Cover Page
Cover Page - shares | 9 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Securities Act File Number | 000-50484 | |
Trading Symbol | MEIP | |
Entity Registrant Name | MEI Pharma, Inc. | |
Entity Tax Identification Number | 51-0407811 | |
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 | |
City Area Code | 858 | |
Local Phone Number | 369-7100 | |
Entity Small Business | true | |
Title of 12(b) Security | Common Stock, $0.00000002 par value | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 11455 El Camino Real | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92130 | |
Entity Interactive Data Current | Yes | |
Entity Bankruptcy Proceedings, Reporting Current | true | |
Entity Common Stock, Shares Outstanding | 6,662,857 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Jun. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,812 | $ 15,740 |
Short-term investments | 103,224 | 137,512 |
Total cash, cash equivalents and short-term investments | 112,036 | 153,252 |
Unbilled receivables | 4,580 | 10,044 |
Prepaid expenses and other current assets | 3,867 | 3,830 |
Total current assets | 120,483 | 167,126 |
Operating lease right-of-use asset | 12,338 | 9,054 |
Property and equipment, net | 1,366 | 1,660 |
Total assets | 134,187 | 177,840 |
Current liabilities: | ||
Accounts payable | 4,389 | 7,918 |
Accrued liabilities | 16,264 | 10,820 |
Deferred revenue | 1,583 | 4,834 |
Operating lease liability | 1,385 | 871 |
Total current liabilities | 23,621 | 24,443 |
Deferred revenue, long-term | 64,545 | 90,610 |
Operating lease liability, long-term | 11,667 | 8,771 |
Warrant liability | 0 | 1,603 |
Total liabilities | 99,833 | 125,427 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 100 shares authorized; none outstanding | 0 | 0 |
Common stock, $0.00000002 par value; 226,000 shares authorized; 6,663 and 6,658 shares issued and outstanding at March 31, 2023 and June 30, 2022,respectively | 0 | 0 |
Additional paid-in capital | 430,322 | 426,572 |
Accumulated deficit | (395,968) | (374,159) |
Total stockholders' equity | 34,354 | 52,413 |
Total liabilities and stockholders' equity | $ 134,187 | $ 177,840 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (parenthetical) - $ / shares | Mar. 31, 2023 | Jun. 30, 2022 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 100,000 | 100,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.00 | $ 0.00 |
Common stock, shares authorized | 226,000,000 | 226,000,000 |
Common stock, shares issued | 6,663,000 | 6,658,000 |
Common stock, shares outstanding | 6,663,000 | 6,658,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue | $ 5,894 | $ 9,694 | $ 47,359 | $ 29,283 |
Operating expenses: | ||||
Research and development | 15,104 | 22,318 | 49,880 | 63,802 |
General and administrative | 7,181 | 8,934 | 23,163 | 24,769 |
Total operating expenses | 22,285 | 31,252 | 73,043 | 88,571 |
Loss from operations | (16,391) | (21,558) | (25,684) | (59,288) |
Other income (expense): | ||||
Change in fair value of warrant liability | 0 | 12,773 | 1,603 | 20,819 |
Interest and dividend income | 957 | 60 | 2,282 | 78 |
Other expense, net | (4) | 0 | (10) | 0 |
Net loss | (15,438) | (8,725) | (21,809) | (38,391) |
Net loss: | ||||
Basic | (15,438) | (8,725) | (21,809) | (38,391) |
Diluted | $ (15,438) | $ (8,725) | $ (21,809) | $ (46,437) |
Net loss per share: | ||||
Basic | $ (2.32) | $ (1.31) | $ (3.27) | $ (6.31) |
Diluted | $ (2.32) | $ (1.31) | $ (3.27) | $ (7.58) |
Shares used in computing net loss per share: | ||||
Basic | 6,663 | 6,653 | 6,663 | 6,080 |
Diluted | 6,663 | 6,653 | 6,663 | 6,124 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Shares | Additional paid in capital | Accumulated Deficit |
Beginning Balance at Jun. 30, 2021 | $ 49,466 | $ 5,631 | $ 369,171 | $ (319,705) |
Net income (loss) | (17,510) | (17,510) | ||
Issuance of common stock for vested restricted stock units | (194) | 3 | (194) | |
Share-based compensation expense | 2,539 | 2,539 | ||
Ending Balance at Sep. 30, 2021 | 34,301 | 5,634 | 371,516 | (337,215) |
Beginning Balance at Jun. 30, 2021 | 49,466 | 5,631 | 369,171 | (319,705) |
Net income (loss) | (38,391) | |||
Ending Balance at Mar. 31, 2022 | 67,806 | 6,658 | 425,902 | (358,096) |
Beginning Balance at Sep. 30, 2021 | 34,301 | 5,634 | 371,516 | (337,215) |
Net income (loss) | (12,156) | (12,156) | ||
Issuance of common stock, net | 48,653 | 1,006 | 48,653 | |
Exercise of stock options | 212 | 5 | 212 | |
Share-based compensation expense | 2,324 | 2,324 | ||
Ending Balance at Dec. 31, 2021 | 73,334 | 6,645 | 422,705 | (349,371) |
Net income (loss) | (8,725) | (8,725) | ||
Exercise of stock options | 360 | 13 | 360 | |
Share-based compensation expense | 2,837 | 2,837 | ||
Ending Balance at Mar. 31, 2022 | 67,806 | 6,658 | 425,902 | (358,096) |
Beginning Balance at Jun. 30, 2022 | 52,413 | 6,658 | 426,572 | (374,159) |
Net income (loss) | (16,624) | (16,624) | ||
Issuance of common stock for vested restricted stock units | (40) | 5 | (40) | |
Share-based compensation expense | 1,559 | 1,559 | ||
Ending Balance at Sep. 30, 2022 | 37,308 | 6,663 | 428,091 | (390,783) |
Beginning Balance at Jun. 30, 2022 | 52,413 | 6,658 | 426,572 | (374,159) |
Net income (loss) | (21,809) | |||
Ending Balance at Mar. 31, 2023 | 34,354 | 6,663 | 430,322 | (395,968) |
Beginning Balance at Sep. 30, 2022 | 37,308 | 6,663 | 428,091 | (390,783) |
Net income (loss) | 10,253 | 10,253 | ||
Share-based compensation expense | 813 | 813 | ||
Ending Balance at Dec. 31, 2022 | 48,374 | 6,663 | 428,904 | (380,530) |
Net income (loss) | (15,438) | (15,438) | ||
Issuance of warrants | 500 | 500 | ||
Share-based compensation expense | 918 | 918 | ||
Ending Balance at Mar. 31, 2023 | $ 34,354 | $ 6,663 | $ 430,322 | $ (395,968) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 3 Months Ended |
Dec. 31, 2021 USD ($) | |
Stock issuance cost | $ 3,672 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (21,809) | $ (38,391) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in fair value of warrant liability | (1,603) | (20,819) |
Share-based compensation expense | 3,290 | 7,700 |
Issuance of warrants | 500 | 0 |
Depreciation and amortization | 288 | 241 |
Non-cash lease expense | 1,063 | 636 |
Changes in operating assets and liabilities: | ||
Unbilled receivables | 5,464 | (864) |
Prepaid expenses and other current assets | (37) | (2,169) |
Accounts payable | (3,529) | 1,902 |
Accrued liabilities | 5,444 | 1,680 |
Deferred revenue | (29,316) | 17,487 |
Operating lease liability | (937) | (645) |
Net cash used in operating activities | (41,182) | (33,242) |
Cash flows from investing activities: | ||
Purchases of short-term investments | (92,098) | (218,164) |
Proceeds from maturity of short-term investments | 126,386 | 205,117 |
Proceeds from (purchases) of property and equipment | 6 | (173) |
Net cash provided by (used in) investing activities | 34,294 | (13,220) |
Cash flows from financing activities: | ||
Payment of RSU tax withholdings in exchange for common shares surrendered by RSU holders | (40) | (194) |
Proceeds from exercise of stock options | 0 | 572 |
Proceeds from issuance of common stock, gross | 0 | 52,325 |
Payment of issuance costs | 0 | (3,672) |
Net cash (used in) provided by financing activities | (40) | 49,031 |
Net (decrease) increase in cash and cash equivalents | (6,928) | 2,569 |
Cash and cash equivalents at beginning of the period | 15,740 | 8,543 |
Cash and cash equivalents at end of the period | 8,812 | 11,112 |
Supplemental disclosures: | ||
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | $ 4,347 | $ 2,386 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 9 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company and Summary of Significant Accounting Policies | Note 1. The Company and Summary of Significant Accounting Policies The Company MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma's portfolio of drug candidates includes drug candidates with differentiated or novel mechanisms of action intended to address unmet medical needs and deliver improved benefit to patients, either as standalone treatments or in combination with other therapeutic options. Our common stock is listed on the Nasdaq Capital Market under the symbol “MEIP.” In February 2023, we, Infinity Pharmaceuticals, Inc. (“Infinity”), and Meadow Merger Sub, Inc., our wholly owned subsidiary (“Merger Sub”) entered into an agreement and plan of merger (“Merger Agreement”). The Merger Agreement provides that Merger Sub will merge with and into Infinity, with Infinity being the surviving entity as a wholly-owned subsidiary of us (transaction referred to as the "Merger"). If the Merger is consummated (the "Closing"), each share of Infinity’s common stock issued and outstanding immediately prior will be automatically converted into the right to receive 0.052245 shares (the “Exchange Ratio”) of our common stock. Subject to stockholder approval and the subsequent closing of the merger, the combined company will be renamed "Kimbrx Therapeutics, Inc." and trade on the Nasdaq Stock Market under the symbol "KMBX". The combined company would be headquartered in San Diego, California. The Merger Agreement has been approved by the Boards of Directors of both companies. The Merger is subject to approvals by our and Infinity's stockholders, respectively. On April 14, 2023, we amended our Certificate of Incorporation to affect a combination of our issued and outstanding common stock at a ratio of one-for-twenty (“Reverse Stock Split”). The par value and authorized shares of our common stock were not adjusted as a result of the Reverse Stock Split. The Reverse Stock Split was effective on April 14, 2023, with a market effective date of April 17, 2023. All historical share and per share amounts have been adjusted to reflect the Reverse Stock Split for all periods presented. All stock options, restricted stock units and warrants outstanding were ratably adjusted to give effect to the Reverse Stock Split. Clinical Development Programs We build our pipeline by licensing or acquiring promising cancer agents and creating value in programs through development, commercialization and strategic partnerships, as appropriate. Our objective is to leverage the mechanisms and properties of our pipeline drug candidates to optimize the balance between efficacy and tolerability to meet the needs of patients with cancer. Our drug candidate pipeline includes: • Voruciclib, an oral cyclin-dependent kinase (“CDK”) inhibitor; • ME-344, an intravenous small molecule targeting the oxidative phosphorylation pathway; and • Zandelisib, an oral phosphatidylinositol 3-kinase delta (“PI3Kδ”) inhibitor. The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current drug candidates may not have favorable results