Cover Page
Cover Page - shares | 9 Months Ended | |
Mar. 31, 2021 | May 04, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
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 Address, State or Province | CA | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 112,591,778 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2021 | Jun. 30, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 9,745 | $ 12,331 |
Short-term investments | 154,879 | 170,299 |
Total cash, cash equivalents and short-term investments | 164,624 | 182,630 |
Receivable for foreign tax withholding | 20,420 | |
Prepaid expenses and other current assets | 11,937 | 5,594 |
Total current assets | 176,561 | 208,644 |
Operating lease right-of-use asset | 7,992 | |
Property and equipment, net | 1,569 | 1,084 |
Total assets | 186,122 | 209,728 |
Current liabilities: | ||
Accounts payable | 5,571 | 2,437 |
Accrued liabilities | 7,762 | 6,090 |
Deferred revenue | 19,143 | 14,777 |
Operating lease liability | 900 | |
Total current liabilities | 33,376 | 23,304 |
Deferred revenue, long-term | 70,734 | 67,723 |
Operating lease liability, long-term | 7,608 | |
Warrant liability | 29,442 | 40,483 |
Total liabilities | 141,160 | 131,510 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 100 shares authorized; none outstanding | ||
Common stock, $0.00000002 par value; 226,000 shares authorized; 112,528 and 111,514 shares issued and outstanding at December 31, 2020 and June 30, 2020, respectively | ||
Additional paid-in capital | 367,055 | 355,452 |
Accumulated deficit | (322,093) | (277,234) |
Total stockholders' equity | 44,962 | 78,218 |
Total liabilities and stockholders' equity | $ 186,122 | $ 209,728 |
CONDENSED BALANCE SHEETS (paren
CONDENSED BALANCE SHEETS (parenthetical) - $ / shares shares in Thousands | Mar. 31, 2021 | Jun. 30, 2020 |
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 | 112,592 | 111,514 |
Common stock, shares outstanding | 112,592 | 111,514 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue | $ 2,418 | $ 1,244 | $ 15,419 | $ 3,409 |
Operating expenses: | ||||
Cost of revenue | 405 | 860 | 1,408 | 2,189 |
Research and development | 17,884 | 8,963 | 53,104 | 26,206 |
General and administrative | 6,215 | 3,864 | 17,780 | 12,189 |
Total operating expenses | 24,504 | 13,687 | 72,292 | 40,584 |
Loss from operations | (22,086) | (12,443) | (56,873) | (37,175) |
Other income (expense): | ||||
Change in fair value of warrant liability | (9,272) | 7,732 | 11,035 | 8,562 |
Interest and dividend income | 58 | 382 | 497 | 1,074 |
Other income (expense) | (13) | 0 | 482 | (1) |
Net loss | (31,313) | (4,329) | (44,859) | (27,540) |
Net loss: | ||||
Basic | (31,313) | (4,329) | (44,859) | (27,540) |
Diluted | $ (31,313) | $ (4,329) | $ (65,166) | $ (27,540) |
Net loss per share: | ||||
Basic | $ (0.28) | $ (0.04) | $ (0.40) | $ (0.32) |
Diluted | $ (0.28) | $ (0.04) | $ (0.57) | $ (0.32) |
Shares used in computing net loss per share: | ||||
Basic | 112,557 | 105,999 | 112,505 | 85,995 |
Diluted | 112,557 | 105,999 | 113,991 | 85,995 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Shares | Additional paid in capital | Accumulated Deficit |
Beginning Balance at Jun. 30, 2019 | $ 47,930 | $ 73,545 | $ 279,148 | $ (231,218) |
Net loss | (2,994) | (2,994) | ||
Issuance of common stock, net | 159 | 64 | 159 | |
Exercise of stock options | 72 | 46 | 72 | |
Share-based compensation expense | 2,113 | 2,113 | ||
Ending Balance at Sep. 30, 2019 | 47,280 | 73,655 | 281,492 | (234,212) |
Beginning Balance at Jun. 30, 2019 | 47,930 | 73,545 | 279,148 | (231,218) |
Net loss | (27,540) | |||
Ending Balance at Mar. 31, 2020 | 74,498 | 105,999 | 333,256 | (258,758) |
Beginning Balance at Sep. 30, 2019 | 47,280 | 73,655 | 281,492 | (234,212) |
Net loss | (20,217) | (20,217) | ||
Issuance of common stock, net | 48,451 | 32,344 | 48,451 | |
Share-based compensation expense | 1,771 | 1,771 | ||
Ending Balance at Dec. 31, 2019 | 77,285 | 105,999 | 331,714 | (254,429) |
Net loss | (4,329) | (4,329) | ||
Issuance of common stock, net | (8) | 0 | (8) | |
Share-based compensation expense | 1,550 | 1,550 | ||
Ending Balance at Mar. 31, 2020 | 74,498 | 105,999 | 333,256 | (258,758) |
Beginning Balance at Jun. 30, 2020 | 78,218 | 111,514 | 355,452 | (277,234) |
Net loss | (2,092) | (2,092) | ||
Issuance of common stock, net | 3,136 | 958 | 3,136 | |
Exercise of stock options | 124 | 50 | 124 | |
Share-based compensation expense | 2,942 | 2,942 | ||
Ending Balance at Sep. 30, 2020 | 82,328 | 112,522 | 361,654 | (279,326) |
Beginning Balance at Jun. 30, 2020 | 78,218 | 111,514 | 355,452 | (277,234) |
Net loss | (44,859) | |||
Ending Balance at Mar. 31, 2021 | 44,962 | 112,592 | 367,055 | (322,093) |
Beginning Balance at Sep. 30, 2020 | 82,328 | 112,522 | 361,654 | (279,326) |
Net loss | (11,454) | (11,454) | ||
Exercise of stock options | 15 | 6 | 15 | |
Share-based compensation expense | 2,609 | 2,609 | ||
Ending Balance at Dec. 31, 2020 | 73,498 | 112,528 | 364,278 | (290,780) |
Net loss | (31,313) | (31,313) | ||
Exercise of warrants | 6 | 1 | 6 | |
Exercise of stock options | 126 | 63 | 126 | |
Share-based compensation expense | 2,645 | 2,645 | ||
Ending Balance at Mar. 31, 2021 | $ 44,962 | $ 112,592 | $ 367,055 | $ (322,093) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (44,859) | $ (27,540) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in fair value of warrant liability | (11,035) | (8,562) |
Share-based compensation | 8,196 | 5,434 |
Depreciation and amortization | 215 | 90 |
Non-cash lease expense | 697 | |
Changes in operating assets and liabilities: | ||
Receivable for foreign tax withholding | 20,420 | |
Prepaid expenses and other current assets | (6,343) | (169) |
Accounts payable | 3,134 | (2,295) |
Accrued liabilities | 1,672 | 667 |
Deferred revenue | 7,377 | (2,479) |
Operating lease liability | (181) | |
Net cash used in operating activities | (20,707) | (34,854) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (700) | (785) |
Purchases of short-term investments | (325,162) | (90,324) |
Proceeds from maturity of short-term investments | 340,582 | 69,863 |
Net cash used in investing activities | 14,720 | (21,246) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 265 | 72 |
Proceeds from issuance of common stock, net | 3,136 | 48,602 |
Collection of common stock proceeds receivable | 5,274 | |
Net cash provided by financing activities | 3,401 | 53,948 |
Net decrease in cash and cash equivalents | (2,586) | (2,152) |
Cash and cash equivalents at beginning of the period | 12,331 | 9,590 |
Cash and cash equivalents at end of the period | 9,745 | 7,438 |
Supplemental disclosures: | ||
Income taxes paid | (8) | $ (1) |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | 8,689 | |
Warrants issued pursuant to cashless exercise | $ 6 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 9 Months Ended |
