Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Jun. 30, 2020 | Sep. 03, 2020 | Dec. 31, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Jun. 30, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | MEIP | ||
Entity Registrant Name | MEI Pharma, Inc. | ||
Entity Central Index Key | 0001262104 | ||
Current Fiscal Year End Date | --06-30 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Title of 12(b) Security | Common Stock | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Entity Address, State or Province | CA | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Common Stock, Shares Outstanding | 112,522,001 | ||
Entity Public Float | $ 261.5 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2020 | Jun. 30, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 12,331 | $ 9,590 |
Short-term investments | 170,299 | 64,899 |
Total cash, cash equivalents and short-term investments | 182,630 | 74,489 |
Receivable for foreign tax withholding | 20,420 | |
Common stock proceeds receivable | 5,274 | |
Prepaid expenses and other current assets | 5,594 | 2,435 |
Total current assets | 208,644 | 82,198 |
Intangible assets, net | 261 | |
Property and equipment, net | 1,084 | 204 |
Total assets | 209,728 | 82,663 |
Current liabilities: | ||
Accounts payable | 2,437 | 4,787 |
Accrued liabilities | 6,090 | 4,559 |
Deferred revenue | 14,777 | 4,955 |
Total current liabilities | 23,304 | 14,301 |
Deferred revenue, long-term | 67,723 | 2,819 |
Warrant liability | 40,483 | 17,613 |
Total liabilities | 131,510 | 34,733 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 100 shares authorized; none outstanding | ||
Common stock, $0.00000002 par value; 226,000 shares authorized; 111,514 and 73,545 shares issued and outstanding at June 30, 2020 and 2019, respectively. | ||
Additional paid-in-capital | 355,452 | 279,148 |
Accumulated deficit | (277,234) | (231,218) |
Total stockholders' equity | 78,218 | 47,930 |
Total liabilities and stockholders' equity | $ 209,728 | $ 82,663 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Jun. 30, 2020 | Jun. 30, 2019 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 100 | 100 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.00 | $ 0.00 |
Common stock, shares authorized | 226,000 | 226,000 |
Common stock, shares issued | 111,514 | 73,545 |
Common stock, shares outstanding | 111,514 | 73,545 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |||
Revenue | $ 28,913 | $ 4,915 | $ 1,622 | ||
Operating expenses: | |||||
Cost of revenue | 2,671 | 4,263 | 3,383 | ||
Research and development | 34,065 | 32,300 | 17,038 | ||
General and administrative | 16,717 | 14,597 | 9,787 | ||
Total operating expenses | 53,453 | 51,160 | 30,208 | ||
Loss from operations | (24,540) | (46,245) | (28,586) | ||
Other income (expense): | |||||
Change in fair value of warrant liability | (22,870) | 27,632 | (9,705) | ||
Financing costs associated with warrants | (2,367) | ||||
Interest and dividend income | 1,395 | 1,795 | 591 | ||
Income tax expense | (1) | (1) | (1) | ||
Net loss | (46,016) | [1] | (16,819) | [1] | (40,068) |
Net loss: | |||||
Basic | (46,016) | (16,819) | (40,068) | ||
Diluted | $ (46,016) | $ (54,613) | $ (40,068) | ||
Net loss per share: | |||||
Basic | $ (0.51) | $ (0.24) | $ (0.97) | ||
Diluted | $ (0.51) | $ (0.75) | $ (0.97) | ||
Shares used in computing net loss per share: | |||||
Basic | 91,080 | 71,139 | 41,431 | ||
Diluted | 91,080 | 72,385 | 41,431 | ||
[1] | We have experienced large changes in our net loss which relates to the change in fair value of the warrant liability for the years ended June 30, 2020 and 2019. Refer to Note 1 for further discussion. |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Shares | Additional paid in capital | Accumulated Deficit | |
Beginning Balance at Jun. 30, 2017 | $ 50,838 | $ 36,772 | $ 225,169 | $ (174,331) | |
Net loss | (40,068) | (40,068) | |||
Issuance of common stock in private placement, net (Note 8) | 35,910 | 33,003 | 35,910 | ||
Issuance of common stock for milestone payment, net (Note 10) | 500 | 167 | 500 | ||
Issuance of common stock for vested restricted stock units | (267) | 271 | (267) | ||
Exercise of stock options | 329 | 193 | 329 | ||
Share-based compensation expense | 3,217 | 3,217 | |||
Ending Balance at Jun. 30, 2018 | 50,459 | 70,406 | 264,858 | (214,399) | |
Net loss | (16,819) | [1] | (16,819) | ||
Issuance of common stock, net | 5,444 | 2,215 | 5,444 | ||
Exercise of warrants | 2,186 | 440 | 2,186 | ||
Issuance of common stock for vested restricted stock units | (324) | 246 | (324) | ||
Exercise of stock options | 422 | 238 | 422 | ||
Share-based compensation expense | 6,562 | 6,562 | |||
Ending Balance at Jun. 30, 2019 | 47,930 | 73,545 | 279,148 | (231,218) | |
Net loss | (46,016) | [1] | (46,016) | ||
Issuance of common stock, net | 69,231 | 37,815 | 69,231 | ||
Exercise of stock options | 272 | 154 | 272 | ||
Share-based compensation expense | 6,801 | 6,801 | |||
Ending Balance at Jun. 30, 2020 | $ 78,218 | $ 111,514 | $ 355,452 | $ (277,234) | |
[1] | We have experienced large changes in our net loss which relates to the change in fair value of the warrant liability for the years ended June 30, 2020 and 2019. Refer to Note 1 for further discussion. |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Cash flows from operating activities: | |||
Net loss | $ (46,016) | $ (16,819) | $ (40,068) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Change in fair value of warrant liability | 22,870 | (27,632) | 9,705 |
Financing costs associated with warrants | 2,367 | ||
Share-based compensation | 6,801 | 6,562 | 3,217 |
Impairment of intangible assets | 227 | ||
Depreciation and amortization | 109 | 80 | 53 |
Changes in operating assets and liabilities: | |||
Receivable for foreign tax withholding | (20,420) | ||
Prepaid expenses and other current assets | (3,159) | (849) | 172 |
Accounts payable | (2,350) | 1,144 | 3,058 |
Accrued liabilities | 1,470 | 1,105 | 669 |
Deferred revenue | 74,726 | 6,986 | (208) |
Net cash provided by (used in) operating activities | 34,258 | (29,423) | (21,035) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (894) | (217) | |
Purchases of short-term investments | (190,279) | (64,655) | (114,233) |
Proceeds from maturity of short-term investments | 84,879 | 89,190 | 69,906 |
Net cash (used in) provided by investing activities | (106,294) | 24,318 | (44,327) |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 272 | 372 | 329 |
Issuance of common stock, net | 69,231 | 220 | 70,151 |
Collection of common stock proceeds receivable | 5,274 | ||
Proceeds from exercise of warrants | 0 | 1,118 | |
Payment of RSU tax withholdings in exchange for common shares surrendered by RSU holders | (324) | (267) | |
Net cash provided by financing activities | 74,777 | 1,386 | 70,213 |
Net increase (decrease) in cash and cash equivalents | 2,741 | (3,719) | 4,851 |
Cash and cash equivalents at beginning of the period | 9,590 | 13,309 | 8,458 |
Cash and cash equivalents at end of the period | 12,331 | 9,590 | 13,309 |
Supplemental cash flow information: | |||
Income taxes paid | $ (1) | (1) | $ (1) |
Non-cash financing activities: | |||
Proceeds receivable- sale of common stock | 5,224 | ||
Proceeds receivable- stock option exercises | 50 | ||
Change in fair value of warrants exercised | $ 1,068 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 12 Months Ended |
Jun. 30, 2020 | |
The Company and Summary of Significant Accounting Policies | Note 1. The Company and Summary of Significant Accounting Policies The Company We are a late-stage pharmaceutical company focused on leveraging our extensive development and oncology expertise to identify and advance new therapies intended to meaningfully improve the treatment of cancer. Our portfolio of drug candidates contains four clinical-stage assets, including zandelisib (formerly known as ME-401), in an ongoing Phase 2 clinical trial that we intend to submit to the U.S. Food and Drug Administration (“FDA”) to support accelerated approval of a marketing application. Our common stock is listed on the NASDAQ Capital Market under the symbol “MEIP”. Clinical Development Programs Our approach to building our pipeline is to license promising cancer agents and build value in programs through development, commercialization and strategic partnerships, as appropriate. Our drug candidate pipeline includes: • Zandelisib (formerly known as ME-401), 3-kinase • Voruciclib, an oral cyclin-dependent kinase (“CDK”) inhibitor; • ME-344, • Pracinostat, an oral histone deacetylase (“HDAC”) inhibitor. The results of pre-clinical ME-344 Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. We use estimates that affect the reported amounts (including assets, liabilities, revenues and expenses) and related disclosures. Actual results could materially differ from those estimates. Liquidity We have accumulated losses of $277.2 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of June 30, 2020, we had $182.6 million in cash and cash equivalents, and short-term investments . Additionally, we have a receivable of $20.4 million representing a tax withholding refund due to us of the $100 million upfront payment associated with the KKC Commercialization Agreement (Note 2). Of the $ 100 20.4 believe that these resources will be sufficient to meet our To date, we have obtained cash and funded our operations primarily through equity financings and license agreements. In order to continue the development of our drug candidates, at some point in the future we expect to pursue one or more capital transactions, whether through the sale of equity securities, license agreements or entry into strategic partnerships. There can be no assurance that we will be able to continue to raise additional capital in the future. Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less when purchased. Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. We have not experienced any losses related to these balances. Short-Term Investments Investments that have maturities of greater than three months but less than one year are classified as short-term investments. As of June 30, 2020 and 2019, our short-term investments consisted of $170.3 million and $64.9 million, respectively, in U.S. government securities. The short-term investments held as of June 30, 2020 and 2019 had maturity dates of less than one year, are considered to be “held to maturity” and are carried at amortized cost. As of June 30, 2020 and 2019, the gross holding gains and losses were immaterial. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy 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 is as follows: • Level 1 — Observable inputs such as quoted prices in active markets for identical assets or liabilities. • Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. We measure the following financial instruments at fair value on a recurring basis. The fair values of these financial instruments were as follows (in thousands): June 30, 2020 June 30, 2019 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant liability $ — $ — $ (40,483 ) $ — $ — $ (17,613 ) Total $ — $ — $ (40,483 ) $ — $ — $ (17,613 ) The carrying amounts of financial instruments such as cash equivalents, short-term investments and accounts payable approximate the related fair values due to the short-term maturities of these instruments. We invest our excess cash in financial instruments which are readily convertible into cash, such as money market funds and U.S. government securities. Cash equivalents, where applicable, and short-term investments are classified as Level 1 as defined by the fair value hierarchy. In May 2018, we issued warrants in connection with our private placement of shares of common stock. Pursuant to the terms of the warrants, we could be required to settle the warrants in cash in the event of an acquisition of the Company and, as a result, the warrants are required to be measured at fair value and reported as a liability in the Balance Sheet. We recorded the fair value of the warrants upon issuance using the Black-Scholes valuation model and are required to revalue the warrants at each reporting date with any changes in fair value recorded on our Statement of Operations. The valuation of the warrants is considered under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that are both significant to the fair value measurement and unobservable. Inputs used to determine estimated fair value of the warrant liabilities include the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends and the expected volatility of the underlying stock. The significant unobservable inputs used in the fair value measurement of the warrant liabilities were the volatility rate and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value measurement. The change in the fair value of the Level 3 warrant liability is reflected in the Statement of Operations