Entero Therapeutics (ENTO) 10-Q 13 Aug 19 2019 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2019	Aug. 12, 2019
Document and Entity Information
Entity Registrant Name	AzurRx BioPharma, Inc.
Document Type	10-Q
Document Period End Date	Jun. 30, 2019
Amendment Flag	false
Entity Central Index Key	0001604191
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		26,103,434
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Small Business	true
Entity Current Reporting Status	Yes
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q2
Entity Interactive Data Current	Yes
Entity Incorporation State Country Code	DE
Entity File Number	001-37853
Title of 12b security	Common Stock, par value $0.0001 per share
Trading Symbol	AZRX
Security Exchange Name	NASDAQ

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Current Assets:
Cash	$ 1,310,687	$ 1,114,343
Other receivables	2,119,700	3,172,676
Prepaid expenses	198,245	512,982
Total Current Assets	3,628,632	4,800,001
Property, equipment, and leasehold improvements, net	108,187	128,854
Other Assets:
In process research & development, net	0	258,929
License agreements, net	0	311,548
Patents	3,670,858	0
Goodwill	1,913,740	1,924,830
Operating lease right-of-use assets	241,714	0
Deposits	49,275	45,233
Total Other Assets	5,875,587	2,540,540
Total Assets	9,612,406	7,469,395
Current Liabilities:
Accounts payable and accrued expenses	3,041,167	2,070,396
Accounts payable and accrued expenses - related party	627,563	670,095
Notes payable	64,714	255,032
Convertible debt	1,837,160	0
Other current liabilities	650,668	0
Total Current Liabilities	6,221,272	2,995,523
Other liabilities	443,032	0
Total Liabilities	6,664,304	2,995,523
Stockholders' Equity:
Convertible preferred stock - Par value $0.0001 per share; 10,000,000 shares authorized and 0 shares issued and outstanding at June 30, 2019 and December 31, 2018; liquidation preference approximates par value	0	0
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 21,103,434 and 17,704,925 shares issued and outstanding, respectively, at June 30, 2019 and December 31, 2018	2,110	1,771
Additional paid in capital	61,385,534	53,139,259
Accumulated deficit	(57,220,637)	(47,517,046)
Accumulated other comprehensive loss	(1,218,905)	(1,150,112)
Total Stockholders' Equity	2,948,102	4,473,872
Total Liabilities and Stockholders' Equity	$ 9,612,406	$ 7,469,395

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2019	Dec. 31, 2018
Statement of Financial Position [Abstract]
Preferred stock shares, par value	$ 0.0001	$ 0.0001
Preferred stock shares, authorized	10,000,000	10,000,000
Preferred stock shares, issued	0	0
Preferred stock shares, outstanding	0	0
Common stock shares, par value	$ 0.0001	$ 0.0001
Common stock shares, authorized	100,000,000	100,000,000
Common stock shares, issued	21,103,434	17,704,925
Common stock shares, outstanding	21,103,434	17,704,925

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Income Statement [Abstract]
Research and development expenses	$ 2,738,768	$ 925,776	$ 4,857,301	$ 2,603,805
General and administrative expenses	2,193,423	2,167,247	4,678,533	4,083,580
Fair value adjustment, contingent consideration	0	170,000	0	160,000
Loss from operations	(4,932,191)	(3,263,023)	(9,535,834)	(6,847,385)
Other:
Interest expense	(110,646)	(46,154)	(167,757)	(94,789)
Total other	(110,646)	(46,154)	(167,757)	(94,789)
Loss before income taxes	(5,042,837)	(3,309,177)	(9,703,591)	(6,942,174)
Income taxes	0	0	0	0
Net loss	(5,042,837)	(3,309,177)	(9,703,591)	(6,942,174)
Other comprehensive loss:
Foreign currency translation adjustment	26,488	(209,913)	(68,793)	(103,893)
Total comprehensive loss	$ (5,016,349)	$ (3,519,090)	$ (9,772,384)	$ (7,046,067)
Basic and diluted weighted average shares outstanding	20,479,917	15,300,197	19,107,534	13,881,698
Loss per share - basic and diluted	$ (0.25)	$ (0.22)	$ (0.51)	$ (0.50)

Consolidated Statements of Chan

Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($)	Convertible Preferred Stock	Common Stock	Additional Paid-In Capital	Subscriptions Receivable	Accumulated Deficit	Accumulated Other Comprehensive Loss	Total
Beginning balance, Shares at Dec. 31, 2017	0	12,042,574
Beginning balance, Amount at Dec. 31, 2017	$ 0	$ 1,205	$ 37,669,601	$ (1,071,070)	$ (33,983,429)	$ (955,715)	$ 1,660,592
Common stock issued from public offering, Shares		4,160,000
Common stock issued from public offering, Amount		$ 416	9,577,524				9,577,940
Common stock issued to consultants, Shares		751
Common stock issued for warrant exercises, Shares		503,070
Common stock issued for warrant exercises, Amount		$ 49	1,253,623	1,071,070			2,324,742
Common stock issued Mayoly for patents, Amount							0
Stock-based compensation			277,948				277,948
Restricted stock granted to employees/directors, Shares		60,000
Restricted stock granted to employees/directors, Amount		$ 6	335,745				335,751
Convertible debt converted into common stock, Shares		26,000
Convertible debt converted into common stock, Amount		$ 3	68,670				68,673
Warrant modification			428,748				428,748
Received from stockholder in relation to warrant modification							0
Foreign currency translation adjustment						(103,893)	(103,893)
Net loss					(6,942,174)		(6,942,174)
Ending balance, Shares at Jun. 30, 2018	0	16,792,395
Ending balance, Amount at Jun. 30, 2018	$ 0	$ 1,679	49,611,859	0	(40,925,603)	(1,059,608)	7,628,327
Beginning balance, Shares at Dec. 31, 2018	0	17,704,925
Beginning balance, Amount at Dec. 31, 2018	$ 0	$ 1,771	53,139,259	0	(47,517,046)	(1,150,112)	4,473,872
Common stock issued from public offering, Shares		2,522,097
Common stock issued from public offering, Amount		$ 252	5,023,704				5,023,956
Common stock issued to consultants, Shares		40,481
Common stock issued to consultants, Amount		$ 4	89,996				90,000
Common stock issued Mayoly for patents, Shares		775,931
Common stock issued Mayoly for patents, Amount		$ 77	1,740,882				1,740,959
Stock-based compensation			511,335				511,335
Restricted stock granted to employees/directors, Shares		60,000
Restricted stock granted to employees/directors, Amount		$ 6	493,448				493,454
Convertible debt converted into common stock, Amount							0
Warrant modification			325,320				325,320
Received from stockholder in relation to warrant modification		$ 61,590					61,590
Foreign currency translation adjustment						(68,793)	(68,793)
Net loss					(9,703,591)		(9,703,591)
Ending balance, Shares at Jun. 30, 2019	0	21,103,434
Ending balance, Amount at Jun. 30, 2019	$ 0	$ 2,110	$ 61,385,534	$ 0	$ (57,220,637)	$ (1,218,905)	$ 2,948,102

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Cash flows from operating activities:
Net loss	$ (9,703,591)	$ (6,942,174)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	34,041	30,420
Amortization	693,176	377,499
Fair value adjustment, contingent consideration	0	160,000
Stock-based compensation	511,335	277,948
Restricted stock granted to employees/directors	493,454	335,751
Restricted stock granted/accrued to consultants	90,000	220,230
Accreted interest on convertible debt	74,521	0
Accreted interest on debt discount - warrants	87,959	92,332
Warrant modification	0	428,748
Changes in assets and liabilities, net of effects of acquisition:
Other receivables	(193,152)	(6,624)
Prepaid expenses	312,672	142,560
Right of use assets	(240,993)	0
Deposits	(4,125)	(15,000)
Accounts payable and accrued expenses	940,347	35,989
Other liabilities	250,579	0
Net cash used in operating activities	(6,653,777)	(4,862,321)
Cash flows from investing activities:
Purchase of property and equipment	(13,337)	(41,041)
Net cash used in investing activities	(13,337)	(41,041)
Cash flows from financing activities:
Issuances of common stock	5,023,956	11,902,682
Issuances of convertible debt	2,000,000	0
Received from stockholder in relation to warrant modification	61,590	0
Repayments of notes payable	(190,318)	(132,344)
Net cash provided by financing activities	6,895,228	11,770,338
(Decrease) increase in cash	228,114	6,866,976
Effect of exchange rate changes on cash	(31,770)	(20,022)
Cash, beginning balance	1,114,343	573,471
Cash, ending balance	1,310,687	7,420,425
Supplemental disclosures of cash flow information:
Cash paid for interest	5,277	2,457
Cash paid for income taxes	0	0
Non-cash investing and financing activities:
Conversion of convertible debt into common shares	0	68,673
Common stock issued for patents purchased from Mayoly	1,740,959	0
Warrant modification related to convertible debt issuance	$ 325,320	$ 0

