ROIV

Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. Roivant Sciences (NasdaqGS:ROIV) is in focus after reporting first quarter results for the period ended June 30, 2026. Sales were US$1.44 million, while the company reported a net loss of US$189.84 million. The loss from continuing operations translated into a basic loss per share of US$0.26. Investors are now weighing how these figures, together with the updated loss profile, fit into the broader story for this clinical stage biopharmaceutical company. See our latest analysis for Roivant Sciences. Roivant Sciences shares have been strong over 2026, with a year to date share price return of 65.71% and a 1 year total shareholder return of 216.28%. This points to building momentum around the company following its first quarter update. If Roivant Sciences has you looking more closely at healthcare and drug development, it can be useful to see what else is moving in this space. You can broaden your watchlist by checking a screener focused on other healthcare focused AI opportunities such as 43 healthcare AI stocks After such a strong run in Roivant Sciences over the past year, the key tension now is simple: Is most of the upside already in the rear-view mirror, or does the current valuation still leave meaningful room ahead? The latest narrative fair value for Roivant Sciences sits at $10.00 per share, well below the last close of $36.34, which creates a wide valuation gap according to this view. The "Roivant Compounding Fantasy" relies on a lazy sum-of-the-parts calculation, treating binary litigation windfalls and a crowded autoimmune pipeline as a bulletproof thesis. Here is why the market is mispricing the structural friction inside Roivant's hub-and-spoke model: 1. The IP Litigation Trap: Relying on the Pfizer/BioNTech mRNA lawsuit for near-term re-rating is highly speculative. Modern’s settlement was a tactical win, but a full-scale global docket against Pfizer can drag out for years with brutal appellate friction. Courts historically discount retroactive royalty damages far more than retail bulls realize. Read the complete narrative. This narrative leans on a detailed revenue build, assumed margin lift and a future earnings multiple that treats Roivant Sciences more like a mature platform than a typical clinical-stage biotech. Curious which specific growth path and profitability profile are doing the heavy lifting in that $10.00 figure. Result: Fair Value of $10.00 (OVERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Roivant Sciences could still surprise investors if key drug candidates progress smoothly through trials or if cash on hand is deployed more efficiently than expected. Find out about the key risks to this Roivant Sciences narrative. With sentiment mixed and Roivant Sciences attracting strong opinions on both sides, it makes sense to move quickly and test the numbers yourself before taking a stance. To see exactly what investors are optimistic about, review the 2 key rewards If Roivant Sciences has sharpened your focus, do not stop here. The next worthwhile opportunity could be sitting in plain sight on a focused stock screener. Target dependable income by checking companies that appear in the 8 dividend fortresses for investors who care about yield and stability working together. Spot potential bargains early by scanning the screener containing 21 high quality undiscovered gems where solid fundamentals have not yet attracted broad attention. Prioritise resilience by reviewing stocks highlighted in the 83 resilient stocks with low risk scores so you are not the last to notice stronger risk profiles. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ROIV. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterizes the current period as a 'calm before the storm,' with the next 6-12 months expected to be busier than the prior year due to multiple pivotal readouts and a commercial launch. The company has successfully initiated the Phase III study for brepocitinib in cutaneous sarcoidosis, citing a 20-point benefit in Phase II against a clinical meaningfulness goal of 5 points. Strategic focus for brepocitinib is shifting toward a 'slow and steady' commercial approach to build a foundation for a multi-indication franchise rather than maximizing immediate week-one volume. The Moderna settlement has provided significant non-dilutive capital, with $950 million received upfront, enabling aggressive share repurchases and funding for the expanding R&D pipeline. Management attributes the rapid enrollment in the lichen planopilaris (LPP) study to high unmet need and physician enthusiasm for a targeted therapy in a space with few options. The D2T RA program is undergoing a strategic review following open-label data, with plans to use randomized withdrawal results to inform a definitive regulatory path with the FDA. Anticipated imminent FDA approval and launch of brepocitinib in dermatomyositis (DM) by the end of September, marking the company's first targeted therapy launch in this indication. Top-line data readouts are expected in the second half of 2026 for brepocitinib in non-infectious uveitis (NIU) and mosliciguat in PH-ILD. Management expects a jam-packed second half of the year, with even more milestones coming in 2027 and beyond., targeting 9 or more pivotal study readouts and at least 3 commercial launches by the end of calendar 2028. Future pipeline expansion assumes that all current molecules are eligible