Q4 2024 Achieve Life Sciences Inc Earnings Call

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Greetings and welcome to be achieved Lifesciences fourth quarter and year end 2024 earnings call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.

Operator: Greetings and welcome to the Achieve Life Sciences fourth quarter and year-end 2024 earnings call and webinar. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

Operator: As a reminder, this conference is being recorded.

As a reminder, this conference is being recorded.

Operator: I would now like to turn the conference over to your host.

I'd now like to turn the conference over to your host.

Speaker Change: Nicole Jones achieve Investor relations. Thank you you may begin.

Nicole Jones: Nicole Jones, Achieve Investor Relations. Thank you. You may begin.

Speaker Change: Thank you operator, good morning, everyone and thank you for joining us today.

Rick Stewart: Life Sciences. Thank you, Operator. Good morning, 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, Mark Occhi, Chief Financial Officer, Jamie Xinos, Chief Commercial Officer, and Jerry Wan, Vice President of Finance and Principal Accounting Officer.

I'm, a cheap life Sciences, where it's only five ex Joy Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Mark Oki, Chief Financial Officer.

Speaker Change: Jamie its chief commercial officer, and Jerry One Vice President of finance and accounting off with that and I said that will be available for Q&A session. Following our prepared remarks.

Speaker: Management will be available for a Q&A session following our prepared remarks.

Speaker: As a reminder, a replay will be available later today by using the information provided in the earnings press release issued prior to this call or visiting the Achieve website.

Speaker Change: As a reminder, a replay will be available later today by using the echinacea provided in the earnings press release issued prior to this call our visibility of cheap website.

Speaker: Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions, and projections as projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast reply. Actual results may differ materially as a result of risk, uncertainties, and other factors, including, but not limited to, the factors set forth in the company's filings with the Achieve undertakes no obligation to update or revise any of these forward-looking statements.

Speaker Change: Today's conference call will contain certain forward looking statements, including statements regarding the goals strategies beliefs expectations.

Speaker Change: What's your potential operating result for the team.

Speaker Change: Although management believes these statements are reasonable based on estimates assumptions and projections as projections as of today.

Speaker Change: Statements are not guarantees of future performance.

Speaker Change: Time sensitive information may no longer be accurate at the time of any telephonic or webcast replay actual results may differ materially as a result of risks uncertainties and other factors, including but not limited to the factors set forth in the company's filings with the FTC Ashish.

Speaker Change: <unk> undertakes no obligation to update or revise any of these forward looking statements.

Speaker: Please research Achieve documents available on our website and files with the SEC concerning factors that could affect the company.

Speaker Change: P. J, it's birch achieved documents are available on our website and filed with the SEC concerning factors that could affect the company.

Rick Stewart: I'll now turn the call over to Rick. Thank you, Nicole, and good morning. It's great to be with you today at this exciting time for Achieve. Achieve expects to submit the NDA for cytosinecline as a treatment for nicotine dependence for smoking cessation with the FDA at the end of next quarter. Cytosinicline will be the first new drug for nicotine dependence in nearly 20 years and will provide patients and doctors with a desperately needed new tool to combat the impact of nicotine dependence for cigarette smoking and vaping. All of our resources are now dedicated to a successful NDA submission, acceptance, and approval.

Rick: I'll turn the call over to Rick.

Rick: Thank you Nicole and good morning, it's great to be with you today at this exciting time to achieve.

Speaker Change: But she expects to submit the NDA for thank you Sidney clean as a treatment for nicotine dependence for smoking cessation with the FDA at the end of next quarter.

Speaker Change: Sorry could you cynically will be the first new drugs for nicotine dependence and nearly 20 years.

Speaker Change: Provide patients and doctors with a desperately needed Youtube to combat the impact of nicotine dependence for cigarette smoking vaping.

Speaker Change: All of our resources are now dedicated to a successful NDA submission acceptance and approval execution of the successful submission is critical.

Rick Stewart: Execution of the successful submission is critical. There's an increasing urgency for new nicotine-dependent treatments because existing treatments are either less effective or have side effects that deter compliance. This, combined with the rapid expansion of vaping and nicotine pouches, puts greater emphasis on the importance of Achieve's mission and the role of cytosinecline to become the only nicotine-dependent product being promoted to healthcare providers. The health risks of smoking are well established, and vaping perils are only now starting to become evidence, with lung injury and disease being seen in a much younger population.

Speaker Change: There is an increasing urgency for noon nicotine dependence treatments because the existing treatments are either less effective.

Speaker Change: Side effects, that's due to compliance.

Speaker Change: This combined with the rapid expansion of vaping and nicotine patches.

Speaker Change: Greater emphasis on the importance of achieves mission and the role of sites you cynically to become the only nicotine dependence product being promoted to health care providers.

Speaker Change: The health risks of smoking, a well established and vaping perils are only now starting to become evident with lung injury and disease being seen in a much younger population.

Rick Stewart: We're extremely proud of the progress we have made in 2024 toward bringing cytosinecline to patients and doctors with a planned commercial launch in the third quarter of 2026. With each milestone met, our confidence and momentum grow as we work to solve this challenging public health crisis while creating long-term shareholder value. Looking back at 2024, we've hit some key milestones that are driving us toward the next stages of development and commercial launch. Here's a quick recap of those accomplishments. We completed enrollment in the ORCA Open Label Long-Term Safety Exposure Clinical Trial and reached the requirement of at least 300 participants receiving six months of cumulative cytosine cleaning treatment, which was a necessary step required by the FDA for submission of the NDA.

Speaker Change: We're extremely proud of the progress we have made in 2020 full toward bringing <unk> to patients and doctors with a planned commercial launch in the third quarter with 2026 with each milestone macs confidence and momentum grow as we work to solve these challenges.

Speaker Change: Public health crisis.

Speaker Change: Creating long term shareholder value.

Speaker Change: Looking back at 2024, we've hit some key milestones that are driving us toward the next stages of development and commercial launch Here's a quick recap of those accomplishments.

Speaker Change: We completed enrollment in the Orca open label long term safety exposure clinical trial and reached the requirement of at least 300 participants receiving six months of cumulative signs you're seeing of getting treatment.

Speaker Change: Which was unnecessary.

Speaker Change: Step required by the FDA for submission of the NDA.

Rick Stewart: We also receive breakthrough therapy designation to cytosinecline as a treatment for vaping cessation. We completed the end of Phase 2 meeting with the FDA for vaping cessation as a future indication, which included agreement on the design of a Phase 3 trial.

Speaker Change: We also received breakthrough therapy designation, just thank you Sidney clean as a treatment debating cessation.

Speaker Change: We completed the end of phase II meeting with the FDA for vaping sensation as the future indication, which included agreement on the design of a phase III trial, we strengthened our leadership team with the hire of a CFO Mark oki to oversee our financial strategy and operational initiatives.

Rick Stewart: We strengthened our leadership team with the hire of our CFO, Mark Oakey, to oversee our financial strategy and operational initiatives. We appointed Dr. Kristen Slaoui and Nancy Phelan to the board of directors, bringing extensive leadership experience in corporate strategy and commercialization. And finally, we advanced our commercial readiness effort. The steps we've been taking all year bring us to where we are today, transitioning from a clinical company towards a commercial one. As a reminder of our mission, nicotine dependence is one of the most pressing yet underserved public health crises of our time, claiming lives, driving severe comorbidities, and burdening the U.S.

Speaker Change: We appointed adult Christians loudly and Nancy feeling to the board of directors, bringing extensive leadership experience in corporate strategy and commercialization and finally, we advanced our commercial readiness efforts.

Speaker Change: The steps, we've been taking old yeah, bringing us to where we are today transitioning from a clinical company towards a commercial one.

Speaker Change: As a reminder of our mission nicotine dependence is one of the most pressing yet understood public health crises.

Speaker Change: Time, claiming lives driving severe comorbidities and burdening the U S health care system with over $300 billion in costs annually.

Rick Stewart: healthcare system with over $300 billion in costs annually. By some reports, nicotine is the third most addictive drug, trailing only heroin and cocaine. Let that sink in for a moment. Right now, 29 million Americans are battling nicotine dependence with 15 million attempting to quit each and every year. Yet, most fail. Not for a lack of willpower, but because available treatment options are inadequate. There have been no new FDA-approved products for the treatment of nicotine dependence in nearly 20 years. Instead, multiple new nicotine delivery systems have been put on the market, all effectively enhancing nicotine dependence rather than decreasing or stopping it.

Speaker Change: By some reports nicotine is the third most addictive drug trailing only heroin and cocaine.

Speaker Change: Sink in for a moment.

Speaker Change: Right now 29 million Americans are battling nicotine dependence with 15 million attempting to quit each and every year.

Speaker Change: Yet most fail.

Speaker Change: Not for a lack of willpower, but because available treatment options are inadequate.

Speaker Change: There'll be no new FDA approved products for the treatment of nicotine dependence in nearly 20 years instead multiple new nicotine delivery systems have been put on the market all effectively in hunting nicotine dependence rather than decreasing or stopping it.

Rick Stewart: It is time to recognize nicotine dependence for what it truly is, a medical condition, not a moral failing. Millions are being left behind to deal with their nicotine dependence without the effective tools they need to quit, and that must change in the same way that the GLP-1s changed the treatment for obesity.

Speaker Change: It is time to recognize nicotine dependence for walk you truly is.

Speaker Change: Medical condition, the other moral failing.

Speaker Change: Millions of being left behind to deal with that nicotine dependence without the effective tools they need to quit and that must change in the same way that the G. L. P ones change the treatment for obesity.

Speaker Change: We're excited about the milestones we've accomplished and have reached a pivotal moment for the company to provide more details on our next steps, including updates on the Orca O L trial, and the NDA submission timing I'll turn it over to Cindy.

