Cover
Cover - shares | 6 Months Ended | |
Sep. 30, 2022 | Oct. 28, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38906 | |
Entity Registrant Name | IMMUNOVANT, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 83-2771572 | |
Entity Address, Address Line One | 320 West 37th Street | |
Entity Address, City or Town | New York, | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10018 | |
City Area Code | 917 | |
Local Phone Number | 580-3099 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | IMVT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 129,182,451 | |
Entity Central Index Key | 0001764013 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --03-31 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Mar. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 405,773 | $ 493,817 |
Accounts receivable | 3,782 | 12,229 |
Prepaid expenses and other current assets | 16,536 | 6,885 |
Total current assets | 426,091 | 512,931 |
Operating lease right-of-use assets | 1,743 | 2,303 |
Property and equipment, net | 312 | 330 |
Total assets | 428,146 | 515,564 |
Current liabilities: | ||
Accounts payable | 7,461 | 18,629 |
Accrued expenses | 23,138 | 24,746 |
Current portion of operating lease liabilities | 1,185 | 1,145 |
Total current liabilities | 31,784 | 44,520 |
Operating lease liabilities, net of current portion | 614 | 1,219 |
Total liabilities | 32,398 | 45,739 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 116,614,088 shares issued and outstanding at September 30, 2022 and 500,000,000 shares authorized, 116,482,899 shares issued and outstanding at March 31, 2022 | 12 | 12 |
Additional paid-in capital | 840,661 | 824,796 |
Accumulated other comprehensive (loss) income | (1,237) | 404 |
Accumulated deficit | (443,688) | (355,387) |
Total stockholders’ equity | 395,748 | 469,825 |
Total liabilities and stockholders’ equity | 428,146 | 515,564 |
Series A preferred stock | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Mar. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, outstanding (in shares) | 116,614,088 | 116,482,899 |
Common stock, issued (in shares) | 116,614,088 | 116,482,899 |
Series A preferred stock | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (in shares) | 10,000 | 10,000 |
Preferred stock, issued (in shares) | 10,000 | 10,000 |
Preferred stock, outstanding (in shares) | 10,000 | 10,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 37,739 | $ 21,361 | $ 66,168 | $ 40,066 |
General and administrative | 11,875 | 16,289 | 23,821 | 27,469 |
Total operating expenses | 49,614 | 37,650 | 89,989 | 67,535 |
Interest income, net | (1,154) | 0 | (1,154) | 0 |
Other (income) expense | (793) | 84 | (1,147) | 711 |
Loss before provision (benefit) for income taxes | (47,667) | (37,734) | (87,688) | (68,246) |
Provision (benefit) for income taxes | 261 | (31) | 613 | (72) |
Net loss | $ (47,928) | $ (37,703) | $ (88,301) | $ (68,174) |
Net loss per common share - basic (in dollars per share) | $ (0.41) | $ (0.35) | $ (0.76) | $ (0.66) |
Net loss per common share - diluted (in dollars per share) | $ (0.41) | $ (0.35) | $ (0.76) | $ (0.66) |
Weighted-average common shares outstanding – basic (in shares) | 116,572,820 | 109,078,427 | 116,630,076 | 103,558,036 |
Weighted-average common shares outstanding – diluted (in shares) | 116,572,820 | 109,078,427 | 116,630,076 | 103,558,036 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (47,928) | $ (37,703) | $ (88,301) | $ (68,174) |
Other comprehensive (loss) income: | ||||
Foreign currency translation adjustments | (974) | 169 | (1,641) | 740 |
Total other comprehensive (loss) income | (974) | 169 | (1,641) | 740 |
Comprehensive loss | $ (48,902) | $ (37,534) | $ (89,942) | $ (67,434) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Series A preferred stock | Common stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit |
Beginning balance (in shares) at Mar. 31, 2021 | 10,000 | 97,971,243 | ||||
Beginning balance at Mar. 31, 2021 | $ 391,480 | $ 10 | $ 590,425 | $ (298) | $ (198,657) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Capital contribution – stock-based compensation | 41 | 41 | ||||
Capital contribution – expenses allocated from Roivant Sciences Ltd. | 91 | 91 | ||||
Stock-based compensation | 3,820 | 3,820 | ||||
Foreign currency translation adjustments | 571 | 571 | ||||
Net loss | (30,471) | (30,471) | ||||
Restricted stock units vested and settled (in shares) | 6,352 | |||||
Ending balance (in shares) at Jun. 30, 2021 | 10,000 | 97,977,595 | ||||
Ending balance at Jun. 30, 2021 | 365,532 | $ 10 | 594,377 | 273 | (229,128) | |
Beginning balance (in shares) at Mar. 31, 2021 | 10,000 | 97,971,243 | ||||
Beginning balance at Mar. 31, 2021 | 391,480 | $ 10 | 590,425 | (298) | (198,657) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (68,174) | |||||
Ending balance (in shares) at Sep. 30, 2021 | 10,000 | 114,998,871 | ||||
Ending balance at Sep. 30, 2021 | 536,397 | $ 12 | 802,774 | 442 | (266,831) | |
Beginning balance (in shares) at Jun. 30, 2021 | 10,000 | 97,977,595 | ||||
Beginning balance at Jun. 30, 2021 | 365,532 | $ 10 | 594,377 | 273 | (229,128) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Capital contribution – stock-based compensation | 692 | 692 | ||||
Capital contribution – expenses allocated from Roivant Sciences Ltd. | 38 | 38 | ||||
Stock-based compensation | 7,669 | 7,669 | ||||
Foreign currency translation adjustments | 169 | 169 | ||||
Net loss | (37,703) | (37,703) | ||||
Issuance of common stock upon investment by Roivant Sciences Ltd. (in shares) | 17,021,276 | |||||
Issuance of common stock upon investment by Roivant Sciences Ltd. | 200,000 | $ 2 | 199,998 | |||
Ending balance (in shares) at Sep. 30, 2021 | 10,000 | 114,998,871 | ||||
Ending balance at Sep. 30, 2021 | 536,397 | $ 12 | 802,774 | 442 | (266,831) | |
Beginning balance (in shares) at Mar. 31, 2022 | 10,000 | 116,482,899 | ||||
Beginning balance at Mar. 31, 2022 | 469,825 | $ 12 | 824,796 | 404 | (355,387) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock options exercised and restricted stock units vested and settled (in shares) | 41,259 | |||||
Stock options exercised and restricted stock units vested and settled | 21 | 21 | ||||
Capital contribution – stock-based compensation | 132 | 132 | ||||
Stock-based compensation | 7,555 | 7,555 | ||||
Foreign currency translation adjustments | (667) | (667) | ||||
Net loss | (40,373) | (40,373) | ||||
Ending balance (in shares) at Jun. 30, 2022 | 10,000 | 116,524,158 | ||||
Ending balance at Jun. 30, 2022 | 436,493 | $ 12 | 832,504 | (263) | (395,760) | |
Beginning balance (in shares) at Mar. 31, 2022 | 10,000 | 116,482,899 | ||||
Beginning balance at Mar. 31, 2022 | 469,825 | $ 12 | 824,796 | 404 | (355,387) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (88,301) | |||||
Ending balance (in shares) at Sep. 30, 2022 | 10,000 | 116,614,088 | ||||
Ending balance at Sep. 30, 2022 | 395,748 | $ 12 | 840,661 | (1,237) | (443,688) | |
Beginning balance (in shares) at Jun. 30, 2022 | 10,000 | 116,524,158 | ||||
Beginning balance at Jun. 30, 2022 | 436,493 | $ 12 | 832,504 | (263) | (395,760) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Capital contribution – stock-based compensation | 106 | 106 | ||||
Stock-based compensation | 8,051 | 8,051 | ||||
Foreign currency translation adjustments | (974) | (974) | ||||
Net loss | (47,928) | (47,928) | ||||
Restricted stock units vested and settled (in shares) | 89,930 | |||||
Ending balance (in shares) at Sep. 30, 2022 | 10,000 | 116,614,088 | ||||
Ending balance at Sep. 30, 2022 | $ 395,748 | $ 12 | $ 840,661 | $ (1,237) | $ (443,688) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (88,301) | $ (68,174) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 15,844 | 12,222 |
Depreciation on property and equipment | 90 | 54 |
Non-cash lease expense | 560 | 551 |
Other non-cash items | 0 | 740 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 8,817 | (387) |
Prepaid expenses and other current assets | (10,126) | 4,408 |
Accounts payable | (10,967) | 1,810 |
Accrued expenses | (1,357) | 7,898 |
Operating lease liabilities | (565) | (383) |
Net cash used in operating activities | (86,005) | (41,261) |
Cash flows from investing activities | ||
Purchase of property and equipment | (73) | (62) |
