Qualigen Therapeutics (QLGN) 10-Q 9 May 17 2017 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2017	May 04, 2017
Document And Entity Information
Entity Registrant Name	RITTER PHARMACEUTICALS INC
Entity Central Index Key	1,460,702
Document Type	10-Q
Document Period End Date	Mar. 31, 2017
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		14,619,197
Trading Symbol	RTTR
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2,017

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)	Mar. 31, 2017	Dec. 31, 2016
Current assets
Cash and cash equivalents	$ 5,092,309	$ 7,046,282
Prepaid expenses	149,727	156,752
Total current assets	5,242,036	7,203,034
Other assets	10,326	10,326
Property and equipment, net	22,235	23,542
Total Assets	5,274,597	7,236,902
Current liabilities
Accounts payable	1,634,698	1,896,368
Accrued expenses	900,762	1,222,735
Other liabilities	15,133	14,736
Total current liabilities	2,550,593	3,133,839
Stockholders’ equity
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2017 and December 31, 2016
Common stock, $0.001 par value; 25,000,000 shares authorized; 11,619,197 shares issued and outstanding as of March 31, 2017 and December 31, 2016	11,619	11,619
Additional paid-in capital	49,853,196	49,559,020
Accumulated deficit	(47,140,811)	(45,467,576)
Total stockholders’ equity	2,724,004	4,103,063
Total Liabilities and Stockholders’ Equity	$ 5,274,597	$ 7,236,902

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2017	Dec. 31, 2016
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	25,000,000	25,000,000
Common stock, shares issued	11,619,197	11,619,197
Common stock, shares outstanding	11,619,197	11,619,197

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Operating costs and expenses
Research and development	$ 432,154	$ 1,882,848
Patent costs	77,702	32,364
General and administrative	1,171,325	1,235,018
Total operating costs and expenses	1,681,181	3,150,230
Operating loss	(1,681,181)	(3,150,230)
Other income
Interest income	7,946	20,566
Other income		1,214
Total other income	7,946	21,780
Net loss	$ (1,673,235)	$ (3,128,450)
Net loss per share, basic and diluted	$ (0.14)	$ (0.36)
Weighted average shares outstanding, basic and diluted	11,619,197	8,583,259

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Cash flows from operating activities
Net loss	$ (1,673,235)	$ (3,128,450)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	1,307	1,254
Stock-based compensation	294,176	377,597
Changes in operating assets and liabilities:
Prepaid expenses	7,025	45,131
Accounts payable	(261,670)	1,388,708
Accrued expenses	(321,973)	(409,963)
Other liabilities	397
Net cash used in operating activities	(1,953,973)	(1,725,723)
Cash flows from investing activities
Purchases of property and equipment		(7,432)
Net cash used in investing activities		(7,432)
Cash flows from financing activities
Proceeds from exercise of options on common stock		2,130
Net cash provided by financing activities		2,130
Net decrease in cash and cash equivalents	(1,953,973)	(1,731,025)
Cash and cash equivalents at beginning of period	7,046,282	15,819,566
Cash and cash equivalents at end of period	5,092,309	14,088,541
Supplemental disclosure of cash flow information
Cash paid for interest
Cash paid for taxes

Organization and Principal Acti

Organization and Principal Activities	3 Months Ended
	Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Principal Activities	NOTE 1 — ORGANIZATION AND PRINCIPAL ACTIVITIES Ritter Pharmaceuticals, Inc. (“Ritter” or the “Company”) is a Delaware corporation headquartered in Los Angeles, California. The Company was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC, and converted into a Delaware corporation on September 16, 2008. Ritter Pharmaceuticals, Inc. develops therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases. The Company conducts human gut health research by exploring metabolic capacity of the gut microbiota and translating the functionality of prebiotic-based therapeutics. The Company’s lead compound, RP-G28, is currently under development for the treatment of lactose intolerance. There currently is no drug approved by the Food and Drug Administration (“FDA”) for the treatment of lactose intolerance, a debilitating disease that affects over 1 billion people worldwide. The Company currently operates in one business segment focusing on the development and commercialization of RP-G28. The Company is not organized by market and is managed and operated as one business. A single management team reports to the chief operating decision maker, the Chief Executive Officer. The Company does not currently operate any separate lines of business or separate business entities.

