Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Sep. 30, 2019 | Nov. 06, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | VistaGen Therapeutics, Inc. | |
Entity Central Index Key | 0001411685 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
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 | 43,222,965 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2020 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation State Country Code | NV | |
Entity File Number | 001-37761 | |
Title of 12b security | Common Stock, par value $0.001 per share | |
Trading Symbol | VTGN | |
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 4,072,400 | $ 13,100,300 |
Receivable from supplier | 0 | 300,000 |
Prepaid expenses and other current assets | 604,500 | 250,900 |
Total current assets | 4,676,900 | 13,651,200 |
Property and equipment, net | 260,600 | 312,700 |
Right of use asset - operating lease | 3,750,200 | 0 |
Security deposits and other assets | 47,800 | 47,800 |
Total assets | 8,735,500 | 14,011,700 |
Current liabilities: | ||
Accounts payable | 1,449,800 | 1,055,000 |
Accrued expenses | 2,215,500 | 1,685,600 |
Current notes payable | 159,300 | 57,300 |
Operating lease oligation | 289,600 | 0 |
Financing lease obligation | 3,100 | 3,000 |
Total current liabilities | 4,117,300 | 2,800,900 |
Non-current liabilities: | ||
Accrued dividends on Series B Preferred Stock | 4,364,500 | 3,748,200 |
Deferred rent liability | 0 | 381,100 |
Operating lease obligation | 3,879,400 | 0 |
Financing lease obligations | 4,700 | 6,300 |
Total non-current liabilities | 8,248,600 | 4,135,600 |
Total liabilities | 12,365,900 | 6,936,500 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 175,000,000 and 100,000,000 shares authorized at September 30, 2019 and March 31, 2019, respectively; 42,758,630 shares issued and outstanding at September 30, 2019 and March 31, 2019 | 42,800 | 42,800 |
Additional paid-in capital | 192,970,100 | 192,129,900 |
Treasury stock, at cost, 135,665 shares of common stock held at September 30, 2019 and March 31, 2019 | (3,968,100) | (3,968,100) |
Accumulated deficit | (192,679,200) | (181,133,400) |
Total stockholders' equity | (3,630,400) | 7,075,200 |
Total liabilities and stockholders' equity | 8,735,500 | 14,011,700 |
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 | Sep. 30, 2019 | Mar. 31, 2019 |
Stockholders deficit: | ||
Preferred Stock, par value | $ 0.001 | $ .001 |
Preferred Stock, authorized | 10,000,000 | 10,000,000 |
Common Stock, par value | $ .001 | $ .001 |
Common Stock, authorized | 175,000,000 | 100,000,000 |
Common Stock, issued | 42,758,630 | 42,758,630 |
Common Stock, outstanding | 42,758,630 | 42,758,630 |
Treasury Stock | 135,665 | 135,665 |
Series A Preferred Stock [Member] | ||
Stockholders deficit: | ||
Preferred Stock, authorized | 500,000 | 500,000 |
Preferred Stock, issued | 500,000 | 500,000 |
Preferred Stock, outstanding | 500,000 | 500,000 |
Series B Preferred Stock [Member] | ||
Stockholders deficit: | ||
Preferred Stock, authorized | 4,000,000 | 4,000,000 |
Preferred Stock, issued | 1,160,240 | 1,160,240 |
Preferred Stock, 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, issued | 2,318,012 | 2,318,012 |
Preferred Stock, outstanding | 2,318,012 | 2,318,012 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 4,205,200 | $ 5,261,100 | $ 8,519,100 | $ 8,004,800 |
General and administrative | 1,146,100 | 2,171,000 | 3,056,200 | 3,637,300 |
Total operating expenses | 5,351,300 | 7,432,100 | 11,575,300 | 11,642,100 |
Loss from operations | (5,351,300) | (7,432,100) | (11,575,300) | (11,642,100) |
Other income (expenses), net: | ||||
Interest income (expense), net | 15,400 | (2,900) | 31,900 | (5,000) |
Loss before income taxes | (5,335,900) | (7,435,000) | (11,543,400) | (11,647,100) |
Income taxes | 0 | 0 | (2,400) | (2,400) |
Net loss and comprehensive loss | (5,335,900) | (7,435,000) | (11,545,800) | (11,649,500) |
Accrued dividends on Series B Preferred stock | (313,800) | (283,600) | (616,300) | (557,100) |
Net loss attributable to common stockholders | $ (5,649,700) | $ (7,718,600) | $ (12,162,100) | $ (12,206,600) |
Basic and diluted net loss attributable to common stockholders per common share | $ (0.13) | $ (0.30) | $ (0.29) | $ (0.50) |
Weighted average shares used in computing basic and diluted net loss attributable to common stockholders per common share | 42,622,965 | 25,815,245 | 42,622,965 | 24,267,816 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (11,545,800) | $ (11,649,500) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 52,100 | 37,900 |
Stock-based compensation | 1,456,500 | 1,785,000 |
Amortization of fair value of common stock issued for services | 92,100 | 207,300 |
Fair value of common stock issued for product license and option | 0 | 2,250,000 |
Amortization of fair value of warrants issued for services | 13,800 | 25,100 |
Changes in operating assets and liabilities: | ||
Receivable from supplier | 300,000 | 0 |
Prepaid expenses and other current assets | (229,200) | 365,400 |
Right of use asset - operating lease | 164,900 | 0 |
Operating lease liability | (127,100) | 0 |
Accounts payable and accrued expenses | 924,500 | (212,300) |
Deferred rent | 0 | 128,000 |
Net cash used in operating activities | (8,898,200) | (7,063,100) |
Cash flows from investing activities: | ||
Construction of tenant improvements | 0 | (169,800) |
Net cash used in investing activities | 0 | (169,800) |
Cash flows from financing activities: | ||
Net proceeds from issuance of common stock and warrants, including Units | 0 | 4,778,700 |
Proceeds from exercise of warrants | 0 | 7,500 |
Repayment of financing lease obligation | (1,500) | (1,300) |
Repayment of notes payable | (128,200) | (98,700) |
Net cash (used in) provided by financing activities | (129,700) | 4,686,200 |
Net decrease in cash and cash equivalents | (9,027,900) | (2,546,700) |
Cash and cash equivalents at beginning of period | 13,100,300 | 10,378,300 |
Cash and cash equivalents at end of period | 4,072,400 | 7,831,600 |
