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 Q4 2020

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

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.

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

SEATTLE and VANCOUVER, British Columbia, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, announced that Dr. Cindy Jacobs, Achieve's President and Chief Medical Officer, presented at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Joint Public Meeting on “Advancing Smoking Cessation: FDA and NIH Priorities” held on October 21, 2024.

Achieve Life Sciences President and CMO, Dr. Cindy Jacobs, Speaks at FDA and NIH Smoking Cessation Public Meeting

SEATTLE and VANCOUVER, British Columbia, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, is pleased to announce the promotion of Ms. Jaime Xinos to Chief Commercial Officer, effective immediately.

Achieve Life Sciences Promotes Jaime Xinos to Chief Commercial Officer to Advance Commercial Readiness of Cytisinicline

SEATTLE and VANCOUVER, British Columbia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, is pleased to announce the appointment of Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings more than two decades of experience in clinical medicine, scientific research, and medical affairs leadership, with a strong focus on preventative medicine and nicotine cessation.

Achieve Life Sciences Strengthens Leadership with Appointment of Dr. Mark Rubinstein, Nicotine Dependence Expert, as New Head of Medical Affairs

Richard Stewart reassumes role of Chief Executive Officer Thomas King appointed Executive Chairman of the Board of Directors SEATTLE and VANCOUVER, British Columbia, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Mr. Richard (Rick) Stewart, Achieve's co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer.

Achieve Life Sciences Announces Changes in Executive Leadership and Board of Directors

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Nicole Jones - IR John Bencich - CEO Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Thomas Flaten - Lake Street Capital Operator Greetings, and welcome to the Achieve Life Sciences Second Quarter 2024 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

Achieve Life Sciences, Inc. (ACHV) Q2 2024 Earnings Call Transcript

Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024 Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024

Achieve Life Sciences Reports Financial Results for Second Quarter 2024 and Provides Corporate Update

Designation is based on results from the Phase 2 ORCA-V1 trial that showed treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo Designation is based on results from the Phase 2 ORCA-V1 trial that showed treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo

Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence

SEATTLE and VANCOUVER, British Columbia, July 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has entered into a $20 million debt refinancing agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank. The new loan agreement refinances the existing debt facility with SVB and SVB Capital and extends the maturity date from August 1, 2024 to December 1, 2027.

Achieve Life Sciences Announces $20M Loan Refinancing with Silicon Valley Bank

SEATTLE and VANCOUVER, British Columbia, July 25, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its second quarter 2024 financial results and provide an update on the cytisinicline development program on Tuesday, August 13, 2024, at 4:30 PM EDT.

Achieve Life Sciences to Announce Second Quarter Financial Results and Host Conference Call and Webcast on August 13, 2024

SEATTLE and VANCOUVER, British Columbia, July 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Achieve management will be attending the JonesHealthcare Seaside Summit 2024 being held July 14-16, 2024, in Encinitas, CA.

Achieve Life Sciences to Present at JonesHealthcare Seaside Summit 2024

Achieve Life Sciences, Inc. initiated an open-label ORCA-OL trial using cytisinicline for smoking cessation; the Efficacy of the drug already established in several prior studies. Alignment with FDA that successful completion of ORCA-OL trial is necessary for NDA filing of cytisinicline in the 1st half of 2025. The global smoking cessation product market is estimated to reach $69.8 billion by the end of 2034.

Achieve Life Sciences: 1st Half 2025 NDA Filing On Track With FDA Agreement

SEATTLE and VANCOUVER, British Columbia, May 17, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced data from the Phase 2 ORCA-V1 vaping cessation trial will be presented today, Friday, May 17, 2024, at the Society of General Internal Medicine (SGIM) Annual Meeting being held in Boston, MA.

Achieve Life Sciences Announces Data from Cytisinicline ORCA-V1 Program to be Presented at Society of General Internal Medicine (SGIM) Annual Meeting

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Michael Higgins - Ladenburg Thalmann John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Operator Greetings. Welcome to Achieve Life Sciences' First Quarter 2024 Earnings Conference Call and Webcast.

Achieve Life Sciences, Inc. (ACHV) Q1 2024 Earnings Call Transcript

Company to host conference call at 4:30 PM EDT today, Thursday, May 9, 2024 Company to host conference call at 4:30 PM EDT today, Thursday, May 9, 2024

Achieve Life Sciences Reports Financial Results for First Quarter 2024 and Provides Corporate Update

Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo

Achieve Life Sciences Announces Publication of Cytisinicline Vaping Cessation Trial Results in JAMA Internal Medicine

SEATTLE and VANCOUVER, British Columbia, April 25, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its first quarter 2024 financial results and provide an update on the cytisinicline development program on Thursday, May 9, 2024, at 4:30 PM EDT.

Achieve Life Sciences to Announce First Quarter Financial Results and Host Conference Call and Webcast on May 9, 2024

Achieve Life Sciences is working to commercialize the smoking cessation drug Cytisinicline, which has shown promising results in clinical trials. The drug has a superior safety profile compared to existing treatment options and has the potential to address a large market. The company is expected to be sold to a larger entity in 2025, with potential returns of 4-9x for investors.

Achieve Life Sciences: An Excellent Drug Addressing A Large Market Could Drive 5x Returns

Achieve Life Sciences, Inc. (ACHV) Q4 2023 Earnings Call Transcript

Company to host conference call at 4:30 PM EDT today, Thursday, March 28, 2024 Company to host conference call at 4:30 PM EDT today, Thursday, March 28, 2024

Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2023 and Provides Corporate Update

SEATTLE and VANCOUVER, British Columbia, March 06, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Achieve management will be participating in the following upcoming investor conferences.

Achieve Life Sciences Announces Participation at Upcoming Investor Conferences

Open-label exposure trial expected to initiate in Q2'24 with NDA filing anticipated in 1H 2025 Open-label exposure trial expected to initiate in Q2'24 with NDA filing anticipated in 1H 2025

Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission

$60 million financing upfront with up to an additional $64.2 million tied to exercise of milestone-driven warrants

Achieve Life Sciences Announces Pricing of up to $124.2 Million Registered Direct Offering and Concurrent Private Placement

Achieve Life Sciences (NASDAQ: ACHV ) stock is dropping on Tuesday after the company provided an update on its New Drug Application (NDA) for cytisinicline. A meeting with the Food and Drug Administration (FDA) saw the agency request additional data concerning cytisinicline before it will approve its NDA.

Why Is Achieve Life Sciences (ACHV) Stock Down 44% Today?

Why Is Achieve Life Sciences (ACHV) Stock Down 25% Today?

Achieve Life Sciences Inc. shares ACHV, -1.09% dropped 25% premarket on Tuesday as analysts forecasted delays in the launch of the company's smoking cessation treatment cytisinicline. In a recent meeting with the U.S. Food and Drug Administration, the agency said it would need longer-term data beyond 12 weeks to assess potential safety risks of cytisinicline, given that the regulator views smoking cessation drugs as products for chronic, intermittent use, Achieve Life Sciences said in a regulatory filing Monday.

News for Achieve Life Sciences Stock (ACHV)