for the years ended June 30, 2020 and 2019. To calculate the fair value of the warrant liability, the following assumptions were used: June 30, 2020 June 30, Risk-free interest rate 0.2 % 1.7 % Expected life (years) 2.9 3.8 Expected volatility 77.4 % 56.8 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ 2.52 $ 1.10 The following table sets forth a summary of changes in the estimated f a Fair Value of Warrants Using Significant 2020 2019 Balance at July 1, $ 17,613 $ 46,313 Reclassification of derivative liability to equity upon exercise of warrants — (1,068 ) Change in estimated fair value of liability classified warrants 22,870 (27,632 ) Balance at June 30, $ 40,483 $ 17,613 Intangible Assets Intangible assets consist of patents acquired fr o Property and Equipment Property and equipment are stated at cost and depreciated over the estimated useful lives of the assets (generally three to seven years) using the straight-line method. Leasehold improvements are stated at cost and are amortized over the shorter of the estimated useful lives of the assets or the lease term. Leases As of July 1, 2019, we adopted Topic 842, Leases Revenue Recognition ASC Topic 606, Revenue from Contracts with Customers (“Topic 606” or the “new revenue standard”) Beginning July 1, 2018, we recognize revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. For enforceable contracts with our customers, we first identify the distinct performance obligations – or accounting units – within the contract. Performance obligations are commitments in a contract to transfer a distinct good or service to the customer. Payments received under commercial arrangements, such as licensing technology rights, may include non-refundable re-evaluate catch-up catch-up We develop estimates of the stand-alone selling price for each distinct performance obligation. Variable consideration that relates specifically to our efforts to satisfy specific performance obligations is allocated entirely to those performance obligations. Other components of the transaction price are allocated based on the relative stand-alone selling price, over which management has applied significant judgment. We develop assumptions that require judgment to determine the stand-alone selling price for license-related performance obligations, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. We estimate stand-alone selling price for research and development performance obligations by forecasting the expected costs of satisfying a performance obligation plus an appropriate margin. In the case of a license that is a distinct performance obligation, we recognize revenue allocated to the license from non-refundable, up-front The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. Revenue is recorded proportionally as costs are incurred. We generally use the cost-to-cost cost-to-cost For arrangements that include sales-based or usage-based royalties, we recognize revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, we have not recognized any sales-based royalty revenue from license agreements. We recognized revenue associated with the following license agreements (in thousands): Years Ended June 30, 2020 2019 2018 KKC Agreements $ 27,543 $ 2,557 $ — Helsinn License Agreement 1,370 2,358 1,622 $ 28,913 $ 4,915 $ 1,622 Timing of Revenue Recognition: License transferred at a point in time $ 20,988 $ 879 $ — Services performed over time 4,860 4,036 1,622 Cumulative catch-up 3,065 — — $ 28,913 $ 4,915 $ 1,622 Based on the characteristics of the KKC Agreements (Note 2), delivery of the Ex-U . . account for any partially unsatisfied performance obligations carried forward into the new agreement as the continuation of the previous contract, and we catch-up 1 , inclusive of cumulative catch-up amounts, d $ Based on the characteristics of the Helsinn License Agreement, control of the remaining deliverables occurs over time and therefore we recognize revenue based on the extent of progress towards completion of the performance obligations. Accordingly we recognized $1.4 million and $2.3 million related to our progress toward satisfying those obligations during the years ended June 30, 2020 and 2019, respectively. As of June 30, 2020, we had $82.5 million of deferred revenue associated with our remaining performance obligations under the KKC and Helsinn license agreements. We expect to recognize approximately $14.8 million of deferred revenue in the next 12 months, and an additional $67.7 million thereafter. Contract Balances Receivables and contract assets are included in our balance sheet in “Prepaid expenses and other current assets”, and contract liabilities are included in “Deferred revenue” and “Deferred revenue long-term”. The following table presents changes in contract assets and contract liabilities during the year ended June 30, 2020 and 2019 (in thousands): Years Ended June 30, 2020 2019 Receivables Receivables, beginning of year $ — $ 82 Net change 2,605 (82 ) Receivables, end of year $ 2,605 $ — Contract assets Contract assets, beginning of year $ 686 $ 312 Net change (82 ) 374 Contract assets, end of year $ 604 $ 686 Contract liabilities Contract liabilities, beginning of year $ 7,774 $ 788 Net change 74,726 6,986 Contract liabilities, end of year $ 82,500 $ 7,774 The timing of revenue recognition, invoicing and cash collections results in billed accounts receivable and unbilled receivables (contract assets), which are classified as “prepaid expenses and other current assets” on our Balance Sheet, and deferred revenue (contract liabilities). We invoice our customers in accordance with agreed-upon contractual terms, typically at periodic intervals or upon achievement of contractual milestones. Invoicing may occur subsequent to revenue recognition, resulting in contract assets. We may receive advance payments from our customers before revenue is recognized, resulting in contract liabilities. The contract assets and liabilities reported on the Balance Sheet relate to the KKC Agreements and Helsinn License Agreement. We recognized revenue of $7.8 million, $0.8 million, and $1.0 million during the years ended June 30, 2020, 2019 and 2018, respectively, related to the contract liability balance at the beginning of each respective fiscal year. Revenues from Collaborators We earn revenue in connection with collaboration agreements, which are detailed in Note 2, KKC Agreements, and Note 3, BeiGene Collaboration. At contract inception, we assess whether the collaboration arrangements are within the scope of ASC Topic 808, Collaborative Arrangements Accounting Standard Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”) Revenue Recognition Payments received under commercial arrangements, such as licensing technology rights, may include non-refundable Multiple Element Arrangements Deliverables under an arrangement will be separate units of accounting, provided (i) a delivered item has value to the customer on a standalone basis; and (ii) the arrangement includes a general right of return relative to the delivered item, and delivery or performance of the undelivered item is considered probable and substantially in our control. We account for revenue arrangements with multiple elements by separating and allocating consideration according to the relative selling price of each deliverable. If an element can be separated, an amount is allocated based upon the relative selling price of each element. We determine the relative selling price of a separate deliverable using the price we charge other customers when we sell that element separately. If the element is not sold separately and third-party pricing evidence is not available, we will use our best estimate of selling price. License Fee Revenue Non-refundable, up-front non-refundable case-by-case Research and Development Revenue Research and development revenue represents ratable recognition of fees allocated to research and development activities. We defer recognition of research and development revenue until the performance of the related research and development activities has occurred. Research and development revenue for the year ended June 30, 2018 related to services provided by third-party vendors related to research and development for activities performed under the KKC and Helsinn License Agreements (Note 2). Cost of Revenue Cost of revenue primarily includes external costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials, and internal compensation and related personnel expenses to support our research and development performance obligations associated with the Helsinn License Agreement. Research and Development Costs Research and development costs are expensed as incurred and include costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials. Clinical trial costs, including costs associated with third-party contractors, are a significant component of research and development expenses. We expense research and development costs based on work performed. In determining the amount to expense, management relies on estimates of total costs based on contract components completed, the enrollment of subjects, the completion of trials, and other events. Costs incurred related to the purchase or licensing of in-process Share-based Compensation Share-based compensation expense for employees and directors is recognized in the Statement of Operations based on estimated amounts, including the grant date fair value and the expected service period. For stock options, we estimate the grant date fair value using a Black-Scholes valuation model, which requires the use of multiple subjective inputs including estimated future volatility, expected forfeitures and the expected term of the awards. We estimate the expected future volatility based on the stock’s historical price volatility. The stock’s future volatility may differ from the estimated volatility at the grant date. For restricted stock unit (“RSU”) equity awards, we estimate the grant date fair value using our closing stock price on the date of grant. We recognize the effect of forfeitures in compensation expense when the forfeitures occur. The estimated forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense recognized during the period. We recognize the value of the awards over the awards’ requisite service or performance periods. The requisite service period is generally the time over which our share-based awards vest. Interest and Dividend Income Interest on cash balances is recognized when earned. Dividend income is recognized when the right to receive the payment is established. Income Taxes Our income tax expense consists of current and deferred income tax expense or benefit. Current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is recognized for the future tax consequences attributable to tax credits and loss carryforwards and to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. As of June 30, 2020 and 2019, we have established a valuation allowance to fully reserve our net deferred tax assets. Tax rate changes are reflected in income during the period such changes are enacted. Changes in our ownership may limit the amount of net operating loss carryforwards that can be utilized in the future to offset taxable income. The Tax Act reduced the corporate tax rate from 34% to 21%, effective for tax years beginning January 1, 2018. We are subject to the provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 740-10, As a result of the Tax Act, beginning with our fiscal year ending June 30, 2021, the deduction of net operating losses is limited to 80% of current year taxable income. As a result of the Tax Act, we non-cash re-measurement our valuation allowance. The FASB Topic on Income Taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not Net Loss Per Share Basic and diluted net loss per share are computed using the weighted-average number of shares of common stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of common stock subject to repurchase or forfeiture for the years ended June 30, 2020, 2019 and 2018. Our potentially dilutive shares, which include outstanding stock options, restricted stock units, and warrants, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The assessment of dilution is made on a quarterly basis and therefore the annual determination of diluted net loss per share only includes those quarters in which the potential common stock equivalents were determined to be dilutive. For the years ended June 30, 2020, 2019 and 2018, we did not have any items that would be classified as other comprehensive income or losses. The following table presents the calculation of net loss used to calculate basic and diluted loss per share (in thousands): Years Ended June 30, 2020 2019 2018 Net loss—basic $ (46,016 ) $ (16,819 ) $ (40,068 ) Change in fair value of warrant liability — (37,794 ) — Net loss—diluted $ (46,016 ) $ (54,613 ) $ (40,068 ) Shares used in calculating net loss per share was determined as follows (in thousands): Years Ended June 30, 2020 2019 2018 Weighted average shares outstanding 91,080 71,139 41,064 Effect of vested restricted stock units — — 367 Weighted average shares used in calculating net loss per share 91,080 71,139 41,431 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — 1,246 — Weighted average shares used in calculating diluted loss per share 91,080 72,385 41,431 The following potentially dilutive shares (in thousands) that have been excluded from the calculation of net loss per share because of their anti-dilutive effect: Years Ended June 30, 2020 2019 2018 Stock options 11,030 8,057 5,606 Restricted stock units — 32 336 Warrants 16,062 8,062 3,532 Total anti-dilutive shares 27,092 16,151 9,474 Recent Accounting Pronouncements Adopted Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases right-of-use |
