Q2 2021 Cerevel Therapeutics Holdings Inc Earnings Call
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Good morning, welcome to the Servile Terry up your therapy.
Operator: Welcome to the Cerevel Therapeutics 2nd Quarter 2021 Financial Results Conference. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the Q&A portion of the call. Please note that this call may be recorded. I will now hand the call over to Mr. Matthew Calistri, Vice President of Corporate Strategy and Investor Relations.
2020, <unk> financial results conference call at.
At this time all participants are in a listen only mode.
Later, you will have the opportunity to ask questions during the Q&A portion of the call.
Please note that this call may be recorded.
I'll now hand, the call a book to Mr. My two colleagues free Vice president of corporate strategy and Investor Relations.
Matthew Calistri: Thank you. Good morning, everyone.
Thank you good morning, everyone. We appreciate you joining us for our second quarter 2021 results call.
Matthew Calistri: We appreciate you joining us for our second quarter 2021 results call. On today's call, you'll be hearing from Dr. Tony Coles, our Chairperson and Chief Executive Officer, Dr. Ray Sanchez, our Chief Medical Officer, Dr. John Renger, our Chief Scientific Officer, and Kathy Yee, our Chief Financial Officer. Please refer to our press release from this morning, discussing our Q2 performance, as well as our updated corporate presentation, both of which are available on our website.
On today's call you'll be hearing from Dr. Tony Coles, our chairperson and Chief Executive Officer, Dr. Rey Sanchez, our Chief Medical Officer, Dr. John <unk>, Our Chief Scientific Officer, and Kathy <unk>, our Chief Financial Officer.
Please refer to our press release from this morning detailing our Q2 performance as well as our updated corporate presentation, both of which are available on our website.
Matthew Calistri: I would like to remind you that we will be making forward-looking statements that reflect our current views related to our financial performance, future events, and industry and market conditions, as well as forward-looking statements including the potential attributes and benefits of our product candidates and the format and timing of our product development activities and clinical trials. We strongly encourage you to review the information that we file with the SEC regarding specific risks and uncertainties. I will now hand it over to Dr. Tony Coles, Chairperson and CEO of Cerebel, to provide an overview of our achievements and outlook. Thanks, Matt, and good morning, everyone.
I would like to remind you that we will be making forward looking statements that reflect our current views related to our financial performance future events and industry and market conditions as well as forward looking statements, including the potential attributes and benefits of our product candidates and the format and timing of our product development activity.
And clinical trials.
We strongly encourage you to review the information that we file with the SEC regarding specific risks and uncertainties.
I will now hand, it over to Dr. Tony Coles chairperson and CEO of <unk> to provide an overview of our achievements and outlook.
Thanks, Matt and good morning, everyone. Thank you for joining us.
Tony Coles: Thank you for joining us. This quarter has been a pivotal one for Cerevel as we begin to deliver on our aspiration to become the premier neuroscience company. We were pleased to announce positive Phase 1b top-line data for CBL-231, our M4-selective PAM in schizophrenia, earlier in the quarter. The results were robust and very encouraging, and we believe this compound has the potential to truly transform schizophrenia therapy and improve the lives of millions of patients and their caregivers.
This quarter has been a pivotal one for Cerro value as we begin to deliver on our aspiration to become the Premier Neuroscience company.
We were pleased to announce.
Positive phase <unk> top line data for CBL $2.31 are for selected Pam and schizophrenia earlier in the quarter.
The results were robust and very encouraging and we believe this compound has the potential to truly transform schizophrenia therapy and improve the lives of millions of patients and their caregivers.
Tony Coles: In a moment, our Chief Medical Officer, Dr. Ray Sanchez, will review the trial results in more detail. Following our positive data readout for CBL-231, we're proud to have completed a $350 million follow-on offering with approximately $328 million in net proceeds. With our continued focus on creative capital formation, including our Tabapedon risk-sharing deal and redemption of our public warrants, we have now raised a total of more than $800 million as a public company.
In a moment, our chief Medical Officer, Dr. Rey Sanchez will review the trial results in more detail.
Following our positive data readout for CBL $2.31, we're proud to have completed a $350 million follow on offering with approximately $328 million in net proceeds.
With our continued focus on creative capital formation, including our tobacco on risk sharing deal and redemption of our public warrants. We've now raised a total of more than $800 million as a public company.
