Qualigen Therapeutics (QLGN) 10-Q 31 Oct 17 2017 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2017	Oct. 27, 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	Sep. 30, 2017
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		49,506,521
Trading Symbol	RTTR
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,017

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Current assets
Cash and cash equivalents	$ 3,558,874	$ 7,046,282
Prepaid expenses	260,597	156,752
Total current assets	3,819,471	7,203,034
Other assets	10,326	10,326
Deferred offering costs	310,786
Property and equipment, net	19,606	23,542
Total Assets	4,160,189	7,236,902
Current liabilities
Accounts payable	2,745,370	1,896,368
Accrued expenses	196,578	1,222,735
Other liabilities	15,927	14,736
Total current liabilities	2,957,875	3,133,839
Stockholders' equity
Preferred stock, $0.001 par value; 15,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016
Common stock, $0.001 par value; 225,000,000 shares authorized; 14,756,521 and 11,619,197 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively	14,757	11,619
Additional paid-in capital	52,302,244	49,559,020
Accumulated deficit	(51,114,687)	(45,467,576)
Total stockholders' equity	1,202,314	4,103,063
Total Liabilities and Stockholders' Equity	$ 4,160,189	$ 7,236,902

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2017	Dec. 31, 2016
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	15,000,000	15,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	225,000,000	225,000,000
Common stock, shares issued	14,756,521	11,619,197
Common stock, shares outstanding	14,756,521	11,619,197

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Operating costs and expenses:
Research and development	$ 915,268	$ 2,348,755	$ 2,121,898	$ 7,112,177
Patent costs	47,431	98,908	175,794	199,888
General and administrative	1,052,236	1,091,647	3,367,781	3,533,608
Total operating costs and expenses	2,014,935	3,539,310	5,665,473	10,845,673
Operating loss	(2,014,935)	(3,539,310)	(5,665,473)	(10,845,673)
Other income:
Interest income	4,083	13,239	18,362	50,466
Other income				1,214
Total other income	4,083	13,239	18,362	51,680
Net loss	$ (2,010,852)	$ (3,526,071)	$ (5,647,111)	$ (10,793,993)
Net loss per common share - basic and diluted	$ (0.14)	$ (0.41)	$ (0.42)	$ (1.26)
Weighted-average common shares outstanding - basic and diluted	14,756,521	8,585,406	13,443,007	8,584,442

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Cash flows from operating activities
Net loss	$ (5,647,111)	$ (10,793,993)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	3,936	3,894
Stock-based compensation	746,362	1,041,656
Changes in operating assets and liabilities:
Prepaid expenses	(103,845)	(57,092)
Accounts payable	849,002	2,131,022
Accrued expenses	(1,026,157)	293,793
Other liabilities	1,191	12,841
Net cash used in operating activities	(5,176,622)	(7,367,879)
Cash flows from investing activities
Purchases of property and equipment		(8,063)
Net cash used in investing activities		(8,063)
Cash flows from financing activities
Proceeds from the issuance of shares from common stock purchase agreement	2,000,000
Proceeds from exercise of options on common stock		8,504
Deferred offering costs	(310,786)
Net cash provided by financing activities	1,689,214	8,504
Net decrease in cash and cash equivalents	(3,487,408)	(7,367,438)
Cash and cash equivalents at beginning of period	7,046,282	15,819,566
Cash and cash equivalents at end of period	3,558,874	8,452,128
Supplemental disclosure of cash flow information
Cash paid for taxes	800	72,112
Non-cash financing activities
Shares issued as a commitment fee	$ 93,380

Organization and Principal Acti

Organization and Principal Activities	9 Months Ended
	Sep. 30, 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 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 one 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	9 Months Ended
	Sep. 30, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Basis of Presentation	NOTE 2 — BASIS OF PRESENTATION The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. However, in the opinion of management, all adjustments consisting of normal recurring adjustments considered necessary for a fair presentation of the financial position and results of operations have been included and management believes the disclosures that are made are adequate to make the information presented not misleading. The condensed balance sheet at December 31, 2016 has been derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the SEC on February 27, 2017 (the “2016 Annual Report”), but does not include all of the information and footnotes required by GAAP for complete financial statements. The results for the three and nine months ended September 30, 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 (“Quarterly Report”) should be read in conjunction with the audited financial statements and notes thereto included in the Company’s 2016 Annual Report. 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 nine months ended September 30, 2017, the Company had a net loss of approximately $5.6 million and had net cash used in operating activities of approximately $5.2 million. At September 30, 2017, the Company had working capital of approximately $0.9 million, an accumulated deficit of approximately $51.1 million, and cash and cash equivalents of approximately $3.6 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 RP-G28; (ii) seek collaborators 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 its rights to RP-G28. 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	9 Months Ended
	Sep. 30, 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 nine months ended September 30, 2017, as compared with the significant accounting policies described in the Company’s 2016 Annual Report. 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 September 30, 2017 and December 31, 2016, approximately $3.6 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), In May 2017, the FASB issued Accounting Standards Update No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting . Other accounting standards updates effective after September 30, 2017 are not expected to have a material effect on the Company’s financial statements.

