Recent Highlights
Announced Company reached agreement with theU.S. Food and Drug Administration (FDA) on long-term cytisinicline exposure requirements to support a New Drug Application (NDA) submission- Completed an equity financing of up to
$124.2 million that included initial upfront gross proceeds of$60.0 million , prior to deducting placement agent fees and estimated offering expenses, and up to an additional approximately$64.2 million of gross proceeds upon exercise of milestone-driven warrants - Presented data from Phase 3 ORCA-2 and ORCA-3 trials, and Phase 2 ORCA-V1 trial at
Society for Research on Nicotine and Tobacco (SRNT)
FDA Agreement on NDA Submission Requirement
Achieve and the FDA have reached agreement that a single, open-label study evaluating for long-term safety exposure of cytisinicline will be sufficient to complete the requirement and enable an NDA submission anticipated in the first half of 2025. Achieve plans to initiate the “ORCA-OL” open-label exposure trial in the second quarter of 2024, which will include investigators and sites
Completed Registered Direct Offering and Concurrent Private Placement
The Company completed an equity financing of up to
ORCA-2, ORCA-3 and ORCA-V1 Data Presented at Annual
During the Annual
Results presented from the Phase 3 participant surveys, showed that 69% of survey respondents
Financial Results
As of
Conference Call Details
Achieve will host a conference call at
About Achieve and Cytisinicline
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in
In addition, there are over 11 million adults in
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 withdrawal 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
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 anticipated proceeds from outstanding milestone-driven warrants, the sufficiency of Achieve’s capital resources to fund the development of cytisinicline through potential FDA approval, the the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. 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 of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape 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 conditions, including inflation, rising interest rates, instability in the global banking sector, and public health crises, such as the COVID-19 pandemic and the other factors described in the risk factors set forth in Achieve’s filings with the
Investor Relations Contact
achv@cg.capital
(404) 736-3838
Media Contact
Glenn.Silver@Finnpartners.com
(646) 871-8485
References
1Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults –
2
3
4Birdsey J, Cornelius M, Jamal A, et al.
Consolidated Statements of Loss | |||||||||||||||
(In thousands, except per share and share data) | |||||||||||||||
Three months ended | Twelve months ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | 2,114 | 8,614 | 15,814 | 30,078 | |||||||||||
General and administrative | 2,272 | 2,248 | 11,436 | 10,722 | |||||||||||
Total operating expenses | 4,386 | 10,862 | 27,250 | 40,800 | |||||||||||
Loss from operations | (4,386 | ) | (10,862 | ) | (27,250 | ) | (40,800 | ) | |||||||
Other income (expense) | (1,090 | ) | (370 | ) | (2,565 | ) | (1,550 | ) | |||||||
Net loss | $ | (5,476 | ) | $ | (11,232 | ) | $ | (29,815 | ) | $ | (42,350 | ) | |||
Basic and diluted net loss per share | $ | (0.26 | ) | $ | (0.83 | ) | $ | (1.50 | ) | $ | (4.00 | ) | |||
Weighted average number of basic and diluted common shares | 21,165,760 | 13,536,944 | 19,827,354 | 10,593,034 | |||||||||||
Consolidated Balance Sheets | |||||||||||||||
(In thousands) | |||||||||||||||
2023 | 2022 | ||||||||||||||
Assets: | |||||||||||||||
Cash and cash equivalents | $ | 15,546 | $ | 24,771 | |||||||||||
Prepaid expenses and other current assets | 1,436 | 2,559 | |||||||||||||
Other assets and restricted cash | 92 | 66 | |||||||||||||
Right-of-use assets | 66 | 123 | |||||||||||||
License agreement | 1,197 | 1,418 | |||||||||||||
1,034 | 1,034 | ||||||||||||||
Total assets | $ | 19,371 | $ | 29,971 | |||||||||||
Liabilities and stockholders' equity: | |||||||||||||||
Accounts payable and accrued liabilities | $ | 4,088 | $ | 5,470 | |||||||||||
Current portion of long-term obligations | 63 | 58 | |||||||||||||
Convertible debt | 16,662 | 16,071 | |||||||||||||
Long-term obligations | 6 | 69 | |||||||||||||
Stockholders' equity | (1,448 | ) | 8,303 | ||||||||||||
Total liabilities and stockholders' equity | $ | 19,371 | $ | 29,971 | |||||||||||
Source:
2024 GlobeNewswire, Inc., source