Tony Coles: The proceeds of this most recent raise will be used to fund a comprehensive phase two program for CBL 231 and to advance several of our earlier stage programs. Together with proceeds from the redemption of our outstanding public warrants, we have strengthened our balance sheet and have the resources we need to advance our pipeline through multiple data readouts over the next three years. Specifically, we anticipate two data readouts for Darigabat in 2022, with data from our phase one acute anxiety trial expected in the first half of the year, and readouts from our phase two focal epilepsy trial in the second half.
Proceeds of this most recent raise will be used to fund a comprehensive phase III program for CBL $2.31 and to advance several of our earlier stage programs together.
Together with proceeds from the redemption of our outstanding public warrants, we have strengthened our balance sheet and have the resources, we need to advance our pipeline through multiple data readouts over the next three years spin.
Specifically.
We anticipate two data Readouts for day rig about in 2022 with data from our phase one acute anxiety trial expected in the first half of the year and the readout from our phase III cultural epilepsy trial in the second half on.
Tony Coles: Also, in the second half of 2022, we expect a phase two readout of CVL 871 in dementia-related applicants and Asta, for which we recently received Fast Track designation from the FDA. And in 2023, we expect data from our Phase 3 program for Tavapidon in early and late-stage Parkinson's. Finally, as I mentioned, we'll be advancing CBL 231 into a Comprehensive Phase II program and will provide additional details on timing and design in the months ahead. As you can see, we have a rich late-stage pipeline that is poised to deliver a number of potential catalysts in 2022 and 2023.
Also on the second half of 2022, we expect a phase two readout of CBL 87, one in dementia related apathy and asset for which we recently received fast track designation from the FDA.
And in 2023, we expect data from our phase III program for to wrap it on an early and late stage Parkinson's.
Finally, as I mentioned, we'll be advancing CPL 231 into a comprehensive phase III program and will provide additional details on timing and design in the months ahead.
So as you can see we have a rich late stage pipeline that is poised to deliver a number of potential catalysts in 2022, and 2023 and we look forward to sharing those results for Q as they become available.
Tony Coles: And we look forward to sharing those results with you as they become available. We're also showing great progress in our earlier-stage pipeline. During the second quarter, we submitted an IND for CBL-354, our Kappa opioid antagonist, and we anticipate another IND submission for CBL-047, our selective PDE4 inhibitor, in the fourth quarter of this year. As we enhance our discovery capabilities, we continue to leverage enabling technologies, such as gene editing and artificial intelligence, at our new Cambridge Crossing facility to identify the most impactful drug targets for neuroscience diseases. I'd now like to ask Dr. Ray Sanchez, our Chief Medical Officer, to provide the latest updates on our clinical development efforts. Ray?
We're also showing great progress on our earlier stage pipeline during the second quarter, we submitted an IND for CBL three five for our Kappa opioid antagonist and we anticipate another R&D submission for CBL zero for seven are selective PD for inhibitor in the fourth quarter of this year.
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As we enhance our discovery capabilities, we continue to leverage enabling technologies, such as gene editing and artificial intelligence at our new Cambridge crossing facility to identify the most impactful drug targets for neuroscience diseases I'd now like to ask Dr. Rey Sanchez, our chief Medical officer to provide the latest updates.
On our clinical development efforts right.
Ramiro Sanchez: Thank you, Tony, and good morning to all of you. I'd like to start by spending a few minutes reviewing the recent Phase 1b data for CVL231, our M4-selective positive allosteric modulator, or PAM, in schizophrenia. CVL-231 is designed as a once-daily oral medication that is highly selective for M4 over other muscarinic receptors. We believe this selective targeting enables CVL-231 to drive antipsychotic effects while avoiding serious GI, extrapyramide, akathisia, and metabolic side effects that are commonly observed with non-selective muscarinic agents and or approved antipsychotic agents. As a reminder, the Phase 1B trial was designed in two parts.
Thank you Tony and good morning to all of you.
I'd like to start by spending a few minutes reviewing the recent phase <unk> data for <unk> three one R. M for selective positive allosteric modulator or Pam and schizophrenia.
<unk> one is designed as a once daily oral medication that is highly selective for <unk> for over other muscular <unk> receptors. We believe this selective targeting enables CBL to three one to drive antipsychotic effect, while avoiding serious gi extra pyramidal akathisia and metabolic side effects.
That are commonly observed with non selective muscarinic agents <unk> approved antipsychotic agents.
As a reminder, the phase one B trial was designed in two parts part a was designed to evaluate the safety and tolerability of multiple ascending doses up to 20 milligrams twice daily.