Property and Equipment

Property and Equipment	9 Months Ended
	Sep. 30, 2017
Property, Plant and Equipment [Abstract]
Property and Equipment	NOTE 4 — PROPERTY AND EQUIPMENT Property and equipment consists of the following: Estimated Life September 30, 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 (13,993 ) (10,057 ) Property and equipment, net $ 19,606 $ 23,542 Depreciation expense of approximately $1,300 was recognized for each of the three months ended September 30, 2017 and 2016 and approximately $3,900 was recognized for the nine months ended September 30, 2017 and 2016, and classified in general and administrative expense in the accompanying unaudited condensed statements of operations.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 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 were subject to a lock-up agreement, pursuant to which RSM agreed that it would 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, which condition was satisfied with the filing of the Company’s quarterly report on Form 10-Q on August 7, 2017. 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 $29,000 and $28,000 for the three months ended September 30, 2017 and 2016, respectively, and $86,000 for the nine months ended September 30, 2017 and 2016, 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	9 Months Ended
	Sep. 30, 2017
Equity [Abstract]
Stockholders' Equity	NOTE 6 — STOCKHOLDERS’ EQUITY Authorized Shares On September 15, 2017, the Company amended its Amended and Restated Certificate of Incorporation to authorize the issuance of up to 225,000,000 shares of common stock, $0.001 par value per share, and 15,000,000 shares of preferred stock, $0.001 par value per share. As of September 30, 2017, the Company had 14,756,521 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. 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 (“Aspire Capital”), pursuant to which Aspire Capital was 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. As of September 30, 2017, the Company had issued an aggregate of 4,577,699 shares of its common stock to Aspire Capital under the 2015 Aspire Purchase Agreement for approximate proceeds of $5.0 million. 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, 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. On any trading day on which the closing sale price of the Company’s common stock exceeds $0.25, 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 $6.5 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 2017 Aspire Purchase Agreement). As a condition to the 2017 Aspire Purchase Agreement, the Company issued 137,324 shares of its common stock to Aspire Capital as a commitment fee. As of the date of this Quarterly Report, 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, 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. October 2017 Public Offering On October 3, 2017, the Company closed a public offering, selling an aggregate of (i) 34,550,000 Class A Units consisting of 34,550,000 shares of the Company’s common stock and warrants to purchase 34,550,000 shares of the Company’s common stock at a public offering price of $0.40 per unit, and (ii) 9,180 Class B Units consisting of 9,180 shares of Series A Convertible Preferred Stock, with a stated value of $1,000 per unit, and convertible into an aggregate of 22,950,000 shares of the Company’s common stock, and warrants to purchase an aggregate of 22,950,000 shares of the Company’s common stock. The warrants have an exercise price of $0.44, are exercisable upon issuance and expire five years from the date of issuance. The Company granted the underwriters a 45-day option to purchase an additional 8,625,000 shares of the Company’s common stock and/or warrants to purchase an additional 8,625,000 shares of the Company’s common stock. As of the closing of the offering, the underwriters have exercised their over-allotment option for warrants to purchase 2,975,000 shares of the Company’s common stock. Aggregate gross proceeds to the Company from the public offering were approximately $23.0 million. The Company paid to the underwriters underwriting discounts and commissions of approximately $1.6 million in connection with the offering, and approximately $0.4 million of other expenses in connection with the offering of which approximately $0.3 million are recorded as deferred offering costs in the Company’s financial statements as of, and for the nine months ended September 30, 2017. The securities described above were offered by the Company pursuant to a registration statement filed with the SEC that was declared effective on September 28, 2017. The final prospectus relating to the offering was filed with the SEC on October 2, 2017.

