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Ally Schott felt lonely when she was diagnosed with endometriosis at the age of 12. With few treatment options and limited information to go on, she and her family had to become self-taught medical researchers.Even the diagnosis was the result of Schotts mother connecting the dots between the pain her daughter was experiencing and the symptoms described by women in a patient organization she had found.That's ultimately what convinced my parents that this is what I was dealing with seeing and reading about the experience of others, and recognizing that I was going through something similar, Schott said.In some ways, Schotts case is rare. Her diagnosis came early, unlike some women who dont learn they have endometriosis for a decade or more due to lack of disease awareness, misdiagnosis or even bias that assumes severe menstrual pain is normal.It's very, very easy to dismiss someone's discomfort if you believe something is meant to be uncomfortable, said Somer Baburek, CEO and co-founder of Hera Biotech, a biotechnology company developing a nonsurgical tool to diagnose endometriosis.Caused by the growth of uterine tissue outside of the uterus, endometriosis typically affects people who menstruate, but it can occur in post-menopausal women, too. The disease is characterized by chronic pelvic pain, especially during menstruation, but can also cause problems across other parts of the body. It is usually identified through a surgical procedure called a laparoscopy, as ultrasounds cant always image the abnormal tissue growth.Although physicians understanding of the disease has improved, endometriosis root causes remain debated even as it affects some 10% of women and girls globally.[Endometriosis research] has been very underfunded and so, despite the prevalence of this disease, it's not very well understood at all, said Marina R. Walther-Antonio, an assistant professor of surgery at the Mayo Clinic in Minnesota and a microbiome researcher.When Schott received her diagnosis, there was little she could do about it a reality that frustrated her and her family. I just felt like I finally had the answer, and that if we had the answer to what was wrong, there would be a solution, she said. Even since, only two new drugs for endometriosis-related pain have been approved in the U.S.That pattern is typical of diseases, like endometriosis, that primarily or only affect women. Insufficient funding of womens health research has stifled development of new products, resulting in prevalent conditions with hardly any available treatments. And while clinical trials are more inclusive than they were in the 1990s and earlier, studies are not always set up to tease out why or how disease symptoms may differ on the basis of biological sex.Information deficitsDevelopment of a drug is no easy feat for any condition. But the process is more difficult when the disorder isnt well understood, as with endometriosis.We're starting from multiple deficits, and one of them is an information deficit, said Heras Baburek. And I think that's something that all founders in women's health struggle from.For instance, researchers sometimes use biobanks collections of medical and biological data from tissue, blood and DNA samples to identify molecular markers of a disease, or develop effective diagnostics. If collected by a government-funded program, the data is often published or made available to scientists, providing a starting point for drug research.But such resources are more limited in endometriosis, according to Baburek and Joseph Nassif, an associate professor of obstetrics and gynecology at Baylor College of Medicine and a clinician. While such work has advanced further in other countries, the U.S. is just getting started.So now in the states, we're trying to do a database about all patients who have [endometriosis], Nassif said. We have banks for cancer and banks for other diseases. Once you have a lot of patients, we can study it better.With less of a foundation, drug developers taking aim at endometriosis, or other womens health conditions like polycystic ovary syndrome or premenstrual dysphoric disorder, can have a harder time starting out.When you're building the data story of your company, yours looks weaker than companies who are focused on indications outside of women's health, because they have access to all of those resources, Baburek said.Such information deficits have deep roots. Up until 30 years ago, the Food and Drug Administration recommended excluding women of childbearing age from participating in Phase 1 and 2 clinical trials, even if they were using contraception. The policies were made in response to birth defects caused by the drug thalidomide, which was prescribed to women to treat nausea in the 1950s and 1960s.A 1993 law mandated the inclusion of women and minorities in clinical research funded by the National Institutes of Health, but the effects of discouraging women from participating in trials have carried through to today.For example, a 2022 study found women made up 41% of participants in Phase 1 through Phase 3 trials for drugs and medical devices run between 2016 and 2019 in the U.S. Women were underrepresented compared to their estimated proportion of the overall patient