in later studies or trials. The commercial opportunity will be reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive than our drug candidates. We will need substantial additional funds to progress the clinical trial programs for the drug candidates voruciclib and ME-344 and to develop new compounds we might license or acquire. The actual amount of funds that will be needed are determined by a number of factors, some of which are beyond our control. Negative U.S. and global economic conditions may pose challenges to our business strategy, which relies on funding from the financial markets or collaborators . Reduction in Force and Current Events In November 2022, we and Kyowa Kirin Co., Ltd. ("Kyowa Kirin") met with the U.S. Food and Drug Administration ("FDA") in a follow-up meeting to the March 2022 end of Phase 2 meeting related to zandelisib. At this meeting, the FDA provided further guidance regarding the design and statistical analysis for the COASTAL trial. Following the November meeting, the companies jointly concluded that a clinical trial consistent with the recent FDA guidance, including modification of the ongoing COASTAL trial, would likely not be feasible to complete within a time period that would support further investment or with sufficient certainty of the regulatory requirements for approval to justify continued global development efforts. As a result, we and Kyowa Kirin jointly decided to discontinue global development of zandelisib for indolent forms of non-Hodgkin lymphoma outside of Japan. The discontinuation of zandelisib development outside of Japan was a business decision based on the most recent regulatory guidance from the FDA and is not related to the zandelisib clinical data generated to date. Kyowa Kirin is continuing certain ongoing Japanese clinical trials, including the Phase 2 MIRAGE trial evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas, and will explore submitting the MIRAGE and TIDAL trials for marketing authorization in Japan. MIRAGE is a Phase 2 trial, similar in design to the global Phase 2, single-arm, TIDAL trial. In November 2022, we and Kyowa Kirin announced positive topline data from the Phase 2 MIRAGE trial. Kyowa Kirin has been evaluating whether to continue developing zandelisib in Japan and after meeting with the Pharmaceuticals and Medical Devices Agency ("PMDA") has concluded that conducting a randomized study consistent with agency guidance to support a marketing application would likely not be feasible to complete within a time period that would support further investment. As a result, in May 2023, Kyowa Kirin decided to discontinue development of zandelisib in Japan. The discontinuation of zandelisib in Japan was a business decision by Kyowa Kirin based on the most recent regulatory guidance from the PMDA and is not related to the zandelisib clinical data generated to date. In light of Kyowa Kirin’s decision to discontinue development of zandelisib in Japan, the parties intend to terminate the global license, development and commercialization agreement executed in April 2020. We and Kyowa Kirin have begun closing all ongoing zandelisib clinical studies outside of Japan, including the Phase 3 COASTAL trial, the Phase 2 TIDAL trial, and the Phase 2 CORAL trial. Depending on the achievement of certain regulatory and commercial milestones in Japan, we may be eligible for additional payments from Kyowa Kirin under the current agreement. In December 2022, we announced a plan to streamline our organization towards the continued clinical development of voruciclib and ME-344. As a result, we initiated a staggered workforce reduction, initially affecting 28 employees in December 2022 (representing approximately 27 % of our workforce) and an additional 14 employees in April 2023. In connection with the reduction in force, we incurred termination costs, which include severance, benefits, and related costs of approximately $ 2.4 million, of which $ 1.8 million was research and development expense and $ 0.6 million was general and administrative expense. Liquidity We have accumulated losses of $ 396.0 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of March 31, 2023 , we had $ 112.0 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 operations and operating expenses may affect actual future use of existing cash resources. 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 condensed consolidated financial statements include the accounts of MEI Pharma, Inc. and our wholly owned subsidiary, Meadow Merger Sub, Inc. We have eliminated all significant intercompany accounts and transactions in consolidation. The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, the accompanying financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements for the quarterly period ended March 31, 2023 should be read in conjunction with the audited financial statements and notes thereto as of and for the fiscal year ended June 30, 2022 , included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on September 8, 2022 ("2022 Annual Report"). Interim results are not necessarily indicative of results for a full year. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and disclosures made in the accompanying notes to the consolidated 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. 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. Revenue Recognition Revenues from Customers In accordance with Accounting Standards Codification ("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 fees at the inception of the arrangements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. At the inception of arrangements that include milestone payments, we use judgment to evaluate whether the milestones are probable of being achieved and we estimate the amount to include in the transaction price using the most likely method. If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of development milestones and any related constraint and, as necessary, we adjust our estimate of the overall transaction price. We may enter into arrangements that consist of multiple performance obligations. Such arrangements may include any combination of our deliverables. To the extent a contract includes multiple promised deliverables, we apply judgment to determine whether promised deliverables are capable of being distinct and are distinct in the context of the contract. If these criteria are not met, the promised deliverables are accounted for as a combined performance obligation. For arrangements with multiple distinct performance obligations, we allocate variable consideration related to our 50-50 cost share for development services directly to the associated performance obligation and then allocate the remaining consideration among the performance obligations based on their relative stand-alone selling price. Stand-alone selling price is the price at which we would sell a promised good or service separately to the customer. When not directly observable, we typically estimate 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 fees at the point in time when the license is transferred to the licensee and the licensee can use and benefit from the license. For licenses that are bundled with other distinct or combined obligations, we use judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. If the performance obligation is satisfied over time, we evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. 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 measure of progress because it best depicts the transfer of control to the customer which occurs as we incur costs. Under the cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation (an “input method” under Topic 606). We use judgment to estimate the total cost expected to complete the research and development performance obligations, which include subcontractors’ costs, labor, materials, other direct costs and an allocation of indirect costs. We evaluate these cost estimates and the progress each reporting period and, as necessary, we adjust the measure of progress and related revenue recognition. 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. In connection with our License, Development and Commercialization Agreement (the "Kyowa Kirin Commercialization Agreement") with Kyowa Kirin, we perform development services related to our 50-50 cost sharing arrangement for which revenue is recognized over time. Additionally, we perform services for Kyowa Kirin at their request, the costs of which are fully reimbursed to us. We record the reimbursement for such pass through services as revenue at 100 % of reimbursed costs, as control of the additional services for Kyowa Kirin is transferred at the time we incur such costs. The costs of these services are recognized in the Condensed Consolidated Statements of Operations as research and development expense. We recognized revenue associated with the Kyowa Kirin Commercialization Agreement for the periods presented (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue $ 5,894 $ 9,694 $ 47,359 $ 29,283 Timing of Revenue Recognition: Services performed over time $ 5,598 $ 9,694 $ 46,430 $ 26,970 Pass through services at a point in time 296 — 929 2,313 $ 5,894 $ 9,694 $ 47,359 $ 29,283 Contract Balances Accounts receivable are included in “Prepaid expenses and other current assets”, and contract liabilities are included in “Defer red revenue" and "Deferred revenue, long-term” on our Condensed Consolidated Balance Sheets. The following table presents changes in accounts receivable, unbilled receivables and contract liabilities accounted for under Topic 606 for the periods presented (in thousands): Nine Months Ended 2023 2022 Accounts receivable Accounts receivable, beginning of period $ — $ — Amounts billed 23,507 45,927 Payments received ( 23,507 ) ( 45,927 ) Accounts receivable, end of period $ — $ — Unbilled receivables Unbilled receivables, beginning of period $ 10,044 $ 7,582 Billable amounts 18,043 46,791 Amounts billed ( 23,507 ) ( 45,927 ) Unbilled receivables, end of period $ 4,580 $ 8,446 Contract liabilities Contract liabilities, beginning of period $ 30,900 $ 14,677 Payments received — 20,000 Revenue recognized ( 4,145 ) ( 2,513 ) Revenue recognized from change in estimate for performance obligations that are being closed ( 16,565 ) — Revenue recognized for performance obligations that will no longer commence ( 8,607 ) — Contract liabilities, end of period $ 1,583 $ 32,164 The timing of revenue recognition, invoicing and cash collections results in billed accounts receivable and unbilled receivables 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 unbilled receivables. We may receive advance payments from our customers before revenue is recognized, resulting in contract liabilities. The