Q3 2024 Achieve Life Sciences Inc Earnings Call
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John House: and thank you, John House.
John W.: and John W.
Greetings and welcome to the achieve life Sciences third quarter 2024 earnings conference call and webcast. At this time all participants are in a listen only mode.
Operator: Greetings and welcome to the Achieve Life Sciences 3rd Quarter 2024 Earnings Conference Call and Webcast. At this time, all participants are in a listen-only mode.
Operator: A question and answer session will follow the formal presentation. And as a reminder, this conference is being recorded.
<unk> and answer session will follow the formal presentation and as a reminder, this conference is being recorded.
Nicole Jones: I would now like to turn the call over to Nicole Jones, Achieve Investor Relations.
I would now like just trying to call over to Nicole Jones, Chief Investor Relations.
Nicole Jones: Thank you, Nicole. You may begin.
Speaker Change: Thank you Nicole you may begin.
Operator: Thank you, Operator.
Nicole Jones: Thank you operator, good afternoon, everyone and thank you for joining us today from a cheese Lifesciences, we're joined by Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Gerry One principal accounting officer, and Jamey Xena, Chief Commercial officer management will be available for.
Rick Stewart: Good afternoon, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Jerry Wan, Principal Accounting Officer, and Jaime Xinos, Chief Commercial Officer.
Rick Stewart: 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 documents available on our website and filed with the SEC concerning factors that could affect the company.
Nicole Jones: 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 Jones: The statements are only predictions and actual results may vary materially from those projected.
Nicole Jones: Please refer to achieve documents available on our website and filed with the SEC.
Speaker Change: Factors that could affect the company I'll now turn the call over to Rick.
Rick Stewart: I'll now turn the call over to Rick.
Rick Stewart: Thanks, Nicole. The third quarter was yet again eventful and productive for Achieve, with a change of management, new hires in key roles, the FDA granting breakthrough therapy designation for e-cigarette or vaping cessation, and refinancing our SVB loan. Much of this activity reflects the rapidly maturing Achieve and reflects the increasing value to patients, physicians and shareholders as the company transitions from a pure play clinical development company towards a more commercially focused company.
Rick Stewart: Thanks Nicole.
Rick Stewart: In the third quarter was yet again, an eventful and productive so cheap with a change of management new highs in key roles. The FDA granting breakthrough therapy designation for E cigarettes, and vaping cessation and refinancing our SBB loan.
Rick Stewart: Much of this activity reflects the rapidly maturing achieved and reflects the increasing value to patients physicians and shareholders as the company transitions from a pure play clinical development company towards a more commercially focused company.
Rick Stewart: As a result, the board decided that as Achieve swiftly approaches NDA submission, acceptance, and approval, the company needed to strengthen executive management with greater commercial and M&A expertise to enhance the future value of the company. The value proposition continues to increase. A target population of more than 40 million Americans with nicotine dependence is awe-inspiring to big pharma, let alone a microbiotech.
Rick Stewart: As a result, the board decided that is S achieve swiftly approaches NDA submission acceptance and approval the company needed to strengthen executive management with greater commercial and M&A expertise to enhance the future value of the company.
Rick Stewart: The value proposition continues to increase.
Target population of more than 14 million Americans with nicotine dependence is all inspiring to big pharma, let alone our micro biotech two.
Rick Stewart: To continue value enhancement, we have carefully and thoughtfully assessed the future strategy of Achieve and cannot rely solely on a third-party exit or strategic partnering to commercialise cytosine clean. In fact, to do so would hold Achieve to ransom for unpalatable terms. We have to move forward from a position of strength with strong conviction about our ability to provide patients with a best-in-class smoking cessation therapy and a first-in-class vaping cessation treatment.
Rick Stewart: To continue value enhancement, we have carefully and thoughtfully as say the future strategy of achieved and cannot rely solely on a third party exit or strategic partnering to commercialize <unk> and.
Rick Stewart: To do so would hold achieve to ransom for unpalatable times.
Rick Stewart: We have to move forward from a position of strength with strong conviction about our ability to provide patients with a best in class smoking cessation therapy, I think first in class vaping cessation treatment.
Rick Stewart: As you will hear a little later, smoking does not only affect the health and life expectancy of the people who smoke, it has a profound impact on family, friends and the wider community. The proliferation of smoking-related diseases, including respiratory, cardiovascular, cancer, diabetes, dementia, and so on, reverberates through society. For far too long we've ignored the medical nature of nicotine dependence and solely focused on the $300 billion a year cost of the consequences of smoking-related diseases. Nicotine dependence is a disease and it needs to be treated as such.
Rick Stewart: As you will hear little later smoking does not only affect the health and the life expectancy of the people who smoke it has a profound impact on family friends and the wider community.
Rick Stewart: The proliferation of smoking related diseases, including respiratory vascular cancer diabetes dementia, and so on whereas the breakthrough society.
Rick Stewart: So far too long, we've ignored the medical nature of nicotine dependence and solely focused on the $300 billion cost of the consequences of smoking related diseases.
Rick Stewart: Nicotine dependence is a disease and it needs to be treated as such.
Rick Stewart: Achieve has the unique privilege to change the health and well-being of millions of Americans, up to 40 million, plus the wider global population of more than 1 billion people suffering from nicotine dependence disease. That is our mission, our goal, and our commitment. Focusing on how Achieve can accomplish this is a priority, but does not preclude an exit, and we believe actually enhances the possibility.
Speaker Change: Achieve has a unique privilege to change the health and wellbeing of millions of Americans up to 40 million plus the wider global population of more than 1 billion people suffering from nicotine dependence disease that is our mission our goal and our commitment.
Focusing on how cheap can accomplish this is a priority but.
Speaker Change: Does not preclude an exit and we believe actually enhances the possibility.
Rick Stewart: A traditional primary care sales force commercial strategy is no longer viable in today's world and must be combined with innovative digital execution. This is what many big pharma are currently grappling with. How do you reach primary care physicians when access is increasingly restricted? Our challenge will be how to target primary care physicians efficiently and raise awareness of our new treatment option in potential quitters.
Speaker Change: A traditional primary care sales force commercial strategy is no longer viable in today's world and must be combined with innovative digital execution.
Speaker Change: This is what many big pharma currently grappling with how do you reach primary care physicians when access is increasingly restricted.
Speaker Change: Our challenge will be housing target primary care physicians efficiently and raise awareness of a new treatment option and potential quiches.
Rick Stewart: That is why we promoted Jaime Xinos to Chief Commercial Officer. Quietly and behind the scenes, Jaime has been working for more than two years to develop an innovative and highly focused digital commercial strategy. She has converged with experts in the field to create a cost-effective strategy which is importantly dynamic and scalable. Our goal is to build for growth, expand when appropriate, so that we can optimise value and patient benefit. Jaime has been with Achieve since 2017, previously serving as our Executive VP of Marketing. She has nearly 25 years of pharma commercial experience from initially carrying the bag as a sales rep to US and global marketing and commercial development roles at Abbott, Novartis, and Pfizer.
Speaker Change: That is why we promoted Jamie <unk> to Chief commercial officer.
