- Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of
September 2026 ; topline data from Phase 3 study in non-infectious uveitis (NIU) expected in the second half of calendar year 2026 - First patients enrolled in the Phase 3 study of brepocitinib in cutaneous sarcoidosis (CS), with topline data expected in calendar year 2028; enrollment in Part 1 of the Phase 2b/3 study in lichen planopilaris (LPP) is progressing well
- IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) topline data expected in the second half of calendar year 2026; all clinical development timelines remain on track for IMVT-1402
- Mosliciguat Phase 2 study in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track, with topline data expected in the second half of calendar year 2026
- Genevant and Arbutus received
$950 million from Moderna inJuly 2026 under$2.25 billion settlement, with additional$1.3 billion contingent on favorable resolution of Moderna’s § 1498 appeal; filed new international lawsuits against Pfizer andBioNTech covering 21 jurisdictions - Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of
$3.9 billion as ofJune 30, 2026 , excluding the cash payment received from Moderna in July, supporting cash runway into profitability - Roivant will host a live conference call and webcast at
8:00 a.m. ET onThursday, August 6, 2026 , to report its financial results for the first quarter endedJune 30, 2026 , and provide a business update
“This quarter has been a moment of relative quiet between our incredibly busy last twelve months and our even busier year ahead,” said
Recent Developments
- Priovant: Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of
September 2026 . The first patients have been enrolled in the Phase 3 study of brepocitinib in cutaneous sarcoidosis (CS). This follows brepocitinib’s Phase 2 study, the first positive placebo-controlled study in CS, which led to FDA Breakthrough Therapy Designation.
The Phase 3 study (BEACON+) will be conducted as a Part B to the positive Phase 2 BEACON trial. BEACON+ will enroll approximately 140 patients with CS across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg once daily and placebo. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity Score (CSAMI-A) at Week 16. In Phase 2, 77% of brepocitinib 45mg patients achieved this endpoint compared to 0% of placebo patients.
CS is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in
Additionally, enrollment in Part 1 of the Phase 2b/3 study in lichen planopilaris (LPP) is progressing well.
- Immunovant: All clinical development timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE).
- Pulmovant: Phase 2 study of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track.
- Genevant: In
July 2026 ,Genevant Sciences GmbH (Genevant) and Arbutus received$950 million from Moderna, the initial payment under the global$2.25 billion patent infringement settlement, and filed new international lawsuits against Pfizer andBioNTech . - Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of
$3.9 billion as ofJune 30, 2026 , excluding the cash payment received from Moderna in July, supporting cash runway into profitability. For the three months endedJune 30, 2026 , Roivant repurchased 7.3 million common shares for an aggregate repurchase price of approximately$208.7 million .
Major Upcoming Milestones
- Priovant expects the commercial launch of brepocitinib in DM by the end of
September 2026 and topline data from the Phase 3 study in NIU and Phase 3 study in CS in the second half of calendar year 2026 and calendar year 2028, respectively. Roivant continues to actively explore other indications for brepocitinib. - Immunovant expects to report topline data from the proof-of-concept trial of IMVT-1402 in CLE and provide an update on the potentially registrational program of IMVT-1402 in D2T RA in the second half of calendar year 2026. In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG. In calendar year 2028, topline data are expected across potentially registrational trials of IMVT-1402 in CIDP and SjD.
- Pulmovant expects to report topline data from the ongoing Phase 2 trial of mosliciguat in PH-ILD in the second half of calendar year 2026.
- Genevant LNP litigation continues to progress. An additional
$1.3 billion payment under the Moderna settlement is contingent upon a resolution of Moderna's Section 1498 appeal favorable to Genevant and Arbutus. Separately, inJuly 2026 they filed three international lawsuits against Pfizer andBioNTech — one inCanada and two before the UPC — seeking to enforce patents protecting their innovative lipid nanoparticle technology. The actions seek relief across 20 European countries (includingFrance ,Germany ,Italy andthe Netherlands ) which, together with the Canadian action, cover 21 jurisdictions in total. The discovery phase of theU.S . Pfizer/BioNTech case is ongoing.
