A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

Start Date31 Aug 2022

Sponsor / Collaborator

Kinevant Sciences GmbH

NCT05351554 / TerminatedPhase 2

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis

A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.

Start Date23 Aug 2022

Sponsor / Collaborator

Kinevant Sciences GmbH

NCT03622658 / CompletedPhase 2

A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis

The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.

Start Date06 Sep 2018

Sponsor / Collaborator

Izana Bioscience Ltd.

[+2]

100 Clinical Results associated with Namilumab

100 Translational Medicine associated with Namilumab

100 Patents (Medical) associated with Namilumab

Literatures (Medical) associated with Namilumab

01 Aug 2024·Lancet Rheumatology

Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial

Article

Author: Gaffney, Karl ; Macdonald, Joanne ; Cook, Jonathan A ; Worth, Claudia ; Packham, Jonathan ; Corn, Tim H ; Gullick, Nicola ; Sengupta, Raj ; Machado, Pedro M ; Taylor, Peter C ; Chan, Antoni ; Bowness, Paul ; Al-Mossawi, M Hussein ; Teh, James ; Fisher, Benjamin A

BACKGROUND:

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a proinflammatory cytokine overproduced in several inflammatory and autoimmune diseases, including axial spondyloarthritis. Namilumab is a human IgG1 monoclonal anti-GM-CSF antibody that potently neutralises human GM-CSF. We aimed to assess the efficacy of namilumab in participants with moderate-to-severe active axial spondyloarthritis.

METHODS:

This proof-of-concept, randomised, double-blind, placebo-controlled, phase 2, Bayesian (NAMASTE) trial was done at nine hospitals in the UK. Participants aged 18-75 years with axial spondyloarthritis, meeting the Assessment in SpondyloArthritis international Society (ASAS) criteria and the ASAS-defined MRI criteria, with active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), were eligible. Those who had inadequately responded or had intolerance to previous treatment with an anti-TNF agent were included. Participants were randomly assigned (6:1) to receive subcutaneous namilumab 150 mg or placebo at weeks 0, 2, 6, and 10. Participants, site staff (except pharmacy staff), and central study staff were masked to treatment assignment. The primary endpoint was the proportion of participants who had an ASAS ≥20% improvement (ASAS20) clinical response at week 12 in the full analysis set (all randomly assigned participants). This trial is registered with ClinicalTrials.gov (NCT03622658).

FINDINGS:

From Sept 6, 2018, to July 25, 2019, 60 patients with moderate-to-severe active axial spondyloarthritis were assessed for eligibility and 42 were randomly assigned to receive namilumab (n=36) or placebo (n=six). The mean age of participants was 39·5 years (SD 13·3), 17 were women, 25 were men, 39 were White, and seven had previously received anti-TNF therapy. The primary endpoint was not met. At week 12, the proportion of patients who had an ASAS20 clinical response was lower in the namilumab group (14 of 36) than in the placebo group (three of six; estimated between-group difference 6·8%). The Bayesian posterior probability η was 0·72 (>0·927 suggests high clinical significance). The rates of any treatment-emergent adverse events in the namilumab group were similar to those in the placebo group (31 vs five).

INTERPRETATION:

Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated.

FUNDING:

Izana Bioscience, NIHR Oxford Biomedical Research Centre (BRC), NIHR Birmingham BRC, and Clinical Research Facility.

01 Mar 2022·The Lancet. Respiratory medicine

Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial

Article

Author: Sapey, Elizabeth ; Rahman, Bushra ; Bathurst, Camilla ; Bowden, Sarah ; Gao-Smith, Fang ; Middleton, Gary ; Rahman, Naj ; Mussai, Francis ; Mee, Susie ; McMichael, Andrew ; Cooke, Graham ; Gordon, Anthony ; Bangash, Mansoor ; Rowe, Anna ; Novak, Alex ; Watkinson, Peter ; Turner, Rebecca ; Gabriel, Zoe ; Van de Wiel, Joseph ; Newsome, Philip N ; Dark, Paul ; Scriven, James ; Williams, Bryan ; Sharpe, Rowena ; Hall, Andrew ; Patel, Jaimin ; McAuley, Danny ; Bion, Julian ; Gaskell, Charlotte ; Faustini, Sian ; Thomas, Mark ; Porter, Joanna ; Parekh, Dhruv ; Richards, Duncan ; Feldman, Marc ; Veenith, Tonny ; Kearns, Pamela ; Ho, Ling-Pei ; Fisher, Benjamin A ; Turner, Karen ; Slade, Daniel ; Hill, Adam ; McShane, Helen ; Rowland, Matthew ; Angus, Brian ; Balasubramaniam, Madhu S ; Mentzer, Alexander J. ; Whitehouse, Tony ; Coles, Mark ; Richter, Alex ; James, Karen ; Thickett, David R ; Matthay, Michael ; Libri, Vincenzo ; Gates, Simon ; Yap, Christina ; Morley, Nick ; Wise, Matthew P

BACKGROUND:

Dysregulated inflammation is associated with poor outcomes in COVID-19. We aimed to assess the efficacy of namilumab (a granulocyte-macrophage colony stimulating factor inhibitor) and infliximab (a tumour necrosis factor inhibitor) in hospitalised patients with COVID-19, to prioritise agents for phase 3 trials.

METHODS:

In this randomised, multicentre, multi-arm, multistage, parallel-group, open-label, adaptive, phase 2, proof-of-concept trial (CATALYST), we recruited patients (aged ≥16 years) admitted to hospital with COVID-19 pneumonia and C-reactive protein (CRP) concentrations of 40 mg/L or greater, at nine hospitals in the UK. Participants were randomly assigned with equal probability to usual care or usual care plus a single intravenous dose of namilumab (150 mg) or infliximab (5 mg/kg). Randomisation was stratified by care location within the hospital (ward vs intensive care unit [ICU]). Patients and investigators were not masked to treatment allocation. The primary endpoint was improvement in inflammation, measured by CRP concentration over time, analysed using Bayesian multilevel models. This trial is now complete and is registered with ISRCTN, 40580903.