Net cash used in investing activities | (73) | (62) |
Cash flows from financing activities | ||
Capital contributions | 0 | 129 |
Proceeds from stock options exercised | 21 | 0 |
Proceeds from investment by Roivant Sciences Ltd. | 0 | 200,000 |
Net cash provided by financing activities | 21 | 200,129 |
Effect of exchange rate changes on cash and cash equivalents | (1,987) | 0 |
Net change in cash and cash equivalents | (88,044) | 158,806 |
Cash and cash equivalents – beginning of period | 493,817 | 400,146 |
Cash and cash equivalents – end of period | $ 405,773 | $ 558,952 |
Description of Business and Liq
Description of Business and Liquidity | 6 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Liquidity | Description of Business and Liquidity [A] Description of Business Immunovant, Inc. together with its wholly owned subsidiaries (the “Company” or “Immunovant”) is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. The Company’s innovative product pipeline includes two compounds that target the neonatal fragment crystallizable receptor (“FcRn”). The Company’s first compound, batoclimab, formerly referred to as IMVT-1401, and its second compound, IMVT-1402, are both novel, fully human, monoclonal antibodies. Designed to be optimized as a simple, subcutaneous injection with dosing that the Company believes can be tailored based on disease severity and stage, batoclimab has been observed to reduce immunoglobulin G (“IgG”) antibodies that cause inflammation and disease. IMVT-1402 has also demonstrated deep IgG antibody reduction in animal studies. The Company has determined that it has one operating and reporting segment. [B] Liquidity The Company has incurred significant losses and negative cash flows from operations since its inception. As of September 30, 2022, the Company’s cash and cash equivalents totaled $405.8 million and its accumulated deficit was $443.7 million. The Company has not generated any revenues to date and does not anticipate generating any revenues unless and until it successfully completes development and obtains regulatory approval for batoclimab, IMVT-1402 or any future product candidate. Management expects to incur additional losses in the future to fund its operations and conduct product research and development and recognizes the need to raise additional capital to fully implement its business plan. The Company intends to raise such additional capital through the issuance of equity securities, debt financings or other sources in order to further implement its business plan. However, if such financing is not available at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of its product candidates. The Company currently expects that its existing cash and cash equivalents as of September 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date these unaudited condensed consolidated financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies [A] Basis of Presentation The Company’s fiscal year ends on March 31 and its first three fiscal quarters end on June 30, September 30, and December 31. The accompanying condensed consolidated financial statements are unaudited. The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. The Company has no unconsolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain amounts in the consolidated financial statements of the prior year have been reclassified to conform to current year presentation. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the unaudited condensed consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair statement of results for the interim periods. The results for the three and six months ended September 30, 2022 are not necessarily indicative of those expected for the year ending March 31, 2023 or for any future period. The condensed consolidated balance sheet as of March 31, 2022 included herein was derived from the audited consolidated financial statements as of that date. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on June 8, 2022. [B] Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. The Company regularly evaluates estimates and assumptions related to assets, liabilities, stock-based compensation, litigation accruals, clinical trial accruals, operating leases, research and development costs and income taxes. The Company bases its estimates and assumptions on historical experience and on various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Additionally, the Company assessed the impact that the COVID-19 pandemic, geopolitical tensions and resulting global slowdown of economic activity, decades-high inflation, rising interest rates and a potential recession in the U.S. has had on its operations and financial results as of September 30, 2022 and through the issuance of these unaudited condensed consolidated financial statements. The Company’s analysis was informed by the facts and circumstances as they were known to the Company. This assessment considered the impact that these uncertainties may have on financial estimates and assumptions that affect the reported amounts of assets and liabilities and expenses. [C] Risks and Uncertainties The Company is subject to risks common to early-stage companies in the biopharmaceutical industry including, but not limited to, uncertainties related to clinical effectiveness of the product, commercialization of products, regulatory approvals, dependence on key products, key personnel and third-party service providers such as contract research organizations (“CROs”), protection of intellectual property rights and the ability to make milestone, royalty or other payments due under any license, collaboration or supply agreements. [D] Concentration of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk include cash and cash equivalents. As of September 30, 2022, the cash and cash equivalents balance is kept in banking institutions that the Company believes are of high credit quality and are in excess of federally insured levels. The Company maintains its cash and cash equivalents with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company has not experienced any losses on its cash and cash equivalents. [E] Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. At September 30, 2022, cash and cash equivalents included $316.1 million of money market funds invested in high-quality, short-term securities that are issued and guaranteed by the U.S. government and its agencies that are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. There were no cash equivalents as of March 31, 2022. [F] Research and Development Expense Research and development costs with no alternative future use are expensed as incurred. Payments for a product license prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are expensed in the period incurred as research and development. Milestone payments made in connection with regulatory approvals are capitalized and amortized to cost of product sales over the remaining useful life of the asset. Research and development expenses primarily consist of employee-related costs, milestone payments under the HanAll Agreement and expenses from third parties who conduct research and development activities (including manufacturing) on behalf of the Company. The Company accrues costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by CROs. In making these estimates, the Company considers various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment. The Company accrues costs for non-clinical studies and contract manufacturing activities over the service periods specified in the contracts and are adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. The estimate of the work completed is developed through discussions with internal personnel and external services providers as to the progress toward completion of the services and the agreed-upon fee to be paid for such services. As actual costs become known, the accrued estimates are adjusted. Such estimates are not expected to be materially different from amounts actually incurred. The Company participates in cost-sharing arrangements with third parties whereas the third parties have agreed to share a portion of the costs incurred by the Company, related to batoclimab drug manufacturing and clinical trials. The Company records the third parties’ share of the costs as a reduction of research and development expenses and an increase to accounts receivable in the accompanying unaudited condensed consolidated financial statements based on actual amounts incurred by the Company and billable to the third parties. These cost-sharing arrangements do not contemplate any future revenue-generating activity or global commercialization efforts of batoclimab benefiting any of the parties. [G] Stock-based Compensation Stock-based awards to employees and directors are valued at fair value on the date of the grant and that fair value is recognized as stock-based compensation expense over the requisite service period. The grant date fair value of the stock-based awards with graded vesting is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. The Company values its stock options that only have service vesting requirements using the Black-Scholes option pricing model. Stock-based compensation related to restricted stock awards is based on the fair value of the Company’s common stock on the grant date. When determining the grant-date fair value of stock-based awards, management further considers whether an adjustment is required to the observable market price or volatility of the Company’s common stock that is used in the valuation as a result of material non-public information, if that information is expected to result in a material increase in share price. Certain assumptions need to be made with respect to utilizing the Black-Scholes option pricing model, including the expected life of the award, volatility of the underlying shares, the risk-free interest rate, expected dividend yield and the fair value of the Company’s common stock. Since the Company has limited option exercise history, it has generally elected to estimate the expected life of an award based upon the “simplified method” with the continued use of this method extended until such time the Company has sufficient exercise history. The expected share price volatility for the Company’s common stock is estimated by taking the average historical price volatility for the Company’s peers. The risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the expected life of the equity award. As the Company has never paid and does not anticipate paying cash dividends on its common stock, the expected dividend yield is assumed to be zero. The Company accounts for pre-vesting award forfeitures when they occur. [H] Net Loss per Common Share Basic net loss per common share is computed by dividing net loss applicable to common stockholders by the weighted-average number of common stock outstanding during the period. Diluted net loss per common share is computed by dividing the net loss applicable to common stockholders by the diluted weighted-average number of common stock outstanding during the period. In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per common share and diluted net loss per common share are equivalent. Potentially dilutive common stock has been excluded from the diluted net loss per common share computations in all periods presented because such securities have an anti-dilutive effect on net loss per common share due to the Company’s net loss. There are no reconciling items used to calculate the weighted-average number of total common stock outstanding for basic and diluted net loss per common share data. The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Six Months Ended September 30, 2022 2021 Preferred stock as converted 10,000 10,000 Options 11,185,963 6,156,944 Restricted stock units 4,587,727 3,394,097 Total 15,783,690 9,561,041 [I] Recent Accounting Pronouncements Recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the SEC did not, or are not expected to, have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures. |
Material Agreements
Material Agreements | 6 Months Ended |
Sep. 30, 2022 | |
Material Agreements [Abstract] | |
Material Agreements | Material Agreements License Agreement On December 19, 2017, Roivant Sciences GmbH (“RSG”), a wholly owned subsidiary of Roivant Sciences Ltd. (“RSL”), entered into a license agreement (the “HanAll Agreement”) with HanAll Biopharma Co., Ltd. (“HanAll”). Under the HanAll Agreement, RSG received (1) the non-exclusive right to manufacture and (2) the exclusive, royalty-bearing right to develop, import, use and commercialize the antibody referred to as batoclimab and certain back-up and next-generation antibodies (including IMVT-1402), and products containing such antibodies, in the United States of America (the “U.S.”), Canada, Mexico, the European Union, the United Kingdom, Switzerland, the Middle East, North Africa and Latin America (the “Licensed Territory”). In exchange for this license, RSG provided or agreed to provide the following consideration: • Upfront, non-refundable payment of $30.0 million; • Up to $20.0 million in shared (50%) research, development, and out-of-pocket costs incurred by HanAll; • Up to an aggregate of $442.5 million (after a $10.0 million milestone payment in August 2019) upon the achievement of certain development, regulatory and sales milestones; and • Tiered royalties ranging from the mid-single digits to mid-teens percentage of net sales of licensed products, subject to standard offsets and reductions, on a product-by-product and country-by-country basis, until the later of (1) expiration of patent and regulatory exclusivity or (2) the 11th anniversary of the first commercial sale of such product in such country. On August 18, 2018, RSG entered into a sublicense agreement (the “Sublicense Agreement”) with Immunovant Sciences GmbH (“ISG”), a wholly-owned subsidiary of the Company, to sublicense this technology, as well as RSG’s know-how and patents necessary for the development, manufacture or commercialization of any compound or product that pertains to immunology. On December 7, 2018, RSG issued a notice to terminate the Sublicense Agreement with ISG and entered into an assignment and assumption agreement to assign to ISG all the rights, title, interest, and future obligations under the HanAll Agreement from RSG, including all rights to batoclimab and IMVT-1402 from RSG in the Licensed Territory, for an aggregate purchase price of $37.8 million. As of September 30, 2022, the Company does not have any amounts payable to HanAll for research and development costs incurred and reported to the Company pursuant to the HanAll Agreement. Product Service Agreement and Master Services Agreement On November 17, 2021, ISG entered into a Product Service Agreement (“PSA”) with Samsung Biologics Co., Ltd. (“Samsung”), pursuant to which Samsung will manufacture and supply the Company with batoclimab drug substance for commercial sale, if approved, and perform other manufacturing-related services with respect to batoclimab. The Company previously entered in a Master Services Agreement (“MSA”) with Samsung, dated April 30, 2021, which governs certain terms of the Company’s relationship with Samsung. Upon execution of the PSA, the Company committed to purchase process performance qualification batches of batoclimab and pre-approval inspection batches of batoclimab which may be used for regulatory submissions and, pending regulatory approval, commercial sale. In addition to these, the Company is obligated to purchase additional batches of batoclimab in the four-year period of 2026 through 2029. The PSA will continue until the later of December 31, 2029 or the completion of the services thereunder, unless the PSA is terminated earlier. If the Company makes a final decision to stop all development of batoclimab and all attempts to obtain regulatory approval for batoclimab, then the Company will have the right to terminate the PSA with 30 days’ written notice to Samsung as long as such notice is provided no later than January 2024. Upon such termination of the PSA, the Company will pay Samsung for non-cancellable service fees and costs that Samsung incurs and for all batches of batoclimab scheduled to be manufactured during the two-year period following such termination. In addition, either party may terminate the PSA on account of (i) the other party’s material breach of the PSA that is not cured within a specified period after the termination notice, (ii) the other party’s insolvency or bankruptcy, or (iii) certain force majeure events. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, 2022 March 31, 2022 Research and development expenses $ 17,174 $ 18,196 Accrued bonuses 3,607 4,456 Legal and other professional fees 835 679 Other expenses 1,522 1,415 Total accrued expenses $ 23,138 $ 24,746 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Roivant Sciences, Inc. (“RSI”) and RSG Services Agreements In August 2018, the Company entered into amended and restated services agreements (the “Services Agreements”) with RSI and RSG, under which RSI and RSG agreed to provide services related to development, administrative and financial activities to the Company. Under each Services Agreement, the Company will pay or reimburse RSI or RSG, as applicable, for any expenses it, or third parties acting on its behalf, incurs for the Company. For any general and administrative and research and development activities performed by RSI or RSG employees, RSI or RSG, as applicable, will charge back the employee compensation expense plus a pre-determined mark-up. Employee compensation expense, inclusive of base salary and fringe benefits, is determined based upon the relative percentage of time utilized on Company matters. All other costs will be billed back at cost. The term of the Services Agreements will continue until terminated by the Company, RSI or RSG, as applicable, upon 90 days’ written notice. For the three and six months ended September 30, 2022, the Company was charged $0.4 million under the Services Agreements, which are included in the accompanying unaudited condensed consolidated statements of operations. For the three and six months ended September 30, 2021, the Company was charged $0.8 million and $0.9 million, respectively, under the Services Agreements, which were treated as capital contributions in the accompanying unaudited condensed consolidated financial statements. RSL Information Sharing and Cooperation Agreement In December 2018, the Company entered into an amended and restated information sharing and cooperation agreement (the “Cooperation Agreement”) with RSL. The Cooperation Agreement, among other things: (1) obligates the Company to deliver to RSL periodic financial statements and other information upon reasonable request and to comply with other specified financial reporting requirements; (2) requires the Company to supply certain material information to RSL to assist it in preparing any future SEC filings; and (3) requires the Company to implement and observe certain policies and procedures related to applicable laws and regulations. The Company has agreed to indemnify RSL and its affiliates and their respective officers, employees and directors against all losses arising out of, due to or in connection with RSL’s status as a stockholder under the Cooperation Agreement and the operations of or services provided by RSL or its affiliates or their respective officers, employees or directors to the Company or any of its subsidiaries, subject to certain limitations set forth in the Cooperation Agreement. No amounts have been paid or received under this agreement. Subject to specified exceptions, the Cooperation Agreement will terminate upon the earlier of (1) the mutual written consent of the parties or (2) the later of when RSL no longer (a) is required by U.S. GAAP to consolidate the Company’s results of operations and financial position, account for its investment in the Company under the equity method of accounting or, by any rule of the SEC, include the Company’s separate financial statements in any filings it may make with the SEC and (b) has the right to elect directors constituting a majority of the Company’s board of directors. RSI Subleases In June 2020, the Company entered into two sublease agreements with RSI for two floors of the building the Company currently occupies as its headquarters in New York. The subleases will expire on February 27, 2024 and April 29, 2024, respectively, and have scheduled rent increases each year. During the three months ended September 30, 2022 and 2021, the Company incurred $0.3 million in each period in rent expense under these operating leases. During the six months ended September 30, 2022 and 2021, the Company incurred $0.6 million in each period in rent expense under these operating leases. RSL Share Purchase Agreement On August 2, 2021, the Company and RSL entered into a share purchase agreement pursuant to which the Company issued 17,021,276 shares of the Company’s common stock, par value $0.0001 per share, to RSL at a per share price of $11.75 and received aggregate net proceeds of $200.0 million. Prior to the share issuance, the Company and RSL explored alternative potential transactions whereby the Company incurred additional costs, including $5.0 million in financial advisory fees, which are included in general and administrative expenses in the accompanying unaudited condensed consolidated financial statements for the three and six months ended September 30, 2021. |
Income Taxes
Income Taxes | 6 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company’s effective tax rates were (0.55)% and 0.08% for the three months ended September 30, 2022 and 2021, respectively, and (0.70)% and 0.11% for the six months ended September 30, 2022 and 2021, respectively. The Company’s effective rate is primarily driven by its jurisdictional earnings by location and a valuation allowance that eliminates the Company’s global net deferred tax assets. The Company assesses the realizability of its deferred tax assets at each balance sheet date based on available positive and negative evidence in order to determine the amount which is more likely than not to be realized and records a valuation allowance as necessary. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Series A Preferred Stock As of September 30, 2022, 10,000 shares of Series A preferred stock, par value $0.0001 per share, were outstanding and held by RSL. Each share of Series A preferred stock will automatically convert into one share of common stock at such time as the holder(s) of Series A preferred stock hold less than 25% of the total voting power of the Company’s outstanding shares. In the event of the Company’s liquidation, dissolution, or winding up, the holder(s) of the Series A preferred stock will receive first an amount per share equal to $0.01 and then will be entitled to share ratably in the assets legally available for distribution to all stockholders. Preferred Stock As of September 30, 2022, the Company has authorized 10,010,000 shares of preferred stock, par value $0.0001 per share. Other than the 10,000 shares of preferred stock designated as Series A preferred stock, there were no issued and outstanding shares of preferred stock as of September 30, 2022. Common Stock As of September 30, 2022, the Company authorized 500,000,000 shares of common stock, par value $0.0001 per share and has 116,614,088 shares of common stock issued and outstanding. See Note 10 - Subsequent Event regarding the Company’s completion of an underwritten public offering in October 2022. The Company has reserved the following shares of common stock for issuance: September 30, 2022 March 31, 2022 Conversion of Series A preferred stock 10,000 10,000 Options outstanding 11,185,963 8,018,731 Restricted stock units outstanding 4,850,221 2,816,197 Equity awards available for future grants 1,510,167 2,188,860 Total 17,556,351 13,033,788 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2019 Equity Incentive Plan In December 2019, the Company’s stockholders approved the 2019 Equity Incentive Plan (the “2019 Plan”) and reserved 5,500,000 shares of common stock for issuance thereunder. The maximum number of shares of common stock that may be issued pursuant to the exercise of incentive options under the 2019 Plan is 16,500,000. The number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on April 1 of each year, continuing through April 1, 2029, by 4.0% of the total number of shares of common stock outstanding on the last day of the preceding month. On April 1, 2022, 4,659,315 shares of common stock were added to the 2019 Plan pool in accordance with the evergreen provision of the 2019 Plan. As of September 30, 2022, options to purchase 8,254,348 shares of common stock and 