Supplemental disclosure of noncash activites: | ||
Insurance premiums settled by issuing note payable | 230,200 | 160,500 |
Accrued dividends on Series B Preferred | $ 616,300 | $ 557,100 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($) | Series A Preferred Stock | Series B Preferred Stock | Series C Preferred Stock | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Deficit | Total |
Balances at beginning (in shares) at Mar. 31, 2018 | 500,000 | 1,160,240 | 2,318,012 | 23,068,280 | ||||
Balances at beginning at Mar. 31, 2018 | $ 500 | $ 1,200 | $ 2,300 | $ 23,100 | $ 16,740,400 | $ (3,968,100) | $ (156,543,800) | $ 6,916,600 |
Proceeds from sale of common stock and warrants for cash in private placement offerings (in shares) | 40,000 | |||||||
Proceeds from sale of common stock and warrants for cash in private placement offerings | 50,000 | 50,000 | ||||||
Proceeds from exercise of warrants (in shares) | 5,000 | |||||||
Proceeds from exercise of warrants | 7,500 | 7,500 | ||||||
Accrued dividends on Series B Preferred stock | (273,500) | (273,500) | ||||||
Stock-based compensation expense | 612,600 | 612,600 | ||||||
Fair value of common stock issued for services (in shares) | 100,000 | |||||||
Fair value of common stock issued for services | $ 100 | 122,900 | 123,000 | |||||
Net loss | (4,214,500) | (4,214,500) | ||||||
Balances at end (in shares) at Jun. 30, 2018 | 500,000 | 1,160,240 | 2,318,012 | 23,213,280 | ||||
Balances at end at Jun. 30, 2018 | $ 500 | $ 1,200 | $ 2,300 | $ 23,200 | 167,920,900 | (3,968,100) | (160,758,300) | 3,221,700 |
Balances at beginning (in shares) at Mar. 31, 2018 | 500,000 | 1,160,240 | 2,318,012 | 23,068,280 | ||||
Balances at beginning at Mar. 31, 2018 | $ 500 | $ 1,200 | $ 2,300 | $ 23,100 | 16,740,400 | (3,968,100) | (156,543,800) | 6,916,600 |
Proceeds from exercise of warrants | 7,500 | |||||||
Balances at end (in shares) at Sep. 30, 2018 | 500,000 | 1,160,240 | 2,318,012 | 28,676,715 | ||||
Balances at end at Sep. 30, 2018 | $ 500 | $ 1,200 | $ 2,300 | $ 28,700 | 176,117,900 | (3,968,100) | (168,193,300) | 3,989,200 |
Balances at beginning (in shares) at Jun. 30, 2018 | 500,000 | 1,160,240 | 2,318,012 | 23,213,280 | ||||
Balances at beginning at Jun. 30, 2018 | $ 500 | $ 1,200 | $ 2,300 | $ 23,200 | 167,920,900 | (3,968,100) | (160,758,300) | 3,221,700 |
Proceeds from sale of common stock and warrants for cash in private placement offerings (in shares) | 3,783,000 | |||||||
Proceeds from sale of common stock and warrants for cash in private placement offerings | $ 3,800 | 4,725,000 | 4,728,800 | |||||
Accrued dividends on Series B Preferred stock | (283,600) | (283,600) | ||||||
Stock-based compensation expense | 1,172,400 | 1,172,400 | ||||||
Fair value of common stock issued for PH94B license and option (in shares) | 1,630,435 | |||||||
Fair value of common stock issued for PH94B license and option | $ 1,600 | 2,248,400 | 2,250,000 | |||||
Fair value of common stock issued for services (in shares) | 50,000 | |||||||
Fair value of common stock issued for services | $ 100 | 334,800 | 334,900 | |||||
Net loss | (7,435,000) | (7,435,000) | ||||||
Balances at end (in shares) at Sep. 30, 2018 | 500,000 | 1,160,240 | 2,318,012 | 28,676,715 | ||||
Balances at end at Sep. 30, 2018 | $ 500 | $ 1,200 | $ 2,300 | $ 28,700 | 176,117,900 | (3,968,100) | (168,193,300) | 3,989,200 |
Balances at beginning (in shares) at Mar. 31, 2019 | 500,000 | 1,160,240 | 2,318,012 | 42,758,630 | ||||
Balances at beginning at Mar. 31, 2019 | $ 500 | $ 1,200 | $ 2,300 | $ 42,800 | 192,129,900 | (3,968,100) | (181,133,400) | 7,075,200 |
Accrued dividends on Series B Preferred stock | (302,500) | (302,500) | ||||||
Stock-based compensation expense | 1,063,000 | 1,063,000 | ||||||
Net loss | (6,209,900) | (6,209,900) | ||||||
Balances at end (in shares) at Jun. 30, 2019 | 500,000 | 1,160,240 | 2,318,012 | 42,758,630 | ||||
Balances at end at Jun. 30, 2019 | $ 500 | $ 1,200 | $ 2,300 | $ 42,800 | 192,890,400 | (3,968,100) | (187,343,300) | 1,625,800 |
Balances at beginning (in shares) at Mar. 31, 2019 | 500,000 | 1,160,240 | 2,318,012 | 42,758,630 | ||||
Balances at beginning at Mar. 31, 2019 | $ 500 | $ 1,200 | $ 2,300 | $ 42,800 | 192,129,900 | (3,968,100) | (181,133,400) | 7,075,200 |
Proceeds from exercise of warrants | 0 | |||||||
Balances at end (in shares) at Sep. 30, 2019 | 500,000 | 1,160,240 | 2,318,012 | 42,758,630 | ||||
Balances at end at Sep. 30, 2019 | $ 500 | $ 1,200 | $ 2,300 | $ 42,800 | 192,970,100 | (3,968,100) | (192,679,200) | (3,630,400) |
Balances at beginning (in shares) at Jun. 30, 2019 | 500,000 | 1,160,240 | 2,318,012 | 42,758,630 | ||||
Balances at beginning at Jun. 30, 2019 | $ 500 | $ 1,200 | $ 2,300 | $ 42,800 | 192,890,400 | (3,968,100) | (187,343,300) | 1,625,800 |
Accrued dividends on Series B Preferred stock | (313,800) | (313,800) | ||||||
Stock-based compensation expense | 393,500 | 393,500 | ||||||
Net loss | (5,335,900) | (5,335,900) | ||||||
Balances at end (in shares) at Sep. 30, 2019 | 500,000 | 1,160,240 | 2,318,012 | 42,758,630 | ||||
Balances at end at Sep. 30, 2019 | $ 500 | $ 1,200 | $ 2,300 | $ 42,800 | $ 192,970,100 | $ (3,968,100) | $ (192,679,200) | $ (3,630,400) |
Description of Business
