Immunovant, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
IMVT$35.15+15.1%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001764013-26-000101
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001764013-26-000122
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 131 previous paragraphs and 147 current paragraphs.
101 unchanged; 27 reworded; 13 added; 3 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
We previously initiated a proof-of-concept study evaluating IMVT-1402 for the treatment of cutaneous lupus erythematosus (“CLE”). In September 2026, we disclosed that the study did not achieve statistical significance on its primary endpoint, and accordingly, we discontinued further development of IMVT-1402 in CLE. More information about the trial is described further under “Recent Developments in Our Clinical Programs” below.
Current report
A total of 118 participants were randomized in Period 2 to IMVT-1402 600 mg SC QW (n=40), IMVT-1402 300 mg SC QW (n=36) or placebo SC QW (n=41) (one participant in the 300mg arm having been excluded due to protocol non-compliance). Baseline characteristics were generally well balanced across the arms. The primary endpoint measured the proportion of participants who maintained an ACR20 response at Week 28.
Current report
In November 2026, we reported top-line results from Period 2. The IMVT-1402 600 mg arm (n=40) met the primary endpoint, with 92.5% of participants maintaining ACR20 response at Week 28, compared to 75.6% on placebo (n=41) (p=0.0139). Participants randomized to IMVT-1402 300 mg (n=36) did not show a difference from placebo, with 75.0% maintaining an ACR20 response at Week 28 (p=0.9426). In a post hoc analysis, among participants who had failed at least a JAK inhibitor and an anti-TNF inhibitor, ACR20 response rates maintained at Week 28 were 92.0% for 600 mg (n=25) and 74.1% for placebo (n=27). This subgroup analysis was not powered or tested for statistical significance.
Current report
In exploratory analyses, ACR50 and ACR70 response rates were observed to increase from baseline to Week 28 in the 600 mg SC QW treatment arm (n=40). The ACR50 response rates at Week 28 were 80.0% for 600 mg and 56.1% for placebo (nominal p=0.0117). The ACR70 response rates were 52.5% and 36.6%, respectively (nominal p=0.1674). The trial was not powered to detect differences in ACR50 or ACR70.
Current report
For each of two secondary endpoints, the least squares mean change from Period 2 baseline to Week 28 demonstrated numerical trends favoring IMVT-1402 600mg in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) scores but did not reach statistical significance. Least squares mean CDAI changes (a decrease indicates improvement) were -0.3 for IMVT-1402 600 mg and +3.1 for placebo (p=0.1096), and least squares mean SDAI changes (a decrease indicates improvement) were +0.1 for IMVT-1402 600 mg and +3.5 for placebo (p=0.1299).
Current report
IMVT-1402 was observed to be well-tolerated in both Periods 1 and 2, and no new drug-related safety signals were identified. In Period 2, no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or adverse events leading to treatment discontinuation were reported in any arm. We plan to hold an End of Phase 2 meeting with the FDA by the end of calendar year 2026 to discuss the path forward, including a second potentially registrational trial in D2T RA.
Current report
IMVT-1402 Trial in Sjögren’s disease (“SjD”)
Current report
In February 2025, we initiated a proof-of-concept trial (NCT06980805) evaluating IMVT-1402 for the treatment of CLE. The study enrolled a total of 57 participants. Study participants were randomized 1:1 to IMVT-1402 or placebo for a 12-week treatment period. The primary endpoint was the percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12 (Period 1). In September 2026, we announced that the study did not achieve statistical significance on the primary endpoint. IMVT-1402 was observed to be well-tolerated in this study, and no new drug-related safety signals were identified. Based on the results from Period 1, the study and further development of IMVT-1402 in CLE were discontinued to allow resources to be directed to the other development programs.
Current report
For the three months ended September 30, 2026, general and administrative expenses increased $1.6 million as compared with the prior-year period, primarily reflecting higher investments in pre-commercial activities.
Current report
Results of Operations for the Six Months Ended September 30, 2026 and 2025
Current report
Research and Development Expenses for the Six Months Ended September 30, 2026 and 2025
Current report
For the six months ended September 30, 2026, research and development expenses increased $12.2 million as compared with the prior-year period.