population for a number of conditions, such as heart disease and psychiatric disorders.Those research gaps, and the knowledge deficits they can cause, ultimately put the lives of girls, women and their families at a huge disadvantage, Schott said.Federal efforts have tried to compensate. Most recently in February, the Biden administration committed to investing $100 million into womens health research. The FDA also recently updated draft guidance to ensure sponsors run more diverse clinical trials, supporting the Food and Drug Omnibus Reform Act of 2022, which requires specific documents and strategic plans.It's really important when you're going to try to understand the efficacy, tolerability and safety of a drug that you're testing it in the representative population of people who you anticipate actually using the product, said Katherine Seay, head of sales and operations at Clinical Trial Media, a patient recruitment and retention company.Limited optionsCompared to other areas of drug R&D, womens health remains underfunded. An analysis of NIH-backed research found that diseases largely affecting men received more funding. The conditions primarily affecting women that do get investment are typically within oncology, such as breast and ovarian cancer, and reproductive medicine.Baburek didnt intend to make reproduction Heras focus, for instance. But the company only gained interest from investors when she mentioned the negative impact endometriosis can have on fertility. While our reproductive organs may be involved in some of these chronic conditions, our ability to reproduce shouldn't be the focus, Baburek said.Hera's struggle for attention isn't an anomaly. Despite its prevalence, endometriosis remains low on drugmaker radar screens.Women with the disease typically take birth control, other hormonal therapies and pain medication to manage symptoms and their menstrual cycles. They may also turn to surgery to either remove the lesions endometriosis causes or, in severe cases, remove their uterus entirely.When Schott was young, the drug Lupron Depot, a hormonal therapy initially approved for the treatment of prostate cancer, was cleared in the U.S. to manage pain associated with endometriosis. The drug can cause side effects similar to that of menopause and was a horrific experience for Schott, who was about 13 years old when it was prescribed to her.Within the past decade, two other products have been approved by the FDA for pain management with endometriosis: AbbVies Orilissa in 2018, and Pfizer and partner Myovant Sciences Myfembree in 2022.The drugs come with hefty price tags: Orilissa and Myfembree each cost over $1,000 per month at their respective list prices. They also dont address the diseases roots, and use is limited to a maximum of two years due to their potential to decrease bone density.Those options are not widely discussed or celebrated because they're not actually treating the disease, Baburek said. [They are] just quieting some of the symptoms that make your life unbearable, but then you get a whole host of other symptoms that also might make your life unbearable.Schott was prescribed Myfembree as an adult, but never took it because of its limitations and potential effects on bone density. She says she likely wouldn't take Orilissa for the same reasons.For the moment being, we have some ways to manage [endometriosis], whether medical or surgical, definitely with some percentage of success and failure either way, said Nassif. But definitely, we need a lot of research for the future.Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen.OGPhoto via Getty ImagesA bare pipelineNeither Orilissa nor Myfembree are big sellers and dont seem to rate high on their makers priority lists.Three years after Orilissas approval, AbbVie tried to sell the womens health unit the drug was housed in, but the deal never materialized. Sales of the drug are no longer reported individually and are instead lumped in with other key products in AbbVies earnings report. The last time AbbVie reported Orilissas net revenue was for its 2021 fiscal year, when it recorded $139 million in U.S.sales.AbbVie did not provide additional details about the drugs development or sales when contacted by BioPharma Dive.In 2022, Japan-based Sumitomo Pharma agreed to acquire Myfembree developer Myovant Sciences for $2.9 billion. The drug is now sold by Sumitomo in Europe, while Pfizer jointly markets it in the U.S. and Canada.Pfizer doesnt report net sales, but lists Myfembree revenue as contributing to alliance revenue in financial filings.Myfembree is marketed for endometriosis pain by Pfizer and partner Sumitomo PharmaPermission granted by Sumitomo Pharma AmericaThe two drugs dont face much competition. Womens health company ObsEva had licensed a compound known as linzagolix from the Japan-based biotechnology company Kissei Pharmaceutical. However, the company terminated the deal and withdrew an approval application after the FDA informed it of deficiencies in its submission.ObsEva shut down operations earlier this year, one of several companies in womens health that had to refocus its research efforts recently.Pharma company Bayer has long sold a hormonal drug called Visanne for endometriosis-related pain, but the company has not submitted it for