Warrants

Warrants	9 Months Ended
	Sep. 30, 2017
Warrants and Rights Note Disclosure [Abstract]
Warrants	NOTE 7 — WARRANTS The following represents a summary of the warrants outstanding at September 30, 2017 and changes during the period then ended: Warrants Weighted Average Exercise Price Outstanding at December 31, 2016 578,323 $ 8.45 Granted — $ — Exercised/Expired/Forfeited — $ — Outstanding at September 30, 2017 578,323 $ 8.45 Exercisable at September 30, 2017 578,323 $ 8.45

Stock-Based Compensation

Stock-Based Compensation	9 Months Ended
	Sep. 30, 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 (the “2015 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. 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. On June 2, 2017, the stockholders of the Company approved an amendment to the 2015 Plan at the 2017 annual meeting of stockholders, which among other things, increased the number of shares that may be issued pursuant to awards under the 2015 Plan by 838,000 shares of common stock. On September 15, 2017, the stockholders of the Company approved an amendment to the 2015 Plan at a special meeting of stockholders, which among other things, increased the number of shares that may be issued pursuant to awards under the 2015 Plan by 25,858,711 shares of common stock. As of September 30, 2017, the aggregate number of shares of common stock authorized for issuance under the 2015 Plan, as amended, was 27,500,000. The following represents a summary of the options granted to employees and non-employees that are outstanding at September 30, 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 ― 8.8 Options forfeited (5,000 ) 2.89 ― ― Outstanding at September 30, 2017 2,559,924 5.91 ― 7.6 Exercisable at September 30, 2017 1,808,972 $ 5.88 $ ― 7.2 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 September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Expected stock price volatility 53.08% - 53.68 % 53.60% - 54.73 % 53.08% – 53.90 % 53.60% - 59.03 % Risk-free interest rate 1.89% - 2.29 % 1.29% - 1.71 % 1.98% - 2.37 % 1.29% - 1.78 % Term of options 10 10 10 10 Stock price $0.35 - $0.65 $1.27 - $1.68 $0.35 - $1.08 $1.13 - $1.68 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 $203,000 and $333,000 for the three months ended September 30, 2017 and 2016, respectively, and $746,000 and $1,042,000 for the nine months ended September 30, 2017 and 2016, respectively. As of September 30, 2017, there was approximately $263,000 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 1.1 years. No stock options were exercised during the three and nine months ended September 30, 2017. Approximately 8,000 options were exercised during the three months ended September 30, 2016, and approximately 11,000 options were exercised during the nine months ended September 30, 2016 with approximate proceeds to the Company of $9,000. The aggregate intrinsic value of stock options exercised during the nine months ended September 30, 2016 was approximately $18,000.

Summary of Significant Accoun14

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 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 September 30, 2017 and December 31, 2016, approximately $3.6 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), In May 2017, the FASB issued Accounting Standards Update No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting . Other accounting standards updates effective after September 30, 2017 are not expected to have a material effect on the Company’s financial statements.

Property and Equipment (Tables)

Property and Equipment (Tables)	9 Months Ended
	Sep. 30, 2017
Property, Plant and Equipment [Abstract]
Schedule of Property and Equipment	Property and equipment consists of the following: Estimated Life September 30, 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 (13,993 ) (10,057 ) Property and equipment, net $ 19,606 $ 23,542

Warrants (Tables)

Warrants (Tables)	9 Months Ended
	Sep. 30, 2017
Warrants and Rights Note Disclosure [Abstract]
Schedule of Warrants Outstanding	The following represents a summary of the warrants outstanding at September 30, 2017 and changes during the period then ended: Warrants Weighted Average Exercise Price Outstanding at December 31, 2016 578,323 $ 8.45 Granted — $ — Exercised/Expired/Forfeited — $ — Outstanding at September 30, 2017 578,323 $ 8.45 Exercisable at September 30, 2017 578,323 $ 8.45

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 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 September 30, 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 ― 8.8 Options forfeited (5,000 ) 2.89 ― ― Outstanding at September 30, 2017 2,559,924 5.91 ― 7.6 Exercisable at September 30, 2017 1,808,972 $ 5.88 $ ― 7.2
Schedule of 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 September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Expected stock price volatility 53.08% - 53.68 % 53.60% - 54.73 % 53.08% – 53.90 % 53.60% - 59.03 % Risk-free interest rate 1.89% - 2.29 % 1.29% - 1.71 % 1.98% - 2.37 % 1.29% - 1.78 % Term of options 10 10 10 10 Stock price $0.35 - $0.65 $1.27 - $1.68 $0.35 - $1.08 $1.13 - $1.68