Speaker Change: Quietly behind the scenes, Jamie who's been working for more than two years to develop an innovative and highly focused digital commercial strategy.
Speaker Change: She has conveyed with experts in the field to create a cost effective strategy, which is importantly dynamic and scalable.
Speaker Change: All of these to be able to growth extend when appropriate so that we can optimize value and patient benefit.
Speaker Change: Shane has been with achieved since 2017 previously serving as our executive VP of marketing.
Speaker Change: She has nearly 25 years at pharma commercial experience from initial you're carrying the bag of the sales reps to U S and global marketing and commercial development roles.
Speaker Change: But novartis and Pfizer.
Speaker Change: With respect to our commitment to smoking cessation and treating nicotine dependence don't just Cindy Jacobs achieves president and Chief Medical Officer.
Cindy Jacobs: With respect to our commitment to smoking cessation and treating nicotine dependence, Dr. Cindy Jacobs, Achieve's president and chief medical officer, presented at the FDA-NIH joint public meeting on advancing smoking cessation held on the 21st of October in D.C. This important meeting gave the opportunity for stakeholders to represent their views regarding the crucial need for future treatments in smoking cessation. The meeting crystallized the public health importance of providing solutions for nicotine dependence.
Speaker Change: Presenting here at the F D. A N NIH joined public meeting on advancing smoking cessation.
Speaker Change: 21st of October in D C.
Speaker Change: This important meeting gave the opportunity to stakeholders to represent our views regarding the crucial need for future treatments in smoking cessation.
Speaker Change: The meeting crystallized the public health importance of providing solutions for nicotine dependence.
Cindy Jacobs: There are 29 million Americans who smoke combustible cigarettes and over 11 million adults in the U.S. who vape nicotine. Approximately 65% of people who smoke attempt to quit annually, with fewer than 10% doing so successfully. Nicotine is immensely addictive and options to help people quit its use are extremely limited.
Speaker Change: 29 million Americans, who smoke combustible cigarettes.
Speaker Change: 11 million adults in the U S Hubei nicotine.
Speaker Change: Approximately 65% of people, who smoke attempt to quit annually with fewer than 10% doing so successfully.
Speaker Change: Academia is immensely addictive and options to help people quit it's use are extremely limited.
Cindy Jacobs: If approved, Cytosinecline will be the first new prescription smoking cessation drug in nearly 20 years. At its peak, Chantix revenues exceeded $1 billion, with 75% of that attributed to the U.S. market. We believe cytosineclean, with its excellent efficacy and tolerability profile, is a significant opportunity to help the millions of people who want to quit smoking and vaping. Our phase three clinical trials demonstrated impressive efficacy while meeting the FDA gold standard endpoint of continuous abstinence. As a result, cytosinecline is poised to become the best-in-class option for smoking cessation and the first-in-class option for vaping cessation.
Speaker Change: If approved Nick sorry to Sydney clean will be the first new prescription smoking cessation drugs in nearly 20 years.
Speaker Change: Peak Chantix revenues exceeded $1 billion with 75% of that attributed to the U S market.
Speaker Change: We believe such as Sydney clean with its excellent efficacy and Tolerability profile is a significant opportunity to help millions of people, who want to quit smoking and baked egg.
Speaker Change: Our phase III clinical trials demonstrated impressive efficacy while meeting the F D. A gold standard endpoint of continuous abstinence as.
Speaker Change: As a result, scientists clinically and is poised to become the best in class option for smoking cessation and at first in class option the vaping cessation.
Cindy Jacobs: Our focus is now looking at the future NDA submission, acceptance, and approval for smoking cessation. Additionally, we are targeting Q3 2025 to commence the Phase III clinical trial for vaping cessation.
Our focus is now looking at the future NDA submission acceptance and approval for smoking cessation.
Speaker Change: Additionally, we are targeting Q3 2025 to commence the phase III clinical trial for vaping cessation.
Cindy Jacobs: On today's call, Cindy will provide an update on the ORCA OL Open Label Safety Study, timing and status for the NDA submission, and comment on her recent participation at the FDA-NIH joint meeting. Then Jaime will share a few thoughts on near-term NDA and launch readiness priorities and overall commercial strategy.
Speaker Change: On today's call Sandy will provide an update on the Orca O L Open label safety study.
Speaker Change: And stay tuned for the NDA submission and comment on her recent participation at the.
Speaker Change: F D a NIH join Nathan.
Speaker Change: Jamie will share a few thoughts on near term NDA launch readiness priorities and overall commercial strategy.
Cindy Jacobs: Finally, Jerry will lead us through the financials before returning to me for closing comments.
Speaker Change: Finally, Jerry will lead us through the financials.
Cindy Jacobs: Before returning to me for closing comments with that I will turn the call. It what you Cindy.
Cindy Jacobs: With that, I will turn the call over to Cindy.
Cindy Jacobs: Thanks, Rick. We began the Open Label ORCA-OL safety trial for long-term cytosine exposure in May 2024 and recently completed enrollment in early October, ahead of expectations with 479 participants across 29 trial sites in the United States. All participants were part of our previous Phase 2 and Phase 3 smoking and e-cigarette cessation studies, allowing for swift enrollment in just over four months. This trial is designed to meet the FDA requirements in providing safety data for at least 300 subjects treated with cytosineclin for a cumulative period of six months to support our NDA submission. In addition, data on at least 100 subjects treated for a cumulative period of one year will also be submitted as an NDA clinical safety update before product approval.
Cindy Jacobs: Thanks, Brad.
Cindy Jacobs: Began the open label Arca O L. T trial for long term, but it's an excellent exposure in May 2024, and recently completed enrollment in early October.
Cindy Jacobs: Ahead of expectation with 479 participants across 29 trial sites in the United States.
Cindy Jacobs: All participants for part of our previous phase two and phase three smoking and E cigarette cessation study.
Cindy Jacobs: Boeing for Swift enrollment and just over four months.
Cindy Jacobs: This trial was designed to meet the FDA requirements, providing safety data for at least 300 subjects treated with Cytosorb at Cowen.
Neil: Neil it's a period of six months.
Neil: The board our NDA submission.
Neil: In addition data on at least 100 subjects treated for cumulative theory would have one year well also be submitted as an NDA clinical thank you update there for product approval.
Cindy Jacobs: Additionally, the Data Safety Monitoring Committee for the ORCA-OL trial recently completed their first safety data review and found no safety concerns. They reported an excellent overall safety profile, allowing the study to continue as planned without any modification.
Neil: Additionally, the data safety monitoring committee for the Orca O L trial recently completed their first safety data review and found no safety concerns.
Neil: They reported an excellent overall safety profile, along with study to continue as planned without any modification.
Cindy Jacobs: I now want to give more detailed timing on the Cytosineclin NDA submission, which remains on track to occur in quarter two, 2025, subject to completion of data collection, safety analysis of the ORCA OL, and on manufactured Cytosineclin product stability data. We expect that at least 300 subjects in the open-label study will have reached their six months of cytosine exposure by late January, early February. It will then take approximately three months to collect the data, monitor it, lock the safety database, and incorporate the safety data into the integrated safety summary document for the NDA. Once complete, the NDA will undergo final quality assurance checks before submission.
