Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Jun. 30, 2019 | Aug. 07, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | ANAVEX LIFE SCIENCES CORP. | |
Entity Central Index Key | 0001314052 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --09-30 | |
Entity File Number | 001-37606 | |
Entity Incorporation, State or Country Code | NV | |
Title of 12(b) Security | Common Stock Par Value $0.001 | |
Trading Symbol | AVXL | |
Security Exchange Name | NASDAQ | |
Entity Reporting Status Current | Yes | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity Filer Category | Accelerated Filer | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 52,650,521 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2019 |
INTERIM CONDENSED CONSOLIDATED
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Jun. 30, 2019 | Sep. 30, 2018 |
Current | ||
Cash and cash equivalents | $ 21,249,206 | $ 22,930,638 |
Sales tax recoverable | 93,314 | 40,171 |
Prepaid expenses | 459,618 | 1,251,798 |
Deposits - short term | 15,000 | |
Current Assets | 21,817,138 | 24,222,607 |
Deferred costs | 151,133 | 101,133 |
Deposits | 52,396 | |
Total Assets | 21,968,271 | 24,376,136 |
Current | ||
Accounts payable and accrued liabilities | 4,336,607 | 3,884,626 |
Total Liabilities | 4,336,607 | 3,884,626 |
Commitments - Note 5 | ||
Capital stock Authorized: 100,000,000 common shares, par value $0.001 per share Issued and outstanding:51,509,871 common shares (September 30, 2018 - 45,933,472) | 51,511 | 45,935 |
Additional paid-in capital | 148,927,688 | 129,377,542 |
Accumulated deficit | (131,347,535) | (108,931,967) |
Total Stockholders' Equity | 17,631,664 | 20,491,510 |
Total Liabilities and Stockholders' Equity | $ 21,968,271 | $ 24,376,136 |
INTERIM CONDENSED CONSOLIDATE_2
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2019 | Sep. 30, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Common shares, authorized | 100,000,000 | 100,000,000 |
Common shares, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common shares, issued | 51,509,871 | 45,933,472 |
Common shares, outstanding | 51,509,871 | 45,933,472 |
INTERIM CONDENSED CONSOLIDATE_3
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating expenses | ||||
General and administrative | $ 1,388,729 | $ 1,620,379 | $ 5,211,287 | $ 4,507,632 |
Research and development | 5,758,446 | 2,997,634 | 17,549,442 | 8,936,969 |
Total operating expenses | (7,147,175) | (4,618,013) | (22,760,729) | (13,444,601) |
Other income (expenses) | ||||
Grant income | 74,944 | 74,528 | 223,999 | 74,528 |
Research and development incentive income | 1,629,513 | 1,629,513 | ||
Interest income, net | 34,838 | 112,226 | 165,103 | 171,249 |
Gain on settlement of accounts payable | 36,978 | 36,978 | ||
Financing related charges | (30,943) | (30,943) | ||
Foreign exchange gain (loss), net | (54,546) | (16,475) | (4,854) | (22,833) |
Total other income, net | 92,214 | 1,768,849 | 421,226 | 1,821,514 |
Net loss before provision for income taxes | (7,054,961) | (2,849,164) | (22,339,503) | (11,623,087) |
Income tax expense | (19,300) | (76,065) | (37,266) | |
Net loss and comprehensive loss | $ (7,074,261) | $ (2,849,164) | $ (22,415,568) | $ (11,660,353) |
Loss per share | ||||
Basic and diluted (in dollars per share) | $ (0.14) | $ (0.06) | $ (0.47) | $ (0.26) |
Weighted average number of shares outstanding | ||||
Basic and diluted (in shares) | 49,622,465 | 45,212,074 | 47,691,921 | 44,365,683 |
INTERIM CONDENSED CONSOLIDATE_4
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 9 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash Flows used in Operating Activities | ||
Net loss | $ (22,415,568) | $ (11,660,353) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Stock-based compensation | 5,194,343 | 4,025,412 |
Changes in non-cash working capital balances related to operations: | ||
Sales tax recoverable | (53,143) | 3,603 |
Prepaid expenses and deposits | 792,180 | (522,632) |
Deposits | 37,396 | |
Accounts payable and accrued liabilities | 451,981 | (375,264) |
Net cash used in operating activities | (15,992,811) | (8,529,234) |
Cash Flows provided by Financing Activities | ||
Issuance of common shares | 14,361,379 | 6,966,569 |
Deferred financing charges | (50,000) | (50,000) |
Net cash provided by financing activities | 14,311,379 | 6,916,569 |
Decrease in cash and cash equivalents during the period | (1,681,432) | (1,612,665) |
Cash and cash equivalents, beginning of period | 22,930,638 | 27,440,257 |
Cash and cash equivalents, end of period | $ 21,249,206 | $ 25,827,592 |
INTERIM CONDENSED CONSOLIDATE_5
INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) (USD $) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Common Shares to be Issued [Member] | Accumulated Deficit [Member] | Total |
Balance Beginning at Sep. 30, 2017 | $ 43,332 | $ 115,689,221 | $ (91,478,558) | $ 24,253,995 | |
Balance Beginning (in shares) at Sep. 30, 2017 | 43,330,817 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Shares issued under 2015 Purchase Agreement - Purchase shares | $ 1,883 | 6,964,686 | 6,966,569 | ||
Shares issued under 2015 Purchase Agreement - Purchase shares (in shares) | 1,883,580 | ||||
Shares issued under 2015 Purchase Agreement - Commitment shares | $ 13 | (13) | |||
Shares issued under 2015 Purchase Agreement - Commitment shares (in shares) | 12,514 | ||||
Shares issued pursuant to cashless exercise of options | $ 87 | (87) | |||
Shares issued pursuant to cashless exercise of options (in shares) | 87,244 | ||||
Share based compensation | 4,025,412 | 4,025,412 | |||
Net loss | (11,660,353) | (11,660,353) | |||
Balance Ending at Jun. 30, 2018 | $ 45,315 | 126,679,219 | (103,138,911) | 23,585,623 | |
Balance Ending (in shares) at Jun. 30, 2018 | 45,314,155 | ||||
Balance Beginning at Mar. 31, 2018 | $ 44,575 | 122,724,029 | (100,289,747) | 22,478,857 | |
Balance Beginning (in shares) at Mar. 31, 2018 | 44,573,788 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Shares issued under 2015 Purchase Agreement - Purchase shares | $ 649 | 2,277,550 | 2,278,199 | ||
Shares issued under 2015 Purchase Agreement - Purchase shares (in shares) | 650,000 | ||||
Shares issued under 2015 Purchase Agreement - Commitment shares | $ 5 | (5) | |||
Shares issued under 2015 Purchase Agreement - Commitment shares (in shares) | 4,093 | ||||
Shares issued pursuant to cashless exercise of options | $ 86 | (86) | |||
Shares issued pursuant to cashless exercise of options (in shares) | 86,274 | ||||
Share based compensation | 1,677,731 | 1,677,731 | |||
Net loss | (2,849,164) | (2,849,164) | |||
Balance Ending at Jun. 30, 2018 | $ 45,315 | 126,679,219 | (103,138,911) | 23,585,623 | |
Balance Ending (in shares) at Jun. 30, 2018 | 45,314,155 | ||||
Balance Beginning at Sep. 30, 2018 | $ 45,935 | 129,377,542 | (108,931,967) | $ 20,491,510 | |
Balance Beginning (in shares) at Sep. 30, 2018 | 45,933,472 | 45,933,472 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Shares issued under 2015 Purchase Agreement - Purchase shares | $ 4,849 | 13,192,755 | $ 13,197,604 | ||
Shares issued under 2015 Purchase Agreement - Purchase shares (in shares) | 4,848,995 | ||||
Shares issued under 2015 Purchase Agreement - Commitment shares | $ 27 | (27) | |||
Shares issued under 2015 Purchase Agreement - Commitment shares (in shares) | 23,701 | ||||
Shares issued under 2019 Purchase Agreement - Purchase shares | $ 375 | 1,163,400 | 1,163,775 | ||
Shares issued under 2019 Purchase Agreement - Purchase shares (in shares) | 375,000 | ||||
Shares issued under 2019 Purchase Agreement - Commitment shares | $ 324 | (324) | |||
Shares issued under 2019 Purchase Agreement - Commitment shares (in shares) | 328,157 | ||||
Shares issued pursuant to cashless exercise of warrants | $ 1 | (1) | |||
Shares issued pursuant to cashless exercise of warrants (in shares) | 546 | 546 | |||
Share based compensation | 5,194,343 | $ 5,194,343 | |||
Net loss | (22,415,568) | (22,415,568) | |||
Balance Ending at Jun. 30, 2019 | $ 51,511 | 148,927,688 | (131,347,535) | $ 17,631,664 | |
Balance Ending (in shares) at Jun. 30, 2019 | 51,509,871 | 51,509,871 | |||
Balance Beginning at Mar. 31, 2019 | $ 48,175 | 138,696,975 | (292,700) | (124,273,274) | $ 14,179,176 |
Balance Beginning (in shares) at Mar. 31, 2019 | 48,173,241 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Shares issued under 2015 Purchase Agreement - Purchase shares | $ 2,619 | 7,833,451 | 292,700 | 8,128,770 | |
Shares issued under 2015 Purchase Agreement - Purchase shares (in shares) | 2,619,403 | ||||
Shares issued under 2015 Purchase Agreement - Commitment shares | $ 14 | (14) | |||
Shares issued under 2015 Purchase Agreement - Commitment shares (in shares) | 14,070 | ||||
Shares issued under 2019 Purchase Agreement - Purchase shares | $ 375 | 1,163,400 | 1,163,775 | ||
Shares issued under 2019 Purchase Agreement - Purchase shares (in shares) | 375,000 | ||||
Shares issued under 2019 Purchase Agreement - Commitment shares | $ 328 | (328) | |||
Shares issued under 2019 Purchase Agreement - Commitment shares (in shares) | 328,157 | ||||
Shares issued pursuant to cashless exercise of warrants | |||||
Shares issued pursuant to cashless exercise of warrants (in shares) | |||||
Share based compensation | 1,234,204 | 1,234,204 | |||
Net loss | (7,074,261) | (7,074,261) | |||