KKC Agreements
KKC Agreements | 12 Months Ended |
Jun. 30, 2020 | |
Related Party Transactions [Abstract] | |
KKC Agreements | Note 2. KKC Agreements KKC License, Development and Commercialization Agreement In April 2020, we entered into a License, Development and Commercialization Agreement with Kyowa Kirin Company (formerly “Kyowa Hakko Kirin Co., Ltd.”) (“KKC”) a Japanese life sciences company (the “KKC Commercialization Agreement”). We granted to KKC a co-exclusive, know-how know-how “Ex-U.S.”) “Ex-U.S. co-exclusive, know-how co-exclusive, know-how Ex-U.S. of million in May 2020. Of the $100 million, million was remitted to the Japanese taxing authorities as a result of the U.S. Internal Revenue Service being closed due to the COVID pandemic, and therefore being unable to provide necessary documentation to support an exemption from the required foreign withholding. We expect to receive the amount paid to the Japanese taxing authorities in fiscal year 2021. Additionally, we may earn up to approximately million in potential development, regulatory and commercialization milestone payments, plus royalties on net sales of zandelisib in the Ex-U.S., KKC will be responsible for the development and commercialization of zandelisib in the Ex-U.S. co-develop co-promote 50-50 Ex-U.S., Ex-U.S. We assessed the KKC Commercialization Agreement in accordance with Topic 808 and Topic 606 and determined that our obligations comprise the U.S. License, the Ex-U.S. Ex-U.S. We determined that the total transaction price of $191.5 million is comprised of the upfront payment of $100.0 million, expected milestone payments of $20.0 million, estimated development cost-sharing of $66.3 million, and deferred revenue of $5.2 million from the KKC Japan License Agreement. We included the amount of estimated variable consideration that is not constrained for development cost-sharing in the transaction price, and also determined that any variable consideration related to sales-based royalties and commercial milestones related to licenses of intellectual property as it is determined when the sale or usage occurs and is therefore excluded from the transaction price. In addition, we are eligible to receive future development and regulatory milestones upon the achievement of certain criteria; however, these amounts are excluded from variable consideration as the risk of significant revenue reversal will only be resolved depending on future research and development and/or regulatory approval outcomes. We will re-evaluate We allocated the initial transaction price to each unit of account. Variable consideration that relates specifically to our efforts to satisfy specific performance obligations are allocated entirely to those performance obligations. Other components of the transaction price are allocated based on the relative stand-alone selling price, over which management has applied significant judgment. We developed the estimated stand-alone selling price for the licenses using the risk-adjusted net present values of estimated cash flows, and the estimated stand-alone selling price of the development services performance obligations by estimating costs to be incurred, and an appropriate margin, using an income approach. We determined that control of the U.S. License and Ex-U.S. million related to the Ex-U.S. non-current non-ASC million for the transaction price allocated to the Development Services performance obligations and will recognize this revenue based on the proportional performance of these development activities, which we expect to recognize through fiscal year 2026. KKC Japan License Agreement In October 2018, we, as licensor, entered into a license agreement with KKC for zandelisib (“the KKC Japan License Agreement”). Under the terms of the KKC Japan License Agreement, KKC was granted the exclusive right to develop and commercialize zandelisib in Japan. We also granted KKC the right to purchase supply of zandelisib for commercial requirements at cost plus a pre-negotiated We assessed the KKC Japan License Agreement in accordance with ASC 606 and determined that our performance obligations comprised the license, research and development obligations, and our obligation to provide clinical trial materials to KKC. We determined that the transaction price amounted to the upfront payment of $10.0 million. We determined that control of the license was transferred to KKC during the year ended June 30, 2019. Revenue allocated to the research and development obligations was recognized based on the proportional performance of these research and development activities. Revenue allocated to providing clinical trial materials was recognized upon delivery. |
BeiGene Collaboration
BeiGene Collaboration | 12 Months Ended |
Jun. 30, 2020 | |
BeiGene Collaboration | Note 3. BeiGene Collaboration In October 2018, we entered into a clinical collaboration with BeiGene, Ltd. (“BeiGene”) to evaluate the safety and efficacy of zandelisib in combination with BeiGene’s zanubrutinib, an investigational inhibitor of Bruton’s tyrosine kinase (“BTK”), for the treatment of patients with B-cell B-cell |
Other License Agreements
Other License Agreements | 12 Months Ended |
Jun. 30, 2020 | |
Licensing Arrangements [Abstract] | |
Other License Agreements | Note 4. Other License Agreements Helsinn License Agreement In August 2016, we, as licensor, entered into an exclusive worldwide license, development, manufacturing and commercialization agreement with Helsinn Healthcare SA, a Swiss pharmaceutical corporation (“Helsinn”) for pracinostat in acute myeloid leukemia (“AML”), myelodisplastic syndrome (“MDS”) and other potential indications (the “Helsinn License Agreement”). Under the terms of the agreement, Helsinn was granted a worldwide exclusive license to develop, manufacture and commercialize pracinostat, and is primarily responsible for funding its global development and commercialization. As compensation for such grant of rights, we received payments of $20.0 million. We determined that the agreement contains multiple performance obligations for purposes of revenue recognition. Revenue related to the research and development elements of the arrangement is recognized based on the extent of progress toward completion of each performance obligation. Revenue is recognized on a gross basis as we are the primary obligor and have discretion in supplier selection. During the year ended June 30, 2020, our only remaining performance obligation under the agreement is the conduct of a Phase 2 dose-optimization study of pracinostat in combination with azacitidine in patients with high and very high risk MDS who are previously untreated with hypomethylating agents (the “POC study”), for which Helsinn has agreed to share third-party expenses. Presage License Agreement In September 2017, we, as licensee, entered into a license agreement with Presage Biosciences, Inc. (“Presage”). Under the terms of the license agreement, Presage granted to us exclusive worldwide rights to develop, manufacture and commercialize voruciclib, a clinical-stage, oral and selective CDK inhibitor, and related compounds. In exchange, we paid $2.9 million. With respect to the first indication, an incremental $2.0 million payment, due upon dosing of the first subject in the first registration trial will be owed to Presage, for total payments of $4.9 million prior to receipt of marketing approval of the first indication in the U.S., E.U. or Japan. Additional potential payments of up to $179 million will be due upon the achievement of certain development, regulatory and commercial milestones. We will also pay mid-single-digit CyDex License Agreement We, as licensee, are party to a license agreement with CyDex Pharmaceuticals, Inc. (“CyDex”). Under the terms of the license agreement, CyDex granted to us an exclusive, nontransferable license to intellectual property rights relating to Captisol ® ME-344). non-refundable |
Intangible Assets
Intangible Assets | 12 Months Ended |
Jun. 30, 2020 | |
Intangible Assets | Note 5. Intangible Assets Intangible assets consisted of the following, in thousands: June 30, 2020 2019 S*Bio Patents—Gross $ 273 $ 500 Less: accumulated amortization (273 ) (239 ) Intangible assets, net $ — $ 261 Amortization expense of intangible assets for the years ended June 30, 2020, 2019 and 2018 was $34,000, $35,000 and $35,000, respectively. As a result of Helsinn discontinuing the Phase 3 study of pracinostat in AML, we assessed the estimated future cash flows associated with the patents acquired from S*Bio and recorded an impairment charge of $0.2 million to write off the remaining book value of the intangible assets. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Jun. 30, 2020 | |
Property and Equipment | Note 6. Property and Equipment Property and eq u June 30, 2020 2019 Furniture and equipment $ 304 $ 250 Leasehold improvements 842 48 1,146 298 Less: accumulated depreciation (62 ) (94 ) Property and equipment, net $ 1,084 $ 204 Depreciation expense of property and equip m |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Jun. 30, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities consisted of the following, in thousands: June 30, 2020 2019 Accrued pre-clinical $ 2,343 $ 2,014 Accrued compensation and benefits 3,410 1,973 Accrued legal and professional services expenses 226 316 Other 111 256 Total accrued liabilities $ 6,090 $ 4,559 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Jun. 30, 2020 | |
Stockholders' Equity | Note 8. Stockholders’ Equity Equity Transactions Underwritten Registered Offering In December 2019, we completed an underwritten registered offering of 32,343,750 shares of common stock at a price per share of $1.60. We received net cash proceeds of $48.5 million associated with the offering, after costs of $3.3 million. At-The-Market In November 2017, we entered into an At-The-Market net procee ds of of Shelf Registration Statement We have a shelf registration statement that permits us to sell, from time to time, up to $200.0 million of common stock, preferred stock and warrants. The shelf registration was filed and declared effective in May 2020, replacing our prior shelf registration statement that was filed and declared effective in May 2017, and carrying forward approximately $107.5 million of unsold securities registered under the prior shelf registration statement. Shares sold in the underwritten registered offering in December 2019 and were sold under the prior shelf registration statement. Shares sold under the ATM Sales Agreement prior to and after May 2020 were issued pursuant to the prior shelf registration statement and shelf registration statement, respectively. As of June 30, 2020, there is $178.9 million aggregate value of securities available under the shelf registration statement, including up to $3.2 million remaining available under the ATM Sales Agreement. May 2018 Private Placement In May 2018, we raised $70.2 million, net of transaction costs, in a private placement of common shares and warrants. We issued and sold 33,003,296 shares of common stock, as well as warrants to purchase 16,501,645 shares. The price was approximately $2.27 to purchase one share with an accompanying warrant; each warrant is for the purchase of one-half 9 19 Description of Capital Stock Our total authorized share capital is 226,100,000 shares consisting of 226,000,000 shares of common stock, $0.00000002 par value per share, and 100,000 shares of preferred stock, $0.01 par value per share. Common Stock The holders of common stock are entitled to one vote per share. In the event of a liquidation, dissolution or winding up of our affairs, holders of the common stock will be entitled to share ratably in all our assets that are remaining after payment of our liabilities and the liquidation preference of any outstanding shares of preferred stock. All outstanding shares of common stock are fully paid and non-assessable. pre-emptive Preferred Stock Our Board of Directors has the authority to issue up to 100,000 shares of preferred stock with par value of $.01 per share in one or more series and to fix the rights, preferences, privileges and restrictions in respect of that preferred stock, including dividend rights, dividend rates, conversion rights, voting rights, terms of redemption (including sinking fund provisions), redemption prices and liquidation preferences, and the number of shares constituting such series and the designation of any such series, without future vote or action by the stockholders. Therefore, the board without the approval of the stockholders could authorize the issue of preferred stock with voting, conversion and other rights that could affect the voting power, dividend and other rights of the holders of shares or that could have the effect of delaying, deferring or preventing a change of control. There were no shares of preferred stock outstanding as of June 30, 2020 or 2019. |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Jun. 30, 2020 | |
