Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 20, 2020 | Jun. 30, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Neurotrope, Inc. | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Central Index Key | 0001513856 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Trading Symbol | NTRP | ||
Entity Interactive Data Current | Yes | ||
Entity Public Float | $ 93,384,208 | ||
Entity Common Stock, Shares Outstanding | 19,748,328 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 17,382,038 | $ 28,854,218 |
Prepaid expenses | 494,112 | 603,324 |
TOTAL CURRENT ASSETS | 17,876,150 | 29,457,542 |
Fixed assets, net of accumulated depreciation | 21,671 | 20,842 |
TOTAL ASSETS | 17,897,821 | 29,478,384 |
CURRENT LIABILITIES | ||
Accounts payable | 413,081 | 2,898,583 |
Accrued expenses | 65,975 | 58,492 |
TOTAL CURRENT LIABILITIES | 479,056 | 2,957,075 |
Commitments and contingencies | ||
TOTAL SHAREHOLDERS' EQUITY | ||
Preferred stock - 100,000 shares authorized, $0.0001 par value; 0 shares issued and outstanding as of December 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock - 150,000,000 shares authorized, $0.0001 par value; 13,068,023 shares issued and outstanding as of December 31, 2019; 12,922,370 shares issued and outstanding as of December 31, 2018 | 1,307 | 1,292 |
Additional paid-in capital | 106,234,301 | 100,202,110 |
Accumulated deficit | (88,816,843) | (73,682,093) |
TOTAL SHAREHOLDERS' EQUITY | 17,418,765 | 26,521,309 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 17,897,821 | $ 29,478,384 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 100,000 | 100,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 13,068,023 | 12,922,370 |
Common stock, shares outstanding | 13,068,023 | 12,922,370 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
OPERATING EXPENSES: | ||
Research and development - related party | $ 0 | $ 262,012 |
Research and development | 4,540,947 | 4,623,551 |
General and administrative - related party | 50,000 | 50,000 |
General and administrative | 6,740,510 | 3,997,222 |
Stock-based compensation - related party | 220,856 | 291,577 |
Stock-based compensation | 3,961,144 | 1,925,034 |
TOTAL OPERATING EXPENSES | 15,513,457 | 11,149,396 |
OTHER INCOME (EXPENSE): | ||
Interest income | 378,707 | 127,110 |
Net loss before income taxes | 15,134,750 | 11,022,286 |
Provision for income taxes | 0 | 0 |
Net loss | $ 15,134,750 | $ 11,022,286 |
PER SHARE DATA: | ||
Basic and diluted loss per common share | $ (1.16) | $ (1.37) |
Basic and diluted weighted average common shares outstanding | 12,992,900 | 8,050,700 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 790 | $ 77,544,976 | $ (62,659,807) | $ 14,885,959 |
Balance (in shares) at Dec. 31, 2017 | 7,895,859 | |||
Sale of common stock and warrants | $ 501 | 20,436,097 | 20,436,598 | |
Sale of common stock and warrants (in shares) | 5,012,677 | |||
Exercise of common stock warrants | $ 1 | 4,426 | 0 | 4,427 |
Exercise of common stock warrants (in shares) | 13,834 | |||
Stock based compensation | $ 0 | 2,216,611 | 0 | 2,216,611 |
Net loss | 0 | 0 | (11,022,286) | (11,022,286) |
Balance at Dec. 31, 2018 | $ 1,292 | 100,202,110 | (73,682,093) | 26,521,309 |
Balance (in shares) at Dec. 31, 2018 | 12,922,370 | |||
Issuance of common stock for consulting fees | $ 5 | 352,743 | 0 | 352,748 |
Issuance of common stock for consulting fees (in shares) | 49,579 | |||
Issuance of warrants for consulting fees | $ 0 | 1,077,615 | 0 | 1,077,615 |
Exercise of common stock warrants | $ 10 | 419,833 | 0 | 419,843 |
Exercise of common stock warrants (in shares) | 96,074 | |||
Stock based compensation | $ 0 | 4,182,000 | 0 | 4,182,000 |
Net loss | 0 | 0 | (15,134,750) | (15,134,750) |
Balance at Dec. 31, 2019 | $ 1,307 | $ 106,234,301 | $ (88,816,843) | $ 17,418,765 |
Balance (in shares) at Dec. 31, 2019 | 13,068,023 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOW USED IN OPERATING ACTIVITIES | ||
Net loss | $ (15,134,750) | $ (11,022,286) |
Adjustments to reconcile net loss to net cash used by operating activities | ||
Stock based compensation | 4,182,000 | 2,216,611 |
Consulting services paid by issuance of common stock | 352,748 | 0 |
Consulting services paid by issuance of common stock warrants | 1,077,615 | 0 |
Depreciation expense | 4,385 | 2,999 |
Change in assets and liabilities | ||
Increase (decrease) in prepaid expenses | 109,212 | (292,887) |
(Decrease) increase in accounts payable | (2,485,502) | 1,658,550 |
Increase (Decrease) in accrued expenses | 7,483 | (209,758) |
Decrease in accrued expenses - related party | 0 | (50,000) |
Total adjustments | 3,247,941 | 3,325,515 |
Net Cash Used in Operating Activities | (11,886,809) | (7,696,771) |
CASH FLOWS USED IN INVESTING ACTIVITIES | ||
Purchase of fixed assets | (5,214) | (3,186) |
Net Cash Used in Investing Activities | (5,214) | (3,186) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Net proceeds from issuance of common stock and warrants | 0 | 20,436,598 |
Net proceeds from exercise of common stock warrants | 419,843 | 4,427 |
Net Cash Provided by Financing Activities | 419,843 | 20,441,025 |
NET (DECREASE) INCREASE IN CASH AND EQUIVALENTS | (11,472,180) | 12,741,068 |
CASH AND EQUIVALENTS AT BEGINNING OF YEAR | 28,854,218 | 16,113,150 |
CASH AND EQUIVALENTS AT END OF YEAR | $ 17,382,038 | $ 28,854,218 |
Organization, Nature of Busines
Organization, Nature of Business, and Liquidity | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Nature of Business, and Liquidity | |
Organization, Nature of Business, and Liquidity: | 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). On September 9, 2019, the Company issued a press release announcing that the confirmatory Phase 2 study of bryostatin-1 in moderate to severe AD did not achieve statistical significance on the primary endpoint, which was change from baseline to Week 13 in the SIB total score. An average increase in SIB total score of 1.3 points and 2.1 points was observed for the bryostatin-1 and placebo groups, respectively, at Week 13. There were multiple secondary outcome measures in this trial, including the changes from baseline at Weeks 5, 9 and 15 in the SIB total score. No statistically significant difference was observed in the change from baseline in SIB total score between the bryostatin -1 and placebo treatment groups. On October 8, 2019, following the Company’s announcement of top-line results from its Phase 2 study of bryostatin-1 in moderate to severe AD, the Company announced its plans to explore strategic alternatives to maximize shareholder value. The Company’s Board of Directors (the “Board”) has formed a strategic alternatives committee to aid in evaluating its alternatives. The Company is continuing to determine how to proceed with respect to its current development programs for bryostatin-1 in its effort to maximize shareholder value. On January 22, 2020, the Company announced the completion of an additional analysis in connection with the confirmatory Phase 2 study, which examined moderately severe to severe AD patients treated with byrostatin-1 in the absence of memantine. To adjust for the baseline imbalance observed in the study, a post-hoc analysis was conducted using paired data for individual patients, with each patient as his/her own control. For the pre-specified moderate stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week 13 values, from which there were 32 patients in the bryostatin-1 treatment group and 33 patients in the placebo group. There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the bryostatin-1 treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed. In the placebo group (33 subjects), there was also a statistically significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen in the overall 203 study. Although there was a signal of bryostatin-1’s benefit for the moderately severe stratum, the difference between the bryostatin-1 and placebo treatment groups was not statistically significant (p=0.2727). Nasdaq Notice of Deficiency On October 23, 2019, the Company received a notification letter from The Nasdaq Stock Market (“Nasdaq”) informing the Company that for the last 30 consecutive business days, the bid price of the Company’s securities had closed below $1.00 per share, which is the minimum required closing bid price for continued listing on The Nasdaq Capital Market pursuant to Listing Rule 5550(a)(2). This notice had no immediate effect on the Company’s Nasdaq listing; the Company had 180 calendar days, or until April 20, 2020, to regain compliance. On January 17, 2020, the Company received a notification letter from Nasdaq informing the Company that for the last ten consecutive business days, the closing bid price of its common stock was $1.00 or greater. Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2). Liquidity As of December 31, 2019, the Company had approximately $17.4 million in cash and cash equivalents. As of February 20, 2020, the Company had approximately $32.7 million in cash and cash equivalents. The increase in cash is attributable to the Company’s issuance of preferred stock and warrants pursuant to a registered direct offering in January 2020 (see “Subsequent Events” Note 9 below) partially offset by cash used for operating activities during the 2020 period. The Company expects that its current cash and cash equivalents will be sufficient to support its projected operating requirements over at least the next 12 months from the Form 10-K filing date, which may include the continuing development of bryostatin, our novel drug targeting the activation of PKC epsilon. This development may include a follow-on Phase 2 clinical study, other non-clinical studies and additional studies in AD and other diseases that might benefit from using bryostatin. The Company is in the process of determining how to proceed with respect to the Company’s current development programs for bryostatin which may affect how our financial resources are deployed. The Company expects to require additional capital in order to initiate and pursue potential additional development projects, including the continuing development of its lead candidate byrostatin-1. The future course of the Company’s product research and development activities will be contingent upon the further analysis of results from its recently completed trial mentioned herein, in addition to the Company’s concurrent plans to explore strategic alternatives to maximize shareholder value. Any additional equity financing, if available, may not be on favorable terms and would likely be significantly dilutive to the Company’s current stockholders and debt financing, if available, may involve restrictive covenants. If the Company is able to access funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that the Company would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm its business, financial condition and results of operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies: | Note 2 – Summary of Significant Accounting Policies : Use of Estimates: The preparation of 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 cash investments with an original maturity of three months or less when purchased to be cash equivalents. At December 31, 2019, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $0.8 million. In addition, approximately $16.6 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash. Fixed Assets: Lease Accounting. The new accounting standard for leases, Accounting Standard Codification (“ASC”) 842, Leases, was adopted for the fiscal year beginning on January 1, 2019. Per the new standard, all leases with a lease term greater than 12 months, regardless of lease type classification, are recorded as an obligation on the balance sheet with a corresponding right-of-use asset. The Company does not have any leases greater than 12 months in duration, hence, the adoption of this standard did not have a material impact to its financial statements based upon the de minimis amount of short-term lease commitments. Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed 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 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, 2019 and 2018. Loss Per Share: Basic loss per common share amounts are computed by dividing net loss by 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, 2019 and 2018, which were approximately 12.8 million shares and 11.7 million shares, respectively. Income Taxes: The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $62.5 million for the period from October 31, 2012 (inception) through December 31, 2019. The net operating loss carryforwards resulted in a deferred tax asset of approximately $15.6 million at December 31, 2019. 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. The deferred tax asset is offset by a full valuation allowance. The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, 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, limited supply of nature raw material, 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, including risk associated with our CRE licensing agreement, for its product candidates and the ability to raise capital to achieve strategic objectives. CRE has entered into a material transfer agreement with the National Cancer Institute (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for our pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of our clinical trials that we are required to conduct in order to seek FDA approval of bryostatin for the treatment of AD. Therefore, CRE or we will have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or we are unable to secure such additional agreements or if the NCI otherwise discontinues for any reason supplying us with bryostatin, then we would have to either secure another source of bryostatin or discontinue our efforts to develop and commercialize bryostatin for the treatment of AD. Stock Compensation: The Company accounts for stock-based awards to employees and consultants in accordance with applicable accounting principles, which requires compensation expense related to share-based transactions, including employee stock options and consultant’s warrants, to be measured and recognized in the financial statements based on a determination of the fair value of the stock options or warrants. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. Employee stock option and consulting expenses are recognized over the employee’s or consultant’s requisite service period (generally the vesting period of the equity grant). The Company’s option and warrant pricing model requires the input of highly assumptions, including the volatility and expected term. Any changes in these highly subjective assumptions significantly impact stock-based compensation expense. Total stock-based compensation for year ended December 31, 2019 was $4,182,000 of which $1,381,198 was classified as research and development expense and $2,800,802 was classified as general and administrative expense. For year ended December 31, 2018, total stock-based compensation was $2,216,611 of which $707,459 was classified as research and development expense and $1,509,152 was classified as general and administrative expense. Recent Accounting Pronouncements 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 and has been adopted. In August 2018, the SEC issued a final rule Release No. 33-10532, “Disclosure Update and Simplification,” to amend certain disclosure requirements now seen as redundant, duplicative, overlapping, outdated or superseded in wake of recent accounting pronouncements. The amended rules became effective November 5, 2018. The Company analyzed the release in preparation of this Form 10-K, which resulted in the additional disclosure of changes to stockholders’ equity during interim periods, as presented within this Form 10-K within the condensed consolidated statements of stockholders’ equity. Many of the amended requirements under this Release are not applicable to the Company. 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 it becomes probable that the Company may generate revenue. Accounting Pronouncements Adopted During the Period: 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. 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 adoption of this standard did not have a material impact to its financial statements based upon the de minimis amount of short-term lease commitments. |
Collaborative Agreements
Collaborative Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Collaborative Agreements | |
