BASEL, Switzerland and LONDON and NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2025, and provided a business update.

   -- Brepocitinib 30 mg demonstrated clinically meaningful and statistically 
      significant improvement compared to placebo on the primary endpoint and 
      all nine key secondary endpoints in Phase 3 VALOR study in 
      dermatomyositis $(DM)$, with NDA filing planned for the first half of 
      calendar year 2026 
 
   -- Brepocitinib program continues to advance with rapid enrollment in Phase 
      3 study in non-infectious uveitis $(NIU)$ and proof-of-concept trial in 
      cutaneous sarcoidosis (CS), with readouts expected in the first half of 
      calendar year 2027 and second half of calendar year 2026, respectively 
 
   -- Immunovant study in uncontrolled Graves' disease $(GD)$ patients treated 
      for 24 weeks showed first-ever potentially disease-modifying outcome with 
      six-month off-treatment data. Immunovant continues to expect the first of 
      the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out 
      before the end of calendar year 2025. However, due to evolving 
      competitive dynamics, Immunovant anticipates sharing topline results from 
      both TED studies concurrently in the first half of calendar year 2026 
 
   -- LNP litigation continues to progress, with the court issuing a favorable 
      Markman ruling in the Pfizer/BioNTech case in September 2025. Jury trial 
      in U.S. Moderna case scheduled for March 2026 and international 
      proceedings continue with first major hearings expected in the first half 
      of calendar year 2026 
 
   -- Roivant reported consolidated cash, cash equivalents, restricted cash and 
      marketable securities of $4.4 billion as of September 30, 2025, 
      supporting cash runway into profitability 
 
   -- Roivant will host a live conference call and webcast at 8:00 a.m. ET on 
      Monday, November 10, 2025, to report its financial results for the second 
      quarter ended September 30, 2025, and provide a business update 
 
   -- Roivant will also host an Investor Day on December 11, 2025 

"This quarter unquestionably represents a moment of transformation for Roivant, with the brepocitinib data in DM putting us on a new and exciting trajectory. This is further supported by Immunovant's remission data in Graves' disease, and by strong continued execution and progress across the board," said Matt Gline, CEO of Roivant. "We look forward to sharing more about our progress and next chapter at our investor day in December."

Recent Developments

   -- Priovant: Brepocitinib 30 mg demonstrated clinically meaningful and 
      statistically significant improvement compared to placebo on the primary 
      endpoint and all nine key secondary endpoints in Phase 3 VALOR study in 
      dermatomyositis (DM); safety profile was consistent with previous 
      clinical trials of brepocitinib and NDA filing is planned for the first 
      half of calendar year 2026. Phase 3 trial for brepocitinib in 
      non-infectious uveitis (NIU) is ongoing and on track for topline readout 
      in the first half of calendar year 2027. Proof-of-concept trial for 
      brepocitinib in cutaneous sarcoidosis (CS) is ongoing and on track for 
      topline readout in the second half of calendar year 2026. 
 
   -- Immunovant: All clinical development timelines remain on track for 
      IMVT-1402 across six 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). Immunovant study in uncontrolled GD patients treated 
      for 24 weeks showed first-ever potentially disease-modifying outcome with 
      six-month off-treatment data. 
 
   -- Genevant: In September 2025, the court issued a favorable Markman ruling 
      in the Pfizer/BioNTech case. 
 
   -- Roivant: Roivant reported consolidated cash, cash equivalents, restricted 
      cash and marketable securities of $4.4 billion as of September 30, 2025, 
      supporting cash runway into profitability. 

Major Upcoming Milestones

   -- Priovant plans to file an NDA for brepocitinib in DM in the first half of 
      calendar year 2026. Topline data from the ongoing Phase 3 trial of 
      brepocitinib in NIU and proof-of-concept trial in CS are expected in the 
      first half of calendar year 2027 and second half of calendar year 2026, 
      respectively. 
 
