Q2 2019 Earnings Call
Operator: Good day, ladies and gentlemen, and welcome to the Trevena, Inc. Second Quarter 2019 Earnings Conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Bob Yoder, Chief Business Officer. Mr. Yoder, you may begin.
Second quarter 2019 earnings conference call at this time, all participants are in a listen only mode. Later, we will conduct a question answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press Star then zero on your touched on telephone as a reminder, this conference call is being recorded I would now like to introduce your host for today's conference Mr., Bob Yoder, Chief Business Officer, Mr. Yoder you may begin.
Thank you and welcome everyone. Thanks for joining us on this morning's call with me today are Cary Bordeaux, our president and CEO , Mark Democrat, Our Chief Medical Officer, and bearish in our Chief Financial Officer.
Bob Yoder: Thank you and welcome everyone. Thanks for joining us on this morning's call. With me today are Kerry Bourdow, our President and CEO, Mark Demitrack, our Chief Medical Officer, and Barry Shin, our Chief Financial Officer. Before we begin, we wish to inform participants that we will be making forward-looking statements on this call, which are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties, including risks detailed from time to time in the company's periodic reports filed with the Securities and Exchange Commission, and we undertake no obligation to update these statements beyond today. During today's call, Carrie will summarize our recent corporate highlights and review the progress we've made across our pipeline. And Mark will provide an update on the Healthy Volunteer QT Study for Oliceridine and outline in further detail our plans for the Proof of Concept Study for TRV250. Barry will then review our financial results, followed by some time for questions. I'll now turn the call over to Carrie.
Before we begin we wish to inform participants that we will be making forward looking statements on this call, which are made pursuant to the safe Harbor provision of the private Securities Litigation Reform Act of 1995.
You are cautioned that such forward looking statements involve risks and uncertainties, including risks detailed from time to time in the company's periodic reports filed with the Securities and Exchange Commission.
And we undertake no obligation to update these statements beyond today.
During today's call carry will summarize our recent corporate highlights and review the progress we've made across our pipeline.
And Mark will provide an update on the healthy volunteer a qt study for all the austerity and outline in further detail our plans for the proof of concept study for TRP to 50.
Gary will then review our financial results followed by some time for questions.
I'll now turn the call over to Carrie.
Carrie L. Bourdow: Thanks, Bob. Good morning, everyone. Thank you for joining us today. In the second quarter, we made significant progress on our plan to resubmit the oloceridine NDA. Thanks to the team's hard work, we were able to initiate the healthy volunteer study on time, and we are encouraged so far with study enrollment. Over half of all subjects have begun dosing, and more than 20 subjects have already received the maximum daily dose of 27 milligrams of oloceridine, one of the FDA requirements from the CRL.
Thanks, Bob.
Good morning, everyone. Thank you for joining us today.
In the second quarter, we made significant progress on our plan to resubmit the oldest ferreting, Indiana.
Thanks to the team's hard work, we were able to initiate the healthy volunteer study on time.
And we are encouraged so far with study enrollment over half of all subjects have begun dosing and more than 20 subjects have already received the maximum daily dose of 27 milligrams of both ferreting one of the FDA requirements from the CRL.
Carrie L. Bourdow: We expect top-line data in the fourth quarter, and all other activities also remain on track to support NDA resubmission as early as possible in the first quarter of 2020. We continue to publish clinical trial data for olitherity and are developing a robust set of peer-reviewed evidence to support our future commercialization. The journal Pain Practice recently published the second of our Pivotal Phase III results, highlighting the efficacy, safety, and tolerability of olitharidine for patients with moderate to severe acute pain following soft tissue surgery. I'm also excited to announce that all of our submitted abstracts for Oliceridine have been accepted for presentation at the 2019 American Society of Anesthesiologists meeting to be held in October. This is the largest global meeting of anesthesiologists, and we are pleased that this important group of healthcare professionals is interested in learning more about oleseridine. We have also made progress across our pipeline.
We expect top line data in the fourth quarter and all other activities also remain on track to support India Resubmission as early as possible in the first quarter of 2020.
We continue to publish the clinical trial data for austerity and are developing a robust set of peer reviewed evidence to support our future commercialization.
The journal pain practice recently published the second of our pivotal phase three results highlighting the efficacy safety and Tolerability of all authority for patients with moderate to severe acute pain following soft tissue surgery.
