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Sep 30, 2024
Immunovant Q2 2025 Earnings Report
Reported development updates and financial results.
Key Takeaways
Immunovant reported its fiscal second quarter results, highlighting the advancement of IMVT-1402 with five IND applications cleared and progress in clinical trials for batoclimab. The company is on track to initiate multiple potentially registrational trials by March 31, 2025, and anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026.
Five Investigational New Drug (IND) applications were cleared across a range of therapeutic areas for lead asset, IMVT-1402.
Proof of concept data from batoclimab trial in Graves’ disease (GD) demonstrate potential of deeper IgG reduction.
IND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA.
Batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) fully enrolled to support data disclosures by March 31, 2025.
Immunovant
Immunovant
Forward Guidance
Immunovant is focused on advancing IMVT-1402 and batoclimab through clinical development across a broad range of indications. The company anticipates initiating multiple potentially registrational trials with IMVT-1402 and expects data readouts from batoclimab trials.
Positive Outlook
- On track to initiate potentially registrational trials with IMVT-1402 in four to five indications by March 31, 2025.
- Anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026.
- IMVT-1402 in GD has the potential to transform the treatment of GD patients who respond poorly to ATDs.
- IMVT-1402 can deliver meaningful clinical benefit in ACPA-positive (ACPA+) D2T RA patients, with a potentially best-in-class profile driven by deeper IgG reduction.
- Enrollment of study participants has completed in the Phase 2b trial evaluating batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) for those patients to be included in the period 1 data readout expected by March 31, 2025.
Challenges Ahead
- Competition for clinical trial participants with acute, active TED has increased.
- Top-line results for batoclimab in TED are now expected in the second half of calendar year 2025.
- Decision to enroll additional patients in the batoclimab CIDP study will be made following the readout of period 1 data.
- Future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release.
- Any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all.