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0001764013FALSE00017640132023-05-222023-05-22

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 22, 2023
IMMUNOVANT, INC.
(Exact name of Registrant as specified in its Charter)

Delaware 001-38906 83-2771572
(State or other jurisdiction of incorporation or organization)
(Commission File Number) (IRS Employer Identification No.)
320 West 37th Street
New York, NY 10018
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (917) 580-3099
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐        Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐        Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐        Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐        Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐





Item 2.02 Results of Operations and Financial Condition.

On May 22, 2023, Immunovant, Inc., or the Company, issued a press release announcing its financial results for its fourth quarter and fiscal year ended March 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, or the Securities Act. The information in this Item 2.02 shall not be incorporated by reference in any filing with the U.S. Securities and Exchange Commission, or the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 8.01 Other Events.

On May 22, 2023, Immunovant, Inc. will provide business updates for investors using a new IMVT-1402 presentation. A copy of the presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits
Exhibit No. Description
99.1
99.2
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
IMMUNOVANT, INC.
By:   /s/ Eva Renee Barnett
  Eva Renee Barnett
  Chief Financial Officer
Date: May 22, 2023

EX-99.1 2 exhibit99120220522.htm EX-99.1 Document

Exhibit 99.1

Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2023

•Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 cleared by the FDA and MEDSAFE, respectively

•Phase 1 clinical trial in healthy subjects initiated in New Zealand

•Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease (GD) initiated in Germany

•Global clinical trials of batoclimab are ongoing in myasthenia gravis (MG), thyroid eye disease (TED), and chronic inflammatory demyelinating polyneuropathy (CIDP)

NEW YORK, May 22, 2023 – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fiscal fourth quarter and fiscal year ended March 31, 2023.

“During the past quarter, we made significant progress with IMVT-1402, including receiving the IND clearance by the FDA, and the initiation of a Phase 1 clinical trial following the approval by MEDSAFE to proceed,” said Pete Salzmann, M.D., chief executive officer at Immunovant. “This is an important step as we seek to expeditiously generate Phase 1 data and accelerate a global development program for IMVT-1402.”

Clinical Development Updates:
IMVT-1402:
Immunovant received IND clearance for IMVT-1402 from the U.S. Food and Drug Administration (FDA) and initiated a Phase 1 clinical trial of IMVT-1402 in healthy volunteers in New Zealand after approval of the CTA by the regulatory authority, MEDSAFE. The clinical trial will evaluate the safety, tolerability and pharmacodynamic profiles of IMVT-1402, a subcutaneously administered, FcRn inhibitor. In the multiple ascending dose (MAD) portion of the study, Immunovant plans to evaluate subcutaneous doses of 300 mg and 600 mg, at a concentration of 150 mg/mL vs. placebo.

Initial data from single-ascending dose cohorts are expected in August/September 2023 and initial data from MAD cohorts are expected in October/November 2023. In a head-to-head, placebo-controlled nonclinical study, IMVT-1402 has been observed to achieve similarly deep IgG reduction as batoclimab and have minimal or no impact on levels of albumin and low-density lipoprotein cholesterol at doses well above the anticipated human effective dose. Immunovant believes this profile could be best in class.

Batoclimab:
A Phase 2 proof-of-concept clinical trial of batoclimab in GD was initiated in Germany, with initial results expected in the fourth quarter of calendar year 2023.

As previously disclosed, Immunovant expects to have initial results from period 1 of the Phase 2b clinical trial in CIDP in the first half of calendar year 2024 and expects to have top-line results from the Phase 3 MG clinical trial and the Phase 3 TED program in the second half of calendar year 2024 and the first half of calendar year 2025, respectively.




Financial Highlights for Fiscal Fourth Quarter Ended March 31, 2023:
Cash Position: As of March 31, 2023, Immunovant’s cash and cash equivalents totaled $376.5 million, which is expected to fund operations into the second half of calendar year 2025.

R&D Expenses: Research and development expenses were $51.8 million for the three months ended March 31, 2023, compared to $32.0 million for the three months ended March 31, 2022. The increase was primarily due to higher batoclimab program-specific research and development costs (including contract manufacturing costs), cross-indication clinical studies and clinical research costs and personnel-related costs. These increases were partially offset by lower contract manufacturing costs related to the development of IMVT-1402, which were initiated in the prior-year period.

G&A Expenses: General and administrative expenses were $12.4 million for the three months ended March 31, 2023, compared to $15.2 million for the three months ended March 31, 2022. The decrease was primarily due to lower personnel-related expenses and financial advisory, legal, and other professional fees.

