Raised
2024 data readout timelines for emraclidine, darigabat, and tavapadon remain on track
Tavapadon investor webcast scheduled for
Conference call today at
“Cerevel is bringing forward one of the broadest neuroscience pipelines in the industry, with novel approaches to treating challenging diseases, and we remain focused on execution as we head into multiple data readouts in 2024,” said
Tavapadon Investor Webcast on
Cerevel will host an investor webcast on
Pipeline Highlights
Leveraging its deep understanding of neurocircuitry and targeted receptor subtype selectivity, Cerevel is advancing its broad and diverse pipeline of novel neuroscience product candidates.
Below are the latest updates for Cerevel’s lead programs.
Emraclidine: an M4-selective positive allosteric modulator (PAM) in development for schizophrenia and Alzheimer’s disease psychosis.
- Cerevel is conducting two adequately-powered placebo-controlled Phase 2 trials in schizophrenia in which emraclidine is being studied as a once-daily medication without the need for titration, known as EMPOWER-1 and EMPOWER-2.
- EMPOWER program data are expected in the second half of 2024.
- The 52-week open-label safety extension trial, EMPOWER-3, is also continuing enrollment.
- In order to support a potential registrational package for emraclidine in schizophrenia, Cerevel is also prioritizing the completion of the necessary non-clinical and clinical pharmacology studies in addition to its EMPOWER program.
- To support development in Alzheimer's disease psychosis as a second potential indication for emraclidine, Cerevel initiated a Phase 1 multiple ascending dose trial to evaluate the safety, tolerability and pharmacokinetics of emraclidine in elderly healthy volunteers, 65-85 years old.
- The FDA granted Fast Track designation for emraclidine for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis.
Darigabat: an α2/3/5-selective GABAA receptor PAM currently under development for epilepsy and panic disorder.
- Cerevel is conducting the REALIZE trial, a Phase 2 proof-of-concept trial in focal epilepsy, and a corresponding open-label safety extension trial.
- Data readout for the REALIZE trial is expected mid-year 2024.
- Cerevel has also initiated the ADAPT trial, a Phase 2 proof-of-concept trial in panic disorder.
Tavapadon: a D1/D5 partial agonist currently in Phase 3 for the treatment of Parkinson’s disease.
- Tavapadon has the potential to be a first-in-class D1/D5 selective partial agonist for Parkinson’s disease, as both monotherapy and adjunctive treatment.
- All three of Cerevel’s Phase 3 trials as monotherapy (early-stage) and adjunctive (late-stage) in Parkinson’s disease (TEMPO-1, -2, and -3) are ongoing, along with the corresponding open-label extension trial (TEMPO-4).
- Data is expected in the first half of 2024 for TEMPO-3 and in the second half of 2024 for TEMPO-1 and TEMPO-2.
CVL-871: a D1/D5 partial agonist in development for treatment of dementia-related apathy.
- Cerevel is conducting a Phase 2a exploratory trial in dementia-related apathy.
- The timeline for this trial remains under review.
In addition to these lead programs, Cerevel is advancing its early clinical pipeline and discovery programs, which include:
- CVL-354, a selective kappa opioid receptor antagonist (KORA) for the treatment of major depressive disorder and substance use disorder.
- Selective M4 agonist program for the treatment of psychiatric and neurological indications.
- Selective PDE4 inhibitor (PDE4D-sparing) program for the treatment of psychiatric, neuroinflammatory and other disorders.
Financial Results for the Third Quarter 2023
- Cash Position: Cash, cash equivalents and marketable securities as of
September 30, 2023 totaled$758.2 million . InOctober 2023 , we completed a follow-on public offering of our common stock raising approximately$498.7 million in aggregate net proceeds, including the full exercise of the underwriters’ option to purchase additional shares. Cerevel’s cash, cash equivalents, and marketable securities are expected to support all planned data readouts in 2024 and fund operations into 2026. - R&D Expense: Research and development expense for the third quarter and nine months ended
September 30, 2023 was$85.3 million and$237.5 million , respectively, compared to$71.4 million and$198.9 million for the prior year periods. Total research and development expense includes equity-based compensation expense of$6.8 million and$20.3 million for the third quarter and nine months endedSeptember 30, 2023 , respectively. These amounts compare to equity-based compensation expense of$4.4 million and$13.2 million for the prior year periods. The increases in research and development expense were primarily due to the continued advancement of our emraclidine and tavapadon programs as well as an increase in personnel costs, including equity-based compensation, as we continue to expand capabilities to advance our pipeline. - G&A Expense: General and administrative expense for the third quarter and nine months ended
September 30, 2023 was$26.1 million and$70.2 million , respectively, compared to$23.7 million and$61.7 million for the prior year periods. Total general and administrative expense include equity-based compensation expense of$10.3 million and$23.9 million for the third quarter and nine months endedSeptember 30, 2023 , respectively. These amounts compare to equity-based compensation expense of$5.3 million and$15.2 million for the prior year periods. Compared to the same periods in the prior year, the increases in general and administrative expense were primarily driven by higher personnel costs, including equity-based compensation, partially offset by a reduction in spend associated with professional fees.
Conference Call Information
Cerevel will host a conference call and webcast today,
A live webcast of the call, along with supporting slides, will be available on the investors section of Cerevel’s website at investors.cerevel.com. Following the live webcast, an archived version of the call will be available on the website.
About
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, timing and objectives of our product development activities and clinical trials; the timing and outcome of regulatory interactions, including whether activities meet the criteria to serve as registrational; the ability to compete with other companies currently marketing or engaged in the development of treatments for relevant indications; the size and growth potential of the markets for product candidates and ability to serve those markets; the rate and degree of market acceptance of product candidates, if approved; the sufficiency of our cash runway; and our tavapadon investor webcast. 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, the post-COVID environment and other factors on the timing, progress and results of clinical trials; our ability to recruit and enroll suitable patients in our clinical trials, including the effectiveness of mitigation measures; 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
Media Contact:
anna.robinson@cerevel.com
Investor Contact:
matthew.calistri@cerevel.com
TABLE 1 | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(unaudited, in thousands, except share amounts and per share amounts) | |||||||||||||||||
For the Three Months Ended | For the Nine Months Ended | ||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 85,252 | $ | 71,385 | $ | 237,514 | $ | 198,947 | |||||||||
General and administrative | 26,055 | 23,680 | 70,187 | 61,654 | |||||||||||||
Total operating expenses | 111,307 | 95,065 | 307,701 | 260,601 | |||||||||||||
Loss from operations | (111,307 | ) | (95,065 | ) | (307,701 | ) | (260,601 | ) | |||||||||
Interest income, net | 9,891 | 3,992 | 28,787 | 4,954 | |||||||||||||
Interest expense | (2,644 | ) | (1,286 | ) | (7,920 | ) | (1,286 | ) | |||||||||
Other income (expense), net | 7,822 | (7,579 | ) | (13,033 | ) | (1,770 | ) | ||||||||||
Loss before income taxes | (96,238 | ) | (99,938 | ) | (299,867 | ) | (258,703 | ) | |||||||||
Income tax benefit (provision), net | (123 | ) | — | (315 | ) | — | |||||||||||
Net loss | $ | (96,361 | ) | $ | (99,938 | ) | $ | (300,182 | ) | $ | (258,703 | ) | |||||
Net loss per share, basic and diluted | $ | (0.61 | ) | $ | (0.66 | ) | $ | (1.91 | ) | $ | (1.73 | ) | |||||
Weighted-average shares used in calculating net loss per share, basic and diluted | 157,498,891 | 152,304,645 | 157,069,093 | 149,544,252 | |||||||||||||
TABLE 2 | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(unaudited, in thousands) | |||||||
As of | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 155,721 | $ | 136,521 | |||
Marketable securities | 521,161 | 755,509 | |||||
Prepaid expenses and other current assets | 10,904 | 13,621 | |||||
Total current assets | 687,786 | 905,651 | |||||
Marketable securities | 81,340 | 58,126 | |||||
Property and equipment, net | 26,613 | 27,467 | |||||
Operating lease assets | 20,580 | 21,820 | |||||
Restricted cash | 1,960 | 1,867 | |||||
Other long-term assets | 3,683 | 2,891 | |||||
Total assets | $ | 821,962 | $ | 1,017,822 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities | $ | 78,838 | $ | 72,564 | |||
Operating lease liabilities, net of current portion | 28,673 | 31,190 | |||||
2027 convertible senior notes, net | 336,933 | 335,482 | |||||
Financing liabilities | 104,556 | 57,348 | |||||
Total stockholders’ equity | 272,962 | 521,238 | |||||
Total liabilities and stockholders’ equity | $ | 821,962 | $ | 1,017,822 | |||
TABLE 3 | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(unaudited, in thousands) | ||||||||
For the Nine Months Ended | ||||||||
2023 | 2022 | |||||||
Net cash flows used in operating activities | $ | (244,881 | ) | $ | (205,709 | ) | ||
Net cash flows provided by (used in) investing activities | 223,930 | (362,102 | ) | |||||
Net cash flows provided by financing activities | 40,244 | 621,060 | ||||||
Net increase in cash, cash equivalents and restricted cash | 19,293 | 53,249 | ||||||
Cash, cash equivalents and restricted cash, beginning of the period | 138,388 | 197,218 | ||||||
Cash, cash equivalents and restricted cash, end of the period | $ | 157,681 | $ | 250,467 | ||||
Note: | ||||||||
Cash, cash equivalents and restricted cash balances include restricted cash of |
Source:
2023 GlobeNewswire, Inc., source