Achieve Life Sciences Reports First Quarter 2025 Financial Results and Highlights Updates in Cytisinicline Program

Rhea-AI Summary

Achieve Life Sciences (NASDAQ: ACHV) reported its Q1 2025 financial results and provided updates on its cytisinicline program for smoking cessation. The company plans to submit a New Drug Application (NDA) to the FDA in June 2025. Key highlights include: publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine involving 792 U.S. adults, completion of long-term exposure requirements with ≥300 participants receiving six months and 100+ participants receiving one year of treatment, and a favorable third safety review by the Data Safety Monitoring Committee. Financial results show cash position of $23.2 million, operating expenses of $12.9 million, and a net loss of $12.8 million for Q1 2025. The company's cytisinicline could become the first new FDA-approved smoking cessation treatment in nearly 20 years.

Positive

• Successfully completed FDA requirements for long-term safety data with over 300 participants completing 6 months and 100+ completing 1 year of treatment
• Strong retention rate with 75% of 479 enrolled participants remaining on treatment
• Phase 3 ORCA-3 trial results published in prestigious JAMA Internal Medicine, validating cytisinicline's efficacy
• No safety concerns identified in third DSMC review of ORCA-OL clinical trial
• Potential to be first new FDA-approved smoking cessation treatment in nearly 20 years

Negative

• Significant quarterly net loss of $12.8 million
• High operating expenses of $12.9 million in Q1 2025
• Cash position of $23.2 million may require additional funding given current burn rate

Insights

Pharmaceutical Clinical Development Expert

Achieve Life Sciences nears NDA submission for cytisinicline, showing promising safety profile and efficacy in Phase 3 trials.

Achieve Life Sciences is approaching a critical regulatory milestone with their planned June 2025 NDA submission for cytisinicline, potentially introducing the first new smoking cessation treatment approved by the FDA in nearly two decades. The company has successfully cleared several essential hurdles required for this submission.

Their Phase 3 ORCA-3 trial results, now published in the prestigious JAMA Internal Medicine, validate earlier ORCA-2 findings and strengthen the evidence supporting cytisinicline's efficacy. The trial involved 792 U.S. adult smokers and demonstrated positive outcomes at both 6 and 12-week treatment durations, with extended quit rates through 24 weeks and reduction in nicotine cravings.

Perhaps most impressive is the safety profile emerging from the ORCA-OL long-term exposure trial. The company has met the FDA's requirements of safety data for ≥300 participants receiving six months and ≥100 participants receiving one year of cumulative treatment. After three comprehensive Data Safety Monitoring Committee reviews, no safety concerns have been identified. The 75% retention rate of enrolled participants is particularly noteworthy in the addiction treatment space, where dropout rates are typically high.

This safety profile could provide cytisinicline with a competitive advantage over existing treatments. The drug's mechanism of selectively binding to nicotine receptors appears to deliver efficacy while maintaining tolerability, addressing a critical limitation of current smoking cessation options.

While the press release doesn't specify the exact nature of the safety advantages, the emphasis on cytisinicline's differentiated safety profile suggests it may avoid some of the concerning side effects associated with current smoking cessation pharmacotherapies, potentially expanding the eligible patient population and improving treatment adherence if approved.

Biotech Financial Analyst

Achieve Life Sciences nears FDA submission with $23.2M cash, advancing a differentiated smoking cessation drug toward potential commercialization.

Achieve Life Sciences is navigating a critical pre-commercialization phase with key clinical and regulatory milestones for cytisinicline. The company reported cash, cash equivalents, and marketable securities of $23.2 million as of March 31, 2025, against quarterly operating expenses of $12.9 million and a net loss of $12.8 million. This financial position requires careful scrutiny with the planned June 2025 NDA submission to the FDA approaching.

The current burn rate suggests approximately 1.8 quarters of cash runway at current spending levels. However, the NDA submission represents a significant inflection point that could catalyze multiple strategic options, including partnerships, licensing agreements, or additional financing rounds potentially at more favorable terms if the regulatory process progresses positively.