Description of Business | 6 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | VistaGen Therapeutics. Inc., a Nevada corporation (which may be referred to as VistaGen Company we our us CNS AV-101 (4-Chlorokynurenine or 4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) glutamate receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with multiple CNS diseases and disorders, including major depressive disorder ( MDD NIH ELEVATE Study Baylor VA Baylor Study PH10 is a novel, rapid-acting CNS neuroactive nasal spray for MDD. Administered in microgram doses, PH10 activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid antidepressant effects without the psychological side effects, systemic exposure or safety concerns often associated with current oral antidepressants and ketamine-based therapies (intravenous ketamine or esketamine nasal spray) ( KBT HAM-D TRD PH94B is also a novel, rapid-acting CNS neuroactive nasal spray administered in microgram doses. We are initially developing PH94B for treatment of social anxiety disorder ( SAD FDA ADs PH94B is fundamentally differentiated from all current treatments for SAD. PH94B activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid suppression of fear and anxiety. In clinical studies to date, PH94B has not shown psychological side effects, systemic exposure, sedation or other safety concerns often associated with current antidepressants approved by the FDA for treatment of SAD, as well as benzodiazepines and beta blockers, which are not approved by the FDA to treat SAD but are often prescribed for treatment of SAD off-label. In a peer-reviewed, published double-blind, placebo-controlled Phase 2 clinical trial, PH94B neuroactive nasal spray was significantly more effective than placebo in reducing public-speaking and social interaction anxiety on laboratory challenges of individuals with SAD within 10 to 15 minutes of self-administration. Based on its novel mechanism of pharmacological action, rapid-onset of therapeutic effects and exceptional safety and tolerability profile in Phase 2 clinical trials to date, we are preparing to begin pivotal Phase 3 development of PH94B neuroactive nasal spray to become the first FDA-approved on-demand treatment for SAD. Additional potential CNS indications for PH94B include, general anxiety disorder ( GAD PTSD In addition to our current CNS product candidates, we have pipeline-enabling programs through our wholly-owned subsidiary, VistaStem Therapeutics ( VistaStem hPSC NCEs RM CardioSafe 3D BlueRock Therapeutics BlueRock Agreement Subsidiaries As noted above, VistaStem, a California corporation, 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 | 6 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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 the 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, 2019 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 $192.7 million accumulated from inception (May 1998) through September 30, 2019. 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 September 30, 2019, 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 $79.0 million, as well as from an aggregate of approximately $17.7 million of government research grant awards (excluding the fair market value of government sponsored and funded clinical trials), 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 noncash 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 September 30, 2019, we had cash and cash equivalents of approximately $4.1 million. As disclosed in Note 11, Subsequent Events Fall 2019 Private Placement S-3 Registration Statement In addition to the potential sale of our equity securities, we may also seek to enter 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 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 provide non-dilutive funding for development of AV-101, PH94B, PH10 or other product candidates, as well as new government grant awards and/or agreements, 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 our current product candidates 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, PH94B, PH10 and, to a lesser extent, 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 | 6 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
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, right-of-use assets and lease liabilities 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 or other grantee 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. 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 amortized 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 six months ended September 30, 2019 and 2018. Three Months Ended September 30, Six Months Ended September 30, 2019 2018 2019 2018 Research and development expense $ 167,500 $ 450,600 $ 558,100 $ 680,700 General and administrative expense 226,000 721,800 898,400 1,104,300 Total stock-based compensation expense $ 393,500 $ 1,172,400 $ 1,456,500 $ 1,785,000 In May 2019, the Compensation Committee of our Board of Directors (the Board 2016 Plan Assumption: May 2019 Market price per share at grant date $ 0.80 Exercise price per share $ 1.00 Risk-free interest rate 2.12 % Expected term in years 5.53 Volatility 85.90 % Dividend rate 0.0 % Shares 1,220,000 Fair Value per share $ 0.54 Additionally, in May 2019, the Compensation Committee approved, subject to subsequent stockholder approval at our 2019 Annual Meeting of Stockholders ( Annual Meeting 2019 Plan Assumption: September 2019 Market price per share at grant date $ 0.84 Exercise price per share $ 1.00 Risk-free interest rate 1.45 % Expected term in years 5.58 Volatility 86.04 % Dividend rate 0.0 % Shares 170,000 Fair Value per share $ 0.56 Upon approval of the 2019 Plan by our stockholders, no further option or other equity awards were permitted from our 2016 Plan and all remaining authorized shares of our common stock available for issuance under the 2016 Plan, 1,388,412 shares, became available for issuance under the 2019 Plan. At September 30, 2019, there were stock options outstanding under our 2016 Plan and 2019 Plan to purchase 8,014,838 shares of our common stock at a weighted average exercise price of $1.40 per share. At that date, there were also 8,718,412 shares of our common stock available for future issuance under the 2019 Plan. See Note 11, Subsequent Events, for disclosure of additional option grants made in October 2019. Leases, Right-of-Use Assets and Lease Liabilities On April 1, 2019, we adopted Financial Accounting Standards Board ( FASB ASU Leases ASC Leases (Topic 842): ASC 842 We determine whether an arrangement is an operating or financing lease at contract inception. Operating lease assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, we include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. In determining the present value of the lease payments, we use the interest rate implicit in the lease when it is readily determinable and we use our estimated incremental borrowing rate based upon information available at the commencement date when the implicit rate is not readily determinable. The lease payments used to determine our operating lease assets include lease incentives and stated rent increases and may include escalation or other clauses linked to rates of inflation or other factors when determinable and are recognized in our operating lease assets in our condensed consolidated balance sheets. Our operating leases are reflected in right of use asset – operating leases, other current liabilities and non-current operating lease liability in our condensed consolidated balance sheets. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. Our accounting for financing leases, previously referred to as “capital leases” under prior guidance, remained substantially unchanged with our adoption of ASC 842. Financing leases are included in property and equipment, net and as current and non-current financing lease liabilities in our condensed consolidated balance sheets. Refer to “Recent Accounting Pronouncements” below and Note 10, Commitments and Contingencies, 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 September 30, 2019 2018 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 Company's Amended and Restated 2016 (formerly 2008) Stock Incentive Plan and 2019 Omnibus Equity Incentive Plan 8,014,838 6,160,338 Outstanding warrants to purchase common stock 21,242,954 20,709,516 Total 33,486,044 31,098,106 ____________ (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; excludes common shares issuable in payment of dividends on Series B Preferred upon conversion. (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 September 30, 2019 or March 31, 2019. Recent Accounting Pronouncements Except as described below, there have been no recent accounting pronouncements or changes in accounting pronouncements during the six months ended September 30, 2019, as compared to the recent accounting pronouncements described in our Form 10-K for our fiscal year ended March 31, 2019, that are of significance or potential significance to us. In February 2016, the FASB issued ASU No. 2016-02, Leases Leases (Topic 842): ASC 842 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Sep. 30, 2019 | |
Other Assets [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets are composed of the following at September 30, 2019 and March 31, 2019: September 30, March 31, 2019 2019 AV-101, PH94B and PH10 materials and contract services $ 357,900 $ 5,900 Fair value of securities issued for professional services - 105,900 Insurance 206,000 96,300 Public offering filing fees and expenses 30,500 22,300 All other 10,100 20,500 $ 604,500 $ 250,900 The fair value of securities issued for professional services reflects the unamortized 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 amortized ratably over the term of the related service agreement. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment is composed of the following at September 30, 2019 and March 31, 2019: September 30, March 31, 2019 2019 Laboratory equipment $ 892,500 $ 892,500 Tenant improvements 214,400 214,400 Computers and network equipment 54,600 54,600 Office furniture and equipment 84,600 84,600 1,246,100 1,246,100 Accumulated depreciation and amortization (985,500 ) (933,400 ) Property and equipment, net $ 260,600 $ 312,700 Included in amounts reported above for office furniture and equipment is the right-of-use asset related to a financing lease of certain office equipment. Amounts associated with assets subject to the financing lease at September 30, 2019 and March 31, 2019 are as follows: September 30, March 31, 2019 2019 Office equipment subject to financing lease $ 14,700 $ 14,700 Accumulated depreciation (8,000 ) (6,500 ) Net book value of office equipment subject to financing lease $ 6,700 $ 8,200 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued expenses are composed of the following at September 30, 2019 and March 31, 2019: September 30, March 31, 2019 2019 Accrued expenses for AV-101, PH94B, and PH10 clinical trial, development and related expenses $ 2,080,700 $ 1,067,600 Accrued compensation - 439,200 Accrued professional services 127,600 172,100 All other 7,200 6,700 $ 2,215,500 $ 1,685,600 |
Notes Payable
Notes Payable | 6 Months Ended |
Sep. 30, 2019 | |
Notes Payable [Abstract] | |
Notes Payable | The following table summarizes our unsecured promissory notes at September 30, 2019 and March 31, 2019: September 30, 2019 March 31, 2019 Accrued Accrued Balance Interest Total Balance Interest Total 7.75% and 7.15% Notes payable to insurance premium financing company (current) $ 159,300 $ - $ 159,300 $ 57,300 $ - $ 57,300 In May 2019, we executed a 7.15% promissory note in the principal amount of $230,200 in connection with certain insurance policy premiums. The note is payable in monthly installments of $23,800, including principal and interest, through March 2020, and had an outstanding principal balance of $139,800 at September 30, 2019. In February 2019, we executed a 7.75% promissory note in the principal amount of $63,500 in connection with other insurance policy premiums. That note is payable in monthly installments of $6,600 including principal and interest, through December 2019 and had an outstanding principal balance of $19,500 at September 30, 2019. |
Capital Stock
