Corporate Events

Nxera Pharma Co., Ltd., Q2 2025 Earnings Call, Aug 08, 2025

Nxera Pharma Co., Ltd. announced the launch of a broad new pipeline strategically focused on advancing next-generation therapies for obesity and associated metabolic disorders. Independent to the productive drug discovery collaborations with Pfizer and Eli Lilly, Nxera has established, expanded and accelerated drug discovery efforts of its own proprietary pipeline across a broad range of validated GPCR targets in these major disorders. Central to Nxera’s pipeline is its new, wholly owned oral small molecule GLP-1 agonist program, focussed on differentiated chemistry, which is distinct, independent and developed separately from Pfizer’s PF-06954522, allowing Nxera full control to drive rapid progress. Complementing this program, Nxera is simultaneously accelerating the advancement of an additional six established GPCR-targeted programs focused on obesity and chronic weight management:Three small molecule agonist programs (GIP, Apelin, Amylin)One small molecule antagonist program (GIP)Two long-acting programs (targets undisclosed)Nxera's pipeline leverages its proprietary NxWave™ GPCR-focused structure-based design platform to rapidly identify unique, highly differentiated lead molecules with novel chemistry. This process utilizes Nxera’s NxHit proprietary small molecule libraries and NxStaR proteins for DNA encoded library (DEL) screening, distinguishing these candidates from others currently in discovery and clinical development globally.Nxera’s focused approach is designed to deliver highly effective therapies addressing critical patient needs:Long-term weight maintenance: Convenient, scalable oral therapies for sustained weight loss.Targeting key obesity-related co-morbidities: Enhanced outcomes in cardiovascular, renal, and liver diseases, with new therapeutic indications emerging continuously.Reducing side effects and broadening out to difficult to treat populations: Targeted treatments for elderly, post-menopausal, and sarcopenic populations.Backed by an expert team with deep experience in GPCR drug discovery, Nxera is strategically positioned to be a leader in developing the next generation of best-in-class obesity and metabolic therapies.Nxera maintains its strong commitment to other key therapeutic areas including neurology, gastroenterology, and immunology, continuing to leverage the NxWave™ platform's proven capabilities in these domains.

Nxera Pharma Co., Ltd. announced that it will receive USD 4.8 million in milestone payments from Centessa Pharmaceuticals pursuant to its research collaboration with Centessa. The milestones were achieved as Centessa initiated clinical development of ORX142, its second novel orexin receptor 2 (OX2R) agonist, following the recent clearance of an investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for a Phase 1 clinical study of ORX142 in healthy volunteers. ORX142 is an investigational, novel, highly potent and selective OX2R agonist being developed by Centessa for the treatment of select neurological and neurodegenerative disorders. Of the milestone receipt, USD 1.8 million associated with the clearance of the IND will be recognized as revenue in the second quarter of 2025, and USD 3.0 million associated with the initiation of clinical development will be recognized as revenue in The third quarter of 2025.

Nxera Pharma Co., Ltd. announced that they will report Q2, 2025 results on Aug 08, 2025

Nxera Pharma Co., Ltd. announced that its partner, Neurocrine Biosciences ("Neurocrine") has dosed the first patient in its Phase 3 registrational program of NBI-1117568 (NBI-1117568) as a potential treatment for schizophrenia, resulting in a payment of USD 15 million to Nxera (Clinical Trial ID: NCT06963034). The USD 15 million payment will be fully recognized as revenue in the second quarter of 2025. Nxera previously announced the initiation of the Phase 3 registrational program ofNBI-1117568 by Neurocrine in May 2025. The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale.

Nxera Pharma Co., Ltd. notes that Neurocrine Biosciences Inc. announced that it had presented new positive data from the Phase 2 study of NBI-1117568 in adults with schizophrenia at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting in Scottsdale, Arizona.

