Q4 2021 Achieve Life Sciences Inc Earnings Call
schedule to begin shortly. Please continue to stand by. Thank you for your patience.
Today's conference is scheduled to begin shortly please continue to standby. Thank you for your patience. Today's conference is scheduled to begin shortly please continue to standby. Thank you for your patience.
Today's conference is scheduled to begin shortly. Please continue to stand by. Thank you for your patience. ??
[music].
?
.
Speaker Change: Good day and thank you for standing by. Welcome to the Achieve Life Sciences fourth quarter and year end 2021 earnings conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone.
Good day and thank you for standing by welcome to the achieved Lifesciences fourth quarter and year end 2021 earnings conference call. At this time, all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker today Nicole Joe.
Speaker Change: please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Nicole Jones. Please go ahead.
Please go ahead.
Thank you operator, and thanks, everyone for joining us.
Nicole Jones: On the call today from ACHIEVE, we have John Binsich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry Wan, Principal Accounting Officer. ACHIEVE Management will be available for Q&A after the prepared remarks.
On the call today from a cheap we have John <unk>, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry One principal accounting officer.
<unk> management will be available for Q&A after the prepared remarks.
Nicole Jones: I'd like to remind everyone that today's conference call contains forward-looking statements based on current expectations.
To remind everyone that todays conference call contains forward looking statements based on current expectations.
Nicole Jones: These statements are only predictions and actual results may vary materially from those projected.
These statements are only predictions and actual results may vary materially from those projected.
Nicole Jones: Please refer to a chief document filed with the SEC concerning factors that could affect the company, copies of which are available on our website. I'll now turn the call over to John . Thank you, Nicole.
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'll now turn the call over to John .
Thank you Nicole and thanks, everyone for joining us today.
John Binsich: During today's call, we will discuss updates on the Cytosinacline Development Program for smoking cessation and nicotine addiction, including the status of the ORCA2, ORCA3, and ORCAV1 studies.
During today's call we will discuss updates on the site has been a claim development program for smoking cessation and nicotine addiction, including the status of the Orca to Orca three at Orca D. One studies. Additionally, Gerry will provide an overview of our Q4 and year end 2021 financial results were.
John Binsich: Additionally, Jerry will provide an overview of our Q4 and year-end 2021 financial results.
John Binsich: We are off to a great start in 2022 with the kickoff of our second phase three trial, evaluating cytosineclean for smoking cessation.
We're off to a great start in 2022 with the kickoff of our second phase III trial evaluating cytosine it cleaner for smoking cessation.
John Binsich: We announced initiation of the ORCA 3 trial in January and are now enrolling adult smokers at 15 clinical trial locations across the United States.
We announced initiation of the Orca three trial in January and are now enrolling adult smokers at 15 clinical trial locations across the United States.
John Binsich: ORCA3 will serve as the confirmatory phase 3 trial required for registrational approval and marketing of cytosineclean in the U.S.
Work at three will serve as the confirmatory phase III trial required for Registrational approval and marketing of cider Scenically and in the U S.
John Binsich: Given our confidence in the safety and efficacy we have seen with cytosine to date, our ability to quickly hire and onboard additional clinical operations personnel, and importantly, our successful securement of capital from Silicon Valley Bank in December , we were able to initiate this trial sooner than expected.
Given our confidence in the safety and efficacy we have seen with cytosine a clean today, our ability to quickly hire and onboard additional clinical operations personnel and importantly, our successful procurement of capital from Silicon Valley Bank in December we were able to initiate this trial sooner than expected.
John Binsich: By expediting ORCA3, we are not only reducing the overall capital requirements of the development program, but also accelerating the overall timelines for cytosine and FDA submission for market approval.
By Expediting Orca three we are not only reducing the overall capital requirements of the development program, but also accelerating the overall timelines for cytosine, a clean and FDA submission for market approval.
John Binsich: This is of critical importance to help the millions of smokers looking for additional treatment options.
This is of critical importance to help the millions of smokers looking for additional treatment options.
John Binsich: Similar in design to the ongoing ORCA2 trial, ORCA3 participants will be randomized to one of three study arms to evaluate 3 milligrams cytosine to clean dose three times daily over a period of either 6 or 12 weeks compared to placebo.
In design to the ongoing Orca two trial Orca three participants will be randomized to one of three study arms to evaluate three milligrams cytosine a clean dose three times daily over a period of either six or 12 weeks compared to placebo.
John Binsich: All subjects will receive standard behavioral support throughout the duration of the trial and will be assigned to receive either 12 weeks of placebo, six weeks of cytosine to clean, followed by six weeks of placebo, or 12 weeks of cytosine to clean.