Basis of Presentation

Basis of Presentation	3 Months Ended
	Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Basis of Presentation	NOTE 2 — BASIS OF PRESENTATION The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The accompanying interim period unaudited condensed financial statements have also been prepared in accordance with GAAP and applicable rules and regulations of the SEC regarding interim financial reporting. The condensed balance sheet as of March 31, 2017, the condensed statements of operations for the three months ended March 31, 2017 and 2016, and the condensed statements of cash flows for the three months ended March 31, 2017 and 2016, are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. The condensed balance sheet at December 31, 2016 has been derived from audited financial statements included in the Annual Report on Form 10-K filed with the SEC on February 27, 2017. The results for the three months ended March 31, 2017 are not necessarily indicative of the results expected for the full fiscal year or any other period. The accompanying interim period unaudited condensed financial statements and related financial information included in this Quarterly Report on Form 10-Q should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Going Concern and Liquidity The accompanying condensed financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any product revenue and has not achieved profitable operations. For the three months ended March 31, 2017, the Company had a net loss of approximately $1.7 million and had net cash used in operating activities of approximately $2.0 million. At March 31, 2017, the Company had working capital of approximately $2.7 million, an accumulated deficit of approximately $47.1 million, and cash and cash equivalents of approximately $5.1 million. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and pre-clinical testing, and commercialization of the Company’s products will require significant financing. These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern. Since inception, the operations of the Company have been funded through the sale of common shares, preferred shares and convertible debt. Management cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct business. If the Company is not able to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and/or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES There have been no material changes in the Company’s significant accounting policies as of and for the three months ended March 31, 2017, as compared with the significant accounting policies described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents Cash consists of amounts held in a financial institution and consists of immediately available fund balances. The funds are maintained at a stable financial institution, generally at amounts in excess of federally insured limits. As of March 31, 2017, and December 31, 2016, approximately $4.6 million and approximately $6.8 million, respectively, in cash and cash equivalents were uninsured. The Company has not experienced any loss on deposits of cash and cash equivalents to date. Clinical Trial and Pre-Clinical Study Accruals The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances known to it at that time. Accrued expenses for pre-clinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, clinical trial investigational sites, and other related vendors. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of milestones. In accruing service fees, management estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other information available to it. If the Company underestimates or overestimates the activity or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in the Company’s accruals. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-02, Leases (Topic 842) i.e., Leases On March 30, 2016, the FASB issued Accounting Standards Update No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting On August 26, 2016, the FASB issued Accounting Standards Update No. 2016-15, Statement of Cash Flows (Topic 230), Other accounting standards updates effective after March 31, 2017 are not expected to have a material effect on the Company’s financial statements.

Property and Equipment

Property and Equipment	3 Months Ended
	Mar. 31, 2017
Property, Plant and Equipment [Abstract]
Property and Equipment	NOTE 4 — PROPERTY AND EQUIPMENT Property and equipment consists of the following: Estimated Life March 31, 2017 December 31, 2016 Computer equipment 5 years $ 10,274 $ 10,274 Furniture and fixtures 7 years 23,325 23,325 Total property and equipment 33,599 33,599 Accumulated depreciation (11,364 ) (10,057 ) Property and equipment, net $ 22,235 $ 23,542 Depreciation expense of approximately $1,300 was recognized for the three months ended March 31, 2017 and 2016, and classified in general and administrative expense in the accompanying unaudited condensed statements of operations.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2017
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	NOTE 5 — COMMITMENTS AND CONTINGENCIES Master Services Agreement On December 30, 2015, the Company entered into a Master Service Agreement with Covance, Inc. (“Covance”), with an effective date of December 29, 2015. Pursuant to the terms of the Master Service Agreement, Covance (or one or more of its affiliates) will provide Phase 1, 2, 3, and 4 clinical services for a clinical study or studies to the Company, and, at the request of the Company, assist with the design of such studies, in accordance with the terms of separate individual project agreements to be entered into by the parties. The term of the agreement is for three years and will renew automatically for successive one year periods unless Covance is no longer providing services under the agreement or either party has terminated the agreement upon written notice. The Company may terminate the Master Service Agreement or any individual project agreement entered into under the Master Service Agreement prior to the applicable study’s completion at any time for any reason upon 30 days written notice to Covance, except when the reason for termination is the safety of subjects, in which case it may be terminated immediately. Covance may not terminate any individual project agreement without cause, except when the reason for the termination is the safety of subjects, in which case it may be terminated immediately. In the event of a termination of the Master Service Agreement, Covance will be entitled to full payment for (i) work performed on the applicable project through the date work on such project is concluded and (ii) reimbursement for all non-cancellable and non-refundable expenses and financial obligations which Covance (or an affiliate) has incurred or undertaken on behalf of the Company. Clinical Supply and Cooperation Agreement with Ricerche Sperimentali Montale (“Ricerche”) and Inalco SpA (“Inalco”) Effective July 24, 2015, the Company entered into an amended Clinical Supply and Cooperation Agreement (the “Amended Supply Agreement”) with Ricerche and Inalco (collectively, “RSM”). The Amended Supply Agreement amends certain terms of the Clinical Supply and Cooperation Agreement, dated December 16, 2009, amended on September 25, 2010. Pursuant to the terms of the Amended Supply Agreement, the Company purchased the exclusive worldwide assignment of all right, title and interest to a purified GOS product (“Improved GOS”), the composition of matter of the Improved GOS and any information relating to the Improved GOS, including certain specified technical information and other intellectual property rights (the “Improved GOS IP”) on July 30, 2015 for $800,000. The Company also issued 100,000 shares of its common stock to RSM pursuant to a stock purchase agreement. The shares issued to RSM are subject to a lock-up agreement, pursuant to which RSM has agreed that it will not sell these shares for a period ending on the earlier of (i) the public release by the Company of the final results of its Phase 2b/3 clinical trial of RP-G28 and (ii) the filing of a Form 10-Q with the SEC for the fiscal quarter in which the Company receives the results of its Phase 2b/3 clinical trial of RP-G28. Under the terms of the Amended Supply Agreement, if the Company fails to make any future option payment to RSM as required under the terms of the Amended Supply Agreement, the Company may be required to return the Improved GOS IP to RSM. The Amended Supply Agreement provides that the Company must pay RSM $400,000 within 10 days following FDA approval of a new drug application for the first product owned or controlled by the Company using Improved GOS as its active pharmaceutical ingredient and to pay RSM the sum of $250 per kilo for clinical supply of Improved GOS. Lease Agreement The Company leases office space for its headquarters in California. On July 9, 2015, the Company entered into a lease with Century Park, a California limited partnership, pursuant to which the Company is leasing approximately 2,780 square feet of office space in Los Angeles, California for its headquarters. The lease provides for a term of sixty-one (61) months, commencing on October 1, 2015. The Company paid no rent for the first month of the term, paid base rent of $9,174 per month for months 2 through 13 of the term, and will pay base rent of $9,449 per month for months 14 to 25 with increasing base rent for each twelve-month period thereafter under the term of the lease to a maximum of $10,325 per month for months 50 through 61. The base rent payments do not include the Company’s proportionate share of any operating expenses, including real estate taxes. The Company has the option to extend the term of the lease for one five-year term, provided that the rent would be subject to market adjustment at the beginning of the renewal term. Rent expense, which is recognized on a straight-line basis over the lease term, was approximately $38,000 and $29,000 for the three months ended March 31, 2017 and 2016, respectively, and is recorded in general and administrative expenses in the accompanying unaudited condensed statements of operations. Legal The Company is not currently involved in any legal matters arising in the normal course of business. From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2017
Equity [Abstract]