Collaborative Agreements: | 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. The Company is 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, the Company must meet specific diligence milestones, and upon meeting such milestones, make specific milestone payments to Stanford. The Company 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. As of December 31, 2019, no royalties nor milestone payments have been required or 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. As of December 31, 2019, no royalties nor milestone payments have been required or made. 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). The Company will pay Mt. Sinai milestone payments of $2 million upon approval of a new drug approval (“NDA”) in the United States and an additional $1.5 million for an NDA approval in the European Union or Japan. In addition, the Company would be obligated to pay Mt. Sinai royalties on net sales of licensed product of 2.0% for up to $250 million of net sales and 3.0% of net sales over $250 million. Since inception, the Company has paid Mt. Sinai approximately $150,000 consisting of licensing fees of $75,000 plus development costs and patent fees of approximately $75,000. As of December 31, 2019, no royalties nor milestone payments have been required or made. 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, was approximately $7.8 million. Of the total estimated Study costs, as of December 31, 2019, the Company has incurred approximately $7.6 million in expenses of which WCT has represented a total of approximately $7.2 million and approximately $400,000 of expenses have been paid to other trial-related vendors and consultants. Of the approximately $7.2 million of expenses incurred with WCT, approximately $7.1 million has been paid with the remaining $0.1 million payable as of December 31, 2019. In addition, the Company paid $1.2 million to WCT as prepaid deposits of which the Company has utilized the entire amount as of December 31, 2019. The Company believes that it has incurred substantially all of the expenses associated with WCT as of December 31, 2019, resulting in a savings of approximately $500,000 in total. |
Related Party Transactions and
Related Party Transactions and Licensing / Research Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions and Licensing / Research Agreements | |
Related Party Transactions and Licensing / Research Agreements | Note 4 – Related Party Transactions and Licensing / Research Agreements : Cognitive Research Enterprises, Inc. James Gottlieb, who resigned as a director of the Company on February 21, 2020, serves as a director of CRE, and Shana Phares, who resigned as a director of the Company on February 25, 2020, serves as President and Chief Executive Officer of CRE. CRE is a stockholder of a corporation, Neuroscience Research Ventures, Inc. (“NRV, Inc.”), which owned approximately 2.2% of the Company’s outstanding common stock as of December 31, 2019. 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. There were no such statements of work agreements entered into during the fiscal years 2019 and 2018. 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”) which shall also include the proceeds from the exercise of any Series A – E warrants. This Fixed Research Fee has not been triggered yet. 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. 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. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2019 | |
Commitments | |
Commitments | Note 5 – Commitments : Consulting Agreements On August 4, 2016, the Company entered into a consulting agreement with SM Capital Management, LLC (“SMCM”), a limited liability company owned and controlled by the Company’s Chairman of the Board, Mr. Joshua N. Silverman (the “Consulting Agreement”). Mr. Silverman was appointed to the Board on August 4, 2016. Pursuant to the Consulting Agreement, SMCM shall provide consulting services which shall include, but not be limited to, providing business development, financial communications and management transition services, for a one-year period, subject to annual review thereafter. SMCM’s annual consulting fee is $120,000, payable by the Company in monthly installments of $10,000. In addition, SMCM shall be reimbursed for (i) all pre-approved travel in connection with the consulting services to the Company, (ii) upon submission to the Company of appropriate vouchers and receipts, for all other out-of-pocket expenses reasonably incurred by SMCM in furtherance of the Company’s business. Effective as of April 1, 2019, the Company entered into a three-month consulting agreement with Katalyst Securities LLC (“Katalyst”), pursuant to which Katalyst agreed to provide investor relations services to the Company. The Company paid Katalyst a total of $125,000, which was fully expensed in the second quarter of 2019 as a general and administrative expense. Effective as of June 1, 2019, the Company entered into a consulting agreement with Katalyst (the “Katalyst Agreement”), pursuant to which Katalyst agreed to provide investment banking consulting services to the Company. The term of the agreement continues until the second anniversary from the effective date and may be canceled by either Katalyst or the Company with 30 days’ advance notice. As consideration for its services under the Katalyst Agreement, the Company agreed to pay to Katalyst $25,000 per month, plus five-year warrants to purchase 90,000 shares of the Company’s common stock on the effective date of the Katalyst Agreement and on each of the three month anniversaries following the effective date. The warrants have an exercise price equal to the closing price of the Company’s stock price on the date of issuance. Katalyst’s cash and stock-based compensation is included as general and administrative expenses in the Company’s statement of operations. Effective as of June 5, 2019, the Company entered into a consulting agreement with GP Nurmenkari, Inc. (“GPN”) (the “GPN Agreement”), pursuant to which GPN agreed to provide investment banking consulting services to the Company. The term of the agreement continues until the second anniversary from the effective date and may be canceled by either GPN or the Company with 30 days’ advance notice. As consideration for its services under the GPN Agreement, the Company agreed to pay to GPN $8,000 per month, plus five-year warrants to purchase 24,000 shares of the Company’s common stock on the effective date and on each of the three month anniversaries following the effective date. The warrants have an exercise price equal to the closing price of the Company’s stock price on the date of issuance. On February 1, 2020, the Company amended the GPN Agreement, increasing the cash compensation to $17,500 per month and increasing the number of warrants issued each three-month period from 24,000 to 50,000 (See “Subsequent Events” in Note 9 below.) GPN’s cash and stock-based compensation is included as general and administrative expenses in the Company’s statement of operations. Resignation of General Counsel and Chief Operating Officer On October 23, 2019, the Company entered into a separation agreement (the “Separation Agreement”) with Michael F. Ciraolo, J.D., Ph.D., pursuant to which Dr. Ciraolo resigned from his positions as General Counsel and Chief Operating Officer of the Company. Dr. Ciraolo’s resignation was effective as of October 31, 2019 (the “Effective Date”). Under the terms of the Separation Agreement, Dr. Ciraolo received severance (the “Severance”) equal to (i) $83,750, which represents three month’s base salary, (ii) a pro-rated bonus in the amount of $58,625 and (iii) $3,435.90 for accrued but unused vacation time. The Severance was paid in substantially equal installments pursuant to the Company’s regular payroll schedule over a period of two months commencing on the Company’s first practicable payroll date following the Effective Date. The Separation Agreement contains certain customary provisions regarding confidentiality and non-disparagement and provides for the release of certain claims between the parties. |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2019 | |
Common Stock | |
Common Stock: | Note 6 – Common Stock : Adoption of a Shareholder Rights Plan Overview On September 9, 2019, the Company announced that its Board had adopted a shareholder rights plan (the “Rights Plan”). The Rights Plan is intended to protect the interests of the Company’s stockholders and enable them realize the full potential value of their investment by reducing the likelihood that any person or group gains control of the Company through open market accumulation or other tactics without appropriately compensating all stockholders. Pursuant to the Rights Plan, the Company issued, by means of a dividend, one preferred share purchase right for each outstanding share of the Company’s common stock to shareholders of record on the close of business on September 19, 2019. Initially, these Rights (as defined below) will trade with, and be represented by, the shares of the Company’s common stock. The Rights will generally become exercisable only if any person (or any persons acting as a group) acquires 15% or more of the Company’s outstanding common stock (the “Acquiring Person”) in a transaction not approved by the Board, subject to certain exceptions, as explained below. If the Rights become exercisable, all holders of Rights, other than the Acquiring Person, will be entitled to acquire shares of the