4,587,727 restricted stock units (“RSUs”) were outstanding under the 2019 Plan and 1,510,167 shares of common stock remained available for future grant under the 2019 Plan. 2018 Equity Incentive Plan As of the effective date of the 2019 Plan, no further stock awards have been or will be made under 2018 Equity Incentive Plan (the “2018 Plan”). As of September 30, 2022, 2,931,615 stock options were outstanding under the 2018 Plan. Stock Option Activity A summary of the stock option activity under the Company’s equity incentive plans is as follows: Number of Weighted- Remaining Aggregate Balance - March 31, 2022 8,018,731 $ 8.48 8.52 $ 60 Granted 3,375,223 4.91 Exercised (11,004) 1.91 Forfeited (171,872) 7.09 Expired (25,115) 8.62 Balance - September 30, 2022 11,185,963 $ 7.43 8.54 $ 2,321 Exercisable - September 30, 2022 4,002,738 $ 8.98 7.37 $ 17 The aggregate intrinsic value is calculated as the difference between the exercise price of all outstanding and exercisable stock options and the fair value of the Company’s common stock as of September 30, 2022. The intrinsic value of stock options exercised for the six months ended September 30, 2022 was de minimis. There were no stock options exercised during the six months ended September 30, 2021. The stock options granted during the six months ended September 30, 2022 had a weighted-average grant date fair value per share of $3.69. The Company estimated the fair value of each option on the date of grant using the Black-Scholes option pricing model applying the weighted-average assumptions in the following table: Three Months Ended September 30, Six Months Ended September 30, 2022 2021 2022 2021 Risk-free interest rate 2.89% - 4.11% 0.80% - 1.12% 2.74% - 4.11% 0.80% - 1.12% Expected term, in years 6.11 6.11 6.11 6.03 - 6.11 Expected volatility 88.53% - 88.78% 88.72% - 91.15% 87.12% - 88.78% 82.92% - 91.15% Expected dividend yield —% —% —% —% Restricted Stock Unit Awards A summary of RSUs activity under the Company’s equity incentive plans is as follows: Number of RSUs Weighted- Average Grant Date Fair Value Nonvested as of March 31, 2022 2,670,864 $ 9.12 Issued 2,329,293 4.88 Vested (238,354) 13.04 Forfeited (174,076) 8.61 Nonvested as of September 30, 2022 4,587,727 $ 6.78 Stock-based Compensation Expense For the three and six months ended September 30, 2022 and 2021, stock-based compensation expense under the Company’s equity incentive plans was as follows (in thousands): Three Months Ended Six Months Ended September 30, 2022 2021 2022 2021 Research and development expenses $ 3,813 $ 3,768 $ 7,419 $ 3,805 General and administrative expenses 4,238 3,901 8,187 7,684 Total stock-based compensation $ 8,051 $ 7,669 $ 15,606 $ 11,489 As of September 30, 2022, total unrecognized compensation expense related to non-vested stock options and RSUs was $40.6 million and $22.9 million, respectively, which is expected to be recognized over the remaining weighted-average service period of 2.82 years and 2.46 years, respectively. Stock-based Compensation Allocated to the Company by RSL In relation to the RSL common share awards and options issued by RSL to employees of Roivant and the Company, stock-based compensation expense of $0.1 million and $0.2 million was recorded for the three months ended September 30, 2022 and 2021, respectively, and $0.2 million and $0.3 million for the six months ended September 30, 2022 and 2021, respectively, in the accompanying unaudited condensed consolidated statements of operations. RSL RSUs |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Litigation The Company is involved in various lawsuits, claims and other legal matters from time to time that arise in the ordinary course of conducting business. The Company records a liability when a particular contingency is probable and estimable. In February 2021, a putative securities class action complaint was filed against the Company and certain of its current and former officers in the U.S. District Court for the Eastern District of New York on behalf of a class consisting of those who acquired the Company’s securities between October 2, 2019 and February 1, 2021. The complaint alleges that the Company and certain of its officers violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, by making false and misleading statements regarding the safety of batoclimab and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including reasonable attorneys’ fees. On December 29, 2021, the U.S. District Court appointed a lead plaintiff. On February 1, 2022, the lead plaintiff filed an amended complaint adding RSL and the Company’s directors and underwriters as defendants, and asserting additional claims under Section 11, 12(a)(2), and 15 of the Securities Act of 1933 on behalf of a putative class consisting of those who purchased or otherwise acquired the Company’s securities pursuant and/or traceable to the Company’s follow-on public offering on or about September 2, 2020. On March 15, 2022, the lead plaintiff filed a further amended complaint. The Company and other defendants served motions to dismiss the amended complaint on May 27, 2022. The fully briefed motion to dismiss, including defendants’ opening briefs, lead plaintiff’s opposition, and defendants’ replies were filed with the court on September 9, 2022. No hearing date has been set. The Company intends to continue to vigorously defend the case and has not recorded a liability related to this lawsuit because, at this time, the Company is unable to reasonably estimate possible losses or determine whether an unfavorable outcome is either probable or remote. Commitments During the year ended March 31, 2022, ISG entered into the PSA with Samsung to manufacture a certain quantity of batoclimab drug substance for, among other things, commercial sale, if approved. In connection with this agreement, the Company has a minimum obligation to Samsung of approximately $36.0 million, of which is $17.7 million is expected to be paid during the fiscal year ending March 31, 2023 and $18.3 million is expected to be paid during the fiscal year ending March 31, 2026. Of the amount expected to be paid in fiscal year 2023, $1.7 million was included in research and development expenses and accrued expenses in the accompanying unaudited condensed consolidated financial statements as of, and for the three and six months ended September 30, 2022. See Note 3 - Material Agreements for additional details. As of September 30, 2022, the Company did not have any other ongoing material contractual obligations for which cash flows were fixed and determinable. In the normal course of business, the Company enters into agreements with CROs for clinical trials and with vendors for nonclinical studies, manufacturing and other services and products for operating purposes, which agreements are generally cancellable by the Company at any time, subject to payment of remaining obligations under binding purchase orders and, in certain cases, nominal early-termination fees. These commitments are not deemed significant. There are certain contracts wherein the Company has a minimum purchase commitment, however, most of it is due and payable within one year. Contingencies The extent of the impact of COVID-19, geopolitical tensions and resulting global slowdown of economic activity, decades-high inflation, rising interest rates and a potential recession in the U.S. on the Company’s future operational and financial performance will depend on certain developments, including the duration and spread of the pandemic, including its variants, impact on employees and vendors, and impact on clinical trial sites and patients, all of which are uncertain and cannot be predicted. At this point, the extent to which these events may impact the Company’s future financial condition or results of operations is uncertain. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent EventIn October 2022, the Company completed an underwritten public offering of 12,500,000 shares of its common stock (including 416,667 shares of common stock purchased by RSL) at a price to the public of $6.00 per share, for net proceeds to the Company of approximately $70.2 million after deducting underwriting discounts and commissions and offering expenses. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | [A] Basis of Presentation The Company’s fiscal year ends on March 31 and its first three fiscal quarters end on June 30, September 30, and December 31. The accompanying condensed consolidated financial statements are unaudited. The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. The Company has no unconsolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain amounts in the consolidated financial statements of the prior year have been reclassified to conform to current year presentation. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | [B] Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. The Company regularly evaluates estimates and assumptions related to assets, liabilities, stock-based compensation, litigation accruals, clinical trial accruals, operating leases, research and development costs and income taxes. The Company bases its estimates and assumptions on historical experience and on various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Additionally, the Company assessed the impact that the COVID-19 pandemic, geopolitical tensions and resulting global slowdown of economic activity, decades-high inflation, rising interest rates and a potential recession in the U.S. has had on its operations and financial results as of September 30, 2022 and through the issuance of these unaudited condensed consolidated financial statements. The Company’s analysis was informed by the facts and circumstances as they were known to the Company. This assessment considered the impact that these uncertainties may have on financial estimates and assumptions that affect the reported amounts of assets and liabilities and expenses. |
Risks and Uncertainties | [C] Risks and Uncertainties The Company is subject to risks common to early-stage companies in the biopharmaceutical industry including, but not limited to, uncertainties related to clinical effectiveness of the product, commercialization of products, regulatory approvals, dependence on key products, key personnel and third-party service providers such as contract research organizations (“CROs”), protection of intellectual property rights and the ability to make milestone, royalty or other payments due under any license, collaboration or supply agreements. |
Concentrations of Credit Risk | [D] Concentration of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk include cash and cash equivalents. As of September 30, 2022, the cash and cash equivalents balance is kept in banking institutions that the Company believes are of high credit quality and are in excess of federally insured levels. The Company maintains its cash and cash equivalents with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company has not experienced any losses on its cash and cash equivalents. |
Cash and Cash Equivalents | [E] Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. At September 30, 2022, cash and cash equivalents included $316.1 million of money market funds invested in high-quality, short-term securities that are issued and guaranteed by the U.S. government and its agencies that are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. There were no cash equivalents as of March 31, 2022. |
Research and Development Expense | [F] Research and Development Expense Research and development costs with no alternative future use are expensed as incurred. Payments for a product license prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are expensed in the period incurred as research and development. Milestone payments made in connection with regulatory approvals are capitalized and amortized to cost of product sales over the remaining useful life of the asset. Research and development expenses primarily consist of employee-related costs, milestone payments under the HanAll Agreement and expenses from third parties who conduct research and development activities (including manufacturing) on behalf of the Company. The Company accrues costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by CROs. In making these estimates, the Company considers various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment. The Company accrues costs for non-clinical studies and contract manufacturing activities over the service periods specified in the contracts and are adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. The estimate of the work completed is developed through discussions with internal personnel and external services providers as to the progress toward completion of the services and the agreed-upon fee to be paid for such services. As actual costs become known, the accrued estimates are adjusted. Such estimates are not expected to be materially different from amounts actually incurred. The Company participates in cost-sharing arrangements with third parties whereas the third parties have agreed to share a portion of the costs incurred by the Company, related to batoclimab drug manufacturing and clinical trials. The Company records the third parties’ share of the costs as a reduction of research and development expenses and an increase to accounts receivable in the accompanying unaudited condensed consolidated financial statements based on actual amounts incurred by the Company and billable to the third parties. These cost-sharing arrangements do not contemplate any future revenue-generating activity or global commercialization efforts of batoclimab benefiting any of the parties. |
Stock-based Compensation | [G] Stock-based Compensation Stock-based awards to employees and directors are valued at fair value on the date of the grant and that fair value is recognized as stock-based compensation expense over the requisite service period. The grant date fair value of the stock-based awards with graded vesting is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. The Company values its stock options that only have service vesting requirements using the Black-Scholes option pricing model. Stock-based compensation related to restricted stock awards is based on the fair value of the Company’s common stock on the grant date. When determining the grant-date fair value of stock-based awards, management further considers whether an adjustment is required to the observable market price or volatility of the Company’s common stock that is used in the valuation as a result of material non-public information, if that information is expected to result in a material increase in share price. Certain assumptions need to be made with respect to utilizing the Black-Scholes option pricing model, including the expected life of the award, volatility of the underlying shares, the risk-free interest rate, expected dividend yield and the fair value of the Company’s common stock. Since the Company has limited option exercise history, it has generally elected to estimate the expected life of an award based upon the “simplified method” with the continued use of this method extended until such time the Company has sufficient exercise history. The expected share price volatility for the Company’s common stock is estimated by taking the average historical price volatility for the Company’s peers. The risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the expected life of the equity award. As the Company has never paid and does not anticipate paying cash dividends on its common stock, the expected dividend yield is assumed to be zero. The Company accounts for pre-vesting award forfeitures when they occur. |
Net Loss per Common Share | [H] Net Loss per Common Share Basic net loss per common share is computed by dividing net loss applicable to common stockholders by the weighted-average number of common stock outstanding during the period. Diluted net loss per common share is computed by dividing the net loss applicable to common stockholders by the diluted weighted-average number of common stock outstanding during the period. In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per common share and diluted net loss per common share are equivalent. Potentially dilutive common stock has been excluded from the diluted net loss per common share computations in all periods presented because such securities have an anti-dilutive effect on net loss per common share due to the Company’s net loss. There are no reconciling items used to calculate the weighted-average number of total common stock outstanding for basic and diluted net loss per common share data. |
