Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Dec. 31, 2018 | Feb. 11, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | VistaGen Therapeutics, Inc. | |
Entity Central Index Key | 1,411,685 | |
Document Type | 10-Q | |
Document Period End Date | Dec. 31, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --03-31 | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding | 31,120,465 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,019 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Mar. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 6,285,300 | $ 10,378,300 |
Prepaid expenses and other current assets | 853,800 | 644,800 |
Total current assets | 7,139,100 | 11,023,100 |
Property and equipment, net | 334,900 | 207,400 |
Security deposits and other assets | 47,800 | 47,800 |
Total assets | 7,521,800 | 11,278,300 |
Current liabilities: | ||
Accounts payable | 1,086,700 | 1,195,700 |
Accrued expenses | 827,100 | 206,300 |
Current notes payable | 49,100 | 53,900 |
Capital lease obligations | 2,900 | 2,600 |
Total current liabilities | 1,965,800 | 1,458,500 |
Non-current liabilities: | ||
Accrued dividends on Series B Preferred Stock | 3,456,300 | 2,608,300 |
Deferred rent liability | 399,800 | 285,600 |
Capital lease obligations | 7,100 | 9,300 |
Total non-current liabilities | 3,863,200 | 2,903,200 |
Total liabilities | 5,829,000 | 4,361,700 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2018 and March 31, 2018; 31,204,380 and 23,068,280 shares issued and outstanding at December 31, 2018 and March 31, 2018, respectively | 31,200 | 23,100 |
Additional paid-in capital | 181,035,800 | 167,401,400 |
Treasury stock, at cost, 135,665 shares of common stock held at December 31, 2018 and March 31, 2018 | (3,968,100) | (3,968,100) |
Accumulated deficit | (175,410,100) | (156,543,800) |
Total stockholders' equity | 1,692,800 | 6,916,600 |
Total liabilities and stockholders' equity | 7,521,800 | 11,278,300 |
Series A Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | 500 | 500 |
Series B Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | 1,200 | 1,200 |
Series C Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock | $ 2,300 | $ 2,300 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Mar. 31, 2018 |
Stockholders deficit: | ||
Preferred Stock, par value | $ 0.001 | $ .001 |
Preferred Stock, Authorized | 10,000,000 | 10,000,000 |
Common Stock, Par Value Par Share | $ .001 | $ .001 |
Common Stock, Shares Authorized | 100,000,000 | 100,000,000 |
Common Stock, Shares, Issued | 31,204,380 | 23,068,280 |
Common Stock, Shares, Outstanding | 31,204,380 | 23,068,280 |
Treasury Stock, Shares | 135,665 | 135,665 |
Series A Preferred Stock [Member] | ||
Stockholders deficit: | ||
Preferred Stock, Authorized | 500,000 | 500,000 |
Preferred Stock, Shares Issued | 500,000 | 500,000 |
Preferred Stock, Shares Outstanding | 500,000 | 500,000 |
Series B Preferred Stock [Member] | ||
Stockholders deficit: | ||
Preferred Stock, Authorized | 4,000,000 | 4,000,000 |
Preferred Stock, Shares Issued | 1,160,240 | 1,160,240 |
Preferred Stock, Shares Outstanding | 1,160,240 | 1,160,240 |
Series C Preferred Stock [Member] | ||
Stockholders deficit: | ||
Preferred Stock, Authorized | 3,000,000 | 3,000,000 |
Preferred Stock, Shares Issued | 2,318,012 | 2,318,012 |
Preferred Stock, Shares Outstanding | 2,318,012 | 2,318,012 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | ||||
Research and development | $ 5,335,500 | $ 1,601,800 | $ 13,340,300 | $ 5,124,600 |
General and administrative | 1,856,800 | 1,266,000 | 5,494,100 | 4,997,400 |
Total operating expenses | 7,192,300 | 2,867,800 | 18,834,400 | 10,122,000 |
Loss from operations | (7,192,300) | (2,867,800) | (18,834,400) | (10,122,000) |
Other expenses, net: | ||||
Interest expense, net | (1,800) | (2,000) | (6,800) | (7,700) |
Loss on extinguishment of accounts payable | (22,700) | (135,000) | (22,700) | (135,000) |
Loss before income taxes | (7,216,800) | (3,004,800) | (18,863,900) | (10,264,700) |
Income taxes | 0 | 0 | (2,400) | (2,400) |
Net loss and comprehensive loss | (7,216,800) | (3,004,800) | (18,866,300) | (10,267,100) |
Accrued dividends on Series B Preferred stock | (290,900) | (263,000) | (848,000) | (766,600) |
Deemed dividend from trigger of down round provision feature | 0 | (199,200) | 0 | (199,200) |
Net loss attributable to common stockholders | $ (7,507,700) | $ (3,467,000) | $ (19,714,300) | $ (11,232,900) |
Basic and diluted net loss attributable to common stockholders per common share | $ (0.24) | $ (0.25) | $ (0.75) | $ (1.03) |
Weighted average shares used in computing basic and diluted net loss attributable to common stockholders per common share | 30,696,312 | 13,895,642 | 26,418,440 | 10,947,556 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (18,866,300) | $ (10,267,100) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 64,800 | 65,300 |
Stock-based compensation | 2,519,700 | 1,386,900 |
Expense related to modification of warrants | 25,800 | 292,700 |
Fair value of common stock granted for services | 277,600 | 1,554,800 |
Fair value of common stock issued for product license and option | 4,250,000 | 0 |
Fair value of warrants granted for services | 79,800 | 0 |
Loss on extinguishment of accounts payable | (22,700) | (135,000) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 34,600 | 259,600 |
Accounts payable and accrued expenses, including accrued interest | 511,800 | (41,800) |
Deferred rent | 109,200 | 159,900 |
Net cash used in operating activities | (10,970,300) | (6,454,700) |
Cash flows from investing activities: | ||
Purchases of equipment | 0 | (1,600) |
Construction of tenant improvements | (169,800) | 0 |
Net cash used in investing activities | (169,800) | (1,600) |
Cash flows from financing activities: | ||
Net proceeds from issuance of common stock and warrants, including Units | 6,608,700 | 16,721,900 |
Proceeds from exercise of warrants | 605,700 | 0 |
Repayment of capital lease obligations | (2,000) | (1,700) |
Repayment of notes payable | (165,300) | (153,400) |
Net cash provided by financing activities | 7,047,100 | 16,566,800 |
Net (decrease) increase in cash and cash equivalents | (4,093,000) | 10,110,500 |
Cash and cash equivalents at beginning of period | 10,378,300 | 2,921,300 |
Cash and cash equivalents at end of period | 6,285,300 | 13,031,800 |
Supplemental disclosure of noncash activites: | ||
Insurance premiums settled by issuing note payable | 160,500 | 142,400 |
Accrued dividends on Series B Preferred | 848,000 | 766,600 |
Deemed dividend from trigger of down round provision feature | 0 | (199,200) |
Settlement of accounts payable by issuance of common stock | $ 40,000 | $ 450,000 |
Description of Business
