Q2 2021 Achieve Life Sciences Inc Earnings Call
Your touch tone telephone.
As a reminder, this call is being recorded I would now like to turn the call over to Jenny Xenos Executive Vice President of commercial at a cheap. Please go ahead.
Thank you Tiffany and thanks, everyone for joining us today on the call we have John <unk>, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Gerry One principal accounting officer, and Rick Stewart Executive Chairman of the board of Directors I would like to remind everyone that todays conference call contains forward looking statements based on current.
Expectations. These statements are only predictions and actual results may vary materially from those projected please refer to achieve documents filed with the SEC concerning factors that could affect the company copies of which are available on our website I'd now like to turn the call over to John.
Thank you Jamie.
On today's call, we will discuss the exciting progress we have made on the side of a cynic claim development program, including key milestones that we have reached so far in 2021 and provide an update on our second quarter financial results.
Let's begin with our phase III Orca two trial that is evaluating the efficacy and safety of three milligrams cider cynically dosed three times daily over a period of six and 12 weeks versus placebo.
<unk> two is being conducted at 17 clinical sites in the United States and as announced in June we have reached a key milestone of enrollment completion.
As you May recall the original enrollment target was 750 smokers. However, we allowed additional subjects that were in screening at the time of our cutoff date to participate in the study, resulting in a total of 810 subjects randomized.
All subjects have now been assigned to one of three arms to receive either 12 weeks of placebo 12 weeks of cytosine a claim or a combination of six weeks of <unk>, followed by six weeks of placebo.
Following the 12 week treatment period subjects are being followed monthly out to 24 weeks.
The study has two independent primary endpoints that we'll evaluate the rate of smoking abstinence of cider cynically compared to placebo at the end of both six weeks and 12 weeks of treatment.
<unk> will be successful if either or both of the cider Scenically and arms show an efficacy benefit over placebo.
Achieve will remain blinded until the completion of all study follow up evaluations and the database has been finalized and locked we.
We expect last patient last visit in the Orca two study to occur at the end of 2021 and top line data results to be announced in the first half of 2022.
We also recently announced an update regarding our plans to expand the evaluation of cytosine, a clean into nicotine E cigarette or vaping cessation.
In July we were notified that we received a federal Grant award from the NIH to begin preparations for the phase two or could be one study.
As part of this process to secure non dilutive funding to offset costs related to this important trial, we applied for the maximum allowable funding of $2.8 million under the NIH small business technology transfer grant.
The NIH grant is awarded in two phases and requires that achieve meet specific milestones in order to receive the second tranche.
The first approved grant amount of 320000 commenced on August one and is being used to complete critical regulatory and clinical operational activities such as protocol Finalization clinical trial site identification and the submission of a new IND to FDA for this specific population.
Upon completion of these milestones as assessed by NIH achieve expects to receive the next stage of the Grant award of approximately $2.5 million that will enable execution of the phase two or could be one clinical study in approximately 150 adult nicotine E cigarette users in the United States.
The NIH funding is expected to cover approximately 50% of the total orca one trial costs.
We are delighted to have doctor Nancy ever Gaudy Professor of Medicine at Harvard Medical School, and director of the Tobacco Research and treatment Center at Massachusetts General Hospital, along with achieved President and Chief Medical Officer, Dr. Cindy Jacobs, leading the efforts on the Orca one trial as co primary investigators.
Doctor regard. He is also the primary investigator in our Orca two phase III study.
Recent data indicate there are more than 11 million adult users of nicotine E cigarettes in the United States alone.
While E cigarettes have historically been viewed as less harmful than combustible cigarettes, there long term safety remains controversial.
Since these products also sustain addiction. Many vapors are now seeking to quit nicotine completely.
And research conducted by achieved roughly 73% of E. Cigarette users expressed a desire to quit within 12 months.
Of those with a more urgent interest in quitting more than half indicated they would be interested in a new prescription cessation therapy.
Currently there are no treatment, specifically indicated to help E cigarette users quit.
We see this as an unmet commercial opportunity.
If our development efforts proved to be successful cider cynically may offer a new cessation option for this growing population of E cigarette users who seek to quit nicotine for good.
Moving onto another important milestone that we just announced yesterday the issuance of two new patents by the U S patent and trademark office.
These patents include claims covering the expected three milligram commercial dose of <unk> administered three times daily.
The claims that have been granted under these patents stem from the results we obtained in our Orca one clinical study that evaluated various doses and administrations of cytosine acclaim.
