
$ in Thousands

Sep. 30, 2019

Dec. 31, 2018

Selected Balance Sheet Information

Accrued manufacturing costs $ 1,283 $ 83

Accrued clinical consulting services 709 674

Accrued vendor payments 323 150

Other accrued expenses 6 12

Total $ 2,321 $ 919

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XML 55 R19.htm IDEA: XBRL DOCUMENT v3.19.3

Stock-Based Compensation (Tables)
9 Months Ended

Sep. 30, 2019

Stock-Based Compensation

Summary of stock option activity

A summary of stock option activity for the nine months ended September 30, 2019 and the year ended December 31, 2018 is as follows:





Weighted



Weighted Average Remaining



Aggregate

Average Exercise

Contractual Life

Intrinsic

Options

Price

(in years)

Value

Balance - December 31, 2017

359,076

$

53.93

4.60

$

1,800

Granted

671,500

$

0.69





Expired

(78,667)

$

67.02





Forfeited

(12,927)

$

23.72





Balance - December 31, 2018

938,982

$

15.18

6.19

$

—

Expired

(68,173)

$

64.76





Forfeited

(67,232)

$

5.95





Balance - September 30, 2019 - outstanding

803,577

$

11.74

5.64

$

—

Balance - September 30, 2019 - exercisable

330,470

$

26.77

4.89

$

—

Grant date fair value of options granted - September 30, 2019

$

—





Weighted average grant date fair value - September 30, 2019

$

—





Grant date fair value of options granted - December 31, 2018

$

301,000





Weighted average grant date fair value - December 31, 2018

$

0.45





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Tabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value.
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Stock-Based Compensation
9 Months Ended

Sep. 30, 2019

Stock-Based Compensation

Stock-Based Compensation

4. 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 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, 2019, there were 8,959 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 Common Stock reserved for issuance under the 2010 Stock Plan from 85,714 to 171,429. On May 15, 2015, 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 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 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 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 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 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, 2019, there were 794,618 options issued and outstanding under the 2010 Stock Plan.

In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. 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, 2019 and 2018. The assumptions used for the awards during the year ended December 31, 2018 are as follows:

Exercise price



$

0.69

Expected dividends

0

%

Expected volatility

86

%

Risk-free interest rate

2.75

%

Expected life of option

4
years

Expected dividends —The Company has never declared or paid dividends on the Common Stock and has no plans to do so in the foreseeable future.

Expected volatility—Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period.

Risk-free interest rate—The assumed risk-free rate used is a zero coupon U.S. Treasury security with a maturity that approximates the expected term of the option.

Expected life of the option—The period of time that the options granted are expected to remain unexercised. Options granted during 2018 have a maximum term of seven years. The Company estimates the expected life of the option based on the weighted average life between the dates that options become fully vested and the maximum life of options granted.

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;

·

half vesting immediately and remaining over three years;

·

in full on one-year anniversary date of grant date;

·

quarterly over three years;

·

annually over three years;

·

one-third immediate vesting and remaining annually over two years;

·

one-half immediate vesting and remaining over nine months;

·

one quarter immediate vesting and remaining over three years;

·

one quarter immediate vesting and remaining over 33 months; and

·

monthly over three years.

A summary of stock option activity for the nine months ended September 30, 2019 and the year ended December 31, 2018 is as follows:





Weighted



Weighted Average Remaining



Aggregate

Average Exercise

Contractual Life

Intrinsic

Options

Price

(in years)

Value

Balance - December 31, 2017

359,076

$

53.93

4.60

$

1,800

Granted

671,500

$

0.69





Expired

(78,667)

$

67.02





Forfeited

(12,927)

$

23.72





Balance - December 31, 2018

938,982

$

15.18

6.19

$

—

Expired

(68,173)

$

64.76





Forfeited

(67,232)

$

5.95





Balance - September 30, 2019 - outstanding

803,577

$

11.74

5.64

$

—

Balance - September 30, 2019 - exercisable

330,470

$

26.77

4.89

$

—

Grant date fair value of options granted - September 30, 2019

$

—





Weighted average grant date fair value - September 30, 2019

$

—





Grant date fair value of options granted - December 31, 2018

$

301,000





Weighted average grant date fair value - December 31, 2018

$

0.45





Stock-based compensation expense included in operating expenses related to stock options issued to employees and consultants for the three months ended September 30, 2019 and 2018 was $90,000 and $475,000 respectively, and $246,000 and $1.7 million for the nine months ended September 30, 2019 and 2018, respectively.

