Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Jun. 30, 2018 | Aug. 14, 2018 | |
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 | Jun. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --03-31 | |
Is Entity a Well-known Seasoned Issuer? | No | |
Is Entity a Voluntary Filer? | No | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 25,815,615 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2,019 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 7,231,200 | $ 10,378,300 |
Prepaid expenses and other current assets | 617,300 | 644,800 |
Total current assets | 7,848,500 | 11,023,100 |
Property and equipment, net | 359,000 | 207,400 |
Security deposits and other assets | 47,800 | 47,800 |
Total assets | 8,255,300 | 11,278,300 |
Current liabilities: | ||
Accounts payable | 629,500 | 1,195,700 |
Accrued expenses | 1,057,900 | 206,300 |
Current notes payable | 181,100 | 53,900 |
Capital lease obligations | 2,700 | 2,600 |
Total current liabilities | 1,871,200 | 1,458,500 |
Non-current liabilities: | ||
Accrued dividends on Series B Preferred Stock | 2,881,800 | 2,608,300 |
Deferred rent liability | 272,000 | 285,600 |
Capital lease obligations | 8,600 | 9,300 |
Total non-current liabilities | 3,162,400 | 2,903,200 |
Total liabilities | 5,033,600 | 4,361,700 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2018 and March 31, 2018; 23,213,280 and 23,068,280 shares issued and outstanding at June 30, 2018 and March 31, 2018, respectively | 23,200 | 23,100 |
Additional paid-in capital | 167,920,900 | 167,401,400 |
Treasury stock, at cost, 135,665 shares of common stock held at June 30, 2018 and March 31, 2017 | (3,968,100) | (3,968,100) |
Accumulated deficit | (160,758,300) | (156,543,800) |
Total stockholders' equity | 3,221,700 | 6,916,600 |
Total liabilities and stockholders' equity | 8,255,300 | 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 | Jun. 30, 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 | 23,213,280 | 23,068,280 |
Common Stock, Shares, Outstanding | 23,213,280 | 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 | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Operating expenses: | ||
Research and development | $ 2,743,700 | $ 1,096,200 |
General and administrative | 1,466,300 | 1,164,300 |
Total operating expenses | 4,210,000 | 2,260,500 |
Loss from operations | (4,210,000) | (2,260,500) |
Other expenses, net: | ||
Interest expense, net | (2,100) | (2,400) |
Loss before income taxes | (4,212,100) | (2,262,900) |
Income taxes | (2,400) | (2,400) |
Net loss and comprehensive loss | (4,214,500) | (2,265,300) |
Accrued dividends on Series B Preferred stock | (273,500) | (247,300) |
Net loss attributable to common stockholders | $ (4,488,000) | $ (2,512,600) |
Basic and diluted net loss attributable to common stockholders per common share | $ (0.20) | $ (0.28) |
Weighted average shares used in computing basic and diluted net loss attributable to common stockholders per common share | 22,987,066 | 9,034,213 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (4,214,500) | $ (2,265,300) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 15,000 | 23,600 |
Stock-based compensation | 612,600 | 367,000 |
Amortization of deferred rent | (13,600) | 63,300 |
Fair value of common stock granted for services | 145,000 | 49,800 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 148,500 | 101,000 |
Accounts payable and accrued expenses, including accrued interest | 171,700 | (473,500) |
Net cash used in operating activities | (3,135,300) | (2,134,100) |
Cash flows from investing activities: | ||
Construction of tenant improvements | (35,400) | 0 |
Net cash used in investing activities | (35,400) | 0 |
Cash flows from financing activities: | ||
Net proceeds from issuance of common stock and warrants, including Units | 57,500 | 873,300 |
Repayment of capital lease obligations | (600) | (600) |
Repayment of notes payable | (33,300) | (31,700) |
Net cash provided by financing activities | 23,600 | 841,000 |
Net increase in cash and cash equivalents | (3,147,100) | (1,293,100) |
Cash and cash equivalents at beginning of period | 10,378,300 | 2,921,300 |
Cash and cash equivalents at end of period | 7,231,200 | 1,628,200 |
Supplemental disclosure of noncash activites: | ||
Insurance premiums settled by issuing note payable | 160,500 | 142,400 |
Accrued dividends on Series B Preferred | $ 273,500 | $ 247,300 |
Description of Business
Description of Business | 3 Months Ended |