Basis of Presentation (Details

Basis of Presentation (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016	Dec. 31, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Net loss	$ 2,010,852	$ 3,526,071	$ 5,647,111	$ 10,793,993
Net cash used in operating activities			(5,176,622)	(7,367,879)
Working capital deficit	900,000		900,000
Accumulated deficit	(51,114,687)		(51,114,687)		$ (45,467,576)
Cash and cash equivalents	$ 3,558,874	$ 8,452,128	$ 3,558,874	$ 8,452,128	$ 7,046,282	$ 15,819,566

Summary of Significant Accoun19

Summary of Significant Accounting Policies (Details Narrative) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Accounting Policies [Abstract]
Cash and cash equivalents uninsured	$ 3,600,000	$ 6,800,000

Property and Equipment (Details

Property and Equipment (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 1,300	$ 1,300	$ 3,936	$ 3,894

Property and Equipment - Schedu

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($)	9 Months Ended
	Sep. 30, 2017	Dec. 31, 2016
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 33,599	$ 33,599
Accumulated depreciation	(13,993)	(10,057)
Property and equipment, net	19,606	23,542
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 10,274	10,274
Estimated Life	5 years
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 23,325	$ 23,325
Estimated Life	7 years

Commitments and Contingencies (

Commitments and Contingencies (Details Narrative)	Jul. 30, 2015USD ($)$ / kgshares	Jul. 09, 2015ft²	Sep. 30, 2017USD ($)	Sep. 30, 2016USD ($)	Sep. 30, 2017USD ($)	Sep. 30, 2016USD ($)
Lease agreement term					5 years
Rent expense			$ 29,000	$ 28,000	$ 86,000	$ 86,000
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 ($)	May 04, 2017	Oct. 31, 2016	Dec. 18, 2015	Sep. 30, 2017	Sep. 15, 2017	Dec. 31, 2016
Common stock, shares authorized				225,000,000	25,000,000	225,000,000
Common stock, par value				$ 0.001	$ 0.001	$ 0.001
Preferred stock, shares authorized				15,000,000	15,000,000	15,000,000
Preferred stock, par value				$ 0.001	$ 0.001	$ 0.001
Common stock, shares issued				14,756,521		11,619,197
Common stock, shares outstanding				14,756,521		11,619,197
Common stock, voting rights				Each share of the Company’s common stock is entitled to one vote, and all shares rank equally as to voting and other matters.
Number of options granted to purchase shares of common stock				88,000
Number of options exercised to purchase shares of common stock
Deferred offering costs				$ 310,786
October 2016 Public Offering [Member]
Aggregate gross proceeds from sale of common stock		$ 5,000,000
Shares of common stock sold, per share		$ 2.35
Number of common shares sold		2,127,660
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
October 2017 Public Offering [Member]
Aggregate gross proceeds from sale of common stock				$ 23,000,000
Number of warrants to purchase common stock				8,625,000
Underwriting discounts and commissions				$ 1,600,000
Other expenses with offering				$ 400,000
Number of options granted to purchase shares of common stock				8,625,000
Number of options exercised to purchase shares of common stock				2,975,000
Deferred offering costs				$ 300,000
October 2017 Public Offering [Member] | Warrant [Member]
Number of warrants to purchase common stock				22,950,000
Number of preferred stock shares convertible into common shares				22,950,000
Warrant term				5 years
October 2017 Public Offering [Member] | Capital Unit, Class A [Member]
Shares of common stock sold, per share				$ 0.40
Number of common shares sold				34,550,000
Number of warrants to purchase common stock				34,550,000
October 2017 Public Offering [Member] | Capital Unit, Class B [Member]
Number of common shares sold				9,180
Warrant exercise price per share				$ 0.44
October 2017 Public Offering [Member] | Capital Unit, Class B [Member] | Series A Convertible Preferred Stock [Member]
Preferred stock, par value				$ 1,000
Number of common shares sold				9,180
Common Stock Purchase Agreement [Member] | Aspire Capital Fund LLC [Member]
Purchase agreement term			30 months
Aggregate of shares issued during period				4,577,699
Aggregate gross proceeds from sale of common stock				$ 5,000,000
Common Stock Purchase Agreement [Member] | Aspire Capital Fund LLC [Member] | Maximum [Member]
Payments to acquire common stock			$ 10,000,000
2017 Aspire Purchase Agreement [Member]
Purchase agreement term	30 months
2017 Aspire Purchase Agreement [Member] | Maximum [Member]
Aggregate gross proceeds from sale of common stock	$ 6,500,000
Number of common shares sold	100,000
2017 Aspire Purchase Agreement [Member] | Minimum [Member]
Shares of common stock sold, per share	$ 0.25
2017 Aspire Purchase Agreement [Member] | Aspire Capital Fund LLC [Member]
Aggregate of shares issued during period				137,324

