Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 28, 2019 | Jun. 30, 2018 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Neurotrope, Inc. | ||
Entity Central Index Key | 1,513,856 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 73,488,239 | ||
Trading Symbol | NTRP | ||
Entity Common Stock, Shares Outstanding | 12,922,370 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 28,854,218 | $ 16,113,150 |
Prepaid expenses | 603,324 | 310,437 |
TOTAL CURRENT ASSETS | 29,457,542 | 16,423,587 |
Fixed assets, net of accumulated depreciation | 20,842 | 20,655 |
TOTAL ASSETS | 29,478,384 | 16,444,242 |
CURRENT LIABILITIES | ||
Accounts payable | 2,898,583 | 1,240,033 |
Accrued expenses | 58,492 | 268,250 |
Accrued expenses - related party | 0 | 50,000 |
TOTAL CURRENT LIABILITIES | 2,957,075 | 1,558,283 |
Commitments and contingencies | ||
SHAREHOLDERS' EQUITY | ||
Common stock - 150,000,000 shares authorized, $.0001 par value; 12,922,370 shares issued and outstanding at December 31, 2018; 7,895,859 shares issued and outstanding at December 31, 2017 | 1,292 | 790 |
Additional paid-in capital | 100,202,110 | 77,544,976 |
Accumulated deficit | (73,682,093) | (62,659,807) |
TOTAL SHAREHOLDERS' EQUITY | 26,521,309 | 14,885,959 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 29,478,384 | $ 16,444,242 |
CONSOLIDATED BALANCE SHEETS _Pa
CONSOLIDATED BALANCE SHEETS [Parenthetical] - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares issued | 12,922,370 | 7,895,859 |
Common stock, shares outstanding | 12,922,370 | 7,895,859 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
OPERATING EXPENSES: | ||
Research and development - related party | $ 262,012 | $ 214,619 |
Research and development | 4,623,551 | 4,548,835 |
General and administrative - related party | 50,000 | 39,417 |
General and administrative | 3,997,222 | 5,455,683 |
Stock-based compensation - related party | 291,577 | 155,320 |
Stock-based compensation | 1,925,034 | 2,288,123 |
TOTAL OPERATING EXPENSES | 11,149,396 | 12,701,997 |
OTHER INCOME (EXPENSE): | ||
Loss on abandonment of fixed assets | 0 | (34,274) |
Gain on settlement of lease obligation | 0 | 53,599 |
Interest income | 127,110 | 67,602 |
Net loss before income taxes | (11,022,286) | (12,615,070) |
Provision for income taxes | 0 | 0 |
Net loss | $ (11,022,286) | $ (12,615,070) |
PER SHARE DATA: | ||
Basic and diluted loss per common share | $ (1.37) | $ (1.64) |
Basic and diluted weighted average common shares outstanding | 8,050,700 | 7,709,400 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2016 | $ 23,604,676 | $ 676 | $ 73,648,737 | $ (50,044,737) |
Balance (in shares) at Dec. 31, 2016 | 6,754,547 | |||
Issuance of common stock for consulting fees | 121,645 | $ 1 | 121,644 | 0 |
Issuance of common stock for consulting fees (in shares) | 12,189 | |||
Exercise of common stock warrants | 1,331,265 | $ 113 | 1,331,152 | 0 |
Exercise of common stock warrants (in shares) | 1,129,092 | |||
Stock based compensation | 2,443,443 | $ 0 | 2,443,443 | 0 |
Shares issued for reverse stock split rounding (in shares) | 31 | |||
Net loss | (12,615,070) | $ 0 | 0 | (12,615,070) |
Balance at Dec. 31, 2017 | 14,885,959 | $ 790 | 77,544,976 | (62,659,807) |
Balance (in shares) at Dec. 31, 2017 | 7,895,859 | |||
Sale of common stock and warrants | 20,436,598 | $ 501 | 20,436,097 | |
Sale of common stock and warrants (in shares) | 5,012,677 | |||
Exercise of common stock warrants | 4,427 | $ 1 | 4,426 | 0 |
Exercise of common stock warrants (in shares) | 13,834 | |||
Stock based compensation | 2,216,611 | $ 0 | 2,216,611 | 0 |
Net loss | (11,022,286) | 0 | 0 | (11,022,286) |
Balance at Dec. 31, 2018 | $ 26,521,309 | $ 1,292 | $ 100,202,110 | $ (73,682,093) |
Balance (in shares) at Dec. 31, 2018 | 12,922,370 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (11,022,286) | $ (12,615,070) |
Adjustments to reconcile net loss to net cash used by operating activities | ||
Stock based compensation | 2,216,611 | 2,443,443 |
Consulting services paid by issuance of common stock | 0 | 121,645 |
Depreciation expense | 2,999 | 3,854 |
Loss on abandonment of fixed assets | 0 | 34,274 |
Change in assets and liabilities | ||
Increase in prepaid expenses | (292,887) | (171,726) |
Increase (decrease) in accounts payable | 1,658,550 | (927,380) |
(Decrease) increase in accrued expenses | (209,758) | 77,506 |
(Decrease) increase in accrued expenses - related party | (50,000) | 45,391 |
Total adjustments | 3,325,515 | 1,627,007 |
Net Cash Used in Operating Activities | (7,696,771) | (10,988,063) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of property and equipment | (3,186) | (3,585) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Net proceeds from issuance of common stock and warrants | 20,436,598 | 0 |
Net proceeds from exercise of common stock warrants | 4,427 | 1,331,265 |
Net Cash Provided by Financing Activities | 20,441,025 | 1,331,265 |
NET INCREASE (DECREASE) IN CASH | 12,741,068 | (9,660,383) |
CASH AT BEGINNING OF YEAR | 16,113,150 | 25,773,533 |
CASH AT END OF YEAR | $ 28,854,218 | $ 16,113,150 |
Organization, Nature of Busines
Organization, Nature of Business, and Liquidity: | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations [Text Block] | Note 1 – Organization, Nature of Business, and Liquidity : Business Neurotrope BioScience was incorporated in Delaware on October 31, 2012. Neurotrope BioScience was formed to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). Neurotrope BioScience is collaborating with Cognitive Research Enterprises, Inc. (formerly known as the Blanchette Rockefeller Neurosciences Institute, or BRNI) (“CRE”), a related party, in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 4). Liquidity As of February 28, 2019, the Company had approximately $25.5 million in cash and cash equivalents. The Company expects that its existing capital resources will be sufficient to support its projected operating requirements over at least the next approximately 24 to 36 months, including the continuing development of bryostatin, our novel drug targeting the activation of PKC epsilon, through our ongoing follow-on clinical study (estimated revised total cost of $7.3 million - see Note 3), conduct other non-clinical studies, plus the plan to conduct additional studies in AD and potentially other diseases that might benefit from using bryostatin. The balance of the funds will be used for general corporate and working capital purposes. We expect to require additional capital in order to initiate and pursue additional development projects in addition to our current confirmatory AD clinical trial. Additional funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to pursue development of such other product candidates. If so, we could be required to delay, scale back or eliminate some or all of our existing or additional contemplated development programs and operations. Any additional equity financing, if available, may not be available on favorable terms, would most likely be significantly dilutive to our current stockholders and debt financing, if available, may involve restrictive covenants. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition and results of operations. To alleviate its going concern qualification, in December 2018, the Company raised approximately $20.5 million in net cash proceeds. These proceeds will enable the Company to continue operations for next approximately 24 to 36 months. |
Summary of Significant Accounti
