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SHANGHAI, March 31, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines, today announced its financial results for the full year ended December 31, 2022, along with a corporate update. "Despite a challenging external capital environment in 2022, we made solid advancements in our key therapeutic areas toward becoming a fully integrated biopharmaceutical company," said Rogers Yongqing Luo, CEO of Everest Medicines. "We received NDA approval for Xerava in China this month and successfully filed for New Drug Application for Nefecon in mainland China with Breakthrough Therapy Designation and Priority Review status, while also receiving fast-track review designations in other Asian territories for Nefecon. We reported positive topline results from multiple clinical studies and achieved the first pre-clinical proof-of-concept milestone from our self-discovery programs. Moreover, our state-of-the-art mRNA vaccine manufacturing facility began production and successfully completed trial runs. The company's loss in 2022 was reduced by RMB 760 million compared with the previous year. We head into 2023 with a strong balance sheet of US$432 million, along with a clear new strategy for the future." "2023 is set to be an exciting year for Everest, as the commercialization of our first product will propel the Company from a clinical-stage biotech to a commercial-stage biopharmaceutical company. We will establish a highly efficient commercial team to bring important novel treatments such as Xerava and Nefecon to Chinese patients as soon as possible. We also strive to make significant progress in clinical and regulatory development, internal R&D and business development across our key therapeutic areas of renal diseases and infectious diseases, as well as to our mRNA platform. We anticipate at least three more drug candidates to receive NDA approval in China over the next two years, which will bring very promising commercial prospects," said Luo. Recent Product Highlights and Anticipated Milestones INFECTIOUS DISEASE PORTFOLIO Xerava (Eravacycline), is a novel, fully synthetic fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive, gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. 2022: ⎯ In August, the Company announced that the Taiwan Food and Drug Administration had accepted its 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 for the commercialization of Xerava in Taiwan. ⎯ In October, the Company announced that the Department of Health of the Hong Kong Special Administrative Region, China, approved an NDA for Xerava for the treatment of cIAI in adult patients in Hong Kong. 2023: ⎯ In March, the Company announced that NMPA of China approved its NDA for Xerava for the treatment of cIAI in adult patients. ⎯ We expect NDA approval of eravacycline for the treatment of cIAI in Taiwan region in 2023. Taniborbactam, is a beta-lactamase inhibitor ("BLI") that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat resistant gram-negative bacteria, most notably carbapenem- resistant Enterobacterales ("CRE") and carbapenem-resistant Pseudomonas aeruginosa ("CRPA"), particularly for those resistance caused by metallo beta-Lactamases. - In March 2022, our licensing partner, Venatorx Pharmaceuticals ("Venatorx"), reported positive results from its pivotal phase 3 study, CERTAIN-1 (Cefepime Rescue with taniborbactam in cUTI), 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. - We expect to file NDA for taniborbactam for the treatment of cUTI in China in 2023. EVER206 (also known as SPR206) is a potentially best-in-class, novel polymyxin derivative designed to reduce toxicity, especially nephrotoxicity, compared to the levels observed clinically with polymyxin B and colistin. ⎯ In January 2023, the Company announced topline results from a China phase 1 study on healthy subjects demonstrating that EVER206 is well-tolerated with no evidence of acute kidney injury and no new safety signals on healthy subjects with dose ranges applied in the study. The pharmacokinetics of healthy subjects in China were comparable to the results of the overseas phase I study (SPR206-101) and the safety profile was also similar to the results from the overseas Phase I trial, supporting Everest's plans to initiate next-phase clinical development in China soon. ⎯ We expect to initiate the phase 3 trial of EVER206 in 2023. RENAL PORTFOLIO Nefecon, our anchor drug candidate in the renal therapeutic area, is a novel oral formulation of budesonide in development for the treatment of primary IgAN. 2022: ⎯ In April, the Company announced the findings of reduction in proteinuria and stabilization of estimated glomerular filtration rate ("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 Calliditas. ⎯ In July, our partner Calliditas was granted conditional marketing authorization for Kinpeygo® (brand name of Nefecon in Europe) by the European Commission for the treatment of primary IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/gram. ⎯ In November, the Company received an acceptance from the China NMPA for its NDA of Nefecon for the treatment of primary IgAN in adults at risk of rapid disease progression. ⎯ In November, the Company announced the Taiwan Food and Drug Administration granted Accelerated Approval Designation to Nefecon and the MFDS in South Korea granted Orphan Drug Designation to Nefecon. 2023: ⎯ In Jan., CDE of the China NMPA granted Priority Review for the NDA of Nefecon. ⎯ In February, South Korea's MFDS granted Global Innovative product on Fast Track ("GIFT") designation to Nefecon for the treatment of primary IgAN. Nefecon is the second product and the first non-oncology product included in MFDS's GIFT program. Inclusion of the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review. ⎯ In March, our partner Calliditas reported positive topline results from Phase 3 NefIgArd Trial evaluating Nefecon in IgAN. The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value <0.0001) in eGFR over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug. ⎯ We expect to receive NDA approval for Nefecon for the treatment of primary IgAN in mainland China and Singapore in 2023. ⎯ We expect to file NDA of Nefecon for the treatment of IgAN in South Korea, Hong Kong and Taiwan region in 2023. EVER001 is the next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. ⎯ In September 2022, the Company announced that the CDE has approved the IND application for a phase 1b study of EVER001, in development for the treatment of glomerular diseases. mRNA PLATFORM PTX-COVID19-B, a potentially best-in-class lipid nanoparticle-formulated mRNA COVID-19 vaccine with strong immunogenicity and benign tolerability profiles. ⎯ In October 2022, our partner Providence reported positive topline data from a phase 2 study evaluating the safety, tolerability and immunogenicity of its mRNA COVID-19 vaccine candidate, PTX-COVID19-B. PTX- COVID19-B demonstrated non-inferiority compared to Comirnaty®, Pfizer's and BioNTech's U.S. Food and Drug Administration ("FDA") - approved mRNA vaccine, with respect to the geometric mean titer ratio of neutralizing antibodies observed two weeks after the second of two intramuscular injections. Additionally, PTX-COVID19-B was generally well-tolerated, with a safety and tolerability profile similar to Comirnaty®. This phase 2 study provides important clinical validation of our mRNA technology platform. EVER-COVID19-M1, is an Omicron-targeting bivalent COVID-19 booster vaccine candidate. ⎯ The Company is working on an Omicron-containing bivalent booster candidate — EVER-COVID19-M1, and initiated rolling submission of IND applications for phase 1 and 2 study which may enable potential emergency use authorization application. mRNA rabies vaccine ⎯ In December 2022, the Company announced it had achieved the pre-clinical proof-of-concept milestones for the mRNA rabies vaccine program. The rabies program is the first non-COVID 19 vaccine developed with our clinically- validated mRNA platform, highlighting the in-house discovery capabilities of the Company. OTHER CLINICAL-STAGE ASSETS ⎯ 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, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis ("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 December 2022, our licensing partner Pfizer received acceptance from the U.S. FDA for the review of an NDA for etrasimod for individuals living with moderately-to-severely active UC. The FDA's decision is expected in the second half of 2023. This anticipated U.S. FDA approval will be the first approval of etrasimod globally. In addition, the European Medicines Agency accepted the Marketing Authorization Application for etrasimod in the same patient population, with the decision anticipated in the first half of 2024. ⎯ We are conducting a phase 3 study in Asia for etrasimod for the treatment of moderate-severe UC, which is expected to complete enrollment in 2023. Business Development Updates ⎯ In March 2022, the Company 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. ⎯ In August 2022, the Company announced that it entered into an agreement with Immunomedics, Inc. ("Immunomedics"), a wholly-owned subsidiary of Gilead, whereby Immunomedics will obtain exclusive rights to develop and commercialize Trodelvy® (sacituzumab govitecan) 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 US$455 million in total considerations with US$280 million in upfront payments payable subject to, among other things, certain regulatory approvals and up to US$175 million in potential future milestone payments. In addition, the Company will be released from payment obligations for up to US$710 million in remaining milestone payments. Drug Discovery Our discovery team is focused on precision disease-modifying mechanisms in key pathogenic pathways in kidney diseases and promising mRNA vaccines such as prophylactic vaccines for infectious disease and therapeutic cancer vaccines against solid tumors. Our mRNA rabies vaccine program achieved pre-clinical proof-of-concept in December 2022 as the first of several non-COVID-19 mRNA vaccine/therapeutics candidates that have demonstrated our discovery capabilities. Manufacturing facility The company's state-of-the-art mRNA manufacturing facility in Jiashan, Zhejiang Province initiated operation and successfully carried out trial production runs in December 2022. The first phase of the project, covering an area of 58,000 square meters, has a set of advanced production facilities built to meet global and China GMP standards, and designed with an annual production capacity of 700 million doses of mRNA vaccines. Commercialization The regulatory approval of Xerava in Singapore was the first product approval wholly applied by and granted to Everest, and Xerava is our first marketed product. As the company transforms to a fully-integrated biopharma, we are building out a highly efficient and industry-leading commercial team, focusing on the therapeutic areas of internal medicines and infectious diseases. We expect to commercially launch Xerava in mainland China in Q3 2023 and the commercial team will be further expanded when approaching the expected approval of Nefecon in mainland China. In addition, under the supporting policies of the Boao Lecheng International Medical Tourism Pilot Zone, our commercial team is working on an early access program of Nefecon to bring benefits to patients sooner. Financial Highlights IFRS Numbers: Total assets of RMB 6.61 billion and net assets of RMB 5.65 billion for the year ended December 31, 2022. Revenue increased by RMB12.7 million to RMB12.8 million for the year ended 31 December 2022, from RMB54,000 for the year ended 31 December 2021, primarily due to the sales of eravacyline and Trodelvy in Singapore. Research and development (the "R&D") expenses increased by RMB196.3 million to RMB809.7 million for the year ended 31 December 2022, from RMB613.4 million for the year ended 31 December 2021, 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. R&D expenses related to Trodelvy after August 1, 2022 would be reimbursed by Gilead. General and administrative expenses increased by RMB33.8 million to RMB276.5 million for the year ended 31 December 2022, from RMB242.7 million for the year ended 31 December 2021, primarily due to increased professional service expenses. Distribution and selling expenses increased by RMB128.5 million to RMB326.7 million for the year ended 31 December 2022, from RMB198.2 million for the year ended 31 December 2021, primarily due to increased employee benefit expenses and launch and pre-launch activities carried out for commercialization. Distribution and selling expenses related to Trodelvy after August 1, 2022 would be reimbursed by Gilead. Net loss for the year ended 31 December 2022 was RMB247.3 million, compared with RMB1,008.7 million for the year ended 31 December 2021, primarily due to the other gain of RMB1,322.3 million from Trodelvy transaction. Cash and cash equivalents and bank deposits amounted to RMB1,651.4 million as of 31 December 2022. Pro forma for the Trodelvy Agreement upfront considerations we received in early 2023, our Cash and cash equivalents and bank deposits amounted to USD432 million. Non-IFRS Measure: Adjusted loss for the year[1] was RMB17.4 million for the year ended 31 December 2022, representing a decrease of RMB759.9 million from RMB777.3 million for the year ended 31 December 2021, primarily due to other gain of RMB1,322.3 million from Trodelvy® transaction. [1] Adjusted loss for the year represents [the loss for the year attributable to the equity holders of the Company excluding the effect of certain non-cash items and one- time events, namely the loss on fair value changes of preferred shares (non-current financial liabilities measured at fair value through profit or loss) and share-based compensation loss.] For the calculation and reconciliation of this non-IFRS measure, please refer to the paragraph numbered [15] under the heading "Financial Review" below. Conference Call Information The English session of the conference call will be held at 9:00 AM on March 31, 2023 Beijing Time (9:00 PM U.S. Eastern Time on March 30, 2023), and the Mandarin session of the conference call will be held at 11:00 AM Beijing Time on the same day (11:00 PM U.S. Eastern Time on March 30, 2023). The conference calls can be accessed by the following links: For English Session: Time: 9:00 AM Beijing Time, Friday, March 31, 2023 Pre -Registration Link: https://www.acecamptech.com/eventDetail/60503323 Webcast Link: https://www.acecamptech.com/meeting_live/70504909/4090?event_id=60503323event_id=60503222 Alternatively, participants may dial in to the conference call using below dial-in information: United States: +1 646 2543594 (EN) Chinese Mainland: +86-10-58084166 (EN) +86-10-58084199 (CN) Hong Kong, China: +852-30051313 (EN) +852-30051355 (CN) United Kingdom: International: +44-20-76600166 (EN) +1-866-6363243 (EN) Password: 519059 For Mandarin Session: Time: 11:00 AM Beijing Time, Friday, March 31, 2023 Webcast Link: https://s.comein.cn/ANQw8 Alternatively, participants may dial into the conference call using below dial-in information: United States: +1-646-5189851 Chinese Mainland: +86-4001668383 +86-01053827136 Hong Kong, China: Taiwan, China: +852-30183077 +886-277414090 Singapore: +65-31589102 United Kingdom: Korean: +44-2034816289 +82-0079885238059 Password: 312416 The replay of English session will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development, and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. 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.