FINDINGS:

Between June 15, 2020, and Feb 18, 2021, we screened 299 patients and 146 were enrolled and randomly assigned to usual care (n=54), namilumab (n=57), or infliximab (n=35). For the primary outcome, 45 patients in the usual care group were compared with 52 in the namilumab group, and 29 in the usual care group were compared with 28 in the infliximab group. The probabilities that the interventions were superior to usual care alone in reducing CRP concentration over time were 97% for namilumab and 15% for infliximab; the point estimates for treatment-time interactions were -0·09 (95% CI -0·19 to 0·00) for namilumab and 0·06 (-0·05 to 0·17) for infliximab. 134 adverse events occurred in 30 (55%) of 55 patients in the namilumab group compared with 145 in 29 (54%) of 54 in the usual care group. 102 adverse events occurred in 20 (69%) of 29 patients in the infliximab group compared with 112 in 17 (50%) of 34 in the usual care group. Death occurred in six (11%) patients in the namilumab group compared with ten (19%) in the usual care group, and in four (14%) in the infliximab group compared with five (15%) in the usual care group.

INTERPRETATION:

Namilumab, but not infliximab, showed proof-of-concept evidence for reduction in inflammation-as measured by CRP concentration-in hospitalised patients with COVID-19 pneumonia. Namilumab should be prioritised for further investigation in COVID-19.

FUNDING:

Medical Research Council.

01 Sep 2021·Journal of clinical pharmacologyQ3 · MEDICINE

Therapeutic Application of Corticosteroids in COVID‐19: A Focus on Optimum Dose and Duration of Therapy

Q3 · MEDICINE

Article

Author: Entezari‐Maleki, Taher ; Khiali, Sajad

The pandemic of coronavirus disease 2019 (COVID-19) has resulted in a global health crisis.Pathophysiol., the disease has the initial phase of viral replication that could be followed by an immunol. phase, which is characterized by a systemic inflammatory response, cytokine release syndrome, acute respiratory distress syndrome (ARDS), and multisystem organ dysfunction, and associated with a considerable rate of mortality.The critical condition of the immunol. phase of the disease has raised many studies investigating the efficacy and safety of a series of anti-inflammatory agents, including proinflammatory cytokine inhibitors (anakinra, tocilizumab, sarilumab, adalimumab, infliximab), Janus kinase inhibitors (baricitinib, tofacitinib, ruxolitinib), convalescent plasma, and granulocyte-macrophage colony-stimulating factors (gimsilumab, lenzilumab, namilumab), as well as nonspecific immune modulators such as corticosteroids in patients with COVID-19.It seems that, due to the substantial heterogeneity of the disease, ongoing RCTs should incorporate plans for understanding heterogeneity and identifying patients who are responsive to corticosteroids and appropriate dose of the medicines considering the burden of lung injury, inflammatory markers such as neutrophil-to-lymphocyte ratio, sedimentation rate, levels of interleukins, presence of poor prognosis risk factors, and other clin. and paraclin. data.Finally, the pharmacokinetics, glucocorticoids/mineralocorticoids ratios, and equivalent doses of corticosteroids, as well as dose and duration of the drugs in similar situations like the classic ARDS, should be considered in the clin. trials and treatment centers.