Summary of Significant Accounting Policies: | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies [Text Block] | Note 2 – Summary of Significant Accounting Policies : Use of Estimates: The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents and Concentration of Credit Risk: The Company considers all highly liquid temporary cash investments with an original maturity of three months or less when purchased to be cash equivalents. At December 31, 2018, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $12.3 million. In addition, approximately $16.2 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. Property and Equipment: Property and equipment is capitalized and depreciated on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years. Research and Development Costs: All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE that do not meet the criteria for capitalization are expensed when incurred. FASB ASC Topic 730 requires companies involved in research and development activities to capitalize non-refundable advance payments for such services pursuant to contractual arrangements because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services at December 31, 2018 and 2017. Loss Per Share: Basic loss per common share amounts are based on the weighted average number of common shares outstanding. Diluted loss per share amounts are based on the weighted average number of common shares outstanding, plus the incremental shares that would have been outstanding upon the assumed exercise of all potentially dilutive stock options and warrants subject to anti-dilution limitations. All such potentially dilutive instruments were anti-dilutive as of December 31, 2018 and 2017, which were approximately 11.7 million shares and 5.8 million shares, respectively. Income Taxes: The Company had federal and state net operating losses for income tax purposes of approximately $51.5 million for the period from October 31, 2012 (inception) through December 31, 2018. The net operating loss carryforwards resulted in a deferred tax asset of approximately $10.8 million at December 31, 2018. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. Under current U.S. federal tax law, the Company would receive a compensation expense deduction related to non-qualified stock options only when those options are exercised. Accordingly, the financial statement recognition of compensation cost for non-qualified stock options creates a deductible temporary difference. The Company does not recognize a tax benefit for compensation expense related to incentive stock options (“ISOs”) unless the underlying shares are disposed of in a disqualifying disposition. Accordingly, compensation expense related to ISOs is treated as a permanent difference for income tax purposes. These deferred tax assets are reduced to zero by an offsetting valuation allowance. As a result, there is no provision for income taxes. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in results of operations in the period that includes the enactment date. The Tax Cuts and Jobs Act (the Act) was enacted on December 22, 2017. The Act reduces the US federal corporate tax rate from 35% to 21%, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred and creates new taxes on certain foreign sourced earnings. As of December 31, 2018 the Company did not have any repatriation of foreign income therefore we recognized a provisional amount of $0. In connection with the Act, we re-measured certain deferred tax assets and liabilities based on the rates at which they are anticipated to reverse in the future, which is generally 21%. The provisional amount recorded related to the re-measurement of our deferred tax balance was a tax expense of $6.7 million which was fully offset with a valuation allowance against our deferred taxes. Income taxes are provided for the tax effects of transactions reported in the financial statements and consist of taxes currently due and deferred taxes. Deferred taxes are recognized for differences between the basis of assets and liabilities for financial statement and income tax purposes and the tax effects of net operating loss and other carryforwards. The deferred tax assets and liabilities represent the future tax consequences of those differences and carryforwards, which will either be taxable or deductible when the related assets, liabilities or carryforwards are recovered or settled. Deferred tax assets are reduced by a valuation allowance when, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company applies the provisions of FASB ASC 740-10, Accounting for Uncertain Tax Positions , which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard also provides guidance on de-recognition, classification, interest and penalties, and accounting in interim periods, disclosure and transitions. The Company has concluded that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing. Under Section 382 of the Internal Revenue Code of 1986, as amended, changes in the Company's ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. The Company has not performed a study to assess whether an ownership change for purposes of Section 382 has occurred, or whether there have been multiple ownership changes since the Company's inception, due to the significant costs and complexities associated with such study. Risks and Uncertainties: The Company operates in an industry that is subject to rapid technological change, intense competition and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risk. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the ability to obtain favorable licensing, manufacturing or other agreements for its product candidates and the ability to raise capital to achieve strategic objectives. Stock Compensation: The Company accounts for stock-based awards to employees in accordance with applicable accounting principles, which requires compensation expense related to share-based transactions, including employee stock options, to be measured and recognized in the financial statements based on a determination of the fair value of the stock options. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. Employee stock option expense is recognized over the employee’s requisite service period (generally the vesting period of the equity grant). The Company’s option pricing model requires the input of highly subjective assumptions, including the volatility and expected term. Any changes in these highly subjective assumptions significantly impact stock-based compensation expense. Recent Accounting Pronouncements In December 2018, the FASB issued ASU-2018-20, Leases (Topic 842). In February 2016, the FASB issued new guidance related to how an entity should account for lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. Accounting for leases by lessors is largely unchanged under the new guidance. The guidance is effective for the Company beginning in the first quarter of 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The Company has determined that this standard is not expected to have a material impact to its financial statements based upon the de minimis amount of short-term lease commitments. In July 2017, the FASB issued new guidance, ASU-2017-11, Distinguishing Liabilities from Equity (Topic 480), which changes the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features and re-characterizes the indefinite deferral of certain provisions within the guidance for distinguishing liabilities from equity. The guidance is effective for the Company beginning in the first quarter of fiscal year 2019. Early adoption is permitted. The Company is evaluating the impact of adopting this guidance on its consolidated financial statements. In November 2018, the FASB issued ASU-2018-18, Collaborative Arrangements (Topic 808). In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and requires, that in a transaction with a collaborative arrangement participant who is not a customer, presenting the transaction together with revenue recognized under contracts with customers is precluded. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted. The Company will assess the impact of the adoption of this guidance on its consolidated financial statements once the Company begins to generate revenue. Accounting Pronouncements Adopted During the Period: In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . This ASU simplifies the accounting for nonemployee share-based payment transactions. Under the new guidance, equity-classified share-based payment awards issued to nonemployees will now be measured on the grant date, instead of the previous requirement to re-measure the awards through performance completion date. Awards that include performance conditions will recognize compensation cost when the achievement of the performance condition is probable, rather than upon achievement of the performance condition. Finally, the current requirement to reassess the classification (equity or liability) for nonemployee awards upon vesting will be eliminated, except for awards in the form of convertible instruments. The ASU is effective for annual periods beginning after December 15, 2018 and interim periods within those annual periods. Early adoption is permitted, including interim periods, but no earlier than the adoption of ASC 606. Effective June 20, 2018, we adopted this standard. As a result of the adoption of this new guidance, certain non-employee equity awards were measured on the grant date. There was no cumulative effect of the change on retained earnings as of January 1, 2018 since we had no unvested non-employee awards outstanding as of that date. |
Collaborative Agreements_
Collaborative Agreements: | 12 Months Ended |
Dec. 31, 2018 | |
Collaborative Agreements [Abstract] | |
Collaborative Agreements [Text Block] | Note 3 – Collaborative Agreements : Stanford License Agreements On May 12, 2014, the Company entered into a license agreement (the “Stanford Agreement”) with The Board of Trustees of The Leland Stanford Junior University (“Stanford”), pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of bryostatin structural derivatives, known as “bryologs,” for use in the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardio protection and traumatic brain injury, for the life of the licensed patents. We are required by the Stanford Agreement to use commercially reasonable efforts to develop, manufacture and sell products (“Licensed Products”) in the Licensed Field of Use (as defined in the Stanford Agreement) during the term of the licensing agreement which expires upon the termination of the last valid claim of any licensed patent under this agreement. In addition, we must meet specific diligence milestones, and upon meeting such milestones, make specific milestone payments to Stanford. We will also pay Stanford royalties of 3% on net sales, if any, of Licensed Products (as defined in the Stanford Agreement) and milestone payments of up to $3.7 million dependent upon stage of product development To-date, no royalties nor milestone payments have been made. On January 19, 2017, the Company entered into an additional, second license agreement with Stanford, pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of “Bryostatin Compounds and Methods of Preparing the Same,” or synthesized bryostatin, for use in the treatment of neurological diseases, cognitive dysfunction and psychiatric disorders, for the life of the licensed patents. The Company paid Stanford $70,000 upon executing the license and is obligated to pay an additional $10,000 annually as a license maintenance fee. In addition, based upon certain milestones which include product development and commercialization, the Company will be obligated to pay up to an additional $2.1 million and between 1.5% and 4.5% royalty payments on certain revenues generated by the Company relating to the licensed technology. The Company has made all required annual maintenance payments. Mt. Sinai License Agreement On July 14, 2014, Neurotrope BioScience entered into an Exclusive License Agreement (the “Mount Sinai Agreement”) with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”). Pursuant to the Mount Sinai Agreement, Mount Sinai granted Neurotrope BioScience (a) a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under Mount Sinai’s interest in certain joint patents held by the Company and Mount Sinai (the “Joint Patents”) as well as in certain results and data (the “Data Package”) and (b) a non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information, both relating to the diagnostic, prophylactic or therapeutic use for treating diseases or disorders in humans relying on activation of Protein Kinase C Epsilon (“PKCε”), which includes Niemann-Pick Disease (the “Mount Sinai Field of Use”). The Mount Sinai Agreement allows Neurotrope BioScience to research, discover, develop, make, have made, use, have used, import, lease, sell, have sold and offer certain products, processes or methods that are covered by valid claims of Mount Sinai’s interest in the Joint Patents or an Orphan Drug Designation Application covering the Data Package (“Mount Sinai Licensed Products”) in the Mount Sinai Field of Use (as such terms are defined in the Mount Sinai Agreement). Clinical Trial Services Agreements On May 4, 2018, Neurotrope BioScience executed a new Services Agreement (the “New Services Agreement”) with Worldwide Clinical Trials (“WCT”). The New Services Agreement relates to services for Neurotrope BioScience’s Phase 2 confirmatory clinical study assessing the safety, tolerability and efficacy of bryostatin in the treatment of moderately severe to severe AD (the “Study”). Pursuant to the terms of the Services Agreement, WCT is providing services to target enrollment of approximately one hundred (100) Study subjects. The total estimated budget for the services, including pass-through costs, drug supply and other statistical analyses, is approximately $7.3 million based upon the progress of the Study. Of the total estimated Study costs, as of December 31, 2018, the Company has incurred approximately $3.9 million in expenses of which WCT has represented a total of approximately $3.7 million and approximately $200,000 of expenses have been incurred to other trial-related vendors and consultants. In addition, the Company paid $1.2 million to WCT as prepaid deposits of which the Company has utilized approximately $900,000, leaving a balance included in prepaid expenses of approximately $300,000. |
Related Party Transactions and
Related Party Transactions and Licensing / Research Agreements: | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | Note 4 – Related Party Transactions and Licensing / Research Agreements : James Gottlieb, a director of the Company, serves as a director of CRE, and Shana Phares, also a director of the Company, serves as President and Chief Executive Officer of CRE. CRE is a stockholder of a corporation, Neuroscience Research Ventures, Inc. (“NRV, Inc.”), which owned 2.2% of the Company's outstanding common stock as of December 31, 2018. Effective October 31, 2012, Neurotrope BioScience executed a Technology License and Services Agreement (the “TLSA”) with CRE, a related party, and NRV II, LLC (“NRV II”), another affiliate of CRE, which was amended by Amendment No. 1 to the TLSA as of August 21, 2013. As of February 4, 2015, the parties entered into an Amended and Restated Technology License and Services Agreement (the “CRE License Agreement”). The CRE License Agreement provides research services and has granted Neurotrope BioScience the exclusive and nontransferable world-wide, royalty-bearing right, with a right to sublicense (in accordance with the terms and conditions described below), under CRE’s and NRV II’s respective right, title and interest in and to certain patents and technology owned by CRE or licensed to NRV II by CRE as of or subsequent to October 31, 2012, to develop, use, manufacture, market, offer for sale, sell, distribute, import and export certain products or services for therapeutic applications for AD and other cognitive dysfunctions in humans or animals (the “Field of Use”). Additionally, the TLSA specifies that all patents that issue from a certain patent application shall constitute licensed patents and all trade secrets, know-how and other confidential information claimed by such patents constitute licensed technology under the