Entero Therapeutics (ENTO) 10-K 1 Apr 19 2018 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2018	Apr. 01, 2019	Jun. 30, 2018
Document and Entity Information
Entity Registrant Name	AzurRx BioPharma, Inc.
Document Type	10-K
Document Period End Date	Dec. 31, 2018
Amendment Flag	false
Entity Central Index Key	0001604191
Current Fiscal Year End Date	--12-31
Enity Public Float			$ 45,211,000
Entity Common Stock, Shares Outstanding		18,537,958
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	true
Entity Emerging Growth Transition Period	false
Entity Small Business	true
Entity Shell Company	false
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Well-known Seasoned Issuer	No
Document Fiscal Year Focus	2018
Document Fiscal Period Focus	FY

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Current Assets:
Cash	$ 1,114,343	$ 573,471
Other receivables	3,172,676	1,104,134
Prepaid expenses	512,982	274,963
Total Current Assets	4,800,001	1,952,568
Property, equipment, and leasehold improvements, net	128,854	133,987
Other Assets:
In process research & development, net	258,929	307,591
License agreements, net	311,548	1,038,364
Goodwill	1,924,830	2,016,240
Deposits	45,233	30,918
Total Other Assets	2,540,540	3,393,113
Total Assets	7,469,395	5,479,668
Current Liabilities:
Accounts payable and accrued expenses	2,070,396	1,187,234
Accounts payable and accrued expenses - related party	670,095	868,105
Notes payable	255,032	159,180
Convertible debt	0	257,365
Interest payable	0	7,192
Total Current Liabilities	2,995,523	2,479,076
Contingent consideration	0	1,340,000
Total Liabilities	2,995,523	3,819,076
Stockholders' Deficit:
Convertible preferred stock - Par value $0.0001 per share; 10,000,000 shares authorized and 0 shares issued and outstanding at December 31, 2018 and 2017; liquidation preference approximates par value	0	0
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 17,704,925 and 12,042,574 shares issued and outstanding, respectively, at December 31, 2018 and 2017	1,771	1,205
Additional paid in capital	53,139,259	37,669,601
Subscriptions receivable	0	(1,071,070)
Accumulated deficit	(47,517,046)	(33,983,429)
Accumulated other comprehensive loss	(1,150,112)	(955,715)
Total Stockholders' Equity (Deficit)	4,473,872	1,660,592
Total Liabilities and Stockholders' Equity (Deficit)	$ 7,469,395	$ 5,479,668

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2018	Dec. 31, 2017
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, 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, outstanding	17,704,925	12,042,574

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Income Statement [Abstract]
Research and development expenses	$ 4,985,553	$ 2,395,478
General & administrative expenses	8,236,218	7,685,706
Fair value adjustment, contingent consideration	210,000	140,000
Loss from operations	(13,431,771)	(10,221,184)
Other:
Interest expense	(101,846)	(875,199)
Total other	(101,846)	(875,199)
Net loss	(13,533,617)	(11,096,383)
Other comprehensive loss (gain):
Foreign currency translation adjustment	(194,397)	506,160
Total comprehensive loss	$ (13,728,014)	$ (10,590,223)
Basic and diluted weighted average shares outstanding	15,439,310	10,628,835
Loss per share - basic and diluted	$ (0.88)	$ (1.04)

Consolidated Statements of Chan

Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($)	Preferred Stock	Common Stock	Additional Paid-In Capital	Subscriptions Receivable	Accumulated Deficit	Accumulated Other Comprehensive Loss	Total
Beginning Balance, Shares at Dec. 31, 2016	0	9,631,088
Beginning Balance, Amount at Dec. 31, 2016	$ 0	$ 963	$ 27,560,960		$ (22,887,046)	$ (1,461,875)	$ 3,213,002
Common stock issued from public offering, Amount							5,009,225
Common stock issued for warrant exercises, Amount							0
Common stock issued for purchase of Protea assets from bankruptcy, Amount							0
Common stock issued in private placement, Shares		1,542,858
Common stock issued in private placement, Amount		$ 154	5,009,071				5,009,225
Convertible debt converted into common stock, Shares		189,256
Convertible debt converted into common stock, Amount		$ 19	717,107				717,126
Stock-based compensation			609,369				609,369
Restricted stock granted to employees/directors, Shares		115,000
Restricted stock granted to employees/directors, Amount		$ 12	487,290				487,302
Restricted stock granted to consultants, Shares		105,944
Restricted stock granted to consultants, Amount		$ 11	381,704				381,715
Warrants issued to consultants			538,945				538,945
Warrants issued in association with convertible debt issuances			410,672				410,672
Beneficial conversion feature on convertible debt issuances			395,589				395,589
Common stock issued for convertible debt extension, Shares		30,000
Common stock issued for convertible debt extension, Amount		$ 3	90,297				90,300
Warrant modification			397,570				397,570
Common stock subscribed, Shares		428,428
Common stock subscribed, Amount		$ 43	1,071,027				1,071,070
Subscriptions receivable				(1,071,070)			(1,071,070)
Foreign currency translation adjustment						506,160	506,160
Net loss					(11,096,383)		(11,096,383)
Ending Balance, Shares at Dec. 31, 2017	0	12,042,574
Ending 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	9,577,647				9,578,063
Common stock issued to consultants, Shares		118,818
Common stock issued to consultants, Amount		$ 12	360,759				360,771
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 for purchase of Protea assets from bankruptcy, Shares		734,463
Common stock issued for purchase of Protea assets from bankruptcy, Amount		$ 74	1,299,926				1,300,000
Convertible debt converted into common stock, Shares		26,000
Convertible debt converted into common stock, Amount		$ 3	68,670				68,673
Stock-based compensation			1,441,475				1,441,475
Restricted stock granted to employees/directors, Shares		120,000
Restricted stock granted to employees/directors, Amount		$ 12	1,038,810				1,038,822
Warrant modification			428,748				428,748
Foreign currency translation adjustment						(194,397)	(194,397)
Net loss					(13,533,617)		(13,533,617)
Ending Balance, Shares at Dec. 31, 2018	0	17,704,925
Ending Balance, Amount at Dec. 31, 2018	$ 0	$ 1,771	$ 53,139,259	$ 0	$ (47,517,046)	$ (1,150,112)	$ 4,473,872

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Cash flows from operating activities:
Net loss	$ (13,533,617)	$ (11,096,383)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	61,909	49,520
Amortization	736,537	704,478
Fair value adjustment, warrants	0	0
Fair value adjustment, contingent consideration	210,000	140,000
Stock-based compensation	1,441,475	609,369
Restricted stock granted to employees/directors	1,038,822	487,302
Restricted stock granted to consultants	360,771	381,715
Warrants issued to consultants	0	538,945
Accreted interest on convertible debt	0	104,328
Convertible debt beneficial conversion feature	0	395,589
Accreted interest on debt discount - warrants	97,837	280,834
Common stock issued for convertible debt extension	0	90,300
Warrant modification	428,748	397,570
Changes in assets and liabilities, net of effects of acquisition:
Other receivables	(2,187,903)	3,438
Prepaid expenses	(243,330)	(43,491)
Deposits	(15,001)	5,625
Accounts payable and accrued expenses	741,624	(233,777)
Interest payable	(7,192)	0
Net cash used in operating activities	(10,869,320)	(7,184,638)
Cash flows from investing activities:
Purchase of property and equipment	(55,473)	(32,168)
Purchase of Protea assets from bankruptcy	(250,000)	0
Net cash used in investing activities	(305,473)	(32,168)
Cash flows from financing activities:
Net proceeds from common stock issued for warrant exercises	2,324,742	0
Net proceeds from issuances of common stock and warrants	9,578,063	5,009,225
Proceeds of notes payable	286,203	296,338
Repayments of notes payable	(190,351)	(292,345)
Issuances of convertible debt	0	1,000,000
Repayments of convertible debt	(286,529)	0
Net cash provided by financing activities	11,712,128	6,013,218
(Decrease) Increase in cash	537,335	(1,203,588)
Effect of exchange rate changes on cash	3,537	3,534
Cash, beginning balance	573,471	1,773,525
Cash, ending balance	1,114,343	573,471
Supplemental disclosures of cash flow information:
Cash paid for interest	4,010	4,148
Cash paid for taxes	0	0
Non-cash investing and financing activities:
Conversion of convertible debt into common stock	0	717,126
Common stock issued for purchase of Protea assets from bankruptcy that extinguished contingent consideration	$ 1,300,000	$ 0

