Entero Therapeutics (ENTO) 10-Q 15 May 20 2020 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2020	May 14, 2020
Document and Entity Information
Entity Registrant Name	AzurRx BioPharma, Inc.
Document Type	10-Q
Document Period End Date	Mar. 31, 2020
Amendment Flag	false
Entity Central Index Key	0001604191
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		28,202,850
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Small Business	true
Entity Shell Company	false
Entity Current Reporting Status	Yes
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q1
Entity Interactive Data Current	Yes
Entity Incorporation State Country Code	DE
Entity File Number	001-37853

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Current Assets:
Cash	$ 1,630,007	$ 175,796
Other receivables	760,232	2,637,303
Prepaid expenses	507,197	595,187
Total Current Assets	2,897,436	3,408,286
Property, equipment, and leasehold improvements, net	73,547	77,391
Other Assets:
Patents, net	3,275,197	3,407,084
Goodwill	1,844,006	1,886,686
Operating lease right-of-use assets	53,399	82,386
Deposits	40,727	41,047
Total Other Assets	5,213,329	5,417,203
Total Assets	8,184,312	8,902,880
Current Liabilities:
Accounts payable and accrued expenses	1,039,219	1,754,682
Accounts payable and accrued expenses - related party	396,853	533,428
Notes payable	279,616	444,364
Convertible debt	2,986,328	1,076,938
Other current liabilities	441,173	476,224
Total Current Liabilities	5,143,189	4,285,636
Total Liabilities	5,143,189	4,285,636
Stockholders' Equity:
Convertible preferred stock 0 Par value $0.0001 per share; 10,000,000 shares authorized and 0 shares issued and outstanding at March 31, 2019 and December 31, 2018; liquidation preference approximates par value	0	0
Common stock 0 Par value $0.0001 per share; 100,000,000 shares authorized; 27,1157,651 and 26,800,519 shares issued and outstanding, respectively, at March 31, 2020 and December 31, 2019	2,716	2,680
Additional paid in capital	72,103,490	68,575,851
Accumulated deficit	(67,956,022)	(62,694,732)
Accumulated other comprehensive loss	(1,109,061)	(1,266,555)
Total Stockholders' Equity	3,041,123	4,617,244
Total Liabilities and Stockholders' Equity	$ 8,184,312	$ 8,902,880

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Preferred stock shares, par value	$ .0001	$ 0.0001
Preferred stock shares, authorized	10,000,000	10,000,000
Preferred stock shares, issued	0	0
Preferred stock shares, outstanding	0	0
Common stock shares, par value	$ .0001	$ 0.0001
Common stock shares, authorized	100,000,000	100,000,000
Common stock shares, issued	27,157,651	26,800,519
Common stock shares, outstanding	27,157,651	26,800,519

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Income Statement [Abstract]
Research and development expenses	$ 1,553,360	$ 3,009,676
General and administrative expenses	1,375,091	1,593,968
Loss from operations	(2,928,451)	(4,603,644)
Other:
Interest expense	(2,332,839)	(57,111)
Total other	(2,332,839)	(57,111)
Loss before income taxes	(5,261,290)	(4,660,755)
Income taxes	0	0
Net loss	(5,261,290)	(4,660,755)
Other comprehensive loss:
Foreign currency translation adjustment	157,494	(95,281)
Total comprehensive loss	$ (5,103,796)	$ (4,756,036)
Basic and diluted weighted average shares outstanding	26,941,803	17,719,902
Loss per share - basic and diluted	$ (.20)	$ (0.26)

Consolidated Statements of Chan

Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($)	Convertible Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Loss	Total
Beginning balance, Shares at Dec. 31, 2018	0	17,704,925
Beginning balance, Amount at Dec. 31, 2018	$ 0	$ 1,771	$ 5,139,259	$ (47,517,046)	$ (1,150,112)	$ 4,473,872
Common stock issued to settle accounts payable, amount						0
Common stock issued to consultants, Shares		27,102
Common stock issued to consultants, Amount		$ 2	59,998			60,000
Common stock issued Mayoly for patents, Shares		775,931
Common stock issued Mayoly for patents, Amount		$ 77	1,740,882			1,740,959
Stock-based compensation			511,335			511,335
Restricted stock granted to employees/directors, Shares		30,000
Restricted stock granted to employees/directors, Amount		$ 3	296,282			296,282
Warrant modification			325,320			325,320
Received from stockholder in relation to warrant modification			61,590			61,590
Foreign currency translation adjustment					(95,281)	(95,281)
Net loss				(4,660,756)		(4,660,755)
Ending balance, Shares at Mar. 31, 2019	0	18,537,958
Ending balance, Amount at Mar. 31, 2019	$ 0	$ 1,853	56,134,666	(52,177,801)	(1,245,393)	2,713,325
Beginning balance, Shares at Dec. 31, 2019	0	26,800,519
Beginning balance, Amount at Dec. 31, 2019	$ 0	$ 2,680	68,575,851	(62,694,732)	(1,266,555)	4,617,244
Common stock issued to settle accounts payable, shares		105,937
Common stock issued to settle accounts payable, amount		$ 11	131,126			131,137
Common stock issued to consultants, Shares		101,195
Common stock issued to consultants, Amount		$ 10	87,095			87,105
Common stock issued to Lincoln Park for Equity Purchase Agreement, shares		150,000
Common stock issued to Lincoln Park for Equity Purchase Agreement, amount		$ 15	143,985			144,000
Warrants issued in association with convertible debt issuances			1,252,558			1,252,558
Beneficial conversion feature on convertible debt issuances			1,838,422			1,838,422
Common stock issued Mayoly for patents, Amount						0
Stock-based compensation			74,453			74,453
Received from stockholder in relation to warrant modification						0
Foreign currency translation adjustment					718,002	157,494
Net loss				(5,261,290)		(5,261,290)
Ending balance, Shares at Mar. 31, 2020	0	27,157,651
Ending balance, Amount at Mar. 31, 2020	$ 0	$ 2,716	$ 72,103,490	$ (67,956,022)	$ (1,109,061)	$ 3,041,123

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Cash flows from operating activities:
Net loss	$ (5,261,290)	$ (4,660,755)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	9,661	17,114
Amortization	131,149	561,289
Non-cash lease expense	6,065	1,030
Stock-based compensation	54,950	511,335
Common stock issued to settle related party accounts payable	131,137	0
Restricted stock granted to employees/directors	19,503	296,285
Restricted stock granted to consultants	87,105	60,000
Accrued interest on convertible debt	164,281	24,658
Accretion of debt discount	2,059,086	29,104
Changes in assets and liabilities, net of effects of acquisition:
Other receivables	2,064,252	(149,508)
Prepaid expenses	87,906	172,886
Deposits	0	(4,125)
Accounts payable and accrued expenses	(832,955)	514,950
Net cash used in operating activities	(1,291,280)	(2,627,797)
Cash flows from investing activities:
Purchase of property and equipment	(4,340)	(13,352)
Net cash used in investing activities	(4,340)	(13,352)
Cash flows from financing activities:
Proceeds issuances of common stock, net	144,000	0
Proceeds issuances of convertible debt, net	3,227,002	2,000,000
Received from stockholder in relation to warrant modification	0	61,590
Repayments of convertible debt	(450,000)	0
Repayments of notes payable	(164,748)	(94,448)
Net cash provided by financing activities	2,756,254	1,967,142
Increase (decrease) in cash	1,460,634	(674,007)
Effect of exchange rate changes on cash	(6,423)	(26,478)
Cash, beginning balance	175,796	1,114,343
Cash, ending balance	1,630,007	413,858
Supplemental disclosures of cash flow information:
Cash paid for interest	104,153	3,933
Cash paid for income taxes	0	0
Non-cash investing and financing activities:
Common stock issued for patents purchased from Mayoly	0	1,740,959
Warrant modification related to convertible debt issuance	$ 0	$ 325,320

The Company and Basis of Presen

The Company and Basis of Presentation	3 Months Ended
	Mar. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
The Company and Basis of Presentation	The Company AzurRx BioPharma, Inc. (“ AzurRx Parent ProteaBio Europe SAS ABS Company The Company is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. Non-systemic biologics are non-absorbable drugs that act locally, i.e. the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. The Company is currently focused on developing its lead drug product candidate, MS1819, EPI CF CP Ongoing and Planned Clinical Studies MS1819 – Phase 2b OPTION 2 Cystic Fibrosis Monotherapy Study On October 17, 2019, the Company announced that the Cystic Fibrosis Foundation Data Safety Monitoring Board (the “ CFF DSMB OPTION 2 Trial The OPTION 2 Trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head manner versus the current standard of care, porcine pancreatic enzyme replacement therapy (PERT) pills. The OPTION 2 Trial will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled. MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption (CFA). Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety. The Company expects to initiate the OPTION 2 Trial by the end of the second quarter of 2020, with target enrollment completion in the fourth quarter of 2020 and study completion anticipated in the first quarter of 2021, however, these timelines may be delayed due to the novel coronavirus (" COVID-19 MS1819 – Phase 2 Combination Therapy Study In addition to the monotherapy studies, the Company launched a Phase 2 multi-center clinical trial (the “ Combination Trial On October 15, 2019, the Company announced that it dosed the first patients in its Combination Trial in Hungary. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, at clinical trial sites in Hungary and additional countries in Europe including Spain and possibly Turkey. Study completion was originally anticipated by the end of 2020; however, this timeline has been delayed due to the COVID-19 pandemic and topline results are now expected in the first quarter of 2021. Basis of Presentation and Principles of Consolidation The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“ U.S. GAAP (“SEC” The unaudited interim consolidated financial statements include the accounts of AzurRx and its wholly-owned subsidiary, AzurRx SAS. Intercompany transactions and balances have been eliminated upon consolidation. Going Concern Uncertainty The accompanying unaudited interim consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception, had negative working capital at March 31, 2020 of approximately $2.2 million, and had an accumulated deficit of approximately $67.9 million at March 31, 2020. The Company is dependent on obtaining, and continues to pursue, additional working capital funding from the sale of securities and debt in order to continue to execute its development plan and continue operations. Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. We will need to raise additional capital through additional equity and/or debt financings, including utilization of our LPC Equity Line of Credit (see Note 11), in order to fund our ongoing operations and to satisfy our obligations under our convertible debt (see Note 9), and the impact of the COVID-19 pandemic which is evolving rapidly could negatively impact our ability to raise additional capital and our ability to repay, extend or restructure our convertible debt.