CRE License. The CRE License Agreement terminates on the later of the date (a) the last of the licensed patent expires, is abandoned, or is declared unenforceable or invalid or (b) the last of the intellectual property enters the public domain. After the initial Series A Stock financing, the CRE License Agreement required Neurotrope BioScience to enter into scope of work agreements with CRE as the preferred service provider for any research and development services or other related scientific assistance and support services. In addition, the CRE License Agreement requires the Company to pay CRE a “Fixed Research Fee” of $1 million per year for five years, commencing on the date that the Company completes a Series B Preferred Stock financing resulting in proceeds of at least $25,000,000 (the “Series B Financing”). This Fixed Research Fee is not yet due. The CRE License Agreement also requires the payment of royalties ranging between 2% and 5% of the Company’s revenues generated from the licensed patents and other intellectual property, dependent upon the percentage ownership that NRV, Inc. holds in the Company. Under the CRE License Agreement, the Company was required to prepay royalty fees at a rate of 5% of all investor funds raised in the Series A or Series B Stock financings or any subsequent rounds of financing prior to a public offering, less commissions. On November 12, 2015, Neurotrope BioScience, CRE, and NRV II entered into an amendment (the “Amendment”) to the TLSA pursuant to which CRE granted rights in certain technology to Neurotrope BioScience. Under the Amendment, the “Advances on Future Royalties” section of the TLSA was amended and restated to (i) eliminate the requirement that Neurotrope BioScience pay CRE prepaid royalties equal to five percent (5%) of financing proceeds received by Neurotrope BioScience in any financing prior to a public offering, and (ii) provide that Neurotrope BioScience will deliver to CRE, following each closing pursuant to a certain securities purchase agreement, an amount equal to 2.5% of the Post-PA Fees Proceeds received at such closing. In addition, the Amendment provides that on or prior to December 31, 2016, Neurotrope Bioscience shall deliver to CRE an amount equal to 2.5% of the aggregate Post-PA Fee Proceeds received at the closings. Each payment would constitute an advance royalty payment to CRE and will be offset (with no interest) against the amount of future royalty obligations payable until such time that the amount of such future royalty obligations equals in full the amount of the advance royalty payments made. “Post-PA Fee Proceeds” means the gross proceeds received, less all amounts paid to the placement agent(s), in relation to such gross proceeds. No other expenses of Neurotrope Bioscience shall be subtracted from the gross proceeds to determine the “Post-PA Fee Proceeds.” As of December 31, 2018, the Company has paid its entire obligation of $1,166,666 resulting from this Amendment. In addition, on November 10, 2018, Neurotrope BioScience and CRE entered into a second amendment (the “Second Amendment”) to the TLSA to which CRE granted certain patent prosecution and maintenance rights to Neurotrope BioScience. Under the Second Amendment, Neurotrope BioScience will have the sole and exclusive right and the obligation, to apply for, file, prosecute and maintain patents and applications for the intellectual property licensed to Neurotrope BioScience, and pay all fees, costs and expenses related to the licensed intellectual property. Neurotrope BioScience paid CRE $10,000 in consideration of this Second Amendment. |
Common Stock_
Common Stock: | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | Note 5 – Common Stock : December 2018 Offering On December 17, 2018, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain investors (the “Purchasers”). Pursuant to the terms of the Purchase Agreement, the Company agreed to sell to the Purchasers in a registered direct offering an aggregate of 5,012,677 shares of its common stock and Series G warrants to purchase up to an aggregate of 5,012,677 shares of common stock at a combined purchase price of $4.495 per share and accompanying warrant. The warrants were not deemed to be derivative securities. As a result, the value of the warrants were accounted for as offsetting entries in the stockholders’ equity section of the balance sheet. The warrants will be exercisable at a price of $4.37 per share beginning six months following the date of issuance and will expire five years from the exercise date. The net proceeds to the Company from the offering were approximately $20.5 million, after deducting placement agent fees, financial advisory fees and estimated offering expenses payable by the Company of approximately $2.1 million. Pursuant to a placement agent agreement, dated December 17, 2018 (the “Placement Agent Agreement”), the Company paid (i) a cash fee of $442,000 (8.0% of the aggregate gross proceeds raised from Purchasers first contacted by the placement agent in connection with the offering) and (ii) warrants to purchase 24,583 shares of common stock (represents the number of shares of common stock equal to 2.0% of the aggregate number of shares sold to Purchasers first contacted by the placement agent in connection with the offering). The Company also agreed to reimburse the placement agent an additional $25,000 for its legal expenses. The placement agent warrants have substantially the same terms as the warrants issued to the investors in the offering, except that the placement agent warrants have an exercise price equal to $6.25 and a term of five years from the effective date of the offering. Pursuant to separate advisory consulting agreements (as amended, the “Consulting Agreements”), the Company engaged advisory financial consultants in connection with the offering. The Company agreed to pay total consulting fees of approximately $1.6 million, plus reimbursement of up to $50,000 of their legal expenses. In addition, the financial consultants received a total of warrants to purchase 75,657 shares of common stock. Such warrants issued to the advisory financial consultants have the same terms and be in the same form as the placement agent warrants described above. |
Stock Options_
Stock Options: | 12 Months Ended |
Dec. 31, 2018 | |
Stock Options [Member] | |
Stock Option Note Disclosure [Text Block] | Note 6 – Stock Options : Option Grants On March 9, 2017, the Company’s Board of Directors approved the Neurotrope, Inc. 2017 Equity Incentive Plan (the “2017 Plan”), which provides for the issuance of incentive awards of up to 800,000 shares of Common Stock to officers, key employees, consultants and directors. The 2017 Plan was approved by stockholders in December 2017. In October 2018, the Company’s Board approved an increase in the total number of shares available under the 2017 Plan by 600,000 to 1.4 million shares. The increase was subsequently approved by stockholders in December 2018. The following is a summary of stock option activity under the stock option plans for the year ended December 31, 2018: Weighted- Average Weighted- Remaining Aggregate Average Contractual Intrinsic Number of Exercise Term Value Shares Price (Years) (in thousands) Options outstanding at January 1, 2018 1,345,835 $ 20.10 8.8 Options granted 276,285 $ 7.77 Less options forfeited (16,873 ) $ 18.03 Less options expired/cancelled (85,001 ) $ 11.71 Less options exercised - $ - Options outstanding at December 31, 2018 1,520,246 $ 18.07 8.2 $ 0 Options exercisable at December 31, 2018 914,964 $ 21.98 7.7 $ 0 Pursuant to the Company’s Board of Directors compensation plan, in March 2018, the Company granted stock options to purchase an aggregate of 70,000 shares of the Company’s common stock to seven members of the Company’s Board of Directors. The stock options have an exercise price of $8.9125 per share and an expiration date that is ten years from the date of