Q3 2019 Earnings Call
The request that the company, we will open up the corporate for questions and answers after the presentation.
Operator: to open up the conference for questions and answers after the presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Just to remind everyone, certain matters discussed in today's conference call or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties relating to future events and the future financial performance of the company. actual results could differ materially from those anticipated in the S.W.O.R.D.
Anyone should require operator, especially during the conference. Please press star zero on your telephone keypad, just to remind everyone certain matters discussed on today's conference call or answers that maybe getting a good questions asked are forward looking statements that are subject to risks and uncertainties relating to future events and or the future financial performance of the company actual results could differ materially from those.
Anticipated any forward looking statements. These risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities Exchange Commission, including its quarterly report on Form 10-Q , four the quarterly period ended September Thirtyth 2019, which can be found on its website www dot biotech cell therapy.
Operator: Looking forward, these risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended September 30, 2019, which can be found on its website www.bioxceltherapeutics.com or on www.sec.gov. I would now like to call over to Vimal Mehta, Chief Executive Officer of BioXcel Therapeutics. Please go ahead, sir.
Next dot com or on Www, <unk> FCC Dr. Bose I would now like turn the call overcome all metals Chief Executive officer for bio except Therapeutics. Please go ahead Sir.
Vimal D. Mehta: Thank you, Operator. Good morning everyone, and thank you for joining our conference call to discuss BioXcel Therapeutics' Financial Results and Business Highlights for the third quarter of 2019. We appreciate everyone's time and attention today as we discuss our third quarter results. We are very pleased with the tremendous clinical advances and strategic initiatives we have made in progressing our pipeline this quarter. To begin, I would like to discuss our lead neuroscience clinical program, BioXcel 501, and the major milestones we have achieved over the past month. Just to remind everyone, BioXcel 501 is our proprietary thin film formulation of dexmedimedine or dex for the treatment of acute agitation. This candidate is designed to be easily administered and have a rapid onset of action that produces a calming effect without excessive sedation. In July, we announced positive top-line data from our Phase 1b trial of BioXcel 501 for the treatment of acute agitation in 135 patients with schizophrenia. The study met its primary endpoint with a rapid and durable reduction in PEC scores.
Thank you operator, good morning, everyone and thank you for joining our conference call to discuss the bikes and kind of Didix financial deserves and business highlights for the third quarter 2019.
We appreciate everyone's time and attention today as we discuss our third quarter the them.
We are very pleased with demand does clinical advances and its strategic initiate days, we I made in progressing our pipeline this quarter.
To begin I would like to discuss our lead notice I instead of nickel program be axiom fiber, one and the major milestones we have achieved over the past month, just to remind everyone be axiata fiber one needs. Our book brightly 10 fit and FOBT militia, no decks, murdo medine or debt for deep.
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This candidate is designed to be easy Lear administered and have evaporated onset of action that produce either calming effect without excessive situation.
In July we announced positive top line data from our phase one be I know bxc in fiber one for the treatment of acute education in London in 35 patients with schizophrenia.
The study met its primary endpoint, we did that pretty then do it enabled reduction in back school, we believe that the outcome of this trial demonstrated that be axiall fiber. One is differentiated from current treatment options, which can often called unwanted side effects like access is today.
Vimal D. Mehta: We believe that the outcome of this trial demonstrated that BioXcel 501 is differentiated from current treatment options which can often cause unwanted side effects like excessive sedation and therefore result in their limited use. With this successful data readout, we plan to initiate pivotal phase 3 studies in schizophrenia and bipolar patients with acute agitation during the fourth quarter of this year. We are fortunate that these studies are short in duration, with a two-hour endpoint, and as a result, we currently believe we will report top-line results in the first half of 2020.
And and therefore, it is everything they had limited use.
With that success wouldn't do that even though we plan to initiate favorite Dumfries. These studies and its schizophrenia and bipolar patients with acute education during the fourth quarter of this year.
Unfortunately that these studies are short in duration, we they do all what I'm fine and as it is very we currently believe we will report top line there doesn't seem to be fun to talk from 2020 [noise].
Vimal D. Mehta: Following our phase 3 trials, we expect to be able to submit our first NDA for BXCL501 during the second half of 2020. We are confident that our initial BXCL501 NDA filing will lay a solid foundation for follow-on indications in dementia, opiate withdrawals, and other indications. In addition, with limited treatment options for acute agitation, we continue to examine the potential of BioXcel 501 for the treatment of agitation and other neuropsychiatric disorders. In parallel with phase 3 studies for the acute treatment of agitation in schizophrenia and bipolar patients, we plan to initiate a phase 1b trial for agitation in geriatric dementia Alzheimer's disease in the fourth quarter of 2009. We also expect that the study should be read out in the first half of 2020.