The Company and Basis of Presen

The Company and Basis of Presentation	12 Months Ended
	Dec. 31, 2018
Disclosure Text Block [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” “CP” “CF” “CFA” “FDA” “IND” 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” Recent Developments Public Offering of Common Stock On May 3, 2018, the Company completed an underwritten, public offering of 4,160,000 shares of its common stock at a public offering price per share of $2.50, resulting in gross proceeds of $10.4 million (the “ May 2018 Public Offering Oppenheimer In addition to the underwriting discount received by Oppenheimer, the Company also issued unregistered warrants to Oppenheimer to purchase up to 208,000 shares of the Company’s common stock (the “ Underwriter Warrants Update and Completion of the Phase IIa Trial of MS1819-SD and Launch of the Phase II OPTION Study On June 29, 2018, the Company announced the successful completion of its Phase IIa trial of MS1819-SD, and on September 24, 2018, the Company announced, in partnership with Mayoly Spindler, a European pharmaceutical company ( "Mayoly" On October 16, 2018, the Company announced that the FDA cleared its IND application for MS1819-SD in patients with EPI due to CF. In connection with the FDA’s clearance of the IND, in the fourth quarter of 2018 the Company initiated a multi-center Phase II OPTION study that was subject to the IND in the United States and Europe, which the Company expects will include approximately 30 patients and conclude in 2019. In addition, on On February 20, 2019, the Company announced that it has dosed the first patients in its Phase II OPTION. Protea Asset Sale and Purchase Agreement On December 7, 2018, the Company entered into an asset sale and purchase agreement (the “Protea Purchase Agreement” (“Protea” “Purchased Assets” Protea previously filed for Chapter 11 protection under the United States Bankruptcy Code on December 1, 2017. On November 27, 2018, the Company participated in a bankruptcy auction for the Purchased Assets and the Company was chosen as the successful bidder at the conclusion of the auction. On December 10, 2018, the transaction was approved by the United States bankruptcy court. On December 14, 2018 (the “Closing Date” “Purchase Price” Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“ U.S. GAAP The financial statements for the years ended December 31, 2018 and 2017 include the accounts of AzurRx and its wholly-owned subsidiary, AzurRx SAS. Intercompany transactions and balances have been eliminated upon consolidation. The accompanying 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 working capital at December 31, 2018 of approximately $1,804,000, and had an accumulated deficit of approximately $47,517,000 at December 31, 2018. The Company is dependent on obtaining, and continues to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue operations. Without adequate funding, the Company may not be able to meet its obligations. Management believes these conditions raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Significant Accounting Policies

Significant Accounting Policies	12 Months Ended
	Dec. 31, 2018
Significant Accounting Policies
Significant Accounting Policies	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 December 31, 2018 and 2017, the Company had approximately $754,261 and $78,859, 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. Property, Equipment, and Leasehold Improvements Property, equipment and leasehold improvements are carried on the cost basis and depreciated over the estimated useful lives of the related assets using the straight-line method. For financial statement purposes, depreciation expense is provided using the straight-line method over the estimated useful lives of the assets as follows: ● Laboratory Equipment 5 years; ● Computer Equipment 5 years; ● Office Equipment 7-8 years; and ● Leasehold Improvements Term of lease or estimated useful life of the assets; whichever is shorter. Expenditures for maintenance and repairs are charged to operations as incurred while renewals and betterments are capitalized. At December 31, 2018 and 2017, there are no restrictions on the Company’s title of property, equipment, and leasehold improvements and no amounts have been pledged as security for liabilities. Goodwill and Intangible Assets Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through December 31, 2018. Intangible assets subject to amortization consist of in process research and development and license agreements reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows: ● In Process Research & Development 12 years; and ● License Agreements 5 years. Research and Development Research & development costs are charged to operations when incurred and are included in operating expenses. Research & 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. Fair Value Measurements The Company follows Accounting Standards Codification (“ASC” (“ASC 820” As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. Stock-Based Compensation The Company’s board of directors and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan which took effect on May 12, 2014. The Company accounts for its stock-based compensation awards to employees and directors in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718” Equity-Based Payments to Non-Employees In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, to expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services for nonemployees. The ASU is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted. As a result of the early adoption of this pronouncement, the Company measures these nonemployee awards at fair value on the grant date. The adoption of this pronouncement did not have a significant impact on the Company’s financial statements. Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740” The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At December 31, 2018 and 2017, the Company does not have any significant uncertain tax positions. All tax years are still open for audit. Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360” 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. Collaboration Agreements As more fully discussed in Note 15, during the year ended December 31, 2018, the Company had joint research collaboration agreements with Laboratoires Mayoly Spindler SAS and INRA TRANSFERT. Any payments due from the Company’s collaboration partners are recorded as a reduction in research and development expenses. Sublicense Agreement As more fully discussed in Note 15, the Company entered into a Sublicense Agreement with TransChem, Inc. pursuant to which TransChem granted the Company an exclusive license to certain patents and patent applications. Any payments made to Transchem for this agreement will be recorded as research and development expenses. Operating Leases The Company recognizes rent expense from operating leases with various escalation clauses on a straight-line basis over the applicable lease term. The Company considers lease renewals in the useful life of its leasehold improvements when such renewals are reasonably assured. Subsequent Events The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. Recent Accounting Pronouncements In July 2017, the FASB issued ASU 2017-11, Earnings per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815). ASU 2017-11 provides guidance on accounting for financial instruments with down round features and clarifies the deferral of certain provisions in Topic 480. ASU 2017-11 will become effective for annual periods beginning after December 15, 2018 and interim periods within those periods. Early adoption is permitted. The adoption of this pronouncement will not have an impact on the Company’s financial statements. 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. In February 2016, the FASB issued an ASU which requires lessees to recognize lease assets and lease liabilities arising from operating leases on the balance sheet. This ASU is effective for annual and interim reporting periods beginning after December 15, 2018 using a modified retrospective approach, with early adoption permitted. The Company believes that the adoption of this pronouncement will not have a material impact on the Company's financial statements. The Company believes that the most significant changes relate to the recognition of new right-of-use assets and lease liabilities on the balance sheet for office space and research facilities amounting to approximately $344,000.

Fair Value Disclosures

Fair Value Disclosures	12 Months Ended
	Dec. 31, 2018
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. At December 31, 2017, the Company had Level 3 instruments consisting of contingent consideration in connection with the Protea Europe SAS acquisition, see Note 7. The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis: Fair Value Measurements at Reporting Date Using Total Level 1 Level 2 Level 3 At December 31, 2017: Contingent consideration $ 1,340,000 $ - $ - $ 1,340,000 The following table provides a reconciliation of the fair value of liabilities using Level 3 significant unobservable inputs: Contingent Consideration Balance at December 31, 2016 $ 1,200,000 Change in fair value 140,000 Balance at December 31, 2017 1,340,000 Change in fair value 210,000 Purchase of Protea assets in bankruptcy (1,550,000 ) Balance at December 31, 2018 $ - The contingent consideration was valued by incorporating a series of Black-Scholes Option Pricing Models (“ BSM 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 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 At December 31, 2017: Cash $ 573,471 $ - $ 573,471 $ - $ 573,471 Other receivables $ 1,104,134 $ - $ - $ 1,104,134 $ 1,104,134 Note payable $ 159,180 $ - $ - $ 159,180 $ 159,180 Convertible debt $ 257,365 $ - $ - $ 387,201 $ 387,201 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 Mayoly, see Note 15. 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	12 Months Ended
	Dec. 31, 2018
Other Receivables
Other Receivables	Other receivables consisted of the following: December 31, December 31, 2018 2017 R&D tax credits $ 2,162,373 $ 954,897 Other 1,010,303 149,237 Total other receivables $ 3,172,676 $ 1,104,134 The R&D tax credits are the 2017 and 2018 refundable tax credits for research conducted in France. Other consists primarily of amounts due from Mayoly, see Note 15, and non-income tax related items from French government entities.

