Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2024 and Provides Update on the Cytisinicline Development Program
Achieve Life Sciences (NASDAQ: ACHV) has announced its Q4 and year-end 2024 financial results, reaffirming plans to submit its New Drug Application (NDA) for cytisinicline by end of Q2 2025. The company reached key milestones in its ORCA-OL long-term exposure trial, including completing enrollment of 479 participants and meeting the FDA requirement of 300 participants receiving six months of cytisinicline treatment.
The company reported positive safety reviews from two Data Safety Monitoring Committee assessments of the ORCA-OL trial. Financial results show cash, equivalents, and marketable securities of $34.4 million as of December 31, 2024. Operating expenses were $12.2 million for Q4 and $39.1 million for the full year, with net losses of $12.4 million and $39.8 million respectively.
Additionally, Achieve received FDA agreement that one Phase 3 trial (ORCA-V2) would be acceptable for a vaping cessation indication as a supplemental NDA, with plans to initiate this trial in H1 2026, subject to funding availability.
Achieve Life Sciences (NASDAQ: ACHV) ha annunciato i risultati finanziari del quarto trimestre e dell'anno 2024, ribadendo i piani di presentare la sua Domanda di Nuovo Farmaco (NDA) per la cytisinicline entro la fine del secondo trimestre del 2025. L'azienda ha raggiunto traguardi chiave nel suo studio di esposizione a lungo termine ORCA-OL, inclusa la conclusione dell'arruolamento di 479 partecipanti e il rispetto del requisito della FDA di 300 partecipanti che ricevono sei mesi di trattamento con cytisinicline.
L'azienda ha riportato recensioni di sicurezza positive da due valutazioni del Comitato di Monitoraggio della Sicurezza dei Dati relative allo studio ORCA-OL. I risultati finanziari mostrano disponibilità liquide, equivalenti e titoli negoziabili di 34,4 milioni di dollari al 31 dicembre 2024. Le spese operative sono state di 12,2 milioni di dollari per il quarto trimestre e di 39,1 milioni di dollari per l'intero anno, con perdite nette di 12,4 milioni di dollari e 39,8 milioni di dollari rispettivamente.
Inoltre, Achieve ha ricevuto l'accordo della FDA che un trial di Fase 3 (ORCA-V2) sarebbe accettabile per un'indicazione di cessazione del vaping come NDA supplementare, con piani per avviare questo trial nel primo semestre del 2026, soggetto alla disponibilità di finanziamenti.
Achieve Life Sciences (NASDAQ: ACHV) ha anunciado sus resultados financieros del cuarto trimestre y del año 2024, reafirmando los planes de presentar su Solicitud de Nuevo Medicamento (NDA) para la cytisinicline a finales del segundo trimestre de 2025. La compañía alcanzó hitos clave en su ensayo de exposición a largo plazo ORCA-OL, incluyendo la finalización de la inscripción de 479 participantes y el cumplimiento del requisito de la FDA de 300 participantes que recibieron seis meses de tratamiento con cytisinicline.
La compañía reportó revisiones de seguridad positivas de dos evaluaciones del Comité de Monitoreo de Seguridad de Datos del ensayo ORCA-OL. Los resultados financieros muestran efectivo, equivalentes y valores negociables de 34,4 millones de dólares al 31 de diciembre de 2024. Los gastos operativos fueron de 12,2 millones de dólares para el cuarto trimestre y de 39,1 millones de dólares para el año completo, con pérdidas netas de 12,4 millones de dólares y 39,8 millones de dólares respectivamente.
Además, Achieve recibió el acuerdo de la FDA de que un ensayo de Fase 3 (ORCA-V2) sería aceptable para una indicación de cesación del vapeo como NDA suplementaria, con planes para iniciar este ensayo en el primer semestre de 2026, sujeto a la disponibilidad de financiamiento.
Achieve Life Sciences (NASDAQ: ACHV)는 2024년 4분기 및 연간 재무 결과를 발표하며 2025년 2분기 말까지 cytisinicline에 대한 신약 신청(NDA)을 제출할 계획을 재확인했습니다. 이 회사는 479명의 참가자가 등록된 ORCA-OL 장기 노출 시험에서 주요 이정표를 달성했으며, 300명의 참가자가 6개월 동안 cytisinicline 치료를 받는 FDA 요구 사항을 충족했습니다.
회사는 ORCA-OL 시험에 대한 두 개의 데이터 안전성 모니터링 위원회의 평가에서 긍정적인 안전성 리뷰를 보고했습니다. 재무 결과는 2024년 12월 31일 기준으로 3,440만 달러의 현금, 현금성 자산 및 유가증권을 보여줍니다. 운영 비용은 4분기 동안 1,220만 달러, 전체 연도 동안 3,910만 달러였으며, 각각 1,240만 달러 및 3,980만 달러의 순손실을 기록했습니다.