Rick Stewart: We're excited about the milestones we've accomplished and have reached a pivotal moment for the company.

Cindy Jacobs: To provide more details on our next steps, including updates on the ORCA OL trial and the NDA submission timing, I'll turn over to Cindy. Thank you, Rick. We continue to make tremendous progress and have kept the momentum toward our goals into the start of this year. We are fast approaching a major milestone, filing our cytosine equivalent NDA. We're in the final stages of preparing our NDA submission with accomplishing a last key requirement, the additional long-term safety exposure data from the open-label ORCA-OL safety trial. In under five months, this trial enrolled 479 participants across 29 trial sites in the United States, underscoring our team's efficiency and commitment.

Cindy: Thank you Rick.

Cindy: Continuing to make tremendous progress and have kept the momentum toward our goal and at the start of this year.

Cindy: We're fast approaching a major milestone filing arthritis clinical an NDA.

Cindy: We're in the final stages of preparing our NDA submission with accomplishing our last key requirement.

Cindy: The additional long term safety exposure data from the open label work, Oh Wow safety trial.

Cindy: Under five months. This trial enrolled 479 participants across 29 trial sites in the United States underscoring our team's efficiency and commitment.

Cindy Jacobs: In January, we successfully reached the critical milestone of treating 300 subjects with cytosinuclein for a cumulative six months. meeting one of the FDA's requirements for the submission. Additionally, we continue to collect for the long-term cumulative one-year exposure safety data on at least 100 subjects during the open-label trial, which we expect to reach in the second quarter of 2025. And we'll submit that safety data with a standard 120-day safety update to be submitted during the NDA review period. Both the first and second Data Safety Monitoring Committee's review of the open-label safety data reaffirmed excellent cytosine adherence with no safety concerns reported and no modifications required in the conduct of the study.

Cindy: In January we successfully reached a critical milestone of treating 300 subjects Society Senate, Glenn correct me or 10 months.

Cindy: Meeting one of the Fda's requirement for the submission.

Cindy: Additionally, we continue to collect as a long term can you or do you have one year expose your safety data on at least 100 subjects during the open label trial.

Cindy: Which we expect to reach in the second quarter of 2025.

Cindy: And well from that that safety data with the standard 120 day safety update to be submitted during the NDA review period.

Cindy: Well the first and second data safety monitoring Committee review of the open label safety data reaffirmed excellent clinical and adherence with no safety concerns reported.

Cindy: No modifications required in the conduct of the study.

Cindy Jacobs: With these various milestones completed, we have now begun the rigorous three-month process of finalizing the safety database for the cumulative six-month exposure data, and we'll be integrating the safety data into our NDA documents. As the documents have finalized, we have been conducting quality audits on them and placing them into the NDA backbone structure. For example, all phase one, phase two, and phase three clinical study reports have been audited, finalized, and are already in the backbone structure. We are now in the process of finalizing the various summary of efficacy documents, and we will then turn our attention on finalizing the summary of safety documents.

Cindy: With these various milestones completed we have now begun the rigorous three months process of finalizing our safety database for the cumulative six month exposure data and we'll be integrating the safety data into our NDA document.

Cindy: Ask the documents are finalized.

Cindy: Quality audits on them and placing them into the N V a backbone structure.

Cindy: For example, all phase one phase two and phase three clinical study reports have been audited finalized and are already in the backbone structure. We are now in the process of finalizing the various summary of efficacy documents and we will then turn our attention on finalizing a summary.

Cindy: Thanks He documents.

Cindy Jacobs: We remain fully confident in our ability to file as planned and bring this important smoking cessation treatment to market.

Cindy: We remain fully confident in our ability to file a plan and bring this important smoking cessation treatment to market.

Cindy: Regarding bringing unimportant vaping cessation treatment to the market.

Cindy Jacobs: regarding bringing an important vaping cessation treatment to the market. Last December in 2024, we had our end of phase two meeting to discuss advancing cytosine indication as a potential first-in-class treatment for e-cigarette or vaping cessation. Based on this meeting, FDA has agreed on our proposed Phase III study design for the treatment of vaping cessation and on the requirements for submitting a supplemental NDA to expand cytosineclin as a treatment for vaping cessation. Specifically, FDA agreed that one well-controlled Phase III trial, ORCA V2, in addition to achieved completed Phase II, ORCA V1 trial, would be acceptable for a vaping cessation indication.

Cindy: Last December in 2024, we had our end of phase two meeting to discuss advancing cited cynic one's indication as a potential first in class treatment for E cigarettes, and vaping cessation.

Cindy: Based on this meeting FDA has agreed on our proposed phase III study design for the treatment of vaping cessation and on their requirements for submitting a supplemental NDA to expand side its been a glen as a treatment prevailing cessation.

Cindy: Specifically FDA agreed that one well controlled phase III trial <unk>. Two in addition to achieve completed phase two or it could be one trial would be acceptable for vapor to sanction indication.

Cindy Jacobs: Additionally, we received agreement that the overall safety exposure data being currently collected in the ongoing ORCA OL study would be adequate for the label expansion. As a reminder, in July 2024, the FDA grants a breakthrough therapy designation for this indication.

Cindy: Additionally, we received agreement that the overall safety exposure data being currently collected in the ongoing Orca O L study would be adequate for the label expansion.

Cindy: As a reminder, in July 2020 for the FDA granted breakthrough therapy designation for this indication.

Cindy: And looking ahead and ensuring that our focus on cash resources are directed towards the NDA for smoking cessation.

Cindy Jacobs: in looking ahead and ensuring that our focus and cash resources are directed towards the NBA for Smoking Cessation. We will be looking to initiate the Phase 3 ORCA V2 clinical trial for vaping cessation within the first half of 2026, dependent on financing. We're confident that cytosinequin is on track to be the best-in-class treatment for nicotine dependence and smoking cessation, where there hasn't been a new FDA-approved treatment in nearly 20 years. We will continue to work diligently to get this product to the market for the millions of people who want to end their dependence on nicotine.

Cindy: Well, you'll be looking to initiate the phase III or cause the two clinical trials of April cessation within the first half of 'twenty 'twenty set dependent on financing.

Cindy: We're confident that flat as Pentagon is on track to be the best in class treatment for nicotine dependence and smoking cessation, where there hasn't been a new FDA approved treatment in nearly 20 years.

We will continue to work diligently to get this product to the market for the millions of people, who want to and their dependence on nicotine.

Jaime Xinos: I'll now pass it over to Jaime for a commercialization update. Thank you, Cindy, and good morning, everyone. We continue to make great progress advancing critical commercial activities required both for the NDA and for launch readiness. Beginning with the commercial NDA requirements, we've worked closely with Cindy and her team to develop a draft product label that effectively highlights the differentiated efficacy and safety profile of cytosine. This cross-functional effort, including commercial team engagement, is critical, as the label will serve as the foundation for future promotional and educational messaging. We have also finalized the details for packaging to be included in the submission and have completed the review and request for proposal process for selection of our third-party logistics or 3PL partner.

Jamie: I'll now pass it over to Jamie for a commercialization update.

Jamie: Thank you Cindy and good morning, everyone. We continued to make great progress advancing critical commercial activities required both for the NDA and for launch readiness beginning with the commercial NDA requirements. We've worked closely with Cindy and her team to develop a draft product label, but effectively highlight the differentiated efficacy and safety profile.

Speaker Change: Cytostatic clean.

Speaker Change: This cross functional effort, including commercial team engagement is critical as the label will serve as the foundation for future promotional and educational messaging.

Speaker Change: We've also finalized the details for packaging to be included in the submission and have completed their review and request for proposal process for selection of our third party logistics or three PL partner.

Jaime Xinos: We expect to make our final decision and sign our letter of intent in the coming weeks.

Speaker Change: We expect to make our final decision and find out a letter of intent in the coming weeks. So to summarize we remain on schedule for the commercial activities required for the NDA submission.

Jaime Xinos: So to summarize, we remain on schedule for the commercial activities required for the NDA submission. Our current launch readiness efforts are centered on three key priorities, awareness, access, and availability, all built on a foundation of measurability to ensure impact and effectiveness of spend. We've established partnerships with leading strategic healthcare agencies with deep expertise in our areas of focus. Over the past quarter, we've been onboarding our agency partners, refining our launch roadmap, and initiating high-priority projects that require immediate action due to long lead times. Aligned with our key priorities, particularly availability and access. As we are advancing our 3PL selection process, we are simultaneously evaluating our distribution channel strategy.

Speaker Change: Our current launch readiness efforts are centered on three key priorities awareness access and availability all built on a foundation of measure ability to ensure impact and effectiveness of spend we've established partnerships with leading strategic health care agencies with deep expertise in our areas of focus.

Speaker Change: Over the past quarter, we've been Onboarding, our agency partners and refining our launch roadmap and initiating high priority projects that require immediate action due to long lead times.

Speaker Change: Aligned with our key priorities, particularly availability and access.

Speaker Change: We are advancing our three PL selection process, we are simultaneously evaluating our distribution channel strategy. Our objective is to ensure that every script written translate into a script filled ensuring tools are in place to mitigate any potential barriers to access.

Jaime Xinos: Our objective is to ensure that every script written translates into a script filled, ensuring tools are in place to mitigate any potential barriers to access. We will begin engaging with payers to assess future pricing and contracting requirements. This includes shaping how we communicate the value proposition of cytosine and providing the necessary evidence to support that value. Our goal is to initiate formal discussions with payers well in advance of launch through pre-approval information exchange, ensuring a smooth market entry.

Speaker Change: We will begin engaging with payers to assess future pricing and contracting requirements. This is.