Jun. 30, 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 Our lead CNS product candidate, AV-101, is an oral, non-opioid and non-sedating therapy that we believe offers the potential to be a new at-home treatment for multiple CNS indications with high unmet medical need. These indications include potential use as a new generation treatment alternative for Major Depressive Disorder ( MDD CNP PD LID where modulation of NMDA (N-methyl-D-aspartate) receptor and AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor pathways may achieve therapeutic benefit. For MDD, we believe AV-101 has potential as an oral, at home, stand-alone first line therapy and as an adjunctive therapy. As an adjunctive therapy, we believe AV-101 has potential to both (i) augment current antidepressants approved by the U.S. Food and Drug Administration ( FDA ketamine IV AV-101 is currently in Phase 2 development in the United States. In the fourth quarter of 2017, we received authorization from the FDA to initiate ELEVATE, our Phase 2 multi-center, multi-dose, double blind, placebo-controlled clinical study to evaluate the efficacy and safety of AV-101 as an 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 two small government-funded clinical studies. The first study is a small Phase 2 clinical study being conducted and funded by the U.S. National Institute of Mental Health (the NIMH CRADA NIMH Study Baylor VA Baylor Study MT CRADA 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 hPSC NCEs RM CardioSafe 3D BlueRock Therapeutics BlueRock Agreement Subsidiaries As noted above, 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 | 3 Months Ended |
Jun. 30, 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 $160.8 million accumulated from inception (May 1998) through June 30, 2018. We expect losses and negative cash flows from operations to continue for the foreseeable future as we engage in further potential development of AV-101, initially as an adjunctive treatment for MDD and subsequently as a new treatment alternative for other CNS conditions, execute our drug rescue programs and pursue potential drug development and regenerative medicine opportunities. Since our inception in May 1998 through June 30, 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 $61.4 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 $33.7 million in non-cash settlements of certain liabilities, including liabilities for professional services rendered to us or as compensation for such services. At June 30, 2018, we had cash and cash equivalents of $7.2 million. Our cash position at June 30, 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, including expenditures required to satisfy a significant portion of the projected expenses associated with our ELEVATE Study, raising substantial doubt that we can continue as a going concern. However, to alleviate that doubt, since June 30, 2018 we have raised $3.36 million of additional capital as described below, and we plan, as we have numerous times in the past, to raise additional capital when and as needed, primarily through the sale of our equity securities in one or more private placements to accredited investors or public offerings. Between July 1, 2018 and August 13, 2018, we sold to accredited investors units consisting of an aggregate of 2,688,000 unregistered shares of our common stock, par value $0.001 per share, and warrants exercisable at least six months and one day following issuance and through February 28, 2022 to purchase 2,688,000 unregistered shares of our common stock at $1.50 per share, from which we received cash proceeds of $3,360,000 (the 2018 Private Placement Subsequent Events S-3 Registration Statement In addition to the potential sale of our equity securities, we may also seek to enter research, development and commercialization collaborations that could generate revenue or provide funding, including non-dilutive funding, for development of AV-101 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. In a manner similar to the BlueRock Agreement, we may also pursue similar arrangements with third-parties involving our intellectual property. Although we may seek additional collaborations that could generate revenue and/or non-dilutive funding for development of AV-101 and 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 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 AV-101 as an adjunctive treatment for MDD and other potential CNS conditions, and various 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 and 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 will be available 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 2018 or 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 | 3 Months Ended |