unbilled receivables and deferred revenue reported on the Condensed Consolidated Balance Sheets relate to the Kyowa Kirin Commercialization Agreement. As of March 31, 2023 and June 30, 2022 , we had $ 66.1 million and $ 95.4 million, respectively, of deferred revenue associated with the Kyowa Kirin Commercialization Agreement, of which $ 64.5 million relates to the U.S. license which is a unit of account under the scope of ASC Topic 808, Collaborative Arrangements ("Topic 808") and is not a performance obligation under Topic 606. The remaining balance of deferred revenue as of March 31, 2023 and June 30, 2022 of $ 1.6 million and $ 30.9 million, respectively, relates to the development services performance obligations which are under the scope of Topic 606. The decrease in deferred revenue comes as a result of our winding down of all zandelisib studies outside of Japan. We updated our estimated costs to complete each of the performance obligations, resulting in a higher progress towards completion based on the ratio of costs incurred to date to the total estimated costs. Additionally, during the three months ended December 31, 2022, we recognized revenue related to non-refundable payments for performance obligations that have not commenced and will no longer be initiated. Our contract liabilities accounted for under Topic 606 relate to the amount of initial upfront consideration that was allocated to the development services performance obligations. Contract liabilities are recognized over the duration of the performance obligations based on the costs incurred relative to total expected costs. Revenues from Collaborators At contract inception, we assess whether the collaboration arrangements are within the scope of Topic 808 to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed based on the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of Topic 808 that contain multiple units of account, we first determine which units of account within the arrangement are within the scope of Topic 808 and which elements are within the scope of Topic 606. For units of account within collaboration arrangements that are accounted for pursuant to Topic 808, an appropriate recognition method is determined and applied consistently, by analogy to authoritative accounting literature. For elements of collaboration arrangements that are accounted for pursuant to Topic 606, we recognize revenue as discussed above. Consideration received that does not meet the requirements to satisfy Topic 606 revenue recognition criteria is recorded as deferred revenue in the accompanying Condensed Consolidated Balance Sheets, classified as either short-term or long-term deferred revenue based on our best estimate of when such amounts will be recognized. 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 research and development for early-stage products or products that are not commercially viable and ready for use, or have no alternative future use, are charged to expense in the period incurred. Leases We account for our leases under ASC Topic 842, Leases (“Topic 842”). Leases which are identified within the scope of Topic 842 and which have a term greater than one year are recognized on our Condensed Consolidated Balance Sheets as right-of-use ("ROU") assets and lease liabilities. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected remaining lease term. The lease term includes any renewal options and termination options that we are reasonably certain to exercise. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, we use our incremental borrowing rate. The incremental borrowing rate is determined based on the rate of interest that we would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. The interest rate implicit in lease contracts to calculate the present value is typically not readily determinable. As such, significant management judgment is required to estimate the incremental borrowing rate. Operating lease 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 components for our real estate leases. Our non-lease components are primarily related to property maintenance, which varies based on future outcomes, and thus is recognized in operating lease expense when incurred. Share-Based Compensation Share-based compensation expense stock options and restricted stock units ("RSUs") granted to employees and directors is recognized in the Condensed Consolidated Statements of Operations based on estimated amounts. The cost of stock options is measured at the grant date, based on the estimated fair value of the stock option using the Black-Scholes valuation model, which incorporates various assumptions, including expected volatility, risk-free interest rate, the expected term of the award and the dividend yield on the underlying stock. Expected volatility is calculated based on the historical volatility of our stock over the expected option life and other appropriate factors. The expected option term is computed using the "simplified" method as permitted under the provisions of ASC Topic 718, Compensation - Stock Compensation . We use the simplified method to calculate the expected term of stock options and similar instruments, as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. Risk-free interest rates are calculated based on continuously compounded risk-free rates for the appropriate term. The dividend yield is assumed to be zero as we have never paid or declared any cash dividends and do not intend to do so in the foreseeable future. For RSUs, we estimate the grant date fair value using our closing stock price on the date of grant. The estimated fair value of stock options and RSUs is amortized on a straight-line basis over the requisite service period, adjusted for actual forfeitures at the time they occur. 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, 2023, 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, 2022, and, as such, the disclosures included in our 2022 Annual Report continue to be relevant for the nine months ended March 31, 2023 . Recent Accounting Pronouncement In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13, Financial Instruments–Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), as amended. The amendments in ASU 2016-13 require, among other things, financial assets measured at amortized cost basis to be presented at the net amount expected to be collected as compared to previous U.S. GAAP which delayed recognition until it was probable a loss had been incurred. The amendments in ASU 2016-13 are effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, with early adoption permitted. We are currently evaluating the impact that adoption of ASU 2016-13 will have on our financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 2. Fair Value Measurements 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 and short-term investments are measured at fair value on a recurring basis and 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 us and, as a result, the warrants are required to be measured at fair value and reported as a liability in the Condensed Consolidated 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 Consolidated 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 Consolidated Statements of Operations for the three and nine months ended March 31, 2023 and 2022, respectively. To calculate the fair value of the warrant liability, the following assumptions were used for the periods presented: March 31, June 30, Risk-free interest rate 4.6 % 2.8 % Expected life (years) 0.1 0.9 Expected volatility 91.5 % 139.4 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ — $ 0.10 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, 2023 and 2022 (in thousands): Fair Value of Warrants Using Significant Unobservable Inputs (Level 3) 2023 2022 Balance at July 1, $ 1,603 $ 22,355 Change in estimated fair value of liability classified warrants ( 1,603 ) ( 20,819 ) Balance at March 31, $ — $ 1,536 |
Short-Term Investments
Short-Term Investments | 9 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-Term Investments | Note 3. Short-Term Investments As of March 31, 2023, and June 30, 2022 , our short-term investments consisted of $ 103.2 million and $ 137.5 million, respectively, in U.S. government securities. The short-term investments held as of March 31, 2023 and June 30, 2022 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, 2023, and June 30, 2022 , the gross holding gains and losses were immaterial. |
License Agreements
License Agreements | 9 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
License Agreements | Note 4. License Agreements Kyowa Kirin License, Development and Commercialization Agreement In April 2020, we entered into the Kyowa Kirin Commercialization Agreement under which we granted to Kyowa Kirin a co-exclusive, sublicensable, payment-bearing license under certain patents and know-how controlled by us to develop and commercialize zandelisib and any pharmaceutical product containing zandelisib for all human indications in the U.S. (the "U.S. License"), and an exclusive (subject to certain retained rights to perform obligations under the Kyowa Kirin Commercialization Agreement), sublicensable, payment-bearing, license under certain patents and know-how controlled by us to develop and commercialize zandelisib and any pharmaceutical product containing zandelisib for all human indications in countries outside of the U.S. (the “Ex-U.S." and the “Ex-U.S. License”). Kyowa Kirin granted to us a co-exclusive, sublicensable, license under certain patents and know-how controlled by Kyowa Kirin to develop and commercialize zandelisib for all human indications in the U.S., and a co-exclusive, sublicensable, royalty-free, fully paid license under certain patents and know-how controlled by Kyowa Kirin to perform our obligations in the Ex-U.S. under the Kyowa Kirin Commercialization Agreement. Kyowa Kirin paid us an initial payment of $ 100.0 million. Kyowa Kirin is responsible for the development and commercialization of zandelisib in the Ex-U.S. and, subject to certain exceptions, is solely responsible for all costs related thereto. We provide to Kyowa Kirin certain drug supplies necessary for the development and commercialization of zandelisib in the Ex-U.S., with the understanding that Kyowa Kirin will assume responsibility for manufacturing for the Ex-U.S. as soon as practicable. We assessed the Kyowa Kirin Commercialization Agreement in accordance with Topic 808 and Topic 606 and determined that our obligations comprise the U.S. License, the Ex-U.S. License, and development services (the “Development Services”). We determined that the Kyowa Kirin Commercialization Agreement is a collaborative arrangement in accordance with Topic 808 that contains multiple units of account, as we and Kyowa Kirin are both active participants in the development and commercialization activities and are exposed to significant risks and rewards that are dependent on commercial success of the activities of the arrangement. The U.S. License is a unit of account under the scope of Topic 808 and is not a deliverable under Topic 606, while the Ex-U.S. License and Development Services performance obligations are under the scope of Topic 606. As discussed in Note 1, we and Kyowa Kirin jointly decided to discontinue zandelisib development in the U.S. As of March 31, 2023, we updated our assessment of the total transaction price from the Kyowa Kirin Commercialization Agreement to be $ 217.0 million, comprised of the upfront payment of $ 100.0 million, milestone payments of $ 20.0 million, estimated development cost-sharing of $ 91.8 million, and deferred revenue of $ 5.2 million. As of March 31, 2023 , the updated assessment reflects a decrease in estimated variable consideration related to development cost sharing of $ 143.1 million from June 30, 2022 . In December 2022, we announced our plan to discontinue the global development of zandelisib outside of Japan. As a result, we decreased our estimate for variable consideration related to development cost sharing. During the three months ended December 31, 2022, we recognized revenue of $ 16.6 million from the change in estimate. Additionally, during the three months ended December 31, 2022, we recognized $ 8.6 million of revenue related to non-refundable payments for performance obligations that have not commenced and will no longer be initiated. 