Property, Equipment, and Leaseh

Property, Equipment, and Leasehold Improvements	12 Months Ended
	Dec. 31, 2018
Property Equipment And Leasehold Improvements
Property, Equipment, and Leasehold Improvements	Property, equipment and leasehold improvements consisted of the following: December 31, December 31, 2018 2017 Laboratory equipment $ 190,406 $ 165,611 Computer equipment 75,417 44,364 Office equipment 37,262 36,334 Leasehold improvements 29,163 29,163 Total property, plant and equipment 332,248 275,472 Less accumulated depreciation (203,394 ) (141,485 ) Property, plant and equipment, net $ 128,854 $ 133,987 Depreciation expense for the years ended December 31, 2018 and 2017 was $61,909 and $49,250, respectively. Depreciation expense is included in general and administrative (“ G&A

Intangible Assets and Goodwill

Intangible Assets and Goodwill	12 Months Ended
	Dec. 31, 2018
Intangible Assets And Goodwill
Intangible Assets and Goodwill	Intangible assets are as follows: December 31, December 31, 2018 2017 In process research and development $ 416,600 $ 436,385 Less accumulated amortization (157,671 ) (128,794 ) In process research and development, net $ 258,929 $ 307,591 License agreements $ 3,398,702 $ 3,560,107 Less accumulated amortization (3,087,154 ) (2,521,743 ) License agreements, net $ 311,548 $ 1,038,364 Amortization expense for the years ended December 31, 2018 and 2017 was $736,537 and $704,478, respectively. As of December 31, 2018, amortization expense is expected to be as follows for the next five years: 2019 $ 346,264 2020 34,717 2021 34,717 2022 34,717 2023 34,717 Goodwill is as follows: Goodwill Balance at January 1, 2017 $ 1,767,550 Foreign currency translation 248,690 Balance at December 31, 2017 2,016,240 Foreign currency translation (91,410 ) Balance at December 31, 2018 $ 1,924,830

Contingent Consideration

Contingent Consideration	12 Months Ended
	Dec. 31, 2018
Contingent Consideration
Contingent Consideration	On June 13, 2014, the Company completed a stock purchase agreement (the “ SPA Protea Group FDA NDA BLA

Accounts Payable and Accrued Ex

Accounts Payable and Accrued Expenses	12 Months Ended
	Dec. 31, 2018
Accounts Payable
Accounts Payable and Accrued Expenses	Accounts payable and accrued expenses consisted of the following: December 31, December 31, 2018 2017 Trade payables $ 1,532,110 $ 705,041 Accrued expenses 285,061 262,200 Accrued payroll 253,225 219,993 Total accounts payable and accrued expenses $ 2,070,396 $ 1,187,234

Notes Payable

Notes Payable	12 Months Ended
	Dec. 31, 2018
Notes to Financial Statements
Notes 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 December 31, 2018 was $255,032. On October 30, 2017, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of $237,137 that bears interest at an annual rate of 5.537%. Monthly payments, including principal and interest, are $26,960 per month. The balance due under this financing agreement at December 31, 2017 was $159,180.

Original Issue Discounted Conve

Original Issue Discounted Convertible Notes	12 Months Ended
	Dec. 31, 2018
Original Issue Discounted Convertible Notes
Original Issue Discounted Convertible Notes	LPC OID Debenture On April 11, 2017, the Company entered into a Note Purchase Agreement with Lincoln Park Capital Fund, LLC ( “LPC” “Debenture” “Tax Credit” “LPC Series A Warrant” On November 10, 2017, the Company and LPC modified the Debenture to extend the Maturity Date to November 29, 2017, subject to the Company’s right to extend the Maturity Date to July 11, 2018 (the “Extension Option” “LPC Series B Warrant” The principal and original issue discount amount of the Debenture is convertible into shares of the Company’s common stock at LPC’s option, at a conversion price equal to $3.872 ( “Conversion Price” On July 11, 2018, the Company paid off the remaining amount due under the terms of this Debenture in the amount of $286,529. The obligations under the Debenture were guaranteed by ABS, as well as a security agreement providing LPC with a secured interest in the Tax Credit. For the year ended December 31, 2018 and 2017, the Company recorded $97,837 and $871,051, respectively, of interest expense related to the amortization of the debt discount and beneficial conversion feature related to the warrant features of the Debenture. Convertible Debt consisted of: December 31, 2017 Convertible debt $ 352,713 Accreted OID interest 34,488 Unamortized debt discount - warrants (129,836 ) Total convertible debt $ 257,365

Equity

Equity	12 Months Ended
	Dec. 31, 2018
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 December 31, 2018 and 2017, the Company had 17,704,925 and 12,042,574, 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 Pursuant to the SPA with the Protea Group, on June 13, 2014, the Company issued 100 shares of Series A Convertible Preferred Stock ( “Series A Preferred” The terms of the Series A Preferred are described below: Voting The Series A Preferred holders are entitled to vote, together with the holders of common stock as one class, on all matters to which holders of common stock shall be entitled to vote, in the same manner and with the same effect as the common stock holders with the same number of votes per share that equals the number of shares of common stock into which the Series A Preferred is convertible at the time of such vote. Dividends The holders of the Series A Preferred shall be entitled to receive dividends, when, as, and if declared by the board of directors, ratably with any declaration or payment of any dividend on common stock. To date there have been no dividends declared or paid by the board of directors. Liquidation The holders of the Series A Preferred shall be entitled to receive, before and in preference to, any distribution of any assets of the Company to the holders of common stock, an amount equal to $0.0001 per share, plus any declared but unpaid dividends. The liquidation preference as of December 31, 2018 and 2017 approximates par value. Conversion The Series A Preferred was convertible into 33% of the issued and outstanding shares of common stock on a fully diluted basis, assuming the conversion, exercise, or exchange for shares of common stock of all convertible securities issued and outstanding immediately prior to such conversion, including the Series A Preferred stock, all outstanding warrants and options, and all outstanding convertible debt, notes, debentures, or any other securities which are convertible, exercisable, or exchangeable for shares of common stock. The Series A Preferred was convertible at the holder’s option any time commencing on the one-year anniversary of the initial issuance date. The Series A Preferred was subject to mandatory conversion at any time commencing on the one-year anniversary of the initial issuance date upon the vote or written consent by the holders of a majority of the Series A Preferred then outstanding or upon the occurrence of certain triggering events, including a public offering coupled with an equity-linked financing with an offering price that values the Company prior to consummation of such financing at not less than $12,000,000 and the aggregate gross proceeds to the Company (before deduction of underwriting discounts and registration expenses) are not less than $6,000,000. On November 11, 2015, the Company and the Protea Group agreed that the Series A Preferred would be convertible into 2,439,365 shares of common stock. During the year ended December 31, 2016, Protea Group converted 71 shares of Series A Preferred into 1,731,949 shares of common stock. As of December 31, 2016, all Series A Preferred has been converted into common stock. Beneficial Conversion The Series A Preferred was recorded at fair value when issued under purchase accounting for the purchase of the Company’s French subsidiary. As such, there was no intrinsic value that would result in a beneficial conversion feature at date of issuance. The Series A Preferred was voluntarily converted and there was no associated beneficial conversion. Restricted Stock During the year ended December 31, 2018, 494,067 shares of restricted common stock were granted or accrued to employees and consultants with a total value of $1,445,311. During the year ended December 31, 2018, 5,000 shares of restricted common stock granted or accrued to employees and consultants were canceled with a total value of $15,200. During the year ended December 31, 2018, 435,235 restricted shares of common stock vested with a value of $1,399,593. 120,000 of these shares with a value of $306,300 were issued and vested to our directors as a part of Board compensation. During the year ended December 31, 2018, 25,000 of these shares valued at $106,250 vested due to the Company completing a Phase IIa clinical trial for MS1819-SD. During the year ended December 31, 2018, 133,833 of these shares valued at $497,602 vested due to the acceptance by the FDA of the Company’s IND application for MS1819-SD. The restricted common stock granted in the year ended December 31, 2018 have vesting terms ranging from immediately to three years or based on the Company achieving certain milestones as set forth below. During the year ended December 31, 2017, 405,944 shares of restricted common stock were granted or accrued to employees and consultants with a total value of $1,582,915. During the year ended December 31, 2017, 248,528 restricted shares of common stock vested with a value of $951,217 of which an aggregate of 115,000 shares with a value of $460,000 have been issued to our directors as a part of Board compensation. As of December 31, 2018, the Company had unrecognized restricted common stock expense of $662,216. $382,028 of this unrecognized expense will be recognized over the average remaining vesting term of the restricted common stock of 2.24 years. $178,853 of this unrecognized expense vests upon the first CF patient doses with MS1819-SD anywhere in the world. $101,333 of this unrecognized expense vests upon the enrollment of the first 30 patients in a CF trial. Neither of these milestones are considered probable at December 31, 2018. June 2017 Private Placement On June 5, 2017, the Company entered into Securities Purchase Agreements (the “Purchase Agreements” Investors Series A Warrant Series A-1 Warrant Units Financing Placement agent fees of $350,475 were paid to Alexander Capital L.P. (“ Alexander Capital Alexander Investors Placement Agent Warrants On June 20, 2017, the Company and Investors executed an amendment to the Purchase Agreements to authorize the Company to issue up to $400,000 of additional Units, and on July 5, 2017, the Company issued additional Units resulting in gross proceeds of $400,000 (“ Subsequent Closing The Company also entered into a Registration Rights Agreement granting the Investors certain registration rights with respect to the shares of common stock issued in connection with the June 2017 Private Placement, as well as the shares of common stock issuable upon exercise of the Series A Warrants and Series A-1 Warrants. All of these shares have been registered pursuant to the registration statement on Form S-1 declared effective by SEC on August 11, 2017.