Net Loss: Net loss was $59.4 million ($0.46 per common share) for the three months ended March 31, 2023, compared to $47.2 million ($0.41 per common share) for the three months ended March 31, 2022. Net loss for the three months ended March 31, 2023 and 2022 included $7.5 million and $11.9 million, respectively, related to non-cash stock-based compensation expense.

Common Stock: As of March 31, 2023, there were 130,329,863 shares of common stock issued and outstanding.

Financial Highlights for Fiscal Year Ended March 31, 2023:
R&D Expenses: Research and development expenses were $160.3 million for the fiscal year ended March 31, 2023, compared to $101.8 million for the fiscal year ended March 31, 2022. The increase was primarily due to higher batoclimab program-specific research and development costs (including contract manufacturing costs), increased personnel-related expenses and higher costs related to cross-indication clinical studies and clinical research.

IPR&D Expenses: Acquired in-process research and development expenses were $10.0 million for the fiscal year ended March 31, 2023, related to the achievement of a development and regulatory milestone for batoclimab in MG as required under the HanAll in-license agreement. There were no acquired in-process research and development expenses for the fiscal year ended March 31, 2022.

G&A Expenses: General and administrative expenses were $48.0 million for the fiscal year ended March 31, 2023, compared to $54.2 million for the fiscal year ended March 31, 2022. The decrease was primarily due to lower financial advisory, legal, and other professional fees, as well as personnel-related expenses, partially offset by higher market research and information technology costs.

Net Loss: Net loss was $211.0 million ($1.71 per common share) for the fiscal year ended March 31, 2023, compared to $156.7 million ($1.43 per common share) for the fiscal year ended March 31, 2022. Net loss for the fiscal year ended March 31, 2023 and 2022 included $32.3 million and $34.2 million, respectively, related to non-cash stock-based compensation expense.





About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit www.immunovant.com.

Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations regarding the timing, design, and results of clinical trials of its product candidates; Immunovant's plan to develop batoclimab and IMVT-1402 across a broad range of autoimmune indications; Immunovant's beliefs regarding its cash runway; and the potential benefits of batoclimab’s and IMVT-1402’s unique product attributes. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; results of animal studies may not be predictive of results in humans; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the timing of the commencement of additional clinical trials and resumption of current trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as the COVID-19 pandemic, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of batoclimab and IMVT-1402; Immunovant is at an early stage in development of for IMVT-1402 and in various stages of clinical development for batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2023, to be filed with the SEC on May 22, 2023, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.












IMMUNOVANT, INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
  Three Months Ended
March 31,
Years Ended
 March 31,
2023 2022 2023 2022
Operating expenses:
Research and development
$ 51,837  $ 31,986  $ 160,257  $ 101,808 
Acquired in-process research and development —  —  10,000  — 
General and administrative
12,422  15,241  48,019  54,225 
Total operating expenses 64,259  47,227  218,276  156,033 
Interest income, net (3,480) —  (7,578) — 
Other expense (income), net (356) (44) 253  781 
Loss before provision (benefit) for income taxes (60,423) (47,183) (210,951) (156,814)
Provision (benefit) for income taxes (992) (12) (84)
Net loss $ (59,431) $ (47,171) $ (210,960) $ (156,730)
Net loss per common share — basic and diluted $ (0.46) $ (0.41) $ (1.71) $ (1.43)
Weighted average common shares outstanding — basic and diluted 129,632,592  116,337,733  123,075,329  109,679,256 






IMMUNOVANT, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
March 31, March 31,
2023 2022
Assets
Current assets:
Cash and cash equivalents $ 376,532  $ 493,817 
Accounts receivable 700  12,229
Prepaid expenses and other current assets 26,916  6,253
Income tax receivable 185  632 
Total current assets 404,333  512,931
Operating lease right-of-use assets 1,172  2,303
Property and equipment, net 333  330
Total assets $ 405,838  $ 515,564 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 1,353  $ 18,629 
Accrued expenses 40,421  24,575
Current portion of operating lease liabilities 1,173  1,145
Due to Roivant Sciences Ltd. 350  171 
Total current liabilities 43,297  44,520 
Operating lease liabilities, net of current portion 47  1,219
Total liabilities 43,344  45,739
Commitments and contingencies
Stockholders’ equity:
Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at March 31, 2023 and March 31, 2022
—  — 
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2023 and March 31, 2022
—  — 
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 130,329,863 shares issued and outstanding at March 31, 2023 and 500,000,000 shares authorized, 116,482,899 shares issued and outstanding at March 31, 2022
13  12
Additional paid-in capital 927,976  824,796
Accumulated other comprehensive income 852  404
Accumulated deficit (566,347) (355,387)
Total stockholders’ equity 362,494  469,825
Total liabilities and stockholders’ equity $ 405,838  $ 515,564 