Not including any patent term extensions to which we may be entitled These patents will expire in the third quarter of 2040.
With this new issuance, we now have seven granted patents.
<unk> patent families and 34 pending patent applications.
We expect to continue to expand our patent portfolio in the future as we seek additional ways to protect our cytosine a clean franchise.
<unk> protecting the IP for cider Scenically and in the U S and beyond is key to our commercial success and we continue to make excellent progress on this front.
That concludes the overview of our recent highlights now I'd like to turn the call over to Gerry to discuss our financial results.
Thanks, John I would like to provide an update on our cash balance as of June 32021, and then review our second quarter financials.
In May we closed an underwritten public offering.
Proceeds of 23 million, which included the full exercise of the underwriters over allotment option.
We received net proceeds of approximately $21.3 million after deducting commissions and offering expenses.
As of June 30, the company's cash cash equivalents short term investments and restricted cash were $42.1 million compared to $35.9 million as of December 31, 2020.
We believe our current cash balance is sufficient to provide runway into 2023.
Turning to our statement of operations.
The company incurred a net loss of $11.3 million for the quarter ended June 32021, as compared to a net loss of $2.9 million for the same period in 2020.
Net loss for the six months ended June 32021 increased to $19.3 million compared to $6.2 million in the six months ended June 32020.
Operating expenses continued to be elevated in the second quarter as we move towards full enrollment in our orca two phase III trial.
We anticipate our operating expenses to remain elevated during 2021.
As we continue to execute on the Orca two trial.
That concludes the summary of our financial results I will now turn the call back over to John.
Thank you Jerry.
It has been an incredible start to 2021 for achieve and we expect to continue to deliver on our milestones and objectives throughout the remaining months of this year.
We will continue to honor our commitment to improve the health and wellbeing of people, who are addicted to nicotine and desperately need new treatment options to help them quit.
Approximately 14% of adults in the U S continue to spoke meaning more than 34 million users of combustible cigarettes and potential quitters.
With more than 480000 deaths directly related to smoking annually. It remains the leading cause of preventable death and disease, we believe status clinically and can make a significant impact in this therapeutic area that has seen no new advances in over a decade.
In closing.
Our orca two phase III trial of <unk> in the U S has completed enrollment and our team will remain focused on execution and monitoring to ensure data results are provided as soon as possible in the first half of 2022.
We've received the first portion of our significant grant that will enable us to expand our development into E cigarettes decision, where we have the potential to be a first in class solution for this growing market segment.
Our focus here will be ensuring the milestones are completed to reach the second phase of the Grant award and initiation of the Orca would be one study.
And finally, we continue to strengthen the IP position for <unk>, which we expect will positively impact our commercial success in partnering discussions as they continue to evolve.
We appreciate you joining us today and your continued support of achieve we will now open up the line for questions operator.
Ladies and gentlemen at this time, if you would like to ask a question. Please press Star then the number one on your telephone keypad again that is star one.
Your first question comes from the line of Frank Cooperates Spa.
From Oppenheimer.
Hey, Thanks for taking my questions just a quick one here on the generic approval yesterday.
For Chantix I was just wondering any comments there on timeline or is this in line with expectations for generic approval and any thoughts about potential pressure from generics here on pricing.
Yeah. Thanks, Frank Good question. So on the generic front, we have been tracking. This we were aware that one of the key patents for Chantix did expire in November of last year. So we have been monitoring for generic entrants.
So seeing power pharma would be the first to get approved was not unexpected. We're also aware of three other generic filers that are out there.
Including a <unk> that the FDA has recently allowed to.
To be available in the U S. So.
So we expect over the next 12 months to 18 months to see the others.
Perhaps also reach approval depending on how they shake out with respect to their analysis of nitrosamines, which has been an impact for Pfizer and chantix.
Okay, great and if I can sneak in another one here, there's recently been a jama article publication.
Discussing side of cynically Interstate ASEAN here against Chantix and it Didnt quite hit.
Non inferiority they were looking for but it seems like the dosing was different any color any comments you'd like to make on that article.
Sure Yeah, we did see that as well. So this is a study that we think was flawed in terms of its overall design. It was investigating 25 days of cider cynically and treatment versus 12 weeks of Chantix.
And we are aware that a quit rates are never higher than when you're on treatment and so when we're looking at a six month endpoint patients onsite is clinically and would've been off drug for five months versus only three months on chantix.
So.
We think the design was not appropriate.
With that being said it did nearly missed.
