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Overview of Achieve Life Sciences Inc
Achieve Life Sciences Inc is a specialty pharmaceutical company with a core focus on the development and commercialization of cytisinicline, a plant-based alkaloid that targets nicotine addiction through its use as a smoking cessation aid. As a company operating in the highly specialized field of pharmaceutical innovation, Achieve employs rigorous clinical research protocols, evidence-based strategies, and robust safety monitoring to address one of the major public health challenges of modern times.
Business Focus and Clinical Development
At the heart of Achieve’s mission is its commitment to transforming the treatment paradigm for nicotine dependence. The company focuses on the advancement of cytisinicline, leveraging a series of clinical trials to validate its safety and efficacy. By incorporating established protocols as well as innovative dosing regimens, Achieve aims to provide a streamlined treatment option that reduces withdrawal symptoms and decreases the reward associated with nicotine consumption. This scientific approach reinforces the company’s commitment to clinical excellence and safety.
Scientific Rigor and Industry Expertise
Achieve Life Sciences distinguishes itself by integrating industry-standard best practices with a focused research agenda. Through multiple phases of clinical trials, including controlled Phase 2 and Phase 3 studies, the company has generated significant clinical data supporting the potential of cytisinicline. Each study is meticulously designed to meet regulatory standards and to gather long-term safety data, underscoring the company’s dedication to evidence-based medicine.
Addressing a Global Public Health Need
The global epidemic of nicotine addiction, fueled by both cigarette smoking and e-cigarette use, is a critical public health concern. With millions of individuals affected worldwide, the need for effective treatments has never been more urgent. Achieve Life Sciences is uniquely positioned in the competitive landscape, leveraging its scientific foundation and strategic clinical programs to address this need. Its focus on cytisinicline targets the biochemical pathways involved in nicotine dependence, offering a therapeutic option that is both innovative and potentially disruptive in a market that has seen little breakthrough in decades.
Operational Strategy and Market Position
Operating with a single, well-defined business segment, Achieve Life Sciences streamlines its efforts toward the development and commercialization of cytisinicline. This focused approach allows the company to allocate resources efficiently and to build deep expertise in the treatment of nicotine addiction. The strategic use of clinical data, combined with proactive regulatory engagement, positions the company favorably among both competitors and potential partners in the specialty pharmaceutical arena.
Commitment to Safety and Compliance
Safety is a fundamental pillar in the company’s operational framework. Achieve Life Sciences continuously evaluates the long-term exposure effects of cytisinicline through open-label studies designed to fulfill regulatory safety requirements. This commitment ensures that each phase of drug development is performed with the utmost care, adhering to industry best practices and reinforcing a trust-based relationship with healthcare providers, regulators, and patients.
Integrating Expertise with Patient-Centered Solutions
The company’s leadership and team of experienced professionals bring years of commercial and clinical expertise to the table. With a deep understanding of the pharmaceutical market and the complexities of addressing nicotine dependence, Achieve Life Sciences builds its strategies on a foundation of clinical innovation, operational precision, and transparent communication. The company’s efforts are aimed at providing patients with a clear, effective path to overcoming nicotine addiction.
Conclusion
Through its unwavering focus on cytisinicline and smoking cessation, Achieve Life Sciences Inc offers a unique, scientifically backed solution in the fight against nicotine addiction. Its comprehensive clinical programs, commitment to safety, and specialized therapeutic approach combine to create an information-rich narrative that underpins the company’s role in advancing public health. Investors and interested stakeholders can rely on the company’s deep industry knowledge and transparent operational practices as it continues to build expertise in a critical area of healthcare.
Achieve Life Sciences (ACHV) announced its fourth quarter and year-end 2020 results. The company is advancing the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation, targeting 750 adult smokers across 15 U.S. sites. In 2020, Achieve raised $17.3 million through a public offering, enhancing its financial position with cash reserves of $35.9 million by year-end. However, the company reported a fourth-quarter net loss of $4.7 million. Data from the SRNT Annual Meeting revealed low satisfaction with current cessation treatments, indicating a market need for effective alternatives.