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 the estimated variable consideration included in the transaction price and any related constraints at the end of each reporting period. We allocated the transaction price of the Ex-U.S. License and Development Services performance obligations 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. License were transferred to Kyowa Kirin during the year ended June 30, 2020, and recognized revenue of $ 21.0 million related to the Ex-U.S. License. The $ 64.5 million transaction price allocated to the U.S. License obligation accounted for under Topic 808 is included as non-current deferred revenue . As described in Note 1 we and Kyowa Kirin intend to terminate the Kyowa Kirin Commercialization Agreement. As of March 31, 2023 and June 30, 2022 , we have deferred revenue of $ 1.6 million and $ 30.9 million, respectively, related to the transaction price allocated to the Development Services performance obligations and are recognizing this revenue based on the proportional performance of these development activities, which we expect to recognize through fiscal year 2024. 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 tiered royalties on the net sales of any product successfully developed. As an alternative to milestone and royalty payments related to countries in which we sublicense product rights, we will pay to Presage a tiered percent (which decreases as product development progresses) of amounts received from such sublicensees. |
BeiGene Collaboration
BeiGene Collaboration | 9 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BeiGene Collaboration | Note 5. 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®), an inhibitor of Bruton’s tyrosine kinase, for the treatment of patients with B-cell malignancies. Under the terms of the clinical collaboration agreement, we amended our ongoing Phase 1b trial to include evaluation of zandelisib in combination with zanubrutinib in patients with B-cell malignancies. Study costs are being shared equally by the parties, and we agreed to supply zandelisib and BeiGene agreed to supply zanubrutinib. We record the costs reimbursed by BeiGene as a reduction of our research and development expenses. We retained full commercial rights for zandelisib and BeiGene retained full commercial rights for zanubrutinib. With the discontinuation of the zandelisib program outside of Japan, this clinical collaboration will be concluding with the discontinuation of the Phase 1b trial. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Note 6. 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, 2023 and 2022. 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 2023 2022 2023 2022 Net loss – basic $ ( 15,438 ) $ ( 8,725 ) $ ( 21,809 ) $ ( 38,391 ) Change in fair value of warrant liability — — — ( 8,046 ) Net loss – diluted $ ( 15,438 ) $ ( 8,725 ) $ ( 21,809 ) $ ( 46,437 ) Share used in calculating net loss per share was determined as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Weighted average shares used in calculating basic net loss per share 6,663 6,653 6,663 6,080 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — — — 44 Weighted average shares used in calculating diluted net loss per share 6,663 6,653 6,663 6,124 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 2023 2022 2023 2022 Stock options 1,258 1,020 1,340 1,029 Warrants 905 11 837 12 Restricted stock units — 803 — 268 Total anti-dilutive shares 2,163 1,834 2,177 1,309 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7. Commitments and Contingencies We have contracted with various consultants and third parties to assist us in pre-clinical research and development and clinical trials work for our leading drug compounds. The contracts are terminable at any time, but obligate us to reimburse the providers for any time or costs incurred through the date of termination. We also have employment agreements with certain of our current employees that provide for severance payments and accelerated vesting for share-based awards if their employment is terminated under specified circumstances. Presage License Agreement As discussed in Note 4, 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, 2023 , we had no t accrued any amounts for potential future payments as achievement of the milestones had not been met. Torreya Partners In October 2022, we engaged Torreya Partners as a financial advisor to help explore additional strategic opportunities. As part of this engagement, we issued warrants to acquire shares of our common stock having a value equal to $ 0.5 million. These warrants were issued during the three months ended March 31, 2023. We will also pay Torreya Partners a transaction fee equal to 20 % of aggregate consideration, up to a maximum of $ 2.0 million, upon completion of a strategic transaction. As of March 31, 2023, we have no t accrued any amount for potential future transaction fees. |
Leases
Leases | 9 Months Ended |
Mar. 31, 2023 | |
Disclosure Text Block [Abstract] | |
Leases | Note 8. Leases In July 2020, we entered into a lease agreement (the "Initial Lease Agreement") for office space in San Diego, California. The Initial Lease Agreement was extended to November 30, 2029 , in accordance with the amended lease agreement that we entered into in January 2022 (the "Amended Lease Agreement"). The Amended Lease Agreement, which began on July 1, 2022 and expires on November 30, 2029 , provides additional office space adjacent to our current office in San Diego. Upon taking control of the additional office space on July 1, 2022, we recognized operating lease ROU assets obtained in exchange for operating lease liabilities of $ 4.3 million. The Initial Lease Agreement and Amended Lease Agreement are collectively referred to as the "Lease Agreements" and have been accounted for as operating leases. The following is a schedule of the future minimum lease payments under the Lease Agreements, reconciled to the operating lease liability, as of March 31, 2023 (in thousands): March 31, Remainder of fiscal year ending June 30, 2023 $ 566 Years ending June 30, 2024 2,335 2025 1,913 2026 2,477 2027 2,551 2028 2,715 Thereafter 4,386 Total lease payments 16,943 Less: Present value discount ( 3,891 ) Total operating lease liability $ 13,052 Balance Sheet Classification – Operating Leases Operating lease liability $ 1,385 Operating lease liability, long-term 11,667 Total operating lease liability $ 13,052 Other Balance Sheet Information – Operating Leases Weighted average remaining lease term (in years) 6.7 Weighted average discount rate 7.50 % The Lease Agreements include rent escalations over the lease terms. In addition, the Lease Agreements include renewal options which were not included in the determination of the ROU assets or lease liabilities as the renewals were not reasonably certain at the inception of the Lease Agreements. Under the terms of the Lease Agreements, we are subject to charges for variable non-lease components (e.g., common area maintenance, maintenance, etc.) that are not included in the ROU assets and operating lease liabilities and are recorded as an expense in the period incurred. The total operating lease costs and supplemental cash flow information related to our operating leases were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Operating lease expense $ 609 $ 377 $ 1,826 $ 1,130 Operating cash flows from operating leases $ 567 $ 380 $ 1,700 $ 1,139 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Mar. 31, 2023 | |
Federal Home Loan Banks [Abstract] | |
Stockholders' Equity | Note 9. Stockholders’ Equity Equity Transactions 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, and carried forward approximately $ 107.5 million of unsold securities registered under the prior shelf registration statement. As of March 31, 2023 , there was $ 123.4 million aggregate value of securities available under the shelf registration statement, including $ 60.0 million remaining available under the 2020 ATM Sales Agreement described below. The shelf registration expires on May 18, 2023 . At-The-Market Equity Offering On November 10, 2020, we entered into an At-The-Market Equity Offering Sales Agreement (the “2020 ATM Sales Agreement”), pursuant to which we may sell an aggregate of up to $ 60.0 million of our common stock pursuant to the shelf registration statement. As of March 31, 2023 , there was $ 60.0 million remaining available under the 2020 ATM Sales Agreement. Warrants As of March 31, 2023 , we have outstanding warrants to purchase 802,949 shares of our common stock related to a private placement equity financing that we closed in May 2018. The warrants are fully vested, exercisable at a price of $ 50.80 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 us and, as a result, the warrants are required to be measured at fair value and reported as a liability in the Condensed Consolidated Balance Sheets. The warrants were revalued as of March 31, 2023 and June 30, 2022 at zero and $ 1.6 million, respectively. The change in fair value of zero and $ 1.6 million was recorded on the Condensed Consolidated Statement of Operations for the three and nine months ended March 31, 2023. As of March 31, 2023 , we also have outstanding warrants to purchase 102,513 shares of our common stock issued to Torreya Partners. The warrants are fully vested, exercisable at a price of $ 6.80 per share and expire in October 2027. |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