Recent Accounting Pronouncements | [I] Recent Accounting Pronouncements Recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the SEC did not, or are not expected to, have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Potentially Dilutive Securities that Have Been Excluded from the Calculation of Diluted Net Loss Per Share Due to their Anti-Dilutive Effect | The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Six Months Ended September 30, 2022 2021 Preferred stock as converted 10,000 10,000 Options 11,185,963 6,156,944 Restricted stock units 4,587,727 3,394,097 Total 15,783,690 9,561,041 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, 2022 March 31, 2022 Research and development expenses $ 17,174 $ 18,196 Accrued bonuses 3,607 4,456 Legal and other professional fees 835 679 Other expenses 1,522 1,415 Total accrued expenses $ 23,138 $ 24,746 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | The Company has reserved the following shares of common stock for issuance: September 30, 2022 March 31, 2022 Conversion of Series A preferred stock 10,000 10,000 Options outstanding 11,185,963 8,018,731 Restricted stock units outstanding 4,850,221 2,816,197 Equity awards available for future grants 1,510,167 2,188,860 Total 17,556,351 13,033,788 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | A summary of the stock option activity under the Company’s equity incentive plans is as follows: Number of Weighted- Remaining Aggregate Balance - March 31, 2022 8,018,731 $ 8.48 8.52 $ 60 Granted 3,375,223 4.91 Exercised (11,004) 1.91 Forfeited (171,872) 7.09 Expired (25,115) 8.62 Balance - September 30, 2022 11,185,963 $ 7.43 8.54 $ 2,321 Exercisable - September 30, 2022 4,002,738 $ 8.98 7.37 $ 17 |
Schedule of Fair Value Assumptions | The Company estimated the fair value of each option on the date of grant using the Black-Scholes option pricing model applying the weighted-average assumptions in the following table: Three Months Ended September 30, Six Months Ended September 30, 2022 2021 2022 2021 Risk-free interest rate 2.89% - 4.11% 0.80% - 1.12% 2.74% - 4.11% 0.80% - 1.12% Expected term, in years 6.11 6.11 6.11 6.03 - 6.11 Expected volatility 88.53% - 88.78% 88.72% - 91.15% 87.12% - 88.78% 82.92% - 91.15% Expected dividend yield —% —% —% —% |
Schedule of Restricted Stock Unit Awards Activity | A summary of RSUs activity under the Company’s equity incentive plans is as follows: Number of RSUs Weighted- Average Grant Date Fair Value Nonvested as of March 31, 2022 2,670,864 $ 9.12 Issued 2,329,293 4.88 Vested (238,354) 13.04 Forfeited (174,076) 8.61 Nonvested as of September 30, 2022 4,587,727 $ 6.78 |
Summary of Stock-based Compensation Expense | For the three and six months ended September 30, 2022 and 2021, stock-based compensation expense under the Company’s equity incentive plans was as follows (in thousands): Three Months Ended Six Months Ended September 30, 2022 2021 2022 2021 Research and development expenses $ 3,813 $ 3,768 $ 7,419 $ 3,805 General and administrative expenses 4,238 3,901 8,187 7,684 Total stock-based compensation $ 8,051 $ 7,669 $ 15,606 $ 11,489 |
Description of Business and L_2
Description of Business and Liquidity - Additional Information (Detail) $ in Thousands | 6 Months Ended | |
Sep. 30, 2022 USD ($) segment | Mar. 31, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of reportable segments | segment | 1 | |
Number of operating segments | segment | 1 | |
Cash and cash equivalents | $ | $ 405,773 | $ 493,817 |
Accumulated deficit | $ | $ 443,688 | $ 355,387 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Sep. 30, 2022 | Mar. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Cash and cash equivalents | $ 405,773,000 | $ 493,817,000 |
Cash equivalents | $ 0 | |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Cash and Cash Equivalents [Line Items] | ||
Cash and cash equivalents | $ 316,100,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (Detail) - shares | 6 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 15,783,690 | 9,561,041 |
Preferred stock as converted | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 10,000 | 10,000 |
Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 11,185,963 | 6,156,944 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,587,727 | 3,394,097 |
Material Agreements - Additiona
Material Agreements - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | |||
Nov. 17, 2021 | Dec. 07, 2018 | Dec. 19, 2017 | Aug. 31, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront, non-refundable payment | $ 30 | |||
Research and development and out-of-pocket (in percent) | 50% | |||
Milestone payments | $ 10 | |||
Purchase price | $ 37.8 | |||
Samsung Biologics Co., Ltd | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Purchase obligation, additional purchases, period (in years) | 4 years | |||
Purchase obligation, termination notice period (in days) | 30 days | |||
Purchase obligation, fees covered, termination period (in years) | 2 years | |||
Maximum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Consideration paid | $ 20 | |||
Maximum | Upon Achievement Of Development Regulatory And Sales Milestones | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Contingent milestone payments | $ 442.5 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Mar. 31, 2022 |
Payables and Accruals [Abstract] | ||
Research and development expenses | $ 17,174 | $ 18,196 |
Accrued bonuses | 3,607 | 4,456 |
Legal and other professional fees | 835 | 679 |
Other expenses | 1,522 | 1,415 |
Total accrued expenses | $ 23,138 | $ 24,746 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Aug. 02, 2021 USD ($) $ / shares shares | Aug. 31, 2018 | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2020 subleaseAgreement | |
Related Party Transaction [Line Items] | |||||||
Related party transaction, amounts | $ 0.4 | $ 0.8 | $ 0.4 | $ 0.9 | |||
Number of sublease agreements | subleaseAgreement | 2 | ||||||
Operating lease rent expense | $ 0.3 | $ 0.3 | $ 0.6 | $ 0.6 | |||
Roivant Sciences Ltd. (RSL) | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase obligation, termination notice period (in days) | 90 days | ||||||
Number of shares issued in transaction (in shares) | shares | 17,021,276 | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||
Price per share issued (in USD per share) | $ / shares | $ 11.75 | ||||||
Consideration received from sale of stock | $ 200 | ||||||
Financial advisory fees | $ 5 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Effective income tax rate (in percent) | (0.55%) | 0.08% | (0.70%) | 0.11% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - $ / shares | Sep. 30, 2022 | Mar. 31, 2022 |
Subsidiary or Equity Method Investee [Line Items] | ||
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, issued (in shares) | 116,614,088 | 116,482,899 |
Common stock, outstanding (in shares) | 116,614,088 | 116,482,899 |
Restricted stock units vested and not settled (not unvested) | ||
Subsidiary or Equity Method Investee [Line Items] | ||
Restricted stock units outstanding (in shares) | 262,494 | |
Series A preferred stock | ||
Subsidiary or Equity Method Investee [Line Items] | ||
Preferred stock, issued (in shares) | 10,000 | 10,000 |
Preferred stock, outstanding (in shares) | 10,000 | 10,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Liquidation amount per share (in dollars per share) | $ 0.01 | |
Preferred stock, authorized (in shares) | 10,000 | 10,000 |
Series A preferred stock | Maximum | ||
Subsidiary or Equity Method Investee [Line Items] | ||
Percentage of voting power of outstanding shares | 25% | |
Roivant Sciences Ltd. | Series A preferred stock | ||
Subsidiary or Equity Method Investee [Line Items] | ||
Preferred stock, issued (in shares) | 10,000 | |
Preferred stock, outstanding (in shares) | 10,000 | |
Preferred stock, par value (in dollars per share) | $ 0.0001 | |
Preferred Stock | ||
Subsidiary or Equity Method Investee [Line Items] | ||
Preferred stock, issued (in shares) | 0 | |
Preferred stock, outstanding (in shares) | 0 | |
Preferred stock, authorized (in shares) | 10,010,000 | |
Common stock | ||
Subsidiary or Equity Method Investee [Line Items] | ||