Warrants

Warrants	12 Months Ended
	Dec. 31, 2018
Warrants Abstract
Warrants	Stock warrant transactions for the period January 1, 2017 through December 31, 2018 were as follows: Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable at January 1, 2017 1,858,340 $ 4.76 - $7.37 $ 5.66 Granted during the period 2,205,080 $ 3.17 - $6.50 $ 5.02 Expired during the period (263,607 ) $ 4.00 $ 4.00 Exercised during the period (428,428 ) $ 2.50 $ 2.50 Warrants outstanding and exercisable at December 31, 2017 3,371,385 $ 3.17 - $7.37 $ 5.28 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 December 31, 2018 3,112,715 $ 2.55 - $7.37 $ 4.83 Number of Weighted Average Weighted Shares Under Remaining Contract Average Exercise Price Warrants Life in Years Exercise Price $ 2.55 - $3.99 881,372 3.60 $ 4.00 - $4.99 196,632 3.01 $ 5.00 - $5.99 1,815,041 2.96 $ 6.00 - $6.99 187,750 2.76 $ 7.00 - $7.37 31,920 1.96 Total 3,112,715 3.12 $4.83 Certain Company warrants were expiring December 31, 2017. The Company offered the holders of these warrants the opportunity to exercise their warrants at a reduced strike price of $2.50, and if so elected, would also have the opportunity to exercise other warrants that they held at $2.50 and/or reprice other warrants that they continue to hold unexercised to $3.25. The offer, which was effective December 28, 2017, was for the repricing only and did not modify the life of the warrants. Warrant holders of approximately 428,000 shares exercised their warrants and had other warrants modified on approximately 226,000 shares, resulting in a charge of approximately $398,000 in December 2017. At December 31, 2017, the Company recorded stock subscriptions receivable and common stock subscribed in the amount of $1,071,070 which are netted against each other within equity. In addition, in January 2018, the Company offered other 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. All cash proceeds on the exercise of the warrants and related stock issuances occurred in January 2018 and amounted to approximately $2,300,000. During the year ended December 31, 2018, 244,400 warrants were issued to investment bankers in association with the May 2018 Public Offering with a value of $416,426. During the year ended December 31, 2017, 250,000 fully vested warrants were issued to consultants with a value of $538,945. These amounts were earned and expensed as G&A expenses in the year ended December 31, 2017. During the year ended December 31, 2017, 1,542,858 During the year ended December 31, 2017, 83,710 The weighted average fair value of warrants granted to non-employees during the years ended December 31, 2018 and 2017 was $1.70 and $2.16, respectively. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions: December 31, December 31, 2018 2017 Expected life (in years) 5 5 Volatility 84 % 73 - 90 % Risk-free interest rate 2.70 % 1.82% - 2.05 % Dividend yield - % - % The expected term of the warrants is based on the actual term of the warrants. Volatility is based on the historical volatility of several public entities that are similar to the Company. The Company bases volatility this way because it does 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.

Stock-Based Compensation Plan

Stock-Based Compensation Plan	12 Months Ended
	Dec. 31, 2018
Stock-based Compensation Plan
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 year ended December 31, 2018, 539,000 stock options were granted with an exercise price of $3.04 and a term of five years. 600,750 options vested in the year ended December 31, 2018 having a fair value of $1,441,475. 88,750 of these shares valued at $219,913 vested due to the Company completing a Phase IIa clinical trial for MS1819-SD. 482,000 of these shares valued at $1,105,491 vested due to the FDA acceptance of the Company’s IND application for MS1819-SD. 90,000 stock options were canceled with exercise prices ranging from of $3.04 to $3.60. The weighted average fair value of stock options granted to employees during the year ended December 31, 2018 was $2.07. During the year ended December 31, 2017, 545,000 stock options were granted with exercise prices ranging from $3.60 to $4.48 and lives ranging from five to ten years. 157,500 options vested in the year ended December 31, 2017 having a fair value of $609,369. The weighted average fair value of stock options granted to employees during the year ended December 31, 2017 was $2.96. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions: December 31, December 31, 2018 2017 Expected life (in years) 5 5 - 10 Volatility 85 % 71% - 90 % Risk-free interest rate 2.82 % 1.78% - 2.48 % Dividend yield - % - % The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of several public entities that are similar to the Company. The Company bases volatility this way because it does 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, 2017 - - Granted during the period 545,000 $ 4.05 7.13 $ - Expired during the period - - Exercised during the period - - Stock options outstanding at December 31, 2017 545,000 $ 4.05 7.13 $ - Exercisable at December 31, 2017 157,500 $ 4.48 9.10 $ - Non-vested stock options outstanding at January 1, 2017 - - Granted during the period 387,500 $ 3.89 6.39 $ - Expired during the period - - Exercised during the period - - Non-vested stock options outstanding at December 31, 2017 387,500 $ 3.89 6.39 $ - 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 - - Canceled during the period (90,000 ) $ 3.26 4.41 $ - Exercised during the period - - Stock options outstanding at December 31, 2018 994,000 $ 3.58 5.42 $ - Exercisable at December 31, 2018 749,500 $ 3.74 5.71 $ - 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 (600,750 ) $ 3.50 5.00 $ - Expired during the period - - Canceled during the period (81,250 ) $ 3.26 4.41 $ - Exercised during the period - - Non-vested stock options outstanding at December 31, 2018 244,500 $ 3.05 4.53 $ - 471,764 shares of common stock were available for future issuance under the 2014 Plan as of December 31, 2018. As of December 31, 2018, the Company had unrecognized stock-based compensation expense of $511,335. $9,669 of this unrecognized expense will be recognized over the average remaining vesting term of the options of 0.10 years. $501,666 of this unrecognized expense vests upon the first CF patient doses with MS1819-SD anywhere in the world. This milestone is not considered probable at December 31, 2018.

Interest Expense

Interest Expense	12 Months Ended
	Dec. 31, 2018
Interest Expense [Abstract]
Interest Expense	During the years ended December 31, 2018 and 2017, the Company incurred $101,846 and $875,199, respectively, of interest expense. During the years ended December 31, 2018 and 2017, $97,837 and $871,051, respectively, of these amounts was in connection with the convertible notes issued by the Company in the form of accretion of original issue debt discount, amortization of debt discount related to the warrants, and beneficial conversion feature. During the years ended December 31, 2018 and 2017, the Company also incurred $4,010 and $4,148, respectively, of miscellaneous interest expense.