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 s tock options and RSUs. In December 2008, we adopted the MEI Pharma, Inc. 2008 Stock Omnibus Equity Compensation Plan (“Omnibus Plan”), as amended and restated from time-to-time, under which 1,450,740 shares of common stock are authorized for issuance. The Omnibus Plan provides for the grant of options and/or other stock-based or stock-denominated awards to our non-employee directors, officers, and employees. In January 2023, our stockholders approved the increase of 400,000 additional shares available for future grant under the Omnibus Plan. As of March 31, 2023 , there were 583,468 shares available for future grant under the Omnibus Plan. In May 2021, we adopted the 2021 Inducement Plan ("Inducement Plan"), under which 125,000 shares of common stock are authorized for issuance. The Inducement Plan is intended to assist us in attracting and retaining selected individuals to serve as employees who are expected to contribute to our success, by providing an inducement for such individuals to enter into employment with us, and to achieve long-ter m objectives that will benefit our stockholders. As of March 31, 2023 , there were 25,185 shares available for future grant under the Inducement Plan. Total share-based compensation expense for all stock awards consisted of the following for the periods presented (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 374 $ 1,118 $ 1,224 $ 2,398 General and administrative 544 1,719 2,066 5,302 Total share-based compensation expense $ 918 $ 2,837 $ 3,290 $ 7,700 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 expire ten years from the date of grant. Stock options granted to directors vest ratably each month for a period of 12 months from the date of grant and expire ten years from the date of grant. Of the total options outstanding of 1,252,931 as of March 31, 2023 , 1,153,116 were granted under the Omnibus Plan and 99,815 were granted under the Inducement Plan. A summary of our stock option activity and related data follows: Number of Weighted- Weighted Average Aggregate Outstanding at June 30, 2022 996,700 $ 57.00 Granted 462,201 10.66 Expired ( 7,834 ) 52.62 Forfeited/Cancelled ( 198,136 ) 40.37 Outstanding at March 31, 2023 1,252,931 42.56 7.5 $ — Vested and exercisable at March 31, 2023 664,330 56.70 6.2 $ — As of March 31, 2023 , the aggregate intrinsic value of outstanding options was calculated as the difference between the exercise price of the underlying options and the closing price of our common stock of $ 4.58 on that date. Unrecognized compensation expense related to non-vested stock options totaled $ 3.9 million as of March 31, 2023 . Such compensation expense is expected to be recognized over a weighted average period of 1.5 years. As of March 31, 2023, we expect all options to vest. We use the 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 for the periods presented: Nine Months Ended 2023 2022 Risk-free interest rate 2.9 % 1.2 % Expected life (years) 6.0 6.0 Expected volatility 84.1 % 68.8 % Dividend yield 0.0 % 0.0 % Weighted average grant date fair value $ 7.71 $ 33.00 Restricted Stock Units A summary of our RSU activity and related data for the nine months ended March 31, 2023 was as follows: Number of Weighted Average Non-vested at June 30, 2022 9,220 $ 69.80 Vested ( 9,220 ) $ 69.80 Non-vested at March 31, 2023 — $ — |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Mar. 31, 2023 | |
Clinical Development Programs | Clinical Development Programs We build our pipeline by licensing or acquiring promising cancer agents and creating value in programs through development, commercialization and strategic partnerships, as appropriate. Our objective is to leverage the mechanisms and properties of our pipeline drug candidates to optimize the balance between efficacy and tolerability to meet the needs of patients with cancer. Our drug candidate pipeline includes: • Voruciclib, an oral cyclin-dependent kinase (“CDK”) inhibitor; • ME-344, an intravenous small molecule targeting the oxidative phosphorylation pathway; and • Zandelisib, an oral phosphatidylinositol 3-kinase delta (“PI3Kδ”) inhibitor. The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current drug candidates may not have favorable results in later studies or trials. The commercial opportunity will be reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive than our drug candidates. We will need substantial additional funds to progress the clinical trial programs for the drug candidates voruciclib and ME-344 and to develop new compounds we might license or acquire. The actual amount of funds that will be needed are determined by a number of factors, some of which are beyond our control. Negative U.S. and global economic conditions may pose challenges to our business strategy, which relies on funding from the financial markets or collaborators |
Reduction in Force and Current Events | Reduction in Force and Current Events In November 2022, we and Kyowa Kirin Co., Ltd. ("Kyowa Kirin") met with the U.S. Food and Drug Administration ("FDA") in a follow-up meeting to the March 2022 end of Phase 2 meeting related to zandelisib. At this meeting, the FDA provided further guidance regarding the design and statistical analysis for the COASTAL trial. Following the November meeting, the companies jointly concluded that a clinical trial consistent with the recent FDA guidance, including modification of the ongoing COASTAL trial, would likely not be feasible to complete within a time period that would support further investment or with sufficient certainty of the regulatory requirements for approval to justify continued global development efforts. As a result, we and Kyowa Kirin jointly decided to discontinue global development of zandelisib for indolent forms of non-Hodgkin lymphoma outside of Japan. The discontinuation of zandelisib development outside of Japan was a business decision based on the most recent regulatory guidance from the FDA and is not related to the zandelisib clinical data generated to date. Kyowa Kirin is continuing certain ongoing Japanese clinical trials, including the Phase 2 MIRAGE trial evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas, and will explore submitting the MIRAGE and TIDAL trials for marketing authorization in Japan. MIRAGE is a Phase 2 trial, similar in design to the global Phase 2, single-arm, TIDAL trial. In November 2022, we and Kyowa Kirin announced positive topline data from the Phase 2 MIRAGE trial. Kyowa Kirin has been evaluating whether to continue developing zandelisib in Japan and after meeting with the Pharmaceuticals and Medical Devices Agency ("PMDA") has concluded that conducting a randomized study consistent with agency guidance to support a marketing application would likely not be feasible to complete within a time period that would support further investment. As a result, in May 2023, Kyowa Kirin decided to discontinue development of zandelisib in Japan. The discontinuation of zandelisib in Japan was a business decision by Kyowa Kirin based on the most recent regulatory guidance from the PMDA and is not related to the zandelisib clinical data generated to date. In light of Kyowa Kirin’s decision to discontinue development of zandelisib in Japan, the parties intend to terminate the global license, development and commercialization agreement executed in April 2020. We and Kyowa Kirin have begun closing all ongoing zandelisib clinical studies outside of Japan, including the Phase 3 COASTAL trial, the Phase 2 TIDAL trial, and the Phase 2 CORAL trial. Depending on the achievement of certain regulatory and commercial milestones in Japan, we may be eligible for additional payments from Kyowa Kirin under the current agreement. In December 2022, we announced a plan to streamline our organization towards the continued clinical development of voruciclib and ME-344. As a result, we initiated a staggered workforce reduction, initially affecting 28 employees in December 2022 (representing approximately 27 % of our workforce) and an additional 14 employees in April 2023. In connection with the reduction in force, we incurred termination costs, which include severance, benefits, and related costs of approximately $ 2.4 million, of which $ 1.8 million was research and development expense and $ 0.6 million was general and administrative expense. |
Liquidity | Liquidity We have accumulated losses of $ 396.0 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of March 31, 2023 , we had $ 112.0 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 operations and operating expenses may affect actual future use of existing cash resources. 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 condensed consolidated financial statements include the accounts of MEI Pharma, Inc. and our wholly owned subsidiary, Meadow Merger Sub, Inc. We have eliminated all significant intercompany accounts and transactions in consolidation. The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, the accompanying financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements for the quarterly period ended March 31, 2023 should be read in conjunction with the audited financial statements and notes thereto as of and for the fiscal year ended June 30, 2022 , included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on September 8, 2022 ("2022 Annual Report"). Interim results are not necessarily indicative of results for a full year. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and disclosures made in the accompanying notes to the consolidated 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. |
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. |
Revenue Recognition | Revenue Recognition Revenues from Customers In accordance with Accounting Standards Codification ("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 fees at the inception of the arrangements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. At the inception of arrangements that include milestone payments, we use judgment to evaluate whether the milestones are probable of being achieved and we estimate the amount to include in the transaction price using the most likely method. If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of development milestones and any related constraint and, as necessary, we adjust our estimate of the overall transaction price. We may enter into arrangements that consist of multiple performance obligations. Such arrangements may include any combination of our deliverables. To the extent a contract includes multiple promised deliverables, we apply judgment to determine whether promised deliverables are capable of being distinct and are distinct in the context of the contract. If these criteria are not met, the promised deliverables are accounted for as a combined performance obligation. For arrangements with multiple distinct performance obligations, we allocate variable consideration related to our 50-50 cost share for development services directly to the associated performance obligation and then allocate the remaining consideration among the performance obligations based on their relative stand-alone selling price. Stand-alone selling price is the price at which we would sell a promised good or service separately to the customer. When not directly observable, we typically estimate 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 fees at the point in time when the license is transferred to the licensee and the licensee can use and benefit from the license. For licenses that are bundled with other distinct or combined obligations, we use judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. If the performance obligation is satisfied over time, we evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. 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 measure of progress because it best depicts the transfer of control to the customer which occurs as we incur costs. Under the cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation (an “input method” under Topic 606). We use judgment to estimate the total cost expected to complete the research and development performance obligations, which include subcontractors’ costs, labor, materials, other direct costs and an allocation of indirect costs. We evaluate these cost estimates and the progress each reporting period and, as necessary, we adjust the measure of progress and related revenue recognition. 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. In connection with our License, Development and Commercialization Agreement (the "Kyowa Kirin Commercialization Agreement") with Kyowa Kirin, we perform development services related to our 50-50 cost sharing arrangement for which revenue is recognized over time. Additionally, we perform services for Kyowa Kirin at their request, the costs of which are fully reimbursed to us. We record the reimbursement for such pass through services as revenue at 100 % of reimbursed costs, as control of the additional services for Kyowa Kirin is transferred at the time we incur such costs. The costs of these services are recognized in the Condensed Consolidated Statements of Operations as research and development expense. We recognized revenue associated with the Kyowa Kirin Commercialization Agreement for the periods presented (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue $ 5,894 $ 9,694 $ 47,359 $ 29,283 Timing of Revenue Recognition: Services performed over time $ 5,598 $ 9,694 $ 46,430 $ 26,970 Pass through services at a point in time 296 — 929 2,313 $ 5,894 $ 9,694 $ 47,359 $ 29,283 Contract Balances Accounts receivable are included in “Prepaid expenses and other current assets”, and contract liabilities are included in “Defer red revenue" and "Deferred revenue, long-term” on our Condensed Consolidated Balance Sheets. The following table presents changes in accounts receivable, unbilled receivables and contract liabilities accounted for under Topic 606 for the periods presented (in thousands): Nine Months Ended 2023 2022 Accounts receivable Accounts receivable, beginning of period $ — $ — Amounts billed 23,507 45,927 Payments received ( 23,507 ) ( 45,927 ) Accounts receivable, end of period $ — $ — Unbilled receivables Unbilled receivables, beginning of period $ 10,044 $ 7,582 Billable amounts 18,043 46,791 Amounts billed ( 23,507 ) ( 45,927 ) Unbilled receivables, end of period $ 4,580 $ 8,446 Contract liabilities Contract liabilities, beginning of period $ 30,900 $ 14,677 Payments received — 20,000 Revenue recognized ( 4,145 ) ( 2,513 ) Revenue recognized from change in estimate for performance obligations that are being closed ( 16,565 ) — Revenue recognized for performance obligations that will no longer commence ( 8,607 ) — Contract liabilities, end of period $ 1,583 $ 32,164 The timing of revenue recognition, invoicing and cash collections results in billed accounts receivable and unbilled receivables 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 unbilled receivables. We may receive advance payments from our customers before revenue is recognized, resulting in contract liabilities. The unbilled receivables and deferred revenue reported on the Condensed Consolidated Balance Sheets relate to the Kyowa Kirin Commercialization Agreement. As of March 31, 2023 and June 30, 2022 , we had $ 66.1 million and $ 95.4 million, respectively, of deferred revenue associated with the Kyowa Kirin Commercialization Agreement, of which $ 64.5 million relates to the U.S. license which is a unit of account under the scope of ASC Topic 808, Collaborative Arrangements ("Topic 808") and is not a performance obligation under Topic 606. The remaining balance of deferred revenue as of March 31, 2023 and June 30, 2022 of $ 1.6 million and $ 30.9 million, respectively, relates to the development services performance obligations which are under the scope of Topic 606. The decrease in deferred revenue comes as a result of our winding down of all zandelisib studies outside of Japan. We updated our estimated costs to complete each of the performance obligations, resulting in a higher progress towards completion based on the ratio of costs incurred to date to the total estimated costs. Additionally, during the three months ended December 31, 2022, we recognized revenue related to non-refundable payments for performance obligations that have not commenced and will no longer be initiated. Our contract liabilities accounted for under Topic 606 relate to the amount of initial upfront consideration that was allocated to the development services performance obligations. Contract liabilities are recognized over the duration of the performance obligations based on the costs incurred relative to total expected costs. Revenues from Collaborators At contract inception, we assess whether the collaboration arrangements are within the scope of Topic 808 to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed based on the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of Topic 808 that contain multiple units of account, we first determine which units of account within the arrangement are within the scope of Topic 808 and which elements are within the scope of Topic 606. For units of account within collaboration arrangements that are accounted for pursuant to Topic 808, an appropriate recognition method is determined and applied consistently, by analogy to authoritative accounting literature. For elements of collaboration arrangements that are accounted for pursuant to Topic 606, we recognize revenue as discussed above. Consideration received that does not meet the requirements to satisfy Topic 606 revenue recognition criteria is recorded as deferred revenue in the accompanying Condensed Consolidated Balance Sheets, classified as either short-term or long-term deferred revenue based on our best estimate of when such amounts will be recognized. |
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 research and development for early-stage products or products that are not commercially viable and ready for use, or have no alternative future use, are charged to expense in the period incurred. |
Leases | Leases We account for our leases under ASC Topic 842, Leases (“Topic 842”). Leases which are identified within the scope of Topic 842 and which have a term greater than one year are recognized on our Condensed Consolidated Balance Sheets as right-of-use ("ROU") assets and lease liabilities. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected remaining lease term. The lease term includes any renewal options and termination options that we are reasonably certain to exercise. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, we use our incremental borrowing rate. The incremental borrowing rate is determined based on the rate of interest that we would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. The interest rate implicit in lease contracts to calculate the present value is typically not readily determinable. As such, significant management judgment is required to estimate the incremental borrowing rate. Operating lease 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 components for our real estate leases. Our non-lease components are primarily related to property maintenance, which varies based on future outcomes, and thus is recognized in operating lease expense when incurred. |
Share-based Compensation | Share-Based Compensation Share-based compensation expense stock options and restricted stock units ("RSUs") granted to employees and directors is recognized in the Condensed Consolidated Statements of Operations based on estimated amounts. The cost of stock options is measured at the grant date, based on the estimated fair value of the stock option using the Black-Scholes valuation model, which incorporates various assumptions, including expected volatility, risk-free interest rate, the expected term of the award and the dividend yield on the underlying stock. Expected volatility is calculated based on the historical volatility of our stock over the expected option life and other appropriate factors. The expected option term is computed using the "simplified" method as permitted under the provisions of ASC Topic 718, Compensation - Stock Compensation . We use the simplified method to calculate the expected term of stock options and similar instruments, as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. Risk-free interest rates are calculated based on continuously compounded risk-free rates for the appropriate term. The dividend yield is assumed to be zero as we have never paid or declared any cash dividends and do not intend to do so in the foreseeable future. For RSUs, we estimate the grant date fair value using our closing stock price on the date of grant. The estimated fair value of stock options and RSUs is amortized on a straight-line basis over the requisite service period, adjusted for actual forfeitures at the time they occur. 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, 2023, 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, 2022, and, as such, the disclosures included in our 2022 Annual Report continue to be relevant for the nine months ended March 31, 2023 . |