BEIJING, Nov. 26, 2025 /PRNewswire/ -- Gaotu Techedu Inc. (NYSE: GOTU) ("Gaotu" or the "Company"), a leading technology-driven education company in China focused on enabling lifelong learning through AI-powered solutions, today announced its unaudited financial results for the third quarter ended September 30, 2025. Third Quarter 2025 Highlights[1] Net revenues were RMB1,579.0 million, increased by 30.7% from RMB1,208.3 million in the same period of 2024. Gross billings[2] were RMB1,188.9 million, increased by 11.2% from RMB1,069.2 million in the same period of 2024. Loss from operations was RMB178.0 million, compared with loss from operations of RMB490.1 million in the same period of 2024. Net loss was RMB147.1 million, compared with net loss of RMB471.3 million in the same period of 2024. Non-GAAP net loss was RMB137.7 million, compared with non-GAAP net loss of RMB457.2 million in the same period of 2024. Net operating cash outflow was RMB660.2 million, compared with net operating cash outflow of RMB714.4 million in the same period of 2024. Third Quarter 2025 Key Financial and Operating Data (In thousands of RMB, except for percentages) For the three months ended September 30, 2024 2025 Pct. Change Net revenues 1,208,253 1,579,026 30.7 % Gross billings 1,069,159 1,188,909 11.2 % Loss from operations (490,107) (178,025) (63.7) % Net loss (471,273) (147,121) (68.8) % Non-GAAP net loss (457,195) (137,745) (69.9) % Net operating cash outflow (714,385) (660,230) (7.6) % [1] For a reconciliation of non-GAAP numbers, please see the table captioned "Reconciliations of non-GAAP measures to the most comparable GAAP measures" at the end of this press release. Non-GAAP income (loss) from operations and non-GAAP net income (loss) exclude share-based compensation expenses. [2] Gross billings is a non-GAAP financial measure, which is defined as the total amount of cash received for the sale of course offerings in such period, net of the total amount of refunds in such period. See "About Non-GAAP Financial Measures" and "Reconciliations of non-GAAP measures to the most comparable GAAP measures" elsewhere in this press release. Nine Months Ended September 30, 2025 Highlights Net revenues were RMB4,461.5 million, increased by 41.0% from RMB3,164.9 million in the same period of 2024. Gross billings were RMB4,330.0 million, increased by 25.4% from RMB3,452.2 million in the same period of 2024. Loss from operations was RMB385.1 million, compared with loss from operations of RMB1,032.6 million in the same period of 2024. Net loss was RMB239.1 million, compared with net loss of RMB913.1 million in the same period of 2024. Non-GAAP net loss was RMB207.3 million, compared with non-GAAP net loss of RMB872.2 million in the same period of 2024. Net operating cash outflow was RMB548.7 million, compared with net operating outflow of RMB525.6 million in the same period of 2024. First Nine Months 2025 Key Financial and Operating Data (In thousands of RMB, except for percentages) For the nine months ended September 30, 2024 2025 Pct. Change Net revenues 3,164,935 4,461,457 41.0 % Gross billings 3,452,211 4,330,021 25.4 % Loss from operations (1,032,559) (385,117) (62.7) % Net loss (913,120) (239,124) (73.8) % Non-GAAP net loss (872,196) (207,255) (76.2) % Net operating cash outflow (525,636) (548,670) 4.4 % Larry Xiangdong Chen, the Company's founder, Chairman and CEO, commented, "With a profound focus on user needs, Gaotu continues to provide end-to-end educational products and solutions across the full learning lifecycle. We have deeply integrated online and offline formats and accelerated full-stack AI integration across our teaching, services, and operations to provide users with increasingly differentiated and personalized services. In the third quarter, we achieved sustained growth momentum and enhanced profitability. Our revenue grew by 30.7% year over year to nearly RMB1.6 billion, while on a non-GAAP basis, both loss from operations and net loss narrowed significantly by 64.6% and 69.9%, respectively. Excluding the impact of share repurchases, our cash position improved year over year, strengthening our balance sheet and demonstrating our disciplined financial management. We also remained committed to delivering shareholder returns, completing our US$80 million share repurchase program initially launched in November 2022 this quarter and initiating the new US$100 million program approved in May. " "Going forward, Gaotu will continue to pursue sustainable growth by strengthening our pipeline of high-quality teachers, enhancing execution and leveraging data-driven operations, delivering enduring, long-term value to all our stakeholders." Shannon Shen, CFO of the Company, added, "In the third quarter, we sustained solid revenue growth while elevating our overall operational quality and efficiency. Operating expenses as a percentage of net revenues decreased significantly, improving by 27.6 percentage points year-over-year. Additionally, our user acquisition efficiency improved 12.8% year over year, and net operating cash outflow narrowed by approximately RMB54.2 million year over year, reflecting the early benefits of structured efficiency gains across our operations. Deferred revenue grew robustly to nearly RMB1.8 billion, up 23.2% year-over-year, providing greater visibility of revenue for the upcoming quarters. We will remain focused on driving high-quality, sustainable growth by optimizing unit economics, while enhancing our operational quality and resilience through continued product refinement, systematic teacher development and brand building." Financial Results for the Third Quarter of 2025 Net Revenues Net revenues increased by 30.7% to RMB1,579.0 million from RMB1,208.3 million in the third quarter of 2024, which was mainly due to the continued year-over-year growth in gross billings as a result of our sufficient and effective response to strong market demand. Furthermore, our high-quality educational products and learning services resulted in improved recognition of our product and service offerings. Cost of Revenues Cost of revenues increased by 24.6% to RMB535.5 million from RMB429.8 million in the third quarter of 2024. The increase was mainly due to expansion of instructors and tutors workforce, higher rental cost, and increased depreciation and amortization cost. Gross Profit and Gross Margin Gross profit increased by 34.0% to RMB1,043.5 million from RMB778.5 million in the third quarter of 2024. Gross profit margin increased to 66.1% from 64.4% in the same period of 2024. Non-GAAP gross profit increased by 33.8% to RMB1,044.5 million from RMB780.7 million in the third quarter of 2024. Non-GAAP gross profit margin increased to 66.1% from 64.6% in the same period of 2024. Operating Expenses Operating expenses decreased by 3.7% to RMB1,221.5 million from RMB1,268.6 million in the third quarter of 2024. The decrease was primarily due to our precise efficiency management and implementation of cost reduction, which resulted in year-over-year decreases in personnel expenses of selling, general and administrative, as well as research and development function. Selling expenses decreased to RMB873.4 million from RMB885.8 million in the third quarter of 2024. Research and development expenses decreased to RMB162.9 million from RMB189.3 million in the third quarter of 2024. General and administrative expenses decreased to RMB185.2 million from RMB193.5 million in the third quarter of 2024. Loss from Operations Loss from operations was RMB178.0 million, compared with loss from operations of RMB490.1 million in the third quarter of 2024. Non-GAAP loss from operations was RMB168.6 million, compared with non-GAAP loss from operations of RMB476.0 million in the third quarter of 2024. Interest Income and Realized Gains from Investments Interest income and realized gains from investments, on aggregate, were RMB14.9 million, compared with a total of RMB21.7 million in the third quarter of 2024. Other Income, net Other income, net was RMB14.6 million, compared with other income, net of RMB4.0 million in the third quarter of 2024. Net Loss Net loss was RMB147.1 million, compared with net loss of RMB471.3 million in the third quarter of 2024. Non-GAAP net loss was RMB137.7 million, compared with non-GAAP net loss of RMB457.2 million in the third quarter of 2024. Cash Flow Net operating cash outflow in the third quarter of 2025 was RMB660.2 million. Basic and Diluted Net Loss per ADS Basic and diluted net loss per ADS were both RMB0.61 in the third quarter of 2025. Non-GAAP basic and diluted net loss per ADS were both RMB0.57 in the third quarter of 2025. Share Outstanding As of September 30, 2025, the Company had 161,367,979 ordinary shares outstanding. Cash, Cash Equivalents, Restricted Cash, Short-term and Long-term Investments As of September 30, 2025, the Company had cash and cash equivalents, restricted cash, short-term and long-term investments of RMB3,040.4 million in aggregate, compared with a total of RMB4,094.3 million as of December 31, 2024. Acquisition of Property In November 2025, the Company entered into an agreement to acquire 100% of equity interest of Zhengzhou You'ai Culture Technology Co., Ltd. ("Zhengzhou You'ai") for a consideration of RMB206.6 million. The underlying assets of Zhengzhou You'ai are four buildings currently under construction, which have been topped out in November 2025. The Company intends to utilize the buildings as a campus premise upon completion. The transaction is a related party transaction and has been approved by both the Company's board of directors and the audit committee of the board. Share Repurchase In November 2022, the Company's board of directors authorized a share repurchase program ("2022 Share Repurchase Program"), under which the Company may repurchase up to US$30 million of its shares, effective until November 22, 2025. In November 2023, the Company's board of directors authorized modifications to the share repurchase program, increasing the aggregate value of shares that may be repurchased from US$30 million to US$80 million, effective until November 22, 2025. As of September 22, 2025, the Company's repurchase amount had reached US$80 million and the 2022 Share Repurchase Program was completed. In May 2025, the Company's board of directors authorized a new share repurchase program ("2025 Share Repurchase Program"), under which the Company may repurchase up to an aggregate value of US$100 million of its shares during the three-year period beginning upon the completion of the Company's 2022 Share Repurchase Program. As of November 25, 2025, the Company had cumulatively repurchased approximately 27.5 million ADSs for approximately US$85.6 million under aforesaid two share repurchase programs. Business Outlook Based on the Company's current estimates, total net revenues for the fourth quarter of 2025 are expected to be between RMB1,628 million and RMB1,648 million, representing an increase of 17.2% to 18.7% on a year-over-year basis. These estimates reflect the Company's current expectations, which are subject to change. Conference Call The Company will hold an earnings conference call at 8:00 AM U.S. Eastern Time on Wednesday, November 26, 2025 (9:00 PM Beijing/Hong Kong Time on Wednesday, November 26, 2025). Dial-in details for the earnings conference call are as follows: International: 1-412-317-6061United States: 1-888-317-6003Hong Kong: 800-963-976Mainland China: 400-120-6115Passcode: 5199067 A telephone replay will be available two hours after the conclusion of the conference call through December 3, 2025. The dial-in details are: International: 1-412-317-0088United States: 1-855-669-9658Passcode: 2149536 Additionally, a live and archived webcast of this conference call will be available at https://ir.gaotu.cn/home. Safe Harbor Statement This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company's ability to continue to attract students to enroll in its courses; the Company's ability to continue to recruit, train and retain qualified teachers; the Company's ability to improve the content of its existing course offerings and to develop new courses; the Company's ability to maintain and enhance its brand; the Company's ability to maintain and continue to improve its teaching results; and the Company's ability to compete effectively against its competitors. Further information regarding these and other risks is included in the Company's reports filed with, or furnished to the U.S. Securities and Exchange Commission. All information provided in this press release and in the attachments is as of the date of this press release, and the Company undertakes no duty to update such information or any forward-looking statement, except as required under applicable law. About Gaotu Techedu Inc. Gaotu is a leading technology-driven education company in China focused on enabling lifelong learning through AI-powered solutions that cultivate interest and drive continuous growth. The Company provides AI-powered, product-led learning solutions for learners from pre-school to adulthood. By combining rare, high-caliber teaching resources with AI-enhanced tools and content, Gaotu creates engaging and effective learning experiences delivered through both online and offline channels. AI and data analytics permeate throughout the Company's operations to adapt content and teaching methods to individual learner needs, enhance efficiency and drive sustained learning progress. About Non-GAAP Financial Measures The Company uses gross billings, non-GAAP gross profit, non-GAAP income (loss) from operations and non-GAAP net income (loss), each a non-GAAP financial measure, in evaluating its operating results and for financial and operational decision-making purposes. The Company defines gross billings for a specific period as the total amount of cash received for the sale of course offerings in such period, net of the total amount of refunds in such period. The Company's management uses gross billings as a performance measurement because the Company generally bills its students for the entire course fee at the time of sale of its course offerings and recognizes revenue proportionally as the classes are delivered. For some courses, the Company continues to provide students with 12 months to 36 months access to the pre-recorded audio-video courses after the online live courses are delivered. The Company believes that gross billings provides valuable insight into the sales of its course packages and the performance of its business. As gross billings have material limitations as an analytical metrics and may not be calculated in the same manner by all companies, it may not be comparable to other similarly titled measures used by other companies. Non-GAAP gross profit, non-GAAP income (loss) from operations and non-GAAP net income (loss) exclude share-based compensation expenses. The Company believes that these non-GAAP financial measures provide meaningful supplemental information regarding its performance and liquidity by excluding share-based expenses that may not be indicative of its operating performance from a cash perspective. The Company believes that both management and investors benefit from these non-GAAP financial measures in assessing its performance and when planning and forecasting future periods. These non-GAAP financial measures also facilitate management's internal comparisons to the Company's historical performance. A limitation of using non-GAAP measures is that these non-GAAP measures exclude share-based compensation charges that have been and will continue to be for the foreseeable future a significant recurring expense in the Company's business. The presentation of these non-GAAP financial measures is not intended to be considered in isolation