As of September 30, 2019, total unrecognized stock-based compensation expense related to stock options was $305,000, which is expected to be expensed through June 2021.

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, 2019 and 2018.

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XML 57 R15.htm IDEA: XBRL DOCUMENT v3.19.3

Common and Preferred Stock
9 Months Ended

Sep. 30, 2019

Common and Preferred Stock

Common and Preferred Stock

8. 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 per Class A Unit, 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 is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Common Stock. The exercise price of the Warrants is subject to adjustment in the event of certain dilutive issuances. During the three and nine months ended September 30, 2019, 185 and 1,523 shares of Series B Preferred Stock, respectively, have been converted resulting in the recognition of $71,000 and $585,000 of unamortized discount from the conversion, respectively. As of September 30, 2019, 8,085 shares of Series B Preferred Stock have been converted resulting in the recognition of $3.1 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 Stock 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 is less than the fair value of the underlying Common Stock at the date of issuance, there is a beneficial conversion feature (“BCF”) at the issuance date. Because the Series B Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the 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 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.

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 (i) redeemable based on contingent events outside of the Company’s control, and (ii) convertible immediately and from time to time. Since the effective conversion price of the Series A Preferred Stock was 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 retained earnings as a “deemed dividend” and impacts earnings per share. 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, 2019, the Company accrued dividends of $63,000 and $185,000, respectively. During the three and nine months ended September 30, 2018, the Company accrued dividends of $62,000 and $182,000, 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 FBR, Inc.), which enables the Company to offer and sell shares of the 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 Common Stock sold on the Company’s behalf. For the year ended December 31, 2018, the Company sold through the B. Riley FBR Sales Agreement an aggregate of 3.5 million shares of the Common Stock, and received net proceeds of approximately $12.2 million. For the three and nine months ending September 30, 2018, the Company sold through the B. Riley FBR Sales Agreement an aggregate of 1.6 and 1.7 million shares of the Common Stock, and received net proceeds of approximately $6.0 million and $6.4 million. The Company has not sold any shares of common stock during 2019 through the B. Riley FBR Sales Agreement.

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Sep. 30, 2019

$ / shares

shares

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Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

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Warrants Exercisable 17,999,999

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Warrants Exercisable 714,286

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Warrants Exercisable 200,852

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Warrants Exercisable 18,915,851

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Dec. 26, 2017

Dec. 31, 2018

Oct. 10, 2014

Closing stock price $ 0.56 $ 61.25

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Consolidated Statements of Stockholders Equity (Parenthetical) - $ / shares
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Sep. 30, 2019

Jun. 30, 2019

Mar. 31, 2019

Sep. 30, 2018

Jun. 30, 2018

Mar. 31, 2018

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Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands

Sep. 30, 2019

Dec. 31, 2018

Current Assets

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Prepaid expenses and other current assets 1,193 593

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Property and equipment, net 425 607

Right of Use Asset 451 0

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Additional paid-in capital 232,485 230,754

Accumulated deficit (232,394) (219,461)

Total Synthetic Biologics, Inc. and Subsidiaries Equity 4,930 17,068

Non-controlling interest (2,841) (2,909)

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Total Liabilities and Stockholders' Equity 20,742 30,141

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Stockholders' Equity:

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Commitments and Contingencies - Future minimum lease payments (Details) $ in Thousands	Dec. 31, 2018 USD ($)
Commitments and Contingencies
2019	$ 300
2020	309
2021	321
2022	192
Total	$ 1,122