News (Medical) associated with Namilumab

30 May 2024

·www.globenewswire.com

Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, May 30, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2024, and provided a business update. Once-daily brepocitinib produced the best Treatment Failure rates observed to date among studies in active non-infectious uveitis (NIU), supporting initiation of a pivotal program in NIU in the second half of calendar year 2024Brepocitinib is well positioned to support a potential multi-blockbuster franchise in rare and orphan autoimmune disease with an ongoing pivotal study in dermatomyositis on track to read out in calendar year 2025Following a recently completed Type B meeting with the FDA, Immunovant is on track to initiate 4-5 potentially registrational studies with IMVT-1402 over the fiscal year ending March 31, 2025Immunovant expects to announce detailed results from the study of batoclimab in Graves’ disease (GD) as well as an overview of the development plan of IMVT-1402 in GD in the fall of 2024VTAMA® sNDA submission for atopic dermatitis was accepted by the FDA; PDUFA action is expected in the fourth quarter of calendar year 2024, potentially enabling a four-fold market expansionVTAMA, approved for psoriasis, net product revenue was $75.1M for the fiscal year ended March 31, 2024, with over 385,000 prescriptions written by over 15,300 unique prescribers since launchRoivant renegotiated Dermavant’s debt obligations, reducing potential cash payments due by over $300M in the aggregate. Approximately $225M of this reduction is expected to be achieved over the next three fiscal yearsRoivant has $852M in share repurchase authorization available following the repurchase of Sumitomo’s entire stake at $9.10 per share for $648M, which reduced outstanding shares by 9%Net cash used in operating activities for the quarter was $108MRoivant reported its consolidated cash, cash equivalents and restricted cash of $6.6B at March 31, 2024, supporting cash runway into profitability “We finished our fiscal year with yet another productive quarter for the company,” said Matt Gline, CEO of Roivant. “The Priovant team announced outstanding data for patients with NIU, reaffirming our view on the blockbuster potential of brepocitinib, which we expect will continue to deliver benefit to patients with unmet need. Our board has approved a significant buyback program, allowing us to return capital to shareholders and to increase exposure to our most exciting current and future programs. I could not be more excited for what we’ve accomplished and what I believe we will deliver in our next chapter ahead.” Recent Developments Priovant: In April 2024, Priovant announced positive results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis. On the pre-specified primary efficacy endpoint of Treatment Failure at week 24, 29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met Treatment Failure criteria (lower failure rates reflect greater treatment benefit). The brepocitinib 45 mg results represent the best Treatment Failure rates observed to date among studies in active NIU measuring this registrational endpoint. All secondary efficacy endpoints were also positive and dose responsive, including measurements of potential benefit on prevention and treatment of uveitic macular edema. NEPTUNE represents the seventh positive Phase 2 study for brepocitinib with over 1,400 subjects and patients treated with brepocitinib in clinical trials. Brepocitinib was generally safe and well-tolerated in the study, with no new safety or tolerability signals identified.Immunovant: Following a recently completed Type B meeting with the FDA, 4-5 potentially registrational programs for IMVT-1402 are on track to be initiated by March 31, 2025. Immunovant is prioritizing the development of IMVT-1402 as the lead asset going forward.In March 2024, Immunovant was awarded U.S. Patent No. 11,926,669 covering composition of matter of IMVT-1402 and its binding sequence to FcRn, method of use of the antibody for treating autoimmune disease, and methods for its manufacturing. Not including any potential patent term extension, the issued composition-of-matter patent term will extend until June 2043. Dermavant: For the fourth quarter and fiscal year ended March 31, 2024, Roivant reported VTAMA net product revenue of $19.3M, and $75.1M, respectively. As of May 2024, over 385,000 VTAMA prescriptions have been written by over 15,300 unique prescribers for psoriasis. VTAMA is covered for over 138M US commercial lives, including coverage by all three of the top pharmacy benefit managers.In April 2024, Dermavant announced FDA acceptance of VTAMA’s sNDA submission for the treatment of atopic dermatitis in adults and children 2 years of age and older. PDUFA action is expected in the fourth quarter of calendar year 2024.In May 2024, Roivant renegotiated Dermavant’s debt obligations, reducing potential cash payments due by over $300M in the aggregate. Approximately $225M of this reduction is expected to be achieved over the next three fiscal years. Genevant: In April 2024, the U.S. District Court for the District of Delaware issued its claim construction (Markman) ruling in the lawsuit brought by Genevant and Arbutus against Moderna. The court agreed with Genevant and Arbutus’ proposed constructions for three of the four disputed terms.Kinevant: In April 2024, Kinevant completed enrollment in RESOLVE-LUNG, a Phase 2 study evaluating namilumab for chronic pulmonary sarcoidosis.Roivant: In April 2024, Roivant announced that its board of directors had authorized a share repurchase program for up to $1.5B of the company’s common shares. Pursuant to that program, the company completed the repurchase of all 71.3M shares held by Sumitomo Pharma at a purchase price of $9.10 per share. The aggregate purchase price for Sumitomo Pharma’s stake was approximately $648.4M, reducing Roivant’s shares outstanding by approximately 9%.Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.6B at March 31, 2024. Giving effect to the Sumitomo share repurchase, Roivant’s cash, cash equivalents and restricted cash at March 31, 2024 would have been approximately $5.9B. Major Upcoming Milestones Dermavant expects PDUFA action for VTAMA in atopic dermatitis in the fourth quarter of calendar year 2024.Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the fourth quarter of calendar year 2024.Priovant expects topline results from the ongoing Phase 3 trial of brepocitinib in dermatomyositis (DM) in calendar year 2025 and to initiate a Phase 3 pivotal trial of brepocitinib in the second half of calendar year 2024.Immunovant plans to have initiated 4-5 potentially registrational programs by March 31, 2025, and plans to have initiated studies in a total of 10 indications by March 31, 2026 for IMVT-1402. Detailed results from the batoclimab study in Graves’ Disease (GD) and an overview of the development plan of IMVT-1402 in GD are expected in the fall of 2024. Immunovant expects to report topline data from the study of batoclimab in MG over this fiscal year with further potentially registrational development of IMVT-1402 in MG expected to begin in the same timeframe. Immunovant has decided to run the study of batoclimab in CIDP longer prior to unblinding period 1 in order to better ensure that the data from the batoclimab study can be used to optimize development of IMVT-1402 in CIDP. Top-line data from the ongoing Phase 3 clinical trial in thyroid eye disease (TED) is expected in the first half of calendar year 2025. Fourth Quarter and Fiscal Year Ended March 31, 2024 Financial Summary Cash Position As of March 31, 2024, the company had cash, cash equivalents and restricted cash of approximately $6.6 billion. Research and Development Expenses Research and development (R&D) expenses decreased by $11.0 million to $120.9 million for the three months ended March 31, 2024, compared to $131.9 million for the three months ended March 31, 2023, primarily due to a decrease in program-specific costs of $25.8 million, partially offset by increases in share-based compensation of $5.9 million, other expenses of $4.6 million, and personnel-related expenses of $4.3 million. The decrease of $25.8 million in program-specific costs was primarily driven by a decrease of $19.8 million in other development and discovery programs, which in part resulted from the deconsolidation of Proteovant in August 2023 along with the reprioritization of certain programs and drug discovery efforts. The change also included a decrease of $5.9 million relating to RVT-3101 as a result of the sale of the rights to further develop and manufacture RVT-3101 to Roche in December 2023. Non-GAAP R&D expenses were $109.7 million for the three months ended March 31, 2024, compared to $126.0 million for the three months ended March 31, 2023. Research and development expenses decreased by $23.5 million to $501.7 million for the year ended March 31, 2024, compared to $525.2 million for the year ended March 31, 2023, primarily due to a decrease in program-specific costs of $42.4 million, partially offset by increases in other expenses of $10.7 million, personnel-related expenses of $4.5 million, and share-based compensation of $3.7 million. The decrease of $42.4 million in program-specific costs was primarily driven by a decrease of $83.1 million in other development and discovery program expense, which in part resulted from the deconsolidation of Proteovant in August 2023 along with the reprioritization of certain programs and drug discovery efforts. This decrease was partially offset by increases of $32.8 million relating to IMVT-1402 and $27.6 million relating to RVT-3101, which was acquired in November 2022. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023. Non-GAAP R&D expenses were $462.6 million for the year ended March 31, 2024, compared to $489.2 million for the year ended March 31, 2023. Acquired In-Process Research and Development Expenses There was no acquired in-process research and development (IPR&D) expense for the three months ended March 31, 2024 and 2023. Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the year ended March 31, 2024, compared to $97.7 million for the year ended March 31, 2023. The decrease was primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2023 as a result of consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 in November 2022 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million. Acquired in-process research and development expenses for the year ended March 31, 2024 was driven by $14.0 million of consideration for the purchase of IPR&D relating to an asset acquisition completed by a newly-formed subsidiary and $12.5 million relating to the achievement of development and regulatory milestones for batoclimab. Selling, General and Administrative Expenses Selling, general and administrative (SG&A) expenses increased by $44.1 million to $169.6 million for the three months ended March 31, 2024, compared to $125.5 million for the three months ended March 31, 2023. The increase was primarily due to an increase in share-based compensation of $15.6 million, an increase in SG&A expenses at Dermavant of $8.5 million due to the progression of the commercial launch of VTAMA, and an increase of $8.5 million resulting from a special one-time cash retention bonus award granted to employees. Non-GAAP SG&A expenses were $131.3 million for the three months ended March 31, 2024, compared to $102.6 million for the three months ended March 31, 2023. Selling, general and administrative expenses increased by $86.9 million to $687.4 million for the year ended March 31, 2024, compared to $600.5 million for the year ended March 31, 2023. The increase was primarily due to an increase in selling, general and administrative expenses of $55.7 million at Dermavant as a result of the progression of the commercial launch of VTAMA and an increase in personnel-related expenses of $25.1 million, primarily as a result of a special one-time cash retention bonus award granted to employees. Non-GAAP SG&A expenses were $514.8 million for the year ended March 31, 2024, compared to $407.6 million for the year ended March 31, 2023. A majority of the non-GAAP SG&A expenses of $514.8 million were related to Dermavant’s SG&A and ongoing VTAMA commercial launch activities. Gain on Sale of Telavant Net Assets Gain on sale of Telavant net assets was approximately $5.3 billion for the year ended March 31, 2024 and resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. At closing, we received approximately $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million. This resulted in a gain of approximately $5.3 billion. Income (Loss) from Continuing Operations Loss from continuing operations was $182.5 million for the three months ended March 31, 2024, compared to $175.4 million for the three months ended March 31, 2023. On a per common share basis, loss from continuing operations was $0.19 and $0.20 for the three months ended March 31, 2024 and 2023, respectively. Non-GAAP loss from continuing operations was $188.1 million for the three months ended March 31, 2024, compared to $189.4 million for the three months ended March 31, 2023. Income from continuing operations was approximately $4.2 billion for the year ended March 31, 2024, compared to a loss from continuing operations of $1.2 billion for the year ended March 31, 2023. On a basic and diluted per common share basis, income from continuing operations was $5.55 and $5.23, respectively, for the year ended March 31, 2024. On a per common share basis, loss from continuing operations was $1.58 for the year ended March 31, 2023. Non-GAAP loss from continuing operations was $799.9 million for the year ended March 31, 2024, compared to $924.3 million for the year ended March 31, 2023. ROIVANT SCIENCES LTD.Selected Balance Sheet Data(in thousands) March 31, 2024 March 31, 2023 Cash, cash equivalents and restricted cash$6,550,450 $1,692,115Total assets 7,222,482 2,389,604Total liabilities 773,953 782,017Total shareholders’ equity 6,448,529 1,607,587Total liabilities and shareholders’ equity 7,222,482 2,389,604 ROIVANT SCIENCES LTD.Consolidated Statements of Operations(in thousands, except share and per share amounts) Three Months Ended March 31, Years Ended March 31, 2024 2023 2024 2023 (Unaudited) (Unaudited) Revenues: Product revenue, net$19,308 $13,657 $75,057 $28,011 License, milestone and other revenue 9,622 13,719 49,738 33,269 Revenue, net 28,930 27,376 124,795 61,280 Operating expenses: Cost of revenues 4,412 4,175 15,560 13,128 Research and development (includes $10,290 and $4,366 of share-based compensation expense for the three months ended March 31, 2024 and 2023, respectively, and $34,595 and $30,914 of share-based compensation expense for the years ended March 31, 2024 and 2023, respectively) 120,902 131,857 501,736 525,215 Acquired in-process research and development — — 26,450 97,749 Selling, general and administrative (includes $36,396 and $20,832 of share-based compensation expense for the three months ended March 31, 2024 and 2023, respectively, and $164,841 and $186,603 of share-based compensation expense for the years ended March 31, 2024 and 2023, respectively) 169,616 125,510 687,443 600,506 Total operating expenses 294,930 261,542 1,231,189 1,236,598 Gain on sale of Telavant net assets — — 5,348,410 — (Loss) income from operations (266,000) (234,166) 4,242,016 (1,175,318) Change in fair value of investments (15,907) (32,462) 47,973 20,815 Change in fair value of debt and liability instruments (6,433) (12,031) 78,943 78,001 Gain on deconsolidation of subsidiaries (15,418) — (32,772) (29,276)Interest income (83,458) (14,284) (146,425) (32,184)Interest expense 7,175 8,575 34,778 27,968 Other expense (income), net 39,494 (4,748) 6,089 (15,808)(Loss) income from continuing operations before income taxes (191,453) (179,216) 4,253,430 (1,224,834)Income tax (benefit) expense (8,957) (3,793) 22,224 5,190 (Loss) income from continuing operations, net of tax (182,496) (175,423) 4,231,206 (1,230,024)Income from discontinued operations, net of tax — 114,561 — 114,561 Net (loss) income (182,496) (60,862) 4,231,206 (1,115,463)Net loss attributable to noncontrolling interests (31,381) (27,245) (117,720) (106,433)Net (loss) income attributable to Roivant Sciences Ltd.$(151,115) $(33,617) $4,348,926 $(1,009,030) Amounts attributable to Roivant Sciences Ltd.: (Loss) income from continuing operations, net of tax$(151,115) $(148,178) $4,348,926 $(1,123,591)Income from discontinued operations, net of tax — 114,561 — 114,561 Net (loss) income attributable to Roivant Sciences Ltd.$(151,115) $(33,617) $4,348,926 $(1,009,030) Net (loss) income per common share, basic: (Loss) income from continuing operations$(0.19) $(0.20) $5.55 $(1.58)Income from discontinued operations, net of tax$— $0.15 $— $0.16 Net (loss) income$(0.19) $(0.05) $5.55 $(1.42)Net (loss) income per common share, diluted: (Loss) income from continuing operations$(0.19) $(0.20) $5.23 $(1.58)Income from discontinued operations, net of tax$— $0.15 $— $0.16 Net (loss) income$(0.19) $(0.05) $5.23 $(1.42)Weighted average shares outstanding: Basic 802,859,062 742,541,052 783,248,906 712,791,115 Diluted 802,859,062 742,541,052 831,049,444 712,791,115 ROIVANT SCIENCES LTD.Reconciliation of GAAP to Non-GAAP Financial Measures(unaudited, in thousands) Three Months Ended March 31, Years Ended March 31, Note 2024 2023 2024 2023 (Loss) income from continuing operations, net of tax $(182,496) $(175,423) $4,231,206 $(1,230,024)Adjustments: Cost of revenues: Amortization of intangibles(1) 2,421 2,298 9,632 7,468 Share-based compensation(2) 38 37 191 95 Research and development: Share-based compensation(2) 10,290 4,366 34,595 30,914 Depreciation and amortization(3) 873 1,539 4,590 5,097 Selling, general and administrative: Share-based compensation(2) 36,396 20,832 164,841 186,603 Depreciation and amortization(3) 1,912 2,116 7,814 6,292 Gain on sale of Telavant net assets(4) — — (5,348,410) — Other: Change in fair value of investments(5) (15,907) (32,462) 47,973 20,815 Change in fair value of debt and liability instruments(6) (6,433) (12,031) 78,943 78,001 Gain on deconsolidation of subsidiaries(7) (15,418) — (32,772) (29,276)Estimated income tax impact from adjustments(8) (19,813) (704) 1,538 (294) Adjusted loss from continuing operations, net of tax (Non-GAAP) $(188,137) $(189,432) $(799,859) $(924,309) Three Months Ended March 31, Years Ended March 31, Note 2024 2023 2024 2023 Research and development expenses $120,902 $131,857 $501,736 $525,215 Adjustments: Share-based compensation(2) 10,290 4,366 34,595 30,914 Depreciation and amortization(3) 873 1,539 4,590 5,097 Adjusted research and development expenses (Non-GAAP) $109,739 $125,952 $462,551 $489,204 Three Months Ended March 31, Years Ended March 31, Note 2024 2023 2024 2023 Selling, general and administrative expenses $169,616 $125,510 $687,443 $600,506 Adjustments: Share-based compensation(2) 36,396 20,832 164,841 186,603 Depreciation and amortization(3) 1,912 2,116 7,814 6,292 Adjusted selling, general and administrative expenses (Non-GAAP) $131,308 $102,562 $514,788 $407,611 Notes to non-GAAP financial measures: (1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals. (2) Represents non-cash share-based compensation expense. (3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals. (4) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023. (5) 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. (6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (7) Represents the one-time gain on deconsolidation of subsidiaries. (8) Represents the estimated tax effect of the adjustments. Roivant will also present at two additional upcoming investor conferences: Fireside Chat at Jefferies Global Healthcare Conference in New York at 11:30 a.m. ET on June 5, 2024Fireside Chat at Goldman Sachs 45th Annual Global Healthcare Conference in Miami at 8:40 a.m. ET on June 10, 2024 Investor Conference Call InformationRoivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 30, 2024, to report its financial results for the fourth quarter and fiscal year ended March 31, 2024, and provide a corporate 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 is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 for the treatment of dermatomyositis and non-infectious uveitis, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, 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 potential share repurchases, the clinical and therapeutic potential of our products and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our products and product candidates and the benefits expected to be realized from Dermavant’s renegotiation of its existing debt obligations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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:InvestorsRoivant Investor Relationsir@roivant.com MediaStephanie LeeRoivant Sciencesstephanie.lee@roivant.com