또한 Achieve는 FDA로부터 한 개의 3상 시험(ORCA-V2)이 보조 NDA로서의 금연 지표에 대해 수용 가능하다는 동의를 받았으며, 자금 조달 가능성에 따라 2026년 상반기에 이 시험을 시작할 계획입니다.
Achieve Life Sciences (NASDAQ: ACHV) a annoncé ses résultats financiers du quatrième trimestre et de l'année 2024, réaffirmant ses projets de soumettre sa Demande de Nouveau Médicament (NDA) pour la cytisinicline d'ici la fin du deuxième trimestre 2025. L'entreprise a atteint des jalons clés dans son essai d'exposition à long terme ORCA-OL, y compris l'achèvement de l'inscription de 479 participants et la satisfaction de l'exigence de la FDA de 300 participants recevant six mois de traitement par cytisinicline.
L'entreprise a rapporté des évaluations de sécurité positives de deux évaluations du Comité de Surveillance de la Sécurité des Données de l'essai ORCA-OL. Les résultats financiers montrent des liquidités, des équivalents et des titres négociables de 34,4 millions de dollars au 31 décembre 2024. Les dépenses d'exploitation étaient de 12,2 millions de dollars pour le quatrième trimestre et de 39,1 millions de dollars pour l'année entière, avec des pertes nettes de 12,4 millions de dollars et 39,8 millions de dollars respectivement.
De plus, Achieve a reçu l'accord de la FDA selon lequel un essai de phase 3 (ORCA-V2) serait acceptable pour une indication de cessation du vapotage en tant que NDA complémentaire, avec des plans pour initier cet essai au premier semestre 2026, sous réserve de la disponibilité de financement.
Achieve Life Sciences (NASDAQ: ACHV) hat seine finanziellen Ergebnisse für das vierte Quartal und das Gesamtjahr 2024 bekannt gegeben und die Pläne bekräftigt, bis Ende des zweiten Quartals 2025 einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) für Cytisiniclin einzureichen. Das Unternehmen erreichte wichtige Meilensteine in seiner ORCA-OL Langzeitstudie, darunter den Abschluss der Rekrutierung von 479 Teilnehmern und die Erfüllung der FDA-Anforderung von 300 Teilnehmern, die sechs Monate lang mit Cytisiniclin behandelt wurden.
Das Unternehmen berichtete von positiven Sicherheitsbewertungen aus zwei Bewertungen des Data Safety Monitoring Committee der ORCA-OL-Studie. Die finanziellen Ergebnisse zeigen zum 31. Dezember 2024 liquide Mittel, Äquivalente und handelbare Wertpapiere in Höhe von 34,4 Millionen Dollar. Die Betriebsausgaben betrugen im vierten Quartal 12,2 Millionen Dollar und im Gesamtjahr 39,1 Millionen Dollar, mit Nettverlusten von 12,4 Millionen Dollar bzw. 39,8 Millionen Dollar.
Darüber hinaus erhielt Achieve die Zustimmung der FDA, dass eine Phase-3-Studie (ORCA-V2) als ergänzender NDA für eine Raucherentwöhnungsanzeige akzeptabel wäre, mit dem Plan, diese Studie im ersten Halbjahr 2026 zu starten, vorbehaltlich der Verfügbarkeit von Finanzmitteln.
- Successfully completed ORCA-OL trial enrollment with 479 participants
- Received positive safety reviews from two DSMC assessments
- FDA agreed to accept one Phase 3 trial for vaping cessation indication
- Obtained Breakthrough Therapy designation for vaping cessation
- Met FDA requirement of 300 participants receiving 6-month cytisinicline treatment
- Net loss of $39.8 million for full-year 2024
- ORCA-V2 trial initiation dependent on additional funding availability
Insights
Achieve Life Sciences' year-end update demonstrates solid execution toward their regulatory pathway while highlighting important financial considerations. The company is maintaining $34.4 million in cash reserves as of December 2024, providing runway through their critical NDA submission for cytisinicline expected in Q2 2025. However, their $39.1 million in annual operating expenses and $39.8 million net loss for 2024 underscore the cash burn reality of late-stage development companies.
The planned NDA submission for smoking cessation represents a significant near-term catalyst, potentially positioning cytisinicline as the first new FDA-approved nicotine dependence treatment in nearly two decades. Their long-term exposure trial (ORCA-OL) has met key FDA requirements with 300+ participants completing six months of treatment and positive safety reviews from the Data Safety Monitoring Committee.