Description of Business | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Description of Business | Overview VistaGen Therapeutics. Inc., a Nevada corporation (which may be referred to as VistaGen Company we our us CNS MDD SAD PRN AV-101 AV-101, an investigational prodrug candidate in Phase 2 clinical development, is an orally bioavailable NMDAR GlyB (N-methyl-D-aspartate receptor glycine B) antagonist in development as a potential new treatment for multiple CNS indications with high unmet need, including MDD, neuropathic pain ( NP PD LID) SI FDA Major Depressive Disorder Major depressive disorder is a serious biologically-based mood disorder, affecting approximately 16 million adults in the United States according to the U.S. National Institute of Mental Health (the NIMH CDC We believe oral AV-101 has potential for multiple applications in global depression markets if successfully developed and approved. Given its excellent tolerability profile, we believe AV-101 has potential as a new generation monotherapy and as an adjunctive therapy to both (i) augment current antidepressants approved by the FDA for patients with MDD who have an inadequate response to standard antidepressants (SSRIs and SNRIs) and (ii) prevent relapse of MDD following successful intravenous or intranasal treatment with ketamine hydrochloride ( ketamine TRD AV-101 is currently in Phase 2 clinical development in the United States for MDD. ELEVATE is our ongoing Phase 2 multi-center, multi-dose, double blind, placebo-controlled clinical study to evaluate the efficacy and safety of AV-101 as a new generation adjunctive treatment of MDD in adult patients with an inadequate therapeutic response to current FDA-approved antidepressants (the ELEVATE Study MGH New England Journal of Medicine NEJM Journal of the American Medical Association JAMA AV-101 is also the subject of a small randomized, double-blind, placebo-controlled cross-over Phase 2 clinical study being conducted and funded by the NIMH, pursuant to our Cooperative Research and Development Agreement ( CRADA NIMH Study The FDA has granted Fast Track designation for development of AV-101 as a potential new adjunctive treatment of MDD. Suicidal Ideation According to the World Health Organization ( WHO SI VA We are collaborating with Baylor College of Medicine ( Baylor Baylor Study MT CRADA Neuropathic Pain Neuropathic pain ( NP The effects of AV-101 as a potential new treatment for NP were assessed in published peer-reviewed preclinical studies involving four well-established models of pain. In these studies, AV-101 was observed to have robust, dose-dependent anti-nociceptive effects, as measured by dose-dependent reversal of NP in the Chung (nerve ligation), formalin and carrageenan thermal models in rats Characterization of the effects of L-4-chlorokynurenine on nociception in rodents The Journal of Pain The FDA has granted Fast Track designation for development of AV-101 as a potential new, non-opioid treatment of NP. Parkinson’s Disease Levodopa-Induced Dyskinesia Parkinson's disease ( PD PD LID In a preclinical monkey model of PD, AV-101 resulted in a 30% reduction of the mean dyskinesia score associated with PD LID. Importantly, AV-101 did not reduce the anti-parkinsonian therapeutic benefit of levodopa. Moreover, the duration of levodopa response and delay to levodopa effect were not affected by treatment with AV-101. We believe AV-101 has potential to reduce troublesome dyskinesia experienced by many patients with PD as a result of their levodopa therapy, but without interfering with levodopa or causing side effects resulting from certain current PD LID treatments, such as amantadine, including hallucinations, dizziness, dry mouth, swelling of legs and feet, constipation and falls. We are planning to advance clinical development of AV-101 for PD LID in an exploratory Phase 2 clinical study, subject to securing sufficient capital, as our next initiative in PD LID. PH94B In September 2018, we acquired, on a non-cash basis through the issuance of unregistered shares of our common stock, a license from Pherin Pharmaceuticals, Inc. ( Pherin PH94B is a synthetic investigational neuroactive steroid for which Phase 2 clinical data showed that the product was well tolerated and demonstrated a rapid onset of effect, as measured by the Subjective Units of Distress ( SUD LSAS Administered as a nasal spray, PH94B is designed to act locally on peripheral nasal chemosensory receptors to trigger rapid activation of the limbic system areas of the brain associated with SAD. In prior clinical studies, PH94B demonstrated rapid (10-15 minutes) anxiety reduction for subjects with SAD, measured by the SUD and LSAS, and was not observed to be addictive, sedative or have other adverse events. Benzodiazepines and beta blockers, which are currently prescribed off-label to treat SAD, have been found in third party literature to have these addictive or sedative properties, and have other adverse effects when used to treat SAD. Based on clinical studies in which PH94B was observed to have rapid-onset of effect on anxiety reduction, as measured by the SUD and LSAS, and to be well-tolerated, and in light of its novel route of administration and on-demand dosing design, we believe PH94B has potential to be the first FDA-approved medication for long-term PRN treatment of individuals with SAD. PH10 In October 2018, we acquired, on a non-cash basis through the issuance of unregistered shares of our common stock, a second license from Pherin giving us the exclusive worldwide rights to develop and commercialize PH10, a synthetic investigational neuroactive steroid nasal spray for which exploratory Phase 2 clinical data showed that it was well tolerated and demonstrated a rapid onset of antidepressant effects. PH10 is designed to bind locally on nasal chemosensory receptors and trigger responses in the hypothalamus, amygdala, prefrontal cortex and hippocampus affecting depression. It is believed that PH10 may initiate nerve impulses that follow defined pathways to directly affect brain function. In a small exploratory Phase 2a study in patients with MDD, PH10 showed a rapid-onset antidepressant effect, as measured by the Hamilton Depression Rating Scale ( HAM - VistaStem In addition to our CNS business, we have two additional programs through our wholly-owned subsidiary VistaGen Therapeutics, Inc., a California corporation, dba VistaStem Therapeutics ( VistaStem NCEs RM CardioSafe 3D BlueRock Therapeutics BlueRock Agreement Subsidiaries VistaStem is our wholly-owned subsidiary. Our Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q ( Report |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Basis of Presentation | The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States ( U.S. GAAP The accompanying unaudited Condensed Consolidated Financial Statements and notes to Condensed Consolidated Financial Statements contained in this Report should be read in conjunction with our audited Consolidated Financial Statements for our fiscal year ended March 31, 2018 contained in our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission ( SEC The accompanying unaudited Condensed Consolidated Financial Statements have been prepared assuming we will continue as a going concern. As a clinical-stage biopharmaceutical company having not yet developed commercial products or achieved sustainable revenues, we have experienced recurring losses and negative cash flows from operations resulting in a deficit of approximately $175.4 million accumulated from inception (May 1998) through December 31, 2018. We expect losses and negative cash flows from operations to continue for the foreseeable future as we engage in further development of AV-101, PH94B and PH10, execute our drug rescue programs and pursue