With that artifact, but we did see in that trial was.
Similar to what we saw in the <unk> study was a significantly lower rates of adverse events. So that continues to be a theme that we see across the trials and we also did see higher quit rates.
At the end of one months for scientists and clean versus Chantix. So I think overall it continues to reinforce our data we've seen historically.
And we will stay focused on what we have now which is a differentiated dosing administration at three milligrams and three times a day.
Okay, Great. That's very helpful. And then just lastly on the grants here you helped us with a little color on the amount and you know what that covers for the trial I was just wondering any color on timing of this trial potentially starting.
And I guess getting the second part of the granted starting the trial and how long it could be any color there at all.
Yes.
Our focus here initially is to get those key milestones like the IND and the protocol finalized over the back half of this year.
So we can set ourselves up in a position to perhaps lodged that vaping trial as soon as the first half of next year. So we'll have more color on that as we go forward, but that's.
That's our goal at the moment.
That's great. Thanks, a lot that's it for me.
Thanks, Greg.
Your next question comes from the line of Patrick you with Zacks SCR.
Hey, John and team this is Ted.
I'm sitting in for John <unk> and today.
Just a quick question.
According to the FDA.
The FDA its website I mean these are required.
Two.
Kind of facilitate the distribution of a drug being investigated to <unk>.
Clinical sites now.
You guys did get A&D clearance in 2017 for citizen Mcglynn.
Isn't required for.
Or coffee one because.
The indication has changed.
Yeah, Thanks to Ed I'm going to pass this one over to Cindy yes.
Yes. It is actually so that is why it would be a <unk>.
<unk> four is the indication of.
E cigarette vaping sensation, obviously all of the manufacturing information would be cross referenced to our original <unk> that we submitted in 2017.
Okay wonderful thank you.
And shifting gears to.
Two citizens dosing.
It became apparent well I was reviewing your patent patents that.
A variety of dosing schemes.
Probably be.
It would probably work.
With you guys settling eventually on three milligrams three times daily.
Is there any opportunity here to explore a slow release formulation or was that.
<unk> looked into.
Yeah. Thanks, Ted So based on the work we've done, especially through Orca. One we did find that three milligrams three times a day.
<unk> showed the most potential and that is what we're driving forward in our phase III program.
Think long term is a lifecycle management play there are opportunities for slow release or other other versions, but for now as we move forward towards initial approval. We will stay focused on the three milligrams three times a day.
Okay. Thank you so much that's it for me.
Your next question comes from the line of Tyler Hampden with Alliance Global partners.
Hi, there. Thank you, yes. This is tyler standing and on behalf of Jim Malloy. Thanks for taking my question could.
Could you just characterize a little bit the partnership landscape would you be looking to self commercialize a partner to launch in the U S and maybe the rest of the world. Thank you.
Yeah.
Yeah. Thanks for the question Tyler So I think as we look at the commercial opportunity here.
We believe that we will need a commercial partner.
Ultimately maximize the revenue opportunity here and so what we will be looking for us.
Partner that already has an existing primary care footprint in place.
A group that has strong capabilities.
First and foremost in the U S. But then also ideally on a global basis, one that we can plug and play this product into.
So some of those discussions have already started we will continue to move forward and expand that that pool as we move into or get to data because we do see orca two data has a key data point and moving those discussions along the data coming out of that trial will be both the safety.
Efficacy that will be in the label so we see that as an important.
Component, but we do see a quite a large universe of potential partners in this indication.
Okay. Thank you.
I also do you have another question as well are you guys potentially looking at bringing any additional compounds or is that not something you are considering at this time.
Yes, I think we're always looking around for other interesting compounds that could be out there that may be complementary to what we're doing today, we don't have anything imminent that we're looking to bring in we will stay focused in terms of utilizing our capital to drive forward on the nicotine.
Addiction side.
But we do continue to look around to see if there are interesting assets that would.
It would have a similar dynamic to what we've done historically, which is drugs that already have human clinical data behind them and have a high probability of success like we have here with side a center claim.
Perfect. Thank you that's all for me.
Thanks Tyler.
At this time I'm currently showing no further questions in queue I will now turn the call over back to Mr. John <unk> for closing remarks.
Yeah, Thanks, Stephanie and thanks for everyone. Joining today, we've made a lot of progress here over the first half of the year.
Look forward to bringing forth further updates as we move forward to thanks again for joining us today.
Ladies and gentlemen, thank you for participating. This concludes today's conference call you may now disconnect.
[music].