for new indication initiations within the next year, with active work ongoing for undisclosed programs. Guidance for the PH-ILD program assumes that effective vasodilation will drive clinical benefit, though the Phase II study is not specifically powered for 6-minute walk distance. Received $772 million as Roivant's portion of the Moderna settlement, bolstering a cash position that was already just under $4 billion at quarter-end. Executed approximately $200 million in share repurchases during the quarter, continuing a strategy to return capital following the Moderna settlement announcement. Ongoing litigation against Pfizer and BioNTech has expanded with three international lawsuits filed in Canada and the Unified Patent Court (UPC) in July. Potential for an additional $1.3 billion in capital contingent on a favorable outcome in the 1498 appellate ruling currently in the Federal Circuit. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management declined to provide specific early-launch metrics, stating they will focus on internal dynamics and physician engagement first. Confirmed that while the label will likely include standard JAK class black box warnings, the high morbidity of DM makes safety concerns less of a barrier to adoption compared to other indications. Management acknowledged the primary risk is the translation from PAH to PH-ILD, but noted that inhaled vasodilation should theoretically deliver drug to healthy lung tissue effectively. Clarified that monotherapy data will be released first, as the combination study started later and is intended primarily for safety and incremental efficacy insights. Management believes the Graves' market is large enough for multiple mechanisms and that being first-to-market will allow them to influence treatment paradigms. Argued that the 'first-mover advantage' seen by competitors in MG and CIDP is a moat they intend to replicate in Graves' and D2T RA. Acknowledged that placebo variability is a standard risk in immunology, but noted that Graves' patients do not typically remit spontaneously, making the endpoint manageable. For NIU, management is relying on the strength of Phase II data to mitigate concerns regarding geographic variation in patient populations.

Interested in Roivant Sciences Ltd.? Here are five stocks we like better. Roivant expects a busy second half of 2026, highlighted by a potential FDA approval and launch of brepocitinib for dermatomyositis by the end of September, plus clinical readouts in noninfectious uveitis, PH-ILD and cutaneous lupus. Brepocitinib development is expanding, with Phase III trials underway in cutaneous sarcoidosis and lichen planopilaris. Roivant also plans further updates on Immunovant’s IMVT-1402 programs in rheumatoid arthritis and Graves’ disease. Roivant reported nearly $4 billion in cash before receiving about $772 million from its Moderna settlement, repurchased roughly $200 million of stock during the quarter and said it will continue buybacks while funding its pipeline. Trump Index: 6 Companies Linked to Trump’s Cabinet Worth Watching Roivant Sciences (NASDAQ:ROIV) said it expects a busy second half of 2026, with a potential launch of brepocitinib in dermatomyositis, several clinical readouts and additional regulatory discussions across its pipeline. Chief Executive Officer Matt Gline characterized the quarter as relatively quiet but said the company has advanced several priorities outlined at its investor day. Those include the anticipated brepocitinib launch, development work at Immunovant, progress in litigation-related matters and continued capital returns. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “The next 6-12 months are in many ways busier than the prior 6-12 months for us,” Gline said on the company’s first-quarter earnings call. Roivant said brepocitinib, which is under priority FDA review for dermatomyositis, is expected to launch by the end of September if it receives approval. Gline said the commercial and patient-support teams at Priovant have been built, trained and are ready for a potential launch. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Management reiterated that it intends to pursue a “slow and steady” launch rather than focus on near-term sales metrics. Gline said the company is seeking to establish access, patient-support, institutional and physician-engagement infrastructure that can support brepocitinib across multiple potential indications beyond dermatomyositis. Gline said physicians and patients have expressed enthusiasm for new treatment options in dermatomyositis, a condition in which patients often use multiple therapies and remain dissatisfied with available treatments. He also said Roivant expects brepocitinib’s label to include the boxed warnings associated with other JAK inhibitors, but management believes physicians will weigh those considerations against the severity of dermatomyositis and risks associated with treatments such as high-dose steroids and immunosuppressants. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling The company also began enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks and uses a primary endpoint of at least a 50% response on the Cutaneous Sarcoidosis Activity and Morphology Instrument, or CSAMI. Participants will undergo a mandatory steroid taper from week two through week eight. Roivant expects top-line data from that study in 2028. Gline said the company estimates there are approximately 40,000 U.S. patients with cutaneous sarcoidosis and pointed to potential overlap with ocular and pulmonary manifestations of sarcoidosis. Roivant also said its registrational study of brepocitinib in lichen planopilaris is enrolling “extremely well,” according to Gline. The company added lichen planopilaris as a fourth brepocitinib indication earlier this year. Roivant expects several important data events during the second half of 2026. These include top-line data from a Phase III study of brepocitinib in noninfectious uveitis, which Gline said could represent an opportunity comparable in size to dermatomyositis. The company also expects top-line data from the Phase II FOCUS study of mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Management said it is looking for a clear signal in pulmonary vascular resistance, or PVR, while noting that the trial is not powered to provide a definitive assessment of six-minute walk distance. Gline said Roivant believes inhaled vasodilation could benefit PH-ILD patients, though the Phase II study is intended to assess whether results seen in pulmonary arterial hypertension translate to the PH-ILD population. He said the company designed the study with limits on emphysema to support broad enrollment while seeking to maximize the therapy’s potential benefit. For mosliciguat, Roivant said monotherapy data will be released before data from an open-label combination study, which began later and remains in enrollment. Management said the combination trial is intended to add safety experience and provide information that may help inform Phase III trial design. Roivant also expects a proof-of-concept readout in cutaneous lupus erythematosus, or CLE, during the second half. The first disclosure will include 12-week data comparing a 600-milligram dose with placebo. Gline described the trial as a small fact-finding study intended to help the company assess treatment benefit and determine whether to advance the program. Roivant plans to provide a fuller update later this year on Immunovant’s IMVT-1402 program in difficult-to-treat rheumatoid arthritis. That update could include results from the randomized-withdrawal portion of the study, feedback from an anticipated FDA discussion and potential next steps for registrational development. The company is also advancing IMVT-1402 in Graves’ disease. Gline said Roivant views the condition as a market with substantial unmet need, rather than one defined primarily by competition among emerging mechanisms. He said the company expects to be the first to bring an advanced therapy to the market if its program succeeds. Separately, Roivant received the initial payment from its settlement with Moderna. Gline said the $950 million payment included approximately $770 million for Genevant and the remainder for Arbutus. He said litigation under Section 1498 remains under review at the Federal Circuit and could result in an additional $1.3 billion with a favorable outcome. Roivant also filed international lawsuits against Pfizer and BioNTech, including actions in Canada and the Unified Patent Court, during July. Roivant reported approximately $200 million in research-and-development expense for the quarter. Non-GAAP adjusted general and administrative expense was just under $100 million, while GAAP general and administrative expense was $166 million. The company reported cash of just under $4 billion before receipt of approximately $772 million associated with the Moderna settlement payment. Roivant repurchased about $200 million of stock during the quarter, with additional repurchases in March, after accelerating its buyback activity following the Moderna settlement announcement. Gline said the company will continue repurchasing shares under its existing authorizations while preparing for a catalyst-rich period that could include multiple clinical readouts, regulatory filings and commercial launches through the end of 2028. Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines. The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women's health. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Roivant Sciences Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. R&D Expense: Approximately $200 million for the first quarter of fiscal 2026. G&A Expense: Just under $100 million on a non-GAAP adjusted basis, or $166 million on a GAAP basis. Cash Position: Just under $4 billion, reported before the receipt of the $772 million settlement payment from Moderna. Share Repurchases: Approximately $200 million in the quarter, with an average buyback price in the high $20s since March. Moderna Settlement Payment: Received the initial $950 million upfront payment, with approximately $770 million allocated to Genevant and the remainder to Arbutus. Warning! GuruFocus has detected 7 Warning Signs with ROIV. Is ROIV fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Roivant Sciences Ltd (NASDAQ:ROIV) has initiated the Phase 3 study in cutaneous sarcoidosis for brepocitinib ahead of schedule, following strong Phase 2 data showing a >20-point benefit on the CSAMI scale versus placebo. The company is on track for the potential launch of brepocitinib in dermatomyositis by the end of September, with priority review and a fully built commercial team ready to deploy. Roivant Sciences Ltd (NASDAQ:ROIV) received the initial $950 million payment from the Moderna settlement, with $772 million going to Genevant, strengthening