Achieve Life Sciences

Achieve Life Sciences, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of cytisinicline for smoking cessation. Its products includes cytisine, a plant-based alkaloid with a binding affinity to the nicotinic acetylcholine receptor. The company was founded in October 1991 and is headquartered in Vancouver, Canada.

Earnings data Q1 2021

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Earnings data Q4 2021

Earnings data Q1 2022

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Achieve Life Sciences reports positive Q4 results, eyes regulatory milestones

Achieve Life Sciences demonstrated strong performance in Q4 2022 with positive trial results and strategic advancements. While facing financial challenges, the company's focus on innovation and upcoming milestones positions it well for growth and regulatory success.

Achieve Life Sciences reports positive trial results, faces funding challenges

Achieve Life Sciences demonstrated promising results in vaping cessation with cytisinicline treatment, showing significant benefits and a strong market demand for cessation solutions.
While facing challenges of increasing expenses and a net loss in Q1 2023, the company's cash balance and upcoming trials provide opportunities for growth and market expansion.
The company's strategic initiatives, including the Board of Directors refresh, position Achieve Life Sciences for future success in addressing the vaping cessation market.

Achieve Life Sciences advances cytisinicline trials, targets FDA approval

Achieve Life Sciences is making significant progress with cytisinicline, despite facing financial losses. Strategic initiatives and a proactive approach to FDA engagement position the company well for future growth and NDA submission.

Achieve Life Sciences reports improved Q3 performance and eyes NDA submission

Achieve Life Sciences shows financial improvement and promising results in the cytisinicline program for smoking cessation. Engaging with the FDA for NDA submission and seeking commercial partners are key priorities. Challenges include finalizing partnerships and defining regulatory pathways, while opportunities exist in global partnerships and public health impact.

Achieve Life Sciences excels in 2023, poised for growth and innovation

Achieve Life Sciences demonstrated strong performance in achieving key milestones, securing financing, and presenting positive trial results in 2023.
While facing challenges in regulatory discussions and trial completion, the company's strategic strengths in financial stability, regulatory compliance, and innovation position it well for future growth.
Opportunities lie in market expansion, partnerships, and visibility enhancement through continued FDA engagement, commercial collaborations, and industry participation.

Achieve Life Sciences excels in trials and secures funding for growth

Achieve Life Sciences demonstrated strong operational and financial performance with positive trial outcomes and strategic financing.
Regulatory advancements and successful trial results underscore the company's credibility and potential for market expansion.
Challenges in recruitment, regulatory compliance, and financial management require attention for sustained growth and success.

Achieve Life Sciences advances vaping cessation program with FDA breakthrough

Achieve Life Sciences showcased progress in its Cytisinicline Development Program and financial stability through debt refinancing.
While facing challenges in trial enrollment and regulatory requirements, the company remains optimistic about future milestones.
The FDA breakthrough therapy designation and focus on public health underscore Achieve Life Sciences' commitment to addressing nicotine dependence.

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SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 24, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock. In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

Achieve Life Sciences Announces Proposed Underwritten Public Offering

Achieve Life Sciences, Inc. (ACHV) CEO John Bencich on Q1 2021 Results - Earnings Call Transcript

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 13, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced first quarter 2021 financial results and provided an update on the cytisinicline clinical development program. Recent Events & Highlights Provided update on the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 17 clinical sites in the United States Published Phase 2b ORCA-1 safety, efficacy, and compliance results in Nicotine and Tobacco Research Announced the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to Achieve's Board of Directors Published RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix® (varenicline) in Addiction "In the first quarter, we've seen great interest and increased momentum in the ORCA-2 trial and look forward to completing enrollment by the middle of the year," commented John Bencich, Chief Executive Officer of Achieve.

Achieve Reports Financial Results for First Quarter 2021 and Provides Corporate Update

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 4, 2021 / Achieve Life Sciences, Inc. (Nasdaq:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it will report its first quarter 2021 financial results and provide an update on the cytisinicline development program on Thursday, May 13, 2021 at 4:30PM EDT. To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts.

Achieve Life Sciences to Announce First Quarter 2021 Financial Results and Host Conference Call and Webcast on May 13, 2021

Cytisinicline Up to Five Times More Likely to Result in Smoking Abstinence Compared to Placebo Phase 3 ORCA-2 Trial Currently Enrolling at 16 sites in United States SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / April 14, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced publication of the results from the Phase 2b ORCA-1 trial in the scientific journal Nicotine and Tobacco Research. ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States.

Achieve Announces Publication of the ORCA-1 Phase 2b Clinical Trial of Cytisinicline in Adult Smokers in Nicotine and Tobacco Research

Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 25, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced online publication of the results from the Phase 3 RAUORA trial in the scientific journal Addiction. The RAUORA study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and evaluated the effectiveness and safety of cytisinicline compared to varenicline (Chantix®) as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family.

