Nxera Pharma Q2 and H1 2024 Highlights and Consolidated Results

Tokyo, Japan and Cambridge, UK, 9 August 2024 – Nxera Pharma, formerly known as Sosei Heptares, has announced updates on its operational activities and financial results for the second quarter and first half of 2024, ending 30 June. The company, listed on the Tokyo Stock Exchange under the ticker TSE: 4565, aims to become a leading biopharmaceutical company, delivering innovative medicines to patients in Japan and globally.

Chris Cargill, President and CEO of Nxera, expressed satisfaction with the positive reception of the company's new name, branding, and strategic direction. The transition to Nxera Pharma underscores a unified identity and a clear mission to excel as a technology-driven biopharma company. In Japan, Nxera has made significant progress in expanding sales of PIVLAZ® and is preparing for its commercialization in South Korea by 2025. Additionally, the company is on track to launch daridorexant in Japan, pending a favorable regulatory decision later this year.

Throughout 2024, Nxera has been advancing its internal programs into clinical trials and supporting the development of partnered programs, reaching several preclinical and clinical milestones. The company's R&D team and its NxWave™ discovery platform have been instrumental in these efforts, reinforcing Nxera as a preferred partner for GPCR-targeted drug design and contributing to potential future revenues.

Operational highlights for the second quarter of 2024 include the effective launch of the new Nxera Pharma brand on 1 April. Nxera joined the World Orphan Drug Alliance (WODA) to represent Japan and South Korea, gaining access to a pipeline of novel medicines targeting rare or orphan diseases. The company has also strengthened its senior team with the appointment of Patrick Branch as Head of Business Development for Japan and APAC.

In terms of in-house programs, Nxera signed an exclusive supply and distribution agreement with Handok for PIVLAZ™ in South Korea. PIVLAZ™ is the first approved drug in South Korea for preventing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage (aSAH) and is expected to be commercially available in early 2025. Nxera also expanded its strategic R&D partnership with PrecisionLife to explore auto-immune disorders, aiming to identify new drug targets and potential precision therapies for chronic conditions.

Progress with partnered programs includes a US$15 million payment from Neurocrine Biosciences, triggered by the successful development of the schizophrenia candidate NBI-1117568, which is advancing through Phase 2 clinical trials. Neurocrine also initiated a Phase 1 clinical study to evaluate the safety and efficacy of NBI-1117567, an investigational oral M1 agonist discovered by Nxera. Additionally, Nxera received a US$10 million payment from AbbVie for reaching the first R&D milestone under their multi-target discovery collaboration. Centessa Pharmaceuticals also made milestone payments totaling US$4.6 million following the approval of an IND application for ORX750, an investigational orexin receptor agonist designed to target orexin neuron loss in narcolepsy and other sleep-wake disorders.

The financial highlights for the six-month period ending 30 June 2024, reveal that Nxera's revenue totaled JPY 12,720 million (US$83.6 million), a significant increase primarily due to the inclusion of PIVLAZ® sales from Nxera Pharma Japan Co., Ltd. R&D expenses increased to JPY 5,487 million (US$36.1 million), reflecting higher investment in discovery activities and the impact of a weaker Yen. General and administrative expenses rose to JPY 8,022 million (US$52.8 million) due to increased spending on personnel, professional fees, and integration under the Nxera Pharma brand.

The company reported an operating loss of JPY 3,654 million (US$24.0 million) and a loss before income tax of JPY 3,158 million (US$20.8 million). The net loss for the six-month period was JPY 4,703 million (US$30.9 million), while core operating profit totaled JPY 1,176 million (US$7.7 million). Cash and cash equivalents were JPY 50,984 million (US$316.9 million) as of 30 June 2024.

Overall, Nxera Pharma remains confident in its strategic direction and is poised to achieve significant commercialization and development milestones in the near and medium term, reinforcing its goal to become a globally competitive biopharma company.