Warrants - Schedule of Warrants

Warrants - Schedule of Warrants Outstanding (Details)	9 Months Ended
	Sep. 30, 2017$ / sharesshares
Warrants and Rights Note Disclosure [Abstract]
Warrants, Outstanding Beginning Balance | shares	578,323
Warrants, Granted | shares
Warrants, Exercised/Expired/Forfeited | shares
Warrants, Outstanding Ending Balance | shares	578,323
Warrants, Exercisable | shares	578,323
Weighted Average Exercise Price, Outstanding Beginning Balance | $ / shares	$ 8.45
Weighted Average Exercise Price, Granted | $ / shares
Weighted Average Exercise Price, Exercised/Expired/Forfeited | $ / shares
Weighted Average Exercise Price, Outstanding Ending Balance | $ / shares	8.45
Weighted Average Exercise Price, Exercisable | $ / shares	$ 8.45

Stock-Based Compensation (Detai

Stock-Based Compensation (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Sep. 15, 2017	Jun. 02, 2017	Dec. 31, 2016
Common stock shares issued	14,756,521		14,756,521				11,619,197
Stock based compensation expense			$ 746,362	$ 1,041,656
Number of stock options exercised
Stock Options [Member]
Number of stock options exercised		8,000		11,000
Cash received from exercise of stock options				$ 9,000
Aggregate intrinsic value of stock options exercised				18,000
Employee Stock Option [Member]
Unrecognized compensation cost related to un-vested stock based compensation	$ 263,000		$ 263,000
Weighted average period of compensation cost expected to be recognized			1 year 1 month 6 days
Employee Stock Option [Member] | General and Administrative Expense [Member]
Stock based compensation expense	$ 203,000	$ 333,000	$ 746,000	$ 1,042,000
2015 Stock Plan [Member]
Number of common stock shares authorized for issuance			27,500,000
2015 Stock Plan [Member] | Employee Stock Option [Member]
Aggregate number of shares of common stock authorized to issue						838,000
Common stock shares issued					25,858,711
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)	9 Months Ended
	Sep. 30, 2017USD ($)$ / sharesshares
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Number of Shares, Outstanding, beginning | shares	2,476,924
Number of Shares, Options granted | shares	88,000
Number of Shares, Options forfeited | shares	(5,000)
Number of shares, Outstanding at ending | shares	2,559,924
Number of shares, Exercisable | shares	1,808,972
Weighted Average Exercise Price, Outstanding, beginning | $ / shares	$ 6.01
Weighted Average Exercise Price, Options granted | $ / shares	2.89
Weighted Average Exercise Price, Options forfeited | $ / shares	2.89
Weighted Average Exercise Price, Outstanding at ending | $ / shares	5.91
Weighted Average Exercise Price, Options Exercisable | $ / shares	$ 5.88
Aggregate Intrinsic Value, Outstanding, beginning | $	$ 497,351
Aggregate Intrinsic Value, Outstanding at ending | $
Aggregate Intrinsic Value, Options Exercisable | $
Weighted- Average Remaining Contractual Life (in years), Outstanding, beginning	8 years 3 months 19 days
Weighted- Average Remaining Contractual Life (in years), Options granted	8 years 9 months 18 days
Weighted- Average Remaining Contractual Life (in years), Outstanding at ending	7 years 7 months 6 days
Weighted- Average Remaining Contractual Life (in years), Options Exercisable	7 years 2 months 12 days

Stock-Based Compensation - Sche

Stock-Based Compensation - Schedule of Assumptions used in Black-Scholes Option-pricing Method (Details) - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Expected stock-price volatility, minimum	53.08%	53.60%	53.08%	53.60%
Expected stock-price volatility, maximum	53.68%	54.73%	53.90%	59.03%
Risk-free interest rate, minimum	1.89%	1.29%	1.98%	1.29%
Risk-free interest rate, maximum	2.29%	1.71%	2.37%	1.78%
Term of options	10 years	10 years	10 years	10 years
Minimum [Member]
Stock price	$ 0.35	$ 1.27	$ 0.35	$ 1.13
Maximum [Member]
Stock price	$ 0.65	$ 1.68	$ 1.08	$ 1.68