Significant Accounting Policies

Significant Accounting Policies and Recent Accounting Pronouncements	3 Months Ended
	Mar. 31, 2020
Accounting Policies [Abstract]
Significant Accounting Policies and Recent Accounting Pronouncements	Use of Estimates The accompanying unaudited 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. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash balances were highly liquid at March 31, 2020 and December 31, 2019, respectively. Concentrations of Credit Risk 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 March 31, 2020 and December 31, 2019, the Company had $236,568 and $0, 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 mitigates its risk by maintaining the majority of its cash and cash equivalents with high quality financial institutions. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. Debt Instruments Detachable warrants issued in conjunction with debt are measured at their relative fair value, if they are determined to be equity instrument, or their fair value, if they are determined to be liability instruments, and recorded as a debt discount. Conversion features that are in the money at the commitment date constitute a beneficial conversion feature that is measured at its intrinsic value and recognized as debt discount. Debt discount is amortized as interest expense over the maturity period of the debt using the effective interest method. Contingent beneficial conversion features are recognized when the contingency has been resolved. Debt Issuance Costs Debt issuance costs are recorded as a direct reduction of the carrying amount of the related debt. Debt issuance costs are amortized over the maturity period of the related debt instrument using the effective interest method. Equity-Based Payments to Non-Employees Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. 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. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. 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 stockholders’ equity. 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 March 31, 2020. Intangible assets subject to amortization consist of in process research and development, license agreements, and patents 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: Patents 7.2 years In Process Research & Development 12 years License Agreements 5 years 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” 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 March 31, 2020 and December 31, 2019, the Company does not have any significant uncertain tax positions. All tax years are still open for audit. Leases “ASU” Effective January 1, 2019, the Company adopted Accounting Standards Update ( “ASU” Research and Development Research and development (“ R&D Stock-Based Compensation The Company’s board of directors (the “ Board (“ASC 718” For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. Sublicense Agreement As more fully discussed in Note 14, the Company entered into a sublicense agreement with TransChem, Inc. (“ TransChem 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 January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other, Simplifying the Accounting for Goodwill Impairment. ASU 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. All other goodwill impairment guidance will remain largely unchanged. Entities will continue to have the option to perform a qualitative assessment to determine if a quantitative impairment test is necessary. This new guidance will be applied prospectively and is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. This ASU, which the Company adopted as of January 1, 2020, did not have a material effect on the Company’s consolidated financial statements.

Fair Value Disclosures

Fair Value Disclosures	3 Months Ended
	Mar. 31, 2020
Fair Value Disclosures [Abstract]
Fair Value Disclosures	Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. The fair value of the Company's financial instruments are as follows: Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value At March 31, 2020: Cash $ 1,630,007 $ - $ 1,630,007 $ - $ 1,630,007 Other receivables $ 760,232 $ - $ - $ 760,232 $ 760,232 Note payable $ 279,616 $ - $ - $ 279,616 $ 279,616 Convertible debt $ 2,986,328 $ - $ - $ 2,986,328 $ 2,986,328 At December 31, 2019: Cash $ 175,796 $ - $ 175,796 $ - $ 175,796 Other receivables $ 2,637,303 $ - $ - $ 2,637,303 $ 2,637,303 Note payable $ 444,364 $ - $ - $ 444,364 $ 444,364 Convertible debt $ 1,076,938 $ - $ - $ 1,076,938 $ 1,076,938 At March 31, 2020, 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. At December 31, 2019, 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. The fair value of the note payable in connection with the financing of directors and officer’s liability insurance approximates carrying value due to the terms of such instruments and applicable interest rates. The convertible debt is based on its fair value less unamortized debt discount plus accrued interest through the date of reporting (see Note 9).

Other Receivables

Other Receivables	3 Months Ended
	Mar. 31, 2020
Receivables [Abstract]
Other Receivables	Other receivables consisted of the following: March 31, December 31, 2020 2019 R&D tax credits $ 695,511 $ 2,566,281 Other 64,721 71,022 Total other receivables $ 760,232 $ 2,637,303 At March 31, 2020, the R&D tax credits were comprised of the 2019 refundable tax credits for research conducted in France. At December 31, 2019, the R&D tax credits were comprised of the 2017, 2018, and 2019 refundable tax credits for research conducted in France. In the quarter ended March 31, 2020, the Company received both the 2017 and 2018 refundable tax credits totaling approximately $1,770,000. At December 31, 2019, Other consisted of amounts due from U.S. R&D tax credits.

Property, Equipment, and Leaseh

Property, Equipment, and Leasehold Improvements	3 Months Ended
	Mar. 31, 2020
Property, Plant and Equipment [Abstract]
Property, Equipment, and Leasehold Improvements	Property, equipment and leasehold improvements consisted of the following: March 31, December 31, 2020 2019 Laboratory equipment $ 193,661 $ 193,661 Computer equipment 74,836 74,836 Office equipment 36,703 36,703 Leasehold improvements 35,711 35,711 Total property, plant and equipment 340,911 340,911 Less accumulated depreciation (267,364 ) (263,520 ) Property, plant and equipment, net $ 73,547 $ 77,391 Depreciation expense for the three months ended March 31, 2020 and 2019 was $9,661 and $17,114, respectively. For the three months ended March 31, 2020, $4,771 of depreciation is included in R&D expense and $4,890 of depreciation is included in G&A expense. For the three months ended March 31, 2019, $12,095 of depreciation has been reclassified to R&D expense and $5,019 of depreciation remains in G&A expense.

Intangible Assets and Goodwill

Intangible Assets and Goodwill	3 Months Ended
	Mar. 31, 2020
Goodwill and Intangible Assets Disclosure [Abstract]
Intangible Assets and Goodwill	Patents Pursuant to the Mayoly APA entered into on March 27, 2019, in which the Company purchased all rights, title and interest in and to MS1819 (see Note 14), the Company recorded Patents in the amount of $3,802,745 as follows: Common stock issued at signing to Mayoly $ 1,740,959 Due to Mayoly at 12/31/19 - €400,000 449,280 Due to Mayoly at 12/31/20 - €350,000 393,120 Assumed Mayoly liabilities and forgiveness of Mayoly debt 1,219,386 $ 3,802,745 Intangible assets are as follows: March 31, December 31, 2020 2019 Patents $ 3,802,745 $ 3,802,745 Less accumulated amortization (527,548 ) (395,661 ) Patents, net $ 3,275,197 $ 3,407,084 Amortization expense for the three months ended March 31, 2020 and 2019 was $131,149 and $561,289, respectively. Amortization expense for the three months ended March 31, 2019 included $384,234 from In process research and development and License agreements written off as a result of the Mayoly APA. As of March 31, 2020, amortization expense related to patents is expected to be as follows for the next five years (2020 through 2024): 2020 (balance of year) $ 395,661 2021 527,548 2022 527,548 2023 527,548 2024 527,548 Goodwill is as follows: Goodwill Balance at January 1, 2019 $ 1,924,830 Foreign currency translation (38,144 ) Balance at December 31, 2019 1,886,686 Foreign currency translation (42,680 ) Balance at March 31, 2020 $ 1,844,006

Accounts Payable and Accrued Ex

Accounts Payable and Accrued Expenses	3 Months Ended
	Mar. 31, 2020
Payables and Accruals [Abstract]
Accounts Payable and Accrued Expenses	Accounts payable and accrued expenses consisted of the following: March 31, December 31, 2020 2019 Trade payables $ 925,284 $ 1,683,505 Accrued expenses 113,935 71,177 Total accounts payable and accrued expenses $ 1,039,219 $ 1,754,682

Note Payable

Note Payable	3 Months Ended
	Mar. 31, 2020
Notes Payable [Abstract]
Note Payable	On December 5, 2019, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of $498,783 that bears interest at an annual rate of 5.461%. Monthly payments, including principal and interest, are $56,689 per month. The balance due under this financing agreement at March 31, 2020 was $279,616.

