Vasospasm, Intracranial

Tokyo, Japan and Cambridge, UK, 9 August 2024 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2024. The full report can be found here. Chris Cargill, President and CEO of Nxera, commented: “The reception we have received to our new name, branding and evolved strategy from all our stakeholders has been fantastic. In transitioning from Sosei Heptares to Nxera Pharma, we are united under a single identity with a clear purpose to become a leading technology driven biopharmaceutical company bringing new medicines to patients in Japan and globally. “In Japan, we have made good progress building sales for PIVLAZ® alongside preparing for its commercialization in South Korea, with launch expected in 2025. Similarly, our preparations to commercialize daridorexant in Japan are progressing well in anticipation of a positive regulatory decision later this year. “In addition, throughout 2024, we have continued to advance our internal programs into clinical trials, and to support the progress of our partnered programs through multiple preclinical and clinical development milestones, with further data and progress anticipated in the third quarter of 2024 and beyond. These are programs that our R&D team and powerful NxWave™ discovery platform have played a major role in creating, further reinforcing our position as the partner of choice for GPCR-targeted drug design, while generating significant value in terms of realised and future potential revenues. “Overall, it is a very exciting time for Nxera, and with multiple important commercialization and development milestones anticipated in the near and medium term, we are confident that we have the right strategy to deliver success and value for our stakeholders as we seek to build a globally competitive next-generation biopharma company.” Operational Highlights for Q2 2024 Corporate highlights Nxera Pharma, the new name for Sosei Heptares, came into effect on 1 April 2024 along with the launch of a new corporate brand and identity designed to capture the Group’s ambition to be at the forefront of the next era of biopharmaceuticals and medicineJoined the World Orphan Drug Alliance (WODA) to represent WODA in Japan and South Korea Through WODA and its global networks, Nxera will gain access to a pipeline of novel medicines targeting rare or orphan diseases as potential licensing opportunities (with no obligation) for its late clinical stage and commercialization operations in these regions Senior team strengthened with appointment of experienced senior strategy consultant Patrick Branch as Head of Business Development for Japan and APAC Progress with in-house programs Exclusive supply and distribution agreement with Handok for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea PIVLAZ™ is the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH) and is expected to become commercially available in South Korea in early 2025 Nxera and PrecisionLife announced an expansion of their 2022 strategic R&D partnership into auto-immune disorders with the potential to identify new drug targets and subsequently potential precision targeted therapies for complex, chronic conditions. Progress with partnered programs US$15 million payment from Neurocrine Biosciences triggered by successful development progress of partnered schizophrenia candidate NBI-1117568 NBI-1117568 is an oral, selective muscarinic M4 receptor agonist advancing through Phase 2 clinical development under a multi-program collaborationSuccessful completion of long-term preclinical toxicity program supports safe, chronic dosing of NBI-1117568 in future clinical trialsTopline clinical results from Neurocrine’s Phase 2 study are expected in Q3 2024 Neurocrine also announced that it had initiated its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117567 in healthy adult participants NBI-1117567 is an investigational, oral, M1 preferring agonist discovered by the Group and licensed to Neurocrine that may have the potential to treat symptoms of cognition in patients with neurological and neuropsychiatric conditions First R&D milestone reached under Nxera’s multi-target discovery collaboration with AbbVie, resulting in a payment of US$10 million to the Company Collaboration aims to leverage Nxera’s NxWave™ platform to discover, develop and commercialize new medicines targeting novel GPCR targets associated with neurological disease US$4.6 million in milestone payments received from Centessa Pharmaceuticals following approval of an Investigational New Drug (IND) application for ORX750 and its progression into a Phase 1 clinical trial ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed utilizing Nxera technology to directly target orexin neuron loss in narcolepsy and other sleep-wake disorders. Financial Highlights for the Six-month Period ended 30 June 2024 Revenue totalled JPY 12,720 million (US$83.6 million*), an increase of JPY 10,574 million (US$67.7 million) vs. the prior corresponding period. The increase was primarily due to the inclusion of Nxera Pharma Japan