Current report
General and Administrative Expenses for the Six Months Ended September 30, 2026 and 2025
Removed paragraphs (3)
Previous report
In April 2026, we announced top-line results from two Phase 3 clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease (“TED”), neither of which met the primary endpoint. The safety profile observed in these studies was consistent with prior batoclimab studies, with no new safety signals identified. Following these results, we made a decision to discontinue further development of batoclimab across all indications to focus fully on IMVT-1402. Learnings from the batoclimab program, including clinical data, operational trial experience, and relationships with investigators, have been and continue to be leveraged to inform the development of IMVT-1402.
Previous report
IMVT-1402 Trial in SjD
Previous report
In February 2025, we initiated a proof-of-concept trial (NCT06980805) evaluating IMVT-1402 in CLE. The trial is fully enrolled and we expect to report top-line results from this trial in the second half of calendar year 2026.
Reworded paragraphs (27)
Previous wording
Consistent evidence observed across the class in eight indications in Phase 2 and 3 trials with FcRn inhibitors has indicated that deeper IgG reductions correlate with meaningful improvements in clinical outcomes. This has also been validated with Immunovant’s own Phase 2 and 3 studies evaluating its first-generation anti-FcRn antibody, batoclimab, in Graves’ disease (“GD”), myasthenia gravis (“MG”) and chronic inflammatory demyelinating polyneuropathy (“CIDP”) which showed that IgG reductions of greater than or equal to 70% led to meaningfully better outcomes compared to reductions below 70% across a range of clinical measures.
Current wording
Consistent observations across the class in eight indications in Phase 2 and 3 trials with FcRn inhibitors have provided evidence that deeper IgG reductions correlated with improvements in clinical outcomes. This has also been validated with Immunovant’s own Phase 2 and 3 studies evaluating its first-generation anti-FcRn antibody, batoclimab, in Graves’ disease (“GD”), myasthenia gravis (“MG”) and chronic inflammatory demyelinating polyneuropathy (“CIDP”) which showed that IgG reductions of greater than or equal to 70% led to meaningfully better outcomes compared to reductions below 70% across a range of clinical measures.
Previous wording
In a Phase 1 clinical trial, healthy adults dosed with IMVT-1402 showed deep, dose-dependent IgG reductions. We expect to be able to reach approximately 80% IgG reductions with continued weekly dosing of 600 mg of IMVT-1402, offering deeper IgG reductions than observed with other competitor anti-FcRn programs, therefore representing a potential best-in-class opportunity. In the Phase 1 clinical trial, across all evaluated doses, IMVT-1402 demonstrated no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels, which are off-target effects observed in some anti-FcRn antibodies, including batoclimab. We believe IMVT-1402’s profile has the potential to offer best-in-class efficacy, in addition to its potentially favorable safety profile and convenient administration with a simple self-administered auto-injector expected at launch.
Current wording
In a Phase 1 clinical trial, healthy adults dosed with IMVT-1402 showed deep, dose-dependent IgG reductions. We expect to be able to reach up to 80% IgG reductions with continued weekly dosing of 600 mg of IMVT-1402, offering deeper IgG reductions than observed with other competitor anti-FcRn programs, therefore representing a potential best-in-class opportunity. In the Phase 1 clinical trial, across all evaluated doses, IMVT-1402 demonstrated no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels, which are off-target effects observed in some anti-FcRn antibodies, including batoclimab. We believe IMVT-1402’s profile has the potential to offer best-in-class efficacy, in addition to its potentially favorable safety profile and convenient administration with a simple self-administered auto-injector expected at launch.
Previous wording
We are currently progressing a broad set of programs for IMVT-1402 and have ongoing studies in six indications, including potentially registrational trials in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MG, CIDP and Sjögren’s disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). Our primary focus is to execute these six indications first, with plans to assess new indications for IMVT-1402 in the future. All studies evaluating IMVT-1402 are being conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized for multiple approved products.
Current wording
We are currently progressing a broad set of programs for IMVT-1402, with ongoing studies in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MG, and CIDP. Our primary focus is to execute these indications first, with plans to assess new indications for IMVT-1402 in the future. All studies evaluating IMVT-1402 are being conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized for multiple approved products.
Previous wording
In May 2026, we reported positive preliminary open-label Week 16 (Period 1) results from our potentially registrational trial in D2T RA, in which IMVT-1402 showed response rates of 72.7% ACR20, 54.5% ACR50, and 35.8% ACR70 in a heavily pretreated patient population - the first efficacy data for IMVT-1402 in patients. These results are described further under “Recent Developments in Our Clinical Programs” below.