Achieve Life Sciences, Inc. (NASDAQ:ACHV) will announce its fourth quarter and year-end 2020 financial results on March 11, 2021, at 4:30 PM ET. The company is focused on the global development of cytisinicline for smoking cessation and nicotine addiction. Interested parties can access the conference call via the Investor Relations page on the Achieve website or by dialing in. A replay will be available after the call. This marks a significant opportunity for stakeholders to assess the company's financial health and developments in their product pipeline.
Achieve Life Sciences (Nasdaq: ACHV) announced the presentation of three posters at the SRNT Annual Meeting on February 24, 2021. The data highlighted the low satisfaction levels among smokers concerning current cessation treatments and indicated that over 75% of Chantix users do not complete the recommended therapy course. Additionally, 73% of e-cigarette users plan to quit vaping within the next year. Achieve is enrolling participants for the Phase 3 ORCA-2 study of cytisinicline, a potential new treatment for nicotine addiction.
Achieve Life Sciences (NASDAQ: ACHV) will present at the MicroCap Rodeo Winter Wonderland Conference from February 16-19, 2021. CEO John Bencich is scheduled to speak on February 16 at 12:30 p.m. EST. The presentation will be available for live streaming and replay at their investor relations site.
The conference highlights 35 investment opportunities recommended by institutional investors, focusing on companies like Achieve, which is dedicated to resolving nicotine addiction through its product, cytisinicline.
Achieve Life Sciences (NASDAQ:ACHV) will have CEO John Bencich present at the H.C. Wainwright BioConnect Conference from January 11-14, 2021. The presentation will be available via webcast starting January 11 at 6:00 AM EST on the Achieve Investor Relations page. The company focuses on developing cytisinicline, a plant-based treatment for nicotine addiction, which is approved in Central and Eastern Europe and has helped over 20 million users. Smoking remains a leading cause of preventable death worldwide, emphasizing the importance of Achieve’s mission.
Achieve Life Sciences (Nasdaq: ACHV) has successfully closed a public offering of 2,472,500 shares at $7.00 each, raising $17.3 million before expenses. The offering included the underwriter's full over-allotment of 322,500 shares. Proceeds will support the Phase 3 ORCA-2 trial, clinical research, and general corporate needs, extending the company's financial runway into mid-2022. Lake Street Capital Markets was the sole bookrunning manager, and the registration was declared effective by the SEC on December 2, 2020.
Achieve Life Sciences (Nasdaq: ACHV) announced a public offering of 2,150,000 shares at $7.00 each, aiming to raise approximately $15 million. The offering, set to close around December 7, 2020, includes a 30-day option for underwriters to purchase an additional 322,500 shares. Proceeds will fund the Phase 3 ORCA-2 trial and support clinical research and corporate purposes. This offering follows a recent SEC registration, positioning Achieve to enhance its development of cytisinicline, a promising aid for smoking cessation.
Achieve Life Sciences (Nasdaq: ACHV) announced a proposed underwritten public offering of 1,500,000 shares of common stock, along with an option for underwriters to purchase an additional 225,000 shares. The offering, managed by Lake Street Capital Markets LLC with Maxim Group LLC as co-manager, aims to fund the Phase 3 ORCA-2 trial and support clinical research, development, and general corporate purposes. A registration statement has been filed with the SEC, but the completion and terms of the offering remain uncertain due to market conditions.
Achieve Life Sciences (Nasdaq: ACHV) reported Q3 2020 financial results, highlighting the initiation of the Phase 3 ORCA-2 trial for cytisinicline, aimed at smoking cessation. The trial involves 750 smokers and compares cytisinicline's efficacy against placebo. The company announced a cash position of $22.4 million with Q3 operating expenses of $3.8 million, leading to a net loss of $3.8 million. Cytisinicline showed promising results in a previous trial against Chantix, revealing fewer adverse events and higher quit rates. A virtual roundtable on smoking cessation is scheduled for November 17, 2020.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) will release its third quarter 2020 financial results on November 12, 2020, at 4:30 PM ET. The company is focused on the development of cytisinicline for smoking cessation and nicotine addiction. The earnings call will provide updates on this program, and interested parties can access the call via their Investor Relations page or by phone. A replay will be available approximately two hours after the call.
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