Recent Accounting Pronouncements | Recent Accounting Pronouncement In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13, Financial Instruments–Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), as amended. The amendments in ASU 2016-13 require, among other things, financial assets measured at amortized cost basis to be presented at the net amount expected to be collected as compared to previous U.S. GAAP which delayed recognition until it was probable a loss had been incurred. The amendments in ASU 2016-13 are effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, with early adoption permitted. We are currently evaluating the impact that adoption of ASU 2016-13 will have on our financial statements and related disclosures. |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule Of Revenue Associated With License Agreement | We recognized revenue associated with the Kyowa Kirin Commercialization Agreement for the periods presented (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenue $ 5,894 $ 9,694 $ 47,359 $ 29,283 Timing of Revenue Recognition: Services performed over time $ 5,598 $ 9,694 $ 46,430 $ 26,970 Pass through services at a point in time 296 — 929 2,313 $ 5,894 $ 9,694 $ 47,359 $ 29,283 |
Schedule of Changes in Contract Assets and Contract Liabilities | The following table presents changes in accounts receivable, unbilled receivables and contract liabilities accounted for under Topic 606 for the periods presented (in thousands): Nine Months Ended 2023 2022 Accounts receivable Accounts receivable, beginning of period $ — $ — Amounts billed 23,507 45,927 Payments received ( 23,507 ) ( 45,927 ) Accounts receivable, end of period $ — $ — Unbilled receivables Unbilled receivables, beginning of period $ 10,044 $ 7,582 Billable amounts 18,043 46,791 Amounts billed ( 23,507 ) ( 45,927 ) Unbilled receivables, end of period $ 4,580 $ 8,446 Contract liabilities Contract liabilities, beginning of period $ 30,900 $ 14,677 Payments received — 20,000 Revenue recognized ( 4,145 ) ( 2,513 ) Revenue recognized from change in estimate for performance obligations that are being closed ( 16,565 ) — Revenue recognized for performance obligations that will no longer commence ( 8,607 ) — Contract liabilities, end of period $ 1,583 $ 32,164 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
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 for the periods presented: March 31, June 30, Risk-free interest rate 4.6 % 2.8 % Expected life (years) 0.1 0.9 Expected volatility 91.5 % 139.4 % Dividend yield 0.0 % 0.0 % Black-Scholes Fair Value $ — $ 0.10 |
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, 2023 and 2022 (in thousands): Fair Value of Warrants Using Significant Unobservable Inputs (Level 3) 2023 2022 Balance at July 1, $ 1,603 $ 22,355 Change in estimated fair value of liability classified warrants ( 1,603 ) ( 20,819 ) Balance at March 31, $ — $ 1,536 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
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 2023 2022 2023 2022 Net loss – basic $ ( 15,438 ) $ ( 8,725 ) $ ( 21,809 ) $ ( 38,391 ) Change in fair value of warrant liability — — — ( 8,046 ) Net loss – diluted $ ( 15,438 ) $ ( 8,725 ) $ ( 21,809 ) $ ( 46,437 ) |
Calculation of Weighted Average Shares Used to Calculate Basic and Diluted Income (Loss) Earnings Per Share | Share used in calculating net loss per share was determined as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Weighted average shares used in calculating basic net loss per share 6,663 6,653 6,663 6,080 Effect of potentially dilutive common shares from equity awards and liability-classified warrants — — — 44 Weighted average shares used in calculating diluted net loss per share 6,663 6,653 6,663 6,124 |
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 2023 2022 2023 2022 Stock options 1,258 1,020 1,340 1,029 Warrants 905 11 837 12 Restricted stock units — 803 — 268 Total anti-dilutive shares 2,163 1,834 2,177 1,309 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Mar. 31, 2023 | |
Disclosure Text Block [Abstract] | |
Schedule of Future Minimum Rental Payments | The following is a schedule of the future minimum lease payments under the Lease Agreements, reconciled to the operating lease liability, as of March 31, 2023 (in thousands): March 31, Remainder of fiscal year ending June 30, 2023 $ 566 Years ending June 30, 2024 2,335 2025 1,913 2026 2,477 2027 2,551 2028 2,715 Thereafter 4,386 Total lease payments 16,943 Less: Present value discount ( 3,891 ) Total operating lease liability $ 13,052 Balance Sheet Classification – Operating Leases Operating lease liability $ 1,385 Operating lease liability, long-term 11,667 Total operating lease liability $ 13,052 Other Balance Sheet Information – Operating Leases Weighted average remaining lease term (in years) 6.7 Weighted average discount rate 7.50 % |
Schedule of Total Operating Costs | The total operating lease costs and supplemental cash flow information related to our operating leases were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Operating lease expense $ 609 $ 377 $ 1,826 $ 1,130 Operating cash flows from operating leases $ 567 $ 380 $ 1,700 $ 1,139 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Mar. 31, 2023 | |
Share-Based Compensation Expense for Stock Awards | Total share-based compensation expense for all stock awards consisted of the following for the periods presented (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 374 $ 1,118 $ 1,224 $ 2,398 General and administrative 544 1,719 2,066 5,302 Total share-based compensation expense $ 918 $ 2,837 $ 3,290 $ 7,700 |
Summary of Stock Option Activity and Related Data | A summary of our stock option activity and related data follows: Number of Weighted- Weighted Average Aggregate Outstanding at June 30, 2022 996,700 $ 57.00 Granted 462,201 10.66 Expired ( 7,834 ) 52.62 Forfeited/Cancelled ( 198,136 ) 40.37 Outstanding at March 31, 2023 1,252,931 42.56 7.5 $ — Vested and exercisable at March 31, 2023 664,330 56.70 6.2 $ — |
Fair Value of Stock Options Weighted-Average Assumptions Used | following weighted average assumptions were used for the periods presented: Nine Months Ended 2023 2022 Risk-free interest rate 2.9 % 1.2 % Expected life (years) 6.0 6.0 Expected volatility 84.1 % 68.8 % Dividend yield 0.0 % 0.0 % Weighted average grant date fair value $ 7.71 $ 33.00 |
Summary of RSU activity | A summary of our RSU activity and related data for the nine months ended March 31, 2023 was as follows: Number of Weighted Average Non-vested at June 30, 2022 9,220 $ 69.80 Vested ( 9,220 ) $ 69.80 Non-vested at March 31, 2023 — $ — |
The Company and Summary of Si_4
The Company and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Jun. 30, 2022 | Feb. 28, 2023 | |
Targeted or Tracking Stock, Stock [Line Items] | |||
Exchange Ratio of common stock | 5.2245% | ||
Reduction of workforce | 27% | ||
Severance benefits, and related costs | $ 2,400 | ||
Unrecognized tax benefits | 0 | ||
Accumulated Losses Since Inception | (395,968) | $ (374,159) | |
Cash And Cash Equivalents,Short Term Investments And Common Stock Proceeds Receivable | 112,000 | ||
Deferred Revenue, Revenue Recognized | 66,100 | 95,400 | |
Research and Development | |||
Targeted or Tracking Stock, Stock [Line Items] | |||
Severance benefits, and related costs | 1,800 | ||
General and Administrative Expense Member | |||
Targeted or Tracking Stock, Stock [Line Items] | |||
Severance benefits, and related costs | $ 600 | ||
Pass Through Services Member | |||
Targeted or Tracking Stock, Stock [Line Items] | |||
Percentage of reimbursement of pass through costs as revenue | 100% | ||
US License | |||
Targeted or Tracking Stock, Stock [Line Items] | |||
Deferred Revenue, Revenue Recognized | $ 64,500 | ||
Development Services Performance Obligations | |||
Targeted or Tracking Stock, Stock [Line Items] | |||
Deferred Revenue, Revenue Recognized | $ 1,600 | $ 30,900 |
The Company and Summary of Si_5
The Company and Summary of Significant Accounting Policies - Revenue Associated With The Following license agreements (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | $ 5,894 | $ 9,694 | $ 47,359 | $ 29,283 |
Services Performed Over Time [Member] | ||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | 5,598 | 9,694 | 46,430 | 26,970 |
Pass through services at a point in time [Member] | ||||
Recognized Revenue Associated with The Following License Agreements [Line Items] | ||||
Revenues | $ 296 | $ 0 | $ 929 | $ 2,313 |
The Company and Summary of Si_6
The Company and Summary of Significant Accounting Policies - Schedule of Changes in Contract Assets and Contract Liabilities (Detail) - USD ($) $ in Thousands | 9 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Contract with Customer Asset and Liability [Line Items] | ||||
Accounts Receivable, beginning of period | $ 0 | $ 0 | ||
Amounts billed | $ 23,507 | $ 45,927 | ||
Payments received | (23,507) | (45,927) | ||
Accounts Receivable, end of period | 0 | 0 | ||
Unbilled receivables, beginning of year | 10,044 | 7,582 | ||
Billable amounts | 18,043 | 46,791 | ||
Amounts billed | (23,507) | (45,927) | ||
Unbilled receivables, end of year | 4,580 | 8,446 | ||
Contract liabilities, beginning of period | 30,900 | 14,677 | ||
Payments received | 0 | 20,000 | ||
Revenue recognized | (4,145) | (2,513) | ||
Revenue recognized from change in estimate for performance obligations that are being closed | (16,565) | 0 | ||
Revenue recognized for performance obligations that will no longer commence | (8,607) | 0 | ||
Contract liabilities, end of period | $ 1,583 | $ 32,164 |
Schedule of Assumptions Used to
Schedule of Assumptions Used to Calculate Fair Value of Warrant Liability (Detail) | Mar. 31, 2023 USD ($) yr | Jun. 30, 2022 yr USD ($) |
Risk Free Interest Rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 4.6 | 2.8 |
Expected life years | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | yr | 0.1 | 0.9 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and Rights Outstanding, Measurement Input | 91.5 | 139.4 |
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 | $ | 0 | 0.10 |
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, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Fair value measurements Significant unobservable inputs [Line Items] | ||||
Beginning balance | $ 1,603 | |||
Change in estimated fair value of liability classified warrants | $ 0 | $ (12,773) | (1,603) | $ (20,819) |
Ending balance | 0 | 0 | ||
Fair Value, Measurements, Recurring [Member] | Level 3 | ||||
Fair value measurements Significant unobservable inputs [Line Items] | ||||
Beginning balance | 1,603 | 22,355 | ||
Change in estimated fair value of liability classified warrants | (1,603) | (20,819) | ||
Ending balance | $ 0 | $ 1,536 | $ 0 | $ 1,536 |