Co., Ltd. (“NPJ”) in the scope of consolidation from July 2023, which resulted in the inclusion of PIVLAZ® sales. R&D expenses totalled JPY 5,487 million (US$36.1 million), an increase of JPY 1,448 million (US$6.1 million) vs. the prior corresponding period. This increase primarily reflects an increased investment in discovery activities, but also reflects the impact of the weaker Yen. JPY 813 million (US$5.3 million) has been included for R&D expenses relating to NPJ/Nxera Pharma Korea Co., Ltd. (“NPK”).G&A expenses totalled JPY 8,022 million (US$52.8 million), an increase of JPY 5,451 million (US$33.7 million) vs. the prior corresponding period. This increase was primarily due to incremental spend on personnel and professional fees to strengthen organizational capabilities, as well as the cost of integrating IT systems and unifying the Group under the Nxera Pharma brand. JPY 4,740 million (US$31.2 million) has been included for G&A expenses relating to the NPJ/NPK businesses, including an amortization charge on Idorsia related intangible assets.Operating loss totalled JPY 3,654 million (US$24.0 million) vs. an operating loss of JPY 4,168 million (US$30.9 million) in the prior corresponding period. This decrease reflects the combined effect of all movements explained above.Loss before income tax totalled JPY 3,158 million (US$20.8 million) vs. a loss before income tax of JPY 3,760 million (US$27.9 million) in the prior corresponding period. This decrease reflects the combined effect of all movements explained above.Net loss for the six-month period ended 30 June 2024 totalled JPY 4,703 million (US$30.9 million) vs. a net loss of JPY 2,060 million (US$15.3 million) in the prior corresponding period. This increase reflects the combined effect of all movements explained above.Core operating profit** totalled JPY 1,176 million (US$7.7 million) vs. a core operating loss of JPY 2,720 million (US$20.2 million) in the prior corresponding period. Cash and cash equivalents as at 30 June 2024 amounted to JPY 50,984 million (US$316.9 million) having increased by JPY 1,919 million (decreased by US$31.0 million) from the beginning of the year. *Convenience conversion to US$ at the following rates: FY 2024: 1US$ =152.12 JPY; FY 2023: 1US$ =134.82 JPY; 30 Jun 2024: 1US$ = 160.91 JPY; 31 Dec 2023: 1US$ = 141.03 JPY ** Core operating profit / loss is an alternative performance measure which adjusts for material non-cash costs and one-off costs in order to provide insights into the recurring cash generation capability of the core business. –END– About Nxera PharmaNxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWave™” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit www.nxera.lifeLinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate StrategyShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life MEDiSTRAVA Consulting (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@medistrava.com Forward-looking statementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Ad hoc announcement pursuant to Art. 53 LR Jean-Paul Clozel to retire as CEO and stand for election as Chairman of the Board of DirectorsMathieu Simon to stand for re-election to the Board – taking on the role of Vice-Chairman and Lead Independent DirectorAndré C. Muller, current CFO of Idorsia, to take over the role of CEO as of June 13, 2024 Allschwil, Switzerland – May 21, 2024Idorsia Ltd (SIX: IDIA) today announced changes to the Idorsia Executive Committee (IEC) and will propose changes in membership of the Board of Directors at the upcoming Annual General Meeting of shareholders (AGM), to be held on June 13, 2024. Jean-Paul Clozel, 69, has decided to retire from his role as Chief Executive Officer (CEO) of Idorsia and stand for election as Chairman of the Board of Directors at this year’s AGM. Jean-Paul has served as CEO of Idorsia since its foundation – the result of demerging the drug discovery and early clinical pipeline of Actelion, as part of the USD 30 billion acquisition. Jean-Paul had previously co-founded Actelion in 1997 and went on to lead the company as CEO in 2000 when the company became publicly traded. Jean-Paul Clozel, MD and CEO of Idorsia, commented: “It has been an absolute privilege to serve as CEO of Actelion and Idorsia for the past 24 years. I can think of no greater endeavor than discovering new medicines that help patients lead better lives. I’ve been very fortunate to work alongside some amazing people from all disciplines and together, we have achieved more than I could have ever imagined when I started out in my research career. The time is right for me to retire from the day-to-day running of Idorsia and hand the reins over to a younger generation to lead the company through the next phase of growth. Having devoted so much energy to Idorsia, I want to stay engaged and support the company to realize its potential, hence me standing for election as Chairman. I’m confident that Mathieu and I will form a strong partnership in leading the Board. I will also be able to devote more time to science