Human Chorionic Gonadotrophin (Mochida Pharmaceutical Co., Ltd.)

Tokyo, Japan and Cambridge, UK, 10 November 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the third quarter and nine months ended 30 September 2023. The full report can be found by clicking here. Chris Cargill, President & CEO of Sosei Heptares, commented: “The third quarter has been an exciting and transformational period for the Group following the acquisition of Idorsia’s pharmaceutical business in Japan and Asia-Pacific (ex-China). The addition of an experienced, high-quality development and commercialization team and two potentially life-changing approved and late-stage assets complements extremely well our world-leading GPCR-targeted discovery and early development business in the UK, enabling us to become a fully integrated biopharmaceutical organization. Together, our enlarged Group can offer broad capabilities, an expanded pipeline addressing multiple therapeutic areas of unmet need, and a lean and agile business model capable of taking drugs from discovery to patients in Japan while progressing existing and initiating new partnerships globally. We are making good progress with the initial integration of these businesses. “Operationally, we are also delighted to have fulfilled the commitment to file an NDA for daridorexant for approval in Japan as a new treatment for patients with insomnia. At the same time, we continue to build on our core activities that have resulted in the successful advancement of multiple new candidates into clinical studies and collaborative programs. “We are confident that our bold strategy, actions and potential will position Sosei Heptares as a new and dynamic leader in the Japanese biopharma industry, delivering life-changing medicines to patients globally and allowing us to create significant value for all our key stakeholders.” Operational Highlights for Q3 2023 Transformational acquisition of Idorsia’s pharmaceutical business in Japan and APAC (ex-China) – achieves key strategic milestone to become a fully integrated biopharmaceutical company: Adds complementary late-stage clinical development capability with profitable and fast-growing commercial operations in Japan.Brings highly experienced team, with proven clinical development and commercial launch track record. Lean, go-to-market commercial model, well positioned to scale rapidly to generate significant value from Japan and APAC (ex-China) geographic expansion. Includes Japan and APAC (ex-China) rights to two life-changing medicines with significant growth potential (PIVLAZ® – approved for cerebral vasospasm, and daridorexant – Japan filing expected and delivered in Q4 2023 for insomnia) and exclusive options and selected rights to up to seven other products from Idorsia’s clinical development pipeline.Purchase price of JPY65 billion is fully funded from existing cash (JPY25 billion) and new JPY40 billion long-term, low-rate corporate loan. First subject dosed with HTL0048149 in Phase 1 Trial – HTL’149 is a first-in-class GPR52 agonist designed by the Company as a once-daily oral treatment to address positive and negative symptoms and cognitive impairment in schizophrenia patients without the adverse effects typically associated with existing antipsychotic drugs. First patient dosed with potential cancer immunotherapy HTL0039732 in Phase 1/2a clinical trial – HTL’732 is an orally available small molecule EP4 antagonist for advanced solid tumors being evaluated under an agreement with Cancer Research UK. Partner Neurocrine Biosciences initiated Phase 1 clinical study with NBI-1117570 – NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist developed utilizing the Group’s SBDD platform and that may have the potential to treat neurological and neuropsychiatric conditions. Post-period Events New Drug Application submitted to the Japanese Pharmaceuticals and Medical Devices Agency for the approval of daridorexant (ACT541468), a novel dual orexin receptor antagonist, for the treatment of adult patients with insomnia – In relation to the filing of this NDA, the Group will receive JPY 1.5 billion, which will be recognized as revenue in Q4 2023. If approved, daridorexant will be co-marketed in Japan by Sosei Group and Mochida Pharmaceutical Co., Ltd. ("Mochida”) and Shionogi & Co. Ltd ("Shionogi"). Mochida and Shionogi entered into a sales partnership agreement in Japan for daridorexant on 1 November 2023.Partner Pfizer entered a new oral small molecule GLP-1 receptor agonist into a Phase 1 clinical trial – PF-06954522 was discovered by Pfizer scientists during a multi-target research collaboration in which Pfizer had access to Sosei Heptares’ proprietary StaR® technology.Collaboration with Verily progressing with launch of new discovery program – new program established based on the successful validation and nomination of a GPCR target for immune-mediated diseases with an initial indication focus of inflammatory