The vaping cessation program received FDA Breakthrough Therapy designation and favorable regulatory feedback, requiring only one additional Phase 3 trial for label expansion. However, this expansion explicitly depends on "availability of funding" with the ORCA-V2 trial targeted for H1 2026, signaling a likely need for additional capital raises despite their current cash position.
Leadership additions of Dr. Slaoui, Ms. Phelan, and CFO Mark Oki strengthen commercial execution capabilities ahead of potential product launch, a strategic move that aligns with their transition from development to commercialization.
Achieve's cytisinicline program is advancing through critical regulatory checkpoints with remarkable efficiency. The completed ORCA-OL enrollment with 479 participants across 29 US sites satisfies the FDA's requirement for long-term safety data, a important component for their upcoming NDA. The consistently clean safety profile across multiple DSMC reviews is particularly encouraging for a smoking cessation product, where tolerability directly impacts medication adherence and efficacy.
The FDA's agreement that a single Phase 3 trial would suffice for the vaping cessation indication (as a supplemental NDA) represents significant regulatory flexibility. This pathway allows Achieve to leverage existing safety data from ORCA-OL rather than duplicating extensive exposure studies, potentially saving millions in development costs. The Breakthrough Therapy designation further confirms the FDA's recognition of vaping cessation as an urgent unmet need.
From a market positioning perspective, being the first new smoking cessation pharmacotherapy in nearly 20 years gives cytisinicline substantial differentiation in a field dominated by generic options and nicotine replacement therapies. The company's strategic focus on both smoking and vaping cessation broadens their addressable market and positions them to capture evolving nicotine addiction patterns.
However, the extended timeline to the ORCA-V2 trial (H1 2026) suggests the company is prioritizing resources toward their lead indication while deferring the vaping program until post-initial approval or additional funding is secured—a pragmatic approach to resource allocation.
Reiterates Planned Cytisinicline NDA Submission Expected at the End of Q2 2025
Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, March 11, 2025
SEATTLE and VANCOUVER, British Columbia, March 11, 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 the fourth quarter and year-end 2024 and reiterated its plans to submit its new drug application (NDA) for cytisinicline at the end of the second quarter of 2025.
Recent Highlights
- Reached key milestones in the ORCA-OL long-term exposure trial, including completion of enrollment and meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment, as required for the submission of the NDA
- Announced positive outcomes from two data safety monitoring committee (DSMC) reviews with no safety concerns in the ORCA-OL clinical trial
- Appointed Dr. Kristen Slaoui and Nancy Phelan to the Board of Directors, bringing extensive leadership experience in corporate strategy and commercialization
- Appointed Mark Oki as Chief Financial Officer to oversee the company's financial strategy and operational initiatives
- Announced the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for defining cytisinicline development as a treatment for vaping cessation
“We are thrilled with our progress to date and excited to have the NDA submission on track for the end of next quarter, furthering our mission to bring cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years,” said Rick Stewart, Achieve’s Chief Executive Officer. “Over the last several months, we’ve reached key milestones enabling the NDA submission and deepened our leadership expertise to execute our strategy. We have a unique opportunity in the very near-term to make a significant impact on a critical public health crisis while driving long-term shareholder value.”
Key Milestones Reached for ORCA-OL Clinical Trial
Achieve has successfully completed enrollment in the cytisinicline ORCA-OL clinical trial, which includes 479 participants across 29 U.S. sites. This study is evaluating the long-term safety of a 3 mg cytisinicline regimen for smoking and vaping cessation, a key requirement for Achieve’s NDA submission planned for the second quarter of 2025. Furthermore, the trial reached the goal of at least 300 participants completing six months of cumulative cytisinicline treatment, as required by the FDA for the company’s planned NDA.
Announced Two Positive DSMC Reviews for ORCA-OL Clinical Trial
After two thorough reviews of the available safety data for the cytisinicline ORCA-OL long-term exposure clinical trial, the DSMC reported that no unexpected treatment-related adverse events were identified and that participant adherence to cytisinicline medication was excellent. The overall safety data remain consistent with prior findings. The DSMC concluded that the study may proceed as planned, without any modifications.
Appointed Two New Members to Board of Directors
Achieve announced the appointment of Dr. Kristen Slaoui and Nancy Phelan to its Board of Directors, bringing extensive expertise in corporate strategy, commercialization, and healthcare innovation. Dr. Slaoui, Chief Corporate Development Officer at Galderma, has led major transactions and strategic initiatives, while Ms. Phelan, Senior VP at Trinity Life Sciences, specializes in data-driven digital transformation and customer engagement. Both directors will play key roles as Achieve progresses toward NDA submission and commercialization for cytisinicline.
