On October 24, 2022 AstraZeneca reported that it’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer (Press release, AstraZeneca, OCT 24, 2022, View Source [SID1234622288]). The novel dose and schedule of the combination, which includes a single dose of the anti-CTLA-4 antibody Imjudo 300mg added to the anti-PD-L1 antibody Imfinzi 1500mg followed by Imfinzi every four weeks, is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

The approval by the US Food and Drug Administration (FDA) was based on positive results from the HIMALAYA Phase III trial. In this trial, patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 95% confidence interval [CI] 0.66-0.92 p=0.0035).1 Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up.2

Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.3,4 It is the fastest rising cause of cancer-related deaths in the US, with approximately 36,000 new diagnoses each year.5,6

Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA Phase III trial, said: "Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favourable three-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer."
Andrea Wilson Woods, President & Founder, Blue Faery: The Adrienne Wilson Liver Cancer Foundation, said: "In the past, patients living with liver cancer had few treatment options and faced poor prognoses. With today’s approval, we are grateful and optimistic for new, innovative, therapeutic options. These new treatments can improve long-term survival for those living with unresectable hepatocellular carcinoma, the most common form of liver cancer. We appreciate the patients, their families, and the broader liver cancer community who continue to fight for new treatments and advocate for others."

The safety profiles of the combination of Imjudo added to Imfinzi and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified.

Regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results.

Notes

Liver cancer
About 75% of all primary liver cancers in adults are HCC.3 Between 80-90% of all patients with HCC also have cirrhosis.7 Chronic liver diseases are associated with inflammation that over time can lead to the development of HCC.7
More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.8 A critical unmet need exists for patients with HCC who face limited treatment options.8 The unique immune environment of liver cancer provides clear rationale for investigating medications that harness the power of the immune system to treat HCC.8

HIMALAYA

HIMALAYA was a randomised, open-label, multicentre, global Phase III trial of Imfinzi monotherapy and a regimen comprising a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks versus sorafenib, a standard-of-care multi-kinase inhibitor.

The trial included a total of 1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localised to the liver and surrounding tissue).

The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia. The primary endpoint was overall survival (OS) for the combination versus sorafenib and key secondary endpoints included OS for Imfinzi versus sorafenib, objective response rate and progression-free survival (PFS) for the combination and for Imfinzi alone.

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi was recently approved to treat patients with advanced biliary tract cancer in the US based on results from the TOPAZ-1 Phase III trial. It is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial. In 2021, updated results from the CASPIAN trial showed Imfinzi plus chemotherapy tripled patient survival at three years versus chemotherapy alone.

Imfinzi is also approved for previously treated patients with advanced bladder cancer in several countries.

Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.
As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several gastrointestinal (GI) cancers, ovarian cancer, endometrial cancer, and other solid tumours.

Imfinzi combinations have also demonstrated clinical benefit in metastatic NSCLC in the POSEIDON Phase III trial.

Imjudo

Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

Beyond HIMALAYA, Imjudo is being tested in combination with Imfinzi across multiple tumour types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

Imjudo is also under review by global regulatory authorities in combination with Imfinzi and chemotherapy in 1st-line metastatic NSCLC based on the results of the POSEIDON Phase III trial, which showed the addition of a short course of Imjudo to Imfinzi plus chemotherapy improved both overall and progression-free survival compared to chemotherapy alone.

AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines spanning a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new diagnoses leading to approximately 3.6 million deaths.9
Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers.

Imfinzi (durvalumab) is being assessed in combinations in oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

The Company aims to understand the potential of Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, in the two most common GI cancers, colorectal and gastric cancers. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in immuno-oncology (IO)
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s immuno-oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumour immune response. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a single treatment and in combination with Imjudo (tremelimumab) and other novel antibodies in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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On October 24, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Taysha Gene Therapies, Inc. (NASDAQ: TSHA, CEO: RA Session II, "Taysha") reported a strategic investment to support the advancement of Taysha’s adeno-associated virus (AAV) gene therapy development programs for the treatment of Rett syndrome and GAN (Press release, Astellas, OCT 24, 2022, View Source [SID1234622287]). The future options to potentially apply Astellas’ global R&D, manufacturing and commercialization capabilities in gene therapy to Taysha’s innovative AAV gene therapy development programs for genetic diseases of the central nervous system (CNS) create the opportunity for the two companies to enhance the development of novel treatment options for patients with Rett syndrome and GAN, who have serious unmet medical needs.