bowel diseases. Collaboration expanded with PharmEnable Therapeutics – expansion focused on driving drug discovery of novel small molecule drug candidates against a second neurological disease target. US$3.75 million milestone payment received from Genentech – the discovery-based payment is related to progression of a potential first-in-class project targeting an undisclosed GPCR. Genentech will now be responsible for further development and commercialization of this potential new medicine. Note regarding the Idorsia transaction: the quarter ended 30 September 2023 (Q3 2023) is the first period in which the Group has consolidated the financial results of Idorsia’s former Japanese and South Korean businesses. Financial Highlights for the Nine-month Period ended 30 September 2023 Revenue totalled JPY 5,474 million (US$39.6 million*), a decrease of JPY 3,167 million (US$27.9 million) vs. the prior corresponding period. The decrease is primarily due to the decrease in revenue related to upfront fees and milestone income due to signing no new partnership agreements and the occurrence of one milestone event in the current period vs. one upfront fee and three milestone events in the prior corresponding period, partially offset by the increase in pharmaceutical product sales due to the inclusion of Idorsia Pharmaceuticals Japan Ltd (“IPJ”) in the scope of consolidation in July, which resulted in the addition of PIVLAZ® sales.R&D expenses totalled JPY 7,013 million (US$50.8 million), an increase of JPY 1,390 million (US$6.9 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 358 million (US$2.6 million) has been included for R&D expenses relating to IPJ and Idorsia Pharmaceuticals Korea Co., Ltd (“IPK”).G&A expenses totalled JPY 6,012 million (US$43.5 million), an increase of JPY 2,842 million (US$18.7 million) vs. the prior corresponding period. This increase is primarily due to the inclusion of non-recurring M&A related costs. JPY 1,417 million (US$10.3 million) has been included for G&A expenses relating to IPJ/IPK.Operating loss totalled JPY 7,992 million (US$57.9 million) vs. an operating loss of JPY 615 million (US$4.8 million) in the prior corresponding period. This increase reflects the combined effect of all the movements explained above.Loss before income tax totalled JPY 7,865 million (US$57.0 million) vs. a loss before income tax of JPY 3,108 million (US$24.3 million) in the prior corresponding period. This increase reflects the combined effect of all the movements explained above.Net loss for the nine-month period ended 30 September 2023 totalled JPY 6,985 million (US$50.6 million) vs. a net loss of JPY 3,225 million (US$25.2 million) in the prior corresponding period. This increase reflects the combined effect of all the movements explained above.Core operating loss** totalled JPY 3,920 million (US$28.4 million) vs. a core operating profit of JPY 1,300 million (US$10.2 million) in the prior corresponding period. Cash and cash equivalents as at 30 September 2023 amounted to JPY 42,386 million (US$283.8 million) having decreased by JPY 24,171 million (US$223.2 million) from the beginning of the year. This decrease was primarily due to the transaction with Idorsia. *Convenience conversion to US$ at the following rates: FY 2023: 1US$ =138.09 JPY; FY 2022: 1US$ =127.94 JPY; 30 Sep 2023: 1US$ = 149.37 JPY; 31 Dec 2022: 1US$ = 131.27 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. -ENDS- About Sosei HeptaresSosei Heptares is a fully integrated biopharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global biopharmaceutical champions. Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the UK with a highly experienced clinical development capability and a commercial operation in Japan. We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in Japan and globally both internally and through our partnerships with global biopharmaceutical companies and emerging technology companies. Sosei Heptares operates from key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea). “Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies. For more information, please visit https://soseiheptares.com/LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco Enquiries Sosei Heptares – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate Strategy Shinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com MEDiSTRAVA Consulting (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | SoseiHeptares@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 Sosei Group Corporation’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 FY23Q3 E_Tanshin_231110_Final