Phase 2Clinical ResultDrug ApprovalPhase 3Financial Statement

25 Apr 2024

·www.biospace.com

Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis

Namilumab is a fully human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a pro-inflammatory cytokine believed to play a key role in the pathogenesis of sarcoidosis RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to be supportive of registration that enrolled 107 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatments Topline results are expected by the end of calendar year 2024 BASEL, Switzerland & LONDON & NEW YORK--(BUSINESS WIRE)-- Roivant (Nasdaq: ROIV) and Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung). Approximately 200,000 people in the U.S. (and more than 1 million worldwide) are estimated to have sarcoidosis, an immune-mediated inflammatory disease that can affect any organ in the body, with about 90% of cases involving the lung. Namilumab is a potent anti-GM-CSF monoclonal antibody formulated to be conveniently administered once-monthly as a subcutaneous injection that has the potential to be the first disease-modifying therapy for sarcoidosis. Potentially supportive of registration, RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to enroll a minimum of 100 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatment options. “People living with pulmonary sarcoidosis clearly need new therapeutic options that can more safely and effectively control or resolve their disease,” said Bill Gerhart, CEO of Kinevant. “Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis. I am grateful for the patients who volunteered to participate in the study, as well as for the extraordinary efforts of the Kinevant team, our industry partners, clinical trial site staff, and patient advocacy groups, all of whom came together to overcome the unique challenges of this disease to successfully enroll this study. We are very hopeful about the outcome, and we look forward to reporting topline results by the end of the year.” Pulmonary sarcoidosis is a lung disease characterized by the presence of granulomas (clumps of immune cells) of unknown etiology that can cause breathlessness, fatigue, and pain. The resulting inflammation, if not effectively treated, can result in lung tissue scarring (fibrosis), lung dysfunction, and eventually lung failure. Approximately 50% of diagnosed patients require chronic therapy to treat symptoms and prevent progression. Oral steroids (e.g., prednisone) and off-label immunosuppressive therapies (e.g., methotrexate) are first- and second-line therapies respectively for sarcoidosis; however, these therapeutic options are often not effective or can be accompanied by serious side effects. Evidence from non-clinical studies indicate that GM-CSF is a key cytokine driving granuloma formation and inflammation in sarcoidosis, and that inhibiting GM-CSF can reduce granuloma activity and the resulting inflammation, leading potentially to a reduction in symptoms and resolution of the underlying disease. Namilumab is a potent inhibitor of GM-CSF that has been observed to be generally safe and well-tolerated in more than 350 participants across multiple clinical trials. Thus, namilumab has the potential to be the only well-tolerated and effective therapy for sarcoidosis, as well as the first therapy approved specifically for pulmonary sarcoidosis. “Pulmonary sarcoidosis is a complex and challenging condition, with limited treatment options, and many unacceptable side effects. There is a need for new and better therapies to be developed,” said Mary McGowan, CEO of the Foundation for Sarcoidosis Research. “We are proud to have worked with Kinevant on the successful enrollment of this clinical trial. We are grateful to the sarcoidosis patient community who embraced this opportunity to lead us toward a potential new therapy as well as a deeper understanding of sarcoidosis.” About RESOLVE-Lung The RESOLVE-Lung study is a Phase 2 randomized, double-blind, placebo-controlled study of namilumab for the treatment of pulmonary sarcoidosis being conducted at multiple sites in the U.S. and Europe. The study has enrolled 107 pulmonary sarcoidosis patients considered not well-controlled despite available therapeutic options. Patients in the study receive a once-monthly subcutaneous injection of namilumab or placebo (following the initial dosing period) for approximately six months. The goal of the study is to assess the efficacy and safety of namilumab in patients with pulmonary sarcoidosis during the 6-month blinded treatment period. The primary endpoint is the difference in the proportion of patients with a rescue event due to worsening of their pulmonary sarcoidosis. Secondary endpoints include changes in pulmonary function, patient reported outcomes, steroid use, safety, and tolerability. All patients who complete the 26-week double-blind treatment period are eligible to participate in a 28-week open-label extension treatment period on namilumab. More information can be found at About Namilumab Namilumab is an investigational, fully human monoclonal antibody formulated to be conveniently administered once a month as a subcutaneous injection. Namilumab is a potent GM-CSF inhibitor that has been well-tolerated so far in more than 350 participants across multiple clinical trials. Evidence from non-clinical studies indicate that GM-CSF promotes macrophage and dendritic cell activity which contributes to granuloma formation. Inhibiting GM-CSF can reduce the presence of granulomas and the resulting inflammation, potentially leading to a reduction in symptoms and resolution of the underlying disease. About Kinevant Sciences Kinevant Sciences, a subsidiary of Roivant, is a clinical-stage biopharmaceutical company developing new medicines for rare autoimmune and inflammatory diseases. The company takes a patient-first approach to drug development, advancing candidates with the potential to resolve the underlying disease and create life-changing benefit for patients. Kinevant is initially focused on the development of namilumab for the treatment of sarcoidosis, a multi-organ systemic disease with a high unmet medical need. For more information, visit or follow us on LinkedIn. About Roivant Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis, non-infectious uveitis, and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, .