Current wording
In November 2026, we reported positive top-line results from the randomized withdrawal period (Period 2) of our potentially registrational trial in D2T RA, in which IMVT-1402 600 mg arm met the primary endpoint, with 92.5% of participants maintaining ACR20 response at Week 28 compared to 75.6% on placebo (p=0.0139). The IMVT-1402 300 mg arm did not demonstrate a statistically significant difference from placebo, with 75.0% maintaining an ACR20 response at Week 28 (p=0.9426). Previously in May 2026, we reported positive preliminary open-label Week 16 (Period 1) results from this trial, in which IMVT-1402 600 mg showed response rates of 72.7% ACR20, 54.5% ACR50, and 35.8% ACR70 (each as defined below) in a heavily pretreated patient population. These results are described further under “Recent Developments in Our Clinical Programs” below.
Previous wording
IMVT-1402 and batoclimab are fully human monoclonal antibodies that target FcRn. These antibodies are the result of a multi-step, multi-year research program conducted in collaboration with HanAll to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that has been shown to deliver better efficacy at the high dose and similar efficacy at the low dose compared to standard FcRn inhibition by competitors.
Current wording
IMVT-1402 and our prior product candidate, batoclimab, for which we discontinued development in April 2026, are fully human monoclonal antibodies that target FcRn. These antibodies are the result of a multi-step, multi-year research program conducted in collaboration with HanAll to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that has been shown to deliver better efficacy at the high dose and similar efficacy at the low dose compared to standard FcRn inhibition by competitors.
Previous wording
In December 2024, we initiated a potentially registrational trial (NCT06754462) evaluating IMVT-1402 in anti-citrullinated protein autoantibody (“ACPA”) positive D2T RA.
Current wording
In December 2024, we initiated a potentially registrational, multicenter, randomized withdrawal trial (NCT06754462) evaluating IMVT-1402 in adults with anti-citrullinated protein autoantibody (“ACPA”) positive D2T RA who have had an inadequate response to two or more prior mechanisms of advanced therapy, including biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).
Previous wording
The trial is currently ongoing and enrolled a total of 170 participants in Period 1. At the completion of Period 1, 165 of the 170 enrolled patients were evaluable for ACR20 response to determine eligibility to continue to Period 2 and the primary efficacy analysis for the study. The enrollment inclusion criteria described above resulted in a heavily pretreated population: 86.7% (143/165) had failed two prior mechanisms of advanced therapies (i.e., biologic or targeted synthetic DMARDs), and the mean time from disease diagnosis was 12.8 years. Baseline disease activity was high, with a mean of 24.2 tender joints, 16.7 swollen joints, and DAS28-CRP score of 6.1.
Current wording
The trial enrolled a total of 170 participants in Period 1. At the completion of Period 1, 165 of the 170 enrolled patients were evaluable for ACR20 response to determine eligibility to continue to Period 2 and the primary efficacy analysis for the study. The enrollment inclusion criteria resulted in a heavily pretreated population: 86.7% (143/165) had failed two prior mechanisms of advanced therapies (i.e., biologic or targeted synthetic DMARDs), and the mean time from disease diagnosis was 12.8 years. Baseline disease activity was high, with a mean of 24.2 tender joints, 16.7 swollen joints, and DAS28-CRP score of 6.1. In Period 1, participants received open-label IMVT-1402 600 mg subcutaneously (SC) once weekly (QW) for 16 weeks.
Previous wording
At Week 16, the ACR20, ACR50, and ACR70 response rates observed were 72.7%, 54.5%, and 35.8%, respectively; participants who discontinued prior to Week 16 were imputed as non-responders. Among the subset of participants who had failed at least a JAK inhibitor and an anti-TNF inhibitor (N=107), the ACR20, ACR50, and ACR70 response rates observed at Week 16 were 72.0%, 53.3%, and 37.4%, respectively. ACR20 response is defined as a ≥ 20% improvement from baseline in tender joint count and swollen joint count and a ≥ 20% improvement from baseline in at least 3 of 5 additional clinical parameters. Similarly, ACR50 and ACR70 responses are a calculation of 50% or 70% improvement, respectively, in the number of swollen and tender joints and 3 of 5 assessment parameters.