U.S. approval in that indication.We focus our research efforts on innovative options in areas of high unmet medical need, a Bayer spokesperson said in comments to BioPharma Dive. We regularly review our research and development portfolio to prioritize the advancement of the most promising projects.Working with researchers in the U.S. and U.K., Bayer also helped identify an inflammation gene that may be linked to endometriosis. While the discovery seemed to point to a possible non-hormonal drug target, further research did not end up moving forward into development, according to a Bayer spokesperson.Last year, Bayer shifted its focus away from womens health altogether. While new R&D could still yield womens health products, a Bayer executive told Reuters that the companys work in the field overall had fallen short of expectations.Elsewhere, Organon agreed in 2021 to acquire Forendo Pharma in a deal worth $75 million upfront, handing it a drug candidate targeting endometriotic lesions without affecting hormones. Other startups have emerged, including Gynica, FimmCyte and SLBST Pharma.Looking forwardWhile endometriosis research continues, Barburek argues that finding a non-hormonal target for treating the condition has to be a priority.We've got to mechanistically understand [endometriosis] so we know which levers to pull and which knobs to push, she said. So more research needs to go into the mechanistic side of it.There is some momentum. Alongside the $100 million the Biden administration pledged to womens health research, the Advanced Research Projects Agency for Health, or ARPA-H, also launched a sprint for womens health to fund health solutions for conditions that primarily or disproportionately affect women.Its not clear whether such efforts will remain a priority under President-elect Donald Trumps administration, however. Trump nominated Robert F. Kennedy Jr. to helm the Department of Health and Human Services, which oversees health agencies including the FDA. While Kennedy has made clear his views on vaccines and the pharmaceutical industry, his views on womens health research are less clear and his stance on abortion has been inconsistent.In a rally prior to the election, Trump said Kennedy is so into womens health, and would let him go wild on healthcare.Some experts worry state abortion bans might hinder recruitment into trials involving in vitro fertilization, or other conditions that might require documenting a womans medical history.I think, once you take that freedom of choice away from women and leave it in the hands of politicians, state or federal, it's not a great thing, Schott said. It's a devastating impact that's going to be further reaching than I think we even have the context to understand right now, and I do think that involves endometriosis.Amid such concerns, there is hope of progress in treating endometriosis. Yet, Baburek said, sustained interest and investment will require a concentrated effort to highlight, educate and draw attention to the issues or consequences of being a woman. '

Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402Proof of concept data from batoclimab trial in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endIND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA; initiation of potentially registrational trial to evaluate IMVT-1402 in D2T RA expected by March 31, 2025On track to initiate potentially registrational trials with IMVT-1402 in four to five indications, inclusive of GD and D2T RA, by March 31, 2025Batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) fully enrolled to support data disclosures by March 31, 2025; data from batoclimab trials in thyroid eye disease (TED) now expected in the second half of calendar year 2025; all batoclimab data will inform future trials with IMVT-1402Immunovant to host development update call today, November 7, at 8 a.m. ET NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported development updates and financial results for its fiscal second quarter ended September 30, 2024. Immunovant continues to focus on moving rapidly to unlock the full potential of its lead asset, IMVT-1402, for the benefit of people with underserved autoantibody-driven diseases. With five IND applications now cleared, the company remains on course to initiate four to five potentially registrational clinical development programs by March 31, 2025. These INDs are expected to support evaluation of IMVT-1402 in a variety of indications and therapeutic areas. As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026. “Since announcing the Phase 1 data for IMVT-1402 a year ago, we have made tremendous progress in advancing IMVT-1402 towards multiple potentially registrational study initiations. We’re ahead of our goal to activate three INDs by calendar year end and we are very excited about all five cleared INDs – both those that have been announced and those that have not yet been announced. In terms of announced indications, we believe our first-in-class program with IMVT-1402 in GD has the potential to transform the treatment of GD patients who respond poorly to ATDs,” said Pete Salzmann, M.D., chief executive officer of Immunovant. “We are also excited to announce expansion of our IMVT-1402 development program into Rheumatology. Our first program in