Non-controlling Interest (Details) - USD ($)		3 Months Ended						9 Months Ended
Non-controlling Interest (Details) - USD ($)	Sep. 05, 2018	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018
Noncontrolling Interest [Line Items]
Net Loss Attributable to Non-controlling Interest		$ (30,000)	$ (27,000)	$ (16,000)	$ (9,000)	$ (16,000)	$ (9,000)	$ (73,000)	$ (35,000)
Stockholders' Equity Attributable to Noncontrolling Interest		(2,841,000)						(2,841,000)		$ (2,909,000)
Related Party Transaction, Expenses from Transactions with Related Party	$ 441,000
Research and Development Expense		$ 4,144,000			$ 2,846,000			$ 9,156,000	$ 9,788,000
Cedarssinai Medical Center [Member]
Noncontrolling Interest [Line Items]
Number Of Common Stock To Be Issued	50,000	50,000						50,000
Research and Development Expense		$ 108,000						$ 318,000
Fair Value Of Shares Issued	$ 285,000

Selected Balance Sheet Information - Schedule of prepaid expenses and other current assets (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Selected Balance Sheet Information
Prepaid manufacturing expense	$ 1,001	$ 0
Prepaid consulting, subscriptions and other expenses	123	132
Prepaid insurance	65	419
Other receivable	4	0
Prepaid conferences, travel	0	42
Total	$ 1,193	$ 593

Stock-Based Compensation - Assumptions used for the awards (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Stock-Based Compensation
Exercise price		$ 0.69
Expected dividends		0.00%
Expected volatility		86.00%
Risk -free interest rate		2.75%
Expected life of option	4 years	4 years

Stock-Based Compensation - Summary of stock option activity (Details) - Stock Option [Member] - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options, Beginning Balance	938,982	359,076
Options, Granted		671,500
Options, Expired	(68,173)	(78,667)
Options, Forfeited	(67,232)	(12,927)
Options, Ending Balance	803,577	938,982	359,076
Options, Exercisable	330,470
Weighted Average Exercise Price, Beginning Balance	$ 15.18	$ 53.93
Weighted Average Exercise Price, Granted		0.69
Weighted Average Exercise Price, Expired	64.76	67.02
Weighted Average Exercise Price, Forfeited	5.95	23.72
Weighted Average Exercise Price, Ending Balance	11.74	$ 15.18	$ 53.93
Weighted Average Exercise Price, Exercisable	$ 26.77
Weighted Average Remaining Contractual Life, Balance Outstanding	5 years 7 months 21 days	6 years 2 months 9 days	4 years 7 months 6 days
Weighted Average Remaining Contractual Life, Exercisable	4 years 10 months 21 days
Aggregate Intrinsic Value, Ending Balance	$ 0	$ 0	$ 1,800
Aggregate Intrinsic Value, Exercisable	0
Grant date fair value of options granted	$ 0	$ 301,000
Weighted average grant date fair value	$ 0	$ 0.45

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, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Nov. 02, 2010
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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								$ 305,000		$ 305,000
Employees and consultants \| Operating Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Allocated Share-based Compensation Expense								$ 90,000	$ 475,000	$ 246,000	$ 1,700,000
2007 Stock Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number							71,429	8,959		8,959
2007 Stock Plan [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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 [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number								794,618		794,618		85,714
2010 Stock Plan [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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 [Line Items]
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

Related Party Transactions	9 Months Ended
Related Party Transactions	Sep. 30, 2019
Related Party Transactions
Related Party Transactions	9. 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 will provide further evaluation of the efficacy and safety of SYN‑010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN‑010 is designed to reduce methane production by certain microorganisms (M. smithii) in 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: (i) issued to CSMC 50,000 shares of Common Stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary Synthetic Biomics, Inc. (“SYN Biomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of 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 Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of the 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. As of September 30, 2019, CSMC has not exercised its right to exchange its SYN Biomics shares for the Common Stock. 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, 2019 and 2018, the Company did not owe and did not pay CSMC for milestone payments related this license agreement.