Common stock, authorized (in shares) | 500,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | |
Common stock, issued (in shares) | 116,614,088 | |
Common stock, outstanding (in shares) | 116,614,088 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of common stock reserved for future issuance (Detail) - shares | Sep. 30, 2022 | Apr. 01, 2022 | Mar. 31, 2022 |
Schedule Of Common Stock Reserved For Future Issuance [Line Items] | |||
Conversion of Series A preferred stock (in shares) | 10,000 | 10,000 | |
Options outstanding (in shares) | 11,185,963 | 8,018,731 | |
Equity awards available for future grants (in shares) | 1,510,167 | 2,188,860 | |
Total (in shares) | 17,556,351 | 4,659,315 | 13,033,788 |
Restricted stock units outstanding | |||
Schedule Of Common Stock Reserved For Future Issuance [Line Items] | |||
Restricted stock units outstanding (in shares) | 4,850,221 | 2,816,197 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jan. 31, 2021 | Dec. 31, 2019 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Apr. 01, 2022 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of common shares available for future issuance (in shares) | 17,556,351 | 17,556,351 | 4,659,315 | 13,033,788 | ||||
Common shares outstanding (in shares) | 1,510,167 | 1,510,167 | 2,188,860 | |||||
Stock options exercised (in shares) | 11,004 | 0 | ||||||
Weighted average fair value at the grant date (in dollars per share) | $ 3.69 | |||||||
Share based compensation expense | $ 8,051 | $ 7,669 | $ 15,606 | $ 11,489 | ||||
Research and Development Expense | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share based compensation expense | 3,813 | 3,768 | 7,419 | 3,805 | ||||
Stock Options | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Unrecognized equity-based compensation related to unvested stock options | $ 40,600 | $ 40,600 | ||||||
Remaining weighted average service period for recognition | 2 years 9 months 25 days | |||||||
Restricted stock units | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Restricted stock units outstanding (in shares) | 4,587,727 | 4,587,727 | 2,670,864 | |||||
Unrecognized equity-based compensation related to RSUs | $ 22,900 | $ 22,900 | ||||||
Remaining weighted average service period for recognition | 2 years 5 months 15 days | |||||||
Restricted stock units, grants in period (in shares) | 2,329,293 | |||||||
Roivant Sciences Ltd. (RSL) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share based compensation expense | 100 | 200 | $ 200 | 300 | ||||
Roivant Sciences Ltd. (RSL) | Restricted stock units | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Unrecognized equity-based compensation related to unvested stock options | 200 | 200 | ||||||
Share based compensation expense | $ 100 | $ 400 | $ 200 | $ 400 | ||||
Restricted stock units, grants in period (in shares) | 73,155 | |||||||
Award vesting period | 4 years | |||||||
2019 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of common shares available for future issuance (in shares) | 5,500,000 | 1,510,167 | 1,510,167 | |||||
Maximum number of shares issued (in shares) | 16,500,000 | |||||||
Percentage of common stock outstanding | 4% | |||||||
Common shares outstanding (in shares) | 8,254,348 | 8,254,348 | ||||||
2019 Equity Incentive Plan | Restricted stock units | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Restricted stock units outstanding (in shares) | 4,587,727 | 4,587,727 | ||||||
2018 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common shares outstanding (in shares) | 2,931,615 | 2,931,615 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of stock option activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | Mar. 31, 2022 | |
Number of Options | |||
Number of options, beginning balance (in shares) | 8,018,731 | ||
Number of options, granted (in shares) | 3,375,223 | ||
Number of options, exercised (in shares) | (11,004) | 0 | |
Number of options, forfeited (in shares) | (171,872) | ||
Number of options, expired (in shares) | (25,115) | ||
Number of options, ending balance (in shares) | 11,185,963 | 8,018,731 | |
Weighted- Average Exercise Price | |||
Weighted-average exercise price, beginning balance (in dollars per share) | $ 8.48 | ||
Weighted-average exercise price, granted (in dollars per share) | 4.91 | ||
Weighted average exercise price, exercised (in dollars per share) | 1.91 | ||
Weighted-average exercise price, forfeited (in dollars per share) | 7.09 | ||
Weighted-average exercise price, expired (in dollars per share) | 8.62 | ||
Weighted-average exercise price, ending balance (in dollars per share) | $ 7.43 | $ 8.48 | |
Additional Disclosures | |||
Remaining contractual term | 8 years 6 months 14 days | 8 years 6 months 7 days | |
Aggregate intrinsic value | $ 2,321 | $ 60 | |
Number of options, exercisable (in shares) | 4,002,738 | ||
Weighted-average exercise price, exercisable (in dollars per share) | $ 8.98 | ||
Remaining contractual term, exercisable | 7 years 4 months 13 days | ||
Aggregate intrinsic value, exercisable | $ 17 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of fair value assumptions (Detail) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term, in years | 6 years 1 month 9 days | 6 years 1 month 9 days | 6 years 1 month 9 days | |
Expected dividend yield | 0% | 0% | 0% | 0% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 2.89% | 0.80% | 2.74% | 0.80% |
Expected term, in years | 6 years 10 days | |||
Expected volatility | 88.53% | 88.72% | 87.12% | 82.92% |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 4.11% | 1.12% | 4.11% | 1.12% |
Expected term, in years | 6 years 1 month 9 days | |||
Expected volatility | 88.78% | 91.15% | 88.78% | 91.15% |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Unit Awards (Details) - Restricted stock units | 6 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Number of RSUs | |
Outstanding, beginning balance (in shares) | shares | 2,670,864 |
Restricted stock units, issued (in shares) | shares | 2,329,293 |
Restricted stock units, vested (in shares) | shares | (238,354) |
Restricted stock units, forfeited (in shares) | shares | (174,076) |
Outstanding, ending balance (in shares) | shares | 4,587,727 |
Weighted- Average Grant Date Fair Value | |
Outstanding, weighted-average grant date fair value, beginning balance (in dollars per share) | $ / shares | $ 9.12 |
Issued, weighted-average grant date fair value (in dollars per share) | $ / shares | 4.88 |
Vested, weighted-average grant date fair value (in dollars per share) | $ / shares | 13.04 |
Forfeited, weighted-average grant date fair value (in dollars per share) | $ / shares | 8.61 |
Outstanding, weighted-average grant date fair value, ending balance (in dollars per share) | $ / shares | $ 6.78 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of share based compensation expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 8,051 | $ 7,669 | $ 15,606 | $ 11,489 |
Research and Development Expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 3,813 | 3,768 | 7,419 | 3,805 |
General and Administrative Expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 4,238 | $ 3,901 | $ 8,187 | $ 7,684 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Long-term Purchase Commitment [Line Items] | ||||
Research and development | $ 37,739 | $ 21,361 | $ 66,168 | $ 40,066 |
Samsung Biologics Co., Ltd | ||||
Long-term Purchase Commitment [Line Items] | ||||
Purchase obligation | 36,000 | 36,000 | ||
Purchase obligation, to be paid in 2023 | 17,700 | 17,700 | ||
Purchase obligation, to be paid in 2026 | 18,300 | 18,300 | ||
Research and development | 1,700 | 1,700 | ||
Accrued Liabilities | $ 1,700 | $ 1,700 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event $ / shares in Units, $ in Millions | 1 Months Ended |
Oct. 31, 2022 USD ($) $ / shares shares | |
Subsequent Event [Line Items] | |
Price per share issued (in USD per share) | $ / shares | $ 6 |
Consideration received from sale of stock | $ | $ 70.2 |
Public Stock Offering | |
Subsequent Event [Line Items] | |
Number of shares issued in transaction (in shares) | 12,500,000 |
Roivant Sciences Ltd. (RSL) | Public Stock Offering - Shares From Existing Shareholders | |
Subsequent Event [Line Items] | |
Number of shares issued in transaction (in shares) | 416,667 |