Following up on phase three times, we expect to be able to submit our first N D for be Axiall fiber one during the second half of 2020.
We have gone through then that already Michelle Big feel fiber. One then be a filing really solid foundation for follow on indications in dementia and opioid withdrawals and other indications.
In addition, with limited treatment options, what acute education, we continue to examine the potential of big till fiber one for the Piedmont of education and other new does that get big disorders.
In parallel with phase three studies for the acute treatment of education in schizophrenia, and bipolar patients we plan to initiate a phase one be to dial in for education engineered big dementia, Alzheimer's disease in the fourth quarter over 2019.
We also expect that do study showed read out in the first talk about 2020 success in this indication.
Vimal D. Mehta: Success in this indication could significantly expand the market potential for BioXcel 5.0. Moreover, we are excited to have launched two strategic initiatives for our neuroscience clinical program, as both will expand our current clinical development of BioXcel 5.0. First, we are investigating the feasibility of the development of digital device technology that can be used in conjunction with BioXcel 501 to enhance the prevention and treatment of agitation. Using the device technology, our approach is to sense the individual's increasing state of hyperarousal and alert the caregiver to take the necessary measures to treat patients at the onset of agitation. This should serve to avoid the escalation of problematic behavior that can cause injury to the patient and caregiver.
Significantly expanding the market for adventure be Axiall fiber one.
Moreover, we are excited to have launched through strategic initiate is what I wasn't sure does things clinical program as boards will expand our caught anything nickel dime lament they'll be axiall fiber one.
For Us we got Investor He had been good <unk> D. O <unk> did your done device technology that can be used in conjunction with big deal fiber 1 billion Menzie prevention and treatment of education.
Using their device technology.
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And I lowered Vicki had to get worked to dig the necessary measures to treat patients at the onset of agitation. This short so do award escalation Oh, probably my big behaviour that can cause injury to the patient and caregiver.
Our second issue there is with the U.S. Department of Defense Congressionally directed medical research programs in which we have received a planning going to investigate would be axiall fiber one for the treatment of alcohol and substandard use disorders related to be DSD and traumatic brain in.
Vimal D. Mehta: Our second initiative is with the U.S. Department of Defense's Congressionally Directed Medical Research Program, in which we have received a planning grant to investigate BXCL501 for the treatment of alcohol and substance use disorders related to PTSD and traumatic brain injury. With agitation as an underserved therapeutic area, we are committed to exploring additional indications with BXCL501 in order to treat the maximum number of possible patients. This grant is in collaboration with Yale University.
Judy.
With education as an underserved kinda do they gave here we are committed to the exploration of additional indications would be axiall fiber one in order to feed the maximum number or placebo patients. This is good and is in collaboration with Yale University.
Vimal D. Mehta: With that, I would like to move to the discussion of our immuno-oncology clinical program, BioXcel 701, or our orally available systemic innate immunity activator with dual mechanism of activation. Our Phase 1b slash 2 double combination study of BioXcel 701 and Keytruda for treatment emergent neuroendocrine prostate cancer, TNEPC, is currently ongoing. In October, we presented safety and tolerability data from the first cohort at the annual Prostate Cancer Foundation scientific retreat. No serious adverse events or dose-limiting toxicities were observed in the initial cohort.
With that I would like to move to the discussion of our immuno oncology clinical program, we exceeded seven to one or our orderly available systemic innate immunity activate the we're doing a mechanism affection.
Oh, what a phase one be slash to double combination has started to all be akcea is that when no one and get through though for treatment emergent new endocrine prostrate cancer de any B C is currently ongoing.
In October we presented safety and Tolerability data from before school hard at the end well prostate cancer Foundation, saying to big victory.
No Tds that the adverse events or dose limiting toxicities, what observer Indonesian cohort.
Vimal D. Mehta: A second cohort is nearly fully enrolled. We expect to announce additional data from the safety and dose escalation portion of the trial in the fourth quarter of 2019 before transitioning to the second stage efficacy portion of the trial. Initial efficacy data readouts of the second stage of the trial are expected in the first half of 2020. The results of the safety portion of the trial of BioXcel 701 in combination with a checkpoint inhibitor may help establish the full potential of combining an innate immunity activator with several IO modalities across multiple tumors. The combination trial of BioXcel 701, BAMPAC from Nectar, Avelimab from Pfizer, and Merck KGA in pancreatic cancer will start following the completion of Nectar and Pfizer's safety run-in studies of BAMPAC and Avelimab and the outcome of that trial.