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Good afternoon, ladies and gentlemen, and welcome to the achieve lifestyle in the second quarter 2021 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 call is being recorded I would now like to turn the call over to Jamie's Venose Executive Vice President of commercial at a cheap. Please go ahead.
Thank you Stephanie and thanks, everyone for joining us today on the call we have John <unk>, Chief Executive Officer, Dr. Cindy Jacobs, our President and Chief Medical Officer, Gerry One principal accounting officer, and Rick Stewart Executive Chairman of the board of Directors I would like to remind everyone that todays conference call contains forward looking statements based on current.
Expectations. These statements are only predictions and actual results may vary materially from those projected please refer to achieve documents filed with the SEC concerning factors that could affect the company copies of which are available on our website I'd now like to turn the call over to John.
Thank you Jamie.
On today's call, we will discuss the exciting progress we have made on the side of Santa claim development program, including key milestones that we have reached so far in 2021 and provide an update on our second quarter financial results.
Let's begin with our phase III Orca two trial that is evaluating the efficacy and safety of three milligrams cider cynically dosed three times daily over a period of six and 12 weeks versus placebo.
<unk> two is being conducted at 17 clinical sites in the United States that was announced in June we have reached a key milestone of enrollment completion.
As you May recall the original enrollment target was 750 smokers. However, we allowed additional subjects that were in screening at the time of our cutoff date to participate in the study, resulting in a total of 810 subjects randomized.
All subjects have now been assigned to one of three arms to receive either 12 weeks of placebo 12 weeks of cider sent a claim or a combination of six weeks of cider cynically, followed by six weeks of placebo.
Following the 12 week treatment period subjects are being followed monthly out to 24 weeks.
The study has two independent primary endpoints that we'll evaluate the rate of smoking abstinence decider scenically compared to placebo at the end of about six weeks and 12 weeks of treatment.
<unk> will be successful if either or both of the cytostatic clean arms show an efficacy benefit over placebo.
Achieve will remain blinded until the completion of all study follow up evaluations and the database has been finalized and locked we.
We expect last patient last visit in the Orca two study to occur at the end of 2021 and topline data results to be announced in the first half of 2022.
We also recently announced an update regarding our plans to expand the evaluation of cider cynically into nicotine E cigarette or vaping cessation.
In July we were notified that we received a federal Grant award from the NIH to begin preparations for the phase two or could be one study.
As part of this process to secure non dilutive funding to offset costs related to this important trial, we applied for the maximum allowable funding up to 8 million under the NIH small business technology transfer grant.
The NIH grant awarded in two phases and it requires that achieve meet specific milestones in order to receive the second tranche.
The first approved grant amount of 320000 commenced on August one and is being used to complete critical regulatory and clinical operational activities such as protocol Finalization clinical trial site identification and the submission of a new IND to FDA for this specific population.
Upon completion of these milestones as assessed by NIH achieve expects to receive the next stage of the Grant award of approximately $2.5 billion that will enable execution of the phase two or could be one clinical study and approximately 150 adult nicotine E cigarette users in the United States.
The NIH funding is expected to cover approximately 50% of the total orca one trial costs.
We are delighted to have Dr. Nancy <unk> Professor of Medicine at Harvard Medical School, and director of the Tobacco Research and treatment Center at Massachusetts General Hospital, along with achieved President and Chief Medical Officer, Dr. Cindy Jacobs, leading the efforts on the Orca one trial as co primary investigators.
Doctor regard is also the primary investigator in our Orca two phase III study.
Recent data indicate there are more than 11 million adult users of nicotine E cigarettes in the United States alone.
While E cigarettes have historically been viewed as less harmful than combustible cigarettes, there long term safety remains controversial.
Since these products also sustain addiction. Many vapors are now seeking to quit nicotine completely.
And research conducted by achieve roughly 73% of E. Cigarette users expressed a desire to quit within 12 months.
Those with a more urgent interest in quitting more than half indicated they would be interested in a new prescription cessation therapy.
Currently there are no treatment, specifically indicated to help E cigarette users quit.
So we see this as an unmet commercial opportunity.
If our development efforts proved to be successful cider cynically may offer a new substation option for this growing population of E cigarette users who seek to quit nicotine for good.
Moving onto another important milestone that we just announced yesterday the issuance of two new patents by the U S patent and trademark office.
These patents include claims covering the expected three milligram commercial dose of <unk> administered three times daily.
The claims that have been granted under these patents stemmed from the results we obtained in our Orca one clinical study that evaluated various doses and administration decide to send their claim.