Capital Stock | 6 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Capital Stock | During the six months ended September 30, 2019, we did not engage in any capital-raising transactions, nor did we grant any equity securities as full or partial compensation to consultants, other than stock options as described in Stock-Based Compensation in Note 3, Summary of Significant Accounting Policies Warrants Outstanding During the quarter ended June 30, 2019, warrants issued in private placement transactions during calendar 2018 to purchase an aggregate of 805,800 shares of our common stock at exercise prices between $1.50 per share and $1.75 per share became fully-exercisable in accordance with their terms. Accordingly, all warrants outstanding at September 30, 2019 are now fully-exercisable at a weighted average exercise price of $2.43 per share as follows: Exercise Weighted Warrants Outstanding Price Average Expiration and Exercisable at per Share per Share Date September 30, 2019 $ 1.50 $ 1.50 11/30/2021 to 12/13/2022 14,335,200 $ 1.59 - $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 - $3.51 $ 2.14 4/30/2021 to 10/19/2022 696,693 $ 5.30 $ 5.30 5/16/2021 2,705,883 $ 6.00 - $10.00 $ 7.15 10/11/2019 to 3/3/2023 1,490,628 $ 2.43 21,242,954 Of the warrants outstanding at September 30, 2019, 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 September 30, 2019, 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 | 6 Months Ended |
Sep. 30, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Cato Holding Company ( CHC CBV CRL CRO In July 2017, we entered into a Master Services Agreement ( MSA During our fiscal year ended March 31, 2019, we issued an aggregate of 2,556,361 shares of our unregistered common stock having an issue-date fair market value of $4,250,000 to Pherin Pharmaceuticals, Inc. ( Pherin During the six months ended September 30, 2019, we engaged the consulting firm headed by one of the independent members of our Board to provide various market research studies for certain of our product pipeline candidates and recorded research and development expense of $75,100 for the quarter ended September 30, 2019 and $102,800 for the six months ended September 30, 2019 related to such studies. We incurred no such expenses for the three and six months ended September 30, 2018. At September 30, 2019, we recorded $45,000 of accrued expenses related to these studies. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Operating Leases We lease our headquarters office and laboratory space in South San Francisco, California under the terms of a lease that expires on July 31, 2022 and that provides an option to renew for an additional five years at then-current market rates. Consistent with the guidance in ASC 842, effective beginning April 1, 2019, we have recorded this lease in our Condensed Consolidated Balance Sheet as an operating lease. For the purpose of determining the right-of-use asset and associated lease liability, we determined that the renewal of this lease is reasonably probable. The lease of our South San Francisco facilities does not include any restrictions or covenants requiring special treatment under ASC 842. The following table summarizes the presentation of the operating lease in our Condensed Consolidated Balance Sheet at September 30, 2019: As of September 30, 2019 Assets Right of use asset – operating lease $ 3,750,200 Liabilities Current operating lease obligation $ 289,600 Non-current operating lease obligation 3,879,400 Total operating lease liability $ 4,169,000 The following table summarizes the effect of operating lease costs in the Company’s condensed consolidated statements of operations: For the Three Months Ended For the Six Months Ended September 30, 2019 September 30, 2019 Operating lease cost $ 203,100 $ 411,900 The minimum (base rental) lease payments related to our South San Francisco operating lease are expected to be as follows: Fiscal Years Ending March 31, 2020 (remaining six months) $ 315,500 2021 645,800 2022 668,400 2023 726,000 2024 766,000 Thereafter 2,720,400 Total lease expense 5,842,100 Less imputed interest (1,673,100 ) Present value of operating lease liabilities $ 4,169,000 Under the prior lease guidance, future minimum lease payments, under the non-cancellable portion (excluding the five-year extension assumed under ASC 842) of the South San Francisco operating lease were as follows at March 31, 2019: Fiscal Years Ending March 31, 2020 $ 623,900 2021 645,800 2022 668,400 2023 225,300 2024 - Thereafter - $ 2,163,400 The remaining lease term, including the assumed five-year extension at the expiration of the current lease period, and the discount rate assumption for our South San Francisco operating lease is as follows: As of September 30, 2019 Assumed remaining lease term in years 7.84 Assumed discount rate 8.54 % The interest rate implicit in lease contracts is typically not readily determinable and, as such, we used our estimated incremental borrowing rate based on information available at the adoption of ASC 842, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Supplemental disclosure of cash flow information related to the Company’s operating leases included in cash flows used by operating activities in the condensed consolidated statements of cash flows is as follows: For the Six Months Ended September 30, 2019 Cash paid for amounts included in the measurement of lease liabilities $ 374,200 During the six months ended September 30, 2019, other than the initial adoption of ASC 842 that required right of use assets and lease liabilities to be recorded, we recorded no new right of use assets arising from new lease liabilities. We also lease a small office in the San Francisco Bay Area under a month-to-month arrangement at insignificant cost and have made an accounting policy election not to apply the ASC 842 operating lease recognition requirements to such short-term lease. We recognize the lease payments for this lease in general and administrative expense over the lease term. We recorded rent expense of $3,500 and $6,900 for the three and six months ended September 30, 2019, respectively, attributable to this lease. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | We have evaluated subsequent events through November 6, 2019 and have identified the following matters requiring disclosure: Grant of Options from the 2019 Plan During October 2019, we granted options from our 2019 Plan to the independent members of our Board, our officers and employees and certain consultants to purchase an aggregate of 1,575,000 shares of our common stock at an exercise price of $1.41 per share, the quoted closing market price of our common stock on the Nasdaq Capital Market on the grant date. The options were vested 25% at grant with the remaining options vesting ratably over the following 24 months. Common Stock and Warrants Issued in Fall 2019 Private Placement Between October 30, 2019 and November 6, 2019, in a self-placed private placement and pursuant to subscription agreements from accredited investors, we sold to such investors units, at a purchase price of $1.00 per unit, consisting of an aggregate of 600,000 unregistered shares of our common stock and warrants, exercisable through November 1, 2023, to purchase 300,000 unregistered shares of our common stock at an exercise price of $2.00 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 prior to six months and one day following issuance. We received aggregate cash proceeds of $600,000 from the sale of the units. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
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, right-of-use assets and lease liabilities 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 or other grantee 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. 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 amortized 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 six months ended September 30, 2019 and 2018. Three Months Ended September 30, Six Months Ended September 30, 2019 2018 2019 2018 Research and development expense $ 167,500 $ 450,600 $ 558,100 $ 680,700 General and administrative expense 226,000 721,800 898,400 1,104,300 Total stock-based compensation expense $ 393,500 $ 1,172,400 $ 1,456,500 $ 1,785,000 In May 2019, the Compensation Committee of our Board of Directors (the Board 2016 Plan Assumption: May 2019 Market price per share at grant date $ 0.80 Exercise price per share $ 1.00 Risk-free interest rate 2.12 % Expected term in years 5.53 Volatility 85.90 % Dividend rate 0.0 % Shares 1,220,000 Fair Value per share $ 0.54 Additionally, in May 2019, the Compensation Committee approved, subject to subsequent stockholder approval at our 2019 Annual Meeting of Stockholders ( Annual Meeting 2019 Plan Assumption: September 2019 Market price per share at grant date $ 0.84 Exercise price per share $ 1.00 Risk-free interest rate 1.45 % Expected term in years 5.58 Volatility 86.04 % Dividend rate 0.0 % Shares 170,000 Fair Value per share $ 0.56 Upon approval of the 2019 Plan by our stockholders, no further option or other equity awards were permitted from our 2016 Plan and all remaining authorized shares of our common stock available for issuance under the 2016 Plan, 1,388,412 shares, became available for issuance under the 2019 Plan. At September 30, 2019, there were stock options outstanding under our 2016 Plan and 2019 Plan to purchase 8,014,838 shares of our common stock at a weighted average exercise price of $1.40 per share. At that date, there were also 8,718,412 shares of our common stock available for future issuance under the 2019 Plan. See Note 11, Subsequent Events, for disclosure of additional option grants made in October 2019. |
Leases, Right-of- Use Assets and Lease Liabilities | On April 1, 2019, we adopted Financial Accounting Standards Board ( FASB ASU Leases ASC Leases (Topic 842): ASC 842 We determine whether an arrangement is an operating or financing lease at contract inception. Operating lease assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, we include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. In determining the present value of the lease payments, we use the interest rate implicit in the lease when it is readily determinable and we use our estimated incremental borrowing rate based upon information available at the commencement date when the implicit rate is not readily determinable. The lease payments used to determine our operating lease assets include lease incentives and stated rent increases and may include escalation or other clauses linked to rates of inflation or other factors when determinable and are recognized in our operating lease assets in our condensed consolidated balance sheets. Our operating leases are reflected in right of use asset – operating leases, other current liabilities and non-current operating lease liability in our condensed consolidated balance sheets. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. Our accounting for financing leases, previously referred to as “capital leases” under prior guidance, remained substantially unchanged with our adoption of ASC 842. Financing leases are included in property and equipment, net and as current and non-current financing lease liabilities in our condensed consolidated balance sheets. Refer to “Recent Accounting Pronouncements” below and Note 10, Commitments and Contingencies, |
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 September 30, 2019 2018 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 Company's Amended and Restated 2016 (formerly 2008) Stock Incentive Plan and 2019 Omnibus Equity Incentive Plan 8,014,838 6,160,338 Outstanding warrants to purchase common stock 21,242,954 20,709,516 Total 33,486,044 31,098,106 ____________ (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; excludes common shares issuable in payment of dividends on Series B Preferred upon conversion. (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 September 30, 2019 or March 31, 2019. |
Recent Accounting Pronouncements | Except as described below, there have been no recent accounting pronouncements or changes in accounting pronouncements during the six months ended September 30, 2019, as compared to the recent accounting pronouncements described in our Form 10-K for our fiscal year ended March 31, 2019, that are of significance or potential significance to us. In February 2016, the FASB issued ASU No. 2016-02, Leases Leases (Topic 842): , ASC 842 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of stock-based compensation expense | Three Months Ended September 30, Six Months Ended September 30, 2019 2018 2019 2018 Research and development expense $ 167,500 $ 450,600 $ 558,100 $ 680,700 General and administrative expense 226,000 721,800 898,400 1,104,300 Total stock-based compensation expense $ 393,500 $ 1,172,400 $ 1,456,500 $ 1,785,000 |
