We hypothesize that topical application of Tapinarof, an FDA-approved topical Aryl hydrocarbon receptor (AHR) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing T cells and lead to improvement of cutaneous lupus lesions. To test this hypothesis, we will perform a prospective, interventional clinical trial in patients with chronic and/or subacute cutaneous lupus. This trial will include outcomes analyzing the change in cutaneous lupus lesions using standardized assessments, but also analyze pre- and post-treatment skin and blood immune parameters to elucidate the immune effects and changes in lupus as a result of topical AHR agonist application. The goals are to 1) identify if topical AHR agonism leads to improvement in cutaneous lupus, and 2) examine the immunopathology of cutaneous lupus and its alteration with topical AHR agonist treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Northwestern University

ChiCTR2400093238 / SuspendedPhase 4IIT

Clinical observation of sequential topical Mometasone Furoate Cream versus Tapinarof in the treatment of atopic dermatitis in adults

Start Date01 Dec 2024

Sponsor / Collaborator

Xiangya Hospital Central South University

CTRI/2024/10/075933 / Not yet recruitingNot Applicable

A Randomized, multicenter, double-blind, parallel group, three-arm, placebo-controlled trial to evaluate the bioequivalence of Tapinarof cream 1 Percent of Mylan Laboratories Ltd versus VTAMA® (Tapinarof cream 1 Percent, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis. - NIL

Start Date27 Nov 2024

Sponsor / Collaborator

Mylan Laboratories Ltd.

[+1]

100 Clinical Results associated with Benvitimod

100 Translational Medicine associated with Benvitimod

100 Patents (Medical) associated with Benvitimod

618

Literatures (Medical) associated with Benvitimod

01 Jan 2025·DERMATOLOGIC CLINICS

Innovations in Psoriasis

Review

Author: Gupta, Rohit ; Wu, Jashin J. ; Martin, Amylee ; Ibraheim, Marina Kristy ; Wu, Jashin J

Despite numerous effective biologics for treating psoriasis, new treatments continue to be investigated due to an unmet need for certain patient populations. This review discusses therapies that were recently Food and Drug Administration (FDA)-approved for treating psoriasis, including the topical agents tapinarof and roflumilast, deucravacitinib, an oral small molecule that selectively inhibits tyrosine kinase 2, and spesolimab, a monoclonal antibody inhibiting interleukin-36 that became the first FDA-approved treatment for generalized pustular psoriasis flares. Other therapies are in the pipeline, such as orismilast, as well as Mind.Px, a tool for predicting biological response, is also highlighted.

31 Dec 2024·Channels (Austin, Tex.)

Novel protocol for multiple-dose oral administration of the L-type Ca ²⁺ channel blocker isradipine in mice: A dose-finding pharmacokinetic study

Article

Author: Theiner, Tamara ; Ortner, Nadine J. ; Tuluc, Petronel ; Oberacher, Herbert ; Stojanovic, Gospava ; Striessnig, Jörg

Studies in genetically modified animals and human genetics have recently provided new insight into the role of voltage-gated L-type Ca²⁺ channels in human disease. Therefore, the inhibition of L-type Ca²⁺ channels in vivo in wildtype and mutant mice by potent dihydropyridine (DHP) Ca²⁺ channel blockers serves as an important pharmacological tool. These drugs have a short plasma half-life in humans and especially in rodents and show high first-pass metabolism upon oral application. In the vast majority of in vivo studies, they have therefore been delivered through parenteral routes, mostly subcutaneously or intraperitoneally. High peak plasma concentrations of DHPs cause side effects, evident as DHP-induced aversive behaviors confounding the interpretation of behavioral readouts. Nevertheless, pharmacokinetic data measuring the exposure achieved with these applications are sparse. Moreover, parenteral injections require animal handling and can be associated with pain, discomfort and stress which could influence a variety of physiological processes, behavioral and other functional readouts. Here, we describe a noninvasive oral application of the DHP isradipine by training mice to quickly consume small volumes of flavored yogurt that can serve as drug vehicle. This procedure does not require animal handling, allows repeated drug application over several days and reproducibly achieves peak plasma concentrations over a wide range previously shown to be well-tolerated in humans. This protocol should facilitate ongoing nonclinical studies in mice exploring new indications for DHP Ca²⁺ channel blockers.