Speaker Change: Crude shaping how we communicate the value proposition of cider Sena clean and providing the necessary evidence to support that value. Our goal is to initiate formal discussions with payers well in advance of launch since your preapproval information exchange, ensuring a smooth market entry.

Jaime Xinos: Finally, regarding our third pillar, ensuring appropriate awareness as we approach launch is crucial. As I mentioned on our last call, our plan will rely heavily on data-driven insights to precisely target and deliver messaging to healthcare providers who are actively prescribing high volumes of smoking cessation treatments and to patients who are motivated to quit. In recent months, we have further refined our patient segmentation and have deeper insight on where to focus our patient awareness launch initiatives. Likewise, with prescribers, our awareness efforts will initially be dedicated on high-volume varenicline prescribers. We believe Cytosinacline's profile will resonate well with these providers and be a compelling alternative to currently available treatments.

Speaker Change: Finally regarding our third pillar, ensuring appropriate awareness as we approach launch is crucial as I mentioned on our last call. Our plan, who rely heavily on data driven insights to precisely target and deliver messaging to health care providers, who are actively prescribing high volumes of smoking cessation treatment and the patients who are motivated to quit.

Speaker Change: Recent months, we have further refined our patient segmentation and have deeper insight on where to focus our patient awareness watch initiatives.

Speaker Change: Likewise with prescribers our awareness efforts will initially be dedicated on high volume Varenicline prescribers, we believe datacenter clean profile will resonate well with these providers and be a compelling alternative to currently available treatments.

Jaime Xinos: Narrowing our focus at launch will enable meaningful and measurable engagements to activate prescribing before we expand awareness activities to a broader audience. We have an exciting and incredibly busy year ahead as we approach launch and this epic opportunity to change the face of public health.

Speaker Change: Narrowing our focus at launch will enable meaningful and measurable engagements to activate prescribing before we expand awareness activities to a broader audience.

Speaker Change: We have an exciting an incredibly busy year ahead, as we approach launch and the epic opportunity to change the face of public health I look forward to sharing further details on our progress in the coming months I will now turn the call over to Mark to review the financials.

Jaime Xinos: I look forward to sharing further details on our progress in the coming months.

Mark Occhi: I will now turn the call over to Mark to review the financials. Thank you, Jaime.

Mark Oki: Thank you Jamie I'm excited to join my first earnings call as CFO of achieved since joining the team I've been impressed with the incredible progress the company's made particularly as we prepare for the NDA filing and the transition to a commercial stage company.

Mark Occhi: I'm excited to join my first earning calls as CFO of Achieve. Since joining the team, I've been impressed with the incredible progress the company has made, particularly as we prepare for the NDA filing and the transition to a commercial stage company. I look forward to working with our talented team to continue executing on our strategic goals and driving long-term shareholder value.

Mark Oki: I look forward to working with our talented team to continue executing on our strategic goals and driving long term shareholder value.

Mark Occhi: With that, I'll turn to the financial update. As of December 31, 2024, the company's cash, cash equivalents, and marketable securities were $34.4 million, up from $15.6 million on December 31, 2023. We believe our current cash balance is sufficient to provide us runway into the third quarter of 2025. Turning to our Statement of Operations, total operating expenses for the fourth quarter and year-ended December 31, 2024, were $12.2 million and $39.1 million, respectively. Net loss for the fourth quarter and year ended December 31, 2024, was $12.4 million and $39.8 million dollars, respectively. as we maintain our focus on executing our strategy.

Mark Oki: With that I will turn to the financial update.

Mark Oki: As of December 31, 2024, the company's cash cash equivalents and marketable securities were $34 $4 million up from $15 6 million on December 31 2023.

Mark Oki: We believe our current cash balance is sufficient to provide us runway into the third quarter of 2025.

Mark Oki: Turning to our statement of operations total operating expenses for the fourth quarter and year ended December 31, 2024 were $12 2 million and $39 $1 million respectively.

Mark Oki: Net loss for the fourth quarter and year ended December 31, 2024 was $12 4 million and $39 $8 million respectively.

As we maintain our focus on executing our strategy.

Mark Occhi: towards NDA submission at the end of the second quarter and advance our plans for commercial readiness in 2025. We're dedicated to upholding strict cash management practice. This ensures that our resources are allocated effectively to continue to accomplish our objectives. specifically bringing cytosine and choline to market, drive sustainable growth, and maximize value for our shareholders.

Mark Oki: <unk> NDA submission at the end of the second quarter and advance our plans for commercial readiness in 2025 with dedicated to uphold and strict cash management practices.

Mark Oki: This ensures that our resources are allocated effectively to continue to accomplish our objectives, specifically, bringing so I just didn't clean to market drive sustainable growth and maximize value for our shareholders.

Speaker: Thank you.

Mark Oki: Thank you and I'll now turn the call back over to Rick for closing remarks, Thank you Mark.

Rick Stewart: And I'll now turn the call back over to Rick for closing remarks. Thank you, Mark. And thanks to all of the Achieve team for your continued commitment and energy.

Mark Oki: Thanks to all of the achieve team for your continued commitment and energy.

Rick Stewart: I want to emphasize that although not head-to-head comparisons, Cytosinecline's efficacy and safety profile has demonstrated superiority over other nicotine-dependent treatments. In fact, cytosineclean has shown up to two and a half times better efficacy than the previous market-leading prescription product, with a far more benign side effect profile. As you've heard, commercial planning is an advanced stage. We're confident in the product, and we need to get it into patients' hands as soon as possible and give physicians the tools to help their patients who most want to quit. Millions of people are suffering and they need a new tool to help them quit.

Mark Oki: I want to emphasize that although not head to head comparisons. So I'm, just gonna Greens efficacy and safety profile as demonstrated superiority over other nicotine dependence treatments.

Mark Oki: In fact, just cynically has shown up to two and a half times Bachelor efficacy than the previous Mafia, leading prescription product with a far more benign side effect profile.

Speaker Change: As you've heard commercial planning is in advanced stage, we have confidence in the product and we need to get it into patients' hands as soon as possible and give physicians the tools to help their patients who most want to quit.

Speaker Change: Millions of people suffering and they need a new tool to help them quit.

Speaker Change: Over half of all smokers make it quicker turn every year, they want to save or improve their own lives, but they don't have effective tools.

Rick Stewart: Over half of all smokers make a quit attempt every year. They want to save or improve their own lives, but they don't have effective tools.

Rick Stewart: I'd also like to highlight that cytosineclean has a greater role than the treatment of nicotine dependence disease. It will be crucial in reducing the disease burden caused by smoking in related conditions. There is evidence that cytosinecline can have near-term benefits on comorbidities such as COPD and other respiratory diseases. About 80% of all diagnosed COPD patients have this progressive disease as a direct result of smoking. Furthermore, approximately 6 million Americans out of the 16 million diagnosed with COPD currently continue to smoke. Cytosinecline can be used for COPD patients who are smokers, as it reduces the number of exacerbations and hospitalizations.

Speaker Change: I'd also like to highlight that's going to cynically has a greater role when the treatments of nicotine dependence disease.

Speaker Change: It will be crucial in reducing the disease burden caused by smoking and related conditions. There is evidence that says you cynically can have near term benefits on comorbidities, such as COPD and other respiratory diseases.

Speaker Change: 80% of all diagnosed COPD patients have this progressive disease as a direct result of smoking.

Speaker Change: Furthermore, approximately 6 million Americans out of the 16 million diagnosed with COPD currently continue to smoke.

Speaker Change: <unk> can be used to COPD patients whose smokers.

Speaker Change: It reduces the number of exacerbations and hospitalizations.

Rick Stewart: Data from our two large-scale Phase III clinical trials show a higher abstinence rate in COPD smokers than non-COPD patients. Cytosinecline itself may well be a potent treatment to deter COPD progression and alleviate the symptoms experienced by COPD smoking. more than half of the 29 million American people who smoke in the U.S. attempt to quit each year.

Speaker Change: Data from our two large scale phase three clinical trials, so a higher absence rates in COPD smokers among COPD patients.

Speaker Change: In fact, if cynically in itself may well be a potent treatment to deter COPD progression and alleviate the symptoms experienced by COPD and smokers.

Speaker Change: More than half of the 29 million American American people, who smoke in the U S.

Speaker Change: <unk> tended to quit each year fewer than 10% do so successfully highlighting the critical need for new treatment option.

Rick Stewart: Fewer than 10% do so successfully, highlighting the critical need for a new treatment option. Cytosinecline offers a breakthrough opportunity with blockbuster potential, and we're excited to be at the forefront of this market.

Speaker Change: So actually cynically offers a breakthrough opportunity with blockbuster potential and we're excited to be at the forefront of this market.

Rick Stewart: Looking ahead to 2025, we remain focused, energized, and on track to file our first cytosine-clean NDA submission as a treatment for nicotine dependence for smoking cessation at the end of next quarter. Following submission, we anticipate acceptance and look forward to securing marketing authorization. While launch readiness moves forward, I'm proud of the extremely dedicated and focused team that want nothing more than to get cytosine clean into the hands of those patients that are ready to quit. Bringing this product to market will ultimately deliver long-term value to our shareholders and help patients who desperately want to improve their health and unburden themselves from this addiction.

Speaker Change: Looking ahead to 2025, we remain focused energized and on track to file our first scientists cynically NDA submission as a treatment for nicotine dependence to smoking cessation at the end of next quarter.

Speaker Change: Following submission, we anticipate acceptance and look forward to securing marketing authorization.

Speaker Change: While the launch readiness moves forward I'm proud of the extremely dedicated and focused team the want nothing more than to get thank you Sidney clean into the hands of those patients that are ready to quit.

Speaker Change: Bringing this product to market will ultimately deliver long term value to our shareholders and help patients who desperately wants to improve their health and unburden themselves from this addiction.