All subjects will receive standard behavioral support throughout the duration of the trial and will be assigned to receive either 12 weeks of placebo.
Weeks of cider cynically, followed by six weeks or placebo for 12 weeks upside its in a claim that.
John Binsich: The primary outcome measure of success in ORCA3 will be biochemically verified continuous abstinence during the last four weeks of treatment in the six and 12-week cytosine treatment arms compared with placebo.
The primary outcome measure of success in Orca three will be biochemically verified continuous abstinence during the last four weeks of treatment and the six and 12 weeks I to scenically and treatment arms compared with placebo.
John Binsich: Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytosine and clean treatment arms show a statistical benefit compared to placebo.
Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cider cynical and treatment arms show a statistical benefit compared to placebo.
John Binsich: Secondary outcome measures will be conducted to assess continued abstinence rates through six months from the start of study.
Secondary outcome measures will be conducted to assess continued abstinence rates through six months from the start of study treatment.
John Binsich: All clinical sites are now enrolling subjects, and we have just recently launched a number of recruitment activities in the cities surrounding the trial location.
All clinical sites are now enrolling subjects and we have just recently launched a number of recruitment activities and the cities surrounding the trial locations we.
John Binsich: We are seeing great interest from smokers who are seeking more information on the trial and who hope to kick the habit.
We are seeing great interest for smokers, who were seeking more information on the trial and who hope to kick the habit.
John Binsich: We look forward to sharing additional details on the trial as we progress throughout this year.
We look forward to sharing additional details on the trial as we progress throughout this year.
John Binsich: Moving on to the highly anticipated ORCA2 trial. Like you, we are eagerly awaiting the results from the first phase three cytosinecline trial in adult U.S. smokers.
Moving onto the highly anticipated Orca two trial like you. We are eagerly awaiting the results from the first phase III cider cynically trial in adult use smokers.
John Binsich: To recap, ORCA 2 enrolled 810 smokers at 17 clinical trial locations.
To recap or get to enrolled 810 smokers at 17 clinical trial locations.
John Binsich: This trial completed enrollment in the summer of last year, and in December , the last subject, last visit, was completed, in line with the six-month follow-up requirement.
This trial completed enrollment in the summer of last year and in December the last subject last visit was completed in line with the six month follow up requirement.
John Binsich: As part of ORCA II, an independent data safety monitoring committee conducted five pre-planned study conduct reviews, which also included safety.
As part of work it to an independent data safety monitoring Committee conducted five Preplanned study conduct reviews, which also included safety.
John Binsich: They concluded there were no concerns regarding the study conduct and the safety and adverse event profile remained favorable. Additionally, the DSMC members commented that compliance with study medication was excellent.
They concluded there were no concerns regarding the study conduct and the safety and adverse event profile remained favorable. Additionally, the TSMC members commented that compliance with study medication was excellent in the study had progressed well despite the challenges of the COVID-19 pandemic.
John Binsich: and the study had progressed well despite the challenges of the COVID-19 pandemic.
John Binsich: With regards to efficacy, ORCA2 has two independent primary end points that will evaluate the rate of smoking abstinence for both six-week and 12-week durations of cytosine and clean treatment compared to placebo treatment.
With regards to efficacy Orca two has two independent primary endpoints that we'll evaluate the rate of smoking abstinence for both six week and 12 week durations of cider cynically treatment compared to placebo treatment.
John Binsich: Beginning at the second week of treatment, assessments for smoking abstinence were performed by a weekly self-reporting of abstinence with biochemical verification of abstinence by exhaled carbon monoxide level.
But getting it the second week of treatment assessments for smoking abstinence were performed by a weekly self reporting of abstinence with biochemical verification of estimates by exhaled carbon monoxide levels.
John Binsich: These weekly assessments occurred through the 12 weeks of blinded study treatment.
These weekly assessments occurred through the 12 weeks of blinded study treatment.
John Binsich: Then, similar monthly follow-up assessments occurred for smoking abstinence at weeks 16, 20, and finally week 24.
Then similar monthly follow up assessments occurred for smoking abstinence at week, 16, 20, and finally week 24.
John Binsich: For both primary and point comparisons, smoking abstinence is defined as continuous abstinence during the last four weeks of treatment.
For both primary end point comparisons smoking abstinence is defined as continuous abstinence during the last four weeks of treatment mean.