The company's focus on cytisinicline positions it in the substantial smoking cessation market, where new treatment options are limited. With smoking remaining a leading cause of preventable death and existing treatments showing limitations in efficacy and tolerability, a new FDA-approved option could capture significant market share. The drug's dual efficacy in both smoking and vaping cessation (as mentioned in the ORCA-OL study description) further expands the potential market opportunity.

The publication of Phase 3 results in JAMA Internal Medicine adds scientific credibility and visibility, potentially enhancing the company's partnership prospects. The consistent safety profile demonstrated across trials may position cytisinicline as a differentiated option in the smoking cessation landscape, potentially commanding premium pricing if approved.

While the immediate financial picture shows limited runway, the proximity to NDA submission represents a transitional phase where clinical success could translate to commercial value, making the coming months pivotal for Achieve's long-term prospects.

Reiterates Planned Submission of an NDA for Cytisinicline to FDA in June 2025

Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, May 13, 2025

SEATTLE and VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced its financial results for first quarter 2025 and confirmed that it plans to submit the upcoming New Drug Application (NDA) for cytisinicline to the U.S. Food and Drug Administration (FDA) in June 2025.

“The Achieve team is fully committed to finalizing the NDA for submission to the FDA next month. This pivotal milestone is the culmination of our team’s tireless efforts. It marks a critical inflection point as we move towards delivering the first new FDA-approved treatment for smoking cessation in nearly 20 years,” said Rick Stewart, Chief Executive Officer of Achieve. “Cytisinicline has the potential to have a significant benefit on U.S. public health with patients and their healthcare providers needing new options to improve cessation outcomes.”

Recent Highlights

• Announced publication of the second Phase 3 ORCA-3 trial results in the Journal of American Medical Association (JAMA) Internal Medicine that evaluated cytisinicline for smoking cessation in 792 U.S. adults
• Reached key requirements in the ORCA-OL long-term exposure trial including safety exposure data for ≥300 participants receiving six months and at least 100 participants receiving one year of cumulative cytisinicline treatment
• Completed third safety review of the ORCA-OL clinical trial with the Data Safety Monitoring Committee (DSMC), which did not identify any safety concerns with longer-term cytisinicline exposure
• Conducted a Science Advisory Board (SAB) meeting with leading experts in nicotine and tobacco cessation research

“Reaching 100 patients with one year of cumulative treatment in the ORCA-OL long-term exposure trial without safety issues further reinforces cytisinicline’s tolerability and differentiates it from currently available treatments,” commented Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve. “Currently, approximately 75% of the 479 enrolled participants remain on treatment, speaking to cytisinicline’s overall benefit and the potential to shift the treatment paradigm for smoking cessation.”

Published Phase 3 ORCA-3 Trial Results in JAMA Internal Medicine
Complete results from the Phase 3 ORCA-3 clinical trial have been published in JAMA Internal Medicine, further validating cytisinicline as a potential treatment for smoking cessation. The randomized, placebo-controlled trial enrolled 792 U.S. adult smokers, and reaffirmed cytisinicline’s efficacy and tolerability at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended quit rates through 24 weeks. These findings, consistent with results from the ORCA-2 trial, further support cytisinicline’s targeted effect on treating nicotine dependence by selectively binding to nicotine receptors.

Reached FDA’s Long-term Exposure Requirements in the ORCA-OL Clinical Trial
Achieve has successfully completed the FDA requirements of having safety data on more than 300 participants completing six months of cumulative cytisinicline treatment and on 100 participants completing one year of cumulative cytisinicline treatment. The ORCA-OL clinical study enrolled 479 participants across 29 U.S. sites. This study is evaluating the long-term safety of the 3 mg cytisinicline regimen for smoking and vaping cessation, a key requirement for Achieve’s NDA submission planned in June 2025.