Second cohort is nearly fully enrolled we expect to have known additionally that from the safety in dose escalation portion of the right in the fourth quarter over 2019 before transitioning to the second stage efficacy portion of that but.
Initial efficacy data read outs of these second stage of their pilot expected in the first talk about 2020, they themselves. The safety portion of that I love Big fields have on a one in combination with checkpoint maybe to me has established a full bore danger of combining an innate.
[noise] immunity activity to be several.
Hi, all modalities across multiple tumor dives.
The combination, but I love Bx is that when no. One then back from neck.
And I barely mab from Pfizer and Mark AG in Fem care <expletive> instead of really start following the completion of next step in Pfizer's safety that in started he have been bag I never really mad and the outcome of that but.
Vimal D. Mehta: Finally, we strengthened our balance sheet in the quarter. Raising $19 million in gross proceeds through a public offering of common stock, we believe that we now have sufficient funding to take us through the data readouts in our Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disease, in addition to other key milestones. With that, I would like to turn the call over to our CFO, Richard Steinhart.
Finally, we strengthened our balance sheet in the quarter.
Raising 19 million in gross proceed through a public offering of common stock. We believed that we now have sufficient funding to take us through the data you don't see in our phase three studies or be Axiall fiber one for dickey acute treatment of vegetation in patients with schizophrenia and bipolar disease in there.
He shouldn't do other key milestones with that I would like to turn the call over to our CFO deterred Stinar deterrent. Thanks, Bill once again. Thank you all for joining US this morning, and welcome to our shareholders.
Richard I. Steinhart: Thanks.
Richard I. Steinhart: Thanks Vimal. Once again, thank you all for joining us this morning, and welcome to our shareholders. For the third quarter of 2019, we reported a net loss of $9 million, compared to a net loss of approximately $4.9 million for the third quarter of 2018. Research and development expenses totaled approximately $7.1 million for the third quarter of 2019, compared to approximately $3.8 million for the same period in 2018. The increase was primarily driven by an expansion of research and development activities, including increased personnel costs, clinical trial expenses, and professional fees associated with our two lead products and two lead drugs, Product Candidate. General and administrative expenses in the third quarter of 2019 were approximately $2 million, compared to approximately $1.3 million for the third quarter of 2018.
For the third quarter 2019, we reported a net loss of $9 million compared to a net loss of approximately 4.9 million the third quarter 2018.
Research and development expenses totaled approximately 7.1 million for the third quarter of 2019 compared to approximately 3.8 million for the same period in 2018.
The increase was primarily driven by an expansion of research and development activities, including increased personnel costs clinical trial expenses professional fees associated with our two lead products to lead drug.
Product candidates.
General and administrative expenses in the third quarter 2019 were approximately 2 million compared to approximately 1.3 million for the third quarter 2018.
Richard I. Steinhart: The increase was primarily due to additional payroll and payroll-related expenses, professional fees, and costs associated with operating as a public company. Total operating expenses for the third quarter of 2019 were approximately $9.1 million as compared to total operating expenses of approximately $5.1 million for the same period in 2018. The 2019 results include approximately $800,000 in non-cash, stock-based compensation. We had cash and cash equivalents of approximately $40.3 million. As of September 30th, 2019. We expect cash burn to increase going forward as we progress our two leading drug candidates. That concludes the financial review of our third quarter 2019. Now, I would like to turn the call back to Vimal for any further comments. Vimal? Thanks.
The increase was primarily due to additional payroll and payroll related expenses professional fees and costs associated with operating as a public company.
Total operating expenses for the third quarter of 2019 were approximately 9.1 million as compared to total operating expenses of approximately 5.1 billion. The same period in 2018.
The 2019 results include approximately $800000 in noncash stock based compensation.
We had cash cash equivalents of 40 of approximately 40 point threemillion.
As of September Thirtyth 2019.
We expect cash burn to increase going forward as we progress our two leading drug candidates.
That concludes the financial review of our third quarter 2019, now we'd like to turn the call back to demo for any further comments demo.
Vimal D. Mehta: Thanks, Richard. We are pleased with the progress we have made during this quarter and remain confident in our ability to execute on both our clinical and strategic plans for the remainder of this year and into 2021. We would now like to open the call to questions, Operator.
Thanks Richard.
We are pleased with the progress being made during this quarter and remain confident in our ability to execute on both our clinical and strategic plans for the remainder of this year and into 2020.
We would now like to open the call two questions operator.
Operator: Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Doe Kim with BMO Capital Markets. Please proceed with your question.