potential drug development and regenerative medicine opportunities. Since our inception in May 1998 through December 31, 2018, we have financed our operations and technology acquisitions primarily through the issuance and sale of our equity and debt securities for cash proceeds of approximately $68.6 million, as well as from an aggregate of approximately $17.6 million of government research grant awards (excluding the fair market value of the NIMH Study and the Baylor Study), strategic collaboration payments, intellectual property sublicensing and other revenues. Additionally, we have issued equity securities with an approximate value at issuance of $38.1 million in non-cash acquisitions of product licenses and in settlements of certain liabilities, including liabilities for professional services rendered to us or as compensation for such services. At December 31, 2018, we had cash and cash equivalents of approximately $6.3 million. Our cash position at December 31, 2018 considered with our recurring and anticipated losses, negative cash flows from operations and limited stockholders’ equity make it probable, in the absence of additional financing, that we will not have sufficient resources to fund our planned operations for the twelve months following the issuance of these financial statements, during which time we plan to complete our ELEVATE study, prepare for pivotal Phase 3 development of PH94B, conduct additional clinical and preclinical studies involving AV-101 and prepare for a Phase 2 clinical trial of PH10, and raises substantial doubt that we can continue as a going concern. Nevertheless, when necessary and advantageous, we plan to raise additional capital, primarily through the sale of our equity securities in one or more private placements to accredited investors or in public offerings. Subject to certain restrictions, our effective Registration Statement on Form S-3 (Registration No. 333-215671) (the S-3 Registration Statement In addition to the potential sale of our equity securities, we may also seek to enter into research, development and/or commercialization collaborations that could generate revenue or provide funding, including non-dilutive funding, for development of AV-101, PH94B, PH10 and/or additional product candidates. We may also seek additional government grant awards or agreements similar, for example, to our current CRADA with the NIMH, which provides for the NIMH to fully fund the NIMH Study, or similar to our relationships with Baylor and the VA in connection with the Baylor Study. Such strategic collaborations may provide non-dilutive resources to advance our strategic initiatives while reducing a portion of our future cash outlays and working capital requirements. We may also pursue intellectual property arrangements similar to the BlueRock Agreement with other parties. Although we may seek additional collaborations that could generate revenue and/or non-dilutive funding for development of AV-101, PH94B, PH10 or other product candidates, as well as new government grant awards and/or agreements similar to our CRADA with NIMH, no assurance can be provided that any such collaborations, awards or agreements will occur in the future. Our future working capital requirements will depend on many factors, including, without limitation, the timing, scope and nature of opportunities related to our success and the success of certain other companies in clinical trials, including our development and commercialization of our current product candidates and various potential drug rescue applications of our stem cell technology platform, the availability of, and our ability to obtain, government grant awards and agreements, and our ability to enter into collaborations on terms acceptable to us. To further advance the clinical development of AV-101, PH10 and PH94B, and, to a lesser extent, drug rescue applications of our stem cell technology platform, as well as support our operating activities, we plan to continue to carefully manage our routine operating costs, including our employee headcount and related expenses, as well as costs relating to regulatory consulting, contract research and development, investor relations and corporate development, legal, acquisition and protection of intellectual property, public company compliance and other professional services and operating costs. Notwithstanding the foregoing, there can be no assurance that future financings or government or other strategic collaborations will be available to us in sufficient amounts, in a timely manner, or on terms acceptable to us, if at all. If we are unable to obtain substantial additional financing on a timely basis when needed in 2019 and beyond, our business, financial condition, and results of operations may be harmed, the price of our stock may decline, we may be required to reduce, defer, or discontinue certain of our research and development activities and we may not be able to continue as a going concern. As noted above, these Condensed Consolidated Financial Statements do not include any adjustments that might result from the negative outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Summary of Significant Accounting Policies | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include those relating to share-based compensation, and assumptions that have been used historically to value warrants and warrant modifications. With the exception of the BlueRock Agreement pursuant to which we recorded sublicense revenue in the third quarter of our fiscal year ended March 31, 2017, we do not currently have, nor have we had during the periods covered by this Report, any arrangements requiring the recognition of revenue. Research and Development Expenses Research and development expenses are composed of both internal and external costs. Internal costs include salaries and employment-related expenses, including stock-based compensation expense, of scientific personnel and direct project costs. External research and development expenses consist primarily of costs associated with clinical and non-clinical development of AV-101, PH94B, PH10, and stem cell research and development costs, and costs related to the application and prosecution of patents related to those product candidates and, to a lesser extent, our stem cell technology platform. All such costs are charged to expense as incurred. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by contract research organizations ( CRO Stock-Based Compensation We recognize compensation cost for all stock-based awards to employees and non-employee consultants based on the grant date fair value of the award. We record non-cash, stock-based compensation expense over the period during which the employee is required to perform services in exchange for the award, which generally represents the scheduled vesting period. We have not granted restricted stock awards to employees nor do we have any awards with market or performance conditions. For option grants to non-employees, we re-measure the fair value of the awards as they vest and the resulting value is recognized as an expense during the period over which the services are performed. Non-cash expense attributable to compensatory grants of stock to non-employees is determined by the quoted market price of the stock on the date of grant and is either recognized as fully-earned at the time of the grant or expensed ratably over the term of the related service agreement, depending on the terms of the specific agreement. The table below summarizes stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended December 31, 2018 and 2017. Three Months Ended December 31, Nine Months Ended December 31, 2018 2017 2018 2017 Research and development expense: Stock option grants $ 274,900 $ 299,100 $ 955,600 $ 627,400 General and administrative expense: Stock option grants 459,800 390,200 1,564,100 759,500 Total stock-based compensation expense $ 734,700 $ 689,300 $ 2,519,700 $ 1,386,900 In August 2018, our Board approved the grant of options from our 2016 Amended and Restated Stock Incentive Plan (the 2016 Plan Assumption: August 2018 Market price per share at grant date $ 1.27 Exercise price per share $ 1.27 Risk-free interest rate 2.84 % Expected term in years 5.50 Volatility 99.29 % Dividend rate 0.0 % Shares 860,000 Fair Value per share $ 0.98 In August 2018, our Board also approved the modification of outstanding options having exercise prices over $1.56 per share and held by independent members of our Board, our officers and our employees to reduce the exercise prices thereof to $1.50 per share. We calculated the fair value of the options immediately before and after the modification using the Black-Scholes Option Pricing Model and the weighted average assumptions indicated in the table below. We immediately recognized the additional fair value attributable to vested options, $258,100, as stock compensation expense, which is included in the figures reported above. The additional fair value resulting from the modification is being expensed over the remaining vesting period of the modified options. Assumption: Pre-modification Post-modification Market price per share $ 1.49 $ 1.49 Exercise price per share $ 3.57 $ 1.50 Risk-free interest rate 2.77 % 2.77 % Remaining expected term in years 5.08 5.08 Volatility 94.9 % 94.9 % Dividend rate 0.0 % 0.0 % Number of option shares 2,419,503 2,419,503 Weighted average fair value per share $ 0.91 $ 1.08 During October 2018, we granted to certain professional service providers and consultants options to purchase an aggregate of 250,000 shares of our common stock at exercise prices ranging from $1.52 per share to $2.20 per share, reflecting the quoted closing price of our common stock on the Nasdaq Capital Market on the date of the grant. We valued the options granted in October 2018 using the Black-Scholes Option Pricing Model and the following weighted average assumptions: Assumption: October 2018 Market price per share at grant date $ 1.83 Exercise price per share $ 1.83 Risk-free interest rate 3.13 % Expected term in years 10.00 Volatility 89.98 % Dividend rate 0.0 % Shares 250,000 Fair Value per share $ 1.59 At December 31, 2018, there were stock options outstanding to purchase 6,410,338 shares of our common stock at a weighted average exercise price of $1.47 per share. See Note 10, Subsequent Events Comprehensive Loss We have no components of other comprehensive loss other than net loss, and accordingly our comprehensive loss is equivalent to our net loss for the periods presented. Loss per Common Share Basic net loss attributable to common stockholders per share of common stock excludes the effect of dilution and is computed by dividing net loss increased by the accrual of dividends on outstanding shares of our Series B 10% Convertible Preferred Stock ( Series B Preferred As a result of our net loss for all periods presented, potentially dilutive securities were excluded from the computation of diluted net loss per share, as their effect would be antidilutive. Potentially dilutive securities excluded in determining diluted net loss attributable to common stockholders per common share are as follows: As of December 31, 2018 2017 Series A Preferred stock issued and outstanding (1) 750,000 750,000 Series B Preferred stock issued and outstanding (2) 1,160,240 1,160,240 Series C Preferred stock issued and outstanding (3) 2,318,012 2,318,012 Outstanding options under the Amended and Restated 2016 (formerly 2008) and 1999 Stock Incentive Plans (1999 Plan in 2017 only) 6,410,338 3,279,871 Outstanding warrants to purchase common stock 21,499,955 16,918,292 Total 32,138,545 24,426,415 ____________ (1) Assumes exchange under the terms of the October 11, 2012 Note Exchange and Purchase Agreement, as amended. (2) Assumes exchange under the terms of the Certificate of Designation of the Relative Rights and Preferences of the Series B 10% Convertible Preferred Stock, effective May 5, 2015. (3) Assumes exchange under the terms of the Certificate of Designation of the Relative Rights and Preferences of the Series C Convertible Preferred Stock, effective January 25, 2016. Fair Value Measurements We do not use derivative instruments for hedging of market risks or for trading or speculative purposes. We carried no assets or liabilities that are measured on a recurring basis at fair value at December 31, 2018 or March 31, 2018. Recent Accounting Pronouncements Except as described below, there have been no recent accounting pronouncements or changes in accounting pronouncements during the nine months ended December 31, 2018, as compared to the recent accounting pronouncements described in our Form 10-K for our fiscal year ended March 31, 2018, that are of significance or potential significance to us. In June 2018, the Financial Accounting Standards Board ( FASB ASU Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting ASU 2018-07 Revenue from Contracts with Customers Topic 606 In February 2016, the FASB issued ASU 2016-02, Leases ASC 842 Leases |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets are composed of the following at December 31, 2018 and March 31, 2018: December 31, March 31, 2018 2018 AV-101 materials and services $ 456,200 $ 505,900 Professional services 166,500 — Insurance 89,900 88,300 Public offering filing fees and expenses 88,400 25,900 All other 52,800 24,700 $ 853,800 $ 644,800 The increase in prepaid professional services is primarily attributable to the unexpensed portion of the fair value of securities we have issued to certain professional service providers as full or partial compensation for services. The fair value of the securities issued is being expensed ratably over the term of the related service agreement. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment is composed of the following at December 31, 2018 and March 31, 2018: December 31, March 31, 2018 2018 Laboratory equipment $ 888,300 $ 888,300 Tenant improvements 214,400 26,900 Computers and network equipment 54,600 54,600 Office furniture and equipment 84,500 79,700 1,241,800 1,049,500 Accumulated depreciation and amortization (906,900 ) (842,100 ) Property and equipment, net $ 334,900 $ 207,400 The increase in tenant improvements reflects recently completed construction at our South San Francisco, California offices. Under the terms of our November 2016 lease extension agreement, our landlord has provided a cash reimbursement of $158,600 of such tenant improvement costs. Such reimbursement is a component of the deferred rent liability shown on our Condensed Consolidated Balance Sheet at December 31, 2018. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Accrued Expenses | Accrued expenses are composed of the following at December 31, 2018 and March 31, 2018: December 31, March 31, 2018 2018 Accrued AV-101 clinical trial, development and related expenses $ 759,300 $ 176,600 Accrued professional services 59,000 27,000 All other 8,800 2,700 $ 827,100 $ 206,300 |