Rheumatology will be a potentially registrational study in patients with D2T RA where we believe that deeper IgG reduction has the potential to deliver better clinical outcomes in an important subset of patients with elevated RA-specific autoantibodies (ACPA). People living with D2T RA have already exhausted multiple therapeutic options yet continue to suffer from active disease, persistent disability and pain,” Salzmann continued. “We believe IMVT-1402 can deliver meaningful clinical benefit in ACPA-positive (ACPA+) D2T RA patients, with a potentially best-in-class profile driven by deeper IgG reduction.” FcRn inhibition represents an attractive mechanism as a potential treatment for the approximately 70,000 US patients with D2T, ACPA+ RA. Recently disclosed in-class data demonstrated that both higher baseline ACPA levels and deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Having received FDA clearance of the IND for IMVT-1402 in RA, Immunovant plans to initiate a potentially registrational trial in ACPA+ D2T RA by March 31, 2025. The trial builds on in-class learning in terms of its target population (enriched for above-normal ACPA levels) and trial design (open-label lead-in followed by randomized withdrawal). The trial will leverage IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the clinical trial to maximize reduction in ACPA levels. Recent Highlights and Upcoming Milestones Endocrinology Program In September 2024, Immunovant provided a GD program update consisting of new epidemiologic data characterizing unmet need in GD patients who are relapsed, uncontrolled or intolerant of ATDs, additional results from the batoclimab GD study, and an overview of the IMVT-1402 development program in GD. In November 2024, additional data on the efficacy and safety of batoclimab in Graves’ thyroidal and extrathyroidal disease were presented in an oral presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a 60% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose) was achieved by Week 2, demonstrating the rapidity of response to batoclimab 680mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both Week 12 and Week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders (defined as T3 and T4 falling below the ULN and ceasing all ATD medications) reporting greater improvements than other participants. The batoclimab data in Graves’ disease support the potential for deep IgG reduction to modify the underlying pathophysiology of the disease, which could enable a transformation of the treatment of Graves’ disease for patients not well controlled on ATDs. Immunovant remains on track to initiate the first potentially registrational trial of IMVT-1402 in GD by calendar year end. Competition for clinical trial participants with acute, active TED has increased over the course of the company’s Phase 3 program to evaluate batoclimab for the treatment of thyroid eye disease (TED). As a result, top-line results are now expected to be available in the second half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED. Data from this trial will be leveraged to inform the overall program in GD for the Company’s lead asset, IMVT-1402. Neurology Program As previously reported, Immunovant completed enrollment of the batoclimab pivotal trial in MG, with top-line results expected to be reported by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which Immunovant expects to initiate by March 31, 2025. Enrollment of study participants has completed in the Phase 2b trial evaluating batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) for those patients to be included in the period 1 data readout expected by March 31, 2025. A decision to enroll additional patients in the batoclimab CIDP study will be made following the readout of period 1 data. Those results, as well as observations drawn from public disclosures of other studies in CIDP, will be used to inform the trial design for a potentially registrational program for IMVT-1402 in CIDP. Corporate Update Immunovant also announced today that it appointed Melanie Gloria as Chief Operating Officer, effective November 18, 2024. Ms. Gloria brings over 20 years of experience in the biotechnology industry, including leadership roles at Acelyrin, Horizon Therapeutics and AbbVie. At AbbVie and Horizon she led teams to achieve global approvals of HUMIRA®, Viekera Pak®, Mavyret®, Skyrizi®, Rinvoq®, TEPEZZA®, and ORILISSA®. “I am thrilled to welcome Melanie to Immunovant where her success in driving late-stage drug development will be incredibly valuable,” said Salzmann. “Melanie’s proven drug development capabilities are a great fit for Immunovant’s portfolio.” Webcast Details Immunovant will host a webcast at 8:00 a.m. ET today to discuss these updates. Please click register here to register for the event. The live webcast will also be available under the News & Events section of Immunovant’s website. A replay of the event and presentation will be available immediately following the event. Financial Highlights for Fiscal Second Quarter Ended September 30, 2024: Cash Position: As of September 30, 2024, Immunovant’s cash and cash equivalents totaled approximately $472.9 million. R&D Expenses: Research and development expenses were $97.3 million for the three months ended September 30, 