Agreements

Agreements	12 Months Ended
	Dec. 31, 2018
Agreements
Agreements	Mayoly Agreement On March 22, 2010, ProteaBio Europe SAS entered into a joint research and development agreement (the “JDLA” (“Mayoly” “INRA Agreement” (“INRA” (“CNRS” Effective January 1, 2014, ProteaBio Europe SAS entered into an amended and restated joint research and development agreement with Mayoly (the “Mayoly Agreement” ● devote sufficient personnel and facilities required for the performance of its assigned tasks; ● make available appropriately qualified personnel to supervise, analyze and report on the results obtained in the furtherance of the development program; and ● deploy such scientific, technical, financial and other resources as is necessary to conduct the development program. During the years ended December 31, 2018 and 2017, the Company was reimbursed $1,000,889 and $785,509, respectively, from Mayoly under the Mayoly Agreement. The Mayoly Agreement grants the ProteaBio Europe SAS the right to cure any breach by Mayoly of its obligations under the INRA agreement. In connection with the acquisition of ProteaBio Europe, ProteaBio Europe SAS, with the consent of INRA and CNRS, assigned all of it rights, title and interest in and to the Mayoly Agreement to the AzurRx SAS. The Mayoly Agreement includes a €1,000,000 payment due to Mayoly upon the U.S. FDA approval of MS1819-SD. At this time, based on management’s assessment of ASC Topic 450, Contingencies, the Company has not recorded any contingent liability related to this payment. See Note 21 - Subsequent Events for a description of the Asset Purchase Agreement executed by the Company and Mayoly in March 2019, which agreement terminated the JDLA. INRA Agreement In February 2006, Mayoly and INRA TRANSFERT, on behalf of INRA and CNRS, 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. See Note 21 - Subsequent Events for a description of the Asset Purchase Agreement executed by the Company and Mayoly in March 2019, pursuant to which the INRA Agreement was transferred from us to Mayoly. 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 provides for a term expiring January 2, 2019. Either party may terminate Mr. Spoor’s employment at any time and for any reason, or for no reason. During the term and for a period of twelve (12) months thereafter, Mr. Spoor shall not engage in competition with the Company either directly or indirectly, in any manner or capacity. The Company will pay Mr. Spoor a base salary of $350,000 per year, which automatically increased to $425,000 per year upon the consummation of the IPO which occurred on October 11, 2016. 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. In addition, subject to any required consents from third parties, Mr. Spoor shall be granted 100,000 shares of restricted common stock, which are to be issued as follows: (i) 50,000 restricted shares upon the first commercial sale in the United States of MS1819-SD, and (ii) 50,000 restricted shares upon the total market capitalization of the Company exceeding $1 billion dollars for 20 consecutive trading days, in each case subject to the earlier determination of a majority of the board of directors. In the event of a Change of Control (as defined in the agreement), all of the restricted shares shall vest in full. The estimated fair value at the date of grant was $210,000 and this amount was expensed in 2016. Subject to any required consents from third parties, Mr. Spoor shall also be entitled to 380,000 10-year stock options pursuant to the 2014 Plan, which options shall vest as follows so long as Mr. Spoor is serving as Chief Executive Officer or President at such time: (i) 100,000 of such stock options shall vest upon consummation of the IPO, (ii) 50,000 of such stock options shall vest upon the Company initiating a Phase II clinical trial in the United States for MS1819-SD (i.e., upon the first individual enrolled in the trial), (iii) 50,000 of such stock options shall vest upon the Company completing a Phase II clinical trial in the United States for MS1819-SD, (iv) 100,000 of such stock options shall vest upon the Company initiating a Phase III clinical trial in the United States for MS1819-SD, (v) 50,000 of such stock options shall vest upon the Company initiating a Phase I clinical trial in the United States for any product other than MS1819-SD, and (vi) 30,000 of such stock options shall vest upon the determination of a majority of the board of directors. On June 8, 2016, the board of directors clarified Mr. Spoor’s agreement as follows: the 380,000 options described have neither been granted nor priced since certain key provisions, particularly the underlying exercise price, have not been determined. The options will be granted at a future date to be determined by the board of directors, and the options will be priced at that future date when they are granted. 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 and the $425,000 was expensed in 2018 due to the Company completing both milestones listed above in 2018. 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. 16,667 of these shares vested and $50,667 was expensed in 2018 due to being earned over time in 2018. 33,333 of these shares vested and $101,332 was expensed in 2018 due to the FDA acceptance of the Company’s IND application for MS1819-SD in 2018. If the Company terminates Mr. Spoor’s employment other than for cause, or he terminates for good reason, as both terms are defined in the agreement, the Company will pay him twelve (12) months of his base salary as severance. If the Company terminates Mr. Spoor’s employment other than for cause, or he terminates for good reason, in connection with a Change of Control, the Company will pay him eighteen (18) months of his base salary in lump sum as severance. On September 29, 2017, the Board approved a 2016 annual incentive bonus equal to 40% of Mr. Spoor’s current base salary pursuant to his employment agreement in the amount of $170,000. On June 28, 2018, the Board approved a 2017 annual incentive bonus pursuant to his employment agreement in the amount of $212,500. 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 and the $336,500 was expensed in 2018 due to the Company completing both milestones listed above in 2018. 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 vested and $103,650 was expensed in 2018 due to the FDA acceptance of the Company’s IND application for MS1819-SD in 2018. On June 28, 2018, the Board approved a 2017 annual incentive bonus pursuant to his employment agreement in the amount of $82,500. 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.

Leases

Leases	12 Months Ended
	Dec. 31, 2018
Leases [Abstract]
Leases	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. Rental expense, which is calculated on a straight-line basis, amounted to $147,051 and $123,735, respectively, in the years ended December 31, 2018 and 2017. Minimum future annual rental payments are as follows: 2019 $ 201,370 2020 $ 153,017

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2018
Income Taxes
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 December 31, 2018 and 2017, the Company had no tax provision for either jurisdictions. The Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act” At December 31, 2018 and 2017, the Company had gross deferred tax assets of approximately $12,490,000 and $9,918,000, 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 $12,490,000 and $9,918,000, respectively, has been established at December 31, 2018 and 2017. The change in the valuation allowance in 2018 and 2017 was $2,572,000 and $2,043,000, respectively. The significant components of the Company’s net deferred tax assets consisted of: December 31, December 31, 2018 2017 Gross deferred tax assets: Net operating loss carry-forwards $ 12,019,000 $ 8,848,000 Temporary differences: Stock compensation 303,000 128,000 Accruals 124,000 913,000 Other 44,000 29,000 Deferred tax asset valuation allowance (12,490,000 ) (9,918,000 ) Net deferred tax asset $ - $ - Income taxes computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following: December 31, December 31, 2018 2017 Income taxes benefit (expense) at statutory rate 21 % 34 % State income tax 14 % 11 % Non-deductible expenses (6 %) (19 %) Change in valuation allowance (29 %) (26 %) 0 % 0 % At December 31, 2018, the Company has gross net operating loss (“ NOL Section 382 At December 31, 2018 and 2017, the Company had approximately $15,406,000 and $12,374,000, respectively, in net operating losses which it can carryforward indefinitely to offset against future French income. At December 31, 2018 and 2017, 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	12 Months Ended
	Dec. 31, 2018
Net Loss Per Common Share
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 December 31, 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, 416,000 shares of restricted stock not yet issued, and 994,000 shares of common stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. At December 31, 2017, diluted net loss per share did not include the effect of 3,371,385 shares of common stock issuable upon the exercise of outstanding warrants, 545,000 shares of common stock issuable upon the exercise of outstanding options, 185,000 shares of restricted stock not yet issued, and 100,000 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	12 Months Ended
	Dec. 31, 2018
Disclosure Text Block [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 From October 1, 2015 through December 31, 2015, the Company used the services of Edward Borkowski, a member of our Board of Directors and the Company’s Audit Committee Chair, as a financial consultant. Included in accounts payable at December 31, 2018 and 2017 is $0 and $90,000, respectively, for Mr. Borkowski’s services. 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. Expense recorded in G&A expense in the accompanying statements of operations related to Mr. Shenouda for the year ended December 31, 2017 was $80,000. Included in accounts payable at December 31, 2018 and 2017 is $50,000 and $70,000, respectively, for Mr. Shenouda’s services. On February 3, 2017, the Board granted 30,000 options each to Messrs. Borkowksi and Shenouda, and Dr. Riddell, with a total value of $348,210 of which $116,073 and $222,469, respectively, vested and was charged to expense in the years ended December 31, 2018 and 2017. During the year ended December 31, 2018, the Company recorded cash Board fees of $35,000 each for Mr. Borkowski, Dr. Riddell, Mr. Charles Casamento and Mr. Vern Schramm. During the year ended December 31, 2017, the Company recorded Board fees of $35,000 for Mr. Borkowski and Dr. Riddell; $25,000 for Mr. Shenouda; $30,000 for Mr. Charles Casamento; and $8,750 for Dr. Vern Schramm. During the year ended December 31, 2018, as part of Board compensation, the Company issued 30,000 shares of restricted common stock each to Mr. Borkowski, Dr. Riddell, Mr. Charles Casamento and Dr. Vern Schramm with a total value of $306,300 which was vested and charged to expense in the year ended December 31, 2018. During the year ended December 31, 2017, as part of Board compensation, the Company issued 30,000 shares of restricted common stock each to Messr. Borkowksi and Dr. Riddell; 22,500 shares of restricted common stock to Messr. Shenouda; 25,000 shares of restricted common stock to Mr. Casamento; and 7,500 shares to Dr. Schramm with a total value of $460,000 which was vested and charged to expense in the year ended December 31, 2017.

Employee Benefit Plans

Employee Benefit Plans	12 Months Ended
	Dec. 31, 2018
Retirement Benefits [Abstract]
Employee Benefit Plans	401(k) Plan The Company sponsors a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company. All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit sharing contributions. Employer contributions under this plan amounted to $40,901 and $23,207 for the years ended December 31, 2018 and 2017, respectively.

Subsequent Events

Subsequent Events	12 Months Ended
	Dec. 31, 2018
Subsequent Events [Abstract]
Subsequent Events	Private Note Offering 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 all 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 issuance of the Notes was exempt from the registration requirements of the Securities Act of 1933, as amended, in accordance with Section 4(a)(2) and/or Regulation 506 promulgated thereunder, as a transaction by an issuer not involving a public offering. First Dosing in our Phase II OPTION Study On February 20, 2019, the Company announced that it has dosed the first patients in the Company's Phase II OPTION study to investigate MS1819-SD in CF patients with exocrine pancreatic insufficiency. Pursuant to the vesting terms of the Company’s restricted stock and options granted, this will result in 58,333 shares of restricted stock vesting with a value of $178,852 and 242,000 options vesting with a value of $501,666 to be charged to expenses in the first quarter of 2019. Common Stock Issuance On March 12, 2019, the Company issued 27,102 shares of its common stock as payment for $45,000 included in accounts payable at December 31, 2018 and $15,000 of expense incurred during 2019. Asset Purchase Agreement with Mayoly On March 27, 2019, the Company entered into an Asset Purchase Agreement with Mayoly (the “ Mayoly APA 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 Director Shares On March 31, 2019, as part of Board compensation, the Company issued 7,500 shares of restricted common stock to each of Mr. Borkowski, Dr. Riddell, Mr. Casamento, and Dr. Schramm with a total value of $72,600.