Rick Stewart: As Mark commented, effective cash management is a priority for the company and I am also grateful for our leading shareholders who've expressed their strong support for the company. They believe in our goal of addressing the nicotine dependence public health crisis with or without a strategic partner. We appreciate your time today, and we look forward to updating you on our progress in the coming months.

Speaker Change: As Mark commented effective cash management is a priority for the company and I am also grateful for our leading shareholders who've expressed their strong support for the company.

Speaker Change: They believe in our goal of addressing the nicotine dependence public health crisis with or without a strategic partner.

Speaker Change: We appreciate your time today, and we look forward to updating you on our progress in the coming months I'll now turn you over to the operator for questions.

Operator: I'll now turn you over to the operator for questions. Thank you. At this time, we'll be conducting a question and answer session.

Speaker Change: Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.

Operator: If you'd like to ask a question, please press star 1 on your telephone. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.

Speaker Change: A confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Gary Nachman with Raymond James. Please proceed with your question.

Gary Nachman: Our first question comes from the line of Gary Nachman with Raymond James. Please proceed with your question. Thanks.

Gary Nachman: Thanks, Good morning, and congrats on all the progress.

Rick Stewart: Good morning, and congrats on all the progress. So, first, regarding the NDA for smoking cessation that should be filed at the end of 2Q, just clarify a bit more what still needs to be done prior to the submission. And, you know, given the way the product is made, is there anything specific that the FDA is requiring from a manufacturing standpoint? So, do you feel buttoned up on the CMC side? And have you hired any external help to help you prep with the NDA?

Gary Nachman: So first regarding the NDA for smoking cessation that should be filed at the end of two Q, just clarify a bit more what still needs to be done prior to the submission and you know given the way. The product is made is there anything specific that the FDA is requiring from a manufacturing standpoint, so do you feel buttoned up.

Gary Nachman: On the CMC side.

Gary Nachman: And have you hired any external help.

Gary Nachman: To help you pressed with the NDA and then I have a couple of follow ups.

Speaker: And then I have a couple of follow-ups.

Rick Stewart: Right, I'll kick off, Gary. Good morning. I think the key here is the absolute focus on getting this NDA It's the execution that really counts in terms of ensuring that the quality of the NDA is as good as it possibly can, and Cindy and her team are doing an absolutely fantastic job in devoting their resources and efforts to making sure that's the case.

Gary Nachman: Okay, Gary good morning.

Gary Nachman: Absolutely.

Gary Nachman: Getting this NDA.

Gary Nachman: Yes.

Gary Nachman: The execution there.

Gary Nachman: Sure.

Gary Nachman: On the call.

Gary Nachman: The NDA.

Gary Nachman: As good as it possibly can.

Gary Nachman: Cindy.

Gary Nachman: And then you can absolutely fantastic job.

Gary Nachman: Yes.

Gary Nachman: The resources and assets to.

Gary Nachman: And making sure that that's the case.

Cindy Jacobs: I'm going to hand over to Cindy. Yeah, and as I stated, we're actually finalizing the summary documents for efficacy, and then we will be turning our attention to all the summary documents for safety. The CMC sections are almost done. There's nothing unusual in this NDA, it's a, you know, the standard routine NDA is pretty much regimented what FDA wants. And so it's all coming together, it's just a lot of work, a lot of documents. And our focus has always been on accuracy and quality, and that's where then a lot of the quality checking at the end is very, very important.

Gary Nachman: Yeah.

Gary Nachman: Actually finalizing the summary documents.

Gary Nachman: Yes.

Gary Nachman: Turning our attention to all the summary documents.

Gary Nachman: Yeah.

Gary Nachman: These actions are almost done.

The usual.

Gary Nachman: Yes.

Gary Nachman: Standard routine.

Gary Nachman: Pretty much regimen, and what FDA wants.

Gary Nachman: So it's all coming together.

Gary Nachman: A lot of work a lot of documents and iron.

Gary Nachman: It's always been.

Gary Nachman: On accuracy.

Gary Nachman: And quality.

Gary Nachman: We're now in a lot of them.

Gary Nachman: Quality checking.

Gary Nachman: It's very very important.

Cindy Jacobs: Have we had other outside? The experts, consultants, vendors, yes, this is something that we actually try to pick the best of the best as far as consultants that have done this before, they've been successful at it, and they've been helping us as well with all of this for the last year.

Gary Nachman: Hum.

Gary Nachman: Other outside.

Gary Nachman: [laughter] consultants.

Gary Nachman: Yeah.

Gary Nachman: Thanks.

Gary Nachman: We actually tried in the past.

Gary Nachman: As far as.

Gary Nachman: And I've done this before they've been successful at it and they've been helping us as well.

Gary Nachman: All of this in the last year.

Gary Nachman: Okay, great that color is helpful.

Speaker: Okay, great. That color is helpful.

Gary Nachman: And then on the commercial side, you know, as you prepare to have good access for cytosine acetylene, do you expect there'll be a PA or step edits in place for generics, or will you have a chance to be first line? That might be something that you're sorting through, but what are your initial thoughts on that? And also, will you be using a specialty pharmacy, you know, just to help also ensure that patients get their refills, so they have the full three months of treatment?

Gary Nachman: And then on the commercial side you know as you prepare to have good access.

Gary Nachman: <unk> clean do you expect though there'll be a a P a or step edits in place for generics.

Gary Nachman: Or will you have a chance to be first flying that might be something that you're sorting through but what are your initial thoughts on that and also will you be using a specialty pharmacy.

Gary Nachman: You know just to help also ensure that patients get their refills. So they have a full three months of treatment.

Gary Nachman: Yeah, Hi, Gary It's David I'll take that question. So first of all I'll work backwards. We are looking at our distribution channel strategy now as I mentioned in the remarks.

Jaime Xinos: Hi, Gary. It's Jaime. I'll take that question.

Jaime Xinos: So, first of all, I'll work backwards. We are looking at our distribution channel strategy now, as I mentioned in the remarks. We will have further color on that in the future, but we are definitely considering at launch a specialty pharmacy because we obviously want to be able to track and monitor the scripts that are being written and those that are being filled and any barriers to access that may be imposed and make sure that we have plans in place to mitigate those. And I think we're calling specialty light pharmacy now instead of a full specialty pharmacy because the price of the product wouldn't consider itself in a specialty tier.

Gary Nachman: We will have further color on that in the future, but we are definitely considering at launch of specialty pharmacy, because we obviously want to be able to track and monitor the scripts that are being written and those that are being filled and any barriers.

Gary Nachman: <unk> be imposed and make sure that we have plans in place to mitigate those and I think specialty pharmacy as well.

Gary Nachman: Colleagues specialty.

Gary Nachman: Pharmacy now instead of a full specialty pharmacy, because the price of the product wouldnt consider itself and a specialty tier.

Jaime Xinos: Regarding your other question, it's hard to know, and it's going to come down to contracting and strategy, where eventually payers put us on their formulary, so we are preparing, and we put pretty conservative estimates in for where we may come out on rebates when we're doing our forecasting. Again, as I mentioned, using a such-as-you-like type of channel will help us to mitigate some of those barriers to access, but the reality is with, forensically, and it's that a number of patients have either tried it and failed, or they simply don't want to use it, and we saw that in our trials, and Cindy can correct me if I'm wrong, but I think it was around 40% of the people had only previously used, yeah.

Gary Nachman: Regarding your other question.

Gary Nachman: It's hard to know when it's going to come down to contracting strategy, where it was actually payers put us on their formularies. So we are preparing and we put a pretty conservative estimates and for where we may come out on rebates. When we're doing our forecasting again as I mentioned, using especially like type of channel will help us to mitigate some of those barriers to access but the.

Speaker Change: The reality is with theoretically and is that a number of patients have either tried it and failed or are they simply don't want to use it and we saw that in our trials and Cindy can correct me, if I'm wrong, but I think it was around 40% of the people had only previously yes.

Jaime Xinos: Yes, antics ever in their journey to try to quit smoking. And these are heavily experienced quitters, if you will, that have made multiple quit attempts in the past, and they still refuse to utilize forensically, and we're seeing an even higher resistance when we look at the claims data, so I think, you know, you can implement step edits that require patients to use products, but there's ways to get around those through medical exceptions and look back periods, and also just patients' refusal to use the medication, so we're certainly looking at all those as we're developing our expertise.

Gary Nachman: And they're in their journey.

Speaker Change: And these are heavily.

Speaker Change: Experience Quintus Quitters, if you will that have made multiple quit attempts in the past and they still refuse to utilize varenicline in and we're seeing an even higher resistance. When we look at the claims data. So I think you can do you can implement.

Speaker Change: Step edits that require patients to use products, but there's ways to get around those through medical exceptions and look back periods and also just patients receive those who use the medication. So we're certainly looking at all of them.

Speaker Change: As we're developing our access strategy.

Speaker Change: Okay, Great and then just last question for you Rick are you getting closer to a potential partner for looking at a co morbid.

Speaker: Okay, great.

Gary Nachman: And then just last question for you, Rick. Are you getting closer to a potential partner for looking at a comorbid indication with cytosinequin and running that study? And are there any other potential partnerships that, you know, we could think about that you might put in place that could help with non-dilutive funding and then maybe accelerate the start of the vaping phase three? You know, now that's scheduled for the first half of next year. Is there any way you think that that could be moved forward potentially if you find a source of funding?

Speaker Change: Indication with cytosine, a clean and running that study and are there any other potential partnerships that you know we could think about that you might put in place that could help with non dilutive funding and then maybe accelerate.

Speaker Change: At the start of the phase three.

Speaker Change: And that's scheduled for the first half of next year is there any way you think that that could be moved forward potentially if you find a source of funding. Thank you.

