Recent Events & Highlights
- Reported statistically significant results from the Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers
- Awarded
$2.5 million grant from theNational Institutes of Health (NIH) to conduct ORCA-V1 Phase 2 trial of cytisinicline in nicotine e-cigarette users - Initiated the Phase 2 ORCA-V1 clinical trial to evaluate cytisinicline in adult e-cigarette users
“We continue to build upon the progress of cytisinicline with the announcement of the initiation of the ORCA-V1 trial and the continued enrolment in ORCA-3, our final NDA-enabling smoking cessation clinical trial,” stated
Reported Phase 3 ORCA-2 Results
In April, Achieve announced positive, statistically significant results in its Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers across 17 clinical trial locations in
Awarded
In June, Achieve was awarded
Initiated Phase 2 ORCA-V1 Trial
Also in June, following the
Financial Results
As of
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. 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
In addition, there are nearly 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 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, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, 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 the COVID-19 pandemic or similar public health crises 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
1
2
3Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Tobacco Product Use Among Adults —
4Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].
5Gentzke AS, Wang TW, Cornelius M, et al.
6
Consolidated Statements of Loss | |||||||||||||||
(In thousands, except per share and share data) | |||||||||||||||
Three months ended | Six months ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | 7,207 | 9,227 | 11,595 | 14,869 | |||||||||||
General and administrative | 2,866 | 2,075 | 5,704 | 4,417 | |||||||||||
Total operating expenses | 10,073 | 11,302 | 17,299 | 19,286 | |||||||||||
Loss from operations | (10,073 | ) | (11,302 | ) | (17,299 | ) | (19,286 | ) | |||||||
Other income (expense) | (395 | ) | (9 | ) | (742 | ) | (24 | ) | |||||||
Net loss | $ | (10,468 | ) | $ | (11,311 | ) | $ | (18,041 | ) | $ | (19,310 | ) | |||
Basic and diluted net loss per share | $ | (1.08 | ) | $ | (1.53 | ) | $ | (1.89 | ) | $ | (2.85 | ) | |||
Weighted average number of basic and diluted common shares | 9,647,726 | 7,390,600 | 9,553,757 | 6,764,688 | |||||||||||
Consolidated Balance Sheets | ||||||||||
(In thousands) | ||||||||||
2022 | 2021 | |||||||||
Assets: | ||||||||||
Cash and cash equivalents | $ | 29,378 | $ | 43,022 | ||||||
Prepaid expenses and other current assets | 1,770 | 1,572 | ||||||||
Other assets and restricted cash | 240 | 183 | ||||||||
Right-of-use assets | 33 | 64 | ||||||||
License agreement | 1,530 | 1,641 | ||||||||
1,034 | 1,034 | |||||||||
Total assets | $ | 33,985 | $ | 47,516 | ||||||
Liabilities and stockholders' equity: | ||||||||||
Accounts payable and accrued liabilities | $ | 5,318 | $ | 4,481 | ||||||
Current portion of long-term obligations | 41 | 69 | ||||||||
Convertible debt | 15,460 | 14,920 | ||||||||
Long-term obligations | — | 4 | ||||||||
Stockholders' equity | 13,166 | 28,042 | ||||||||
Total liabilities and stockholders' equity | $ | 33,985 | $ | 47,516 | ||||||
Source:
2022 GlobeNewswire, Inc., source