I'm also excited to announce that all of our submitted abstracts for all this Saturday and have been accepted for presentation at the 2019 American Society. They Gotta Cc Allergists meeting to be held in October .
This is the largest global meeting of Anesthesiologists and we're pleased that this important group of health care professionals is interested in learning more about all this entity.
We also made progress across our pipeline.
Carrie L. Bourdow: We announced this morning that we have advanced the acute migraine study protocol for TRV-250 and expect to initiate this proof of concept study next quarter. TRV-250 is another new and differentiated mechanism of action, this one at the delta receptor. Delta receptors are located in the brain and play an important role in the regulation of pain, anxiety, and mood.
We announced this morning that we have a dance the acute migraine study protocol for TRP to 50 and expect to initiate this proof of concept study next quarter.
PRB to 50 is another new and differentiated mechanism of action. This one if the delta receptor.
Delta receptors are located in the brain and play an important role in the regulation of pain anxiety and mood migraine pain continues to be a large market with over 600 million migraines treated annually in the U.S., we believe a sizeable market opportunity exists for T. RV to 50, and we look forward to exploring the potential of this asset not only for migraine, but also in the CNS space more broadly.
Carrie L. Bourdow: Migraine pain continues to be a large market, with over 600 million migraines treated annually in the U.S. We believe a sizable market opportunity exists for TRV250, and we look forward to exploring the potential of this asset not only for migraines, but also in the CNS space more broadly. The National Institute on Drug Abuse, or NIDA, has remained engaged in progressing TRV-734 as a potential maintenance therapy for opioid use NIDA will be fully funding a proof-of-concept study in patients and anticipates starting this study before the end of this year. And finally, we've begun the non-clinical and CMC activities to support a future IND filing for TOV 045, our novel S1P receptor modulator. TRV045 has the potential to be a new mechanism for the non-opioid treatment of chronic pain, including chemo-induced peripheral neuropathy.
The National Institute on drug abuse or night I. His <unk> remain engaged in progressing PRB 734, as a potential maintenance therapy for for opioid use disorder.
Neither will be fully funding a proof of concept study in patients and anticipate starting this study before the end of this year.
And finally, we have begun the non clinical and CMC activities to support future I, Andy filing for T. O V O four or five our novel S. One p. receptor modulator.
TRD O four or five has the potential to be a new mechanism for non opioid treatment of chronic pain, including chemo induced peripheral neuropathy.
Carrie L. Bourdow: Importantly, our current cache runway supports the OLSERITY and TopLine data readout, NDA resubmission, and the pipeline work I just outlined. One last highlight from the quarter. We added an important member to our leadership team. Barry Shin has joined Trevena as our Chief Financial Officer and brings more than 17 years of strategic and financial experience focused on the biopharmaceutical sector. I'm thrilled to have Barry on board, and his leadership and expertise will be invaluable as we prepare for a busy remainder of the year and for continued momentum into next year. With that, let me hand the call over to Mark to provide more details on our recent accomplishments with Oliceridine and TRD250. Mark?
Importantly, our current cash runway supports the oldest dirty and top line data readout indicate resubmission and the pipeline work I just outlined.
One last highlight from the quarter, we added an important member to our leadership team very Shen has joined <unk> as our Chief financial Officer and brings more than 17 years of strategic and financial experience focused in the biopharmaceutical sector I'm thrilled to have very onboard and his leadership and expertise will be invaluable as we prepare for a busy remainder of the year and for continued momentum into next year.
With that let me hand, the call over to Mark to provide more details around our recent accomplishments with all this everything into your 30 to 50.
Mark A. Demitrack: Thanks, Carrie. And good morning, everyone. To recap the current status of our Oloceridine program, we successfully initiated the Healthy Volunteer QT Interval Study for Oloceridine at the end of June. We're conducting this study at a single site as a three-period crossover design. Each subject moves through all three study periods, receiving oloceridine, placebo, and amoxifloxacin positive control in a randomized sequence, with a short intervening washout period between each treatment. Combined, the total study period for each subject lasts about 20 days.
Thanks, Kerry and good morning, everyone.
To recap the current status of our oldest Ceridian program, we successfully initiated the healthy volunteer Qt interval study for all the Sarah Dan at the end of June .
We're conducting this study at a single site as a three period crossover design.