Mar. 31, 2021 | |
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), 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, Liquidity We have accumulated losses of $322.1 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of March 31, 2021, we had $164.6 million in cash and cash equivalents and short-term investments. We believe that these resources will be sufficient to meet our obligations and fund our liquidity and capital expenditure requirements for at least the next 12 months from the issuance of these financial statements. Our current business operations are focused on continuing the clinical development of our drug candidates. Changes to our research and development plans or other changes affecting our operating expenses may affect actual future use of existing cash resources. Our research and development expenses are expected to increase in the foreseeable future. We cannot determine with certainty costs associated with ongoing and future clinical trials or the regulatory approval process. The duration, costs and timing associated with the development of our product candidates will depend on a variety of factors, including uncertainties associated with the results of our clinical trials. 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, debt financing, 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. Basis of Presentation The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q S-X. The accompanying unaudited financial statements should be read in conjunction with the audited financial statements and notes thereto as of and for the fiscal year ended June 30, 2020, included in our Annual Report on Form 10-K Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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. Revenue Recognition ASC Topic 606, Revenue from Contracts with Customers (“Topic 606”) 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 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 or usage-based royalty revenue from license agreements . We recognized revenue associated with the following license agreements (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 KKC License Agreements $ 2,321 $ 812 $ 14,979 $ 2,282 Helsinn License Agreement 97 432 440 1,127 $ 2,418 $ 1,244 $ 15,419 $ 3,409 Timing of Revenue Recognition: Services performed over time $ 2,418 $ 1,244 $ 15,419 $ 3,409 $ 2,418 $ 1,244 $ 15,419 $ 3,409 The KKC Commercialization Agreement and KKC Japan License Agreement (Note 3) include other distinct performance obligations that will be satisfied over time, and accordingly we recognized $2.3 million and $0.8 million related to our progress toward satisfying those obligations during the three months ended March 31, 2021 and 2020, respectively, and $15.0 million and $2.3 million during the nine months ended March 31, 2021 and 2020, respectively. Based on the characteristics of the Helsinn License Agreement (Note 3), 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 $0.1 million and $0.4 million related to our progress toward satisfying those obligations during the three months ended March 31, 2021 and 2020, respectively, and $0.4 million and $1.1 million during the nine months ended March 31, 2021 and 2020, respectively. 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 nine months ended March 31, 2021 and 2020 (in thousands): Nine Months Ended 2021 2020 Receivables Receivables, beginning of period $ 2,605 $ — Amounts billed 15,744 1,088 Payments received (18,349 ) (1,014 ) Receivables, end of period $ — $ 74 Contract assets Contract assets, beginning of period $ 335 $ 511 Billable amounts 22,841 930 Amounts billed (15,744 ) (1,088 ) Contract assets, end of period $ 7,432 $ 353 Contract liabilities Contract liabilities, beginning of period $ 82,497 $ 7,771 Net change 7,380 (2,479 ) Contract liabilities, end of period $ 89,877 $ 5,292 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 Condensed 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 Condensed Balance Sheet relate to the KKC Agreements and Helsinn License Agreement . As of March 31, 2021, we had $7.4 million of contract assets related to our remaining performance obligations under the KKC Commercialization Agreement and no contract assets related to the Helsinn License Agreement as the remaining performance obligations have been completed. During the nine months ended March 31, 2021, contract assets increased by $22.8 million, primarily due the recognition of revenue related to the satisfaction or partial satisfaction of performance obligations for which we had not yet billed KKC or Helsinn, partially offset by billings of $15.7 million to KKC and Helsinn. As of March 31, 2021, we had $89.9 million of deferred revenue associated with our remaining performance obligations under the KKC Commercialization Agreement, of which $64.5 million relates to the U.S. License which is a unit of account under the scope of Topic 808 and is not a deliverable under Topic 606, and $25.4 million relates to the Ex-U.S. decreased Revenues from Collaborators We earn revenue in connection with collaboration agreements, which are described in Note 3, License Agreements, and Note 4, BeiGene Collaboration. At contract inception, we assess whether the collaboration arrangements are within the scope of ASC Topic 808, Collaborative Arrangements 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 Condensed 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. 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 March 31, 2021 and 2020, 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. There have been no material changes in our unrecognized tax benefits since June 30, 2020, and, as such, the disclosures included in our 2020 Annual Report continue to be relevant for the nine months ended March 31, 2021. Leases Effective July 1, 2019, we adopted FASB ASC Topic 842, Leases right-of-use right-of-use Rent expense for operating leases is recognized on a straight-line basis over the lease term based on the total lease payments. We have elected the practical expedient to not separate lease and non-lease non-lease |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Mar. 31, 2021 | |
Fair Value Measurements | Note 2. 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): March 31, 2021 June 30, 2020 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant liability $ — $ — $ (29,442 ) $ — $ — $ (40,483 ) Total $ — $ — $ (29,442 ) $ — $ — $ (40,483 ) 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 Condensed 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 Condensed 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 Condensed Statement of Operations for the three and nine months ended March 31, 2021 and 2020, respectively. To calculate the fair value of the warrant liability, the following assumptions were used: March 31, June 30, Risk-free interest rate 0.1 % 0.2 % Expected life (years) 2.1 2.9 Expected volatility 82.4 % 77.4 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ 1.83 $ 2.52 The following table sets forth a summary of changes in the estimated fair value of our Level 3 warrant liability for the nine months ended March 31, 2021 and 2020 (in thousands): Fair Value of Warrants Using Significant 2021 2020 Balance at July 1, $ (40,483 ) $ (17,613 ) Reclassification of derivative liability to equity upon exercise of warrants 6 — Change in estimated fair value of liability classified warrants 11,035 830 Balance at March 31, $ (29,442 ) $ (16,783 ) |
