Phase 1 data for darigabat in acute anxiety now expected by the end of Q1 2022
Submissions of additional PK/PD data for CVL-231 in schizophrenia accepted for presentation at the Annual Meeting of the American College of Neuropsychopharmacology
Conference call and webcast scheduled today at 8:00 a.m. ET
CAMBRIDGE, Mass., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the quarter ended September 30, 2021 and provided key pipeline and business updates.
“We continue to execute on our vision of becoming the premier neuroscience company as we advance our pipeline and secure the capital required for our next stage of growth as a company,” said Tony Coles, M.D., chairperson and chief executive officer of Cerevel Therapeutics. “We are advancing our clinical programs with speed and determination and preparing our company for the future in order to bring medicines to patients with neuroscience diseases including schizophrenia, anxiety, epilepsy, Parkinson’s, and dementia-related apathy as quickly as possible.”
Pipeline Highlights
Leveraging its deep understanding of neurocircuitry and receptor subtype selectivity, Cerevel continues to execute on its broad pipeline of novel neuroscience drug candidates.
CVL-231: CVL-231 is an M4-selective positive allosteric modulator (PAM) in development as a once-daily medication for schizophrenia without the need for titration. In June 2021, Cerevel announced positive topline data for its Phase 1b trial of CVL-231 in people with schizophrenia.
Darigabat (formerly CVL-865): Darigabat is an α2/3/5-selective GABAA receptor PAM currently under development for anxiety and epilepsy.
Tavapadon: Tavapadon is a D1/D5 partial agonist currently in Phase 3 trials for the treatment of Parkinson’s disease.
CVL-871: CVL-871 is a D1/D5 partial agonist in development for treatment of dementia-related apathy.
CVL-936: CVL-936 is a D3-preferring dopamine D3/D2 antagonist in development for substance use disorder (SUD).
Other Programs: Cerevel has an active drug discovery effort and a number of earlier-stage programs, including CVL-354 and CVL-047.
Financial Results for the Third Quarter 2021
Conference Call Information
Cerevel will host a conference call and webcast today, November 10, at 8:00 a.m. ET to discuss its third quarter 2021 financial results and pipeline updates. To access the call, please dial 833-665-0655 (domestic) or 702-495-1044 (international) and refer to conference ID 9784674. The live webcast and accompanying slides can be accessed on the investor relations section of the Cerevel Therapeutics website here. A replay will be available in the same section of the company’s website for approximately 90 days.
About Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases with a targeted approach to neuroscience that combines expertise in neurocircuitry with a focus on receptor selectivity. Cerevel Therapeutics has a diversified pipeline comprising six clinical-stage investigational therapies and several pre-clinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia, and substance use disorder. Headquartered in Cambridge, Mass., Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations, or potential acquisitions. For more information, visit www.cerevel.com.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about the potential attributes and benefits of our product candidates, the format and timing of our product development activities and clinical trials, including the advancement of CVL-231 into a comprehensive Phase 2 program in schizophrenia, the presentation of additional CVL-231 PK/PD data at ACNP, the timing and status of our Phase 1 trial of darigabat in acute anxiety and other statements regarding the design of clinical trials and preclinical studies and the timing of initiation, completion and data readouts for clinical trials, the timing and outcome of IND submissions and other regulatory interactions, the sufficiency of our financial resources and our cash runway. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: clinical trial results may not be favorable; uncertainties inherent in the product development process (including with respect to the timing of results and whether such results will be predictive of future results); the impact of COVID-19 on the timing, progress and results of ongoing or planned clinical trials; other impacts of COVID-19, including operational disruptions or delays or to our ability to raise additional capital; whether and when, if at all, our product candidates will receive approval from the FDA or other regulatory authorities, and for which, if any, indications; competition from other biotechnology companies; uncertainties regarding intellectual property protection; and other risks identified in our SEC filings, including those under the heading “Risk Factors” in our Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021 and our subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Media Contact:
Kate Contreras
Real Chemistry
[email protected]
Investor Contact:
Matthew Calistri
Cerevel Therapeutics
[email protected]
TABLE 1
CEREVEL THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share amounts and per share amounts)
For the Three Months Ended September 30, | For the Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 40,159 | $ | 24,026 | $ | 114,014 | $ | 73,168 | |||||||
General and administrative | 14,368 | 10,336 | 41,594 | 34,052 | |||||||||||
Total operating expenses | 54,527 | 34,362 | 155,608 | 107,220 | |||||||||||
Loss from operations | (54,527 | ) | (34,362 | ) | (155,608 | ) | (107,220 | ) | |||||||
Interest income, net | 13 | 1 | 38 | 210 | |||||||||||
Other income (expense), net | (7,545 | ) | (4,684 | ) | (10,709 | ) | (11,976 | ) | |||||||
Loss before income taxes | (62,059 | ) | (39,045 | ) | (166,279 | ) | (118,986 | ) | |||||||
Income tax benefit (provision), net | — | 5 | — | 21 | |||||||||||
Net loss | $ | (62,059 | ) | $ | (39,040 | ) | $ | (166,279 | ) | $ | (118,965 | ) | |||
Net loss per share, basic and diluted | $ | (0.43 | ) | $ | (0.62 | ) | $ | (1.25 | ) | $ | (1.93 | ) | |||
Weighted-average shares used in calculating net loss per share, basic and diluted | 144,022,109 | 63,270,340 | 132,971,450 | 61,726,114 | |||||||||||
TABLE 2
CEREVEL THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
As of | |||||
September 30, 2021 | December 31, 2020 | ||||
ASSETS | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 669,676 | $ | 383,623 | |
Prepaid expenses and other current assets | 5,353 | 6,937 | |||
Total current assets | 675,029 | 390,560 | |||
Property and equipment, net | 28,404 | 24,165 | |||
Operating lease assets | 23,576 | 24,459 | |||
Restricted cash | 4,200 | 4,200 | |||
Other long-term assets | 2,271 | 1,889 | |||
Total assets | $ | 733,480 | $ | 445,273 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
Current liabilities: | |||||
Accounts payable | $ | 5,445 | $ | 4,993 | |
Accrued expenses and other current liabilities | 23,020 | 22,519 | |||
Operating lease liabilities, current portion | 2,335 | 2,036 | |||
Total current liabilities | 30,800 | 29,548 | |||
Operating lease liabilities, net of current portion | 34,752 | 30,969 | |||
Other long-term liabilities | 38,848 | 236 | |||
Total stockholders’ equity | 629,080 | 384,520 | |||
Total liabilities and stockholders’ equity | $ | 733,480 | $ | 445,273 | |
TABLE 3
CEREVEL THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
For the Nine Months Ended September 30, | |||||||
2021 | 2020 | ||||||
Net cash flows used in operating activities | $ | (125,802 | ) | $ | (76,099 | ) | |
Net cash flows used in investing activities | (9,431 | ) | (11,341 | ) | |||
Net cash flows provided by financing activities | 421,286 | 20,766 | |||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 286,053 | (66,674) | |||||
Cash, cash equivalents and restricted cash, beginning of the period | 387,823 | 83,682 | |||||
Cash, cash equivalents and restricted cash, end of the period | $ | 673,876 | $ | 17,008 | |||
Note: | |||||||
Cash, cash equivalents and restricted cash balances include restricted cash of $4.2 million as of September 30, 2021 and September 30, 2020. |
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