The Company and Basis of Presen

The Company and Basis of Presentation	6 Months Ended
	Jun. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
The Company and Basis of Presentation	The Company AzurRx BioPharma, Inc. (“ AzurRx Parent ProteaBio Europe SAS ABS Company The Company is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. Non-systemic biologics are non-absorbable drugs that act locally, i.e. the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. The Company’s current product pipeline consists of two therapeutic proteins under development: MS1819-SD MS1819-SD is a yeast derived recombinant lipase for exocrine pancreatic insufficiency (“EPI”) associated with chronic pancreatitis (“CP”) and cystic fibrosis (“CF”). A lipase is an enzyme that breaks up fat molecules. MS1819-SD is considered recombinant because it was created from new combinations of genetic material in yeast called Yarrowia lipolytica In October 2018, the U.S. Food and Drug Administration (“FDA”) cleared the Company’s Investigational New Drug (“IND”) application for MS1819-SD in patients with EPI due to CF. In connection with the FDA’s clearance of the IND, the Company initiated a multi-center Phase 2 OPTION study in the fourth quarter of 2018 in the United States and Europe (the “OPTION Study”). The Company targeted enrollment of 30 to 35 patients for the OPTION Study and dosed the first patients in February 2019. In June 2019, the Company reached its enrollment target for the study. The Company expects to announce topline results from the OPTION Study in the third quarter of 2019. In addition to the OPTION Study, in July 2019 the Company launched a Phase 2 multi-center clinical trial in Hungary to investigate MS1819-SD in combination with standard porcine enzyme replacement therapy (“PERT”), the digestive standard of care for both CF and CP patients with EPI, for CF patients who suffer from severe EPI, but continue to experience clinical symptoms of fat malabsorption despite taking the maximum daily dose of PERTs. The Phase 2 study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, in conjunction with a stable dose of PERTs, in order to increase CFA and relieve abdominal symptoms. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in 2020. b-Lactamase Program The Company’s b-lactamase program focuses on products with an enzymatic combination of bacterial origin for the prevention of hospital-acquired infections and antibiotic-associated diarrhea (“AAD”) by resistant bacterial strains induced by parenteral administration of several antibiotic classes. Currently, the Company has two compounds in pre-clinical development in this program, AZX1101 and AZX1103. Both AZX1101 and AZX1103 are composed of several distinct enzymes that break up individual classes of antibiotic molecules. AZX1103 is a b-lactamase enzyme combination that has shown positive pre-clinical activity, with degradation of amoxicillin in the presence of clavulanic acid in the upper gastrointestinal tract in the Gottingen minipig model. Currently, the Company is focused on advancing pre-clinical development of AZX1103. The Company is also currently assessing its plans for the continuation of the development of AZX1101. Recent Developments Asset Purchase Agreement with Mayoly On March 27, 2019, the Company entered into an Asset Purchase Agreement with Mayoly (the “ Mayoly APA JDLA In accordance with the Mayoly APA, the Company provided to Mayoly the following consideration for the purchase of MS1819-SD: (i) the Company assumed certain of Mayoly’s liabilities with respect to MS1819-SD; (ii) the Company forgave all amounts currently owed to AzurRx SAS by Mayoly under the JDLA; (iii) the Company agreed to pay, within 30 days after the execution of the Mayoly APA, all amounts incurred by Mayoly for the maintenance of patents related to MS1819-SD from January 1, 2019 through the date of the Mayoly APA; (iv) the Company made an initial payment to Mayoly of €800,000, which amount was paid by the issuance of 400,481 shares of the Company’s common stock at a price of $2.29 per share (the “ Closing Payment Shares (v) the Company agreed to pay to Mayoly an additional €1,500,000, payable in a mix of cash and shares of the Company’s common stock as follows (the “ Milestone Payments 2019 Escrow Shares 2020 Escrow Shares Escrow Shares The Closing Payment Shares and the Escrow Shares were all issued upon execution of the Mayoly APA; provided however April 2019 Registered Direct Public Offering In April 2019, the Company completed a public offering of 1,294,930 shares of its common stock at a public offering price of $2.13 per share, resulting in net proceeds of approximately $2,500,000, after deducting the selling agent fee paid to Alexander Capital, L.P. and other offering expenses payable by the Company (the “April 2019 Public Offering”). The April 2019 Public Offering was completed pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-226065) and the prospectus supplement filed on April 2, 2019. In connection with the April 2019 Public Offering, the Company entered into a Selling Agent Agreement with Alexander Capital, L.P., pursuant to which we paid to Alexander Capital, L.P. (i) a cash fee equal to 7% of the aggregate gross proceeds of the April 2019 Public Offering, and (ii) issued to Alexander Capital, L.P. warrants to purchase 38,848 shares of the Company’s common stock (the “April 2019 Selling Agent Warrants”), an amount equal to 3% of the aggregate number of shares of common stock sold in the April 2019 Public Offering. The April 2019 Selling Agent Warrants will become exercisable one year from the date of issuance, expire on April 2, 2024 and have an exercise price of $2.55 per share. Also see Note 12. The Company also reimbursed Alexander Capital, L.P. for its expenses on a non-accountable basis in an amount equal to 1% of the gross proceeds of the April 2019 Public Offering and $50,000 for other accountable expenses. May 2019 Registered Direct Public Offering On May 9, 2019, the Company completed a second public offering with Alexander Capital of 1,227,167 shares of the Company’s common stock at a public offering price of $2.35 per share, resulting in net proceeds of approximately $2,550,000, after deducting the selling agent fee paid to Alexander Capital and other offering expenses payable by the Company (the “May 2019 Public Offering”). The May 2019 Public Offering was completed pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-226065) and the prospectus supplement filed on May 9, 2019. In connection with the May 2019 Public Offering, the Company entered into a Selling Agent Agreement with Alexander Capital, pursuant to which the Company (i) paid Alexander Capital a cash fee equal to 7.0% of the aggregate gross proceeds of the May 2019 Public Offering, and (ii) issued Alexander Capital warrants to purchase up to 36,815 shares of Common Stock, an amount equal to 3.0% of the aggregate number of shares of Common Stock sold in the Offering. The May 2019 Selling Agent Warrants will become exercisable one year from the date of issuance, expire on May 9, 2024 and have an exercise price of $2.82 per share. Also see Note 12. The Company also agreed to reimburse Alexander Capital for its expenses in connection with the Offering on a non-accountable basis in an amount equal to 1.0% of the gross proceeds of the Offering and up to $50,000 for other accountable expenses. Basis of Presentation and Principles of Consolidation The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“ U.S. GAAP (“SEC” The unaudited interim consolidated financial statements include the accounts of AzurRx and its wholly-owned subsidiary, AzurRx SAS. Intercompany transactions and balances have been eliminated upon consolidation. Going Concern Uncertainty The accompanying unaudited interim consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception, had negative working capital at June 30, 2019 of approximately $2,593,000, and had an accumulated deficit of approximately $57,221,000 at June 30, 2019. The Company is dependent on obtaining, and continues to pursue, additional working capital funding from the sale of securities and debt in order to continue to execute its development plan and continue operations. Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Significant Accounting Policies

Significant Accounting Policies and Recent Accounting Pronouncements	6 Months Ended
	Jun. 30, 2019
Accounting Policies [Abstract]
Significant Accounting Policies and Recent Accounting Pronouncements	Use of Estimates The accompanying consolidated financial statements are prepared in conformity with U.S. GAAP and include certain estimates and assumptions which affect the reported amounts of assets and liabilities at the date of the financial statements (including goodwill, intangible assets and contingent consideration), and the reported amounts of revenues and expenses during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. Concentrations Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At June 30, 2019 and December 31, 2018, the Company had $967,813 and $754,261, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. Leases Effective January 1, 2019, the Company adopted Accounting Standards Update ( “ASU” Equity-Based Payments to Non-Employees Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. Research and Development Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, the fees paid to maintain the Company’s licenses, and the payments to third parties for clinical trial and additional product development and testing. Foreign Currency Translation For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of shareholders’ equity. Recent Accounting Pronouncements In January 2017, the FASB issued guidance to simplify the subsequent measurement of goodwill impairment. The new guidance eliminates the two-step process that required identification of potential impairment and a separate measure of the actual impairment. Goodwill impairment charges, if any, would be determined by reducing the goodwill balance by the difference between the carrying value and the reporting unit’s fair value (impairment loss is limited to the carrying value). This standard is effective for annual or any interim goodwill impairment tests beginning after December 15, 2019. The Company believes that the adoption of this pronouncement will not have an impact on the Company’s measurement of goodwill impairment.