Phase 2Clinical ResultDrug Approval

13 Feb 2024

·www.globenewswire.com

Roivant Reports Financial Results for the Third Quarter Ended December 31, 2023, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2023, and provided a business update. Roivant completed the sale of Telavant to Roche for $7.1B with an additional $150M in cash payable upon the completion of a near-term milestoneBatoclimab produced positive results in Graves’ disease with response rates meaningfully exceeding 50% in the initial cohort of an ongoing 24-week Phase 2 trialVTAMA® (tapinarof) cream, 1% net product revenue was $20.7M for the quarter ended December 31, 2023, with over 300,000 prescriptions written by approximately 14,000 unique prescribers since launchNew VTAMA positive long-term efficacy and safety data announced from analyses of the ADORING Phase 3 program in atopic dermatitis. Data from these analyses will be included in sNDA submission expected this quarterBrepocitinib topline data from the Phase 2 trial in patients with non-infectious uveitis (NIU) is expected this quarterRoivant reported its consolidated cash, cash equivalents and restricted cash of $6.7B at December 31, 2023, supporting cash runway into profitability “This was another productive quarter across the company - we were pleased to announce the closing of the Telavant transaction with Roche in December. I am proud of our continued progress in clinical development, with another positive result generated by the Immunovant team in Graves’ disease. The positive initial data continues to support our view of the broad applicability of FcRn and the potentially meaningful clinical benefits associated with deeper IgG suppression,” said Matt Gline, CEO of Roivant. “Looking ahead, we are excited about multiple upcoming clinical data readouts and other catalysts expected this year, as well as the prospect of expanding our clinical pipeline. 2024 will be a year of growth for Roivant.” Recent Developments Roivant: In December 2023, Roivant announced the completion of the sale of Telavant to Roche for an upfront payment of approximately $7.1 billion with an additional $150 million in cash payable upon the completion of a near-term milestone. Under the terms of the agreement, Roche gained the rights to develop, manufacture and commercialize RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially other diseases. Prior to the closing of the transaction, Roivant owned 75% of the issued and outstanding shares of common stock and preferred stock of Telavant and Pfizer owned the remaining 25%, in each case on an as-converted basis. Roivant’s net cash proceeds from the transaction are approximately $5.2 billion. Approximately $110 million of the additional milestone payment will be payable to Roivant.Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.7 billion at December 31, 2023. Immunovant: In November 2023, Immunovant reported IMVT-1402, a second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn), continued to show potentially best-in-class profile in a Phase 1 clinical trial in healthy adults. Initial data from the 600 mg MAD cohort showed that four subcutaneously administered doses of 600 mg IMVT-1402 reduced total immunoglobulin G (IgG) levels by a mean of 74%, very similar to the 76% IgG reduction after four weekly injections of 680 mg batoclimab, but with no or minimal changes in serum albumin and LDL cholesterol, consistent with observations in placebo.In December 2023, Immunovant reported in an open-label Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease, response rates from an initial cohort of patients who were hyperthyroid despite treatment with an anti-thyroid medication for more than 12 weeks were meaningfully higher than 50 percent, after receiving once-weekly subcutaneous injections of 680 mg batoclimab for 12 weeks. This trial is ongoing. Dermavant: For the third quarter ended December 31, 2023, Roivant reported VTAMA net product revenue of $20.7M, representing a 28.5% gross-to-net yield for the quarter. As of February 2024, over 300,000 VTAMA prescriptions1 have been written by approximately 14,000 unique prescribers for psoriasis2, based on IQVIA data. VTAMA is covered for 137 million US commercial lives, including coverage by all three of the top pharmacy benefit managers.In January 2024, Dermavant announced new positive efficacy and safety data from analyses of ADORING 3, an ongoing open-label, long-term extension Phase 3 trial being conducted to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD for up to 48 weeks of total treatment. The integrated analysis across the ADORING development program showed that efficacy continued to improve beyond the 8-week double blind treatment period in ADORING 1 and ADORING 2 across multiple endpoints including: vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline was observed in 73% (519/711) of patients included80.7% (574/711) of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75)77.9% (218/280) of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point reduction in PP-NRS92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD scoreThe interim analysis of the ADORING 3 open-label, long-term extension Phase 3 trial demonstrated that 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0). No new safety signals were observed with up to 56 weeks of treatment. Data from these analyses will be included in sNDA submission expected this quarter. Hemavant: We have discontinued the development of RVT-2001 after an interim data analysis from the Phase 1/2 study. Major Upcoming Milestones Immunovant expects initial results from period 1 of the Phase 2b clinical trial of batoclimab in CIDP in the second or third quarter of calendar year 2024, while top-line data from the Phase 3 clinical trials of batoclimab in MG and TED are on track and expected in the second half of calendar year 2024 and the first half of calendar year 2025, respectively. For IMVT-1402, Immunovant plans to initiate 4-5 potentially registrational programs by March 31, 2025 and plans to initiate trials in 10 indications by March 31, 2026 (inclusive of the 4-5 potentially registrational programs).Priovant expects to announce topline results from the Phase 2 POC study in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024. Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024. Third Quarter Ended December 31, 2023 Financial SummaryCash PositionAs of December 31, 2023, the Company had consolidated cash, cash equivalents and restricted cash of $6.7 billion. Research and Development ExpensesResearch and development expenses decreased by $1.8 million to $123.7 million for the three months ended December 31, 2023, compared to $125.5 million for the three months ended December 31, 2022. Changes in the components of research and development expenses included a decrease in program-specific costs of $10.0 million offset by increases in personnel-related expenses of $6.5 million and other expenses of $1.1 million. Within program-specific costs, the decrease of $10.0 million was primarily driven by a decrease of $9.5 million related to other development and discovery programs due to the deconsolidation of Proteovant Sciences, Inc. (“Proteovant”) in August 2023, along with the reprioritization of certain programs and drug discovery efforts, and decreases of $3.1 million each related to RVT-2001 and batoclimab. These decreases were partially offset by an increase in expense of $4.0 million related to RVT-3101, which was acquired in November 2022, and an increase of $3.5 million related to IMVT-1402. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023. The increase of $6.5 million in personnel-related expenses was primarily driven by a special one-time cash retention bonus award granted to employees during the three months ended December 31, 2023. Non-GAAP R&D expenses were $115.2 million for the three months ended December 31, 2023, compared to $117.4 million for the three months ended December 31, 2022. Selling, General and Administrative ExpensesSelling, general and administrative expenses increased by $29.0 million to $197.3 million for the three months ended December 31, 2023, compared to $168.3 million for the three months ended December 31, 2022, primarily due to an increase in personnel-related expenses of $27.0 million as a result of a special one-time cash retention bonus award granted to employees. Non-GAAP SG&A expenses were $148.4 million for the three months ended December 31, 2023, compared to $115.9 million for the three months ended December 31, 2022. Gain on Sale of Telavant Net AssetsGain on sale of Telavant net assets resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. At closing, we received approximately $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million. This resulted in a gain of approximately $5.3 billion. Net Income (Loss)Net income was approximately $5.1 billion for the three months ended December 31, 2023, compared to a net loss of $384.9 million for the three months ended December 31, 2022. On a basic and diluted per common share basis, net income was $6.37 and $6.03, respectively, for the three months ended December 31, 2023. Basic and diluted net loss per common share was $0.49 for the three months ended December 31, 2022. Non-GAAP net loss was $174.9 million for the three months ended December 31, 2023, compared to $297.5 million for the three months ended December 31, 2022. ROIVANT SCIENCES LTD.Selected Balance Sheet Data(unaudited, in thousands) December 31, 2023 March 31, 2023 Cash, cash equivalents and restricted cash$6,685,458 $1,692,115Total assets 7,312,679 2,389,604Total liabilities 728,097 782,017Total shareholders’ equity 6,584,582 1,607,587Total liabilities and shareholders’ equity 7,312,679 2,389,604 ROIVANT SCIENCES LTD.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share amounts) Three Months Ended December 31, Nine Months Ended December 31, 2023 2022 2023 2022 Revenues: Product revenue, net$20,666 $9,244 $55,749 $14,354 License, milestone and other revenue 16,474 7,808 40,116 19,550 Revenue, net 37,140 17,052 95,865 33,904 Operating expenses: Cost of revenues 3,668 3,586 11,148 8,953 Research and development (includes $7,475 and $6,888 of share-based compensation expense for the three months ended December 31, 2023 and 2022 and $24,305 and $26,548 for the nine months ended December 31, 2023 and 2022, respectively) 123,717 125,533 380,834 393,358 Acquired in-process research and development — 97,749 26,450 97,749 Selling, general and administrative (includes $46,944 and $50,741 of share-based compensation expense for the three months ended December 31, 2023 and 2022 and $128,445 and $165,771 for the nine months ended December 31, 2023 and 2022, respectively) 197,282 168,261 517,827 474,996 Total operating expenses 324,667 395,129 936,259 975,056 Gain on sale of Telavant net assets 5,348,410 — 5,348,410 — Income (loss) from operations 5,060,883 (378,077) 4,508,016 (941,152) Change in fair value of investments 10,467 (25,948) 63,880 53,277 Change in fair value of debt and liability instruments 9,331 62,360 85,376 90,032 Gain on deconsolidation of subsidiaries — (12,514) (17,354) (29,276)Interest income (31,953) (10,249) (62,967) (17,900)Interest expense 9,444 8,446 27,603 19,393 Other income, net (34,743) (18,095) (33,405) (11,060)Net income (loss) before income taxes 5,098,337 (382,077) 4,444,883 (1,045,618)Income tax expense 25,672 2,819 31,181 8,983 Net income (loss) 5,072,665 (384,896) 4,413,702 (1,054,601)Net loss attributable to noncontrolling interests (23,519) (32,882) (86,339) (79,188)Net income (loss) attributable to Roivant Sciences Ltd.$5,096,184 $(352,014) $4,500,041 $(975,413) Net income (loss) per common share: Basic$6.37 $(0.49) $5.79 $(1.39)Diluted$6.03 $(0.49) $5.46 $(1.39) Weighted average shares outstanding: Basic 800,587,716 713,319,399 776,759,728 703,054,773 Diluted 844,461,685 713,319,399 824,310,013 703,054,773 ROIVANT SCIENCES LTD.Reconciliation of GAAP to Non-GAAP Financial Measures(unaudited, in thousands) Three Months Ended December 31, Nine Months Ended December 31, Note 2023 2022 2023 2022 Net income (loss) $5,072,665 $(384,896) $4,413,702 $(1,054,601)Adjustments: Cost of revenues Amortization of intangible assets(1) 2,442 2,228 7,211 5,170 Share-based compensation(2) 55 — 153 — Research and development: Share-based compensation(2) 7,475 6,888 24,305 26,548 Depreciation and amortization(3) 1,023 1,258 3,717 3,558 Selling, general and administrative: Share-based compensation(2) 46,944 50,741 128,445 165,771 Depreciation and amortization(3) 1,956 1,664 5,902 4,176 Gain on sale of Telavant net assets(4) (5,348,410) — (5,348,410) — Other: Change in fair value of investments(5) 10,467 (25,948) 63,880 53,277 Change in fair value of debt and liability instruments(6) 9,331 62,360 85,376 90,032 Gain on deconsolidation of subsidiaries(7) — (12,514) (17,354) (29,276)Estimated income tax impact from adjustments(8) 21,199 756 21,351 410 Adjusted net loss (Non-GAAP) $(174,853) $(297,463) $(611,722) $(734,935) Three Months Ended December 31, Nine Months Ended December 31, Note 2023 2022 2023 2022 Research and development expenses $123,717 $125,533 $380,834 $393,358 Adjustments: Share-based compensation(2) 7,475 6,888 24,305 26,548 Depreciation and amortization(3) 1,023 1,258 3,717 3,558 Adjusted research and development expenses (Non-GAAP) $115,219 $117,387 $352,812 $363,252 Three Months Ended December 31, Nine Months Ended December 31, Note 2023 2022 2023 2022 Selling, general and administrative expenses $197,282 $168,261 $517,827 $474,996 Adjustments: Share-based compensation(2) 46,944 50,741 128,445 165,771 Depreciation and amortization(3) 1,956 1,664 5,902 4,176 Adjusted selling, general and administrative expenses (Non-GAAP) $148,382 $115,856 $383,480 $305,049 Notes to non-GAAP financial measures: (1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals. (2) Represents non-cash share-based compensation expense. (3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals. (4) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023. (5) Represents the unrealized loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (7) Represents the one-time gain on deconsolidation of subsidiaries. (8) Represents the estimated tax effect of the adjustments. Investor Conference Call InformationRoivant will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, February 13, 2024, to report its financial results for the third quarter ended December 31, 2023, and provide a corporate 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 is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, 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,” “suggest,” “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 products and product candidates, plans to develop our product candidates for particular indications, the availability and success of topline results from our ongoing clinical trials, cash runway and profitability and any commercial potential of our products and product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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:InvestorsRoivant Investor Relationsir@roivant.com MediaStephanie LeeRoivant Sciencesstephanie.lee@roivant.com 1 IQVIA National Prescription Audit (NPA) for the 3-month period ending 1/26/2024, reflecting estimates of real-world activity. All rights reserved.2 NPA for the period 5/20/22 to 1/19/2024, reflecting estimates of real-world activity. All rights reserved.