Ramiro Sanchez: Part A was designed to evaluate the safety and tolerability of multiple ascending doses up to 20 milligrams twice daily. The results of Part A informed the dose selection for Part B, which was a placebo-controlled, double-blind, pharmacodynamic assessment to detect trends in the antipsychotic potential of the compound over six weeks of treatment, in addition to evaluating the pharmacokinetic safety and tolerability profiles of two doses. Both doses of CVL231 demonstrated clinically meaningful and statistically significant antipsychotic effects with no meaningful differences in gastrointestinal side effects, extrapyramide symptoms, or weight gain compared with placebo.
The results from part a and for the dose selection for part D, which was a placebo controlled double blind Pharmacodynamic assessment to detect trends in the antipsychotic potential of the compound over six weeks of treatment. In addition to evaluating the pharmacokinetic safety and Tolerability profiles of two doses.
Both doses of <unk>, three one demonstrated clinically meaningful and statistically significant antipsychotic effects with no meaningful differences in gastrointestinal side effects extra pyramidal symptoms of weight gain compared with placebo.
Ramiro Sanchez: The antipsychotic effect observed after six weeks of treatment was truly remarkable, given that Part B of the trial was only 59% powered to show a 7-point difference from placebo on the PANS total score. The 30mg once daily group demonstrated an absolute improvement versus baseline of 19.5 points, while the 20mg twice daily cohort showed an improvement of 17.9 points on the PANS total score. And relative to placebo, both treatment groups had statistically significant reductions of 12.7 and 11.1 points, respectively.
The antipsychotic effect observed after six weeks of treatment was truly remarkable given that part b of the trial was only 59% powered to show a seven point difference from placebo on the pans total score.
The 30 milligram once daily group demonstrated an absolute improvement versus based on a 19 five points. While the 20 milligram twice daily cohort showed an improvement of 17 nine points on the pans total score.
And relative to placebo both treatment groups had statistically significant reductions of $12 seven at 11 point.
One points respectively.
Ramiro Sanchez: These results are further supported by statistically significant and clinically meaningful improvements in the PANS negative subscale for both doses. For example, the 30 milligram once daily group resulted in a 3.1 point improvement over placebo with a p-value of 0.009. And the 20 milligram twice daily group showed a 3.7 point improvement over placebo with a p-value of 0.002. We also observed clinically meaningful improvements on the PANS-positive subscale for both doses, with the 30 mg once daily group demonstrating a statistically significant reduction of 4.3 points versus placebo.
These results are further supported by statistically significant and clinically meaningful improvements in the pan's negative subscale for both doses.
The 30 milligram once daily group resulted in a three one point improvement over placebo with a P value of 0.009, and the 20 milligram twice Daily group showed a three seven point improvement over placebo with a P value of 0.00 too.
We also observed clinically meaningful improvements on the pans positive subscale for both doses with 30 milligram once daily group, demonstrating a statistically significant reduction of four three points versus placebo.
Ramiro Sanchez: While there were no clinically meaningful differences on the brief assessment of cognition in schizophrenia symbol coding tests, Changes in the CGIS were consistent with other metrics, with the 30 milligram Q-day dose showing a clinically meaningful and statistically significant improvement of 0.9 versus placebo at week six, and the 20 milligrams twice daily cohort also achieving a clinically meaningful outcome. With respect to safety and tolerability, CBL-231 was Treatment-emerging adverse events were similar across all three arms, and very low rates of gastrointestinal AEs were observed.
While there were no clinically meaningful differences on the brief assessment of cognition schizophrenia symbol clothing test.
Changes in the CGI S were consistent with other metrics with the 30 milligram two day dose showing a clinically meaningful and statistically significant improvement of 0.9 versus placebo at week, six and 20 milligrams twice daily cohort also achieving a clinically meaningful outcome.
With respect to safety and Tolerability CBL to three one was overall well tolerated in the trial.
Treatment emergent adverse events were similar across all three harms zone.
And very low rates of gastrointestinal aes were observed.
Ramiro Sanchez: Importantly, CBL-231 was not associated with extrapyramide side effects, akathisia, or weight gain. Cardiovascular AEs were observed in only a few patients, and the details can be found on page 55 of today's accompanying presentation. These six subjects had asymptomatic cardiovascular changes reaching the pre-specified threshold, including three in the placebo group and three in the active treatment. However, no events were clinically significant or associated with
Importantly, <unk> was not associated with extra pyramidal side effects akathisia or weight gain.
Cardiovascular Aes were observed in only a few patients with the <unk> and the details can be found on page 55 of today's accompanying presentation.