Consolidated Statements of Stockholders Equity - USD ($)	Series B Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Noncontrolling Interest [Member]	Total
Balance at Dec. 31, 2017		$ 4,000	$ 192,670,000	$ (194,170,000)	$ (1,914,000)	$ (3,410,000)
Balance (in shares) at Dec. 31, 2017		3,671,014
Stock-based compensation	$ 0	$ 0	676,000	0	0	676,000
Fair Value of Warrants issued	0	0	9,000	0	0	9,000
Series A Preferred Stock Dividends	0	0	0	(59,000)	0	(59,000)
Net loss	$ 0	0	0	(2,316,000)	0	(2,316,000)
Non-controlling interest		0	0	0	(9,000)	(9,000)
Balance at Mar. 31, 2018		$ 4,000	193,355,000	(196,545,000)	(1,923,000)	(5,109,000)
Balance (in shares) at Mar. 31, 2018		3,671,014
Balance at Dec. 31, 2017		$ 4,000	192,670,000	(194,170,000)	(1,914,000)	(3,410,000)
Balance (in shares) at Dec. 31, 2017		3,671,014
Net loss						(10,194,000)
Non-controlling interest						(35,000)
Balance at Sep. 30, 2018		$ 5,000	200,807,000	(204,545,000)	(1,948,000)	(5,681,000)
Balance (in shares) at Sep. 30, 2018		5,349,002
Balance at Mar. 31, 2018		$ 4,000	193,355,000	(196,545,000)	(1,923,000)	(5,109,000)
Balance (in shares) at Mar. 31, 2018		3,671,014
Stock-based compensation			557,000			557,000
Series A Preferred Stock Dividends				(61,000)		(61,000)
Stock issued under "at-the-market" offering			400,000			400,000
Stock issued under "at-the-market" offering (in shares)	0	49,490
Net loss				(4,198,000)		(4,198,000)
Non-controlling interest					(16,000)	(16,000)
Balance at Jun. 30, 2018		$ 4,000	194,312,000	(200,804,000)	(1,939,000)	(8,427,000)
Balance (in shares) at Jun. 30, 2018		3,720,504
Stock-based compensation			475,000			475,000
Series A Preferred Stock Dividends				(61,000)		(61,000)
Stock issued under "at-the-market" offering		$ 1,000	6,020,000			6,021,000
Stock issued under "at-the-market" offering (in shares)		1,628,498
Net loss				(3,680,000)		(3,680,000)
Non-controlling interest					(9,000)	(9,000)
Balance at Sep. 30, 2018		$ 5,000	200,807,000	(204,545,000)	(1,948,000)	(5,681,000)
Balance (in shares) at Sep. 30, 2018		5,349,002
Balance at Dec. 31, 2018	$ 5,760,000	$ 15,000	230,754,000	(219,461,000)	(2,909,000)	14,159,000
Balance (in shares) at Dec. 31, 2018	9,161	15,482,083
Stock-based compensation	$ 0	$ 0	64,000	0	0	64,000
Series A Preferred Stock Dividends	0	0	0	(61,000)	0	(61,000)
Issuance of SYN Biomics Stock	0	0	(36,000)	0	53,000	17,000
Conversion of Series B Preferred Stock to Common	$ (638,000)	$ 1,000	1,035,000	(398,000)	0	0
Conversion of Series B Preferred Stock to Common (in shares)	(1,036)	900,869
Net loss	$ 0	$ 0	0	(3,512,000)	0	(3,512,000)
Non-controlling interest		0	0	0	(16,000)	(16,000)
Balance at Mar. 31, 2019	$ 5,122,000	$ 16,000	231,817,000	(223,432,000)	(2,872,000)	10,651,000
Balance (in shares) at Mar. 31, 2019	8,125	16,382,952
Balance at Dec. 31, 2018	$ 5,760,000	$ 15,000	230,754,000	(219,461,000)	(2,909,000)	14,159,000
Balance (in shares) at Dec. 31, 2018	9,161	15,482,083
Net loss						(12,163,000)
Non-controlling interest						(73,000)
Balance at Sep. 30, 2019	$ 4,822,000	$ 17,000	232,485,000	(232,394,000)	(2,841,000)	2,089,000
Balance (in shares) at Sep. 30, 2019	7,638	16,806,430
Balance at Mar. 31, 2019	$ 5,122,000	$ 16,000	231,817,000	(223,432,000)	(2,872,000)	10,651,000
Balance (in shares) at Mar. 31, 2019	8,125	16,382,952
Stock-based compensation	$ 0	$ 0	91,000	0	0	91,000
Series A Preferred Stock Dividends	0	0	0	(61,000)	0	(61,000)
Issuance of SYN Biomics Stock	0	0	0	0	45,000	45,000
Conversion of Series B Preferred Stock to Common	$ (187,000)	$ 1,000	303,000	(117,000)	0	0
Conversion of Series B Preferred Stock to Common (in shares)	(302)	262,608
Net loss		$ 0	0	(3,531,000)	0	(3,531,000)
Non-controlling interest		0	0	0	(27,000)	(27,000)
Balance at Jun. 30, 2019	$ 4,935,000	$ 17,000	232,211,000	(227,141,000)	(2,854,000)	7,168,000
Balance (in shares) at Jun. 30, 2019	7,823	16,645,560
Stock-based compensation	$ 0	$ 0	91,000	0	0	91,000
Series A Preferred Stock Dividends	0	0	0	(63,000)	0	(63,000)
Issuance of SYN Biomics Stock	0	0	0	0	43,000	43,000
Conversion of Series B Preferred Stock to Common	$ (113,000)	$ 0	183,000	(70,000)	0	0
Conversion of Series B Preferred Stock to Common (in shares)	(185)	160,870
Net loss	$ 0	$ 0	0	(5,120,000)	0	(5,120,000)
Non-controlling interest	0	0	0	0	(30,000)	(30,000)
Balance at Sep. 30, 2019	$ 4,822,000	$ 17,000	$ 232,485,000	$ (232,394,000)	$ (2,841,000)	$ 2,089,000
Balance (in shares) at Sep. 30, 2019	7,638	16,806,430