Achieve Announces Publication of the RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix(R) (varenicline) in Addiction

Presenting Innovative Small and Mid-Cap Companies in Healthcare, Industrials, Electric Vehicles, TMT, and Consumer Products SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 16, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that John Bencich, Achieve's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M-Vest and Maxim Group. The conference will take place on March 17 to 19 from 9:00 am-5:00 pm EDT featuring roundtable discussions, issuer presentations, fireside chats, and live Q&A with company CEOs moderated by Maxim Research Analysts.

Achieve Life Sciences to Participate in M-Vest and Maxim Group Inaugural Emerging Growth Virtual Conference

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 15, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, is pleased to announce the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to the company's Board of Directors, effective immediately. "We are excited to welcome Dr. Martell and Dr. Jacobs to the board", commented Rick Stewart, Achieve's Executive Chairman of the Board of Directors.

Achieve Life Sciences Announces Appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to Board of Directors

Achieve Life Sciences, Inc. (ACHV) CEO John Bencich on Q4 2020 Results - Earnings Call Transcript

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 11, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced fourth quarter and year-end 2020 financial results and provided an update on the cytisinicline clinical development program. Recent Events & Highlights Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States Presented data on smoker and e-cigarette user attitudes and perceptions on quitting at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting on February 24, 2021 Closed financing of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses, in December 2020 Facilitated Smoking Cessation Key Opinion Leader Virtual Roundtable in November 2020 "We concluded 2020 in the best financial position since the Company's inception and with the Phase 3 ORCA-2 trial underway at 15 well-established smoking cessation research centers in the United States.

Achieve Reports Financial Results for Fourth Quarter and Year-End 2020 and Provides Corporate Update

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 4, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it will report its fourth quarter and year-end 2020 financial results and provide an update on the cytisinicline development program on Thursday, March 11, 2021 at 4:30 PM ET. To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts.

Achieve Life Sciences to Announce Fourth Quarter and Year-End 2020 Financial Results and Host Conference Call and Webcast on March 11, 2021

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / January 7, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that John Bencich, Chief Executive Officer, will present at the H.C. Wainwright BioConnect Conference being held virtually January 11-14, 2021.

Achieve Life Sciences to Present at H.C. Wainwright Virtual BioConnect Conference

SEATTLE and VANCOUVER, B.C., Dec. 7, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced the...

Achieve Life Sciences, Inc. Announces Closing of $17.3 Million Underwritten Public Offering, Including Full Exercise of Overallotment Option

SEATTLE and VANCOUVER, B.C., Dec. 3, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced the...

Achieve Life Sciences Announces Pricing of $15 Million Public Offering

SEATTLE and VANCOUVER, BC, Nov. 30, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced a proposed...

Achieve Life Sciences Announces Proposed Public Offering

Achieve Life Sciences, Inc. (ACHV) CEO John Bencich on Q3 2020 Results - Earnings Call Transcript

SEATTLE and VANCOUVER, BC, Oct. 29, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it...

Achieve Life Sciences to Announce Third Quarter 2020 Financial Results and Host Conference Call and Webcast on November 12, 2020

SEATTLE and VANCOUVER, BC, Oct. 27, 2020 /PRNewswire/ --Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced the Company...

Achieve Life Sciences to Host Smoking Cessation Key Opinion Leader Virtual Roundtable on November 17th, 2020

SEATTLE and VANCOUVER, B.C., Oct. 7, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced initiation...

Achieve Life Sciences Announces Start of Phase 3 ORCA-2 Clinical Trial Evaluating Cytisinicline for Smoking Cessation

SEATTLE and VANCOUVER, BC, Sept. 18, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced...

Achieve Announces Presentation of Investigator-Led RAUORA Trial Data Demonstrating Significantly Fewer Side Effects with Higher Quit Rates for Cytisinicline (cytisine) Compared to Chantix® (varenicline) in First Head-to-Head Comparative Study

SEATTLE, and VANCOUVER, British Columbia, Sept. 18, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced data presented at...

Achieve Life Sciences Announces Results from Evaluation of Cytisinicline (cytisine) versus Chantix® (varenicline) in 5-HT3 Receptor Binding Assay Study

SEATTLE and VANCOUVER, BC, Sept. 10, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc.

Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 20th Annual Society for Research on Nicotine & Tobacco Europe (SRNT-E) Virtual Conference

SEATTLE and VANCOUVER, BC, Sept. 3, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc.

Achieve Life Sciences to Present at Upcoming Investor Conferences

Achieve Life Sciences, Inc. (ACHV) CEO Richard Stewart on Q2 2020 Results - Earnings Call Transcript

SEATTLE and VANCOUVER, British Columbia, Aug. 6, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc.

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