Convertible Notes

Convertible Notes	3 Months Ended
	Mar. 31, 2020
Debt Disclosure [Abstract]
Convertible Notes	ADEC Notes On February 14, 2019, the Company entered into a Note Purchase Agreement (the “ADEC NPA” “ADEC” “Note A” “Note B,” “ADEC Note,” “ADEC Notes” ADEC Note Offering The ADEC Notes accrue interest at a rate of 10% per annum; provided, however “2019 Tax Credit” “2020 Tax Credit” “Maturity Dates” Each of the ADEC Notes is convertible, at ADEC’s option, into shares of Common Stock, at a conversion price equal to $2.50 per share; provided however ADEC Note Conversion Shares As additional consideration for entering into the ADEC NPA, the Company entered into a warrant amendment agreement, whereby the Company agreed to reduce the exercise price of 1,009,565 outstanding warrants previously issued by the Company to ADEC and its affiliates (the “ADEC Warrants” ADEC Warrant Amendment In December 2019, the Company repaid $1,550,000 principal amount of the ADEC Notes and on January 2, 2020 repaid the remaining principal balance of $450,000 plus outstanding accrued interest of $104,153. Senior Convertible Promissory Note Offering On December 20, 2019, the Company began an offering of (i) Senior Convertible Promissory Notes (each a “ Promissory Note Promissory Notes Note Investors Note Warrants Promissory Promissory Note Offering In December 2019, the Company issued Promissory Notes to the Note Investors in the aggregate principal amount of $3,386,300. The Promissory Notes mature on September 20, 2020, accrue interest at a rate of 9% per annum, and are convertible, at the sole option of the holder, into shares of Common Stock (the “ Promissory Note Conversion Shares Conversion Option Prepayment Option On January 2, 2020, January 3, 2020, and January 9, 2020, the Company issued Promissory Notes to the Note Investors in the aggregate principal amount of $3,517,700. As additional consideration for the execution of the Promissory NPA, each Note Investor also received Note Warrants to purchase that number of shares of Common Stock equal to one-half (50%) of the Promissory Note Conversion Shares issuable upon conversion of the Promissory Notes (the “ Warrant Shares RRA In connection with the four closings in December 2019 of the Promissory Placement Agent Warrants In connection with the three closings in January 2020 of the Promissory The Company determined the Prepayment Option feature represents a contingent call option. The Company evaluated the Prepayment Option in accordance with ASC 815-15-25. The Company determined that the Prepayment Option feature is clearly and closely related to the debt host instrument and is not an embedded derivative requiring bifurcation. Additionally, the Company determined the Conversion Option represents an embedded call option. The Company evaluated the Conversion Option in accordance with ASC 815-15-25. The Company determined that the Conversion Option feature meets the scope exception from ASC 815 and is not an embedded derivative requiring bifurcation. The Company evaluated the Promissory Notes for a beneficial conversion feature in accordance with ASC 470-20. The Company determined that at each commitment date the effective conversion price was below the closing stock price (market value), and the Convertible Notes contained a beneficial conversion feature. Pursuant to the December 2019 closings of the Promissory Note Offering, the principal amount of $3,386,300 was first allocated based on the relative fair value of the Promissory Notes and the Note Warrants. The fair value of the Note Warrants amounted to $912,648. Then the beneficial conversion feature was calculated, which amounted to $1,359,284. The Company incurred debt issuance costs of $588,017 related to the offering. The initial carrying value of the Promissory Notes issued amounted to $526,351. Pursuant to the January 2020 closings of the Promissory Note Offering, the principal amount of $3,517,700 was first allocated based on the relative fair value of the Promissory Notes and the Note Warrants. The fair value of the Note Warrants amounted to $2,439,272. Then the beneficial conversion feature was calculated, which amounted to $1,838,422. The Company incurred debt issuance costs of $472,326 related to the offering. The initial carrying value of the Promissory Notes issued amounted to $128,524. During the three months ended March 31, 2020, the Company recognized $2,209,163 of interest expense related to these Promissory Notes, including amortization of debt discount related to the value of the Note Warrants of $658,126, amortization of the beneficial conversion feature of $1,053,366, amortization of debt discount related to debt issuance costs of $347,594, and accrued interest expense of $150,077. Convertible Debt consisted of: Total Promissory Notes ADEC Notes Total March 31, March 31, March 31, December 31, 2020 2020 2020 2019 Convertible debt $ 6,904,000 $ 6,904,000 $ - $ 3,836,300 Unamortized debt discount - revalued warrants - - - (118,356 ) Unamortized debt discount - warrants (1,299,280 ) (1,299,280 ) - (878,979 ) Unamortized debt discount - BCF (2,092,811 ) (2,092,811 ) - (1,307,755 ) Unamortized debt discount - debt issuance costs (684,048 ) (684,048 ) - (566,815 ) Accrued interest 158,467 158,467 - 112,543 Total convertible debt $ 2,986,328 $ 2,986,328 $ - $ 1,076,938

Other Liabilities

Other Liabilities	3 Months Ended
	Mar. 31, 2020
Other Liabilities [Abstract]
Other Liabilities	Other liabilities consisted of the following: March 31, December 31, Current 2020 2019 Due to Mayoly $ 386,925 $ 392,989 Lease liabilities 54,248 83,235 $ 441,173 $ 476,224

Equity

Equity	3 Months Ended
	Mar. 31, 2020
Equity [Abstract]
Equity	On December 19, 2019, the Company held its Annual Meeting of Stockholders (the “ Annual Meeting Reverse Split Common Stock The Company had 27,157,651 and 26,800,519 shares of its Common Stock issued and outstanding at March 31, 2020 and December 31, 2019, respectively. The holders of our Common Stock are entitled to one vote per share. In addition, the holders of our Common Stock will be entitled to receive ratably such dividends, if any, as may be declared by our Board out of legally available funds; however Voting Each holder of common stock has one vote for each share held. 2014 Equity Incentive Plan The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “ 2014 Plan As Converted Shares The Company issued an aggregate of 335,006 and 0 stock options, during the three months ended March 31, 2020 and 2019, respectively, under the 2014 Plan (see Note 13). As of March 31, 2020, there were an aggregate of 4,245,905 total shares available under the 2014 Plan, of which 1,997,506 are issued and outstanding, 632,667 shares are reserved subject to issuance of restricted stock and RSUs and 1,615,732 shares are available for potential issuances. The Company may issue securities outside of the 2014 Plan. Series A Convertible Preferred Stock At March 31, 2020 and December 31, 2019, there were no shares of Series A Convertible Preferred Stock (“ Series A Preferred LPC Equity Line of Credit On November 13, 2019, the Company entered into a purchase agreement (the “ LPC Purchase Agreement LPC Registration Rights Agreement LPC Equity Line of Credit Commitment Shares Under the LPC Purchase Agreement, on any business day over the term of the LPC Purchase Agreement, the Company has the right, in its sole discretion, to present LPC with a purchase notice (each, a “ Purchase Notice Regular Purchase Purchase Price ● the lowest sale price of Common Stock on the purchase date; and; ● the average of the three lowest closing sale prices for the Common Stock during the ten consecutive business days ending on the business day immediately preceding the purchase date of such shares; In addition, on any date on which the Company submits a Purchase Notice to LPC, the Company also has the right, in its sole discretion, to present LPC with an accelerated purchase notice (each, an “ Accelerated Purchase Notice Accelerated Purchase Accelerated Purchase Measurement Period ● 97% of the volume weighted average price of the Company’s common stock during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and ● the closing sale price of Common Stock on the applicable Accelerated Purchase Date. The Company may also direct LPC on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to LPC in accordance with the LPC Purchase Agreement, to purchase an amount of stock (the “ Additional Accelerated Purchase Additional Accelerated Purchase Measurement Period ● 97% of the volume weighted average price of the Company’s common stock during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and ● the closing sale price of Common Stock on the applicable Additional Accelerated Purchase. During the three months ended March 31, 2020, the Company issued 150,000 shares of Common Stock in connection with the LPC Purchase Agreement, resulting in gross proceeds to the Company of $144,000. Common Stock Issuances During the three months ended March 31, 2020, the Company issued an aggregate of 101,195 shares of its Common Stock to consultants with a grant date fair value of $87,105 for services provided, that was recorded as part of G&A expense. During the three months ended March 31, 2020, the Company issued its outside Board members an aggregate of 105,937 shares of Common Stock for the settlement of accounts payable in the aggregate amount of $131,137. The aggregate effective settlement price was $1.24 per share, and each individual stock issuance was based on the closing stock price of the Common Stock on the initial date the payable was accrued. During the three months ended March 31, 2019, the Company issued 27,102 shares of its common stock to a consultant as payment of $60,000 of accounts payable. During the three months ended March 31, 2019, the Company issued an aggregate of 30,000 shares of its Common Stock to outside members of its Board as payment of Board fees with an aggregate grant date fair value of $296,285, that was recorded as part of G&A expense. Restricted Stock and Restricted Stock Units During the three months ended March 31, 2020, an aggregate of 5,417 unvested restricted shares of Common Stock subject to time-based vesting, vested with a total grant date fair value of $19,500. During the three months ended March 31, 2019, an aggregate of 72,583 unvested restricted shares of Common Stock subject to milestone-based vesting, vested with a total grant date fair value of $223,685. 58,833 of these 72,583 shares with a total grant date fair value of $178,852 vested during the three months ended March 31, 2019 due to the Company achieving certain clinical milestones. 13,750 of these 72,583 shares with a total grant date fair value of $44,833 vested during the three months ended March 31, 2019 due to the terms of such grants. As of March 31, 2020, the Company had unrecognized restricted common stock expense of $424,439. $31,189 of this unrecognized expense will be recognized over the average remaining vesting term of 0.4 years. $196,625 of this unrecognized expense vests upon the first commercial sale in the United States of MS1819 and $196,625 of this unrecognized expense vests upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days. These milestones were not considered probable at March 31, 2020. As of March 31, 2019, the Company had unrecognized restricted common stock expense of $438,528. $337,193 of this unrecognized expense will be recognized over the average remaining vesting term of the restricted common stock of 2.04 years. $101,335 of this unrecognized expense vests upon the enrollment of the first 30 patients in a CF trial. This milestone was not considered probable at March 31, 2019.