from or as a substitute for the financial information prepared and presented in accordance with GAAP. For more information on these non-GAAP financial measures, please see the table captioned "Reconciliations of non-GAAP measures to the most comparable GAAP measures" set forth at the end of this release. The accompanying tables have more details on the reconciliations between GAAP financial measures that are most directly comparable to non-GAAP financial measures. Exchange Rate The Company's business is primarily conducted in China and a significant majority of revenues generated are denominated in Renminbi ("RMB"). This announcement contains currency conversions of RMB amounts into U.S. dollars ("USD") solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to USD are made at a rate of RMB7.1190 to USD1.0000, the effective noon buying rate for September 30, 2025 as set forth in the H.10 statistical release of the Federal Reserve Board. No representation is made that the RMB amounts could have been, or could be, converted, realized or settled into USD at that rate on September 30, 2025, or at any other rate. For further information, please contact: Gaotu Techedu Inc.Investor RelationsE-mail: ir@gaotu.cn Piacente Financial CommunicationsBrandi PiacenteTel: +1 212 481-2050Jenny CaiTel: +86 10 6508-0677E-mail: Gaotu@tpg-ir.com Gaotu Techedu Inc. Unaudited condensed consolidated balance sheets (In thousands of RMB and USD, except for share, per share and per ADS data) As of December 31, As of September 30, 2024 2025 2025 RMB RMB USD ASSETS Current assets Cash and cash equivalents 1,321,118 318,731 44,772 Restricted cash 5,222 125,272 17,597 Short-term investments 1,845,242 2,095,986 294,421 Inventory, net 36,401 53,401 7,501 Prepaid expenses and other current assets, net 431,829 526,989 74,026 Total current assets 3,639,812 3,120,379 438,317 Non-current assets Operating lease right-of-use assets 503,601 506,882 71,201 Property, equipment and software, net 670,237 834,745 117,256 Land use rights, net 25,762 45,424 6,381 Long-term investments 922,740 500,401 70,291 Rental deposit 45,834 49,271 6,921 Other non-current assets 20,091 57,636 8,096 TOTAL ASSETS 5,828,077 5,114,738 718,463 LIABILITIES Current liabilities Short-term borrowings of the consolidated VIE without recourse to the Group - 48,544 6,819 Accrued expenses and other current liabilities (including accrued expenses and other current liabilities of the consolidated VIE without recourse to the Group of RMB811,879 and RMB944,484 as of December 31, 2024 and September 30, 2025, respectively) 1,245,207 1,320,853 185,539 Deferred revenue, current portion (including current portion of deferred revenue of the consolidated VIE without recourse to the Group of RMB1,867,096 and RMB1,534,148 as of December 31, 2024 and September 30, 2025, respectively) 1,867,096 1,534,246 215,515 Operating lease liabilities, current portion (including current portion of operating lease liabilities of the consolidated VIE without recourse to the Group of RMB114,471 and RMB132,281 as of December 31, 2024 and September 30, 2025, respectively) 147,635 140,337 19,713 Income tax payable (including income tax payable of the consolidated VIE without recourse to the Group of RMB606 and RMB39 as of December 31, 2024 and September 30, 2025, respectively) 665 88 12 Total current liabilities 3,260,603 3,044,068 427,598 Gaotu Techedu Inc. Unaudited condensed consolidated balance sheets (In thousands of RMB and USD, except for share, per share and per ADS data) As of December 31, As of September 30, 2024 2025 2025 RMB RMB USD Non-current liabilities Deferred revenue, non-current portion of the consolidated VIE without recourse to the Group 218,797 238,924 33,561 Operating lease liabilities, non-current portion (including non-current portion of operating lease liabilities of the consolidated VIE without recourse to the Group of RMB337,258 and RMB332,307 as of December 31, 2024 and September 30, 2025, respectively) 344,609 343,158 48,203 Deferred tax liabilities (including deferred tax liabilities of the consolidated VIE without recourse to the Group of RMB70,316 and RMB76,056 as of December 31, 2024 and September 30, 2025, respectively) 70,604 76,073 10,686 TOTAL LIABILITIES 3,894,613 3,702,223 520,048 SHAREHOLDERS' EQUITY Ordinary shares 116 116 16 Treasury stock, at cost (242,866) (461,340) (64,804) Additional paid-in capital 7,991,421 7,950,976 1,116,867 Accumulated other comprehensive loss (2,832) (25,738) (3,615) Statutory reserve 66,042 66,042 9,277 Accumulated deficit (5,878,417) (6,117,541) (859,326) TOTAL SHAREHOLDERS' EQUITY 1,933,464 1,412,515 198,415 TOTAL LIABILITIES AND TOTAL SHAREHOLDERS' EQUITY 5,828,077 5,114,738 718,463 Gaotu Techedu Inc. Unaudited condensed consolidated statements of operations (In thousands of RMB and USD, except for share, per share and per ADS data) For the three months ended September 30, For the nine months ended September 30, 2024 2025 2025 2024 2025 2025 RMB RMB USD RMB RMB USD Net revenues 1,208,253 1,579,026 221,804 3,164,935 4,461,457 626,697 Cost of revenues (429,791) (535,528) (75,225) (1,014,638) (1,460,829) (205,201) Gross profit 778,462 1,043,498 146,579 2,150,297 3,000,628 421,496 Operating expenses: Selling expenses (885,769) (873,399) (122,686) (2,227,547) (2,403,766) (337,655) Research and development expenses (189,305) (162,912) (22,884) (503,013) (461,562) (64,835) General and administrative expenses (193,495) (185,212) (26,017) (452,296) (520,417) (73,103) Total operating expenses (1,268,569) (1,221,523) (171,587) (3,182,856) (3,385,745) (475,593) Loss from operations (490,107) (178,025) (25,008) (1,032,559) (385,117) (54,097) Interest income 15,661 8,577 1,205 55,608 31,553 4,432 Realized gains from investments 6,001 6,346 891 20,285 19,566 2,748 Other income, net 3,964 14,621 2,054 52,220 91,822 12,898 Loss before provision for income tax and share of results of equity investees (464,481) (148,481) (20,858) (904,446) (242,176) (34,019) Income tax (expenses)/benefits (6,792) 1,360 191 (8,674) 3,052 429 Net loss (471,273) (147,121) (20,667) (913,120) (239,124) (33,590) Net loss attributable to Gaotu Techedu Inc.'s ordinary shareholders (471,273) (147,121) (20,667) (913,120) (239,124) (33,590) Net loss per ordinary share Basic (2.75) (0.91) (0.13) (5.30) (1.46) (0.20) Diluted (2.75) (0.91) (0.13) (5.30) (1.46) (0.20) Net loss per ADS Basic (1.83) (0.61) (0.09) (3.54) (0.97) (0.14) Diluted (1.83) (0.61) (0.09) (3.54) (0.97) (0.14) Weighted average shares used in net loss per share Basic 171,135,287 161,927,833 161,927,833 172,165,794 163,986,613 163,986,613 Diluted 171,135,287 161,927,833 161,927,833 172,165,794 163,986,613 163,986,613 Note: Three ADSs represent two ordinary shares. Gaotu Techedu Inc. Reconciliations of non-GAAP measures to the most comparable GAAP measures (In thousands of RMB and USD, except for share, per share and per ADS data) For the three months ended September 30, For the nine months ended September 30, 2024 2025 2025 2024 2025 2025 RMB RMB USD RMB RMB USD Net revenues 1,208,253 1,579,026 221,804 3,164,935 4,461,457 626,697 Less: other revenues(1) 60,581 41,708 5,859 117,081 78,624 11,044 Add: VAT and surcharges 72,056 98,101 13,780 192,049 277,259 38,946 Add: ending deferred revenue 1,439,217 1,773,170 249,076 1,439,217 1,773,170 249,076 Add: ending refund liability 77,869 110,621 15,539 77,869 110,621 15,539 Less: beginning deferred revenue 1,582,135 2,196,993 308,610 1,237,621 2,085,893 293,004 Less: beginning refund liability 85,520 133,308 18,726 67,157 127,969 17,976 Gross billings 1,069,159 1,188,909 167,004 3,452,211 4,330,021 608,234 Note (1): Include miscellaneous revenues generated from services other than courses. For the three months ended September 30, For the nine months ended September 30, 2024 2025 2025 2024 2025 2025 RMB RMB USD RMB RMB USD Gross profit 778,462 1,043,498 146,579 2,150,297 3,000,628 421,496 Share-based compensation expenses(1) in cost of revenues 2,265 1,017 143 4,543 4,480 629 Non-GAAP gross profit 780,727 1,044,515 146,722 2,154,840 3,005,108 422,125 Loss from operations (490,107) (178,025) (25,008) (1,032,559) (385,117) (54,097) Share-based compensation expenses(1) 14,078 9,376 1,317 40,924 31,869 4,477 Non-GAAP loss from operations (476,029) (168,649) (23,691) (991,635) (353,248) (49,620) Net loss (471,273) (147,121) (20,667) (913,120) (239,124) (33,590) Share-based compensation expenses(1) 14,078 9,376 1,317 40,924 31,869 4,477 Non-GAAP net loss (457,195) (137,745) (19,350) (872,196) (207,255) (29,113) Note (1): The tax effects of share-based compensation expenses adjustments were nil.
SHANGHAI, Aug. 28, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced its interim results for the first half of 2024 along with a corporate update. "Our total revenue for the first half of 2024 reached RMB 301.5 million, a significant growth of 158% compared to the second half of 2023, while operating expenses as a percentage of revenue[1] declined by 249%, reflecting significant improvement on operating efficiency," commented Rogers Yongqing Luo, CEO of Everest Medicines. "Notably, our non-IFRS loss narrowed by 35%, and our gross margin excluding non-cash items was 83%. For the first time in Company history, we have achieved commercial level profitability[2]. Our cash balance of RMB1.93 billion remains strong and provides significant flexibility to fund the continued growth of our business. In the first half of 2024, we accomplished multiple commercialization milestones. NEFECON®, our lead product in the renal portfolio and the first-in-disease treatment for adults with primary IgAN, was commercially launched in mainland China and Singapore, and approved in Hong Kong. XERAVA®, our first commercialized product in China and a first-in-class fluorocycline antibiotic, continues to show robust sales growth. In the autoimmune disease space, our lead product etrasimod was approved in Macau." "We will continue to drive revenue growth through our dual-engine strategy. First, we seek to license in products that can leverage the current commercial platform to maximize synergies, and continuously boost revenue, operational efficiency and profits through our efficient and focused commercialization model. We believe this will lead to stable and healthy revenue growth. Second, we look to unlock partnering and value creation opportunities with our mRNA discovery pipeline and our products with global rights . We recently announced the launch of the first-in-human Investigator-Initiated Clinical Trial (IIT) for EVM16, a personalized mRNA cancer vaccine program. We also anticipate submitting investigational new drug applications in the United States and China in 2025 for EVM14, a Tumor-Associated Antigens (TAA) cancer vaccine program. In the second half of 2024, we intend to continue to expand our market presence, revenue base and operational efficiency, by continuing to carry out our efficient and focused commercialization model, with "improvement, integration, and transformation" as our motto. We will continue to grow NEFECON® sales and actively engage in China's National Reimbursement Drug List (NRDL) negotiations to enhance affordability and accessibility. By deepening penetration at our core hospitals and ramping up CSO collaborations, we aim to boost XERAVA® sales. Finally, we expect to launch etrasimod in Macau and access patients in China through preferential policies in the Greater Bay Area, and therefore we expect to have three commercialized products by the end of 2024. We maintain our revenue guidance of RMB 700 million for this year and remain confident in achieving our goal of cash flow breakeven by the end of 2025," Mr. Luo concluded. Recent Key Product Highlights and Anticipated Milestones RENAL PRODUCTS PORTFOLIO NEFECON® - In March 2024, Singapore Health Sciences Authority approved NEFEGAN® for the treatment of primary IgAN in adults at risk of disease progression. NEFEGAN®, known in other Everest's territories as NEFECON®, was the first ever treatment for IgAN fully approved by the U.S. Food and Drug Administration, and Singapore marks the third region in Everest's territories that received New Drug Application ("NDA") approval after Macau and mainland China. The product has been launched in Singapore following its approval. - In March 2024, our partner Calliditas Therapeutics AB ("Calliditas") announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO® (the U.S. trade name for NEFECON®), expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. - In April 2024, our partner Calliditas announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating NEFECON® in patients with IgAN were presented at the ISN World Congress of Nephrology. The data showed the treatment effect of NEFECON® on the risk of kidney function decline was consistent regardless of baseline UPCR and there were no meaningful differences in any quality of life ("QoL") domains between NEFECON® and placebo groups after 9 months of treatment. - In April 2024, our partner Calliditas announced positive results of the global Open Label Extension ("OLE") study to the Phase 3 NefIgArd study. The OLE study was designed to provide 9 months of treatment with NEFECON® for all patients who completed the NefIgArd study and who at that time had > 1g/g of proteinuria over 24h and>30 ml/min of estimated glomerular filtration rate ("eGFR"). Topline data from the OLE study showed that the treatment response was consistent with the NefIgArd study's findings regarding the endpoints of UPCR and eGFR at 9 months across all patients, irrespective of whether they had previously been treated with NEFECON® or with placebo. The safety data after 9 months of treatment or retreatment with NEFECON® in patients who completed the NefIgArd study were consistent with previously reported safety data. - In April 2024, the Hong Kong Department of Health approved NEFECON® for the treatment of primary IgAN in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories that NEFECON® received NDA approval after Singapore, Macau and mainland China. - In May 2024, NEFECON® was successfully launched in mainland China. The official launch of NEFECON® marks the inception of better patient care in mainland China, heralding a new era in the treatment of IgAN. The first prescription of NEFECON® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving their accessibility. As part of the pre-launch preparation, Everest had initiated an early access program in the Hainan Boao pilot zone in 2023. Approximately 700 patients registered for this program. Following the NDA approval of NEFECON® in Macau in December 2023, a few hundred patients from mainland China received prescription of the medication in Macau. In addition, over 23,000 Chinese patients have registered in an IgAN patient program. These initiatives highlight the urgent and unmet medical needs for NEFECON® in IgAN patients, and provide a foundation for the rapid adoption in mainland China. - In May 2024, our partner Calliditas disclosed Asahi Kasei Corporation's ("Asahi Kasei") public cash offer to acquire all shares in Calliditas for SEK 208 in cash per Share (the "Offer"). The Offer will also include a concurrent offer by Asahi Kasei to acquire all American Depositary Shares ("ADS"), each representing two Shares in Calliditas, for SEK 416 in cash per ADS, which will be conducted pursuant to the securities rules of the United States. The total value of the Offer corresponds to SEK 11,164 million. - In June 2024, our partner Calliditas announced an analysis of the treatment benefits of of NEFECON® compared with sparsentan in IgAN at the 61st European Renal Association Congress (ERA 2024). The presented analysis showed that treatment with NEFECON® 16 mg/day for 9 months was associated with eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years. Post-Reporting Period achievements and expected milestones: - In July 2024, China's National Medical Products Administration accepted the submission of a supplemental New Drug Application (sNDA) seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. NEFECON® is expected to become the first-in-disease IgA nephropathy (IgAN) treatment to receive full approval by the NMPA. - In July 2024, our partner Calliditas announced that the European Commission has granted a full marketing authorization for Kinpeygo (the European trade name for NEFECON®) for the treatment of adults with primary IgAN. - We expect to report topline results from our open label study of NEFECON® in China in the second half of 2024. - We expect to receive NEFECON® NDA approval in South Korea in the second half of 2024. - We expect to commercially launch NEFECON® in Hong Kong in the second half of 2024. - We expect inclusion of NEFECON® in the Kidney Disease: Improving Global Outcomes ("KDIGO") 2024 guidelines as well as in the first Chinese guideline for IgAN in the second half of 2024. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for a range of immune-mediated disorders, including lupus nephritis ("LN"). It was licensed from Kezar Life Sciences ("Kezar") in September 2023 for development and commercialization in Greater China, South Korea and Southeast Asia. - In February 2024, the Center for Drug Evaluation (CDE) of NMPA approved Kezar's IND application of zetomipzomib for initiation of the Phase 2b PALIZADE trial in China in patients with active LN. LN is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney failure. There are an estimated 400,000-600,000 LN patients in China. - In July 2024, the first Chinese patient has been dosed in the global Phase 2b PALIZADE trial for the treatment of active LN. Leveraging the company's strengths in clinical development, regulatory filing, and commercialization, we will accelerate the development of zetomipzomib to benefit patients in China as soon as possible. EVER001 (previously known as XNW1011), is the next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. - We expect to report topline results from EVER001 Phase 1b study in membranous nephropathy in the second half of 2024. INFECTIOUS DISEASE PORTFOLIO XERAVA® (eravacycline) - In January 2024, eravacycline's clinical breakpoint was officially approved by Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST), so that the drug can be used more accurately in clinical practice in China. - In August 2024, the Expert Committee on Clinical Application and Resistance Evaluation of Antimicrobial Drugs of the National Health Commission published positive interim results from the "Comprehensive Evaluation Project on the Clinical Application of Eravacycline". The results showed that the overall efficacy rate of eravacycline was 89.0% at the end of treatment, and incidence of adverse effect was only 2.9%. Taniborbactam is a beta-lactamase inhibitor ("BLI") that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat resistant gram-negative bacteria, most notably carbapenem- resistant Enterobacterales ("CRE") and carbapenem-resistant Pseudomonas aeruginosa ("CRPA"). - In February 2024, our partner Venatorx Pharmaceuticals announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections ("cUTI"), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of cUTI that included acute pyelonephritis, with a similar safety profile to meropenem. - We expect to submit NDA of cefepime-taniborbactam for the cUTI indication in mainland Chinain 2025. AUTOIMMUNE DISEASE PORTFOLIO VELSIPITY® (etrasimod) - In Feb. 2024, partner Pfizer Inc. announced that the European Commission has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. - In March 2024, Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® (etrasimod) for the treatment of moderately to severely active ulcerative colitis. - In April2024, Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China approved the NDA for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active UC. It marks the first approval of VELSIPITY® in Everest territories. The number of UC patients in China is projected to double from 2019 to 2030 to approximately one million by 2030, highlighting the urgent need for novel treatments. Leveraging the preferential policies in the Greater Bay Area in China, we're poised to accelerate drug accessibility for mainland China following the Macau approval. - In May 2024, Singapore Health Sciences Authority approved VELSIPITY™ (etrasimod) for adults with moderately to severely active ulcerative colitis (UC). Post-Reporting Period achievements and expected milestones: - In July 2024, Everest announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of subjects with moderately-to-severely active UC. This is the largest Phase 3 trial of moderately-to-severely active UC in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The data of maintenance period confirmed that, after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed. - We expect to commercially launch VELSIPITY® (etrasimod) in Macau and take advantage of the preferential policies in the Greater Bay Area of China to accelerate drug accessibility to patients in China in the second half of 2024. - We expect to submit NDA for VELSIPITY® (etrasimod) to China's NMPA for approval in the second half of 2024. - We expect to submit NDA for VELSIPITY® (etrasimod) in Hong Kong in the second half of 2024. mRNA PLATFORM The clinically-validated mRNA platform is a core part of our discovery efforts and the Company made an important strategic transformation in 2024 by terminating the collaboration and license agreement with Providence Therapeutics Holdings Inc. Everest has shifted our focus to mRNA cancer therapeutic vaccine, to which we have full intellectual property rights and global rights. We currently have four mRNA cancer therapeutic vaccine programs under development for various solid tumor indications. We have deprioritized the development of the COVID19 vaccines due to declining economic and social benefits. We believe our therapeutic cancer vaccines under development hold great potential to address significant unmet medical needs globally. - In Feb. 2024, Everest announced the termination of the collaboration and license agreements with Providence Therapeutics Holdings Inc. Everest continues to develop its own therapeutic vaccine products utilizing the mRNA platform. - In August 2024, Everest announced the launch of an Investigator-Initiated Clinical Trial (IIT) for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human (FIH) trial for EVM16. - We expect to submit investigational new drug applications for the Tumor-Associated Antigens (TAA) cancer vaccine in 2025. Commercialization We have made significant commercial progress and meaningfully advanced both of our marketed products in the first half of 2024. For NEFECON®, the leading drug in our renal portfolio, we have successfully launched the product utilizing a combination oftraditional hospitals detailing and innovative online prescribing, to meet the urgent and significant unmet needs of an estimated 5 million IgAN patients. So far this year, we have completed the build-out of the NEFECON® sales force to more than 100 representatives. This team will cover400-600 core hospitals which represent more than 60% of the addressable IgAN population. Additionally, over 23,000 patients have registered pre-product launch in an IgAN patient program, which underscores the significant unmet needs for this first-in-disease medicine. Earlier this year, we also started working with partners to establish an innovative ecosystem for kidney disease diagnostics and treatment, with the aim to provide IgAN patients a tool to enhance disease diagnosis and track disease progression without biopsy. XERAVA® (eravacycline), our first commercialized product in China and a first-in-class fluorocycline antibiotic, is in its first full year of sales and growth remains robust. To further increase the availability of XERAVA® and expand our reach to more patients in need, we have started partnering with Contract Sales Organizations ("CSO") to benefit patients outside of our 300 covered core hospitals. This will contribute to product revenue growth, but the vast majority of our product revenue will still be generated by our in-house commercial team. Eravacycline's clinical breakpoint was officially approved by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST) for clinical use in China. With the new breakpoint, eravacycline can be recognized by more physicians and patients as the preferred treatment in clinical practice across the country and over 100 hospitals in China have already adopted the new breakpoint. In addition, inclusion of eravacycline in the Catalogue of Hierarchical Management of Clinical Application of Antimicrobial Drugs in Shanghai, Beijing and Guangdong underscores recognition of the drug's clinical benefits by China's key opinion leaders. This year, eravacycline was newly included into The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update and China's Clinical Diagnosis and Treatment Guidelines for Multidrug-resistant Bacterial Infections in Renal Transplantation, and was published in the following medical publications: Title Publication Name Publication Date Clinical Analysis of Eracycline in the Treatment of Neurologically Critically Immunosuppressed Patients with Carbapenem-resistant Acinetobacter Baumannii Pneumonia Chinese Journal of Critical Care & Intensive Care Medicine(Electronic Edition) 2024/3/18 Comparison of Efficacy and Safety of Eracycline and Ertapenem in the Treatment of Complicated Intra-abdominal Infections in ChineseAdults Chinese Journal of Infection and Chemotherapy 2024/5/20 Establishment of epidemiological cut-off values for eravacycline, against Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Acinetobacter baumannii and Staphylococcus aureus J Antimicrob Chemother 2024/06/14 Research progress of a new antibacterial drug eravacycline Chinese Journal of New Drugs and Clinical Remedies 2024/07/01 Dynamic evolution of ceftazidime-avibactam resistance from a single patient through the IncX3_NDM-5 plasmid transfer and blaKPC mutation International Journal of Antimicrobial Agents 2024/08/01 We will continue to grow and strengthen our commercial portfolio in the second half of 2024 through persistent efforts and innovative approaches. We maintain full year sales guidance of RMB700 million from the combined sales of NEFECON® and XERAVA®. Multiple initiatives are expected to accelerate growth of NEFECON® sales. First, we anticipate inclusion of NEFECON® in the 2024 revised Kidney Disease Improving Global Outcomes (KDIGO) guidelines as well as the first Chinese guideline for IgAN as a first-line treatment for IgAN patients with risk of disease progression. We also plan to actively participate in China's National Reimbursement Drug List (NDRL) negotiations in the second half of 2024, to make the drug more affordable in order to achieve wide penetration of the large IgAN population of approximately 5 million patients in China. Those initiatives are expected to drive higher sales volumes along with the expansion of sales force to around 150 representatives. In parallel, we are working to enhance physician and patient education on the benefits of early treatment with NEFECON® to further improve kidney function protection. Our team is also launching several real-world studies on NEFECON® usage to provide physicians with additional clinical use guidance. Furthermore, later in 2024 we intend to expand availability of this first-in-disease medication to more IgAN patients in Asian regions including Singapore and Hong Kong. We will continue to grow the sales of XERAVA® through deeper penetration of our covered core hospitals such as expanding usage scenarios. With over a year of XERAVA® clinical experience in China, we expect to publish real world data on eravacycline usage in different types of patients in the second half of this year. We expect this will help guide hospitals and physicians on potentially wider treatment scope. We also anticipate XERAVA® to be included in additional treatment guidelines for anti-infectives and further strengthen its position as a foundational empirical treatment of multidrug-resistant infections. We will have three commercialized products in the second half of this year with the expected commercial launch of etrasimod in Macau. We will also take advantage of the preferential policies in the Greater Bay area of China to accelerate drug accessibility to patients in mainland China this year. Discovery Internal discovery is a key growth driver for the company's value creation. In about three years, Everest has successfully localized a clinically validated mRNA platform and built end-to-end capabilities in house to develop and manufacture mRNA therapeutics. Our internal discovery team in Shanghai consists of over 30 scientists developing multiple mRNA cancer therapeutics based on our fully integrated and clinically validated platform. We continue to innovate the platform by developing next generation delivery system and improving our mRNA sequence algorism. Everest also established a Good Manufacturing Practices (GMP) compliant manufacturing facility capable of producing clinical and commercial scale mRNA products In February 2024, the Company agreed to terminate the collaboration and license agreements with Providence and will continue to develop our own mRNA products with full intellectual property and global commercial rights Therapeutic cancer vaccines is currently the core focus area of Everest's discovery efforts as this area holds great potential to address unmet medical needs globally. An Investigator-Initiated Clinical Trial (IIT) for a personalized mRNA cancer vaccine, EVM16, was launched in August 2024. EVM16 is the first therapeutic vaccine independently developed by Everest utilizing the mRNA platform. In the pipeline are various other cancer vaccine programs including a Tumor-Associated Antigens (TAA) cancer vaccine and an immune-modulatory cancer vaccine. In addition, we are also working on mRNA-based in vivo CAR-Tprograms which can be used for cancer and autoimmune diseases. Business Development In 2024 our business development strategy remains focused on first-in-class or best-in-class assets in less crowded, high value therapeutic areas such as renal diseases, autoimmune disorders, and anti-infective categories. Given our established strong commercial presence, we are increasing our attention on commercial-stage assets where we can leverage our experienced and effective sales organization to create operational synergies and build scale. We believe that we can continue to solidify our leadership position across these therapeutic categories through effective pipeline buildup to drive growth of commercial cash flows for the Company and advance our profitability targets.On outward partnerships, ourcutting-edge cancer vaccine programs based on our mRNA technology platform with full intellectual property rights could potentially bring global partnership opportunities starting at early stage and expand value creation for our shareholders. Key Corporate Developments We are working with partners to establish an innovative ecosystem for kidney disease diagnostics and treatment, with the aim to provide IgAN patients with a tool to enhance disease diagnosis and track disease progression without biopsy. Financial Highlights IFRS Numbers: Revenue increased by RMB 292.6 million from RMB 8.9 million for