Clinical ResultPhase 2Phase 1Financial StatementPhase 3

100 Deals associated with Namilumab

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KEGG	Wiki	ATC	Drug Bank
-	Namilumab	-	DB13037

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sarcoidosis, Pulmonary	Phase 2	US	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	BE	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	FR	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	DE	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	NL	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	TR	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	GB	Kinevant Sciences GmbH	31 Aug 2022
Cardiac sarcoidosis	Phase 2	US	Kinevant Sciences GmbH	23 Aug 2022
Axial Spondyloarthritis	Phase 2	GB	Izana Bioscience Ltd.	06 Sep 2018
Ankylosing Spondylitis	Phase 2	GB	Izana Bioscience Ltd.	08 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03622658 (NAMASTE, Pubmed) Manual	Phase 2	Axial Spondyloarthritis	42	Namilumab 150 mg	ydnjdjvhdh(xuovnuotpp) = lfsiohudlo rlexerngvt (bqnvdpwylu ) Not Met View more	Negative	25 Jun 2024
				Placebo	ydnjdjvhdh(xuovnuotpp) = usctntrjro rlexerngvt (bqnvdpwylu ) Not Met View more
NCT03622658 (NAMASTE, CTgov)	Phase 2	Axial Spondyloarthritis	42	Placebo (Placebo)	yspwticets(myvcxnqhuw) = bxfztyxvsa tvjcghpclb (fwjddoviyn, swrntuefzj - klstotgypm) View more	-	08 Mar 2022
				Namilumab (Namilumab)	yspwticets(myvcxnqhuw) = pimxsaqtgr tvjcghpclb (fwjddoviyn, gkjqecxjjv - ujfrwsypox) View more
NCT02129777 (NEPTUNE, Pubmed \| Br J Dermatol) Manual	Phase 2	Psoriasis	122	namilumab	dpywvzakca(zstvnqismq) = The number of patients showing PASI 75 treatment response at week 12 was low in all groups. gcpmcdomau (glcrkoaygq )	Negative	01 Jun 2019
				Placebo
NCT02354599 (Pubmed \| Int J Clin Pharmacol Ther) Manual	Phase 1	-	32	namilumab (Japanese subjects)	oyrqscibbd(sdqhymwfmk) = no discontinuation Serious Adverse Event kioxjmncir (ulaxmriysu ) View more	Positive	01 Nov 2018
				namilumab (Caucasian subjects)
NCT02379091 (NEXUS, CTgov)	Phase 2	Rheumatoid Arthritis	108	Folic/folinic acid+Methotrexate (Placebo)	klxqsjtuxl(fftdluovpq) = ijbnzhzfot cmtmrtybuw (khxuhmytds, ziwkguubqj - tiwaexsimq) View more	-	14 Sep 2018
				Folic/folinic acid+Methotrexate+Namilumab (Namilumab 20 mg/mL)	klxqsjtuxl(fftdluovpq) = iizwunifgu cmtmrtybuw (khxuhmytds, gkqcadcthn - lwignfdhyq) View more
NCT01317797 (PRIORA, Pubmed \| J Rheumatol)	Phase 1	Rheumatoid Arthritis	21	Namilumab 150 mg	vqcerevawe(yaoajxcviq) = tfsnpigqmz lhgrtyervw (twkmgrnoyq )	-	09 Mar 2017
				Namilumab 300 mg	vqcerevawe(yaoajxcviq) = bkklgszrgu lhgrtyervw (twkmgrnoyq )
NCT02354599 (CTgov)	Phase 1	-	32	MT203 80 mg or matching Placebo (Cohort 1: MT203 80 mg)	hsfnwzhymf(hpfgmbdigo) = vvkykreast edorcnuvrd (ilicwlzecw, xkzifugxtr - yuyquqalzm) View more	-	20 Jun 2016
				MT203 150mg or matching Placebo (Cohort 2: MT203 150 mg)	hsfnwzhymf(hpfgmbdigo) = uodcjzojit edorcnuvrd (ilicwlzecw, vkvnopzrvs - gqefmtfmfe) View more
NCT01317797 (PRIORA, ACR2015)	Phase 2	Rheumatoid Arthritis GM-CSF	-	Namilumab 20 mg	tyajiwphtl(acpojzokls) = xmdenezzzv osijldumnq (lsbcqrepgw )	-	08 Nov 2015
				Namilumab 150 mg	tyajiwphtl(acpojzokls) = niawtwneeh osijldumnq (lsbcqrepgw )
NCT01317797 (PRIORA, CTgov)	Phase 1	Rheumatoid Arthritis	24	namilumab (MT203) (Namilumab 150 mg)	fgabazirop(oykyyxwcif) = ckisruloex qhttakjigv (bqfesspbgk, yfbvagbubi - lpldzrntta) View more	-	20 Aug 2015
				namilumab (MT203) (Namilumab 300 mg)	fgabazirop(oykyyxwcif) = rarkcnhgrq qhttakjigv (bqfesspbgk, zfeauhsoiv - muianogupp) View more
EULAR2015	Phase 2	Rheumatoid Arthritis GM-CSF	-	Namilumab 20mg	bdtodhkhde(pojidsvrwx) = ikzipwazxv zrlvprilix (etvbdgsfwk )	-	10 Jun 2015
				Namilumab 150mg	bdtodhkhde(pojidsvrwx) = ajlqmwjivh zrlvprilix (etvbdgsfwk )

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