Not including any patent term extensions to which we may be entitled These patents will expire in the third quarter of 2040.
With this new issuance, we now have seven granted patents five patent families and 34 pending patent applications.
We expect to continue to expand our patent portfolio in the future as we seek additional ways to protect our site to Scenically and franchise.
<unk> protecting the IP for <unk> in the U S and beyond is key to our commercial success and we continue to make excellent progress on this front.
That concludes the overview of our recent highlights now I'd like to turn the call over to Gerry to discuss our financial results.
Thanks, John I would like to provide an update on our cash balance as of June 32021, and then review our second quarter financials.
In May we closed an underwritten public offering with gross proceeds of $23 million, which included the full exercise of the underwriters over allotment option.
We received net proceeds of approximately $21.3 million after deducting commissions and offering expenses.
As of June 30, the company's cash cash equivalents short term investments and restricted cash were $42.1 million compared to $35.9 million as of December 31, 2020.
We believe our current cash balance is sufficient to provide runway into 2023.
Turning to our statement of operations.
The company incurred a net loss of $11.3 million for the quarter ended June 32021, as compared to a net loss of $2.9 million for the same period in 2020.
Net loss for the six months ended June 32021 increased to $19.3 million compared to $6.2 million in the six months ended June 32020.
Operating expenses continued to be elevated in the second quarter as we move towards full enrollment in our orca two phase III trials.
We anticipate our operating expenses to remain elevated during 2021 as we continued to execute on the Orca two trial.
That concludes the summary of our financial results I will now turn the call back over to John.
Thank you Jerry.
It has been an incredible start to 2021 for achieve and we expect to continue to deliver on our milestones and objectives throughout the remaining months of this year.
We will continue to honor our commitment to improve the health and wellbeing.
Who are addicted to nicotine and desperately need new treatment options to help them quit.
Proximately, 14% of adults in the U S continue to spoke meaning more than 34 million users of combustible cigarettes and potential quitters with more than 480000 desk directly related to smoking annually. It remains the leading cause of preventable death and disease, we believe status clinically and can make a significant impact in this.
Therapeutic area that has seen no new advances in over a decade.
In closing our Orca two phase III trial of <unk> in the U S has completed enrollment and our team will remain focused on execution and monitoring to ensure data results are provided as soon as possible in the first half of 2022.
We've received the first portion of a significant grant that will enable us to expand our development into E cigarettes decision, where we have the potential to be a first in class solution for this growing market segment.
Our focus here will be ensuring the milestones are completed to reach the second phase of the Grant award and initiation of the Orca One study.
Finally, we continue to strengthen the IP position for <unk>, which we expect will positively impact our commercial success in partnering discussions as they continue to evolve.
We appreciate you joining us today and your continued support of achieve we will now open up the line for questions operator.
Ladies and gentlemen at this time, if you like to ask a question. Please press Star then the number one on your telephone keypad again that is star one.
Your first question comes from the line of Brent cooperates Spa.
Oppenheimer.
Hey, Thanks for taking my questions just.
A quick one here on generic approval yesterday for.
For Chantix I was just wondering any comments there on timeline is this in line with expectations for generic approval and any thoughts about potential pressure from generics here on pricing.
Yeah. Thanks, Frank Good question. So on the generic front, we have been tracking. This we were aware that one of the key patents for Chantix did expire in November of last year. So we have been monitoring for generic entrants so seeing power pharma that'd be the first to get approved.
Unexpected. We're also aware of three other generic filers that are out there, including app attacks that the FDA has recently allowed.
To be available in the U S. So.
So we expect over the next 12 months to 18 months to see the others.
Perhaps also reach approval depending on how they shake out with respect to their analysis of nitrile domains, which has been an impact for Pfizer and chantix.
Okay, great and if I can.
And another one here, there's recently been a Jama article publication discussed.
Discussing cited clinically and if that is in here.
Against Chantix and it Didnt quite hit.
The non inferiority they were looking for but it seems like the dosing was different any color any comments you'd like to make on that article.
Sure, Yes, we did see that as well. So this is a study that we think was flawed in terms of its overall design. It was investigating 25 days of cider scenically and treatment versus 12 weeks of Chantix.
And we are aware that quit rates are never higher than when you're on treatment and so when looking at a six month endpoint patients onsite is clinically and would've been off drug for five months versus only three months on chantix. So.
We think the design was not appropriate but with that being said.
Nearly missed.
