Transforming the Possible in Neuroscience
Virtual R&D Event
October 7, 2021
Forward-Looking Statements
This presentation 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 presentation, 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 presentation include, but are not limited to: statements about the potential attributes and benefits of our product candidates, including with respect to receptor subtype selectivity, activity, side effect and tolerability profile and relevant indications; the format and timing of our product development activities and clinical trials, including our Phase 2a trial for CVL-871, our Phase 2 program for CVL-231 and other statements regarding the design of clinical trials and the timing of initiation, completion and data readouts for clinical trials; the timing and outcome of regulatory interactions; 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; and the rate and degree of market acceptance of product candidates, if approved.
We cannot assure you that the forward-looking statements in this presentation 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: that 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 Annual 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 presentation represent our views as of the date of this presentation. 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 presentation.
© Cerevel Therapeutics Holdings, Inc. | 2 |
Cerevel:
Transforming the Possible in Neuroscience
© Cerevel Therapeutics Holdings, Inc. | 3 |
Who We Are is in Our Name
- c e r e b r u m
- r e v e l a t i o n / r e v e a l
We are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that could have real impact on people's lives.
Brain hemispheres
Lock in key
Selective / Targeted Mechanisms
© Cerevel Therapeutics Holdings, Inc. | 4 |
Multiple Milestones Expected Over Next Three Years
Compound
Phase / | 2021 | 2022 | 2023 | |||||||||
Disease | ||||||||||||
Mechanism | 1H | 2H | 1H | 2H | 1H | 2H | ||||||
Area |
CVL-231
Darigabat
Darigabat
Tavapadon
Tavapadon
(adjunct with l-dopa)
CVL-871
CVL-936
M4
GABA
GABA
D1
D1
D1
D3
Phase 1b /
Schizophrenia
Phase 1 /
Anxiety
Phase 21 /
Epilepsy
Phase 31 /
Early PD
Phase 31 /
Late PD
Phase 2a /
Dementia-Related
Apathy
Phase 12 /
Substance Use
Disorder
REALIZE
TEMPO-1 (Fixed Dose)
TEMPO-2 (Flex Dose)
TEMPO-3
Estimated Trial Initiation | Estimated Topline Data |
1. In addition, there are two open-label extension trials ongoing (REALIZE OLE for darigabat in epilepsy and TEMPO-4 for tavapadon) | 5 | |
2. We initiated a Phase 1 SAD trial for CVL-936 in January 2020. We concluded dosing of Cohort 1 of the Phase 1 SAD trial. We intend to conduct a | © Cerevel Therapeutics Holdings, Inc. |
multiple dose non-clinical safety pharmacology study before additional Phase 1 SAD and MAD evaluations.
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Cerevel Therapeutics Holdings Inc. published this content on 07 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 October 2021 11:06:05 UTC.