Clearside Biomedical(US:CLSD)2020-11-10 22:15Financial Performance - The company reported a net loss of $2.4 million for the three months ended September 30, 2020, compared to a net loss of $6.5 million for the same period in 2019, indicating a reduction in losses [75]. - The net loss for the nine months ended September 30, 2020, was $11.1 million, compared to a net loss of $27.7 million in 2019, an improvement of $16.6 million [93]. - The net loss decreased to $11.1 million for the nine months ended September 30, 2020, from $27.7 million for the same period in 2019, attributed to the discontinuation of certain clinical trials [102]. Revenue Generation - The company has not generated any revenue from drug sales and primarily relies on license agreements for revenue generation [78]. - License and other revenue for the three months ended September 30, 2020, was $3.4 million, a significant increase from $141,000 in the same period of 2019, representing a change of $3.3 million [89]. - For the nine months ended September 30, 2020, license and other revenue was $7.9 million, compared to $231,000 in 2019, marking a period-to-period change of $7.7 million [93]. Research and Development - The company expects to resubmit the New Drug Application (NDA) for XIPERE no later than the first half of 2021, with the FDA expected to review it within six months of resubmission [69]. - The company is advancing its proprietary suspension of axitinib (CLS-AX) into further preclinical development, with plans to initiate a Phase 1/2a clinical trial by the end of 2020 [71]. - Research and development expenses for the three months ended September 30, 2020, increased to $3.5 million from $2.7 million in 2019, primarily due to costs related to the initiation of the CLS-AX Phase 1/2a clinical trial [89]. - Research and development expenses for the nine months ended September 30, 2020, decreased to $10.6 million from $14.4 million in 2019, a reduction of $3.8 million [93]. Operating Expenses - General and administrative expenses decreased to $2.4 million for the three months ended September 30, 2020, down from $3.8 million in 2019, reflecting a $0.8 million reduction in marketing-related expenses [89]. - General and administrative expenses for the nine months ended September 30, 2020, were $8.1 million, down from $13.2 million in 2019, a decrease of $5.1 million [93]. Cash Flow and Capital Resources - As of September 30, 2020, the company had cash and cash equivalents of $14.8 million [94]. - The company incurred a net cash outflow of $8.7 million from operating activities for the nine months ended September 30, 2020, compared to $28.8 million for the same period in 2019, primarily due to lower research and development expenses [102]. - The company expects to require additional capital to fund ongoing operations and mitigate going concern risks, with plans to raise funds through equity or debt financings [100]. - The company anticipates that its cash and cash equivalents will fund operating expenses into the third quarter of 2021, based on current plans and forecasted expenses [100]. - The company has no committed external sources of funds and may face challenges in raising additional capital due to global economic conditions and market volatility [100]. Collaborations and Agreements - The company has entered into a license agreement with Arctic Vision for the commercialization of XIPERE in China, Hong Kong, Macau, Taiwan, and South Korea [74]. - The company is collaborating with Bausch Health for the commercialization of XIPERE in the United States and Canada, with an option for Bausch to develop XIPERE in additional regions [72]. Other Financial Information - The company incurred costs related to being a public entity, including board fees, audit fees, and compliance expenses [99]. - The company does not have any off-balance sheet arrangements as defined under SEC rules [106]. - The company received $3.0 million in milestone payments under the REGENXBIO agreement in September 2020 [94]. - The company used $55,000 in investing activities for equipment purchases during the nine months ended September 30, 2020, compared to a net cash inflow of $32.9 million in 2019 from short-term investments [102]. - Financing activities provided $1.0 million in net cash during the nine months ended September 30, 2020, primarily from the sale of common stock and a PPP loan [102].