Nxera Pharma Operational Highlights and Consolidated

Tokyo, Japan and Cambridge, UK, May 9, 2024 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) provides an update on its operations and reports consolidated results for the first quarter ended March 31, 2024. The full report can be found here.

Chris Cargill, president and CEO of Nxera, commented: “We enter 2024 with a clear vision to seize a number of strategic opportunities and build on the strong foundations we have established, positioning the company for the next phase of its journey to become a leading biopharmaceutical company to be in Japan. The past three months, marked by our bold actions, have been proof of this.

“A key milestone this quarter was the change of company name from Sosei Heptares to Nxera Pharma and the unveiling of a bold new brand and identity that reflects our ambition to pioneer the next era of biopharmaceuticals and medicines. The decision to make this change was driven by the significant growth and development of the business, which has been accelerated by several key strategic acquisitions in recent years, and by the progress made in advancing our extensive pipeline, both internally as with our partners.

“I would like to express my gratitude to our brilliant team in Japan, Great Britain, South Korea and Switzerland, whose dedication and expertise made these important achievements possible and will strengthen our future success.”

Operational highlights for Q1 2024

Business highlights

• Change of company name to Nxera Pharma
  • Approved on March 27 at the company’s 34th annual meeting of shareholders and effective on April 1, 2024
• Appointment of Chief Operating Officer, Toshihiro Maeda
  • Mr. Maeda, an experienced pharmaceutical executive, will lead the post-acquisition integration of the Nxera Pharma Japan (“NPJ”) and Nxera Pharma Korea (“NPK”) businesses into Nxera and will be responsible for all technical activities.

Progress with internal programs

• First subject administered a dose of NXE0033744, a novel, potent, selective and gut-restricted EP4 receptor agonist discovered by Nxera in development for the treatment of inflammatory bowel disease (IBD) in a Phase 1 study
• GSK regained full ownership of NXE0027477, a clinical, highly selective, first-in-class, oral GPR35 agonist in development as a potential new treatment for IBD
  • Nxera expects to determine the optimal strategy for the further clinical development of the program, including internal development and/or renewed collaboration.

Progress with affiliate programs

• Entered into a global collaboration and exclusive option-to-license agreement with Boehringer Ingelheim to develop first-in-class treatments targeting all symptoms of schizophrenia
  • Single-target agreement aimed at developing novel small molecule agonists of GPR52 discovered by Nxera with the potential to simultaneously address positive, negative and cognitive symptoms of schizophrenia
  • Nxera received an upfront sum of EUR 25 million from Boehringer Ingelheim and is eligible to receive an option exercise payment of EUR 60 million and further milestone payments totaling up to EUR 670 million, plus incremental royalties
• Received US$2.5 million milestone payment from Formosa Pharmaceuticals for US approval of APP13007 (originally designed and developed by Activus Pharma, formerly a wholly owned subsidiary of the company), for the treatment of postoperative inflammation and pain following ocular surgery

Events after the period

• 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 be commercially available in South Korea in early 2025
• $15 Million Payment from Neurocrine Biosciences Triggered by Successful Development Progress of Partner Schizophrenia Candidate NBI-1117568
  • NBI-1117568 is an oral, selective muscarinic M4 receptor agonist in Phase 2 clinical development in a multi-program collaboration
  • Successful completion of preclinical long-term toxicity program supports safe, chronic dosing of NBI-1117568 in future clinical trials
• Joined the World Orphan Drug Alliance (“WODA”) to represent WODA in Japan and South Korea
  • Through the Alliance and its global networks, Nxera will have access to a pipeline of novel medicines targeting rare or orphan diseases as potential licensing opportunities (without obligation) for its late clinical stage and commercialization activities in these regions.
• Senior team strengthened with the appointment of experienced senior strategy consultant Patrick Branch as Head of Business Development for Japan and APAC

Financial highlights for the three-month period ending March 31, 2024

• Sales totaled JPY 4,611 million (US$31.1 million*), an increase of JPY 3,668 million (US$23.9 million) compared to the previous corresponding period. The increase is mainly due to the inclusion of NPJ in the consolidation scope as of July 2023, which resulted in the addition of PIVLAZ® sales.
• R&D expenses totaled JPY 3,163 million (US$21.3 million), an increase of JPY 1,206 million (US$6.5 million) compared to the previous corresponding period. This increase reflects increased investment in discovery activities, but also reflects the impact of the weaker yen. JPY 414 million (US$2.8 million) has been recognized for R&D expenses related to NPJ/NPK.
• General and administrative expenses amounted to JPY 3,650 million (US$24.6 million), an increase of JPY 2,541 million (US$16.2 million) compared to the previous corresponding period. This increase was mainly due to increasing expenditure on personnel and professional compensation to strengthen our organizational capabilities, as well as the costs of integrating our IT systems and unifying the Group under the Nxera Pharma brand. JPY 2,049 million (US$13.8 million) has been recognized for general and administrative expenses related to the NPJ/NPK business, including an amortization charge on Idorsia-related intangible assets.
• Operating losses totaled JPY 3,076 million (US$20.7 million), compared to an operating loss of JPY 1,964 million (US$14.8 million) in the previous corresponding period. This increase reflects the combined effect of all the movements outlined above.
• The loss before income tax amounted to JPY 2,796 million (US$18.8 million) versus a loss before income tax of JPY 1,863 million (US$14.1 million) in the previous corresponding period. This increase reflects the combined effect of all the movements outlined above.
• Net losses for the three-month period ended March 31, 2024 totaled JPY 3,281 million (US$22.1 million), versus a net loss of JPY 1,402 million (US$10.6 million) in the previous corresponding period. This increase reflects the combined effect of all the movements outlined above.
• Core operating loss** totaled JPY 931 million (US$6.3 million), compared to a core operating loss of JPY 1,465 million (US$11.1 million) in the previous corresponding period.
• Cash and cash equivalents amounted to JPY 46,515 million (US$307.3 million) as of March 31, 2024, after a decrease of JPY 2,550 million (US$40.6 million) from the beginning of the year.

*Convenience conversion to US$ at the following rates: FY 2024: 1US$ =148.40 JPY; Fiscal year 2023: 1US$ =132.32 JPY; March 31, 2024: 1US$ = 151.35 JPY; December 31, 2023: 1US$ = 141.03 JPY
** Core operating profit/loss is an alternative performance measure that adjusts for material non-cash costs and non-recurring costs to provide insight into the recurring cash generating capacity of the core business.

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About Nxera Pharma
Nxera Pharma (formerly Sosei Heptares) is a technology-driven biopharmaceutical company pursuing new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.

In addition to a number of products commercialized in Japan, we are advancing an extensive pipeline of more than 30 active programs internally and in collaboration with leading pharmaceutical and biotech companies, from discovery to late clinical. This pipeline aims to address major unmet needs in some of the fastest growing areas of medicine in neurology, gastrointestinal 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-in-class or first-in-class candidates.

Nxera employs over 350 talented people in 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.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma

To ask:

Nxera – Media and Investor Relations
Kentaro Tahara, VP of Investor Relations and Corporate Strategy
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 |[email protected]

MEDiSTRAVA Consulting (for international media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | [email protected]

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding product discovery, development and commercialization. Various risks could cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied in the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial restrictions imposed by patents owned or controlled by third parties; dependence on strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to commercialize products and services due to development efforts; the need for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives of competitors. Due to these factors, potential investors are cautioned not to rely on 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.

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