Immunovant, Inc. IMVT reported third-quarter fiscal 2025 net loss of 76 cents per share, wider than the Zacks Consensus Estimate of a loss of 73 cents. The reported figure is also wider than the year-ago quarter's loss of 36 cents per share.
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Currently, Immunovant does not have any approved product in its portfolio. As a result, it is yet to generate revenues.
The stock declined 9.6% following the lower-than-expected earnings results.
Research and development (R&D) expenses totaled $94.5 million, up 96% from the year-ago quarter’s figure. The massive uptick can be attributed to activities in preparation for potential future clinical studies of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical study costs related to batoclimab development programs and increased personnel-related expenses.
General and administrative expenses amounted to $19.8 million, up 50% on a year-over-year basis. The rise was primarily due to an increase in personnel-related expenses, legal and other professional fees, along with information technology and market research costs.
As of Dec. 31, 2024, Immunovant had a cash balance of $374.7 million compared with $472.9 million as of Sept. 30, 2024.
Immunovant has crowned IMVT-1402, a next-generation FcRn inhibitor, as the lead asset going forward given its broad potential across several indications.
The company is on track to initiate clinical studies in a total of 10 indications for IMVT-1402 by March 31, 2026. The company expects to achieve financial efficiencies in its IMVT-1402 development program by leveraging the data already available from batoclimab studies.
The broad set of late-stage studies expected to be initiated for IMVT-1402 will include several indications, including Graves’ disease (GD), Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
In the past three months, shares of Immunovant have plunged 33.6% compared with the industry’s 6.6% decline.
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Immunovant is evaluating its second candidate, batoclimab, in several ongoing mid-late-stage studies across different autoimmune indications, including GD, MG, CIDP and thyroid eye disease (TED).
In September, the company announced positive data from the mid-stage study on, batoclimab, which is being developed for GD. Leveraging the encouraging results from the phase IIa GD study of batoclimab, Immunovant has initiated the first potentially registrational study of IMVT-1402 for adult patients with GD who are hyperthyroid despite antithyroid drug treatment. IMVT plans to report additional batoclimab proof-of-concept data for GD, including six-month treatment-free remission results, in summer 2025 to highlight IMVT-1402's potential.
Top-line results from the MG study of batoclimab are expected by the end of this fiscal year (March 31, 2025), which will guide the next steps and shape a potential registrational program for IMVT-1402 for this indication. IMVT may also transition its batoclimab CIDP study to a registrational CIDP program with IMVT-1402. The company believes that the data from the ongoing batoclimab CIDP study will substantially benefit the design of a potentially registrational study with IMVT-1402 for the same indication. Top-line data from the phase IIb study of batoclimab for CIDP is expected by March 31, 2025.
Furthermore, the company is also scheduled to share top-line data from the late-stage TED study of batoclimab in the second half of 2025, based on which IMVT will decide whether to file for regulatory approval.
Immunovant recently initiated a potentially registrational study of IMVT-1402 (600 mg) in adult patients with ACPA-positive difficult-to-treat rheumatoid arthritis, aiming to achieve deeper ACPA reduction for improved clinical outcomes.
Immunovant, Inc. price-consensus-eps-surprise-chart | Immunovant, Inc. Quote
Immunovant currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY. While CSTL sportsa Zacks Rank #1 (Strong Buy), BMRN and ALNY carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 45 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $1.51. In the past three months, shares of Castle Biosciences have plunged 16.4%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have remained constant at $3.28. Estimates for 2025 earnings per share have decreased from $4.01 to $4 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 4.1%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 41 cents. In the past three months, shares of Alnylam Pharmaceuticals have gained 0.3%.
ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.
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