License Agreements
License Agreements | 9 Months Ended |
Mar. 31, 2021 | |
License Agreements | Note 3. License Agreements KKC License, Development and Commercialization Agreement In April 2020, we entered into the License, Development and Commercialization Agreement (the “KKC Commercialization Agreement”) with Kyowa Kirin Company (“KKC”). Under the 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. 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, at the time of our initial assessment, 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 (as defined below). During the nine months ended March 31, 2021, we updated our initial assessment to reflect estimated development cost-sharing of $94.9 million. We included the amount of estimated variable consideration that is not constrained for development cost-sharing in the transaction price. Any variable consideration related to sales-based royalties and commercial milestones related to licenses of intellectual property will be 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 re-evaluate We allocated the 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. Ex-U.S. non-current non-ASC 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. Helsinn License Agreement In August 2016, we 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”), myelodysplastic 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 nine months ended March 31, 2021, our only remaining performance obligation under the agreement was 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. As of March 31, 2021, our performance obligations related to the Helsinn License Agreement have been met, and no future revenue or costs of revenue will be recognized. Presage License Agreement In September 2017, we entered into a license agreement with Presage Biosciences, Inc. (“Presage”). Under the terms of such license agreement (the “Presage 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 are party to a license agreement with CyDex Pharmaceuticals, Inc. (“CyDex”). Under the license agreement, CyDex granted to us an exclusive, nontransferable license to intellectual property rights relating to Captisol ® ME-344). non-refundable |
BeiGene Collaboration
BeiGene Collaboration | 9 Months Ended |
Mar. 31, 2021 | |
BeiGene Collaboration | Note 4. 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 (marketed as Brukinsa ® B-cell B-cell |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Mar. 31, 2021 | |
Net Loss Per Share | Note 5. 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 three and nine months ended March 31, 2021 and 2020. Diluted net loss per share is computed based on the sum of the weighted average number of common shares and potentially dilutive common shares outstanding during the period. The following table presents the calculation of net loss used to calculate basic loss and diluted loss per share (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Net loss – basic $ (31,313 ) $ (4,329 ) $ (44,859 ) $ (27,540 ) Change in fair value of warrant liability — — (20,307 ) — Net loss – diluted $ (31,313 ) $ (4,329 ) $ (65,166 ) $ (27,540 ) Share used in calculating net loss per share was determined as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Weighted average shares used in calculating basic net loss per share 112,557 105,999 112,505 85,995 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — — 1,486 — Weighted average shares used in calculating diluted net loss per share 112,557 105,999 113,991 85,995 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 following table presents weighted-average potentially dilutive shares that have been excluded from the calculation of net loss per share because of their anti-dilutive effect (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Stock options 16,161 11,064 15,618 10,974 Restricted stock units 430 — 430 — Warrants 16,060 16,062 5,354 16,062 Total anti-dilutive shares 32,651 27,126 21,402 27,036 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies | Note 6. 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 3, 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 March 31, 2021, we have not accrued any amounts for potential future payments as achievement of the milestones has not been met. 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 $74.5 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. As of March 31, 2021, we have not accrued any amounts for potential future payments as achievement of the milestones has not been met. CyDex License Agreement As discussed in Note 3, 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 March 31, 2021, 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 originating in Wuhan, China (the “COVID-19 COVID-19 COVID-19 mid-2020, COVID-19 re-imposition COVID-19, COVID-19 COVID-19, CARES Act On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was signed into law. 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. There is substantial uncertainty with respect to the scope, content or timing of any further economic stimulus programs to address the economic downturn related to the COVID-19 Legal Proceedings On August 10, 2020, Guy Bahat, an individual who allegedly purchased 50 shares of our common stock filed a putative securities class action lawsuit (the “Securities Class Action”) in the United States District Court for the Southern District of California against the Company, Dr. Daniel P. Gold, and Mr. Brian G. Drazba, asserting claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 On October 21, 2020, Peter D’Arcy, an individual who alleges that he is a Company stockholder, filed a putative stockholder derivative action nominally on behalf of the Company in the United States District Court for the District of Delaware (the “Derivative Action”) against Dr. Gold, Mr. Drazba, Mr. Charles V. Baltic, III, Dr. Kevan E. Clemens, Mr. Frederick W. Driscoll, Dr. Nicholas R. Glover, Ms. Tamar D. Howson, Dr. Thomas C. Reynolds, Mr. William D. Rueckert, and Dr. Christine A. White, and naming the Company as a nominal defendant. Additional putative stockholder derivative suits were filed in the same court naming the same defendants plus Dr. Robert D. Mass on December 2, 2020 and December 15, 2020 by Gerald Wright and William Trablicy, respectively, who also allege that they are Company stockholders, and these additional suits were consolidated into the Derivative Action by court order. The Derivative Action is based upon the pracinostat-related allegations in the Securities Class Action described above, and alleges claims under Section 14(a) of the Exchange Act and claims for breach of fiduciary duty, unjust enrichment, corporate waste, and contribution. On February 24, 2021, following the resolution of the class action litigation, the parties stipulated request for voluntary dismissal without prejudice, which the court granted on February 25, 2021. |