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2019	Oct. 31, 2019
Document and Entity Information
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q3
Current Fiscal Year End Date	--12-31
Entity Registrant Name	Synthetic Biologics, Inc.
Entity Central Index Key	0000894158
Trading Symbol	SYN
Entity Current Reporting Status	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		16,806,430

Commitments and Contingencies - Additional Information (Details) - USD ($)		3 Months Ended	9 Months Ended		12 Months Ended
	Jan. 01, 2019	Sep. 30, 2019	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2019
Operating Lease, Weighted Average Discount Rate, Percent		9.90%	9.90%
Operating Lease, Cost		$ 50,000	$ 151,000
Operating Lease, Payments		$ 75,000	224,000
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability			$ 538,000	$ 0	$ 0
Operating Lease Expiration Year			2022
ASU 2016-02
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability	$ 538,000

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 ($)	Oct. 31, 2018 USD ($) $ / shares	Sep. 30, 2019 USD ($) $ / shares shares	Sep. 30, 2018 USD ($) shares	Sep. 30, 2019 USD ($) $ / shares shares	Sep. 30, 2018 USD ($) shares	Dec. 31, 2018 USD ($) $ / shares shares
Preferred Stock, Dividend Rate, Percentage										2.00%
Proceeds from Issuance of Common Stock										$ 12,200,000
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%
Preferred Shares, Unamortized Discount From Conversion						$ 71,000		$ 585,000
Proceeds from Issuance Initial Public Offering					$ 16,700,000
Common Stock, Discount on Shares						$ 3,100,000		$ 3,100,000
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
Issue of warrants to purchase common stock \| shares		1,807,826
Warrant [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares	13,672,173
Fbr Capital Markets Co [Member]
Stock Issued During Period, Shares, New Issues \| shares							1,600,000		1,700,000	3,500,000
Stock Issued During Period, Value, New Issues				$ 40,000,000
Brokerage Commission percentage				3.00%
Proceeds from Issuance of Common Stock							$ 6,000,000		$ 6,400,000	$ 12,200,000
Series A Preferred Stock [Member]
Preferred Stock, Par or Stated Value Per Share \| $ / shares						$ 0.001		$ 0.001		$ 0.001
Preferred Stock, Dividend Rate, Percentage			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 Dividends, Income Statement Impact						$ 63,000	61,000	$ 185,000	181,000
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					$ 1,000		$ 1,000		$ 1,000
Preferred Stock Dividends, Income Statement Impact						$ 70,000	$ 0	$ 585,000	$ 0
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						185		1,523
Conversion of Stock, Shares Converted \| shares	13,672,173							8,085
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