With that artifact, what we did see in that trial was.
Similar to what we saw in the <unk> study was significantly lower rates of adverse events. So that continues to be a theme that we see across the trials and we also did see higher quit rates at the end of one months for scientists and claim versus Chantix. So I think overall it continues to reinforce the data we've seen.
Historically.
And we will stay focused on what we have now which is a differentiated dose and administration at three milligrams and three times a day.
Okay, Great. That's very helpful. And then just lastly on the grants here you helped us a little color on the amount and what that covers for the trial I was just wondering any color on timing of this trial potentially starting.
And I guess getting the second part of the grant and starting the trial and how long it could be any color there at all.
Yes.
Our focus here initially is to get those key milestones like the IND and the protocol finalized over the back half of this year.
So we can set ourselves up in a position to perhaps launch that vaping trial as soon as the first half of next year. So we'll have more color on that as we go forward, but that's.
That's our goal at the moment.
That's great. Thanks, a lot thats it for me.
Thanks, Greg.
Your next question comes from the line of Patrick you with Zacks SCR.
Hey, John and team this is Ted sit.
Sitting in for John Banner, most and today.
Just a quick question.
According to the FDA.
<unk> website I mean these are required.
Two.
Kind of facilitate the distribution of a drug being investigated to <unk>.
Cynical sites now you guys did get A&D clearance in 2017 for citizen Mcglynn.
Isn't required for.
Or coffee, one because the indication has changed.
Yeah, Thanks to Ed I'm going to pass this one over to Cindy yes.
Yes. It is actually so that is why it would be a <unk>.
<unk> four is the indication of.
E cigarette vaping sensation, obviously all of the manufacturing information would be cross referenced to our original <unk> that we submitted in 2017.
Okay wonderful thank you.
And shifting gears to.
To citizens and dosing.
Became apparent well I was reviewing your.
Your patent patents that.
A variety of dosing schemes.
<unk>.
<unk>.
It would probably work.
With you guys settling eventually on three milligrams three times daily.
<unk>.
Is there any opportunity here to explore a slow release formulation or was that.
[noise] looked into.
Yeah. Thanks, Ted So based on the work we've done, especially through Orca. One we did find that three milligrams three times a day.
Showed the most potential and that is what we're driving forward in our phase III program. I think long term is a lifecycle management play there are opportunities for slow release or other other versions, but for now as we move forward towards initial approval. We will stay focused on the three milligrams three times a day.
Okay. Thank you so much that's it for me.
Your next question comes from the line of Tyler Hampden with Alliance Global partners.
Hi, there. Thank you yeah. This is tyler standing and on behalf of Jim Malloy. Thanks for taking my question.
Could you just characterize a little bit the partnership landscape would you be looking to self commercialize a partner to launch in the U S and maybe the rest of the world. Thank you.
Yeah. Thanks for the question Tyler So I think as we look at the commercial opportunity here.
We believe that we will need a commercial partner.
Ultimately maximize the revenue opportunity here and so what we will be looking for us.
Partner that already has an existing primary care footprint in place.
A group that has strong capabilities.
First and foremost in the U S. But then also ideally on a global basis, one that we can plug and play this product into.
So some of those discussions have already started we will continue to move forward and expand that that pool as we move into or get to data because we do see orca two data as a key data point and moving those discussions along the data coming out of that trial will be both the safety.
Efficacy that will be in the label so we see that as an important.
Component, but we do see a quite a large universe of potential partners in this indication.
Okay. Thank you.
I also do have another question as well are you guys potentially looking at bringing any additional compounds or is that not something you are considering at this time.
Yes, I think we're always looking around for other interesting compounds that could be out there that may be complementary to what we're doing today, we don't have anything imminent that we're looking to bring in we will stay focused.
In terms of utilizing our capital to drive forward on the nicotine addiction side.
But we do continue to look around to see if there are interesting assets.
It would have a similar dynamic to what we've done historically, which is drugs that already have human clinical data behind them and have a high probability of success like we have here with cytokine acclaim.
Perfect. Thank you that's all for me.
Thanks Tyler.
At this time I'm currently showing no further questions in queue I will now turn the call over back to Mr. John <unk> for closing remarks.
Yes, Thanks, Stephanie and thanks for everyone. Joining today, we've made a lot of progress here over the first half of the year.
Look forward to bringing forth further updates as we move forward to thanks again for joining us today.
Ladies and gentlemen, thank you for participating. This concludes today's conference call you may now disconnect.