Leases
Leases | 9 Months Ended |
Mar. 31, 2021 | |
Disclosure Text Block [Abstract] | |
Leases | Note 7. Leases In December 2019, we entered into a lease agreement for approximately 32,800 square feet of office space in San Diego, California. We have accounted for the lease as an operating lease. The contractual lease term began in July 2020 and is scheduled to expire in March 2028. The lease contains an option to renew and extend the lease terms. We have not included the lease extension within the ROU asset and lease liability on the balance sheet as it is not reasonably certain to be exercised. The lease includes variable non-lease The total operating lease costs were as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Operating lease cost $ 377 $ 201 $ 1,130 $ 603 Supplemental cash flow information related to our operating leases were as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 369 $ 201 $ 615 $ 603 Right-of-use — — 8,689 — The following is a schedule of the future minimum rental payments for our operating lease, reconciled to the lease liability as of March 31, 2021 (in thousands): March 31, Remainder of fiscal year ending June 30, 2021 $ 368 Years ending June 30, 2022 1,519 2023 1,565 2024 1,612 2025 1,168 2026 1,710 Thereafter 3,122 Total lease payments 11,064 Less: Present value discount (2,556 ) Total operating lease liability $ 8,508 Balance Sheet Classification – Operating Lease Operating lease liability $ 900 Operating lease liability, long-term 7,608 Total operating lease liability $ 8,508 Other Balance Sheet Information – Operating Lease Weighted average remaining lease term (in years) 7.0 Weighted average discount rate 7.50 % |
Short-Term Investments
Short-Term Investments | 9 Months Ended |
Mar. 31, 2021 | |
Short-Term Investments | Note 8. Short-Term Investments As of March 31, 2021 and June 30, 2020, our short-term investments consisted of $154.9 million and $170.3 million, respectively, in U.S. government securities. The short-term investments held as of March 31, 2021 and June 30, 2020 had maturity dates of less than one year, are considered to be “held to maturity” and are carried at amortized cost. As of March 31, 2021 and June 30, 2020, the gross holding gains and losses were immaterial. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Mar. 31, 2021 | |
Stockholders' Equity | Note 9. Stockholders’ Equity Equity Transactions At-The-Market On November 10, 2020, we entered into an At-The-Market At-The-Market 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. As of March 31, 2021, there is $175.7 million aggregate value of securities available under the shelf registration statement, including up to $60.0 million remaining available under the 2020 ATM Sales Agreement. Warrants As of March 31, 2021, we have outstanding warrants to purchase 16,058,985 shares of our common stock. The warrants are fully vested, exercisable at a price of $2.54 per share and expire in May 2023. 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 Condensed Balance Sheet. Therefore, we are required to account for the warrants as liabilities and record them at fair value. The warrants were revalued as of March 31, 2021 at $29.4 million and as of June 30, 2020 at $40.5 million; the changes in fair value were recorded in our Condensed Statement of Operations. During the nine months ended March 31, 2021, a warrant holder completed a cashless exercise of 2,617 warrants for 964 shares of common stock. No warrants were exercised during the nine months ended March 31, 2020. |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Mar. 31, 2021 | |
Share-based Compensation | Note 10. 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, 2018 and 2020, under which 29,014,794 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): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development $ 1,207 $ 696 $ 3,496 $ 2,220 General and administrative 1,438 854 4,700 3,214 Total share-based compensation $ 2,645 $ 1,550 $ 8,196 $ 5,434 Stock Options Stock option activity for the nine months ended March 31, 2021 was as follows: Number of Weighted- Weighted-Average Aggregate Outstanding at June 30, 2020 11,252,976 $ 2.81 Granted 5,763,300 3.40 Exercised (119,042 ) 2.22 Forfeited / Cancelled (223,828 ) 3.65 Outstanding at March 31, 2021 16,673,406 3.01 7.9 $ 9,775,096 Vested and exercisable at March 31, 2021 7,802,361 2.74 6.7 $ 7,006,856 The fair value of each stock option granted during the nine months ended March 31, 2021 is estimated on the grant date under the fair value method using a Black-Scholes valuation model. Stock options granted to employees during the nine months ended March 31, 2021 vest 25% one year from the date of grant and ratably each month thereafter for a period of 36 months and expire ten years from the date of grant. Stock options granted to directors during the nine months ended March 31, 2021 vest ratably each month for a period of 12 months from the date of grant and expire ten years from the date of grant. The estimated fair values of the stock options, including the effect of estimated forfeitures, are expensed over the service period. The following weighted-average assumptions were used to determine the fair value of options granted during the period: Nine Months Ended 2021 2020 Risk-free interest rate 0.5 % 1.8 % Expected life (years) 6.0 6.0 Expected volatility 81.1 % 73.6 % Dividend yield 0.0 % 0.0 % Weighted-average grant date fair value $ 2.32 $ 1.60 As of March 31, 2021, there was $10.2 million of unrecognized compensation expense related to the unvested portion of stock options. Such compensation expense is expected to be recognized over a weighted-average period of 1.7 years. Restricted Stock Units In July 2020, we granted 442,650 RSUs to employees. Each RSU represented the contingent right to receive one share of our common stock. The RSUs will vest in periods of either one year or two years from the date of grant. The fair value of the RSUs was measured at $3.49 per unit. Under the terms of the 2008 Plan, each of the RSUs is calculated as 1.25 shares of common stock for purposes of determining the number of shares available for future grant. There were forfeitures of 12,000 RSUs during the nine months ended March 31, 2021, and 430,650 unvested RSUs were outstanding as of March 31, 2021. As of March 31, 2021, unrecognized compensation expense related to the unvested portion of our RSUs was approximately $0.8 million and is expected to be recognized over approximately 1.1 years. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Mar. 31, 2021 | |