Share-based Compensation | Note 9. Share-based Compensation We use equity-based compensation programs to provide long-term performance incentives for our employees. These incentives consist primarily of stock options and RSUs. In December 2008, we adopted the MEI Pharma, Inc. 2008 Stock Omnibus Equity Compensation Plan (“2008 Plan”), as amended and restated in 2011, 2013, 2014, 2015, 2016 and 2018, under which 19,089,794 shares of common stock are authorized for issuance. The 2008 Plan provides for the grant of options and/or other stock-based or stock-denominated awards to our non-employee Total share-based compensation expense for all stock awards consists of the following, in thousands: Years Ended June 30, 2020 2019 2018 Research and development $ 2,777 $ 2,239 $ 1,176 General and administrative 4,024 4,323 2,041 Total share-based compensation $ 6,801 $ 6,562 $ 3,217 Stock Options Stock options granted to employees vest 25% one year from the date of grant and ratably each month thereafter for a period of 36 months and expir e A summary of our stock option activity and related data follows: Number of Weighted-Average Weighted-Average Aggregate Outstanding at June 30, 2019 8,356,961 $ 3.20 Granted 3,733,333 $ 2.50 Exercised (153,679 ) $ 1.77 Forfeited / Cancelled (125,749 ) $ 2.45 Expired (557,890 ) $ 6.89 Outstanding at June 30, 2020 11,252,976 $ 2.81 7.8 $ 15,290,655 Vested and exercisable at June 30, 2020 5,475,069 $ 2.66 7.0 $ 8,330,387 As of June 30, 2020, the aggregate intrinsic value of outstanding options is calculated as the difference between the exercise price of the underlying options and the closing price of our common stock of $4.13 on that date. The total fair value of options that vested during the years ended June 30, 2020, 2019 and 2018 was $5.4 million, $3.4 million and $2.4 million, respectively. A summary of our non - Number of Weighted-Average Nonvested at June 30, 2019 4,376,928 $ 3.51 Granted 3,733,333 $ 2.50 Forfeited (76,563 ) $ 2.86 Vested (2,255,791 ) $ 3.26 Nonvested at June 30, 2020 5,777,907 $ 2.96 Unrecognized compensation expense related to non-vested We use a Black-Scholes valuation model to estimate the grant date fair value of stock options. To calculate these fair values, the following weighted-average assumptions were used: Years Ended June 30, 2020 2019 2018 Risk-free interest rate 1.7 % 2.7 % 2.3 % Expected life (years) 6.0 6.0 6.0 Expected volatility 74.1 % 82.5 % 93.7 % Dividend yield 0.0 % 0.0 % 0.0 % Weighted-average grant date fair value $ 1.64 $ 2.78 $ 2.40 Restricted Stock Units In March 2013, the Compensation Committee of the Board of Directors granted 400,000 RSUs to our Chief Executive Officer. Each RSU represented the contingent right to receive one share of our common stock. The shares underlying the RSUs were delivered on March 29, 2018, and we issued 271,080 shares of common stock, net of shares withheld to cover taxes and fees. The fair value of the RSUs on the date of grant was $3.5 million. In June 2016, we granted 364,726 RSUs to employees. Each RSU represented the contingent right to receive one share of our common stock. The RSUs were subject to performance criteria that were met in August 2016. The fair value of the RSUs was measured at $1.61 per unit on the date the performance criteria were met. The RSUs vested in August 2018, and we released 332,193 RSU shares. We issued 245,782 shares of common stock to RSU holders; 86,411 shares were surrendered to us by RSU holders as payment for the employee portion of the required withholding of associated payroll taxes. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies | Note 10. Commitments and Contingencies We have contracted with various consultants and third parties to assist us in pre-clinical Presage License Agreement As discussed in Note 2, we are party to a license agreement with Presage under which we may be required to make future payments upon the achievement of certain development, regulatory and commercial milestones, as well as potential future royalties based upon net sales. As of June 30, 2020, we have not accrued any amounts for potential future payments. S*Bio Purchase Agreement We are party to a definitive asset purchase agreement with S*Bio, pursuant to which we acquired certain assets comprised of intellectual property and technology including rights to pracinostat. We agreed to make certain milestone payments to S*Bio based on the achievement of certain clinical, regulatory and net sales-based milestones, as well as to make certain contingent earnout payments to S*Bio. Milestone payments will be made to S*Bio up to an aggregate amount of $75.2 million if certain U.S., E.U. and Japanese regulatory approvals are obtained and if certain net sales thresholds are met in North America, the E.U. and Japan. The first milestone payment of $200,000 plus 166,527 shares of our common stock having a value of $500,000 was paid in August 2017 upon the first dosing of a patient in a Phase 3 clinical trial. Subsequent milestone payments will be due upon certain regulatory approvals and sales-based events. As of June 30, 2020, we have not accrued any amounts for potential future payments. CyDex License Agreement As discussed in Note 2, we are party to a license agreement with CyDex under which we may be required to make future payments upon the achievement of certain milestones, as well as potential future royalties based upon net sales. Contemporaneously with the license agreement, CyDex entered into a commercial supply agreement with us, pursuant to which we agreed to purchase 100% of our requirements for Captisol from CyDex. As of June 30, 2020, we have not accrued any amounts for potential future payments. COVID-19 In January 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus (the “COVID-19 COVID-19 COVID-19 COVID-19. In light of the COVID-19 COVID-19 . . . . CARES Act On March 27, 2020, President Trump signed into law the “Coronavirus Aid, Relief, and Economic Security (CARES) Act.” The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property. Regulatory guidance has indicated that public companies are ineligible to participate in certain of the loan programs provided by the CARES Act. We do not expect that the CARES Act will have a material impact on our financial condition, results of operation, or liquidity. Legal Proceedings On August 10, 2020, an individual who allegedly purchased 50 shares of our common stock filed a putative securities class action lawsuit in the United States District Court for the Southern District of California against the Company, Daniel P. Gold, and Brian G. Drazba, asserting claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 |
Leases
Leases | 12 Months Ended |
Jun. 30, 2020 | |
Disclosure Text Block [Abstract] | |
Leases | Note 11. Leases In December 2019, we entered into a lease agreement for approximately 32,800 square feet of office space in San Diego, California. The contractual lease term is from July 2020 through March 2028. The average annual lease payments over the term of the lease will approximate $1.5 million, plus a pro rata share of certain building expenses. Our total contractual obligation over the term of the lease is approximately $11.5 million. |
Segment Information
Segment Information | 12 Months Ended |
Jun. 30, 2020 | |
Segment Information | Note 12. Segment Information We have one operating segment, the development of pharmaceutical compounds. All of our assets and liabilities were located in the United States of America as of June 30, 2020, 2019 and 2018. |
Income Taxes
Income Taxes | 12 Months Ended |
Jun. 30, 2020 | |
Income Taxes | Note 13. Income Taxes Pre-tax Years Ended June 30, 2020 2019 2018 Domestic $ (46,016 ) $ (16,819 ) $ (40,068 ) Foreign — — — Pre-tax $ (46,016 ) $ (16,819 ) $ (40,068 ) The reconciliation of income tax computed at the U.S. federal statutory tax rates to income tax expense is as follows (in thousands): Years Ended June 30, 2020 2019 2018 $ % $ % $ % Tax benefit (expense) at U.S. statutory rates $ 9,663 21 % $ 3,532 21 % $ 11,019 28 % State tax 9 0 % 86 1 % (5,370 ) -13 % Warrant liability costs (4,803 ) -10 % 5,803 35 % (3,320 ) -8 % Equity compensation (2 ) 0 % 138 1 % (837 ) -2 % (Increase) decrease in valuation allowance (4,230 ) -9 % (9,082 ) -54 % 14,914 37 % Revaluation of deferred taxes — 0 % — 0 % (15,870 ) -40 % Other (638 ) -1 % (478 ) -3 % (537 ) -1 % $ (1 ) 0 % $ (1 ) 0 % $ (1 ) 0 % Deferred tax liabilities and assets are comprised of the following (in thousands): June 30, 2020 2019 Deferred tax assets: Deferred revenue $ 17,325 $ 1,635 Fixed and intangible assets 18,832 15,328 Share-based payments 3,834 3,081 Tax losses carried forward 2,214 18,510 Compensation accruals 709 85 Consultant and other accruals 20 41 Charitable contributions — 22 Total deferred tax assets 42,934 38,702 Valuation allowance for deferred tax assets (42,934 ) (38,702 ) Net deferred tax assets and liabilities $ — $ — We evaluate the recoverability of the deferred tax assets and the amount of the required valuation allowance. Due to the uncertainty surrounding the realization of the tax deductions in future tax returns, we have recorded a valuation allowance against our net deferred tax assets as of June 30, 2020 and 2019. At such time as it is determined that it is more likely than not that the deferred tax assets will be realized, the valuation allowance would be reduced. We had federal and state net operating loss carryforwards of approximately $4.2 million and $19.1 million as of June 30, 2020. T carryforward indefinitely until utilized. State net operating loss carryforwards will begin to expire in Our ability to utilize our net operating loss carryforwards may be substantially limited due to ownership changes that have occurred or that could occur in the future under Section 382 of the Internal Revenue Code and similar state laws. During 2020, we completed a study to analyze whether one or more ownership changes had occurred and determined that two such ownership changes did occur. While the ownership changes do limit the amount of net operating loss we are able to use each year, all of our net operating losses are expected to be available for utilization prior to expiring. The Tax Act limits the deduction of net operating losses to 80% of current year taxable income, however, as a result of the CARES Act, the 80% limitation was temporarily repealed until our fiscal year ending June 30, 2021. Additionally, the CARES Act allows for NOLs arising from taxable years beginning after December 31, 2017 and before January 1, 2021 to be carried back to each of the five years prior to the taxable year of such losses. None of our prior income tax returns have been selected for examination by a major taxing jurisdiction; however, the statutes of limitations for various filings remain open. The oldest filings subject to potential examination for federal and state purposes are 2016 and 2015, respectively. If we utilize a net operating loss related to a closed year, the stature for the year would re-open. income-tax |
Selected Quarterly Financial In
Selected Quarterly Financial Information (Unaudited) | 12 Months Ended |
Jun. 30, 2020 | |
Selected Quarterly Financial Information (Unaudited) | Note 14. Selected Quarterly Financial Information (Unaudited) The following table presents our unaudited quarterly results of operations for the years ended June 30, 2020 and 2019 (in thousands, except per share amounts). Quarters Ended Year Ended June 30, March 31, December 31, September 30, June 30, Total revenues $ 25,504 $ 1,244 $ 1,008 $ 1,157 $ 28,913 Net loss (1) $ (18,476 ) $ ) $ (20,217 ) $ (2,994 ) $ (46,016 ) Basic loss per share $ (0.17 ) $ (0.04 ) $ (0.26 ) $ (0.04 ) $ (0.51 ) Diluted loss per share $ (0.17 ) $ (0.04 ) $ (0.26 ) $ (0.04 ) $ (0.51 ) Quarters Ended Year Ended June 30, March 31, December 31, September 30, June 30, Total revenues $ 1,129 $ 1,249 $ 2,049 $ 488 $ 4,915 Net income (loss) (1) $ 3,052 $ ) $ 12,025 $ (14,542 ) $ (16,819 ) Basic income (loss) per share $ 0.04 $ (0.24 ) $ 0.17 $ (0.21 ) $ (0.24 ) Diluted loss per share $ (0.15 ) $ (0.24 ) $ (0.15 ) $ (0.21 ) $ (0.75 ) (1) We have experienced large changes in our net loss which relates to the change in fair value of the warrant liability for the years ended June 30, 2020 and 2019. Refer to Note 1 for further discussion. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Jun. 30, 2020 | |