   -- Immunovant expects to report results from the open-label portion of the 
      potentially registrational trial of IMVT-1402 in D2T RA and topline 
      results from the proof-of-concept trial of IMVT-1402 in CLE in calendar 
      year 2026. In calendar year 2027, topline results are expected across 
      three indications from the potentially registrational trials of IMVT-1402 
      in GD, MG and D2T RA. Immunovant continues to expect the first of the two 
      batoclimab Phase 3 thyroid eye disease (TED) studies to read out before 
      the end of calendar year 2025. However, due to evolving competitive 
      dynamics, Immunovant anticipates sharing topline results from both TED 
      studies concurrently in the first half of calendar year 2026. 
 
   -- Pulmovant plans to report topline data from the ongoing Phase 2 trial of 
      mosliciguat in pulmonary hypertension associated with interstitial lung 
      disease in the second half of calendar year 2026. 
 
   -- Genevant LNP litigation continues to progress, with summary judgment 
      phase ongoing in the U.S. Moderna case and jury trial currently scheduled 
      for March 2026. International proceedings continue as expected with first 
      major hearings expected in the first half of calendar year 2026. 
      Pfizer/BioNTech discovery phase ongoing. 

Second Quarter Ended September 30, 2025 Financial Summary

Cash Position and Marketable Securities

As of September 30, 2025, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $4.4 billion.

Research and Development Expenses

Research and development (R&D) expenses increased by $21.5 million to $164.6 million for the three months ended September 30, 2025, compared to $143.1 million for the three months ended September 30, 2024. This increase was primarily driven by an increase in program-specific costs of $13.2 million and personnel-related expenses of $7.1 million.

The increase of $13.2 million in program-specific costs was primarily driven by an increase of $10.2 million related to the anti-FcRn franchise and $4.2 million related to brepocitinib, reflecting the progression of our programs.

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. The increase of $7.1 million in personnel-related expenses was primarily driven by higher headcount to support additional clinical studies for the anti-FcRn franchise.

Non-GAAP R&D expenses were $152.9 million for the three months ended September 30, 2025, compared to $132.4 million for the three months ended September 30, 2024.

General and Administrative Expenses

General and administrative (G&A) expenses decreased by $59.8 million to $143.1 million for the three months ended September 30, 2025, compared to $202.9 million for the three months ended September 30, 2024. This decrease was due to a decrease in personnel-related expense of $71.9 million, largely as a result of higher expense during the three months ended September 30, 2024 related to one-time cash retention awards from the 2024 Senior Executive Compensation Program.

Non-GAAP G&A expenses were $72.1 million for the three months ended September 30, 2025, compared to $142.3 million for the three months ended September 30, 2024.

Loss from discontinued operations, net of tax

Loss from discontinued operations, net of tax was $43.1 million for the three months ended September 30, 2024 and represents the financial results of Dermavant during this period.

Loss from continuing operations, net of tax

Loss from continuing operations, net of tax was $166.0 million for the three months ended September 30, 2025, compared to $236.8 million for the three months ended September 30, 2024. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.17 and $0.25, respectively, for the three months ended September 30, 2025 and 2024.

Non-GAAP loss from continuing operations, net of tax was $187.8 million for the three months ended September 30, 2025, compared to $218.7 million for the three months ended September 30, 2024.

 
                           ROIVANT SCIENCES LTD. 
                         Selected Balance Sheet Data 
                          (unaudited, in thousands) 
 
                                       September 30, 2025    March 31, 2025 
                                      --------------------  ---------------- 
Cash, cash equivalents and 
 restricted cash                       $         1,247,160   $     2,725,661 
Marketable securities                            3,148,825         2,171,480 
Total assets                                     5,062,598         5,436,940 
Total liabilities                                  257,140           249,742 
Total shareholders' equity                       4,805,458         5,187,198 
Total liabilities and shareholders' 
 equity                                          5,062,598         5,436,940 
 
 
                                ROIVANT SCIENCES LTD. 
                    Condensed Consolidated Statements of Operations 
                 (unaudited, in thousands, except share and per share 

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