Fair value assumptions | In May 2019, the Compensation Committee of our Board of Directors (the Board 2016 Plan Assumption: May 2019 Market price per share at grant date $ 0.80 Exercise price per share $ 1.00 Risk-free interest rate 2.12 % Expected term in years 5.53 Volatility 85.90 % Dividend rate 0.0 % Shares 1,220,000 Fair Value per share $ 0.54 Additionally, in May 2019, the Compensation Committee approved, subject to subsequent stockholder approval at our 2019 Annual Meeting of Stockholders ( Annual Meeting 2019 Plan Assumption: September 2019 Market price per share at grant date $ 0.84 Exercise price per share $ 1.00 Risk-free interest rate 1.45 % Expected term in years 5.58 Volatility 86.04 % Dividend rate 0.0 % Shares 170,000 Fair Value per share $ 0.56 |
Schedule of potentially dilutive securities excluded from computation of earnings per share | As of September 30, 2019 2018 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 Company's Amended and Restated 2016 (formerly 2008) Stock Incentive Plan and 2019 Omnibus Equity Incentive Plan 8,014,838 6,160,338 Outstanding warrants to purchase common stock 21,242,954 20,709,516 Total 33,486,044 31,098,106 ____________ (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; excludes common shares issuable in payment of dividends on Series B Preferred upon conversion. (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 Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Other Assets [Abstract] | |
Prepaid expenses | September 30, March 31, 2019 2019 AV-101, PH94B and PH10 materials and contract services $ 357,900 $ 5,900 Fair value of securities issued for professional services - 105,900 Insurance 206,000 96,300 Public offering filing fees and expenses 30,500 22,300 All other 10,100 20,500 $ 604,500 $ 250,900 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment | September 30, March 31, 2019 2019 Laboratory equipment $ 892,500 $ 892,500 Tenant improvements 214,400 214,400 Computers and network equipment 54,600 54,600 Office furniture and equipment 84,600 84,600 1,246,100 1,246,100 Accumulated depreciation and amortization (985,500 ) (933,400 ) Property and equipment, net $ 260,600 $ 312,700 September 30, March 31, 2019 2019 Office equipment subject to financing lease $ 14,700 $ 14,700 Accumulated depreciation (8,000 ) (6,500 ) Net book value of office equipment subject to financing lease $ 6,700 $ 8,200 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Accrued expenses | September 30, March 31, 2019 2019 Accrued expenses for AV-101, PH94B, and PH10 clinical trial, development and related expenses $ 2,080,700 $ 1,067,600 Accrued compensation - 439,200 Accrued professional services 127,600 172,100 All other 7,200 6,700 $ 2,215,500 $ 1,685,600 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Notes Payable [Abstract] | |
Notes payable | September 30, 2019 March 31, 2019 Accrued Accrued Balance Interest Total Balance Interest Total 7.75% and 7.15% Notes payable to insurance premium financing company (current) $ 159,300 $ - $ 159,300 $ 57,300 $ - $ 57,300 |
Capital Stock (Tables)
Capital Stock (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Warrants outstanding | Exercise Weighted Warrants Outstanding Price Average Expiration and Exercisable at per Share per Share Date September 30, 2019 $ 1.50 $ 1.50 11/30/2021 to 12/13/2022 14,335,200 $ 1.59 - $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 - $3.51 $ 2.14 4/30/2021 to 10/19/2022 696,693 $ 5.30 $ 5.30 5/16/2021 2,705,883 $ 6.00 - $10.00 $ 7.15 10/11/2019 to 3/3/2023 1,490,628 $ 2.43 21,242,954 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of presentation of operating lease | As of September 30, 2019 Assets Right of use asset – operating lease $ 3,750,200 Liabilities Current operating lease obligation $ 289,600 Non-current operating lease obligation 3,879,400 Total operating lease liability $ 4,169,000 |
Summary of operating lease costs | For the Three Months Ended For the Six Months Ended September 30, 2019 September 30, 2019 Operating lease cost $ 203,100 $ 411,900 |
Summary of expected lease expense | Fiscal Years Ending March 31, 2020 (remaining six months) $ 315,500 2021 645,800 2022 668,400 2023 726,000 2024 766,000 Thereafter 2,720,400 Total lease expense 5,842,100 Less imputed interest (1,673,100 ) Present value of operating lease liabilities $ 4,169,000 |
Summary of future minimum lease payments | Fiscal Years Ending March 31, 2020 $ 623,900 2021 645,800 2022 668,400 2023 225,300 2024 - Thereafter - $ 2,163,400 |
Other Lease disclosure | As of September 30, 2019 Assumed remaining lease term in years 7.84 Assumed discount rate 8.54 % |
Supplemental disclosure of cash flow information | For the Six Months Ended September 30, 2019 Cash paid for amounts included in the measurement of lease liabilities $ 374,200 |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Mar. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit during its development stage | $ (192,679,200) | $ (181,133,400) | ||
Cash and cash equivalents | $ 4,072,400 | $ 13,100,300 | $ 7,831,600 | $ 10,378,300 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock option expense | $ 393,500 | $ 1,172,400 | $ 1,456,500 | $ 1,785,000 |
Research and Development Expense [Member] | ||||
Stock option expense | 167,500 | 450,600 | 558,100 | 680,700 |
General and Administrative Expense [Member] | ||||
Stock option expense | $ 226,000 | $ 721,800 | $ 898,400 | $ 1,104,300 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details 1) | 6 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Exercise price per share | $ 2.43 |
2016 Plan | |
Market price per share at grant date | .80 |
Exercise price per share | $ 1 |
Risk-free interest rate | 2.12% |
Estimated term in years | 5 years 6 months 11 days |
Volatility | 85.90% |
Dividend rate | 0.00% |
Shares | shares | 1,220,000 |
Fair value per share | $ .54 |