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, |
Liquidity | Liquidity We have accumulated losses of $322.1 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of March 31, 2021, we had $164.6 million in cash and cash equivalents and short-term investments. We believe that these resources will be sufficient to meet our obligations and fund our liquidity and capital expenditure requirements for at least the next 12 months from the issuance of these financial statements. Our current business operations are focused on continuing the clinical development of our drug candidates. Changes to our research and development plans or other changes affecting our operating expenses may affect actual future use of existing cash resources. Our research and development expenses are expected to increase in the foreseeable future. We cannot determine with certainty costs associated with ongoing and future clinical trials or the regulatory approval process. The duration, costs and timing associated with the development of our product candidates will depend on a variety of factors, including uncertainties associated with the results of our clinical trials. 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, debt financing, 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. |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q S-X. The accompanying unaudited financial statements should be read in conjunction with the audited financial statements and notes thereto as of and for the fiscal year ended June 30, 2020, included in our Annual Report on Form 10-K |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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. |
Revenue Recognition | Revenue Recognition ASC Topic 606, Revenue from Contracts with Customers (“Topic 606”) 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 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 or usage-based royalty revenue from license agreements. We recognized revenue associated with the following license agreements (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 KKC License Agreements $ 2,321 $ 812 $ 14,979 $ 2,282 Helsinn License Agreement 97 432 440 1,127 $ 2,418 $ 1,244 $ 15,419 $ 3,409 Timing of Revenue Recognition: Services performed over tim e $ 2,418 $ 1,244 $ 15,419 $ 3,409 $ 2,418 $ 1,244 $ 15,419 $ 3,409 The KKC Commercialization Agreement and KKC Japan License Agreement (Note 3) include other distinct performance obligations that will be satisfied over time, and accordingly we recognized $2.3 million and $0.8 million related to our progress toward satisfying those obligations during the three months ended March 31, 2021 and 2020, respectively, and $15.0 million and $2.3 million during the nine months ended March 31, 2021 and 2020, respectively. Based on the characteristics of the Helsinn License Agreement (Note 3), 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 $0.1 million and $0.4 million related to our progress toward satisfying those obligations during the three months ended March 31, 2021 and 2020, respectively, and $0.4 million and $1.1 million during the nine months ended March 31, 2021 and 2020, respectively. 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 nine months ended March 31, 2021 and 2020 (in thousands): Nine Months Ended 2021 2020 Receivables Receivables, beginning of period $ 2,605 $ — Amounts billed 15,744 1,088 Payments received (18,349 ) (1,014 ) Receivables, end of period $ — $ 74 Contract assets Contract assets, beginning of period $ 335 $ 511 Billable amounts 22,841 930 Amounts billed (15,744 ) (1,088 ) Contract assets, end of period $ 7,432 $ 353 Contract liabilities Contract liabilities, beginning of period $ 82,497 $ 7,771 Net change 7,380 (2,479 ) Contract liabilities, end of period $ 89,877 $ 5,292 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 Condensed 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 Condensed Balance Sheet relate to the KKC Agreements and Helsinn License Agreement. As of March 31, 2021, we had $ 7.4 As of March 31, 2021, we had $89.9 million of deferred revenue associated with our remaining performance obligations under the KKC Commercialization Agreement, of which $64.5 million relates to the U.S. License which is a unit of account under the scope of Topic 808 and is not a deliverable under Topic 606, and $25.4 million relates to the Ex-U.S. 2.1 Revenues from Collaborators We earn revenue in connection with collaboration agreements, which are described in Note 3, License Agreements, and Note 4, BeiGene Collaboration. At contract inception, we assess whether the collaboration arrangements are within the scope of ASC Topic 808, Collaborative Arrangements 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 Condensed 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. |
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 March 31, 2021 and 2020, 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. There have been no material changes in our unrecognized tax benefits since June 30, 2020, and, as such, the disclosures included in our 2020 Annual Report continue to be relevant for the nine months ended March 31, 2021. |
Leases | Leases Effective July 1, 2019, we adopted FASB ASC Topic 842, Leases right-of-use right-of-use Rent expense for operating leases is recognized on a straight-line basis over the lease term based on the total lease payments. We have elected the practical expedient to not separate lease and non-lease non-lease |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Mar. 31, 2021 | |
Schedule Of Revenue Associated With License Agreement | We recognized revenue associated with the following license agreements (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 KKC License Agreements $ 2,321 $ 812 $ 14,979 $ 2,282 Helsinn License Agreement 97 432 440 1,127 $ 2,418 $ 1,244 $ 15,419 $ 3,409 Timing of Revenue Recognition: Services performed over tim e $ 2,418 $ 1,244 $ 15,419 $ 3,409 $ 2,418 $ 1,244 $ 15,419 $ 3,409 |
Schedule of Changes in Contract Assets and Contract Liabilities | The following table presents changes in contract assets and contract liabilities during the nine months ended March 31, 2021 and 2020 (in thousands): Nine Months Ended 2021 2020 Receivables Receivables, beginning of period $ 2,605 $ — Amounts billed 15,744 1,088 Payments received (18,349 ) (1,014 ) Receivables, end of period $ — $ 74 Contract assets Contract assets, beginning of period $ 335 $ 511 Billable amounts 22,841 930 Amounts billed (15,744 ) (1,088 ) Contract assets, end of period $ 7,432 $ 353 Contract liabilities Contract liabilities, beginning of period $ 82,497 $ 7,771 Net change 7,380 (2,479 ) Contract liabilities, end of period $ 89,877 $ 5,292 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Mar. 31, 2021 | |