Contact:
Chau Cheng, PhD, MBA
Vice President, Investor Relations
Immunovant, Inc.
info@immunovant.com

EX-99.2 3 exhibit992.htm EX-99.2 exhibit992
IMVT-1402 Update May 22, 2023 Exhibit 99.2


 
Forward-looking Statements 2 This presentation contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations regarding patient enrollment, timing, design, and results of clinical trials of its product candidates and indication selections; Immunovant's expectations with respect to the safety and monitoring plan and size of the safety database for the IMVT-1402 Phase 1 clinical trial; and Immunovant’s plan to explore in subsequent study periods follow-on treatment with alternative dosing regimens. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; results of animal studies may not be predictive of results in humans; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the timing of the commencement of additional clinical trials and resumption of current trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this presentation; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant's pending composition of matter patent for IMVT-1402 may not be issued; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the effect of global factors, such as the potential impact of the ongoing COVID-19 pandemic, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s buisness operations and supply chains, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of batoclimab and IMVT-1402; Immunovant is at an early stage in development for IMVT-1402 and in various stages of clinical development for batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2023, to be filed with the SEC on May 22, 2023, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All trademarks, trade names, service marks, and copyrights appearing in this presentation are the property of their respective owners.


 
3 Significant Progress in Developing IMVT-1402 as Next-Generation FcRn Inhibitor for Autoimmune Disease Therapy Phase 1 clinical trial in healthy volunteers initiated in New Zealand Investigational New Drug (IND) application cleared by the FDA Initial data readout for single-ascending dose cohorts expected in August/September 2023, and for multiple-ascending dose cohorts expected in October/November 2023


 
IMVT-1402 Phase 1 Clinical Trial Objectives 4 Expeditiously evaluate safety, pharmacokinetic & pharmacodynamic profile Validate the IMVT-1402 dose that achieves FcRn saturation Confirm doses for future studies 1 2 3


 
IMVT-1402 Phase 1 Clinical Trial Design* 5 Single-Ascending Intravenous Dose Single-Ascending Subcutaneous Dose Multiple-Ascending Subcutaneous Dose Fixed 300 mg Fixed 100 mg Fixed 600 mg Fixed 300 mg Fixed 600 mg Fixed 300 mg Fixed 600 mg Single Ascending Dose • 6 IMVT-1402 + 2 placebo participants per dose cohort Multiple Ascending Dose • 10 IMVT-1402 + 2 placebo participants per dose cohort • Once weekly dosing x 4 weeks IMVT-1402 is delivered as a 2 mL simple subcutaneous injection with a 27-gauge needle at a concentration of 150 mg/mL in the Subcutaneous Dose cohorts * Additional / optional cohorts may include 1,200 mg IV SAD, 150 mg SC MAD and 450 mg SC MAD. The first MAD cohort will be initiated after review of PK and safety data from SAD cohorts at the same or higher dose levels, with the final dose selection for the first MAD cohort dependent on this PK review. SAD and MAD cohorts will be initiated following review of safety data and PK data from all previously dosed cohorts.


 
6 Batoclimab Phase 1 Trial Suggests SAD Data May be Predictive of MAD Data -40 -30 -20 -10 0 10 0 10 20 30 40 50 60 Day Placebo 340 mg 680 mg -25 -20 -15 -10 -5 0 5 10 0 20 40 60 80 Day Placebo 340 mg 500 mg 765 mg Albumin % change from baseline following subcutaneous dosing of batoclimab* * Data on file Single-ascending dose Multiple-ascending dose


 
7 Batoclimab Phase 1 Trial Suggests SAD Data May be Predictive of MAD Data Total IgG % change from baseline following subcutaneous dosing of batoclimab* * Data on file Single-ascending dose Multiple-ascending dose -100 -80 -60 -40 -20 0 20 0 10 20 30 40 50 60 Day Placebo 340 mg 680 mg -60 -50 -40 -30 -20 -10 0 10 0 20 40 60 80 Day Placebo 340 mg 500 mg 765 mg