Balance Ending at Jun. 30, 2019 | $ 51,511 | $ 148,927,688 | $ (131,347,535) | $ 17,631,664 | |
Balance Ending (in shares) at Jun. 30, 2019 | 51,509,871 | 51,509,871 |
Business Description and Basis
Business Description and Basis of Presentation | 9 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Description and Basis of Presentation | Note 1 Business Description and Basis of Presentation Business Anavex Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics by applying precision medicine to central nervous system (“CNS”) diseases with high unmet need. Anavex analyzes genomic data from clinical studies to identify biomarkers, which select patients that will receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental diseases. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding protein 2 (“MECP2”). Basis of Presentation These unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim reporting. Accordingly, certain information and note disclosures normally included in the annual financial statements in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information presented not misleading. These accompanying unaudited interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management are necessary for fair presentation of the information contained herein. The consolidated balance sheet as of September 30, 2018 was derived from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended September 30, 2018 filed with the SEC on December 12, 2018. The Company follows the same accounting policies in the preparation of interim reports. Operating results for the nine months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the year ending September 30, 2019. Liquidity All of the Company’s potential drug compounds are in the clinical development stage and the Company cannot be certain that its research and development efforts will be successful or, if successful, that its potential drug compounds will ever be approved for sales to pharmaceutical companies or generate commercial revenues. To date, we have not generated any revenues from our operations. The Company expects the business to continue to experience negative cash flows for the foreseeable future and cannot predict when, if ever, our business might become profitable. The Company believes that its existing cash and cash equivalents, along with existing financial commitments from third parties, will be sufficient to meet its cash commitments for in excess of two years after the date these condensed consolidated interim financial statements are issued. The process of drug development can be costly, and the timing and outcomes of clinical trials is uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the design, timing and duration of future clinical trials, the progress of the Company’s research and development programs and the level of financial resources available. The Company has the ability to adjust its operating plan spending levels based on the timing of future clinical trials. Other than our rights related to the Sales Agreement (Note 4) and the 2019 Purchase Agreement (Note 4), there can be no assurance that additional financing will be available to the Company when needed or, if available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional financing on a timely basis, if and when it is needed, the Company will be forced to delay or scale down some or all of its research and development activities. Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting period. The Company regularly evaluates estimates and assumptions related to deferred income tax asset valuations, asset impairment, stock-based compensation and loss contingencies. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will be affected. Principles of Consolidation These consolidated financial statements include the accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiaries, Anavex Australia Pty Limited, a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws of Germany, and Anavex Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company transactions and balances have been eliminated. Fair Value Measurements The fair value hierarchy under GAAP is based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2 - observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and Level 3 - assets and liabilities whose significant value drivers are unobservable by little or no market activity and that are significant to the fair value of the assets or liabilities. The book value of cash and cash equivalents and accounts payable and accrued liabilities approximate their fair values due to the short-term maturity of those instruments. At June 30, 2019 and September 30, 2018, the Company did not have any Level 3 assets or liabilities. Basic and Diluted Loss per Share Basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased to include the weighted average number of all potentially dilutive securities convertible into shares of common stock that were outstanding during the period. As of June 30, 2019, loss per share excludes 8,818,766 (September 30, 2018 – 7,185,296) potentially dilutive common shares related to outstanding options and warrants, as their effect was anti-dilutive. Reclassifications Certain amounts from the prior year have been reclassified to conform to the current year’s presentation. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Jun. 30, 2019 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Recent Accounting Pronouncements | Note 2 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In May 2014, the FASB and the International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers, ASU 2014-09 (Topic 606 and IFRS 15). This standard superseded nearly all existing revenue recognition guidance. ASU 2014-09 was effective for the Company on a prospective basis beginning on October 1, 2018. The adoption of this standard did not have a material impact for any period presented. In May 2017, the FASB issued ASU No. 2017-09, “Compensation–Stock Compensation (Topic 718): Scope of Modification Accounting,” clarifying when a change to the terms or conditions of a share-based payment award must be accounted for as a modification. The new guidance requires modification accounting if the fair value, vesting condition or the classification of the award is not the same immediately before and after a change to the terms and conditions of the award. The new guidance was effective for the Company on a prospective basis beginning on October 1, 2018. The adoption of this standard did not have a material impact for any period presented. Recent Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-based Payments (“ASU 2018-07”). This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The effective date for the standard is for interim periods in fiscal years beginning after December 15, 2018, with early adoption permitted, but no earlier than the Company’s adoption date of Topic 606. The new guidance is effective for the Company beginning on October 1, 2019. The new guidance is required to be applied retrospectively with the cumulative effect recognized at the date of initial application. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows. Other than noted above, the Company does not expect the adoption of recently issued accounting pronouncements to have a significant impact on its results of operations, financial position or cash flow. |
Other Income
Other Income | 9 Months Ended |
Jun. 30, 2019 | |
Component of Operating Income [Abstract] | |
Other Income | Note 3 Other Income Grant Income Clinical Study Grant During the year ended September 30, 2017, the Company was awarded grant funding in the amount of $597,886. The grant is being received in equal quarterly installments over a period of two years beginning during the year ended September 30, 2018 in exchange for a commitment to complete clinical testing for a therapeutic drug candidate for the treatment of Rett syndrome. The grant income is deferred when received and amortized to other income as the related research and development expenditures are incurred. During the three and nine months ended June 30, 2019, the Company recognized $74,944 and $223,999, respectively (2018: $74,528 and $74,528, respectively) of this grant on its statement of operations within grant income. |
Equity Offering Agreements
Equity Offering Agreements | 9 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Equity Offering Agreements | Note 4 Equity Offering Agreements Controlled Equity Offering Sales Agreement On July 6, 2018, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell shares of common stock, for aggregate gross sale proceeds of up to $50,000,000 from time to time through Cantor Fitzgerald (the “Offering”). Upon delivery of a placement notice based on the Company’s instructions and subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald may sell the Shares by methods deemed to be an “at the market offering” offering, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to the prior written consent of the Company. The Company is not obligated to make any sales of Shares under the Sales Agreement. The Company or Cantor Fitzgerald may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. Cantor Fitzgerald will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq. The Company has agreed to pay Cantor Fitzgerald commissions for its services of acting as agent of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company has also agreed to provide Cantor Fitzgerald with customary indemnification and contribution rights. At June 30, 2019, the Company had incurred $151,133 in legal and accounting fees associated with the Sales Agreement. This amount is included in deferred financing charges at June 30, 2019 and is expected to be reclassified to share capital upon issuance of shares under the Sales Agreement. At June 30, 2019, no shares have been sold pursuant to the Offering. 