Rick Stewart: Thank you. Gary, multiple questions in there. I think I'll start over the beginning. You know, the impact of Cytosine ethylene. COPD patients is something that we will be saying more about, perhaps later on in the year. But it's certainly got the attention of some interested parties. But the focus is purely right now, given we're resource-bound on getting that NDA submitted. So, you know, I wouldn't expect it to be announcing anything on that regard in the near future. But I think that the bigger picture is our preference is that, you know, we are driving towards the launch of CytoSeneClean ourselves, and I think that as we gain increasing confidence in terms of the overall opportunity, that gives us, you know, a better leverage in terms of the discussions that we might have with a partner.

Speaker Change: Okay, alright multiple questions.

Speaker Change: I think I'll start at the beginning.

Speaker Change: Yes.

Speaker Change: Thank you Scott Mclean.

Speaker Change: Maybe patients.

Speaker Change: Something that we will be saying.

Speaker Change: More about.

Speaker Change: Ladies and gentlemen.

Speaker Change: But then they go to the attention of some interest.

Speaker Change: Yeah.

Speaker Change: The focus is purely right now given where we're at.

Speaker Change: <unk> was found on getting that NDA submission.

Speaker Change: So I wouldn't expect it to be announcing anything on that regard.

Speaker Change: But I think the big.

Speaker Change: Preferences.

Speaker Change: Driving the.

Speaker Change: Launch of scientists in the Green.

Speaker Change: Yeah.

Speaker Change: And I think.

Speaker Change: We gain increasing confidence in terms of the overall opportunity.

Speaker Change: Okay.

Speaker Change: Leverage in terms of the discussions that we might have with a partner.

Rick Stewart: But, you know, at the end of the day, we have to act in the interest of our shareholders. And, you know, if somebody comes along, we have to evaluate whatever the transaction is on its merits.

Speaker Change: Yes.

Speaker Change: And we have.

Speaker Change: Interest of our shareholders.

Speaker Change: If somebody comes along we have to evaluate.

Speaker Change: The transaction is on its merits.

Speaker Change: Okay, great. Thank you.

Speaker: Okay, great. Thank you.

Speaker Change: Yeah.

Speaker Change: Thank you. Our next question comes from the line of Thomas Flaten with Lake Street Capital markets. Please proceed with your question.

Thomas Flaten: Our next question comes from the line of Thomas Flaten with Lake Street Capital Markets. Hey, good morning. I appreciate you taking the questions.

Thomas Flaten: Hey, good morning, I appreciate you taking the questions Cindy are there future TSMC reviews, coming and if so when might we expect to see the results of those.

Cindy Jacobs: Cindy, are there future DSMC reviews coming? And if so, when might we expect to see the results of those? Are you talking about for the open label safety? Yes, correct. Yeah, correct. Yes, we'll probably have one more. And that would probably be reviewing, obviously, the longer-term, one-year safety data. And I think that would probably be about the last one. Excellent.

Cindy: Yeah, you're talking about.

Speaker Change: For the open label safety, Yes, correct, Yeah correct yeah.

Speaker Change: We'll probably have one more schedule and that would probably be reviewing obviously the longer term one year safety data.

Speaker Change: I think that would probably be.

Speaker Change: The last one.

Speaker Change: Excellent and then.

Cindy Jacobs: And then following up on the question around CMC, how are the kind of mock reviews going with SoFarma? Do you feel like they're in pretty good shape and would successfully pass an FDA inspection at this point? Or do you think there's still work to be done?

Speaker Change: Following up on the question around CMC, how are the kind of mark reviews going with so far but do you feel like they're in pretty good shape. It would be which successfully passed an FDA inspection at this point or do you think there's still work to be done there.

Speaker Change: Yes.

Cindy Jacobs: Yeah, no, as we look across the board, frankly, the whole NDA activity, you know, as Cindy said, we've brought in external consultants to assist us with ensuring that the NDA is the highest possible quality there is. So I think the simple answer to the question, Thomas, is that we're using all the resources that we need to ensure the quality of that NDA. Got it.

Speaker Change: Across the board and frankly as a whole.

Speaker Change: Activity.

Speaker Change: Sandy.

Speaker Change: External consultants to assist us with ensuring the NDA is the highest possible quality.

Thomas Flaten: So I think the simple answer of the question Thomas is yeah, we're using all the resources that we need to ensure the quality of that NDA.

Mark Oki: Got it and then a quick one for Mark.

Mark Occhi: And then a quick one for Mark. Last quarter, GNA was up pretty, pretty substantially, but I think there was some one timers in there. But the number was the same this quarter or this past quarter. Sorry.

Speaker Change: And last quarter, G&A was up pretty pretty substantially but I think there were some one timers in there, but the number was the same this quarter or this past quarter, sorry, do you expect that $4 nine to be kind of a starting place going into 2025 or is there something onetime in nature.

Mark Occhi: Do you expect that 4.9 to be kind of a good starting place going into 2025? Or is there something one time in nature? No, we consider that the starting point. We obviously will manage our costs and hope to bring the number down a bit, but that's a good start.

Speaker Change: Oh, no we consider that as a starting point, we obviously, we will manage our costs and hope to bring that number down a bit but.

Speaker Change: That's a good starting point.

Speaker: Excellent. Thanks for taking the questions.

Speaker Change: Excellent thanks for taking the questions.

Speaker Change: Thank you.

Speaker Change: Thank you. Our next question comes from the line of Francois Rosemont with Oppenheimer and company. Please proceed with your question.

Francois Brisebois: Thank you. Our next question comes from the line of Francois Brisebois with Oppenheimer and Company. Please proceed with your question. All right. Thanks for the questions. Just a couple here.

Speaker Change: Alright, thanks for the questions just a couple here in terms of the sales ramp can you help us understand I think you mentioned a launch in third quarter 26 is just you know can you just help us figure out a little bit how we should expect this ramp to go and just a little more color on the segmentation that you discussed and.

Rick Stewart: In terms of the sales ramp, can you help us understand? I think you mentioned launch in third quarter 26. Can you just help us figure out a little bit how we should expect this ramp to go, and just a little more color on the segmentation that you discussed, and any color on partnership or not? You talked about going either way. Is this kind of a 50-50, or should we expect this as a market to have a partner try to help out here? Thank you.

Speaker Change: Any color on partnership or not you talked about going either way.

Speaker Change: Is this kind of a 50 50 or should.

Should we expect the size of the market to have a partner to try to help out here. Thank you I have a follow up.

Jaime Xinos: Sure, hi. I will start with the first couple of questions regarding the ramp. So we're not really disclosing our forecasting assumptions at this point as far as revenue potential, but we do anticipate a slow ramp because it takes time to get access and awareness. And so, you know, we're not expecting this to move super quickly initially out of the gate. I think that was the first part of your question. Sorry, can you repeat the second, number three? I know the ramp was the first one. Yeah, I guess maybe any color on partnership availability, you talk about awareness and you know, affecting the ramp.

Speaker Change: Sure.

Speaker Change: I will start with the first couple of questions regarding the ramp so we're not really disclosing our forecasting assumptions at this point as far as revenue potential, but we do anticipate a slow ramp because it takes time to get access and awareness.

Speaker Change: And so we're not expecting this to them to move Super quickly initially out of the gate I think that was the first part of your question I'm, sorry can you repeat the second.

Speaker Change: [laughter] another ramp.

Speaker Change: Yeah, just I guess, maybe any color on on partnership with availability you talked about awareness.

Speaker Change: And you know affecting the ramp I know, there's there's been discussions about going at it with a partner without if you could give any color on that preference and a little bit more on the segmentation of these doctors that you talked about.

Jaime Xinos: I know there's been discussions about going at it with a partner, without. If you could give any color on that preference and a little bit more on the segmentation of these doctors.

Jaime Xinos: Okay, I can take the segmentation, then I'll hand the partnership question over to Rick. But on the segmentation, a lot of the work that we've done is both on patients and the physician side. So we know that these varenicline scripts are really concentrated in those top deciles. So there's about 460,000 physicians who are writing smoking cessation treatments in the U.S., but we've narrowed it down to about 10% of those that are writing about 60% of the varenicline. And so really our initial efforts when we look at the physician segmentation will be going after those high volume prescribers who are most likely to adopt the product.

Speaker Change: Okay, I can take the segmentation them all and the like.

Speaker Change: Just a question on with the rest of it.

Speaker Change: Segmentation a lot of the work that we've done.

Speaker Change: Both on patients and the physician side. So we know that these varenicline scripts are really concentrated in those top decile. So theres about 460000 physicians, who are writing and smoking cessation treatments in the U S. But we've narrowed it down to about 10% of those that are writing about 60% of the varenicline and so really our initial effort when we looked at the physician segmentation will be go.

Speaker Change: After those high volume prescribers, who are most likely to adopt the product.

Jaime Xinos: And then on the patient side, again, I think as I've mentioned in the past, you know, we're looking at these highly motivated quitters who are ready and willing to take prescription treatments to help them to quit. And so this is what we've seen through our market research and also when we've looked at the Chantix launch plans. It's really going after people that who are convinced that they need help and are willing to talk to their physicians and engaging actively and quit conversations with them and they just need another option. So that narrows it down to about 25% of that highly motivated.

And then on the patient side again, I think as I've mentioned in the past you know we're looking at these highly motivated quitters, who are who are ready and willing to take prescription treatments to help them quit and so this is what we've seen through our market research and also when we've looked at the time of the Chantix launch plan, but it's really going after people who.

Speaker Change: Who are convinced that they need help and are willing to talk to their physicians engaging actively and quick conversations with them and they just need another option so that narrows it down to about 25% of that highly motivated and then our segmentation work that we've recently completed looking at claims across medical and just general consumer behavior, we can narrow it down even further.

