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.

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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 and VANCOUVER, British Columbia, Jan. 25, 2022 (GLOBE NEWSWIRE) -- 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 it has initiated screening of ORCA-3, the confirmatory Phase 3 trial required for registrational approval of cytisinicline in the United States. ORCA-3 will evaluate the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites.

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

SEATTLE, Wash, Jan. 06, 2022 (GLOBE NEWSWIRE) -- 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, Chief Executive Officer, will give a presentation at the H.C. Wainwright BIOCONNECT Virtual Conference. The conference is taking place virtually from January 10 - 13, 2022. Details for access to the presentation are as follows:

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

Topline ORCA-2 Results Expected in Q2 2022 Topline ORCA-2 Results Expected in Q2 2022

Achieve Life Sciences Announces Completion of Last Subject, Last Follow-Up Visit in Phase 3 ORCA-2 Trial of Cytisinicline for Smoking Cessation

Achieve Life Sciences Inc (NASDAQ: ACHV) has entered into a $25 million debt agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P.  The proceeds and funds available under the debt agreement are expected to fund the completion of the cytisinicline smoking cessation clinical development program.

Achieve Life Sciences Secures $25M Loan Facility To Fund Smoking Cessation Program

SEATTLE and VANCOUVER, British Columbia, Dec. 22, 2021 (GLOBE NEWSWIRE) -- 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 has entered into a $25 million debt agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. (“SVB”). The proceeds and funds available under the debt agreement are expected to fund the completion of the cytisinicline smoking cessation clinical development program.

Achieve Life Sciences Announces $25 Million Loan Facility from Silicon Valley Bank to Fund Cytisinicline Smoking Cessation Clinical Development

SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 23, 2021 (GLOBE NEWSWIRE) -- 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 will host a Key Opinion Leader (KOL) virtual panel event on smoking and e-cigarette cessation on Thursday, December 2nd, 2021, at 1:00 PM EST.

Achieve Life Sciences to Host Key Opinion Leader Panel on Smoking and e-Cigarette Cessation

Following the fifth and final DSMC review, committee has concluded no concerns with cytisinicline safety or Phase 3 trial conduct Following the fifth and final DSMC review, committee has concluded no concerns with cytisinicline safety or Phase 3 trial conduct

Achieve Life Sciences Announces Phase 3 ORCA-2 Trial of Cytisinicline in Smoking Cessation Clears Final Review by Data Safety Monitoring Committee (DSMC)

Achieve Life Sciences, Inc. (ACHV) CEO John Bencich on Q3 2021 Results - Earnings Call Transcript

SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 09, 2021 (GLOBE NEWSWIRE) -- -- 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 third quarter 2021 financial results and provided an update on the cytisinicline clinical development program.

Achieve Reports Financial Results for Third Quarter 2021 and Provides Update on Cytisinicline Development

SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 04, 2021 (GLOBE NEWSWIRE) -- 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 its management team will hold one-on-one investor meetings at the Alliance Global Partners' (A.G.P.) Biotech & Specialty Pharma Conference and the Torrey Hills Capital Emerging Growth Conference during November 2021. Details are as follows:

Achieve Life Sciences Announces Participation in November Investor Conferences

The FDA has signed off Achieve Life Sciences Inc's (NASDAQ: ACHV) Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. In addition to the ongoing Phase 3 program for cytisinicline treatment in combustible cigarette cessation, the Company expects to initiate the ORCA-V1 e-cigarette and vape cessation trial in Q2 of 2022.

Achieve Life Sciences To Start Cytisinicline's Trial For Nicotine E-cigarette Cessation

Seattle, WA/ Vancouver, BC , Oct. 26, 2021 (GLOBE NEWSWIRE) -- 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 third-quarter 2021 financial results and provide an update on the cytisinicline development program on Tuesday, November 9, 2021, at 4:30 PM EST.

Achieve Life Sciences to Announce Third Quarter 2021 Financial Results and Host Conference Call and Webcast on November 9, 2021

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / September 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, today announced that John Bencich, Chief Executive Officer, will participate in two upcoming investor conferences. Mr. Bencich will present at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 21st at 3:45PM ET.

