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Cerevel Therapeutics Reports Second Quarter 2022 Financial Results and Business Updates

·9 min read
Cerevel Therapeutics
Cerevel Therapeutics

Initiated two parallel, adequately-powered Phase 2 trials of emraclidine in schizophrenia with data expected 1H 2024

Phase 1 trial of emraclidine to be initiated by year-end to support future development in Alzheimer’s disease psychosis

Panic disorder selected as second indication for darigabat, planning underway for Phase 2 proof-of-concept

Cash, cash equivalents and marketable securities of $531M as of June 30, 2022, expected to support operations into 2024

Conference call today at 8:00 a.m. ET

CAMBRIDGE, Mass., Aug. 01, 2022 (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 June 30, 2022 and provided key pipeline and business updates.

“At Cerevel, it is our aspiration to become the premier neuroscience company. We are well on our way to achieving this distinction with a broad and deep pipeline of potential new therapies and compelling early data in schizophrenia, which has led us to initiate a potentially pivotal Phase 2 program for emraclidine,” said Tony Coles, M.D., chairperson and chief executive officer of Cerevel Therapeutics. “With five data readouts expected next year, a robust set of mid- to late-stage assets, world-class capabilities in drug development, and an ability to execute rapidly to advance our late-stage programs, Cerevel is well-positioned to transform what is possible in neuroscience.”

Pipeline Highlights

Leveraging its deep understanding of neurocircuitry and targeted receptor subtype selectivity, Cerevel is executing on its broad, diverse pipeline of novel neuroscience drug candidates. Below are the latest updates for Cerevel’s lead programs.

Emraclidine: an M4-selective positive allosteric modulator (PAM) in development for schizophrenia as a once-daily medication without the need for titration.

  • In June 2022, Cerevel initiated its Phase 2 program in schizophrenia:

    • Cerevel is conducting two adequately-powered placebo-controlled Phase 2 trials, known as EMPOWER-1 and EMPOWER-2. Data for both trials are expected in the first half of 2024.

    • The primary endpoint is the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after six weeks of in-patient treatment.

    • Each trial will enroll 372 individuals living with schizophrenia and experiencing an acute exacerbation of psychotic symptoms who exhibit baseline PANSS total scores from 85 to 120, inclusive.

    • In each trial, patients will be randomized 1:1:1 into one of two emraclidine dose arms or placebo.

      • The first trial will test emraclidine 10 mg QD, emraclidine 30 mg QD, and placebo.

      • The second trial will test emraclidine 15 mg QD, emraclidine 30 mg QD, and placebo.

    • The trials will enable the full exploration of the therapeutic dose range of emraclidine.

    • In order to accelerate a potentially registrational package for emraclidine in schizophrenia, Cerevel is prioritizing nonclinical and clinical pharmacology studies. Cerevel expects to initiate a 52-week open-label safety extension trial, EMPOWER-3, in the third quarter of 2022. Data from the ongoing eight-week ambulatory blood pressure monitoring trial are expected by the end of 2022.

  • To support future development in Alzheimer’s disease psychosis, Cerevel also plans to initiate a Phase 1 multiple ascending dose trial by the end of the year to evaluate the safety, tolerability and pharmacokinetics of emraclidine in elderly healthy volunteers, 65-85 years old.

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. Cerevel expects data in mid-year 2023.

  • Based on the positive topline results reported in February 2022 for the Phase 1 trial of darigabat in acute anxiety, Cerevel has selected panic disorder as the second indication for development, in addition to epilepsy, and plans are underway for a Phase 2 proof-of-concept trial in panic disorder, which is the second most common anxiety disorder and can be the most debilitating.

  • Cerevel recently presented darigabat data at the American Society of Clinical Psychopharmacology Annual Meeting, which took place on May 31 – June 3, 2022.

    • Cerevel presented the positive topline results for its Phase 1 trial of darigabat in acute anxiety.