Fair Value Disclosures

Fair Value Disclosures	6 Months Ended
	Jun. 30, 2019
Fair Value Disclosures [Abstract]
Fair Value Disclosures	Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. The fair value of the Company's financial instruments are as follows: Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value At June 30, 2019: Cash $ 1,310,687 $ - $ 1,310,687 $ - $ 1,310,687 Other receivables $ 2,119,700 $ - $ - $ 2,119,700 $ 2,119,700 Note payable $ 64,714 $ - $ - $ 64,714 $ 64,714 Convertible debt $ 1,837,160 $ - $ - $ 1,837,160 $ 1,837,160 At December 31, 2018: Cash $ 1,114,343 $ - $ 1,114,343 $ - $ 1,114,343 Other receivables $ 3,172,676 $ - $ - $ 3,172,676 $ 3,172,676 Note payable $ 255,032 $ - $ - $ 255,032 $ 255,032 The fair value of other receivables approximates carrying value as these consist primarily of French R&D tax credits that are normally received the following year and amounts due from our collaboration partner Mayoly, see Note 14. The fair value of note payable approximates carrying value due to the terms of such instruments and applicable interest rates. The fair value of convertible debt is based on the par value plus accrued interest through the date of reporting due to the terms of such instruments and interest rates, or the current interest rates of similar instruments.

Other Receivables

Other Receivables	6 Months Ended
	Jun. 30, 2019
Receivables [Abstract]
Other Receivables	Other receivables consisted of the following: June 30, December 31, 2019 2018 R&D tax credits $ 2,119,700 $ 2,162,373 Other - 1,010,303 Total other receivables $ 2,119,700 $ 3,172,676 The research and development ( “R & D”

Property, Equipment, and Leaseh

Property, Equipment, and Leasehold Improvements	6 Months Ended
	Jun. 30, 2019
Property, Plant and Equipment [Abstract]
Property, Equipment, and Leasehold Improvements	Property, equipment and leasehold improvements consisted of the following: June 30, December 31, 2019 2018 Laboratory equipment $ 193,661 $ 190,406 Computer equipment 78,986 75,417 Office equipment 37,264 37,262 Leasehold improvements 35,711 29,163 Total property, plant and equipment 345,622 332,248 Less accumulated depreciation (237,435 ) (203,394 ) Property, plant and equipment, net $ 108,187 $ 128,854 Depreciation expense for the three months ended June 30, 2019 and 2018 was $16,927 and $15,657, respectively. Depreciation expense for the six months ended June 30, 2019 and 2018 was $34,041 and $30,420, respectively. Depreciation expense is included in general and administrative (“ G&A

Intangible Assets and Goodwill

Intangible Assets and Goodwill	6 Months Ended
	Jun. 30, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
Intangible Assets and Goodwill	Patents Pursuant to the Mayoly APA entered into on March 27, 2019, in which the Company purchased all rights, title and interest in and to MS1819-SD (see Note 14), the Company recorded Patents in the amount of $3,802,745 as follows: Common stock issued at signing to Mayoly $ 1,740,959 Due to Mayoly at 12/31/19 - €400,000 449,280 Due to Mayoly at 12/31/20 - €350,000 393,120 Assumed Mayoly liabilities and forgiveness of Mayoly debt 1,219,386 $ 3,802,745 Intangible assets are as follows: June 30, December 31, 2019 2018 In process research and development $ - $ 416,600 Less accumulated amortization - (157,671 ) In process research and development, net $ - $ 258,929 License agreements $ - $ 3,398,702 Less accumulated amortization - (3,087,154 ) License agreements, net $ - $ 311,548 Patents $ 3,802,745 $ - Less accumulated amortization (131,887 ) - Patents, net $ 3,670,858 $ - Amortization expense for the three months ended June 30, 2019 and 2018 was $131,887 and $185,818, respectively. Amortization expense for the six months ended June 30, 2019 and 2018 was $693,176 and $377,499, respectively. Amortization expense for the six months ended June 30, 2019 included $384,234 from In process research and development and License agreements written off as a result of the Mayoly APA. As of June 30, 2019, amortization expense is expected to be as follows for the next five years: 2019 (balance of year) $ 263,774 2020 527,548 2021 527,548 2022 527,548 2023 527,548 Goodwill is as follows: Goodwill Balance at January 1, 2018 $ 2,016,240 Foreign currency translation (91,410 ) Balance at December 31, 2018 1,924,830 Foreign currency translation (11,090 ) Balance at June 30, 2019 $ 1,913,740

Accounts Payable and Accrued Ex

Accounts Payable and Accrued Expenses	6 Months Ended
	Jun. 30, 2019
Payables and Accruals [Abstract]
Accounts Payable and Accrued Expenses	Accounts payable and accrued expenses consisted of the following: June 30, December 31, 2019 2018 Trade payables $ 2,170,434 $ 1,532,110 Accrued expenses 758,230 285,061 Accrued payroll 112,503 253,225 Total accounts payable and accrued expenses $ 3,041,167 $ 2,070,396

Note Payable

Note Payable	6 Months Ended
	Jun. 30, 2019
Notes Payable [Abstract]
Note Payable	On December 14, 2018, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of $286,203 that bears interest at an annual rate of 5.99%. Monthly payments, including principal and interest, are $32,599 per month. The balance due under this financing agreement at June 30, 2019 was $64,714.

Original Issue Discounted Conve

Original Issue Discounted Convertible Notes and Warrants	6 Months Ended
	Jun. 30, 2019
Debt Disclosure [Abstract]
Original Issue Discounted Convertible Notes and Warrants	ADEC Notes On February 14, 2019, the Company entered into a Note Purchase Agreement (the “NPA” “ADEC” “Note A” “Note B,” “Note,” “Notes” The Notes accrue interest at a rate of 10% per annum (the “Interest Rate” “2019 Tax Credit” “2020 Tax Credit” “Maturity Dates” Prior to their respective Maturity Dates, each of the Notes is convertible, at ADEC’s option, into shares of the Company’s common stock, at a conversion price equal to the principal and accrued interest due under the terms of the Notes divided by $2.50 ( “Conversion Shares” As additional consideration for entering into the NPA, pursuant to a Warrant Amendment Agreement, the Company agreed to reduce the exercise price of 1,009,565 outstanding warrants previously issued by the Company to ADEC and its affiliates (the “Warrants” In connection with the above transaction, the Company also entered into a registration rights agreement with ADEC, pursuant to which the Company agreed to file a registration statement with the Securities and Exchange Commission no later than 45 days after the closing date of February 14, 2019 in order to register, on behalf of ADEC, the Conversion Shares. ADEC subsequently agreed to extend the date to file a registration statement to April 30, 2019. The registration statement was filed on April 25, 2019. During the three months ended June 30, 2019, the Company accrued $49,863 of interest expense in connection with these convertible notes. During the three months ended June 30, 2019, the Company recorded $58,855 of interest expense in the form of amortization of debt discount related to the repriced warrants. During the six months ended June 30, 2019, the Company accrued $74,521 of interest expense in connection with these convertible notes. During the six months ended June 30, 2019, the Company recorded $87,959 of interest expense in the form of amortization of debt discount related to the repriced warrants. Convertible Debt consisted of: June 30, December 31, 2019 2018 Convertible debt $ 2,000,000 $ — Unamortized debt discount - revalued warrants (237,361 ) — Accrued interest 74,521 Total convertible debt $ 1,837,160 $ — LPC OID Debenture On April 11, 2017, the Company entered into a Note Purchase Agreement with Lincoln Park Capital Fund, LLC ( “LPC” “Debenture” On July 11, 2018, the Company paid off the remaining amount due under the terms of this Debenture in the amount of $286,529. For the three months ended June 30, 2018, the Company recorded $45,537 of interest expense related to the amortization of the debt discount related to the warrant features of the Debenture. For the six months ended June 30, 2018, the Company recorded $92,332 of interest expense related to the amortization of the debt discount related to the warrant features of the Debenture.