Notes Payable
Notes Payable | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Notes Payable | The following table summarizes our unsecured promissory notes at December 31, 2018 and March 31, 2018: December 31, 2018 March 31, 2018 Principal Accrued Principal Accrued Balance Interest Total Balance Interest Total 6.50% (2018) Notes payable to insurance premium financing company (current) $ 49,100 $ — $ 49,100 $ 53,900 $ — $ 53,900 In May 2018, we executed a 6.50% promissory note in the principal amount of $160,500 in connection with certain insurance policy premiums. The note is payable in monthly installments of $16,500, including principal and interest, through March 2019, and had an outstanding principal balance of $49,100 at December 31, 2018. In February 2018, we executed a 7.15% promissory note in the principal amount of $59,700 in connection with other insurance policy premiums. That note was payable in monthly installments of $6,200, including principal and interest, through December 2018, and had been fully paid at December 31, 2018. |
Capital Stock
Capital Stock | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Capital Stock | Common Stock and Warrants Issued in Summer 2018 Private Placement Between June 2018 and October 2018, we completed a self-placed private placement with accredited investors, pursuant to which we sold units, at a purchase price of $1.25 per unit, consisting of 4,605,000 unregistered shares of our common stock and warrants, exercisable through February 28, 2022, to purchase 4,605,000 unregistered shares of our common stock at an exercise price of $1.50 per share (the Summer 2018 Private Placement Common Stock and Warrants Issued in Fall 2018 Private Placement The Summer 2018 Private Placement was oversubscribed. To accommodate additional investor interest, during October 2018, we accepted subscription agreements from accredited investors, pursuant to which we sold to such investors units, at a unit purchase price equal to $0.15 above the closing quoted market price of our common stock on the Nasdaq Capital Market on the effective date of the investor’s subscription agreement, consisting of an aggregate of 420,939 unregistered shares of our common stock and four-year, immediately exercisable warrants to purchase 420,939 unregistered shares of our Common Stock at a per share exercise price equal to the closing quoted market price of our common stock on the Nasdaq Capital Market on the effective date of the investor’s subscription agreement (the Fall 2018 Private Placement Modification of Warrants issued in Summer 2018 Private Placement Subsequent to the completion of the Summer 2018 Private Placement, we amended warrants to purchase an aggregate of 304,000 shares of our common stock issued to investors who submitted Summer 2018 Private Placement subscription agreements between October 3, 2018 and October 5, 2018 to increase the exercise price of their warrants from $1.50 per share to $1.59 per share or $1.69 per share, depending on the effective date of the related subscription agreement, to comply with certain provisions of The Nasdaq Stock Market Rules applicable to the private placement. As additional consideration for agreeing to the increase in the warrant exercise price, we granted the investors additional warrants to purchase an aggregate of 23,800 unregistered shares of our common stock at an exercise price of $1.75 per share through February 28, 2022. We calculated the fair value of the modified warrants immediately before and after the modification using the Black Scholes Option Pricing Model and determined that the increase in the exercise price resulted in a decrease in the fair value of the warrants, which decrease is not recognized. We calculated the fair value of the new warrants using the Black Scholes Option Pricing Model and the weighted average assumptions indicated in the table below, recognizing $25,800 as the fair value of the new warrants and as warrant modification expense, included as a component of general and administrative expenses, in our Condensed Consolidated Statement of Operations and Comprehensive Loss for the quarter and nine months ended December 31, 2018. Assumption: New Warrants Market price per share $ 1.80 Exercise price per share $ 1.75 Risk-free interest rate 2.83 % Remaining contractual term in years 3.25 Volatility 88.80 % Dividend rate 0.0 % Number of warrant shares 23,800 Weighted average fair value per share $ 1.08 Issuance of Common Stock for Product Licenses and Option As indicated in Note 1, Description of Business Summary of Significant Accounting Policies Issuance of Common Stock and Warrants to Professional Services Providers During the quarter ended June 30, 2018, we issued an aggregate of 100,000 shares of our unregistered common stock having a fair value on the date of issuance of $123,000 as full or partial compensation to an investor relations service provider and under a financial advisory agreement. During the quarter ended September 30, 2018, we issued 50,000 shares of our unregistered common stock having a fair value on the date of issuance of $68,000 as partial compensation to a corporate awareness service provider. We also issued four-year warrants to three service providers to purchase an aggregate of 288,000 unregistered shares of our common stock at an exercise price of $1.50 per share as full or partial compensation for investor relations and corporate awareness services. We valued the warrants at an aggregate fair value of $266,900 using the Black-Scholes Option Pricing Model and the following grant date weighted average assumptions: exercise price per share: $1.50; market price per share: $1.40; risk-free interest rate: 2.71%; contractual term: 4 years; volatility: 94.17%; dividend rate: 0%; deriving a value per warrant share of $0.93. The fair value of the common stock and warrants is being recognized in expense ratably over the term of the underlying contracts. Warrants Outstanding Through December 31, 2018, the holders of warrants exercisable at $1.50 per share issued in our December 2017 public offering fully or partially exercised such warrants to purchase an aggregate of 403,800 registered shares of our common stock and we received cash proceeds of $605,700. Following the warrant issuances and exercises described above, at December 31, 2018, we had warrants outstanding to purchase shares of our common stock at a weighted average exercise price of $2.54 per share as follows: Weighted Warrants Average Outstanding at Exercise Price Exercise Price Expiration December 31, per Share per Share Date 2018 $1.50 $1.50 11/30/2021 to 12/13/2022 14,335,200 $1.59 to $1.80 $1.67 2/28/2022 to 10/10/2022 625,619 $1.82 $1.82 3/7/2023 1,388,931 $2.00 to $4.50 $2.23 9/216/2019 to 10/16/2022 721,693 $5.30 $5.30 5/16/2021 2,705,883 $6.00 $6.00 9/26/2019 to 11/30/2019 97,750 $7.00 $7.00 3/19/2019 to 3/3/2023 1,309,431 $8.00 to $20.00 $12.33 9/15/2019 to 3/25/2021 315,448 $2.54 21,499,955 Of the warrants outstanding at December 31, 2018, 2,705,883 shares of common stock underlying the warrants exercisable at $5.30 per share issued in our May 2016 public offering, 1,388,931 shares of common stock underlying the warrants exercisable at $1.82 per share issued in our September 2017 public offering and 9,596,200 shares of common stock underlying the warrants exercisable at $1.50 per share issued in our December 2017 public offering are registered for resale by the warrant holders. The common shares issuable upon exercise of our remaining outstanding warrants are unregistered. At December 31, 2018, none of our outstanding warrants are subject to down round anti-dilution protection features and all of the outstanding warrants are exercisable by the holders only by payment in cash of the stated exercise price per share. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Related Party Transactions | Cato Holding Company ( CHC CBV CRL CRO In July 2017, we entered into a Master Services Agreement ( MSA As noted above, in September 2018, we issued an aggregate of 1,630,435 shares of our unregistered common stock having a fair market value of $2,250,000 to acquire an exclusive worldwide license to develop and commercialize PH94B and an option to acquire a similar license for PH10. In October 2018, we issued an additional 925,926 shares of our unregistered common stock having a fair market value of $2,000,000 to exercise the option to acquire an exclusive worldwide license to develop and commercialize PH10. The acquisition of the licenses and option was recorded as research and development expense. Additionally, during the nine months ended December 31, 2018, we have recorded $40,000 of monthly support payments to Pherin under the terms of the PH94B license agreement. At December 31, 2018, Pherin held approximately 8% of our outstanding Common Stock. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Subsequent Events | We have evaluated subsequent events through February 11, 2019 and have identified the following matters requiring disclosure: Grants and Exercise of Options from 2016 Plan During January 2019, in connection with the appointment of a new independent member to our Board, the Board authorized the grant of options to purchase 25,000 shares of our common stock under our 2016 Plan at an exercise price of $1.74 per share, the quoted closing price of our common stock on the Nasdaq Capital Market on the date of the grant. Additionally, one of our officers and one of our independent Board members exercised options to purchase an aggregate of 26,750 registered shares of our common stock at an exercise price of $1.50 per share and we received cash proceeds of $40,100. Also in January 2019, the Compensation Committee of the Board authorized the grant of options to purchase 220,000 shares of our common stock at an exercise price of $1.70 per share, the quoted closing price of our common stock on the Nasdaq Capital Market on the date of the grant, to one of our executive officers. In February 2019, we granted 25,000 shares of common stcok from our 2016 Plan as partial compensation under the terms of a social media services contract. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Dec. 31, 2018 | |
Summary Of Significant Accounting Policies Policies | |
Use of Estimates | The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include those relating to share-based compensation, and assumptions that have been used historically to value warrants and warrant modifications. With the exception of the BlueRock Agreement pursuant to which we recorded sublicense revenue in the third quarter of our fiscal year ended March 31, 2017, we do not currently have, nor have we had during the periods covered by this Report, any arrangements requiring the recognition of revenue. |
Research and Development Expenses | Research and development expenses are composed of both internal and external costs. Internal costs include salaries and employment-related expenses, including stock-based compensation expense, of scientific personnel and direct project costs. External research and development expenses consist primarily of costs associated with clinical and non-clinical development of AV-101, PH94B, PH10, and stem cell research and development costs, and costs related to the application and prosecution of patents related to those product candidates and, to a lesser extent, our stem cell technology platform. All such costs are charged to expense as incurred. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by contract research organizations ( CRO |
Stock-Based Compensation | We recognize compensation cost for all stock-based awards to employees and non-employee consultants based on the grant date fair value of the award. We record non-cash, stock-based compensation expense over the period during which the employee is required to perform services in exchange for the award, which generally represents the scheduled vesting period. We have not granted restricted stock awards to employees nor do we have any awards with market or performance conditions. For option grants to non-employees, we re-measure the fair value of the awards as they vest and the resulting value is recognized as an expense during the period over which the services are performed. Non-cash expense attributable to compensatory grants of stock to non-employees is determined by the quoted market price of the stock on the date of grant and is either recognized as fully-earned at the time of the grant or expensed ratably over the term of the related service agreement, depending on the terms of the specific agreement. The table below summarizes stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended December 31, 2018 and 2017. Three Months Ended December 31, Nine Months Ended December 31, 2018 2017 2018 2017 Research and development expense: Stock option grants $ 274,900 $ 299,100 $ 955,600 $ 627,400 General and administrative expense: Stock option grants 459,800 390,200 1,564,100 759,500 Total stock-based compensation expense $ 734,700 $ 689,300 $ 2,519,700 $ 1,386,900 In August 2018, our Board approved the grant of options from our 2016 Amended and Restated Stock Incentive Plan (the 2016 Plan Assumption: August 2018 Market price per share at grant date $ 1.27 Exercise price per share $ 1.27 Risk-free interest rate 2.84 % Expected term in years 5.50 Volatility 99.29 % Dividend rate 0.0 % Shares 860,000 Fair Value per share $ 0.98 In August 2018, our Board also approved the modification of outstanding options having exercise prices over $1.56 per share and held by independent members of our Board, our officers and our employees to reduce the exercise prices thereof to $1.50 per share. We calculated the fair value of the options immediately before and after the modification using the Black-Scholes Option Pricing Model and the weighted average assumptions indicated in the table below. We immediately recognized the additional fair value attributable to vested options, $258,100, as stock compensation expense, which is included in the figures reported