Company’s common stock at a 50% discount or the Company may exchange each Right held by such holders for one share of its common stock. In such situation, Rights held by the Acquiring Person would become void and will not be exercisable. If any person at the time of the first public announcement of the Rights Plan owned more than the triggering percentage then that stockholder’s existing ownership percentage will be grandfathered, although, with certain exceptions, the Rights will become exercisable if at any time after the announcement of the Rights Plan such stockholder increases its ownership of the Company’s common stock. Unless earlier redeemed, terminated or exchanged pursuant to the terms of the Rights Plan, the Rights will expire at the close of business on September 8, 2021. The Board may terminate the Rights Plan before that date if the Board determines that there is no longer a threat to shareholder value. Key Features On September 9, 2019, the Board declared a dividend of one preferred share purchase right (a “Right”), payable on September 19, 2019, for each share of common stock, par value $0.0001 per share, of the Company outstanding on September 19, 2019, to the stockholders of record on that date. In connection with the distribution of the Rights, the Company entered into a Rights Agreement (the “Rights Agreement”), dated as of September 9, 2019, between the Company and Philadelphia Stock Transfer, Inc., as rights agent. Each Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series C Preferred Stock, par value $0.0001 per share (the “Preferred Shares”), of the Company at a price of $20 per one one-thousandth of a Preferred Share represented by a Right, subject to adjustment. Each one one-thousandth of a Preferred Share entitles the holder thereof to receive (i) the same dividends and liquidation rights as if the holder held one share of common stock and will be treated the same as one share of common stock in the event of a merger, consolidation or other share exchange and (ii) one vote on all matters submitted to a vote of the Company’s stockholders, in each case subject to adjustment as described in the Certificate of Designations, Preferences and Rights of Series C Preferred Stock of Neurotrope, Inc. Until a right is exercised, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends. 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 are exercisable at a price of $4.37 per share beginning six months following the date of issuance and expire five years from the exercise date. The net In connection with the offering, the Company entered into a placement agent agreement and advisory consulting agreements with certain consultants in connection with the issuance and sale of the shares and warrants. The Company paid to the placement agent (i) a cash fee equal to 8% of the aggregate gross proceeds raised from purchasers first contacted by the placement agent in connection with the offering and (ii) warrants to purchase 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. Pursuant to separate advisory consulting agreements for the offering, the Company engaged two consultants, pursuant to which it agreed to pay the consultants an aggregate total of $1.36 million and warrants to purchase an aggregate of 75,657 shares of common stock, at an exercise price of $6.25 per share. The Company also reimbursed the consultants an additional $50,000 for legal expenses. January 2020 Offering On January 22, 2020, the Company entered into a securities purchase agreement with certain institutional investors and certain pre-existing high net worth individual investors. Pursuant to the terms of the purchase agreement, the Company issued to the purchasers in a registered offering an aggregate of 18,000 shares of Series D Preferred Stock (which are convertible into a total of 10,909,100 shares of common stock) and Series H warrants to purchase up to an aggregate of 10,909,100 shares of common stock for an aggregate purchase price of approximately $18 million. (See “Subsequent Events” Note 9 for further offering details.) The net proceeds to the Company from the offering were approximately $16.4 million, after deducting financial advisory fees and estimated offering expenses payable by the Company. During January and February 2020, 12,012 shares of Series D Preferred Stock were converted into 7,280,306 shares of common stock. The remaining 5,988 shares of Series D Preferred Stock are convertible into 3,628,794 shares of common stock. |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2019 | |
Warrant [Member] | |
Common Stock Warrants: | Note 8 – Common Stock Warrants : The following is a summary of common stock warrant activity for the year ended December 31, 2019: Number of shares Warrants outstanding January 1, 2019 10,236,232 Warrants issued 342,000 Warrants exercised (96,074) Warrants outstanding December 31, 2019 10,482,158 The Company used the Black-Scholes valuation model to calculate the fair value of warrants. The fair value of the 342,000 warrants issued in connection with certain consulting agreements for the year ended December 31, 2019 was estimated at the grant date using the following weighted average assumptions: Dividend yield 0%; Expected term five years; Volatility 94.6%; and Risk-free interest rate 1.64%. The weighted average grant date fair value of warrants granted for the year ended December 31, 2019 is $3.151 per warrant, or $1.1 million. As of December 31, 2019, the Company’s warrants by exercise price were as follows: 147,606 warrants exercisable at $0.32, 114,000 warrants exercisable at $0.86, 4,916,603 warrants exercisable at $4.37, 114,000 warrants exercisable at $5.31, 100,240 warrants exercisable at $6.25, 382,887 warrants exercisable at $6.40, 24,000 warrants exercisable at $7.12, 90,000 warrants exercisable at $7.13, 3,772,908 warrants exercisable at $12.80 and 819,914 warrants exercisable at $32.00. |
Stock Options
Stock Options | 12 Months Ended |
Dec. 31, 2019 | |
Stock Options [Member] | |
Stock Options: | Note 7 – Stock Options : Option Grants The following is a summary of stock option activity under the stock option plans for the year ended December 31, 2019: Weighted- Average Weighted- Remaining Aggregate Average Contractual Intrinsic Number of Exercise Term Value Shares Price (Years) (in millions) Options outstanding at January 1, 2019 1,520,246 $ 18.07 8.2 Options granted 905,680 $ 3.68 Less options forfeited — $ — Less options expired/cancelled 59,407 $ 6.32 Less options exercised — $ — Options outstanding at December 31, 2019 2,366,519 $ 12.86 7.5 $ — Options exercisable at December 31, 2019 1,693,512 $ 15.49 7.6 $ — In January 2019, the Company granted stock options to purchase an aggregate of 595,000 shares of the Company’s common stock to eight members of the Board, three Company officers 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. All of the options vest 50% at time of issuance and 50% quarterly over the subsequent two year period after the issuance date. Options to purchase an aggregate of 29,923 shares could not be exercised until, and were initially subject to, stockholder approval of an increase in shares under the Company's 2017 Equity Incentive Plan, which approval was obtained on July 23, 2019. Pursuant to the Company's non-employee director compensation plan, in March 2019, the Company granted stock options to purchase an aggregate of 80,000 shares of the Company’s common stock to eight members of the Board. The stock options have an exercise price of $4.06 per share and an expiration date that is ten years from the date of issuance. All of these options vest upon the first anniversary of the issuance date. Such options could not be exercised until, and were initially subject to, stockholder approval of an increase in shares under the Company's 2017 Equity Incentive Plan, which approval was obtained on July 23, 2019 as the shareholders approved an additional 850,000 plan shares. On April 15, 2019, the Company granted its General Counsel and Chief Operating Officer options to purchase 100,000 shares of common stock. In connection with the termination of such officer's employment effective October 31, 2019, the 56,250 shares that had not vested as of such date were forfeited and cancelled. The 43,750 stock options that had vested have an exercise price of $5.67 per share and an expiration date that is ten years from the date of issuance. On December 14, 2019, the Company granted stock options to purchase an aggregate of 130,680 shares of the Company’s common stock to the Chief Executive Officer pursuant to his employment contract. The stock options have an exercise price of $0.7825 per share, have an expiration date that is ten years from the date of issuance and vest daily over a two-year period. Including the additional 850,000 options approved by shareholders on July 23, 2019, 615,679 options are issuable in the future. The following is a summary of stock options outstanding under the plans as of December 31, 2019: Stock Options Stock Options Outstanding Exercisable 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 1,634,638 7.84 $ 6.15 1,032,177 $ 7.02 $19.10 - $22.72 489,540 7.29 $ 19.48 419,119 $ 19.48 $25.60 - $32.00 95,694 6.52 $ 29.83 95,694 $ 29.83 $35.52 - $49.60 35,003 5.75 $ 42.11 34,878 $ 42.13 $52.48 - $71.04 111,644 4.39 $ 58.22 111,644 $ 58.22 2,366,519 7.48 $ 12.86 1,693,512 $ 15.49 As of December 31, 2019, there was approximately $2.4 million of total unrecognized compensation costs related to unvested stock options. These costs are expected to be recognized over a weighted average period of 1.4 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, 2019 was estimated at the grant date using the following weighted average assumptions: Dividend yield 0%; Expected term 10 years; an aggregate volatility based upon a blend of the Company's and guideline company historical volatility of 93.2%; and Risk-free interest rate 2.57%. The weighted average grant date fair value of options granted for the year ended December 31, 2019 is $3.38 per option, or a total for all grants of approximately $3.1 million. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events | |
Subsequent Events | Note 9 – Subsequent Events On January 22, 2020, the Company announced the receipt of a $2.7 million award from the National Institutes of Health to support an additional Phase 2 clinical study focused on the moderate stratum for which the Company saw improvement in the 203 study. The grant provides for funds in the first year of approximately $1.0 million and funding in year 2 of approximately $1.7 million subject to satisfactory progress of the project. The Company is planning to meet with the Food and Drug Administration to present the totality of the clinical data for bryostatin-1. The Company is continuing to determine how to proceed with respect to its current development programs for bryostatin-1. On January 22, 2020, the Company entered into a securities purchase agreement with certain institutional investors and certain pre-existing high net worth individual investors. Pursuant to the terms of the purchase agreement, the Company issued to the purchasers in a registered offering an aggregate of 18,000 shares of Series D Preferred Stock (which are convertible into a total of 10,909,100 shares of common stock) and Series H warrants to purchase up to an aggregate of 10,909,100 shares of common stock for an aggregate purchase price of approximately $18 million. The warrants are exercisable at a price of $1.65 per share immediately upon issuance. They feature a five-year term and a right by the Company, in certain circumstances, to call for the cancellation of up to 50% of the shares of common stock underlying such warrants for consideration equal to $0.0001 per share of underlying common stock in the event the value weighted average price of the Company’s common stock exceeds $5.00 for each of 10 consequence trading days in a 30-day calendar period. The Series D Preferred Stock and the Series H warrants are immediately separable and were issued separately. The net proceeds to the Company from the offering were approximately $16.4 million, after deducting financial advisory fees and estimated offering expenses payable by the Company. In connection with the offering, on January 22, 2020, the Company filed with the Secretary of State of the State of Nevada a Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (the “Series D Certificate of Designation”) establishing and designating the rights, powers and preferences of the Series D Preferred Stock. The Company designated 18,000 shares of Series D Preferred Stock. Pursuant to the Series D Certificate of Designation, the holders of the Series D Preferred Stock are entitled, among other things, to the right to participate in any dividends and distributions paid to common stockholders on an as-converted basis. The Series D Preferred Stock has no voting rights except as required by law. The Series D Preferred Stock will be convertible at any time and from time to time without the payment of additional consideration into shares of the Company’s common stock at a conversion price of $1.65 per share, subject to certain adjustments and has a stated value of $1,000 per share of Series D Preferred Stock. In the event of any liquidation or dissolution of the Company, the Series D Preferred Stock will rank junior to the Company's Series C Preferred Stock and any other class of preferred stock of senior rank to the Series D Preferred Stock, senior to any other class of preferred stock and to the Company’s common stock in the distribution of assets, to the extent legally available for distribution. During January and February 2020, 12 investors in the Company’s January 22, 2020 registered direct offering converted 12,012 shares of Series D Convertible Preferred Stock into 7,280,306 shares of the Company’s common stock. Effective February 1, 2020, the Company amended the GPN Agreement, increasing the cash compensation to $17,500 per month and increasing the number of warrants issued each three-month period from 24,000 to 50,000. All other terms and conditions of the GPN Agreement remain the same. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Use of Estimates: | Use of Estimates: The preparation of 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: | Cash and Cash Equivalents and Concentration of Credit Risk: The Company considers all highly liquid cash investments with an original maturity of three months or less when purchased to be cash equivalents. At December 31, 2019, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $0.8 million. In addition, approximately $16.6 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC. Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash. |
Fixed Assets: | Fixed Assets: Lease Accounting. The new accounting standard for leases, Accounting Standard Codification (“ASC”) 842, Leases, was adopted for the fiscal year beginning on January 1, 2019. Per the new standard, all leases with a lease term greater than 12 months, regardless of lease type classification, are recorded as an obligation on the balance sheet with a corresponding right-of-use asset. The Company does not have any leases greater than 12 months in duration, hence, the adoption of this standard did not have a material impact to its financial statements based upon the de minimis amount of short-term lease commitments. Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed 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: | Research and Development Costs: All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE 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, 2019 and 2018. |
Loss Per Share: | Loss Per Share: Basic loss per common share amounts are computed by dividing net loss by 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, 2019 and 2018, which were approximately 12.8 million shares and 11.7 million shares, respectively. |
Income Taxes: | Income Taxes: The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $62.5 million for the period from October 31, 2012 (inception) through December 31, 2019. The net operating loss carryforwards resulted in a deferred tax asset of approximately $15.6 million at December 31, 2019. 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. The deferred tax asset is offset by a full valuation allowance. The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, 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: | 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, limited supply of nature raw material, 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, including risk associated with our CRE licensing agreement, for its product candidates and the ability to raise capital to achieve strategic objectives. CRE has entered into a material transfer agreement with the National Cancer Institute (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for our pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of our clinical trials that we are required to conduct in order to seek FDA approval of bryostatin for the treatment of AD. Therefore, CRE or we will have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or we are unable to secure such additional agreements or if the NCI otherwise discontinues for any reason supplying us with bryostatin, then we would have to either secure another source of bryostatin or discontinue our efforts to develop and commercialize bryostatin for the treatment of AD. |
