ROIV 8-K
Roivant Sciences Ltd. (ROIV)
8-K
2025-12-11
For: 2025-12-11
View Original
Added on
April 08, 2026
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): December 11, 2025
(Exact name of registrant as specified in its charter)
|
|
|
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
(Address of principal executive offices, and Zip Code)
+44 207 400-3347
Registrant’s Telephone Number, Including Area Code
Not Applicable
(Former name or former address, if changed since last report)
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 (see General Instruction A.2. below):
|
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
|
||
|
|
|
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 December 11, 2025, Roivant Science Ltd. (the “Company”) issued a press release in connection with the Company’s 2025 Investor Day. A copy of the press release is
attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Also on December 11, 2025, the Company posted the presentation to be used in connection with its 2025 Investor Day on the “Events & Presentations” page of its investor
relations website at https://investor.roivant.com. A copy of the presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The contents of the Company’s website referenced in this Current
Report on Form 8-K are not incorporated into this Current Report on Form 8-K.
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 or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933. The information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed incorporated by reference into any other filing
with the U.S. Securities Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
|
Item 9.01.
|
Financial Statements and Exhibits.
|
|
(d)
|
Exhibits.
|
|
Exhibit No.
|
Description of Exhibit
|
|
|
Press release dated December 11, 2025.
|
||
|
Presentation dated December 11, 2025.
|
||
|
104
|
Cover Page Interactive Data File (embedded with 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.
|
ROIVANT SCIENCES LTD.
|
||
|
By:
|
/s/ Keyur Parekh
|
|
|
Name: Keyur Parekh
|
||
|
Title: Authorized Signatory
|
||
|
Dated: December 11, 2025
|
||
Exhibit 99.1
Roivant Highlights Continued Pipeline Progress and Outlook for Company’s Next Phase of Growth at 2025 Investor Day
|
•
|
Roivant enters new phase of corporate journey with 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof-of-concept study readouts
expected over the next three years
|
|
•
|
|
o
|
Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected
early in calendar year 2027
|
|
o
|
Brepocitinib Phase 3 trial in non-infectious uveitis (NIU) fully enrolled with topline data now expected in the second half of calendar year 2026
|
|
o
|
Brepocitinib proof-of-concept trial in cutaneous sarcoidosis (CS) fully enrolled with topline data now expected in the first half of calendar year
2026
|
|
o
|
IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) topline data now expected in calendar year 2026
|
|
•
|
Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million,
extending Immunovant’s cash runway to the launch of IMVT-1402 in Graves’ disease (GD); Roivant cash balance continues to support runway into profitability
|
|
•
|
All other pipeline programs remain on track with previously communicated timelines
|
|
•
|
Roivant will host our Investor Day today at 8:00 a.m. ET to discuss our progress and next chapter in detail
|
BASEL, Switzerland and LONDON and NEW YORK, December 11, 2025 – Roivant (Nasdaq: ROIV) today is hosting an Investor Day in New York City. Roivant leadership will highlight key pipeline updates and provide an update on the Company’s strategy for long-term value creation.
“We are at transformational moment for Roivant. We have a unique opportunity to execute on three major potential products, each of
which represents a pipeline-in-a-product opportunity, each with multiple blockbuster-potential indications. I’m proud of the clinical execution across our teams, and we have accelerated timing guidance for topline readouts in three significant
programs. We have an opportunity for three meaningful first-in-class commercial launches over the next three years,” said Matt Gline, CEO of Roivant. “First among them is brepocitinib in DM, where the Phase 3 data generated earlier this year
represents a significant step forward for patients in need. We remain well-positioned to generate shareholder value, and we are excited to share updates across our late-stage pipeline and long-term strategy at our Investor Day today.”
Program-Specific Highlights and Updates
Brepocitinib
|
•
|
Preparation for commercial launch of brepocitinib in DM is underway; NDA filing expected in early calendar year 2026 with potential commercial
launch early in calendar year 2027
|
|
•
|
Phase 3 trial for brepocitinib in NIU is fully enrolled ahead of schedule with topline data expected in the second half of calendar year 2026,
previously expected in the first half of calendar year 2027
|
|
•
|
Proof-of-concept trial for brepocitinib in CS is fully enrolled ahead of schedule with topline data expected in the first half of calendar year
2026, previously expected in the second half of calendar year 2026
|
IMVT-1402
|
•
|
Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million,
extending Immunovant’s cash runway to the launch of IMVT-1402 in GD
|
|
•
|
Potentially registrational trial for IMVT-1402 in D2T RA topline data now expected in calendar year 2026; previously expected Period 1 data in
calendar year 2026 and topline data in calendar year 2027
|
|
•
|
All other clinical development timelines remain on track, including potentially registrational trials in GD, myasthenia gravis (MG), chronic
inflammatory demyelinating polyneuropathy (CIDP) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE)
|
Mosliciguat
|
•
|
Enrollment in the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on
track; Pulmovant plans to report topline data in the second half of calendar year 2026
|
|
•
|
Pulmovant also expects to imminently initiate a Phase 2 study (n=20) evaluating mosliciguat in combination with inhaled treprostinil in patients
with PH-ILD
|
Genevant
|
•
|
In the US Moderna litigation, a jury trial has been scheduled for March 2026. Awaiting court scheduling in the Pfizer/BioNTech litigation
|
|
•
|
Initial court hearings and rulings in the ex-US Moderna litigation expected in calendar year 2026
|
Investor Day Webcast Information
Roivant will host an Investor Day in New York City at 8:00 a.m. ET on Thursday, December 11, 2025. The event will be webcasted for
those unable to attend in person.
To access the webcast, please register online using this registration link. The presentation and
webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the
event.
About Roivant
Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development
and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis;
IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with
interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology
startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not
historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are
usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or
similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results
from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results
or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will
be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very
competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to
certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking
statements, whether as a result of new information, future events or otherwise.
Contacts:
Investors
Keyur Parekh
Media
Stephanie Lee
Exhibit 99.2