01 Dec 2024·JAAD case reports

Successful treatment of discoid lupus erythematosus with tapinarof 1% cream monotherapy

Article

Author: Garg, Kareena S. ; Garg, Kareena S ; Tjahjono, Leonardo

107

News (Medical) associated with Benvitimod

16 Dec 2024

·www.businesswire.com

FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

JERSEY CITY, N.J.--( BUSINESS WIRE )--Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA ® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older. 1 Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025. “With the FDA’s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” said Kevin Ali, Organon’s Chief Executive Officer. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.” In the ADORING pivotal studies, VTAMA cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) 45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P <0.0001). The difference between patients who received VTAMA cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age. The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%). ADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were VTAMA cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria. In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with VTAMA cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with VTAMA cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with VTAMA cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8. “VTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease,” said Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program. “Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream.” In May 2022, the FDA approved VTAMA ® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis with no label warnings or precautions, contraindications, restrictions on duration of use, or percentage of body surface area affected. For more information about VTAMA (tapinarof) cream, 1%, visit www.VTAMA.com . IMPORTANT SAFETY INFORMATION Indications: VTAMA ® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis); pain or swelling in the nose and throat (nasopharyngitis); skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis); headache; itching (pruritus); and flu (influenza). Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection; red raised bumps around the hair pores (folliculitis); lower respiratory tract infection; headache; asthma; vomiting; ear infection; pain in extremity; and stomach-area (abdominal) pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. About Atopic Dermatitis Atopic dermatitis (AD), commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . vIGA-AD is the trademark of Eli Lilly and Co. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about the potential safety, effectiveness, tolerability, uses, and market for VTAMA cream. Forward-looking statements may be identified by words such as “pursuing,” “opportunities,” “future,” “potential,” “potentially,” “expected,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or additional risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of the FDA approval described above; weakening of economic conditions that could adversely affect the level of demand for VTAMA; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans; an inability to adapt to the industry-wide trend toward highly discounted channels; expanded brand and class competition in the markets in which Organon operates; and governmental initiatives that adversely impact Organon’s marketing activities. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (SEC), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov . References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites. 1 VTAMA label.

Drug ApprovalClinical Result

13 Dec 2024

·endpts.com

Organon's steroid-free cream Vtama wins approval in atopic dermatitis

Organon won a label expansion on Friday for the steroid-free topical cream it picked up from its October acquisition of Dermavant. Vtama, also known as tapinarof, is now approved to treat adults and children two years and older with atopic dermatitis, according to an FDA notification . The agency had delayed its decision last month, notifying Organon that the submission of additional datasets from a long-term extension study would push its action date to March. But the approval ended up coming months ahead of schedule. Organon struck a $1.2 billion deal for Dermavant in September, including $175 million upfront and a $75 million milestone payment hinging on an approval in atopic dermatitis. The deal included commercial milestone payments of up to $950 million. Vtama was first approved in 2022 for adults with plaque psoriasis. Dermavant, formerly a Roivant subsidiary, previously said that the atopic dermatitis market is three to four times larger than the plaque psoriasis market. As of May 2024, more than 385,000 Vtama prescriptions had been written in plaque psoriasis, according to Roivant. Vivek Ramaswamy’s team announced a deal to acquire Vtama from GSK back in 2018 for close to $200 million upfront.

