imvt-20210630

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 June 30, 2021


☐			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 August 9, 2021, there were 114,998,871 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 JUNE 30, 2021

Table of Contents



		Page
Summary Risk Factors		2
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)	4
	Condensed Consolidated Balance Sheets as of June 30, 2021 and March 31, 2021	4
	Condensed Consolidated Statements of Operations for the Three Months Ended June 30, 2021 and 2020	5
	Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended June 30, 2021 and 2020	6
	Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended June 30, 2021 and 2020	7
	Condensed Consolidated Statements of Cash Flows for the Three Months Ended June 30, 2021 and 2020	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	28
PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	29
Item 1A.	Risk Factors	29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	83
Item 3.	Defaults Upon Senior Securities	83
Item 4.	Mine Safety Disclosures	83
Item 5.	Other Information	83
Item 6.	Exhibits	84
SIGNATURES		85

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 candidates, 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.

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SUMMARY RISK FACTORS

You should consider carefully the risks described under “Risk Factors” in Part II, Item 1.A 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 success relies upon a singular product candidate, IMVT-1401, for which all clinical development by the Company has paused after elevated lipid levels were observed in some patients dosed with the drug. Unless we can determine a dosing regimen, target patient population, safety monitoring and risk management for IMVT-1401 in autoimmune diseases for which the risks of lipid elevations and albumin reductions can be mitigated, we will not be able to show adequate benefit to risk ratio and will not be able to continue clinical development or seek or obtain marketing authorization in any jurisdiction.

•Our product candidate has caused and may cause adverse events (including but not limited to, elevated total cholesterol and low-density lipoprotein (“LDL”) levels and reductions in albumin) or have other properties that could delay or prevent its 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 candidate, 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.

•Our business is heavily dependent on the successful development, regulatory approval and commercialization of our sole product candidate, IMVT-1401.

•We may not be able to successfully develop and commercialize our product candidate IMVT-1401 on a timely basis or at all.

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

•Our business, operations and clinical development plans and timelines and supply chain could be adversely affected by the effects of health epidemics, including the ongoing global Novel Coronavirus Disease 2019 (“COVID-19”) pandemic, on the 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 (“CROs”), shippers and others.

•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, cause a loss of patient confidence in us or our products, among other negative consequences.

•We are reliant 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.

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

•Our third-party manufacturers may encounter difficulties in production, or our quality management program fails to detect quality issues at our third-party manufacturers, that may delay or prevent our ability to obtain marketing approval or commercialize our product candidates, after approval.

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

•We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of IMVT-1401.

•Raising additional funds by issuing equity securities may 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. (the "HanAll Agreement") to provide rights to the core intellectual property relating to IMVT-1401. Any termination or loss of significant rights under the HanAll Agreement would adversely affect our development or commercialization of IMVT-1401.

•The HanAll Agreement obligates us to make certain milestone payments, some of which may be triggered prior to our potential commercialization of IMVT-1401.

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

•We are subject to stringent and changing privacy and data 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 has and could decline.

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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)


	June 30, 2021		March 31, 2021
Assets
Current assets:
Cash	$	379,005	$	400,146
Prepaid expenses and other current assets	5,821		8,860


Total current assets	384,826		409,006
Operating lease right-of-use assets	3,008		3,282
Property and equipment, net	193		201

Total assets	$	388,027	$	412,489
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,107	$	2,432
Accrued expenses	16,331		15,160
Current portion of operating lease liabilities	1,085		1,179

Total current liabilities	20,523		18,771
Operating lease liabilities, net of current portion	1,972		2,238
Total liabilities	22,495		21,009
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 June 30, 2021 and March 31, 2021	—		—
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2021 and March 31, 2021	—		—
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 97,977,595 shares issued and outstanding at June 30, 2021 and 500,000,000 shares authorized, 97,971,243 shares issued and outstanding at March 31, 2021	10		10
Additional paid-in capital	594,377		590,425
Accumulated other comprehensive income (loss)	273		(298)
Accumulated deficit	(229,128)		(198,657)
Total stockholders’ equity	365,532		391,480
Total liabilities and stockholders’ equity	$	388,027	$	412,489

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 June 30,
	2021		2020
Operating expenses:
Research and development	$	18,705	$	16,922
General and administrative	11,181		9,664
Total operating expenses	29,886		26,586

Other expense, net	626		74
Loss before (benefit) provision for income taxes	(30,512)		(26,660)
(Benefit) provision for income taxes	(41)		48
Net loss	$	(30,471)	$	(26,708)
Net loss per common share – basic and diluted	$	(0.31)	$	(0.38)
Weighted-average common shares outstanding – basic and diluted	97,976,982		70,818,867

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 June 30,
	2021		2020
Net loss	$	(30,471)	$	(26,708)
Other comprehensive income:
Foreign currency translation adjustments	571		26
Total other comprehensive income	571		26
Comprehensive loss	$	(29,900)	$	(26,682)

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, 2021	10,000	$	—	97,971,243	$	10	$	590,425	$	(298)	$	(198,657)	$	391,480
Restricted stock units vested and settled	—	—		6,352	—		—		—		—		—
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)
Balance at June 30, 2021	10,000	$	—	97,977,595	$	10	$	594,377	$	273	$	(229,128)	$	365,532


	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, 2020	10,000	$	—	54,655,376	$	5	$	185,306	$	(16)	$	(91,226)	$	94,069
Issuance of common stock upon underwritten public offering	—	—		9,613,365	1		130,427		—		—		130,428
Issuance of common stock upon achievement of earnout shares milestone	—	—		10,000,000	1		(1)		—		—		—
Vesting of sponsor restricted shares	—	—		900,000	—		—		—		—		—
Issuance of common stock upon warrant redemption	—	—		5,719,145	1		65,751		—		—		65,752
Stock options exercised	—	—		23,841	—		63		—		—		63
Capital contribution – stock-based compensation	—	—		—	—		63		—		—		63
Capital contribution – expenses allocated from Roivant Sciences Ltd.	—	—		—	—		164		—		—		164
Stock-based compensation	—	—		—	—		3,918		—		—		3,918
Foreign currency translation adjustments	—	—		—	—		—		26		—		26
Net loss	—	—		—	—		—		—		(26,708)		(26,708)
Balance at June 30, 2020	10,000	$	—	80,911,727	$	8	$	385,691

SEC Form 10-Q filed by Immunovant, Inc.