Verve Therapeutics(US:VERV)2021-11-10 12:03Financial Performance - As of September 30, 2021, the company reported a net loss of $22.7 million for the three months and $89.0 million for the nine months, with an accumulated deficit of $155.5 million[112]. - The net loss for Q3 2021 was $22.7 million, compared to a net loss of $9.0 million in Q3 2020, representing an increase of $13.8 million[144]. - The company incurred a net loss of $89.0 million for the nine months ended September 30, 2021, compared to a net loss of $22.2 million for the same period in 2020[164][167]. - Cash used in operating activities was $49.8 million for the nine months ended September 30, 2021, an increase from $20.3 million in the prior year[163][167]. Revenue Generation - The company has not generated any revenue to date and does not expect to do so in the near future until successful development and regulatory approval of product candidates[127]. Research and Development - The lead product candidate, VERVE-101, demonstrated an average reduction of blood LDL-C levels by 59% at two weeks post-treatment, maintained at an average of 60% for 15 months[118]. - In preclinical studies, VERVE-101 achieved a 70% mean editing rate at the PCSK9 target gene site in liver biopsies, with an average reduction of blood LDL-C levels of 62% maintained to 180 days[119]. - The ANGPTL3 program aims to permanently turn off the ANGPTL3 gene, with preclinical studies showing approximately 94% and 97% reductions in blood ANGPTL3 protein in different models[122]. - Research and development expenses are expected to increase as the company advances its programs and product candidates into clinical development[131]. - The company plans to pursue regulatory submissions and begin clinical development of VERVE-101 in 2022[117]. - Research and development expenses for Q3 2021 were $17.5 million, an increase of $9.9 million from $7.6 million in Q3 2020[145]. - For the nine months ended September 30, 2021, research and development expenses totaled $42.3 million, an increase of $22.5 million from $19.8 million in the same period of 2020[153]. - The company expects continued increases in research and development expenses as it advances current and new research programs and clinical trials[154]. Operating Expenses - General and administrative expenses for Q3 2021 were $6.0 million, up approximately $4.7 million from $1.4 million in Q3 2020[149]. - Total operating expenses for Q3 2021 reached $23.5 million, compared to $9.0 million in Q3 2020, reflecting a change of $14.5 million[144]. - General and administrative expenses for the nine months ended September 30, 2021 were $12.3 million, compared to $3.2 million for the same period in 2020, marking an increase of $9.0 million[155]. - The company anticipates an increase in general and administrative expenses in the future to support research and development activities and compliance costs associated with being a public company[135]. - The company expects significant increases in operating expenses as it advances its research programs and product candidates into clinical development[172]. Cash and Funding - The company had cash, cash equivalents, and marketable securities of $389.2 million as of September 30, 2021, expected to fund operations into 2024[116]. - The company raised an aggregate of $523.2 million in gross proceeds from equity offerings through September 30, 2021, including $281.6 million from its IPO[161][162]. - Net cash provided by financing activities was $375.9 million for the nine months ended September 30, 2021, compared to $92.6 million in the prior year[170][171]. - The company used $182.1 million in investing activities for the nine months ended September 30, 2021, primarily for marketable securities purchases[168]. - As of September 30, 2021, the company had cash and equivalents totaling $148.1 million, primarily in U.S. government-backed securities and treasuries[188]. - The company also held marketable securities amounting to $241.1 million, consisting of U.S. treasury securities and agency securities[188]. - The company anticipates needing substantial additional funds to achieve its business objectives, as product candidates may not achieve commercial success[174]. Market and Economic Conditions - The ongoing impact of COVID-19 has not significantly affected the company's business results for the three and nine months ended September 30, 2021[125]. - Inflation did not have a material effect on the company's business, financial condition, or results of operations during the three and nine months ended September 30, 2021[191]. - An immediate 10% change in interest rates would not materially affect the fair market value of the company's cash equivalents and marketable securities due to their short-term maturities and low risk profile[189]. - The company is not currently exposed to significant market risk related to foreign currency exchange rates, although it contracts with vendors outside the U.S.[190]. - Future contracts with foreign vendors may increase the company's exposure to foreign currency exchange risk[190]. Other Financial Adjustments - The change in fair value of success payment liability resulted in a $0.7 million adjustment to other income in Q3 2021, with obligations to Harvard and Broad totaling $6.3 million triggered during the same period[150]. - The total other income (expense) for Q3 2021 was $753,000, compared to an expense of $18,000 in Q3 2020, reflecting a change of $771,000[144]. - The fair value adjustment to the antidilution rights liability was $25.6 million due to the issuance of 878,098 shares of common stock[158]. - The company reported a fair value adjustment of $9.0 million to the success payments liability during the nine months ended September 30, 2021[159].