Thank you, ladies and gentlemen, we will now be conducting the question and answer session.
I would like to ask your question. Please press star one on your telephone keypad the confirmation.
That your line is on the question Q.
Press Star to what you said, we'd like to remove your question from the Q for participants using speaker equipment and may be necessary to pick up your handset for pressing the star.
Our first question comes on line of del Kim with BMO Capital markets. Please proceed with your question.
Doe Kim: Good morning. Thanks for taking my questions. First, in Vimal, the Phase 1b study for 701, what kind of biomarker data are you collecting for these dose cohorts and for potential signals of inflammation or immune activation? And will you provide those results when you report the safety for Cohort 2 later this year?
Good morning, Thank for taking my questions.
First I I think.
The phase one study for 71.
Biomarker data.
It was core.
And potential signals.
And.
Immune activation and.
Provide that.
Results.
The safety for cohort.
This year.
Thanks, Joe Yes, we intend to provide that is elds for the second go hard.
Vimal D. Mehta: Thanks, Joe. Yes, we intend to provide the results for the second cohort this year. I'd like to add that today I'm joined by two of my colleagues, Vince O'Neill, who is our SVP and Chief Medical Officer, and Frank Yocca, who is our SVP and Chief Scientific Officer. Regarding your question about the biomarker, I will pass it on to...
This year.
I like to areas that today I'm joined by two of my colleagues, Vince So need who is our SVP and Chief Medical Officer and Thank you. All are who is our SVP and Chief Scientific officer for regarding your question about the biomarker got I will pass it onto Vince So he can elaborate on it.
Vince O'Neill: Thanks so much. Thanks, guys. Yeah.
Thanks, Brian Yeah, So just a just to add to [noise].
Unknown Executive: Thanks, Bill.
Unknown Executive: Vimala Seth. So we will, in fact, capture a full cytokine profile from the prostate study. In addition, all of our patients actually in the efficacy portion, not necessarily safety, but in the efficacy portion are required to have biopsies. We have the option of a second biopsy on therapy. So we do have biomarkers substantially built into the study.
I had been like that so we will in fact capture those sites can profile.
From the prostate study and an additional all about patients.
Actually in the efficacy portion not necessarily secure within the efficacy portion are required to have biopsies. We have the auction all the second biopsy on therapy. So we do have biomarkers and substantially built into the study.
Okay, great and in the first.
Unknown Executive: Okay, great. And in the first cohort, how active is the 0.4 milligram dose? And the efficacy signs that you saw of stable disease, do you consider that meaningful? And how much of a step up do you see?
How active.
Four milligram dose.
And.
African see signs that you saw on stable disease.
Meaningful and how much of a step up.
Would you expect to see the points.
Yeah, So I would definitely view the first two cohorts as fundamentally safety.
Unknown Executive: Yeah.
Unknown Executive: So I would definitely watch the first two cohorts.
Unknown Executive: Safety Cohorts with Safety Outcomes. So it is certainly true to say that all patients remained on study, but I wouldn't from there rush to make claims on efficacy. I think it's a small number of patients, and really, we're doing the first two cohorts primarily from a safety point of view. I mean, that said, it's nice to see no patients progressing. But I'm not sure I would extrapolate that to claim efficacy. I think we need some more patience.
50 cohorts with that you know safety and come so it is certainly through to see the all patients.
Remained on study.
But I'm not I wouldn't from their rush to make claims on on efficacy I think is a small number of patients and I'm really wondering.
Yes, two cohorts from.
From a safety point of view I mean that said, it's nice to see.
No patient aggressive.
But I'm not sure I would extrapolate that clean and efficacy I think I think when he's more patients.
Vimal D. Mehta: Okay, thank you. And for 501... What is left to do in the startup efforts for the phase three clinical trial before you can start screening and enrolling patients?
Okay. Thank you.
For five or one.
What is left to do.
And in the startup efforts.
The clinical phase three clinical trial before you start screening.
Patients.
So we are having endo.
Vimal D. Mehta: So we are having a phase two meeting with the FDA, and that is a key step in initiating the trial. After our FDA interaction, we intend to start the trial this year, and we feel, we believe we feel very confident about it.
Based on meeting with the FDA and that is a key step.
Any new shedding that Ben I'll, Oh, whatever the infection, we intend to start, thereby lithia and Oh, we feel we believe we feel very confident about it.
And maybe you could talk.
Vimal D. Mehta: And maybe you could talk a little bit about your commercialization strategy for 501. Will you be looking for regional partners, the size of Salesforce, and what kind of infrastructure you would need?