Neil: And now I want to give more detail timing on our side in Senegal, and NDA submission, which remains on track to occur in quarter, two 2025 subject.
Neil: Subject to completion of data collection.
Neil: As of the Orca O L and on many factors, but it's been a clinton product stability data.
Neil: We expect that at least 300 subjects in the open label study.
Neil: <unk> reached the six month subsided silicone exposure by late January early February.
Speaker Change: He will then take approximately three months to collect the data monitor it blocked the safety database and incorporate the safety data into the integrated safety summary documents for the NDA.
Speaker Change: Once complete the NDA will undergo final quality assurance checks before submission.
Cindy Jacobs: We expect the NDA submission acceptance subject to FDA's review within 74 days of NDA submission and then product approval approximately 12 months after that.
Speaker Change: We expect the NDA submission acceptance subject to FDA review within 74 days of NDA submission and then product approval approximately 12 months after that.
Cindy Jacobs: As Rick mentioned, we recently participated in a joint public meeting with the FDA and NIH on priorities for advancing smoking cessation innovation. I have the opportunity to share and present our Achieve Life Sciences journey regarding cytosine equivalent to representatives from FDA, NIH, NIDA, and other smoking cessation experts. During this meeting, I spoke about the urgent need for new FDA-approved treatments for smoking cessation. I appreciated the opportunity to speak on the issue and to be a part of this important meeting. Comments from my presentation are available on the FDA website as noted in our press release.
Speaker Change: As Rick mentioned, we recently participated in a joint public meeting with the FDA and NIH on priority for advancing smoking cessation innovation.
Speaker Change: I had the opportunity to share them prevent or achieve lifesciences journey regarding Senate Glenn.
Speaker Change: Presentative Trop F D a N.
Speaker Change: H Ida and other smoking cessation expert.
Speaker Change: During this meeting I spoke about the urgent need for new FDA approved treatment for smoking cessation.
Speaker Change: I appreciated the opportunity to speak on the issue and it would be a part of this important meeting.
Speaker Change: Comments from my presentation are available on the FDA website.
Speaker Change: Noted in our press release.
Cindy Jacobs: Finally, we were pleased to announce this quarter that FDA granted Breakthrough Therapy designation to cytosineclin for the vaping cessation indication. Breakthrough Therapy designation is important because it offers access to an FDA cross-disciplinary project management team for interactive communications with senior managers and reviewers at FDA. This will be beneficial in completing the regulatory requirements necessary for expanding cytosineclin treatment as the first approved pharmacotherapy in treating nicotine dependence for e-cigarette cessation, not only in adults, but also potentially for an adolescent vaping population.
Speaker Change: Finally, we were pleased to announce this quarter that FDA granted breakthrough therapy designation to cytostatic, Glenn for the Vaca <unk>.
Speaker Change: [noise] occasion.
Speaker Change: Great Kids therapy designation is important because it offers access to an F. D. A cross disciplinary project management team for interactive communications for senior managers and reviewers at F. D. A.
Speaker Change: It will be beneficial in completing the regulatory requirements necessary, we're expanding clinical and treatment as the first group pharmacotherapy and treating nicotine dependence for E cigarettes cessation.
Speaker Change: Only in adults, but also potentially for an adolescent vaping population.
Jaime Xinos: I will now turn the call over to Thanks, Cindy.
Speaker Change: I will now turn the call over to James.
James: Thanks, Cindy commercial planning is moving forward as we begin to set the stage for a successful launch of Cytosorb clean in the U S for over two years, we've been working closely with agencies and partners to create a one strategy that ensures we're ready to go upon FDA approval, regardless of partnering status.
Jaime Xinos: Commercial planning is moving forward as we begin to set the stage for a successful launch of cytosinuclein in the U.S. For over two years, we've been working closely with agencies and partners to create a launch strategy that ensures we're ready to go upon FDA approval, regardless of partnering status. We've conducted extensive customer research diving into patient, prescriber, and payer perceptions about smoking and vaping, the challenges of quitting, experiences with currently available treatments, and opinions about cytosine exposure. This invaluable feedback is guiding our approach, particularly as we position cytosineclean as a promising new treatment option. Over the next several months, our focus will be on key activities essential for NDA filing and foundational projects that typically require 18-plus months to execute prior to FDA approval.
James: We've conducted extensive customer research diving into pesos prescriber and payer perceptions about smoking vaping the challenges of quitting experiences with currently available treatments and opinions about cytosine acclaim. This invaluable feedback is guiding our approach, particularly as we position side has been a clean as a promising new treatment option.
James: <unk>.
James: Over the next several months our focus will be on key activities essential for NDA filing and foundational projects that typically require 18 plus months to execute prior to FDA approval.
Jaime Xinos: These include, but are not limited to, packaging design, label and promotional claims drafting, third-party logistics selection, channel and distribution strategy, state licensure, compendia listings, and health outcomes research to enhance our value messaging, which is essential groundwork for effective pre-approval communication with payers. Achieve has always operated with a lean, efficient team since our inception in 2017. We remain dedicated to this approach and will continue outsourcing where feasible. As we begin key commercial activities, we're strategically building our in-house team, focusing on experts with deep, relevant experience. A great example of this approach is our recent hire, Dr. Mark Rubenstein, a nicotine addiction specialist with rich cross-functional experience.
James: These include but are not limited to packaging design label and promotional claims drafting third party logistics selection channel and distribution strategy State licensure compendium listings and health outcomes research to enhance our value messaging, which is the central groundwork for effective.
James: Reapproval communication with payers.
James: Achieve has always operated with a lean efficient team since our inception in 2017, we remain dedicated to this approach and we will continue outsourcing where feasible and we began key commercial activities were strategically building our in house team focusing on experts with deep relevant experience.
James: A great example of this approach is our recent hires Dr. Marc Rubin Stein and nicotine addiction specialists with rich cross functional experience.
Jaime Xinos: Mark's expertise in direct patient treatment, clinical research, and his experience across medical affairs in both small and large companies brings an immediate valuable impact to our team. Our next key commercial hire will be a lead for trade and market access with extensive experience managing the complexities of a small biotech preparing for its first launch. We are currently onboarding this role in a consulting capacity until project demands As Rick has shared, if Achieve takes on the commercial launch of Cytosine and Clean in the U.S., we plan to adopt an innovative, digital-first strategy. We've extensively explored all models for launch, ranging from full outsourcing with a single service provider to a complete commercial infrastructure build-out.
James: Mark's expertise and direct patient treatment clinical research and has experienced across medical affairs, and both small and large companies brings an immediate valuable impact to our team.
James: Our next key commercial higher will be a lead for trade and market access with extensive experience managing the complexities of a small biotech preparing for its first launch.
James: We are currently Onboarding this role in a consulting capacity until project demands increase.
James: As Rick has shared if achieve takes on the commercial launch the site has been a clean in the U S. We plan to adopt an innovative digital first strategy.