Nxera Pharma Co., Ltd. announced the appointment of Shinya Tsuzuki as Head of Investor Relations. Mr. Tsuzuki will lead Nxera's Investor Relations (IR) team in Japan and report to the Company's Chief Financial Officer, Hironoshin Nomura. Mr. Tsuzuki joins Nxera from Mizuho Securities, where he served as a Senior Investment Analyst and has covered the pharmaceutical and biotechnology sector since 2018. During this time, Mr. Tsuzuki was ranked 2nd among pharma and biotech analysts in the Nikkei Veritas rankings in both 2022 and 2023, and 3rd in both 2024 and 2025. He was also ranked 2nd in the Extel rankings, formerly Institutional Investor Biotechnology Pharmaceuticals category, in both 2022 and 2023, and 4th in both 2024 and 2025. Mr. Tsuzuki graduated from School of Engineering and Graduate School of Engineering, Nagoya University, Nagoya, Aichi Prefecture, Japan.

Nxera Pharma Co., Ltd. announced that Ms. Naoko Shimura and Ms. Nicola Rabson appointed as new External Directors.

AGM

Nxera Pharma Co., Ltd., Board Meeting, Apr 16, 2025. Agenda: To consider issuance of new shares under the RSU Plan.

Nxera Pharma Co., Ltd. expected to report First-Half, 2025 results on August 7, 2025. This event was calculated by S&P Global (Created on April 1, 2025).

Nxera Pharma Co., Ltd. announced two new appointments to its Leadership team: Mr. Kiyoshi Kaneko, is appointed as Chief Commercial Officer (CCO), and Ms. Mariko Nakafuji is promoted into the role of Chief Legal Officer (CLO).Mr. Kaneko brings experience in business development, corporate strategy, marketing and commercial roles within the pharmaceutical and healthcare industries in Japan. At AstraZeneca, a leading global pharmaceutical company,he held the position of Senior Vice President for its commercial organization and corporate strategy in Japan,and prior to that, as Senior Vice President of its Primary Care business unit. Since 2017, he has been representative Director and President of Luye Life Sciences Group Japan and has led strategic partnerships with Japanese life sciences companies working across pharmaceuticals, medical devices and hospital businesses. Mr.Kaneko will take up the newly created position of CCO at Nxera and will be based in Japan. Ms. Nakafuji joined Nxera in 2021 as General Counsel and played a key role in the Company’s transformational acquisition of the Japan and South Korean businesses of Idorsia Pharmaceuticals, as well as several other strategic projects. She previously worked at Deloitte LLP and Jones Day LLP where she specialised in corporate M&A, investments and private equity with a particular focus on the life sciences sector. Ms. Nakafuji is a qualified solicitor in England and Wales. In the new role of CLO, Ms. Nakafuji will be responsible for global (ex-Japan) legal affairs and will be based in the UK. This appointments will come into effect on April1, 2025. Leadership Team (Effective 1 April 2025): President & Chief Executive Officer - Chris Cargill; EVP, Chief Financial Officer - Hironoshin Nomura; EVP, Chief Operating Officer - Toshihiro Maeda; EVP, President of Nxera Japan, Chief Medical Officer - Makoto Sugita; EVP, President of Nxera UK, Chief Scientific Officer - Matt Barnes; EVP, Chief Accounting Officer - Kieran Johnson; EVP, Chief Compliance Officer - Kazuhiko Yoshizumi; EVP, Chief of Staff - Candelle Chong; EVP, Chief Commercial Officer - Kiyoshi Kaneko (New); EVP, Chief Legal Officer - Mariko Nakafuji (New).

Nxera Pharma Co., Ltd. announced that they will report Q1, 2025 results on May 02, 2025

Nxera Pharma Co., Ltd. announced that it has entered a license, supply and commercialization agreement with Holling Bio-Pharma Corp. for daridorexant in Taiwan. Daridorexant is an oral dual orexin receptor antagonist (DORA) for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep. According to Taiwan’s National Health Research Institutes, sleep disorders such as insomnia affected 12-20% of the adult population in 2021, approximately 4-5 million people. Under the terms of the agreement, Nxera will be responsible for the supply of drug product and Holling will be responsible for regulatory, commercial and distribution activities and will hold all regulatory approvals. Holling expects to file a New Chemical Entity (NCE) to the Taiwan Food and Drug Administration (FDA) in mid-2025, which if approved would lead to an expected launch in mid-2026. Nxera will receive an upfront payment on signing and is eligible for near-term regulatory and sales milestones plus royalties on net sales from Holling, as well as revenue on the supply of drug product to Holling.