Stock Compensation: | Stock Compensation: The Company accounts for stock-based awards to employees and consultants in accordance with applicable accounting principles, which requires compensation expense related to share-based transactions, including employee stock options and consultant’s warrants, to be measured and recognized in the financial statements based on a determination of the fair value of the stock options or warrants. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. Employee stock option and consulting expenses are recognized over the employee’s or consultant’s requisite service period (generally the vesting period of the equity grant). The Company’s option and warrant pricing model requires the input of highly assumptions, including the volatility and expected term. Any changes in these highly subjective assumptions significantly impact stock-based compensation expense. Total stock-based compensation for year ended December 31, 2019 was $4,182,000 of which $1,381,198 was classified as research and development expense and $2,800,802 was classified as general and administrative expense. For year ended December 31, 2018, total stock-based compensation was $2,216,611 of which $707,459 was classified as research and development expense and $1,509,152 was classified as general and administrative expense. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 and has been adopted. In August 2018, the SEC issued a final rule Release No. 33-10532, “Disclosure Update and Simplification,” to amend certain disclosure requirements now seen as redundant, duplicative, overlapping, outdated or superseded in wake of recent accounting pronouncements. The amended rules became effective November 5, 2018. The Company analyzed the release in preparation of this Form 10-K, which resulted in the additional disclosure of changes to stockholders’ equity during interim periods, as presented within this Form 10-K within the condensed consolidated statements of stockholders’ equity. Many of the amended requirements under this Release are not applicable to the Company. 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 it becomes probable that the Company may generate revenue. Accounting Pronouncements Adopted During the Period: 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. 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 adoption of this standard did not have a material impact to its financial statements based upon the de minimis amount of short-term lease commitments. |
Stock Options (Tables)
Stock Options (Tables) - Stock Options [Member] | 12 Months Ended |
Dec. 31, 2019 | |
Schedule of Stock option activity | The following is a summary of stock option activity under the stock option plans for the year ended December 31, 2019: Weighted- Average Weighted- Remaining Aggregate Average Contractual Intrinsic Number of Exercise Term Value Shares Price (Years) (in millions) Options outstanding at January 1, 2019 1,520,246 $ 18.07 8.2 Options granted 905,680 $ 3.68 Less options forfeited — $ — Less options expired/cancelled 59,407 $ 6.32 Less options exercised — $ — Options outstanding at December 31, 2019 2,366,519 $ 12.86 7.5 $ — Options exercisable at December 31, 2019 1,693,512 $ 15.49 7.6 $ — |
Schedule of stock outstanding under the plans | The following is a summary of stock options outstanding under the plans as of December 31, 2019: Stock Options Stock Options Outstanding Exercisable 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 1,634,638 7.84 $ 6.15 1,032,177 $ 7.02 $19.10 - $22.72 489,540 7.29 $ 19.48 419,119 $ 19.48 $25.60 - $32.00 95,694 6.52 $ 29.83 95,694 $ 29.83 $35.52 - $49.60 35,003 5.75 $ 42.11 34,878 $ 42.13 $52.48 - $71.04 111,644 4.39 $ 58.22 111,644 $ 58.22 2,366,519 7.48 $ 12.86 1,693,512 $ 15.49 |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Warrant [Member] | |
Schedule of Common stock warrant activity | The following is a summary of common stock warrant activity for the year ended December 31, 2019: Number of shares Warrants outstanding January 1, 2019 10,236,232 Warrants issued 342,000 Warrants exercised (96,074) Warrants outstanding December 31, 2019 10,482,158 |
Organization, Nature of Busin_2
Organization, Nature of Business, and Liquidity (Details) - USD ($) | Feb. 20, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Cash and cash equivalents | $ 17,382,038 | $ 28,854,218 | $ 16,113,150 | |
Subsequent Event [Member] | ||||
Cash and cash equivalents | $ 32,700,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) shares in Millions | 12 Months Ended | 86 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2019 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 12.8 | 11.7 | |
Capitalized Research and Development Services | $ 0 | $ 0 | $ 0 |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | 62,500,000 | ||
Deferred Tax Assets, Operating Loss Carryforwards | 15,600,000 | 15,600,000 | |
Allocated Share-based Compensation Expense | 4,182,000 | 2,216,611 | |
Research and Development Expense [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Allocated Share-based Compensation Expense | 1,381,198 | 707,459 | |
General and Administrative Expense [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Allocated Share-based Compensation Expense | $ 2,800,802 | $ 1,509,152 | |
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 | ||
Cash [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash, Uninsured Amount | $ 800,000 | 800,000 | |
Money Market Funds [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash, Uninsured Amount | $ 16,600,000 | $ 16,600,000 |
Collaborative Agreements (Detai
Collaborative Agreements (Details) - USD ($) | Jan. 19, 2017 | Jul. 14, 2014 | Dec. 31, 2019 | Dec. 31, 2018 | May 04, 2018 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Licensing fees | $ 75,000 | ||||
Development costs and patent fees | 75,000 | ||||
Operating Expenses | $ 15,513,457 | $ 11,149,396 | |||
Prepaid Expense, Current | 494,112 | $ 603,324 | |||
Stand Ford License Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Annual License Maintenance Fee | $ 10,000 | ||||
Commitment To Pay Fees | 2.1 | ||||
Milestone payments made | $ 0 | ||||
Royalty Payment Percentage | 3.00% | ||||
Payments for Royalties | $ 0 | ||||
Milestone Payments | 3,700,000 | ||||
Mt. Sinai License Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Milestone payments made | 0 | ||||
Milestone Payments Payable | 2,000,000 | ||||
Additional Milestone Payments Payable | $ 1,500,000 | ||||
Payments for Royalties | 0 | ||||
Mt. Sinai License Agreement | Net sales up to $250 million | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Royalty Payment Percentage | 2.00% | ||||
Threshold net sales | $ 250,000,000 | ||||
Mt. Sinai License Agreement | Net sales over $250 million | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Royalty Payment Percentage | 3.00% | ||||
Threshold net sales | $ 250,000,000 | ||||
Clinical Trial Services Agreements | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Estimated Budget For Services | $ 7,800,000 | ||||
Payments for Advance to Affiliate | 7,100,000 | ||||
Payable to affiliate | 100,000 | ||||
Service [Member] | Clinical Trial Services Agreements | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Operating Expenses | 7,600,000 | ||||
License [Member] | Stand Ford License Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Cost of Goods and Services Sold | 70,000 | ||||
Aggregate amount paid | $ 70,000 | ||||
License [Member] | Mt. Sinai License Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Cost of Goods and Services Sold | 150,000 | ||||
Aggregate amount paid | $ 150,000 | ||||
Worldwide Clinical Trials [Member] | Clinical Trial Services Agreements | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Total savings from services received | 500,000 | ||||
Payments for Advance to Affiliate | 7,200,000 | ||||
Prepaid Deposits | 1,200,000 | ||||
Other Trial Related Vendor [Member] | Clinical Trial Services Agreements | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Payments for Advance to Affiliate | $ 400,000 | ||||
Minimum [Member] | Stand Ford License Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Royalty Payment Percentage | 1.50% | ||||
Maximum [Member] | Stand Ford License Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Royalty Payment Percentage | 4.50% |
Related Party Transactions an_2
Related Party Transactions and Licensing / Research Agreements (Details) - USD ($) | Nov. 10, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Related Party Transaction [Line Items] | |||