which has always been my passion.” From June 13, 2024, André C. Muller will take on the position of CEO. André has served as the Chief Financial Officer (CFO) of Idorsia since its foundation and has taken the lead in the company’s Business Development initiatives in recent years. Before establishing Idorsia, André served as CFO of Actelion from 2013, leading the company through its acquisition and playing a crucial role in the demerger process. Jean-Paul Clozel, commented: “André has played a critical role in advancing Idorsia, particularly regarding our fund-raising and business development activities. He has shown the perfect qualities of a biotech leader; creativity, solution-oriented, resilient, a team-player and pragmatic – all qualities that we need to successfully discover and develop innovative drugs. Having worked with André for more than 10 years, I have observed that, despite not being a scientist by training, he has a keen understanding of innovative drug discovery and development. I have absolute confidence that he is the right person to prepare the company for an exciting future.” As a result of André becoming CEO, the role of CFO will remain an IEC member and be taken by Arno Groenewoud, the current Head of Finance and Procurement. In addition, Julien Gander, Group General Counsel, will become a member of the IEC. André C. Muller, Chief Financial Officer, commented: “I am very honored that the Board, its current Chairman, Mathieu Simon, and Jean-Paul have put this trust in me, particularly following such a long and successful tenure for Jean-Paul as CEO. I look forward to the challenge of delivering on the high expectations we have for Idorsia and will work closely with all colleagues around the globe who never fail to impress with their commitment and expertise. I welcome Arno and Julien to the executive team. Having worked closely with both Arno and Julien, I am convinced that their skills and strategic thinking will be vital as the company moves towards financial sustainability while managing multiple partnerships.” As of June 13, 2024, the IEC will consist of 5 members: André Muller, CEO; Martine Clozel, Chief Scientific Officer; Alberto Gimona, Head of Global Clinical Development; Arno Groenewoud, CFO; and Julien Gander, Group General Counsel. At this year’s Annual General Meeting, the Board will propose a reduced number of Board members for the time being. Three of the current Board members – Jörn Aldag, Felix Ehrat, Peter Kellogg – will not stand for re-election, with only one new member, Bart Filius, being proposed to the Board. The following Board members will stand for re-election: Jean-Paul Clozel (proposed Chairman), Mathieu Simon (Vice-Chairman and Lead Independent Director), Srishti Gupta, Sophie Kornowski, and Sandy Mahatme. Mathieu Simon, Chairman of the Board of Idorsia commented:“This year, the Board has held numerous additional meetings to discuss and review the various strategic initiatives. I’m very grateful for each member contributing generously with their expertise and experience. To those not standing for re-election, I say thank you for serving the company with professionalism and dedication. Bart’s very extensive financing, business development, and commercial experience in the biotechnology and pharmaceutical industry would be invaluable to Idorsia. I am completely behind the new management team, and proposing Jean-Paul to the Chairmanship, and I look forward to serving as Vice-Chairman and Lead Independent Director with the other members of the Board focused on guiding Idorsia as we execute our strategy.” Following a competitive selection process, the company considers it appropriate to invite a fresh perspective by proposing the election of Deloitte AG, Basel as a new statutory auditor. Notes to the editor About Jean-Paul ClozelJean-Paul Clozel, 69, is a cardiologist educated in France. He furthered his training in pharmacology and physiology at the University of Montreal, Canada, University of California, and San Francisco. After eleven years as a clinician, he decided to move to applied research and joined the Roche Cardiovascular Drug Discovery group. During his 12 years at F. Hoffmann-La Roche Ltd, Jean-Paul was responsible for the selection of the first calcium T-channel blocker and contributed to several key research programs, such as the selection of the first orally active renin inhibitor and the characterization of several anti-thrombotic agents. During his 25-year-career in cardiovascular research, Jean-Paul has published widely in peer-reviewed medical and scientific journals. At the same time, his passion has remained unchanged: being involved as closely as possible in bringing innovative medicine to "his" patients. He has developed various novel experimental models allowing for the differentiation of these drugs, work honored with the 1997 Hoffmann-La Roche Research Prize. In 2007, he was nominated for a professorship at the Collège de France in Paris, France (Chair of Technical Innovation). At the end of 1997, Jean-Paul