First Quarter Ended
As of
Research and Development Expenses
Research and development (R&D) expenses increased by
The increase of
The majority of share-based compensation and personnel-related expenses, which are unallocated internal costs, were related to the anti-FcRn franchise activities at Immunovant during the three months ended
Non-GAAP R&D expenses were
General and Administrative Expenses
General and administrative (G&A) expenses increased by
Non-GAAP G&A expenses were
Net Loss
Net loss was
| Selected Balance Sheet Data | |||||||
| (unaudited, in thousands) | |||||||
| Cash and cash equivalents | $ | 1,248,456 | $ | 1,419,232 | |||
| Marketable securities | 2,593,626 | 2,872,601 | |||||
| Litigation settlement receivable | 771,627 | 770,235 | |||||
| Total assets | 5,306,493 | 5,708,687 | |||||
| Total liabilities | 384,624 | 416,275 | |||||
| Total shareholders’ equity | 4,921,869 | 5,292,412 | |||||
| Total liabilities and shareholders’ equity | 5,306,493 | 5,708,687 | |||||
| Condensed Consolidated Statements of Operations | |||||||
| (unaudited, in thousands, except share and per share amounts) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Revenue | $ | 1,442 | $ | 2,170 | |||
| Operating expenses: | |||||||
| Cost of revenues | 284 | 154 | |||||
| Research and development (includes | 202,016 | 152,919 | |||||
| General and administrative (includes | 165,527 | 134,019 | |||||
| Total operating expenses | 367,827 | 287,092 | |||||
| Gain on litigation settlement | 392 | — | |||||
| Loss from operations | (365,993 | ) | (284,922 | ) | |||
| Change in fair value of investments | (36,637 | ) | 19,125 | ||||
| Change in fair value of liability instruments | — | 2,329 | |||||
| Interest income | (36,922 | ) | (48,322 | ) | |||
| Other expense, net | 2,130 | 11,208 | |||||
| Loss before income taxes | (294,564 | ) | (269,262 | ) | |||
| Income tax (benefit) expense | (3,958 | ) | 4,649 | ||||
| Net loss | (290,606 | ) | (273,911 | ) | |||
| Net loss attributable to noncontrolling interests | (100,769 | ) | (50,556 | ) | |||
| Net loss attributable to | $ | (189,837 | ) | $ | (223,355 | ) | |
| Net loss per common share—basic and diluted | $ | (0.26 | ) | $ | (0.33 | ) | |
| Weighted average shares outstanding—basic and diluted | 720,776,739 | 680,286,922 | |||||
| Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||||
| (unaudited, in thousands) | ||||||||||
| Three Months Ended | ||||||||||
| Note | 2026 | 2025 | ||||||||
| Net loss | $ | (290,606 | ) | $ | (273,911 | ) | ||||
| Adjustments: | ||||||||||
| Research and development: | ||||||||||
| Share-based compensation | (1 | ) | 8,721 | 11,099 | ||||||
| Depreciation and amortization | (2 | ) | 346 | 786 | ||||||
| General and administrative: | ||||||||||
| Share-based compensation | (1 | ) | 74,621 | 71,079 | ||||||
| Depreciation and amortization | (2 | ) | 254 | 312 | ||||||
| Gain on litigation settlement | (3 | ) | (392 | ) | — | |||||
| Other: | ||||||||||
| Change in fair value of investments | (4 | ) | (36,637 | ) | 19,125 | |||||
| Change in fair value of liability instruments | (5 | ) | — | 2,329 | ||||||
| Estimated income tax impact from adjustments | (6 | ) | — | (943 | ) | |||||
| Adjusted net loss (Non-GAAP) | $ | (243,693 | ) | $ | (170,124 | ) | ||||
| Three Months Ended | ||||||||||
| Note | 2026 | 2025 | ||||||||
| Research and development expenses | $ | 202,016 | $ | 152,919 | ||||||
| Adjustments: | ||||||||||
| Share-based compensation | (1 | ) | 8,721 | 11,099 | ||||||
| Depreciation and amortization | (2 | ) | 346 | 786 | ||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 192,949 | $ | 141,034 | ||||||
| Three Months Ended | ||||||||||
| Note | 2026 | 2025 | ||||||||
| General and administrative expenses | $ | 165,527 | $ | 134,019 | ||||||
| Adjustments: | ||||||||||
| Share-based compensation | (1 | ) | 74,621 | 71,079 | ||||||
| Depreciation and amortization | (2 | ) | 254 | 312 | ||||||
| Adjusted general and administrative expenses (Non-GAAP) | $ | 90,652 | $ | 62,628 | ||||||
Notes to non-GAAP financial measures:
(1) Represents non-cash share-based compensation expense.
(2) Represents non-cash depreciation and amortization expense.
(3) As a result of the global settlement with Moderna entered in
(4) Represents the unrealized (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.
(5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.
(6) Represents the estimated tax effect of the adjustments.
Investor Conference Call Information
Roivant will host a live conference call and webcast at
To access the conference call by phone, 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 conference call.
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 currently under review at the FDA for the treatment of dermatomyositis and also in late stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody 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. For more information, visit www.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, any commercial potential of our product candidates following applicable regulatory approvals and the outcome of any pending litigation. 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
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