issuance. All of the options vest on the first anniversary of the issuance date. During July 2018, the Company granted stock options to purchase an aggregate of 110,000 shares of the Company’s common stock to the five members of the Company’s newly-formed Scientific Advisory Board. The stock options have exercise prices of $10.19 and $10.23 per share and an expiration date that is ten years from the date of issuance. Options to purchase 90,000 shares of common stock vest in equal installments on the first, second and third anniversary of the date of issuance; options to purchase the remaining 20,000 shares of common stock vest quarterly over a three-year period. During December 2018, the Company granted stock options to purchase an aggregate of 96,285 shares of the Company’s common stock to the Chief Executive Officer, pursuant to his employment contract and to two new members of the Company’s Board of Directors. The stock options have exercises prices ranging from $4.10 to $4.44 per share and an expiration date that is ten years from the date of issuance. All of the options vest daily over a three-year period. The following is a summary of stock options outstanding under the plans as of December 31, 2018: Stock Options Stock Options Outstanding Exercisable Remaining Weighted Avg. Weighted Avg. Weighted Avg. Range of Number of Contractual Life Exercise Number of Exercise Exercise Prices Shares (years) Price Shares Price $ 0.32 - $15.77 785,208 8.78 $ 8.96 389,502 $ 9.75 $19.10 - $22.72 492,697 8.23 $ 19.48 283,841 $ 19.44 $25.60 - $32.00 95,694 6.80 $ 29.83 95,693 $ 29.83 $35.52 - $49.60 35,003 6.31 $ 42.11 34,753 $ 42.15 $52.48 - $71.04 111,644 5.20 $ 58.22 111,175 $ 58.23 1,520,246 8.16 $ 18.07 914,964 $ 21.98 As of December 31, 2018, there was approximately $3.4 million of total unrecognized compensation costs related to unvested stock options. These costs are expected to be recognized over a weighted average period of 2.2 years. The Company used the Black-Scholes valuation model to calculate the fair value of stock options. The fair value of stock options issued for the year ended December 31, 2018 was estimated at the grant date using the following weighted average assumptions: Dividend yield 0%; Expected term 10 years; Volatility 91.5%; and Risk-free interest rate 2.88%. The weighted average grant date fair value of options granted for the year ended December 31, 2018 is $6.80 per share. The total stock option-based compensation recorded as operating expense was $2,216,609 and $2,443,444 for the years ended December 31, 2018 and 2017, respectively. |
Common Stock Warrants_
Common Stock Warrants: | 12 Months Ended |
Dec. 31, 2018 | |
Warrant [Member] | |
Stock Option Note Disclosure [Text Block] | Note 7 – Common Stock Warrants : The following is a summary of common stock warrant activity for the year ended December 31, 2018: Number of shares Warrants outstanding January 1, 2018 5,115,274 Warrants issued 5,112,917 Warrants exercised (13,834 ) Warrants outstanding December 31, 2018 10,214,357 As of December 31, 2018, the Company’s warrants by exercise price were as follows: 147,606 warrants exercisable at $0.32, 5,012,677 warrants exercisable at $4.37, 100,240 warrants exercisable at $6.25, 382,887 warrants exercisable at $6.40, 3,751,033 warrants exercisable at $12.80 and 819,914 warrants exercisable at $32.00. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | Note 8 – Commitments and Contingencies The Company is a party to various contractual commitments pursuant to its normal course of business. The Company maintains two offices for which it pays approximately $80,000 per year. In addition, the Company has a contractual relationship with WCT. Further, the Company maintains strategic agreements with certain academic institutions for product development opportunities in various therapeutic categories and for potential drug product supply (See Footnote 3 above for additional details.) Since May 17, 2017, two purported class action lawsuits were commenced in the United States District Court for the Southern District of New York (the “NY Litigation”). On August 10, 2017, the lawsuits were consolidated and Plaintiffs filed their Amended Consolidated Complaint on October 9, 2017. The Amended Consolidated Complaint named as defendants the Company, its former Chief Executive Officer and its co-founder and President/Chief Scientific Officer. The lawsuit alleged violations of the Securities Exchange Act of 1934, as amended, in connection with allegedly false and misleading statements made by the Company in certain press releases and in its Annual Report on Form 10-K relating to the results stemming from our Phase 2 clinical trial for bryostatin. Plaintiffs sought, among other things, damages for purchasers of the Company’s securities between January 7, 2016 and July 18, 2017. On November 21, 2017, the Company and the other named defendants filed a motion to dismiss all of the claims (the “Motion”). On June 4, 2018 the Court granted the Motion and dismissed with prejudice the NY Litigation. Plaintiffs’ time to appeal the Court’s decision expired on July 5, 2018. Additionally, on August 3, 2017 a derivative action was filed against the Company and all members of the Board of Directors at that time. The lawsuit alleged that the Board of Directors breached its fiduciary duty by making misleading statements and omitting information pertaining to the results of the Company’s Phase 2 clinical trials for bryostatin. The Company and the Board of Directors reached an agreement with counsel for the Plaintiff to stay this action pending a decision by the Court in the NY Litigation. On July 24, 2018, after reviewing the decision in the NY Litigation, Plaintiff voluntarily dismissed the derivative action. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | Note 9 – Subsequent Events On January 22, 2019, the Company granted stock options to purchase an aggregate of 595,000 shares of the Company’s common stock to nine members of the Company’s Board of Directors, the Chief Scientific Officer, the Chief Financial Officer and two Company employees. The stock options have an exercise price of $3.93 per share and an expiration date that is ten years from the date of issuance. 50% of the options vest immediately with the remaining 50% vesting quarterly over a two-year period. On February 4, 2019, the Company announced its entry into a Cooperative Research and Development Agreement (“CRADA”) with the National Cancer Institute (“NCI”) for the research and clinical development of Bryostatin-1. Under the CRADA, the Company will collaborate with the NCI's Center for Cancer Research, Pediatric Oncology Branch to develop a Phase I clinical trial testing the safety and toxicity of Bryostatin-1 in children and young adults with CD22 + leukemia and B-cell lymphoma. The Company also announced the completion of the first safety evaluation of its confirmatory Phase 2 trial evaluating Bryostatin-1 in moderate to severe AD patients not on memantine. Bryostatin continues to be safe. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies: (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates: The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents and Concentration Of credit Risk [Policy Text Block] | Cash and Cash Equivalents and Concentration of Credit Risk: The Company considers all highly liquid temporary cash investments with an original maturity of three months or less when purchased to be cash equivalents. At December 31, 2018, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $12.3 million. In addition, approximately $16.2 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment: Property and equipment is capitalized and depreciated on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Costs: All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE that do not meet the criteria for capitalization are expensed when incurred. FASB ASC Topic 730 requires companies involved in research and development activities to capitalize non-refundable advance payments for such services pursuant to contractual arrangements because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services at December 31, 2018 and 2017. |