Jun. 30, 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, stem cell research and development costs, and costs related to the application and prosecution of patents related to AV-101 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. Compensatory grants of stock to non-employees are generally treated as fully-earned at the time of the grant and the non-cash expense recognized is based on the quoted market price of the stock on the date of grant. The table below summarizes stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended June 30, 2018 and 2017. Three Months Ended June 30, 2018 2017 Research and development expense: Stock option grants $ 230,100 $ 191,400 230,100 191,400 General and administrative expense: Stock option grants 382,500 175,600 382,500 175,600 Total stock-based compensation expense $ 612,600 $ 367,000 We did not grant any options pursuant to our 2016 Amended and Restated Stock Incentive Plan (the 2016 Plan At June 30, 2018, there were stock options outstanding to purchase 5,300,338 shares of our common stock at a weighted average exercise price of $2.43 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 both periods presented, potentially dilutive securities were excluded from the computation of diluted 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 June 30, 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) 5,300,338 2,522,593 Outstanding warrants to purchase common stock 16,638,516 4,796,506 Total 26,167,106 11,547,351 ____________ (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 at fair value at June 30, 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 three months ended June 30, 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 | 3 Months Ended |
Jun. 30, 2018 | |
Notes to Financial Statements | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets are composed of the following at June 30, 2018 and March 31, 2018: June 30, March 31, 2018 2018 AV-101 materials and services $ 352,200 $ 505,900 Insurance 227,400 88,300 Public offering filing fees and expenses 25,900 25,900 All other 11,800 24,700 $ 617,300 $ 644,800 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment is composed of the following at June 30, 2018 and March 31, 2018: June 30, March 31, 2018 2018 Laboratory equipment $ 888,300 $ 888,300 Tenant improvements 193,500 26,900 Computers and network equipment 54,600 54,600 Office furniture and equipment 79,700 79,700 1,216,100 1,049,500 Accumulated depreciation and amortization (857,100 ) (842,100 ) Property and equipment, net $ 359,000 $ 207,400 The increase in tenant improvements reflects construction in progress at our South San Francisco, California offices at June 30, 2018, including approximately $113,700 of which is included in our Accounts Payable balance at that date. Under the terms of our November 2016 lease extension agreement, our landlord will reimburse us for up to $163,600 of such tenant improvement costs. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Jun. 30, 2018 | |
Notes to Financial Statements | |
Accrued Expenses | Accrued expenses are composed of the following at June 30, 2018 and March 31, 2018: June 30, March 31, 2018 2018 Accrued AV-101 development and related expenses $ 889,500 $ 176,600 Accrued professional services 164,900 27,000 All other 3,500 2,700 $ 1,057,900 $ 206,300 |
Notes Payable
Notes Payable | 3 Months Ended |
Jun. 30, 2018 | |
Notes to Financial Statements | |
Notes Payable | The following table summarizes our unsecured promissory notes at June 30, 2018 and March 31, 2018. June 30, 2018 March 31, 2018 Principal Accrued Principal Accrued Balance Interest Total Balance Interest Total 6.50% and 7.15% Notes payable to insurance premium financing company (current) $ 181,100 $ — $ 181,100 $ 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 balance of $144,800 at June 30, 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 is payable in monthly installments of $6,200, including principal and interest, through December 2018, and had an outstanding balance of $36,300 at June 30, 2018. |
Capital Stock
Capital Stock | 3 Months Ended |
Jun. 30, 2018 | |
Notes to Financial Statements | |