Stockholders' Equity	NOTE 6 — STOCKHOLDERS’ EQUITY Authorized Shares On June 29, 2015, the Company amended and restated its Certificate of Incorporation (“the Amended Certificate”) authorizing the issuance of 25,000,000 shares of common stock, $0.001 par value per share, and 5,000,000 shares of preferred stock, $0.001 par value per share. As of March 31, 2017, the Company had 11,619,197 shares of common stock issued and outstanding. Each share of the Company’s common stock is entitled to one vote, and all shares rank equally as to voting and other matters. There are currently no shares of preferred stock issued and outstanding. Any preferred stock issued in the future will have the rights, preferences and privileges that the Company’s Board of Directors may determine from time to time. 2015 Aspire Capital Financing Arrangement On December 18, 2015, the Company entered into a common stock purchase agreement (the “2015 Aspire Purchase Agreement”), with Aspire Capital Fund, LLC, an Illinois limited liability company, (“Aspire Capital”), pursuant to which Aspire Capital is committed to purchase up to an aggregate of $10.0 million of the Company’s shares of common stock over the approximate 30-month term of the 2015 Aspire Purchase Agreement. In consideration for entering into the 2015 Aspire Purchase Agreement, concurrently with the execution of the 2015 Aspire Purchase Agreement, the Company issued to Aspire Capital 188,864 shares of the Company’s common stock as a commitment fee (the “Commitment Shares”). The fair value of the Commitment Shares were capitalized and recorded as a reduction of additional paid-in capital. Upon execution of the 2015 Aspire Purchase Agreement, the Company sold 500,000 shares of common stock to Aspire Capital at $2.00 per share for proceeds of $1.0 million. The Company sold an additional 888,835 shares of common stock to Aspire Capital on December 8, 2016 at $2.28 per share for approximate proceeds of $2.0 million. As of March 31, 2017, the Company had issued an aggregate of 1,577,699 shares of its common stock to Aspire Capital for approximate proceeds of $3.0 million. From March 31, 2017 through May 4, 2017, the Company issued an aggregate of 3,000,000 shares of its common stock to Aspire Capital for approximate proceeds of $2.0 million. Any trading day on which the closing sale price of the Company’s common stock exceeds $0.50, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice, directing Aspire Capital (as principal) to purchase up to 100,000 shares of the Company’s common stock per trading day, for up to $7.0 million of the Company’s common stock in the aggregate at a per share price, calculated by reference to the prevailing market price of the Company’s common stock (as provided in the 2015 Aspire Purchase Agreement). Concurrently with entering into the 2015 Aspire Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital, as amended (the “Registration Agreement”), in which the Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, as amended (the “Securities Act”), the sale of the shares of its common stock that have been and may be issued to Aspire Capital under the 2015 Aspire Purchase Agreement. On December 31, 2015, the Company filed a registration statement on Form S-1 (File No. 333-208818) pursuant to the terms of the Registration Agreement, which registration statement was declared effective on February 11, 2016. The Company filed a second registration statement on Form S-1 (File No. 333-215143), which registration statement was declared effective on February 13, 2017. On May 4, 2017, the Company terminated the 2015 Aspire Purchase Agreement and entered into a new common stock purchase agreement with Aspire Capital (the “2017 Aspire Purchase Agreement”), which provides that upon the terms and conditions set forth therein (which terms and conditions are substantially similar to those provided in the 2015 Aspire Purchase Agreement), Aspire Capital is committed to purchase up to an aggregate of $6.5 million of shares of the Company’s common stock over the 30-month term of the 2017 Aspire Purchase Agreement. As a condition to the 2017 Aspire Purchase Agreement, the Company will issue 137,324 shares of its common stock to Aspire Capital as a commitment fee (the “2017 Commitment Shares”). Concurrently with entering into the 2017 Aspire Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital, in which the Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, the sale of shares of its common stock that may be issued to Aspire Capital under the 2017 Aspire Purchase Agreement (including the 2017 Commitment Shares”). As of the date of filing this Quarterly Report with the SEC no shares of common stock have been sold to Aspire Capital under the 2017 Aspire Purchase Agreement. October 2016 Public Offering On October 31, 2016, the Company closed a public offering, selling 2,127,660 shares of the Company’s common stock at a price to the public of $2.35 per share, for aggregate gross proceeds to the Company of approximately $5.0 million. The Company paid to the underwriters underwriting discounts and commissions of approximately $0.4 million in connection with the offering, and approximately $0.2 million of other expenses in connection with the offering. This offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-213087), which was declared effective by the SEC on August 23, 2016. The shelf registration statement allows the Company to issue, from time to time at prices and on terms to be determined at or prior to the time of an offering, up to $150,000,000 of any combination of an indeterminate number of shares of common stock, an indeterminate number of shares of preferred stock, an indeterminate principal amount of debt securities, an indeterminate number of warrants, rights and purchase contracts to purchase common stock or debt securities, and an indeterminate number of units. If any debt securities are issued at an original issue discount, then the offering price of such debt securities shall be in such greater principal amount as shall result in an aggregate offering price not to exceed $150,000,000, less the aggregate dollar amount of all securities previously issued hereunder. The securities registered also include such indeterminate number of shares of common stock and preferred stock that may be issued upon conversion or exchange of convertible or exchangeable securities being registered or pursuant to the anti-dilution provisions of any such securities.