Jaime Xinos: And then our segmentation work that we've recently completed looking at claims across medical and just general consumer behavior, we can narrow it down even further.

Jaime Xinos: So we'll have a very clear plan of how to engage with these patients at the time of launch.

Speaker Change: So we'll have a very clear plan of how to engage with these ah patients at the time of launch and I'll, let Rick handle partnering.

Rick Stewart: And I'll let Rick handle partnering. Right, Frank, I think the key to all of this is, and I know we've said it right the way through, is the NDA preparation, getting the execution right, getting everything in place. And I think part of the message now to our strategic partnering thoughts is to really emphasize the fact that nicotine dependence is a medical condition. You know, I think that the market has generally thought that this is a lack of willpower on behalf of patients. But it isn't. You know, as I said in the call, nicotine is reported to be the third most addictive substance after heroin and cocaine, and therefore it needs to be treated as such.

Speaker Change: Right right I think the key.

Speaker Change: Yes.

Speaker Change: You said it right the way through Louisiana.

Getting the execution right getting everything in place.

Speaker Change: Todd is a message now too strategic.

Speaker Change: Is to really emphasize the fact that independence is a medical condition.

I think the.

Speaker Change: Market is generally.

Speaker Change: The lack of willpower.

Speaker Change: Patients, but it is.

Speaker Change: Cool.

Speaker Change: It is reported to be the most.

Speaker Change: Take two substance.

Speaker Change: Okay.

Speaker Change: Before it needs to be treated as such.

Rick Stewart: And I think you'll see that in our kind of discussion about future strategy, we start to look at other areas, as we mentioned, COPD, but it really is reinforcing that message that nicotine dependence is a medical condition. And we do look quite closely at the change in attitude to obesity that the GLP-1s actually created. So that's really a long-winded way of saying that, you know, as is, we're focused on getting the NDA submitted.

Speaker Change: Okay.

Speaker Change: Discussion about future strategy, we start to look at other areas as we mentioned.

Speaker Change: But it really is reinforcing that message.

Speaker Change: Dependent.

Speaker Change: Condition, and we do look quite closely.

Speaker Change: Change.

Speaker Change: An attitude to obesity that the G. L. P. One was actually created so thats not really.

Speaker Change: Way of saying that.

Speaker Change: We're focused on getting the NDA submitted we have a commercialization plan, which is extremely well thought out.

<unk> side that we are looking for somebody.

Speaker Change: Great.

Speaker Change: Actually exploit perhaps then optimize revenue potential in the U S. And also globally I think whilst we are absolutely laser focused on the NDA submission.

Speaker Change: We're focused on the U S market opportunity.

Speaker Change: The rest of the world represents.

Speaker Change: Any significant revenue opportunity for somebody else.

Speaker Change: Okay, Great and then just lastly in terms of their financial position can you help us maybe mark go.

Mark Occhi: Okay, great. And then just lastly, in terms of the financial position, can you help us, maybe Mark, go through, so you have 34 million shares, but there's been a lot of warrants and stuff, and can you just remind us, are there pre-funded warrants, just how do you get to the fully diluted share count, and what is that?

Speaker Change: Go through so you had 34 million shares.

Speaker Change: But theres been all the warrants and stuff and can you just remind us are there pre funded warrants just how do you get to the fully diluted share count and what is that thank you.

Mark Occhi: Thank you. Yeah, we'll get that over to you. I'll get you a firm number with it broken down.

Speaker Change: Yeah.

Speaker Change: Yeah.

Speaker Change: Get that over to you.

Speaker Change: I'll give you a firm number with it's broken down.

Mark Occhi: Hopkins, and Warren, so that way we have a fuller picture rather than just one. Understood. And that's mostly in the 10K already, right? So, I mean, are we talking like an extra $35-$40 million kind of ballpark to get to fully diluted? No, it's closer to another $20 million. Excellent. All right.

Speaker Change: Options and warrants.

Speaker Change: So that way you have a.

Speaker Change: Fuller picture rather than just one number.

Speaker Change: I understand that that's that's mostly in the in the 10-K already right. So I mean are.

Speaker Change: Are we talking like an extra 35 40 million kind of ballpark of to get the fully diluted or.

Speaker Change: Okay.

Speaker Change: No it is closer to another $20 million.

Speaker Change: Excellent alright, thank you.

Speaker Change: Thanks.

Speaker Change: Yeah.

Speaker Change: Thank you. Our next question comes from the line of Justin Walsh with Jones trading. Please proceed with your question.

Justin Walsh: Our next question comes from the line of Justin Walsh with Jones Trading. Hi, thanks for taking the question. You mentioned that the initial launch will target converting high-volume providers from the varinocline to cistocinocline.

Justin Walsh: Hi, Thanks for taking my question you mentioned that the initial launch will target converting high volume providers from the are there any clean to assist the Sena clean could you provide any color on what narrative <unk> data you believe will be most effective and actually triggering conversion I'm highlighting the the nicotine dependence that you just mentioned as them.

Jaime Xinos: Can you provide any color on what narrative and or data you believe will be most effective in actually triggering conversion? Highlighting the nicotine dependence that you just mentioned as a medical condition does make sense, but that would seem to apply to both drugs.

Speaker Change: Medical condition doesn't makes sense, but that would seem to apply to both drug options.

Justin Walsh: Yeah, I think one of the.

Jaime Xinos: Yeah, I think one of the kind of anecdotally, thanks for the question, Justin, I think anecdotally, one of the things that we've heard from our key opinion leaders that kind of gives us a laugh is that we could have named this product not Chantix, and it would be wildly successful. And so I think that, you know, the huge thing here is that there's been nothing new in 20 years, and physicians need new options to help them help their patients. And so, you know, when we're looking at the label, and we're talking about how we're going to position this drug in the market, we've got some solid evidence from both our tolerability profile, the efficacy, the compliance of the product, and so it's really packaged very nicely in something that's going to be compelling and different.

Justin Walsh: Just kind of anecdotally. Thanks for the question Justin I think anecdotally one of the things that we've heard from our key opinion leaders that kind of gives us a lapses that we could have named this product not chantix and it would be wildly successful and so I think that you know the huge thing here is that there's been nothing new in 20 years and physicians need new options to help them help there.

Justin Walsh: Patients and so you know when we were looking at the label and we're talking about how we're going to position this drug in the market.

Justin Walsh: Scott said solid evidence from both our Tolerability profile the efficacy the compliance of the product and so its really package very nicely and something that's gonna be compelling and different.

Rick Stewart: And Rick, would you like to add something? Yeah, if I can add this, you know, the experience from the two phase three clinical trials, the response from the patients was pretty much uniformly positive. And in fact, we've got one patient in particular who we use as a kind of exemplar, who, she'd been smoking for 30-odd years, she was smoking at least a pack of cigarettes a day, had tried to quit more than 20 times, and yet, even today, cytosinecline is the only treatment that she's ever successfully quit. So I think what you find is that the patients actually really like cytosinecline, and I think that that feedback stands in really good stead, because it's reputational.

Justin Walsh: And Rick I, just add something to it.

Speaker Change: As you.

Justin Walsh: You know the experience from the two phase III clinical trial.

Justin Walsh: The response from the patients was pretty much uniformly positive.

Justin Walsh: And in fact, we've got one patient treated.

Justin Walsh: He uses.

Justin Walsh: <unk>.

Justin Walsh: It should be this month.

Justin Walsh: She was smoking at least a pack of cigarettes, a day trying to create more than 20 times.

Justin Walsh: Yeah.

Justin Walsh: Even today.

Justin Walsh: The only treatment that she's having successfully.

Justin Walsh: So I think what you find is those patients actually really like.

Justin Walsh: And again I think you get that feedback.

Justin Walsh: In really good stead, because he's registrational.

Rick Stewart: You know, I think that we can benefit from the reputation that we got in the two phase threes. We can build on that going forward.

Justin Walsh: I think that we can benefit from the reputation that we got in the two phase threes.

Justin Walsh: We can build on that going forward.

Speaker Change: Great. Thanks, one more question for me you guys have noted your your anticipated exclusivity period for this isn't a clean is expected to extend into and through the 2040 I'm acknowledging that that we expect these to be in place I'm wondering if you can comment on if there are potential barriers for generics that could enter the.

Speaker: Great, thanks.

Speaker: One more question for me. You guys have noted your anticipated exclusivity period for fistosinocline is expected to extend into and through the 2040s. Acknowledging that we expect these to be in place, I'm wondering if you can comment on if there are potential barriers for generics that could enter the market down the line. I'm just curious if the drug being derived from plant extraction would make it easier or harder for others to manufacture.

Speaker Change: Down the line I'm, just curious if the drug being derived from our plant extraction would make it easier or harder for others to the manufacturer.

Speaker Change: No.

Rick Stewart: I think that's a great question. The key in our mind is, you know, the actual starting material, and it isn't easy to extract the kind of volumes that we're going to be talking about. And, you know, I think over the years, you know, we've had the discussion around the source of it, you know, it takes a while for these plants to actually reach maturity, and, you know, that is a barrier to entry in itself. But I think if you layer on top of that a pretty comprehensive IP estate that, as you say, takes us out beyond 2040, I think that combination of factors really does play very strongly in our favor.

Speaker Change: Great question.

Speaker Change: The key in our mind is.

Speaker Change: Actual.

Speaker Change: Starting material.

Speaker Change: And it isn't easy to extract the kind of boat.

Speaker Change: We're going to be talking about.

Speaker Change: And I think over the years, we'd have the discussion around the source of it.

Speaker Change: Takes a while to for these.

Speaker Change: So actually reach maturity.

Speaker Change: Two and three in itself, but I think if you layer on top of that a pretty comprehensive.

Speaker Change: Thank you.

Speaker Change: He said he takes it beyond 2014.

