CERE - Cerevel drops 14% most since August amid delay for lead clinical programs

Cerevel Therapeutics ( NASDAQ: CERE ) lost ~14% on Wednesday, marking the steepest selloff since August after neuroscience-focused biotech pushed back the timeline for multiple clinical programs with its Q4 2022 results.

Citing lower-than-expected patient enrollment due to the post-COVID environment and other factors, Cerevel ( CERE ) said it no longer expects data from its Phase 2 trial REALIZE for Darigabat in focal epilepsy this year.

The company plans to issue an updated timeline for the proof-of-concept trial by mid-year.

In November, Cerevel ( CERE ) said that the timelines for its TEMPO-1, -2, and -3 Phase 3 trials for Tavapadon in early- and late-stage Parkinson’s disease were under review amid enrollment challenges due to post COVID landscape and other factors.

The company now expects TEMPO-3 to read out in mid-2024 and anticipates data from TEMPO-1 and TEMPO- 2 in H2 2024. Cerevel ( CERE ) has also delayed the timeline for Phase 2a exploratory trial for CVL-871 in dementia-related apathy, pushing back its data readout to H2 2024.

However, the company reaffirmed H1 2024 readouts for EMPOWER-1 and EMPOWER-2 Phase 2 studies for once-daily emraclidine in schizophrenia.

Stifel analyst Paul Matteis with a Buy rating on Cerevel ( CERE ), said that the Emraclidine readout remains key for the company despite a delay for the Darigabat readout.

“The way this sets up, however, assuming no more delays we may get 7 clinical readouts in 2024, making that a huge year for CERE, and again the majority of the valuation remains emraclidine which is on track,” Matteis wrote.

“One question however is on the financing side—CERE has cash into 2025—and what these delays mean for the optimal timing of a future raise.”

The company reported $950.2M in cash, cash equivalents, and marketable securities at the 2022 year-end, which, according to its estimates, is expected to support operations into 2025.

In December, Cerevel ( CERE ) shared Phase 1 data for emraclidine noting that the candidate didn’t cause a significant increase in blood pressure in schizophrenia patients.

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