co-founded Actelion to continue his work in cardiovascular research and development. In April 2000, he assumed the role of CEO when Actelion became a publicly traded company and subsequently launched three blockbuster drugs. With the acquisition of Actelion by Johnson & Johnson in June 2017, Jean-Paul co-founded Idorsia, a new biopharmaceutical company that was established by demerging the drug discovery and early clinical pipeline business from Actelion. Idorsia is specialized in the discovery and development of small molecules to provide innovative medicines in areas of unmet patient need. In the first 7 years of Idorsia’s existence, the company launched two innovative drugs, one for the treatment of insomnia disorder and one for the prevention of cerebral vasospasm following subarachnoid hemorrhage, with a third medicine on the verge of being launch for the treatment of uncontrolled blood pressure. Idorsia continues to perform innovative research across multiple therapeutic areas to feed its broad and diversified drug development pipeline. As a result of the establishment of Actelion and Idorsia, several hundred new jobs have been created in Switzerland as well as in other European countries, the US and Japan. About André C. MullerAndré C. Muller joined Idorsia at the time of its creation in June 2017 as Chief Financial Officer from Actelion, where he held the same position since 2013. Prior to joining Actelion he held various financial positions at Pierre Fabre SA, an international pharmaceutical and dermo-cosmetic company, serving as CFO from 2002. André, a French citizen, has a master’s degree in Business Administration from EMLYON Business School, Lyon, France. André also serves as a member of the Board of Directors of the listed company Carmat SA and the unlisted company Chiron Investments AG. About Bart FiliusMr. Filius is the former President of Galapagos, a position he held from 2021 to June 2023. He joined Galapagos in 2014 as Chief Financial Officer and added the role of Chief Operating Officer in 2017. During his tenure at Galapagos, Bart managed the substantial growth and financing of the company, including the IPO on Nasdaq in 2015 and subsequent follow-on financing transactions. He led the negotiations of the R&D collaboration with Gilead in 2019 and was instrumental in the build-out of the European commercial organization. Bart is also a member of the Board and Chairman of the Audit Committee of ProQR Therapeutics since 2019. Prior to joining Galapagos, Mr. Filius held a variety of executive positions at Sanofi between 2001 and 2014, including the role of Vice President, Head of Mergers & Acquisitions, Country manager for The Netherlands and Vice President, Chief Financial Officer for Europe. Prior to joining Sanofi, Mr. Filius was a strategy consultant at Arthur D. Little. Mr. Filius has an MBA degree from INSEAD, France and a bachelor’s degree in business from Nyenrode University, the Netherlands About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com media.relations@idorsia.com www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

PIVLAZ™ is the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH) PIVLAZ™ will become commercially available in South Korea in early 2025 15 April 2024 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – today announces that its operating business Nxera Pharma Korea (“NPK”) has entered into an exclusive supply and distribution agreement with Handok Inc. (“Handok”) to commercialize PIVLAZ™ (clazosentan sodium) 150 mg in South Korea. Under the terms of the agreement, NPK will provide drug product to Handok at an agreed price and Handok is exclusively responsible for the promotion, marketing, sales and distribution of PIVLAZ™ in South Korea. Nxera will receive a one-off upfront payment from Handok upon signing of the agreement and is eligible for further commercial milestone payments plus sales coming from product supply. Handok is a leading innovation-driven pharmaceutical/healthcare company in South Korea. Handok has been a pioneer in the Korean pharmaceutical industry by introducing new products to the Korean market through partnerships, internal R&D, and state-of-the-art manufacturing while maintaining a global standard compliance program. PIVLAZ™ is approved in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). Satoshi Tanaka, Dr Med Sci., Executive Officer and Executive Vice President of Nxera, Chairman of NPK, added: “We are pleased to be continuing our long-standing partnership with Handok to bring PIVLAZ™ to patients in South Korea. PIVLAZ™ represents a potentially life-changing treatment option for patients and Handok’s wealth of expertise and history of delivering products to the Korean market makes them the ideal partner. With this partnership in place, we are confident that we will be able to deliver PIVLAZ™ to physicians and patients in South Korea in early 2025.” Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). The content above comes from the network. if any infringement, please contact us to modify.