the six months ended 30 June 2023 to RMB 301.5 million for the six months ended 30 June 2024, primarily due to the combined effect of continued expansion of XERAVA® sales in mainland China and Hong Kong, the launch of NEFECON® in mainland China and Singapore, and NEFECON® sales in other territories under our license. Gross profit margin increased from 62.7% for the six months ended 30 June 2023 to 76.6% for the six months ended 30 June 2024, and gross profit margin excluding intangible assets amortization increased from 62.7% for the six months ended 30 June 2023 to 83.0% for the six months ended 30 June 2024, primarily due to the launch of new products. Research and development ("R&D") expenses decreased by RMB 35.3 million from RMB 288.5 million for the six months ended 30 June 2023 to RMB 253.2 million for the six months ended 30 June 2024, primarily due to (i) lower expenditure on clinical trials; and (ii) continued investment in new products from our discovery platform which remained stable. General and administrative expenses were mostly stable at RMB 87.0 million for the six months ended 30 June 2024 in comparison to the six months ended 30 June 2023. Distribution and selling expenses increased by RMB 136.3 million from RMB 64.1 million for the six months ended 30 June 2023 to RMB 200.4 million for the six months ended 30 June 2024, primarily due to the expansion of the commercial team and increased commercial activities to support the launch of new products and the growth of existing product sales. Commercialization expense-to-sales ratio decreased as we continue to build a more efficient and focused commercialization model. Net loss for the period increased by RMB 208.8 million from RMB 423.6 million for the six months ended 30 June 2023 to RMB 632.4 million for the six months ended 30 June 2024, primarily attributable to the one-time, non-recurring impairment loss from an intangible asset related to mRNA COVID-19 Vaccines.Net loss excluding impairment loss of an intangible asset for the period decreased by RMB 95.5 million from RMB 371.6 million for the six months ended 30 June 2023 to RMB 276.1 million for the six months ended 30 June 2024. Cash and cash equivalents and bank deposits amounted to RMB 1,925.5 million as of 30 June 2024. Non-IFRS Measure: Adjusted loss for the period decreased by RMB 114.3 million from RMB 326.9 million for the six months ended 30 June 2023 to RMB 212.6 million for the six months ended 30 June 2024, primarily adjusting for expenses of share-based compensation, loss on impairment of an intangible asset and amortization of intangible assets. Conference Call Information The English session of the conference call will be held at 9:00 AM on August 28, 2024 Beijing Time (9:00 PM U.S. Eastern Time on August 27, 2024), and the Mandarin session of the conference call will be held at 10:30 AM Beijing Time on the same day (10:30 PM U.S. Eastern Time on August 27, 2024). The conference calls can be accessed by the following links: For English Session: Time: 9:00 AM Beijing Time, Wednesday, August 28, 2024 (9:00 PM U.S. Eastern Time, Tuesday, August 27, 2024) Pre-Registration Link: https://www.acecamptech.com/eventDetail/60508616 Webcast Link: https://www.acecamptech.com/meeting_live/70510585/750453?event_id=60508616 Alternatively, participants may dial in to the conference call using below dial-in information: United States: +1-646-2543594 (EN) Chinese Mainland: +86-10-58084166 (EN) +86-10-58084199 (CN) Hong Kong, China: +852-30051313 (EN) +852-30051355 (CN) United Kingdom: International: +44-20-76600166 (EN) +1-866-6363243 (EN) Password: 833889 For Mandarin Session: Time: 10:30 AM Beijing Time, Wednesday, August 28, 2024 (10:30 PM U.S. Eastern Time, Tuesday, August 27, 2024) Webcast Link: https://s.comein.cn/AHczP Alternatively, participants may dial into the conference call using below dial-in information: United States: +1-202-5524791 Chinese Mainland: +86-400-188-8938 Hong Kong, China: Taiwan, China: +852-57006920 +886-277031747 Singapore: +65-31586120 United Kingdom: +44-2034816288 International: +86-10-53827720 Password: 313729 The replay of English session will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. 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. [1] Operating expenses as a percentage of revenue = (general and administrative expenses + research and development expenses + distribution and selling expenses)/revenue. [2] Commercial profit = Gross margin – distribution and selling expenses
SHANGHAI, March 28, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines and vaccines, today announced its financial results for the full year ended December 31, 2023, along with a corporate update. "2023 was an exciting year for Everest as we transformed into a fully integrated biopharmaceutical company with full value chain of capabilities," commented Rogers Yongqing Luo, CEO of Everest Medicines. "We have taken a lean and focused approach to commercialization, and built an effective commercial organization around the launch of our first product, Xerava®, in the Chinese market at the end of July. Nefecon®, the first-in-disease treatment for adults with primary IgAN and our blockbuster product in the renal portfolio, was also approved in mainland China and commercially launched in Macau in December 2023. The successful sales of these two products resulted in the ninefold increase in revenue last year to RMB125.9 million, significantly exceeding our guidance in mid-2023. Nefecon® will be launching in mainland China soon and our anchor product in the autoimmune space etrasimod is expected to receive approval in Macau and start commercialization in the Greater Bay area this year, so Everest will have three commercialized products before end of 2024. With these product launches and several other drugs advancing through clinical and regulatory approval stages, we have paved the way for even more substantial growth in 2024 and set a revenue guidance of RMB700 million. " "We also head into 2024 with an upgraded dual-engine approach to our pipeline growth strategy, which is in-house discovery plus in-licensing. As we terminated the collaboration and licensing agreements with Providence, we will develop our own discovery products utilizing this mRNA platform, but now hold full intellectual property rights and global rights. We have developed cancer vaccines from this platform which will enter clinical stage this year. Meanwhile, we will continue our in-licensing efforts, focused on our carefully chosen, less-crowded therapeutic areas of renal disease, infectious disease and autoimmune disease. This dual-engine approach will enable us to further capitalize on our commercial organization's capabilities to maximize synergies in our core product areas, while developing those products we have full intellectual property rights and global rights," Mr. Luo concluded. Recent Key Product Highlights and Anticipated Milestones RENAL PRODUCTS PORTFOLIO Nefecon® 2023 - In February 2023, South Korea's Ministry of Food and Drug Safety (MFDS) granted Global Innovative product on Fast Track (GIFT) designation to Nefecon® for the treatment of primary IgAN. - In March 2023, partner Calliditas reported positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon® versus placebo in patients with primary IgAN over 2 years. The trial met its primary endpoint with Nefecon® demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Nefecon® or placebo and 15-months of follow-up off drug. The key primary endpoint, eGFR over 2 years, was on average 5.05 mL/min/1.73 m2 higher with Nefecon® compared to placebo (p<0.0001). A treatment benefit on eGFR was apparent across baseline urine protein creatinine ratio (UPCR) subgroups, and sustained proteinuria effects and long lasting eGFR treatment benefit were observed even 15 months after discontinuation, supporting disease modification. The results also indicate that Nefecon® was generally well-tolerated. - In April 2023, the Company launched Nefecon® for clinical use in Shanghai Ruijin Hospital's Hainan Bo'ao subsidiary through an early-access program. The launch of this early-access program in Hainan marked the beginning of a new treatment era for IgA nephropathy in China. - In June 2023, our partner Calliditas presented data from the NeflgArd Phase 3 Study at the European Renal Association — European Dialysis and Transplant Association Congress (ERA-EDTA). The presentations showed data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon® in patients with IgAN. In addition to data disclosed in March, at 24 months, eGFR was reduced by 6.11 mL/min/1.73 m2 from baseline in the Nefecon® arm compared with 12.00 mL/min/1.73 m2 reduction in the placebo arm, demonstrating 50% less loss of kidney function. - In August 2023, the Company announced the completion of patient enrollment for the China open-label extension (cOLE) of the Phase 3 NefIgArd study. The cOLE study offers an additional 9 months of treatment with Nefecon® to all qualifying patients who have completed the NefIgArd study and evaluates the efficacy and safety of extended and repeated Nefecon® treatment in patients with IgAN. We hope this will provide more insight into Nefecon future clinical use. - In October 2023, our partner Calliditas presented new biomarker and subgroup analyses from Nefecon®'s Phase 3 NefIgArd study in both posters and oral presentations at the 17th International Symposium on IgA Nephropathy. Investigation of the effect of Nefecon® on circulating levels of IgA-IC in the Part A population of the NefIgArd clinical trial showed that patients treated with Nefecon® 16mg/day exhibited a statistically significant decrease in IgA-IC levels compared to patients who received placebo when evaluated at the 3-, 6- and 9-months post randomization. Suppression by treatment with Nefecon® of both IgA-IC formation and galactose-deficient IgA1 as previously reported offers an unprecedented opportunity to target the fundamental immune abnormalities that drive IgA deposition in the kidney and development of IgAN. - In October 2023, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, approved the New Drug Application (NDA) for Nefecon® for the treatment of IgAN in adults at risk of disease progression. - In November 2023, the Company made a late-breaking poster presentation at the American Society of Nephrology (ASN) Kidney Week 2023 on Chinese patients enrolled from mainland China. Clinical results from the global Phase 3 trials of Nefecon® demonstrated even stronger results in the subpopulation of patients from mainland China. At 24 months, the eGFR in the Chinese patients was 66% less deteriorated compared to 50% in the global population. The mean percent reduction in UPCR was 31% greater at 9 months vs. placebo in Chinese patients and 43% greater than placebo at 24 months. Lastly, the percent of Chinese patients without microhematuria during the observational follow-up period increased to 57.5% from 26.9% at baseline, while it was maintained at 14.3% in the placebo group. These data demonstrate Chinese patients show faster disease progression compared to the global population. - In November 2023, China's National Medical Products Administration (NMPA) approved Nefecon® for the treatment of primary IgAN in adults at risk of disease progression. China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients. - In November 2023, the Nefecon® NDA was accepted for review by South Korea's Ministry of Food and Drug Safety (MFDS) for the treatment of primary IgAN in adult patients. - In December 2023, partner Calliditas announced that the U.S. Food and Drug Administration (FDA) had fully approved Nefecon® delayed release capsules to reduce the loss of kidney function in adults with IgAN at risk for disease progression, irrespective of proteinuria levels. - In December 2023, Nefecon® issued its first prescription at Kiang Wu Hospital in Macau, marking the official start of the company's first-in-disease drug to patients across Asia, opening a new era of treatment for IgA nephropathy patients in the region. At the same time, a PAP program was officially launched at the Kiang Wu Hospital, which will provide financial assistance to Chinese mainland citizens who prescribe Nefecon® in Macau. - In December 2023 the New Drug Application (NDA) for Nefecon® was accepted for review by the Taiwan Food and Drug Administration (TFDA) for the treatment of primary IgAN in adult patients. 2024 - In March 2024, Singapore Health Sciences Authority (HSA) approved NEFEGAN® for the treatment of primary IgAN in adults at risk of disease progression. The NDA for NEFEGAN®, known in other Everest's territories as Nefecon®, was accepted by HSA in April 2023. - We expect Nefecon® to be commercially launched in mainland China, Hong Kong and Singapore in 2024 - We anticipate receiving Nefecon® NDA approvals in Taiwan and South Korea in 2024. - We expect to report Nefecon® China open label study results in 3Q 2024. INFECTIOUS DISEASE PORTFOLIO XERAVA® (eravacycline) 2023 - In March 2023, the NMPA of China approved the NDA for XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. The Company launched XERAVA® in July 2023 in mainland China. - In April 2023, the Company signed a Memorandum of Understanding for a strategic partnership with a subsidiary of Shanghai Pharma, SPH Keyuan Xinhua Pharmaceutical Co., Ltd. to promote import and channel distribution of XERAVA® (eravacycline) in China. - In July 2023, the Company launched XERAVA® (eravacycline) in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial- stage innovative biopharmaceutical company. - In September 2023, the TFDA approved the NDA for XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in Taiwan. - In 2024, eravacycline's clinical breakpoint was officially approved by ECAST, so that the drug can be used more accurately in clinical practice. Cefepime-taniborbactam 2023 - In September 2023, the Center for Drug Evaluation of the China NMPA recommended Priority Review for cefepime-taniborbactam for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, based on the criteria of "innovative drugs for the prevention and treatment of major infectious diseases and rare diseases that meet urgent clinical needs." 2024 - In February 2024, partner Venatorx Pharmaceuticals announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem. - We expect to submit NDA of the cUTI indication in China in 2024. AUTOIMMUNE DISEASE PORTFOLIO Etrasimod (VELSIPITY™) 2023 - In October 2023, licensing partner Pfizer Inc. received FDA approval for VELSIPITY™ (etrasimod) for adults with moderately to severely active ulcerative colitis (UC). - In November 2023, the Company reported positive topline data results from a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-to-severe active ulcerative colitis (UC). Etrasimod treatment resulted in a clinically meaningful and statistically significant improvement in the primary endpoint and all key secondary and other secondary endpoints (including mucosal healing, symptomatic remission and endoscopic normalization) after the 12-week induction treatment period. The safety profile was consistent with previous etrasimod studies and no new safety findings were observed. 2024 - In March 2024, Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest's NDA for etrasimod for the treatment of moderately to severely active ulcerative colitis. Macau is expected to be the first of Everest's Asian territories to get etrasimod regulatory approval. - We expect to report etrasimod topline results from the Phase 3 Asian clinical trial maintenance period in 2H 2024. - We expect to submit NDA for etrasimod to the China NMPA in 2H 2024. Zetomipzomib 2023 - In September 2023, Everest entered into a collaboration and license agreement with Kezar Life Sciences to develop and commercialize Kezar's lead drug candidate zetomipzomib, a novel, first-in-class, selective inhibitor of the immunoproteasome for a range of autoimmune diseases including lupus nephritis, in Greater China, South Korea and some Southeast Asian countries. 