Drug ApprovalAcquisition

12 Nov 2024

·www.globenewswire.com

Roivant Reports Financial Results for the Second Quarter Ended September 30, 2024, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2024, and provided a business update. Brepocitinib 52-week data from the Phase 2 NEPTUNE study in non-infectious uveitis (NIU) showed potential best-in-indication efficacy sustained to one year; first patients enrolled in Phase 3 NIU program IMVT-1402 cleared five Investigational New Drug (IND) applications across a range of therapeutic areas and FDA divisions, including the potentially registrational trial for difficult-to-treat rheumatoid arthritis (D2T RA) expected to initiate by March 31, 2025Batoclimab proof of concept data in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endMosliciguat, a once-daily inhaled soluble guanylate cyclase (sGC) activator, unveiled as new pipeline program. Mosliciguat Phase 1b data in pulmonary hypertension (PH) patients demonstrated some of the highest pulmonary vascular resistance (PVR) reductions (~38%) in PH trials to date. The global Phase 2 PHocus trial for mosliciguat has been initiated in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD)Roivant continued to return capital through share repurchases with $106M purchased for the quarter, resulting in $754M cumulative share repurchases (inclusive of Sumitomo) through September 30, 2024Dermavant transaction with Organon closed on October 28, 2024. At closing, Roivant received $184M in cash, and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in Q1 2025Roivant reported consolidated cash, cash equivalents and marketable securities of approximately $5.4B at September 30, 2024 “I am pleased to finish out another quarter with continued clinical execution, including positive data in Graves’ Disease and FDA’s clearance of INDs in 5 indications at Immunovant,” said Matt Gline, CEO of Roivant. “I am also excited today to present the 52-week data from our Phase 2 study of brepocitinib in NIU. The sustained treatment benefits observed further our belief that brepocitinib is a potentially compelling and durable agent for a disease that is poorly treated today. We have a busy year ahead with major data expected in 2025 from Immunovant and Priovant, along with continued execution across other programs.” Recent Developments Immunovant: Endocrinology ProgramIn September 2024, Immunovant reported additional positive results from the Phase 2a trial of batoclimab in Graves’ Disease. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% Response rate. In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response. During Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in mean IgG reduction of 65% (vs. 77% on 680mg dose) with a correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response rate of 36% was also observed in the second 12 weeks. Patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%). Batoclimab was well tolerated with no new safety signals identified.In November 2024, additional data on the efficacy and safety of batoclimab in Graves’ thyroidal and extrathyroidal disease were presented in an oral presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a 60% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose) was achieved by Week 2, demonstrating the rapidity of response to batoclimab 680mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both Week 12 and Week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders (defined as T3 and T4 falling below the ULN and ceasing all ATD medications) reporting greater improvements than other participants.Neurology ProgramIn November 2024, Immunovant announced completion of enrollment for patients included in Period 1 of the Phase 2b trial of batoclimab in CIDP, with data expected by March 31, 2025, to inform the trial design for a potentially registrational program with IMVT-1402.Rheumatology ProgramIn November 2024, Immunovant also announced FDA clearance of the IND for IMVT-1402 in D2T RA and expects to initiate a potentially registrational trial by March 31, 2025. Priovant: In September 2024, Priovant announced receipt of Fast Track designation from FDA for brepocitinib in NIU and enrolled the first patients in the Phase 3 program. New 52-week data from the Phase 2 NEPTUNE study of brepocitinib in NIU showed potential best-in-indication efficacy sustained to one year. Treatment failure rate in the 45 mg dose arm was 35% at week 52 vs. 29% at week 24. Treatment failure rate in the 15 mg dose arm was 56% vs. 44% at week 24. In each treatment arm only one additional patient failed from week 24 to 52. Other important efficacy measurements at week 52 were consistent with the week 24 data, including measurements of retinal vascular leakage and prevention and treatment of macular edema. Safety and tolerability were consistent with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely prescribed JAK inhibitors. Pulmovant: In September 2024, Roivant unveiled mosliciguat, a potential first-in-class and best-in-category inhaled once-daily sGC activator. Mosliciguat is being developed for PH-ILD, which affects ~200,000 patients in the U.S. and Europe with limited or no treatment options. In September 2024, Pulmovant also presented data from the Phase 1b ATMOS study showing a single dose of inhaled mosliciguat in PH patients (N=38) led to