James: We've extensively explored all models for launch ranging from full outsourcing with a single service provider to a complete commercial infrastructure build out we.
Jaime Xinos: We are deeply aware of both the challenges and opportunities and the expense that these options present. Our strategy is a hybrid model, leveraging top-tier strategic partners who share our passion for bringing new products to market that will make a meaningful impact. Our industry has shifted significantly in recent years, with fewer opportunities for face-to-face engagement with health care providers than ever before. Today's pharma companies are carefully balancing the effectiveness and the return of investment of traditional sales visits with virtual detailing and digital communication. Through comprehensive data analysis, we're positioned to precisely target and deliver the right message at the right time to the right prescriber.
James: We are deeply aware of both the challenges and opportunities and the expense that these options for that.
James: Our strategy is a hybrid model leveraging top tier strategic partners, who share our passion for bringing new products to market that will make a meaningful impact.
James: Our industry has shifted significantly in recent years with fewer opportunities for face to face engagement with health care providers than ever before today's pharma companies are carefully balancing the effectiveness and the return of investment of traditional sales visits with virtual detailing and digital communication through comprehensive data analysis.
James: We're positioned to precisely target and deliver the right message at the right time to the right prescribers.
Jaime Xinos: At launch, we will solely focus on primary care physicians who treat high volumes of nicotine-dependent patients, maximizing the impact of each engagement. And we're adopting a similar data-driven approach for patients. With 29 million who smoke in the U.S. and roughly a quarter who are highly motivated to quit, our initial efforts will focus on those who are ready to engage in cessation conversations with their physicians, who trust in the healthcare system, and who believe in the power of medicine to help them quit. Targeting this group allows us to efficiently connect with our key audience, learn from each interaction, and adapt based on performance metrics.
James: At launch we will solely focus on primary care physicians, who treat high volumes of nicotine dependent patient maximizing the impact of each engagement.
James: And we are adopting a similar data driven approach for patients with 29 million, who smoke in the U S and roughly a quarter who are highly motivated to quit our initial efforts will focus on those who are ready to engage in the station conversations with their physicians, who trust in the health care system, and who believe in the power of medicine.
James: To help them quit.
James: Targeting this group allows us to efficiently connect with our key audience learn from each interaction and adapt based on performance metrics.
Jaime Xinos: I look forward to sharing more on our phased value-driven launch approach in the months to come.
James: I look forward to sharing more on our phase value driven launch approach in the months to come.
Jaime Xinos: Since this may be the first time many of you are hearing from me directly, I'd like to close my remarks with a personal note. I joined Achieve in 2017, often working behind the scenes to bring a commercial and customer-centric perspective to our development strategies and corporate communications. My career spans nearly 25 years in pharma, most of it in oncology, dedicated to advancing treatments for life-threatening diseases. I entered this industry with the conviction that I could make a meaningful difference, and that belief has only grown stronger over time. For me, this mission is deeply personal. Smoking has left a profound mark on my family.
Speaker Change: This may be the first time. Many of you are hearing from me directly I'd like to close my remarks with a personal note.
Speaker Change: I joined achieve in 2017, often working behind the scenes to bring a commercial and customer centric perspective to our development strategies and corporate communications Mike.
Speaker Change: My career spans nearly 25 years in pharma most of it in oncology dedicated to advancing treatment for life threatening diseases I.
Speaker Change: I entered this industry with the conviction that I can make a meaningful difference and that belief has only grown stronger over time.
Speaker Change: For me. This mission is deeply personal smoking has left a profound mark on my family until.
Jaime Xinos: Until recently, both of my parents were lifelong smokers. Two years ago, my mother was diagnosed with lung cancer, and in July of this year, my father faced a total laryngectomy after being diagnosed with throat cancer, which has severely impacted his ability to eat and communicate. Experiencing the devastation of this disease firsthand has made it clear how urgently we need to transform not just the treatment options, but the conversation around smoking itself. At Achieve, we have the immense responsibility to shift the narrative on smoking. It is time we remove the stigma associated with smoking and move this conversation from a moral one to a medical one.
Speaker Change: Until recently both of my parents were lifelong smokers.
Speaker Change: Two years ago, My mother was diagnosed with lung cancer and in July of this year. My father face a total laryngectomy after being diagnosed with throat cancer, which has severely impacted his ability to eat and communicate.
Speaker Change: Experiencing the devastation of this disease firsthand has made it clear how urgently we need to transform not just the treatment options, but the conversation around smoking itself.
Speaker Change: At a cheap we have the immense responsibility to shift the narrative on smoking.
Speaker Change: It is time, we removed the stigma associated with smoking and moved this conversation from a moral one to a medical won this work is essential and we are driven by an extraordinary commitment to change lives.
Jaime Xinos: This work is essential, and we are driven by an extraordinary commitment to change lives. We carry this responsibility with an unwavering passion, knowing that what we are doing has the potential to impact public health on a global scale. I could not be any prouder to be part of this journey.
Speaker Change: We carry this responsibility with an unwavering passion knowing that what we are doing has the potential to impact public health on a global scale.
Speaker Change: I cannot be any prouder to be part of this journey and with that I'll turn the call over to Jerry for an update on our financials.
Jerry Wan: And with that, I'll turn the call over to Jerry for an update on our finances.
Jerry Wan: Thank you, Jaime.
Jerry: Thank you Jamie good afternoon, everyone.
Jerry Wan: Good afternoon, everyone. I'd like to provide an update on our financial activity this quarter and then review our current financial status and forward out. Beyond our clinical progress this quarter, we are also pleased to have successfully completed a debt refinancing agreement with SVD that provides for up to $20 million in availability. Under the terms of this new agreement, the $20 million term loan is divided into three tranches. The first charge of $10 million was received at closing. The second tranche of $5 million will be available upon FDA acceptance of the NDA for cytosine decline, and the final $5 million tranche will be available subject to FCB's discretion and credit committee approval.
Jerry: I'd like to provide an update on our financial activity. This quarter, and then review our current financial status and forward outlook.
Jerry: Beyond our clinical progress. This quarter. We are also pleased to have successfully completed a debt refinancing agreement with SCB that provides for up to $20 million and availability.
Jerry: Under the terms of this new agreement the $20 million term loan is divided into three tranches.
Jerry: First tranche of $10 million was received at closing.
Jerry: The second tranche of $5 million will be available upon F. T. A S substance of the NDA for <unk> and the final $5 million tranche will be available subject to fcb's discretion and credit Committee approval.
Jerry Wan: Let's now take a look at that third quarter final. As of September 30, 2024, the company's cash, cash equivalents, restricted cash, and short-term investments were $42.9 million, as compared to $61.3 million for the prior quarter. We believe our current cash balance is sufficient to provide us runway into the second half of 2025, including through potential NDA submission. Turning to our Statement of Operations, the company incurred a net loss of $12.5 million for the quarter ended September 30, 2024, as compared to a net loss of $7.1 million for the same quarter in the prior year. Net loss for the nine months ended September 30, 2024, increased to $27.5 million, as compared to $24.3 million for the same period in 2023.
Jerry: Let's now take a look at our third quarter financials.