Selected Balance Sheet Information - Schedule of accrued employee benefits (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Organization, Nature of Operations and Basis of Presentation
Accrued bonus expense	$ 524	$ 907
Accrued vacation expense	95	118
Accrued severance	0	307
Total	$ 619	$ 1,332

Fair Value of Financial Instruments (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Fair Value of Financial Instruments
Cash and cash equivalents	$ 98,000	$ 98,000

Non-controlling Interest	9 Months Ended
Non-controlling Interest	Sep. 30, 2019
Non-controlling Interest
Non-controlling Interest	7. Non-controlling Interest The Company’s non-controlling interest is accounted for under ASC 810, Consolidation, 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 (the 'Stock Purchase Agreement") with Cedars-Sinai Medical Center (CSMC) for an investigator-sponsored Phase 2b clinical study of SYN‑010 to be co-funded by the Company and CSMC (the “Study”). The Study will provide further evaluation of the efficacy and safety of SYN‑010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN‑010 is designed to reduce methane production by certain microorganisms (M. smithii) in 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 will 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 50,000 shares of Common Stock of the Company; and (ii) transferred to CSMC an additional 2,420,000 shares of common stock of its subsidiary SYN Biomics, Inc. (“Synbiomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of 7,480,000 shares of common stock of SYN Biomics, representing 17% of the issued and outstanding shares of SYN Biomics’ common stock. The services rendered are recorded to research and development expense in proportion with the progress of the study and are based overall on the fair value of the shares ($285,000) as determined at the date of IRB approval. During 2019, research and development expense recorded related to this transaction approximated $108,000 and $318,000 for the three and nine months ended September 30, 2019, respectively. The Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of the 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.

Stock Warrants - Additional Information (Details) - USD ($)				1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended
	Oct. 15, 2018	Oct. 10, 2018	Oct. 10, 2014	Nov. 18, 2016	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Oct. 31, 2018	Dec. 26, 2017
Equity, Class of Treasury Stock [Line Items]
Proceeds from Issuance or Sale of Equity	$ 18,600,000
Warrants Not Settleable in Cash, Fair Value Disclosure											$ 9,000
Proceeds from Issuance of Common Stock									$ 12,200,000
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	13,672,173
Fair Value Adjustment of Warrants					$ 0	$ (626,000)	$ 0	$ (4,064,000)	$ (4,083,000)
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 1.38									$ 1.38
Class A [Member]
Equity, Class of Treasury Stock [Line Items]
Stock Issued During Period, Shares, New Issues	2,520,000
Class B [Member]
Equity, Class of Treasury Stock [Line Items]
Stock Issued During Period, Shares, New Issues	15,723
Preferred Stock Conversion Price Per Share	$ 1.15
Series B Preferred Stock [Member]
Equity, Class of Treasury Stock [Line Items]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	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		$ 1,000		$ 1,000
Conversion of Stock, Shares Converted	13,672,173						8,085
IPO [Member]
Equity, Class of Treasury Stock [Line Items]
Warrants Not Settleable in Cash, Fair Value Disclosure				$ 15,700,000	$ 100,000	19,000	$ 100,000	19,000
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
Fair Value Adjustment of Warrants						605,000		3,600,000
Sale of Stock, Price Per Share			$ 1.47	$ 35.00
IPO [Member] \| Series A [Member]
Equity, Class of Treasury Stock [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights				50.05
IPO [Member] \| Series B [Member]
Equity, Class of Treasury Stock [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights				$ 60.20
Over-Allotment Option [Member]
Equity, Class of Treasury Stock [Line Items]
Issuance Of Warrants To Purchase Of Common Stock	1,807,826
Stock Issued During Period, Shares, New Issues	2,428,825	2,428,825
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	2,428,825	2,428,825
Underwritten Public Offering [Member] \| October 2018 Warrants [Member]
Equity, Class of Treasury Stock [Line Items]
Warrant Term	5 years
Series A Warrants [Member]
Equity, Class of Treasury Stock [Line Items]
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, Options, Exercisable, Number			61.25
Share Based Compensation Arrangement By Share Based Payment Award Warrants Vested and Expected To Vest Outstanding Number			200,852
Fair Value of Warrant Liability					$ 0	200	$ 0	200
Fair Value Adjustment of Warrants			$ 7,400,000			$ 21,000		$ 415,000
Warrant [Member]
Equity, Class of Treasury Stock [Line Items]
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