Earnings Per Share, Policy [Policy Text Block] | Loss Per Share: Basic loss per common share amounts are based on the weighted average number of common shares outstanding. Diluted loss per share amounts are based on the weighted average number of common shares outstanding, plus the incremental shares that would have been outstanding upon the assumed exercise of all potentially dilutive stock options and warrants subject to anti-dilution limitations. All such potentially dilutive instruments were anti-dilutive as of December 31, 2018 and 2017, which were approximately 11.7 million shares and 5.8 million shares, respectively. |
Income Tax, Policy [Policy Text Block] | Income Taxes: The Company had federal and state net operating losses for income tax purposes of approximately $51.5 million for the period from October 31, 2012 (inception) through December 31, 2018. The net operating loss carryforwards resulted in a deferred tax asset of approximately $10.8 million at December 31, 2018. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. Under current U.S. federal tax law, the Company would receive a compensation expense deduction related to non-qualified stock options only when those options are exercised. Accordingly, the financial statement recognition of compensation cost for non-qualified stock options creates a deductible temporary difference. The Company does not recognize a tax benefit for compensation expense related to incentive stock options (“ISOs”) unless the underlying shares are disposed of in a disqualifying disposition. Accordingly, compensation expense related to ISOs is treated as a permanent difference for income tax purposes. These deferred tax assets are reduced to zero by an offsetting valuation allowance. As a result, there is no provision for income taxes. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in results of operations in the period that includes the enactment date. The Tax Cuts and Jobs Act (the Act) was enacted on December 22, 2017. The Act reduces the US federal corporate tax rate from 35% to 21%, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred and creates new taxes on certain foreign sourced earnings. As of December 31, 2018 the Company did not have any repatriation of foreign income therefore we recognized a provisional amount of $0. In connection with the Act, we re-measured certain deferred tax assets and liabilities based on the rates at which they are anticipated to reverse in the future, which is generally 21%. The provisional amount recorded related to the re-measurement of our deferred tax balance was a tax expense of $6.7 million which was fully offset with a valuation allowance against our deferred taxes. Income taxes are provided for the tax effects of transactions reported in the financial statements and consist of taxes currently due and deferred taxes. Deferred taxes are recognized for differences between the basis of assets and liabilities for financial statement and income tax purposes and the tax effects of net operating loss and other carryforwards. The deferred tax assets and liabilities represent the future tax consequences of those differences and carryforwards, which will either be taxable or deductible when the related assets, liabilities or carryforwards are recovered or settled. Deferred tax assets are reduced by a valuation allowance when, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company applies the provisions of FASB ASC 740-10, Accounting for Uncertain Tax Positions , which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard also provides guidance on de-recognition, classification, interest and penalties, and accounting in interim periods, disclosure and transitions. The Company has concluded that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing. Under Section 382 of the Internal Revenue Code of 1986, as amended, changes in the Company's ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. The Company has not performed a study to assess whether an ownership change for purposes of Section 382 has occurred, or whether there have been multiple ownership changes since the Company's inception, due to the significant costs and complexities associated with such study. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Risks and Uncertainties: The Company operates in an industry that is subject to rapid technological change, intense competition and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risk. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the ability to obtain favorable licensing, manufacturing or other agreements for its product candidates and the ability to raise capital to achieve strategic objectives. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock Compensation: The Company accounts for stock-based awards to employees in accordance with applicable accounting principles, which requires compensation expense related to share-based transactions, including employee stock options, to be measured and recognized in the financial statements based on a determination of the fair value of the stock options. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. Employee stock option expense is recognized over the employee’s requisite service period (generally the vesting period of the equity grant). The Company’s option pricing model requires the input of highly subjective assumptions, including the volatility and expected term. Any changes in these highly subjective assumptions significantly impact stock-based compensation expense. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In December 2018, the FASB issued ASU-2018-20, Leases (Topic 842). In February 2016, the FASB issued new guidance related to how an entity should account for lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. Accounting for leases by lessors is largely unchanged under the new guidance. The guidance is effective for the Company beginning in the first quarter of 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The Company has determined that this standard is not expected to have a material impact to its financial statements based upon the de minimis amount of short-term lease commitments. In July 2017, the FASB issued new guidance, ASU-2017-11, Distinguishing Liabilities from Equity (Topic 480), which changes the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features and re-characterizes the indefinite deferral of certain provisions within the guidance for distinguishing liabilities from equity. The guidance is effective for the Company beginning in the first quarter of fiscal year 2019. Early adoption is permitted. The Company is evaluating the impact of adopting this guidance on its consolidated financial statements. In November 2018, the FASB issued ASU-2018-18, Collaborative Arrangements (Topic 808). In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and requires, that in a transaction with a collaborative arrangement participant who is not a customer, presenting the transaction together with revenue recognized under contracts with customers is precluded. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted. The Company will assess the impact of the adoption of this guidance on its consolidated financial statements once the Company begins to generate revenue. Accounting Pronouncements Adopted During the Period: In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . This ASU simplifies the accounting for nonemployee share-based payment transactions. Under the new guidance, equity-classified share-based payment awards issued to nonemployees will now be measured on the grant date, instead of the previous requirement to re-measure the awards through performance completion date. Awards that include performance conditions will recognize compensation cost when the achievement of the performance condition is probable, rather than upon achievement of the performance condition. Finally, the current requirement to reassess the classification (equity or liability) for nonemployee awards upon vesting will be eliminated, except for awards in the form of convertible instruments. The ASU is effective for annual periods beginning after December 15, 2018 and interim periods within those annual periods. Early adoption is permitted, including interim periods, but no earlier than the adoption of ASC 606. Effective June 20, 2018, we adopted this standard. As a result of the adoption of this new guidance, certain non-employee equity awards were measured on the grant date. There was no cumulative effect of the change on retained earnings as of January 1, 2018 since we had no unvested non-employee awards outstanding as of that date. |