2024 - In February 2024, China's NMPA approved Kezar's IND application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN). Everest plans to join its partner, Kezar Life Sciences, in PALIZADE, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active lupus nephritis. Commercialization We achieved RMB125.9 million in revenue in 2023, substantially above the previous guidance of RMB70-100 million. In 2023, the Company launched two products, developed a focused commercialization model driven by product clinical value, and built a 200-member lean and efficient commercial platform. This team worked on a concentrated strategy and managed to promote Xerava® in around 300 core tertiary hospitals in just five months, laying a solid foundation for our future commercial success. Xerava® has been recommended by multiple treatment guidelines in China and globally for multidrug-resistant bacterial infections. Nefecon® received NDA approvals in Macau and mainland China in Oct. 2023 and Nov. 2023, respectively and Everest plans to make the product available to an estimated five million patients in mainland China in 2024. The Company prepared for this launch by initiating an early access program in the Hainan Boao pilot zone. This program demonstrated significant demand for Nefecon®, with approximately 700 patients signed up. In addition, approximately 20,000 Chinese patients have registered in an IgAN patient program funded through a charity foundation, which underscores the significant unmet needs for this first-in-disease medicine and these patients will be a part of our patient base when Nefecon® is officially launched in mainland China. By the end of 2024, we expect to have three commercialized products in our core therapeutic areas. We will focus on successfully commercializing Nefecon® in China, continuing to grow the sales of Xerava®, while starting to commercialize etrasimod in the Greater Bay area. We expect to achieve a revenue target of RMB700 million in 2024 from the combined sales of Xerava® and Nefecon®. With our strong balance sheet and expected substantial increases in revenue, the Company has set a goal of reaching cash breakeven by the end of 2025. We will continue to increase patient access through patients registered for our charity program for Nefecon®, and gradually establish a second sales team of up to 120 nephrology-focused representatives commercializing Nefecon® across 600 hospitals, which covers approximately 60% of the IgAN patient population in China. We also plan to engage in National Reimbursement Drug List (NRDL) negotiations in 2024 for Nefecon®, with the goal to be included in 2025 so more patients can enjoy the benefits of the medicine. We plan to expand Nefecon approvals to additional territories, including Hong Kong, Taiwan and South Korea this year. Discovery Everest will develop its own products utilizing the mRNA platform, of which it now has full intellectual property rights and full global rights. Based on this clinically-validated mRNA platform, therapeutic vaccines such as cancer vaccines will be the focus of research and discovery activities at Everest. Everest plans to announce new mRNA pipeline products that are entering clinical stage in 2024. Business Development Our business development efforts centered around renal diseases and autoimmune disorders in 2023. We continue to bolster our leadership position in these areas by expanding our pipeline. In September 2023, the Company entered into a collaboration and license agreement with Kezar Life Sciences to develop and commercialize zetomipzomib in lupis nephritis and other potential autoimmune diseases. The in-licensing of zetomipzomib added another mid-to-late stage autoimmune asset to our pipeline. Going forward, we will continue to pursue first-in-class or best-in-class assets in our focused therapeutic areas, including commercial-stage products that could utilize our established commercial capabilities and complement our pipeline. In February 2024, Everest terminated the collaboration and license agreements with Providence Therapeutics Holdings Inc. Everest will continue to develop its own products utilizing the mRNA platform, and will own full intellectual property rights and full global rights of those products going forward, with no obligation to pay milestone or royalty fees for products it develops in the future, except for if we develop the rabies or shingles vaccines which were developed in collaboration with Providence. KEY CORPORATE DEVELOPMENTS In March 2023, the Company received full upfront payment of $280 million from Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc., for Trodelvy® rights in certain Asian territories. We will work with partners to establish an innovative ecosystem for kidney disease diagnostics and treatment, with the aim to provide IgAN patients with a tool to diagnose the disease and show disease progression without biopsy. Financial Highlights IFRS Numbers: Revenue increased by RMB113.1 million or 884% to RMB125.9 million for the year ended 31 December 2023, from sales growth of Xerava® in Singapore, the launch of Xerava® in mainland China and Hong Kong, the launch of Nefecon® in Macau and sales of Trodelvy® during the transition period with Gilead in Singapore. Our general and administrative expenses decreased by RMB111.3 million or 40.3% to RMB165.2 million for the year ended 31 December 2023. The decrease was primarily attributable to optimization and rationalization of the organizational structure. Research and development (the "R&D") expenses decreased by RMB269.6 million or 33.3% to RMB540.1 million. The decrease was primarily attributable to a number of our drug candidates having completed clinical trials and advanced to the registration phase or commercial stages. Our distribution and selling expenses decreased by RMB95.3 million or 29.2% to RMB231.4 million for the year ended 31 December 2023. The decrease was primarily attributable to the building of a more efficient and leaner commercial team for optimal value creation. Net loss for the year increased by RMB597.2 million to RMB844.5 million for the year ended 31 December 2023, primarily attributable to gain from Trodelvy® transaction in 2022, which was a one-time item. Adjusted for one-time gain from Trodelvy transaction, net loss for the year declined by RMB725.1 million due to growth of product sales and optimization of the organizational structure. Cash and cash equivalents and term deposits amounted to RMB2,349.7 million as of 31 December 2023. Non-IFRS Measure: Adjusted loss for the year was RMB713.6 million for the year ended 31 December 2023, representing an increase of RMB696.2 million, primarily due to increased IFRS loss. Adjusted for one-time gain from Trodelvy transaction in 2022, loss for the year declined by RMB626.2million due to growth of product sales and optimization of the organizational structure. — Financial Table — Years Ended December 31 RMB'000 2023 2022 Revenue 125,932 12,792 Cost of revenue (34,414) (4,645) Gross profit 91,518 8,147 General and administrative expenses (165,155) (276,547) Research and development expenses (540,054) (809,736) Distribution and selling expenses (231,419) (326,687) Other income 13,175 4,624 Other (losses)/gains - net (100,803) 1,143,399 Operating loss (932,738) (256,800) Finance income – net 84,608 32,887 Fair value change in financial assets at fair value through profit or loss ("FVPL") 848 (21,748) Fair value change in financial instruments issued to investors 2,819 (1,614) Loss before income tax (844,463) (247,275) Income tax expense - (8) Loss for the year (IFRS measure) (844,463) (247,283) Adjustments to Non-IFRS measure Loss for the year (Non-IFRS measure) (713,614) (17,426) Loss for the year (Non-IFRS adjusted for Trodelvy one-time transaction gain) (713,614) (1,339,733) Conference Call Information The English session of the conference call will be held at 9:00 AM on March 28, 2024 Beijing Time (9:00 PM U.S. Eastern Time on March 27, 2024) and the Mandarin session of the conference call will be held at 11:00 AM Beijing Time on the same day (11:00 PM U.S. Eastern Time on March 27, 2024). The conference calls can be accessed by the following links: For English Session: Time: 9:00 AM Beijing Time, Thursday, March 28, 2024 Pre-Registration Link: https://www.acecamptech.com/eventDetail/60505757 Webcast Link: https://www.acecamptech.com/meeting_live/70507680/12318?event_id=60505757 Alternatively, participants may dial in to the conference call using below dial-in information: United States: +1-646-2543594 (EN) Chinese Mainland: +86-10-58084166 (EN) +86-10-58084199 (CN) Hong Kong, China: +852-30051313 (EN) +852-30051355 (CN) United Kingdom: International: +44-20-76600166 (EN) +1-866-6363243 (EN) Password: 886892 For Mandarin Session: Time: 11:00 AM Beijing Time, Thursday, March 28, 2024 Webcast Link: https://s.comein.cn/AkXE8 Alternatively, participants may dial into the conference call using below dial-in information: United States: +1-202-5524791 Chinese Mainland: +86-400-188-8938 +86-10-53827720 +86-10-53560182 Hong Kong, China: Taiwan, China: +852-57006920 +886-277031747 Singapore: +65-31586120 United Kingdom: +44-2034816288 Password: 726461 The replay of English session will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of first-in-disease or best-in-class products in the Company's therapeutic areas of interest including renal diseases, infectious diseases, autoimmune disorders and mRNA platform. For more information, please visit its website at www.everestmedicines.com. 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.
First placebo-controlled randomized trial in active psoriatic arthritis (PsA) using a Nanobody® to report positive topline results in support of potential best-in-class profile Primary endpoint ACR50 met with up to 47% (p<0.01 versus placebo) of patients on sonelokimab achieving ACR50 as early as week 12 All key secondary endpoints met including up to 77% (p<0.001 versus placebo) of patients on sonelokimab achieving PASI90 as early as week 12 Other secondary endpoints also reached statistical significance at week 12, including endpoints focused on deep tissue inflammation, Minimal Disease Activity (MDA) and patient reported outcomes High threshold outcomes, including ACR70 and PASI100, continue to improve beyond week 12, consistent with previous studies of sonelokimab Discontinuation rate below 4% and safety results of sonelokimab consistent with previously reported studies with no new safety signals The top-line data will be discussed on Monday 6 November, at 2pm CET/8am ET, via webcast (registration link below) ZUG, Switzerland, November 5, 2023 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced positive top-line results from its global Phase 2 ARGO trial evaluating the efficacy and safety of the Nanobody® sonelokimab in patients with active psoriatic arthritis (PsA). The ARGO trial (M1095-PSA-201), which enrolled 207 patients, met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an American College of Rheumatology (ACR) 50 response compared to those on placebo atweek 12. Specifically, for the 60mg and 120mg doses with induction, respectively, 46% and 47% of patients treated with sonelokimab achieved ACR50 (p<0.01 versus placebo); 78% and 72% of patients achieved ACR20; and 29% and 26% achieved ACR70. The primary analyses were based on the most stringent type of analysis for such trials, intention-to-treat with non-responder imputation (ITT-NRI). As expected, the 60mg dose without induction did not reach statistical significance, confirming the 60mg and 120mg with induction as the potential dose regimens to carry forward into Phase 3. All key secondary endpoints were met for the 60mg and 120mg doses with induction. The key secondary endpoint Psoriasis Area and Severity Index (PASI) 90 was met for all doses with induction; 77% of patients responding at week 12 to the 60mg dose (ITT-NRI, p<0.001 versus placebo). For this dose, 58% of patients achieved complete skin clearance (PASI100) at week 12. PASI responses across dose arms were consistent with the previously reported Phase 2b data of sonelokimab in moderate-to-severe plaque-type psoriasis, with the 120mg dose achieving the highest responses for PASI100 (close to 60% of patients at week 12, ITT-NRI) in patients with more severe skin lesions (PASI score ≥ 10 at baseline). Other clinically relevant secondary endpoints, such as Minimal Disease Activity (MDA), the modified Nail Psoriasis Severity Index (mNAPSI), the Leeds Enthesitis Index (LEI) and the patient self-reported Psoriatic Arthritis Impact of Disease (PsAID-12), each show promising levels of response at week 12. Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake, said: “As part of our efforts to elevate outcomes for patients, we set ambitious goals for our Nanobody® sonelokimab. ARGO is MoonLake’s third Phase 2 trial and the first trial in psoriatic arthritis using a Nanobody® to report positive topline results, setting another landmark milestone. Again, we met the objectives we set out for ourselves, in this case for PsA. As with our hidradenitis suppurativa program, the preparation of our Phase 3 program in PsA is rapidly advancing and expected timing of end-of-Phase 2 regulatory meetings will be announced in due course.” Adalimumab was used as an active reference to validate responses across arms (not powered for statistical comparisons to active treatment). Sonelokimab 60mg and 120mg (with induction) numerically outperformed adalimumab on the primary endpoint and all key secondary endpoints, with the observed deltas further supporting the potential for sonelokimab as a future leading therapy. The patient discontinuation rate in the ARGO trial was low at week 12 (less than 4%), similar to what was observed in previous trials of sonelokimab in psoriasis and hidradenitis suppurativa. The safety profile of sonelokimab in ARGO was consistent with previously reported studies with no new safety signals. Specifically, oral candidiasis was observed in less than 2% of patients on sonelokimab, with no case leading to discontinuation. No cases of inflammatory bowel disease (IBD), major adverse cardiovascular events (MACE) or suicidal ideation and behavior (SI/B) were observed. Overall, sonelokimab continues to show a favorable safety profile. Across the sonelokimab clinical program to date, the company has not seen any signal of SI/B or liver enzyme elevations related to sonelokimab treatment. The results suggest that, as early as week 12, the Nanobody® sonelokimab reaches levels of clinical response at or above those seen with other therapies tested in similarly stringent trials. The high performance of sonelokimab and its favorable safety profile continue to support the potential of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases. Kristian Reich, MD, PhD, Founder and Chief Scientific Officer at MoonLake, commented: “The positive topline results from the pivotal-like ARGO trial establish the Nanobody® sonelokimab as an innovative potential treatment in another chronic inflammatory disease, psoriatic arthritis. Importantly, the results confirm our expectations in terms of dosing, clinical responses and safety findings. We believe that we have elevated the therapeutic bar by reaching important clinical outcomes at week 12. The data also support sonelokimab’s