Each subject moves through all three study periods, receiving all the ceridian placebo and the Moxifloxacin positive control in a randomized sequence with a short intervening washout in between each treatment.
Combined the total study period for each subject last about 20 days.
We plan to submit data on approximately 60 healthy subjects with at least 20, receiving a cumulative dose of 27 milligrams of all the surrounding the proposed maximum daily dose.
Mark A. Demitrack: We plan to submit data on approximately 60 healthy subjects, with at least 20 receiving a cumulative dose of 27 mg of Oloceridine, the proposed maximum daily dose. As Carrie mentioned, I'm pleased to report that as of today, over half of our target total study population has initiated dosing. Of the subjects who have completed dosing, more than 20, have received a cumulative dose of 27 mg of oloceridine, meeting FDA's minimum required number of subjects exposed at this level. Based on this progress in enrollment, we believe this study is proceeding on schedule for top-line data readout next quarter. We've also made significant strides with our TRV-250 program, our novel delta receptor agonist aimed at the potential treatment of acute migraine. We've developed a protocol for an acute migraine proof-of-concept study. I'll spend a few minutes outlining some of the key study design elements.
As Carey mentioned I'm pleased to report that as of today over half of our target total study population have initiated dosing.
Oh, the subjects, who have completed dosing more than 20 have received a cumulative dose of 27 milligrams of all asserting.
Meeting ft is minimum required number of subjects exposed at this level.
Based on this progress in enrollment we believe this study is proceeding on schedule for top line data readout next quarter.
We've also made significant strides with our TRP to 50 program our novel Delta receptor agonist aimed at the potential treatment of acute migraine.
We've developed a protocol for an acute migraine proof of concept study.
I'll spend a few minutes outlining some of the key study design elements.
This will be a double blind placebo controlled clinical study that will leverage and nitroglycerin publication migraine model, a well validated approach for the study of migraine headache that has been evaluated in the scientific literature over the past several years.
Mark A. Demitrack: This will be a double-blind, placebo-controlled clinical study that will leverage a nitroglycerin provocation migraine model, a well-validated approach for the study of migraine headache that has been evaluated in the scientific literature over the past several years. Patients suffering from migraine are known to be particularly vulnerable to developing a sustained headache following a nitroglycerin challenge that carries all of the clinical features of a spontaneously occurring migraine, making it a very attractive clinical model to study potential treatment interventions like TRV250. The primary objective of this study is to determine target engagement at the delta receptor, which will be measured by the ability of TRV250 to reduce the number of subjects who experience a sustained nitroglycerin-induced headache. We plan to enroll approximately 120 migraineurs at a single site.
Patients suffering from migraines are known to be particularly vulnerable to developing a sustained headache. Following nitroglycerin challenge. The carries all of the clinical features of a spontaneously occurring migraine.
Making it a very attractive clinical model to study potential treatment interventions like PRB to 50.
The primary objective of this study is to determine target engagement at the Delta receptor.
Which will be measured by the ability of TRP to 50 to reduce the number of subjects, who experience a sustained not nitroglycerin induced headache.
We plan to enroll approximately 120 microliters at a single site.
Mark A. Demitrack: All subjects will be randomized before receiving a continuous nitroglycerin infusion, followed by administration of a 20 mg subcutaneous dose of TRV-250 or placebo at a fixed time, after which they will be monitored in a hospital setting for 24 hours. We expect to initiate this study next quarter, and I'm looking forward to studying this new mechanism of action in actual migraine sufferers, an important clinical development milestone for this exciting program. I'll now hand the call over to Barry to review our second quarter financials.
All subjects will be randomized before receiving a continuous nitroglycerin infusion.
Followed by administration of a 20 milligram subcutaneous dose of TRP to 50 or placebo at a fixed time point.
After which they will be monitored in a hospital setting for 24 hours.
We expect to initiate this study next quarter.
And I'm looking forward to studying this new mechanism of action in actual migraine sufferers.
An important clinical development milestones for this exciting program.
I'll now hand, the call over to Barry to review, our second quarter financials.
Thanks, Mark and thank you carry for the introduction.
Barry Shin: Thanks, Mark. And thank you, Carrie, for the introduction. It's great to be here this morning.
It's great to be here this morning.