its cash position to nearly $4 billion. The company has filed international lawsuits against Pfizer and BioNTech in Canada and the UPC, advancing its litigation strategy for additional potential recoveries. Roivant Sciences Ltd (NASDAQ:ROIV) continues to execute on its share repurchase program, buying back shares at an average price in the high $20s since March, returning capital to shareholders. The pipeline is advancing with multiple upcoming catalysts, including top-line data from the NIU study, the Mosley Phase 3 study in PH-ILD, and the D2T RA program at Immunovant, all expected in the second half of 2026. Roivant Sciences Ltd (NASDAQ:ROIV) expects a 'slow and steady' launch for brepocitinib in dermatomyositis, which may not meet investor expectations for rapid revenue growth. The company faces uncertainty in the PH-ILD program, with the Phase 3 study not powered for six-minute walk distance, and the potential for unexpected results in translating PVR reductions from PAH to PH-ILD. There is a risk of high placebo response rates in the NIU Phase 3 study, which could impact the trial's ability to show a statistically significant benefit. Roivant Sciences Ltd (NASDAQ:ROIV) has not provided specific metrics or guidance for tracking the DM launch, leaving investors without clear benchmarks to assess early performance. The company's R&D expenses remain high at approximately $200 million for the quarter, with significant ongoing investment in multiple programs, which could pressure near-term profitability. The D2T RA program faces a higher bar for success in the randomized withdrawal phase due to strong open-label response rates, and the company is still awaiting FDA feedback to finalize the pivotal study design. Q: Regarding the upcoming brepocitinib launch in dermatomyositis (DM), what metrics will the company provide to track the initial launch, and what are the implications of baseline characteristics in the PH-ILD (PHocus) study on the bar for success?A: CEO Matt Gline stated that beyond a "slow and steady" launch, top-line metrics will be visible in quarterly financials, but the company will not provide a ton of early detail. For PH-ILD, he noted the study was designed with care around emphysema allowances to maximize benefit. He expects a clearer signal on PVR, but does not expect much clarity on six-minute walk distance, which is not essential for the go/no-go decision. Q: For the Mosley (PH-ILD) program, what type of six-minute walk distance would be relevant to clinicians and patients if a large trial were run?A: Gline explained that PH-ILD patients are very sick with few options, and the focus should be on having an approvable therapy rather than a specific numerical bar. He emphasized that six-minute walk is a noisy clinical artifice, and if the drug effectively vasodilates and improves PVR, patients will see significant benefit in daily life. Q: Could you discuss the cadence of formulary reviews for rare disease drugs, given that P&T committees often wait six months for mass-market drugs?A: Gline said the company is having normal engagement with the payer community and is focused on ensuring physician and patient access. He noted that while formulary processes are similar across diseases, the company has a dedicated team at Priovant to handle medical exception procedures so patients and physicians don't have to worry about coverage delays. Q: Beyond the listed programs, what pipeline and product opportunities could see new study initiations over the next year?A: Gline stated that every program in the pipeline, including potentially undisclosed ones, could announce new trials or indications in the next year. He confirmed the company has specific ideas and is actively preparing to initiate programs, with real progress being made across all molecules. Q: How translatable are PVR reductions from PAH patients to the PH-ILD population in the PHocus study, and could disease aspects influence the magnitude of PVR reduction?A: Gline acknowledged that translation from PAH to PH-ILD is the fundamental question being answered. While Phase 1 data in PAH patients looks good on PVR, the lungs of PH-ILD patients differ, potentially affecting pharmacodynamics. However, he believes inhaled vasodilators should deliver drug to healthy lung tissue and be effective, though the study will ultimately provide the answer. Q: Given JAK class safety concerns, how are physicians receiving brepocitinib for DM, especially since DM patients have higher underlying cancer risk?A: Gline noted that dermatomyositis is a "poster child" for JAK use because patients have no other options. He emphasized that current therapies like high-dose steroids carry worse safety risks than JAK inhibitors. Physicians are comfortable using these agents, and while the label will include black box warnings, doctors expect this and are not overly concerned given the severity of the disease. Q: What percentage of DM patients are on off-label JAKs, and would they rapidly switch to brepocitinib? Also, what is the biggest risk for the Phase 3 NIU trial?A: Gline said low-to-mid single-digit percentages of DM patients have JAK experience, and some physicians using off-label JAKs expect to switch patients. For NIU, the biggest risk is variability in placebo response rates, which is common in immunology trials. He acknowledged geographic variation as a feature of such studies but remains optimistic given the compelling Phase 2 data. Q: What launch analogs are you assessing for brepocitinib in DM, either patient or market share curves?A: Gline stated there has never been a targeted therapy launch in dermatomyositis, so there is no good analog. He emphasized the company is focused on the DM opportunity itselfthe doctors, patients, and benefitsrather than comparing to other launches, as being a pioneering indication requires charting its own course. Q: For the difficult-to-treat RA program (1402), what is the strategy? Would one or two more studies be needed, and what should be expected from the randomized withdrawal phase?A: Gline said the company will provide a full update later this year, including randomized withdrawal data and an FDA conversation planned for the fall. The results will inform whether the study can serve as one of two pivotal studies. He noted the high response rates in the open-label period set a higher bar for hitting a P-value in the randomized withdrawal section. Q: For the Graves' disease program, how is the company thinking about the competitive landscape, and what is the approach to future studies for 1402?A: Gline dismissed competition concerns, noting Graves' disease has had no novel therapy since the 1950s-60s, leaving massive unmet need. He stated 1402 will be first to market, allowing the company to influence treatment paradigms. He emphasized building the market rather than beating competitors, and the company will leverage learnings from studies and physician engagement for future development. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

All IMVT-1402 clinical development timelines remain on track, including ongoing studies in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), Sjögren’s disease (SjD) and cutaneous lupus erythematosus (CLE) Current cash balance provides runway to the potential launch of IMVT-1402 in GD Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026 DURHAM, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- 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 first fiscal quarter ended June 30, 2026. Recent Highlights and Upcoming Milestones: Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. The Company expects to provide further updates on its potentially registrational IMVT-1402 D2T RA program and report topline data from the proof-of-concept trial of IMVT-1402 in CLE in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in GD and MG. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in CIDP and SjD. Financial Highlights for Fiscal First Quarter Ended June 30, 2026: Cash Position: As of June 30, 2026, Immunovant’s cash and cash equivalents totaled $797.8 million, 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 $142.6 million for the three months ended June 30, 2026, compared to $101.2 million for the three months ended June 30, 2025. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, partially offset by lower overall costs as we wind-down our batoclimab clinical trials. Non-GAAP R&D expenses were $135.4 million for the three months ended June 30, 2026, compared to $93.3 million for the three months ended June 30, 2025. General and Administrative Expenses: General and administrative (G&A) expenses were $17.7 million for the three months ended June 30, 2026, compared to $26.0 million for the three months ended June 30, 2025. The decrease was primarily due to lower personnel-related expenses, professional fees, market research costs and information technology costs. Non-GAAP G&A expenses were $11.2 million for the three months ended June 30, 2026, compared to $15.4 million for the three months ended June 30, 2025. Net Loss: Net loss was $153.2 million ($0.75 per common share) for the three months ended June 30, 2026, compared to $120.6 million ($0.71 per common share) for the three months ended June 30, 2025. Net loss for the three months ended June 30, 2026 and June 30, 2025 included $13.8 million and $18.5 million, respectively, related to non-cash stock-based compensation expense. Non-GAAP net loss was $139.4 million for the three months ended June 30, 2026, compared to $102.1 million for the three months ended June 30, 2025. Common Stock: As of June 30, 2026, there were 206,264,878 shares of common stock issued and outstanding. Non-GAAP Financial Measures: In addition to reporting the financial results in accordance with accounting principles generally accepted in the United States of America (GAAP), Immunovant reports certain financial results that differ from what is reported under GAAP. Immunovant believes these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and they may be used by institutional investors and the analyst community to help them analyze the health of Immunovant’s business. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, Immunovant’s financial results prepared in accordance with GAAP. Other companies, including companies in Immunovant’s industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). 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. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026. To access the conference call by phone, please register online using this Registrational link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant’s website after the conference call. 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 progress towards developing IMVT-1402 across a broad range of indications; Immunovant’s expectations regarding the availability of results of clinical trials of IMVT-1402 and whether those results may be adequate to support registration; and the Company’s beliefs regarding the potential sufficiency of its cash runway. 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, regulatory strategy, 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; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 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 20, 2026, 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. (1) Represents non-cash stock-based compensation expense Contacts:InvestorsKeyur [email protected] MediaStephanie [email protected]

Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of September 2026; topline data from Phase 3 study in non-infectious uveitis (NIU) expected in the second half of calendar year 2026 First patients enrolled in the Phase 3 study of brepocitinib in cutaneous sarcoidosis (CS), with topline data expected in calendar year 2028; enrollment in Part 1 of the Phase 2b/3 study in lichen planopilaris (LPP) is progressing well IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) topline data expected in the second half of calendar year 2026; all clinical development timelines remain on track for IMVT-1402 Mosliciguat Phase 2 study in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track, with topline data expected in the second half of calendar year 2026 Genevant and Arbutus received $950 million from Moderna in July 2026 under $2.25 billion settlement, with additional $1.3 billion contingent on favorable resolution of Moderna’s § 1498 appeal; filed new international lawsuits against Pfizer and BioNTech covering 21 jurisdictions Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion as of June 30, 2026, excluding the cash payment received from Moderna in July, supporting cash runway into profitability Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026, to report its financial results for the first quarter ended June 30, 2026, and provide a business update BASEL, Switzerland and LONDON and NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2026, and provided a business update. “This quarter has been a moment of relative quiet between our incredibly busy last twelve months and our even busier year ahead,” said Matt Gline, CEO of Roivant. “Our teams are deep in preparation for the potential launch of brepocitinib in dermatomyositis, we have enrolled the first patients in a new Phase 3 trial in cutaneous sarcoidosis, and we expect topline readouts from our NIU, PH-ILD and CLE studies before year end. We remain focused on delivering for patients across each of these programs, and if we are successful across even some of these endeavors, we will look radically different on the other side.” Recent Developments Priovant: Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of September 2026. The first patients have been enrolled in the Phase 3 study of brepocitinib in cutaneous sarcoidosis (CS). This follows brepocitinib’s Phase 2 study, the first positive placebo-controlled study in CS, which led to FDA Breakthrough Therapy Designation.The Phase 3 study (BEACON+) will be conducted as a Part B to the positive Phase 2 BEACON trial. BEACON+ will enroll approximately 140 patients with CS across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg once daily and placebo. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity Score (CSAMI-A) at Week 16. In Phase 2, 77% of brepocitinib 45mg patients achieved this endpoint compared to 0% of placebo patients.CS is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. The condition disproportionately impacts Black Americans. Unlike many inflammatory skin diseases, inadequately treated cutaneous sarcoidosis can rapidly cause permanent scarring and destruction of bone, cartilage and hair follicles. Despite this significant unmet therapeutic need, there are currently no FDA-approved therapies for CS.Additionally, enrollment in Part 1 of the Phase 2b/3 study in lichen planopilaris (LPP) is progressing well. Immunovant: All clinical development timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). Pulmovant: Phase 2 study of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track. Genevant: In July 2026, Genevant Sciences GmbH (Genevant) and Arbutus received $950 million from Moderna, the initial payment under the global $2.25 billion patent infringement settlement, and filed new international lawsuits against Pfizer and BioNTech. Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion as of June 30, 2026, excluding the cash payment received from Moderna in July, supporting cash runway into profitability. For the three months ended June 30, 2026, Roivant repurchased 7.3 million common shares for an aggregate repurchase price of approximately $208.7 million. Major Upcoming Milestones Priovant expects the commercial launch of brepocitinib in DM by the end of September 2026 and topline data from the Phase 3 study in NIU and Phase 3 study in CS in the second half of calendar year 2026 and calendar year 2028, respectively. Roivant continues to actively explore other indications for brepocitinib. Immunovant expects to report topline data from the proof-of-concept trial of IMVT-1402 in CLE and provide an update on the potentially registrational program of IMVT-1402 in D2T RA in the second half of calendar year 2026. In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG. In calendar year 2028, topline data are expected across potentially registrational