Warrants

Warrants	3 Months Ended
	Mar. 31, 2017
Warrants and Rights Note Disclosure [Abstract]
Warrants	NOTE 7 — WARRANTS Warrants to purchase an aggregate of 578,323 shares of the Company’s common stock were outstanding at March 31, 2017. These warrants are all vested and exercisable, have exercise prices ranging from $6.25 to $9.30 per share, with a weighted average exercise price of $8.45, and expire at various dates through December 2021.

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2017
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation	NOTE 8 — STOCK-BASED COMPENSATION Equity Incentive Plans The Company has issued equity awards pursuant to its 2015 Equity Incentive Plan, 2009 Stock Plan and 2008 Stock Plan (collectively the “Plans”.) The Plans permit the Company to grant non-statutory stock options, incentive stock options and other equity awards to the Company’s employees, outside directors and consultants; however, incentive stock options may only be granted to the Company’s employees. Beginning June 29, 2015, no further awards may be granted under the 2009 Stock Plan or 2008 Stock Plan. As of March 31, 2017, the aggregate number of shares of common stock available for issuance under the 2015 Equity Incentive Plan was 360. However, to the extent awards under the 2008 Plan or 2009 Plan are forfeited or lapse unexercised or are settled in cash, the common stock subject to such awards will be available for future issuance under the 2015 Equity Incentive Plan. The following represents a summary of the options granted to employees and non-employees that are outstanding at March 31, 2017 and changes during the period then ended: Number of Shares Weighted- Average Exercise Price Aggregate Intrinsic Value Weighted- Average Remaining Contractual Life (in years) Outstanding at December 31, 2016 2,476,924 $ 6.01 $ 497,351 8.3 Options granted 88,000 $ 2.89 Options forfeited ― $ ― Options exercised ― $ ― Outstanding at March 31, 2017 2,564,924 $ 5.90 $ 20,110 8.1 Exercisable at March 31, 2017 1,612,603 The exercise price for an option issued under the Plans is determined by the Board of Directors, but will be (i) in the case of an incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the date of grant. The options awarded under the Plans will vest as determined by the Board of Directors but will not exceed a ten-year period. Fair Value of Equity Awards The Company utilizes the Black-Scholes option pricing model to value awards under its Plans. Key valuation assumptions include: ● Expected dividend yield. ● Expected stock-price volatility. ● Risk-free interest rate. ● Expected term. The Company elected to adopt the amendments of ASU 2016-09 (described in Note 3) related to the presentation of excess tax benefits on the statement of cash flows using a prospective transition method but does not expect any impact on its financial statements. The material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented were as follows: Three months ended March 31, 2017 2016 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 53.90% - 54.08 % 53.53% - 59.03 % Risk-free interest rate 2.31% - 2.58 % 0.18% - 2.25 % Term of options 10 10 Stock price $1.42 - $3.48 $1.07 - $1.79 Stock-Based Compensation The Company recognized stock-based compensation expense for services within general and administrative expense in the accompanying statements of operations of approximately $294,000 and $378,000 for the three months ended March 31, 2017 and 2016, respectively. As of March 31, 2017, there was approximately $1.0 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 1.3 years. No stock options were exercised during the three months ended March 31, 2017. 2,657 options were exercised during the three months ended March 31, 2016, with approximate proceeds to the Company of $2,000. There was no aggregate intrinsic value of stock options exercised during the three months ended March 31, 2016.