Other Liabilities

Other Liabilities	6 Months Ended
	Jun. 30, 2019
Other Liabilities [Abstract]
Other Liabilities	Other liabilities consisted of the following: June 30, December 31, Current 2019 2018 Due to Mayoly $ 455,560 $ - Lease liabilities 195,108 - $ 650,668 $ - June 30, December 31, Long-term 2019 2018 Due to Mayoly $ 398,615 $ - Lease liabilities 44,417 - $ 443,032 $ -

Equity

Equity	6 Months Ended
	Jun. 30, 2019
Equity [Abstract]
Equity	On July 13, 2016, the Company amended its Certificate of Incorporation to increase the authorized shares of its common stock, $0.0001 par value, to 100,000,000 shares from 9,000,000 shares and increase the authorized shares of its preferred stock, $0.0001 par value, to 10,000,000 shares from 1,000,000 shares. Common Stock At June 30, 2019 and December 31, 2018, the Company had 21,103,434 and 17,704,925, respectively, of shares of its common stock issued and outstanding. Voting Each holder of common stock has one vote for each share held. Stock Option Plan The Company’s board of directors and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “ 2014 Plan Series A Convertible Preferred Stock At June 30, 2019 and December 31, 2018, there were no Series A Convertible Preferred Stock (“Series A Preferred”) outstanding. However, all terms of the Series A Preferred are still in effect. Restricted Stock During the three months ended June 30, 2019, 77,084 restricted shares of common stock vested with a fair value of $197,169. 33,334 of these 77,084 shares having a fair value of $101,335 vested during the three months ended June 30, 2019 due to the Company reaching enrollment of 30 patients in the Company's Phase II study to investigate MS1819-SD in CF patients. 30,000 of these 77,084 shares having a fair value of $51,000 were issued during the three months ended June 30, 2019 to our directors as a part of Board compensation. 13,750 of these 77,084 shares having a fair value of $44,834 vested during the three months ended June 30, 2019. During the six months ended June 30, 2019, 179,667 restricted shares of common stock vested with a fair value of $493,454. 58,833 of these 179,667 shares having a fair value of $178,852 vested during the six months ended June 30, 2019 due to the Company dosing the first patients in the Company's Phase II study to investigate MS1819-SD in CF patients. 33,334 of these 179,667 shares having a fair value of $101,335 vested during the six months ended June 30, 2019 due to the Company reaching enrollment of 30 patients in the Company's Phase II study to investigate MS1819-SD in CF patients. 60,000 of these 179,667 shares having a fair value of $123,600 were issued during the six months ended June 30, 2019 to our directors as a part of Board compensation. 27,500 of these 179,667 shares having a fair value of $89,667 vested during the six months ended June 30, 2019. During the three months ended June 30, 2019, the Company issued 13,379 shares of its common stock to a consultant as payment of $30,000 of accounts payable. During the six months ended June 30, 2019, the Company issued 40,481 shares of its common stock to a consultant as payment of $90,000 of accounts payable. As of June 30, 2019, the Company had unrecognized restricted common stock expense of $292,359 that will be recognized over the average remaining vesting term of 1.80 years. During the three months ended June 30, 2018, 317,500 shares of restricted common stock were granted or accrued to employees and consultants with a total value of $986,160. During the three months ended June 30, 2018, 91,917 shares of restricted common stock vested with a value of $333,671 of which an aggregate of 30,000 shares with a value of $96,300 have been issued to our directors as a part of Board compensation. During the six months ended June 30, 2018, 379,000 shares of restricted common stock were granted or accrued to employees and consultants with a total value of $1,188,970. During the six months ended June 30, 2018, 158,834 shares of restricted common stock vested with a value of $555,981 of which an aggregate of 60,000 shares with a value of $190,500 have been issued to our directors as a part of Board compensation. The restricted common stock granted have vesting terms ranging from immediately to three years or based on the Company achieving certain milestones.

Warrants

Warrants	6 Months Ended
	Jun. 30, 2019
WarrantsDisclosureTextBlock
Warrants	In February 2019, as additional consideration for issuing convertible notes with ADEC and pursuant to a Warrant Amendment Agreement, the Company agreed to reduce the exercise price of certain outstanding warrants previously issued by the Company to ADEC and its affiliates, see Note 9. Stock warrant transactions for the periods January 1 through June 30, 2019 and 2018 are as follows: Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable at January 1, 2018 3,371,385 $ 3.17 - $7.37 $ 5.28 Granted during the period 244,400 $ 2.55 - $2.75 $ 2.58 Expired during the period - - - Exercised during the period (503,070 ) $ 2.50 $ 2.50 Warrants outstanding and exercisable at June 30, 2018 3,112,715 $ 2.55 - $7.37 $ 4.83 Warrants outstanding and exercisable at January 1, 2019 3,112,715 $ 2.55 - $7.37 $ 4.83 Granted during the period 75,663 $ 2.55 - $2.82 $ 2.68 Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable at June 30, 2019 3,188,378 $ 1.50 - $7.37 $ 3.51 Number of Weighted Average Weighted Shares Under Remaining Contract Average Exercise Price Warrants Life in Years Exercise Price $ 1.50 - $2.99 1,329,628 2.75 $ 3.00 - $3.99 636,972 2.82 $ 4.00 - $4.99 196,632 2.51 $ 5.00 - $5.99 805,476 2.63 $ 6.00 - $6.99 187,750 2.26 $ 7.00 - $7.37 31,920 1.46 Total 3,188,378 2.68 $3.51 In January 2018, the Company offered certain warrant holders the opportunity to exercise their warrants at a reduced strike price of $2.50, and if so elected, would also have the opportunity to reprice other warrants that they continued to hold unexercised to $3.25. The offer, which was effective January 12, 2018, was for the repricing only and did not modify the life of the warrants. Warrant holders of approximately 503,000 shares exercised their warrants and had other warrants modified on approximately 197,000 shares, which resulted in a charge of approximately $429,000 in January 2018. During the three and six months ended June 30, 2019, 75,663 warrants were issued to investment bankers in association with the April and May 2019 Public Offerings with a value of $116,582 that had no effect on expenses or stockholders’ equity. During the three and six months ended June 30, 2018, 244,400 warrants were issued to investment bankers in association with the May 2018 Public Offering with a value of $416,426 that had no effect on expenses or stockholders’ equity.

Stock-Based Compensation Plan

Stock-Based Compensation Plan	6 Months Ended
	Jun. 30, 2019
Share-based Payment Arrangement, Noncash Expense [Abstract]
Stock-Based Compensation Plan	Under the 2014 Plan, the fair value of options granted is estimated on the grant date using the Black-Scholes option valuation model. This valuation model for stock-based compensation expense requires the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the volatility of the common stock price and the assumed risk-free interest rate. The Company recognizes stock-based compensation expense for only those shares expected to vest over the requisite service period of the award. No compensation cost is recorded for options that do not vest and the compensation cost from vested options, whether forfeited or not, is not reversed. During the three and six months ended June 30, 2019 893,500 stock options were granted with an exercise price of $1.70 and a term of five years. During the three months ended June 30, 2019, no options vested. During the six months ended June 30, 2019, 244,500 options vested having a fair value of $511,335 and an intrinsic value of $0. 242,000 of these options valued at $501,666 vested due to the Company having its first CF patient dosed with MS1819-SD anywhere in the world, which was achieved by the dosing of the first patient in the OPTION Study. During the three and six months ended June 30, 2018, 539,000 stock options were granted with an exercise price of $3.04 and a term of five years. During the three months ended June 30, 2018, 96,250 options vested having a fair value of $248,930 and an intrinsic value of $0. During the six months ended June 30, 2018, 103,750 options vested having a fair value of $277,948 and an intrinsic value of $0. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions: June 30, June 30, 2019 2018 Contractual term (in years) 5 5 Volatility 71 % 85 % Risk-free interest rate 2.19 % 2.82 % Dividend yield - % - % The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of the Company’s common stock if available or of several public entities that are similar to the Company. The Company bases volatility this way because it may not have sufficient historical transactions in its own shares on which to solely base expected volatility. The risk-free interest rate is based on the U.S. Treasury rates at the date of grant with maturity dates approximately equal to the expected term at the grant date. The Company has not historically declared any dividends and does not expect to in the future. The Company realized no income tax benefit from stock option exercises in each of the periods presented due to recurring losses and valuation allowances. Stock option activity under the 2014 Plan is as follows: Number Average Remaining Contract Intrinsic of Shares Exercise Price Life in Years Value Stock options outstanding at January 1, 2018 545,000 $ 4.05 7.13 $ - Granted during the period 539,000 $ 3.04 5.00 $ - Expired during the period - - Exercised during the period - - Stock options outstanding at June 30, 2018 1,084,000 $ 3.72 5.82 $ - Exercisable at June 30, 2018 261,250 $ 4.26 8.60 $ - Non-vested stock options outstanding at January 1, 2018 387,500 $ 3.89 6.39 $ - Granted during the period 539,000 $ 3.04 5.00 $ - Vested during the period (103,750 ) $ 3.92 6.02 $ - Expired during the period - - Exercised during the period - - Non-vested stock options outstanding at June 30, 2018 822,750 $ 3.32 5.77 $ - Stock options outstanding at January 1, 2019 994,000 $ 3.58 5.42 $ - Granted during the period 893,500 $ 1.70 4.96 Expired during the period - - Canceled during the period - - Exercised during the period - - Stock options outstanding at June 30, 2019 1,887,500 $ 2.58 4.94 $ - Exercisable at June 30, 2019 994,000 $ 3.58 4.92 $ - Non-vested stock options outstanding at January 1, 2019 244,500 $ 3.05 4.53 $ - Granted during the period 893,500 $ 1.70 4.96 Vested during the period (244,500 ) $ 3.05 4.53 Expired during the period - - Canceled during the period - - Exercised during the period - - Non-vested stock options outstanding at June 30, 2019 893,500 $ 1.70 4.96 $ - 5,681 shares of common stock were available for future issuance under the 2014 Plan as of June 30, 2019. As of June 30, 2019, the Company had unrecognized stock-based compensation expense of $905,116. $121,560 of this unrecognized expense will be recognized over the average remaining vesting term of the options of one year. $713,405 of this unrecognized expense vests upon the completion of enrollment of the next trial of MS 1819-SD in the U.S. $70,151 of this unrecognized expense vests upon the completion of enrollment of the ongoing clinical trial assessing MS1819-SD in cystic fibrosis patients as a combination therapy with the standard of care. The expense related to these milestones will be recognized when the milestones become probable.