    • In a separate panel presentation, Cerevel discussed efforts to achieve diversity in clinical trials, an imperative that is a key component of a broader commitment to diversity, equity, and inclusion across all facets of the company.

Tavapadon: a D1/D5 partial agonist currently in Phase 3 for the treatment of Parkinson’s disease.

  • All three of Cerevel’s Phase 3 trials in early- and late-stage Parkinson’s disease (TEMPO-1, -2, and -3) are ongoing, along with the corresponding open-label extension trial (TEMPO-4).

  • Data readouts from the Phase 3 program are expected beginning in the first half of 2023.

CVL-871: a D1/D5 partial agonist in development for treatment of dementia-related apathy.

  • In the second quarter of 2021, Cerevel received Fast Track Designation from the FDA for the development of CVL-871 in dementia-related apathy.

  • Cerevel is conducting a Phase 2a exploratory trial in dementia-related apathy.

  • Data for this trial are anticipated in the first half of 2023.

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 (MDD) and substance use disorder.

  • Selective M4 agonist program for the treatment of psychosis and other related indications.

  • CVL-047, a selective PDE4 inhibitor (PDE4D-sparing) for the treatment of MDD and schizophrenia.

Financial Results for the Second Quarter 2022

  • Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022, were $531.2 million, inclusive of $37.5M from the tavapadon risk-sharing arrangement received in April 2022. The company’s cash, cash equivalents and marketable securities are expected to continue to support operations into 2024.

  • R&D Expense: Research and development expense for the second quarter and six months ended June 30, 2022, was $72.5 million and $127.6 million, respectively, compared to $37.3 million and $73.9 million for the prior year periods. Total research and development expense includes equity-based compensation expense of $4.8 million and $8.8 million for the second quarter and six months ended June 30, 2022, respectively. These amounts compare to equity-based compensation expense of $2.1 million and $3.9 million for the prior year periods. The increase in R&D expense is primarily attributable to continued advancement of Cerevel’s clinical programs for tavapadon, emraclidine, and darigabat; investment in preclinical and discovery efforts; and higher personnel and other infrastructure costs as Cerevel expands capabilities to advance its pipeline.

  • G&A Expense: General and administrative expense for the second quarter and six months ended June 30, 2022, was $20.5 million and $38.0 million, compared to $13.2 million and $27.2 million for the prior year periods. Total general and administrative expense includes equity-based compensation expense of $5.3 million and $9.9 million for the second quarter and six months ended June 30, 2022. These amounts compare to equity-based compensation expense of $3.1 million and $7.4 million for the prior year periods. The increase in G&A expense is primarily due to higher personnel costs as Cerevel continued to grow the organization, the initiation of commercial planning activities, and higher fees and services supporting ongoing business activities.

Conference Call Information
Cerevel will host a conference call and webcast today, August 1, 2022 at 8:00 a.m. ET to discuss its second quarter 2022 financial results and pipeline updates. To access the call, please register at this link. Once registered, you will receive the dial-in information and a unique PIN number.

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 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 five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia, and dementia-related apathy. 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 timing, details and objectives of the emraclidine Phase 2 program, nonclinical and clinical pharmacology studies, ambulatory blood pressure monitoring trial, Phase 1 elderly healthy volunteer trial and plans for future development in other indications, including Alzheimer’s disease psychosis, the timing for the darigabat Phase 2 proof-of-concept trial in focal epilepsy, the timing and details of the darigabat Phase 2 proof-of-concept trial in panic disorder, 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 regulatory interactions, including whether trials meet the criteria to serve as pivotal; 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; and the sufficiency of our cash, cash equivalents and marketable securities. 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 May 10, 2022 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:
Anna Robinson
Cerevel Therapeutics
anna.robinson@cerevel.com

Investor Contact:
Matthew Calistri
Cerevel Therapeutics
matthew.calistri@cerevel.com


TABLE 1

 

 

 

 

 

 

 

 

 