These six subjects had asymptomatic cardiovascular changes, reaching the pre specified thresholds, including three in the placebo group and three in the active treatment groups no events were clinically significant or associated with other reported aes as expected, we did see modest elevations in heart rate and blood pressure with CBL.
Ramiro Sanchez: As expected, we did see modest elevations in heart rate and blood pressure with CVL231 compared with placebo, which are described on page 56. However, these increases attenuated over the six-week course of treatment. At week six, the average systolic blood pressure increase relative to placebo was 1.2 and 0.9 millimeters of mercury with the 30 milligram once daily dose and the 20 milligram twice daily dose, respectively, as measured two hours post-morning. There were no meaningful differences in diastolic blood pressure at week six.
Three one compared with placebo, which are described on page 56.
These increases attenuated over the six week course of treatment at week six the average systolic blood pressure increase relative to placebo was one two and 0.9 millimeters of Mercury with the 30 milligram once daily dose and the 20 milligram twice daily dose respectively as measured two hours post morning dose.
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There were no meaningful differences in diastolic blood pressure at week six heart rate increases at week six relative to placebo were for four and five three beats per minute for the 30 milligram once daily and 20 milligram twice daily doses, respectively also as measured two hours post morning dose on.
Ramiro Sanchez: Heart rate increases at week six relative to placebo were 4.4 and 5.3 beats per minute for the 30 milligram once daily and 20 milligram twice daily doses, respectively, also measured two hours post-morning. However, all cardiovascular effects were asymptomatic, and the increases were not clinically significant.
All cardiovascular effects were asymptomatic and the increases were not clinically significant.
We are highly encouraged by the safety and Tolerability profile for CBL for 301, given the very strong antipsychotic activity observed we're eager to advance <unk> into phase two development for the treatment of schizophrenia. We also plan to evaluate the potential of the M for mechanism in other populations such.
Ramiro Sanchez: We are highly encouraged by the safety and tolerability profile for CBL-231. Given the very strong anti-psychotic activity observed, we're eager to advance CBL-231 into Phase 2 development for the treatment of schizophrenia. We also plan to evaluate the potential of the M4 mechanism in other populations, such as those with dementia-related psychosis.
Dementia related psychosis.
Ramiro Sanchez: This is an important step in the execution of our pipeline, and as Tony mentioned, we believe CVL231 has the potential to be a transformative treatment for psychosis. We're taking a deliberate and thoughtful approach regarding the next steps in the development of CVL-231, and we're exploring every avenue to bring this therapy to market as rapidly as possible. Our next expected data readout will be for Darigabat, our Alpha-235 selective GABA-A receptor PAM in acute anxiety.
This is an important step on the execution of our pipeline and as Tony mentioned, we believe Cvs 231 has the potential to get transformative treatment for psychosis.
We're taking a deliberate and thoughtful approach regarding next steps on the development of <unk> three one and we are exploring every avenue to bring this therapy to market as rapidly as possible.
Our next expected data readout will be for day rig about our alpha II grew five selective Gaba a receptor Pam in acute anxiety.
Ramiro Sanchez: Derigabat is currently being studied in a Phase I randomized, positive, and placebo-controlled proof-of-principle trial in healthy volunteers. This trial utilizes a well-established hypercapnia or carbon dioxide inhalation model to evaluate the potential of Darigabat for acute anxiety. Acute inhalation of 35% carbon dioxide can reliably trigger a transient acute emotional response and symptoms that resemble a naturally occurring panic attack in both panic disorder patients and healthy volunteers.
<unk> is currently being studied in a phase one randomized positive and placebo controlled proof of principle trial in healthy volunteers.
This trial sizes are well established hypercalcemia or carbon dioxide inhalation model to evaluate the potential of day rig about an acute anxiety.
Acute inhalation of 35% carbon dioxide can rollout can reliably trigger a transient acute emotional response and symptoms that resemble a naturally occurring panic attack in both panic disorder patients and healthy volunteers.
Ramiro Sanchez: This model has been shown to be sensitive to pharmacological treatments by a range of drugs used to treat anxiety disorder, including benzodiazepines and SSRIs, as well as emerging new treatments with novel mechanisms of action. Recently, it was used as a proof-of-principle study by Johnson & Johnson with their Orexin-1 receptor antagonist to support advancement of the molecule into clinical development for major depression with anxious distress. Our ongoing hypercaffeine trial is carefully designed to assess the anxiolytic activity of two doses of Darigabat administered over eight days.
This model has been shown to be sensitive to pharmacopeia.