Appointed New Chief Financial Officer
In December 2024, Mark Oki was appointed as Achieve’s Chief Financial Officer and brings over 25 years of experience in financial leadership within the biotechnology and pharmaceutical industries. He oversees the company’s financial strategy, including accounting, investor relations, and key administrative functions, to support Achieve’s mission of advancing cytisinicline for the treatment of nicotine dependence. Mr. Oki’s expertise will be crucial as Achieve moves towards NDA submission and commercialization.
Announced End-of-Phase 2 Meeting for Vaping Cessation
The End-of-Phase 2 meeting was held with the FDA to confirm alignment on the proposed Phase 3 study design. The FDA agreed that one well-controlled Phase 3 trial (ORCA-V2), in addition to the completed Phase 2 ORCA-V1 trial, would be acceptable for a vaping cessation indication as a supplemental NDA. Additionally, the company’s safety exposure data from the ongoing ORCA-OL study was deemed sufficient for label expansion. In July 2024, the FDA granted Breakthrough Therapy designation for vaping cessation, aimed at accelerating development and review for treatments showing significant improvement over current therapies. Dependent on availability of funding, Achieve plans to initiate the Phase 3 ORCA-V2 trial in the first half of 2026.
Financial Results
As of December 31, 2024, the company’s cash, cash equivalents, and marketable securities was
Conference Call Details
Achieve will host a conference call at 8:30 am EDT today, Tuesday, March 11, 2025. To access the webcast, please use the following link: 4Q24 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or 1 201-689-7817 (International), referencing conference ID 13751745. 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 Q2 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 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
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 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 December 31, | Twelve months ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development | 7,296 | 2,114 | 22,817 | 15,814 | ||||||||||||||
| General and administrative | 4,894 | 2,272 | 16,252 | 11,436 | ||||||||||||||
| Total operating expenses | 12,190 | 4,386 | 39,069 | 27,250 | ||||||||||||||
| Loss from operations | (12,190 | ) | (4,386 | ) | (39,069 | ) | (27,250 | ) | ||||||||||
| Other income (expense) | (170 | ) | (1,090 | ) | (758 | ) | (2,565 | ) | ||||||||||
| Net loss | $ | (12,360 | ) | $ | (5,476 | ) | $ | (39,827 | ) | $ | (29,815 | ) | ||||||
| Basic and diluted net loss per share | $ | (0.36 | ) | $ | (0.26 | ) | $ | (1.24 | ) | $ | (1.50 | ) | ||||||
| Weighted average number of basic and diluted common shares | 34,510,786 | 21,165,760 | 32,071,146 | 19,827,354 | ||||||||||||||
| Consolidated Balance Sheets | ||||||||||||||||||
| (In thousands) | ||||||||||||||||||
| December 31, | December 31, | |||||||||||||||||
| 2024 | 2023 | |||||||||||||||||
| Assets: | ||||||||||||||||||
| Cash, cash equivalents and short-term investments | $ | 34,360 | $ | 15,546 | ||||||||||||||
| Prepaid expenses and other current assets | 2,107 | 1,436 | ||||||||||||||||
| Other assets and restricted cash | 39 | 92 | ||||||||||||||||
| Right-of-use assets | 119 | 66 | ||||||||||||||||
| License agreement | 974 | 1,197 | ||||||||||||||||
| Goodwill | 1,034 | 1,034 | ||||||||||||||||
| Total assets | $ | 38,633 | $ | 19,371 | ||||||||||||||
| Liabilities and stockholders' equity: | ||||||||||||||||||
| Accounts payable and accrued liabilities | $ | 6,627 | $ | 3,560 | ||||||||||||||
| Current portion of long-term obligations | 55 | 63 | ||||||||||||||||
| Current portion of convertible debt | — | 16,662 | ||||||||||||||||
| Non-current portion of convertible debt | 9,837 | — | ||||||||||||||||
| Contingent consideration | 1,149 | 528 | ||||||||||||||||
| Other long-term obligations | 66 | 6 | ||||||||||||||||
| Stockholders' equity | 20,899 | (1,448 | ) | |||||||||||||||
| Total liabilities and stockholders' equity | $ | 38,633 | $ | 19,371 | ||||||||||||||
FAQ
When will Achieve Life Sciences (ACHV) submit its NDA for cytisinicline?
How many participants were enrolled in ACHV's ORCA-OL clinical trial?
What is ACHV's current financial position as of December 2024?
When does ACHV plan to start the Phase 3 ORCA-V2 trial for vaping cessation?
What were ACHV's operating expenses and net losses for full-year 2024?