Research and Development Expense, Total | $ 4,540,947 | $ 4,623,551 | |
Costs and Expenses, Related Party | $ 10,000 | ||
Fixed Research Fee [Member] | |||
Related Party Transaction [Line Items] | |||
Research and Development Expense, Total | $ 1,000,000 | ||
Contract Payments, Term | 5 years | ||
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] | Minimum [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% |
Commitments (Details)
Commitments (Details) - USD ($) | Feb. 01, 2020 | Oct. 23, 2019 | Jun. 05, 2019 | Jun. 01, 2019 | Apr. 01, 2019 | Aug. 06, 2016 | Aug. 04, 2016 | Dec. 17, 2018 | Jan. 22, 2020 |
Other Commitments [Line Items] | |||||||||
Payments for consulting | $ 1,360,000 | ||||||||
Warrants to purchase shares of common stock | 75,657 | ||||||||
Subsequent Event [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Warrants term | 5 years | ||||||||
Employee Severance [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Separation Agreement, Number Of Months Of Base Salary Payable | 3 months | ||||||||
Separation Agreement, Amount Of Base Salary Payable | $ 83,750 | ||||||||
Separation Agreement, Amount Of Pro Rated Bonus Payable | 58,625 | ||||||||
Separation Agreement, Amount Of Accrued But Unused Vacation Time Payable | $ 3,435.90 | ||||||||
Separation Agreement, Number Of Months For Payment Of Severance | 2 months | ||||||||
Consulting Agreement with SM Capital Management, LLC [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Contract Payments, Term | 1 year | ||||||||
Annual consulting fee | $ 120,000 | ||||||||
Monthly installment of annual consulting fee | $ 10,000 | ||||||||
Consulting Agreement with Katalyst Securities LLC [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Consulting agreement term | 3 months | ||||||||
Payments for consulting | $ 25,000 | $ 125,000 | |||||||
Notice for cancellation | 30 days | ||||||||
Warrants term | 5 years | ||||||||
Warrants to purchase shares of common stock | 90,000 | ||||||||
Warrants term following the effective date | 3 months | ||||||||
Consulting Agreement with GP Nurmenkari, Inc [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Monthly installment of annual consulting fee | $ 8,000 | ||||||||
Notice for cancellation | 30 days | ||||||||
Warrants term | 5 years | ||||||||
Warrants to purchase shares of common stock | 24,000 | ||||||||
Warrants term following the effective date | 3 months | ||||||||
Consulting Agreement with GP Nurmenkari, Inc [Member] | Subsequent Event [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Monthly installment of annual consulting fee | $ 17,500 | ||||||||
Warrants to purchase shares of common stock | 50,000 | ||||||||
Warrants term following the effective date | 3 months |
Common Stock (Details)
Common Stock (Details) | Sep. 09, 2019itemVote$ / sharesshares | Dec. 17, 2018USD ($)$ / sharesshares | Dec. 31, 2019$ / sharesshares | Sep. 19, 2019$ / shares | Dec. 31, 2018$ / shares |
Share holder Rights Plan, Number Of Preferred Share Purchase Right Per Common Shares | item | 1 | ||||
Share holder Rights Plan, Exercise Of Rights, Minimum Percentage Of Common Stock To Be Acquired | 15.00% | ||||
Share holder Rights Plan, Exercise Of Rights, Discount Available, Percent | 50.00% | ||||
Share holder Rights Plan, Exercise Of Rights, Number Of Common Stock Issuable In Exchange For Each Right | shares | 1 | ||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Preferred Stock, Par or Stated Value Per Share | 0.0001 | $ 0.0001 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.25 | $ 3.151 | |||
Class of Warrant or Right, Outstanding | shares | 1,100,000 | ||||
Percentage of payment to placement agent | 8.00% | ||||
Percentage of aggregate warrants to purchase the number of shares | 2.00% | ||||
Reimbursement incurred to placement agent for legal expenses | $ | $ 25,000 | ||||
Number of consultants | $ | 2 | ||||
Payments for consulting | $ | $ 1,360,000 | ||||
Warrants to purchase shares of common stock | shares | 75,657 | ||||
Reimbursement made to consultants for additional legal expenses | $ | $ 50,000 | ||||
Rights Agreement [Member] | |||||
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 20 | ||||
Number Of Common Stock Representing One One Thousandth Of Preferred Stock | shares | 1 | ||||
Number Of Votes Per One Thousandth Of Preferred Stock | Vote | 1 | ||||
Securities Purchase Agreement [Member] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.37 | ||||
Stock Issued During Period, Shares, New Issues | shares | 5,012,677 | ||||
Class of Warrant or Right, Outstanding | shares | 5,012,677 | ||||
Sale of Stock, Price Per Share | $ 4.495 | ||||
Proceeds from Issuance or Sale of Equity | $ | $ 20,500,000 |
Common Stcok - January 2020 off
Common Stcok - January 2020 offering (Details) - USD ($) $ in Millions | Jan. 22, 2020 | Feb. 29, 2020 | Jan. 31, 2020 | Jan. 31, 2019 | Dec. 31, 2019 |
Number of Shares, Options granted | 595,000 | 905,680 | |||
Subsequent Event [Member] | |||||
Net proceeds from the offering | $ 16.4 | ||||
Purchase price of common stock | $ 18 | ||||
Subsequent Event [Member] | Series D Preferred Stock [Member] | |||||
Number of Shares, Options granted | 18,000 | ||||
Number of shares converted | 12,012 | 12,012 | |||
Number of shares issued in conversion | 10,909,100 | 7,280,306 | 7,280,306 | ||
Number of shares convertible | 5,988 | 5,988 | |||
Number of shares to be issued in conversion | 3,628,794 | 3,628,794 | |||
Subsequent Event [Member] | Series H Preferred Stock [Member] | |||||
Number of shares issued in conversion | 10,909,100 |
Stock Option - Stock option act
Stock Option - Stock option activity (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock Options | |||
Number of Shares, Outstanding | 1,520,246 | 1,520,246 | |
Number of Shares, Options granted | 595,000 | 905,680 | |
Number of Shares, Less options expired/cancelled | 59,407 | ||
Number of Shares, Outstanding | 2,366,519 | 1,520,246 | |
Number of Shares, Options exercisable | 1,693,512 | ||
Weighted-Average Exercise Price, Outstanding | $ 18.07 | $ 18.07 | |
Weighted-Average Exercise Price, Options granted | 3.68 | ||
Weighted-Average Exercise Price, Options, Less options expired/cancelled | 6.32 | ||
Weighted-Average Exercise Price, Outstanding | $ 3.93 | 12.86 | $ 18.07 |
Weighted-Average Exercise Price, Options exercisable | $ 15.49 | ||
Weighted-Average Remaining Contractual Term, Outstanding (in years) | 7 years 6 months | ||
Weighted-Average Remaining Contractual Term, Exercisable (in years) | 7 years 7 months 6 days | 8 years 2 months 12 days |
Stock Options - Stock Options O
Stock Options - Stock Options Outstanding (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Jan. 31, 2019 | |
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 | 2,366,519 | 1,520,246 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 7 months 6 days | 8 years 2 months 12 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 12.86 | $ 18.07 | $ 3.93 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,693,512 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 15.49 | ||
Exercise Price [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 | 2,366,519 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 5 months 23 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 12.86 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,693,512 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 15.49 | ||
Exercise Price Range One [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 | 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 | 1,634,638 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 10 months 2 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 6.15 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,032,177 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 7.02 | ||
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 | 489,540 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 3 months 15 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 | 419,119 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 19.48 | ||
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 6 months 7 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 | 95,694 | ||
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 | 5 years 9 months | ||
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 | 34,878 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 42.13 | ||
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 | 4 years 4 months 21 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 | 111,644 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 58.22 |
Stock Options - Additional Info