Agreements

Agreements	6 Months Ended
	Jun. 30, 2019
Agreements
Agreements	Mayoly Agreement During the three months ended June 30, 2019 and 2018, the Company charged $0 and $399,622, respectively, to Mayoly under the JDLA that was in effect during both periods. During the six months ended June 30, 2019 and 2018, the Company charged $403,020 and $525,605, respectively, to Mayoly under the JDLA that was in effect during both periods. On March 27, 2019, the Company entered into the Mayoly APA pursuant to which the Company purchased substantially all rights, title and interest in and to MS1819-SD, see Recent Developments above. INRA Agreement In February 2006, Mayoly and INRA TRANSFERT, on behalf of INRA and CNRS (French government research centers), entered into a Usage and Cross-Licensing Agreement granting Mayoly exclusive worldwide rights to exploit Yarrowia lipolytica and other lipase proteins based on their patents for use in humans. The INRA Agreement provides for the payment by Mayoly of royalties on net sales, subject to Mayoly’s right to terminate such obligation upon the payment of a lump sum specified in the agreement. Upon execution of the Mayoly APA, all rights, obligations and interests under the INRA Agreement were transferred to the Company. TransChem Sublicense On August 7, 2017, the Company entered into a Sublicense Agreement with TransChem, Inc. (“TransChem” “Licensed Patents” “Sublicense Agreement” Employment Agreements Johan (Thijs) Spoor On January 3, 2016, the Company entered into an employment agreement with its President and Chief Executive Officer, Johan Spoor. The employment agreement provided for a term expiring January 2, 2019. Although Mr. Spoor’s employment agreement has expired, he remains employed as the Company’s President and Chief Executive Officer under the terms of his prior employment agreement. Either party may terminate Mr. Spoor’s employment at any time and for any reason, or for no reason. For a period of twelve (12) months after Mr. Spoor’s termination, Mr. Spoor shall not engage in competition with the Company either directly or indirectly, in any manner or capacity. Mr. Spoor is paid a base salary of $425,000 per year. At the sole discretion of the board of directors or the compensation committee of the board, following each calendar year of employment, Mr. Spoor shall be eligible to receive an additional cash bonus based on his attainment of certain financial, clinical development, and/or business milestones to be established annually by the board of directors or the compensation committee. Mr. Spoor was originally entitled to 380,000 10-year stock options pursuant to the 2014 Plan. In the first quarter of 2017, 100,000 options having a value of $386,900 were granted and expensed. On September 29, 2017, Mr. Spoor was granted 100,000 shares of restricted common stock subject to vesting conditions as follows: (i) 75% upon FDA acceptance of a U.S. IND application for MS1819-SD, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819-SD, in satisfaction of the Company’s obligation to issue the additional 280,000 options to Mr. Spoor described above, with an estimated fair value at the grant date of $425,000. All of these shares vested during 2018. $106,250 was expensed in the second quarter of 2018 and $318,750 was expensed in the fourth quarter of 2018 due to the Company completing both milestones. On June 28, 2018, Mr. Spoor was granted 200,000 shares of restricted common stock subject to vesting conditions as follows: (i) 50% shall vest in three equal installments beginning one year from the date of issuance, and (ii) the remaining 50% shall vest as follows: one-third shall vest upon U.S. acceptance of IND for MS1819-SD, one-third upon the first dosing of a CF patient with MS1819-SD anywhere in the world, and the remaining one-third upon enrollment of the first 30 patients in a CF trial. These restricted shares had an estimated fair value at the grant date of $608,000 to be expensed when the above milestones are probable. 8,333 shares with a fair value of $25,332 vested and was expensed in the three months ended June 30, 2019 due to being earned over that time. 16,666 shares with a fair value of $50,664 vested and was expensed in the six months ended June 30, 2019 due to being earned over that time. 33,333 shares with a fair value of $101,332 vested and was expensed in the six months ended June 30, 2019 due to the first dosing of CF patients with MS1819-SD anywhere in the world. On June 28, 2018, the Board approved a 2017 annual incentive bonus pursuant to his employment agreement in the amount of $212,500. On June 13, 2019, Mr. Spoor was granted stock options to purchase 150,000 shares of the Company’s common stock, issuable pursuant to the 2014 Plan, that vest upon the completion of enrollment of the next trial of MS 1819-SD in the U.S. These options had an estimated fair value at the grant date of $151,950 to be expensed when the above milestone is probable. On June 29, 2019, the Board approved a 2018 annual incentive bonus pursuant to his employment agreement in the amount of $255,000 that is included in accrued expenses at June 30, 2019. Maged Shenouda On September 26, 2017, the Company entered into an employment agreement with Maged Shenouda, a member of the Company’s Board of Directors, pursuant to which Mr. Shenouda serves as the Company’s Chief Financial Officer. Mr. Shenouda’s employment agreement provides for the issuance of stock options to purchase 100,000 shares of the Company’s common stock, issuable pursuant to the 2014 Plan. These options will vest as follows so long as Mr. Shenouda is serving as either Executive Vice-President of Corporate Development or as Chief Financial Officer (i) 75% upon FDA acceptance of a U.S. IND application for MS1819-SD, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819-SD. The option is exercisable for $4.39 per share and will expire on September 25, 2027. All of these shares vested in 2018. $84,125 was expensed in the second quarter of 2018 and $252,375 was expensed in the fourth quarter of 2018 due to the Company completing both milestones. On June 28, 2018, Mr. Shenouda was granted stock options to purchase 100,000 shares of the Company’s common stock, issuable pursuant to the 2014 Plan, subject to vesting conditions as follows: (i) 50% upon U.S. acceptance of an IND for MS1819-SD, and (ii) 50% upon the first CF patient doses with MS1819-SD anywhere in the world. These options had an estimated fair value at the grant date of $207,300 to be expensed when the above milestones are probable. 50,000 of these options having a fair value of $103,650 vested and was expensed in 2018 due to the FDA acceptance of the Company’s IND application for MS1819-SD. The remaining 50,000 options having a fair value of $103,650 vested and was expensed in the six months ended June 30, 2019 due to the first dosing of CF patients with MS1819-SD anywhere in the world. On June 28, 2018, the Board approved a 2017 annual incentive bonus pursuant to his employment agreement in the amount of $82,500. On June 13, 2019, Mr. Shenouda was granted stock options to purchase 100,000 shares of the Company’s common stock, issuable pursuant to the 2014 Plan, that vest upon the completion of enrollment of the next trial of MS 1819-SD in the U.S. These options had an estimated fair value at the grant date of $101,300 to be expensed when the above milestone is probable. On June 28, 2019, the Board approved a 2018 annual incentive bonus pursuant to his employment agreement in the amount of $100,000 that is included in accrued expenses at June 30, 2019. Dr. James E. Pennington On May 28, 2018, the Company entered into an employment agreement with Dr. Pennington to serve as the Company’s Chief Medical Officer. The employment agreement with Dr. Pennington provides for a base annual salary of $250,000. In addition to his salary, Dr. Pennington is eligible to receive an annual milestone bonus, awarded at the sole discretion of the Board based on his attainment of certain financial, clinical development, and/or business milestones established annually by the Board or Compensation Committee. The employment agreement is terminable by either party at any time. In the event of termination by the Company other than for cause, Dr. Pennington is entitled to three months’ severance payable over such period. In the event of termination by the Company other than for cause in connection with a Change of Control, Dr. Pennington will receive six months’ severance payable over such period. On June 28, 2018, Mr. Pennington was granted stock options to purchase 75,000 shares of the Company’s common stock, issuable pursuant to the 2014 Plan, subject to vesting conditions as follows: (i) 50% upon U.S. acceptance of an IND for MS1819-SD, and (ii) 50% upon the first CF patient doses with MS1819-SD anywhere in the world. These options had an estimated fair value at the grant date of $155,475 to be expensed when the above milestones are probable. 37,500 of these options vested and $77,738 was expensed in 2018 due to the FDA acceptance of the Company’s IND application for MS1819-SD in 2018. 37,500 of these options having a fair value of $77,738 vested and was expensed in the six months ended June 30, 2019 due to the first dosing of CF patients with MS1819-SD anywhere in the world. On June 13, 2019, Mr. Pennington was granted stock options to purchase 110,000 shares of the Company’s common stock, issuable pursuant to the 2014 Plan, that vest upon the completion of enrollment of the next trial of MS 1819-SD in the U.S. These options had an estimated fair value at the grant date of $111,430 to be expensed when the above milestone is probable. On June 13, 2019, the Board approved a 2018 annual incentive bonus pursuant to his employment agreement in the amount of $75,000 that is included in accrued expenses at June 30, 2019.

