imvt-20230930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number 001-38906

IMMUNOVANT, INC.

(Exact name of Registrant as specified in its Charter)


Delaware		83-2771572
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

320 West 37th Street		10018
New York,	NY
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (917) 580-3099

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange
on which registered

Common Stock, $0.0001 par value per share

IMVT

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated Filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 3, 2023, there were 144,661,930 shares of the Registrant’s common stock, $0.0001 par value per share, outstanding.

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IMMUNOVANT, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023

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		Page

PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)	4
	Condensed Consolidated Balance Sheets as of September 30, 2023 and March 31, 2023	4
	Condensed Consolidated Statements of Operations for the Three and Six Months Ended September 30, 2023 and 2022	5
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended September 30, 2023 and 2022	6
	Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended September 30, 2023 and 2022	7
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended September 30, 2023 and 2022	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	31
PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	32
Item 1A.	Risk Factors	32
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	86
Item 3.	Defaults Upon Senior Securities	86
Item 4.	Mine Safety Disclosures	86
Item 5.	Other Information	86
Item 6.	Exhibits	87
SIGNATURES		88

Where You Can Find More Information

Investors and others should note that we may announce material business and financial information to our investors using our investor relations website (www.immunovant.com), filings we make with the Securities and Exchange Commission, webcasts, press releases, and conference calls. We use these mediums, including our website, to communicate with our stockholders and the public about our company, our product candidate, and other matters. It is possible that the information that we make available may be deemed to be material information. We therefore encourage investors and others interested in our company to review the information that we make available on our website.

The information contained on the website referenced in this Quarterly Report on Form 10-Q is not incorporated by reference into this filing, and the website address is provided only as an inactive textual reference.

All trademarks, trade names, service marks, and copyrights appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.

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SUMMARY RISK FACTORS

You should consider carefully the risks described under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. References to “we,” “us,” and “our” in this section titled “Summary Risk Factors” refer to Immunovant, Inc. and its wholly owned subsidiaries. A summary of the risks that could materially and adversely affect our business, financial condition, operating results and prospects include the following:

•Our business is currently dependent on the successful and timely development, regulatory approval and commercialization of our product candidates, batoclimab and IMVT-1402.

•Our product candidates, or anti-FcRn product candidates developed by others, may cause adverse events or undesirable side effects or have other properties that could delay or prevent their regulatory approval, cause us to further suspend or discontinue clinical trials, abandon further development or limit the scope of any approved label or market acceptance.

•Clinical trials are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes.

•Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.

•The results of our nonclinical and clinical trials may not support our proposed claims for our product candidates, or regulatory approval on a timely basis or at all, and the results of earlier studies and trials may not be predictive of future trial results.

•Interim, “top-line” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

•Roivant Sciences Ltd. owns a significant percentage of shares of our common stock and may exert significant control over matters subject to stockholder approval.

•Our business, operations, clinical development plans, timelines and supply chain could be adversely affected by the effects of health epidemics and pandemics on manufacturing, clinical trials and other business activities performed by us or by third parties with whom we conduct business, including our contract manufacturers, contract research organizations, suppliers, shippers and others.

•Our business could be adversely affected by economic downturns, changes in inflation, increases in interest rates, natural disasters, political crises, geopolitical events, such as the crisis in Ukraine and the Middle East, or other macroeconomic conditions, which may in the future negatively impact our business and financial performance.

•We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

•Our failure to maintain or continuously improve our quality management program could have an adverse effect upon our business, subject us to regulatory actions and cause a loss of patient confidence in us or our products, among other negative consequences.

•We rely on third parties to conduct, supervise and monitor our clinical trials and if those third parties perform in an unsatisfactory manner or fail to comply with applicable requirements or our quality management program fails to detect such events in a timely manner, it may harm our business.

•We may not be able to manage our business effectively if we are unable to attract and retain key personnel.

•We plan to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.

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•Our third-party manufacturers may encounter difficulties in production or our quality management program may fail to detect quality issues at our third-party manufacturers which may delay or prevent our ability to obtain marketing approval or commercialize batoclimab or IMVT-1402 if approved.

•We have a limited operating history and have never generated any product revenue.

•We will require additional capital to fund our operations. If we fail to obtain necessary financing, we may not be able to complete the development and commercialization of batoclimab or IMVT-1402.

•Raising additional funds by issuing equity securities will cause dilution to existing stockholders. Raising additional funds through debt financings may involve restrictive covenants and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.

•We rely on the license agreement with HanAll Biopharma Co., Ltd., or the HanAll Agreement, to provide us rights to the core intellectual property relating to batoclimab and IMVT-1402. Any termination or loss of significant rights under the HanAll Agreement would adversely affect our development or commercialization of batoclimab and IMVT-1402.

•The HanAll Agreement obligates us to make milestone payments, some of which may be triggered prior to our potential commercialization of batoclimab or IMVT-1402.

•We face significant competition from other biotechnology and pharmaceutical companies targeting autoimmune disease indications. Our operating results will suffer if we fail to compete effectively.

•International expansion of our business exposes us to business, legal, regulatory, political, operational, financial and economic risks associated with conducting business outside of the U.S.