Current wording
As previously reported in May 2026, the ACR20, ACR50, and ACR70 response rates observed were 72.7%, 54.5%, and 35.8%, respectively among the 165 participants who were evaluable for ACR20 response; participants who discontinued prior to Week 16 were imputed as non-responders. Among the subset of participants who had failed at least a JAK inhibitor and an anti-TNF inhibitor (N=107), the ACR20, ACR50, and ACR70 response rates observed at Week 16 were 72.0%, 53.3%, and 37.4%, respectively. ACR20 response is defined as a ≥ 20% improvement from baseline in tender joint count and swollen joint count and a ≥ 20% improvement from baseline in at least 3 of 5 additional clinical parameters. ACR50 and ACR70 responses are defined in the same manner, using thresholds of 50% and 70% improvement, respectively.
Previous wording
Period 1 was conducted in an open-label setting, with joint assessments performed by independent assessors blinded to treatment status to control for the potential for assessor bias in the response measures. IMVT-1402 was observed to be safe and well-tolerated in Period 1, and no new drug-related safety signals were identified. Study participants meeting the criteria for an ACR20 response at Weeks 14 and 16 are eligible to advance to Period 2 of the trial, where the primary endpoint will be assessed at Week 28. Further updates on this program are expected in the second half of calendar year 2026.
Current wording
Period 1 was conducted in an open-label setting, and joint assessments were performed throughout the entire study by independent assessors blinded to treatment status to control for the potential for assessor bias in the response measures. Study participants meeting the criteria for an ACR20 response at Weeks 14 and 16 were eligible to advance to Period 2 of the trial, in which the primary endpoint was assessed at Week 28.
Previous wording
In June 2025, we initiated a potentially registrational trial (NCT06979531) evaluating IMVT-1402 in SjD. We expect to report top-line results from this trial in calendar year 2028.
Current wording
In June 2025, we initiated a potentially registrational trial (NCT06979531) evaluating IMVT-1402 in SjD. In light of the evolving SjD landscape and recent data in the field, we expect it is unlikely that we will advance IMVT-1402 further in SjD beyond the ongoing, fully enrolled Phase 2 trial.
Previous wording
Research and development activities will continue to be central to our business model. We expect to incur research and development expenses with respect to our IMVT-1402 development activities and we have ongoing clinical trials evaluating IMVT-1402 in GD, D2T RA, MG, CIDP, SjD and CLE. We expect to continue to incur research and development expenses over the next several years as we execute IMVT-1402 trials, manufacture IMVT-1402 and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.
Current wording
Research and development activities will continue to be central to our business model. We expect to incur research and development expenses with respect to our IMVT-1402 development activities and we have ongoing clinical trials evaluating IMVT-1402 in GD, D2T RA, MG, CIDP and SjD. We expect to continue to incur research and development expenses over the next several years as we execute IMVT-1402 trials, manufacture IMVT-1402 and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.
Previous wording
We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates and fees to outside consultants for professional services. In addition, if IMVT-1402 or any other product candidate obtains regulatory approval, we expect that we would incur significant additional expenses associated with market research activities and building commercial teams.
Current wording
We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates and fees to outside consultants for professional services. In addition, if IMVT-1402 or any other product candidate obtains regulatory approval, we expect that we would incur significant additional expenses associated with market research and pre-commercial activities and building commercial teams.
Previous wording
For the three months ended June 30, 2026, research and development expenses increased $41.4 million as compared with the prior-year period.
Current wording
For the three months ended September 30, 2026, research and development expenses decreased $29.2 million as compared with the prior-year period.
Previous wording
For the three months ended June 30, 2026, unallocated research and development costs decreased $3.4 million as compared with the prior-year period. This decrease primarily reflected lower costs that were not allocated to specific therapeutic areas as a result of the Company’s focus on the development of IMVT-1402 of $2.4 million and a decrease in personnel-related expenses of $1.0 million aligned with a decrease in headcount.
Current wording
For the three months ended September 30, 2026, unallocated research and development costs decreased $10.9 million as compared with the prior-year period. This decrease primarily reflected lower personnel-related expenses of $8.5 million aligned with a decrease in headcount, as well as lower costs that were not allocated to specific therapeutic areas of $2.3 million resulting from the Company’s focus on the development of IMVT-1402 in the therapeutic areas discussed above.
