8-K
Immunovant, Inc. (IMVT)
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): November 12, 2021
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 7.01 Regulation FD Disclosure.
On November 12, 2021, Immunovant, Inc. issued a press release that it will provide a presentation regarding its business at the Stifel 2021 Virtual Healthcare Conference on November 17, 2021. Copies of the press release and the presentation are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.
The information furnished under this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the SEC made by Immunovant, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated November 12, 2021. |
| 99.2 | Presentation, dated November 17, 2021. |
| 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: November 17, 2021 |
Document
Exhibit 99.1
Immunovant to Present at the Stifel 2021 Virtual Healthcare Conference
NEW YORK, Nov. 12, 2021 – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today announced that Pete Salzmann, M.D., Chief Executive Officer, will provide a corporate overview at the Stifel 2021 Virtual Healthcare Conference, taking place November 15-17, 2021.
Stifel 2021 Virtual Healthcare Conference Presentation
Date: Wednesday, November 17th, 2021
Time: 2:00pm Eastern Time
Webcast: The presentation will be available via webcast and can be accessed at the Investor Relations section of the Company’s website, located at www.immunovant.com
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases. Immunovant is developing IMVT-1401 (batoclimab), a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
Contact:
Tom Dorney, MS, MBA
Director, Investor Relations & Strategy
Immunovant, Inc.
info@immunovant.com
stifelconference2021immu
Stifel 2021 Virtual Healthcare Conference Investor Presentation November 17, 2021 For Investor Audiences Only 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 “may,” “might,” “will,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “future,” “potential,” “continue” and other similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For example, forward-looking statements include statements Immunovant makes regarding its business strategy, its plans to develop and commercialize its product candidates, the potential safety and efficacy of Immunovant’s current or future product candidates, including batoclimab for Myasthenia Gravis, Thyroid Eye Disease and Warm Autoimmune Hemolytic Anemia, its expectations regarding timing, the design and results of clinical trials of its product candidates, Immunovant’s plans and expected timing with respect to regulatory filings and approvals, the size and growth potential of the markets for Immunovant’s product candidates, and its ability to serve those markets. 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 expressed or implied by such forward-looking statements. 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; 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 candidates 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 the ongoing COVID-19 pandemic on Immunovant’s clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of its sole product candidate, IMVT-1401 (“batoclimab”); Immunovant is at an early stage in development of batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 filed with the SEC on November 5, 2021. 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. For Investor Audiences Only
Rethinking possibilities in autoimmune disease 3 Love Trailblazing All Voices Bolder Faster Our vision: Normal lives for people with autoimmune diseases For Investor Audiences Only
4 Anti-FcRn Market: Potential therapeutic benefit across wide range of indications Fifteen indications announced by at least one anti-FcRn program ENDOCRINOLOGY Thyroid eye disease RHEUMATOLOGY Primary Sjögrens Syndrome Lupus Nephritis Systemic lupus erythematosus Rheumatoid arthritis DERMATOLOGY Bullous pemphigoid Pemphigus foliaceus/ Pemphigus vulgaris NEUROLOGY Myasthenia Gravis Chronic inflammatory demyelinating polyneuropathy Myositis Autoimmune encephalitis Myelin oligodendrocyte glycoprotein antibody disorders (MOG-antibody disorder) HEMATOLOGY Warm autoimmune hemolytic anemia Hemolytic disease of the fetus and newborn Idiopathic thrombocytopenic purpura Source: https://www.clinicaltrials.gov/ For Investor Audiences Only
5 In-depth Interviews Patient Advisory Council Digital Community Insights Broad approach to understanding patient insights for Myasthenia Gravis (MG) 5 Multi-pronged methodology Online Survey For Investor Audiences Only
People with MG recognize limitations of current therapies, which keep them from living their normal lives Historical standards of care have important limitations Episodic or cyclical treatment – especially steroids and IvIg Prolonged time to onset for other immunosuppressants Potential trade-offs to achieve therapeutic benefit Potential safety concerns Some invasive with burdensome route of administration As medications adjusted, anxiety about flares remain Desire confidence in ability to sustain an adequate response Fear of flare may limit patients’ outlook of the future 6 MG patient research feedback For Investor Audiences Only
7 Nearly 80% of people with MG (on treatment) reported moderate or major lifestyle modifications 7 Source: MG Patient Survey (n=50). Q: What is the extent of lifestyle modifications you make around your myasthenia gravis? Slight lifestyle modifications Major lifestyle modifications Moderate lifestyle modifications 38% None of the respondents stated that they make “no lifestyle modifications” around their MG 22% 40% MG patient survey feedback For Investor Audiences Only
8 Chronic Dosing: “I want to stay on my MG treatment, even when my symptoms are under control, so that I can maintain a response and avoid potential symptom flares” "It's easier to schedule life around something so consistent" 94% of MG patients surveyed preferred a chronic versus intermittent dosing approach MG patient survey feedback Source: Analysis – MG Patient Quantitative Survey (n=50) Intermittent Dosing: “I only want MG treatment intermittently when my symptoms flare” 94% 6% For Investor Audiences Only
Batoclimab’s (IMVT-1401) differentiated attributes provide a unique opportunity to address patients’ unmet needs 9 Subcutaneous route of administration: Designed and developed for simple subcutaneous injection to provide human-centric, give and go dosing experience Significant impact on quality of life Reliable treatment options Flexible treatment options People-centered delivery of treatment Flexible dosing potential: Deep, rapid IgG suppression in the short-term; adjustable IgG suppression in the long-term Batoclimabli For Investor Audiences Only