Leases

Leases	6 Months Ended
	Jun. 30, 2019
Leases [Abstract]
Leases	The Company adopted ASU 2016-02, Leases, as of January 1, 2019, using the modified retrospective approach. Prior year financial statements were not recast under the new standard. The Company leases its office and research facilities under operating leases which are subject to various rent provisions and escalation clauses expiring at various dates through 2020. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments. Lease expense amounted to $51,011 and $36,766, respectively, in the three months ended June 30, 2019 and 2018. Lease expense amounted to $101,666 and $67,993, respectively, in the six months ended June 30, 2019 and 2018. The weighted-average remaining lease term and weighted-average discount rate under operating leases at June 30, 2019 are: June 30, 2019 Lease term and discount rate Weighted-average remaining lease term 1.25 years Weighted-average discount rate 6.0% Maturities of operating lease liabilities at June 30, 2019 are as follows: 2019 $ 101,359 2020 154,066 Total lease payments 255,425 Less imputed interest (15,900 ) Present value of lease liabilities $ 239,525

Income Taxes

Income Taxes	6 Months Ended
	Jun. 30, 2019
Income Tax Disclosure [Abstract]
Income Taxes	The Company is subject to taxation at the federal level in both the United States and France and at the state level in the United States. At June 30, 2019 and December 31, 2018, the Company had no tax provision for either jurisdiction. At June 30, 2019 and December 31, 2018, the Company had gross deferred tax assets of approximately $14,500,000 and $12,490,000, respectively. As the Company cannot determine that it is more likely than not that the Company will realize the benefit of the deferred tax asset, a valuation allowance of approximately $14,500,000 and $12,490,000, respectively, has been established at June 30, 2019 and December 31, 2018. The change in the valuation allowance in the six months ended June 30, 2019 and 2018 was $2,010,000 and $1,399,000, respectively. At June 30, 2019, the Company has gross net operating loss (“ NOL Section 382 At June 30, 2019 and December 31, 2018, the Company had approximately $17,072,000 and $15,406,000, respectively, in net operating losses which it can carryforward indefinitely to offset against future French income. At June 30, 2019 and December 31, 2018, the Company had taken no uncertain tax positions that would require disclosure under ASC 740, Accounting for Income Taxes.

Net Loss per Common Share

Net Loss per Common Share	6 Months Ended
	Jun. 30, 2019
Earnings Per Share [Abstract]
Net Loss per Common Share	Basic net loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options and warrants is computed using the treasury stock method. At June 30, 2019, diluted net loss per share did not include the effect of 3,188,378 shares of common stock issuable upon the exercise of outstanding warrants, 416,000 shares of restricted stock not yet issued, and 1,887,500 shares of common stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. At June 30, 2018, diluted net loss per share did not include the effect of 3,112,715 shares of common stock issuable upon the exercise of outstanding warrants, 1,084,000 shares of common stock issuable upon the exercise of outstanding options, and 74,000 shares of common stock issuable upon the conversion of convertible debt as their effect would be antidilutive during the periods prior to conversion.

Related Party Transactions

Related Party Transactions	6 Months Ended
	Jun. 30, 2019
Related Party Transactions [Abstract]
Related Party Transactions	During the year ended December 31, 2015, the Company employed the services of JIST Consulting (“ JIST During the year ended December 31, 2015, the Company's President, Christine Rigby-Hutton, was employed through Rigby-Hutton Management Services (“ RHMS Starting on October 1, 2016 until his appointment as the Company’s Chief Financial Officer on September 25, 2017, the Company used the services of Maged Shenouda as a financial consultant. Included in accounts payable at June 30, 2019 and December 31, 2018 is $10,000 and $50,000, respectively, for Mr. Shenouda’s services.

Subsequent Events

Subsequent Events	6 Months Ended
	Jun. 30, 2019
Subsequent Events [Abstract]
Subsequent Events	July 2019 Underwritten Public Offering On July 17, 2019, we entered into an underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC. (“Wainwright”) as representatives of the several underwriters named therein (the “Underwriters”), relating to the issuance and sale of 5 million shares of our common stock. Each share of common stock was sold at a public offering price of $1.00 per share, resulting in gross proceeds to us of $5,000,000, or net proceeds of approximately $4,500,000, after deducting the underwriting discount, estimated legal fees and other offering expenses payable by the Company (the “July 2019 Public Offering”). In addition, pursuant to the terms of the Underwriting Agreement, the Company granted to the Underwriters a 30-day option to purchase up to an additional 750,000 shares of Common Stock at the same public offering price per share. The July 2019 Public Offering was conducted pursuant to our effective shelf registration statement on Form S-3 (File No. 333-231954), filed with the Securities and Exchange Commission (the “SEC”) on June 5, 2019, and declared effective on June 25, 2019, including the base prospectus dated June 4, 2019 included therein and the related prospectus supplement filed on July 19, 2019. In addition to the underwriting discount received by the Underwriters, we also issued unregistered common stock purchase warrants to Wainwright to purchase up to 200,000 shares of common stock (the “Wainwright Warrants”). The Wainwright Warrants are exercisable immediately upon issuance, expire on July 17, 2024 and have an exercise price of $1.25 per share. Cyber-Related Fraud On August 8, 2019, management was advised that it was a victim of a cyber-related fraud whereby a hacker impersonated one of the Company’s key vendors to redirect payments, totaling approximately $400,000. The Company, including the Audit Committee, is currently conducting an investigation and reviewing all available avenues of recovery, including from the Company’s financial institution and potential insurance claims to recover the payments. As of August 12, 2019, management is unable to determine the magnitude of the loss, if any, resulting from the cyber-related fraud.

Significant Accounting Polici_2

Significant Accounting Policies and Recent Accounting Pronouncements (Policies)	6 Months Ended
	Jun. 30, 2019
Accounting Policies [Abstract]
Use of Estimates	The accompanying consolidated financial statements are prepared in conformity with U.S. GAAP and include certain estimates and assumptions which affect the reported amounts of assets and liabilities at the date of the financial statements (including goodwill, intangible assets and contingent consideration), and the reported amounts of revenues and expenses during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates.
Concentrations	Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At June 30, 2019 and December 31, 2018, the Company had $967,813 and $754,261, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros.
Leases	Effective January 1, 2019, the Company adopted Accounting Standards Update ( “ASU”
Equity-Based Payments to Non-Employees	Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting.
Research and Development	Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, the fees paid to maintain the Company’s licenses, and the payments to third parties for clinical trial and additional product development and testing.
Foreign Currency Translation	For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of shareholders’ equity.
Recent Accounting Pronouncements	In January 2017, the FASB issued guidance to simplify the subsequent measurement of goodwill impairment. The new guidance eliminates the two-step process that required identification of potential impairment and a separate measure of the actual impairment. Goodwill impairment charges, if any, would be determined by reducing the goodwill balance by the difference between the carrying value and the reporting unit’s fair value (impairment loss is limited to the carrying value). This standard is effective for annual or any interim goodwill impairment tests beginning after December 15, 2019. The Company believes that the adoption of this pronouncement will not have an impact on the Company’s measurement of goodwill impairment.

Fair Value Disclosures (Tables)

Fair Value Disclosures (Tables)	6 Months Ended
	Jun. 30, 2019
Fair Value Disclosures [Abstract]
Financial instruments measured at fair value on a recurring basis	Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value At June 30, 2019: Cash $ 1,310,687 $ - $ 1,310,687 $ - $ 1,310,687 Other receivables $ 2,119,700 $ - $ - $ 2,119,700 $ 2,119,700 Note payable $ 64,714 $ - $ - $ 64,714 $ 64,714 Convertible debt $ 1,837,160 $ - $ - $ 1,837,160 $ 1,837,160 At December 31, 2018: Cash $ 1,114,343 $ - $ 1,114,343 $ - $ 1,114,343 Other receivables $ 3,172,676 $ - $ - $ 3,172,676 $ 3,172,676 Note payable $ 255,032 $ - $ - $ 255,032 $ 255,032

Other Receivables (Tables)

Other Receivables (Tables)	6 Months Ended
	Jun. 30, 2019
Receivables [Abstract]
Other receivables	June 30, December 31, 2019 2018 R&D tax credits $ 2,119,700 $ 2,162,373 Other - 1,010,303 Total other receivables $ 2,119,700 $ 3,172,676

Property, Equipment, and Leas_2

Property, Equipment, and Leasehold Improvements (Tables)	6 Months Ended
	Jun. 30, 2019
Property, Plant and Equipment [Abstract]
Property, equipment and leasehold improvements	June 30, December 31, 2019 2018 Laboratory equipment $ 193,661 $ 190,406 Computer equipment 78,986 75,417 Office equipment 37,264 37,262 Leasehold improvements 35,711 29,163 Total property, plant and equipment 345,622 332,248 Less accumulated depreciation (237,435 ) (203,394 ) Property, plant and equipment, net $ 108,187 $ 128,854