Speaker Change: I think that combination of factors really does play very strongly in our favor.

Speaker Change: Yeah.

Speaker Change: Great. Thanks for taking the question.

Speaker: Great, thanks for taking the question.

Speaker Change: Yes.

Speaker Change: Thank you. Our next question comes from the line of Brandon Folkes with Rodman and Renshaw. Please proceed with your question.

Brandon Folks: Thank you. Our next question comes from a line of Brandon folks with Rodman and Renshaw. All right, thanks for taking my question. and I do just want to follow up. I'm hearing you answer on. But any color in terms of how satisfied patients are at these high prescribers and the satisfaction of these high prescribers.

Brandon Folkes: Hi, Thanks for taking my questions and congratulations on all the progress and I do just want to follow up on an earlier question I think it might be nice probably question and sharing your answer Ron said, if you could've named Australia, Chantix and but any color in terms of how satisfied patients are at these high prescribe as Andy.

Speaker Change: The satisfaction of these high prescribers using that Varenicline and you know just given the high usage is that just because there is nothing else how much education do you think you would need for the high prescribers to understand the differentiation in your product and change that very ingrained prescribing habit given there.

Jaime Xinos: Breonna Kleen. You know, just given their heart usage, is that just? in your product and change that very ingrained prescribing habit. Yeah, so some of the work that, thanks for the question, Brandon, some of the work that we've done on the physician side, they've reported a relatively low satisfaction rate with Chantix. In fact, if I recall from our data off the top of my head, I think it was about two-thirds of their patients ultimately fail the product, yet it's the most prescribed product that they utilize. And so it's a rather unique. So I think they are going to be very receptive to something that's got an excellent efficacy and safety profile, and as far as conversions, you know, we did some analysis with our prescribers in that initial research asking them of conversion rates of what they would transfer over their prescriptions, and a majority of them, based on our profile, converted not only varenicline, but from the NRT and the bupropion patients over to cytosine as well.

Brandon Folkes: I haven't really been much change for so many years.

Brandon Folkes: Yeah. So some of the work that thanks for the question Brandon and some of the work that we've done on the physician side.

Speaker Change: <unk> reported a relatively low satisfaction rate with Chantix in fact that if I recall from our data off the top of my head I think it was about.

Speaker Change: Two thirds of their patients ultimately fail the product, yes, it's the most prescribed products that they utilize and so it's.

Speaker Change: It's a rather unique treatment landscape, where you continue to use a product that doesn't work, but in light of not having any other options that just what what they're using so I think they are going to be very receptive to something that's got a.

Speaker Change: Excellent efficacy and safety profile and as far as conversions.

Speaker Change: We did some analysis with our prescribers in that our initial research asking them of conversion rates of what they would transfer over their prescriptions and a majority of them based on our profile converted not only varenicline, but from the NRT in appropriate patients over to satisfy clean as well. So I think you know.

Jaime Xinos: So I think, you know, we've baked kind of some of those numbers on a much more conservative basis into our forecast, but, you know, there's a great likelihood and interest in having something new and having something that works in the marketplace.

Speaker Change: We've we've based kind of some of those numbers on a much more conservative basis into our forecast.

Speaker Change: But you know there's a there's a great likelihood of an interest in having something new and having something that work are in the marketplace.

Rick Stewart: If I can add, Brandon, this goes to the very heart of our commercialization strategy. So it's a question of how. The commercialization strategy is really founded on a digital-first strategy where increasing the awareness to both the physicians and the patients is absolutely vital to success. And I think already we're starting to see the awareness of the benefits of cytosine clinically and certainly in the quicker community. And I think there's clearly, shall we say, pent-up interest and demand from that community. And as soon as we have a commercial launch, we can really capitalize on that level.

Speaker Change: If I can add Brian then let's go to some of the very hot about commercializing strategy. So.

Speaker Change: It's a question of how.

Speaker Change: Yeah.

Speaker Change: Commercialization strategy is really founded on.

Speaker Change: Digital first strategy.

Speaker Change: Yeah.

Speaker Change: Recently awareness to both the physicians and the patients.

Speaker Change: You can find them for success.

Speaker Change: Oh, Randy we starting to see the awareness of the benefits of scientifically and suddenly in the Christian community.

Speaker Change: There's clearly.

Speaker Change: So we like that.

Speaker Change: Interest and demand.

Speaker Change: From that community.

Speaker Change: Soon as we can.

Speaker Change: Actual launch we can really capitalize on that with that level of interest.

Speaker Change: Okay.

Speaker: Great.

Speaker Change: Great. Thanks, very much and one follow up if I may just how different of a commercial approach is vaping just given it is a much younger population.

Speaker: Thanks very much.

Speaker: And one follow-up, if I may. Just how different of a commercial approach is vaping, just given it's a much younger population? You know, I heard you mention digital first there, so I'd just love to sort of understand, you know, not jumping too far ahead here, but just how different is the commercial approach on vaping, or how similar is the commercial approach?

Speaker Change: You know I heard you mentioned digital first day, so I'd just love to sort of understand that's jumping too far ahead here, but just how different is the commercial approach and very painful how similar is the commercial approach. Thank you.

Jaime Xinos: Thank you. So I think from a physician perspective, the commercial approach is very similar, because the same doctors, primary care prescribers, or primary care physicians are the key prescriber in that audience. From the consumer, that's where we're going to have a lot more unique opportunities to engage in partnership conversations with those who have apps and perhaps wearables. So the digital tech space could be really interesting for that younger population, as you mentioned. And also, they're engaging more, not to say that the smoking population isn't also engaging in social, but really when you see the younger audiences, you're expanding the utilization of social and how frequently and how the number of social channels that they're utilizing.

So I think from a physician perspective, the commercial approach is very similar to the same doctors primary care prescribers are primary care physicians are the key prescribers in the audience from the consumer that's where we're gonna have a lot more unique opportunities to engage in and partnership conversations with those who have.

Speaker Change: And then perhaps wearable.

Speaker Change: So that the digital tax base could be really interesting for that younger population as he mentioned and also they're engaging more I'm not to say that the smoking population isn't also engaging and social but really when you see the younger audiences, you're you're expanding the utilization of social and how frequently and how.

Speaker Change: Or of social channels that they are utilizing so it's it's certainly nuance.

Speaker: Certainly nuanced.

Speaker Change: Okay.

Speaker: Great, thanks for taking my questions and congrats on all the progress. Thank you.

Speaker Change: Great. Thanks for taking my questions and congrats on all the progress.

Speaker Change: Thank you.

Speaker Change: Yeah.

Speaker Change: Thank you. Our next question comes from the line of Jon Vander Boston with Zacks SCR. Please proceed with your question.

John Vandermosten: Our next question comes from the line of John Vandermosten with Zax SCR. Great. Thank you and good morning, everyone. There were a couple of relevant JAMA articles that came out in the last week or so. One was on the high rate of smoking during pregnancy, or at least I thought it was high. They found a rate of about 7% during pregnancy and almost 12% after. And then there was another article that was looking at vaping and how it was ineffective in really controlling smoking. And I thought these were really interesting coming out now as you are developing your commercialization strategy and wondered if you had any thoughts on how these two items might impact your move forward, especially on the pregnancy side, because I don't think anyone's really pursued that.

Speaker Change: Great. Thank you and good morning, everyone. There were a couple of relevant jamba articles that came out in the in the last week.

Speaker Change: Weaker so one was on the high rate of smoking during pregnancy or at least I thought it was high they they found a rate of about 7%.

Speaker Change: During pregnancy to an almost 12% after and then there was another article that was looking at.

Speaker Change: At Vaping, and how it was ineffective and really controlling smoking and I thought that was really interesting coming out now as you are developing your commercialization strategy and wondered if you had any thoughts on how these two items might impact your move forward, especially on the pregnancy side, because I don't think anyone's really.

Speaker Change: We pursued that I mean, I guess, we all assumed that that people just didn't smoke love to hear your thoughts on that.

Cindy Jacobs: I mean, I guess we all assume that people just didn't smoke. Let me hear your thoughts.

Speaker Change: Yeah.

Cindy Jacobs: You know, as far as pregnancy, we don't have any, actually. We don't have any new data as far as cytosine equivalent with pregnancy. We do have, certainly, animal studies that show that... Thank you. So that is definitely an area that obviously... might actually view that it is important for the patient, the pregnant patient, to consider it. And so that obviously is a natural kind of... Options in that regard.

Speaker Change: Yeah as far as pregnancy, we don't have any actually human data as far as tenants in England with pregnancy.

Speaker Change: We do have certainly animal Tox studies.

Speaker Change: That's it.

Speaker Change: It isn't a safety issue.

Speaker Change: So that is definitely an area that obviously physicians might actually.

Speaker Change: It is important for the patients.

Speaker Change: And so that obviously is a natural kind of action in that regard.

Jaime Xinos: Yeah, one interesting point on that, thanks for the question, John, is, you know, we've talked about primary care prescribers as our key audience, but there are a lot of women, you know, visiting their OB-GYNs who are planning pregnancy, and so that would be a unique market expansion opportunity for us to start tapping into that broader audience to help people with their family planning and why they should start cessation early in that process. So it certainly expands the opportunity over the longer horizon. And then I think, you know, regarding your question about vaping being ineffective for smoking cessation, to us that's, you know, not really surprising.

Speaker Change: And one interesting point on that thanks for the question John as.

You know we've talked about primary care prescribers as our key audience, but there are a lot of women you know visiting their ob gyn into our planning pregnancy, and so that would be a unique market expansion opportunity for us to start tapping into that broader audience to help people with their family planning and why they should start sensation them early in that process. So it's certain.

Speaker Change: Expands the opportunity over the longer horizon.