2015 Purchase Agreement On October 21, 2015, the Company entered into a $50,000,000 purchase agreement (the “2015 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which the Company could sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up to $50,000,000 in value of its shares of common stock from time to time over a 36-month period. During the nine months ended June 30, 2019, the Company issued to Lincoln Park an aggregate of 4,872,696 (2018: 1,896,094) shares of common stock under the Purchase Agreement, including 4,848,995 (2018: 1,883,580) shares of common stock for an aggregate purchase price of $13,197,604 (2018: $6,966,569) and 23,701 (2018: 12,514) commitment shares. At June 30, 2019, all remaining purchase amounts available under the 2015 Purchase Agreement have been utilized. As such, no further shares will be sold under the 2015 Purchase Agreement. 2019 Purchase Agreement On June 7, 2019, the Company entered into a $50,000,000 purchase agreement (the “2019 Purchase Agreement”) with Lincoln Park, which succeeded the Company’s 2015 Purchase Agreement, pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $50,000,000 in value of its shares of common stock from time to time over a 36-month period starting from the effective date of the respective registration statement, to June 12, 2022. The Company may direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2,000,000. The purchase price of shares of common stock related to the future funding will be based on the then prevailing market prices of such shares at the time of sales as described in the 2019 Purchase Agreement. The 2019 Purchase Agreement limits the Company’s sale shares of Common Stock to Lincoln Park to 10,076,680 shares of Common Stock, representing 19.99% of the shares of the Common Stock outstanding on the date of the 2019 Purchase Agreement unless (i) shareholder approval is obtained to issue more than such amount or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the 2019 Purchase Agreement equals or exceeds the lower of (A) the closing price of the Common Stock on the Nasdaq Capital Market immediately preceding the Execution Date or (B) the average of the closing price of the Common Stock on the Nasdaq Capital Market for the five Business Days immediately preceding the Execution Date. In consideration for entering into the 2019 Purchase Agreement, the Company issued to Lincoln Park 324,383 shares of common stock as a commitment fee and agreed to issue up to 162,191 shares pro rata, when and if, Lincoln Park purchases at the Company’s discretion the $50,000,000 aggregate commitment. During the nine months ended June 30, 2019, the Company issued to Lincoln Park an aggregate of 703,157 (2018: Nil) shares of common stock under the Purchase Agreement, including 375,000 (2018: Nil) shares of common stock for an aggregate purchase price of $1,163,775 (2018: $Nil) and 328,157 (2018: Nil) commitment shares. At June 30, 2019, an amount of $48,836,225 remained available under the 2019 Purchase Agreement. |
Commitments
Commitments | 9 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 5 Commitments a) Litigation The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s consolidated financial statements. The Company does not believe that any of such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements. b) Share Purchase Warrants A summary of the status of the Company’s outstanding share purchase warrants is presented below: Number of Shares Weighted Average Balance, October 1, 2017 1,609,309 $ 2.66 Issued 350,000 $ 4.19 Exercised (756,143 ) $ 2.96 Expired (524,787 ) $ 3.00 Balance, September 30, 2018 678,379 $ 2.87 Exercised (1,250 ) $ 1.68 Expired (319,629 ) $ 1.46 Balance, June 30, 2019 357,500 $ 4.12 During the nine months ended June 30, 2019, the Company issued 546 shares in connection with the exercise of 1,250 share purchase warrants on a cashless basis. c) Stock–based Compensation Plan 2015 Stock Option Plan On September 18, 2015, the Company’s board of directors (the “Board”) approved a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provides for the grant of stock options and restricted stock awards to directors, officers, employees