trials of IMVT-1402 in CIDP and SjD. Pulmovant expects to report topline data from the ongoing Phase 2 trial of mosliciguat in PH-ILD in the second half of calendar year 2026. Genevant LNP litigation continues to progress. An additional $1.3 billion payment under the Moderna settlement is contingent upon a resolution of Moderna's Section 1498 appeal favorable to Genevant and Arbutus. Separately, in July 2026 they filed three international lawsuits against Pfizer and BioNTech — one in Canada and two before the UPC — seeking to enforce patents protecting their innovative lipid nanoparticle technology. The actions seek relief across 20 European countries (including France, Germany, Italy and the Netherlands) which, together with the Canadian action, cover 21 jurisdictions in total. The discovery phase of the U.S. Pfizer/BioNTech case is ongoing. First Quarter Ended June 30, 2026 Financial Summary Cash Position and Marketable Securities As of June 30, 2026, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion. Research and Development Expenses Research and development (R&D) expenses increased by $49.1 million to $202.0 million for the three months ended June 30, 2026, compared to $152.9 million for the three months ended June 30, 2025. This increase was primarily driven by an increase in program-specific costs of $49.4 million and personnel-related expenses of $3.8 million. The increase of $49.4 million in program-specific costs was primarily driven by increases of $44.8 million related to the anti-FcRn franchise and $4.7 million related to mosliciguat, reflecting the progression of our programs. The increase of $3.8 million in personnel-related expenses was primarily driven by $4.1 million in employee bonuses related to the global settlement reached with Moderna in March 2026. The majority of share-based compensation and personnel-related expenses, which are unallocated internal costs, were related to the anti-FcRn franchise activities at Immunovant during the three months ended June 30, 2026 and 2025. Non-GAAP R&D expenses were $192.9 million for the three months ended June 30, 2026, compared to $141.0 million for the three months ended June 30, 2025. General and Administrative Expenses General and administrative (G&A) expenses increased by $31.5 million to $165.5 million for the three months ended June 30, 2026, compared to $134.0 million for the three months ended June 30, 2025. This increase was primarily due to an increase in personnel-related expense of $26.1 million, largely resulting from $18.8 million in employee bonuses related to the global settlement reached with Moderna in March 2026 and $6.3 million of employer payroll taxes associated with equity award activity. Non-GAAP G&A expenses were $90.7 million for the three months ended June 30, 2026, compared to $62.6 million for the three months ended June 30, 2025. Net Loss Net loss was $290.6 million for the three months ended June 30, 2026, compared to $273.9 million for the three months ended June 30, 2025. On a per common share basis, net loss was $0.26 and $0.33, respectively, for the three months ended June 30, 2026 and 2025. Non-GAAP net loss was $243.7 million for the three months ended June 30, 2026, compared to $170.1 million for the three months ended June 30, 2025. Notes to non-GAAP financial measures: (1)   Represents non-cash share-based compensation expense. (2)   Represents non-cash depreciation and amortization expense. (3)   As a result of the global settlement with Moderna entered in March 2026, the Company recognized a gain for Genevant’s expected portion of a non-contingent, non-creditable and non-refundable payment to be made by Moderna to Genevant and Arbutus during the year ended March 31, 2026. The Company recognized an additional gain during the three months ended June 30, 2026, reflecting the final allocation to Genevant once litigation costs incurred were finalized. (4)   Represents the unrealized (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (5)   Represents the change in fair value of liability instruments, which is non-cash and primarily includes the loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (6)   Represents the estimated tax effect of the adjustments. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026, to report its financial results for the first quarter ended June 30, 2026, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 currently under review at the FDA for the treatment of dermatomyositis and also in late stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur [email protected] MediaStephanie [email protected]

Fortrea Holdings Inc. (FTRE) came out with quarterly earnings of $0.23 per share, beating the Zacks Consensus Estimate of $0.18 per share. This compares to earnings of $0.19 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +27.78%. A quarter ago, it was expected that this company would post earnings of $0.03 per share when it actually produced earnings of $0.16, delivering a surprise of +433.33%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Fortrea Holdings Inc., which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $678.2 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 4.62%. This compares to year-ago revenues of $710.3 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Fortrea Holdings Inc. shares have added about 20% since the beginning of the year versus the S&P 500's gain of 8.5%. While Fortrea Holdings Inc. has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Fortrea Holdings Inc. was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.23 on $661.06 million in revenues for the coming quarter and $0.80 on $2.61 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Roivant Sciences Ltd. (ROIV), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This company is expected to post quarterly loss of $0.33 per share in its upcoming report, which represents a year-over-year change of -83.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Roivant Sciences Ltd.'s revenues are expected to be $2.24 million, up 3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Fortrea Holdings Inc. (FTRE) : Free Stock Analysis Report Roivant Sciences Ltd. (ROIV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