Warrants

Warrants	3 Months Ended
	Mar. 31, 2020
WarrantsDisclosureTextBlock
Warrants	For the three months ended March 31, 2020, in connection with the January 2020 closings of the Promissory Note Offering, the Company issued Note Warrants to investors to purchase an aggregate of 1,813,257 shares of Common Stock with the issuance of the Promissory Notes as referenced in Note 9. These Note Warrants were issued between January 2, 2020 and January 9, 2020, are exercisable commencing six (6) months following the issuance date at $1.07 per share and expire five years from issuance. The total grant date fair value of these warrants was determined to be approximately $1,574,886, as calculated using the Black-Scholes model, and were recorded as a debt discount based on their relative fair value. For the three months ended March 31, 2020, in connection with the January 2020 closings of the Promissory Note Offering, the Company issued placement agent warrants to purchase an aggregate of 199,732 shares of Common Stock. These placement agent warrants were issued between January 2, 2020 and January 9, 2020, vested immediately, and expire five years from issuance. 41,495 of these Placement Agent Warrants are exercisable at $1.21 per share and 158,237 are exercisable at $1.42 per share. The total grant date fair value of these placement agent warrants was determined to be approximately $174,130, as calculated using the Black-Scholes model, and was charged to debt discount that will be amortized over the life of the debt. Warrant transactions for the three months ended March 31, 2020 and 2019 were as follows: Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable at January 1, 2019 3,112,715 $ 2.55 - 7.37 $ 4.83 Granted during the period - - - Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable at March 31, 2019 3,112,715 $ 2.55 - 7.37 $ 3.53 Warrants outstanding and exercisable at January 1, 2020 5,378,288 $ 1.07 - 7.37 $ 2.53 Granted during the period 2,012,989 $ 1.07 - 1.42 $ 1.10 Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable at March 31, 2020 7,391,277 $ 1.07 - 7.37 $ 2.14 Number of Weighted Average Weighted Shares Under Remaining Contract Average Exercise Price Warrants Life in Years Exercise Price $1.07 - $1.99 5,212,464 4.12 $2.00 - $2.99 320,063 3.32 $3.00 - $3.99 636,972 2.06 $4.00 - $4.99 196,632 1.76 $5.00 - $5.99 805,476 1.88 $6.00 - $6.99 187,750 1.51 $7.00 - $7.37 31,920 0.71 Total 7,391,277 3.52 $2.14 The weighted average fair value of warrants granted during the three months ended March 31, 2020 was $0.87 per share. The fair value was estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted average assumptions: March 31, 2020 Expected life (in years) 5 Volatility 81.9 % Risk-free interest rate 1.64 % Dividend yield - %

Stock Options

Stock Options	3 Months Ended
	Mar. 31, 2020
Share-based Payment Arrangement, Noncash Expense [Abstract]
Stock Options	Under the 2014 Plan, the fair value of options granted is estimated on the grant date using the Black-Scholes option valuation model. This valuation model for stock-based compensation expense requires the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the volatility of the common stock price and the assumed risk-free interest rate. The Company recognizes stock-based compensation expense for only those shares expected to vest over the requisite service period of the award. No compensation cost is recorded for options that do not vest and the compensation cost from vested options, whether forfeited or not, is not reversed. During the three months ended March 31, 2020, the Company issued stock options to purchase an aggregate of 335,006 shares of Common Stock with a strike price of $1.03 per share and a term of ten years to its chief financial officer that vest quarterly over three years. These options had a total fair value of approximately $281,405, as calculated using the Black-Scholes model. During the three months ended March 31, 2020, stock options to purchase an aggregate of 15,000 shares of Common Stock were cancelled with strike prices ranging between $1.75 and $3.60 per share. During the three months ended March 31, 2020, stock options to purchase an aggregate of 57,917 shares of Common Stock, subject to time-based vesting, vested with a total grant date fair value of $54,950 and were recorded as G&A stock-based compensation. During the three months ended March 31, 2019, the Company did not issue any stock options. During the three months ended March 31, 2019, stock options to purchase an aggregate of 244,500 shares of Common Stock with a total grant date fair value of $511,335 vested. 242,000 of these options with a total grant date fair value of $501,666 vested due to the Company achieving certain clinical milestones for MS1819. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions: March 31, 2020 Expected life (in years) 10 Volatility 80.5 % Risk-free interest rate 1.88 % Dividend yield - % The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of the Company’s Common Stock if available or of several public entities that are similar to the Company. The Company bases volatility this way because it may not have sufficient historical transactions in its own shares on which to solely base expected volatility. The risk-free interest rate is based on the U.S. Treasury rates at the date of grant with maturity dates approximately equal to the expected term at the grant date. The Company has not historically declared any dividends and does not expect to in the future. During the three months ended March 31, 2020 and 2019, stock option activity under the 2014 Plan was as follows: Number Average Remaining Contract Intrinsic of Shares Exercise Price Life in Years Value Stock options outstanding at January 1, 2019 994,000 $ 3.58 5.42 $ - Granted during the period - - Expired during the period - - Canceled during the period - - Exercised during the period - - Stock options outstanding at March 31, 2019 994,000 $ 3.58 5.17 $ - Exercisable at March 31, 2019 749,500 $ 3.74 5.71 $ - Non-vested stock options outstanding at January 1, 2019 244,500 $ 3.05 4.53 $ - Granted during the period - - Vested during the period (244,500 ) $ 3.05 4.53 Expired during the period - - Canceled during the period - - Exercised during the period - - Non-vested stock options outstanding at March 31, 2019 - $ - - $ - Stock options outstanding at January 1, 2020 1,677,5000 $ 2.17 5.37 $ - Granted during the period 335,006 $ 1.03 10.00 $ - Expired during the period - - Canceled during the period (15,000 ) $ 2.80 3.28 $ - Exercised during the period - - Stock options outstanding at March 31, 2020 1,997,506 $ 2.08 5.91 $ - Exercisable at March 31, 2020 841,917 $ 3.23 4.33 $ - Non-vested stock options outstanding at January 1, 2020 883,500 $ 1.33 6.26 $ - Granted during the period 335,006 $ 1.03 10.00 $ - Vested during the period (57,917 ) $ 1.40 6.88 $ - Expired during the period - - - Canceled during the period (5,000 ) $ 3.32 2.82 $ - Exercised during the period - - - Non-vested stock options outstanding at March 31, 2020 1,155,589 $ 1.24 7.06 $ - As of March 31, 2020, the Company had unrecognized stock-based compensation expense of $965,280. $289,455 of this unrecognized expense will be recognized over the average remaining vesting term of the options of 9.27 years. $522,513 of this unrecognized expense will vest upon enrollment completion next MS1819 clinical trial in the U.S. for CF (the OPTION 2 Trial). $72,713 of this unrecognized expense will vest upon enrollment completion of the ongoing Combination Trial in Europe. $40,300 of this unrecognized expense vests upon the Company initiating a Phase III clinical trial in the U.S. for MS1819. $40,300 of this unrecognized expense vests upon initiating a U.S. Phase I clinical trial for any product other than MS1819. The Company will recognize the expense related to these milestones when the milestones become probable.