John Binsich: meaning for the six-week treatment arm, biochemically verified abstinence is required at weeks three, four, five, and six. And for the 12-week arm, abstinence is required at the assessments conducted at weeks nine, 10, 11, and 12.
Meaning for the six week treatment arm Biochemically verified abstinence is required at weeks 345, and six and for the 12 week arm abstinence is required at the assessments conducted at weeks 910, 11 and 12.
John Binsich: This four-week continuous abstinence measure is the FDA-approvable endpoint for smoking cessation medication.
This four week continuous abstinence measure is the F D. A approvable endpoint for smoking cessation medications.
John Binsich: Secondary endpoint outcome measures will assess continued smoking abstinence from the end of cytosineclean treatment in both arms out to week 24 compared to placebo, as well as reduction in risk of relapse at week 24 for subjects treated with 12 weeks of cytosineclean versus 6 weeks of cytosineclean.
Secondary endpoint outcome measures will assess continued smoking abstinence from the end of side a center clean treatment in both arms out to week 24, compared to placebo as well as reduction in risk of relapse at week 24 for subjects treated with 12 weeks of cytosine, a clean versus six weeks a cytostatic claim.
John Binsich: ORCA2 was designed with over 95% power to be able to demonstrate a continued abstinence benefit compared to placebo at the long-term follow-up comparison at 24 weeks.
Orca two was designed with over 95% power to be able to demonstrate a continued absent its benefit compared to placebo at the long term follow up comparison at 24 weeks.
John Binsich: Finally, on ORCA 2, we continue to expect top-line results to be announced in the second quarter of this year, and until then, we remain blinded to the outcome.
Finally on Orca two we continue to expect top line results to be announced in the second quarter of this year and until then we remain blinded to the outcome.
John Binsich: Concluding our updates on the development program is the status of ORCA V1, which is the phase two trial evaluating cytosineclean as a cessation treatment for nicotine e-cigarette users.
Completing our updates on the development program is the status of Orca V. One which is the phase II trial evaluating cytosine to clean as a cessation treatment for nicotine E cigarette users.
John Binsich: Following the smoking cessation approval, our ultimate goal is to later expand the cytosine label indication to help nicotine vapors to quit.
Following the smoking cessation approval our ultimate goal is to later expand the cider cynically label indication to help nicotine vapors to quit.
John Binsich: With more than 11 million adult users of e-cigarettes in the United States and no currently approved treatment options available specifically for this population, there is a growing unmet need for a cessation therapy to help the significant numbers of vapors who want to quit.
With more than 11 million adult users of E cigarettes in the United States and no currently approved treatment options available specifically for this population there is a growing unmet need for a cessation therapy to help the significant numbers of vapors, who want to quit.
John Binsich: Based on survey data that we have collected in partnership with IQVIA, approximately 73% of e-cigarette users expressed an interest in quitting.
Based on survey data that we've collected in partnership with IQ via approximately 73%. The V cigarette users expressed an interest in quitting.
John Binsich: We announced last year that ACHIEVE was awarded a grant from the National Institutes of Health, or NIH, to support the execution of the ORCA V1 trial.
We announced last year that achieved was awarded a grant from the National institutes of health or NIH to support the execution of the Orca one trial.
John Binsich: In addition to the preparation of trial-related operational activities, the first phase of the grant funding enabled submission to the FDA of a new IND specific to e-cigarette cessation, which was accepted by the agency in November .
In addition to the preparation of trial related operational activities. The first phase of the grant funding enabled submission to the FDA of a new I N D specific to E cigarette cessation, which was accepted by the agency in November .
John Binsich: We have recently submitted documentation to the NIH outlining our completion of activities associated with the first phase of the grant.
We have recently submitted documentation to the NIH outlining our completion of activities associated with the first phase of the grant.
John Binsich: Pending their review, we expect the second stage of the grant award of approximately $2.5 million to be released and to enable the initiation of the ORCA V1 trial in the second quarter of this year.
Pending their review we expect the second stage of the Grant award of approximately $2 $5 million to be released and to enable the initiation of the Orca one trial in the second quarter of this year.
John Binsich: As a reminder, ORCA V1 is designed to enroll approximately 150 subjects and will be led by Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director of the Tobacco Research and Treatment Center at Massachusetts General Hospital.
As a reminder, or could be one is designed to enroll approximately 150 subjects and will be led by a doctor and Nancy regarding <unk> Professor of Medicine at Harvard Medical School and director of the Tobacco Research and treatment Center at Massachusetts General Hospital.
John Binsich: I'd now like to turn the call over to Jerry to discuss our financial results and our strong cash position that we ended with in 2021.