BASEL, Switzerland and LONDON and NEW YORK, July 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026, to report its financial results for the first quarter ended June 30, 2026, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 currently under review at the FDA for the treatment of dermatomyositis and also in late stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts:InvestorsKeyur [email protected] MediaStephanie [email protected]

This article first appeared on GuruFocus. Cash and Cash Equivalents: $4.3 billion as of March 31, 2026, before the Moderna settlement. Debt: No debt reported. Moderna Settlement: $2.25 billion settlement with $950 million upfront expected in July. R&D Expenses: Increased due to the expansion of program scope. Share Repurchase: Active share repurchase program ongoing. Warning! GuruFocus has detected 7 Warning Signs with ROIV. Is ROIV fairly valued? Test your thesis with our free DCF calculator. Release Date: May 20, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Roivant Sciences Ltd (NASDAQ:ROIV) reported strong clinical data from its 1,402 study, showing high ACR response rates, with 73% of patients achieving ACR20, over half achieving ACR50, and over a third achieving ACR70. The company received breakthrough therapy designation for PrEP/Sitnib for retinue sarcoidosis, highlighting its potential impact on patient treatment. Roivant Sciences Ltd (NASDAQ:ROIV) announced a $2.25 billion settlement with Moderna, with $950 million expected upfront in July, strengthening its financial position. The company is on track to launch brevacitinib for dermatomyositis by the end of September, pending FDA approval, indicating strong commercial preparation. Roivant Sciences Ltd (NASDAQ:ROIV) has a robust pipeline with multiple upcoming data readouts, including Phase 3 NIU data and Moseley PNHLD Phase 2B top-line data, suggesting continued growth and innovation. The failure of the betokumab studies in TED was announced, although hyperthyroid patients showed normalization, indicating mixed results in ongoing studies. The Phase 2 study for Mosley is not powered to achieve a p-value on the six-minute walk test, which may limit the immediate impact of the results. There is uncertainty regarding the period two data of the 1,402 study, as the primary endpoint is losing an ACR-20 response, which may not fully capture the drug's efficacy. Roivant Sciences Ltd (NASDAQ:ROIV) faces a competitive landscape in the CLE market, requiring strong data to support its program amidst emerging mechanisms. The company is still analyzing detailed patient-level data and has not yet finalized its path forward with the FDA, indicating potential regulatory hurdles. Q: Can you contextualize the ACR responses seen at 16 weeks, and how might these responses trend with more time on therapy? A: Matthew Gline, CEO: We don't know for sure as this is the first time this patient population has been studied in detail. Sicker patients generally need more time to improve, and while there's potential for continued improvement beyond 16 weeks, we'll need to observe the patient population further to understand the trends. Q: Have you been able to assess whether your assumptions for standard deviation in PVR and six-minute walk are aligning with what you're seeing? A: Matthew Gline, CEO: We are largely blinded to that data, so it's difficult to say. However, given the patient population enrolled, we feel confident about the study's direction and the drug's efficacy. Q: Other FCRN drugs haven't achieved this level of efficacy in RA. Do you have ACPA antibody reduction data, and will it be available before unblinding period two data? A: Matthew Gline, CEO: We don't have that data now. IMDK-1402 suppresses IgG deeply, which might contribute to our clinical data. We will provide more information when we're ready to discuss the program's future. Q: If the Phase 2 focus study shows a statistically significant benefit on six-minute walk, could it represent a pivotal study? A: Matthew Gline, CEO: It's hard to say until we see the data. If the data supports a productive conversation with the FDA, we might consider it. However, the study isn't powered to show a benefit on a six-minute walk, so we'll see what the data reveals. Q: Is there any chance to amend the protocol to avoid the step-down issue in period two? A: Matthew Gline, CEO: There are many possibilities, but given the quality of the data, we might not gain much from extending the study. We'll analyze the data, have discussions with the FDA, and plan the path forward. For the complete transcript of the earnings call, please refer to the full earnings call transcript.