Nxera Pharma has entered an assignment agreement with Viatris Inc. and Idorsia Pharmaceuticals Ltd. regarding the development and commercialization of cenerimod, a clinical-stage immunology candidate for autoimmune diseases, in Japan, South Korea, and certain countries in the Asia-Pacific region (excluding China). The agreement was signed concurrently with Nxera's assignment of its option to these same rights from Idorsia Pharmaceuticals Ltd. under its agreement in July 2023 to acquire Idorsia Pharmaceuticals Japan Ltd. Nxera will receive an upfront payment of USD 10 million from Viatris and is eligible to receive a milestone payment upon regulatory approval of cenerimod in Japan plus royalties on net sales should it be commercialized in the assigned territories. Nxera will pay no option exercise fee or make any other payments to Idorsia in relation to cenerimod. Viatris will be the exclusive owner of cenerimod rights in Japan and APAC (ex-China). Viatris gained exclusive rights to cenerimod in all other territories from Idorsia through a research and development agreement signed in February 2024 and following this agreement with Nxera, now owns exclusive global rights to the candidate. Cenerimod, a highly selective, oral sphingosine-1-phosphate receptor 1 modulator, was discovered by Idorsia and is being developed by Viatris and Idorsia for multiple immune disorders, including in Phase 3 trials as a potential first-in-class, oral therapy for systemic lupus erythematosus.

Nxera Pharma Co., Ltd., Board Meeting, Feb 20, 2025. Agenda: To discuss the proposal Reduction of the Amount of Capital Reserve and Disposition of Surplus.

Nxera Pharma Co., Ltd. expected to report Q1 2025 results on May 2, 2025. This event was calculated by S&P Global (Created on February 15, 2025).

Nxera Pharma Co., Ltd., Annual General Meeting, Mar 26, 2025.

Nxera Pharma Co., Ltd's Board of Directors announced the retirement of Shinichi Tamura as Director, Chairman of the Board, Tomohiro Tohyama as External Director and Kuniaki Kaga as External Director.

­ Nxera Pharma Co., Ltd. announced that its Board of Directors resolved to submit the proposal "Partial Amendments to the Articles of Incorporation" to the 35th Ordinary General Meeting of Shareholders scheduled to be held on 26 March 2025. Reason for the amendment; With the enforcement of the "Act for Partial Revision of the Act on Strengthening Industrial Competitiveness, etc." (Act No. 70 of 2021), listed companies can hold general shareholders meetings without a defined location (so-called "Virtual-Only General Meeting of Shareholders") under certain conditions by stipulating so in their Articles of Incorporation. Given the purpose of the legislation and the advancement of society digitalization, and to reduce the risk of holding meetings in the event of major disasters, they believe that expanding the methods of holding general meetings of shareholders so that they can respond flexibly to situations, will benefit all shareholders and propose establishing new Article 12, Paragraph 2 of the Articles of Incorporation. For the amendment to the Articles of Incorporation, the Company received confirmation from the Minister of Economy, Trade and Industry and the Minister of Justice required under Article 66, Paragraph 1 of the Act on Strengthening Industrial Competitiveness (Act No. 98 of 2015). Content of the Amendment; Current Articles of Incorporation; The Ordinary General Meeting of Shareholders of the Company shall be convened within three months after the end of each business year and an Extraordinary General Meeting of Shareholders shall be convened whenever necessary. Proposed Amendment; (Same as current provision). Date of General Meeting of Shareholders for the amendment and effective date of the amendments: 26 March 2025 (scheduled).

Nxera Pharma Co., Ltd., 2024 Earnings Call, Feb 14, 2025

Nxera Pharma Co., Ltd. announced that they will report fiscal year 2024 results on Feb 14, 2025

Nxera Pharma Co., Ltd. Presents at 43rd Annual J.P. Morgan Healthcare Conference 2025, Jan-15-2025 03:00 PM. Venue: The Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Christopher Cargill, Representative Executive Officer, President, CEO & Director.