Jerry: As of September 30th 2024, the company's cash cash equivalents restricted cash and short term investments of $42 9 million as compared to $61 3 million for the prior quarter.
Jerry: We believe our current cash balance is sufficient to provide us runway into the second half of 2025, including sort of potential NDA submission.
Jerry: Turning to our statement of operations the.
Jerry: The company incurred a net loss of $12 5 million for the quarter ended September 32024, as compared to a net loss of $7 1 million for the same quarter in the prior year.
Jerry: Net loss for the nine months ended September 30 of 2024.
Jerry: Increased to $27 5 million as compared to $24 3 million for the same period in 2023.
Jerry Wan: In line with expectations, operating expenses increased in the third quarter with the achievement of the targeted enrollment in our ORCA OL trial. We expect our quarterly operating expenses will remain elevated as we continue to progress forward with ORCA OL. With our continued focus to execute on our strategy towards NDA submission and plans to expand our M&A and commercial preparation activities, we remain committed to maintaining rigorous expense controls to ensure resources are applied efficiently and effectively to achieve our goals, fuel our growth, and create shareholder value.
Jerry: In line with expectations.
Jerry: <unk> expenses increased in the third quarter with the achievement of the targeted enrollment in our trial.
We expect our quarterly operating expenses will remain elevated as we continue to progress forward with Walker O L.
Jerry: With our continued focus to execute on our strategy towards NDA submission and plastics spanned our M&A and commercial preparation activities.
Jerry: We remain committed to maintaining rigorous expense controls.
Jerry: Our resources are applied efficiently and effectively to achieve our goals feel our growth and create shareholder value.
Jerry Wan: I will now turn the call back over to.
Speaker Change: I will now turn the call back over to Rick.
Rick Stewart: Thank you, Jerry. There are 16 million people in the U.S. currently suffering from smoking-related diseases. For every one death that smoking is responsible for, 30 other people are living with diseases that have been caused as a result. That is a staggering number. As I mentioned earlier, cytosinecline has a greater role in the treatment of nicotine-dependent disease. It will be crucial in reducing the disease burden caused by smoking in related conditions such as respiratory diseases like COPD and asthma, cardiovascular disease, stroke, complications from diabetes, dementia, and numerous forms of cancer. COPD is a particular focus for Achieve because 80% of all diagnosed COPD patients have this progressive disease as a result of smoking.
Rick Stewart: Thank you Jerry.
Rick Stewart: There are 16 million people in the U S. Currently suffering from smoking related diseases.
Rick Stewart: For every one death that smoking is responsible for 30 other people are living with diseases that have been closed as a result that is a staggering number.
Speaker Change: As I mentioned earlier, such as Sydney clean has a greater role in the treatment of nicotine dependent disease.
Speaker Change: The crucial in reducing the disease burden caused by smoking and related conditions, such as respiratory diseases, like COPD and asthma cardiovascular disease stroke complications from diabetes dementia numerous forms of cancer.
Speaker Change: COPD is a particular focus for cheap because 80% of all diagnosed COPD patients and at least progressive disease as a result of smoking.
Rick Stewart: Roughly 6 million Americans currently living with COPD continue to smoke. Abstinence from smoking reduces the number of exacerbations and hospitalizations, and there is increasing evidence that standard of care COPD drugs have greater efficacy in non-smokers than current smokers.
Roughly 6 million Americans currently living with COPD continue to smoke.
Speaker Change: Absent an SKU smoking reduces the number of exacerbations and hospitalizations and there is increasing evidence that standard of care COPD drugs have greater efficacy in non smokers than current smokers.
Rick Stewart: Our goal is to work with a COPD or asthma potential partner with greater resources and expertise than Achieve to exploit this potential. But for now, please do not misinterpret this statement as Achieve is losing focus. We are not. Nicotine dependence disease through smoking and vaping cessation is our core strategy. In time, we're also optimistic that Achieve will address the next potential nicotine dependence crisis in tobacco pouches.
Our goal is to work with COPD or asthma potential partner with greater resources and expertise and achieve to exploit this potential.
Speaker Change: But for now please do not misinterpret. This statement is achieved is losing focus we are not.
Speaker Change: Nicotine dependence disease to smoking vaping cessation is our core strategy.
Speaker Change: Time, we're also optimistic that achieve will address the next potential nicotine dependence crisis and tobacco pouches.
Rick Stewart: Our near term focus is executing according to the plan with NDA submission, acceptance and approval the priority, closely followed by the ORCA V2 Phase 3 clinical trial. Finally, commercial planning to fully optimize the cytosine-cycline opportunity in the U.S. The importance of nicotine-dependent treatment and Achieve's role in this fight is gaining recognition, and this is just the beginning.
Speaker Change: Our near term focus is executing according to the plan with NDA submission acceptance and approval the priority closely followed by the okay. The two phase III clinical trial.
Speaker Change: Finally, commercial planning to fully optimize the science you see seemingly an opportunity in the U S.
Speaker Change: The importance of nicotine dependence treatments and achieves role in this fine is gaining recognition and this is just the beginning.
Rick Stewart: Psychokinecline has been featured in many recent articles, including those in the New York Times and Time magazine, and I'd like to thank Emily Schmoll and Jamie Ducham for their interest in this global public health crisis and in Achieve. Thank you again for joining us today.
Speaker Change: Thank you Sidney claims has been featured in many recent schools, including those in the New York Times, and time magazine and I'd like to thank Emily Schmuhl and Jamie Duchamp for their interest in its global public health crisis and didn't achieve.
Speaker Change: Thank you again for joining us today I'll now turn the call over to the operator for questions.
Operator: I'll now turn the call over to the operator for questions. Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press the star key followed by 1 on your telephone keypad. A confirmation tone will indicate that your line is busy. You may press star 2 to remove a question. participants using speaker equipment. It may be necessary to pick up your handset before pressing the start key.
Speaker Change: Thank you at this time, we will be conducting a question and answer session. If he would like to ask a question. Please press the star key followed by one on your telephone keypad, a confirmation tone will indicate that your line is in the queue. You May press star two to remove a question from the queue for participants using speaker equipment.
Speaker Change: It may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Operator: One moment, please, while we poll for questions.
Thomas Flaten: And the first question comes from the line of Thomas Flaten with Lake Street Capital.
Speaker Change: And the first question comes from the line of Thomas Flaten with Lake Street Capital. Please proceed with your question Hey, good.
Jerry Wan: Please proceed with your question. Good afternoon. I appreciate you taking my questions and congrats on all the progress. Just a quick one for Jerry. Jerry, there was a spike in GNA in the third quarter. Were there one-time or non-recurring amounts in that $4.9 million? Thanks for the question, Thomas. That's correct. There were one-time charges this quarter relating to the executive restructure and associated severance costs. got it.
Speaker Change: Good afternoon I appreciate you taking my questions and congrats on all the progress just a quick one for Gerry Gerry just a spike in G&A in the third quarter were there onetime or nonrecurring amounts in that $4 9 million.
Speaker Change: Hi, Thanks for the question Thomas that's correct there were onetime charges this quarter relating to the executive restructure and associated severance costs.
Speaker Change: Got it.
Cindy Jacobs: And then, Cindy, if I may, you mentioned that all the patients that were enrolled in ORC-OL had come from prior studies. Would you be willing to share how many of those patients had prior exposure to cytosineclean and how many of them might have had a full 12 weeks? Yeah, actually it's pretty much similar to what the ratios were in the phase 3 trials. We basically have about a third that were on the 12-week arm and a third on the 6-week arm and a third in placebo.
Speaker Change: Cindy if I may you mentioned that all the patients that were enrolled in ortho well had come from prior studies would you be willing to share how many of those patients were had prior exposure decided to clean and how many that might've had a full 12 weeks.
Cindy Jacobs: Yeah actually it is pretty much similar to what the.
Cindy Jacobs: Our ratios were in the phase III trials. He basically I have about a third of that is where on the 12 week arm and a third on the six week arm and a third in placebo.
Cindy Jacobs: Excellent.
Speaker Change: Excellent I appreciate you taking my questions. Thank you.
Thomas Flaten: I appreciate you taking my question. Thank you.
Speaker Change: Thank you.
Justin Walsh: And the next question comes from the line of Justin Walsh with Jones Trading. Please proceed with your question. Hi, thanks for taking the questions. Sorry if I missed this. What are your expectations with respect to disclosing data from the ORCA OL trial? Do you expect...
Speaker Change: And the next question comes from the line of Justin Walsh with Jones trading. Please proceed with your question.
Speaker Change: Hi, Thanks for taking my questions I'm, sorry, if I missed this what are your expectations with respect to disclosing data from the Orca O. L trial do you expect that we'll get to see a complete presentation of the results of that before the NDA submission moves forward.
Cindy Jacobs: I'll hand that one over to Cindy.
Speaker Change: And that one that I would just Cindy.
Cindy Jacobs: Yeah, not at this time, actually, because it's an ongoing, we are not going to be presenting results at a meeting before submitting to the NDA. I think we'll probably be looking at what presentation or meeting that we could actually present after we submit the NDA. I mean at this point, focus on the Data Safety Monitoring Committee reviews that all the safety looks good and there are no safety concerns. Got it, thanks. And one more quick question. Obviously, smoking cessation is the near-term focus. I'm curious if any efforts have been made towards laying the groundwork. Yeah, Justin, I think the key here is keep focused on the smoking cessation opportunity.
Yeah not at this time actually because it's an ongoing we are not going to be presenting results at a meeting before submitting to the NDA I think we'll probably be looking at what presentation or some yep.
Speaker Change: Meaning that we could actually present.
Speaker Change: After we submit the NDA.
Speaker Change: I mean at this point.
Speaker Change: Focus on the data safety monitoring committee reviews that all the safety looks good and there are no safety concerns.
Speaker Change: Got it thanks, and one more quick question from me, obviously smoking cessation as the near term focus in terms of commercial preparations, but I'm curious if any efforts had been made towards laying the groundwork for a potential vaping cessation label expansion down the line.
Speaker Change: Yeah, Justin I think the key here is to keep it keep focused on the smoking cessation opportunity.
Speaker Change: And Jamie thinking terrific job in terms of scoping that opportunity in terms of the market.
Rick Stewart: And Jaime's doing a terrific job in terms of scoping that opportunity in terms of the market. But I think the vaping opportunity is increasing at a pretty dramatic rate as well, and I think trying to get a very firm grasp on the actual revenue potential for it is a dynamic situation.
Speaker Change: But I think the vaping opportunity is increasing at a pretty dramatic race as well and I think trying to get a very firm grasp on.
Speaker Change: The actual kind of.
Speaker Change: The revenue potential for it is a dynamic.
Speaker Change: The situation.
Rick Stewart: But once we've got the commercial structure in place for smoking cessation, we'll expand it into vaping cessation.
Speaker Change: But they they once we've got the commercial.
Speaker Change: Our structure in place for smoking cessation, we will expand it into that.
Speaker Change: Cessation.
Speaker Change: Great. Thanks for taking my question.
Francois Brisebois: And the next question comes from the line of Francois Brisebois with Oppenheimer.
Speaker Change: And the next question comes from the line of Francois Brisbois with Oppenheimer. Please proceed with your question.
Francois Brisebois: Please proceed with your question. Hi, thanks for taking our questions.
Speaker Change: Alright, thanks for taking our questions. This is Dan on for Frank.
Francois Brisebois: This is Dan on for Frank. I guess, firstly, with regards to the ORCA OL, once the data analysis is completed, are there any additional steps needed before submission? Do you need any more pre-submission meetings? Or does the positive feedback from the DSMC so far provide confidence that you are all set for the NDA submission? Basically, any additional steps needed before submission.
Speaker Change: I guess, firstly with regards to the Oh L. Once the data analysis is completed are there any additional steps needed before submission do you need any more.
Speaker Change: He used to measure meetings or does the positive feedback from the DSM, Steve So far provide confidence that you are all set for the NDA submission basically any additional steps needed before submission.
Rick Stewart: I think the key here is going to be the step process, you know, once the Orca OL six-month data with 300 patients is complete, as Cindy said on the call, we're going to have to monitor the data, effectively put it into the ISS and then insert that into the NDA and then do a full quality control on the actual NDA itself, and hence, you know, late January, early February for the completion of the 300 patients at six months, and then, you know, step process through that to the NDA submission. In the meantime, obviously, you know, the 100 patients at 12 months will be ongoing, so that is roughly the plan.
I think the key here is going to be the step process once the Olga O L E.
Speaker Change: Six month data with 300 patients is complete.
Speaker Change: As Cindy said on the call we're gonna have to monitor the data.
Speaker Change: It's effectively put it into the ISS.
Speaker Change: And then insert that into the NDA and then do a full quality control the actual NDA itself.
Speaker Change: Late January early.
Speaker Change: February for the completion of the 300 patients at six months.
Speaker Change: And then step process to that to the NDA submission in the meantime, obviously, yeah. The 100 patients at 12 months will be ongoing so.
Speaker Change: That is roughly the plan.
Francois Brisebois: Great, thanks for taking the question.
Speaker Change: Great. Thanks for taking my question.
John Vandermosten: And the next question comes from the line of John Vandermosten with Zach's Small Cap Research. Please proceed with your question. Great. Thank you, and good afternoon, everyone.
Speaker Change: And the next question comes from the line of John Zander Marston with Zacks small cap research. Please proceed with your question.
Speaker Change: Great. Thank you and good afternoon, everyone and Jamie Congratulations on your role as C. C O you.
John Vandermosten: And Jaime, congratulations on your role as CCO. You hired Dr. Rubenstein about a little bit over a month ago, and I'm just wondering what he has been able to add to the strategy discussion so far, and perhaps some of that was already discussed, but I'd like to hear kind of what he's been delivering to the table. Yeah, I'd be happy to answer that. Oh, go ahead, Greg. I was just going to say, if I can add, and I'll hand it over to Jaime, I think it's been a terrific addition because his experience and insights as a practitioner and being in the nicotine-dependent space for many, many years has really allowed us to really hone in on some of the messaging.