Barry Shin: I'm excited to be joining Trevena at this critical inflection point. We have clarity on the regulatory pathway, our healthy volunteer study for oloceridine is well underway, and we're making solid, cost-effective progress on our pipeline candidates. The leadership team has done a great job addressing the CRL quickly and efficiently. I look forward to supporting the efforts to resubmit the NDA and advance our other pipeline assets. Bow to the numbers
I'm excited to be joining trevino at this critical inflection point.
We have clarity on the regulatory pathway.
Our healthy volunteer study for over 17 is well underway.
And we're making solid cost effective progress on our pipeline candidates.
The leadership team has done a great job addressing the CRL quickly and efficiently.
I look forward to supporting the efforts to resubmit, the NDA and advance our other pipeline assets.
Now to the numbers.
We disclosed key financial measures earlier today in our press release and full financial statements in our Form 10-Q .
Barry Shin: We disclosed key financial measures earlier today in our press release and full financial statements in our Form 10-Q. For now, I'll summarize the headline numbers. For the second quarter of 2019, we reported a net loss to common stockholders of approximately $4.7 million, or $0.05 per share, compared to approximately $9.3 million, or $0.13 per share, for the second quarter of 2018. This decrease in net loss and net loss per share was driven primarily by a decrease in expenditures resulting from the 2018 Restructuring and Reduction in Force and associated cost saving initiatives. As planned, we expect expenditures will increase in the second half of 2019, mainly due to the Healthy Volunteer Study for Volatility, which we initiated in June of this year. Cash, Cash Equivalents, and Marketable Securities were $54 million as of June 30, 2019.
For now I'll summarize the headline numbers.
For the second quarter of 2019, we reported a net loss to common stockholders of approximately $4.7 million or five cents per share.
Compared to approximately $9.3 million or 13 cents per share for the second quarter of 2018.
This decrease in net loss and net loss per share was driven primarily by a decrease in expenditures, resulting from the 2018 restructuring and reduction in force.
And associated cost saving initiatives.
As planned.
We expect expenditures will increase in the second half of 2019, mainly due to the healthy volunteer study for all this equity.
Which we initiated in June of this year.
Cash cash equivalents and marketable securities were $54 million as of June Thirtyth 2019.
Our guidance remains unchanged and we continue to expect this amount together with interest income.
Operator: Our guidance remains unchanged, and we continue to expect this amount, together with interest income, will fund our operating expenses, debt service, and capital expenditures for at least 12 months into the third quarter of 2020. This period covers key milestones, including the completion of the Healthy Volunteer Study for Ola Saradine and the initiation of the Proof of Concept Study for TRV250 in the fourth quarter of this year. IND enabling activities for TRV 045 that have already begun, and resubmission of the NDA for oloceridine in the first quarter of 2020. We'll now open the call to questions, after which Carrie will provide some closing remarks. Thank you for joining us, Josh.
Of under operating expenses debt service and capital expenditures for at least 12 months into the third quarter of 2020.
This period covers key milestones, including the completion of healthy of the healthy volunteer study all the Saturday.
Initiation of the proof of concept study for TRP to 50 in the fourth quarter of this year.
Hi, Andy enabling activities for TRP or four or five that have already begun.
And resubmission of the NDA for all the severity in the first quarter of 2020.
Well now open the call for questions after which carry who will provide some closing remarks.
Josh.
Thank you ladies and gentlemen, if you have a question at this time. Please press. The Star then the number one can your touchstone telephone. If your question has been answered are you a string of yourself from the queue. Please press the pound key to prevent any background noise. Please place your line on mute. Once your question has been stated our first question comes from Jason Butler with JMP Securities. You May proceed with your question.
Operator: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. To prevent any background noise, we ask that you please place your line on mute once your question has been stated. Our first question comes from Jason Butler with JMP Securities. You may proceed with your question.
Hi, Thanks for taking the questions. Just first analyst 13 can you just maybe frame for us what we should expect you to disclose from the Qt study for for example, as well as top line conclusions will you provide any quantitative.
Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc,
Mark A. Demitrack: Great. Good morning, Jason. Mark.
Information on Q teams roles on a on an average basis or any patients crossing outlier thresholds. Thanks.