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2019	Dec. 31, 2018
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	16,808,758	15,484,411
Common stock, Shares Outstanding	16,806,430	15,482,083
Series A Preferred Stock [Member]
Preferred Stock, Par or Stated Value Per Share	$ 0.001	$ 0.001
Preferred Stock, Shares Authorized	10,000,000	10,000,000
Preferred Stock, Shares Issued	120,000	120,000
Preferred Stock, Shares Outstanding	120,000	120,000
Series B Preferred Stock [Member]
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	7,638	9,161
Preferred Stock, Shares Outstanding	7,638	9,161

Commitments and Contingencies - Maturity analysis of operating leases (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Jan. 01, 2019	Dec. 31, 2018
Commitments and Contingencies
2019	$ 77
2020	309
2021	321
2022	192
Total	899
Discount factor	(119)
Lease liability	780
Amount due within 12 months	(241)	$ (939)	$ 0
Non-current lease liability	$ 539		$ 0

Selected Balance Sheet Information - Schedule of property, plant and equipment, net (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Property and equipment, net
Property and equipment, Gross	$ 1,302	$ 1,302
Less accumulated depreciation and amortization	(877)	(695)
Total	425	607
Computers and office equipment [Member]
Property and equipment, net
Property and equipment, Gross	852	852
Leasehold Improvements [Member]
Property and equipment, net
Property and equipment, Gross	439	439
Software [Member]
Property and equipment, net
Property and equipment, Gross	$ 11	$ 11

Organization, Nature of Operations and Basis of Presentation (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions			1 Months Ended	9 Months Ended	12 Months Ended
	Jan. 01, 2019	Aug. 10, 2018	Oct. 31, 2018	Sep. 30, 2019	Dec. 31, 2018	Nov. 30, 2019	Sep. 30, 2018	Dec. 31, 2017
Organization, Nature of Operations and Basis of Presentation
Cash and cash equivalents				$ 18,650	$ 28,918		$ 9,549	$ 17,116
Net proceeds from sale of securities			$ 16,700
Net proceeds from sale of common stock					$ 12,200
Common stock, par value (in dollars per share)				$ 0.001	$ 0.001
Cash						$ 17,600
Reverse stock spilt		128.5		3.7
Lessee, Operating Lease, Term of Contract				12 months
Lease, Practical Expedients, Package [true false]	true
Right of Use Asset	$ 537			$ 451	$ 0
Operating Lease Liability	$ 939			$ 241	$ 0

Selected Balance Sheet Information - Schedule of accrued expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Selected Balance Sheet Information
Accrued manufacturing costs	$ 1,283	$ 83
Accrued clinical consulting services	709	674
Accrued vendor payments	323	150
Other accrued expenses	6	12
Total	$ 2,321	$ 919

