Cerevel Therapeutics Holdings(CERE) - 2021 Q2 - Quarterly Report

Financial Performance - The net loss for the three months ended June 30, 2021, was $53,239,000, a 99% increase compared to a net loss of $26,717,000 in the same period of 2020[187]. - For the six months ended June 30, 2021, the company reported a net loss of $104.2 million, compared to a net loss of $79.9 million for the same period in 2020, resulting in an accumulated deficit of $495.1 million as of June 30, 2021[196]. - The total operating expenses for the three months ended June 30, 2021, were $50,510,000, a 44% increase from $35,156,000 in the same period of 2020[187]. - Research and development expenses for the three months ended June 30, 2021, increased by 68% to $37,294,000 compared to $22,183,000 in the same period of 2020[188]. - General and administrative expenses for the three months ended June 30, 2021, rose by 2% to $13,216,000 from $12,973,000 in the same period of 2020[190]. - Cash used in operating activities for the six months ended June 30, 2021, was $82.0 million, a 46% increase compared to $56.0 million for the same period in 2020[215][219]. Capital and Funding - The company completed a follow-on public offering on July 7, 2021, issuing 14,000,000 shares at $25.00 per share, raising approximately $328.2 million in net proceeds after expenses[120]. - The company entered into funding agreements on April 12, 2021, to receive up to $125.0 million for the development of tavapadon, with $31.1 million received in April 2021[198]. - The company anticipates requiring additional capital for operational needs, clinical trials, and research and development expenditures in the future[200]. - The company reported net cash provided by financing activities of $33.7 million for the six months ended June 30, 2021, mainly from the Funding Agreements[222]. Research and Development - The company has a pipeline of 11 small molecule programs, including five clinical-stage candidates, with ongoing clinical trials including three Phase 3 trials for tavapadon in Parkinson's disease[118]. - Positive topline results for CVL-231 in a Phase 1b trial for schizophrenia showed statistically significant improvement in PANSS total score at six weeks[121]. - Tavapadon is expected to provide initial Phase 3 data in the first half of 2023, targeting early- and late-stage Parkinson's disease[134]. - Darigabat is in a Phase 2 trial for focal epilepsy, with data expected in the second half of 2022, and a Phase 1 trial for acute anxiety with data expected in the first half of 2022[131][133]. - CVL-871 received Fast Track Designation from the FDA for dementia-related apathy, with Phase 2a data expected in the second half of 2022[135]. - The company is utilizing advanced technologies, including artificial intelligence, to identify new therapeutic molecules with disease-modifying potential[138]. Operational Challenges - The company currently has no product candidates approved for commercial sale and relies on significant additional capital for ongoing research and development efforts[144]. - The company has incurred significant operating losses since inception and does not expect to generate revenues from product sales in the near future[163]. - The company anticipates significant increases in expenses related to advancing clinical-stage product candidates and hiring additional personnel[147]. - General and administrative expenses are expected to increase as the company builds corporate infrastructure, though the growth rate is anticipated to moderate throughout 2021[174]. Market and Industry Context - The biopharmaceutical industry is highly competitive, with risks including the introduction of new products and the need for regulatory approvals[140][141]. - The company has not incurred significant impairment losses in asset values due to the COVID-19 pandemic[162]. - The impact of COVID-19 has caused modifications to business practices, including temporary work-from-home policies and restrictions on non-essential travel[157]. Assets and Liabilities - As of June 30, 2021, the company had an accumulated deficit of $495.1 million and had not yet generated any revenues[146]. - The available cash resources as of June 30, 2021, were $327.1 million, expected to fund operations for at least twelve months[146]. - The company's cash and cash equivalents totaled $327.1 million as of June 30, 2021, reflecting a significant decrease in total current assets by $58.8 million since December 31, 2020[196][212]. - As of June 30, 2021, the company had no debt obligations and recorded accrued expenses of approximately $11.2 million for expenditures incurred by contract research organizations (CROs) and contract manufacturing organizations (CMOs)[224][228]. Corporate Structure - The company completed a business combination transaction on October 27, 2020, resulting in Old Cerevel becoming a wholly owned subsidiary of ARYA[149]. - The company is classified as an "emerging growth company" and a "smaller reporting company," which allows it to take advantage of certain exemptions from reporting requirements[235].