Intangible Assets and Goodwill

Intangible Assets and Goodwill (Tables)	6 Months Ended
	Jun. 30, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
Patents	Common stock issued at signing to Mayoly $ 1,740,959 Due to Mayoly at 12/31/19 - €400,000 449,280 Due to Mayoly at 12/31/20 - €350,000 393,120 Assumed Mayoly liabilities and forgiveness of Mayoly debt 1,219,386 $ 3,802,745
Intangible assets	June 30, December 31, 2019 2018 In process research and development $ - $ 416,600 Less accumulated amortization - (157,671 ) In process research and development, net $ - $ 258,929 License agreements $ - $ 3,398,702 Less accumulated amortization - (3,087,154 ) License agreements, net $ - $ 311,548 Patents $ 3,802,745 $ - Less accumulated amortization (131,887 ) - Patents, net $ 3,670,858 $ -
Future amortization expense	2019 (balance of year) $ 263,774 2020 527,548 2021 527,548 2022 527,548 2023 527,548
Goodwill	Goodwill Balance at January 1, 2018 $ 2,016,240 Foreign currency translation (91,410 ) Balance at December 31, 2018 1,924,830 Foreign currency translation (11,090 ) Balance at June 30, 2019 $ 1,913,740

Accounts Payable and Accrued _2

Accounts Payable and Accrued Expenses (Tables)	6 Months Ended
	Jun. 30, 2019
Payables and Accruals [Abstract]
Accounts payable and accrued expenses	June 30, December 31, 2019 2018 Trade payables $ 2,170,434 $ 1,532,110 Accrued expenses 758,230 285,061 Accrued payroll 112,503 253,225 Total accounts payable and accrued expenses $ 3,041,167 $ 2,070,396

Original Issue Discounted Con_2

Original Issue Discounted Convertible Notes and Warrants (Tables)	6 Months Ended
	Jun. 30, 2019
Debt Disclosure [Abstract]
Convertible debt	June 30, December 31, 2019 2018 Convertible debt $ 2,000,000 $ - Unamortized debt discount - revalued warrants (237,361 ) - Accrued interest 74,521 Total convertible debt $ 1,837,160 $ -

Other Liabilities (Tables)

Other Liabilities (Tables)	6 Months Ended
	Jun. 30, 2019
Other Liabilities [Abstract]
Other liabilities	June 30, December 31, Current 2019 2018 Due to Mayoly $ 455,560 $ - Lease liabilities 195,108 - $ 650,668 $ - June 30, December 31, Long-term 2019 2018 Due to Mayoly $ 398,615 $ - Lease liabilities 44,417 - $ 443,032 $ -

Warrants (Tables)

Warrants (Tables)	6 Months Ended
	Jun. 30, 2019
WarrantsDisclosureTextBlock
Stock warrant transactions	Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable at January 1, 2018 3,371,385 $ 3.17 - $7.37 $ 5.28 Granted during the period 244,400 $ 2.55 - $2.75 $ 2.58 Expired during the period - - - Exercised during the period (503,070 ) $ 2.50 $ 2.50 Warrants outstanding and exercisable at June 30, 2018 3,112,715 $ 2.55 - $7.37 $ 4.83 Warrants outstanding and exercisable at January 1, 2019 3,112,715 $ 2.55 - $7.37 $ 4.83 Granted during the period 75,663 $ 2.55 - $2.82 $ 2.68 Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable at June 30, 2019 3,188,378 $ 1.50 - $7.37 $ 3.51
Warrants by exercise price	Number of Weighted Average Weighted Shares Under Remaining Contract Average Exercise Price Warrants Life in Years Exercise Price $ 1.50 - $2.99 1,329,628 2.75 $ 3.00 - $3.99 636,972 2.82 $ 4.00 - $4.99 196,632 2.51 $ 5.00 - $5.99 805,476 2.63 $ 6.00 - $6.99 187,750 2.26 $ 7.00 - $7.37 31,920 1.46 Total 3,188,378 2.68 $3.51

Stock-Based Compensation Plan (

Stock-Based Compensation Plan (Tables)	6 Months Ended
	Jun. 30, 2019
Share-based Payment Arrangement, Noncash Expense [Abstract]
Share-based payment weighted average assumptions	June 30, June 30, 2019 2018 Contractual term(in years) 5 5 Volatility 71 % 85 % Risk-free interest rate 2.19 % 2.82 % Dividend yield - % - %
Stock option activity	Number Average Remaining Contract Intrinsic of Shares Exercise Price Life in Years Value Stock options outstanding at January 1, 2018 545,000 $ 4.05 7.13 $ - Granted during the period 539,000 $ 3.04 5.00 $ - Expired during the period - - Exercised during the period - - Stock options outstanding at June 30, 2018 1,084,000 $ 3.72 5.82 $ - Exercisable at June 30, 2018 261,250 $ 4.26 8.60 $ - Non-vested stock options outstanding at January 1, 2018 387,500 $ 3.89 6.39 $ - Granted during the period 539,000 $ 3.04 5.00 $ - Vested during the period (103,750 ) $ 3.92 6.02 $ - Expired during the period - - Exercised during the period - - Non-vested stock options outstanding at June 30, 2018 822,750 $ 3.32 5.77 $ - Stock options outstanding at January 1, 2019 994,000 $ 3.58 5.42 $ - Granted during the period 893,500 $ 1.70 4.96 Expired during the period - - Canceled during the period - - Exercised during the period - - Stock options outstanding at June 30, 2019 1,887,500 $ 2.58 4.94 $ - Exercisable at June 30, 2019 994,000 $ 3.58 4.92 $ - Non-vested stock options outstanding at January 1, 2019 244,500 $ 3.05 4.53 $ - Granted during the period 893,500 $ 1.70 4.96 Vested during the period (244,500 ) $ 3.05 4.53 Expired during the period - - Canceled during the period - - Exercised during the period - - Non-vested stock options outstanding at June 30, 2019 893,500 $ 1.70 4.96 $ -

Leases (Tables)

Leases (Tables)	6 Months Ended
	Jun. 30, 2019
Leases [Abstract]
Operating lease information	June 30, 2019 Lease term and discount rate Weighted-average remaining lease term 1.25 years Weighted-average discount rate 6.0%
Maturities of operating lease liabilities	2019 $ 101,359 2020 154,066 Total lease payments 255,425 Less imputed interest (15,900 ) Present value of lease liabilities $ 239,525

Significant Accounting Polici_3

Significant Accounting Policies and Recent Accounting Pronouncements (Details Narrative) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Accounting Policies [Abstract]
Cash in excess of FDIC limit	$ 967,813	$ 754,261

Fair Value Disclosures (Details

Fair Value Disclosures (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Cash	$ 1,310,687	$ 1,114,343
Other receivables	2,119,700	3,172,676
Notes payable	64,714	255,032
Convertible debt	1,837,160	0
Level 1
Cash	0	0
Other receivables	0	0
Notes payable	0	0
Convertible debt	0
Level 2
Cash	1,310,687	1,114,343
Other receivables	0	0
Notes payable	0	0
Convertible debt	0
Level 3
Cash	0	0
Other receivables	2,119,700	3,172,676
Notes payable	64,714	$ 255,032
Convertible debt	$ 1,837,160

Other Receivables (Details)

Other Receivables (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Receivables [Abstract]
R&D tax credits	$ 2,119,700	$ 2,162,373
Other	0	1,010,303
Other receivables	$ 2,119,700	$ 3,172,676

Property, Equipment, and Leas_3

Property, Equipment, and Leasehold Improvements (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Property, equipment and leasehold improvements, gross	$ 345,622	$ 332,248
Less accumulated depreciation	(237,435)	(203,394)
Property, equipment and leasehold improvements, net	108,187	128,854
Laboratory Equipment
Property, equipment and leasehold improvements, gross	193,661	75,417
Computer Equipment
Property, equipment and leasehold improvements, gross	78,986	37,262
Office Equipment
Property, equipment and leasehold improvements, gross	37,264	190,406
Leasehold Improvements
Property, equipment and leasehold improvements, gross	$ 35,711	$ 29,163

Property, Equipment, and Leas_4

Property, Equipment, and Leasehold Improvements (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 16,927	$ 15,657	$ 34,041	$ 30,420

Intangible Assets and Goodwil_2

Intangible Assets and Goodwill (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Patents	$ 3,670,858	$ 0
Common stock issued at signing to Mayoly
Patents	1,740,959
Due to Mayoly at 12/31/19
Patents	449,280
Due to Mayoly at 12/31/20
Patents	393,120
Assumed Mayoly liabilties and forgiveness of Mayoly debt
Patents	$ 1,219,386

Intangible Assets and Goodwil_3

Intangible Assets and Goodwill (Details 1) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
License Agreements
Intangible assets, gross	$ 0	$ 416,600
Less accumulated amortization	0	(157,671)
Intangible assets, net	0	258,929
In Process Research and Development
Intangible assets, gross	0	3,398,702
Less accumulated amortization	0	(3,087,154)
Intangible assets, net	0	311,548
Patents
Intangible assets, gross	3,802,745	0
Less accumulated amortization	(131,887)	0
Intangible assets, net	$ 3,670,858	$ 0