above. The additional fair value resulting from the modification is being expensed over the remaining vesting period of the modified options. Assumption: Pre-modification Post-modification Market price per share $ 1.49 $ 1.49 Exercise price per share $ 3.57 $ 1.50 Risk-free interest rate 2.77 % 2.77 % Remaining expected term in years 5.08 5.08 Volatility 94.9 % 94.9 % Dividend rate 0.0 % 0.0 % Number of option shares 2,419,503 2,419,503 Weighted average fair value per share $ 0.91 $ 1.08 During October 2018, we granted to certain professional service providers and consultants options to purchase an aggregate of 250,000 shares of our Common Stock at exercise prices ranging from $1.52 per share to $2.20 per share, reflecting the quoted closing price of our Common Stock on the Nasdaq Capital Market on the date of the grant. We valued the options granted in October 2018 using the Black-Scholes Option Pricing Model and the following weighted average assumptions: Assumption: October 2018 Market price per share at grant date $ 1.83 Exercise price per share $ 1.83 Risk-free interest rate 3.13 % Expected term in years 10.00 Volatility 89.98 % Dividend rate 0.0 % Shares 250,000 |
Fair Value per share | At December 31, 2018, there were stock options outstanding to purchase 6,410,338 shares of our common stock at a weighted average exercise price of $1.47 per share. See Note 10, Subsequent Events |
Comprehensive Loss | We have no components of other comprehensive loss other than net loss, and accordingly our comprehensive loss is equivalent to our net loss for the periods presented. |
Loss per Common Share | Basic net loss attributable to common stockholders per share of common stock excludes the effect of dilution and is computed by dividing net loss increased by the accrual of dividends on outstanding shares of our Series B 10% Convertible Preferred Stock ( Series B Preferred As a result of our net loss for all periods presented, potentially dilutive securities were excluded from the computation of diluted net loss per share, as their effect would be antidilutive. Potentially dilutive securities excluded in determining diluted net loss attributable to common stockholders per common share are as follows: As of December 31, 2018 2017 Series A Preferred stock issued and outstanding (1) 750,000 750,000 Series B Preferred stock issued and outstanding (2) 1,160,240 1,160,240 Series C Preferred stock issued and outstanding (3) 2,318,012 2,318,012 Outstanding options under the Amended and Restated 2016 (formerly 2008) and 1999 Stock Incentive Plans (1999 Plan in 2017 only) 6,410,338 3,279,871 Outstanding warrants to purchase common stock 21,499,955 16,918,292 Total 32,138,545 24,426,415 ____________ (1) Assumes exchange under the terms of the October 11, 2012 Note Exchange and Purchase Agreement, as amended (2) Assumes exchange under the terms of the Certificate of Designation of the Relative Rights and Preferences of the Series B 10% Convertible Preferred Stock, effective May 5, 2015 (3) Assumes exchange under the terms of the Certificate of Designation of the Relative Rights and Preferences of the Series C Convertible Preferred Stock, effective January 25, 2016 |
Fair Value Measurements | We do not use derivative instruments for hedging of market risks or for trading or speculative purposes. We carried no assets or liabilities that are measured on a recurring basis at fair value at December 31, 2018 or March 31, 2018. |
Recent Accounting Pronouncements | Except as described below, there have been no recent accounting pronouncements or changes in accounting pronouncements during the nine months ended December 31, 2018, as compared to the recent accounting pronouncements described in our Form 10-K for our fiscal year ended March 31, 2018, that are of significance or potential significance to us. In June 2018, the Financial Accounting Standards Board ( FASB ASU Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting ASU 2018-07 Revenue from Contracts with Customers Topic 606 In February 2016, the FASB issued ASU 2016-02, Leases ASC 842 Leases |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Dec. 31, 2018 | |
Summary Of Significant Accounting Policies Tables | |
Summary of stock-based compensation expense | Three Months Ended December 31, Nine Months Ended December 31, 2018 2017 2018 2017 Research and development expense: Stock option grants $ 274,900 $ 299,100 $ 955,600 $ 627,400 General and administrative expense: Stock option grants 459,800 390,200 1,564,100 759,500 Total stock-based compensation expense $ 734,700 $ 689,300 $ 2,519,700 $ 1,386,900 |
Fair value assumptions | Assumption: August 2018 Market price per share at grant date $ 1.27 Exercise price per share $ 1.27 Risk-free interest rate 2.84 % Expected term in years 5.50 Volatility 99.29 % Dividend rate 0.0 % Shares 860,000 Fair Value per share $ 0.98 Assumption: Pre-modification Post-modification Market price per share $ 1.49 $ 1.49 Exercise price per share $ 3.57 $ 1.50 Risk-free interest rate 2.77 % 2.77 % Remaining expected term in years 5.08 5.08 Volatility 94.9 % 94.9 % Dividend rate 0.0 % 0.0 % Number of option shares 2,419,503 2,419,503 Weighted average fair value per share $ 0.91 $ 1.08 Assumption: October 2018 Market price per share at grant date $ 1.83 Exercise price per share $ 1.83 Risk-free interest rate 3.13 % Expected term in years 10.00 Volatility 89.98 % Dividend rate 0.0 % Shares 250,000 Fair Value per share $ 1.59 |
Schedule of potentially dilutive securities excluded from computation of earnings per share | As of December 31, 2018 2017 Series A Preferred stock issued and outstanding (1) 750,000 750,000 Series B Preferred stock issued and outstanding (2) 1,160,240 1,160,240 Series C Preferred stock issued and outstanding (3) 2,318,012 2,318,012 Outstanding options under the Amended and Restated 2016 (formerly 2008) and 1999 Stock Incentive Plans (1999 Plan in 2017 only) 6,410,338 3,279,871 Outstanding warrants to purchase common stock 21,499,955 16,918,292 Total 32,138,545 24,426,415 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Dec. 31, 2018 | |
Prepaid Expenses And Other Current Assets Tables | |
Prepaid Expenses | December 31, March 31, 2018 2018 AV-101 materials and services $ 456,200 $ 505,900 Professional services 166,500 — Insurance 89,900 88,300 Public offering filing fees and expenses 88,400 25,900 All other 52,800 24,700 $ 853,800 $ 644,800 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | December 31, March 31, 2018 2018 Laboratory equipment $ 888,300 $ 888,300 Tenant improvements 214,400 26,900 Computers and network equipment 54,600 54,600 Office furniture and equipment 84,500 79,700 1,241,800 1,049,500 Accumulated depreciation and amortization (906,900 ) (842,100 ) Property and equipment, net $ 334,900 $ 207,400 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Dec. 31, 2018 | |
Accrued Expenses Tables | |
Accrued Expenses | December 31, March 31, 2018 2018 Accrued AV-101 clinical trial, development and related expenses $ 759,300 $ 176,600 Accrued professional services 59,000 27,000 All other 8,800 2,700 $ 827,100 $ 206,300 |
Notes Payable (Tables)
Notes Payable (Tables) | 9 Months Ended |
Dec. 31, 2018 | |
Convertible Promissory Notes And Other Notes Payable Tables | |