Previous wording
For the three months ended June 30, 2026, interest income increased $0.8 million as compared with the prior-year period, primarily reflecting higher average money market fund balances, partially offset by lower average interest rates.
Current wording
For the three months ended September 30, 2026, interest income increased $1.3 million as compared with the prior-year period, primarily reflecting higher average money market fund balances, partially offset by lower average interest rates.
Previous wording
For the three months ended June 30, 2026, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $44.8 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $23.6 million. This increase was primarily due to our ongoing clinical trials of IMVT-1402 in GD, partially offset by lower costs related to the wind-down of our batoclimab clinical trials. Research and development costs related to neurological diseases, which include MG and CIDP, increased $4.5 million, primarily due to higher costs related to our clinical trials of IMVT-1402 in neurological diseases, partially offset by lower costs related to the wind-down of our batoclimab clinical trials. Research and development costs related to rheumatology diseases increased $14.1 million, reflecting higher expenses incurred with our ongoing clinical trials of IMVT-1402 in D2T RA and SjD. Research and development costs related to dermatology diseases increased $2.4 million, reflecting higher overall clinical trial costs for our proof-of-concept trial in CLE.
Current wording
For the six months ended September 30, 2026, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $26.5 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $21.1 million. This increase was primarily due to our ongoing clinical trials of IMVT-1402 in GD, partially offset by lower costs related to the wind-down of our batoclimab clinical trials. Research and development costs related to neurological diseases, which include MG and CIDP, decreased $0.3 million, reflecting lower costs related to the wind-down of our batoclimab clinical trials, mostly offset by higher expenses incurred from our ongoing clinical trials of IMVT-1402. Research and development costs related to rheumatology diseases increased $10.4 million, reflecting higher expenses incurred with our ongoing clinical trials of IMVT-1402 in D2T RA and SjD. Research and development costs related to dermatology diseases decreased $4.9 million, reflecting lower overall expenses incurred with our proof-of-concept trial of IMVT-1402 in CLE, for which we have discontinued further development.
Previous wording
For the three months ended June 30, 2026, general and administrative expenses decreased $8.3 million as compared with the prior-year period, primarily reflecting lower personnel-related expenses, driven by a one-time stock-based compensation charge in the prior-year period related to the retirement of our former chief executive officer, as well as lower professional fees, market research costs and information technology costs.
Current wording
For the six months ended September 30, 2026, general and administrative expenses decreased $6.7 million as compared with the prior-year period, primarily reflecting lower personnel-related expenses, driven by a one-time stock-based compensation charge in the prior-year period related to the retirement of our former chief executive officer, as well as lower professional fees, partially offset by higher investments in pre-commercial activities.
Previous wording
We had cash and cash equivalents of $797.8 million and $902.1 million as of June 30, 2026 and March 31, 2026, respectively. For the three months ended June 30, 2026 and 2025, we had net losses of $153.2 million and $120.6 million, respectively. We expect to continue to incur significant expenses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for IMVT-1402 or any future product candidate.
Current wording
We had cash and cash equivalents of $722.3 million and $902.1 million as of September 30, 2026 and March 31, 2026, respectively. For the three months ended September 30, 2026 and 2025, we had net losses of $97.2 million and $126.5 million, respectively and for the six months ended September 30, 2026 and 2025, we had net losses of $250.5 million and $247.1 million, respectively. We expect to continue to incur significant expenses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for IMVT-1402 or any future product candidate.
Previous wording
We have a sales agreement with Leerink Partners LLC (“Leerink Partners”), as sales agent, pursuant to which we may offer and sell, from time to time, shares of our common stock (the “ATM Shares”), subject to certain conditions as specified in the sales agreement. We agreed to pay Leerink Partners up to 3% of the gross proceeds from each sale of ATM Shares sold through the sales agreement. The ATM Shares would be sold at prevailing market prices at the time of the sale and, as a result, prices may vary. The ATM Shares to be sold under the sales agreement, if any, would be issued and sold pursuant to an automatic shelf registration statement on Form S-3, which we filed with the SEC on November 9, 2023, along with a prospectus supplement relating to the offer and sale of up to $150.0 million of ATM Shares pursuant to the sales agreement. We have not issued or sold any ATM Shares pursuant to the ATM offering program.