Clinical Development Programs | Clinical Development Programs Our approach to building our pipeline is to license promising cancer agents and build value in programs through development, commercialization and strategic partnerships, as appropriate. Our drug candidate pipeline includes: • Zandelisib (formerly known as ME-401), 3-kinase • Voruciclib, an oral cyclin-dependent kinase (“CDK”) inhibitor; • ME-344, • Pracinostat, an oral histone deacetylase (“HDAC”) inhibitor. The results of pre-clinical ME-344 |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. We use estimates that affect the reported amounts (including assets, liabilities, revenues and expenses) and related disclosures. Actual results could materially differ from those estimates. |
Liquidity | Liquidity We have accumulated losses of $277.2 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of June 30, 2020, we had $182.6 million in cash and cash equivalents, and short-term investments . Additionally, we have a receivable of $20.4 million representing a tax withholding refund due to us of the $100 million upfront payment associated with the KKC Commercialization Agreement (Note 2). Of the $ 100 20.4 believe that these resources will be sufficient to meet our To date, we have obtained cash and funded our operations primarily through equity financings and license agreements. In order to continue the development of our drug candidates, at some point in the future we expect to pursue one or more capital transactions, whether through the sale of equity securities, license agreements or entry into strategic partnerships. There can be no assurance that we will be able to continue to raise additional capital in the future. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less when purchased. Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. We have not experienced any losses related to these balances. |
Short-Term Investments | Short-Term Investments Investments that have maturities of greater than three months but less than one year are classified as short-term investments. As of June 30, 2020 and 2019, our short-term investments consisted of $170.3 million and $64.9 million, respectively, in U.S. government securities. The short-term investments held as of June 30, 2020 and 2019 had maturity dates of less than one year, are considered to be “held to maturity” and are carried at amortized cost. As of June 30, 2020 and 2019, the gross holding gains and losses were immaterial. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy 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 is as follows: • Level 1 — Observable inputs such as quoted prices in active markets for identical assets or liabilities. • Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. We measure the following financial instruments at fair value on a recurring basis. The fair values of these financial instruments were as follows (in thousands): June 30, 2020 June 30, 2019 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant liability $ — $ — $ (40,483 ) $ — $ — $ (17,613 ) Total $ — $ — $ (40,483 ) $ — $ — $ (17,613 ) The carrying amounts of financial instruments such as cash equivalents, short-term investments and accounts payable approximate the related fair values due to the short-term maturities of these instruments. We invest our excess cash in financial instruments which are readily convertible into cash, such as money market funds and U.S. government securities. Cash equivalents, where applicable, and short-term investments are classified as Level 1 as defined by the fair value hierarchy. In May 2018, we issued warrants in connection with our private placement of shares of common stock. Pursuant to the terms of the warrants, we could be required to settle the warrants in cash in the event of an acquisition of the Company and, as a result, the warrants are required to be measured at fair value and reported as a liability in the Balance Sheet. We recorded the fair value of the warrants upon issuance using the Black-Scholes valuation model and are required to revalue the warrants at each reporting date with any changes in fair value recorded on our Statement of Operations. The valuation of the warrants is considered under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that are both significant to the fair value measurement and unobservable. Inputs used to determine estimated fair value of the warrant liabilities include the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends and the expected volatility of the underlying stock. The significant unobservable inputs used in the fair value measurement of the warrant liabilities were the volatility rate and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value measurement. The change in the fair value of the Level 3 warrant liability is reflected in the Statement of Operations for the years ended June 30, 2020 and 2019. To calculate the fair value of the warrant liability, the following assumptions were used: June 30, 2020 June 30, Risk-free interest rate 0.2 % 1.7 % Expected life (years) 2.9 3.8 Expected volatility 77.4 % 56.8 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ 2.52 $ 1.10 The following table sets forth a summary of changes in the estimated f a Fair Value of Warrants Using Significant 2020 2019 Balance at July 1, $ 17,613 $ 46,313 Reclassification of derivative liability to equity upon exercise of warrants — (1,068 ) Change in estimated fair value of liability classified warrants 22,870 (27,632 ) Balance at June 30, $ 40,483 $ 17,613 |
Intangible Assets | Intangible Assets Intangible assets consist of patents acquired fr o |
Property and Equipment | Property and Equipment Property and equipment are stated at cost and depreciated over the estimated useful lives of the assets (generally three to seven years) using the straight-line method. Leasehold improvements are stated at cost and are amortized over the shorter of the estimated useful lives of the assets or the lease term. |
Leases | Leases As of July 1, 2019, we adopted Topic 842, Leases |
Revenue Recognition | Revenue Recognition ASC Topic 606, Revenue from Contracts with Customers (“Topic 606” or the “new revenue standard”) Beginning July 1, 2018, we recognize revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. For enforceable contracts with our customers, we first identify the distinct performance obligations – or accounting units – within the contract. Performance obligations are commitments in a contract to transfer a distinct good or service to the customer. Payments received under commercial arrangements, such as licensing technology rights, may include non-refundable re-evaluate catch-up catch-up We develop estimates of the stand-alone selling price for each distinct performance obligation. Variable consideration that relates specifically to our efforts to satisfy specific performance obligations is allocated entirely to those performance obligations. Other components of the transaction price are allocated based on the relative stand-alone selling price, over which management has applied significant judgment. We develop assumptions that require judgment to determine the stand-alone selling price for license-related performance obligations, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. We estimate stand-alone selling price for research and development performance obligations by forecasting the expected costs of satisfying a performance obligation plus an appropriate margin. In the case of a license that is a distinct performance obligation, we recognize revenue allocated to the license from non-refundable, up-front The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. Revenue is recorded proportionally as costs are incurred. We generally use the cost-to-cost cost-to-cost For arrangements that include sales-based or usage-based royalties, we recognize revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, we have not recognized any sales-based royalty revenue from license agreements. We recognized revenue associated with the following license agreements (in thousands): Years Ended June 30, 2020 2019 2018 KKC Agreements $ 27,543 $ 2,557 $ — Helsinn License Agreement 1,370 2,358 1,622 $ 28,913 $ 4,915 $ 1,622 Timing of Revenue Recognition: License transferred at a point in time $ 20,988 $ 879 $ — Services performed over time 4,860 4,036 1,622 Cumulative catch-up 3,065 — — $ 28,913 $ 4,915 $ 1,622 Based on the characteristics of the KKC Agreements (Note 2), delivery of the Ex-U . . account for any partially unsatisfied performance obligations carried forward into the new agreement as the continuation of the previous contract, and we catch-up 1 , inclusive of cumulative catch-up amounts, d $ Based on the characteristics of the Helsinn License Agreement, control of the remaining deliverables occurs over time and therefore we recognize revenue based on the extent of progress towards completion of the performance obligations. Accordingly we recognized $ 1.4 2.3 As of June 30, 2020, we had $82.5 million of deferred revenue associated with our remaining performance obligations under the KKC and Helsinn license agreements. We expect to recognize approximately $14.8 million of deferred revenue in the next 12 months, and an additional $67.7 million thereafter. Contract Balances Receivables and contract assets are included in our balance sheet in “Prepaid expenses and other current assets”, and contract liabilities are included in “Deferred revenue” and “Deferred revenue long-term”. The following table presents changes in contract assets and contract liabilities during the year ended June 30, 2020 and 2019 (in thousands): Years Ended June 30, 2020 2019 Receivables Receivables, beginning of year $ — $ 82 Net change 2,605 (82 ) Receivables, end of year $ 2,605 $ — Contract assets Contract assets, beginning of year $ 686 $ 312 Net change (82 ) 374 Contract assets, end of year $ 604 $ 686 Contract liabilities Contract liabilities, beginning of year $ 7,774 $ 788 Net change 74,726 6,986 Contract liabilities, end of year $ 82,500 $ 7,774 The timing of revenue recognition, invoicing and cash collections results in billed accounts receivable and unbilled receivables (contract assets), which are classified as “prepaid expenses and other current assets” on our Balance Sheet, and deferred revenue (contract liabilities). We invoice our customers in accordance with agreed-upon contractual terms, typically at periodic intervals or upon achievement of contractual milestones. Invoicing may occur subsequent to revenue recognition, resulting in contract assets. We may receive advance payments from our customers before revenue is recognized, resulting in contract liabilities. The contract assets and liabilities reported on the Balance Sheet relate to the KKC Agreements and Helsinn License Agreement. We recognized revenue of $ 7.8 0.8 1.0 Revenues from Collaborators We earn revenue in connection with collaboration agreements, which are detailed in Note 2, KKC Agreements, and Note 3, BeiGene Collaboration. At contract inception, we assess whether the collaboration arrangements are within the scope of ASC Topic 808, Collaborative Arrangements Accounting Standard Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”) Revenue Recognition Payments received under commercial arrangements, such as licensing technology rights, may include non-refundable Multiple Element Arrangements Deliverables under an arrangement will be separate units of accounting, provided (i) a delivered item has value to the customer on a standalone basis; and (ii) the arrangement includes a general right of return relative to the delivered item, and delivery or performance of the undelivered item is considered probable and substantially in our control. We account for revenue arrangements with multiple elements by separating and allocating consideration according to the relative selling price of each deliverable. If an element can be separated, an amount is allocated based upon the relative selling price of each element. We determine the relative selling price of a separate deliverable using the price we charge other customers when we sell that element separately. If the element is not sold separately and third-party pricing evidence is not available, we will use our best estimate of selling price. License Fee Revenue Non-refundable, up-front non-refundable case-by-case Research and Development Revenue Research and development revenue represents ratable recognition of fees allocated to research and development activities. We defer recognition of research and development revenue until the performance of the related research and development activities has occurred. Research and development revenue for the year ended June 30, 2018 related to services provided by third-party vendors related to research and development for activities performed under the KKC and Helsinn License Agreements (Note 2). Cost of Revenue Cost of revenue primarily includes external costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials, and internal compensation and related personnel expenses to support our research and development performance obligations associated with the Helsinn License Agreement. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred and include costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials. Clinical trial costs, including costs associated with third-party contractors, are a significant component of research and development expenses. We expense research and development costs based on work performed. In determining the amount to expense, management relies on estimates of total costs based on contract components completed, the enrollment of subjects, the completion of trials, and other events. Costs incurred related to the purchase or licensing of in-process |