sustained, clinically meaningful mean-max reductions in PVR of up to ~38%, one of the highest reductions seen in PH trials to date. Mosliciguat was generally well-tolerated, with low rates of treatment-emergent adverse events (TEAEs).Pulmovant initiated the global Phase 2 PHocus trial of mosliciguat in patients with PH-ILD. Roivant: In October 2024, Roivant reported the close of Organon’s acquisition of Dermavant. At closing, Roivant received $184M in cash and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in the first quarter of calendar year 2025. The transaction also includes payments of up to $950 million for the achievements of certain commercial milestones, in addition to the tiered royalties on net sales that Organon will pay Dermavant shareholders.Roivant continued to return capital through share repurchases with $106M purchased for the quarter ending September 30, 2024, resulting in $754M cumulative share repurchases (inclusive of the repurchase of Sumitomo’s stake in April 2024) through September 30, 2024.Roivant reported consolidated cash, cash equivalents and marketable securities of approximately $5.4B at September 30, 2024. Major Upcoming Milestones 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. 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. In pursuit of this goal, Immunovant now has active INDs in Graves’ Disease and difficult-to-treat rheumatoid arthritis and expects to initiate potentially registrational trials in these indications by December 31, 2024 and March 31, 2025 respectively. Topline data from the batoclimab trial in MG is expected by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which is expected to initiate by March 31, 2025. Data from the batoclimab trial in CIDP is expected by March 31, 2025 and will be used to inform the trial design for a potentially registrational program for IMVT-1402. Topline data from the current pivotal program evaluating batoclimab in thyroid eye disease (TED) now expected in the second half of calendar year 2025. Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025.Genevant Markman hearing in Pfizer / BioNTech action scheduled for December 2024. Summary judgment phase of Moderna action scheduled for second and third quarter of calendar year 2025; Moderna trial scheduled for September 2025. Second Quarter Ended September 30, 2024 Financial Summary Cash and Marketable Securities As of September 30, 2024, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.4 billion. Research and Development Expenses Research and development (R&D) expenses increased by $28.3 million to $143.1 million for the three months ended September 30, 2024, compared to $114.8 million for the three months ended September 30, 2023. This increase was primarily driven by increases in program-specific costs of $19.2 million, personnel-related expenses of $7.2 million, and share-based compensation of $1.6 million. Within program-specific costs, the increase of $19.2 million was primarily driven by an increase in expense of $34.2 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $18.6 million related to RVT-3101, which was sold to Roche in December 2023. Non-GAAP R&D expenses were $132.4 million for the three months ended September 30, 2024, compared to $105.3 million for the three months ended September 30, 2023. General and Administrative Expenses General and administrative (G&A) expenses increased by $114.3 million to $202.9 million for the three months ended September 30, 2024, compared to $88.6 million for the three months ended September 30, 2023. This increase was primarily due to an increase in personnel-related expenses of $87.0 million, of which $79.1 million related to the one-time cash retention awards approved in July 2024 for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Chief Operating Officer (the "2024 Senior Executive Compensation Program") and $6.6 million related to the special one-time cash retention bonus award granted to employees, following approval in December 2023. The increase was also driven by an increase in share-based compensation expense of $21.7 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation Program. Non-GAAP G&A expenses were $142.3 million for the three months ended September 30, 2024, compared to $49.6 million for the three months ended September 30, 2023. Loss from continuing operations, net of tax Loss from continuing operations, net of tax was $236.8 million for the three months ended September 30, 2024, compared to a loss from continuing operations, net of tax of $244.6 million for the three months ended September 30, 2023. On a basic and diluted per common share basis, loss from continuing operation was $0.25 and $0.28, respectively, for the three months ended September 30, 2024 and September 30, 2023. Non-GAAP loss from continuing operations, net of tax was $218.7 million for the three months ended September 30, 2024, compared to $154.8 million for the three months ended September 30, 2023. ROIVANT SCIENCES LTD.Selected Balance Sheet Data(unaudited, in thousands) September 30, 2024 March 31, 2024 Cash, cash equivalents and restricted cash$1,969,914 $6,506,189 Marketable securities 3,428,021 — Total assets 6,206,028 7,222,482 Total liabilities 625,986 773,953 Total shareholders’ equity 5,580,042 6,448,529 Total liabilities and shareholders’ equity 6,206,028 7,222,482 ROIVANT SCIENCES LTD.