Agreements

Agreements	3 Months Ended
	Mar. 31, 2020
Agreements
Agreements	Mayoly Agreement On March 27, 2019, the Company and Laboratories Mayoly Spinder (“ Mayoly Mayoly APA JDLA During the three months ended March 31, 2019, the Company charged $403,020 to Mayoly under the JDLA that was in effect during both periods. TransChem Sublicense On August 7, 2017, the Company and TransChem entered into the TransChem Sublicense Agreement pursuant to which TransChem granted to us an exclusive license to certain patents (the “TransChem Licensed Patents” On March 11, 2020, the Company provided TransChem with sixty (60) days prior written notice of its intent to terminate the TransChem Sublicense Agreement. Amounts paid under this Sublicense Agreement during the three months ended March 30, 2020 and 2019 were $0 and $50,000, respectively, and are included in R&D expense. Employment Agreements Current Named Executive Officers James Sapirstein Effective October 8, 2019, the Company entered into an employment agreement with Mr. Sapirstein to serve as its President and Chief Executive Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Sapirstein provides for a base salary of $450,000 per year. In addition to the base salary, Mr. Sapirstein is eligible to receive (i) a cash bonus of up to 40% of his base salary on an annual basis, based on certain milestones that are yet to be determined; (ii) 1% of net fees received by the Company upon entering into license agreements with any third-party with respect to any product current in development or upon the sale of all or substantially all assets of the Company; (iii) a grant of 200,000 restricted stock units (“ RSUs In the event that Mr. Sapirstein’s employment is terminated by the Company for Cause, as defined in his employment agreement, or by Mr. Sapirstein voluntarily, then he will not be entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. In the event that Mr. Sapirstein’s employment is terminated as a result of an Involuntary Termination Other than for Cause, as defined in his employment agreement, Mr. Sapirstein will be entitled to receive the following compensation: (i) severance in the form of continuation of his salary (at the base salary rate in effect at the time of termination, but prior to any reduction triggering Good Reason (as such term is defined in Mr. Sapirstein’s employment agreement) for a period of twelve months following the termination date; (ii) payment of Mr. Sapistein’s premiums to cover COBRA for a period of twelve months following the termination date; and (iii) a prorated annual bonus. Daniel Schneiderman Effective January 2, 2020, the Company entered into an employment agreement with Mr. Schneiderman to serve as the Company’s Chief Financial Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Schneiderman provides for a base salary of $285,000 per year. In addition to the base salary, Mr. Schneiderman is eligible to receive (a) an annual milestone cash bonus based on certain milestones that will be established by the Company’s Board or the Compensation Committee, and (b) a grant of stock options to purchase 335,006 shares of common stock with an exercise price of $1.03 per share, which shall vest in three equal portions on each anniversary date of the execution of Mr. Schneiderman’s employment agreement, commencing on January 2, 2021, the first anniversary date of the agreement. Mr. Schneiderman is entitled to receive 20 days of paid vacation, participate in full employee health benefits and receive reimbursement for all reasonable expenses incurred in connection with his service to the Company. The Company may terminate Mr. Schneiderman’s employment agreement at any time, with or without Cause, as such term is defined in his employment agreement. In the event that Mr. Schneiderman’s employment is terminated by the Company for Cause, as defined in Mr. Schneiderman’s employment agreement, or by Mr. Schneiderman voluntarily, then he will not be entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. If the Company terminates his employment agreement without Cause, not in connection with a Change of Control, as such term is defined in Mr. Schneiderman’s employment agreement, he will be entitled to (i) all salary owed through the date of termination; (ii) any unpaid annual milestone bonus; (iii) severance in the form of continuation of his salary for the greater of a period of six months following the termination date or the remaining term of the employment agreement; (iv) payment of premiums to cover COBRA for a period of six months following the termination date; (v) a prorated annual bonus equal to the target annual milestone bonus, if any, for the year of termination multiplied by the formula set forth in the agreement. If the Company terminates Mr. Schneiderman’s employment agreement without Cause, in connection with a Change of Control, he will be entitled to the above and immediate accelerated vesting of any unvested options or other unvested awards. Dr. James E. Pennington Effective May 28, 2018, the Company entered into an employment agreement with Dr. Pennington to serve as its 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 Company may terminate Dr. Pennington’s employment agreement at any time, with or without Cause, as such term is defined in Dr. Pennington’s employment agreement. 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 as such term is defined in Dr. Pennington’s employment agreement, Dr. Pennington will receive six months’ severance payable over such period. Former Named Executive Officers Johan (Thijs) Spoor On January 3, 2016, the Company entered into an employment agreement with its former President and Chief Executive Officer, Johan Spoor. The employment agreement provided for a term expiring January 2, 2019. Although Mr. Spoor’s employment agreement expired, he remained employed as the Company’s President and Chief Executive Officer under the terms of his prior employment agreement through his resignation from all positions with the Company on October 8, 2019. In addition, Mr. Spoor resigned as a member of the Board on April 29, 2020. The employment agreement with Mr. Spoor provided for a base salary of $425,000 per year. At the sole discretion of the Board or the Compensation Committee of the Board, following each calendar year of employment, Mr. Spoor was 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 or the Compensation Committee. Mr. Spoor’s employment agreement was terminable by either party at any time. On June 29, 2019, the Company accrued an incentive bonus in the amount of $255,000. Subsequent to Mr. Spoor’s resignation, the Compensation Committee reviewed the accrued bonus and determined that such amount was not owed by the Company, which determination is being challenged by Mr. Spoor. Mr. Spoor received no additional or severance compensation and all unvested stock options and unvested shares of restricted common stock granted to Mr. Spoor were cancelled as a result of Mr. Spoor’s resignation. As of March 31, 2020, there were 241,667 shares earned, but unissued shares of restricted common stock due to Mr. Spoor. However, Mr. Spoor declined the right to receive these shares on April 29, 2020. Maged Shenouda On September 26, 2017, the Company entered into an employment agreement with Mr. Shenouda to serve as its Executive Vice-President of Corporate Development and Chief Financial Officer for a term of three years, during which time he received a base salary of $275,000. In addition to the base salary, Mr. Shenouda was eligible to receive an annual milestone cash bonus based on the achievement of certain financial, clinical development, and/or business milestones, which milestones were established annually at the sole discretion of the Company’s Board or the Compensation Committee. Mr. Shenouda’s employment agreement provided for the issuance of stock options to purchase 100,000 shares of common stock, pursuant to the 2014 Plan, with an exercise price of $4.39 per share and a term of ten years. These stock options vested according to the following performance-based criteria, so long as Mr. Shenouda served as either Executive Vice-President of Corporate Development or as Chief Financial Officer of the Company: (i) 75% upon FDA acceptance of a U.S. IND application for MS1819, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819. These stock options vested during the year ended December 31, 2018. Mr. Shenouda’s employment agreement provided that the Company may terminate Mr. Shenouda’s employment agreement at any time, with or without Cause, as such term is defined in the agreement. If the Company terminated the agreement without Cause, or if the agreement was terminated due to a Change of Control, as such term is defined in the agreement, Mr. Shenouda was entitled to (i) all salary owed through the date of termination; (ii) any unpaid annual milestone bonus; (iii) severance in the form of continuation of his salary for the greater of a period of 12 months following the termination date or the remaining term of his employment agreement; (iv) payment of premiums to cover COBRA for a period of 12 months following the termination date; (v) a prorated annual bonus equal to the target annual milestone bonus, if any, for the year of termination multiplied by the formula set forth in the agreement; and (vi) immediate accelerated vesting of any unvested options or other unvested awards. On June 28, 2019, the Compensation Committee approved the accrual of an incentive bonus in the amount of $100,000. Subsequent to Mr. Shenouda’s resignation, the Compensation Committee reviewed the accrued bonus and determined that such amount was not owed, and the Company reversed the accrual in the quarter ended December 31, 2019. Mr. Shenouda resigned from his position as the Company’s Chief Financial Officer effective November 30, 2019. Mr. Shenouda received no additional or severance compensation and all unvested stock options and shares of restricted common stock granted to Mr. Shenouda were cancelled as a result of Mr. Shenouda’s resignation. Mr. Shenouda has a period of twelve months following his resignation to exercise all vested stock options

Leases

Leases	3 Months Ended
	Mar. 31, 2020
Leases [Abstract]
Leases	The Company adopted ASU 2016-02, Leases, as of January 1, 2019, using the modified retrospective approach. Prior year financial statements were not recast under the new standard. The Company leases its office and research facilities under operating leases which are subject to various rent provisions and escalation clauses expiring at various dates through 2020. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments. Lease expense amounted to $35,098 and $50,655, respectively, in the three months ended March 31, 2020 and 2019. The weighted-average remaining lease term and weighted-average discount rate under operating leases at March 31, 2020 are: March 31, 2020 Lease term and discount rate Weighted-average remaining lease term 0.66 years Weighted-average discount rate 6.0 % Maturities of operating lease liabilities at March 31, 2020 are as follows: 2020 $ 56,442 Total lease payments 56,442 Less imputed interest (2,194 ) Present value of lease liabilities $ 54,248

Income Taxes

Income Taxes	3 Months Ended
	Mar. 31, 2020
Income Tax Disclosure [Abstract]
Income Taxes	The Company is subject to taxation at the federal level in both the United States and France and at the state level in the United States. At March 31, 2020 and December 31, 2019, the Company had no tax provision for either jurisdiction. At March 31, 2020 and December 31, 2019, the Company had gross deferred tax assets of approximately $16,020,000 and $16,372,000, 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 $16,020,000 and $16,372,000, respectively, has been established at March 31, 2020 and December 31, 2019. The change in the valuation allowance in the three months ended March 31, 2020 and 2019 was $(352,000) and $1,160,000, respectively. At March 31, 2020, the Company has gross net operating loss (“ NOL Section 382 At March 31, 2020 and December 31, 2019, the Company had approximately $19,782,000 and $19,475,000, respectively, in net operating losses which it can carryforward indefinitely to offset against future French income. At March 31, 2020 and December 31, 2019, 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	3 Months Ended
	Mar. 31, 2020
Earnings Per Share [Abstract]
Net Loss per Common Share	Basic net loss per share is computed by dividing net loss available to common stockholders 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 March 31, 2020, diluted net loss per share did not include the effect of 7,117,559 shares of Common Stock issuable upon the conversion of convertible debt, 7,391,277 shares of Common Stock issuable upon the exercise of outstanding warrants, 632,667 shares of Common Stock pursuant to unissued restricted stock and RSUs, and 1,997,506 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. At March 31, 2019, 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.

Related Party Transactions

Related Party Transactions	3 Months Ended
	Mar. 31, 2020
Related Party Transactions [Abstract]
Related Party Transactions	Johan (Thijs) Spoor During the year ended December 31, 2015, the Company employed the services of JIST Consulting (“ JIST On June 29, 2019, the Company accrued an incentive bonus in the amount of $255,000 payable to Mr. Spoor. Subsequent to Mr. Spoor’s resignation, the Compensation Committee reviewed the accrued bonus and determined that such amount was not owed by the Company, which determination is being challenged by Mr. Spoor. As a result of management’s determination, the Company reversed the accrual in the quarter ended December 31, 2019. All unvested shares of restricted stock and stock options subject to time and other performance-based vesting conditions have been forfeited in connection with Mr. Spoor's resignation as the Company’s President and Chief Executive Officer. Mr. Spoor also declined the right to receive 241,667 shares earned, but unissued shares of restricted stock on April 29, 2020. Management is currently negotiating with Mr. Spoor regarding the amounts, if any, that should be paid to Mr. Spoor relating to payments due to JIST, any bonus payable, as well as the equity awards due to Mr. Spoor. Maged Shenouda From October 1, 2016 until his appointment as the Company’s Chief Financial Officer on September 25, 2017, the Company employed the services of Maged Shenouda as a financial consultant. Included in accounts payable at December 31, 2019 and 2018 is $10,000 and $50,000, respectively, for Mr. Shenouda’s services. On November 1, 2019, Mr. Shenouda submitted his resignation as Chief Financial Officer of the Company, effective November 30, 2019. On June 29, 2019, the Company accrued an incentive bonus in the amount of $100,000 payable to Mr. Shenouda. Subsequent to Mr. Shenouda’s resignation, the Compensation Committee reviewed the accrued bonus and determined that such amount should not be paid, and the Company reversed the accrual in the quarter ended December 31, 2019.