 

 

CEREVEL THERAPEUTICS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(unaudited, in thousands, except share amounts and per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended
June 30,

 

For the Six Months Ended
June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

72,539

 

 

$

37,294

 

 

$

127,562

 

 

$

73,855

 

 

General and administrative

 

 

20,467

 

 

 

13,216

 

 

 

37,974

 

 

 

27,226

 

 

Total operating expenses

 

 

93,006

 

 

 

50,510

 

 

 

165,536

 

 

 

101,081

 

 

Loss from operations

 

 

(93,006

)

 

 

(50,510

)

 

 

(165,536

)

 

 

(101,081

)

 

Interest income, net

 

 

667

 

 

 

10

 

 

 

962

 

 

 

25

 

 

Other income (expense), net

 

 

1,868

 

 

 

(2,739

)

 

 

5,809

 

 

 

(3,164

)

 

Loss before income taxes

 

 

(90,471

)

 

 

(53,239

)

 

 

(158,765

)

 

 

(104,220

)

 

Income tax benefit (provision), net

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(90,471

)

 

$

(53,239

)

 

$

(158,765

)

 

$

(104,220

)

 

Net loss per share, basic and diluted

 

$

(0.61

)

 

$

(0.42

)

 

$

(1.07

)

 

$

(0.82

)

 

Weighted-average shares used in calculating net loss per share, basic and diluted

 

 

148,295,716

 

 

 

127,482,127

 

 

 

148,141,180

 

 

 

127,354,540

 

 

 

 

 

 

 

 

 

 

 

 



TABLE 2

 

 

 

 

 

 

 

CEREVEL THERAPEUTICS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(unaudited, in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of

 

 

 

June 30,
2022

 

December 31,
2021

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

138,218

 

$

193,018

 

Marketable securities

 

 

392,990

 

 

372,670

 

Prepaid expenses and other current assets

 

 

8,933

 

 

12,329

 

Total current assets

 

 

540,141

 

 

578,017

 

Marketable securities

 

 

 

 

52,269

 

Property and equipment, net

 

 

29,314

 

 

28,449

 

Operating lease assets

 

 

22,573

 

 

23,251

 

Restricted cash

 

 

1,867

 

 

4,200

 

Other long-term assets

 

 

2,762

 

 

2,733

 

Total assets

 

$

596,657

 

$

688,919

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

11,008

 

$

11,298

 

Accrued expenses and other current liabilities

 

 

43,063

 

 

28,803

 

Operating lease liabilities, current portion

 

 

2,672

 

 

2,437

 

Total current liabilities

 

 

56,743

 

 

42,538

 

Operating lease liabilities, net of current portion

 

 

32,688

 

 

34,110

 

Other long-term liabilities

 

 

54,412

 

 

33,542

 

Total stockholders’ equity

 

 

452,814

 

 

578,729

 

Total liabilities and stockholders’ equity

 

$

596,657

 

$

688,919

 

 

 

 

 

 

 



TABLE 3

 

 

 

 

 

CEREVEL THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited, in thousands)

 

 

 

 

 

 

 

 

For the Six Months Ended
June 30,

 

 

 

2022

 

 

 

2021

 

Net cash flows used in operating activities

 

$

(125,304

)

 

$

(82,026

)

Net cash flows provided by (used in) investing activities

 

 

25,752

 

 

 

(8,243

)

Net cash flows provided by financing activities

 

 

42,419

 

 

 

33,706

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(57,133

)

 

 

(56,563

)

Cash, cash equivalents and restricted cash, beginning of the period

 

 

197,218

 

 

 

387,823

 

Cash, cash equivalents and restricted cash, end of the period

 

$

140,085

 

 

$

331,260

 

 

 

 

 

 

Note:

 

 

 

 

Cash, cash equivalents and restricted cash balances include restricted cash of $1.9 million and $4.2 million as of June 30, 2022 and June 30, 2021, respectively.