unique molecule characteristics and mode of action to effectively inhibit IL-17F in addition to IL-17A in deep tissue inflammation. The positive outcome of the ARGO trial would not have been possible without the support and participation of the patients and investigators to whom we are grateful.” Joseph F. Merola, MD, MMSc, Professor of Dermatology, Medicine and Rheumatology, Distinguished Chair of Dermatology at UT Southwestern Medical Center added: “Psoriatic arthritis is a chronic, inflammatory, recurrent, and debilitating multidomain disease that has profound and wide-ranging impacts across many aspects of patients’ lives. As a physician, I see tremendous need for new treatment options for people living with PsA, particularly for therapies that reach high thresholds of response (e.g., ACR70, PASI100) and that simultaneously improve the disease domains that matter most for patients. The positive high clinical responses across joint and skin endpoints and stringent composite measures such as minimal disease activity observed with sonelokimab as early as week 12 in the Phase 2 ARGO trial are encouraging, demonstrating its promise as a potential future treatment option.” These topline data will be discussed on Monday November 6, 2023 at 2pm CET/8am ET before the Nasdaq market opens, via webcast at: https://edge.media-server.com/mmc/p/bp43a4xr A replay of the webcast and the presentation document will be made available at https://ir.moonlaketx.com. The ARGO trial proceeds to week 24, with a 4-week safety follow-up. Important data is being collected regarding longer-term efficacy and safety of sonelokimab, as well as results from the cross-over of patients treated with placebo or adalimumab to sonelokimab and the continued monthly dosing of sonelokimab. Today’s top-line data announcement follows the announcement in July 2023 that the ARGO trial successfully completed randomization of its target 200 patients, several weeks ahead of schedule (read more here). Full results from the ARGO trial will be submitted for publication in a peer-reviewed medical journal and for presentation at an upcoming scientific meeting. The positive top-line12-week results from the Phase 2 ARGO trial in PsA follows the positive top-line 12-week and 24-week results from the Phase 2 MIRA trial in hidradenitis suppurativa (HS) as announced in June 2023 (read more here) and October 2023 (read more here). The MIRA trial set a landmark milestone as the first placebo-controlled randomized trial in HS to report positive top-line results using HiSCR75 as the primary endpoint. Sonelokimab is not yet approved for use in any indication. - Ends - About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints. The clinical features of PsA are diverse, involving pain, swelling, and stiffness of the joints, which can result in restricted mobility and fatigue. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. The symptom burden of PsA can have a substantial negative impact on patient quality of life. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the ARGO trial The ARGO trial (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active PsA. The trial is designed to evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving ≥50% improvement in signs and symptoms of disease from baseline, compared to placebo, as measured by the American College of Rheumatology (ACR) 50 response. The trial also evaluates a number of secondary endpoints, including improvement compared to placebo in ACR20, complete skin clearance as measured by at least a 100% improvement in the Psoriasis Area and Severity Index (PASI), physical function as measured by the Health Assessment Questionnaire-Disability Index, enthesitis as measured by the Leeds Enthesitis Index and pain as measured by the Patients Assessment of Arthritis Pain. Further details are available on: https://clinicaltrials.gov/ct2/show/NCT05640245 About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two trials, the Phase 2 ARGO trial in PsA (trial ongoing) and the Phase 2 MIRA trial in HS. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other clinically relevant outcomes. Sonelokimab has also been assessed in a randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. Clinical response (considering the Investigator’s Global Assessment Score 0 or 1, and the Psoriasis Area and Severity Index 90/100) was observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for clinical trials and research and development programs; and the anticipated timing of the results from those trials, including completing the MIRA trial and top-line data from the ARGO trial; and the efficacy of our products, if approved, including in relation to other products. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, and reliance on third parties to conduct and support its clinical trials, and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward- looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. MoonLake Immunotherapeutics InvestorsMatthias Bodenstedt, CFOinfo@moonlaketx.com MoonLake Immunotherapeutics MediaPatricia Sousamedia@moonlaketx.com ICR ConsiliumMary-Jane Elliott, Namrata Taak, Ashley TappTel: +44 (0) 20 3709 5700media@moonlaketx.comMoonLake@consilium-comms.com
Company maintains priority focus on clinical programs to develop a novel functional cure for hepatitis B viral (HBV) infection and a potential first-of-its-kind treatment for postpartum depression (PPD) and major depressive disorders (MDD) Multiple Phase 2a proof-of-concept (POC) clinical data readouts and Phase 2b clinical trial initiations expected in 2023 Operations well-funded through 2025 Company to host conference call today at 8:00 PM HKT / 8:00 AM ET DURHAM, N.C. and BEIJING, March 24, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced a corporate update and reported its annual results for the year ended December 31, 2022. "In 2022 we achieved several key clinical, commercial and corporate milestones that strengthen our overall position to tackle major public health challenges on behalf of patients." Stated Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, "Throughout the upcoming year, we will continue to advance our lead clinical development programs as we work to bring a functional cure for hepatitis B viral infection to patients in China and potential first-of-its-kind treatment options for postpartum depression and major depressive disorders to patients in the U.S. Across our broader infectious and central nervous system disease portfolios, we look forward to adding new best-in-class partnerships and applying our proven internal discovery capabilities to strategically shape and position the Company for long-term growth and success." Beyond its lead clinical programs in hepatitis B viral (HBV) infection, postpartum depression (PPD) and major depressive disorders (MDD), Brii Bio and its partners are advancing a broad pipeline of more than 10 differentiated treatment options for anxiety and major depressive disorders, human immunodeficiency virus (HIV), multidrug resistant (MDR) and extensively drug resistant (XDR) Gram-negative infections and non-tuberculous mycobacterial (NTM) lung disease. In addition, Brii Bio has made the decision to discontinue its amubarvimab/romlusevimab antibody combination program for COVID-19 and has stopped manufacturing efforts in order to redirect resources to high-priority programs. This determination is based on constantly evolving COVID-19 trends and policy updates, as well as protracted regulatory inspections at our contract development and manufacturing organization (CDMO) sites. Fiscal Year 2022 and Recent Corporate Developments Brii Bio expanded its executive leadership team and strengthened its Board structure and corporate development initiatives with the additions of Dr. Ankang Li, Chief Strategy and Financial Officer, to the Board of Directors as an executive director and chair of the Strategy Committee, and Dr. Taiyin Yang as an independent non-executive director of the Board and co-chair of the Audit and Risk Committee. New additions to the Brii Bio senior leadership team included Dr. Susannah Cantrell, Chief Business Officer, Dr. Eleanor de Groot, Chief Technology Officer, Dr. Aleksandar Skuban, Central Nervous System Diseases Therapy Area Head, and Karen D. Neuendorff, Chief People Officer. Brii Bio strengthened the China leadership team, which included the appointments of Dr. Qing Zhu to Head of China Research & Development, and Mr. Rico Liang to General Manager of China. Brii Bio was added to the MSCI China Small Cap Index, an international benchmark for global institutional investors seeking to optimize their investment portfolios. Brii Bio commercially launched the amubarvimab/romlusevimab combination as a long-acting COVID-19 neutralizing antibody in China. Brii Bio continued to foster partnerships with key maternal health advocacy groups to address patient needs and preferences in the U.S., including supporting the Postpartum Support International's Climb Out of the Darkness event, and sponsorship of the 20/20 Mom Annual Forum, Maternal Mental Health Now, the 35th Annual Postpartum Support International Conference and the 2022 Black Maternal & Mental Health Summit. Brii Bio continues to receive broad industry recognition for its corporate and clinical development accomplishments across more than 10 awards and feature lists, including "50 Women in Tech" by Forbes China, "2022 Annual Biotechnology Innovation" by China Times, "Top 10 Chinese Pharmaceutical Listed Companies in ESG Investment Value in 2022" by Healthcare Executives, "2022-2023 Gold Bell Seal for Workplace Mental Health" by Mental Health America and more. Brii Bio also received an "A" rating by MSCI ESG Rating, a globally recognized assessment of a company's resilience to long-term environmental, social and governance (ESG) risks. Fiscal Year 2022 Clinical Pipeline Highlights and Upcoming Milestones Hepatitis B Virus (HBV) Program (China team core project) Led by Brii Bio's team in China and partners, Vir Biotechnology, Inc. ("Vir," NASDAQ: VIR) and VBI Vaccines, Inc. ("VBI," NASDAQ: VBIV), the Company is progressing multiple combination studies for the treatment of HBV to improve the probability of achieving a high rate of functional cure for chronic HBV patients in China. China has the largest prevalence of HBV in the world, with 87 million people impacted by this disease, yet there is no effective functional cure currently available for patients. BRII-179 (VBI-2601) in Combination with BRII-835 (VIR-2218) (Study conducted by Brii Bio) In February 2023, interim results were presented in an oral session at the Asian Pacific Association for the Study of Liver (APASL) 2023 indicating that combination therapy with BRII-835 (VIR-2218) and BRII-179 (VBI-2601) was safe and well-tolerated, induced stronger anti-hepatitis B surface antigen (HBsAg) antibody responses and led to improved HBsAg-specific T-cell responses, when compared with BRII-835 (VIR-2218) or BRII-179 (VBI-2601) alone. In the data presented at APASL, 50 participants in all cohorts achieved HBsAg reduction at the end of treatment with a mean decrease of -1.7 to -1.8 log10 IU/mL. In addition, two participants in combination cohorts achieved maximum reductions in HBsAg at or below the lower limit of quantification (LLOQ) by Week 40, along with robust HBsAg-specific antibody and T-cell responses. Additional data from the Phase 2 study of BRII-179/BRII-835 combination are expected in the second half of 2023. BRII-179 (VBI-2601) in Combination with PEG-IFN-α (Study conducted by Brii Bio) In December 2022, the Company completed patient enrollment in part one of a Phase 2 combination trial evaluating the addition of BRII-179 (VBI-2601) in chronic HBV patients already receiving pegylated interferon alpha (PEG-IFN-α) and nucleotide/nucleoside reverse transcriptase inhibitors (NRTI) treatment. Topline results are expected in the second half of 2023. VIR-2218 (BRII-835) in Combination with PEG-IFN-α (Study conducted by Vir) Vir announced end-of-treatment data from an ongoing Phase 2 trial of combination 48 weeks of VIR-2218 (BRII-835) with PEG-IFN-α at the American Association for the Study of Liver Diseases (AASLD) 2022 meeting, which demonstrated that nearly 31% of patients with chronic HBV infection achieved HBsAg seroclearance with anti-HBs seroconversion with no new safety signals. Additional data from the Phase 2 study led by Vir are expected in the first half of 2023. VIR-2218 (BRII-835) in Combination with VIR-3434 (BRII-877) (MARCH Study conducted by Vir) In November 2022, Vir presented initial end-of-treatment data at AASLD's The Liver Meeting® from Part A of its ongoing Phase 2 MARCH study evaluating VIR-2218 (BRII-835) in combination with VIR-3434 (BRII-877) in participants with chronic HBV infection who received NRTI therapy. The data indicated additive HBsAg reductions from VIR-2218 (BRII-835) and VIR-3434 (BRII-877) with combination regimens achieving a much greater HBsAg reduction than either alone in all patients with no safety signals. Additional data from Part A of Vir's ongoing Phase 2 MARCH trial are expected in the first half of 2023. Initial data to evaluate VIR-2218 (BRII-835) and VIR-3434 (BRII-877) with or without PEG-IFN-α, are expected in the second half of 2023 from Part B of Vir's ongoing Phase 2 MARCH trial. Brii Bio is working closely with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase 1 study of BRII-877 (VIR-3434) in China. Postpartum Depression (PPD) Program and Major Depressive Disorder (MDD) (U.S. team core project) Brii Bio is developing its internally-discovered BRII-296 therapeutic candidate as a first-of-its-kind one-time injection treatment with the potential to expand the PPD and MDD treatment landscapes for patients in the U.S. BRII-296 In September 2022, Brii Bio announced positive topline results from its Phase 1 study of BRII-296 with data that demonstrated a single administration of the investigational therapy at 600 mg delivered a favorable pharmacokinetic (PK) profile and was safe and well-tolerated in healthy subjects. Early feedback from physicians and patient communities is very positive and reinforces the potential for a first-of-its-kind single-injection treatment option for PPD. Brii Bio is working closely with the U.S. Food and Drug Administration (FDA) to align and agree on a PPD treatment protocol in preparation for its Phase 2 proof-of-concept (POC) study. The Company is actively working to expand the clinical indications for BRII-296 in 2023 and plans to initiate additional Phase 2 studies in the U.S. by the end of the year. BRII-297 Brii Bio has conducted Investigational New Drug (IND)-enabling studies with BRII-297 targeting various anxiety and depressive disorders. Brii Bio plans to initiate a first-in-human PK, safety and tolerability study with BRII-297 in Australia in the first half of 2023. Additional Clinical and Pre-Clinical Development Updates Human Immunodeficiency Virus (HIV) Program BRII-732 In October 2022, Brii Bio presented positive Phase 1 data showing that BRII-732 demonstrated an acceptable safety and tolerability profile, as well as a favorable and linear PK profile that achieved therapeutic targets in healthy volunteers, reinforcing its potential as an oral once-weekly therapy for the treatment of HIV infections. In December 2022, Brii Bio was notified by the U.S. FDA that it had lifted the clinical hold on the Company's planned Phase 1 study to investigate a lower oral dose of once-weekly BRII-732. The Company is exploring partnership opportunities to continue developing BRII-732 as part of a potential oral, once-weekly, long-acting combination treatment option for HIV patients. BRII-753 