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Under the terms of the agreement, Astellas will invest a total of $50 million to acquire 15% of the outstanding common stock of Taysha and to receive an exclusive option to license two of Taysha’s clinical stage programs: TSHA-102 for Rett syndrome and TSHA-120 for GAN. In addition, Taysha has granted Astellas certain rights related to any potential change of control of Taysha. Definitive agreements would be executed upon Astellas’ exercise of any such option, and any change of control transaction would require approval by Taysha’s stockholders.

Taysha is engaged in the development of intrathecally-delivered AAV gene therapies for monogenic CNS diseases. As a part of this platform approach, Taysha has a promising pipeline, including TSHA-102, which is the first-and-only gene therapy in clinical development for Rett syndrome, and TSHA-120, which is in Phase 1/2 development for the treatment of GAN and awaiting regulatory feedback.

Astellas is continuing to build its capability to bring novel gene therapies to patients, following the acquisition of Audentes (now Astellas Gene Therapies, California) in January 2020 and the construction of a state-of-the-art commercial GMP manufacturing facility in North Carolina, which was opened in June of this year.

"Gene therapy is the corner stone of Astellas’ Primary Focus, Genetic Regulation*1; our goal is to bring new transformative treatment options to patients living with serious genetic diseases and limited treatment options," said Naoki Okamura, Chief Strategy Officer, at Astellas. "Taysha is an industry leader in CNS gene therapies and this partnership fits strategically with our long-term vision of expanding Astellas’ gene therapy capabilities, allowing the company to impact the lives of a broader range of patients with urgent unmet medical needs."

"We are excited to enter this strategic investment with Astellas, a premier biopharmaceutical company with global R&D, manufacturing and commercial capabilities," said RA Session II, Taysha’s Chief Executive Officer. "We believe this investment not only further validates the potential of our technology platform, but also reinforces the therapeutic and market opportunity of our two lead clinical assets."

To further strategically align Astellas and Taysha, in connection with its equity investment, Astellas will receive one Board observer seat on Taysha’s Board of Directors, enabling Taysha to leverage Astellas’ gene therapy clinical and commercial expertise as Taysha advances TSHA-120 and TSHA-102.

*1: Astellas has established a Focus Area Approach for its research and development strategy. For more information, please visit our website at View Source

About TSHA-102
TSHA-102 is a self-complementary intrathecally delivered AAV9 gene replacement therapy under development for the treatment of Rett syndrome. TSHA-102 utilizes the novel miRNA-Responsive Auto-Regulatory Element (miRARE) platform to regulate transgene expression genotypically on a cell-by-cell basis. The miRARE technology is designed to prevent toxicity associated with transgene overexpression and can be potentially utilized across other indications. TSHA-102 has received Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Commission.

About Rett Syndrome
Rett syndrome is a severe genetic neurodevelopmental disorder caused by a mutation in the X-linked MECP2 gene essential for neuronal and synaptic function in the brain. Primarily occurring in females, Rett syndrome is one of the most common genetic causes of severe intellectual disability worldwide. Patients have normal early development, with symptom onset typically beginning between 6 to 18 months of age. Rett syndrome is characterized by rapid developmental regression that leads to intellectual disabilities, loss of speech, loss of purposeful use of hands, loss of mobility, seizures, cardiac impairments and breathing issues. Currently, there are no approved therapies that treat the underlying cause of this progressive disease.

About TSHA-120
TSHA-120, an intrathecally dosed AAV9 gene replacement therapy delivering the gene gigaxonin for the treatment of GAN, is currently being evaluated in an ongoing Phase 1/2 clinical trial. TSHA-120 has received Orphan Drug and Rare Pediatric Disease designations from FDA and Orphan Drug Designation from the European Commission.

About Giant Axonal Neuropathy (GAN)
GAN is rare inherited genetic disorder that is a progressive neurodegenerative disease that affects both the central and peripheral nervous systems. The disease is caused by loss-of-function mutations in the gene coding for gigaxonin, which results in dysregulation of intermediate filament turnover, an important structural component of the cell. Children with GAN present before the age of five with symptoms including unsteady gait, frequent falls, and motor weakness. Currently, there are no approved treatments for GAN, which results in death for patients in their late teens or early twenties.