Share-based Compensation | Share-based Compensation Share-based compensation expense for employees and directors is recognized in the Statement of Operations based on estimated amounts, including the grant date fair value and the expected service period. For stock options, we estimate the grant date fair value using a Black-Scholes valuation model, which requires the use of multiple subjective inputs including estimated future volatility, expected forfeitures and the expected term of the awards. We estimate the expected future volatility based on the stock’s historical price volatility. The stock’s future volatility may differ from the estimated volatility at the grant date. For restricted stock unit (“RSU”) equity awards, we estimate the grant date fair value using our closing stock price on the date of grant. We recognize the effect of forfeitures in compensation expense when the forfeitures occur. The estimated forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense recognized during the period. We recognize the value of the awards over the awards’ requisite service or performance periods. The requisite service period is generally the time over which our share-based awards vest. |
Interest and Dividend Income | Interest and Dividend Income Interest on cash balances is recognized when earned. Dividend income is recognized when the right to receive the payment is established. |
Income Taxes | Income Taxes Our income tax expense consists of current and deferred income tax expense or benefit. Current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is recognized for the future tax consequences attributable to tax credits and loss carryforwards and to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. As of June 30, 2020 and 2019, we have established a valuation allowance to fully reserve our net deferred tax assets. Tax rate changes are reflected in income during the period such changes are enacted. Changes in our ownership may limit the amount of net operating loss carryforwards that can be utilized in the future to offset taxable income. The Tax Act reduced the corporate tax rate from 34% to 21%, effective for tax years beginning January 1, 2018. We are subject to the provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 740-10, As a result of the Tax Act, beginning with our fiscal year ending June 30, 2021, the deduction of net operating losses is limited to 80% of current year taxable income. As a result of the Tax Act, we non-cash re-measurement our valuation allowance. The FASB Topic on Income Taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share are computed using the weighted-average number of shares of common stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of common stock subject to repurchase or forfeiture for the years ended June 30, 2020, 2019 and 2018. Our potentially dilutive shares, which include outstanding stock options, restricted stock units, and warrants, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The assessment of dilution is made on a quarterly basis and therefore the annual determination of diluted net loss per share only includes those quarters in which the potential common stock equivalents were determined to be dilutive. For the years ended June 30, 2020, 2019 and 2018, we did not have any items that would be classified as other comprehensive income or losses. The following table presents the calculation of net loss used to calculate basic and diluted loss per share (in thousands): Years Ended June 30, 2020 2019 2018 Net loss—basic $ (46,016 ) $ (16,819 ) $ (40,068 ) Change in fair value of warrant liability — (37,794 ) — Net loss—diluted $ (46,016 ) $ (54,613 ) $ (40,068 ) Shares used in calculating net loss per share was determined as follows (in thousands): Years Ended June 30, 2020 2019 2018 Weighted average shares outstanding 91,080 71,139 41,064 Effect of vested restricted stock units — — 367 Weighted average shares used in calculating net loss per share 91,080 71,139 41,431 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — 1,246 — Weighted average shares used in calculating diluted loss per share 91,080 72,385 41,431 The following potentially dilutive shares (in thousands) that have been excluded from the calculation of net loss per share because of their anti-dilutive effect: Years Ended June 30, 2020 2019 2018 Stock options 11,030 8,057 5,606 Restricted stock units — 32 336 Warrants 16,062 8,062 3,532 Total anti-dilutive shares 27,092 16,151 9,474 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adopted Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases right-of-use |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Schedule of Financial Instruments Measured at Fair Value on Recurring Basis | We measure the following financial instruments at fair value on a recurring basis. The fair values of these financial instruments were as follows (in thousands): June 30, 2020 June 30, 2019 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant liability $ — $ — $ (40,483 ) $ — $ — $ (17,613 ) Total $ — $ — $ (40,483 ) $ — $ — $ (17,613 ) |
Schedule of Assumptions Used to Calculate Fair Value of Warrant Liability | To calculate the fair value of the warrant liability, the following assumptions were used: June 30, 2020 June 30, Risk-free interest rate 0.2 % 1.7 % Expected life (years) 2.9 3.8 Expected volatility 77.4 % 56.8 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ 2.52 $ 1.10 |
Schedule of Changes in Estimated Fair Value of Warrant Liability | The following table sets forth a summary of changes in the estimated f a Fair Value of Warrants Using Significant 2020 2019 Balance at July 1, $ 17,613 $ 46,313 Reclassification of derivative liability to equity upon exercise of warrants — (1,068 ) Change in estimated fair value of liability classified warrants 22,870 (27,632 ) Balance at June 30, $ 40,483 $ 17,613 |
Schedule Of Revenue Associated With License Agreement | We recognized revenue associated with the following license agreements (in thousands): Years Ended June 30, 2020 2019 2018 KKC Agreements $ 27,543 $ 2,557 $ — Helsinn License Agreement 1,370 2,358 1,622 $ 28,913 $ 4,915 $ 1,622 Timing of Revenue Recognition: License transferred at a point in time $ 20,988 $ 879 $ — Services performed over time 4,860 4,036 1,622 Cumulative catch-up 3,065 — — $ 28,913 $ 4,915 $ 1,622 |
Schedule of Changes in Contract Assets and Contract Liabilities | The following table presents changes in contract assets and contract liabilities during the year ended June 30, 2020 and 2019 (in thousands): Years Ended June 30, 2020 2019 Receivables Receivables, beginning of year $ — $ 82 Net change 2,605 (82 ) Receivables, end of year $ 2,605 $ — Contract assets Contract assets, beginning of year $ 686 $ 312 Net change (82 ) 374 Contract assets, end of year $ 604 $ 686 Contract liabilities Contract liabilities, beginning of year $ 7,774 $ 788 Net change 74,726 6,986 Contract liabilities, end of year $ 82,500 $ 7,774 |
Schedule of Income (Loss) Per Share, Basic and Diluted | The following table presents the calculation of net loss used to calculate basic and diluted loss per share (in thousands): Years Ended June 30, 2020 2019 2018 Net loss—basic $ (46,016 ) $ (16,819 ) $ (40,068 ) Change in fair value of warrant liability — (37,794 ) — Net loss—diluted $ (46,016 ) $ (54,613 ) $ (40,068 ) |
Calculation of Weighted Average Shares Used to Calculate Basic and Diluted (Loss) Earnings Per Share | Shares used in calculating net loss per share was determined as follows (in thousands): Years Ended June 30, 2020 2019 2018 Weighted average shares outstanding 91,080 71,139 41,064 Effect of vested restricted stock units — — 367 Weighted average shares used in calculating net loss per share 91,080 71,139 41,431 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — 1,246 — Weighted average shares used in calculating diluted loss per share 91,080 72,385 41,431 |
Antidilutive Securities | The following potentially dilutive shares (in thousands) that have been excluded from the calculation of net loss per share because of their anti-dilutive effect: Years Ended June 30, 2020 2019 2018 Stock options 11,030 8,057 5,606 Restricted stock units — 32 336 Warrants 16,062 8,062 3,532 Total anti-dilutive shares 27,092 16,151 9,474 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Schedule of Intangible Assets | Intangible assets consisted of the following, in thousands: June 30, 2020 2019 S*Bio Patents—Gross $ 273 $ 500 Less: accumulated amortization (273 ) (239 ) Intangible assets, net $ — $ 261 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Schedule of Property and Equipment | Property and eq u June 30, 2020 2019 Furniture and equipment $ 304 $ 250 Leasehold improvements 842 48 1,146 298 Less: accumulated depreciation (62 ) (94 ) Property and equipment, net $ 1,084 $ 204 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Liabilities | Accrued liabilities consisted of the following, in thousands: June 30, 2020 2019 Accrued pre-clinical $ 2,343 $ 2,014 Accrued compensation and benefits 3,410 1,973 Accrued legal and professional services expenses 226 316 Other 111 256 Total accrued liabilities $ 6,090 $ 4,559 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Share-Based Compensation Expense for Stock Awards | Total share-based compensation expense for all stock awards consists of the following, in thousands: Years Ended June 30, 2020 2019 2018 Research and development $ 2,777 $ 2,239 $ 1,176 General and administrative 4,024 4,323 2,041 Total share-based compensation $ 6,801 $ 6,562 $ 3,217 |
Summary of Stock Option Activity and Related Data | A summary of our stock option activity and related data follows: Number of Weighted-Average Weighted-Average Aggregate Outstanding at June 30, 2019 8,356,961 $ 3.20 Granted 3,733,333 $ 2.50 Exercised (153,679 ) $ 1.77 Forfeited / Cancelled (125,749 ) $ 2.45 Expired (557,890 ) $ 6.89 Outstanding at June 30, 2020 11,252,976 $ 2.81 7.8 $ 15,290,655 Vested and exercisable at June 30, 2020 5,475,069 $ 2.66 7.0 $ 8,330,387 |
Non-vested Stock Option Activity | A summary of our non - Number of Weighted-Average Nonvested at June 30, 2019 4,376,928 $ 3.51 Granted 3,733,333 $ 2.50 Forfeited (76,563 ) $ 2.86 Vested (2,255,791 ) $ 3.26 Nonvested at June 30, 2020 5,777,907 $ 2.96 |
Fair Value of Stock Options Weighted-Average Assumptions Used | We use a Black-Scholes valuation model to estimate the grant date fair value of stock options. To calculate these fair values, the following weighted-average assumptions were used: Years Ended June 30, 2020 2019 2018 Risk-free interest rate 1.7 % 2.7 % 2.3 % Expected life (years) 6.0 6.0 6.0 Expected volatility 74.1 % 82.5 % 93.7 % Dividend yield 0.0 % 0.0 % 0.0 % Weighted-average grant date fair value $ 1.64 $ 2.78 $ 2.40 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Pre-Tax loss Information | Pre-tax Years Ended June 30, 2020 2019 2018 Domestic $ (46,016 ) $ (16,819 ) $ (40,068 ) Foreign — — — Pre-tax $ (46,016 ) $ (16,819 ) $ (40,068 ) |
Reconciliation of Income Taxes Computed at U.S Federal Statutory Tax Rates to Income Tax Expense | The reconciliation of income tax computed at the U.S. federal statutory tax rates to income tax expense is as follows (in thousands): Years Ended June 30, 2020 2019 2018 $ % $ % $ % Tax benefit (expense) at U.S. statutory rates $ 9,663 21 % $ 3,532 21 % $ 11,019 28 % State tax 9 0 % 86 1 % (5,370 ) -13 % Warrant liability costs (4,803 ) -10 % 5,803 35 % (3,320 ) -8 % Equity compensation (2 ) 0 % 138 1 % (837 ) -2 % (Increase) decrease in valuation allowance (4,230 ) -9 % (9,082 ) -54 % 14,914 37 % Revaluation of deferred taxes — 0 % — 0 % (15,870 ) -40 % Other (638 ) -1 % (478 ) -3 % (537 ) -1 % $ (1 ) 0 % $ (1 ) 0 % $ (1 ) 0 % |
