AKESO(HK:09926)2020-09-17 08:34Drug Development and Innovation - Akeso, Inc. has developed over 20 innovative drug candidates targeting major diseases, with 9 currently in clinical stages, including two first-in-class bispecific antibody drugs[5]. - The company has established a comprehensive drug development platform (ACE platform) that integrates drug discovery and development functions[5]. - Akeso, Inc. aims to become a leading global biopharmaceutical company by developing innovative drugs that provide best-in-class therapies[5]. - The company has successfully developed a bispecific antibody development technology known as TETRABODY technology[5]. - Akeso, Inc. is focused on creating affordable innovative antibody drugs for global patients[5]. - The company is actively pursuing market expansion and strategic partnerships to enhance its product pipeline and market presence[5]. - Akeso, Inc. is committed to high-efficiency and breakthrough R&D innovations to develop international first-in-class and best-in-class drugs[5]. - The company has received regulatory approvals for its clinical trials, indicating progress in its drug development efforts[5]. - Akeso, Inc. is positioned to leverage its end-to-end drug development capabilities to accelerate the commercialization of its innovative therapies[5]. - The company is continuously exploring new strategies for growth, including potential mergers and acquisitions to strengthen its market position[5]. Financial Performance - Total revenue for the six months ended June 30, 2020, was RMB 41.0 million, an increase of 78.96% from RMB 22.9 million in the same period of 2019[17]. - Research and development expenses rose to RMB 240.7 million, a 95.35% increase from RMB 123.2 million year-over-year, primarily due to the development of clinical trials for candidate drugs[17]. - Administrative expenses surged to RMB 99.5 million, a significant increase of 631.66% from RMB 13.6 million in the previous year, mainly due to IPO-related costs and increased employee compensation[17]. - The net loss for the period was RMB 718.3 million, a 520.65% increase compared to RMB 115.7 million in the same period of 2019[17]. - Adjusted total comprehensive loss amounted to RMB 216.7 million, up 88.15% from RMB 115.2 million in the prior year[17]. - The increase in net loss was attributed to a one-time non-cash change in the fair value of convertible redeemable preferred shares amounting to RMB 412.4 million[18]. - The company received increased government subsidies for research and development activities, contributing to the rise in other income and net gains[18]. - The company plans to continue expanding its research capabilities and product pipeline in the upcoming periods[18]. - The IPO-related expenses and stock-based compensation significantly impacted the administrative costs, indicating a strategic focus on growth and market presence[18]. Clinical Trials and Approvals - The company received FDA IND approval for AK104 in April 2020, initiating a registration clinical trial for recurrent or metastatic cervical cancer patients[21]. - In May 2020, the company obtained NMPA approval to start a pivotal registration trial for AK104 in third-line treatment of metastatic nasopharyngeal carcinoma, with the first patient successfully dosed[21]. - The first patient was successfully dosed in a Phase II clinical trial for AK104 targeting advanced unresectable or MSI-H solid tumors in May 2020[21]. - The company appointed Professor MONK from the University of Arizona as the chief advisor for the global Phase II multi-center clinical study of AK104 in July 2020[21]. - The company received NMPA approval for AK112 in August 2020 to conduct an Ib phase clinical trial for advanced solid tumors in China[24]. - The first patient was successfully dosed with AK109 for advanced solid tumors in June 2020[25]. - The company has developed a diverse pipeline with over 20 drug development projects, including 12 in clinical stages and six bispecific antibodies[34]. - The company established a partnership with a major subsidiary of China National Pharmaceutical Group to co-develop and commercialize the PD-1 antibody candidate penpulimab (AK105)[34]. Employee and Organizational Growth - As of June 30, 2020, the company had a total of 458 employees, with 24.2% in R&D and 26.6% in clinical roles[31]. - The company aims to attract and retain top talent to enhance capabilities in clinical development and commercialization[30]. - The company has 12 clinical-stage drug candidates, including 9 internally developed and 3 licensed to third parties[35]. - The company is strategically developing expertise in immunology to address the growing autoimmune disease market in China[35]. - The company has a joint venture agreement with Dongrui Pharmaceutical for the PCSK-9 monoclonal antibody ebronucimab (AK102)[35]. - The company has nine clinical-stage antibody candidates under development as of June 30, 2020, with a focus on various cancers and autoimmune diseases[36]. Production and Capacity Expansion - The company has established a GMP-compliant production facility in Zhongshan, covering approximately 3,200 square meters, with a production capacity of 3,700 liters[56]. - A new commercial production base in Guangzhou is under construction on a 56,573 square meter site, expected to have a capacity of up to 40,000 liters, with an annual production capacity of 2 million doses anticipated to start in early 2021[57]. - The company plans to establish a commercial operation team of approximately 300 to 500 personnel by the end of 2021 to enhance commercialization capabilities[64]. - The company plans to expand its GMP-compliant production capacity in response to increased demand for candidate drugs[65]. Shareholder and Equity Information - The company completed its initial public offering on April 24, 2020, resulting in the conversion of all preferred shares into ordinary shares[152]. - The total amount of government subsidies related to research and clinical trials was RMB 48,065,000 as of June 30, 2020[151]. - The company reported a basic and diluted loss per share of RMB 1.13 for the six months ended June 30, 2020, compared to RMB 1.32 for the same period in 2019[133]. - The total equity attributable to owners of the parent company reached RMB 3,618,271,000 as of June 30, 2020, compared to RMB 406,289,000 at the same time last year[113]. - The company raised approximately RMB 2,174,530,000 from the issuance of 183,419,000 ordinary shares at a price of HKD 16.18 per share during its initial public offering[160]. Financial Liabilities and Assets - The fair value loss on convertible redeemable preferred shares was recorded at RMB 412.4 million, attributed to non-cash and non-recurring accounting adjustments[72]. - The company reported a pre-tax loss of RMB 718,339,000 for the six months ended June 30, 2020, compared to a loss of RMB 115,740,000 for the same period in 2019, indicating a significant increase in losses[109]. - The total comprehensive loss for the period was RMB (728,709,000), compared to RMB (115,550,000) for the same period in 2019, reflecting a year-over-year increase of 528.5%[110]. - The company recognized a foreign exchange loss of RMB 1,584,000, which may impact overall financial results[116]. - The company reported a net cash outflow from investing activities of RMB 477,300,000, a substantial increase from RMB 56,349,000 in the prior year[116].