Annexon(US:ANNX)2021-08-15 16:00Financial Performance - The company reported a net loss of $31.3 million for the three months ended June 30, 2021, compared to a net loss of $12.2 million for the same period in 2020, representing a 156% increase in losses [100]. - As of June 30, 2021, the company had an accumulated deficit of $223.3 million and cash and cash equivalents of $302.4 million [100]. - Cash used in operating activities for the six months ended June 30, 2021 was $48.1 million, compared to $20.2 million for the same period in 2020 [125]. - Total operating expenses for the six months ended June 30, 2021 were $57.6 million, an increase of $32.9 million, or 133%, compared to the same period in 2020 [117]. - The company believes its existing cash and cash equivalents will fund operating expenses through 2023, but may require additional funding in the future [130]. Research and Development - Research and development expenses increased by $15.3 million, or 165%, for the three months ended June 30, 2021, primarily due to increased clinical trial activities for product candidates ANX005, ANX007, and ANX009 [111]. - The company expects substantial increases in research and development expenses as it advances product candidates into later stages of development and larger clinical trials [106]. - The company expects research and development expenses to increase substantially as it continues to invest in clinical trials and related activities [128]. - The company is conducting ongoing clinical trials for multiple serious autoimmune and neurodegenerative diseases, with data anticipated over the next two years [98]. - The company has completed Phase 1b clinical trials for ANX005 and ANX007, both of which showed full inhibition of C1q and the classical complement pathway [97]. General and Administrative Expenses - General and administrative expenses are anticipated to increase significantly as the company supports research and development activities and compliance with public company regulations [108]. - General and administrative expenses increased by $3.9 million, or 131%, for the three months ended June 30, 2021 compared to the same period in 2020 [116]. - General and administrative expenses for the six months ended June 30, 2021 were $12.3 million, an increase of $7.1 million, or 137%, compared to the same period in 2020 [121]. Funding and Capital Structure - The company completed an IPO on July 28, 2020, raising approximately $262.4 million in net proceeds [101]. - The company raised net cash proceeds of $233.9 million from private placements and $262.4 million from the IPO of its common stock [122]. Accounting and Reporting - The company adopted ASU No. 2016-02, Leases (Topic 842) on January 1, 2021, using the modified retrospective approach [137]. - Operating lease right-of-use (ROU) assets and liabilities are recognized based on the present value of lease payments over the lease term [138]. - The company elected not to separate non-lease components from lease components for all facility leases, treating them as a single lease component [139]. - There were no material changes to the company's critical accounting policies or estimates from those described in the previous Annual Report [137]. - The company is assessing the impacts of its transition to a large accelerated filer on its internal control over financial reporting [134]. - The company has not yet adopted recent accounting pronouncements and is evaluating their potential impact on its financial condition [140]. - Quantitative and qualitative disclosures about market risk are not required for the company as a smaller reporting company [142]. Company Status - As of June 30, 2021, the company retained its eligibility as a smaller reporting company and an emerging growth company [133]. - The aggregate worldwide market value of the company's voting common stock held by non-affiliates exceeded $700 million on June 30, 2021, qualifying it as a "large accelerated filer" by the end of the current fiscal year [134].