Speaker Change: And then I think you know regarding your question about vaping being ineffective for smoking cessation of two assets you know not really surprising I think you know this is a journey that that people go on over many years and most people when we did our vaping search they indicated they started they ping to quit smoking and then what they ended up doing with both.

Jaime Xinos: I think, you know, this is a journey that people go on over many years, and most people when we did our vaping research, they indicated they started vaping to quit smoking, and then what they ended up doing was both. So then you have dual users who are essentially consuming nicotine 24-7 because they're smoking when they're not vaping, and when they're indoors or working, they're vaping. So I think, you know, we're looking at an audience of people who are looking to get off of nicotine altogether, and that's going to be our focus. And, you know, we know they're out there, and we know that they're ready to quit, you know, whether it's financial or health or a combination of both.

Speaker Change: So then you have dual users who are essentially consuming nicotine 24, seven because they're smoking when they're not vaping and when they're indoors or working there. They're vaping. So I think you know we're looking at an audience of people who are looking to get off of nicotine altogether and that's going to be our focus and we know they're out there and we know that they're ready to quit you know, whether it's financial or health or a combination of both.

Speaker Change: They're they're really interested in and and Unburdening themselves from this dependent as Rick commented during our call if I can add something John.

Rick Stewart: You know, they're really interested in unburdening themselves from this dependence, as Rick commented during our call. If I can add something, John, I've also commented in the past that this is like whack-a-mole. We started this journey with smoking cessation, it migrated to include vaping cessation, and now we've got, you know, the tobacco patches are now presenting another, yet another method of nicotine dependency. So I think that this is expanding in front of our eyes, and each one of those interplays really reinforces that nicotine dependence. So I think that we're aware on all fronts in terms of...

Speaker Change: Okay.

Speaker Change: Commented in the past like.

Speaker Change: Whack a mole.

Speaker Change: We started this journey with smoking cessation.

Speaker Change: Microwave to.

Speaker Change: Do you include vaping cessation and now we've got the tobacco.

Speaker Change: Presenting on.

Speaker Change: The masses of nicotine dependency.

Speaker Change: So I think that this is expanding in front of our eyes.

Speaker Change: So it was into place.

Speaker Change: Really reinforces that nicotine dependence so.

Speaker Change: We're aware of on all fronts in terms of.

Speaker: You know, the opportunity is expanding and we have a drug that can actually help these patients with their nicotine dependence. Right, and that UCSD study that I referenced, they actually found the same thing that you said, Jaime, is that people who tried to stop with vaping actually ended up doing both and consuming more.

Speaker Change: Maturity is expanding.

Speaker Change: And we have a drug that can actually help these patients with nicotine dependence.

Speaker Change: Yeah.

Right.

Speaker Change: That U C. S. D study that I referenced that they actually found the same thing that you you said Jamie is that people who've tried to stop with the vaping actually ended up doing both and consuming more nicotine. A second question is on on just to ramp up its so far but I guess you know it's the products that they make will be exclusive to the U S market I assume because I think.

Rick Stewart: A second question is on, just to ramp up it so far, I guess, you know, the product that they make will be exclusive to the U.S. market, I assume, because I think the dosing schedule that they're preparing, or producing for now, or manufacturing for now, is different. How will that affect when they start manufacturing supply for the commercialization, will they start that after the approval is given or will they kind of prepare in anticipation of it? Yeah, I think the key to the whole situation in terms of the NDA submission preparation is to ensure that we've got the right resources available to us at the right time.

Speaker Change: The dosing schedule. This that's that they're preparing for the producing for an hour of manufacturing for and ours is different.

Speaker Change: How will that affect when they start manufacturing supply for the commercialization commercialization when they start that after the approval is given a really well they kind of prepare in an anticipation of it.

Speaker Change: Yeah, I think the key to our situation in terms of your NDA submission preparation.

Speaker Change: Ensure that we've got.

Speaker Change: Resources available to us at the right time.

Rick Stewart: So, you know, we're actually planning to ensure that, as Cindy said, you know, we bring in external consultants to assist us across the board. So I think, you know, as far as, you know, the manufacturing area is concerned, you know, that's exactly the same. We brought in consultants and we're prioritizing the resources that we need to make sure that we've got, you know, product available at launch.

Speaker Change: So you know, we're actually planning to ensure that.

Sandy: Sandy said.

Sandy: Bringing in external consultants.

Sandy: Across the board.

Sandy: So I think that as far as yeah.

Sandy: Manufacturing.

Sandy: Ara is concerned.

Exactly the same way we brought in consultants and were prioritizing the resources that we need to make sure that we've got product available at launch.

Rick Stewart: Okay. Okay, and just one last thing, you kind of give us a clue that it will not be, the brand name will not be Not Chantix, but I was wondering if there's any clue on what it might be when you roll it out? Is that in progress, determining that name? Yeah, we actually have preconditional approval or conditional approval on a name from FDA.

Sandy: Okay.

Sandy: Okay, and then just one last thing you could you kind of give us a clue that it will not be the brand name will be not not be not chantix [laughter], but I was wondering is there any clue on on what it might be a two oh when when you when you roll. It out is that is that the progress determining that name.

Sandy: We actually have a precondition for approval or conditional approval on the name from FDA. We are not sharing that at this time because interactive fashion, that's subject to change upon final approval. So but no. We have we've moved forward with a brand name that has been researched Ah and cleared through various analyses of.

Rick Stewart: We are not sharing that at this time because in true FDA fashion, that's subject to change upon final approval. So, but no, we've moved forward with a brand name that has been researched and cleared through various analyses of legibility and pronounceability and all of the things that are required by FDA. And we've started working on some of the brand identity aspects as well, including our logo. So we're definitely making progress and this is a really exciting time.

Sandy: Legibility and pronounced ability and all of the things that are required by FDA and we started working on some of the brand identity aspects as well, including I loved though so where we're we're definitely making progress.

Sandy: Exciting time for us.

Speaker: Great, thanks so much. Thank you.

Sandy: Great. Thanks, so much.

Sandy: Yeah.

Speaker Change: Thank you. Our final question. This morning comes from the line of Boris <unk> with a freedom broker. Please proceed with your question.

Speaker: Good morning everyone and thanks for taking the question. I have a quick one for regarding the future vaping study. Given the relatively high placebo effect observed in RKV1 trial, could you briefly share, if possible, your views and expectations for the effect size? And I was also wondering whether such questions were raised by FDA. and the face to make. Sure, and that's where the ORCA V1 trial was most valuable for being able to assess and look at the sample sizing. And that phase 3 study is definitely powered for higher placebo rates. And, you know, higher placebo rates were seen when the smoking cessation trials were being conducted 20 years ago.

Speaker Change: Good morning, everyone and thanks for taking the question I have a quick one for everybody the future leading study given the relatively high placebo effects observed in Orca one trial could you briefly share with possible your views and expectations for the effect size.

Speaker Change: Phase III study and I was also wondering whether such questions were raised about M D.

Speaker Change: Until phase two meeting thank you.

Speaker Change: Yeah, Arhab Li one trial with the most valuable for being able to SaaS.

Speaker Change: That's a family sample sizing.

Speaker Change: And that phase III study is definitely powered for a higher placebo rate and higher for Piedmont raised Christine win.

Speaker Change: Patient trials.

Speaker Change: That's 20 years ago. So we didn't we kind of expected that.

Speaker: So we didn't, we kind of expected that it would be slightly higher. So the arms are... a little higher in number to be able, then, as the sample size to accommodate that.

Speaker Change: Finally higher so.

Speaker Change: R R.

Speaker Change: A little higher in number.

Speaker Change: Well, Dan as the sample size to accommodate that certainly.

Cindy Jacobs: Certainly, as a company, you do not run a Phase III study that's underpowered. So we still have power at greater than 90% for a trial that's now estimated about 800 subjects and looking at, really, because of that, what we view as maybe a little higher prediction with vaping. We're only going to be looking at the 12-week regimen with the placebo regimen, so that's where 400 subjects per each of those arms is definitely powered to accommodate that higher placebo rate. Okay, thank you so much. Thank you.

Speaker Change: The company used to run a phase three studies and stop your power. So we still have them power.

Speaker Change: Greater than 90% for a trial that's now estimated at about 800 subject and looking at really because of that we view as maybe a little higher than it headwinds facing them, we're only going to be looking at the 12 week regimen with the placebo regimens.

Speaker Change: So that's where 400 subjects per each of those arms is definitely empowered to accommodate that higher placebo rate.

Speaker Change: Okay. Thank you so much.

Speaker Change: Okay.

Mr. Stewart: Thank you, ladies and gentlemen that concludes our question and answer session I'll turn the floor back to Mr. Stewart for any final comments.

Speaker: Ladies and gentlemen, that concludes our question and answer session.

Rick Stewart: I'll turn the floor back to Mr. Stewart for any final comments. Well, I'd just like to thank you all for your continuing interest in Achieve and our mission. The NDA submission next quarter is going to be a critical value creation event, and the opportunity is only getting bigger in terms of our ability to treat patients for nicotine dependence. So we're across the board, the company is excited, and I just want to thank all the employees for their dedication and commitment to getting us to where we are today and where we're about to go. So thank you very much.

Speaker Change: Thank.

Speaker Change: Thank you all for your continuing interest in cheese and our mission.

Speaker Change: The NDA submission and next quarter is gonna be critical value creation.

Speaker Change: And the opportunity is only getting bigger in terms of our ability to treat patients.

Speaker Change: Nicknamed dependence.

Speaker Change: With across the board the company is excited and I just want to thank all the employees.

Speaker Change: Dedication and commitment to getting us to where we are today and where we're at.

Speaker Change: So thank you very much.

Speaker Change: Thank you. This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.

Speaker: Thank you.

Operator: This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.