Recent Events & Highlights
- Reported clinically robust and statistically significant Phase 3 topline results from the ORCA-2 clinical trial of cytisinicline in adult smokers
- Following positive ORCA-2 results, Achieve updated its agreements with
Silicon Valley Bank , providing access to an additional$10.0 million of capital - Cytisinicline development program overview presented at
Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting - Appointed Dr.
Vaughn Himes to Achieve’s Board of Directors
“Cytisinicline exceeded our expectations in the ORCA-2 trial by delivering impressive efficacy and tolerability in a difficult-to-treat population of smokers,
Positive Phase 3 ORCA-2 Topline Results
The Phase 3 ORCA-2 trial of cytisinicline achieved statistically significant results in primary and secondary endpoints for both 6- and 12-week cytisinicline treatment compared to placebo, and was very well tolerated with single-digit rates of adverse events observed.
Subjects
Subjects
Updated Debt Facility Agreement with SVB
In connection with the positive ORCA-2 trial results, Achieve received approval from
Cytisinicline Development Program Presented at SRNT Annual Meeting
An overview of the cytisinicline development program was included in the “Promising New Smoking Cessation Pharmacotherapies” Symposium during the
Dr. Vaughn Himes Appointed to the Board of Directors
In March, Achieve announced the appointment of
Financial Results
As of
Conference Call Details
Achieve will host a conference call at
About Achieve and 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
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.
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, the development and effectiveness of new treatments, and the intention to submit cytisinicline to the FDA for approval. 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 Russian military action in
Investor Relations Contact
achv@cg.capital
(404) 736-3838
Media Contact
Glenn.Silver@Finnpartners.com
(646) 871-8485
References
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Consolidated Statements of Loss | |||||||||
(In thousands, except per share and share data) | |||||||||
Three months ended | |||||||||
2022 | 2021 | ||||||||
Operating expenses: | |||||||||
Research and development | 4,388 | 5,642 | |||||||
General and administrative | 2,838 | 2,342 | |||||||
Total operating expenses | 7,226 | 7,984 | |||||||
Loss from operations | (7,226 | ) | (7,984 | ) | |||||
Other income (expense) | (347 | ) | (15 | ) | |||||
Net loss | $ | (7,573 | ) | $ | (7,999 | ) | |||
Basic and diluted net loss per share | $ | (0.80 | ) | $ | (1.30 | ) | |||
Weighted average number of basic and diluted common shares | 9,458,745 | 6,131,821 | |||||||
Consolidated Balance Sheets | |||||||||
(In thousands) | |||||||||
2022 | 2021 | ||||||||
Assets: | |||||||||
Cash and cash equivalents | $ | 36,337 | $ | 43,022 | |||||
Prepaid expenses and other current assets | 1,355 | 1,572 | |||||||
Other assets and restricted cash | 253 | 183 | |||||||
Right-of-use assets | 49 | 64 | |||||||
License agreement | 1,586 | 1,641 | |||||||
1,034 | 1,034 | ||||||||
Total assets | $ | 40,614 | $ | 47,516 | |||||
Liabilities and stockholders' equity: | |||||||||
Accounts payable and accrued liabilities | $ | 3,951 | $ | 4,481 | |||||
Current portion of long-term obligations | 59 | 69 | |||||||
Convertible debt | 15,171 | 14,920 | |||||||
Long-term obligations | — | 4 | |||||||
Stockholders' equity | 21,433 | 28,042 | |||||||
Total liabilities and stockholders' equity | $ | 40,614 | $ | 47,516 | |||||
Source:
2022 GlobeNewswire, Inc., source