Speaker Change: You hired Dr Rubenstein.
Speaker Change: But over a month ago and I'm. Just wondering you know what he has been able to add to the you know the strategy.
Speaker Change: Discussions so far and perhaps some of that was already discussed, but you know I like to hear kind of what he's been able to bring to the table yeah.
Speaker Change: Oh go ahead Greg.
Speaker Change: I was just going to say if I can add.
Speaker Change: Jamie I think he's been a terrific addition, because you know his experience and insights.
Speaker Change: As a practitioner and B I mean being in the nicotine dependence space for many many years.
Speaker Change: It really allowed us to really hone in on some of the the messaging. So I think it's been a great addition, so well know how that one I wish Jamie Yeah, sorry, Rick Thanks, John.
Rick Stewart: So I think it's been a great addition.
Jaime Xinos: So I'll now hand that one over to Jaime. Yeah, sorry, Rick. Thanks, John. I absolutely agree with Rick. I mean, Mark's ability to go out and talk to his peers to get insights for us that will help inform future positioning and messaging, as well as the medical education strategy and the need. So he's able to help us think about publication planning, where we need to be submitting data, and how we need to be talking to And he's, you know, again, like as Rick mentioned, he also has a different insight because he's treated patients. And so he knows what some of the hurdles and challenges are to getting them.
Speaker Change: Absolutely agree with Rick I mean, mark the ability to go out and talk to his peers to get insights for us that will help inform future positioning and messaging as well the the medical education strategy and the need so he's able to help us think about publication planning, where we need to be submitting data and how we need to be talking to.
Speaker Change: Potential prescribers and again like as Rick mentioned, he also has a different insight because he has treated patients and so he knows what some of the hurdles and challenges are to getting them to consider taking medications and and and helped us to understand how we need to be speaking to patients as well.
Jaime Xinos: consider taking medications and helped us to understand how we need.
Speaker Change: Okay, great and thank you for the the further refinement on the on the start of the Vaping trial is there any idea how much that'll cost and kind of the flow of of cost as as that as we move into you know mid 2025.
Jaime Xinos: Okay, great. And thank you for the refinement on the start of the vaping trial. Is there any idea how much that'll cost and kind of the flow of cost as we move into mid-2025? Yeah, I think likely it's going to be similar to previous phase 3 trials, but I think we can get better guidance on that after the FDA agreement is met on the protocol side, etc. But I think as a bellwether, I'd look at something similar to the previous phase 3. Great, thank you.
Speaker Change: Yeah, I think it likely is going to be similar to the previous phase III trials.
Speaker Change: But I think we can give better guidance on that.
Speaker Change: FTA agreements is match on the protocol side et cetera, but I think as a bellwether I'd look at something similar to the previous phase threes.
Speaker Change: Okay, great. Thank you.
Gary Nachman: And the next question comes to the line of Gary Nachman with Raymond James. Please proceed with your question. My first question is, you mentioned vaping, potentially setting that down to the adolescent population. What might a trial look like there?
And the next question comes from the line of Gary Nachman with Raymond James. Please proceed with your question.
Speaker Change: That's my first question is.
Speaker Change: You mentioned vaping potentially extending that down to the adolescent population.
Speaker Change: A trial look like there what kind of special considerations or you're going to have to take into account to get that.
Cindy Jacobs: What kinds of special considerations are you going to have to take into account to get that, you know, adolescent teen population? Obviously, there's a big need there. And then also, you mentioned nicotine pouches as well. That's another use case that's been growing. What would that look like? And could that be combined with vaping?
Speaker Change: Adolescent children population, obviously, there's a big need there and then also you mentioned.
Speaker Change: Nicotine pouches as well that's another.
Speaker Change: Use case, that's growing what would that look like and not <unk>.
Speaker Change: That could be combined with feedback.
Yeah, I'll hand that question over to Sandy in terms of the pediatrics.
Cindy Jacobs: I'll hand that question over to Cindy in terms of the pediatrics. Yeah, we'll be focusing on getting the Phase III completed in adults 18 years and older. And one of the discussions we'll have with FDA as we proceed toward this clinical development is we will need to agree on what is called a Pediatric Study Plan. And that will be when we'll have more discussions with FDA on a possible adolescent trial, what that would look like, the timing of that, and the ability to do that. So that will be future discussions with FDA in regards to adolescents younger than 18.
Speaker Change: Yeah, we'll be focusing on getting the phase three completed in adults 18 years and older.
Speaker Change: And one of the discussions we'll have with FDA as we proceed toward this clinical development as we will need to agree on what is called a pediatric study plan and that what that will be when it will have more discussions with FDA on a possible adolescent trial, but that would look like the timing of that.
Speaker Change: That and the ability to do that so that will be future discussions with FDA in regards to adolescence younger than 18.
Rick Stewart: I'll take the question about the tobacco pouches. I think the key here, Gary, is it almost seems that you have one nicotine-dependent product after another, where initially, obviously, everything was focused on combustible cigarettes. Then we moved on to vaping and starting to understand some of the issues that are related to vaping. Then, as soon as that is acknowledged, we're now looking at tobacco pouches. I think, for now, our focus is really on getting the ORCA V2 Vaping Phase 3 up and running, during which time we'll be able to start to assess how you address the tobacco pouches.
Speaker Change: Oh I'll take the question about the tobacco patches I think the key here Gary is it only seems that you have one nicotine dependence a product after another way initially obviously everything is focused on.
Speaker Change: Cigarette combustible cigarettes, then we moved on to vaping and starting to understand some of the issues as it related to vaping.
Speaker Change: As soon as that is acknowledged we're now looking at tobacco patches.
Speaker Change: I think for now our focus is really on.
Speaker Change: Getting the Oh, Okay V to vaping phase III up and running I wish joining waste time, we'd be able to start to assess how you address the tobacco patches, but it's certainly on our radar screen, but I think the priority. One is obviously the NDA submission for smoking cessation.
Rick Stewart: It's certainly on our radar screen, but I think the priority one is, obviously, the NDA submission for the smoking cessation, then the vaping phase, Phase 3, and then we'll move on to tobacco pouches. Thanks.
Speaker Change: Then debating phase.
Speaker Change: Three and then we'll move on to tobacco pouches.
Speaker Change: Thanks, and I just had one follow up question as well.
Gary Nachman: And I just had one follow-up question as well.
Rick Stewart: Do you have any updates you could share on the potential synthetic cytosine aqueen development process, you know, where that timeline is, if there's anything you have to share? And then, what would the regulatory process getting that approved look like at all? Yeah, I mean, that's an ongoing process. As you know, we've tried on multiple occasions to crack the synthetic. We continue to make progress on that front.
Speaker Change: Do you have any updates you could share on the potential synthetic citizen at Queen development process, where that timeline is if theres anything you have to share and then what.
Speaker Change: The regulatory process getting that approved looked like at all.
Speaker Change: Yeah.
Speaker Change: Yeah, I mean, that's an ongoing process as you know we've tried multiple.