and consultants of the Company. The maximum number of our common shares reserved for issue under the plan is 6,050,553 shares, subject to adjustment in the event of a change of the Company’s capitalization. The 2015 Plan provides that it may be administered by the Board, or the Board may delegate such responsibility to a committee. The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. Stock options may be granted under the 2015 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser periods as may be determined by the board, subject to earlier termination in accordance with the terms of the 2015 Plan. 2019 Stock Option Plan On January 15, 2019, the Board approved the 2019 Omnibus Incentive Plan (the “2019 Plan”), which provides for the grant of stock options and restricted stock awards to directors, officers, employees, consultants and advisors of the Company. Under the terms of the 2019 Plan, 6,000,000 additional shares of Common Stock are available for issuance under the 2019 Plan, in addition to the shares available under the 2015 Plan. Any awards outstanding under the 2015 Plan or the Company’s 2007 Stock Option Plan (the “2007 Plan”) will remain subject to and be paid under the 2015 Plan or the 2007 Plan, respectively, and any shares subject to outstanding awards under the 2015 Plan or the 2007 Plan that subsequently cease to be subject to such awards (other than by reason of settlement of the awards in shares) will automatically become available for issuance under the 2019 Plan. The 2019 Plan provides that it may be administered by the Board, or the Board may delegate such responsibility to a committee. The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. Stock options may be granted under the 2019 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser periods as may be determined by the board, subject to earlier termination in accordance with the terms of the 2019 Plan. A summary of the status of Company’s outstanding stock purchase options is presented below: Number of Weighted Weighted Average Aggregate Outstanding at October 1, 2017 5,092,030 $ 4.13 $ 5,280,544 Granted 1,730,000 $ 2.71 $ 2.09 Forfeited (164,280 ) $ 3.66 Exercised (150,833 ) $ 1.18 Outstanding at September 30, 2018 6,506,917 $ 3.83 $ 2,353,088 Granted 2,240,399 $ 2.79 $ 2.27 Forfeited (286,050 ) $ 3.30 Outstanding at June 30, 2019 8,461,266 $ 3.58 $ 5,196,106 Exercisable at June 30, 2019 5,460,583 $ 3.79 $ 3,798,337 The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted market price of the Company’s stock for the options that were in-the-money at June 30, 2019. During the three and nine months ended June 30, 2019, the Company recognized stock-based compensation expense in connection with the issuance and vesting of stock options in exchange for services. These amounts have been included in general and administrative expenses and research and development expenses on the Company’s statement of operations as follows: Three months ended June 30, Nine months ended June 30, 2019 2018 2019 2018 General and administrative $ 579,636 $ 802,592 $ 2,586,223 $ 1,999,633 Research and development 654,568 875,139 2,608,120 2,025,779 Total share based compensation $ 1,234,204 $ 1,677,731 $ 5,194,343 $ 4,025,412 An amount of approximately $6,446,000 in stock-based compensation is expected to be recorded over the remaining term of such options through June 2022. The fair value of each option award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted average assumptions: 2019 2018 Risk-free interest rate 2.51 % 2.73 % Expected life of options (years) 6.04 6.84 Annualized volatility 104.51 % 108.67 % Dividend rate 0.00 % 0.00 % |
Subsequent Events
Subsequent Events | 9 Months Ended |
Jun. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 6 Subsequent Events Subsequent to June 30, 2019, the Company received research and development incentive income of $1,658,277 (AUD 2,360,201). This amount will be recognized as other income during the Company’s fourth quarter, in accordance with the Company’s accounting policy which requires the Company to recognize such income in the period in which it is received. |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Jun. 30, 2019 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Recent Accounting Pronouncements | Note 2 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In May 2014, the FASB and the International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers, ASU 2014-09 (Topic 606 and IFRS 15). This standard superseded nearly all existing revenue recognition guidance. ASU 2014-09 was effective for the Company on a prospective basis beginning on October 1, 2018. The adoption of this standard