2019 Plan | |
Market price per share at grant date | .84 |
Exercise price per share | $ 1 |
Risk-free interest rate | 1.45% |
Estimated term in years | 5 years 6 months 29 days |
Volatility | 86.04% |
Dividend rate | 0.00% |
Shares | shares | 170,000 |
Fair value per share | $ .56 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details 2) - shares | 6 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | ||
Antidilutive securities | 33,486,044 | 31,098,106 | |
Series A Preferred Stock [Member] | |||
Antidilutive securities | [1] | 750,000 | 750,000 |
Series B Preferred Stock [Member] | |||
Antidilutive securities | [2] | 1,160,240 | 1,160,240 |
Series C Preferred Stock [Member] | |||
Antidilutive securities | [3] | 2,318,012 | 2,318,012 |
Amended and Restated 2016 (formerly 2008) Stock Incentive Plan and 2019 Omnibus Equity Incentive Plan [Member] | |||
Antidilutive securities | 8,014,838 | 6,160,338 | |
Warrant [Member] | |||
Antidilutive securities | 21,242,954 | 20,709,516 | |
[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; excludes common shares issuable in payment of dividends on Series B Preferred upon conversion. | ||
[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 Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Other Assets [Abstract] | ||
AV-101 materials and services | $ 357,900 | $ 5,900 |
Professional services | 0 | 105,900 |
Insurance | 206,000 | 96,300 |
Public offering filing fees and expenses | 30,500 | 22,300 |
All other | 10,100 | 20,500 |
Total | $ 604,500 | $ 250,900 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Property and equipment, gross | $ 1,246,100 | $ 1,246,100 |
Accumulated depreciation and amortization | (985,500) | (933,400) |
Property and equipment, net | 260,600 | 312,700 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 892,500 | 892,500 |
Tenant Improvements [Member] | ||
Property and equipment, gross | 214,400 | 214,400 |
Computers and Network Equipment [Member] | ||
Property and equipment, gross | 54,600 | 54,600 |
Office Furniture And Equipment [Member] | ||
Property and equipment, gross | $ 84,600 | $ 84,600 |
Property and Equipment (Detai_2
Property and Equipment (Details 1) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Property And Equipment | ||
Office equipment subject to financing lease | $ 14,700 | $ 14,700 |
Accumulated depreciation | (8,000) | (6,500) |
Net book value of office equipment subject to financing lease | $ 6,700 | $ 8,200 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued AV-101 development and related expenses | $ 2,080,700 | $ 1,067,600 |
Accrued compensation | 0 | 439,200 |
Accrued professional services | 127,600 | 172,100 |
All other | 7,200 | 6,700 |
Total | $ 2,215,500 | $ 1,685,600 |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Principal balance | $ 159,300 | $ 57,300 |
Accrued interest | 0 | 0 |
Total | 159,300 | 57,300 |
Notes Payable 1 [Member] | ||
Principal balance | 159,300 | 57,300 |
Accrued interest | 0 | 0 |
Total | $ 159,300 | $ 57,300 |
Capital Stock (Details)
Capital Stock (Details) | 6 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Average per share | $ / shares | $ 2.43 |
Warrants outstanding | shares | 21,242,954 |
Warrant 1 [Member] | |
Average per share | $ / shares | $ 1.50 |
Expiration date range | 11/30/2021 to 12/13/2022 |
Warrants outstanding | shares | 14,335,200 |
Warrant 2 [Member] | |
Average per share | $ / shares | $ 1.67 |
Expiration date range | 2/28/2022 to 10/10/2022 |
Warrants outstanding | shares | 625,619 |
Warrant 3 [Member] | |
Average per share | $ / shares | $ 1.82 |
Expiration date range | 3/7/2023 |
Warrants outstanding | shares | 1,388,931 |
Warrant 4 [Member] | |
Average per share | $ / shares | $ 2.14 |
Expiration date range | 4/30/2021 to 10/19/2022 |
Warrants outstanding | shares | 696,693 |
Warrant 5 [Member] | |
Average per share | $ / shares | $ 5.30 |
Expiration date range | 5/16/2021 |
Warrants outstanding | shares | 2,705,883 |
Warrant 6 [Member] | |
Average per share | $ / shares | $ 7.15 |
Expiration date range | 10/11/2019 to 3/3/2023 |
Warrants outstanding | shares | 1,490,628 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Incurred expenses on research and subsequent other projects | $ 4,205,200 | $ 5,261,100 | $ 8,519,100 | $ 8,004,800 |
CRL [Member] | ||||
Incurred expenses on research and subsequent other projects | $ 1,610,900 | $ 752,200 | $ 3,106,000 | $ 1,603,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | Sep. 30, 2019 | Mar. 31, 2019 |
Assets | ||
Right of use asset - operating lease | $ 3,750,200 | $ 0 |
Liabilities | ||
Current operating lease obligation | 289,600 | 0 |
Non-current operating lease obligation | 3,879,400 | $ 0 |
Total operating lease liability | $ 4,169,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details 1) - USD ($) | 3 Months Ended | 6 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 203,100 | $ 411,900 |
Commitments and Contingencies_4
Commitments and Contingencies (Details 2) | Sep. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 (remaining six months) | $ 315,500 |
2021 | 645,800 |
2022 | 726,000 |
2023 | 726,000 |
2024 | 766,000 |
Thereafter | 2,720,400 |
Total lease expense | 5,842,100 |
Less imputed interest | (1,673,100) |
Present value of operating lease liabilities | $ 4,169,000 |
Commitments and Contingencies_5
Commitments and Contingencies (Details 3) | Sep. 30, 2019USD ($) |
Fiscal Years Ending March 31, | |
2020 | $ 623,900 |
2021 | 645,800 |
2022 | 668,400 |
2023 | 225,300 |
2024 | 0 |
Thereafter | 0 |
Total | $ 2,163,400 |
Commitments and Contingencies_6
Commitments and Contingencies (Details 4) | Sep. 30, 2019 |
Commitments and Contingencies Disclosure [Abstract] | |
Assumed remaining lease term in years | 7 years 10 months 2 days |
Assumed discount rate | 8.54% |
Commitments and Contingencies_7
Commitments and Contingencies (Details 5) | 6 Months Ended |
Sep. 30, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Cash paid for amounts included in the measurement of lease liabilities | $ 374,200 |