Deferred Tax Liabilities and Assets | Deferred tax liabilities and assets are comprised of the following (in thousands): June 30, 2020 2019 Deferred tax assets: Deferred revenue $ 17,325 $ 1,635 Fixed and intangible assets 18,832 15,328 Share-based payments 3,834 3,081 Tax losses carried forward 2,214 18,510 Compensation accruals 709 85 Consultant and other accruals 20 41 Charitable contributions — 22 Total deferred tax assets 42,934 38,702 Valuation allowance for deferred tax assets (42,934 ) (38,702 ) Net deferred tax assets and liabilities $ — $ — |
Selected Quarterly Financial _2
Selected Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Jun. 30, 2020 | |
Unaudited Quarterly Results of Operations | The following table presents our unaudited quarterly results of operations for the years ended June 30, 2020 and 2019 (in thousands, except per share amounts). Quarters Ended Year Ended June 30, March 31, December 31, September 30, June 30, 2020 2020 2019 2019 2020 Total revenues $ 243 $ 1,244 $ 1,008 $ 1,157 $ 3,652 Net loss (1) $ (43,510 ) $ (4,329 ) $ (20,217 ) $ (2,994 ) $ (71,050 ) Basic income (loss) per share $ (0.41 ) $ (0.04 ) $ (0.26 ) $ (0.04 ) $ (0.78 ) Diluted loss per share $ (0.41 ) $ (0.04 ) $ (0.26 ) $ (0.04 ) $ (0.78 ) Quarters Ended Year Ended June 30, March 31, December 31, September 30, June 30, 2019 2019 2018 2018 2019 Total revenues $ 1,129 $ 1,249 $ 2,049 $ 488 $ 4,915 Net income (loss) (1) $ 3,052 $ (17,354 ) $ 12,025 $ (14,542 ) $ (16,819 ) Basic income (loss) per share $ 0.04 $ (0.24 ) $ 0.17 $ (0.21 ) $ (0.24 ) Diluted loss per share $ (0.15 ) $ (0.24 ) $ (0.15 ) $ (0.21 ) $ (0.75 ) (1) We have experienced large changes in our net loss which relates to the change in fair value of the warrant liability for the years ended June 30, 2020 and 2019. Refer to Note 1 for further discussion. |
The Company and Summary of Si_4
The Company and Summary of Significant Accounting Policies - Additional Information (Detail) | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)ClinicalTrialsshares | Jun. 30, 2019USD ($)shares | Jun. 30, 2018USD ($)shares | Jun. 30, 2017 | May 31, 2020USD ($) | |
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Number of clinical stage candidates | ClinicalTrials | 4 | |||||
Number of candidate in an ongoing global registration trial | ClinicalTrials | 1 | |||||
Short-term investments | $ 64,899,000 | $ 170,299,000 | $ 64,899,000 | |||
Estimated life of the intellectual property | 14 years | |||||
Corporate tax rate | 21.00% | 21.00% | 21.00% | 28.00% | 34.00% | |
Non-Cash Tax Expense | $ 0 | $ 0 | $ 15,870,000 | |||
Deferred Revenue Associated With Remaining Performance Obligation | 82,500,000 | |||||
Unrecognized tax benefits | $ 0 | 0 | 0 | |||
Recognition Of Deferred Revenue | 14,800,000 | |||||
Additional Recognition Of Deferred Revenue | 67,700,000 | |||||
Revenue Recognised With Performance Obligation | $ 6,600,000 | $ 1,700,000 | ||||
Common stock subject to repurchase or forfeiture | shares | 0 | 0 | 0 | |||
Accumulated Losses Since Inception | (231,218,000) | $ (277,234,000) | $ (231,218,000) | |||
Cash And Cash Equivalents,Short Term Investments And Common Stock Proceeds Receivable | $ 182,600,000 | |||||
Changes in unrecognized tax position | An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. | |||||
Impairment of finite lived intangible assets | $ 227,000 | |||||
Effective Income Tax Rate Reconciliation, Deduction, Percent | 80.00% | |||||
Helsinn License Agreement | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Deferred Revenue Associated With Remaining Performance Obligation | $ 2,300,000 | $ 1,400,000 | 2,300,000 | |||
KKC Agreements and Helsinn License Agreement [Member] | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Contract with Customer, Liability, Revenue Recognized | 7,800,000 | 800,000 | $ 1,000,000 | |||
S*Bio Patents | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Impairment of finite lived intangible assets | $ 200,000 | |||||
Minimum [Member] | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Property and equipment, estimated useful life | 3 years | |||||
Maximum | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Property and equipment, estimated useful life | 7 years | |||||
KHK License Agreement | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Revenue Recognised With Performance Obligation | $ 21,000,000 | $ 900,000 | ||||
Termination Of KKC Japan License Agreement And Execution Of KKC License Agreement | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Performance obligation cumulative catch up adjustment | 3,100,000 | |||||
Kyowa Kirin Co | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Milestone payment receivable current | 20,400,000 | |||||
Total upfront payment receivable for grant of rights | 100,000,000 | $ 100,000,000 | ||||
Kyowa Kirin Co | Potential Payments on Achievement of Development Regulatory and Commercial Milestones [Member] | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Total upfront payment receivable for grant of rights | $ 100,000,000 |
Schedule of Financial Instrumen
Schedule of Financial Instruments Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | May 31, 2018 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Warrant liability | $ (40,483) | $ (17,613) | $ (17,600) | $ (36,600) |
Level 3 | Fair Value, Measurements, Recurring [Member] | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Warrant liability | (40,483) | (17,613) | $ (46,313) | |
Total liability | $ (40,483) | $ (17,613) |
Schedule of Assumptions Used to
Schedule of Assumptions Used to Calculate Fair Value of Warrant Liability (Detail) - ClinicalTrials | Jun. 30, 2020 | Jun. 30, 2019 |
Risk Free Interest Rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 0.2 | 1.7 |
Expected life years | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 2.9 | 3.8 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 77.4 | 56.8 |
Dividend Yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 0 | 0 |
Black-Scholes Fair Value | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 2.52 | 1.10 |
Schedule of Changes in Estimate
Schedule of Changes in Estimated Fair Value of Warrant Liability (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Fair value measurements Significant unobservable inputs [Line Items] | |||
Beginning balance | $ 17,613 | $ 17,600 | |
Change in estimated fair value of liability classified warrants | 22,870 | (27,632) | $ 9,705 |
Ending balance | 40,483 | 17,613 | 17,600 |
Fair Value, Measurements, Recurring [Member] | Level 3 | |||
Fair value measurements Significant unobservable inputs [Line Items] | |||
Beginning balance | 17,613 | 46,313 | |
Reclassification of derivative liability to equity upon exercise of warrants | (1,068) | ||
Change in estimated fair value of liability classified warrants | 22,870 | (27,632) | |
Ending balance | $ 40,483 | $ 17,613 | $ 46,313 |
The Company - Revenue Associate
The Company - Revenue Associated With The Following license agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Recognized Revenue Associated with The Following License Agreements [Line Items] | |||||||||||
Revenues | $ 25,504 | $ 1,244 | $ 1,008 | $ 1,157 | $ 1,129 | $ 1,249 | $ 2,049 | $ 488 | $ 28,913 | $ 4,915 | $ 1,622 |
KKC Agreements [Member] | |||||||||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | |||||||||||
Revenues | 27,543 | 2,557 | |||||||||
Helsinn License Agreement [Member] | |||||||||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | |||||||||||
Revenues | 1,370 | 2,358 | 1,622 | ||||||||
License transferred at a point in time [Member] | |||||||||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | |||||||||||
Revenues | 20,988 | 879 | |||||||||
Services performed over time [Member] | |||||||||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | |||||||||||
Revenues | 4,860 | $ 4,036 | $ 1,622 | ||||||||
Cumulative catch-up adjustment [Member] | |||||||||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | |||||||||||
Revenues | $ 3,065 |
The Company - Schedule of Chang
The Company - Schedule of Changes in Contract Assets and Contract Liabilities (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Contract with Customer Asset and Liability [Line Items] | |||
Receivables, beginning of year | $ 82 | ||
Net change | 2,605 | (82) | |
Receivables, end of year | 2,605 | ||
Contract assets, beginning of year | 686 | 312 | |
Net change | (82) | 374 | |
Contract assets, end of year | 604 | 686 | $ 312 |
Contract liabilities, beginning of year | 7,774 | 788 | |
Net change | 74,726 | 6,986 | (208) |
Contract liabilities, end of year | $ 82,500 | $ 7,774 | $ 788 |
Calculation of Net (Loss) Incom
Calculation of Net (Loss) Income Used to Calculate Basic and Diluted (Loss) Per Share (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Potentially Dilutive Securities Outstanding [Line Items] | |||
Net loss—basic | $ (46,016) | $ (16,819) | $ (40,068) |
Change in fair value of warrant liability | (37,794) | ||
Net loss—diluted | $ (46,016) | $ (54,613) | $ (40,068) |
Calculation of Weighted Average
Calculation of Weighted Average Shares Used to Calculate Basic and Diluted (Loss) Earnings Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average shares outstanding | 91,080 | 71,139 | 41,064 |
Effect of vested restricted stock units | 367 | ||
Weighted average shares used in calculating net loss per share | 91,080 | 71,139 | 41,431 |
Effect of potentially dilutive common shares from equity awards and liability-classified warrants | 1,246 | ||
Weighted average shares used in calculating diluted loss per share | 91,080 | 72,385 | 41,431 |
Antidilutive Securities (Detail
Antidilutive Securities (Detail) - shares shares in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Potentially Dilutive Securities Outstanding [Line Items] | |||
Total anti-dilutive shares | 27,092 | 16,151 | 9,474 |
Employee Stock option | |||
Potentially Dilutive Securities Outstanding [Line Items] | |||
Total anti-dilutive shares | 11,030 | 8,057 | 5,606 |
Restricted Stock Units (RSUs) | |||
Potentially Dilutive Securities Outstanding [Line Items] | |||
Total anti-dilutive shares | 32 | 336 | |
Warrants | |||
Potentially Dilutive Securities Outstanding [Line Items] | |||
Total anti-dilutive shares | 16,062 | 8,062 | 3,532 |
KKC Agreements - Additional Inf
KKC Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2018 | Jun. 30, 2020 | May 31, 2020 | |
Receivable for foreign tax withholding | $ (20,420) | ||
Kyowa Kirin Co | |||
Total upfront payment receivable for grant of rights | 100,000 | $ 100,000 | |
Upfront payment | $ 10,000 | ||
Receivable for foreign tax withholding | 20,400 | ||
Kyowa Kirin Co | Potential Payments on Achievement of Development Regulatory and Commercial Milestones | |||
Total upfront payment receivable for grant of rights | 100,000 | ||
Kyowa Kirin Co | Potential Payments on Achievement of Development Regulatory and Commercial Milestones | Maximum | |||
Milestone payment receivable amount | 582,500 | ||
Kyowa Kirin Co | KKC License Agreement | |||
Upfront payment | 100,000 | ||
Transaction price relating to the performance obligation | 191,500 | ||
Estimated development cost sharing recovered through earnings | 66,300 | ||
Deferred revenue | 5,200 | ||
Expected milestone payment receivable | 20,000 | ||
Kyowa Kirin Co | KKC License Agreement | Ex US License | |||
Performance obligation revenue recognised | 21,000 | ||
License Obligation Account Transaction Price Allocated | 64,300 | ||
Kyowa Kirin Co | KKC License Agreement | Development Services | |||
Contract with customer liability non current | $ 18,100 |
Other License Agreements - Addi
Other License Agreements - Additional Information (Detail) | Aug. 31, 2016USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2020 |
Related Party Transaction [Line Items] | |||
Percentage of Purchase Requirement | 100.00% | ||
License and supply agreement notice period | 90 days | ||
Profit sharing ratio | 0.5 | ||
Helsinn License Agreement | |||
Related Party Transaction [Line Items] | |||
Compensation receivable for grant of rights | $ 20,000,000 | ||
Presage License Agreement | Presage Biosciences, Inc. | |||
Related Party Transaction [Line Items] | |||
Compensation payable for grant of rights | $ 4,900,000 | ||
Payment for license | 2,900,000 | ||
Presage License Agreement | Presage Biosciences, Inc. | Incremental Payment | |||
Related Party Transaction [Line Items] | |||
Compensation payable for grant of rights | 2,000,000 | ||
Presage License Agreement | Presage Biosciences, Inc. | Potential Payments on Achievement of Development Regulatory and Commercial Milestones | Maximum | |||