I'd now like to turn the call over to Gerry to discuss our financial results that our strong cash position that we ended with in 2021.
Jerry Wan: I would like to provide an update on our cash position as of December 31st, 2021 as well as review our operating expenses for the fourth quarter of 2021.
Thanks, John I would like to provide an update on our cash position as of December 31, 2021, as well as review our operating expenses for the fourth quarter of 2021.
Jerry Wan: As of December 31st, the company's cash, cash equivalents, short-term investment and restricted cash were $43.1 million.
As of December 31st the company's cash cash equivalents short term investments and restricted cash were $43 1 million compared to $33 4 million as of September 30th 2021 .
Jerry Wan: compared to 33.4 million as of September 30th, 2021.
Jerry Wan: The increase in cash over the prior quarter was due to our Silicon Valley Bank financing we closed in December .
The increase in cash with the prior quarter was due to our Silicon Valley Bank financing we closed in December .
Jerry Wan: The Silicon Valley Bank Agreement provided a total debt facility of $25 million, of which we drew down $15 million at the closing.
Second Valley Bank agreement provided a total debt facility of $25 million.
We drew down $15 million at the closing.
Jerry Wan: As John mentioned earlier, the funding from Silicon Valley Bank has allowed us to accelerate the ORCA III trial, which we initiated in January of this year.
As John mentioned earlier, the funding from Silicon Valley Bank has allowed us to accelerate the Orca three trial, which we initiated in January of this year.
Jerry Wan: We believe our current cash balance is sufficient to provide runway into 2023.
We believe our current cash balance is sufficient to provide runway into 2023.
Now turning to our statement of operations.
Jerry Wan: The company incurred a net loss of $7.2 million for the quarter ended December 31, 2021.
Company incurred a net loss of $7 2 million for the quarter ended December 31 2021.
Jerry Wan: as compared to a net loss of $4.7 million for the same quarter of 2020.
As compared to a net loss of $4 7 million for the same quarter of 2020.
Jerry Wan: Total operating expenses in the fourth quarter of 2021 increased to 7.1 million as compared to 4.7 million for the same quarter of 2020.
Total operating expenses in the fourth quarter of 2021 increased to $7 1 million as compared to $4 7 million for the same quarter of 2020.
Jerry Wan: Operating expenses increased for the quarter ended December 31, 2021 due to higher costs associated with the ORCA II trial, along with pre-initiation costs associated with the ORCA III trial.
Operating expenses increased for the quarter ended December 31, 2021 due to higher costs associated with the Orca two trial, along with pre initiation cost associated with the Orca three trial.
Jerry Wan: We anticipate our operating expenses to increase during 2022 as we further execute on both the ORCA III and ORCA V1 trials.
We anticipate our operating expenses to increase during 2022 as we further execute on both the orca three and or could be one trials.
Jerry Wan: As a reminder, approximately half the costs from the ORCA V1 trial are expected to be funded through a grant from the NIH.
As a reminder.
We have the cost from the Orca one trial are expected to be funded through a grant from the NIH.
Jerry Wan: That concludes the summary of our financial results. I'll turn the call back over to John .
That concludes the summary of our financial results I'll turn the call back over to John .
John Binsich: In conclusion, and as you've heard, we continue to deliver on the ORCA program milestones on time or ahead of schedule. We are excited to have our first phase 3 data readout next quarter, along with the expected launch of ORCA V1 in vaping cessation.
Thank you Jerry.
Conclusion that as you've heard we continue to deliver on the Orca program milestones on time or ahead of schedule. We are excited to have our first phase III data readout next quarter, along with the expected launch of Orca V. One in vaping cessation.
John Binsich: We believe Cytosinecline will continue to demonstrate best-in-class safety and offer efficacy in line with current treatments, enabling smokers to successfully quit and live healthier and better lives.
We believe cider cynically and we will continue to demonstrate best in class safety and offer efficacy in line with current treatments, enabling smokers to successfully quit and live healthier and better lives. We appreciate your continued support of achieve and will now open the line for questions.
Speaker Change: We appreciate your continued support of Achieve, and we'll now open the line for questions.
Speaker Change: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster.
As a reminder to ask a question you will need to press star one on your telephone.
Draw your question press the pound key please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Thomas Flan from Lake Street Capital. Your line is now open.
Our first question comes from the line of Thomas Flaten from Lake Street Capital. Your line is now open.
Thomas Flan: Hey, good afternoon guys. Two quick questions. With respect to ORCA3, do you have designs on expanding the number of sites to keep the trial moving forward, given that you have the capital on hand, or is that something that will be driven by the ORCA2 results?