Stock Options_ (Tables)
Stock Options: (Tables) - Stock Options [Member] | 12 Months Ended |
Dec. 31, 2018 | |
Share-based Compensation, Stock Options, Activity [Table Text Block] | The following is a summary of stock option activity under the stock option plans for the year ended December 31, 2018: Weighted- Average Weighted- Remaining Aggregate Average Contractual Intrinsic Number of Exercise Term Value Shares Price (Years) (in thousands) Options outstanding at January 1, 2018 1,345,835 $ 20.10 8.8 Options granted 276,285 $ 7.77 Less options forfeited (16,873 ) $ 18.03 Less options expired/cancelled (85,001 ) $ 11.71 Less options exercised - $ - Options outstanding at December 31, 2018 1,520,246 $ 18.07 8.2 $ 0 Options exercisable at December 31, 2018 914,964 $ 21.98 7.7 $ 0 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range [Table Text Block] | The following is a summary of stock options outstanding under the plans as of December 31, 2018: Stock Options Stock Options Outstanding Exercisable Remaining Weighted Avg. Weighted Avg. Weighted Avg. Range of Number of Contractual Life Exercise Number of Exercise Exercise Prices Shares (years) Price Shares Price $ 0.32 - $15.77 785,208 8.78 $ 8.96 389,502 $ 9.75 $19.10 - $22.72 492,697 8.23 $ 19.48 283,841 $ 19.44 $25.60 - $32.00 95,694 6.80 $ 29.83 95,693 $ 29.83 $35.52 - $49.60 35,003 6.31 $ 42.11 34,753 $ 42.15 $52.48 - $71.04 111,644 5.20 $ 58.22 111,175 $ 58.23 1,520,246 8.16 $ 18.07 914,964 $ 21.98 |
Common Stock Warrants_ (Tables)
Common Stock Warrants: (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Warrant [Member] | |
Share-based Compensation, Stock Options, Activity [Table Text Block] | The following is a summary of common stock warrant activity for the year ended December 31, 2018: Number of shares Warrants outstanding January 1, 2018 5,115,274 Warrants issued 5,112,917 Warrants exercised (13,834 ) Warrants outstanding December 31, 2018 10,214,357 |
Organization, Nature of Busin_2
Organization, Nature of Business, and Liquidity: (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |
Feb. 28, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Proceeds from Issuance or Sale of Equity | $ 20,436,598 | $ 0 | |
Subsequent Event [Member] | |||
Cash, Cash Equivalents, and Short-term Investments | $ 25,500,000 | ||
Subsequent Event [Member] | Clinical Study [Member] | |||
Development Costs, Period Cost | $ 7,300,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies: (Details Textual) - USD ($) shares in Millions | 12 Months Ended | 74 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 11.7 | 5.8 | |
Cash, FDIC Insured Amount | $ 12,300,000 | $ 12,300,000 | |
Cash, Uninsured Amount | 16,200,000 | 16,200,000 | |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | 51,500,000 | ||
Deferred Tax Assets, Operating Loss Carryforwards | $ 10,800,000 | 10,800,000 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | |
Income Tax Expense (Benefit) | $ 0 | $ 0 | |
Deferred Tax Assets, Tax Deferred Expense | $ 6,700,000 | $ 6,700,000 | |
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Useful Life | 10 years | ||
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Useful Life | 3 years |
Collaborative Agreements_ (Deta
Collaborative Agreements: (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jan. 19, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | May 04, 2018 | |
Collaborative Agreements [Line Items] | ||||
Annual License Maintenance Fee | $ 10,000 | |||
Commitment To Pay Fees | 2,100,000 | |||
Estimated Budget For Services | $ 7,300,000 | |||
Prepaid Expense, Current | $ 603,324 | $ 310,437 | ||
Operating Expenses | $ 11,149,396 | $ 12,701,997 | ||
StandFord License Agreement [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Royalty Payment Percentage | 3.00% | |||
Milestone Payments | $ 3,700,000 | |||
Service [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Operating Expenses | 3,900,000 | |||
License [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Cost of Goods and Services Sold | $ 70,000 | |||
Worldwide Clinical Trials [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Payments for Advance to Affiliate | 3,700,000 | |||
Prepaid Expense, Current | 300,000 | |||
Prepaid Deposits | 1,200,000 | |||
Ulitilization Of Prepaid Deposits | 900,000 | |||
Other Trial Related Vendor [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Payments for Advance to Affiliate | $ 200,000 | |||
Minimum [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Royalty Payment Percentage | 1.50% | |||
Maximum [Member] | ||||
Collaborative Agreements [Line Items] | ||||
Royalty Payment Percentage | 4.50% |
Related Party Transactions an_2
Related Party Transactions and Licensing / Research Agreements: (Details Textual) - USD ($) | Nov. 10, 2018 | Nov. 12, 2015 | Dec. 31, 2018 | Dec. 31, 2017 |
Related Party Transaction [Line Items] | ||||
Research and Development Expense, Total | $ 4,623,551 | $ 4,548,835 | ||
Payments for Royalties | 1,166,666 | |||
Costs and Expenses, Related Party | $ 10,000 | |||
Blanchette Rockefeller Neurosciences Institute [Member] | ||||
Related Party Transaction [Line Items] | ||||
Royalties Percentage | (5.00%) | |||
Post PA Fee Proceeds Percent | 2.50% | |||
Fixed Research Fee [Member] | ||||
Related Party Transaction [Line Items] | ||||
Research and Development Expense, Total | $ 1,000,000 | |||
Services Reimbursement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Royalties Percentage | 5.00% | |||
Services Reimbursement [Member] | Minimum [Member] | ||||
Related Party Transaction [Line Items] | ||||
Royalties Percentage | 2.00% | |||
Services Reimbursement [Member] | Maximum [Member] | ||||
Related Party Transaction [Line Items] | ||||
Royalties Percentage | 5.00% | |||
Series B Preferred Stock [Member] | Fixed Research Fee [Member] | ||||
Related Party Transaction [Line Items] | ||||
Proceeds from Issuance of Preferred Stock and Preference Stock | $ 25,000,000 | |||
President [Member] | ||||
Related Party Transaction [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 2.20% |
Common Stock_ (Details Textual)
Common Stock: (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |
Dec. 17, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Proceeds from Issuance or Sale of Equity | $ 20,436,598 | $ 0 | |
Securities Purchase Agreement [Member] | |||
Stock Issued During Period, Shares, New Issues | 5,012,677 | ||
Class of Warrant or Right, Outstanding | 5,012,677 | ||
Sale of Stock, Price Per Share | $ 4.495 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.37 | ||
Proceeds from Issuance or Sale of Equity | $ 20,500,000 | ||
Deferred Offering Costs | $ 2,100,000 | ||
Placement Agent Agreement Member [Member] | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.25 | ||
Agency Fee | $ 442,000 | ||
Cash Paid to Agent Given at Rate of Gross Proceeds From the Offering | 8.00% | ||
Shares issued at Rate | 2.00% | ||
Legal Fees | $ 25,000 | ||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 24,583 | ||
Consulting Agreement [Member] | |||