What about your commercialization strategy for fiber one.
You for regional partners.
Cycle sale force and what kind of infrastructure.
So that's a good question, though in you as we have the gave the ability to double up this drug.
Vimal D. Mehta: So that's a great question though. In the US, we have the capability to develop this drug, and outside the US, particularly in Japan, we don't have much capability to develop the drug or commercialize it. So we have started exploring potential partners in Japan and potentially Europe. We are looking for regional partners, and that effort is ongoing. In terms of the commercialization infrastructure, we have started doing pre-commercialization activities and mapping out what kind of commercial infrastructure requirements there will be to commercialize the drug, but it is a specialized www.youtube.com.uk
And outside you as particularly in Japan, we don't have as much capability to download there Doug Koman chalet. So we haven't started exploding for danger in part not in Japan and potentially Europe .
So we are looking for these nobody knows and that out for these ongoing.
In terms of the commercialization and was such a we haven't started doing pre commercialization.
Activities and mapping it out what kind of a commercial infrastructure requirements will be to commercialize their dog, but it does this specialized.
Let's see there this is doug needs to be door. So we don't expect the number to be do large but in next few months, we'll be able to provide more guidance on exact number associated to that I know everybody that will be needed in you as good or to get the best penetration in the marketplace.
Doe Kim: Okay, thanks for taking my questions.
Operator: Thank you. Our next question comes from the line of Robyn Karnauskas with SunTrust. Please proceed with your question.
Okay. Thanks for taking my question.
Robyn Kay Shelton Karnauskas: Thank you. Hi, everyone. This is Min Vong, on behalf of Robyn.
Thank you. My next question comes from the line of Robyn Karnauskas Suntrust. Please proceed with your question.
Min Vong: Thanks for taking our questions, and congratulations on the progress this quarter. I guess first, with regard to 501, could you talk a little bit more about your ongoing PK-PD modeling? Can you help us understand, you know, how you're thinking about it? through balancing the reduction of agitation with, you know, duration and degree of drowsiness. Maybe you've seen any, if the correlation is linear, you've seen efficacy, and maybe you've been able to identify a dose where you can see a clinically meaningful reduction of agitation without, you know, even transient effects on drowsiness.
Thank you hi, everyone. This isn't involved on for Rob. Thanks for taking my questions and congrats on the progress this quarter I guess first with regards to five though wine can you talk little bit more about your ongoing PK PD modeling can you help us understand you know how you're thinking through balancing the reductions agitation and with the recent and degree.
And then maybe have you seen any if he had the correlation is when you have what you've seen efficacy and you know maybe if you've been able to identify dose where you can see clinically meaningful reduction agitation well thought you know even fanciness Exxon drowsiness.
Frank D. Yocca: Frank, thanks for the question. Frank is our CSO and is leading the 501 program. He will address that question.
Frank.
Thanks for the question men, Frank is I'll, Oh, I see as someone leading the fiber one program. He will it does that cushion.
Yes, Hi men. So as you know well, we did a fair a fairly thorough dose response.
Frank D. Yocca: Hi guys, as you know, we did a fairly thorough dose response in Phase 1b. And we definitely have an understanding of the PKPD. What you're talking about more is how do we extrapolate that, say, for example, to adverse events, if you will. And what the data basically has told us right now is that even at the highest dose, we see minimal adverse events. So in terms of relating the PKPD even back to the IV, it's been holding up quite well. So our belief basically right now is that the 180 dose, which was the top dose, really performed very well in reducing agitation in the absence of severe adverse reactions.
In the phase one be and we definitely have.
An understanding of the PK PD.
What you're talking about more is how do we extrapolate that say for example.
To adverse events, if you will and what the data basically has told US right now is that even at the highest dose we see minimal adverse events. So in terms of Oh relating the PK PD, even back to the idea it's been holding up quite well so our belief.
Basically right now is that the 180 dose which was the top dose a really performed very well in reducing agitation in the absence of severe adverse events. So we actually like that those very much. So he is really the modeling held up quite true.
Frank D. Yocca: www.youtube.com.uk So, really, the modeling has held up quite true. Great, thank you. And then, one other question. On your initiative to incorporate 501 into a device, can you talk a bit about how you're thinking through the device? I mean, can these patients remove the device on their own? Are they, you know, given that option?
Great. Thank you and then.
One other question on you know, what's your initiation to incorporate father, one into a device can you talk a bit at the how you're thinking through with if I mean.
Can be patients are moved advice on their own given that option on how does it have to be and if you can comment on just any patient experience. You have you know in this geriatric population with wherein devices that they're familiar or you see wearing watches or device is there anything like that.