Mark A. Demitrack: Well, when we report top-line data, Jason, that's exactly what we'll report. We'll be looking at the placebo-corrected change from baseline in the QT interval, rate-corrected, so the so-called QTC interval, and then we will also be reporting the proportion of outliers at standard categorical thresholds for the magnitude of change from baseline as well as the absolute length of the corrected QT interval itself.
Great Good morning, Jason Mark.
Well when we report topline data that's Jason It that's exactly what we'll report will be looking.
At the hub.
Placebo corrected changed from baseline.
In the Qt interval rate corrected.
So the so called Q T C.
The interval and then we will also be reporting the proportion of outliers at standard categorical thresholds for magnitude of change from baseline as well as the absolute length of the corrected Qt interval itself.
Great very helpful. And then on CRB to 50 can you just give us a little bit more background around see the nitric western induction how many patients would you expect to get a headache.
Mark A. Demitrack: Great, very helpful. And then on TRV250, can you just give us a little bit more background on nitroglycerin induction? How many patients would you expect to get a headache post, you know, NTG induction? And what's the time course of onset for the headache? And then when you're looking at a treatment effect for 250, how do you define whether a patient gets, you know, has a, how do you define the reduction in headaches? Is it a categorical yes, no, has a headache, doesn't, or is it passing some kind of threshold or using a scale?
Entergy induction and what's the time course of onset.
For the headache, and then when you're looking at a treatment effect for 250, how do you define whether a patient gets you right.
The hazard how do you define the reduction in had a categorical yes, no has a headache down or is that passing some kind of threshold or using a scale.
Mark A. Demitrack: Thanks.
Thanks.
Sure. So this model is conducted with a 20 minute infusion of intravenously of nitroglycerine and that approach and the dosing paradigm. That's been use has been well established in the literature over a couple of decades of research of this model and we also with the the research side that were working with we we actually validated the performance of this model at that site in an early study in in migrant area. So we know a lot about the parameters of performance. What typically is saying is there is a brief.
Mark A. Demitrack: Sure. So this model is conducted with a 20-minute infusion of intravenously nitroglycerin. And that approach and the dosing paradigm that's been used has been well established in the literature over a couple of decades of research on this model. And we also, with the research site that we're working with, actually validated the performance of this model at that site in an early study in migraineurs. So we know a lot about the parameters of performance.
Mark A. Demitrack: What typically is seen is there is a brief vascular-type headache during the infusion. For a healthy individual, that would be the end of it. Then the infusion is done, and there's no sequelae to it.
Vascular type headache during the infusion for a healthy individuals that would be the end of it are there then the infusion is done and there's no.
The quality of it.
Mark A. Demitrack: In someone with migraine, virtually all individuals with migraine experience not just that immediate vascular headache, but it progresses over several hours, usually around the next six to eight hours, to a headache that has all of the clinical features of a spontaneously occurring migraine. And it's really, very characteristic of migraine sufferers, this pattern of headache. Our outcome will use rating scales, standard rating scales that are used to grade the intensity of a headache, and we will use categorical cut points to determine whether a headache is present or absent. We'll have, obviously, several secondary outcome measures that will look at various other thresholds and durations and that sort of thing. But that's, in general terms, the approach that we take with this study.
And someone with migraine.
Virtually all individuals with migraine experience not just that immediate vascular headache, but it progresses over several hours usually around the next six to eight hours.
To a headache that has all of the clinical features of a spontaneously occurring migraine and it's really very very characteristic of migraine sufferers.
This pattern of headache, or outcome will use a rating scales standard rating scale sort of use to grade the intensity of a headache.
And we will use categorical cut points.
To determine whether a headache is present or apps that will have obviously SEC several secondary.
Outcome measures that we'll look at various other thresholds and durations and that sort of thing, but that's in general terms. The approach that we take with the study.
Okay, great. Thanks for taking the questions.
Mark A. Demitrack: Okay, great. Thanks for taking the questions.
Thank you and our next question comes from Douglas Tsao with H.C. Wainwright you May proceed with your question.
Douglas Dylan Tsao: Thank you, and our next question comes from Douglas Tsao with HC Wainwright. You may proceed with your question.
Hi, good afternoon, I couldn't point and thanks for your questions just in terms of for all this Saturday and in terms of completion of the study and once that's completed is there anything else that needs to be done in terms of the resubmission or is it just simply compilation of that data. You know is the final step towards towards re filing.