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share amounts) Three Months Ended September 30, Six Months Ended September 30, 2024 2023 2024 2023 Revenue, net$4,475 $3,648 $12,465 $8,131 Operating expenses: Cost of revenues 234 223 447 1,206 Research and development (includes $9,911 and $8,309 of share-based compensation expense for the three months ended September 30, 2024 and 2023 and $20,443 and $15,726 for the six months ended September 30, 2024 and 2023, respectively) 143,073 114,790 263,580 224,206 Acquired in-process research and development — 13,950 — 26,450 General and administrative (includes $59,443 and $37,755 of share-based compensation expense for the three months ended September 30, 2024 and 2023 and $96,284 and $76,472 for the six months ended September 30, 2024 and 2023, respectively) 202,881 88,576 302,773 179,858 Total operating expenses 346,188 217,539 566,800 431,720 Gain on sale of Telavant net assets — — 110,387 — Loss from operations (341,713) (213,891) (443,948) (423,589)Change in fair value of investments (48,375) 45,849 (63,601) 53,413 Change in fair value of liability instruments (635) 11,789 515 51,967 Gain on deconsolidation of subsidiaries — (17,354) — (17,354)Interest income (69,773) (14,299) (141,900) (31,014)Other expense, net 1,453 1,530 5,061 4,357 Loss from continuing operations before income taxes (224,383) (241,406) (244,023) (484,958)Income tax expense 12,458 3,236 24,421 4,911 Loss from continuing operations, net of tax (236,841) (244,642) (268,444) (489,869)(Loss) income from discontinued operations, net of tax (43,083) (86,476) 46,010 (169,094)Net loss (279,924) (331,118) (222,434) (658,963)Net loss attributable to noncontrolling interests (49,740) (26,791) (87,547) (62,820)Net loss attributable to Roivant Sciences Ltd.$(230,184) $(304,327) $(134,887) $(596,143)Amounts attributable to Roivant Sciences Ltd.: Loss from continuing operations, net of tax$(187,101) $(218,226) $(181,052) $(427,784)(Loss) income from discontinued operations, net of tax (43,083) (86,101) 46,165 (168,359)Net loss attributable to Roivant Sciences Ltd.$(230,184) $(304,327) $(134,887) $(596,143) Basic and diluted net (loss) income per common share:Basic and diluted loss from continuing operations$(0.25) $(0.28) $(0.25) $(0.56)Basic and diluted (loss) income from discontinued operations$(0.06) $(0.11) $0.06 $(0.22)Basic and diluted net loss per common share$(0.31) $(0.40) $(0.18) $(0.78) Weighted average shares outstanding: Basic 735,470,796 770,227,849 735,642,721 764,780,630 Diluted 735,470,796 770,227,849 735,642,721 764,780,630 ROIVANT SCIENCES LTD.Reconciliation of GAAP to Non-GAAP Financial Measures(unaudited, in thousands) Three Months Ended September 30, Six Months Ended September 30, Note 2024 2023 2024 2023 Loss from continuing operations, net of tax $(236,841) $(244,642) $(268,444) $(489,869)Adjustments: Research and development: Share-based compensation(1) 9,911 8,309 20,443 15,726 Depreciation and amortization(2) 724 1,205 1,419 2,694 General and administrative: Share-based compensation(1) 59,443 37,755 96,284 76,472 Depreciation and amortization(2) 1,094 1,235 2,184 2,485 Gain on sale of Telavant net assets(3) — — (110,387) — Other: Change in fair value of investments(4) (48,375) 45,849 (63,601) 53,413 Change in fair value of liability instruments(5) (635) 11,789 515 51,967 Gain on deconsolidation of subsidiaries(6) — (17,354) — (17,354)Estimated income tax impact from adjustments(7) (3,986) 1,100 (4,190) 369 Adjusted loss from continuing operations, net of tax (Non-GAAP) $(218,665) $(154,754) $(325,777) $(304,097) Three Months Ended September 30, Six Months Ended September 30, Note 2024 2023 2024 2023 Research and development expenses $143,073 $114,790 $263,580 $224,206 Adjustments: Share-based compensation(1) 9,911 8,309 20,443 15,726 Depreciation and amortization(2) 724 1,205 1,419 2,694 Adjusted research and development expenses (Non-GAAP) $132,438 $105,276 $241,718 $205,786 Three Months Ended September 30, Six Months Ended September 30, Note 2024 2023 2024 2023 General and administrative expenses $202,881 $88,576 $302,773 $179,858 Adjustments: Share-based compensation(1) 59,443 37,755 96,284 76,472 Depreciation and amortization(2) 1,094 1,235 2,184 2,485 Adjusted general and administrative expenses (Non-GAAP) $142,344 $49,586 $204,305 $100,901 Notes to non-GAAP financial measures:(1) Represents non-cash share-based compensation expense.(2) Represents non-cash depreciation and amortization expense.(3) Represents a gain on the sale of Telavant net assets to Roche due to achievement of a one-time milestone in June 2024.(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 unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.(6) Represents the one-time gain on deconsolidation of subsidiaries.(7) 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 Tuesday, November 12, 2024, to report its financial results for the second quarter ended September 30, 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 biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease; and namilumab, an anti-GM-CSF monoclonal antibody in development for the treatment of pulmonary sarcoidosis. 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 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 Parekh keyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com