Frank D. Yocca: You know, how strong does it have to be? And if you can comment on just any patient experience you have had with this geriatric population with wearing devices, if they're familiar or, you know, used to wearing watches or devices or anything. So, what I can say about that right now is that we're using our concept, which is hyperarousal, to drive what we're developing. Okay. We're thinking about exactly what kind of a device, a wearable, and how that would fit in terms of the elderly population, if you will. Now there are others who are thinking...
So what I can say about that right now is that we were using our concept, which is the hyper Russell to drive what we're developing okay. We're thinking about exactly what kind of a device a wearable how that would fit in terms of the elderly population. If you will now there are others with.
Thinking along these lines as well they realize that if you can't predict the agitation event or the building of the agitation than prior to it actually becoming a full blown issue that you would benefit clearly from that so what we're doing basically is we believe that that event is tied to the hyper arousal, which.
Frank D. Yocca: Robert Risinger, Yatin Suneja, Robert Risinger, Yatin Suneja, Samir Devani, Mary Kate, Raghuram We believe we can pick that up in a number of different ways, including skin conductance. So our goal right now is to be able to show that there is definitely a correlation between increases in some of these biomarkers and the agitation event. And once we have that, then I think we will focus very hard on the type of wearable we would give to an elderly patient to make sure that they can't remove it.
I think very very closely tied to sympathetic activity and we believe we can pick that up in a number of different ways, including the skins conductance. So our goal right now is to be able to show that there is definitely a correlation between increases in some of these biomarkers and the agitation event and once we have that.
Then I think we will focus down very hard on the type of wearable, we would give to an elderly patient to make sure that they can't remote.
Min Vong: Great. Thank you. And last quick follow-up. Can you remind us if there's going to be an update from the safety run-in of 701 in Pancreatic?
Great. Thank you I didn't say last quick follow up on can you remind us that there's going to be in any any update from the safety brought in 71 and out pancreatic.
So we won't see data from that study this year it'll be next year.
Vimal D. Mehta: So we won't see data from that study this year.
Min Vong: Thanks so much, everyone.
Great. Thanks, so much everyone.
Operator: Thank you. Our next question comes from Sumant Kulkarni with Canaccord. Please proceed with your question. Sumant, your line is live. You may proceed with your question.
Right.
Thank you. Our next question comes from Salons Kulkarni with Canaccord. Please proceed with your question.
Good luck. Your line is why do you May proceed with your question.
Sumant Satchidanand Kulkarni: Good morning. Sorry about that.
Mike sorry about that I have a couple of questions and thanks for taking them. The first one is on fiber one.
Sumant Satchidanand Kulkarni: I have a couple of questions, and thanks for taking them. The first one is on 501. At what point do you expect to have more clarity on the scheduling of the end of phase 2 meeting with the FDA?
At what point do you expect to have more clarity on scheduling of the end of phase two meeting with the FDA.
We have not come negated here do you have that clarity that what does the scheduling good idea or on the meeting, but very shortly if we are looking or reinvented <unk> an issue that you do see as we believe that Ah things are progressing well with the idea.
Vimal D. Mehta: We have not communicated, we have not had the clarity of what the scheduling of the meeting with the FDA is, but very shortly, if we are looking, or we intend to initiate the trial this year, so we believe that things are progressing well with the FDA, that will allow us, but we haven't just given the exact date when the FDA interaction meeting date is.
That will allow us, but you haven't just given the exact date event dived into action a meeting David.
Sumant Satchidanand Kulkarni: And then my next question is on 701. We've seen, you know, fledgling safety data there, and we know you're focused on pancreatic and NEPC or TNEPC, but this innate immunity activator has potential other uses. At what point do you think that you can explore more potential combinations without sort of distracting yourself from the effort that you have already in place?
Okay and then my next question is on 701, we've seen.
Fledgling safety data dad, and you know you're focused on pancreatic and a and B C or D N B C.
This innate immunity <unk> activity that has potential other uses at what point do you think that you can.
Explore more potential combinations without.
Distracting aside from the effort that you have already in place.
Vimal D. Mehta: That's a great question, Sumant. We think establishing safety like 701 in combination with immune checkpoint with Keytruda, which we have demonstrated, was a key step in the success of this program, and we are progressing on that path. Once we have established safety, besides, as you mentioned, these two chosen indications, we have the large potential to explore other opportunities. I will pass this question to Vin so he can more elaborate on how we are thinking about, you know, once we have complete safety data on 701 with checkpoint inhibitor.
