Nxera Pharma Q1 2024 Operational Highlights and Results

Nxera Pharma, a biopharmaceutical company based in Tokyo, Japan and Cambridge, UK, has provided an update on its operational activities and reported its consolidated financial results for the first quarter ending 31 March 2024.

Chris Cargill, President and CEO of Nxera, highlighted the company's strategic advancements and emphasized the robust groundwork laid for achieving its vision of becoming a leading biopharmaceutical entity in Japan. A notable development this quarter was the rebranding from Sosei Heptares to Nxera Pharma, symbolizing the company's ambition to lead the next era of biopharmaceuticals. This rebranding was necessitated by the company's significant growth and development, driven by strategic acquisitions and advancements in its extensive pipeline.

Operational highlights for the first quarter of 2024 included the appointment of Toshihiro Maeda as Chief Operating Officer. Mr. Maeda, a seasoned pharmaceutical executive, will oversee the integration of Nxera Pharma Japan and Nxera Pharma Korea into the broader Nxera brand, managing all technical operations.

In terms of in-house programs, Nxera commenced a Phase 1 trial for NXE0033744, an EP4 receptor agonist aimed at treating Inflammatory Bowel Disease (IBD). Additionally, the company regained full rights from GSK for NXE0027477, an oral GPR35 agonist also intended for IBD treatment.

Nxera also made significant progress with its partnered programs. The company entered into a collaboration with Boehringer Ingelheim to develop treatments targeting all symptoms of schizophrenia. This agreement includes the development of novel GPR52 agonists, and Nxera received an upfront payment of EUR 25 million, with potential further payments totaling up to EUR 730 million.

Further advancements included receiving a US$2.5 million milestone payment from Formosa Pharmaceuticals following the US approval of APP13007 for post-operative inflammation and pain management after ocular surgery. Post-period, Nxera signed an exclusive supply and distribution agreement with Handok for PIVLAZ™ in South Korea, expected to be available commercially in 2025. Additionally, a US$15 million payment was received from Neurocrine Biosciences for progress on the schizophrenia candidate NBI-1117568, which is advancing through Phase 2 clinical trials.

Nxera also joined the World Orphan Drug Alliance (WODA), representing WODA in Japan and South Korea. This membership will provide access to a pipeline of novel medicines targeting rare or orphan diseases, offering potential licensing opportunities.

Financially, Nxera reported revenue of JPY 4,611 million (US$31.1 million) for the three-month period ended 31 March 2024, a substantial increase compared to the prior year. This growth was primarily due to the inclusion of NPJ sales. Research and development expenses rose to JPY 3,163 million (US$21.3 million), reflecting increased investment in discovery activities and the impact of the weaker Yen. General and administrative expenses also saw an increase, totaling JPY 3,650 million (US$24.6 million), which was attributed to higher personnel and professional fees, as well as integration costs under the new Nxera Pharma brand.

However, the company reported an operating loss of JPY 3,076 million (US$20.7 million) and a net loss of JPY 3,281 million (US$22.1 million) for the period, primarily due to the increased expenses. Cash and cash equivalents as of 31 March 2024 stood at JPY 46,515 million (US$307.3 million), a decrease from the beginning of the year.

Nxera Pharma continues to focus on advancing its pipeline and strategic collaborations, leveraging its unique GPCR-targeted drug discovery platform, NxWave™, to address major unmet medical needs. The company employs over 350 people across key locations in Japan, the UK, Switzerland, and South Korea, and remains committed to improving the lives of patients globally through innovative biopharmaceutical solutions.