Avidity Biosciences(US:RNA)2024-11-07 21:15Financial Performance - The company reported net losses of $212.2 million and $174.0 million for the years ended December 31, 2023 and 2022, respectively, and $220.0 million for the nine months ended September 30, 2024, with an accumulated deficit of $790.8 million as of September 30, 2024[68]. - Revenue for the three months ended September 30, 2024, decreased by $0.5 million to $2.336 million compared to $2.818 million in the same period of 2023, while revenue for the nine months increased by $0.6 million to $7.924 million from $7.367 million[78][79]. - Other income increased by $11.5 million for the three months ended September 30, 2024, totaling $17.736 million, and by $20.8 million for the nine months to $37.901 million[78][83]. Cash and Financing - The company has approximately $1.6 billion in cash, cash equivalents, and marketable securities as of September 30, 2024, expected to fund operations for at least 12 months[68]. - The company raised $379.8 million from a private placement of 15,224,773 shares at $16.50 per share on March 4, 2024, and $432.8 million from a public offering of 12,132,500 shares at $38.00 per share on June 17, 2024[84][85]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $1.2 billion, a substantial increase from $62.0 million in the same period in 2023, mainly from common stock sales[92]. Research and Development - Delpacibart zotadirsen (del-zota) demonstrated a mean increase of 37% in exon 44 skipping and a greater than 80% reduction of creatine kinase compared to baseline in the EXPLORE44 trial[64]. - Delpacibart etedesiran (del-desiran) is currently in Phase 3 development with the ongoing global HARBOR™ trial, with enrollment on track[63]. - The company is advancing additional exon-skipping candidates from its DMD franchise, with exon 45 currently in IND-enabling studies[65]. - The company is pursuing a potential accelerated approval path for del-brax, with enrollment in the biomarker cohort expected to be completed in the first half of 2025[66]. - The company expects research and development expenses to continue increasing as it advances preclinical and clinical development programs[75][76]. Expenses - Research and development expenses increased by $29.5 million for the three months ended September 30, 2024, totaling $77.197 million, compared to $47.714 million in the same period of 2023, and increased by $69.8 million for the nine months to $207.968 million from $138.151 million[78][80][81]. - General and administrative expenses rose by $9.5 million for the three months ended September 30, 2024, reaching $23.273 million, compared to $13.729 million in the same period of 2023, and increased by $19.8 million for the nine months to $57.902 million from $38.071 million[78][82]. - The company expects to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution if regulatory approval is obtained for any product candidates[86]. Capital Requirements and Market Risks - Future capital requirements are uncertain and will depend on various factors, including clinical trial costs, regulatory review outcomes, and market acceptance of approved products[86]. - The company faces uncertainty in the timelines and costs associated with research and development activities, which can vary significantly for each product candidate[75]. - As of September 30, 2024, there have been no material changes in market risk from previous disclosures[97]. - The company may seek additional capital due to favorable market conditions or strategic considerations, even if current funds are deemed sufficient[86]. Operational Activities - The company has not generated any revenue from product sales since inception and plans to finance cash needs through equity offerings and collaborations[68]. - The company has incurred operating losses in each year since inception, with expectations for substantial increases in expenses and operating losses as clinical trials progress[68]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $201.0 million, an increase of $65.4 million compared to $135.6 million for the same period in 2023[90]. - Net cash used in investing activities for the nine months ended September 30, 2024, was $790.0 million, significantly higher than $181.1 million for the same period in 2023, primarily due to $1.1 billion in marketable securities purchases[91]. - The company entered into a sublease agreement in April 2024, with total future lease commitments of approximately $72.6 million[95]. - The company does not expect to generate revenue from product sales until successful development and regulatory approval of product candidates, which may take several years[86].