Farmer pharmacological treatments by a range of drugs used to treat anxiety disorder, including benzodiazepines and ssris as well as the emerging new treatments with novel mechanisms of action.
Recently, it was used as a proof of principle study by Johnson <unk> Johnson with the Orexin, one receptor antagonist to support advancement of the molecule into clinical development for major depression with anxious distress.
Our ongoing hyper caffeine trial is carefully designed to assess the NGO lytic activity of two doses of <unk> administered over eight days.
Ramiro Sanchez: The trial is a two-period, two-sequence crossover design, with three cohorts comparing Darigabat at high doses of 25 mg VID, a low dose of 7.5 mg VID, and a positive control treatment of Alprazolam extended release 1 mg VID versus placebo. Importantly, only individuals who are found to be sensitive to the anxiogenic effects of CO2 inhalation at screening will be eligible
Trial is a two period to sequence crossover design with three cohorts comparing to rig about at high doses of 25 milligram PID, a low dose of seven five milligrams PID and a positive control treatment on PRASM extended release, one milligram versus placebo.
Importantly, only individuals who are found to be sensitive to the angiogenic effects of Sidoti <unk> at screening will be eligible for randomization.
John J. Renger: Participants in each cohort will be randomly assigned to one of two sequences and exposed to both an active arm and placebo. The primary endpoint for the trial is a change in the panic symptoms checklist score. This trial is being conducted at the Center for Human Drug Research, or CHDR, which is a single specialized site in the Netherlands and is therefore uniquely affected by national Dutch regulations related to the ongoing COVID-19 pandemic.
Participants in each cohort will be randomly assigned to one of two sequences and exposed to both on active arm and placebo. The primary endpoint for the trial is a change in the panic symptom checklists score.
This trial is being conducted at the center for human Drug Research CH, Dr. Which is a single specialized site in the Netherlands and is therefore, a uniquely affected by national Dutch regulations related to the ongoing COVID-19 pandemic in.
John J. Renger: In July, Dutch government authorities reimposed restrictions due to rising Delta variant cases in young unvaccinated adults, which have impacted the recruitment timelines for this trial. While the trial remains ongoing and actively recruiting, we now expect data in the first half of 2022 and will continue to closely monitor the evolving COVID-19 guidance from the Dutch Authority. The results from this acute anxiety trial will inform how we advance this compound in one or more anxiety-related indications.
In July Dutch government authorities, we imposed restrictions due to rising Delta Varian cases in young unvaccinated adults, which have impacted the recruitment timelines for this trial.
While the trial remains ongoing and actively recruiting we now expect data in the first half of 2022, and we will continue to closely monitor the evolving COVID-19 guidance from the Dutch authorities.
The results from this acute anxiety trial will inform how we advance this compound in one or more anxiety related indications.
John J. Renger: We're also dosing Darigabat in our Phase 2 global proof of concept trial in focal epilepsy, now known as the REALIZE trial, as well as its corresponding open-label extension. Data in focal epilepsy continues to be expected to root out in the second half of 2020. Meanwhile, our Phase 3 Global Tempo Program for Travapidon and Parkinson's Disease is ongoing. We continue to dose in all three of the phase 3 trials. Tempo 3 in late stage Parkinson's and Tempo 1 and 2 in early stage Parkinson's.
We're also dosing the rig about in our phase II global proof of concept trial in focal epilepsy now known as the realized trial as well as its corresponding open label extension.
Data in focal epilepsy continues to be expected to read out in the second half of 2022.
Meanwhile, our phase III global tempo program for to wrap it on in Parkinson's disease is ongoing we continue to dose on all three of the phase III trials tempo three in late stage, Parkinson's and tempo one and two in early stage Parkinsons. In addition, we're also dosing both rollover on de Novo patients in.
John J. Renger: In addition, we're also dosing both rollover and de novo patients in TEMPA-4, our 58-week open-label extension trial. We expect data from Tempo 3 in the first half of 2023 and data from Tempos 1 and 2 in the second half of 2023. Now that I've reviewed the updates to our three lead clinical programs, Dr. John Renger, our Chief Science Officer, will provide updates on the rest of our pipeline
Tempo for our 58 week open label extension trial, we expect data from $10 three in the first half of 2023 and data from temple's one and two in the second half of 2023.
Now that I've reviewed the updates to our three lead clinical programs Dr. John <unk>, Our Chief Science Officer will up we'll provide updates on the rest of our pipeline John.
John J. Renger: Thank you, Ray. Good morning, everyone.
Thank you Ray good morning, everyone.