Summary of Significant Accoun14

Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents	Cash and Cash Equivalents Cash consists of amounts held in a financial institution and consists of immediately available fund balances. The funds are maintained at a stable financial institution, generally at amounts in excess of federally insured limits. As of March 31, 2017, and December 31, 2016, approximately $4.6 million and approximately $6.8 million, respectively, in cash and cash equivalents were uninsured. The Company has not experienced any loss on deposits of cash and cash equivalents to date.
Clinical Trial and Pre-Clinical Study Accruals	Clinical Trial and Pre-Clinical Study Accruals The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances known to it at that time. Accrued expenses for pre-clinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, clinical trial investigational sites, and other related vendors. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of milestones. In accruing service fees, management estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other information available to it. If the Company underestimates or overestimates the activity or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in the Company’s accruals.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-02, Leases (Topic 842) i.e., Leases On March 30, 2016, the FASB issued Accounting Standards Update No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting On August 26, 2016, the FASB issued Accounting Standards Update No. 2016-15, Statement of Cash Flows (Topic 230), Other accounting standards updates effective after March 31, 2017 are not expected to have a material effect on the Company’s financial statements.

Property and Equipment (Tables)

Property and Equipment (Tables)	3 Months Ended
	Mar. 31, 2017
Property, Plant and Equipment [Abstract]
Schedule of Property and Equipment	Property and equipment consists of the following: Estimated Life March 31, 2017 December 31, 2016 Computer equipment 5 years $ 10,274 $ 10,274 Furniture and fixtures 7 years 23,325 23,325 Total property and equipment 33,599 33,599 Accumulated depreciation (11,364 ) (10,057 ) Property and equipment, net $ 22,235 $ 23,542

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2017
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Summary of Stock Option Activity	The following represents a summary of the options granted to employees and non-employees that are outstanding at March 31, 2017 and changes during the period then ended: Number of Shares Weighted- Average Exercise Price Aggregate Intrinsic Value Weighted- Average Remaining Contractual Life (in years) Outstanding at December 31, 2016 2,476,924 $ 6.01 $ 497,351 8.3 Options granted 88,000 $ 2.89 Options forfeited ― $ ― Options exercised ― $ ― Outstanding at March 31, 2017 2,564,924 $ 5.90 $ 20,110 8.1 Exercisable at March 31, 2017 1,612,603
Schedule Assumptions Used in Black-Scholes Option-pricing Method	The material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented were as follows: Three months ended March 31, 2017 2016 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 53.90% - 54.08 % 53.53% - 59.03 % Risk-free interest rate 2.31% - 2.58 % 0.18% - 2.25 % Term of options 10 10 Stock price $1.42 - $3.48 $1.07 - $1.79