Nxera Pharma Co., Ltd. announced randomization of the first patient in a Phase 3 clinical trial evaluating daridorexant, its novel dual orexin receptor antagonist, for the treatment of adult patients in South Korea with insomnia. Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6.5-11 million people. The randomized, double-blind, placebo-controlled Phase 3 study aims to recruit adult and elderly subjects with insomnia at multiple centers in South Korea. The purpose of the trial is to provide additional efficacy and safety data, alongside the substantial data already generated in earlier trials completed in North America, Europe and Japan, that are required by the Ministry of Food and Drug Safety (MFDS) to grant marketing authorization for the drug in South Korea. The trial is expected to run for approximately 12 months with results expected during 1H 2026. Daridorexant 25mg and 50mg was approved in Japan in September 2024 based on robust clinical efficacy and safety data, including from a Phase 3 trial in Japan that met all primary and secondary endpoints. Nxera owns the Japanese and APAC (ex-China) rights for daridorexant, which will be marketed in Japan as QUVIVIQ™ under a commercialization agreement between Nxera and Shionogi. QUVIVIQ™ is expected to be launched in Japan in Fourth Quarter 2024. QUVIVIQ™ is also approved in the US, Europe and certain other countries where it is marketed by Idorsia Pharmaceuticals.

Nxera Pharma and Antiverse have announced a multi-target partnership and licensing agreement to design antibodies for G-protein coupled receptors (GPCRs). The collaboration combines Antiverse’s generative AI antibody design expertise, including its proprietary machine-learning-generated ‘epitope-specific libraries,’ with Nxera’s NxWave™ platform, a powerful tool for GPCR target selection, validation and structural determination. The partnership aims to bring transformative therapies for multiple diseases of high unmet need. The first project will be aimed at designing antibodies with agonistic function for a challenging GPCR target. Under the terms of the multi-year agreement, Antiverse will receive an upfront payment and research funding and is eligible for milestone payments. Nxera will retain an exclusive worldwide license to the antibody assets, providing full rights to develop and commercialize the candidates.

Nxera Pharma Co., Ltd. expected to report Fiscal Year 2024 results on February 10, 2025. This event was calculated by S&P Global (Created on November 1, 2024).

Nxera Pharma Co., Ltd. - Special Call

Nxera Pharma Co., Ltd. announced the appointment of Dr. Makoto Sugita, M.D., Ph.D., MBA, as President of Nxera Pharma Japan, and Executive Officer, Executive Vice President and Chief Medical Officer (CMO) of Nxera Pharma. Dr. Sugita is the former Vice President, and Head of R&D at Bristol Myers Squibb in Japan. He is a highly experienced medical professional having spent the past 20 years in R&D and commercial leadership positions within the Japanese businesses of global biopharmaceutical companies, including Johnson & Johnson/Janssen Pharmaceutical K.K. and AstraZeneca K.K., and Parexel, the global Contract Research Organization (CRO). Dr. Sugita holds a Doctor of Medicine and Doctor of Philosophy (Ph.D.) from Tohoku University (Sendai, Japan) and an MBA from McGill University (Montreal, Canada).

Nxera Pharma Co., Ltd. announced that they will report Q3, 2024 results on Nov 01, 2024

Nxera Pharma Co., Ltd. announced that it will receive a USD 35 million payment from Neurocrine Biosciences ('Neurocrine'), triggered by the successful completion of the Phase 2 trial with NBI-1117568 (NBI-1117568) in adults with schizophrenia, as announced on 28 August 2024. Receipt of the USD 35 million payment will be recognized as one-time revenue in the third quarter of 2024. The NBI-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose and was generally safe and well tolerated at all doses studied, supporting Neurocrine's intentions to advance NBI-1117568 into Phase 3 clinical trials in early 2025. NBI-1117568 is the first oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. The candidate is the most advanced from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under a 2021 global collaboration with Neurocrine for the treatment of major neurological and neuropsychiatric disorders. To date, Nxera has received multiple, significant payments from Neurocrine including those based on developmental progress of four candidates in clinical trials. Overall, Nxera is eligible to receive up to USD 1.5 billion in development milestone payments through to approvals, plus commercial milestones, which together total up to USD 2.6 billion, plus product royalties, provided the criteria under the agreement are satisfied. Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications, subject to certain exceptions.