Please wait while we load the requested 10-K report or click the link below:
Immunovant Reports Financial Results for the Quarter and Fiscal Year Ended March 31, 2020 and Announces Plans for Phase 3 Registrational Trial of IMVT-1401 in Myasthenia Gravis
Based on compelling proof-of-biology for anti-FcRn agents in Myasthenia Gravis (MG), Immunovant has begun preparations to initiate a Phase 3 registrational trial of IMVT-1401 in MG
IMVT-1401s development program is entirely based on a subcutaneous injection format
Cash balance as of June 29, 2020, is approximately $280.4 million
NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today reported financial results for its fiscal fourth quarter and fiscal year ended March 31, 2020. As of today, June 29, 2020, Immunovants cash balance is approximately $280.4 million. We recently strengthened our balance sheet, facilitating the continued advancement of IMVT-1401 as we progress towards our goal of enabling normal lives for patients with autoimmune diseases, said Pete Salzmann, M.D., Chief Executive Officer of Immunovant.
In March, Immunovant announced positive clinical results from ASCEND GO-1, a Phase 2a trial of IMVT-1401 in Thyroid Eye Disease (TED), which reaffirmed IMVT-1401s prior safety and pharmacodynamic findings and demonstrated encouraging potential efficacy for patients with TED. Complementing these findings, two recent successful studies for other drug candidates with the same mechanism of action provided strong clinical validation in MG and demonstrated a within-study relationship between the degree of IgG lowering and the magnitude of clinical benefit in MG. With proof-of-biology now established for anti-FcRn agents in MG, Immunovant has chosen to accelerate Phase 3 development of IMVT-1401 in MG. Immunovant expects to engage the FDA on the design and conduct of the pivotal program and we expect the Agencys feedback to be an important part of the final plan, said Dr. Salzmann.
In light of the challenges created by COVID-19, including some clinical sites closing enrollment for new patients, Immunovant has taken several actions to ensure patient safety and quality trial execution. During the past three months, our very experienced clinical development team has successfully maintained open lines of communication with our sites. Based on this strong link, we can report that new patients enrolled in our programs during calendar Q2 did not miss any in-person clinic visits during the initial treatment period. Weve also been working with our partners to ensure that backup services are in place, which has enabled some virtual visits to replace in-person visits during the follow-up period after initial treatment. As always, we continue to stay abreast of evolving guidance from regulatory agencies emphasizing patient safety, flexibility within certain guardrails and very good documentation, said Dr. Salzmann.
Immunovant expects to report results from ASCEND MG, a Phase 2a trial of IMVT-1401 in MG, in late calendar Q3 or early calendar Q4. As previously communicated, results from the high dose cohort of ASCEND WAIHA, a Phase 2a trial of IMVT-1401 in Warm Autoimmune Hemolytic Anemia (WAIHA) are still possible by the end of the second half of 2020 and results from ASCEND GO-2, a Phase 2b trial of IMVT-1401 in TED, are still possible in the first half of 2021. Immunovant intends to provide an update on its anticipated clinical development timelines for TED and WAIHA in the third quarter of calendar year 2020.
The following information was filed by Immunovant, Inc. (IMVT) on Monday, June 29, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one year to another to evaluate Immunovant, Inc.'s financial trajectory
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Immunovant, Inc..