That's a great questions or month, B. I think establishment of safety like seven no one in combination with immune checkpoint with get to drive that we have demonstrated what are the key step in success of this program.
And we are progressing on that bad ones. We have this stably safety. Besides as you mentioned these two chosen indications we have large potential odd to explore other opportunities I read pauses cushion to Vince. So he can more elaborate like how we're thinking about like you know ones we have come.
At least 50 did on several no one bit checkpoint inhibitor.
Sure. Thanks, well, so am I think as I alluded to in prior calls and we are interested in testing seven to one of the context of EM, either warm tumors or tumors or one talk too much and all the Bob's those would be patients who had that progressed on their own checkpoint.
Unknown Executive: Sure. Thanks, Will.
Unknown Executive: So, I think, as I alluded to in prior calls, we are interested in testing 701 in the context of either warm tumors or hot tumors or once-hot tumors. In other words, those would be patients who have progressed on checkpoint inhibition. I'm confident that the drug will perform well there. Just looking at the recent CITSE presentations we had from Sting and TLR. So, it does certainly seem possible and feasible that you can reverse resistance to checkpoint inhibition using this mechanism. And I think the fact that 701 is an oral drug, I think it just lends itself beautifully to that setting. So, as I said before, we are planning to test those types of questions in an IST setting, very soon actually, and you will hear more about that later.
In addition.
I'm confident that the drug M. will perform well there just looking at the recent since he presentations, we'd updates from staying and TLR [noise]. So it does certainly seem possible in feasible that that you can divest resistance to checkpoint. In addition, we using this mechanism I think the fact that test of no one is an oil.
Drug I think it just want to so beautifully to that setting. So I think I said before we are planning to test those types of questions in a nice t. setting.
And very soon actually I knew you will hear more about such school.
Sumant Satchidanand Kulkarni: Got it. And then my last question again on 701 about the triple combo study in pancreatic cancer. How long do you expect the Nectar and Pfizer safety trials to run?
Got it and then my last question again on seven one on the Triple combo study in pancreatic cancer, how long do you expect the Nektar and find the safety done in trials glass. So you can get going on on the Triple combo.
Unknown Executive: Yeah, so maybe just to explain that, the design of the study was to combine BEMPEG and AbelNAP because that hasn't been done before, and so there's a requirement to have at least some safety data with that and then add in 7.0.1 and really titrate 7.0.1 up, and that was clearly the plan. I think it probably didn't make sense to run two separate Phase 1s of those two agents.
Yes, that's maybe to explain the design of the study was to to combine been peg in about a lot because that hasn't been done before and so there's a requirement to have at least some safety data with that and then I didn't seven to one or really tightly seven to one up and that that was clearly the plan EM.
I think probably didn't make sense to run two separate phase ones of those that those two agents and for that reason, we've decided with our partners to two weeks and get the data from.
Unknown Executive: And for that reason, we've decided with our partners to wait and get the data from... This is a 1B study being run. So that study's open. I don't know whether Pfizer has made announcements as to whether or when they expect to get full safety data. It'll be mixed. But just to stress that that study is open and ongoing.
This is the one beside even done by Pfizer and celebrities, Okay, and I don't know whether finds it has made announcements as to whether or when rather the m. They expect to get that food safety data and it'll be next year.
But just to stress the that study is open an ongoing.
Thank you.
Yeah.
Thank you. Our next question comes from the line of Raj from self excuse me Selvaraju, what H.C. Wainwright. Please proceed with your question.
Operator: Thank you. Our next question comes from the line of Raghuram Selvaraju with HC Wainwright. Please proceed with your question.
Raghuram Selvaraju: Good morning, this is Edward Markson for ROM, and I appreciate you taking the questions. For that Pivotal Phase III with 501, you mentioned that initiation is going to happen later this year. I'm wondering how long after this initiation of enrollment it is likely to take for complete full enrollment? And what are likely to be the most key secondary endpoints?
Good morning. This is Ed remarks on for Rob I appreciate you taking the questions.
For that pivotal phase three with fiber one you mentioned that initiation is going to happen later this year I'm wondering how long. After this initiation of enrollment is it likely to take complete full enrollment and what are likely to be the most key secondary endpoints in that study.
Frank D. Yocca: Frank, do you want to speak right now? Yeah, yeah. Okay.
[noise].
So thanks.
Right.
Yes, yes so.
As you know.
Frank D. Yocca: As you know, we completed the Phase 1B study in a very short time period, so we don't see enrollment as a problem. If we start the study as we are planning at the end of this year, we see full enrollment and almost completion of the study occurring within a four to five month period. So we're very excited about that, and that's for both. I'm talking about separate studies that would go on for both schizophrenia and bipolar disorder.
