“A key milestone this quarter has been the change of company name from Sosei Heptares to
“I extend my gratitude to our brilliant team in
Operational Highlights for Q1 2024
Corporate highlights
- Change of company name to
Nxera Pharma - Approved on 27 March at the Company’s 34th Annual Shareholders’ Meeting and came into effect on
1 April 2024
- Approved on 27 March at the Company’s 34th Annual Shareholders’ Meeting and came into effect on
- Appointment of Chief Operating Officer,
Toshihiro Maeda Mr Maeda , an experienced pharmaceutical executive, is leading 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 operations
Progress with in-house programs
- First subject dosed in a Phase 1 trial with NXE0033744, a novel, potent, selective and gut-restricted EP4 receptor agonist discovered by Nxera in development for the treatment of Inflammatory Bowel Disease (IBD)
- Regained full ownership from GSK of NXE0027477, a clinic-ready, 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 further clinical development of the program, which could include in-house development and/or re-partnering
Progress with partnered programs
- Entered 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 focused on development of novel, small molecule agonists of GPR52 discovered by Nxera with the potential to simultaneously address positive, negative and cognitive symptoms of schizophrenia
- Nxera received
EUR 25 million upfront fromBoehringer Ingelheim and is eligible for an option exercise payment ofEUR 60 million and further milestone payments totalling up toEUR 670 million plus tiered royalties
US$2.5 million milestone payment received from Formosa Pharmaceuticals for US approval of APP13007 (originally designed and developed at Activus Pharma, formerly a wholly owned subsidiary of the Company), for the treatment of post-operative inflammation and pain following ocular surgery
Post-period events
- 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 inSouth Korea in early 2025
- PIVLAZ™ is the first drug approved in
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 collaboration
- Successful completion of long-term preclinical toxicity program supports safe, chronic dosing of NBI-1117568 in future clinical trials
- Joined the
World Orphan Drug Alliance (“WODA”) to represent WODA inJapan andSouth Korea - Through the Alliance 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 forJapan and APAC
Financial Highlights for the Three-month Period ended
- Revenue totalled
JPY 4,611 million (US$31.1 million *), an increase ofJPY 3,668 million (US$23.9 million ) vs. the prior corresponding period. The increase is primarily due to the inclusion of NPJ in the scope of consolidation fromJuly 2023 , which resulted in the addition of PIVLAZ® sales. - R&D expenses totalled
JPY 3,163 million (US$21.3 million ), an increase ofJPY 1,206 million (US$6.5 million ) vs. the prior corresponding period. This increase reflects an increased investment in discovery activities, but also reflects the impact of the weaker Yen.JPY 414 million (US$2.8 million ) has been included for R&D expenses relating to NPJ/NPK. - G&A expenses totalled
JPY 3,650 million (US$24.6 million ), an increase ofJPY 2,541 million (US$16.2 million ) vs. the prior corresponding period. This increase was primarily due to incremental spend on personnel and professional fees to strengthen our organizational capabilities, as well as the cost of integrating our IT systems and unifying the Group under the Nxera Pharma brand.JPY 2,049 million (US$13.8 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 3,076 million (US$20.7 million ) vs. an operating loss ofJPY 1,964 million (US$14.8 million ) in the prior corresponding period. This increase reflects the combined effect of all movements explained above. - Loss before income tax totalled
JPY 2,796 million (US$18.8 million ) vs. a loss before income tax ofJPY 1,863 million (US$14.1 million ) in the prior corresponding period. This increase reflects the combined effect of all movements explained above. - Net loss for the three-month period ended
31 March 2024 totalledJPY 3,281 million (US$22.1 million ) vs. a net loss ofJPY 1,402 million (US$10.6 million ) in the prior corresponding period. This increase reflects the combined effect of all movements explained above. - Core operating loss** totalled
JPY 931 million (US$6.3 million ) vs. a core operating loss ofJPY 1,465 million (US$11.1 million ) in the prior corresponding period. - Cash and cash equivalents as at
31 March 2024 amounted toJPY 46,515 million (US$307.3 million ) having decreased byJPY 2,550 million (US$40.6 million ) from the beginning of the year.
*Convenience conversion to US$ at the following rates: FY 2024:
** 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
In addition to several products being commercialized in
Nxera employs over 350 talented people at key locations in
For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma
Enquiries:
Nxera – Media and Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
+44 (0)203 928 6900 | Nxera@medistrava.com
Forward-looking statements
This 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.
Attachment
- FY24Q1 E_Tanshin_Final_0509
Source:
2024 GlobeNewswire, Inc., source