John J. Renger: Let me begin by updating everyone on ACBL 871, which is our D1-D5 partial agonist in Phase 2 development for the treatment of dementia-related apathy. As you will recall, apathy is among the most common neuropsychiatric comorbidities associated with dementias and remains a devastating condition without a currently approved treatment option, given the seriousness of the condition and the significant unmet patient need. The FDA has expressed strong interest in the development of a treatment for apathy in dementia patients.
Let's begin by updating everyone on a CBO 871, which is our day one day five partial agonist in phase III development for the treatment of dementia related apathy.
As Youll recall for apathy is among the most common neuropsychiatric comorbidities associated with dementia is and remains a devastating condition without a currently approved treatment option.
Given the seriousness of the condition and the significant unmet patient need and the FDA has expressed strong interest in the development of a treatment for apathy and dementia patients.
John J. Renger: In June of this year, we announced that we were granted fast-track designation for CBL-871 for the treatment of dementia-related apathy. This designation by the agency has the potential to enable early and more frequent interactions with the FDA, as well as the potential option for rolling and priority review of our NDA. This is a particularly exciting opportunity for us to work more closely with the agency as we have begun screening in our exploratory Phase IIa trial for dementia-related apathy.
In June of this year, we announced that we were granted fast track designation for CBL is 71 for the treatment of dementia related apathy.
This designation by the agency has the potential to enable early and more frequent interactions with the FDA as well as the potential option for rolling and priority review of our NDA.
This is a particularly exciting opportunity for us to work more closely with the agency as we have begun screening in our exploratory phase Iia trial for dementia related apathy.
John J. Renger: We anticipate clinical trials to be available in this novel indication in the second half of next year, 2022. Based on the results of this trial, we are looking forward to interacting closely with the FDA in determining the best clinical development strategy for bringing forward a treatment for this novel but impactful indication. As announced today, we'll be hosting an R&D event on October 7th to discuss the scientific background of our CBL 871 program in greater detail, along with updates on CBL 231 and schizophrenia and other programs. I hope you will all be able to join us.
We anticipate clinical trials to be available on this novel indication in the second half of next year 2022.
Based on the results for this trial, we're looking forward to interacting closely with the FDA and determining the best clinical development strategy for bringing forward a treatment in this novel, but impactful indication.
As announced today, we will be hosting an R&D event on October seven to discuss the scientific background of our CBL 871 program in greater detail along with updates on CBS 231 in schizophrenia and other programs I Hope you will all be able to join us.
John J. Renger: Now, moving beyond 871, we're also advancing CBL-936. This molecule is our D3-preferring dopamine receptor antagonist for the treatment of opioid use disorder. As we can all acknowledge, this is an incredibly challenging area of unmet patient need, and Cerevel is excited to be progressing a potential treatment in this important area, where there's been a worrying expansion of overdose and overdose-related deaths due to opioid misuse. We plan to initiate a non-clinical safety pharmacology study in support of continuing a phase one single and multiple sending dose trial with CBL 936 to evaluate this compound's safety and tolerability profile.
Now moving beyond 87, one we're also advancing CBL 93, six this molecule is a G. Three preferring dopamine receptor antagonist for the treatment of opioid use disorder.
As we can all acknowledge this is an incredibly challenging area of unmet patient need and <unk> is excited to be progressing on potential treatment. In this important area, where theres been a concerning expansion of overdose and overdose related deaths due to opioid misuse.
We plan to initiate a non clinical safety pharmacology study.
In support of continuing our phase one single and multiple ascending dose trial with CBR $93 six to evaluate this tough on safety and Tolerability profile.
John J. Renger: As we guided previously, in the second quarter of this year, we submitted an IND for CVL354, our selective capital opioid receptor antagonist, also known as a CORA lead molecule, which has the potential to be a novel mechanism of action and a much needed differentiated treatment option, potentially addressing major depressive disorder or MDD. We intend to initiate our Phase 1, first-in-human, single and multiple ascending dose trial in healthy volunteers for CBL 354 in the third quarter of this year. Furthermore, in the fourth quarter of this year, we continue to plan to submit an IND for CBL-047.
As we guided previously in the second quarter of this year, we submitted an IND for CBL III phase for our selective Kappa opioid receptor antagonist also known as a core lead molecule, which has the potential to be a novel mechanism of action on a much needed differentiated treatment option in potentially addressing major depressive disorder or NBD.
We intend to initiate a phase one first in human single and multiple ascending dose trial in healthy volunteers for CBL III flow for in the third quarter of this year.
Furthermore, in the fourth quarter of this year, we continue to plan to submit an IND for CBL zero for seven.