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): March 31, 2021 June 30, 2020 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant liability $ — $ — $ (29,442 ) $ — $ — $ (40,483 ) Total $ — $ — $ (29,442 ) $ — $ — $ (40,483 ) |
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: March 31, June 30, Risk-free interest rate 0.1 % 0.2 % Expected life (years) 2.1 2.9 Expected volatility 82.4 % 77.4 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ 1.83 $ 2.52 |
Schedule of Changes in Estimated Fair Value of Warrant Liability | The following table sets forth a summary of changes in the estimated fair value of our Level 3 warrant liability for the nine months ended March 31, 2021 and 2020 (in thousands): Fair Value of Warrants Using Significant 2021 2020 Balance at July 1, $ (40,483 ) $ (17,613 ) Reclassification of derivative liability to equity upon exercise of warrants 6 — Change in estimated fair value of liability classified warrants 11,035 830 Balance at March 31, $ (29,442 ) $ (16,783 ) |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Mar. 31, 2021 | |
Schedule of Income (Loss) Per Share, Basic and Diluted | The following table presents the calculation of net loss used to calculate basic loss and diluted loss per share (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Net loss – basic $ (31,313 ) $ (4,329 ) $ (44,859 ) $ (27,540 ) Change in fair value of warrant liability — — (20,307 ) — Net loss – diluted $ (31,313 ) $ (4,329 ) $ (65,166 ) $ (27,540 ) |
Calculation of Weighted Average Shares Used to Calculate Basic and Diluted (Loss) Earnings Per Share | Share used in calculating net loss per share was determined as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Weighted average shares used in calculating basic net loss per share 112,557 105,999 112,505 85,995 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — — 1,486 — Weighted average shares used in calculating diluted net loss per share 112,557 105,999 113,991 85,995 |
Antidilutive Securities | The following table presents weighted-average potentially dilutive shares that have been excluded from the calculation of net loss per share because of their anti-dilutive effect (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Stock options 16,161 11,064 15,618 10,974 Restricted stock units 430 — 430 — Warrants 16,060 16,062 5,354 16,062 Total anti-dilutive shares 32,651 27,126 21,402 27,036 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Mar. 31, 2021 | |
Disclosure Text Block [Abstract] | |
Schedule of Total Operating Costs | The total operating lease costs were as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Operating lease cost $ 377 $ 201 $ 1,130 $ 603 |
Schedule of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to our operating leases were as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 369 $ 201 $ 615 $ 603 Right-of-use — — 8,689 — |
Schedule of Future Minimum Rental Payments | The following is a schedule of the future minimum rental payments for our operating lease, reconciled to the lease liability as of March 31, 2021 (in thousands): March 31, Remainder of fiscal year ending June 30, 2021 $ 368 Years ending June 30, 2022 1,519 2023 1,565 2024 1,612 2025 1,168 2026 1,710 Thereafter 3,122 Total lease payments 11,064 Less: Present value discount (2,556 ) Total operating lease liability $ 8,508 Balance Sheet Classification – Operating Lease Operating lease liability $ 900 Operating lease liability, long-term 7,608 Total operating lease liability $ 8,508 Other Balance Sheet Information – Operating Lease Weighted average remaining lease term (in years) 7.0 Weighted average discount rate 7.50 % |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Mar. 31, 2021 | |
Share-Based Compensation Expense for Stock Awards | Total share-based compensation expense for all stock awards consists of the following (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development $ 1,207 $ 696 $ 3,496 $ 2,220 General and administrative 1,438 854 4,700 3,214 Total share-based compensation $ 2,645 $ 1,550 $ 8,196 $ 5,434 |
Summary of Stock Option Activity and Related Data | Stock option activity for the nine months ended March 31, 2021 was as follows: Number of Weighted- Weighted-Average Aggregate Outstanding at June 30, 2020 11,252,976 $ 2.81 Granted 5,763,300 3.40 Exercised (119,042 ) 2.22 Forfeited / Cancelled (223,828 ) 3.65 Outstanding at March 31, 2021 16,673,406 3.01 7.9 $ 9,775,096 Vested and exercisable at March 31, 2021 7,802,361 2.74 6.7 $ 7,006,856 |
Fair Value of Stock Options Weighted-Average Assumptions Used | The following weighted-average assumptions were used to determine the fair value of options granted during the period: Nine Months Ended 2021 2020 Risk-free interest rate 0.5 % 1.8 % Expected life (years) 6.0 6.0 Expected volatility 81.1 % 73.6 % Dividend yield 0.0 % 0.0 % Weighted-average grant date fair value $ 2.32 $ 1.60 |
The Company and Summary of Si_4
The Company and Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) | Mar. 31, 2021USD ($)ClinicalTrials | Mar. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | |
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Number of clinical stage candidates | ClinicalTrials | 4 | |||||
Deferred Revenue Associated With Remaining Performance Obligation | $ 89,900,000 | $ 89,900,000 | ||||
Unrecognized tax benefits | 0 | 0 | $ 0 | |||
Revenue Recognised With Performance Obligation | 2,300,000 | $ 800,000 | 15,000,000 | $ 2,300,000 | ||
Accumulated Losses Since Inception | (322,093,000) | (322,093,000) | (277,234,000) | |||
Cash And Cash Equivalents,Short Term Investments And Common Stock Proceeds Receivable | 164,600,000 | 164,600,000 | ||||
Contract assets, Current | 7,432,000 | 353,000 | 7,432,000 | 353,000 | $ 335,000 | $ 511,000 |
Increase (Decrease) in Deferred Revenue | (2,100,000) | 7,377,000 | (2,479,000) | |||
US License | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Deferred Revenue Associated With Remaining Performance Obligation | 64,500,000 | 64,500,000 | ||||
Ex US License | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Deferred Revenue Associated With Remaining Performance Obligation | 25,400,000 | 25,400,000 | ||||
Helsinn License Agreement | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Deferred Revenue, Revenue Recognized | 100,000 | 400,000 | 400,000 | 1,100,000 | ||
KKC Commercialization Agreement And The Helsinn License Agreement | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Contract assets, Current | 7,400,000 | 7,400,000 | ||||
Increase in contract assets | 22,800,000 | |||||
