Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025
- Strong clinical results from batoclimab trials with MG study meeting primary endpoint
- Robust cash position of $714M providing runway through 2027 GD readout
- Expansion into six different indications with potentially registrational trials
- Positive correlation between deeper IgG reductions and improved clinical outcomes
- Increased net loss to $106.4M in Q4 2025 from $75.3M in Q4 2024
- Higher R&D expenses at $93.7M compared to $66.1M year-over-year
- Increased G&A expenses to $20.2M from $14.8M year-over-year
Insights
Immunovant shows strong pipeline progress with IMVT-1402 in six indications, but widening losses despite $714M cash runway through 2027.
Immunovant's quarterly report reveals a company transitioning from early-stage development to a multi-indication late-stage clinical organization. The most significant development is the aggressive expansion of IMVT-1402's clinical program into six distinct autoimmune indications, with potentially registrational trials in five of these areas. This broad approach substantially increases their addressable market potential.
The positive data from batoclimab trials in myasthenia gravis and CIDP are particularly encouraging. In MG, the higher dose arm achieved a
Financially, Immunovant reported a cash position of
The leadership changes with Roivant increasing operational involvement signal a strategic shift, likely aimed at maximizing the value of their expanding clinical pipeline. This restructuring, combined with the accelerated development timeline for multiple indications, suggests a more aggressive approach to bringing their assets to market.
The upcoming catalysts include batoclimab six-month remission data from the Graves' disease study and Phase 3 thyroid eye disease data expected in the second half of 2025, which will be critical valuation inflection points for investors to monitor.
Promising clinical data for IMVT-1402 across multiple autoimmune indications shows correlation between IgG reduction and clinical improvement.
The clinical development strategy for IMVT-1402 represents one of the most ambitious programs in the autoimmune space, targeting six indications simultaneously. The decision to pursue potentially registrational trials in five indications (GD, D2T RA, MG, CIDP, and SjD) suggests strong confidence in the drug's mechanism and preliminary efficacy signals.
The positive batoclimab data in MG is particularly noteworthy, with the primary endpoint being met and showing a dose-response relationship. The
The correlation between IgG reduction and clinical efficacy across multiple endpoints and timepoints is mechanistically consistent and supports the company's hypothesis that deeper IgG suppression leads to better outcomes. This dose-response relationship will likely inform optimal dosing strategies for IMVT-1402.
The expansion into Sjögren's disease is particularly interesting as this represents an area of significant unmet need with limited treatment options. Similarly, the proof-of-concept trial in cutaneous lupus erythematosus could open up another first-in-class opportunity.
The aggressive timeline, with two new registrational trials planned for summer 2025, reflects the competitive landscape in the FcRn inhibitor space. Immunovant appears to be positioning IMVT-1402 as a potential best-in-class agent based on the observed IgG reduction profile, which could differentiate it from competitors if the safety profile remains favorable across these expanded indications.
The upcoming GD remission data and TED Phase 3 results will provide critical validation of this approach across different autoimmune pathologies and set expectations for the broader development program.
- Immunovant’s new management team is focused on rapid clinical execution for the six announced indications for IMVT-1402, including a second potentially registrational study in Graves’ disease (GD) and a potentially registrational study in Sjögren’s disease (SjD), both expected to start in summer 2025
- Positive data from first-generation batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) demonstrated that deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints suggesting a potential best-in-class efficacy profile for IMVT-1402
- Current cash balance provides runway for announced indications through GD readout expected in 2027
NEW YORK, May 29, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fourth quarter and fiscal year ended March 31, 2025.
Recent Highlights and Upcoming Milestones:
In April 2025, Immunovant announced changes to its leadership team as part of a broader strategic transition with Roivant increasing operational involvement and oversight of Immunovant. Eric Venker, M.D. was appointed as CEO of Immunovant, and Tiago Girao as CFO of Immunovant. Given the strength of its potential best-in-class profile, IMVT-1402 is being developed in six announced indications, including potentially registrational trials in Graves’ disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE).
In March 2025, Immunovant announced positive results from its batoclimab MG and CIDP studies. The potentially registrational study in MG met its primary endpoint of change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ population at week 12, with the higher dose arm achieving a 5.6-point improvement (with
In March 2025, Immunovant initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive D2T RA and a proof-of-concept study in CLE. Both indications represent potential first-in-class and best-in-class opportunities based on positive in-class competitor data (D2T RA) and promising efficacy data from patients dosed with IMVT-1402 as part of an open-label case study program (CLE).
Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025.
Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease (TED) data in the second half of calendar year 2025.
Financial Highlights for Fiscal Fourth Quarter Ended March 31, 2025:
Cash Position: As of March 31, 2025, Immunovant’s cash and cash equivalents totaled approximately
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Common Stock: As of March 31, 2025, there were 170,111,593 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Year Ended March 31, 2025:
R&D Expenses: Research and development expenses were
IPR&D Expenses: There were no acquired in-process research and development expenses for the fiscal year ended March 31, 2025. During the fiscal year ended March 31, 2024, acquired in-process research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s expectations regarding the timing, design, and results of clinical trials of IMVT-1402; Immunovant’s plan to develop IMVT-1402 and batoclimab across a broad range of indications; the number and timing of potentially registrational programs and clinical trials Immunovant plans to initiate for IMVT-1402; and potential benefits of IMVT-1402’s unique product attributes and potential best-in-class and first-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; 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; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402 or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 29, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
| IMMUNOVANT, INC. Consolidated Statements of Operations (In thousands, except share and per share data) | ||||||||||||||||||
| Three Months Ended March 31, | Years Ended March 31, | |||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development | $ | 93,652 | $ | 66,056 | $ | 360,917 | $ | 212,928 | ||||||||||
| Acquired in-process research and development | — | — | — | 12,500 | ||||||||||||||
| General and administrative | 20,174 | 14,823 | 77,235 | 57,281 | ||||||||||||||
| Total operating expenses | 113,826 | 80,879 | 438,152 | 282,709 | ||||||||||||||
| Interest income | (6,889 | ) | (8,379 | ) | (24,732 | ) | (24,948 | ) | ||||||||||
| Other (income) expense, net | (1,071 | ) | 2,587 | (471 | ) | 1,008 | ||||||||||||
| Loss before provision for income taxes | (105,866 | ) | (75,087 | ) | (412,949 | ) | (258,769 | ) | ||||||||||
| Provision for income taxes | 583 | 232 | 891 | 567 | ||||||||||||||
| Net loss | $ | (106,449 | ) | $ | (75,319 | ) | $ | (413,840 | ) | $ | (259,336 | ) | ||||||
| Net loss per common share – basic and diluted | $ | (0.64 | ) | $ | (0.52 | ) | $ | (2.73 | ) | $ | (1.88 | ) | ||||||
| Weighted-average common shares outstanding – basic and diluted | 166,732,686 | 145,355,546 | 151,573,553 | 138,100,577 | ||||||||||||||
| IMMUNOVANT, INC. Consolidated Balance Sheets (In thousands, except share and per share data) | |||||||
| March 31, | |||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 713,971 | $ | 635,365 | |||
| Accounts receivable | 2,084 | 5,337 | |||||
| Prepaid expenses and other current assets | 51,180 | 24,902 | |||||
| Income tax receivable | 427 | 166 | |||||
| Total current assets | 767,662 | 665,770 | |||||
| Operating lease right-of-use assets | 98 | 133 | |||||
| Property and equipment, net | 844 | 462 | |||||
| Other assets | 7,618 | — | |||||
| Total assets | $ | 776,222 | $ | 666,365 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 17,656 | $ | 7,155 | |||
| Accrued expenses | 50,748 | 41,300 | |||||
| Current portion of operating lease liabilities | 98 | 138 | |||||
| Due to Roivant Sciences Ltd. | 273 | 15 | |||||
| Total current liabilities | 68,775 | 48,608 | |||||
| Total liabilities | 68,775 | 48,608 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Series A preferred stock, par value | — | — | |||||
| Preferred stock, par value | — | — | |||||
| Common stock, par value | 16 | 14 | |||||
| Additional paid-in capital | 1,945,495 | 1,441,518 | |||||
| Accumulated other comprehensive income | 1,459 | 1,908 | |||||
| Accumulated deficit | (1,239,523 | ) | (825,683 | ) | |||
| Total stockholders’ equity | 707,447 | 617,757 | |||||
| Total liabilities and stockholders’ equity | $ | 776,222 | $ | 666,365 | |||
Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
FAQ
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