The Company also selected a new clinical candidate, BRII-753, as a long-acting subcutaneous injection therapy with the goal to extend the dosing schedule to once monthly, once quarterly or twice-yearly. BRII-778 Based on the PK data from a completed Phase 1 study, which determined additional development work was required to achieve optimal PK targets for the treatment of HIV, Brii Bio has made the decision to discontinue development of BRII-778. Multidrug- and Extensively Drug-Resistant (MDR/XDR) Gram-negative Bacteria Infections Program BRII-693 (QPX-9003) Qpex Biopharma, Inc. (Qpex) announced in early 2022 that BRII-693 received Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA. In October 2022, Qpex presented at IDWeek interim Phase 1 results from its completed first-in-human clinical study, demonstrating that BRII-693 is safe and well-tolerated at all doses tested and supports continued development of BRII-693 for the treatment of Acinetobacter baumannii and Pseudomonas aeruginosa infections resistant to carbapenem. Qpex continues to work closely with the U.S. FDA to align its next steps in clinical development. Brii Bio plans to submit a pre-IND to the NMPA in the first half of 2023 for development of BRII-693 in China. BRII-672 (ORAvance™) Qpex announced in early 2022 that BRII-672, in combination with a non-disclosed oral beta-lactam antibiotic, received QIDP designation by the U.S. FDA. Preclinical data and interim Phase 1 clinical results were presented at IDWeek in October 2022. In the fourth quarter of 2022, Qpex completed the first-in-human Phase 1 study in the U.S. No subjects discontinued treatment due to adverse events (AEs) and no serious adverse events (SAEs) were observed in this Phase 1 single ascending dose (SAD) study. In December, Brii Bio submitted a pre-IND to the NMPA seeking regulatory guidance around a development plan for BRII-672 in China. Qpex continues to work closely with the U.S. FDA to align its next steps in clinical development. BRII-636 (OMNIvance®) Qpex announced in early 2022 that BRII-636 received QIDP designation by the U.S. FDA. Qpex completed a first-in-human Phase 1 study and a drug-drug interaction study and presented findings at IDWeek in the fourth quarter of 2022. This Phase 1 multiple ascending dose (MAD) study indicated that overall, BRII-636 (xeruborbactam), alone and in combination with meropenem, at doses associated with efficacy in animal models of infection was well-tolerated. Qpex continues to work closely with the U.S. FDA to align its next stages in clinical development. Non-tuberculous Mycobacterial (NTM) Lung Disease Program BRII-658 (epetraborole) Brii Bio's partner, AN2 Therapeutics, Inc. (NASDAQ: ANTX), is advancing a pivotal Phase 2/3 clinical trial for treatment-refractory Mycobacterium avium complex (MAC) lung disease. AN2 also completed and reported topline results from its Phase 1 bridging study designed to evaluate the PK, safety and tolerability of oral BRII-658 (epetraborole) in Japanese subjects. COVID-19 Program Following commercial launch in July 2022, Brii Bio sold substantially all available products of the amubarvimab/romlusevimab combination, with distribution to 25 provinces and 358 hospitals, with a revenue of RMB51.6 million. And as part of its commitment to ensuring humanitarian access and contributing to the containment of the pandemic outbreak, the Company donated nearly 3,000 doses for emergency use to 21 cities and 22 hospitals in China prior to the commercial launch. In January 2023, the amubarvimab/romlusevimab combination is the recommended antiviral treatment for COVID-19 in both the 10th COVID-19 Diagnosis and Treatment Guideline and the 4th COVID-19 Diagnosis and Treatment Protocol for Severe/Critical Cases. The Company has made the decision to discontinue its amubarvimab/romlusevimab antibody combination program and has stopped manufacturing efforts in order to redirect resources to high-priority programs. This determination is based on the constantly evolving COVID-19 trends including the upcoming expiration of the federal Public Health Emergency (PHE) by the U.S. Department of Health and Human Services' (HHS) in May 2023, as well as protracted regulatory inspections at our CDMO sites. The Company is working with the U.S. FDA to withdraw the Emergency Use Authorization (EUA) application at an appropriate time following the completion of activities required by the regulatory authority and also with the China NMPA to withdraw the Biologics License Application (BLA) in the third quarter of 2023 once all necessary regulatory requirements have been completed. No significant revenue is expected in the future from the commercialization of amubarvimab/romlusevimab injection combination either in China or in the U.S. and other territories. Full Year 2022 Financial Results The revenues increased by RMB51.6 million from nil for the year ended December 31, 2022. The increase was due to the commercialization of the long-acting amubarvimab/romlusevimab combination therapy in China for the treatment of COVID-19. Other income was RMB107.9 million for the year ended December 31, 2022, representing an increase of RMB8.9 million or 9.0%, compared with RMB99.0 million for the year ended December 31, 2021. The increase was mainly due to the increase in bank interest income of RMB30.7 million attributable to the increased bank and cash balances after the Global Offering. The increase was partially offset by the decrease in income recognized from PRC government grants. Research and development expenses were RMB440.6 million for the year ended December 31, 2022, representing a decrease of RMB54.0 million, or 10.9%, compared with RMB494.6 million for the year ended December 31, 2021. The decrease was primarily due to the decrease in third party contracting costs relating to COVID-19 programs. It was partially offset by the increase in the employee cost for our continuous development in clinical trials. Selling and marketing expenses increased by RMB26.9 million from nil for the year ended December 31, 2022. The increase was primarily attributable to the commercialization of COVID-19 therapy. Administrative expenses were RMB168.6 million for the year ended December 31, 2022, representing a decrease of RMB39.8 million, or 19.1%, compared with RMB208.4 million for the year ended December 31, 2021. The decrease was primarily attributable to the decrease in the employee costs. Total comprehensive expense for the year ended December 31, 2022 was RMB238.5 million, representing a decrease of RMB4,010.5 million, or 94.4%, compared with RMB4,249.0 million for the year ended December 31, 2021. The decrease was primarily attributable to the decrease in fair value loss on financial liabilities at FVTPL. Conference Call Information A live conference call will be hosted on March 24, 2023, at 8:00 PM Hong Kong time (8:00 AM U.S. Eastern Time). All participants are required to register in advance of the call. For the registration link, please click here. All participants shall use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive an email with important details for this call, including the call date, time and access link. This link is to be kept confidential and not shared with other participants. Additionally, a replay of the conference call will be available after the call and can be accessed by visiting the Company's website at www.briibio.com under the Investor Relations section. About Brii Bio's Programs Hepatitis B Virus (HBV) (Licensed from VBI and Vir, China team core project) As one of its leading clinical development programs, Brii Bio is building a broad pipeline of novel HBV therapeutic candidates in order to improve the probability of achieving a high rate of functional cure for each subpopulation of HBV patients. Each of Brii Bio's HBV candidates has a unique therapeutic modality with proven clinical benefit targeting this chronic infection, which allows the Company to explore an expansive set of potential combination treatment options for various patient subgroups. Brii Bio holds exclusive rights in Greater China to develop and commercialize BRII-179 (VBI-2601), BRII-835 (VIR-2218) and BRII-877 (VIR-3434). BRII-179 (VBI-2601) is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced B-cell and T-cell immunity. BRII-835 (VIR-2218) is a GalNAc-conjugated small interfering ribonucleic acid (siRNA) targeting all HBV viral RNAs that has shown to block viral transcription, reduce viral protein and alleviate immune suppression. BRII-877 (VIR-3434) is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (VIR-3434), which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV in infected patients, as well as to have an extended half-life. Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS disorders (Internally discovered, U.S. team core project) Leveraging patient insights, Brii Bio is developing BRII-296 and BRII-297 to expand treatment options for patients with psychiatric disorders who are often underserved and overlooked across the industry. Utilizing applied drug formulation know-how to develop long-acting therapies, Brii Bio is focused on improving drug administration convenience and patient compliance to ensure potential treatment success. BRII-296 is a novel, long-acting, single injection therapeutic candidate in development for the treatment PPD and MDD. It acts as a gamma-aminobutyric acid A (GABAA) receptor positive allosteric modulator (PAM) and is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD and MDD with the potential to lead to greater adherence, convenience and fewer side effects compared to the current standard of care. BRII-297 is a new chemical entity (NCE) discovered internally in development as a long-acting injectable (LAI) treatment of various anxiety and depression disorders. Human Immunodeficiency Virus (HIV) (Internally discovered, U.S. team project) Brii Bio is seeking partners to collaborate on the development of BRII-732 as a once-weekly oral single-tablet regimen for the treatment or prevention of HIV. Brii is also seeking development partnership for BRII 753, a novel low volume, subcutaneous injection therapy with potential to dose monthly to every six months. Both compounds demonstrate considerable promise to serve as a key component for long-acting HIV treatment regimens that will offer more discreet and convenient options for patients living with HIV, and as monotherapy for HIV prevention. BRII-732 is a proprietary prodrug NCE that, upon oral administration, is rapidly metabolized into EFdA and is under evaluation as a potential HIV treatment or prevention option. BRII-732 is a nucleoside analogue reverse transcriptase translocation inhibitor (NRTTI) that acts as both a chain terminator and translocation inhibitor of HIV. BRII-753 is an NCE currently in the preclinical stage of development. It has been internally discovered and is being developed as a long-acting subcutaneous injection with potential for dosing once monthly to once every six months. BRII-753 can be used in a combination therapy for HIV treatment and as monotherapy for pre-exposure prophylaxis (PrEP). Multidrug- and Extensively Drug-Resistant (MDR/XDR) Gram-negative Infections (Licensed from Qpex, China team project) Brii Bio is developing MDR/XDR therapies in collaboration with Qpex as part of their global development plan. Based on a licensing agreement with Qpex, Brii Bio has the exclusive rights to develop and commercialize BRII-636, BRII-672 and BRII-693 in Greater China. Qpex is progressing BRII-636, BRII-672 and BRII-693 in parallel with a goal of moving each to global Phase 3 studies, at which time Brii Bio will participate in the China-based arm of the global research protocols. BRII-636, BRII-672 and BRII-693 candidates all obtained QIDP designation from the U.S. FDA, which may receive incentives in the future. BRII-693 (QPX-9003) is a novel synthetic lipopeptide in development for the treatment of MDR/XDR Gram-negative bacterial infections. Based on a combination of increased in vitro and in vivo potency, and an improved safety profile compared with currently available polymyxins, BRII-693 has the potential to be an important addition to hospital-administered intravenous antibiotics. BRII-672 (ORAvanceTM) is a prodrug of BRII-636 and an oral beta-lactamase inhibitor (BLI) in development for the treatment of MDR/XDR Gram-negative bacterial infections. These agents were discovered by Qpex as part of their expertise in BLIs, using the boron atom as a part of its pharmacophore. BRII-636 (OMNIvance®) is an intravenously administered novel cyclic boronic acid derived broad-spectrum inhibitor in development for the treatment of MDR/XDR Gram-negative bacterial infections. Non-tuberculous Mycobacterial (NTM) Lung Disease Program (Licensed from AN2, China team project) Brii Bio's strategic partner, AN2 Therapeutics, is developing epetraborole (BRII-658) as a once-daily oral treatment for patients with chronic NTM lung disease, with an initial focus on treatment-refractory Mycobacterium avium complex (MAC) lung disease, which is the subpopulation of MAC lung disease with the highest unmet medical need for new therapies. Brii Bio holds a license to develop, manufacture and commercialize epetraborole (BRII-658) in Greater China. BRII-658 (epetraborole) is in development as a once-daily oral treatment for patients with chronic NTM lung disease, with an initial focus on treatment of refractory MAC lung disease. It is a boron-containing, small molecule inhibitor of mycobacterial leucyl-tRNA synthetase, or LeuRS, an enzyme that inhibits protein synthesis. COVID-19 (Discovered in collaboration with Tsinghua University and Third People's Hospital of Shenzhen through Brii Bio's subsidiary, TSB Therapeutics Ltd (Beijing) Co. Limited.) Amubarvimab and romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. Approved by China's NMPA in December 2021, the long-acting amubarvimab/romlusevimab cocktail therapy is approved to be administered by intravenous infusion in two sequential doses for the treatment in adults and pediatric patients (age 12-17 weighing at least 40 kg) of mild- and normal-type COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under conditional approval. In January 2023, the National Health Commission of China reiterated the amubarvimab/romlusevimab combination in its COVID-19 Diagnosis and Treatment Guidelines (10th Edition) for the treatment of COVID-19 and the 4th COVID-19 Diagnosis and Treatment Protocol for Severe/Critical Cases. The live virus testing data as well as pseudovirus testing data from multiple independent labs have demonstrated that the amubarvimab/romlusevimab combination retains activity against commonly identified SARS-CoV-2 variants B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.617.2 (Delta), AY.4.2 (Delta Plus), C.37 (Lambda), B.1.621 (Mu), B.1.1.529-BA.1 (Omicron) and BA.1.1, BA.2, BA.2.12.1, BA.4/5, BF.7 (Omicron subvariants). This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information. About Brii Bio Brii Biosciences ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address some of the world's most common diseases where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs to develop a novel functional cure for hepatitis B viral infection (HBV) and a first-of-its-kind treatment for postpartum depression (PPD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com. Forward Looking Statement The information communicated in this press release contains certain statements that are or may be forward looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company are unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
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