Hey, good afternoon, guys. Two quick questions with respect to Orca three do you have designs on expanding the number of sites to keep the trial moving forward given that you have capital on hand or was that something that'll be driven by the orca two results.
You want me to get that John .
Thomas Flan: Actually, right now with the 15 sites, we're looking at that we would have no problem with our targeted enrollment timelines. If it looks like we need to have more sites, we will. To remind you, we added two more sites because we were actually enrolling ORCA2 during the pandemic and that's where we needed more additional sites.
Actually right now it's at 15 side, we're looking at that we would have no problem with our targeted enrollment timeline, if it looks like we need to have more sites we will.
To remind you we added two more sites and because we were actually enrolling arca too during the pandemic and that's where we need needed more additional sites.
Speaker Change: Got it. And then with respect to V1, is that, is the start of that study intended to coincide with the release of the ORCA2, or are those two things D-linked completely?
Got it and then with respect to V. One is.
Is that is the the started that study intended to coincide with the release of the Orca two or are those two things dealing completely.
Speaker Change: They're de-linked completely. The starting of ORCA2 is really based on getting our second phase of our grant funding, and we've just put in all the documents to NIH that we've completed the phase one, so now we're just waiting for the release of the phase one, of the phase two funding to start the vaping trial.
There are D link completely the starting embark or two is really based on getting our second phase of our grant funding and we've just put in all the documents to NIH that we've completed the phase one. So now we're just waiting for the release of the phase one of the phase two funding.
The vaping trial.
Excellent appreciate it thank you.
Speaker Change: Thank you. Our next question comes from the line of Francois Brisebois from Oppenheimer. Your line is now open.
Thank you. Our next question comes from the line of Francois Green Boy from Oppenheimer. Your line is now open.
Francois Brisebois: Thanks for taking the questions. Just to be clear, between ORCA 2 and ORCA 3, I think they're very similar in terms of design. Are there any differences at all? I think I saw maybe a little less patience. Anything else that's different?
Alright, thanks for taking the questions just a couple here so just to be clear between orca two in Orca three I think there are very very similar in terms of design or are there any differences at all I think I saw maybe a little less patients anything else that's different.
Francois Brisebois: The only difference is the inclusion-exclusion criteria have been loosened just a little bit. Otherwise, it really is exactly the same design. There may be one less clinical visit that was required at day three, but otherwise, yes, it is exactly the same.
The only difference is the inclusion exclusion try criteria have been loosen just do a little bit otherwise. It really is exactly the same design there may be one less clinical visit that was required and day, three but otherwise yes. It.
Francois Brisebois: In terms of the end point, hitting either six weeks or 12 weeks, you mentioned that either or would be considered successful, but do you have any thoughts on the commercial potential depending on whether it hits six weeks or 12 weeks or both or one or the other just based on the competitive landscape?
Is exactly the same.
Okay, Great and then is there any the endpoint hitting either six weeks to 12 weeks, you mentioned that either or would be considered successful, but do you have any thoughts on the commercial potential depending on whether it had six weeks or 12 weeks or both or one or the other just based on the competitive landscape.
Speaker Change: Yeah, thanks. Thanks, Frank. You know, in terms of, you know, whether six or 12 is preferred. I mean, I think, ideally, we'd love to have both, you know, and I think that's our expectation is it will hit on on both six and 12 weeks, I think, from a competitive landscape. I'm not sure it matters all that much. I think what we continue to see is a heavily pretreated group of smokers that have tried and relapsed multiple times to quit.
Jim.
Yeah. Thanks, Thanks, Frank.
In terms of whether six or 12 as preferred I mean, I think ideally we'd love to have both you know and I think that's our expectation is it will hit on both six and 12 weeks I think from a competitive landscape.
I'm not sure it matters all that much I think what we continue to see is a heavily pretreated group of smokers that have tried in relapsed multiple times to quit and I think our the safety profile in particular in better Tolerability that comes with cytosine, a clean is going to resonate regardless of a short.
Speaker Change: And I think the safety profile in particular and better tolerability that comes with cytosineclean is going to resonate regardless of a shorter or slightly longer duration.
Or you know slightly longer duration of treatment.
Speaker Change: Okay, great. And then I'll sneak in a last one here, if I can. In terms of the efficacy, you know, we talked about being comparable and just maybe beating on safety, but can you just help us? I know it's a cross-comparison. It's difficult to do, and other than Rioira, there hasn't really been a head-to-head with Chantix, but can you remind maybe the listeners of the efficacy in a similar kind of design that Chantix saw versus placebo?
Okay, Great and then I'll sneak in a last one here if I can be in terms of the efficacy you know we talked about being comparable in just maybe beating on safety, but can you just help us I know, it's a cross comparison is difficult to do in other than <unk> there.
There hasn't really been a head to head with Chantix, but.
Can you remind the listeners of the efficacy and a similar kind of design that they are chancy salt versus placebo.
Speaker Change: Yeah, yeah, great, great question. And one that I'm sure is on everyone's minds going into data. And I think the best way to think about this is in terms of
Yeah, Yeah, great Great question, and one that I'm sure is on everyone's minds going into data and I think the best way to think about this is in terms of you know benefit over placebo that I think the the way that's typically viewed as looking at the odds ratio.
Speaker Change: you know, benefit over placebo, and I think the way that's typically viewed is looking at an odds ratio, which basically looks at the magnitude of effect of the drug over placebo. And when we look at the currently available treatment options that are on the market today, we have NRT, bupropion, and varenicline.
Which basically looks at the magnitude of effect of the drug over placebo and when we look at the currently available treatment options that are on the market today.
NRT Bupropion and Varenicline.
Speaker Change: And for NRT and bupropion, those are just below 2 to 1 in terms of their benefit. And varenicline, or what's been known historically as Chantix, before it was withdrawn from the market, has been just under 3.
And for NRT and Bupropion those are just below two to one in terms of their benefit.
N varenicline or what's been down historically is chantix before it was withdrawn from the market.
Then just under three.
Speaker Change: And so, you know, what we continue to hear from, you know, key opinion leaders in the space is that kind of the baseline benefit needs to be a 2x over placebo. And I think, you know, we've seen.
And so what we continue to hear from key opinion leaders in the spaces.
Kind of the baseline benefit needs to be a two X over placebo.
Speaker Change: You know, multiple trials, you know, quit rates, you know, do range, depending on trial design and subject demographics, things like that. But I think that, you know, looking at at the odds ratio is a way to kind of mute the differences between the trials and there's been lots of publications out there from the Cochran group and others.
And I think we've seen across multiple trials quit rates do range, depending on trial design and subject demographics things like that but I think that a lot.
Looking at at the odds ratio as a way to kind of mute the differences between the trials and theres been lots of publications out there from the Cochrane group and others.
Speaker Change: that help articulate this, but that's really what we're looking for is at least a 2x multiple over placebo in this trial.
That help articulate this but that's really what we're looking for is at least the 222 X multiple over placebo in this trial.
Alright, Thank you very much.
Speaker Change: Thank you. Our next question comes from the line of John Vandermosten from Zax. Your line is now.
Thank you. Our next question comes from the line of John Bender, Most Chen from Zacks. Your line is now open.
Speaker Change: Thank you. Actually, this is Richard Hanke calling for John . Hello, John and everyone. How are you? I just got two.
Thank you actually this is Richard Hanky, calling for John how Allo, John and everyone. How are you I just got two.
Richard Hanke: kind of topics that I want to discuss and then our John will follow up with you after the call. The first is just picking up some more on Chantex. Pfizer I guess reported, disclosed that the revenues were down 56% in 2021.
Topics that I want to discuss them and then our John will follow up with you after the call and the first is just picking picking up some more on chantix.
Is there I guess reported.
<unk> disclosed that the revenues were down 56% in 2021 and and we understand.
Richard Hanke: And we understand that it came off patent. We understand there's some contamination issues. But if there's anything more that you're aware of and what caused that kind of decline, that may be translated, obviously, to your drug and how might that affect things down the road in commercialization. And then do you have any, in terms of generics, any idea how they performed? So that was my first set of questions.
Stand that it came off patent and we understand that some contamination issues, but if there's anything more that you're aware of and you know what caused that kind of decline there may be translated obviously to your to your drug and how might that affect things.
Down the road and commercialization and then do you have any in terms of the generics any idea how they performed so that was my first set of questions.
Speaker Change: Yeah, thanks Richard. So in terms of Chantix revenues, you know, I think it's been compounded with two factors there. The first obviously was the first generic
Yeah. Thanks, Richard So in terms of Chantix revenues.
It's been compounded with two factors there are the first obviously was the first generics hitting last year that was launched and I think probably more importantly is the fact that Pfizer poll chantix from the market last year that started early summer with some limited withdrawals and then went to full.
Speaker Change: hitting last year that was launched, and I think probably more importantly is the fact that Pfizer pulled Chantix from the market last year. That started early summer with some limited withdrawals and then went to full global withdrawal of Chantix. So, the brand is currently no longer on the market. So, I think the combination of not being able to sell product and generics hitting is why we've seen that decline in revenues.
<unk> global withdrawal of Chantix or the brand is currently no longer on the market. So I think the combination of not being able to sell products and generic sitting is why we've seen that decline in revenues.
Speaker Change: You know, I don't think there's any real read in terms of the market opportunity here. We don't have details in terms of the, you know, how the first generic is performed. It was a stub period anyway. We do know that it's out there. From what we've seen, it's about a...
No I don't think there's any real read in terms of the market opportunity here, we don't have details in terms of the.
How the first generic has performed it was a stub period anyway.
We do know that it's out there from what we've seen it's about a 25% reduction off the list price of Chantix, but something we will continue to monitor for US. We've always known we were going to be launching this product into a generic market.
Speaker Change: 25% reduction off the list price of Chantix, but something we will continue to monitor. For us, we've always known we were going to be launching this product into a generic market.
Speaker Change: And I think, you know, I think the beauty of this indication is that the Affordable Care Act mandates that smoking cessation products
I think you know.
I think the beauty of this indication is that the affordable care Act mandates that smoking cessation products be covered and I think when you combine that with the fact that even with kind of the most efficacious products out there today. The majority of patients are still relapsing and going back to smoking and will need another treatment option.
Speaker Change: be covered. And I think when you combine that with the fact that even with kind of the most efficacious products out there today, the majority of patients are still relapsing and going back to smoking and will need another treatment option down the road. So, you know, we still continue to feel strongly about the market opportunity.
Option down the road. So we still continue to feel strongly about the market opportunity here.
Speaker Change: Excellent, thank you. And then the second question, the $2.5 million that you expect to receive in Q2 for the grant, is that on track? My understanding, or through John , is that you expected to launch the trial in Q2. Has that trial been backed up at all, or is everything on schedule?
Excellent. Thank you and then the second question.
The $2 5 million that you expect to receive in Q2.
No.
For the grant is that on is that on track I. My understanding from John is that are you expected to.
The launch the trial in Q2.
It has that trial been backed up at all or is everything on schedule.
Speaker Change: Yeah, good question. So we continue to believe that's on track. We are currently working through the grant logistics with the NIH. We've submitted the documentation showing that we've completed the initial stages that were of the milestones.
Yeah. Good question. So we continue to believe that's on track. We are currently working through the grant logistics with the NIH, we submitted the documentation showing that we've completed the initial stages of the milestones.
Speaker Change: that were set out under the grant and so we're just awaiting a response from the NIH that we can proceed into the the next phase which unlocks the two and a half million for funding for the trial itself. So yeah, at the moment everything remains on track but we are beholden to the grant process with the NIH to ultimately move that.
That were set out under the grant.
And so we're just awaiting a response from the NIH that we can proceed into the next phase, which unlocks the two and a half million for funding for the trial itself. So yeah at the moment everything remains on track, but we are beholden to the grant process with the NIH to ultimately move that forward.
Speaker Change: Got it, all right, thank you. That's enough for now, knowing John , he's got a list of other questions. He'll get ahold of you after the call. Thank you.
Got it alright, thank you with that that's enough for now knowing John He's got a list of other questions he'll he'll get a hold of the after the call. Thank you.
Very good thanks Richard.
Speaker Change: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
Speaker Change: Our next question comes in the line of James Malloy from Alliance Global. Your line is now open.
Our next question comes from the line of James Molloy from Alliance Global Your line is now open.
James Malloy: Hey, John , thanks for taking my question. I had a quick question on potential partners, U.S. partnerships. I know that much will depend on how the data looks in the second quarter, but is there any color that you could provide for outsiders looking in on how those discussions are going and sort of the nature of the process? Hi, Jim. Yeah, thanks.
Hey, John Thanks for taking my question I had a quick question on <unk>.
Partners U S partnerships I know that much will depend on how the data looks in the second quarter, but is there any color you can provide for outsiders looking in on how those discussions are going and sort of the nature of the of the process.
Hi, Jim Yeah. Thanks, Thanks for the good question.
Speaker Change: So, you know, this is an ongoing process in terms of our outreach looking for potential commercial partners.
So this is an ongoing process in terms of our outreach looking for potential commercial partners.
Speaker Change: And we have, you know, continued to expand, you know, the outreach going into Orca2Data. I think the closer we get to data and ultimately to commercialization.
And we have continued to expand the outreach going into or going to data I think the closer we get to the data and ultimately to commercialization.
Speaker Change: You know, we think there will continue to be more interested parties, and we have seen an uptick in terms of interest here this year, and we would expect that to continue with data in hand.
Think there will continue to be more interested parties and we have seen an uptick in terms of interest here. This year and we would expect that to continue with data in hand.
Speaker Change: as we get results from the ORCA2 trial. But I think
As we get results from the Orca two trial, but I think you know, we're not going to get into individual conversations or details, but yes, we have a process up and running and we will continue to push that forward.
Speaker Change: You know, we're not going to get into individual conversations or details, but yes, we have a process up and running and we will continue to push that forward and orchid to results will be.
<unk> results will be a big part of that.
Speaker Change: And maybe one question we touched on, I think, last time we spoke, given what looks to be a significant AE advantage versus Chantix, can you speak a little bit about potential for expanding the market beyond sort of the billions, a pretty good number to be sure, but beyond that, given how many people dropped out with the AEs on Chantix?
Maybe one question we touched on I think last time, we spoke.
Given what.
It looks to be a significant.
Advantage.
Versus chantix.
Can you speak a little bit about potential potential for expanding the market beyond sort of a 1 billion is a pretty good number to be sure.
But beyond that just given how many people dropped out would you he's on chantix.
Speaker Change: Yeah, so I think that the safety and tolerability profile is clearly a key differentiator. And we continue to hear from not only physicians, but also patients that the profile for existing products, in particular for Chantix, really is a big hindrance to uptake. So we do see a product that is more tolerable and easy to utilize without the adverse events.
Yeah, So I think that the safety and Tolerability profile is clearly a key differentiator and we continue to hear from you know not only physicians, but also patients that are the profile for existing products in particular for <unk>.
<unk> really is a big hindrance to uptake. So we do see a product that is more tolerable and easy easy to utilize without the adverse events are to.
Speaker Change: to be something that patients are interested in. And when you couple that with the fact that there hasn't been a new product in over 15 years, I think there is a real opportunity to grow the market here. And I think that's just within smoking cessation. I think that's.
To be something that patients are interested in and when you couple that with the fact that there hasn't been a new product in over 15 years I think there is a real opportunity to grow the market here and.
And I think that's just within smoking cessation I think that's why we're excited about expanding into E cigarette cessation as well with the work of the one because I think that really is an opportunity that that has not been tapped into yet there was some recent data points that came across today, indicating there.
Speaker Change: why we're excited about expanding into e-cigarette cessation as well with ORCA V1, because I think that really is an opportunity that has not been tapped into yet. There was some recent data points that came across today, you know, indicating there's over 80 million e-cigarette users around the globe today, and that's one that continues to grow. And we know those.
There's over 80 million.
E cigarette users around the globe today.
One that continues to grow.
Speaker Change: e-cigarette users and vapors are looking to quit, and there's currently no products indicated to help them. I think that's where the market will go long-term. It's been a rapid uptake, but it hasn't dented the cigarette consumption market, which remains high at over a billion smokers around the globe. I think when you combine those two markets together, we see a large market ahead of us with the product that should resonate with patients.
And we know those.
E cigarette users and vapors are looking to quit and there's currently no products indicated to help them and I think that's where the market will go long term it's been.
A rapid uptake, but it hasnt dented, the cigarette consumption market, which remains high at over 1 billion smokers around the globe. So I think when you combine those two markets together we see.
A large market ahead of us with the product that should resonate with patients.
Thank you for taking the questions.
Speaker Change: Thank you. At this time, I am showing no further questions. I would like to turn the call back over to John Bensich for closing remarks.
Thank you at this time I am showing no further questions I would like to turn the call back over to John Benson for closing remarks.
John Bensich: Thank you, and thanks everyone again for joining us today and the continued support of ACHIEVE. We continue to be excited about what lies ahead for us, including the ORCA 2 results, which are right around the corner, the expected launch of ORCA V1 in the second quarter, and the continued execution of the recently launched confirmatory ORCA 3 trial. So we look forward to continue to provide everyone updates throughout the year as things progress, and thanks again for joining us.
Thank you and thanks, everyone again for joining us today and the continued support of achieve we continue to be excited about what lies ahead for us, including the Orca two results, which are right around the corner. The expected launch of work would be one in the second quarter and the continued execution of the recently launched.
Confirmatory Orca three trial. So we look forward to continue to provide everyone updates throughout the year as things progress and thanks again for joining us today.
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: ??? ??? ???
Okay.
[music].
Yes.
[music].
Speaker Change: You
Yeah.