Intangible Assets and Goodwil_4

Intangible Assets and Goodwill (Details 2)	Jun. 30, 2019USD ($)
Amortization expense
2019	$ 263,774
2020	527,548
2021	527,548
2022	527,548
2023	$ 527,548

Intangible Assets and Goodwil_5

Intangible Assets and Goodwill (Details 3) - USD ($)	6 Months Ended	12 Months Ended
	Jun. 30, 2019	Dec. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]
Goodwill, beginning	$ 1,924,830	$ 2,016,240
Foreign currency translation	(11,090)	(91,410)
Goodwill, ending	$ 1,913,740	$ 1,924,830

Intangible Assets and Goodwil_6

Intangible Assets and Goodwill (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Goodwill and Intangible Assets Disclosure [Abstract]
Amortization expense	$ 131,887	$ 185,818	$ 693,176	$ 377,499

Accounts Payable and Accrued _3

Accounts Payable and Accrued Expenses (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Payables and Accruals [Abstract]
Trade payables	$ 2,170,434	$ 1,532,110
Accrued expenses	758,230	285,061
Accrued payroll	112,503	253,225
Total accounts payable and accrued expenses	$ 3,041,167	$ 2,070,396

Original Issue Discounted Con_3

Original Issue Discounted Convertible Notes and Warrants (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Debt Disclosure [Abstract]
Convertible debt, gross	$ 2,000,000	$ 0
Unamortized debt discount - revalued warrants	(237,361)	0
Accrued interest	74,521	0
Convertible debt, net	$ 1,837,160	$ 0

Other Liabilities (Details)

Other Liabilities (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Other Liabilities [Abstract]
Due to Mayoly, current	$ 455,560	$ 0
Lease liabilities, current	195,108	0
Other liabilities, current	650,668	0
Due to Mayoly, long-term	398,615	0
Lease liabilities, long-term	44,417	0
Other liabilities, long-term	$ 443,032	$ 0

Equity (Details Narrative)

Equity (Details Narrative) - shares	Jun. 30, 2019	Dec. 31, 2018
Equity [Abstract]
Common stock shares, outstanding	21,103,434	17,704,925

Warrants (Details)

Warrants (Details) - $ / shares	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Warrants issued and exercisable, beginning	3,112,715	3,371,385
Granted	75,663	244,400
Expired	0	0
Exercised	0	(503,070)
Warrants issued and exercisable, ending	3,188,378	3,112,715
Exercise price exercised		$ 2.50
Weighted average exercise price, beginning	$ 4.83	5.28
Weighted average exercise price, granted	2.68	2.58
Weighted average exercise price warrants, expired	0	0
Weighted average exercise price warrants, exercised	0	2.5
Weighted average exercise price, ending	3.51	4.83
Minimum
Exercise price outstanding, beginning	2.55	3.17
Exercise price granted	2.55	2.55
Exercise price exercised	0
Exercise price outstanding, ending	1.50	2.55
Maximum
Exercise price outstanding, beginning	7.37	7.37
Exercise price granted	2.82	2.75
Exercise price outstanding, ending	$ 7.37	$ 7.37

Warrants (Details 1)

Warrants (Details 1)	6 Months Ended
	Jun. 30, 2019$ / sharesshares
Number of shares under warrants	3,188,378
Weighted average remaining contract life in years	2 years 8 months 5 days
Weighted average exercise price | $ / shares	$ 3.51
Warrant 1
Exercise price	1.50 - $2.99
Number of shares under warrants	1,329,628
Weighted average remaining contract life in years	2 years 9 months
Warrant 2
Exercise price	3.00 - $3.99
Number of shares under warrants	636,972
Weighted average remaining contract life in years	2 years 9 months 25 days
Warrant 3
Exercise price	4.00 - $4.99
Number of shares under warrants	196,632
Weighted average remaining contract life in years	2 years 6 months 4 days
Warrant 4
Exercise price	5.00 - $5.99
Number of shares under warrants	805,476
Weighted average remaining contract life in years	2 years 7 months 17 days
Warrant 5
Exercise price	6.00 - $6.99
Number of shares under warrants	187,750
Weighted average remaining contract life in years	2 years 3 months 4 days
Warrant 6
Exercise price	7.00 - $7.37
Number of shares under warrants	31,920
Weighted average remaining contract life in years	1 year 5 months 16 days

Stock-Based Compensation Plan_2

Stock-Based Compensation Plan (Details)	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Share-based Payment Arrangement, Noncash Expense [Abstract]
Contractual term (in years)	5 years	5 years
Volatility	71.00%	85.00%
Risk-free interest rate	2.19%	2.82%
Dividend yield	0.00%	0.00%

Stock-Based Compensation Plan_3

Stock-Based Compensation Plan (Details 1) - USD ($)	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Stock Option
Number of Options Outstanding, Beginning	994,000	545,000
Number of Options Granted	893,500	539,000
Number of Options Expired	0	0
Number of Options Exercised	0	0
Number of Options Outstanding, Ending	1,887,500	1,084,000
Number of Options Exercisable	994,000	261,250
Weighted Average Exercise Price Outstanding, Beginning	$ 3.58	$ 4.05
Weighted Average Exercise Price Granted	1.70	3.04
Weighted Average Exercise Price Expired	0	0
Weighted Average Exercise Price Exercised	0	0
Weighted Average Exercise Price Outstanding, Ending	2.58	3.72
Weighted Average Exercise Price Exercisable	$ 3.58	$ 4.26
Weighted Average Remaining Contract Life in Years, Beginning	5 years 5 months 1 day	7 years 1 month 17 days
Weighted Average Remaining Contract Life in Years, Ending	4 years 11 months 8 days	5 years 9 months 25 days
Weighted Average Remaining Contract Life in Years Exercisable	4 years 11 months 1 day	8 years 7 months 6 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 0
Aggregate Intrinsic Value Outstanding, Ending	0	0
Aggregate Intrinsic Value Exercisable	$ 0	$ 0
Non-vested Stock Option
Number of Options Outstanding, Beginning	244,500	387,500
Number of Options Granted	893,500	539,000
Number of Options Vested	(244,500)	(103,750)
Number of Options Expired	0	0
Number of Options Exercised	0	0
Number of Options Outstanding, Ending	893,500	822,750
Weighted Average Exercise Price Outstanding, Beginning	$ 3.05	$ 3.89
Weighted Average Exercise Price Granted	1.7	3.04
Weighted Average Exercise Price Vested	3.05	3.92
Weighted Average Exercise Price Expired	0	0
Weighted Average Exercise Price Exercised	0	0
Weighted Average Exercise Price Outstanding, Ending	$ 1.70	$ 3.32
Weighted Average Remaining Contract Life in Years, Beginning	4 years 6 months 11 days	6 years 4 months 20 days
Weighted Average Remaining Contract Life in Years, Ending	4 years 11 months 16 days	5 years 9 months 7 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 0
Aggregate Intrinsic Value Vested	0	0
Aggregate Intrinsic Value Outstanding, Ending	$ 0	$ 0

Leases (Details)

Leases (Details)	Jun. 30, 2019
Leases [Abstract]
Weighted-average remaining lease term	1 year 3 months
Weighted-average discount rate	6.00%

Leases (Details 1)

Leases (Details 1)	Jun. 30, 2019USD ($)
Leases [Abstract]
2019	$ 101,359
2020	154,066
Total lease payments	255,425
Less: imputed interest	(15,900)
Present value of lease liabilities	$ 239,525

Leases (Details Narrative)

Leases (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Leases [Abstract]
Lease expense	$ 51,011	$ 36,766	$ 101,666	$ 67,993

Income Taxes (Details Narrative

Income Taxes (Details Narrative) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Income Tax Disclosure [Abstract]
Gross deferred tax asset	$ 14,500,000	$ 12,490,000
Deferred tax asset valuation allowance	(14,500,000)	(12,490,000)
Net operating loss carry-forwards	$ 17,072,000	$ 15,406,000

Net Loss per Common Share (Deta

Net Loss per Common Share (Details Narrative) - shares	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Warrants
Anti-dilutive shares excluded from earnings per share	3,188,378	3,112,715
Stock Option
Anti-dilutive shares excluded from earnings per share	1,887,500	1,084,000
Convertible Debt
Anti-dilutive shares excluded from earnings per share		74,000
Restricted stock
Anti-dilutive shares excluded from earnings per share	416,000	0

Related Party Transactions (Det

Related Party Transactions (Details Narrative) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Accounts payable	$ 3,041,167	$ 2,070,396
JIST
Accounts payable	478,400	478,400
RHMS
Accounts payable	38,453	38,453
Consultant
Accounts payable	$ 10,000	$ 50,000