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2020
Subsequent Events [Abstract]
Subsequent Events	LPC Equity Line of Credit In April and May 2020, the Company issued an aggregate of 788,464 shares of Common Stock in connection with the LPC Purchase Agreement, resulting in gross proceeds to the Company of $456,698. Change in Directors Effective April 3, 2020, the Company appointed Gregory Oakes to the Board. Mr. Oakes, age 52, brings over 25 years of pharmaceutical industry and leadership experience and currently serves as Corporate Vice President, Global Integration Lead for Otezla at Amgen where he is responsible for the integration and continued success for sustained growth of the brand with $2 billion in assets. Prior to Amgen from 2017 to 2019, Mr. Oakes served as Corporate Vice President and U.S. General Manager at Celgene, a global biopharmaceutical company which develops and commercializes medicines for cancer and inflammatory disorders. Mr. Oakes also served as the Global Commercial Integration Lead at Celgene where he helped steer the $74 billion acquisition by Bristol-Myers Squibb and the $13.4 billion divestiture of Otezla. From 2010 to 2017, Mr. Oakes held several positions at Novartis, the most recent as Head of Sandoz Biopharmaceuticals, North America. He began his career at Schering-Plough (Merck) where he held executive roles in both the U.S. and Europe. Mr. Oakes holds a bachelor's degree in Marketing and Business Administration from Edinboro University and a M.B.A. from Clemson University. He currently sits on the Board of BioNJ and previously served on various Executive Committees at Celgene, Novartis, and Schering-Plough (Merck). In connection with his service on the Board for 2020, Mr. Oakes received an initial grant of stock options to purchase 60,000 shares of Common Stock 20,000 vest , in accordance with the Company's director compensation plan. On April 29, 2020, Mr. Spoor resigned as a member of the Board. Additionally, Mr. Spoor provided notice to the Company that he declined the right to receive 241,667 earned shares, but unissued shares of restricted stock. French R&D (CIR) Tax Credit In May 2020, the Company received payment for the 2019 refundable tax credits for research conducted in France of approximately $721,000. CARES ACT PPP Loan In April 2020, the Company applied for and received a CARES Act Paycheck Protection Program (PPP) loan of approximately $180,000 through the Small Business Administration (SBA). Subsequently, in May 2020, the Company returned the loan of approximately $180,000 after analysis of the updated guidance from the U.S. Department of Treasury and the SBA regarding the eligibility of such loans. 2020 Board Compensation On April 6, 2020, the Company issued each of its five outside Board members stock options to purchase a total of 80,000 shares of Common Stock each with an exercise price of $0.97 per share. 20,000 of these stock options were vested immediately with the remainder vesting in equal installments on each of June 30, 2020, September 30, 2020 and December 31, 2020.

Significant Accounting Polici_2

Significant Accounting Policies and Recent Accounting Pronouncements (Policies)	3 Months Ended
	Mar. 31, 2020
Accounting Policies [Abstract]
Use of Estimates	The accompanying unaudited 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.
Cash and Cash Equivalents	The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash balances were highly liquid at March 31, 2020 and December 31, 2019, respectively.
Concentrations of Credit Risk	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 March 31, 2020 and December 31, 2019, the Company had $236,568 and $0, 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 mitigates its risk by maintaining the majority of its cash and cash equivalents with high quality financial institutions. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros.
Debt Instruments	Detachable warrants issued in conjunction with debt are measured at their relative fair value, if they are determined to be equity instrument, or their fair value, if they are determined to be liability instruments, and recorded as a debt discount. Conversion features that are in the money at the commitment date constitute a beneficial conversion feature that is measured at its intrinsic value and recognized as debt discount. Debt discount is amortized as interest expense over the maturity period of the debt using the effective interest method. Contingent beneficial conversion features are recognized when the contingency has been resolved.
Debt Issuance Costs	Debt issuance costs are recorded as a direct reduction of the carrying amount of the related debt. Debt issuance costs are amortized over the maturity period of the related debt instrument using the effective interest method.
Equity-Based Payments to Non-Employees	Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting.
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. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.
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 stockholders’ equity.
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 March 31, 2020. Intangible assets subject to amortization consist of in process research and development, license agreements, and patents 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: Patents 7.2 years In Process Research & Development 12 years License Agreements 5 years
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”
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 March 31, 2020 and December 31, 2019, the Company does not have any significant uncertain tax positions. All tax years are still open for audit.
Leases	Effective January 1, 2019, the Company adopted Accounting Standards Update ( “ASU”
Research and Development	Research and development (“ R&D
Stock-Based Compensation	The Company’s board of directors (the “ Board (“ASC 718” For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock.
Sublicense Agreement	As more fully discussed in Note 14, the Company entered into a sublicense agreement with TransChem, Inc. (“ TransChem
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 January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other, Simplifying the Accounting for Goodwill Impairment. ASU 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. All other goodwill impairment guidance will remain largely unchanged. Entities will continue to have the option to perform a qualitative assessment to determine if a quantitative impairment test is necessary. This new guidance will be applied prospectively and is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. This ASU, which the Company adopted as of January 1, 2020, did not have a material effect on the Company’s consolidated financial statements.

Significant Accounting Polici_3

Significant Accounting Policies and Recent Accounting Pronouncements (Tables)	3 Months Ended
	Mar. 31, 2020
Accounting Policies [Abstract]
Goodwill and Intangible Assets	Patents 7.2 years In Process Research & Development 12 years License Agreements 5 years

Fair Value Disclosures (Tables)

Fair Value Disclosures (Tables)	3 Months Ended
	Mar. 31, 2020
Fair Value Disclosures [Abstract]
Financial instruments measured at fair value on a recurring basis	Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value At March 31, 2020: Cash $ 1,630,007 $ - $ 1,630,007 $ - $ 1,630,007 Other receivables $ 760,232 $ - $ - $ 760,232 $ 760,232 Note payable $ 279,616 $ - $ - $ 279,616 $ 279,616 Convertible debt $ 2,986,328 $ - $ - $ 2,986,328 $ 2,986,328 At December 31, 2019: Cash $ 175,796 $ - $ 175,796 $ - $ 175,796 Other receivables $ 2,637,303 $ - $ - $ 2,637,303 $ 2,637,303 Note payable $ 444,364 $ - $ - $ 444,364 $ 444,364 Convertible debt $ 1,076,938 $ - $ - $ 1,076,938 $ 1,076,938

Other Receivables (Tables)

Other Receivables (Tables)	3 Months Ended
	Mar. 31, 2020
Receivables [Abstract]
Other receivables	March 31, December 31, 2020 2019 R&D tax credits $ 695,511 $ 2,566,281 Other 64,721 71,022 Total other receivables $ 760,232 $ 2,637,303

Property, Equipment, and Leas_2

Property, Equipment, and Leasehold Improvements (Tables)	3 Months Ended
	Mar. 31, 2020
Property, Plant and Equipment [Abstract]
Property, equipment and leasehold improvements	March 31, December 31, 2020 2019 Laboratory equipment $ 193,661 $ 193,661 Computer equipment 74,836 74,836 Office equipment 36,703 36,703 Leasehold improvements 35,711 35,711 Total property, plant and equipment 340,911 340,911 Less accumulated depreciation (267,364 ) (263,520 ) Property, plant and equipment, net $ 73,547 $ 77,391

Intangible Assets and Goodwill

Intangible Assets and Goodwill (Tables)	3 Months Ended
	Mar. 31, 2020
Goodwill and Intangible Assets Disclosure [Abstract]
Patents	Common stock issued at signing to Mayoly $ 1,740,959 Due to Mayoly at 12/31/19 - €400,000 449,280 Due to Mayoly at 12/31/20 - €350,000 393,120 Assumed Mayoly liabilities and forgiveness of Mayoly debt 1,219,386 $ 3,802,745
Intangible assets	March 31, December 31, 2020 2019 Patents $ 3,802,745 $ 3,802,745 Less accumulated amortization (527,548 ) (395,661 ) Patents, net $ 3,275,197 $ 3,407,084
Future amortization expense	2020 (balance of year) $ 395,661 2021 527,548 2022 527,548 2023 527,548 2024 527,548
Goodwill	Goodwill Balance at January 1, 2019 $ 1,924,830 Foreign currency translation (38,144 ) Balance at December 31, 2019 1,886,686 Foreign currency translation (42,680 ) Balance at March 31, 2020 $ 1,844,006

Accounts Payable and Accrued _2

Accounts Payable and Accrued Expenses (Tables)	3 Months Ended
	Mar. 31, 2020
Payables and Accruals [Abstract]
Accounts payable and accrued expenses	March 31, December 31, 2020 2019 Trade payables $ 925,284 $ 1,683,505 Accrued expenses 113,935 71,177 Total accounts payable and accrued expenses $ 1,039,219 $ 1,754,682