John J. Renger: This compound is a phosphoesterase subtype-selected PDE4B inhibitor. We are particularly excited about this clinically validated anti-inflammatory mechanism of action, where clinical development of brain penetrant molecules has been hindered by dose-limiting side effects, which we believe are related to non-selective action of prior compounds that acted equally across all PDE4 subtypes. By selectively sparing inhibition of the PDE4D subtype, we believe CBL47 has the potential to address symptoms of both MVD and schizophrenia.
This compound is a phosphate esters subtype selective PD for B inhibitor, we're particularly excited about this clinically validated anti inflammatory mechanism of action, where clinical development of brain penetrant molecule has been hindered by dose limiting side effects, which we believe are related to non selective action of prior compounds that act it equally across all PD.
For subtypes, but selectively sparing inhibition of PD for D. Subtype, we believe CBL for seven has the potential to address symptoms of both MTV and schizophrenia.
John J. Renger: At Cerevel, we are in the midst of building a robust, world-class drug discovery engine. In our newly opened research labs at Cambridge Crossing, we are leveraging our differentiated understanding of neurocircuitry and world-class chemistry to develop and explore the potential of highly sophisticated small molecules. Currently, we are positioned to be a scientific leader in identifying and progressing selected muscarinic compounds. As such, we are actively working through a range of additionally highly potent and M4-selective agonists and modulators to potentially advance into the clinical setting alongside CVL231 to expand on the clinical utility that we have demonstrated with that lead molecule.
At Cerro, though we are in the midst of building a robust world class drug discovery engine and our newly opened research labs at Cambridge crossing we are leveraging our differentiated understanding of neurosurgery tree and world class chemistry to develop and explore the potential of highly sophisticated small molecules.
Currently we are positioned to be a scientific leader in identifying and progressing selective muscarinic compounds and.
And as such we are actively working through a range of additionally, highly potent and for selective agonist and modulators to potentially advance into the clinical setting alongside <unk> three one to explain to expand on the clinical utility that we've demonstrated with that lead molecule.
John J. Renger: Complimentary Medicinal Chemistry Molecule Optimization Approaches are a cutting-edge combination of neuroscience research-enabling technologies including comp-chemistry, gene modification approaches, AI-based compound screening, and DNA-encoded library screening activities that are all designed to enable us to rapidly and efficiently validate some of the most promising new drug targets and lead us to identify candidates to address the underlying processes in debilitating neuroscience diseases. We believe the discovery engine we are creating will allow us to maintain a regenerative pipeline of novel therapeutics that will continue to fuel Cerevel's goal of becoming the premier neuroscience company.
Complementing our medicinal chemistry molecule optimization approaches or cutting edge combination of neuroscience research, enabling technologies, including top chemistry, Jim on vacation approaches AI based compound screening in DNA encoded library screening activities are all designed to enable us to rapidly and efficiently validate some of the most promising new.
Drug targets on latest to identify candidates to address the underlying processes and debilitating neuroscience disease.
We believe the discovery engine.
We believe the discovery engine, we are creating will allow us to maintain our regenerative pipeline of novel Therapeutics that will continue to fuel <unk> goal of becoming the Premier Neuroscience company.
John J. Renger: We're looking forward to updating you on the ongoing progress of our extensive early and late-stage pipeline in the months to come. However, I'd like to now turn it over to Kathy Yee, our CFO, to review our financial performance for this quarter. Thank you.
We're looking forward to updating you on the ongoing progress for extensive early and late stage pipeline in the months to come on.
I would like to now turn it over to Kathy our CFO to review our financial performance for this quarter Kathy.
Michael Yee: Thank you, John. Good morning everyone, and thank you for joining today's call. We issued a press release earlier today that included a financial update, which I will briefly summarize. Our total operating expenses were $50.5 million for the second quarter of 2021, which includes R&D expenses of $37.3 million and G&A expenses of $13.2 million. Relative to the second quarter of last year, R&D expense increased by $15.1 million, and the second quarter results included $2.1 million of equity-based compensation.
Thank you John Good morning, everyone and thank you for joining today's call.
We issued a press release earlier today that included a financial update which I will briefly summarize.
Our total operating expenses were $55 million for the second quarter of 2021, which includes R&D expense of $37.3 million and G&A expense of $13.2 million.
Relative to the second quarter last year R&D expense increased by $15.1 million in the second quarter results included $2.1 million of equity based compensation.