Basis of Presentation (Details

Basis of Presentation (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016	Dec. 31, 2016	Dec. 31, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Net loss	$ 1,673,235	$ 3,128,450
Net cash used in operating activities	1,953,973	1,725,723
Working capital deficit	2,700,000
Accumulated deficit	(47,140,811)		$ (45,467,576)
Cash and cash equivalents	$ 5,092,309	$ 14,088,541	$ 7,046,282	$ 15,819,566

Summary of Significant Accoun18

Summary of Significant Accounting Policies (Detail Narrative) - USD ($)	Mar. 31, 2017	Dec. 31, 2016
Accounting Policies [Abstract]
Cash and cash equivalents uninsured	$ 4,600,000	$ 6,800,000

Property and Equipment (Details

Property and Equipment (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 1,307	$ 1,254

Property and Equipment - Schedu

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($)	3 Months Ended
	Mar. 31, 2017	Dec. 31, 2016
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 33,599	$ 33,599
Less: Accumulated depreciation and amortization	(11,364)	(10,057)
Property and equipment, net	22,235	23,542
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 10,274	10,274
Useful Life (Years)	5 years
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 23,325	$ 23,325
Useful Life (Years)	7 years

Commitments and Contingencies (

Commitments and Contingencies (Details Narrative)	Jul. 30, 2015USD ($)$ / kgshares	Jul. 09, 2015ft²	Mar. 31, 2017USD ($)	Mar. 31, 2016USD ($)
Lease agreement term			5 years
Rent expense			$ 38,000	$ 29,000
Century Park [Member]
Area of lease | ft²		2,780
Lease agreement term		61 months
Months 2 Through 13 [Member]
Rent expense			$ 9,174
Lease term description			months 2 through 13 of the term
Months 14 To 25 [Member]
Rent expense			$ 9,449
Lease term description			months 14 to 25
Months 50 Through 61 [Member]
Rent expense			$ 10,325
Lease term description			months 50 through 61
Ricerche Sperimentali Montale Spa And Inalco Spa [Member] | Amended Clinical Supply And Cooperation Agreement [Member] | Contractual Rights [Member]
Payment for GOS IP	$ 800,000
Payment required following FDA approval to RSM	$ 400,000
GOS price per kilo | $ / kg	250
Ricerche Sperimentali Montale Spa And Inalco Spa [Member] | Stock Purchase Agreement [Member]
Number of common shares to be issued | shares	100,000

Stockholders' Equity (Details N

Stockholders' Equity (Details Narrative) - USD ($)	Dec. 08, 2016	Oct. 31, 2016	Dec. 18, 2015	Mar. 31, 2017	Dec. 31, 2016	Jun. 29, 2015
Common stock, shares authorized				25,000,000	25,000,000	25,000,000
Common stock, par value				$ 0.001	$ 0.001	$ 0.001
Preferred stock, shares authorized				5,000,000	5,000,000	5,000,000
Preferred stock, par value				$ 0.001	$ 0.001	$ 0.001
Common stock, shares issued				11,619,197	11,619,197
Common stock, shares outstanding				11,619,197	11,619,197
October 2016 Public Offering [Member]
Number of common shares sold		2,127,660
Shares of common stock sold, per share		$ 2.35
Aggregate gross proceeds from sale of common stock		$ 5,000,000
Underwriting discounts and commissions		400,000
Other expenses with offering		$ 200,000
October 2016 Public Offering [Member] | Maximum [Member]
Aggregate gross proceeds from sale of common stock				$ 150,000,000
Aggregate offering price				$ 150,000,000
Common Stock Purchase Agreement [Member] | Aspire Capital Fund LLC [Member]
Payments to acquire common stock			$ 10,000,000
Purchase agreement term			30 months
Aggregate of shares issued during period			188,864
Number of stock sold during period, value	$ 2,000,000		$ 1,000,000
Number of common shares sold	888,835		500,000	1,577,699
Shares of common stock sold, per share	$ 2.28		$ 2
Aggregate gross proceeds from sale of common stock				$ 3,000,000
Common Stock Purchase Agreement [Member] | Aspire Capital Fund LLC [Member] | March 31, 2017 through May 4, 2017 [Member]
Number of common shares sold				3,000,000
Aggregate gross proceeds from sale of common stock				$ 2,000,000
2015 Aspire Purchase Agreement [Member] | Aspire Capital Fund LLC [Member]
Closing sale price of common stock exceeds				18.00%
Number of common shares sold				100,000
Aggregate gross proceeds from sale of common stock				$ 7,000,000
2017 Aspire Purchase Agreement [Member] | May 4, 2017 [Member]
Purchase agreement term				30 months
Number of common shares sold				137,324
Aggregate gross proceeds from sale of common stock				$ 6,500,000