Related Party Transaction [Line Items] | |||
Milestone payments payable amount | $ 179,000,000 |
Schedule of Intangible Assets (
Schedule of Intangible Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Jun. 30, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, net | $ 261 | |
S*Bio Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
S*Bio Patents—Gross | $ 273 | 500 |
Less: accumulated amortization | $ (273) | (239) |
Intangible assets, net | $ 261 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization expense | $ 34,000 | $ 35,000 | $ 35,000 |
Impairment of finite lived intangible assets | 227,000 | ||
S*Bio Patents | |||
Finite-Lived Intangible Assets [Line Items] | |||
Impairment of finite lived intangible assets | $ 200,000 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Jun. 30, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 1,146 | $ 298 |
Less: accumulated depreciation | (62) | (94) |
Property and equipment, net | 1,084 | 204 |
Furniture And Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 304 | 250 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 842 | $ 48 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation expense | $ 75,000 | $ 45,000 | $ 18,000 |
Accrued Liabilities (Detail)
Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Jun. 30, 2019 |
Accrued Liabilities [Line Items] | ||
Accrued pre-clinical and clinical trial expenses | $ 2,343 | $ 2,014 |
Accrued compensation and benefits | 3,410 | 1,973 |
Accrued legal and professional services expenses | 226 | 316 |
Other | 111 | 256 |
Total accrued liabilities | $ 6,090 | $ 4,559 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Dec. 31, 2019 | May 31, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | Nov. 30, 2017 |
Class of Stock [Line Items] | ||||||
Issuance of common stock and warrants | $ 69,231,000 | $ 220,000 | $ 70,151,000 | |||
Fair value of warrants | $ 36,600,000 | 40,483,000 | $ 17,613,000 | $ 17,600,000 | ||
Aggregate value of securities available under shelf registration statement | $ 400,000 | |||||
Total authorized share capital | 226,100,000 | |||||
Common stock, shares authorized | 226,000,000 | 226,000,000 | ||||
Common stock, par value | $ 0.00 | $ 0.00 | ||||
Preferred stock, shares authorized | 100,000 | 100,000 | ||||
Preferred stock, par value | $ 0.01 | $ 0.01 | ||||
Common stock voting rights | one vote per share | |||||
Preferred stock, shares outstanding | 0 | 0 | ||||
Warrants exercised for common stock | $ 440,043 | |||||
Proceeds from warrant exercised | 0 | $ 1,118,000 | ||||
Common stock Value Issued | 69,231,000 | $ 5,444,000 | ||||
Unsold Securities Shares and Warrants Under Agreement | 107,500,000 | |||||
Aggregate Value of Securities Available Under Agreement | 178,900,000 | |||||
Remaining Available Under ATM Sales Agreement | $ 3,200,000 | |||||
ATM Sales Agreement | ||||||
Class of Stock [Line Items] | ||||||
Common stock share issued | 5,471,684 | |||||
Common stock Value Issued | $ 20,700,000 | |||||
Private Placement | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock and warrants | $ 70,200,000 | |||||
Common stock share issued | 33,003,296 | |||||
Common stock share issued, per share | $ 2.27 | |||||
Number of warrants to purchase | 16,501,645 | |||||
Exercise price | $ 2.54 | |||||
Warrants expiration date | 2023-05 | |||||
Warrants outstanding | 16,061,602 | |||||
Underwritten Registered Offering | ||||||
Class of Stock [Line Items] | ||||||
Offering price per share | $ 1.60 | |||||
Proceeds from offering net of costs | $ 48,500,000 | |||||
Stock Issuance Costs | $ 3,300,000 | |||||
Number of shares offered | 32,343,750 | |||||
Maximum | ||||||
Class of Stock [Line Items] | ||||||
Sale of shares and warrants under agreement | $ 200,000,000 | |||||
Maximum | ATM Sales Agreement | ||||||
Class of Stock [Line Items] | ||||||
Sale of shares under agreement | $ 30,000,000 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Aug. 31, 2018 | Jun. 30, 2016 | Mar. 31, 2013 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense related to unvested stock options | $ 4.7 | |||||
Expected weighted average period for recognition of compensation expense | 1 year 7 months 6 days | |||||
Total fair value of options vested | $ 5.4 | $ 3.4 | $ 2.4 | |||
Options outstanding | 11,252,976 | 8,356,961 | ||||
Employee Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock option vested percentage | 25.00% | |||||
Share-based compensation arrangement by share-based payment award, award vesting period | 0 months | |||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | |||||
Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Issuance of shares | 271,080 | |||||
Fair value of RSUs on the date of grant | $ 3.5 | |||||
Restricted Stock Units (RSUs) | Employees | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
RSUs granted | 332,193 | 364,726 | ||||
Number of common stock to be received for each RSUs | 1 | |||||
RSUs grant date fair value per unit | $ 245,782 | $ 1.61 | ||||
Shares withheld to satisfy tax withholding obligations | 86,411 | |||||
Restricted Stock Units (RSUs) | Chief Executive Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
RSUs granted | 400,000 | |||||
Number of common stock to be received for each RSUs | 1 | |||||
Stock Compensation Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Closing price of common stock | $ 4.13 | |||||
2008 Omnibus Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock authorized | 19,089,794 | |||||
Shares available for future grant | 6,437,150 | |||||
Minimum [Member] | Directors | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, award vesting period | 12 months |
Share-Based Compensation Expens
Share-Based Compensation Expense for Stock Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation | $ 6,801 | $ 6,562 | $ 3,217 |
Research and development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation | 2,777 | 2,239 | 1,176 |
General and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation | $ 4,024 | $ 4,323 | $ 2,041 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) | 12 Months Ended |
Jun. 30, 2020USD ($)$ / sharesshares | |
Number of Options | |
Beginning Balance | shares | 8,356,961 |
Granted | shares | 3,733,333 |
Exercised | shares | (153,679) |
Forfeited / Cancelled | shares | (125,749) |
Expired | shares | (557,890) |
Ending balance | shares | 11,252,976 |
Vested and exercisable at end of period | shares | 5,475,069 |
Weighted- Average Exercise Price | |
Beginning Balance | $ / shares | $ 3.20 |
Granted | $ / shares | 2.50 |
Exercised | $ / shares | 1.77 |
Forfeited / Cancelled | $ / shares | 2.45 |
Expired | $ / shares | 6.89 |
Ending balance | $ / shares | 2.81 |
Vested and exercisable at end of period | $ / shares | $ 2.66 |
Weighted Average Remaining Contractual Term (in years) | |
Outstanding at end of period | 7 years 9 months 18 days |
Vested and exercisable at end of period | 7 years |
Aggregate Intrinsic Value | |
Outstanding at end of period | $ | $ 15,290,655 |
Vested and exercisable at end of period | $ | $ 8,330,387 |
Non-vested Stock Option Activit
Non-vested Stock Option Activity (Detail) - $ / shares | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Number of options | |||
Beginning balance | 4,376,928 | ||
Granted | 3,733,333 | ||
Forfeited | (76,563) | ||
Vested | (2,255,791) | ||
Ending balance | 5,777,907 | 4,376,928 | |
Weighted average grant date fair value | |||
Beginning balance | $ 3.51 | ||
Granted | 2.50 | $ 2.78 | $ 2.40 |
Forfeited | 2.86 | ||
Vested | 3.26 | ||
Ending balance | $ 2.96 | $ 3.51 |
Fair Value of Stock Options Wei
Fair Value of Stock Options Weighted-Average Assumptions Used (Detail) - $ / shares | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 1.70% | 2.70% | 2.30% |
Expected life (years) | 6 years | 6 years | 6 years |
Expected volatility | 74.10% | 82.50% | 93.70% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Weighted-average grant date fair value | $ 2.50 | $ 2.78 | $ 2.40 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2017 | Jun. 30, 2020 | Jun. 30, 2019 | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Future aggregate milestone payments | $ 75,200,000 | ||
Percentage of Purchase Requirement | 100.00% | ||
Common stock value | |||
Phase Three Clinical Trial | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
First milestone payment | $ 200,000 | ||
Common stock value | $ 166,527 | ||
Issuance of common stock to purchase asset, shares | shares | 500,000 | ||
S*Bio Purchase Agreement | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Accrued payment for potential future payments | 0 | ||
CyDex License Agreement | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Accrued payment for potential future payments | 0 | ||
Presage License Agreement | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Accrued payment for potential future payments | $ 0 |
Leases - Additional Information
Leases - Additional Information (Detail) - Accounting Standards Update 2016-02 [Member] - San Diego California [Member] $ in Millions | Dec. 01, 2019USD ($)ft² |
Number of square feet under lease | ft² | 32,800 |
Average Annual Lease Payments | $ 1.5 |
Contractual obligation | $ 11.5 |
Lease expire date | Mar. 31, 2028 |
Segment Information - Additiona
Segment Information - Additional Information (Detail) | 12 Months Ended |
Jun. 30, 2020Segment | |
Segment Reporting Information [Line Items] | |
Number of Operating Segments | 1 |
Pre- Tax loss Jurisdictions (De
Pre- Tax loss Jurisdictions (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |
Pre tax Income Loss [Line Items] | |||
Domestic | $ (46,016) | $ (16,819) | $ (40,068) |
Foreign | 0 | 0 | 0 |
Pre-tax loss | $ (46,016) | $ (16,819) | $ (40,068) |
Reconciliation of Income Taxes
Reconciliation of Income Taxes Computed at U.S Federal Statutory Tax rates to Income Tax Expense (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2017 | |
Reconciliation Of Statutory Federal Tax Rate [Line Items] | |||||
Tax benefit (expense) at U.S. statutory rates | $ 9,663 | $ 3,532 | $ 11,019 | ||
State tax | 9 | 86 | (5,370) | ||
Warrant liability costs | (4,803) | 5,803 | (3,320) | ||
Equity compensation | (2) | 138 | (837) | ||
(Increase) decrease in valuation allowance | (4,230) | (9,082) | 14,914 | ||
Revaluation of deferred taxes | 0 | 0 | (15,870) | ||
Other | (638) | (478) | (537) | ||
Income tax expense | $ (1) | $ (1) | $ (1) | ||
Tax benefit (expense) at U.S. statutory rates | 21.00% | 21.00% | 21.00% | 28.00% | 34.00% |
State tax | 0.00% | 1.00% | (13.00%) | ||
Warrant liability costs | (10.00%) | 35.00% | (8.00%) | ||
Equity compensation | 0.00% | 1.00% | (2.00%) | ||
(Increase) decrease in valuation allowance | (9.00%) | (54.00%) | 37.00% | ||
Revaluation of deferred taxes | 0.00% | 0.00% | (40.00%) | ||
Other | (1.00%) | (3.00%) | (1.00%) | ||
Effective Income Tax Rate, Continuing Operations, Total | 0.00% | 0.00% | 0.00% |
Deferred Tax Liabilities and As
Deferred Tax Liabilities and Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Jun. 30, 2019 |
Deferred tax assets: | ||
Deferred revenue | $ 17,325 | $ 1,635 |
Fixed and intangible assets | 18,832 | 15,328 |
Share-based payments | 3,834 | 3,081 |
Tax losses carried forward | 2,214 | 18,510 |
Compensation accruals | 709 | 85 |
Consultant and other accruals | 20 | 41 |
Charitable contributions | 0 | 22 |
Total deferred tax assets | 42,934 | 38,702 |
Valuation allowance for deferred tax assets | (42,934) | (38,702) |
Net deferred tax assets and liabilities | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) $ in Millions | 12 Months Ended |
Jun. 30, 2020USD ($) | |
Income Taxes Line Items [Line Items] | |
Federal net operating loss carry forwards | $ 4.2 |
State net operating loss carry forwards | $ 19.1 |
State | |
Income Taxes Line Items [Line Items] | |
Expiration year of operating loss carry forwards | 2030 |
Quarterly Financial Information
Quarterly Financial Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||||||||
Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||||||||||||
Total revenues | $ 25,504 | $ 1,244 | $ 1,008 | $ 1,157 | $ 1,129 | $ 1,249 | $ 2,049 | $ 488 | $ 28,913 | $ 4,915 | $ 1,622 | ||||||||||
Net income (loss) | $ (18,476) | [1] | $ (4,329) | [1] | $ (20,217) | [1] | $ (2,994) | [1] | $ 3,052 | [1] | $ (17,354) | [1] | $ 12,025 | [1] | $ (14,542) | [1] | $ (46,016) | [1] | $ (16,819) | [1] | $ (40,068) |
Basic income (loss) per share | $ (0.17) | $ (0.04) | $ (0.26) | $ (0.04) | $ 0.04 | $ (0.24) | $ 0.17 | $ (0.21) | $ (0.51) | $ (0.24) | $ (0.97) | ||||||||||
Diluted loss per share | $ (0.17) | $ (0.04) | $ (0.26) | $ (0.04) | $ (0.15) | $ (0.24) | $ (0.15) | $ (0.21) | $ (0.51) | $ (0.75) | $ (0.97) | ||||||||||
[1] | We have experienced large changes in our net loss which relates to the change in fair value of the warrant liability for the years ended June 30, 2020 and 2019. Refer to Note 1 for further discussion. |