Phase 2Clinical ResultPhase 1Phase 3Drug Approval

100 Deals associated with Benvitimod

External Link

KEGG	Wiki	ATC	Drug Bank
-	Benvitimod	D05	DB06083

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	JP	Japan Tobacco, Inc.	24 Jun 2024
Psoriasis vulgaris	JP	Japan Tobacco, Inc.	24 Jun 2024
Plaque psoriasis	US	Dermavant Sciences, Inc.	23 May 2022
Psoriasis	CN	Guangdong Zhonghao Pharmaceutical Co. Ltd.	29 May 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 3	CN	Guangdong Zhonghao Pharmaceutical Co. Ltd.	01 Apr 2022
Moderate Atopic Dermatitis	Phase 3	US	Dermavant Sciences, Inc.	01 Sep 2021
Moderate Atopic Dermatitis	Phase 3	CA	Dermavant Sciences, Inc.	01 Sep 2021
Severe Atopic Dermatitis	Phase 3	US	Dermavant Sciences, Inc.	01 Sep 2021
Severe Atopic Dermatitis	Phase 3	CA	Dermavant Sciences, Inc.	01 Sep 2021
Keratoderma, Palmoplantar	Phase 2	US	Dermavant Sciences, Inc.	30 Oct 2024
Pruritus	Phase 1	JP	GSK Plc	27 Oct 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05142774 (ADORING 3, Biospace) Manual	Phase 3	Dermatitis, Atopic	728	VTAMA cream, 1%	gnocompvcx(kmblssrkrq) = ylkmwvcpsj rgbpndmiiw (jqrdpwypoi ) View more	Positive	25 Oct 2024
NCT05014568 \| NCT05032859 (ADORING 2, Biospace) Manual	Phase 3	Dermatitis, Atopic	813	VTAMA cream (ADORING 1)	nodfiqgxtw(fuyzqafdke) = dfrebfpwxs zlasarfquq (fnaiwybmpv ) View more	Positive	24 Oct 2024
				VTAMA cream (ADORING 2)	nodfiqgxtw(fuyzqafdke) = macxynlecq zlasarfquq (fnaiwybmpv ) View more
ADORING 1 and 2 (ACAAI2024)	Phase 3	Dermatitis, Atopic	813	Tapinarof cream 1%	xqptlhyspd(fcjqgrzotc) = ifbkgceiwc vccswcvrop (rctrdwiexa ) View more	Positive	24 Oct 2024
				Vehicle	edydcillyr(ezshqadxbf) = cvwrmpmciw pgzyomgacq (qsgnqaxgkv ) View more
Literature Manual	Not Applicable	Pustulosis of Palms and Soles	47	Benvitimod	cslaxgrpeu(zfpjlwzuxh) = jmsfrcyxmr bvmlhohhgb (iianbqthth ) View more	Positive	22 Oct 2024
NCT05680740 (DMVT-505-4001, CTgov)	Phase 4	Plaque psoriasis	34	VTAMA® (tapinarof) Cream 1%	rwjibnupmj(ugkkzmidkc) = svyjayeklh uvadthbzkh (qtusprlhtz, pgjbaaqyja - cryzlswuvv) View more	-	08 Jul 2024
NCT05014568 (ADORING 1, BusinessWire) Manual	Phase 3	Dermatitis, Atopic	407	VTAMA cream, 1% QD (ASIAN)	vhauwxzjbz(vgumktgtmz) = emomekulvp mfxdthsmja (coqoflhjmv ) View more	Positive	08 Mar 2024
				Vehicle QD (ASIAN)	vhauwxzjbz(vgumktgtmz) = hlyqpldkrq mfxdthsmja (coqoflhjmv ) View more
NCT05032859 (ADORING 2, BusinessWire) Manual	Phase 3	Dermatitis, Atopic	406	VTAMA cream, 1% QD (ASIAN)	lcbprpevvd(jqkfkeviua) = romcvovpcp iwrnbhtapk (lpqndmfnlk ) View more	Positive	08 Mar 2024
				Vehicle QD (ASIAN)	lcbprpevvd(jqkfkeviua) = lxqphbuwio iwrnbhtapk (lpqndmfnlk ) View more
AAAAI2024	Phase 3	Dermatitis, Atopic	-	Tapinarof cream 1%	gqxjevjlzp(nrwkcipyjl) = yikrjztkrs nqtplwyfkm (yaaeaqjxvz )	Positive	23 Feb 2024
				Vehicle	gqxjevjlzp(nrwkcipyjl) = mywupxsiwe nqtplwyfkm (yaaeaqjxvz )
ADORING 3 (NEWS) Manual	Phase 3	Dermatitis, Atopic	728	Vtama	muecmuoyww(ttbxutoyfp) = ddvalmeqre ovrgkxvvrk (hfqwoaqtro, 711) View more	Positive	12 Jan 2024
NCT05014568 \| NCT05032859 (DMVT-505-3102 \| ADORING 2, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	711	VTAMA cream, 1%	trcjdtnhol(xtlavefcwu) = cqajwkmexy xiwcdwbfcu (ueatwpgmpk, 711) View more	Positive	11 Jan 2024

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