Convertible Notes (Tables)

Convertible Notes (Tables)	3 Months Ended
	Mar. 31, 2020
Debt Disclosure [Abstract]
Convertible Notes	Total Promissory Notes ADEC Notes Total March 31, March 31, March 31, December 31, 2020 2020 2020 2019 Convertible debt $ 6,904,000 $ 6,904,000 $ - $ 3,836,300 Unamortized debt discount - revalued warrants - - - (118,356 ) Unamortized debt discount - warrants (1,299,280 ) (1,299,280 ) - (878,979 ) Unamortized debt discount - BCF (2,092,811 ) (2,092,811 ) - (1,307,755 ) Unamortized debt discount - debt issuance costs (684,048 ) (684,048 ) - (566,815 ) Accrued interest 158,467 158,467 - 112,543 Total convertible debt $ 2,986,328 $ 2,986,328 $ - $ 1,076,938

Other Liabilities (Tables)

Other Liabilities (Tables)	3 Months Ended
	Mar. 31, 2020
Other Liabilities [Abstract]
Other liabilities	March 31, December 31, Current 2020 2019 Due to Mayoly $ 386,925 $ 392,989 Lease liabilities 54,248 83,235 $ 441,173 $ 476,224

Warrants (Tables)

Warrants (Tables)	3 Months Ended
	Mar. 31, 2020
WarrantsDisclosureTextBlock
Stock warrant transactions	Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable at January 1, 2019 3,112,715 $ 2.55 - 7.37 $ 4.83 Granted during the period - - - Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable at March 31, 2019 3,112,715 $ 2.55 - 7.37 $ 3.53 Warrants outstanding and exercisable at January 1, 2020 5,378,288 $ 1.07 - 7.37 $ 2.53 Granted during the period 2,012,989 $ 1.07 - 1.42 $ 1.10 Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable at March 31, 2020 7,391,277 $ 1.07 - 7.37 $ 2.14
Warrants by exercise price	Number of Weighted Average Weighted Shares Under Remaining Contract Average Exercise Price Warrants Life in Years Exercise Price $1.07 - $1.99 5,212,464 4.12 $2.00 - $2.99 320,063 3.32 $3.00 - $3.99 636,972 2.06 $4.00 - $4.99 196,632 1.76 $5.00 - $5.99 805,476 1.88 $6.00 - $6.99 187,750 1.51 $7.00 - $7.37 31,920 0.71 Total 7,391,277 3.52 $2.14
Share-based payment weighted average assumptions	March 31, 2020 Expected life (in years) 5 Volatility 81.9 % Risk-free interest rate 1.64 % Dividend yield - %

Stock Options (Tables)

Stock Options (Tables)	3 Months Ended
	Mar. 31, 2020
Share-based Payment Arrangement, Noncash Expense [Abstract]
Share-based payment weighted average assumptions	March 31, 2020 Expected life (in years) 10 Volatility 80.5 % Risk-free interest rate 1.88 % Dividend yield - %
Stock option activity	Number Average Remaining Contract Intrinsic of Shares Exercise Price Life in Years Value Stock options outstanding at January 1, 2019 994,000 $ 3.58 5.42 $ - Granted during the period - - Expired during the period - - Canceled during the period - - Exercised during the period - - Stock options outstanding at March 31, 2019 994,000 $ 3.58 5.17 $ - Exercisable at March 31, 2019 749,500 $ 3.74 5.71 $ - Non-vested stock options outstanding at January 1, 2019 244,500 $ 3.05 4.53 $ - Granted during the period - - Vested during the period (244,500 ) $ 3.05 4.53 Expired during the period - - Canceled during the period - - Exercised during the period - - Non-vested stock options outstanding at March 31, 2019 - $ - - $ - Stock options outstanding at January 1, 2020 1,677,5000 $ 2.17 5.37 $ - Granted during the period 335,006 $ 1.03 10.00 $ - Expired during the period - - Canceled during the period (15,000 ) $ 2.80 3.28 $ - Exercised during the period - - Stock options outstanding at March 31, 2020 1,997,506 $ 2.08 5.91 $ - Exercisable at March 31, 2020 841,917 $ 3.23 4.33 $ - Non-vested stock options outstanding at January 1, 2020 883,500 $ 1.33 6.26 $ - Granted during the period 335,006 $ 1.03 10.00 $ - Vested during the period (57,917 ) $ 1.40 6.88 $ - Expired during the period - - - Canceled during the period (5,000 ) $ 3.32 2.82 $ - Exercised during the period - - - Non-vested stock options outstanding at March 31, 2020 1,155,589 $ 1.24 7.06 $ -

Leases (Tables)

Leases (Tables)	3 Months Ended
	Mar. 31, 2020
Leases [Abstract]
Operating lease information	March 31, 2020 Lease term and discount rate Weighted-average remaining lease term 0.66 years Weighted-average discount rate 6.0 %
Maturities of operating lease liabilities	2020 $ 56,442 Total lease payments 56,442 Less imputed interest (2,194 ) Present value of lease liabilities $ 54,248

The Company and Basis of Pres_2

The Company and Basis of Presentation (Details Narrative) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Accumulated deficit	$ (67,956,022)	$ (62,694,732)

Significant Accounting Polici_4

Significant Accounting Policies and Recent Accounting Pronouncements (Details	3 Months Ended
	Mar. 31, 2020
Accounting Policies [Abstract]
Patents	7 years 2 months 12 days
In process research and development	12 years
License Agreements	5 years

Significant Accounting Polici_5

Significant Accounting Policies and Recent Accounting Pronouncements (Details Narrative) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Accounting Policies [Abstract]
Cash in excess of FDIC limit	$ 236,568	$ 0

Fair Value Disclosures (Details

Fair Value Disclosures (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Cash	$ 1,630,007	$ 175,796
Other receivables	760,232	2,637,303
Notes payable	279,616	444,364
Convertible debt	2,986,328	1,076,938
Carrying Amount
Cash	1,630,007	175,796
Other receivables	760,232	2,637,303
Notes payable	279,616	444,364
Convertible debt	2,986,328	1,076,938
Level 1
Cash	0	0
Other receivables	0	0
Notes payable	0	0
Convertible debt	0	0
Level 2
Cash	1,630,007	175,796
Other receivables	0	0
Notes payable	0	0
Convertible debt	0	0
Level 3
Cash	0	0
Other receivables	760,232	2,637,303
Notes payable	279,616	444,364
Convertible debt	$ 2,986,328	$ 1,076,938

Other Receivables (Details)

Other Receivables (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Receivables [Abstract]
R&D tax credits	$ 695,511	$ 2,566,281
Other	64,721	71,022
Other receivables	$ 760,232	$ 2,637,303

Property, Equipment, and Leas_3

Property, Equipment, and Leasehold Improvements (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Property, equipment and leasehold improvements, gross	$ 340,911	$ 340,911
Less accumulated depreciation	(267,364)	(263,520)
Property, equipment and leasehold improvements, net	73,547	77,391
Laboratory Equipment
Property, equipment and leasehold improvements, gross	193,661	74,836
Computer Equipment
Property, equipment and leasehold improvements, gross	74,836	36,703
Office Equipment
Property, equipment and leasehold improvements, gross	36,703	193,661
Leasehold Improvements
Property, equipment and leasehold improvements, gross	$ 35,711	$ 35,711

Property, Equipment, and Leas_4

Property, Equipment, and Leasehold Improvements (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 9,661	$ 17,114

Intangible Assets and Goodwil_2

Intangible Assets and Goodwill (Details)	Mar. 31, 2020USD ($)
Patents	$ 3,802,745
Common stock issued at signing to Mayoly
Patents	1,740,959
Due to Mayoly at 12/31/19
Patents	449,280
Due to Mayoly at 12/31/20
Patents	393,120
Assumed Mayoly liabilties and forgiveness of Mayoly debt
Patents	$ 1,219,386

Intangible Assets and Goodwil_3

Intangible Assets and Goodwill (Details 1) - Patents - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Intangible assets, gross	$ 3,802,745	$ 3,802,745
Less accumulated amortization	(527,548)	(395,661)
Intangible assets, net	$ 3,275,197	$ 3,407,804

Intangible Assets and Goodwil_4

Intangible Assets and Goodwill (Details 2)	Mar. 31, 2020USD ($)
Amortization expense
2020 (balance of year)	$ 395,661
2021	527,548
2022	527,548
2023	527,548
2024	$ 527,548

Intangible Assets and Goodwil_5

Intangible Assets and Goodwill (Details 3) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2020	Dec. 31, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
Goodwill, beginning	$ 1,886,686	$ 1,924,830
Foreign currency translation	(42,680)	(38,144)
Goodwill, ending	$ 1,844,006	$ 1,886,686

Intangible Assets and Goodwil_6

Intangible Assets and Goodwill (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
Amortization expense	$ 131,149	$ 561,289

Accounts Payable and Accrued _3

Accounts Payable and Accrued Expenses (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Payables and Accruals [Abstract]
Trade payables	$ 925,284	$ 1,683,505
Accrued expenses	119,935	71,177
Total accounts payable and accrued expenses	$ 1,039,219	$ 1,754,682

Convertible Notes (Details)