KKC Agreements and Helsinn License Agreement | ||||||
Targeted or Tracking Stock, Stock [Line Items] | ||||||
Contract with Customer, Liability, Revenue Recognized | $ 2,400,000 | $ 800,000 | $ 15,400,000 | $ 2,600,000 |
The Company - Revenue Associate
The Company - Revenue Associated With The Following license agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | $ 2,418 | $ 1,244 | $ 15,419 | $ 3,409 |
KKC License Agreement [Member] | ||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | 2,321 | 812 | 14,979 | 2,282 |
Helsinn License Agreement [Member] | ||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | 97 | 432 | 440 | 1,127 |
Services performed over time [Member] | ||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | $ 2,418 | $ 1,244 | $ 15,419 | $ 3,409 |
The Company - Schedule of Chang
The Company - Schedule of Changes in Contract Assets and Contract Liabilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | |
Contract with Customer Asset and Liability [Line Items] | |||
Receivables, beginning of period | $ 2,605 | ||
Amounts billed | 15,744 | 1,088 | |
Payments received | (18,349) | (1,014) | |
Receivables, end of period | $ 0 | 0 | 74 |
Contract assets, beginning of period | 335 | 511 | |
Billable amounts | 22,841 | 930 | |
Amounts billed | (15,744) | (1,088) | |
Contract assets, end of period | 7,432 | 7,432 | 353 |
Contract liabilities, beginning of period | 82,497 | 7,771 | |
Net change | (2,100) | 7,377 | (2,479) |
Contract liabilities, end of period | $ 89,877 | $ 89,877 | $ 5,292 |
Schedule of Financial Instrumen
Schedule of Financial Instruments Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Warrant liability | $ (29,442) | $ (40,483) | ||
Level 3 | Fair Value, Measurements, Recurring [Member] | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Warrant liability | (29,442) | (40,483) | $ (16,783) | $ (17,613) |
Total liability | $ (29,442) | $ (40,483) |
Schedule of Assumptions Used to
Schedule of Assumptions Used to Calculate Fair Value of Warrant Liability (Detail) - ClinicalTrials | Mar. 31, 2021 | Jun. 30, 2020 |
Risk Free Interest Rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 0.1 | 0.2 |
Expected life years | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 2.1 | 2.9 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 82.4 | 77.4 |
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 | 1.83 | 2.52 |
Schedule of Changes in Estimate
Schedule of Changes in Estimated Fair Value of Warrant Liability (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Fair value measurements Significant unobservable inputs [Line Items] | ||||
Beginning balance | $ (40,483) | |||
Change in estimated fair value of liability classified warrants | $ (9,272) | $ 7,732 | 11,035 | $ 8,562 |
Ending balance | (29,442) | (29,442) | ||
Fair Value, Measurements, Recurring [Member] | Level 3 | ||||
Fair value measurements Significant unobservable inputs [Line Items] | ||||
Beginning balance | (40,483) | (17,613) | ||
Reclassification of derivative liability to equity upon exercise of warrants | 6 | |||
Change in estimated fair value of liability classified warrants | 11,035 | 830 | ||
Ending balance | $ (29,442) | $ (16,783) | $ (29,442) | $ (16,783) |
License Agreements - Additional
License Agreements - Additional Information (Detail) | Aug. 31, 2016USD ($) | Oct. 31, 2018USD ($) | Sep. 30, 2017USD ($) | Mar. 31, 2021USD ($) | Jun. 30, 2020USD ($) | May 31, 2020USD ($) |
Related Party Transaction [Line Items] | ||||||
Percentage of Purchase Requirement | 100.00% | |||||
License and supply agreement notice period | 90 days | |||||
Profit sharing ratio | 0.5 | |||||
Receivable for foreign tax withholding | $ 20,420,000 | |||||
Kyowa Kirin Co | ||||||
Related Party Transaction [Line Items] | ||||||
Upfront payment | $ 10,000,000 | |||||
Total upfront payment receivable for grant of rights | 100,000,000 | $ 100,000,000 | ||||
Receivable for foreign tax withholding | 20,400,000 | |||||
Kyowa Kirin Co | Updation of Initial Assessment | ||||||
Related Party Transaction [Line Items] | ||||||
Estimated development cost sharing recovered through earnings | 94,900,000 | |||||
Kyowa Kirin Co | Potential Payments on Achievement of Development Regulatory and Commercial Milestones | ||||||
Related Party Transaction [Line Items] | ||||||
Total upfront payment receivable for grant of rights | $ 10,000,000 | |||||
Kyowa Kirin Co | Potential Payments on Achievement of Development Regulatory and Commercial Milestones | Maximum | ||||||
Related Party Transaction [Line Items] | ||||||
Milestone payment receivable amount | 582,500,000 | |||||
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 | |||||
KKC License Agreement | Kyowa Kirin Co | ||||||
Related Party Transaction [Line Items] | ||||||
Upfront payment | 100,000,000 | |||||
Transaction price relating to the performance obligation | 191,500,000 | |||||
Expected milestone payment receivable | 20,000,000 | |||||
Estimated development cost sharing recovered through earnings | 66,300,000 | |||||
Deferred revenue | 5,200,000 | |||||
KKC License Agreement | Kyowa Kirin Co | Ex US License | ||||||
Related Party Transaction [Line Items] | ||||||
Performance obligation revenue recognised | 21,000,000 | |||||
License Obligation Account Transaction Price Allocated | 64,500,000 | |||||
KKC License Agreement | Kyowa Kirin Co | Development Services | ||||||
Related Party Transaction [Line Items] | ||||||
Contract with customer liability non current | $ 25,400,000 | $ 18,100,000 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Common stock subject to repurchase or forfeiture | 0 | 0 | 0 | 0 |
Schedule of (Loss) Per Share, B
Schedule of (Loss) Per Share, Basic and Diluted (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Net loss - basic | $ (31,313) | $ (4,329) | $ (44,859) | $ (27,540) |
Change in fair value of warrant liability | (20,307) | |||
Net loss - diluted | $ (31,313) | $ (4,329) | $ (65,166) | $ (27,540) |
Calculation of Weighted Average
Calculation of Weighted Average Shares Used to Calculate Basic and Diluted (Loss) Earnings Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average shares used in calculating basic net loss per share | 112,557 | 105,999 | 112,505 | 85,995 |
Effect of potentially dilutive common shares from equity awards and liability-classified warrants | 1,486 | |||
Weighted average shares used in calculating diluted net loss per share | 112,557 | 105,999 | 113,991 | 85,995 |
Antidilutive Securities (Detail
Antidilutive Securities (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 32,651 | 27,126 | 21,402 | 27,036 |
Employee Stock option | ||||
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 16,161 | 11,064 | 15,618 | 10,974 |
Restricted Stock Units (RSUs) | ||||
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 430 | 430 | ||
Warrants | ||||