did not have a material impact for any period presented. In May 2017, the FASB issued ASU No. 2017-09, “Compensation–Stock Compensation (Topic 718): Scope of Modification Accounting,” clarifying when a change to the terms or conditions of a share-based payment award must be accounted for as a modification. The new guidance requires modification accounting if the fair value, vesting condition or the classification of the award is not the same immediately before and after a change to the terms and conditions of the award. The new guidance was effective for the Company on a prospective basis beginning on October 1, 2018. The adoption of this standard did not have a material impact for any period presented. Recent Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-based Payments (“ASU 2018-07”). This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The effective date for the standard is for interim periods in fiscal years beginning after December 15, 2018, with early adoption permitted, but no earlier than the Company’s adoption date of Topic 606. The new guidance is effective for the Company beginning on October 1, 2019. The new guidance is required to be applied retrospectively with the cumulative effect recognized at the date of initial application. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows. Other than noted above, the Company does not expect the adoption of recently issued accounting pronouncements to have a significant impact on its results of operations, financial position or cash flow. |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of exercisable share purchase warrants outstanding | A summary of the status of the Company’s outstanding share purchase warrants is presented below: Number of Shares Weighted Average Exercise Price Balance, October 1, 2017 1,609,309 $ 2.66 Issued 350,000 $ 4.19 Exercised (756,143 ) $ 2.96 Expired (524,787 ) $ 3.00 Balance, September 30, 2018 678,379 $ 2.87 Exercised (1,250 ) $ 1.68 Expired (319,629 ) $ 1.46 Balance, June 30, 2019 357,500 $ 4.12 |
Schedule of outstanding stock purchase options | A summary of the status of Company’s outstanding stock purchase options is presented below: Number of Shares Weighted Average Exercise Price Weighted Average Grant Date Fair Value Aggregate intrinsic value Outstanding at October 1, 2017 5,092,030 $ 4.13 $ 5,280,544 Granted 1,730,000 $ 2.71 $ 2.09 Forfeited (164,280 ) $ 3.66 Exercised (150,833 ) $ 1.18 Outstanding at September 30, 2018 6,506,917 $ 3.83 $ 2,353,088 Granted 2,240,399 $ 2.79 $ 2.27 Forfeited (286,050 ) $ 3.30 Outstanding at June 30, 2019 8,461,266 $ 3.58 $ 5,196,106 Exercisable at June 30, 2019 5,460,583 $ 3.79 $ 3,798,337 |
Schedule of general and administrative expenses and research and development expenses | These amounts have been included in general and administrative expenses and research and development expenses on the Company’s statement of operations as follows: Three months ended June 30, Nine months ended June 30, 2019 2018 2019 2018 General and administrative $ 579,636 $ 802,592 $ 2,586,223 $ 1,999,633 Research and development 654,568 875,139 2,608,120 2,025,779 Total share based compensation $ 1,234,204 $ 1,677,731 $ 5,194,343 $ 4,025,412 |
Schedule of weighted average assumptions for fair value of each option award | The fair value of each option award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted average assumptions: 2019 2018 Risk-free interest rate 2.51 % 2.73 % Expected life of options (years) 6.04 6.84 Annualized volatility 104.51 % 108.67 % Dividend rate 0.00 % 0.00 % |
Business Description and Basi_2
Business Description and Basis of Presentation (Details Narrative) - shares | 9 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Loss per share for potentially dilutive common shares | 8,818,766 | 7,185,296 |
Other Income (Details Narrative
Other Income (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Sep. 30, 2017 | |
Grant income | $ 74,944 | $ 74,528 | $ 223,999 | $ 74,528 | |
Clinical Study Grant [Member] | |||||
Grant income | $ 597,886 |
Equity Offering Agreements (Det
Equity Offering Agreements (Details Narrative) - USD ($) | Jun. 07, 2019 | Jul. 06, 2018 | Oct. 21, 2015 | Jun. 30, 2019 | Jun. 30, 2018 |
Gross sale proceeds | $ 14,361,379 | $ 6,966,569 | |||
2019 Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | |||||
Total number of shares obligated to purchase | $ 50,000,000 | ||||
Agreement term | 36 months | ||||
Description of purchases price | The Company may direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2,000,000. The purchase price of shares of common stock related to the future funding will be based on the then prevailing market prices of such shares at the time of sales as described in the 2019 Purchase Agreement. | ||||
