Cerevel blames Covid for delayed neuroscience studies, says president is leaving

Neuroscience biotech Cerevel Therapeutics said data readouts for several clinical trials will come later than originally expected, and also disclosed the upcoming departure of its president, Abraham Ceesay.

The affected trials include a Phase II in focal epilepsy for darigabat, three Phase III trials for tavapadon in Parkinson’s and a Phase IIa of CVL-871 in dementia-related apathy. The epilepsy trial will read out sometime after 2023, the company said. Data had been expected in mid-2023. Another Phase II for darigabat will start next quarter in panic disorder.

Meanwhile, the three Phase III Parkinson’s trials will now read out in mid-year 2024 and the second half of 2024. Timelines for those trials have been impacted before, with the last quarterly update also including notes about “residual post-Covid landscape challenges.” The dementia-related apathy study is being delayed more than a year, from the first half of this year to the second half of 2024.

The delays are a blow to Cerevel, and the company’s stock $CERE slid 12% after the opening bell. The Pfizer spinout went public in 2020 via a combination with a blank check company.

Ceesay will leave on March 9 to fill the CEO role at an undisclosed private biotech, Cerevel said. Ceesay joined in 2021 after leading rare endocrine biotech Tiburio Therapeutics, which appears to have shuttered, per corporation filings. He did not immediately respond to an Endpoints News inquiry about his next post.

Abraham Ceesay

Cerevel did not cite any delays to readouts for its lead schizophrenia and Alzheimer’s disease psychosis drug candidate known as emraclidine. That’s going through two placebo-controlled Phase II trials and a 52-week open-label safety extension study in schizophrenia and a healthy volunteer study in people 65 to 85 years old for Alzheimer’s disease psychosis.

The biotech reeled in $573 million from a common stock and convertible note financing last August on the back of data from another schizophrenia drugmaker, Karuna Therapeutics, which reported a Phase III success.

Executives reiterated on an analyst call that the company has the financing to get through seven mid- to late-stage readouts in 2024, before its current runway expiration of 2025. The company had $950.2 million in cash, cash equivalents and marketable securities at the end of 2022.

CEO and chair Tony Coles declined to provide details of other biopharmas experiencing trial delays on the call, saying they don’t comment on other companies. Coles said his team pulled data from the federal trials database and said there are six- to 12-month delays “across the landscape, including in epilepsy,” but the impacts aren’t specific to neuroscience drugs. Coles cited residual Covid impacts and staffing shortages at sites as some factors for the trial struggles.

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