Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| With a product that is well tolerated, we anticipate a high level of compliance and adherence to treatment, thereby enhancing their chances of successfully quitting |
| So really excited about where the program sits today and the interest that we continue to see from commercialization organization |
| Well, Nancy Rigatti actually presenting and our other KOLs are pretty excited as far as the efficacy that cytisinicline shows but actually, there are even more impressed and excited about the safety profile, which allows them individuals to stay on treatment and get the benefit |
| and global marketing opportunity |
| We believe pending FDA approval cytisinicline holds promise for providing a fresh start to the millions grappling with quitting smoking and vaping |
| market opportunity, strong U.S |
| We have strong confidence in cytisinicline's effectiveness in assisting individuals who are motivated to quit smoking |
| Our Phase 3 clinical trial results demonstrate a significant advantage with smokers treated with cytisinicline being up to 8x more likely to successfully quit smoking compared to those receiving placebo |
| Our endeavors to combat the vaping epidemic have been met with strong support from government agencies, clinicians and prospective commercial partners, highlighting the pressing unmet need in this area |
| As seen across our development program, cytisinicline was very well tolerated and no treatment-related serious adverse events were reported |
| As I stated at the beginning of the call, 2023 has been a remarkable year for Achieve and the cytisinicline development program |
| So what are we looking for exactly? Our ideal partner would have global capabilities with an established footprint and strong commercial capabilities and resources to maximize the global health impact that cytisinicline offers |
| So it's really a combination of the efficacy and safety profile that they are the most excited for smokers and in the future of vapors to actually have a new therapy to help their nicotine dependence |
| It's been a tremendous year with data coming out of not only our second confirmatory Phase 3 trial, but also the first ever randomized placebo-controlled trial in vaping and publication of our first Phase 3 trial in JAMA |
| As we have stated previously, we continue to believe the fifth asset in the hands of a larger organization will maximize the full commercial opportunity |
| We have seen significant additional commercial interest in the cytisinicline program |
| We maintain our confidence in cytisinicline's ability to change the face of public health and we appreciate your support as we work diligently to bring forward this important treatment |
| The market potential for cytisinicline is substantial and its potential impact on global public health is unparalleled |
| Our continued belief is that this asset belongs in the hands of a single global partner, one that does have strong U.S |
| Notably, cytisinicline stands out from existing treatments due to its excellent tolerability with the most common adverse events affecting fewer than 10% of trial participants |
| We are pleased to share that we have completed all of the in-clinic treatment portion of three NDA-enabling clinical trials that have been running over the course of this year |
| Over the last quarter as well as throughout the entire year, significant progress has been made in establishing the foundation for the first novel nicotine dependence treatment in almost two decades |
| We perceive a distinct opportunity with cytisinicline to reinvigorate the nicotine de-addiction market and make a profound impact on public health |
| Our confidence in cytisinicline is reinforced by leaders in the smoking-cessation community who have consistently shown their willingness to collaborate, express interest in new research and assist us in disseminating these crucial findings |
| We are pleased with the dialogue and engagement with potential commercialization partners and are focused on continuing to move this process forward expeditiously |
| We appreciate all the continued interest |
| Reported a statistically significant efficacy benefit in the Phase 2 ORCA-V1 trial, the first ever randomized controlled trial for e-cigarettes cessation |
| ORCA-V1 was the first randomized placebo-controlled trial to achieve success in demonstrating the efficacy of the treatment for addressing this type of nicotine dependence |
| capabilities to maximize the opportunity here in the U.S |
| So far this year, with a small and efficient team of only 22 full-time employees, Achieve accomplished many significant milestones including the announcement of positive results from our second Phase 3 cytisinicline trial for smoking cessation and published results from our first Phase 3 trial in JAMA |
| Statement |
|---|
| Net loss for the nine months ended September 30, 2023, decreased to $24.3 million compared to $31.1 million for the same period of 2022 |
| With respect to our statement of operations, net loss decreased to $7.1 million for the quarter ended September 30, 2023, compared to $13.1 million for the same quarter of 2022 |
| Given the substantial U.S |
| While e-cigarettes can serve as a helpful tool for some transitioning away from combustible cigarettes, the long-term effects remain unknown |
| We're not able to refine anything further on that |
| So I think if you look at the third quarter in terms of kind of the decrease in burn that we saw from the first half of this year, I think you can expect that will continue through the fourth quarter of this year as well |
| In line with expectations, operating expenses continued to decrease for the third quarter of 2023 with the completion and wind down of both the ORCA-3 Phase 3 trial and the ORCA-V1 Phase 2 trial |
| Obviously, it's not fully blessed until the NDA review gets through the end |
| We expect our quarterly operating expenses to remain lower in the fourth quarter as compared to the first half of 2023 |
Please consider a small donation if you think this website provides you with relevant information