Immunovant — Second Quarter 2026 Earnings Summary

Financial Performance:

• Net loss was $97.2 million ($0.47 per share) for the three months ended September 30, 2026, compared to $126.5 million ($0.73 per share) for the same period in 2025.
• Non-GAAP net loss was $84.0 million for the three months ended September 30, 2026, compared to $113.3 million for the same period in 2025.
• Research and development (R&D) expenses were $85.0 million for the three months ended September 30, 2026, a decrease from $114.2 million in the prior year period.
• Non-GAAP R&D expenses were $78.5 million for the three months ended September 30, 2026, compared to $106.5 million in the prior year period.
• General and administrative (G&A) expenses were $19.1 million for the three months ended September 30, 2026, an increase from $17.5 million in the prior year period.
• Non-GAAP G&A expenses were $12.4 million for the three months ended September 30, 2026, compared to $11.9 million in the prior year period.
• Cash and cash equivalents totaled $722.3 million as of September 30, 2026, down from $902.1 million as of March 31, 2026.
• Total operating expenses were $104.2 million for the three months ended September 30, 2026, compared to $131.8 million in the prior year period.
• Net loss for the six months ended September 30, 2026, was $250.5 million ($1.22 per share), compared to $247.1 million ($1.43 per share) for the six months ended September 30, 2025.
• Non-GAAP net loss for the six months ended September 30, 2026, was $223.4 million, compared to $215.4 million for the same period in 2025.

Guidance and Future Outlook:

• FDA discussions are planned for later in 2026 to determine the path forward for the registrational program of IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA).
• Topline data for potentially registrational trials of IMVT-1402 in Graves' disease (GD) and myasthenia gravis (MG) are expected in calendar year 2027.
• Topline data for the potentially registrational trial of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy (CIDP) are expected in calendar year 2028.
• The cash position of $722.3 million provides runway to the potential commercial launch of IMVT-1402 in GD based on the current operating plan.
• All other clinical development timelines remain on track.

Business Segments and Product Lines:

• IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 in Period 2 of the D2T RA trial (92.5% vs. 75.6% placebo, p=0.0139).
• In exploratory analyses for D2T RA, ACR50 and ACR70 response rates for IMVT-1402 600 mg reached 80.0% and 52.5% respectively at Week 28.
• IMVT-1402 300 mg did not show a statistically significant difference from placebo for ACR20 response at Week 28 (75.0% vs. placebo, p=0.9426).
• Secondary endpoints (CDAI and SDAI) numerically favored IMVT-1402 600 mg over placebo in the D2T RA trial.
• IMVT-1402 was generally well tolerated in Period 2 of the D2T RA trial with no serious adverse events or Grade 3+ treatment-emergent adverse events reported.
• The company expects it is unlikely to advance IMVT-1402 further in Sjögren's disease (SjD) beyond the ongoing, fully enrolled Phase 2 trial.
• The D2T RA trial involved 170 participants in Period 1 (open-label lead-in) and 117 participants in the Period 2 efficacy analysis.

Market and Competitive Landscape:

• The company noted an evolving SjD landscape and recent data in the field as the rationale for not advancing IMVT-1402 further in SjD.
• Immunovant is a majority-owned subsidiary of Roivant (Nasdaq: ROIV).

Risks and Challenges:

• The business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402.
• Product candidates may not progress through clinical development or receive regulatory approvals within expected timelines or at all.
• Future clinical trials may not confirm safety, potency, or other product characteristics described in the press release.
• The company will require additional capital to fund operations and advance IMVT-1402 through clinical development.
• Risks include potential inability to protect or enforce intellectual property rights and the impact of global factors such as trade tariffs and geopolitical tensions.

Management Commentary and Tone:

• Management indicated that the decrease in R&D expenses was primarily due to the wind-down of batoclimab clinical trials and lower costs from IMVT-1402 activities driven by contract manufacturing timing.
• The increase in G&A expenses was attributed to higher investments in pre-commercial activities.
• The decrease in G&A expenses for the six-month period was due to lower personnel-related expenses and professional fees, partially offset by pre-commercial investments.

Other Key Points:

• There were 206,785,540 shares of common stock issued and outstanding as of September 30, 2026.
• Non-cash stock-based compensation expense included in the net loss was $13.3 million for the three months ended September 30, 2026, and $27.1 million for the six months ended September 30, 2026.
• Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 9, 2026.