Current wording
We have a sales agreement with Leerink Partners LLC (“Leerink Partners”), as sales agent, pursuant to which we may offer and sell, from time to time, shares of our common stock (the “ATM Shares”), subject to certain conditions as specified in the sales agreement. We agreed to pay Leerink Partners up to 3% of the gross proceeds from each sale of ATM Shares sold through the sales agreement. The ATM Shares would be sold at prevailing market prices at the time of the sale and, as a result, prices may vary. The ATM Shares to be sold under the sales agreement, if any, would be issued and sold pursuant to an automatic shelf registration statement on Form S-3, along with a prospectus supplement relating to the offer and sale of up to $150.0 million of ATM Shares pursuant to the sales agreement. We have not issued or sold any ATM Shares pursuant to the ATM offering program.
Previous wording
The following table sets forth a summary of our cash flows for the three months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table sets forth a summary of our cash flows for the six months ended September 30, 2026 and 2025 (in thousands):
Previous wording
For the three months ended June 30, 2026, $124.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $153.2 million, partially offset by non-cash charges of $13.9 million and a net change in operating assets and liabilities of $14.9 million. The non-cash charges consisted mainly of stock-based compensation of $13.8 million, reflecting the lower headcount and related incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected an increase in accrued expenses and other current liabilities of $10.1 million, primarily reflecting payments and services related to our ongoing clinical trials and contract manufacturing, partially offset by payments related to employee incentive compensation, a decrease in other assets of $6.8 million driven by the amortization of prepaid expenses related to certain contract manufacturing activities, and an increase in accounts payable of $2.6 million related to CRO clinical trial costs. These changes were partially offset by higher prepaid and other current assets of $5.0 million, primarily reflecting the timing of payments and services related to our ongoing clinical trials.
Current wording
For the six months ended September 30, 2026, $207.6 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $250.5 million, partially offset by non-cash charges of $27.3 million and a net change in operating assets and liabilities of $15.6 million. The non-cash charges consisted mainly of stock-based compensation of $27.1 million, reflecting the lower headcount and related incentive equity awards as compared with the prior year. The change in operating assets and liabilities primarily reflected lower prepaid and other current assets of $7.9 million, primarily reflecting the timing of payments and services related to our ongoing clinical trials, and a decrease in other assets of $7.0 million driven by the amortization of prepaid expenses related to certain contract manufacturing activities.
Previous wording
For the three months ended June 30, 2025, $117.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $120.6 million and a net change in operating assets and liabilities of $15.4 million, partially offset by non-cash charges of $18.6 million. The non-cash charges consisted mainly of stock-based compensation of $18.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected a decrease in accounts payable of $9.4 million, primarily related to payments to CROs for clinical trial costs. Accrued expenses and other current liabilities decreased $5.3 million, primarily reflecting payments related to employee incentive compensation, partially offset by the timing of payments and services related to our ongoing clinical trials.
Current wording
For the six months ended September 30, 2025, $219.9 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $247.1 million and a net change in operating assets and liabilities of $4.9 million, partially offset by non-cash charges of $32.1 million. The non-cash charges consisted mainly of stock-based compensation of $31.9 million, reflecting the higher headcount and incentive equity awards as compared with the prior year, as well as a one-time stock-based compensation charge related to the retirement of our former chief executive officer. The change in operating assets and liabilities reflected a decrease in accounts payable of $10.5 million, primarily related to payments for clinical trial costs and contract manufacturing. These changes were partially offset by an increase in accrued expenses and other current liabilities of $5.0 million, primarily reflecting costs incurred for our ongoing clinical trials.
Previous wording
For the three months ended June 30, 2026 and 2025, cash provided by financing activities consisted of proceeds from the exercise of stock options, driven by exercises from our former executive officers and director.
Current wording
For the six months ended September 30, 2026 and 2025, cash provided by financing activities consisted of proceeds from the exercise of stock options.
Previous wording
Potential future payments due under the HanAll Agreement are contingent upon future events. As of June 30, 2026, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million paid for milestone events achieved as of June 30, 2026) upon the achievement of certain regulatory and sales milestone events. We have commenced discussions with HanAll regarding the future disposition of batoclimab, including the potential return to HanAll of certain rights for batoclimab, which could impact the aggregate amount (if any) of potential future payments under the HanAll Agreement. In April 2026, we notified HanAll of our decision to indefinitely delay further development of batoclimab and focus our resources fully on IMVT-1402. For additional considerations regarding associated risks, see Part I, Item 2—Key Agreementsof this Quarterly Report on Form 10-Q.