Capital Stock | Common Stock and Warrants Issued in Private Placement During the quarter ended June 30, 2018, in connection with our self-placed 2018 Private Placement, we accepted a subscription agreement from an accredited investor, pursuant to which we sold units, at a purchase price of $1.25 per unit, consisting of 40,000 unregistered shares of our common stock and warrants, exercisable through February 28, 2022, to purchase 40,000 unregistered shares of our common stock at an exercise price of $1.50 per share. The purchaser of the units has no registration rights with respect to the shares of common stock, warrants or the shares of common stock issuable upon exercise of the warrants comprising the units sold. The warrants are not exercisable until at least six months and one day following the date of issuance. We received aggregate cash proceeds of $50,000 in connection with this self-placed private placement transaction, and the entire amount of the proceeds was credited to stockholders’ equity. Refer to Note 10, Subsequent Events Issuance of Common Stock to Professional Services Providers During the quarter ended June 30, 2018, we issued 25,000 shares of our unregistered common stock having a fair value on the date of issuance of $24,000 as partial compensation to an investor relations service provider. We also issued 75,000 shares of our unregistered common stock having a fair value on the date of issuance of $99,000 as compensation under a financial advisory agreement. Warrants Outstanding During the quarter ended June 30, 2018, the holder of a warrant to purchase 5,000 shares of our common stock at $1.50 per share issued in our December 2017 public offering fully exercised the warrant and we received cash proceeds of $7,500. Following the warrant issuance in the 2018 Private Placement and the warrant exercise, at June 30, 2018, we had outstanding warrants to purchase shares of our common stock at a weighted average exercise price of $2.85 per share as follows: Warrants Exercise Outstanding at Price Expiration June 30, per Share Date 2018 $ 1.50 11/30/2021 to 12/13/2022 10,185,000 $ 1.82 3/7/2023 1,388,931 $ 2.00 4/30/2021 523,573 $ 3.51 12/31/2021 50,000 $ 4.50 9/26/2019 25,000 $ 5.30 5/16/2021 2,705,883 $ 6.00 9/26/2019 to 11/30/2019 97,750 $ 7.00 12/11/2018 to 3/3/2023 1,346,931 $ 8.00 3/25/2021 185,000 $ 10.00 1/11/2020 20,000 $ 20.00 9/15/2019 110,448 16,638,516 Of the warrants outstanding at June 30, 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 9,995,000 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 June 30, 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 | 3 Months Ended |
Jun. 30, 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 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Jun. 30, 2018 | |
Notes to Financial Statements | |
Subsequent Events | We have evaluated subsequent events through August 13, 2018 and have identified the following matters requiring disclosure: Common Stock and Warrants Issued in 2018 Private Placement Between July 1 and August 14, 2018, in connection with our self-placed 2018 Private Placement, we accepted subscription agreements from accredited investors, pursuant to which we sold to such investors units, at a purchase price of $1.25 per unit, consisting of an aggregate of 2,688,000 unregistered shares of our common stock and warrants, exercisable through February 28, 2022, to purchase 2,688,000 unregistered shares of our common stock at an exercise price of $1.50 per share. The purchasers of the units have no registration rights with respect to the shares of common stock, warrants or the shares of common stock issuable upon exercise of the warrants comprising the units sold. The warrants are not exercisable until at least six months and one day following the date of issuance. We received aggregate cash proceeds of $3,360,000 in connection with these self-placed private placement transactions. Issuance of Common Stock and Warrants to Professional Services Providers During July 2018, we issued: (i) a four-year warrant to purchase 48,000 unregistered shares of our common stock at an exercise price of $1.50 per share as compensation under a financial advisory consulting agreement; and (ii) 50,000 unregistered shares of our common stock having a fair value on the date of issuance of $68,000 and a four-year warrant to purchase 150,000 unregistered shares of our common stock at an exercise price of $1.50 per share as partial compensation under an additional financial advisory consulting agreement. Grant of Options from 2016 Plan On August 5, 2018, the Compensation Committee of the Board approved the grant of options to independent members of the Board, certain officers and employees to purchase an aggregate of 860,000 shares of our common stock at an exercise price of $1.27 per share, the quoted closing price of our common stock on the Nasdaq Capital Markets on the trading date preceding the grant. 25% of the options will vest immediately upon grant, and the remaining shares will vest ratably over the next twenty-four months. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Jun. 30, 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, stem cell research and development costs, and costs related to the application and prosecution of patents related to AV-101 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. Compensatory grants of stock to non-employees are generally treated as fully-earned at the time of the grant and the non-cash expense recognized is based on the quoted market price of the stock on the date of grant. The table below summarizes stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended June 30, 2018 and 2017. Three Months Ended June 30, 2018 2017 Research and development expense: Stock option grants $ 230,100 $ 191,400 230,100 191,400 General and administrative expense: Stock option grants 382,500 175,600 382,500 175,600 Total stock-based compensation expense $ 612,600 $ 367,000 We did not grant any options pursuant to our 2016 Amended and Restated Stock Incentive Plan (the 2016 Plan At June 30, 2018, there were stock options outstanding to purchase 5,300,338 shares of our common stock at a weighted average exercise price of $2.43 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 both periods presented, potentially dilutive securities were excluded from the computation of diluted 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 June 30, 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) 5,300,338 2,522,593 Outstanding warrants to purchase common stock 16,638,516 4,796,506 Total 26,167,106 11,547,351 ____________ (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 at fair value at June 30, 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 three months ended June 30, 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 Accoun17
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Summary Of Significant Accounting Policies Tables | |
Summary of stock-based compensation expense | Three Months Ended June 30, 2018 2017 Research and development expense: Stock option grants $ 230,100 $ 191,400 230,100 191,400 General and administrative expense: Stock option grants 382,500 175,600 382,500 175,600 Total stock-based compensation expense $ 612,600 $ 367,000 |
Schedule of potentially dilutive securities excluded from computation of earnings per share | As of June 30, 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) 5,300,338 2,522,593 Outstanding warrants to purchase common stock 16,638,516 4,796,506 Total 26,167,106 11,547,351 ____________ (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 |
Prepaid Expenses and Other Cu18
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Prepaid Expenses And Other Current Assets Tables | |
Prepaid Expenses | June 30, March 31, 2018 2018 AV-101 materials and services $ 352,200 $ 505,900 Insurance 227,400 88,300 Public offering filing fees and expenses 25,900 25,900 All other 11,800 24,700 $ 617,300 $ 644,800 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | June 30, March 31, 2018 2018 Laboratory equipment $ 888,300 $ 888,300 Tenant improvements 193,500 26,900 Computers and network equipment 54,600 54,600 Office furniture and equipment 79,700 79,700 1,216,100 1,049,500 Accumulated depreciation and amortization (857,100 ) (842,100 ) Property and equipment, net $ 359,000 $ 207,400 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Accrued Expenses Tables | |
Accrued Expenses | June 30, March 31, 2018 2018 Accrued AV-101 development and related expenses $ 889,500 $ 176,600 Accrued professional services 164,900 27,000 All other 3,500 2,700 $ 1,057,900 $ 206,300 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Convertible Promissory Notes And Other Notes Payable Tables | |
Notes Payable | June 30, 2018 March 31, 2018 Principal Accrued Principal Accrued Balance Interest Total Balance Interest Total 6.50% and 7.15% Notes payable to insurance premium financing company (current) $ 181,100 $ — $ 181,100 $ 53,900 $ — $ 53,900 |
Capital Stock (Tables)
Capital Stock (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Capital Stock Tables | |
Warrants Outstanding | Warrants Exercise Outstanding at Price Expiration June 30, per Share Date 2018 $ 1.50 11/30/2021 to 12/13/2022 10,185,000 $ 1.82 3/7/2023 1,388,931 $ 2.00 4/30/2021 523,573 $ 3.51 12/31/2021 50,000 $ 4.50 9/26/2019 25,000 $ 5.30 5/16/2021 2,705,883 $ 6.00 9/26/2019 to 11/30/2019 97,750 $ 7.00 12/11/2018 to 3/3/2023 1,346,931 $ 8.00 3/25/2021 185,000 $ 10.00 1/11/2020 20,000 $ 20.00 9/15/2019 110,448 16,638,516 |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - USD ($) | 3 Months Ended | |||
Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2017 | Mar. 31, 2017 | |
Basis Of Presentation And Going Concern Details Narrative | ||||