We completed the phase one be study in a very quick time period.
So we don't see enrollment as a problem. If we start the study as we are planning and de ended this year, we see a full enrollment and almost completion of the study occurring within a four to five months period. So we're very excited about that and that that's per boat that I'm talking about separate studies that would go on.
On a for both a schizophrenia.
As well as bipolar.
And also friend cushion is about the secondary endpoint like work I was thinking yes, one will be.
Frank D. Yocca: And also, Frank, the question is about the secondary end point, like what our secondary end point will be.
Yes, so oh, we use the a secondary endpoints we use the ace is.
Frank D. Yocca: So, we use a secondary...
As a secondary endpoint, but we think that the critical secondary measurement.
Frank D. Yocca: [inaudible] the end point. As in most psychiatric studies, the CGI always sort of comes in at the rear, if you will, but it tells you a lot about how the patients feel after treatment.
Because it really talks to how how well the treatment works in the patience and how they respond is really the C.G.
That's really going to be our key secondary endpoint.
As I've been asked most psychiatric studies the C.G. I always sort of brings up the rear if you will but it tells you a lot about how the patients feel after treatment.
Frank D. Yocca: Okay, thank you. And then, maybe because that study is happening so quickly, is the proof of concept phase 1b trial with 501 and Alzheimer's agitation slated to be released before or after that phase 3 data in schizophrenia?
Okay. Thank you.
And then maybe because that study is happening.
So quickly.
The proof of concept phase one b trial with fiber one in Alzheimers agitation slated to leave before or after that the three did in schizophrenia.
So if you're talking about how when we're going to present the data. So we have actually have that an abstract into the eightseventy that was accepted so the AC N. P. I believe this year's December seven through 11, and it will be presented there.
Frank D. Yocca: So if you're talking about when we're going to present the data, we actually have an abstract for the ACNP that was accepted. So the ACNP, I believe this year is December 7th through 11th, and it will be presented there.
Okay excellent look forward.
Edward Markson: Okay, excellent. Look forward to seeing that. And then, final question just on 701, sort of building on that last question about the combination. Do you have any strategic plans to pursue development of 701 in combination with any additional novel IL-2 targeting modalities after BEMPEG, maybe with some of the information that you've seen from CITSE recently?
And then final question just on seven to one sort of building on that last question about the combination.
Do you have any strategic plans to pursue development of seven to one in combination with any additional novel I O. Two targeting modalities after been pig, maybe with some of the information that you've seen from Citi recently.
[noise] EM, so I shouldn't say that we have presents a de said previously preclinical data looking a number of potential combination combination partners EM.
Unknown Executive: So it's true to say that we have presented data previously, preclinical data, looking at a number of potential combination partners. It's probably also true to say we haven't pursued or don't have any immediate plans to pursue these novel combinations as company-sponsored studies, but again, the IST mechanism is really a nice way to signal-see. It tends to be low dollar for the company. It's done at well-respected institutions, and I think that's the setting where we probably will branch out, as I said. And the other point is, of course, I mean, 701 combines really beautifully with many other agents, very easy to combine.
It's probably also Tuesday, we we haven't pursued I don't have any immediate plans to pursue these novel combinations as company sponsored studies, but again the ice tea mechanism is really a nicely to signal seek EM. It tends to be low dollar for the company has done it well respected EM instead.
Fusions M. I think that's the setting where we probably will branch I'd say as I said that.
The other part of course means something to one combines just by virtue again Im the fact that as an oil is taking once daily combines really beautifully with them with many other agents. They use it took a thing.
Okay I appreciate that detail I. Thank you.
Edward Markson: Okay, I appreciate that detail. Thank you.
Operator: Thank you. It appears we have no additional questions at this time, so I'd like to pass the floor back over to management for any additional concluding comments.
Thank you. It appears we have no additional questions at this time.
I'd like to pass the floor back over to management for any additional conclude my comments.
[noise]. Thank you again for joining our call today have a great Dan please reach out to us if you have any additional cushion.
Vimal D. Mehta: Thank you again for joining our call today.
Vimal D. Mehta: Amen. Amen. Amen.
Vimal D. Mehta: Have a great day, and please reach out to us if you have any additional questions. Thank you.
Thank you.
Operator: Ladies and gentlemen, this does conclude today's teleconference. Once again, we thank you for your participation, and you may disconnect your lines at this time.
Ladies and gentlemen, this does conclude today's teleconference. Once again, we thank you for your participation and you may disconnect your lines at this time.