Warrants (Details Narrative)

Warrants (Details Narrative)	3 Months Ended
	Mar. 31, 2017$ / sharesshares
Issuance of warrants to purchase of common stock shares | shares	578,323
Weighted average exercise price	$ 8.45
Warrants expiration date	Dec. 31, 2021
Minimum [Member]
Warrants exercise prices ranging	$ 6.25
Maximum [Member]
Warrants exercise prices ranging	$ 9.30

Stock-Based Compensation (Detai

Stock-Based Compensation (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Stock based compensation expense	$ 294,176	$ 377,597
Number of stock options exercised		2,657
Cash received from exercise of stock options		$ 2,130
Aggregate intrinsic value of stock options exercised
Employee Stock Option [Member]
Unrecognized compensation cost related to un-vested stock based compensation	$ 1,000,000
Weighted average period of compensation cost expected to be recognized	1 year 3 months 18 days
Employee Stock Option [Member] | General and Administrative Expense [Member]
Stock based compensation expense	$ 294,000	$ 378,000
2015 Stock Plan [Member] | Employee Stock Option [Member]
Aggregate number of shares of common stock authorized to issue	360
Stock Plan 2015 [Member] | Employee Stock Option [Member]
Stock option description	The exercise price for an option issued under the Plans is determined by the Board of Directors, but will be (i) in the case of an incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the date of grant. The options awarded under the Plans shall vest as determined by the Board of Directors but shall not exceed a ten-year period.
Vesting period of options	10 years

Stock-Based Compensation - Summ

Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Number of Shares, Outstanding, beginning	2,476,924
Number of Shares, Options granted	88,000
Number of Shares, Options forfeited
Number of Shares, Options exercised		2,657
Number of Options, Outstanding at ending	2,564,924
Number of Options, Exercisable	1,612,603
Weighted Average Exercise Price, Outstanding, beginning	$ 6.01
Weighted Average Exercise Price, Options granted	2.89
Weighted Average Exercise Price, Options forfeited
Weighted Average Exercise Price, Options exercised
Weighted Average Exercise Price, Outstanding at ending	$ 5.90
Aggregate Intrinsic Value, Outstanding, beginning	$ 497,351
Aggregate Intrinsic Value, Outstanding at ending	$ 20,110
Weighted- Average Remaining Contractual Life (in years), Outstanding, beginning	8 years 3 months 18 days
Weighted- Average Remaining Contractual Life (in years), Outstanding at ending	8 years 1 month 6 days

Stock-Based Compensation - Sche

Stock-Based Compensation - Schedule Assumptions Used in Black-Scholes Option-pricing Method (Details) - $ / shares	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Expected dividend yield	0.00%	0.00%
Expected stock-price volatility, Minimum	53.90%	53.53%
Expected stock-price volatility, Maximum	54.08%	59.03%
Risk-free interest rate, Minimum	2.31%	0.18%
Risk-free interest rate, Maximum	2.58%	2.25%
Term of options	10 years	10 years
Minimum [Member]
Stock price	$ 1.42	$ 1.07
Maximum [Member]
Stock price	$ 3.48	$ 1.79