Cerevel Therapeutics Holdings(CERE)
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Cerevel Therapeutics Holdings(CERE) - 2022 Q3 - Quarterly Report
2022-11-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39311 CEREVEL THERAPEUTICS HOLDINGS, INC. (Exact Name of Regist ...
Cerevel Therapeutics Holdings(CERE) - 2022 Q2 - Quarterly Report
2022-07-31 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39311 CEREVEL THERAPEUTICS HOLDINGS, INC. (Exact Name of Registrant ...
Cerevel Therapeutics Holdings(CERE) - 2022 Q1 - Quarterly Report
2022-05-09 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39311 CEREVEL THERAPEUTICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its Chart ...
Cerevel Therapeutics Holdings(CERE) - 2021 Q4 - Annual Report
2022-02-28 16:00
Financial Performance - The company has incurred net losses of $225.3 million, $152.1 million, and $128.4 million for the years ended December 31, 2021, 2020, and 2019, respectively, with an accumulated deficit of $616.2 million as of December 31, 2021[247]. - The company has not generated any revenue from product sales to date and does not expect to do so for the next few years[247]. - The company has incurred significant financial losses since its inception and expects to continue incurring losses for the foreseeable future[247]. - The company has not yet demonstrated an ability to generate revenues or conduct successful sales and marketing activities necessary for product commercialization[247]. - The company may need to delay, reduce, or terminate product development programs if it is unable to raise additional capital when needed[251]. - The company may not have sufficient capital to meet required payments to funding investors, which could adversely affect financial condition[258]. - The company has no current plans to pay cash dividends, meaning returns on investment will rely solely on capital appreciation of common stock[416]. - Future offerings of debt or equity securities may dilute existing stockholders' ownership and adversely affect the market price of common stock[418]. Clinical Development - The company is currently focused on its Phase 2 program for emraclidine for schizophrenia and an ongoing Phase 3 program for tavapadon[251]. - The company has six clinical-stage product candidates and is prioritizing development based on available resources[254]. - The company has initiated a registration-directed Phase 3 program for tavapadon, including two trials in early-stage Parkinson's and one in late-stage Parkinson's, with plans to start two Phase 2 trials of emraclidine in schizophrenia by mid-2022[260]. - The ongoing COVID-19 pandemic has caused delays in clinical trials, including a postponement of data for the Phase 2a exploratory trial for CVL-871 from the second half of 2022 to the first half of 2023[268]. - The company is experiencing challenges in clinical trial enrollment and completion due to COVID-19, which may impact data integrity and regulatory approval processes[270]. - The company is currently evaluating darigabat in a Phase 2 trial for focal epilepsy, but competition from newly approved treatments may affect enrollment timelines[285]. - The company may incur unexpected costs or delays in completing clinical trials, which could adversely affect its ability to obtain regulatory approval and commercialize its product candidates[275]. Regulatory and Compliance Risks - The regulatory approval process for product candidates is lengthy and unpredictable, with no current submissions for NDA or similar approvals made to the FDA[262]. - The company faces risks of failing to demonstrate the safety and efficacy of product candidates, which could hinder regulatory approval[267]. - The company must navigate complex negotiations for collaborations, which may not lead to efficient development or commercialization of product candidates[343]. - The company is subject to extensive laws and regulations in the healthcare industry, which could lead to significant liabilities and reputational harm if compliance is not maintained[324]. - The company may face increased scrutiny from federal and state enforcement bodies regarding compliance with healthcare laws, leading to potential investigations and penalties[366]. - Compliance with evolving global data protection laws, such as the GDPR, may incur substantial costs and penalties for non-compliance, potentially affecting operations[380]. Funding and Capital Requirements - The company will require substantial additional funding to complete its clinical trials and commercialization efforts, with no assurance that such funding will be available on acceptable terms[253]. - The company has entered into funding agreements to support the development of tavapadon for Parkinson's disease, which impose various obligations and covenants that may limit operational flexibility[257]. - The company has secured up to an additional $37.5 million from Funding Agreements, with $31.3 million and $25.0 million due on the first and second anniversaries, respectively, subject to customary funding conditions[341]. Market and Competitive Landscape - The competitive landscape for neuroscience diseases is highly competitive, with many large pharmaceutical and biotechnology companies pursuing similar indications[299]. - Market acceptance of approved products will depend on factors such as efficacy, safety, side effects, and competitive pricing[292]. - The company may face significant harm if it fails to obtain patent term extensions and data exclusivity for its product candidates, which could allow competitors to launch similar products after patent expiration[403]. Intellectual Property and Legal Risks - The company may face challenges in maintaining and enforcing its intellectual property rights, which could adversely affect its ability to commercialize products[389]. - There is a risk of third-party claims regarding intellectual property infringement, which could delay product development and commercialization[395]. - The company may need to obtain licenses from third parties to advance research or commercialize product candidates, which may not be available on reasonable terms[400]. Operational Challenges - The company may face operational challenges in managing growth, which could lead to increased expenses and reduced revenue generation capabilities[327]. - The company relies on third parties for conducting clinical trials, and any failure in their performance could delay regulatory approval or commercialization of product candidates[337]. - The company has provisions in its governing documents that could delay or prevent hostile takeovers, potentially impacting stockholder interests[333]. Employee and Management Risks - The company relies heavily on its executive officers and key personnel, and the loss of these individuals could materially harm its business[320]. - The biotechnology and pharmaceutical industries face intense competition for hiring qualified personnel, which may limit the company's ability to attract and retain necessary talent[320]. - The company expects significant growth in employee numbers and operational scope, which may require substantial capital expenditures and could divert resources from product development[325].
Cerevel Therapeutics Holdings(CERE) - 2021 Q3 - Quarterly Report
2021-11-09 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39311 CEREVEL THERAPEUTICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its C ...
Cerevel Therapeutics Holdings(CERE) - 2021 Q2 - Quarterly Report
2021-08-10 16:00
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].
Cerevel Therapeutics Holdings(CERE) - 2021 Q1 - Quarterly Report
2021-05-16 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |---------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | | | | For the ...
Cerevel Therapeutics Holdings(CERE) - 2020 Q4 - Annual Report
2021-03-23 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39311 CEREVEL THERAPEUTICS HOLDINGS, INC. (Exact name of Registrant as specified in its Charter) Delaware 85-3911080 (State or other ...
Cerevel Therapeutics Holdings(CERE) - 2020 Q3 - Quarterly Report
2020-11-16 21:43
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number: 001-39311 CEREVEL THERAPEUTICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 98-1533670 ...
Cerevel Therapeutics Holdings(CERE) - 2020 Q2 - Quarterly Report
2020-08-14 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to________________ ARYA SCIENCES ACQUISITION CORP II (Exact name of registrant as specified in its charter) Cayman Islands 98-1533670 (State or other jurisdiction of inco ...