NDA includes robust data from a Phase 3 trial that demonstrated efficacy of daridorexant on improving Total Sleep Time and Latency for Sleep Onset, while maintaining a favorable safety profileSosei Heptares to receive JPY 1.5 billion milestone revenue in relation to the submission Tokyo, Japan and Cambridge, UK, 31 October 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) announces that Idorsia Pharmaceuticals Japan Ltd. (“Idorsia Japan”), a Sosei Group company, has submitted a New Drug Application (“NDA”) to the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) for the approval of daridorexant (ACT-541468), a dual orexin receptor antagonist which has been co-developed with Mochida Pharmaceutical Co., Ltd. ("Mochida”), for the treatment of adult patients with insomnia. The NDA is supported by positive results of a randomized, double-blind, placebo-controlled Phase 3 study in Japan to investigate the efficacy and safety of daridorexant. The study met both primary and secondary efficacy endpoints. Daridorexant significantly improved subjective Total Sleep Time (“sTST”), a primary endpoint defined as the change from baseline compared to placebo at 28 days (p<0.001 for 50 mg, p=0.042 for 25 mg). Daridorexant also significantly improved sleep onset as measured by a decrease in subjective Latency for Sleep Onset (“sLSO”), a primary endpoint defined as the change from baseline compared to placebo at 28 days (p<0.001 for 50 mg, p=0.006 for 25 mg). The rate of adverse events was comparable between placebo and daridorexant at both treatment doses. Treatment-emergent adverse events (“TEAEs”) during the double-blind study period were reported in 23.5% and 22.7% of the patients treated with 50 mg and 25 mg daridorexant, respectively (24.4% for placebo). Sosei Heptares gained Japan and Asia-Pacific (ex-China) rights to daridorexant from Idorsia Pharmaceuticals Ltd (Allschwil, Switzerland) in July 2023 in the context of its acquisition of Idorsia Japan and Idorsia Pharmaceuticals Korea Co., Ltd. Daridorexant was approved in the US and Europe in January and April 2022, respectively, and is marketed by Idorsia in these and other approved territories as QUVIVIQ™. In December 2019, Mochida and Idorsia Pharmaceuticals Ltd entered into an exclusive license agreement for the co-development and co-marketing of daridorexant for insomnia and related disorders in Japan. Under the agreement, Mochida and Idorsia Japan have jointly developed daridorexant and plan to co-market daridorexant pending Idorsia Japan receiving Japanese PMDA approval. In relation to the filing of this NDA, Sosei Heptares will receive JPY 1.5 billion (US$10 million*). The milestone receipt will be recognized as revenue in the fourth quarter of the financial year ending 31 December 2023. * USD1 = JPY149.86 Makoto Uchiyama, M.D., Ph.D., medical advisor of the Japanese Phase 3 study, Director of Tokyo Adachi Hospital, Visiting Professor of Nihon University, and Visiting Professor of Toho University, commented: “Insomnia is highly prevalent in Japan and is recognized as an important national health issue. Patients with insomnia have trouble falling or staying asleep, as well as waking up earlier than desired, all of which lead to detrimental effects on both physical and mental health. Daridorexant is the first drug for a decade to have been clinically investigated in more than 100 centers in Japan and showed marked positive results in the studies. The Japanese Phase 3 trial showed that daridorexant increased total sleep time and shortened sleep latency in patients with insomnia without marked hangover symptoms the next morning, which clearly indicates its potency to improve core symptoms of insomnia. Such a promising outcome was likely due to the unique characteristics of the drug, a dual orexin receptor antagonist with an optimal elimination half-life.” Satoshi Tanaka, Dr Med Sci., President of Idorsia Pharmaceuticals Japan (a Sosei Group company), and Executive Officer and Executive Vice President of Sosei Heptares, added: “The team has worked rapidly to analyze the data and prepare the dossier for the PMDA so that we can bring daridorexant to patients as soon as possible. We will now work together with the authorities through the regulatory process, and in parallel, prepare the scientific publication and the commercial launch of 10, 25 and 50 mg tablets, which we hope to see in the second half of 2024. Together with the development partner Mochida, the whole team is eager to rapidly make daridorexant available to Japanese patients with insomnia.” QUVIVIQ™ is a registered trademark of Idorsia Ltd. -ENDS- Notes to Editors About Insomnia DisorderInsomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. This impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep. Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to a survey by the Ministry of Health, Labour and Welfare in 2018, about 20% of Japanese adults struggle to get enough rest from sleep. Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels. The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy. About the Orexin systemWake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness. There are two forms of orexin neuropeptides – small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain – orexin A and orexin B. Orexin promotes wakefulness through its receptors OX1R and OX2R. Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system – leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) – to promote wakefulness. Under normal circumstances, orexin levels rise throughout the day as wakefulness is promoted and then fall at night. Overactivity of the wake system is an important driver of insomnia. About the Japanese Phase 3 StudyThe Japanese Phase 3 study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to investigate the efficacy and safety of daridorexant in patients with insomnia disorder. The primary objective of the study was to demonstrate the efficacy of 50 mg of daridorexant once daily at bedtime versus placebo for 4 weeks in patients with insomnia disorder. The efficacy of daridorexant was measured by patient reported total sleep time (“sTST”) and latency to sleep onset (“sLSO”). The primary efficacy endpoint was change from baseline to Week 4 in sTST and change from baseline to Week 4 in sLSO with 50 mg daridorexant versus placebo. The secondary efficacy endpoint was change from baseline to Week 4 in sTST and change from baseline to Week 4 in sLSO with 25 mg daridorexant versus placebo. The study also evaluated the dose effect of 50 or 25 mg of daridorexant versus placebo using other patient reported sleep measures. The study enrolled 490 patients, randomized 1:1:1 to daridorexant 50 mg, 25 mg or placebo. As insomnia often presents later in life, and older adults are more susceptible to experience fragmented sleep, early awakening, and daytime sleepiness, around 30% of the recruited population was at least 65 years of age. Key Literature Riemann, D., et al. Sleep. 2017;26(6):675-700.The Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM–5; American Psychiatric Association, 2013).Wardle-Pinkston S., et al. Sleep Med Rev. 2019;48.Mignot, E., et al. Lancet Neurol. 2022;21:125–39.Muehlan, C., et al. Expert Opin. Drug Metab. Toxicol. 2020;16(11):1063–1078.Muehlan, C., et al. J Psychopharmacol. 2020;34(3):326-335.Buysse, D.J., et al. Drug Discov Today Dis Models. 2011;8(4):129-137.Levenson, J.C., et al. Chest. 2015;147(4):1179-1192.Boof, M.L., et al. Eur J Clin Pharmacol. 2019;75(2):195-205.Clifford, B.S., et al. Trends Neurosci. 2001;24(12).726-31.Gotter, A.L., et al. BMC Neuroscience. 2013;14(1):14-19.Patel, D., et al. J Clin Sleep Med. 2018;14(06):1017–1024.Fietze I., et al. Drugs Aging. 2022 Oct;39(10):795-810.Kunz D, et al. CNS Drugs. 2022 Dec 9. About Makoto Uchiyama, M.D., Ph.D.Director, Tokyo Adachi Hospital, TokyoVisiting Professor, Departments of Psychiatry and Sleep Medicine, Nihon University School of Medicine, TokyoVisiting Professor, Department of Psychiatry, Toho University School of Medicine, TokyoEducational Achievements and certificates:M.D., Tohoku University, School of Medicine, Sendai, 1980Ph.D., Tokyo Medical and Dental University, Tokyo, 1994Designated Physicians of Mental Health, Ministry of Health, Labor and Welfare, 1987Board Certified Physician of the Japanese Society of Sleep Research, 2002Certified Psychiatrist of the Japanese Board of Psychiatry, 2006Board-certified Clinical Neurophysiologist (EEG section), Japanese Society of Clinical Neurophysiology, 2006 Dr. Uchiyama serves as a consultant to Idorsia Pharmaceuticals Japan. About Idorsia Pharmaceuticals JapanIdorsia Pharmaceuticals Japan was established in 2018 to conduct clinical development and prepare the commercialization of innovative and promising compounds for patients in Japan. Idorsia Pharmaceuticals Japan is a wholly owned subsidiary of Sosei Group Corporation. About Sosei HeptaresSosei Heptares is a fully integrated biopharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global biopharmaceutical champions. Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the UK with a highly experienced clinical development capability and a commercial operation in Japan. We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in Japan and globally both internally and through our partnerships with global biopharmaceutical companies and emerging technology companies. Sosei Heptares operates from key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea). “Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies. For more information, please visit https://soseiheptares.com/LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco Enquiries: Sosei Heptares – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate Strategy Shinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com Idorsia Pharmaceuticals Japan – Product Information Drug Information Center +81 (0)3 5962 5674 MEDiSTRAVA Consulting (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | SoseiHeptares@medistrava.com Sosei Group Corporation Forward-Looking StatementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Sosei Group Corporation’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.