•We are subject to stringent and changing privacy, data protection, and information security laws, contractual obligations, self-regulatory schemes, government regulation and standards related to data privacy and security. Further, if our security measures are compromised now or in the future, or the security, confidentiality, integrity or availability of our information technology, software, services, communications or data is compromised, limited or fails, this could result in a material adverse effect on our business.

•If securities or industry analysts do not publish research or reports about our business or publish negative reports about our business, our share price and trading volume could decline and has declined in the past upon downgrades of our common stock.

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

IMMUNOVANT, INC.

Condensed Consolidated Balance Sheets

(Unaudited, in thousands, except share and per share data)


	September 30, 2023		March 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	269,928	$	376,532
Accounts receivable	1,421		700
Prepaid expenses and other current assets	19,828		27,101


Total current assets	291,177		404,333
Operating lease right-of-use assets	589		1,172
Property and equipment, net	304		333

Total assets	$	292,070	$	405,838
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	7,511	$	1,353
Accrued expenses	32,134		40,771
Current portion of operating lease liabilities	614		1,173


Total current liabilities	40,259		43,297
Operating lease liabilities, net of current portion	—		47
Total liabilities	40,259		43,344
Commitments and contingencies (Note 9)
Stockholders’ equity:
Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2023 and March 31, 2023	—		—
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2023 and March 31, 2023	—		—
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 131,442,024 shares issued and outstanding at September 30, 2023 and 500,000,000 shares authorized, 130,329,863 shares issued and outstanding at March 31, 2023	13		13
Additional paid-in capital	950,231		927,976
Accumulated other comprehensive income	513		852
Accumulated deficit	(698,946)		(566,347)
Total stockholders’ equity	251,811		362,494
Total liabilities and stockholders’ equity	$	292,070	$	405,838

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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IMMUNOVANT, INC.

Condensed Consolidated Statements of Operations

(Unaudited, in thousands, except share and per share data)


	Three Months Ended September 30,				Six Months Ended September 30,
	2023		2022		2023		2022
Operating expenses:
Research and development	$	47,959	$	37,739	$	98,534	$	66,168
Acquired in-process research and development	—		—		12,500		—
General and administrative	13,841		11,875		29,243		23,821
Total operating expenses	61,800		49,614		140,277		89,989

Interest income	(3,572)		(1,154)		(7,637)		(1,154)
Other income, net	(20)		(793)		(484)		(1,147)
Loss before provision for income taxes	(58,208)		(47,667)		(132,156)		(87,688)
Provision for income taxes	454		261		443		613
Net loss	$	(58,662)	$	(47,928)	$	(132,599)	$	(88,301)
Net loss per common share – basic and diluted	$	(0.45)	$	(0.41)	$	(1.01)	$	(0.76)
Weighted-average common shares outstanding – basic and diluted	131,155,642		116,572,820		130,872,717		116,630,076

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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IMMUNOVANT, INC.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited, in thousands)


	Three Months Ended September 30,				Six Months Ended September 30,
	2023		2022		2023		2022
Net loss	$	(58,662)	$	(47,928)	$	(132,599)	$	(88,301)
Other comprehensive (loss) income:
Foreign currency translation adjustments	69		(974)		339		(1,641)
Total other comprehensive (loss) income	69		(974)		339		(1,641)
Comprehensive loss	$	(58,593)	$	(48,902)	$	(132,260)	$	(89,942)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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IMMUNOVANT, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited, in thousands except share data)


	Series A preferred stock			Common stock			Additional paid-in capital		Accumulated other comprehensive income (loss)		Accumulated deficit		Total stockholders’ equity
	Shares	Amount		Shares	Amount
Balance at March 31, 2023	10,000	$	—	130,329,863	$	13	$	927,976	$	852	$	(566,347)	$	362,494
Stock options exercised and restricted stock units vested and settled	—	—		235,566	—		890		—		—		890
Capital contribution – stock-based compensation	—	—		—	—		35		—		—		35
Stock-based compensation	—	—		—	—		10,653		—		—		10,653
Foreign currency translation adjustments	—	—		—	—		—		(270)		—		(270)
Net loss	—	—		—	—		—		—		(73,937)		(73,937)
Balance at June 30, 2023	10,000	$	—	130,565,429	$	13	$	939,554	$	582	$	(640,284)	$	299,865
Stock options exercised and restricted stock units vested and settled	—	—		876,595	—		148		—		—		148
Capital contribution – stock-based compensation	—	—		—	—		28		—		—		28
Stock-based compensation	—	—		—	—		10,501		—		—		10,501
Foreign currency translation adjustments	—	—		—	—		—		(69)		—		(69)
Net loss	—	—		—	—		—		—		(58,662)		(58,662)
Balance at September 30, 2023	10,000	$	—	131,442,024	$	13	$	950,231	$	513	$	(698,946)	$	251,811


	Series A preferred stock			Common stock			Additional paid-in capital		Accumulated other comprehensive income (loss)		Accumulated deficit		Total stockholders’ equity
	Shares	Amount		Shares	Amount
Balance at March 31, 2022	10,000	$	—	116,482,899	$	12	$	824,796	$	404	$	(355,387)

SEC Form 10-Q filed by Immunovant Inc.