On October 24, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported that the Company has voluntarily terminated enrollment in both clinical studies involving davoceticept (ALPN-202), an investigational CD28 costimulator and dual checkpoint inhibitor, including the NEON-1 study of davoceticept as monotherapy and the NEON-2 study of davoceticept in combination with pembrolizumab (Press release, Alpine Immune Sciences, OCT 24, 2022, View Source [SID1234622286]). Following these decisions, the Company plans to focus its development resources primarily on ALPN-303, a potentially best-in-class dual BAFF/APRIL B cell cytokine inhibitor in development for multiple autoantibody-related inflammatory diseases, as well as acazicolcept (ALPN-101), a potentially first-in-class dual CD28/ICOS inhibitor in development for systemic lupus erythematosus (SLE) in collaboration with AbbVie.

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The decision to terminate enrollment in the davoceticept studies was made in the interest of patient safety after the Company was notified of a second death in the NEON-2 study, attributed to cardiogenic shock. The participant, who had metastatic colorectal cancer previously treated with colectomy and multiple prior systemic chemotherapies, had received a single dose each of davoceticept and pembrolizumab. NEON-2 had previously been subject to a partial clinical hold due to a death attributed to cardiogenic shock. The Company is conducting an ongoing, comprehensive assessment of all NEON study participants.

"Patient safety remains our highest priority," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We have determined it is in the best interest of all patients to terminate enrollment in the davoceticept studies and we will continue to work with the U.S. Food and Drug Administration, Merck, the study Safety Monitoring Committee, and the study investigators to further understand this important safety issue. Davoceticept has shown encouraging signs of clinical activity and it is unfortunate we have not yet been able to identify a safe dose regimen for the combination with pembrolizumab. We will now prioritize the bulk of our development resources towards advancing our lead wholly-owned program ALPN-303 in multiple autoimmune and inflammatory indications, as well as acazicolcept in SLE in collaboration with AbbVie."

About Davoceticept and the NEON Studies

Davoceticept (ALPN-202) is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor intended for the treatment of cancer. Preclinical studies of davoceticept have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. In phase 1 studies, davoceticept has demonstrated encouraging clinical activity, especially in renal cell carcinoma, as monotherapy and in combination with pembrolizumab.

NEON-1 (NCT04186637) is a phase 1 monotherapy dose escalation and expansion study in adults with advanced malignancies. NEON-2 (NCT04920383) is a phase 1 dose escalation and expansion combination study of davoceticept (ALPN-202) and pembrolizumab.

About ALPN-303

ALPN-303 is a dual B cell cytokine antagonist being developed for multiple autoimmune and/or inflammatory diseases. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, ALPN-303 in preclinical studies shows robust inhibition of B cell activating factor/B lymphocyte stimulator (BAFF, BLyS) and a proliferation inducing ligand (APRIL). These two pleiotropic B cell cytokines play key roles in B cell development, differentiation, and survival, and together contribute to the pathogenesis of multiple autoimmune diseases like systemic lupus erythematosus (SLE) and many other autoantibody-related inflammatory diseases. By simultaneously blocking these two cytokines, ALPN-303 has the potential to improve outcomes in patients suffering from severe autoimmune and/or inflammatory diseases. Alpine plans to conduct a phase 2 proof-of-concept study in SLE and open-label basket studies in renal, hematologic, and dermatologic autoimmune diseases, with the first of these anticipated to begin in the first half of 2023.

On October 24, 2022 Enochian BioSciences (the Company) reported that significant progress toward re-prioritizing its focus on curing some of the world’s deadliest diseases (Press release, Enochian BioSciences, OCT 24, 2022, View Source [SID1234622284]). Last week, the Company announced its oncology platform was awarded a U.S. patent and has produced promising early results in studies conducted in conjunction with Dr. Ana Jewett at UCLA. The Company also awaits potentially positive results from studies on its HIV platform, which are being conducted by scientists at the Fred Hutchinson Cancer Center.

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"We continue to prioritize the efficient research, development, and commercialization of our promising oncology and HIV pipelines," said Enochian CEO Dr. Mark Dybul. "Enochian’s future is bright, and we look forward to advancing potentially curative therapies for some of the world’s deadliest diseases."

The Company also announced it filed a complaint against Serhat Gumrukcu, William Anderson Wittekind, SG & AW Holdings LLC, and Seraph Research Institute in the California Superior Court for Los Angeles County. As alleged in the complaint, the defendants engaged in a "concerted, deliberate scheme to alter, falsify, and misrepresent to [the Company] the results of multiple studies supporting its [Hepatitis B] and SARS-CoV-2/influenza pipelines." "Defendants manipulated negative results to reflect positive outcomes from various studies, and even fabricated studies out of whole cloth. Defendants’ conduct amounts to nothing short of brazen fraud, which has caused Enochian substantial harm." Through this lawsuit, the Company "intends to hold [the] Defendants responsible for their conduct and recover damages resulting" from their actions.

On October 23, 2022 Sumitovant Biopharma Ltd. ("Sumitovant"), in conjunction with parent company Sumitomo Pharma Co., Ltd. ("Sumitomo Pharma"), and Myovant Sciences ("Myovant") (NYSE: MYOV) reported that they have entered into a definitive agreement pursuant to which Sumitovant will acquire all outstanding shares of Myovant not already owned by Sumitovant for $27.00 per share in cash (Press release, Sumitovant Biopharma, OCT 23, 2022, View Source [SID1234622281]). This corresponds to a total transaction value of $1.7 billion on a fully diluted basis, and a total company value of $2.9 billion on a fully diluted basis. Sumitovant currently beneficially owns 52% of the issued and outstanding shares of Myovant as more particularly described in Sumitovant’s Schedule 13D/A filed with the U.S. Securities and Exchange Commission (the "SEC").

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The purchase price represents a premium of approximately 50% to Myovant’s closing share price on September 30, 2022, the last day of trading prior to Sumitovant’s initial non-binding proposal, and a premium of approximately 55% to the 60-day volume weighted average price of Myovant’s shares through September 30, 2022. The agreement has been approved by the boards of Sumitovant and Sumitomo Pharma and unanimously recommended by a Special Committee of the independent directors of Myovant and, acting upon such recommendation, approved by its full board of directors with the Sumitovant designated directors recusing themselves and abstaining from the deliberations and vote.

"This transaction represents an industry-leading opportunity to combine unique expertise, platforms, and resources to successfully commercialize products in Myovant’s program and to accelerate development of a robust pipeline addressing patient needs in women’s health and prostate cancer," said Myrtle Potter, CEO of Sumitovant. "We look forward to harnessing the combined strength of our talented teams to bring needed therapies to patients sooner and are confident both Myovant and its employees will benefit from the greater resources Sumitovant can provide to further support business growth and career opportunities overall."

"Myovant’s two products, ORGOVYX and MYFEMBREE have substantial potential. We believe the combination of Sumitovant and Myovant will strengthen Myovant’s product capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women’s health," said Hiroshi Nomura, CEO of Sumitomo Pharma. "By making Myovant a wholly owned subsidiary of Sumitovant, we believe that we will be able to accelerate implementation of management strategies that make full use of cash flow generated by ORGOVYX and MYFEMBREE for sustained growth of the Sumitomo Pharma Group."

"We are pleased to have reached an agreement with Sumitovant and Sumitomo Pharma that recognizes the remarkable success Myovant has achieved," said David Marek, CEO of Myovant. "With the expertise and resources of Sumitovant to best support Myovant, and our employees, we can do more to expand the impact of our differentiated therapies, advance our clinical programs, and work to remove barriers to access quality care for the patients we serve."

"After careful consideration and consultation with our legal and financial advisors, the Special Committee believes that this transaction provides immediate and compelling value to Myovant’s minority shareholders, as well as positioning the Company for continued growth, and is in the best interest of Myovant and its shareholders," said Mark Guinan, Chairman of the Special Committee.

Transaction Details
The transaction is anticipated to close in the first quarter of 2023, subject to customary closing conditions, including obtaining the requisite regulatory approvals and approval by Myovant shareholders holding a majority of the outstanding shares not beneficially owned by Sumitovant and its affiliates. The transaction will be financed through a combination of cash on hand and external debt financing. A financing commitment has been received from Sumitomo Mitsui Banking Corporation. The transaction is not subject to a financing condition.

Upon completion of the transaction, Myovant will become a wholly owned subsidiary of Sumitovant and Myovant’s shares will no longer be listed on the New York Stock Exchange.

Advisors
J.P. Morgan Securities LLC is serving as financial advisor and Sullivan & Cromwell LLP is serving as legal counsel to Sumitovant and Sumitomo Pharma. Goldman Sachs & Co. LLC is serving as financial advisor to the Special Committee of the Board of Directors of Myovant and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to the Special Committee.