Short-Term Investments - Additi
Short-Term Investments - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Jun. 30, 2022 |
Schedule of Equity Method Investments [Line Items] | ||
Short-term investments | $ 103,224 | $ 137,512 |
License Agreements - Additional
License Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Dec. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2022 | May 31, 2020 | |
Related Party Transaction [Line Items] | ||||||
Revenue recognized | $ (4,145) | $ (2,513) | ||||
Kyowa Kirin Co | ||||||
Related Party Transaction [Line Items] | ||||||
Total upfront payment receivable for grant of rights | $ 100,000 | |||||
Presage License Agreement | Presage Biosciences, Inc. | ||||||
Related Party Transaction [Line Items] | ||||||
Compensation payable for grant of rights | $ 4,900 | |||||
Payment for license | 2,900 | |||||
Presage License Agreement | Presage Biosciences, Inc. | Incremental Payment | ||||||
Related Party Transaction [Line Items] | ||||||
Compensation payable for grant of rights | 2,000 | |||||
Presage License Agreement | Presage Biosciences, Inc. | Potential Payments on Achievement of Development Regulatory and Commercial Milestones | ||||||
Related Party Transaction [Line Items] | ||||||
Milestone payment receivable amount | $ 179,000 | |||||
Kkc Agreements [Member] | Kyowa Kirin Co | ||||||
Related Party Transaction [Line Items] | ||||||
Upfront payment | 100,000 | |||||
Transaction price relating to the performance obligation | 217,000 | |||||
Expected milestone payment receivable | 20,000 | |||||
Estimated development cost sharing recovered through earnings | 91,800 | |||||
Deferred revenue | 5,200 | |||||
Revenue recognized | $ 16,600 | |||||
Revenue related to non-refundable payments for performance obligations | $ 8,600 | |||||
Kkc Agreements [Member] | Kyowa Kirin Co | Ex US License | ||||||
Related Party Transaction [Line Items] | ||||||
Revenue recognized | 21,000 | |||||
License Obligation Account Transaction Price Allocated | 64,500 | |||||
Kkc Agreements [Member] | Kyowa Kirin Co | Development Services | ||||||
Related Party Transaction [Line Items] | ||||||
Contract with customer liability non current | 1,600 | $ 30,900 | ||||
Kkc Agreements [Member] | Kyowa Kirin Co | Maximum | ||||||
Related Party Transaction [Line Items] | ||||||
Estimated development cost sharing recovered through earnings | $ 143,100 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Common stock subject to repurchase or forfeiture | 0 | 0 | 0 | 0 |
Schedule of Net Income (Loss) P
Schedule of Net Income (Loss) Per Share, Basic and Diluted (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Net loss - basic | $ (15,438) | $ (8,725) | $ (21,809) | $ (38,391) |
Change in fair value of warrant liability | 0 | 0 | 0 | (8,046) |
Net loss - diluted | $ (15,438) | $ (8,725) | $ (21,809) | $ (46,437) |
Calculation of Weighted Average
Calculation of Weighted Average Shares Used to Calculate Basic and Diluted Income (Loss) Earnings Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average shares used in calculating basic net loss per share | 6,663 | 6,653 | 6,663 | 6,080 |
Effect of potentially dilutive common shares from equity awards and liability-classified warrants | 0 | 0 | 0 | 44 |
Weighted average shares used in calculating diluted net loss per share | 6,663 | 6,653 | 6,663 | 6,124 |
Antidilutive Securities (Detail
Antidilutive Securities (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 2,163 | 1,834 | 2,177 | 1,309 |
Employee Stock option | ||||
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 1,258 | 1,020 | 1,340 | 1,029 |
Warrants | ||||
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 905 | 11 | 837 | 12 |
Restricted Stock Units (RSUs) | ||||
Potentially Dilutive Securities Outstanding [Line Items] | ||||
Total anti-dilutive shares | 0 | 803 | 0 | 268 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Common stock value | $ 0 | $ 0 | $ 0 |
Torreya partners | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Accrued payment for potential future payments | $ 0 | 0 | |
Transaction fee | 20% | ||
Torreya partners | Maximum | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Business Combination, Consideration Transferred | 2,000,000 | ||
General and administrative | Torreya partners | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Acquire shares of common stock grant date fair value | 500,000 | ||
Presage License Agreement | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Accrued payment for potential future payments | $ 0 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Mar. 31, 2023 | Jul. 01, 2022 | |
Extended date | November 30, 2029 | |
Lease expire date | Nov. 30, 2029 | |
Operating lease liabilities, Total | $ 13,052 | |
San Diego California [Member] | ||
Operating lease liabilities, Total | $ 4,300 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Jun. 30, 2022 |
Disclosure Text Block [Abstract] | ||
Remainder of fiscal year ending June 30, 2023 | $ 566 | |
2024 | 2,335 | |
2025 | 1,913 | |
2026 | 2,477 | |
2027 | 2,551 | |
2028 | 2,715 | |
Thereafter | 4,386 | |
Total lease payments | 16,943 | |
Less: Present value discount | (3,891) | |
Total operating lease liability | 13,052 | |
Operating lease liabilities | 1,385 | $ 871 |
Operating lease liabilities, long-term | 11,667 | $ 8,771 |
Operating lease liabilities, Total | $ 13,052 | |
Weighted average remaining lease term (in years) | 6 years 8 months 12 days | |
Weighted average discount rate | 7.50% |
Schedule of Total Operating Cos
Schedule of Total Operating Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Leases [Abstract] | ||||
Operating lease cost | $ 609 | $ 377 | $ 1,826 | $ 1,130 |
Operating cash flows from operating leases | $ 567 | $ 380 | $ 1,700 | $ 1,139 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2022 | Nov. 10, 2020 | |
Class of Stock [Line Items] | ||||||
Fair value of warrants | $ 0 | $ 0 | $ 1,603 | |||
Unsold Securities Shares and Warrants Under Agreement | 107,500 | |||||
Aggregate Value of Securities Available Under Agreement | 123,400 | 123,400 | ||||
Change in fair value of warrant liability | $ 0 | $ 12,773 | $ 1,603 | $ 20,819 | ||
Shelf registration expiration date | May 18, 2023 | |||||
Warrant [Member] | ||||||
Class of Stock [Line Items] | ||||||
Exercise price | $ 50.80 | $ 50.80 | ||||
Warrants outstanding | 802,949,000 | 802,949,000 | ||||
Change in fair value of warrant liability | $ 0 | $ 1,600 | ||||
Warrant [Member] | Torreya Partners [Member] | ||||||
Class of Stock [Line Items] | ||||||
Exercise price | $ 6.80 | $ 6.80 | ||||
Warrants outstanding | 102,513,000 | 102,513,000 | ||||
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 | $ 60,000 | ||||
Maximum | ||||||
Class of Stock [Line Items] | ||||||
Sale of shares and warrants under agreement | 200,000 | |||||
Maximum | Two Thousand And Twenty At The Market Sale Agreement | ||||||
Class of Stock [Line Items] | ||||||
Sale of shares under agreement | $ 60,000 | $ 60,000 | $ 60,000 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | |||
Mar. 31, 2023 | Jan. 31, 2023 | Jun. 30, 2022 | May 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding Options | 1,252,931 | 996,700 | ||
Unrecognized compensation expense related to unvested stock options | $ 3.9 | |||
Expected weighted average period for recognition of compensation expense | 1 year 6 months | |||
Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Closing price of common stock | $ 4.58 | |||
Employee Stock Option | 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 arrangement by share-based payment award, expiration period | 10 years | |||
Employee Stock Option | Employees | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock option vested percentage | 25% | |||
Share-based compensation arrangement by share-based payment award, award vesting period | 36 months | |||
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vested | (9,220) | |||
2008 Omnibus Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock authorized | 1,450,740,000 | |||
Shares available for future grant | 583,468,000 | |||
Number of additional shares available for future grant | 400,000,000 | |||
2008 Omnibus Plan | Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for future grant | 1,153,116,000 | |||
Outstanding Options | 1,252,931,000 | |||
Inducement Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock authorized | 125,000,000 | |||
Shares available for future grant | 25,185,000 | |||
Inducement Plan [Member] | Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for future grant | 99,815,000 |
Share-Based Compensation Expens
Share-Based Compensation Expense for Stock Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 918 | $ 2,837 | $ 3,290 | $ 7,700 |
Research and Development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 374 | 1,118 | 1,224 | 2,398 |
General and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 544 | $ 1,719 | $ 2,066 | $ 5,302 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) | 9 Months Ended |
Mar. 31, 2023 USD ($) $ / shares shares | |
Number of Options | |
Beginning Balance | shares | 996,700 |
Granted | shares | 462,201 |
Expired | shares | (7,834) |
Forfeited / Cancelled | shares | (198,136) |
Ending balance | shares | 1,252,931 |
Vested and exercisable at end of period | shares | 664,330 |
Weighted- Average Exercise Price | |
Beginning Balance | $ / shares | $ 57 |
Granted | $ / shares | 10.66 |
Expired | $ / shares | 52.62 |
Forfeited / Cancelled | $ / shares | 40.37 |
Ending balance | $ / shares | 42.56 |
Vested and exercisable at end of period | $ / shares | $ 56.70 |
Weighted Average Remaining Contractual Term (in years) | |
Outstanding at end of period | 7 years 6 months |
Vested and exercisable at end of period | 6 years 2 months 12 days |
Aggregate Intrinsic Value | |
Outstanding at end of period | $ | $ 0 |
Vested and exercisable at end of period | $ | $ 0 |
Share-based Compensation - Fair
Share-based Compensation - Fair Value of Stock Options Weighted-Average Assumptions Used (Detail) - $ / shares | 9 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.90% | 1.20% |
Expected life (years) | 6 years | 6 years |
Expected volatility | 84.10% | 68.80% |
Dividend yield | 0% | 0% |
Weighted-average grant date fair value | $ 7.71 | $ 33 |
Share Based Compensation - Summ
Share Based Compensation - Summary of RSU activity and related data (Details) - Restricted Stock Units (RSUs) [Member] | 9 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares [Roll Forward] | |
Beginning balance | shares | 9,220 |
Vested | shares | (9,220) |
Ending balance | shares | 0 |
Weighted average grant date fair value | |
Beginning balance | $ / shares | $ 69.80 |
Vested | $ / shares | 69.80 |
Ending balance | $ / shares | $ 0 |