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2018
Significant Accounting Policies Policies
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.
Concentration	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 December 31, 2018 and 2017, the Company had approximately $754,261 and $78,859, 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.
Property, Equipment, and Leasehold Improvements	Property, equipment and leasehold improvements are carried on the cost basis and depreciated over the estimated useful lives of the related assets using the straight-line method. For financial statement purposes, depreciation expense is provided using the straight-line method over the estimated useful lives of the assets as follows: ● Laboratory Equipment 5 years; ● Computer Equipment 5 years; ● Office Equipment 7-8 years; and ● Leasehold Improvements Term of lease or estimated useful life of the assets; whichever is shorter. Expenditures for maintenance and repairs are charged to operations as incurred while renewals and betterments are capitalized. At December 31, 2018 and 2017, there are no restrictions on the Company’s title of property, equipment, and leasehold improvements and no amounts have been pledged as security for liabilities.
Goodwill and Intangible Assets	Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through December 31, 2018. Intangible assets subject to amortization consist of in process research and development and license agreements reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows: ● In Process Research & Development 12 years; and ● License Agreements 5 years.
Research and Development	Research & development costs are charged to operations when incurred and are included in operating expenses. Research & 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.
Fair Value Measurements	The Company follows Accounting Standards Codification (“ASC” (“ASC 820” As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.
Stock-based Compensation	The Company’s board of directors and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan which took effect on May 12, 2014. The Company accounts for its stock-based compensation awards to employees and directors in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”
Equity-Based Payments to Non-Employees	In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, to expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services for nonemployees. The ASU is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted. As a result of the early adoption of this pronouncement, the Company measures these nonemployee awards at fair value on the grant date. The adoption of this pronouncement did not have a significant impact on the Company’s financial statements.
Income Taxes	Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740” The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At December 31, 2018 and 2017, the Company does not have any significant uncertain tax positions. All tax years are still open for audit.
Impairment of Long-lived Assets	The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360”
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.
Collaboration Agreements	As more fully discussed in Note 15, during the year ended December 31, 2018, the Company had joint research collaboration agreements with Laboratoires Mayoly Spindler SAS and INRA TRANSFERT. Any payments due from the Company’s collaboration partners are recorded as a reduction in research and development expenses.
Sublicense Agreement	As more fully discussed in Note 15, the Company entered into a Sublicense Agreement with TransChem, Inc. pursuant to which TransChem granted the Company an exclusive license to certain patents and patent applications. Any payments made to Transchem for this agreement will be recorded as research and development expenses.
Operating Leases	The Company recognizes rent expense from operating leases with various escalation clauses on a straight-line basis over the applicable lease term. The Company considers lease renewals in the useful life of its leasehold improvements when such renewals are reasonably assured.
Subsequent Events	The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements.
Recent Accounting Pronouncements	In July 2017, the FASB issued ASU 2017-11, Earnings per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815). ASU 2017-11 provides guidance on accounting for financial instruments with down round features and clarifies the deferral of certain provisions in Topic 480. ASU 2017-11 will become effective for annual periods beginning after December 15, 2018 and interim periods within those periods. Early adoption is permitted. The adoption of this pronouncement will not have an impact on the Company’s financial statements. 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. In February 2016, the FASB issued an ASU which requires lessees to recognize lease assets and lease liabilities arising from operating leases on the balance sheet. This ASU is effective for annual and interim reporting periods beginning after December 15, 2018 using a modified retrospective approach, with early adoption permitted. The Company believes that the adoption of this pronouncement will not have a material impact on the Company's financial statements. The Company believes that the most significant changes relate to the recognition of new right-of-use assets and lease liabilities on the balance sheet for office space and research facilities amounting to approximately $344,000.

Significant Accounting Polici_3

Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2018
Significant Accounting Policies Tables
Property, equipment and leasehold improvements	Laboratory Equipment 5 years Computer Equipment 5 years Office Equipment 7-8 years Leasehold Improvements Term of lease or estimated useful life of the assets; whichever is shorter
Goodwill and Intangible Assets	In Process Research & Development 12 years License Agreements 5 years

Fair Value Disclosures (Tables)

Fair Value Disclosures (Tables)	12 Months Ended
	Dec. 31, 2018
Fair Value Disclosures Tables
Financial instruments at fair value on a recurring basis	Fair Value Measurements at Reporting Date Using Total Level 1 Level 2 Level 3 At December 31, 2017: Contingent consideration $ 1,340,000 $ - $ - $ 1,340,000
Fair value of liabilities using Level 3 significant unobservable inputs	Contingent Consideration Balance at December 31, 2016 $ 1,200,000 Change in fair value 140,000 Balance at December 31, 2017 1,340,000 Change in fair value 210,000 Purchase of Protea assets in bankruptcy (1,550,000 ) Balance at December 31, 2018 $ -
Fair value of the Company's financial instruments	Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value 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 At December 31, 2017: Cash $ 573,471 $ - $ 573,471 $ - $ 573,471 Other receivables $ 1,104,134 $ - $ - $ 1,104,134 $ 1,104,134 Note payable $ 159,180 $ - $ - $ 159,180 $ 159,180 Convertible debt $ 257,365 $ - $ - $ 387,201 $ 387,201

Other Receivables (Tables)

Other Receivables (Tables)	12 Months Ended
	Dec. 31, 2018
Other Receivables Tables
Other receivables	December 31, December 31, 2018 2017 R&D tax credits $ 2,162,373 $ 954,897 Other 1,010,303 149,237 Total other receivables $ 3,172,676 $ 1,104,134

Property, Equipment, and Leas_2

Property, Equipment, and Leasehold Improvements (Tables)	12 Months Ended
	Dec. 31, 2018
Property Equipment And Leasehold Improvements Tables
Property, equipment and leasehold improvements	December 31, December 31, 2018 2017 Laboratory equipment $ 190,406 $ 165,611 Computer equipment 75,417 44,364 Office equipment 37,262 36,334 Leasehold improvements 29,163 29,163 Total property, plant and equipment 332,248 275,472 Less accumulated depreciation (203,394 ) (141,485 ) Property, plant and equipment, net $ 128,854 $ 133,987

Intangible Assets and Goodwill

Intangible Assets and Goodwill (Tables)	12 Months Ended
	Dec. 31, 2018
Intangible Assets And Goodwill Tables
Intangible assets	December 31, December 31, 2018 2017 In process research and development $ 416,600 $ 436,385 Less accumulated amortization (157,671 ) (128,794 ) In process research and development, net $ 258,929 $ 307,591 License agreements $ 3,398,702 $ 3,560,107 Less accumulated amortization (3,087,154 ) (2,521,743 ) License agreements, net $ 311,548 $ 1,038,364
Future amortization expense	2019 $ 346,264 2020 34,717 2021 34,717 2022 34,717 2023 34,717
Goodwill	Goodwill Balance at January 1, 2017 $ 1,767,550 Foreign currency translation 248,690 Balance at December 31, 2017 2,016,240 Foreign currency translation (91,410 ) Balance at December 31, 2018 $ 1,924,830

Accounts Payable and Accrued _2

Accounts Payable and Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2018
Accounts Payable Tables
Accounts payable and accrued expenses	December 31, December 31, 2018 2017 Trade payables $ 1,532,110 $ 705,041 Accrued expenses 285,061 262,200 Accrued payroll 253,225 219,993 Total accounts payable and accrued expenses $ 2,070,396 $ 1,187,234

Original Issue Discounted Con_2

Original Issue Discounted Convertible Notes (Tables)	12 Months Ended
	Dec. 31, 2018
Original Issue Discounted Convertible Notes Tables
Convertible debt	December 31, 2017 Convertible debt $ 352,713 Accreted OID interest 34,488 Unamortized debt discount - warrants (129,836 ) Total convertible debt $ 257,365

Warrants (Tables)