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 16,060 | 16,062 | 5,354 | 16,062 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 9 Months Ended |
Mar. 31, 2021USD ($) | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |
Future aggregate milestone payments | $ 74,500,000 |
Percentage of Purchase Requirement | 100.00% |
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) $ in Thousands | Dec. 01, 2019ft² | Mar. 31, 2021USD ($) |
Operating lease right of use assets | $ 8,700 | |
Operating lease liabilities | $ 8,508 | |
Accounting Standards Update 2016-02 [Member] | San Diego California [Member] | ||
Number of square feet under lease | ft² | 32,800 | |
Lease expire date | Mar. 31, 2028 |
Schedule of Total Operating Cos
Schedule of Total Operating Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Leases [Abstract] | ||||
Operating lease cost | $ 377 | $ 201 | $ 1,130 | $ 603 |
Schedule of Supplemental Cash F
Schedule of Supplemental Cash Flow Information Related to Operating Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||||
Operating cash flows from operating leases | $ 369 | $ 201 | $ 615 | $ 603 |
Right-of-use assets obtained in exchange for operating lease obligations: | $ 8,689 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Disclosure Text Block [Abstract] | |
Remainder of fiscal year ending June 30, 2021 | $ 368 |
2022 | 1,519 |
2023 | 1,565 |
2024 | 1,612 |
2025 | 1,168 |
2026 | 1,710 |
Thereafter | 3,122 |
Total lease payments | 11,064 |
Less: Present value discount | (2,556) |
Total operating lease liability | 8,508 |
Operating lease liabilities | 900 |
Operating lease liabilities, long-term | 7,608 |
Total operating lease liability | $ 8,508 |
Weighted average remaining lease term (in years) | 7 years |
Weighted average discount rate | 7.50% |
Short-Term Investments - Additi
Short-Term Investments - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Jun. 30, 2020 |
Schedule of Equity Method Investments [Line Items] | ||
Short-term investments | $ 154,879 | $ 170,299 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Mar. 31, 2021 | Nov. 10, 2020 | Jun. 30, 2020 | Nov. 08, 2017 | |
Class of Stock [Line Items] | ||||||||
Fair value of warrants | $ 29,442,000 | $ 40,483,000 | ||||||
Aggregate value of securities available under shelf registration statement | 100,000 | |||||||
Common stock Value Issued | $ 3,136,000 | $ (8,000) | $ 48,451,000 | $ 159,000 | ||||
Unsold Securities Shares and Warrants Under Agreement | 107,500,000 | |||||||
Aggregate Value of Securities Available Under Agreement | $ 175,700,000 | |||||||
Number of warrants exercised | 2,617 | |||||||
Number of shares issued on warrant exercise | 964 | |||||||
Warrant [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Exercise price | $ 2.54 | |||||||
Warrants outstanding | 16,058,985 | |||||||
ATM Sales Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock share issued | 958,083 | |||||||
Common stock Value Issued | $ 3,100,000 | |||||||
Two Thousand And Twenty At The Market Sale Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate value of securities available under shelf registration statement | 60,000,000 | |||||||
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 | |||||||
Maximum | Two Thousand And Twenty At The Market Sale Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of shares under agreement | $ 60,000,000 | $ 60,000,000 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Detail) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended |
Jul. 31, 2020shares | Mar. 31, 2021USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to unvested stock options | $ | $ 10.2 | |
Expected weighted average period for recognition of compensation expense | 1 year 8 months 12 days | |
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, expiration period | 10 years | |
Employee Stock Option | Share-based Payment Arrangement Tranche Two | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 36 months | |
Employee Stock Option | Directors | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | |
Restricted Stock Units (RSUs) | Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected weighted average period for recognition of compensation expense | 1 year 1 month 6 days | |
RSUs granted | 442,650 | |
Number of common stock to be received for each RSUs | 1 | |
RSUs grant date fair value per unit | $ / shares | $ 3.49 | |
Restricted stock units forfeiture during the period | 12,000 | |
Share based compensation by share based payment arrangement other than options unvested outstanding | 430,650 | |
Share based compensation by share based payment arrangement other than options unvested cost not yet recognised amount | $ | $ 0.8 | |
Number of shares for each unit of restricted stock | 1.25 | |
2008 Omnibus Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock authorized | 29,014,794 | |
Shares available for future grant | 10,284,365 | |
Maximum [Member] | Restricted Stock Units (RSUs) | Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 2 years | |
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 | |
Minimum [Member] | Restricted Stock Units (RSUs) | Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 1 year |
Share-Based Compensation Expens
Share-Based Compensation Expense for Stock Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 2,645 | $ 1,550 | $ 8,196 | $ 5,434 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | 1,207 | 696 | 3,496 | 2,220 |
General and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 1,438 | $ 854 | $ 4,700 | $ 3,214 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) | 9 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Number of Options | |
Beginning Balance | shares | 11,252,976 |
Granted | shares | 5,763,300 |
Exercised | shares | (119,042) |
Forfeited / Cancelled | shares | (223,828) |
Ending balance | shares | 16,673,406 |
Vested and exercisable at end of period | shares | 7,802,361 |
Weighted- Average Exercise Price | |
Beginning Balance | $ / shares | $ 2.81 |
Granted | $ / shares | 3.40 |
Exercised | $ / shares | 2.22 |
Forfeited / Cancelled | $ / shares | 3.65 |
Ending balance | $ / shares | 3.01 |
Vested and exercisable at end of period | $ / shares | $ 2.74 |
Weighted Average Remaining Contractual Term (in years) | |
Outstanding at end of period | 7 years 10 months 24 days |
Vested and exercisable at end of period | 6 years 8 months 12 days |
Aggregate Intrinsic Value | |
Outstanding at end of period | $ | $ 9,775,096 |
Vested and exercisable at end of period | $ | $ 7,006,856 |
Fair Value of Stock Options Wei
Fair Value of Stock Options Weighted-Average Assumptions Used (Detail) - $ / shares | 9 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 0.50% | 1.80% |
Expected life (years) | 6 years | 6 years |
Expected volatility | 81.10% | 73.60% |
Dividend yield | 0.00% | 0.00% |
Weighted-average grant date fair value | $ 2.32 | $ 1.60 |