Convertible Notes (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Convertible debt, gross	$ 6,904,000	$ 3,836,300
Unamortized debt discount - revalued warrants	0	(118,356)
Unamortized debt discount - warrants	(1,299,280)	(878,979)
Unamortized debt discount - BCF	(2,092,811)	(1,307,755)
Unamortized debt discount - debt issuance costs	(684,048)	(566,815)
Accrued interest	148,467	112,543
Convertible debt, net	2,986,328	$ 1,076,938
Promissory Notes
Convertible debt, gross	6,904,000
Unamortized debt discount - revalued warrants	0
Unamortized debt discount - warrants	(1,299,280)
Unamortized debt discount - BCF	(2,092,811)
Unamortized debt discount - debt issuance costs	(684,048)
Accrued interest	158,467
Convertible debt, net	2,986,328
ADEC Notes
Convertible debt, gross	0
Unamortized debt discount - revalued warrants	0
Unamortized debt discount - warrants	0
Unamortized debt discount - BCF	0
Unamortized debt discount - debt issuance costs	0
Accrued interest	0
Convertible debt, net	$ 0

Other Liabilities (Details)

Other Liabilities (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Other Liabilities [Abstract]
Due to Mayoly, current	$ 386,925	$ 392,989
Lease liabilities, current	54,248	83,235
Other liabilities, current	$ 441,173	$ 476,224

Equity (Details Narrative)

Equity (Details Narrative) - shares	Mar. 31, 2020	Dec. 31, 2019
Equity [Abstract]
Common stock shares, outstanding	27,157,651	26,800,519

Warrants (Details)

Warrants (Details) - $ / shares	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Warrants issued and exercisable, beginning	5,378,288	3,112,715
Granted	2,012,989	0
Expired	0	0
Exercised	0	0
Warrants issued and exercisable, ending	7,391,277	3,112,715
Exercise price granted		$ .00
Exercise price expired	$ 0	.00
Exercise price exercised	0	.00
Weighted average exercise price, beginning	2.53	4.83
Weighted average exercise price, granted	1.10	.00
Weighted average exercise price warrants, expired	.00	.00
Weighted average exercise price warrants, exercised	.00	.00
Weighted average exercise price, ending	2.14	3.53
Minimum
Exercise price outstanding, beginning	1.07	2.55
Exercise price granted	1.07
Exercise price outstanding, ending	1.07	2.55
Maximum
Exercise price outstanding, beginning	7.37	7.37
Exercise price granted	1.472
Exercise price outstanding, ending	$ 7.37	$ 7.37

Warrants (Details 1)

Warrants (Details 1)	3 Months Ended
	Mar. 31, 2020$ / sharesshares
Number of shares under warrants	7,391,277
Weighted average remaining contract life in years	3 years 6 months 7 days
Weighted average exercise price | $ / shares	$ 2.14
Warrant 1
Exercise price	$1.07 - $1.99
Number of shares under warrants	5,212,464
Weighted average remaining contract life in years	4 years 1 month 13 days
Warrant 2
Exercise price	$2.00 - $2.99
Number of shares under warrants	320,063
Weighted average remaining contract life in years	3 years 3 months 25 days
Warrant 3
Exercise price	$3.00 - $3.99
Number of shares under warrants	636,972
Weighted average remaining contract life in years	2 years 22 days
Warrant 4
Exercise price	$4.00 - $4.99
Number of shares under warrants	196,632
Weighted average remaining contract life in years	1 year 9 months 4 days
Warrant 5
Exercise price	$5.00 - $5.99
Number of shares under warrants	805,476
Weighted average remaining contract life in years	1 year 10 months 17 days
Warrant 6
Exercise price	$6.00 - $6.99
Number of shares under warrants	187,750
Weighted average remaining contract life in years	1 year 6 months 4 days
Warrant 7
Exercise price	$7.00 - $7.37
Number of shares under warrants	31,920
Weighted average remaining contract life in years	8 months 16 days

Warrants (Details 2)

Warrants (Details 2)	3 Months Ended
	Mar. 31, 2020
WarrantsDisclosureTextBlock
Expected life (in years)	5 years
Volatility	81.90%
Risk-free interest rate	1.64%
Dividend yield	0.00%

StockOptions (Details)

StockOptions (Details)	3 Months Ended
	Mar. 31, 2020
Expected life (in years)	5 years
Volatility	81.90%
Risk-free interest rate	1.64%
Dividend yield	0.00%
Stock Option
Expected life (in years)	10 years
Volatility	80.50%
Risk-free interest rate	1.88%
Dividend yield	0.00%

Stock Options (Details 1)

Stock Options (Details 1) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Stock Option
Number of Options Outstanding, Beginning	1,677,500	994,000
Number of Options Granted	335,006	0
Number of Options Vested	0	0
Number of Options Expired	0	0
Number of Options Canceled	(15,000)	0
Number of Options Exercised	0	0
Number of Options Outstanding, Ending	1,997,506	994,000
Number of Options Exercisable	841,917	749,500
Weighted Average Exercise Price Outstanding, Beginning	$ 2.17	$ 3.58
Weighted Average Exercise Price Granted	1.03	.00
Weighted Average Exercise Price Vested	.00	.00
Weighted Average Exercise Price Expired	.00	.00
Weighted Average Exercise Price Canceled	2.80	.00
Weighted Average Exercise Price Exercised	.00	.00
Weighted Average Exercise Price Outstanding, Ending	2.08	3.58
Weighted Average Exercise Price Exercisable	$ 3.23	$ 3.74
Weighted Average Remaining Contract Life in Years, Beginning	5 years 4 months 13 days	5 years 5 months 1 day
Weighted Average Remaining Contract Life in Years Granted	10 years
Weighted Average Remaining Contract Life in Years Canceled	3 years 3 months 11 days
Weighted Average Remaining Contract Life in Years, Ending	5 years 10 months 28 days	5 years 2 months 1 day
Weighted Average Remaining Contract Life in Years Exercisable	4 years 3 months 29 days	5 years 8 months 16 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 0
Aggregate Intrinsic Value Granted	0	0
Aggregate Intrinsic Value Vested	0	0
Aggregate Intrinsic Value Expired	0	0
Aggregate Intrinsic Value Canceled	0	0
Aggregate Intrinsic Value Exercised	0	0
Aggregate Intrinsic Value Outstanding, Ending	0	0
Aggregate Intrinsic Value Exercisable	$ 0	$ 0
Non-vested Stock Option
Number of Options Outstanding, Beginning	883,500	244,500
Number of Options Granted	335,006	0
Number of Options Vested	(57,917)	(244,500)
Number of Options Expired	0	0
Number of Options Canceled	(5,000)	0
Number of Options Exercised	0	0
Number of Options Outstanding, Ending	1,155,589	0
Weighted Average Exercise Price Outstanding, Beginning	$ 1.33	$ 3.05
Weighted Average Exercise Price Granted	1.03	.00
Weighted Average Exercise Price Vested	1.40	3.05
Weighted Average Exercise Price Expired	.00	.00
Weighted Average Exercise Price Canceled	3.32	.00
Weighted Average Exercise Price Exercised	.00	.00
Weighted Average Exercise Price Outstanding, Ending	$ 1.24	$ .00
Weighted Average Remaining Contract Life in Years, Beginning	6 years 3 months 4 days	4 years 6 months 11 days
Weighted Average Remaining Contract Life in Years Granted	10 years
Weighted Average Remaining Contract Life in Years Vested	6 years 10 months 17 days	4 years 6 months 11 days
Weighted Average Remaining Contract Life in Years Canceled	2 years 9 months 25 days
Weighted Average Remaining Contract Life in Years, Ending	722 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 0
Aggregate Intrinsic Value Granted	0
Aggregate Intrinsic Value Vested	0
Aggregate Intrinsic Value Expired	0
Aggregate Intrinsic Value Canceled	0
Aggregate Intrinsic Value Exercised	0
Aggregate Intrinsic Value Outstanding, Ending	$ 0	$ 0

Leases (Details)

Leases (Details)	Mar. 31, 2020
Leases [Abstract]
Weighted-average remaining lease term	7 months 28 days
Weighted-average discount rate	6.00%

Leases (Details 1)

Leases (Details 1)	Mar. 31, 2020USD ($)
Leases [Abstract]
2020	$ 56,442
Total lease payments	56,442
Less: imputed interest	(2,194)
Present value of lease liabilities	$ 54,248

Leases (Details Narrative)

Leases (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Leases [Abstract]
Lease expense	$ 35,098	$ 50,655

Income Taxes (Details Narrative

Income Taxes (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019
Income Tax Disclosure [Abstract]
Gross deferred tax asset	$ 16,020,000		$ 16,372,000
Deferred tax asset valuation allowance	16,020,000		16,372,000
Change in valuation allowance	(352,000)	$ 1,160,000
Net operating loss carry-forwards	$ (30,904,000)		$ (20,846,000)

Net Loss per Common Share (Deta

Net Loss per Common Share (Details Narrative) - shares	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Convertible Debt
Anti-dilutive shares excluded from earnings per share	7,117,559	0
Warrants
Anti-dilutive shares excluded from earnings per share	7,391,277	3,112,715
Restricted stock
Anti-dilutive shares excluded from earnings per share	632,667	416,000
Stock Option
Anti-dilutive shares excluded from earnings per share	1,997,506	994,000

Related Party Transactions (Det

Related Party Transactions (Details Narrative) - USD ($)	Mar. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Accounts payable	$ 1,039,219	$ 1,754,682
JIST
Accounts payable		348,400	$ 478,400
Consultant
Accounts payable		$ 10,000	$ 50,000