Warrants (Tables)	12 Months Ended
	Dec. 31, 2018
Warrants Tables
Stock warrant transactions	Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable at January 1, 2017 1,858,340 $ 4.76 - $7.37 $ 5.66 Granted during the period 2,205,080 $ 3.17 - $6.50 $ 5.02 Expired during the period (263,607 ) $ 4.00 $ 4.00 Exercised during the period (428,428 ) $ 2.50 $ 2.50 Warrants outstanding and exercisable at December 31, 2017 3,371,385 $ 3.17 - $7.37 $ 5.28 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 December 31, 2018 3,112,715 $ 2.55 - $7.37 $ 4.83
Warrants by exercise price	Number of Weighted Average Weighted Shares Under Remaining Contract Average Exercise Price Warrants Life in Years Exercise Price $ 2.55 - $3.99 881,372 3.60 $ 4.00 - $4.99 196,632 3.01 $ 5.00 - $5.99 1,815,041 2.96 $ 6.00 - $6.99 187,750 2.76 $ 7.00 - $7.37 31,920 1.96 Total 3,112,715 3.12 $4.83
Warrants, weighted average assumptions	December 31, December 31, 2018 2017 Expected life (in years) 5 5 Volatility 84 % 73 - 90 % Risk-free interest rate 2.70 % 1.82% - 2.05 % Dividend yield - % - %

Stock-Based Compensation Plan (

Stock-Based Compensation Plan (Tables)	12 Months Ended
	Dec. 31, 2018
Stock-based Compensation Plan Tables
Share-based payment weighted average assumptions	December 31, December 31, 2018 2017 Expected life (in years) 5 5 - 10 Volatility 85 % 71% - 90 % Risk-free interest rate 2.82 % 1.78% - 2.48 % Dividend yield - % - %
Stock option activity	Number Average Remaining Contract Intrinsic of Shares Exercise Price Life in Years Value Stock options outstanding at January 1, 2017 - - Granted during the period 545,000 $ 4.05 7.13 $ - Expired during the period - - Exercised during the period - - Stock options outstanding at December 31, 2017 545,000 $ 4.05 7.13 $ - Exercisable at December 31, 2017 157,500 $ 4.48 9.10 $ - Non-vested stock options outstanding at January 1, 2017 - - Granted during the period 387,500 $ 3.89 6.39 $ - Expired during the period - - Exercised during the period - - Non-vested stock options outstanding at December 31, 2017 387,500 $ 3.89 6.39 $ - 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 - - Canceled during the period (90,000 ) $ 3.26 4.41 $ - Exercised during the period - - Stock options outstanding at December 31, 2018 994,000 $ 3.58 5.42 $ - Exercisable at December 31, 2018 749,500 $ 3.74 5.71 $ - 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 (600,750 ) $ 3.50 5.00 $ - Expired during the period - - Canceled during the period (81,250 ) $ 3.26 4.41 $ - Exercised during the period - - Non-vested stock options outstanding at December 31, 2018 244,500 $ 3.05 4.53 $ -

Leases (Tables)

Leases (Tables)	12 Months Ended
	Dec. 31, 2018
Leases [Abstract]
Minimum future annual rental payments	2019 $ 201,370 2020 $ 153,017

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2018
Income Taxes Tables
Deferred tax assets (liabilities)	December 31, December 31, 2018 2017 Gross deferred tax assets: Net operating loss carry-forwards $ 12,019,000 $ 8,848,000 Temporary differences: Stock compensation 303,000 128,000 Accruals 124,000 913,000 Other 44,000 29,000 Deferred tax asset valuation allowance (12,490,000 ) (9,918,000 ) Net deferred tax asset $ - $ -
Income tax reconciliation	December 31, December 31, 2018 2017 Income taxes benefit (expense) at statutory rate 21 % 34 % State income tax 14 % 11 % Non-deductible expenses (6 %) (19 %) Change in valuation allowance (29 %) (26 %) 0 % 0 %

The Company and Basis of Pres_2

The Company and Basis of Presentation (Details Narrative)	12 Months Ended
	Dec. 31, 2018
Company And Basis Of Presentation Details Narrative
State of incorporation	Delaware
Date of incorporation	Jan. 30, 2014

Significant Accounting Polici_4

Significant Accounting Policies (Details)	12 Months Ended
	Dec. 31, 2018
Laboratory Equipment
Property, equipment, and leasehold improvements useful life	5 years
Computer Equipment
Property, equipment, and leasehold improvements useful life	5 years
Office Equipment | Minimum
Property, equipment, and leasehold improvements useful life	7 years
Office Equipment | Maximum
Property, equipment, and leasehold improvements useful life	8 years
Leasehold Improvements
Leasehold improvements useful life	Term of lease or estimated useful life of the assets; whichever is shorter

Significant Accounting Polici_5

Significant Accounting Policies (Details 1)	12 Months Ended
	Dec. 31, 2018
In Process Research and Development
Intangible asset, useful life	12 years
License Agreements
Intangible asset, useful life	5 years

Significant Accounting Polici_6

Significant Accounting Policies (Details Narrative) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Significant Accounting Policies Details Narrative
Prepaid expenses	$ 512,982	$ 274,963

Fair Value Disclosures (Details

Fair Value Disclosures (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Contingent Consideration	$ 0	$ 1,340,000
Level 1
Contingent Consideration	0	1,340,000
Level 2
Contingent Consideration	0	0
Level 3
Contingent Consideration	$ 0	$ 0

Fair Value Disclosures (Detai_2

Fair Value Disclosures (Details 1) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Significant Accounting Policies Details 3
Warrant liability, beginning	$ 1,340,000	$ 1,200,000
Change in fair value	210,000	140,000
Purchase of Protea assets in bankruptcy	(1,550,000)
Warrant liability, ending	$ 0	$ 1,340,000

Fair Value Disclosures (Detai_3

Fair Value Disclosures (Details 2) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Cash	$ 1,114,343	$ 573,471	$ 1,773,525
Other receivables	3,172,676	1,104,134
Notes Payable	255,032	159,180
Convertible debt	0	257,365
Level 1
Cash	0	0
Other receivables	0	0
Notes Payable	0	0
Convertible debt		0
Level 2
Cash	1,114,343	573,471
Other receivables	0	0
Notes Payable	0	0
Convertible debt		0
Level 3
Cash	0	0
Other receivables	3,172,676	1,104,134
Notes Payable	$ 255,032	159,180
Convertible debt		$ 387,201

Other Receivables (Details)

Other Receivables (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Other Receivables Details
R&D tax credits	$ 2,162,373	$ 954,897
Other	1,010,303	149,237
Other receivables	$ 3,172,676	$ 1,104,134

Property, Equipment, and Leas_3

Property, Equipment, and Leasehold Improvements (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Property, equipment and leasehold improvements, gross	$ 332,248	$ 275,472
Less accumulated depreciation	(203,394)	(141,485)
Property, equipment and leasehold improvements, net	128,854	133,987
Laboratory Equipment
Property, equipment and leasehold improvements, gross	190,406	165,611
Computer Equipment
Property, equipment and leasehold improvements, gross	75,417	44,364
Office Equipment
Property, equipment and leasehold improvements, gross	37,262	36,334
Leasehold Improvements
Property, equipment and leasehold improvements, gross	$ 29,163	$ 29,163

Property, Equipment, and Leas_4

Property, Equipment, and Leasehold Improvements (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Property Equipment And Leasehold Improvements Details Narrative
Depreciation expense	$ 61,909	$ 49,520

Intangible Assets and Goodwil_2

Intangible Assets and Goodwill (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
In Process Research and Development
Intangible assets, gross	$ 416,600	$ 436,385
Less accumulated amortization	(157,671)	(128,794)
Intangible assets, net	258,929	307,591
License Agreements
Intangible assets, gross	3,398,702	3,560,107
Less accumulated amortization	(3,087,154)	(2,521,743)
Intangible assets, net	$ 311,548	$ 1,038,364

Intangible Assets and Goodwil_3

Intangible Assets and Goodwill (Details 1)	Dec. 31, 2018USD ($)
Amortization expense
2019	$ 346,264
2020	34,717
2021	34,717
2022	34,717
2023	$ 34,717

Intangible Assets and Goodwil_4

Intangible Assets and Goodwill (Details 2) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Intangible Assets And Goodwill Details 1
Goodwill, beginning	$ 2,016,240	$ 1,767,550
Foreign currency translation	(91,410)	248,690
Goodwill, ending	$ 1,924,830	$ 2,016,240

Intangible Assets and Goodwil_5

Intangible Assets and Goodwill (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Intangible Assets And Goodwill Details Narrative
Amortization expense	$ 736,537	$ 704,478

Accounts Payable and Accrued _3

Accounts Payable and Accrued Expenses (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Accounts Payable Details
Trade payables	$ 1,532,110	$ 705,041
Accrued expenses	285,061	262,200
Accrued payroll	253,225	219,993
Accounts payable, net	$ 2,070,396	$ 1,187,234

Original Issue Discounted Con_3

Original Issue Discounted Convertible Notes (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Original Issue Discounted Convertible Notes Details
Convertible Debt		$ 352,713
Accreted OID interest		34,488
Unamortized debt discount - warrants		(129,836)
Total convertible debt	$ 0	$ 257,365