Common and Preferred Stock	9 Months Ended
Common and Preferred Stock	Sep. 30, 2019
Common and Preferred Stock
Common and Preferred Stock	8. 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 per Class A Unit, 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 is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Common Stock. The exercise price of the Warrants is subject to adjustment in the event of certain dilutive issuances. During the three and nine months ended September 30, 2019, 185 and 1,523 shares of Series B Preferred Stock, respectively, have been converted resulting in the recognition of $71,000 and $585,000 of unamortized discount from the conversion, respectively. As of September 30, 2019, 8,085 shares of Series B Preferred Stock have been converted resulting in the recognition of $3.1 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 Stock 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 is less than the fair value of the underlying Common Stock at the date of issuance, there is a beneficial conversion feature (“BCF”) at the issuance date. Because the Series B Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the 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 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. 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 (i) redeemable based on contingent events outside of the Company’s control, and (ii) convertible immediately and from time to time. Since the effective conversion price of the Series A Preferred Stock was 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 retained earnings as a “deemed dividend” and impacts earnings per share. 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, 2019, the Company accrued dividends of $63,000 and $185,000, respectively. During the three and nine months ended September 30, 2018, the Company accrued dividends of $62,000 and $182,000, 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 FBR, Inc.), which enables the Company to offer and sell shares of the 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 Common Stock sold on the Company’s behalf. For the year ended December 31, 2018, the Company sold through the B. Riley FBR Sales Agreement an aggregate of 3.5 million shares of the Common Stock, and received net proceeds of approximately $12.2 million. For the three and nine months ending September 30, 2018, the Company sold through the B. Riley FBR Sales Agreement an aggregate of 1.6 and 1.7 million shares of the Common Stock, and received net proceeds of approximately $6.0 million and $6.4 million. The Company has not sold any shares of common stock during 2019 through the B. Riley FBR Sales Agreement.

Stock Warrants - Summary of all outstanding and exercisable warrants (Details)	9 Months Ended
	Sep. 30, 2019 $ / 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)	4 years 15 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)	3 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 year 1 month 21 days
Exercise Price 61.25 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise Price \| $ / shares	$ 61.25
Warrants Outstanding	200,852
Warrants Exercisable	200,852
Weighted Average Remaining Contractual Life (in years)	11 days
Exercise Price 3.85 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise Price \| $ / shares	$ 3.85
Warrants Outstanding	18,915,851
Warrants Exercisable	18,915,851
Weighted Average Remaining Contractual Life (in years)	3 years 10 months 17 days

Stock Warrants (Details) - $ / shares		1 Months Ended
Stock Warrants (Details) - $ / shares	Oct. 01, 2018	Dec. 26, 2017	Dec. 31, 2018	Oct. 10, 2014
Closing stock price			$ 0.56	$ 61.25
Closing Stock Price [Member]
Closing stock price	$ 0.88	$ 18.55
Expected Dividends [Member]
Warrants, Measurement Input	0.00%	0.00%
Expected Volatility [Member]
Warrants, Measurement Input	90.00%	85.00%
Risk Free Interest Rate [Member]
Warrants, Measurement Input	3.01%	2.42%
Expected Life Of Warrant [Member]
Expected life of warrant (years)	5 years	4 years 11 months 1 day

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Current Assets
Cash and cash equivalents	$ 18,650	$ 28,918
Prepaid expenses and other current assets	1,193	593
Total Current Assets	19,843	29,511
Property and equipment, net	425	607
Right of Use Asset	451	0
Deposits and other assets	23	23
Total Assets	20,742	30,141
Current Liabilities:
Accounts payable	2,452	1,034
Accrued expenses	2,321	919
Accrued employee benefits	619	1,332
Deferred rent	0	99
Lease liability	241	0
Total Current Liabilities	5,633	3,384
Long term deferred rent	0	302
Lease liability - Long term	539	0
Total Liabilities	6,172	3,686
Series A convertible preferred stock, $0.001 par value; 10,000,000 shares authorized; 120,000 issued and outstanding	12,481	12,296
Stockholders' Equity:
Common stock, $0.001 par value; 200,000,000 shares authorized, 16,808,758, issued and 16,806,430 outstanding and 15,484,411, issued and 15,482,083 outstanding	17	15
Additional paid-in capital	232,485	230,754
Accumulated deficit	(232,394)	(219,461)
Total Synthetic Biologics, Inc. and Subsidiaries Equity	4,930	17,068
Non-controlling interest	(2,841)	(2,909)
Total Stockholders' Equity	2,089	14,159
Total Liabilities and Stockholders' Equity	20,742	30,141
Series B Preferred Stock [Member]
Stockholders' Equity:
Series B Convertible Preferred stock, $1,000 par value; 10,000,000 shares authorized, 7,638 issued and outstanding and 9,161 issued and outstanding	4,822	5,760
Total Stockholders' Equity	$ 4,822	$ 5,760

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Smaller Reporting Company

Emerging growth company