Number of share issued | 324,383 | 703,157 | |||
Pro rata basic number of shares obligated to purchase | 162,191 | ||||
Number of shares issued for aggregate purchase price | 375,000 | ||||
Number of shares issued for aggregate purchase price, value | $ 1,163,775 | ||||
Number of shares issued for commitment | 328,157 | ||||
Amount of shares remain available | $ 48,836,225 | ||||
2019 Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | Common Stock [Member] | |||||
Number of share issued | 10,076,680 | ||||
Percentage of gross proceeds from sales | 19.99% | ||||
Equity Offering Sales Agreement [Member] | Cantor Fitzgerald & Co [Member] | |||||
Gross sale proceeds | $ 50,000,000 | ||||
Percentage of gross proceeds from sales | 3.00% | ||||
Legal and accounting fees | $ 151,133 | ||||
2015 Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | |||||
Total number of shares obligated to purchase | $ 50,000,000 | ||||
Agreement term | 36 months | ||||
Number of share issued | 4,872,696 | 1,896,094 | |||
Number of shares issued for aggregate purchase price | 4,848,995 | 1,883,580 | |||
Number of shares issued for aggregate purchase price, value | $ 13,197,604 | $ 6,966,569 | |||
Number of shares issued for commitment | 23,701 | 12,514 |
Commitments (Details)
Commitments (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Exercised | 1,250 | |
Purchase Warrants [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Balance, at beginning | 678,379 | 1,609,309 |
Issued | 350,000 | |
Exercised | (1,250) | (756,143) |
Expired | (319,629) | (524,787) |
Balance, at ending | 357,500 | 678,379 |
Share based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Outstanding Weighted Average Exercise Price [Roll Forward] | ||
Balance, at beginning | $ 2.87 | $ 2.66 |
Issued | 4.19 | |
Exercised | 1.68 | 2.96 |
Expired | 1.46 | 3 |
Balance, at ending | $ 4.12 | $ 2.87 |
Commitments (Details 1)
Commitments (Details 1) - 2015 Omnibus Incentive Plan [Member] - USD ($) | 9 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Outstanding at beginning | 6,506,917 | 5,092,030 |
Granted | 2,240,399 | 1,730,000 |
Forfeited | (286,050) | (164,280) |
Exercised | (150,833) | |
Outstanding at ending | 8,461,266 | 6,506,917 |
Exercisable at ending | 5,460,583 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | ||
Outstanding at beginning | $ 3.83 | $ 4.13 |
Granted | 2.79 | 2.71 |
Forfeited | 3.30 | 3.66 |
Exercised | 1.18 | |
Outstanding at ending | 3.58 | 3.83 |
Exercisable at ending | 3.79 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Weighted Average Grant Date Fair Value [Roll Forward] | ||
Granted | $ 2.27 | $ 2.09 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Aggregate intrinsic value [Roll Forward] | ||
Outstanding at beginning | $ 2,353,088 | $ 5,280,544 |
Outstanding at ending | 5,196,106 | $ 2,353,088 |
Exercisable at ending | $ 3,798,337 |
Commitments (Details 2)
Commitments (Details 2) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Total share based compensation | $ 1,234,204 | $ 1,677,731 | $ 5,194,343 | $ 4,025,412 |
General and administrative [Member] | ||||
Total share based compensation | 579,636 | 802,592 | 2,586,223 | 1,999,633 |
Research and development [Member] | ||||
Total share based compensation | $ 654,568 | $ 875,139 | $ 2,608,120 | $ 2,025,779 |
Commitments (Details 3)
Commitments (Details 3) | 9 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Risk-free interest rate | 2.51% | 2.73% |
Expected life of options (years) | 6 years 14 days | 6 years 10 months 2 days |
Annualized volatility | 104.51% | 108.67% |
Dividend rate | 0.00% | 0.00% |
Commitments (Details Narrative)
Commitments (Details Narrative) | 9 Months Ended |
Jun. 30, 2019USD ($)shares | |
Remaining stock based compensation | $ | $ 6,446,000 |
Shares issued pursuant to cashless exercise of warrants | 546 |
Shares issued pursuant to cashless exercise of warrants | 1,250 |
2015 Omnibus Incentive Plan [Member] | |
Maximum number of common shares reserved for future issuance | 6,050,553 |
Description of grant option | The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. |
Expiration period | 10 years |
2019 Omnibus Incentive Plan [Member] | |
Description of grant option | The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. |
Expiration period | 10 years |
Additional shares of common stock available for issuance | 6,000,000 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) | 9 Months Ended |
Jun. 30, 2019USD ($) | |
Research and development incentive income | $ 1,658,277 |
Australia, Dollars | |
Research and development incentive income | $ 2,360,201 |