Accumulated Deficit during its development stage | $ (160,758,300) | $ (156,543,800) | ||
Cash proceeds from issuance of common stock | 61,400,000 | |||
Cash proceeds from grant awards and other events | 17,600,000 | |||
Cash and cash equivalents | $ 7,231,200 | $ 10,378,300 | $ 1,628,200 | $ 2,921,300 |
Private placement shares | 1,758,000 | |||
Proceeds from private placement | $ 2,197,500 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Stock option expense | $ 612,600 | $ 367,000 |
ResearchAndDevelopmentExpenseMember | ||
Stock option expense | 230,100 | 191,400 |
ResearchAndDevelopmentExpenseMember | Options [Member] | ||
Stock option expense | 230,100 | 191,400 |
GeneralAndAdministrativeExpenseMember | ||
Stock option expense | 382,500 | 175,600 |
GeneralAndAdministrativeExpenseMember | Options [Member] | ||
Stock option expense | $ 382,500 | $ 175,600 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Details 1) - shares | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Antidilutive securities | 26,167,106 | 11,547,351 |
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 | 5,300,338 | 2,522,593 |
Warrant [Member] | ||
Antidilutive securities | 16,638,516 | 4,796,502 |
Prepaid Expenses and Other Cu26
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Prepaid Expenses And Other Current Assets Details | ||
AV-101 materials and services | $ 352,200 | $ 505,900 |
Insurance | 227,400 | 88,300 |
Public offering expenses | 25,900 | 25,900 |
All other | 11,800 | 24,700 |
Total | $ 617,300 | $ 644,800 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Property and equipment, gross | $ 1,216,100 | $ 1,049,500 |
Accumulated depreciation and amortization | (857,100) | (842,100) |
Property and equipment, net | 359,000 | 207,400 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 888,300 | 888,300 |
Tenant Improvements [Member] | ||
Property and equipment, gross | 193,500 | 26,900 |
Computers and Network Equipment [Member] | ||
Property and equipment, gross | 54,600 | 54,600 |
Office Furniture And Equipment [Member] | ||
Property and equipment, gross | $ 79,700 | $ 79,700 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Accrued Expenses Details | ||
Accrued AV-101 development and related expenses | $ 889,500 | $ 176,600 |
Accrued professional services | 164,900 | 27,000 |
All other | 3,500 | 2,700 |
Total | $ 1,057,900 | $ 206,300 |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Principal Balance | $ 181,100 | $ 53,900 |
Accrued Interest | 0 | 0 |
Total | 181,000 | 53,900 |
Notes Payable 1 [Member] | ||
Principal Balance | 181,100 | 53,900 |
Accrued Interest | 0 | 0 |
Total | $ 181,000 | $ 53,900 |
Capital Stock (Details)
Capital Stock (Details) | 3 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Warrants outstanding | 16,638,516 |
Warrant 1 [Member] | |
Exercise price per share | $ / shares | $ 1.50 |
Expiration date range | 11/30/2021 to 12/13/2022 |
Warrants outstanding | 10,185,000 |
Warrant 2 [Member] | |
Exercise price per share | $ / shares | $ 1.82 |
Expiration date range | 3/7/2023 |
Warrants outstanding | 1,388,931 |
Warrant 3 [Member] | |
Exercise price per share | $ / shares | $ 2 |
Expiration date range | 4/30/2021 |
Warrants outstanding | 523,573 |
Warrant 4 [Member] | |
Exercise price per share | $ / shares | $ 3.51 |
Expiration date range | 12/31/2021 |
Warrants outstanding | 50,000 |
Warrant 5 [Member] | |
Exercise price per share | $ / shares | $ 4.50 |
Expiration date range | 9/26/2019 |
Warrants outstanding | 25,000 |
Warrant 6 [Member] | |
Exercise price per share | $ / shares | $ 5.30 |
Expiration date range | 5/16/2021 |
Warrants outstanding | 2,705,883 |
Warrant 7 [Member] | |
Exercise price per share | $ / shares | $ 6 |
Expiration date range | 9/26/2019 to 11/30/2019 |
Warrants outstanding | 97,750 |
Warrant 8 [Member] | |
Exercise price per share | $ / shares | $ 7 |
Expiration date range | 12/11/2018 to 3/3/2023 |
Warrants outstanding | 1,346,931 |
Warrant 9 [Member] | |
Exercise price per share | $ / shares | $ 8 |
Expiration date range | 3/25/2021 |
Warrants outstanding | 185,000 |
Warrant 10 [Member] | |
Exercise price per share | $ / shares | $ 10 |
Expiration date range | 1/11/2020 |
Warrants outstanding | 20,000 |
Warrant 11 [Member] | |
Exercise price per share | $ / shares | $ 20 |
Expiration date range | 9/15/2019 |
Warrants outstanding | 110,448 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Incurred expenses on research and subsequent other projects | $ 2,743,700 | $ 1,096,200 |
CRL [Member] | ||
Incurred expenses on research and subsequent other projects | $ 877,500 | $ 128,200 |