Original Issue Discounted Con_4

Original Issue Discounted Convertible Notes (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Original Issue Discounted Convertible Notes Details Narrative
Warrant liability	$ 0	$ 1,340,000	$ 1,200,000
Interest expense related to the original issue discount and warrant features	$ 97,837	$ 871,051

Equity (Details Narrative)

Equity (Details Narrative) - $ / shares	Dec. 31, 2018	Dec. 31, 2017
Equity Details Narrative
Preferred stock shares, par value	$ 0.0001	$ 0.0001
Preferred stock shares, authorized	10,000,000	10,000,000
Common stock shares, par value	$ 0.0001	$ 0.0001
Common stock shares, authorized	100,000,000	100,000,000
Common stock shares, issued	17,704,925	12,042,574
Common stock shares, outstanding	17,704,925	12,042,574

Warrants (Details)

Warrants (Details) - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Warrants issued and exercisable, beginning	3,371,385	1,858,340
Granted	244,400	2,205,080
Expired	0	(263,607)
Exercised	(503,070)	(428,428)
Warrants issued and exercisable, ending	3,112,715	3,371,385
Exercise price per share, Expired	$ 0	$ 4
Exercise price per share, Exercised	2.50	2.50
Weighted average exercise price, beginning	5.28	5.66
Weighted average exercise price, Granted	2.58	5.02
Weighted average exercise price warrants, Expired	0	4
Weighted average exercise price warrants, Exercised	2.5	2.5
Weighted average exercise price, ending	4.83	5.28
Minimum
Exercise price per share, beginning	3.17	4.76
Exercise price per share, Granted	2.55	3.17
Exercise price per share, ending	2.55	3.17
Maximum
Exercise price per share, beginning	7.37	7.37
Exercise price per share, Granted	2.75	6.50
Exercise price per share, ending	$ 7.37	$ 7.37

Warrants (Details 1)

Warrants (Details 1)	12 Months Ended
	Dec. 31, 2018$ / sharesshares
Number of shares under warrants | shares	3,112,715
Weighted average remaining contract life in years	3 years 1 month 13 days
Weighted average exercise price	$ 4.83
Warrant 1
Exercise price, minimum	2.55
Exercise price, maximum	$ 3.99
Number of shares under warrants | shares	881,372
Weighted average remaining contract life in years	3 years 7 months 6 days
Warrant 2
Exercise price, minimum	$ 4
Exercise price, maximum	$ 4.99
Number of shares under warrants | shares	196,632
Weighted average remaining contract life in years	3 years 4 days
Warrant 3
Exercise price, minimum	$ 5
Exercise price, maximum	$ 5.99
Number of shares under warrants | shares	1,815,041
Weighted average remaining contract life in years	2 years 11 months 16 days
Warrant 4
Exercise price, minimum	$ 6
Exercise price, maximum	$ 6.99
Number of shares under warrants | shares	187,750
Weighted average remaining contract life in years	2 years 9 months 4 days
Warrant 5
Exercise price, minimum	$ 7
Exercise price, maximum	$ 7.37
Number of shares under warrants | shares	31,920
Weighted average remaining contract life in years	1 year 11 months 16 days

Warrants (Details 2)

Warrants (Details 2)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Expected life (in years)	5 years
Volatility	85.00%
Risk-free interest rate	2.82%
Dividend yield	0.00%	0.00%
Minimum
Expected life (in years)		5 years
Volatility		71.00%
Risk-free interest rate		1.78%
Maximum
Expected life (in years)		10 years
Volatility		90.00%
Risk-free interest rate		2.48%
Warrants
Expected life (in years)	5 years	5 years
Volatility	84.00%
Dividend yield	0.00%	0.00%
Warrants | Minimum
Volatility		73.00%
Risk-free interest rate		1.82%
Warrants | Maximum
Volatility		90.00%
Risk-free interest rate		2.05%

Stock-Based Compensation Plan_2

Stock-Based Compensation Plan (Details)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Expected life (in years)	5 years
Volatility	85.00%
Risk-free interest rate	2.82%
Dividend yield	0.00%	0.00%
Minimum
Expected life (in years)		5 years
Volatility		71.00%
Risk-free interest rate		1.78%
Maximum
Expected life (in years)		10 years
Volatility		90.00%
Risk-free interest rate		2.48%

Stock-Based Compensation Plan_3

Stock-Based Compensation Plan (Details 1) - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Number of Options Outstanding, Beginning Balance	545,000	0
Number of Options, Granted	539,000	545,000
Number of Options, Exercised	0	0
Number of Options, Canceled	(90,000)
Number of Options, Forfeited	0	0
Number of Options Outstanding, Ending Balance	994,000	545,000
Number of Options Exercisable, Ending Balance	749,500	157,500
Weighted-Average Exercise Price Outstanding, Beginning Balance	$ 4.48	$ 0
Weighted-Average Exercise Price, Granted	3.04	4.05
Weighted-Average Exercise Price, Exercised	0	0
Weighted-Average Exercise Price, Canceled	3.26	0
Weighted-Average Exercise Price, Forfeited	0	4.05
Weighted-Average Exercise Price Outstanding, Ending Balance	3.58	$ 4.48
Weighted-Average Exercise Price Exercisable, Ending Balance	$ 3.74
Weighted-Average Remaining Contractual Term, Granted	5 years	7 years 1 month 17 days
Weighted-Average Remaining Contractual Term, Canceled	4 years 4 months 28 days
Weighted-Average Remaining Contractual Term, Outstanding Ending Balance	5 years 5 months 1 day	7 years 1 month 17 days
Weighted-Average Remaining Contractual Term, Exercisable Ending Balance	5 years 8 months 16 days	9 years 1 month 6 days
Nonvested
Number of Options Outstanding, Beginning Balance	387,500	0
Number of Options, Granted	539,000	387,500
Number of Options, Expired	(600,750)	0
Number of Options, Exercised	0	0
Number of Options, Canceled	(81,250)
Number of Options, Forfeited	0
Number of Options Outstanding, Ending Balance	244,500	387,500
Number of Options Exercisable, Ending Balance		545,000
Weighted-Average Exercise Price Outstanding, Beginning Balance	$ 3.89	$ 0
Weighted-Average Exercise Price, Granted	3.04	3.89
Weighted-Average Exercise Price, Vested	3.5
Weighted-Average Exercise Price, Expired	0	0
Weighted-Average Exercise Price, Exercised	0	0
Weighted-Average Exercise Price, Canceled	3.26
Weighted-Average Exercise Price Outstanding, Ending Balance	$ 3.05	$ 3.89
Weighted-Average Remaining Contractual Term, Outstanding Beginning Balance	6 years 4 months 20 days
Weighted-Average Remaining Contractual Term, Granted	5 years	6 years 4 months 20 days
Weighted-Average Remaining Contractual Term, Vested	5 years
Weighted-Average Remaining Contractual Term, Canceled	4 years 4 months 28 days
Weighted-Average Remaining Contractual Term, Outstanding Ending Balance	4 years 6 months 11 days	6 years 4 months 20 days

Interest Expense (Details Narra

Interest Expense (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Interest expense	$ 101,846	$ 875,199
Convertible Notes [Member]
Interest expense	97,837	871,051
Miscellaneous Interest Expense [Member]
Interest expense	$ 4,010	$ 4,148

Leases (Details)

Leases (Details)	Dec. 31, 2018USD ($)
Leases [Abstract]
2019	$ 201,370
2020	$ 153,017

Income Taxes (Details)

Income Taxes (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Gross deferred tax assets:
Net operating loss carry-forwards	$ 12,019,000	$ 8,848,000
Stock compensation	303,000	128,000
Accruals	124,000	913,000
Other	44,000	29,000
Deferred tax asset valuation allowance	(12,490,000)	(9,918,000)
Net deferred tax asset	$ 0	$ 0

Income Taxes (Details 1)

Income Taxes (Details 1)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Income Taxes Details 1
Income taxes benefit (expense) at statutory rate	21.00%	34.00%
State income tax, net of federal benefit	14.00%	11.00%
Non-deductible expenses	(6.00%)	(19.00%)
Change in valuation allowance	(29.00%)	(26.00%)
Total	0.00%	0.00%

Income Taxes (Details Narrative

Income Taxes (Details Narrative) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Deferred tax asset valuation allowance	$ (12,490,000)	$ (9,918,000)
Federal
Net operating loss carry-forwards	15,406,000
State
Net operating loss carry-forwards	$ 12,374,000

Related Party Transactions (Det

Related Party Transactions (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
General & administrative expenses	$ 8,236,218	$ 7,685,706
Accounts payable	2,070,396	1,187,234
Mr. Shenouda [Member]
General & administrative expenses		80,000
Accounts payable	$ 50,000	$ 70,000