2024, compared to $48.0 million for the three months ended September 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. G&A Expenses: General and administrative expenses were $18.5 million for the three months ended September 30, 2024, compared to $13.8 million for the three months ended September 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, and information technology costs. Net Loss: Net loss was $109.1 million ($0.74 per common share) for the three months ended September 30, 2024, compared to $58.7 million ($0.45 per common share) for the three months ended September 30, 2023. Net loss for the three months ended September 30, 2024 and September 30, 2023 included $12.7 million and $10.5 million, respectively, related to non-cash stock-based compensation expense. Common Stock: As of September 30, 2024, there were 146,565,049 shares of common stock issued and outstanding. Financial Highlights for Fiscal Six Months Ended September 30, 2024: R&D Expenses: Research and development expenses were $172.7 million for the six months ended September 30, 2024, compared to $98.5 million for the six months ended September 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. IPR&D Expenses: There were no acquired in-process research and development expenses for the six months ended September 30, 2024. During the six months ended September 30, 2023, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll in-license agreement. G&A Expenses: General and administrative expenses were $37.3 million for the six months ended September 30, 2024, compared to $29.2 million for the six months ended September 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, and information technology costs. Net Loss: Net loss was $196.3 million ($1.34 per common share) for the six months ended September 30, 2024, compared to $132.6 million ($1.01 per common share) for the six months ended September 30, 2023. Net loss for the six months ended September 30, 2024 and September 30, 2023 included $26.1 million and $21.2 million, respectively, related to non-cash stock-based compensation expense. 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,” “anticipate,” “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 and batoclimab, including the number and timing of (a) FDA clearance with respect to IND applications, (b) potential registrational programs and clinical trials of IMVT-1402, (c) expected data readouts from batoclimab trials in MG and CIDP, and (d) estimates of the target populations for IMVT-1402, including in RA; Immunovant’s plan to develop IMVT-1402 and batoclimab across a broad range of indications; and potential benefits of IMVT-1402’s unique product attributes and potential best-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 of 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 macroeconomic and geopolitical factors 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 and/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 Form 10-Q to be filed with the SEC on November 7, 2024, 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(Unaudited, in thousands, except share and per share data) Three Months EndedSeptember 30, Six Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development$97,272 $47,959 $172,745 $98,534 Acquired in-process research and development — — — 12,500 General and administrative 18,471 13,841 37,279 29,243 Total operating expenses 115,743 61,800 210,024 140,277 Interest income (6,073) (3,572) (13,254) (7,637)Other income, net (629) (20) (657) (484)Loss before provision for income taxes (109,041) (58,208) (196,113) (132,156)Provision for income taxes 78 454 156 443 Net loss$(109,119) $(58,662) $(196,269) $(132,599)Net loss per common share – basic and diluted$(0.74) $(0.45) $(1.34) $(1.01)Weighted-average common shares outstanding – basic and diluted 146,468,991 131,155,642 146,313,696 130,872,717 IMMUNOVANT, INC.Consolidated Balance Sheets(Unaudited, in thousands, except share and per share data) September 30, 2024 March 31, 2024Assets Current assets: Cash and cash equivalents$472,941 $635,365 Accounts receivable 1,876 5,337 Prepaid expenses and other current assets 32,555 25,068 Total current assets 507,372 665,770 Operating lease right-of-use assets 45 133 Other assets 7,619 — Property and equipment, net 671 462 Total assets$515,707 $666,365 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$20,727 $7,155 Accrued expenses 45,879 41,315 Current portion of operating lease liabilities 47 138 Total current liabilities 66,653 48,608 Total liabilities 66,653 48,608 Commitments and contingencies Stockholders’ equity: Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2024 and March 31, 2024 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2024 and March 31, 2024 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 146,565,049 shares issued and outstanding at September 30, 2024 and 500,000,000 shares authorized, 145,582,999 shares issued and outstanding at March 31, 2024 14 14 Additional paid-in capital 1,469,082 1,441,518 Accumulated other comprehensive income 1,910 1,908 Accumulated deficit (1,021,952) (825,683)Total stockholders’ equity 449,054 617,757 Total liabilities and stockholders’ equity$515,707 $666,365 Contact:Renee Barnett, MBAChief Financial OfficerImmunovant, Inc.info@immunovant.com