Current wording
Potential future payments due under the HanAll Agreement are contingent upon future events. As of September 30, 2026, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million paid for milestone events achieved as of September 30, 2026) upon the achievement of certain regulatory and sales milestone events. We have commenced discussions with HanAll regarding the future disposition of batoclimab, including the potential return to HanAll of certain rights for batoclimab, which could impact the aggregate amount (if any) of potential future payments under the HanAll Agreement. In April 2026, we notified HanAll of our decision to indefinitely delay further development of batoclimab and focus our resources fully on IMVT-1402. For additional considerations regarding associated risks, see Part I, Item 2—Our Key Agreementsof this Quarterly Report on Form 10-Q.
Previous wording
We currently expect that our existing cash and cash equivalents as of June 30, 2026 of $797.8 million will be sufficient to fund our operating expenses and capital expenditure requirements, based on our current operating plan, to the potential commercial launch of IMVT-1402 in GD.
Current wording
We currently expect that our existing cash and cash equivalents as of September 30, 2026 of $722.3 million will be sufficient to fund our operating expenses and capital expenditure requirements, based on our current operating plan, to the potential commercial launch of IMVT-1402 in GD.
Previous wording
Following positive results from Period 1 in our D2T RA trial and continued strong execution across our pipeline, we are evaluating potential expansions of our development plans, including additional investment in late-stage development. Any such expansion is not reflected in our current operating plan, and we expect to provide updated cash runway guidance if and as we finalize these plans, following top-line results from Period 2 of our D2T RA and CLE trials later this year.
Current wording
Following positive results from our D2T RA trial and continued strong execution across our pipeline, we are evaluating potential expansions of our development plans, including additional investment in late-stage development. Any such expansion is not reflected in our current operating plan, and we expect to provide updated cash runway guidance if and as we finalize these plans.
Previous wording
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three months ended June 30, 2026, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2026 included in our Annual Report.
Current wording
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three and six months ended September 30, 2026, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2026 included in our Annual Report.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
For the three months ended September 30, 2026, therapeutic area-specific research and development costs, including contract manufacturing costs, decreased $18.3 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and thyroid eye disease (“TED”), decreased $2.4 million. This decrease was primarily due to lower costs related to the timing of IMVT-1402 contract manufacturing costs and the wind-down of our batoclimab clinical trials, partially offset by higher costs related to our ongoing clinical trials of IMVT-1402 in GD. Research and development costs related to neurological diseases, which include MG and CIDP, decreased $4.8 million, primarily due to lower costs related to the wind-down of our batoclimab clinical trials. Research and development costs related to rheumatology diseases decreased $3.7 million, primarily due to lower costs related to the timing of IMVT-1402 contract manufacturing costs and lower expenses incurred with our ongoing clinical trials of IMVT-1402 in D2T RA and SjD. Research and development costs related to dermatology diseases decreased $7.3 million, reflecting lower costs related to the timing of IMVT-1402 contract manufacturing costs and lower expenses incurred with our proof-of-concept trial of IMVT-1402 in CLE, for which we have recently discontinued further development.
Current report — wording carried from elsewhere
The following table sets forth our results of operations for the six months ended September 30, 2026 and 2025 (in thousands):
Current report — wording carried from elsewhere
The following table summarizes the period-over-period changes in research and development expenses for the six months ended September 30, 2026 and 2025 (in thousands):
Current report — wording carried from elsewhere
For the six months ended September 30, 2026, unallocated research and development costs decreased $14.3 million as compared with the prior-year period. This decrease primarily reflected lower personnel-related expenses of $9.6 million aligned with a decrease in headcount, as well as lower costs that were not allocated to specific therapeutic areas of $4.7 million resulting from the Company’s focus on the development of IMVT-1402 in the therapeutic areas discussed above.
Current report — wording carried from elsewhere
Interest Income, net for the Six Months Ended September 30, 2026 and 2025
Current report — wording carried from elsewhere
For the six months ended September 30, 2026, interest income increased $2.1 million as compared with the prior-year period, primarily reflecting higher average money market fund balances, partially offset by lower average interest rates.