Speaker Change: Multiple occasions too to crank the the synthetic.
Speaker Change: We continue to make progress on that front.
Gary Nachman: But I think the best thing to do is we'll keep you updated when we've got something more to say about that one. Okay. Thanks for taking my questions. Congrats on the quarter. Thank you.
Speaker Change: But I think the best thing to do is we will keep you updated.
Speaker Change: When we go something more to say about that one okay.
Speaker Change: Thanks for taking my questions congrats on the quarter.
Speaker Change: Thank you.
Boris Tolkachev: And the next question comes from the line of Boris Tolkachev with Freedom Broker. Please proceed with your question. Good afternoon, everyone. Thanks for taking the question. Initially, you planned to include 650 patients, but actual enrollment was completed with 20% fewer participants.
Speaker Change: And the next question comes from the line of Boris <unk> with Freedom broker. Please proceed with your question.
Good afternoon, everyone. Thanks for taking the question.
Speaker Change: Usually you plan to include 600 patients, but actual enrollment was completed with the <unk>.
Speaker Change: 20% fewer participants could you give some clarification regarding the decision to decrease the debt number.
Cindy Jacobs: Could you give some clarification regarding the decision to decrease that number and as the Orca oil study continues, is there a risk that the discontinuation rate will be higher as participants become more and more less and less motivated to stay in therapy? Are there any strategies employed to maintain engagement? Thank you.
Speaker Change: As the Orca oil study continues is there a risk that the discontinuation rates will be higher.
Discipline has become more and more but less and less motivated to stay on therapy are there any strategies employed to maintain.
Speaker Change: Engagement. Thank you.
Speaker Change: Alright, thanks, Brian So I'll hand that one I would just Cindy.
Cindy Jacobs: Thanks Boris, I'll hand that one over to Cindy. Sure, we had put in 650 as the maximum, not sure that we actually needed it. When we started to get to 450 and the early discontinuation rate was so low, that's where then we decided to go ahead and cap enrollment under 500. The early discontinuation rate remains very low, so we don't have concerns that we won't be able to achieve 300 subjects at a cumulative six months and 100 for one year. Regarding the one year, we do have kind of retention programs at all the 29 sites for the subjects, and obviously right now we kind of view that they're working as far as the discontinuation rate continues to remain very low.
Cindy Jacobs: Sure we had to put in 650 is the maximum not sure that we actually needed. It when we are starting to get to 450 and the discontinuation early discontinuation rate was so low that's where then we decided to go ahead and cap enrollment under 500.
Cindy Jacobs: Read the disc in early discontinuation rate remains very low. So we don't have concerns that we wont be able to achieve 300 subjects had cumulative six months and 100 for one year.
Cindy Jacobs: Regarding the one year, we do have kind of retention programs at all of the 29 sites for the subjects and obviously right now we kind of view that they're working as far as the discontinuation rate continues to remain very low.
Boris Tolkachev: Okay, thank you so much.
Speaker Change: Okay. Thank you so much.
Thomas Flaten: And the next question comes from the line of Thomas Flaten with Lake Street Capital. Please proceed with your question. Hey guys, thanks for letting me back in. Cindy, I was just looking at my notes and I just want to confirm, you said that following the 74-day letter, you would have, did you say 10 or 12-month review process? I wrote down 12, but I think you meant 10 or did I misunderstand that? Yeah, it's 12 months total from the time we submit, but in 74 days from submitting, that's when FDA accepts the NDA. No, no problem.
Speaker Change: And the next question comes from the line of Thomas Flaten with Lake Street Capital. Please proceed with your question.
Speaker Change: Yeah, Hey, guys. Thanks for letting me back in Cindy I was just looking at my notes and I. Just wanted to confirm you said that following the 74 day letter you would have did you say 10 or 12 month review process I broke down 12, but I think you meant 10 or did I misunderstand that yeah. Its 12 12 month's total him from the time, we submit but in 74 days from submitting.
Speaker Change: That's when the FDA accepts the N D a.
Yes.
Speaker Change: Yeah, Yeah got it all right.
Speaker Change: No no no no no problem and then.
Rick Stewart: And then for Rick or Cindy, I know we talked previously about leveraging some non-dilutive financing from the NIH to fund the vaping study. Is that still on the cards or should we think about that coming out of internal cash? You know, that's definitely still on the cards. I mean, I think once we've actually scoped out the size and the protocol related to the vaping study, we'll be able to engage more fully. So, definitely still on the cards.
Speaker Change: For Rick or Cindy I know, we've talked previously about liberating some leveraging some non dilutive financing from.
Speaker Change: From the NIH to fund the <unk> study is that still on the cards or should we think about that coming out of internal cash.
Speaker Change: No that's definitely still on the cards.
Speaker Change: What once we've actually scoped out the size on the protocol related to the <unk> study will be able to engage more fully.
Speaker Change: It's definitely still on the cards.
Thomas Flaten: Great. Thanks again.
Speaker Change: Great. Thanks again.
Rick Stewart: And at this time there are no further questions and I would like to turn the floor back over to Rick Stewart for any closing comments. Well, thank you. We are in exciting times. As the NDA submission to smoking cessation approaches, we're making tremendous progress on a quarter-by-quarter basis. Yeah, obviously, the priority and the focus in the near term is that NDA submission.
Speaker Change: And at this time there are no further questions now I'd like to turn the floor back over to Rick Stewart for any closing comments.
Rick Stewart: Well thank you.
Speaker Change: Exciting times.
Speaker Change: As the NDA submission for smoking cessation approaches, we're making tremendous progress on a quarter by quarter basis.
Speaker Change: Yeah, obviously, the priority and the focus in the near term is that NDA submission and as Cindy said with we're targeting the second quarter of 2025.
Rick Stewart: And as Cindy said, we're targeting the second quarter of 2025. But the role of cytosinecline in the public health crisis in the U.S. with nicotine dependence is significant. There are over 40 million Americans suffering from nicotine independence. And as Jaime said, yeah, we're privileged to be in a position to be able to actually do something about that. We can alter the lifespan of millions of Americans by getting them to cease nicotine dependence. And cytosinecline will be the first new product in nearly 20 years, offering hope to nicotine dependence patients, not just in the U.S., but up to a billion globally.
Speaker Change: So the role of <unk> in the public health crisis in the U S with nicotine dependence is significant.
Speaker Change: There are over 40 million Americans suffering from nicotine independence, and as Jamie said, yeah, we're privileged to be in a position to be.
To be able to actually do something about that we can also they the lifespan of millions of Americans by getting to see some nicotine dependence.
Speaker Change: And so that's a clinically and will be the first new product in nearly 20 years offering hope to nicotine dependence patients not just in the U S, but up to 1 billion globally. So yeah, we like to thank you again for your continuing support of the company and we look forward to updating you.
Operator: So, yeah, we'd like to thank you again for your continuing support of the company. And we look forward to updating you on the fourth quarter call. Thank you.
Nicole Jones: On the fourth quarter Nicole Thank you.
Nicole Jones: Okay.
Operator: And ladies and gentlemen, that does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: And ladies and gentlemen that does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
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