Douglas Dylan Tsao: Hi, good afternoon. Good morning. Thanks for asking the questions. Just in terms of Oliceridine, in terms of completion of the study, once that's completed, is there anything else that needs to be done in terms of the resubmission? Or is it just simply compilation of that data, you know, the final step towards refiling?
Carrie L. Bourdow: Good afternoon, Doug. I'm not quite sure where you are.
Yes.
Douglas Dylan Tsao: Okay. It's morning. It's morning.
Good morning, or good afternoon, Doug I'm, not quite sure where you are Sol [laughter] a warning.
Okay. Good morning, it's morning.
Carrie L. Bourdow: So you may remember that the other area that we need to finalize is the PK work that we need to do to characterize the metabolite. That will be done before the QT study is finished, so that will be part of the submission as well. And then the other two questions were really just – the other question that will be involved in the submission is the validation reports that we have already completed. And it's really more of a clerical thing that we need to provide in the data package. So we should be well on our way once the study is finished to resubmit as early as we can in the first quarter of next year.
So you may remember that the other the other area that we need to have to finalize is the the PK work that we need to do to characterize the metabolite that will be done before the Qt study is finished so that will be part of the submission as well and then there are the other.
The other two questions where really the other one question that will be involved in the submission.
Validation report that we have already completed and now it's really more of a a clerical thing that we need to provide any in the data package.
So we should be well on our way once the study is finished two to resubmit as early as we can in the first quarter of next year.
Okay and then just.
Douglas Dylan Tsao: Okay, and then just, you know, in terms of how long it takes once you enroll a patient does it take them to go through the three-period crossover?
You know in terms of the how long once you enroll a patient does it take them to go through the three period crossover.
About 20 days Mark right right its about 20 days from.
Carrie L. Bourdow: It's about 20 days, Mark, right?
Mark A. Demitrack: Right, it's about 20 days from the day they come in to the day they complete the last period.
The day they come in to the day, they complete the last period.
Okay, great. Thank you very much.
Douglas Dylan Tsao: Okay, great. Thank you very much. Thank you.
Thank you.
Thank you.
Carrie L. Bourdow: Thank you. And I am not showing any further questions at this time. I would now like to turn the call back over to Kerry Bourdow, CEO, for any further remarks.
And I'm not showing any further questions at this time I would now like to turn the call back over to Kerry Burgos CEO for any further remarks.
Carrie L. Bourdow: Great. Thank you. Thank you for your questions.
Great. Thank you. Thank you for your question as you heard today, we have important work ahead of us and we look forward to sharing updates with you as we enter a busy second half of 2019, our focus remains on progressing our starting towards the successful resubmission topline data from the healthy Volunteer study is expected next quarter and we will re file the NDA as early as possible in first quarter of next year.
Carrie L. Bourdow: As you heard today, we have important work ahead of us, and we look forward to sharing updates with you as we enter a busy second half of 2019. Our focus remains on progressing oloceridine towards a successful resubmission. Top-line data from the Healthy Volunteer Study is expected next quarter, and we will refile the NDA as early as possible in the first quarter of next year. We also continue to advance our CNS pipeline with plans to move all our assets toward key development milestones over the next six months. We're on track to initiate the acute migraine proof-of-concept study for TRV-250 also next quarter, and we're supporting our partners at NIDA as they finalize preparations for the TRV-734 proof-of-concept study by year-end, and IND-enabling work for TRV-045 has already commenced. In summary, we remain disciplined, optimistic, and committed to developing novel medicines for patients with CNS conditions. Thank you. Thank you for joining us today.
We also continue to advance our CNS pipeline with plans to move all our assets towards key development milestones over the next six months, we're on track to initiate the acute migraine proof of concept study for TV to 50 also next quarter and we're supporting our partners at night as they finalize preparations for the PRB 734 proof of concept study by year end and I, Andy enabling work for Ti Vo for fine has already commenced.
In summary, we remain disciplined optimistic and committed to developing novel medicines for patients with CNS conditions. Thank you. Thank you for joining us today.
Thank you ladies and gentlemen, thank you for participating in today's conference. This does conclude todays program and you may all disconnect everyone have a wonderful day.
Operator: Thank you, ladies and gentlemen. Thank you for participating in today's conference. This does conclude today's program, and you may all disconnect. Everyone have a wonderful day.
Yeah.
Operator: [inaudible]