Notes Payable | December 31, 2018 March 31, 2018 Principal Accrued Principal Accrued Balance Interest Total Balance Interest Total 6.50% (2018) Notes payable to insurance premium financing company (current) $ 49,100 $ — $ 49,100 $ 53,900 $ — $ 53,900 |
Capital Stock (Tables)
Capital Stock (Tables) | 9 Months Ended |
Dec. 31, 2018 | |
Capital Stock Tables | |
Warrants Outstanding | Weighted Warrants Average Outstanding at Exercise Price Exercise Price Expiration December 31, per Share per Share Date 2018 $ 1.50 $ 1.50 11/30/2021 to 12/13/2022 14,335,200 $1.59 to $1.80 $ 1.67 2/28/2022 to 10/10/2022 625,619 $ 1.82 $ 1.82 3/7/2023 1,388,931 $2.00 to $4.50 $ 2.23 9/216/2019 to 10/16/2022 721,693 $ 5.30 $ 5.30 5/16/2021 2,705,883 $ 6.00 $ 6.00 9/26/2019 to 11/30/2019 97,750 $ 7.00 $ 7.00 3/19/2019 to 3/3/2023 1,309,431 $8.00 to $20.00 $ 12.33 9/15/2019 to 3/25/2021 315,448 $ 2.54 21,499,955 |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - USD ($) | 9 Months Ended | |||
Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | |
Basis Of Presentation And Going Concern Details Narrative | ||||
Accumulated Deficit during its development stage | $ (175,410,100) | $ (156,543,800) | ||
Cash proceeds from issuance of common stock | 68,600,000 | |||
Cash proceeds from grant awards and other events | 17,600,000 | |||
Cash and cash equivalents | $ 6,285,300 | $ 10,378,300 | $ 13,031,800 | $ 2,921,300 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock option expense | $ 734,700 | $ 689,300 | $ 2,519,700 | $ 1,386,900 |
ResearchAndDevelopmentExpenseMember | ||||
Stock option expense | 274,900 | 299,100 | 955,600 | 627,400 |
ResearchAndDevelopmentExpenseMember | Options [Member] | ||||
Stock option expense | 274,900 | 299,100 | 955,600 | 627,400 |
GeneralAndAdministrativeExpenseMember | ||||
Stock option expense | 459,800 | 390,200 | 1,564,100 | 759,500 |
GeneralAndAdministrativeExpenseMember | Options [Member] | ||||
Stock option expense | $ 459,800 | $ 390,200 | $ 1,564,100 | $ 759,500 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details 1) | 9 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Exercise price per share | $ 2.54 |
Employee Stock Option | |
Market price per share at grant date | 1.83 |
Exercise price per share | $ 1.83 |
Risk-free interest rate | 3.13% |
Estimated term in years | 10 years |
Volatility | 89.98% |
Dividend rate | 0.00% |
Shares | shares | 250,000 |
Fair Value per share | $ 1.59 |
Pre-modification | |
Market price per share at grant date | 1.49 |
Exercise price per share | $ 3.57 |
Risk-free interest rate | 2.77% |
Estimated term in years | 5 years 29 days |
Volatility | 94.90% |
Dividend rate | 0.00% |
Shares | shares | 2,419,503 |
Fair Value per share | $ 0.91 |
Post-Modification | |
Market price per share at grant date | 1.49 |
Exercise price per share | $ 1.50 |
Risk-free interest rate | 2.77% |
Estimated term in years | 5 years 29 days |
Volatility | 94.90% |
Dividend rate | 0.00% |
Shares | shares | 2,419,503 |
Fair Value per share | $ 1.08 |
2016 Plan | |
Market price per share at grant date | 1.27 |
Exercise price per share | $ 1.27 |
Risk-free interest rate | 2.84% |
Estimated term in years | 5 years 6 months |
Volatility | 99.29% |
Dividend rate | 0.00% |
Shares | shares | 860,000 |
Fair Value per share | $ 0.98 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details 2) - shares | 9 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive securities | 32,138,545 | 24,426,415 |
Series A Preferred Stock [Member] | ||
Antidilutive securities | 750,000 | 750,000 |
Series B Preferred Stock [Member] | ||
Antidilutive securities | 1,160,240 | 1,160,240 |
Series C Preferred Stock [Member] | ||
Antidilutive securities | 2,318,012 | 2,318,012 |
2016 (formerly 2008) and 1999 Stock Incentive Plans [Member] | ||
Antidilutive securities | 6,410,338 | 3,279,871 |
Warrant [Member] | ||
Antidilutive securities | 21,499,955 | 16,918,292 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2018 | Mar. 31, 2018 |
Prepaid Expenses And Other Current Assets Details | ||
AV-101 materials and services | $ 456,200 | $ 505,900 |
Professional services | 166,500 | 0 |
Insurance | 89,900 | 88,300 |
Public offering expenses | 88,400 | 25,900 |
All other | 52,800 | 24,700 |
Total | $ 853,800 | $ 644,800 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Dec. 31, 2018 | Mar. 31, 2018 |
Property and equipment, gross | $ 1,241,800 | $ 1,049,500 |
Accumulated depreciation and amortization | (906,900) | (842,100) |
Property and equipment, net | 334,900 | 207,400 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 888,300 | 888,300 |
Tenant Improvements [Member] | ||
Property and equipment, gross | 214,400 | 26,900 |
Computers and Network Equipment [Member] | ||
Property and equipment, gross | 54,600 | 54,600 |
Office Furniture And Equipment [Member] | ||
Property and equipment, gross | $ 84,500 | $ 79,700 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2018 | Mar. 31, 2018 |
Accrued Expenses Details | ||
Accrued AV-101 development and related expenses | $ 759,300 | $ 176,600 |
Accrued professional services | 59,000 | 27,000 |
All other | 8,800 | 2,700 |
Total | $ 827,100 | $ 206,300 |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | Dec. 31, 2018 | Mar. 31, 2018 |
Principal Balance | $ 49,100 | $ 53,900 |
Accrued Interest | 0 | 0 |
Total | 49,100 | 53,900 |
Notes Payable 1 [Member] | ||
Principal Balance | 49,100 | 53,900 |
Accrued Interest | 0 | 0 |
Total | $ 49,100 | $ 53,900 |
Capital Stock (Details)
Capital Stock (Details) | 9 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Exercise price per share | $ / shares | $ 2.54 |
Warrants outstanding | shares | 21,499,955 |
Warrant 1 [Member] | |
Exercise price per share | $ / shares | $ 1.50 |
Expiration date range | 11/30/2021 to 12/13/2022 |
Warrants outstanding | shares | 14,335,200 |
Warrant 2 [Member] | |
Exercise price per share | $ / shares | $ 1.67 |
Expiration date range | 2/28/2022 to 10/10/2022 |
Warrants outstanding | shares | 625,619 |
Warrant 3 [Member] | |
Exercise price per share | $ / shares | $ 1.82 |
Expiration date range | 3/7/2023 |
Warrants outstanding | shares | 1,388,931 |
Warrant 4 [Member] | |
Exercise price per share | $ / shares | $ 2.23 |
Expiration date range | 9/216/2019 to 10/16/2022 |
Warrants outstanding | shares | 721,693 |
Warrant 5 [Member] | |
Exercise price per share | $ / shares | $ 5.30 |
Expiration date range | 5/16/2021 |
Warrants outstanding | shares | 2,705,883 |
Warrant 6 [Member] | |
Exercise price per share | $ / shares | $ 6 |
Expiration date range | 9/26/2019 to 11/30/2019 |
Warrants outstanding | shares | 97,750 |
Warrant 7 [Member] | |
Exercise price per share | $ / shares | $ 7 |
Expiration date range | 3/19/2019 to 3/3/2023 |
Warrants outstanding | shares | 1,309,431 |
Warrant 8 [Member] | |
Exercise price per share | $ / shares | $ 12.33 |
Expiration date range | 9/15/2019 to 3/25/2021 |
Warrants outstanding | shares | 315,448 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Incurred expenses on research and subsequent other projects | $ 5,335,500 | $ 1,601,800 | $ 13,340,300 | $ 5,124,600 |
CRL [Member] | ||||
Incurred expenses on research and subsequent other projects | $ 1,067,300 | $ 292,700 | $ 2,697,100 | $ 904,900 |