EDDC-2214

SHANGHAI, Aug. 24, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, today announced its interim results for first half of 2022 along with a corporate progress update. Everest has made significant progress on all fronts of our business and therapeutic areas in the first half of 2022 as the company continued to progress clinical and regulatory development across our diverse pipeline, build up self-discovery capabilities and expand key partnerships. Looking ahead, by strengthening our capital structure through the recent strategic sale of the rights to Trodelvy in Asia territories, Everest has the capacity to accelerate the development of important assets in our portfolio with first-in-class or best-in-class potential, further advance our internal discovery efforts and pursue business development opportunities that will maximize impact for patients worldwide and create sustained, long-term value for our shareholders. Below are product highlights in 1H and anticipated future milestones: NEFECON (TarpeyoTM), a novel oral formulation of budesonide (budesonide delayed release capsules) in the development for the treatment of primary immunoglobulin A nephropathy (IgAN). - Product development achievements during the Reporting Period: In March 2022, the Company announced it entered into a license agreement with Calliditas to develop and commercialize NEFECON for the treatment of primary IgAN in South Korea, expanding its license in addition to rights held in Greater China and Singapore. The deal signaled the Company's latest efforts to further enhance its international commercial footprint. In April 2022, the Company announced the findings of reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after nine months of treatment with NEFECON are in line with topline results from Part A of the pivotal global Phase 3 clinical trial NefIgArd, which were reported in November 2020 by our partner, Calliditas Therapeutics. - Post-Reporting Period achievements and expected milestones: In July 2022, our partner Calliditas was granted conditional marketing authorization for Kinpeygo® (developed under the name NEFECON) by the European Commission for the treatment of IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/gram. We expect to file a New Drug Application (NDA) for NEFECON in China in the second half of 2022. Etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC). - Product development achievements during the Reporting Period: In May 2022, our licensing partner, Pfizer Inc., presented detailed results from two pivotal studies that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod for the treatment of moderately-to-severely active UC. Both Phase 3, multi-center, randomized, placebo-controlled trials achieved all primary and key secondary endpoints, with etrasimod demonstrating a safety profile consistent with previous studies. In the 52-week ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P=<.001) and was 32.1% compared with 6.7% at week 52 (25.4% differential, P=<.001). In the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients receiving etrasimod compared with 15.2% of patients receiving placebo (9.7% differential, P=.0264). The data from ELEVATE UC 52 & UC 12 are expected to form the basis for planned future regulatory filings, which Pfizer expects to initiate later this year. - Post-Reporting Period achievements and expected milestones: We are conducting a Phase 3 study for etrasimod for the treatment of moderate-severe UC, which is expected to complete enrollment in 2023. PTX-COVID19-B, a potentially best-in-class lipid nanoparticle-formulated mRNA COVID-19 vaccine with strong immunogenicity and tolerability profiles. - Product development achievements during the Reporting Period: In April 2022, the Company announced it entered into a memorandum of understanding (MOU) for a partnership with China Resources Pharmaceutical Group Limited with the intention to establish an independent company ("the mRNA Co.") focused on the discovery, development and commercialization of messenger RNA (mRNA) vaccines. Through this proposed partnership with CR Pharma, the mRNA Co. will be well-positioned to advance its potentially best-in-class mRNA vaccine candidates through Chinese regulatory pathways and into commercialization. Under the terms of the MOU, the mRNA Co. will be a fully functional, independent operating company by assuming the rights under the existing collaboration with Providence Therapeutics Holdings Inc., including the full technology platform, as well as the Company's mRNA manufacturing infrastructure. The Company will be the majority and controlling shareholder of the mRNA Co. - Post- Reporting Period achievements and expected milestones: Providence will readout the data from the pivotal Phase 2 trial of PTX-COVID19-B in 2022. Providence and the Company will initiate a Phase 3 trial of PTX-COVID19-B for booster indication in 2022. Providence and the Company are working on an Omicron-containing bivalent booster candidate, EVER-COVID19-M1, and expect to file investigational new drug application (IND) for phase 3 registrational study in the first half of 2023. Providence and the Company expect rolling regulatory submissions of our mRNA COVID-19 vaccines starting in 2023 globally and anticipate approval and launch in 2023. Sacituzumab govitecan (Trodelvy®), a first-in-class TROP-2 directed antibody-drug conjugate (ADC). - Product development achievements during the Reporting Period: In January 2022, the Company announced it would participate in a study pursuant to a clinical trial collaboration between Gilead Sciences, Inc. ("Gilead") and Merck & Co., Inc. ("MSD") to evaluate the combination of sacituzumab govitecan and MSD's anti-PD-1 therapy Keytruda® (pembrolizumab) in first-line metastatic non-small cell lung cancer ("NSCLC"). As part of the collaboration, MSD will sponsor this trial. The Company will participate in the global phase 3 study in Asia through its existing collaboration agreement with Gilead. In January 2022, the Health Sciences Authority ("HSA") of Singapore approved the Company's New Drug Application ("NDA") for sacituzumab govitecan for the treatment of second-line and later lines metastatic triple negative breast cancer ("TNBC"). In March 2022, the Company submitted an NDA to the Department of Health of Hong Kong for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC. In June 2022, our partner Gilead reported positive results from the primary analysis of phase 3 TROPiCS-02 study of Trodelvy® (sacituzumab govitecan) versus physician's choice of chemotherapy ("TPC") in heavily pre-treated hormone receptor positive, HER2 negative metastatic breast cancer ("HR+/HER2- mBC") patients who received prior endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy. The study met its primary endpoint of progression-free survival ("PFS") with a statistically significant 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53–0.83; P<0.0003). In June 2022, the Company announced that the China National Medical Products Administration ("NMPA") had approved Trodelvy® for the treatment of adult patients with second-line metastatic TNBC. This represents the first drug that the Company has obtained an NDA approval to launch in China, and it follows the NMPA's acceptance of the Company's NDA for Trodelvy® with Priority Review designation in May 2021. - Post- Reporting Period achievements: In August 2022, the Company announced it entered into an agreement with Immunomedics, Inc., ("Immunomedics"), a wholly-owned subsidiary of Gilead Sciences, Inc., whereby Immunomedics will obtain exclusive rights to develop and commercialize Trodelvy® in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia (the "Agreement"). Under the terms of the Agreement, the Company will receive up to $455 million in total considerations with $280 million in upfront payments payable subject to, among other things, certain regulatory approvals and up to $175 million in potential future milestone payments. In addition, Everest will be released from payment obligations for up to $710 million in remaining milestone payments under a licensing agreement entered into with Immunomedics in April 2019 to develop, register, and commercialize Trodelvy® in Greater China, South Korea and certain other countries and territories. Under the Agreement, the licensing agreement will be terminated. The TRODELVY trademark is used under license from Gilead Sciences, Inc. Other clinical-stage assets - Product development achievements during the Reporting Period: In March 2022, our licensing partner, Venatorx Pharmaceuticals ("Venatorx"), reported positive results from its pivotal Phase 3 study, CERTAIN-1, evaluating cefepime-taniborbactam, an investigational new drug, versus meropenem as a potential treatment for hospitalized adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The CERTAIN-1 trial enrolled 661 adult patients globally, including in China, who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for seven days (up to 14 days for patients with bacteremia). Cefepime-taniborbactam met the primary efficacy endpoint of statistical non-inferiority (NI) to meropenem in the microbiological intent-to-treat (microITT) population at Test of Cure (TOC) with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% CI, 2.4, 21.6). Venatorx plans to submit an NDA with the U.S. FDA for cefepime-taniborbactam for the treatment of cUTI in hospitalized adult patients later this year. Ralinepag is a next-generation, potent, selective oral IP receptor agonist being developed for the treatment of pulmonary arterial hypertension (PAH). We continue to progress our Phase 3 registrational trial for PAH in China as part of a global Phase 3 study conducted together with our partner, United Therapeutics. - Post- Reporting Period achievements and expected milestones: In August 2022, the Company announced that the Taiwan Food and Drug Administration (TFDA) accepted the submission of an NDA for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). In addition, the Company entered into an exclusive partnership agreement with TTY Biopharm for the commercialization of Xerava in Taiwan. We expect NDA approval for eravacycline for the treatment of cIAI in China within 2022. Business Development Updates In January 2022, the Company entered into a global licensing agreement with Singapore's national platform for drug discovery and development, the Experimental Drug Development Centre ("EDDC"), for the exclusive worldwide rights to develop, manufacture and commercialize EDDC's series of viral 3C-like (3CL) protease inhibitors as a potentially best-in-class oral antiviral treatment against SAR-CoV-2 (the virus causing COVID-19) and its variants. The Company has full rights to sub-license the drug further and will receive full technology transfer. We expect Phase 1 clinical trials of EDDC-2214, as an oral antiviral treatment against SAR-CoV-2 and its variants, to begin in 2023. Discovery Updates: In Feb. 2022, the Company officially launched its first research center for innovative drugs in Shanghai's Zhangjiang Hi-Tech Park, and has initiated more than 10 discovery projects across multiple therapeutic areas, such as oncology, renal disease and mRNA vaccine. We expect some of the discovery projects to advance to IND filing in 2023. Commercialization: We have built up an industry-leading commercial team with an extensive track record of successfully commercializing novel therapies across a range of therapeutical areas to support our anticipated commercial launch of multiple late-stage products. Our commercial team has been conducting key opinion leaders (KOL) engagements and medical education activities about IgAN and cIAI. Financial Highlights IFRS Numbers: Research and development ("R&D") expenses increased by RMB94.7 million from RMB250.8 million for the six months ended 30 June 2021 to RMB345.5 million for the six months ended 30 June 2022, primarily due to (i) additional clinical trials for our drug candidates; (ii) expansion of internal discovery team to build up in-house R&D capabilities; (iii) increased technical transfer related costs for our drug candidates. General and administrative expenses increased by RMB11.5 million from RMB107.4 million for the six months ended 30 June 2021 to RMB118.9 million for the six months ended 30 June 2022, mainly due to increased office expenses and other infrastructure expenses to support expanded organization. Distribution and selling expenses increased by RMB106.1 million from RMB42.1 million for the six months ended 30 June 2021 to RMB148.2 million for the six months ended 30 June 2022, primarily due to the expansion of our commercial organization and launch and pre-launch activities carried out for product commercialization. Net loss for the period increased by RMB284.9 million from RMB383.1 million for the six months ended 30 June 2021 to RMB668.0 million for the six months ended 30 June 2022, primarily attributable to increased R&D expenses and distribution and selling expenses. Cash and cash equivalents amounted to RMB1,956.8 million as of 30 June 2022. Non-IFRS Measure: Adjusted loss for the period[i] increased by RMB220.6 million from RMB303.1 million for the six months ended 30 June 2021 to RMB523.7 million for the six months ended 30 June 2022, primarily attributable to an increase in R&D expenses and distribution and selling expenses. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines