Q1 2024 Achieve Life Sciences Inc Earnings Call
Operator: Greetings. Welcome to the Achieve Life Sciences first quarter 2024 earnings conference call and webcast. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would like to hand the call over to Nicole Jones, Investor Relations. Thank you. You may begin.
Greetings and welcome to the achieve life Sciences first quarter 2024 earnings conference call and webcast.
Operator: At this time all participants are in a listen only mode.
Nicole P. Jones: A question and answer session will follow the formal presentation.
Operator: As a reminder, this conference is being recorded.
Operator: I would like to hand, the call over to Nicole Jones Investor Relations.
Nicole P. Jones: You you may begin.
Nicole P. Jones: Thank you operator.
Nicole P. Jones: Good afternoon, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by John Bencich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry Wan, Principal Accounting Officer.
Nicole P. Jones: Good afternoon, everyone and thank you for joining us today.
Nicole P. Jones: I'm a cheap life Sciences, we are joined by John <unk>, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry One principal accounting officer.
Nicole P. Jones: Management will be available for Q&A session. Following today's prepared remarks before we begin I'd like to remind everyone that todays conference call contains forward looking statements based on current expectations.
Nicole P. Jones: Management will be available for a Q&A session following today's prepared remarks. Before we begin, I'd like to remind everyone that today's 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's documents available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to John
Nicole P. Jones: Payments are only predictions and actual results may vary materially from those projected please refer that she's documents are available on our website and filed with the STC concerning factors that could affect the company.
Nicole P. Jones: I'll now turn the call over to John.
John A. Bencich: Thank you, Nicole, and thanks, everyone, for joining us today. Today, we will review our first quarter 2024 financial performance and discuss key highlights, including reaching agreement with the FDA on the long-term cytosine and clean exposure data necessary for our NDA filing. Critically for the timing of the NDA submission, we agreed on the number of subjects required with six months' exposure to enable the NDA filing. Cindy will provide an update on the ORCA OL study and discuss the status of initiation in just a moment.
John: Thank you Nicole and thanks, everyone for joining us today.
John A. Bencich: Today, We will review, our first quarter 2024 financial performance and discuss key highlights, including reaching agreement with the FDA on the long term side its been a clean exposure data necessary for NDA filing.
John A. Bencich: Critically for the timing of the NDA submission, we agreed on the number of subjects required with six months exposure to enable the NDA filing.
John A. Bencich: Andy will provide an update on the Orca O L study and discuss the status of initiation in just a moment.
John A. Bencich: Concurrently with the F. D. A decision we successfully secured financing of up to $124 million, enabling achieved to execute the orca O L trial and provide cash runway through the NDA submission NDA approval and beyond.
John A. Bencich: Concurrently with the FDA decision, we successfully secured financing of up to $124 million, enabling Achieve to execute the ORCA-OL trial and provide cash runway through the NDA submission, NDA approval, and beyond. The financing included participation from new fundamental healthcare investors, including our manufacturing partner, Sopharma.
John A. Bencich: The financing included participation from new fundamental health care investors, including our manufacturing partner so far with the.
John A. Bencich: The investor demand for the financing demonstrates the importance of cytosineclean in battling nicotine dependence and a growing confidence in cytosineclean's market opportunity. The visibility of cytosinecline as a drug for nicotine dependence has been raised markedly during the quarter, and as many of you will have read, the results from the Phase 2 ORCA V1 trial of cytosinecline for vaping cessation were published in JAMA The ORCA V1 study included 160 adults who used e-cigarettes daily and desired to quit. There was incredible interest in this trial, and it enrolled quickly in approximately four months.
John A. Bencich: Investor demand for the financing demonstrates the importance of cider scenically and battling nicotine dependence into growing confidence insider scenically and market opportunity.
John A. Bencich: The visibility of cider cynically as a drug for nicotine dependence that's been raised markedly during the quarter and as many of you will have read the results from the phase III Orca, one trial of cider Scenically and for Vaping cessation were published in Jama internal medicine earlier this week.
John A. Bencich: The Orca one study included 160, adults, who use E cigarettes daily and desire to quit.
John A. Bencich: Was incredible interest in this trial and enrolled quickly in approximately four months.
John A. Bencich: The results show that cytosinecline more than doubled the odds of quitting e-cigarettes compared to placebo, with 31.8% of cytosinecline-treated participants achieving continuous vaping abstinence, compared to just 15.1% of those receiving placebo. As seen in our other trials, cytosineclean was incredibly well-tolerated, and compliance with study treatment was exceptional. The prevalence rates of vaping continue to increase, and it is estimated that 11 million adults and 2 million middle and high school-age students use e-cigarettes in the US alone.
John A. Bencich: The results showed that cider cynically and more than doubled the odds are quitting E cigarettes compared to placebo with 31, 8% of cider scenically and treated participants achieving continuous vaping abstinence compared to just 15.1% of those receiving placebo.
John A. Bencich: As seen in our other trials decided to Scenically and was incredibly well tolerated and compliance with study treatment was exceptional.
John A. Bencich: The prevalence rates that they've been continued to increase and it is estimated that 11 million adults and 2 million middle and high school age students use E cigarettes in the U S alone.
John A. Bencich: More than half of adult Hubei have reported interest in quitting and many who tried to quit struggled to do so successfully.
John A. Bencich: More than half of adults who vape have reported interest in quitting, and many who have tried to quit struggle to do so successfully. If approved, cytosineclean would be the first FDA-approved treatment specifically evaluated and approved for e-cigarette cessation. We plan to further our discussions with the FDA on a label expansion for vaping cessation and expect to conduct an end of Phase II meeting later this year to discuss clinical requirements. Additionally, in the first quarter, we presented detailed trial results from our ORCA program at the Society for Research on Nicotine and Tobacco Annual Meeting.
John A. Bencich: If approved cytostatic clean would be the first FDA approved treatment, specifically evaluated and approved for E cigarettes decision.
John A. Bencich: We plan to further our discussions with the FDA at a label expansion for vaping cessation and expect to conduct an end of phase two meeting later this year to discuss clinical requirements.
John A. Bencich: Additionally, in the first quarter, we presented detailed trial results from our Orca program at the Society for research on nicotine and tobacco annual meeting to.
John A. Bencich: The ORCA-2 and ORCA-3 Phase III trials have consistently demonstrated cytosinuclein's efficacy in achieving smoking cessation with favorable safety and tolerability profiles. For the first time, we presented survey results from participants in our Phase 3 trials. Of the participants who responded, over 80% had been treated with cytosine. Of these cytosinically treated subjects, 69% of them had successfully quit smoking, and of those who did not quit completely, approximately one quarter cut their smoking in half.
John A. Bencich: The orca two and Orca three phase III trials have consistently demonstrated cytostatic cleans efficacy in achieving smoking cessation with favorable safety and Tolerability profiles.
John A. Bencich: For the first time, we presented survey results from participants in our phase III trials.
John A. Bencich: Of the participants who responded over 80% had been treated with Cytosorb clean of these scientists cynically treated subjects, 69% of them had successfully quit smoking and of those who did not quit completely approximately one quarter cut their smoking in half.
John A. Bencich: These respondents attributed their success in quitting to cytosineclean, noting that, amongst other things, it helped reduce craving. Nearly all participants of the survey were willing to recommend cytosine to others, and notably, 86% of participants, including those who did not quit completely, showed interest in using cytosine again if needed. Thank you, John.
John A. Bencich: These respondents attributed their success and quitting decide to send a clean noting that amongst other things it helped reduce cravings near.
John A. Bencich: Nearly all participants of the survey, we're willing to recommend cytostatic clean to others, and notably 86% of participants, including those who did not quit completely showed interest in using cytostatic clean again if needed.
Speaker Change: This is a great segue into cindy's update on the Orca O L trial Cindy.
Cindy Jacobs: Our focus for the first quarter has been on preparations for the NDA submission, most importantly on the initiation of the ORCA OL study. I am pleased to update you that plans remain on track with our guidance, and we expect to begin enrollment within the next few weeks.
John A. Bencich: John our focus for the first quarter has been on preparations for the NDA submission. Most importantly on the initiation of the Orca O. L study I'm pleased to update that plans remain on track with our guidance and we expect to begin enrollment within the next few weeks.
Cindy Jacobs: As a reminder, the archive Oh Wow is a single arm open label study that will collect safety data on the long term use inside a cynic Clinton.
Cindy Jacobs: As a reminder, ORCA OL is a single-arm, open-label study that will collect safety data on the long-term use of cytosineclin. Our agreement with FDA is to provide safety data on a minimum of 300 subjects treated with cytosineclin for a cumulative period of 6 months as part of the NDA submission. Subsequently, and prior to product approval, we will provide data on at least 100 subjects treated for a total period of one year.
Cindy Jacobs: Our agreement with FDA is to provide safety data on a minimum of 300 subjects treated with Cytosorb nicklin for cumulative period of six months as part of the NDA submission.
Cindy Jacobs: Subsequently and prior to product approval, we will provide data on at least 100 subjects treated for a total period of one year.
Cindy Jacobs: Because FDA has allowed cumulative exposure, enrolling from the pool of subjects previously treated with cytosineclin for either 6 or 12 weeks in our smoking or vaping cessation trials will allow us to expedite the time required to generate this long-term exposure data. We are first focusing on recruitment from those subjects who have already received three months of prior cytosineclin treatment, as they would only need another three months of treatment in the open-label study to fulfill the six-month exposure requirement for the NDA submission.
Cindy Jacobs: Because the FDA has allowed community of exposure and rolling from the pool of subjects previously treated with side of silicon for either six or 12 weeks in our smoking vaping sensation cessation trial will allow us to expedite the time required to generate this long term exposure.
Cindy Jacobs: Your data.
Cindy Jacobs: We are first focusing on recruitment from those subjects, who have already received three months of prior side a cynic on treatment.
Cindy Jacobs: They would only need another three months of treatment on the open label study to fulfill their six month exposure requirement for the NDA submission.
Cindy Jacobs: As an update our Oh well is planned to be conducted at 29 clinical sites all of which participated in our previous studies all contracts and planning have been completed with our clinical operations partners and vendors. We have also completed the packaging of the drug.
Cindy Jacobs: As an update, ORCA OL is planned to be conducted at 29 clinical sites, all of which have participated in our previous studies. All contracts and planning have been completed with our clinical operations partners and vendors. We have also completed the packaging of the drug product and are preparing for shipments to the sites. Meanwhile, of the 1,700 participants from our earlier trials, the sites have been conducting outreach to more than 1,100 subjects who were previously treated with cytosineclin and are scheduling initiation visits for those who are interested.
Cindy Jacobs: The product and are preparing for shipments to the site.
Cindy Jacobs: Meanwhile, at the 1700 participants from our earlier trials the sides have been conducting outreach to them more than the 1100 subjects, who were previously treated with society Senate, Glenn and our scheduling initiation visits for those who are interested.
Cindy Jacobs: We have received feedback that there is high enthusiasm for participation from those who are eligible. Interestingly, the primary reason for not being eligible for the open-label trial is that about 25% of the previously cytosine when treated subjects continue to be smoke or vape free. Even after completing their treatment in the prior trial over one to two years ago. Even though only 7 to 9% of subjects have been lost to contact or are not interested, the remaining two-thirds who have been contacted want to be considered for the trial.
Cindy Jacobs: We have received feedback that there is high enthusiasm for participation from those who are eligible.
Cindy Jacobs: Interestingly the primary reason for not being eligible for the open label trial is that about 25% of the previously cited a cynic when treated subjects continue to be smoke or vape free.
Cindy Jacobs: Even after completing their treatment on the prior trial over one to two years ago.
Cindy Jacobs: Given only 7% to 9% of subjects had been lost to contact or not interested.
Cindy Jacobs: Meaning to Sears, who had been contacted wants to be considered for the trial.
Cindy Jacobs: Thus, we believe the planned enrollment should be achieved swiftly in 2024. So, in summary, we are moving forward as expected and continue to anticipate an NDA submission in the first half of 2025 and look forward to providing an update in the coming weeks once enrollment has been initiated. Now, I'll turn it over to Jerry for a review of the financials for the quarter.
Cindy Jacobs: Thus, we believe the planned enrollment should be achieved swiftly in 2024.
Jerry: So in summary, we are moving forward as expected and continue to anticipate an NDA submission in the first half of 'twenty to 'twenty five and look forward to providing an update in the coming weeks once enrollment has been initiated.
Cindy Jacobs: Now I'll turn it over to Jerry for a review of the financials for the quarter.
Jerry: Thank you Sandy good afternoon, everyone.
Jerry Wan: Thank you, Cindy. Good afternoon, everyone.
Jerry Wan: I'd like to provide an update on our financial activities this quarter, focusing on the financing and strategic implications for our operations and then review our current financial status and forward outlook.
Jerry Wan: Echoing John's earlier points.
Jerry Wan: I'd like to provide an update on our financial activities this quarter, focusing on the financing and strategic implications for our operation, and then review our current financial status and forward outlook, echoing John's earlier points. This quarter, we successfully secured a significant financial boost with a registered direct offering of common stock and a concurrent private placement of warrants, collectively worth up to $124.2 million. The initial amount raised was $60 million, with the potential to receive up to an additional $64.2 million upon the execution of milestone-driven work.
Jerry Wan: This quarter, we successfully secured a significant financial boost with a registered direct offering of common stock and a concurrent private placement of warrants collectively worth up to $124 2 million.
Jerry Wan: The initial amount raised was $60 million with the potential to receive up to an additional $64 2 million upon the exercise of milestone driven warrants.
Jerry Wan: This recent cash infusion ensures that we have the necessary resources to continue our clinical development plans effectively.
Jerry Wan: This recent cash infusion ensures that we have the necessary resources to continue our clinical development plans effectively, including the Pivotal Orca OL trial and our anticipated NDA submission. As of March 31st, 2024, our cash, cash equivalents, and restricted cash was $66.4 million. Looking forward, we anticipate that the initial net proceeds from this financing will sustain our operations well into the second half of 2025. If the milestone-driven warrants are fully exercised, we anticipate they will extend our financial runway into 2026 and through potential approval of cytosineclin in the U.S.
Jerry Wan: Including the pivotal Orca O L trial, and our anticipated NDA submission.
Jerry Wan: As of March 31st 2024, our cash cash equivalents and restricted cash were $66 4 million.
Jerry Wan: Looking forward, we anticipate that the initial net proceeds from this financing will sustain our operations well into the second half of 2025.
Jerry Wan: If the milestone driven once fully exercised we anticipate it will extend our financial runway into 2026 and through potential approval I'll stay to silicon in the U S.
Jerry Wan: In regards to our statement of operations.
Jerry Wan: Total operating expenses in the first quarter of 2024 decreased to $6 million, as compared to $8.6 million for the same quarter of 2023. The company incurred a net loss of $6.5 million for the quarter ended March 31, 2024, as compared to a net loss of $9 million for the same quarter of 2023. We expect our operating expenses and net loss to increase over the coming quarters as we initiate the ORCA OL study.
Jerry Wan: Total operating expenses in the first quarter of 2024 decreased to $6 million as compared to $8 6 million for the same quarter of 2023.
Jerry Wan: The company incurred a net loss of $6 5 million for the quarter ended March 31, 2024, as compared to a net loss of 9 million for the same quarter of 2023.
Jerry Wan: We expect our operating expenses and net loss to increase over the coming quarters as we initiate the Orca O L study.
Jerry Wan: In summary, this quarter has strengthened our position both financially and strategically with a strong cash position and a clear path forward, we are well prepared to meet our upcoming milestones and continue our journey towards bringing <unk> to market.
Jerry Wan: In summary, this quarter has strengthened our position both financially and strategically. With a strong cash position and a clear path forward, we are well prepared to meet our upcoming milestones and continue our journey towards bringing Cytosineclin to market. That concludes my update. I'll now turn the call back over to John for closing remarks.
Jerry Wan: That concludes my update I'll now turn the call back over to John for closing remarks.
John: Thank you Jerry.
John: We've had a dynamic start to 2020 for advancing FDA discussions on NDA submission requirements and securing capital to provide resources for the execution of those required activities in particular for the Orca O L trial.
John A. Bencich: We've had a dynamic start to 2024, advancing FDA discussions on NDA submission requirements and securing capital to provide resources for the execution of those required activities, in particular for the ORCA-OL trial. The recent positive reception of our clinical data published in JAMA and presented at SR&T not only reinforces the scientific validity of our findings but also highlights the medical community's recognition of cytosinecline as a potentially promising treatment for smoking and vaping cessation.
John A. Bencich: The recent positive reception of our clinical data published in Jama and presented a S. R. A T.
John A. Bencich: Not only reinforces the scientific validity of our findings, but also highlights the medical communities recognition.
John A. Bencich: <unk> as a potentially promising treatment for smoking in vaping cessation.
John A. Bencich: Smoking remains the leading cause of preventable death, killing more than 8 million people globally each year, with nearly half a million of those deaths in the U.S. Smoking and exposure to secondhand smoke contribute to various cancers, as well as other pulmonary and cardiovascular diseases, creating devastating consequences for patients and their families. Cytosinecline's future role in disease reduction is perhaps highlighted by chronic obstructive pulmonary disease or COPD, a lung disease primarily caused by cigarette smoke.
John A. Bencich: Smoking remains the leading cause of preventable deaths, killing more than 8 million people globally, each year with nearly half a million of those deaths in the U S.
John A. Bencich: Looking at exposure to secondhand smoke contribute to various cancers as well as other pulmonary and cardiovascular diseases, creating devastating consequences to patients and their families.
John A. Bencich: Sorry to Scenically and his future role in disease reduction is perhaps highlighted by chronic obstructive pulmonary disease or C. O P. D lung disease, primarily caused by cigarette smoking.
John A. Bencich: According to the CDC, 38% of the nearly 16 million U.S. adults diagnosed with COPD report current smoking. COPD is the sixth leading cause of death in the US, with estimated annual patient-related costs of $31 billion, which is expected to nearly double by 2029. Providing people with better options to quit smoking has the potential to reduce overall rates of COPD and offset the associated rising costs in the future. Additionally, smoking is a major cause of cardiovascular disease, such as heart attacks and strokes. According to the American Heart Association, cardiovascular disease accounts for about 800,000 U.S. deaths every year, making it the leading cause of all deaths in the United States. Of those, nearly 20% are due to cigarette smoking.
John A. Bencich: According to the CDC, 38% of the nearly 16 million U S. Adults diagnosed with C. O P. D report current smoking.
John A. Bencich: COPD is the sixth leading cause of death in the U S. With estimated annual patient related costs of 31 billion, which is expected to nearly double by 2029.
John A. Bencich: Providing people with better options to quit smoking has the potential to reduce overall rates of C. O P D and offset the associated rising costs in the future.
John A. Bencich: Additionally, smoking is a major cause of cardiovascular diseases, such as heart attacks and stroke.
John A. Bencich: According to the American Heart Association cardiovascular disease accounts for about 800000 U S deaths every year, making it the leading cause of all deaths in the United States of those nearly 20% are due to cigarette smoking.
John A. Bencich: These statistics and the importance of disease reduction validate the urgent need for effective cessation treatment, particularly as there have been no new approved smoking cessation agents in nearly 20 years and currently no FDA-approved treatment for e-cigarette cessation to mitigate the broad public health impacts of smoking and vaping. It is clear the complexity of nicotine dependence increases healthcare costs and necessitates specialized intervention. We believe cytosineclean can play a critical role in this preventable health crisis and help achieve better long-term outcomes for patients. For the balance of 2024, our priorities are clearly defined.
John A. Bencich: These statistics and the importance of disease reduction validate the urgent need for effective cessation treatments, particularly as there has been no new approved smoking cessation agents in nearly 20 years and currently no FDA approved treatment for E cigarettes decision to mitigate the broad public health impacts of.
John A. Bencich: Smoking vaping.
John A. Bencich: It is clear the complexity of nicotine dependence increases health care costs.
John A. Bencich: That necessitates specialized interventions, we believe cider cynically and can play a critical role in this preventable health crisis and help achieve better long term outcomes for patients.
John A. Bencich: For the balance of 2024, our priorities are clearly defined we will continue our focus on initiation and completion of enrollment of the Orca O L study.
John A. Bencich: We will continue our focus on initiation and completion of enrollment in the ORCA OL study, continue preparations for the NDA submission for smoking cessation, and obtain further FDA guidance for expansion into the e-cigarette cessation indication. In closing, I want to express my gratitude to our shareholders for your continued support and the dedication of our trial participants and their healthcare providers. We remain committed to providing a new therapeutic option that can significantly impact the lives of those affected by nicotine dependence. Thank you again for joining us today. We are eager to continue our progress, and we'll now open up the line for questions.
John A. Bencich: Continued preparations for the NDA submission for smoking cessation and.
John A. Bencich: And obtain further F D a guidance for expansion into E cigarette cessation indication.
John A. Bencich: In closing I want to express my gratitude to our shareholders for your continued support and the dedication of our trial participants and their health care providers.
John A. Bencich: We remain committed to providing a new therapeutic option that can significantly impact the lives of those affected by nicotine dependence. Thank.
John A. Bencich: Thank you again for joining US today, we are eager to continue our progress and we'll now open up the line for questions.
Speaker Change: Thank you the floor is now open for questions. If he would like to ask a question. Please press star one on your telephone keypad at this time a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to move your question from the queue for participants using speaker equipment. It may be necessary to pick up the handset before pressing the <unk>.
Operator: Thank you. The floor is now open to questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.
Operator: Once again, that's star one to register a question at this time. Today's first question is coming from Thomas Flaten of Lake Street. Please go ahead. Hey, good afternoon. I appreciate it. One more one, please.
Operator: Turkey's.
Thomas Flaten: Once again Thats Star one to register a question at this time.
Operator: Today's first question is coming from Thomas Flaten with Lake Street. Please go ahead.
Thomas Flaten: Hey, good afternoon I appreciate it.
Operator: Hey, good afternoon. I appreciate one moment, please. Thomas, please go ahead.
Operator: Okay.
Operator: Okay.
Speaker Change: One moment please.
Operator: Yeah.
Thomas Flaten: Thomas Please go ahead.
Thomas Flaten: Sorry about that Cindy I just wanted to confirm with you dimension you made about the 29 sites and the status of contracting I was little confused are all those sites under contract and ready to enroll or was the contracted comment related to the other vendors that you're using now those sites are finishing up their contracts are going to be ready to go to.
Thomas Flaten: Sorry about that. Cindy, I just wanted to confirm with you the dimension you made about the 29 sites and the status of contracting. I was a little confused. Are all those sites under contract and ready to enroll? Or was the contracting comment related to the other vendors that you're using?
Cindy Jacobs: Nope, those sites are finishing up their contracts. They're going to be ready to go to roll out all of them within the next couple of weeks.
Cindy Jacobs: All all of them within the next couple of weeks.
Speaker Change: Great and then the 1100 subjects just so I understood. That's two thirds of the 1700 you'd previously identified at about 25% of those 1700 worst smoker vape free and the rest were lost to follow up are not interested that did I catch that math correctly, yeah, but what we're doing is we're still getting contacting all of the 1100.
Cindy Jacobs: Great. And then the 1,100 subjects, just so I understood, that's two-thirds of the 1,700 you'd previously identified, and about 25% of those 1,700 were smoke or vape-free, and the rest were lost to follow-up or not interested. Did I catch that math correctly? Yeah, but what we're doing is we're still getting, and contacting all of the 1,100. So those that we've contacted, which is getting close to almost most of them, yes. So we're just, as each week goes by, contacting more subjects, and so those are the numbers as we get in contact with those subjects. It is pleasing, actually, for us.
Cindy Jacobs: Those have we've we've contacted which is getting close to almost most of them. Yes. So we're just as each week. We go we're contacting more subjects and so those are the numbers as we get contact with those subjects about 20, 25% or not eligible because there.
Cindy Jacobs: Moca Vape free which is very.
Cindy Jacobs: Pleasing actually for us.
Cindy Jacobs: And then there was only about seven nine maybe 10% again the numbers keep rolling in during the week that are either their lost to contact or they're not interested so.
Cindy Jacobs: And then there were only about 7, 9, maybe 10 percent, again, the numbers keep rolling in during the week that either they're lost to contact or they're not interested. So yeah, we consistently get about two-thirds of the individuals we're calling are interested in participating and are making contact, obviously, with the sites for screening. And then just from a statistical perspective, if you're starting with a group of 1100, do you feel comfortable that from that group, 650 of them will actually enter the study?
Cindy Jacobs: Yeah, we are consistently about two thirds of.
Cindy Jacobs: Individuals we're calling are interested in participating in are making contact obviously with the site for screening.
Cindy Jacobs: And then just from a statistic statistical perspective, if youre starting with the group of 1100 do you feel comfortable that from that 650 of them will be able to actually enter the study.
Cindy Jacobs: Yes, but we're also going to open a few spots to placebo subjects in those studies to increase our overall numbers of exposed subjects for the Integrated Safety Summary. Got it. I appreciate it. Thanks.
Speaker Change: Yeah, but we're also going to open a few spots to placebo subjects on those studies to increase our overall numbers that are exposed subject for the integrated safety summary.
Speaker Change: Got it I appreciate it thanks for taking the questions.
Thomas Flaten: Got it. I appreciate it. Thanks for taking the time to answer the question.
Thomas Flaten: Thank you. The next question is coming from Michael Higgins of Ladenburg Thalmann. Please go ahead.
Operator: Thank you. The next question is coming from Michael Higgins of Lautenberg-Fellman. Please go ahead.
Michael John Higgins: Thanks, Operator, hi, guys. Thanks for taking the questions. Congrats again on the solidified balance sheet agreements with USDA progress on enrolling work out well.
Michael John Higgins: Hey guys, thanks for taking the questions. Congratulations again on the solidified balance sheet, agreements with the FDA, and progress on enrolling ORCA-OL. Regarding that latter, just to follow up from the prior question, I just want to understand which two-thirds or so of the 1,100 that you reached out to, it sounds like from the comments that all of them are willing and interested to come back into the study. But have you gotten more granular as to what percent of those that you think will actually reenter the study and get back on the cytosinic link? Thanks.
Michael John Higgins: Regarding that ladder, just a follow up from the prior question just wanted to understand.
Michael John Higgins: The two thirds or so of the 11 Hunter that you reach out to.
Michael John Higgins: It sounds like from the comments that all of them are are willing and interested to come back into the study but.
Michael John Higgins: Have you got any more granularity as to what percent of those are that you think will actually reenter. The study you can get back on site isn't it great. Thanks.
Cindy Jacobs: Yeah, we won't really know that until the screening process starts and they go through the inclusion and exclusion criteria, but just on that note, they've already gone through the inclusion and exclusion criteria in prior trials and we've loosened it up for the open label study. So we don't think the screening failure rate is going to be high, let's put it that way.
Speaker Change: Yeah, we won't really know that until the screening process start and they go through the inclusion exclusion criteria, but just on that note they've already been through the inclusion exclusion criteria on the prior trials and we've loosen that up for the open label study. So we don't think the screening failure rate is gonna be.
Cindy Jacobs: Hi, let's put it that way.
Speaker Change: Okay, and then a follow up on your comment about the placebo patients.
Cindy Jacobs: Okay, and then a follow-up question to your comment about the placebo patients, re-enrolling these patients now with the expectation that they would go right into serotonin cleaning, how do you handle the potential for those going on placebo and how many in ORCA OL would be on placebo?
Speaker Change: Re enrolling these patients now with the expectation that they would go right into so cynically.
Speaker Change: How do you handle the potential for those going on with placebo and how many and orca oil would be on placebo.
Cindy Jacobs: And there will be no one in the Open Label Study on placebo. These are prior subjects who were on placebo in the previous trials, and they would be seeing cytosineclin for the first time, and that would increase our overall exposure of individuals to cytosineclin.
Cindy Jacobs: And there'll be no one in the open label study on placebo. These are prior subjects, who were on placebo in the previous trials and they would be seen side a cynic when for the first time and that would increase our overall exposure of individuals' with Titan cynical and overall.
Michael John Higgins: Okay, makes sense. I thought maybe you were dosing them placebos all of a sudden, so okay, got it. And then you mentioned going after those that have been treated for three months.
Cindy Jacobs: Okay. It makes sense I thought maybe you were dosing than placebo all of a sudden.
Speaker Change: Got it.
Michael John Higgins: And then you mentioned going after those that had been treated for three months. What is your number would you Hum how big is that a is that pool, how many had been treated for three months.
Cindy Jacobs: What is your number? What do you know how big that pool is? How many have been treated for three months?
Cindy Jacobs: I don't have the exact numbers that have been called in that they're currently interested in, but those are the things that we're going to be monitoring as they come into the trial and start getting treated. We already have a link that will link their prior treatment to the treatment that they're getting in the open label so we can monitor the overall exposure level as we do the study.
Cindy Jacobs: I can't I don't have the exact numbers that have been called them that they're currently interested those are the things that we're gonna be monitoring as they come into the trial and start getting treated we have already a link says it will link their prior treatment to the treatments that they are getting in the open label. So we can monitor the overall exposure level.
Cindy Jacobs: As we do the study.
Michael John Higgins: Okay, that makes sense. And then, thank you, Cindy and John. One for you here before it goes.
Speaker Change: Okay makes sense and then thank you Sandy and John one for you here before it goes.
John A. Bencich: In your partnering discussions, you know, we're seeing increasingly that Pfizer, Lilly, and others, big and small, have been leveraging these virtual physician connections and the direct drug shipments to patients approach. How has that development affected your partnering discussions? Because it's, I can just see it coloring the partner that you're most interested in working with. But just curious about your feedback on that. Thanks.
John A. Bencich: And your partnering discussions.
John A. Bencich: We're seeing.
John A. Bencich: Increasingly it seems Pfizer Lilly and others are big and small has been leveraging these virtual physician connections and the direct drug treatments to patients approach.
John A. Bencich: Or was that development affected your partnering discussions because it's.
John A. Bencich: Yeah.
John A. Bencich: I can just see it coloring the partner that you're most interested in working with them, but just curious your feedback on that thanks.
Michael John Higgins: Yeah, thanks, Michael. So I'm not able to comment on any specific discussions that are ongoing, but I will say kind of the new digital techniques and virtual techniques that are being utilized today and have come into effect over the last five or so years, in particular during the pandemic, are key attributes that we're looking for. We think those are the right approaches to really move the needle forward in this category.
Speaker Change: Yeah. Thanks, Michael so not able to comment on any specific discussions that are ongoing but I will say it kind of the new.
Michael John Higgins: Digital techniques and virtual techniques that are that are being utilized.
Michael John Higgins: Utilized today.
Michael John Higgins: Have come into effect over the last five or so years in particular during the pandemic.
Michael John Higgins: Our key attributes that were looking for we think those are the right approaches to really move the needle moving forward in this category and I think this will only continue and I think the tailwind from some of the larger <unk>.
Michael John Higgins: And I think this will only continue. And I think the tailwinds from some of the larger pharmas that have gotten involved in other similar indications, call them, you know, think obesity, diabetes, areas like that where, you know, finding a way to get the awareness out is critical. We think those are our great sort of tools that will be used as we think about cytosine and clean launching. Yeah.
Michael John Higgins: Farmers that have gotten involved in other similar indications call. It you know think obesity diabetes areas like that where youre.
Michael John Higgins: Finding a way to to get the awareness out is critical and we think those are our great sort of tools that will be used as we think about side to scenically and lodging.
Michael John Higgins: Yeah, I think it's a real win for you at your back as you're partnering here, so great to see it all happen. I appreciate it. I'll jump back in the queue. Thanks, guys.
Speaker Change: Yes, I think it's a real win at <unk> at your back as Youre partnering here, so great to see it all happen and I appreciate it I'll jump back in the queue. Thanks guys.
Michael John Higgins: Yeah.
Michael John Higgins: Thank you. The next question is coming from Frank <unk> of Oppenheimer. Please go ahead.
Operator: Thank you. The next question is coming from Frank Brisebois of Oppenheimer. Please go ahead.
Operator: Hi, This is Dan on for Frank Thanks for taking our questions.
Franois Daniel Brisebois: Hi, this is Dan Alperfrank. Thanks for taking our questions regarding the 29 sites. Do you expect a certain subset of them to be higher enrolling sites based on any factors, or do you expect sort of an equal distribution across the board? Any insights you can share based on the previous enrollment rates that you saw at these sites from the previous trials?
Franois Daniel Brisebois: Regarding the 29 sites do you expect a certain subset of them to be a higher enrolling sites based on many factors or do you expect sort of equal distribution across the board any any insights you can share based on the previous enrollment rates that you saw the sites from the previous trials.
Speaker Change: Yeah. So obviously these sites because of whatever their enrollment was on the previous study there were some that were higher rollers than others than they are using that basically those subjects coming back in.
Cindy Jacobs: Yeah, so obviously these sites, because of whatever their enrollment was in the previous study, there were some that were higher rollers than others, then they are using basically those subjects coming back in. Of the 29 subjects, the 29 sites, these are all sites that did very well in the previous studies, not only in getting subjects enrolled but also in data management. So, although obviously there will be differences between the sites due to their prior enrollment, we expect all sites to be up and running quickly with subjects already contacted.
Cindy Jacobs: Of the 29 subjects. The 29 sites. These are all sites that did very well in the previous studies not only in getting subjects enrolled but also the data management. So.
Cindy Jacobs: Although obviously there'll be differences in the sites due to their prior enrollment we expect all sides to be up and running quickly with the subjects already contacted.
Cindy Jacobs: Great.
Franois Daniel Brisebois: Great. And just one quick follow-up. Could you remind us what the frequency of visits and follow-ups is in this trial? And particularly any potential challenges you foresee in terms of patient compliance or monitoring in this trial versus phase three?
Speaker Change: Just one quick follow up could.
Speaker Change: Could you remind us the what the frequency of visits and follow ups is on this trial, yeah that particular, many potential challenges you foresee in terms of patient compliance for monitoring in this trial versus the.
Franois Daniel Brisebois: The phase III.
Cindy Jacobs: You know, and in fact, the phase threes were weekly clinic visits during the 12 weeks of treatment, and the open labels, it's monthly treatment visits or clinic visits. So that actually is 12 visits basically spread over the year.
Franois Daniel Brisebois: No and in fact, the phase Threes, where weekly clinic visits during the 12 weeks treatment in the open label, it's monthly treatment visits I mean clinic visits.
Cindy Jacobs: So that actually is a 12 visits basically spread over the year. So it's not onerous as far as the clinic visits.
Cindy Jacobs: So it's not onerous as far as the clinic visits are concerned. As far as drug accountability is concerned, a lot of the same processes and procedures are in place to monitor drug accountability. I think as far as the compliance of the subjects in the study, the commitment of the subjects, they know what it is; they will know what is being asked of them by the time they get through the screening and the informed consent form.
Cindy Jacobs: As far as the drive accountability and a lot of this the same processes and procedures are in place to monitor drug accountability I think as far as the compliance of the subjects on the study.
Cindy Jacobs: The commitment of the subjects them. They they know what is they will know what is being asked of them by the time, they get through the screening and the informed consent form.
Cindy Jacobs: And that's important as well as the commitment in the protocol for the company and the sites to help them quit and stay smoke and vape free during the study. So I think the compliance for staying in the study will be there because of the commitment of both sides, the subject as well as the sites and the company.
Cindy Jacobs: And that's important as well as the commitment and the protocols for the with the company and the science to help them quit and stay smoke and vape free during the study.
Cindy Jacobs: I think the compliance for staying on this study will be there on the commitment of both sides the subject as well as the sites in the company.
Franois Daniel Brisebois: That's very helpful. Thanks for taking our questions.
Speaker Change: That's very helpful. Thanks for taking my questions.
Speaker Change: Thank you. The next question is coming from John <unk> of Zacks. Please go ahead.
Operator: Thank you. The next question is coming from John Vandermosten of Zax. Please go ahead.
John D. Vandermosten: Alright, Thank you and good afternoon, John Cindy and Jerry.
John D. Vandermosten: All right, thank you, and good afternoon, John, Cindy, and Jerry. I was looking at some of the vaping trials that are out there. There are a bunch of them, and they're probably at different levels of seriousness. Some are using cell phones with teens to help them stop vaping, and some are using a Varenicline to measure that. And I'm wondering, just in your time at SRNT and maybe some of the other conferences and just looking around, poking around, if there are any serious other vaping trials that are going on that you've seen out there.
John D. Vandermosten: I was looking at some of the the vaping trials that are out there there are a bunch of them and they're probably in a bunch of different levels of seriousness summer using cell phones with teams to help them stop vaping and some are using varenicline.
John D. Vandermosten: To measure that and I'm wondering just in your in your time at SRN T and maybe some of the other conferences and just looking around poking around what are if there are any serious other vaping trials that are going on.
John D. Vandermosten: That that you've seen out there.
John A. Bencich: Yeah, John, thanks for the question there. Something we continue to monitor in terms of what else is happening out in the landscape. And I think with respect to vaping and, frankly, smoking cessation overall, we're just not seeing any real serious studies being run at the moment. We did see another readout from a vaping trial at SR&T, but it was significantly smaller and less controlled than what we just published earlier this week with ORCA V1. So something we continue to monitor, but there really isn't anything else going on that we see is really moving the needle in this space.
Speaker Change: Yeah, John Thanks for the question there are some.
John A. Bencich: We continue to monitor in terms of what else is happening out in the landscape and I think with respect to the vaping and frankly smoking cessation overall, we're just not seeing any real serious studies being being run at the moment are there.
John A. Bencich: What we did see another read out from our vaping trial at S. R. A T.
John A. Bencich: But it was significantly smaller and less control than then what we do.
John A. Bencich: Published earlier this week with Orca would be one.
John A. Bencich: So something we continue to monitor but there really isn't anything else going on that we see is really moving the needle in this space.
John D. Vandermosten: Okay, was that in Varenicline, or was that some other other product that's used?
Speaker Change: Was that was that varenicline or was that some of their other product that's.
John A. Bencich: It was a veridically in trial, and again, most of what's being done out there is academically driven, and not, I would say, company driven, that would actually lead to an indication for vaping.
John D. Vandermosten: It wasn't a radically in trial and again most of what's being done out there is is academic driven and.
John A. Bencich: And not a I would say company driven that would actually lead to an indication for vaping.
John D. Vandermosten: Okay, great. That's all for me. Thank you. Thanks, John.
Speaker Change: Okay, Great. That's all for me. Thank you.
Speaker Change: Thanks, John.
Speaker Change: Thank you. The next question is coming from Ilya <unk> of Freedom brokers. Please go ahead.
Operator: Thank you. The next question is coming from Ilya Upkov of Freedom Brokers. Please go ahead.
Ilya Upkov: Good afternoon, and thank you for taking my question.
Ilya Upkov: Good afternoon. Thank you for taking my question. You mentioned that patients who have taken the drug in previous studies for at least three months can only take the drug for three plus months in NarcoL to get into the statistics for NDA. Correct me if I'm misunderstood. My question is, does it matter how long ago these patients finished taking the drug in the previous study to include already achieved duration of taking the two final exposures?
Ilya Upkov: You've mentioned that patients who have taken the drug can do for studies for at least three months and I'm going to tell you. The drive for three plus months in North go out to get into the statistics, Randy correct me if I'm into misunderstood.
Speaker Change: My question is.
Ilya Upkov: It doesn't matter how long ago. These patients show senior stake in big drop in the previous study to include all of our debt duration of taking them to find out of exposure.
Speaker Change: Yeah. So you know what the F. D. A is looking for is cumulative treatment. So it doesn't have to be continuous.
Cindy Jacobs: Yeah, so you know, what the FDA is looking for is cumulative treatment, so it doesn't have to be continuous, which I think is what your question is getting at. So if someone saw, you know, six or 12 weeks of the drug two years ago, and they get, you know, incremental three months today, we would just add that total exposure together. So as we bring in the patients, whether they were, you know, six weeks, or 12 weeks of exposure previously, we'll just start adding the incremental exposure as part of the trial together until we get those 300 subjects that have been treated for six months. Cumulative
Cindy Jacobs: Is what your question is getting at so if someone's.
Cindy Jacobs: Six or 12 weeks of drug two years ago, and they get incremental three months today, we would just add that total exposure together so as we bring in the patients whether they were you know six weeks 12 weeks of exposure previously.
Cindy Jacobs: We'll just start adding the incremental exposure as part of the O L trial together until we get that those 300 subjects that have been treated for for six months.
Cindy Jacobs: Cumulatively.
Cindy Jacobs: Yeah.
Speaker Change: Okay. Thank you and one more from me place regarding possible label extension for E cigarettes cessation.
Ilya Upkov: Okay, thank you. And one more question from me, please, regarding possible label extension for e-cigarette cessation. Do you expect FDA to require separate long-term safety data beyond 12 weeks in the population of e-cigarette smokers?
Speaker Change: Do you expect FDA to require separate long term safety data beyond 12 weeks in the population of cigarette smokers.
Speaker Change: Yeah. Good good question, so as part of our discussion with FDA around the open label trial that they indicated that this study one would be needed for both our smoking indication and debating indications, but I think the key piece here is that this trial, we're running now will work for both.
John A. Bencich: Yeah, good, good question. So, as part of our discussion with FDA around the open-label trial, they indicated that this study would be needed for both a smoking indication and a vaping indication. But I think the key piece here is that this trial we're running now will work for both. So we will not have to run a separate longer-term exposure trial for a vaping indication, which is why we are allowing both subjects from our smoking trials as well as the vaping study into this new trial.
Ilya Upkov: Great. Thank you, John.
Ilya Upkov: So we will not have to run a separate longer term exposure trial for vaping indication, which is why we are allowing both subjects from our smoking trials as well as the vaping study into this this new trial.
Speaker Change: Great. Thank you John.
John: Yes, Thank you Julia.
Speaker Change: Thank you that brings us to the end of the question and answer session I would like to turn the floor back over to Mr. <unk> for closing comments.
Operator: Thank you. That brings us to the end of the question and answer session. I would like to turn the floor back over to Mr. Bencich for closing comments.
Bencich: Thanks Donna.
John A. Bencich: We have made tremendous progress this year and look forward to providing additional updates as we proceed, in particular in the coming weeks as we look to initiate enrollment in the ORCA OL trial. So thanks again, everyone, for joining us today and for your continued support of Achieve. Ladies and gentlemen, this concludes today's event. You may disconnect your lines and log off the webcast at this time and enjoy the rest of your day. Unknown Executive, Thomas Flaten, Cindy Jacobs, John Bencich, Jerry Wan, Achieve, [inaudible]
Operator: We made tremendous progress this year and look forward to providing additional updates as we proceed in particular in the coming weeks as we look to initiate enrollment in the orca well trial. So thanks again, everyone for joining us today and for your continued support of achieve.
John A. Bencich: Okay.
Operator: Ladies and gentlemen, this concludes today's event. You may disconnect your lines and log off the webcast at this time and enjoy the rest of your day.
John A. Bencich: Ladies and gentlemen. This concludes today's event you may disconnect your lines and log off the webcast at this time and enjoy the rest of your day.
Operator: [music].
Operator: Yeah.
Operator: [music].
Operator: Dr. Michael Higgins, Franois Brisebois, Nicole Jones, John Bencich, Franois Brisebois, [inaudible] Unknown Executive, Michael Higgins, Franois Brisebois, John Bencich, Nicole Jones, Unknown Executive, Thomas Flaten, Cindy Jacobs, Jerry Wan, Achieve [inaudible]