Achieve Life Sciences to Participate in Upcoming Investor Conferences

SEATTLE, WA & VANCOUVER, BC / ACCESSWIRE / September 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, announced that cytisinicline data will be presented at two sessions during the upcoming Society for Research on Nicotine & Tobacco (SRNT-E) Conference to be held virtually September 15-17, 2021. Presentation Details "Cytisinicline may benefit smokers who previously failed to quit smoking with varenicline: A subgroup analysis of the ORCA-1 trial" A subgroup analysis from the ORCA-1 Phase 2 study of smokers who had previously failed Chantix® (varenicline) demonstrated a Week 4 abstinence rate of 51.3% upon treatment with cytisinicline using the three times daily (TID) regimen, compared with 15.8% with placebo (p= 0.009).

Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 21st Annual Society for Research on Nicotine & Tobacco (SRNT-E) Virtual Conference

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / September 9, 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, Chief Executive Officer, will be participating in two upcoming investor conferences. Mr. Bencich will present a virtual corporate overview at the HC Wainwright 23rd Annual Global Investment Conference.

Achieve Life Sciences to Participate in Two Upcoming Investor Conferences

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 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 that the Company has expanded its Clinical Operations Team with the hiring of a Director of Clinical Operations, a Senior Manager of Clinical Trials, and a Senior Director of Biometrics. "We are excited to welcome our new clinical team members to Achieve and look forward to their contributions to the cytisinicline development program, including their efforts to support our fully enrolled Phase 3 ORCA-2 trial in combustible cigarette cessation and the planned Phase 2 ORCA-V1 trial in nicotine e-cigarette cessation," commented Dr. Cindy Jacobs, Achieve's President and Chief Medical Officer.

Achieve Life Sciences Announces Expansion of Cytisinicline Clinical Operations Team and Granting of Inducement Awards

Achieve Life Sciences, Inc. (ACHV) CEO John Bencich on Q2 2021 Results - Earnings Call Transcript

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 12, 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 second quarter 2021 financial results and provided an update on the cytisinicline clinical development program. Recent Events & Highlights Announced completion of enrollment in the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily (TID) compared to placebo in adult smokers Awarded grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) for the evaluation of cytisinicline in cessation of nicotine e-cigarette use Issued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimen Closed financing with gross proceeds of $23 million, prior to deducting underwriting discounts and offering expenses "In the second quarter, we continued to demonstrate our commitment to stakeholders by delivering on key milestones that advance our clinical program, and ultimately, cytisinicline's potential ability to help millions of people who struggle with nicotine addiction to live healthier lives," commented John Bencich, Chief Executive Officer of Achieve.

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

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 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 that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,083,715 and U.S. Patent No.

Achieve Announces Two Patents Granted by USPTO for Novel Cytisinicline Dosing and Administration Regimen

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 3, 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 second quarter 2021 financial results and provide an update on the cytisinicline development program on Thursday, August 12, 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 Second Quarter 2021 Financial Results and Host Conference Call and Webcast on August 12, 2021

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / July 22, 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 has been awarded a grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) to evaluate the use of cytisinicline as a treatment for cessation of nicotine e-cigarette use. This initial grant award, to commence on August 1, 2021, will be utilized to complete critical regulatory and clinical operational activities, such as protocol finalization, clinical trial site identification, and submission of a new IND to FDA for investigating cytisinicline in nicotine e-cigarette users.

Achieve Life Sciences Awarded Grant from the National Institutes of Health (NIH) for the Evaluation of Cytisinicline in Cessation of Nicotine E-cigarette Use

ORCA-2 Designed to Assess the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo in Adult Smokers in the United States SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / June 29, 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 the Phase 3 ORCA-2 trial of cytisinicline has reached its enrollment target of 750 adult smokers. The ORCA-2 trial sites are no longer enrolling new subjects, however those currently in screening will be allowed to participate provided they meet entry criteria.

Achieve Announces Completion of Target Enrollment of 750 Subjects in Phase 3 ORCA-2 Smoking Cessation Trial of Cytisinicline

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / June 3, 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 the United States Patent and Trademark Office has allowed U.S. Patent Application No. 16/993,522 (the ‘522 Application) and U.S. Patent Application No.

Achieve Announces Allowance of U.S. Patents for Dosing and Administration of Cytisinicline for the Treatment and Prevention of Addiction

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / June 2, 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 the company will be participating in the LD Micro Invitational XI Conference, being held virtually from June 8-10, 2021. John Bencich, Chief Executive Officer, is scheduled to host a virtual presentation on Wednesday, June 9, 2021, at 2:30 p.m.

Achieve Life Sciences to Present at LD Micro Invitational XI Virtual Conference

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 27, 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 the closing of its underwritten public offering of 3,285,714 shares of its common stock at a public offering price of $7.00 per share, which includes 428,571 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $23.0 million.

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