Michael Yee: The increase was primarily driven by the advancement of our late-stage and early-stage programs, as well as increased infrastructure costs to support the progress of our pipeline. We expect R&D expenses to continue to increase as we advance our 11 clinical and preclinical assets. General and administrative expenses for the second quarter of this year were $13.2 million, relative to $13.0 million for the same period last year. GNA for the second quarter included equity-based compensation of $3.1 million.
The increase was primarily driven by the advancement of our late stage and early stage programs as well as increased infrastructure costs to support the progress of our pipeline.
We expect R&D expenses to continue to increase as we advance our 11 clinical and preclinical assets.
General and administrative expenses for the second quarter of this year were $13.2 million relative to 13 point there a million for the same period last year.
G&A for the second quarter included equity based compensation of $3.1 million.
Michael Yee: To date, we have maintained a slower growth in G&A expenses relative to R&D, but we do expect a modest G&A increase over the coming quarters as we support the expansion of our programs and general infrastructure of the company. Moving to our cash position, as of June 30th, our cash and cash equivalents were $327.1 million. This cash position does not include the approximately $328 million of net proceeds from our recent follow-on offering in July.
To date, we have maintained a slower growth in G&A expenses relative to relative to R&D.
Do we expect a modest G&A increase over the coming quarters as we support the expansion of our programs in general on infrastructure of the company.
Moving to our cash position as of June 30, our cash and cash equivalents were $327.1 million.
This cash position does not include the approximately $328 million for net proceeds from our recent follow on offering in July.
Michael Yee: In addition, we recently announced the redemption of our outstanding public warrants, which could provide up to approximately $57 million of additional capital, assuming full exercise. With our current balance sheet, we're well-positioned to advance our LEAD programs, including mid- to late-stage clinical trials in Parkinson's, epilepsy, dementia-related apathy, and schizophrenia, as well as pursue other earlier-stage programs, such as Therigabad in Anxiety Overall, we have multiple opportunities for value creation milestones over the next few years.
In addition, we recently announced the redemption of our outstanding public warrants, which could provide up to approximately $57 million of additional capital assuming full exercise.
With our current balance sheet, we are well positioned to advance our lead programs, including mid to late stage clinical trials in Parkinson's.
Buffy dementia related apathy and schizophrenia as well as push to other earlier stage programs, such as Derek about an anxiety Cora MPD for.
Overall, we have multiple opportunities for value creation milestones for the next few years.
Michael Yee: And Cerevel is in a very strong financial position to fund these programs to their next inflection point. Finally, we expect our current balance sheet to fund our operations into 2024. I would like to now hand the call back over to Tony to conclude.
And if there isn't a very strong financial position to fund these programs to the next inflection points.
Finally, we expect our current balance sheet to fund our operations into 2024.
I'd like to now hand, the call back over to Tony to conclude.
Thanks Kathy.
Tony Coles: As you can see, we've made tremendous progress here at Cerevel in just a few short months. And as you heard this morning, we're advancing our extensive pipeline in order to bring novel therapies to patients facing some of the most challenging neuroscience diseases. We believe that neuroscience is the last great frontier in medicine, and we're at the point where that frontier is born. Over the next three years, we anticipate important data readouts across a range of vexing neuroscience diseases, including anxiety, focal epilepsy, dementia-related apathy, and Parkinson's.
As you can see we've made tremendous progress here at Cerro volume just a few short months as you've heard this morning, we're advancing our expense a pipeline in order to bring novel therapies for patients.
Some of the most challenging neuroscience research.
We believe gross sciences, the last great Frontier Medicine, and we're at the point.
Of that frontier.
Over the next three parents for anticipated important data readouts across a range of vaccine neuroscience diseases, including anxiety for.
Local epilepsy dementia related apathy and Parkinson's and we will move successful programs ahead with speed and determination is we're going to do with our phase III program for CBL to three one in schizophrenia.
Tony Coles: And we will move successful programs ahead with speed and determination, as we are going to do with our Phase II program for CBL-231 in Schizophrenia. And through a robust early discovery program, we expect to bring forward additional novel compounds in other disease areas, as we continue on our mission to unravel the mysteries of birth. Thank you for being on this journey with us, and I hope you'll be able to join us for our October 7th R&D event, where we will focus on CVL 871 and dementia-related apathy, along with updates on.
And for a robust early discovery program, we expect to bring forward a bit on novel compounds and other disease areas.
As we continue on our mission to unravel the mysteries of sprint.
Thank you for being on this journey with us and I hope you'll be able to join us for our October seven R&D event, where we will focus on <unk> seven one in dementia related apathy along with updates.