Class of Warrant or Right, Outstanding | 75,657 | ||
Legal Fees | $ 50,000 | ||
Consulting Fees | $ 1,600,000 |
Stock Options_ (Details)
Stock Options: (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Outstanding | 1,345,835 | ||
Number of Shares, Options granted | 70,000 | 276,285 | |
Number of Shares, Less options forfeited | (16,873) | ||
Number of Shares, Less options expired/cancelled | (85,001) | ||
Number of Shares, Less options exercised | 0 | ||
Number of Shares, Outstanding | 1,520,246 | 1,345,835 | |
Number of Shares, Options exercisable | 914,964 | ||
Weighted-Average Exercise Price, Outstanding | $ 20.10 | ||
Weighted-Average Exercise Price, Options granted | 7.77 | ||
Weighted-Average Exercise Price, Less options forfeited | 18.03 | ||
Weighted-Average Exercise Price, Options, Less options expired/cancelled | 11.71 | ||
Weighted-Average Exercise Price, Options exercised | 0 | ||
Weighted-Average Exercise Price, Outstanding | $ 8.9125 | 18.07 | $ 20.10 |
Weighted-Average Exercise Price, Options exercisable | $ 21.98 | ||
Weighted-Average Remaining Contractual Term, Outstanding (in years) | 8 years 2 months 12 days | 8 years 9 months 18 days | |
Weighted-Average Remaining Contractual Term, Exercisable (in years) | 8 years 1 month 28 days | ||
Aggregate Intrinsic Value, Outstanding | $ 0 | ||
Aggregate Intrinsic Value, Exercisable | $ 0 |
Stock Options_ (Details 1)
Stock Options: (Details 1) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | $ 0.32 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 15.77 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 1,520,246 | 1,345,835 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 1 month 28 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 18.07 | $ 8.9125 | $ 20.10 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 914,964 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 21.98 | ||
Exercise Price Range One [Member] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 785,208 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 9 months 11 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 8.96 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 389,502 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 9.75 | ||
Exercise Price Range Two [Member] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | 19.10 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 22.72 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 492,697 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 2 months 23 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 19.48 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 283,841 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 19.44 | ||
Exercise Price Range Three [Member] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | 25.60 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 32 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 95,694 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 9 months 18 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 29.83 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 95,693 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 29.83 | ||
Exercise Price Range Four [Member] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | 35.52 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 49.60 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 35,003 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 3 months 22 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 42.11 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 34,753 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 42.15 | ||
Exercise Price Range Five [Member] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | 52.48 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 71.04 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 111,644 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 5 years 2 months 12 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 58.22 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 111,175 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 58.23 |
Stock Options_ (Details Textual
Stock Options: (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Oct. 31, 2018 | Jul. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 09, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 91.50% | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 2.88% | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 6.80 | |||||
Employee Benefits and Share-based Compensation | $ 2,216,611 | $ 2,443,443 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 3,400,000 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 2 months 12 days | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 10 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 70,000 | 276,285 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 8.9125 | $ 18.07 | $ 20.10 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 800,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 600,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||||
Chief Executive Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 110,000 | 96,285 | ||||
Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 1,400,000 | |||||
Share-based Compensation Award, Tranche One [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 90,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 10.19 | |||||
Share-based Compensation Award, Tranche Two [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 20,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 10.23 | |||||
Share-based Compensation Award, Tranche Two [Member] | Maximum [Member] | Chief Executive Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 4.44 | |||||
Share-based Compensation Award, Tranche Two [Member] | Minimum [Member] | Chief Executive Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 4.10 |
Common Stock Warrants_ (Details
Common Stock Warrants: (Details) | 12 Months Ended |
Dec. 31, 2018shares | |
Warrants outstanding January 1, 2018 | 5,115,274 |
Warrants issued | 5,112,917 |
Warrants exercised | (13,834) |
Warrants outstanding December 31, 2018 | 10,214,357 |
Common Stock Warrants_ (Detai_2
Common Stock Warrants: (Details Textual) | Dec. 31, 2018$ / sharesshares |
Exercise Price 0.32 [Member] | |
Class of Warrant or Right, Outstanding | shares | 147,606 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.32 |
Exercise Price 6.40 [Member] | |
Class of Warrant or Right, Outstanding | shares | 382,887 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 6.40 |
Exercise Price 12.80 [Member] | |
Class of Warrant or Right, Outstanding | shares | 3,751,033 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 12.80 |
Exercise Price 32.00 [Member] | |
Class of Warrant or Right, Outstanding | shares | 819,914 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 32 |
Exercise Price 4.30 [Member] | |
Class of Warrant or Right, Outstanding | shares | 5,012,677 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 4.37 |
Exercise Price 6.25 [Member] | |
Class of Warrant or Right, Outstanding | shares | 100,240 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 6.25 |
Commitments and Contingencies (
Commitments and Contingencies (Details Textual) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Cost, Maintenance | $ 80,000 |
Subsequent Events (Details Text
Subsequent Events (Details Textual) - $ / shares | 1 Months Ended | 12 Months Ended | ||
Jan. 22, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Subsequent Event [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 70,000 | 276,285 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 8.9125 | $ 18.07 | $ 20.10 | |
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 595,000 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 3.93 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | 50% vesting quarterly over a two-year period. | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 50.00% |