Announced Completion of Third DSMC Review on Safety Data for ORCA-OL Clinical Trial
Following its third comprehensive review of safety data from the ongoing ORCA-OL long-term exposure clinical trial, the DSMC reported no unexpected treatment-related adverse events and continued to note excellent participant adherence to cytisinicline. The overall safety data remain consistent with previous findings, and the DSMC recommended that the study continue as planned with no changes.

Conducted SAB Meeting
In May, Achieve convened an SAB meeting, including ten leading experts in nicotine and tobacco cessation research. This meeting provided an opportunity to share updates on clinical progress and NDA preparations for cytisinicline, while also benefiting from the insights of some of the foremost researchers in the field.

Financial Results
As of March 31, 2025, the company’s cash, cash equivalents, and marketable securities were $23.2 million. Total operating expenses for the quarter ended March 31, 2025 were $12.9 million. Total net loss for the quarter ended March 31, 2025 was $12.8 million.

Conference Call Details
Achieve will host a conference call at 8:30 am EDT today, Tuesday, May 13, 2025. To access the webcast, please use the following link: 1Q25 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International), referencing conference ID 13752599. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.

About Achieve Life Sciences, Inc. 
Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in June 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.

About Cytisinicline
There are approximately 29 million adults in the United States who smoke combustible cigarettes.¹ Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.^2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.³

In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.⁴ In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.⁵ There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical need.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable.

Achieve Contact
Nicole Jones
ir@achievelifesciences.com
425-686-1510

References
¹VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
³U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
⁴Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
⁵Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924

Consolidated Statements of Loss
(In thousands, except per share and share data)
	Three months ended March 31,
	2025				2024
Operating expenses:
Research and development		7,097				2,799
General and administrative		5,797				3,183
Total operating expenses		12,894				5,982
Loss from operations		(12,894	)			(5,982	)
Other income (expense)		67				(512	)
Net loss	$	(12,827	)		$	(6,494	)
Basic and diluted net loss per share	$	(0.37	)		$	(0.26	)
Weighted average number of basic and diluted common shares		34,685,072				25,048,134
Consolidated Balance Sheets
(In thousands)
	March 31,				December 31,
	2025				2024
Assets:
Cash, cash equivalents and short-term investments	$	23,245			$	34,360
Prepaid expenses and other current assets		1,755				2,107
Other assets and restricted cash		300				39
Right-of-use assets		106				119
License agreement		918				974
Goodwill		1,034				1,034
Total assets	$	27,358			$	38,633
Liabilities and stockholders' equity:
Accounts payable and accrued liabilities	$	5,879			$	6,627
Current portion of long-term obligations		57				55
Current portion of convertible debt		1,194				—
Non-current portion of convertible debt		8,657				9,837
Contingent consideration		1,240				1,149
Other long-term obligations		52				66
Stockholders' equity		10,279				20,899
Total liabilities and stockholders' equity	$	27,358			$	38,633

FAQ

When will Achieve Life Sciences (ACHV) submit its NDA for cytisinicline to the FDA?

Achieve Life Sciences plans to submit its New Drug Application (NDA) for cytisinicline to the FDA in June 2025.

What were the key findings from ACHV's ORCA-3 Phase 3 trial for cytisinicline?

The ORCA-3 trial, involving 792 U.S. adults, demonstrated cytisinicline's efficacy and tolerability at both 6- and 12-week treatment durations, showing reduced nicotine cravings and extended quit rates through 24 weeks.

What is ACHV's current cash position as of Q1 2025?

As of March 31, 2025, Achieve Life Sciences had $23.2 million in cash, cash equivalents, and marketable securities.

How many participants are enrolled in ACHV's ORCA-OL long-term safety study?

The ORCA-OL clinical study enrolled 479 participants across 29 U.S. sites, with approximately 75% of participants remaining on treatment.

What were Achieve Life Sciences' (ACHV) Q1 2025 financial results?

In Q1 2025, ACHV reported operating expenses of $12.9 million and a total net loss of $12.8 million.