Stock Options - Additional Information (Details) | Dec. 14, 2019$ / sharesshares | Apr. 15, 2019$ / sharesshares | Mar. 31, 2019director$ / sharesshares | Jan. 31, 2019director$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / shares | Jul. 23, 2019shares |
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 Term | 10 years | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 93.20% | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 2.57% | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 3.38 | ||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ | $ 2,400,000 | ||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 4 months 24 days | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 595,000 | 905,680 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Terms of Award | Options to purchase an aggregate of 29,923 shares could not be exercised until, and were initially subject to, stockholder approval of an increase in shares under the Company's 2017 Equity Incentive Plan, which approval was obtained on July 23, 2019. | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | All of the options vest 50% at time of issuance and 50% quarterly over the subsequent two year period after the issuance date. | ||||||
Weighted-Average Exercise Price, Options granted | $ / shares | $ 3.68 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ / shares | $ 3.93 | $ 12.86 | $ 18.07 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||
Allocated Share-based Compensation Expense | $ | $ 4,182,000 | $ 2,216,611 | |||||
Fair value of grants | $ | $ 3,100,000 | ||||||
Chief Executive Officer and Directors [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 | shares | 130,680 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 2 years | ||||||
Director [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of Directors | director | 8 | ||||||
Director, Scientific Advisory Board [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 | shares | 80,000 | ||||||
Number of Directors | director | 8 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||
New General Counsel and Chief Operating Officer [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Terms of Award | options to purchase 100,000 shares of common stock. In connection with the termination of such officer's employment effective October 31, 2019, the 56,250 shares that had not vested as of such date were forfeited and cancelled. The 43,750 stock options that had vested have an exercise price of $5.67 per share and an expiration date that is ten years from the date of issuance. | ||||||
Common Stock, Capital Shares Reserved for Future Issuance | shares | 615,679 | ||||||
Weighted-Average Exercise Price, Options granted | $ / shares | $ 5.67 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | shares | 850,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||
Minimum [Member] | Chief Executive Officer and Directors [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 | $ / shares | $ 0.7825 | ||||||
Share-based Compensation Award, Tranche One [Member] | Director, Scientific Advisory Board [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 | shares | 100,000 | ||||||
Share-based Compensation Award, Tranche Two [Member] | Director, Scientific Advisory Board [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 | $ / shares | $ 4.06 |
Common Stock Warrants - Common
Common Stock Warrants - Common stock warrant activity (Details) | 12 Months Ended |
Dec. 31, 2019shares | |
Common Stock Warrants | |
Warrants outstanding January 1, 2019 | 10,236,232 |
Warrants issued | 342,000 |
Warrants exercised | (96,074) |
Warrants outstanding December 31, 2019 | 10,482,158 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2019$ / sharesshares | Dec. 17, 2018$ / shares | |
Class of Warrant or Right, Outstanding | 1,100,000 | |
Warrants exercise price | $ / shares | $ 3.151 | $ 6.25 |
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Granted | 342,000 | |
Measurement Input, Expected Dividend Rate [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 0 | |
Measurement Input, Expected Term [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 5 | |
Measurement Input, Price Volatility [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 94.6 | |
Measurement Input, Risk Free Interest Rate [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 1.64 | |
Exercise Price 0.32 [Member] | ||
Class of Warrant or Right, Outstanding | 147,606 | |
Warrants exercise price | $ / shares | $ 0.32 | |
Exercise Price 0.86 [Member] | ||
Class of Warrant or Right, Outstanding | 114,000 | |
Warrants exercise price | $ / shares | $ 0.86 | |
Exercise Price 4.37 [Member] | ||
Class of Warrant or Right, Outstanding | 4,916,603 | |
Warrants exercise price | $ / shares | $ 4.37 | |
Exercise Price 5.31 [Member] | ||
Class of Warrant or Right, Outstanding | 114,000 | |
Warrants exercise price | $ / shares | $ 5.31 | |
Exercise Price 6.25 [Member] | ||
Class of Warrant or Right, Outstanding | 100,240 | |
Warrants exercise price | $ / shares | $ 6.25 | |
Exercise Price 6.40 [Member] | ||
Class of Warrant or Right, Outstanding | 382,887 | |
Warrants exercise price | $ / shares | $ 6.40 | |
Exercise Price 7.12 [Member] | ||
Class of Warrant or Right, Outstanding | 24,000 | |
Warrants exercise price | $ / shares | $ 7.12 | |
Exercise Price 7.13 [Member] | ||
Class of Warrant or Right, Outstanding | 90,000 | |
Warrants exercise price | $ / shares | $ 7.13 | |
Exercise Price 12.80 [Member] | ||
Class of Warrant or Right, Outstanding | 3,772,908 | |
Warrants exercise price | $ / shares | $ 12.80 | |
Exercise Price 32.00 [Member] | ||
Class of Warrant or Right, Outstanding | 819,914 | |
Warrants exercise price | $ / shares | $ 32 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) | Feb. 01, 2020USD ($)shares | Jan. 22, 2020USD ($)$ / sharesshares | Jun. 05, 2019USD ($)shares | Feb. 29, 2020shareholdershares | Jan. 31, 2020shareholdershares | Jan. 31, 2019shares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018$ / shares | Dec. 17, 2018$ / sharesshares |
Subsequent Event [Line Items] | |||||||||
Number of Shares, Options granted | 595,000 | 905,680 | |||||||
Warrants to purchase shares of common stock | 75,657 | ||||||||
Warrants exercise price | $ / shares | $ 3.151 | $ 6.25 | |||||||
Preferred stock, stated value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||||
Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Warrants exercise price | $ / shares | $ 1.65 | ||||||||
Warrants term | 5 years | ||||||||
Percentage of cancellation of common shares underlying on the warrants | 50.00% | ||||||||
Share price of underlying common stock | $ / shares | $ 0.0001 | ||||||||
Minimum share price for cancellation of shares underlying warrants | $ / shares | $ 5 | ||||||||
Number of trading days for observing common stock price for cancellation of shares underlying the warrants | 10 days | ||||||||
Calendar period | 30 days | ||||||||
Net proceeds from the offering | $ | $ 16,400,000 | ||||||||
Purchase price of common stock | $ | $ 18,000,000 | ||||||||
Subsequent Event [Member] | Series D Preferred Stock [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Number of Shares, Options granted | 18,000 | ||||||||
Preferred stock, stated value (in dollars per share) | $ / shares | $ 1,000 | ||||||||
Number of investors exercised the option of conversion in to common stock | shareholder | 12 | 12 | |||||||
Number of shares converted | 12,012 | 12,012 | |||||||
Number of shares issued in conversion | 10,909,100 | 7,280,306 | 7,280,306 | ||||||
Conversion price per share | $ / shares | $ 1.65 | ||||||||
Subsequent Event [Member] | Series H Preferred Stock [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Number of shares issued in conversion | 10,909,100 | ||||||||
Subsequent Event [Member] | National Institutes of Health [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Amount of award received | $ | $ 2,700,000 | ||||||||
Funds received in first year | $ | 1,000,000 | ||||||||
Funds received in second year | $ | $ 1,700,000 | ||||||||
Consulting Agreement with GP Nurmenkari, Inc [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Warrants to purchase shares of common stock | 24,000 | ||||||||
Warrants term | 5 years | ||||||||
Monthly installment of annual consulting fee | $ | $ 8,000 | ||||||||
Warrants term following the effective date | 3 months | ||||||||
Consulting Agreement with GP Nurmenkari, Inc [Member] | Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Warrants to purchase shares of common stock | 50,000 | ||||||||
Monthly installment of annual consulting fee | $ | $ 17,500 | ||||||||
Warrants term following the effective date | 3 months |