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Immunovant IMVT

Immunovant reported Q2 2026 financial results

Item 2.02 Reports results

Form
8-K
Filed
Importance
Major
  1. IMVT-1402 600 mg met primary endpoint of ACR20 response at Week 28 (92.5% vs. 75.6% placebo)
  2. Net loss was $97.2 million for Q2 2026, down from $126.5 million in Q2 2025
  3. Cash position was $722.3 million as of September 30, 2026

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The reading, claim by claim

  1. Under Item 2.02, it said it issued a press release that day announcing financial results for its fiscal second quarter and six months ended September 30, 2026.
  2. The release is furnished as Exhibit 99.1.
  3. Item 2.02 states that the information, including Exhibit 99.1, shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934.
  4. It also shall not be incorporated by reference in any SEC filing by the Company.
  5. Item 9.01 lists the press release as Exhibit 99.1 and the cover page data file as Exhibit 104.
  6. The press release says IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 in Period 2 of the trial in difficult-to-treat rheumatoid arthritis, at 92.5% vs. 75.6% placebo (p=0.0139).
  7. The 300 mg arm did not show a difference from placebo, with 75.0% maintaining an ACR20 response (p=0.9426).
  8. FDA discussions are planned for later this year.
  9. The release also says the Company expects it is unlikely to advance IMVT-1402 further in Sjögren's disease beyond the ongoing, fully enrolled Phase 2 trial.
  10. It expects topline data in Graves' disease and myasthenia gravis in calendar year 2027, and in CIDP in calendar year 2028.
  11. For the quarter ended September 30, 2026, the release reports cash and cash equivalents of $722.3 million and R&D expenses of $85.0 million, versus $114.2 million a year earlier.
  12. Net loss was $97.2 million ($0.47 per common share), versus $126.5 million ($0.73 per common share) a year earlier.

12 of 13 claims matched the filing text.

Not found in the filing text

  • In its 10-Q for the quarter ended June 30, 2026, Immunovant reported net income of -$153.2 million.

From the filing

Item 2.02. Results of Operations and Financial Condition.

On November 9, 2026, Immunovant, Inc. ("the Company") issued a press release announcing its financial results for its fiscal second quarter and six months ended September 30, 2026.1 A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K2 and is incorporated herein by reference.

The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended3, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 2.02 shall not be incorporated by reference in any filing with the U.S. Securities and Exchange Commission, or the SEC, made by the Company4, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1 Press release, dated November 9, 2026.5

104 Cover Page Interactive Data File (embedded within the Inline XBRL document).5

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

IMMUNOVANT, INC.

By: /s/ Tiago Girao

Tiago Girao

Chief Financial Officer

Date: November 9, 2026

Immunovant Provides Corporate Updates and Reports Financial Results for the Quarter Ended September 30, 2026

•IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (92.5% vs. 75.6% placebo, p=0.0139) in Period 26 (randomized withdrawal design following open-label lead-in) of the potentially registrational trial in patients with difficult-to-treat rheumatoid arthritis (D2T RA) •In exploratory analyses, ACR50 and ACR70 response rates for patients who remained on IMVT-1402 600 mg in Period 2 continued to increase, reaching 80.0% ACR50 and 52.5% ACR70 at Week 28

•FDA discussions planned for later this year to determine the path forward regarding the registrational program for IMVT-1402 in D2T RA

•In light of the evolving Sjögren's disease (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

•All other clinical development timelines remain on track

•Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 9, 2026

DURHAM, N.C. November 9, 2026 – Immunovant (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 second fiscal quarter ended September 30, 2026.

Recent Highlights and Upcoming Milestones:

Following the open-label lead-in in Period 1 of the potentially registrational trial in patients with D2T RA, where a total of 170 participants were enrolled to receive IMVT-1402 600 mg for 16 weeks, study participants meeting the criteria for an ACR20 response at Weeks 14 and 16 were eligible to advance to Period 2 of the trial. A total of 117 participants were included in the Period 2 efficacy analysis and randomized to IMVT-1402 600 mg (n=40), IMVT-1402 300 mg (n=36), or placebo (n=41). IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (92.5% vs. 75.6% placebo, p=0.0139). Participants randomized to IMVT-1402 300 mg did not show a difference from placebo, with 75.0% maintaining an ACR20 response at Week 28 (p=0.9426).7 The secondary endpoints, change in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) from Period 2 baseline to Week 28, numerically favored IMVT-1402 600 mg over placebo. 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). In exploratory analyses, ACR50 response rates at Week 28 were 80.0% for IMVT-1402 600 mg vs. 56.1% for placebo (nominal p=0.0117), and ACR70 response rates were 52.5% vs. 36.6% (nominal p=0.1674); the trial was not powered to detect differences in these measures. IMVT-1402 was generally well tolerated in Period 2, with no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or adverse events leading to treatment discontinuation reported in any arm. FDA discussions are planned for later this year to determine the path forward for the registrational program of IMVT-1402 in D2T RA.8

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.9

The Company expects to report topline data across potentially registrational trials of IMVT-1402 in Graves' disease (GD) and myasthenia gravis (MG) in calendar year 2027.10 In calendar year 2028, topline data are expected for the potentially registrational trial of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy (CIDP).10

Financial Highlights for Fiscal Second Quarter Ended September 30, 2026:

Cash Position: As of September 30, 2026, Immunovant's cash and cash equivalents totaled $722.3 million11, providing runway to the potential commercial launch of IMVT-1402 in GD, based on our current operating plan.

Research and Development Expenses: Research and development (R&D) expenses were $85.0 million for the three months ended September 30, 2026, compared to $114.2 million for the three months ended September 30, 2025.11 The decrease was primarily due to the wind-down of activities for our batoclimab clinical trials and lower costs from activities related to our clinical trials of IMVT-1402, driven by the timing of contract manufacturing costs.

Non-GAAP R&D expenses were $78.5 million for the three months ended September 30, 2026, compared to $106.5 million for the three months ended September 30, 2025.

General and Administrative Expenses: General and administrative (G&A) expenses were $19.1 million for the three months ended September 30, 2026, compared to $17.5 million for the three months ended September 30, 2025, primarily due to higher investments in pre-commercial activities.

Non-GAAP G&A expenses were $12.4 million for the three months ended September 30, 2026, compared to $11.9 million for the three months ended September 30, 2025.

Net Loss: Net loss was $97.2 million ($0.47 per common share) for the three months ended September 30, 2026, compared to $126.5 million ($0.73 per common share) for the three months ended September 30, 2025.12 Net loss for the three months ended September 30, 2026 and September 30, 2025 included $13.3 million and $13.4 million, respectively, related

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Data on this page was fetched . The filing on SEC.gov is the record.