Recent Highlights
- Provided an update on the ORCA-2 Phase 3 clinical trial, including announcing that all subjects have completed the treatment portion of the study and are in follow-up, and that topline data is expected in the first half of 2022
- Discussed ongoing planning activities for ORCA-3, the second Phase 3 clinical trial supporting cytisinicline regulatory submission in
the United States , which Achieve anticipates could launch by early 2022 - Announced FDA acceptance of IND application for the evaluation of cytisinicline in nicotine e-cigarette cessation
- Issued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimen
- Presented cytisinicline data at the
Society for Research on Nicotine & Tobacco Europe (SRNT-E) annual meeting - Announced expansion of cytisinicline clinical operations team
“It has been another successful quarter as we continue to focus on meeting our key development milestones, specifically, completing the Phase 3 ORCA-2 trial, and preparing for the initiation of two new cytisinicline trials,” commented
Ongoing ORCA-2 Phase 3 Clinical Trial
Achieve provided an update on the cytisinicline development program in adult cigarette smokers in
Planned ORCA-3 Phase 3 Clinical Trial
Achieve reviewed ORCA-3 planning activities and announced that it has completed selection of a Contract Research Organization (CRO), finalized cytisinicline packaging and drug supply, and is currently undergoing clinical trial site selection. The trial is expected to initiate enrollment of approximately 750 adult cigarette smokers by early 2022.
FDA Acceptance of IND for Study of Cytisinicline in e-Cigarette Cessation
Achieve announced that the
Patents Issued for 3.0 mg TID Dosing Regimen
The
Cytisinicline Data Presented at SRNT-E Annual Meeting
Two cytisinicline data presentations were included in the SRNT-E annual meeting, held in
Expanded Clinical Operations Team
Achieve announced the expansion of its clinical operations team to include a Senior Director of Biometrics, Senior Manager of Clinical Trials, and Director of Clinical Operations, to support efforts with the ongoing and planned cytisinicline development program.
Financial Results
As of
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 and commercialization activities, the ability to provide patent protection for Achieve’s cytisinicline program, the potential listing of the patents in the FDA’s Orange Book, the potential market size for cytisinicline, the potential benefits 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
References
1
2 U.S. Department of
Chantix® is a registered trademark of Pfizer, Inc.
Consolidated Statements of Loss | |||||||||||||||||
(In thousands, except per share and share data) | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 4,591 | 1,891 | 19,460 | 4,535 | |||||||||||||
General and administrative | 2,102 | 1,863 | 6,519 | 5,494 | |||||||||||||
Total operating expenses | 6,693 | 3,754 | 25,979 | 10,029 | |||||||||||||
Loss from operations | (6,693 | ) | (3,754 | ) | (25,979 | ) | (10,029 | ) | |||||||||
Other income (expense) | 2 | (10 | ) | (22 | ) | 23 | |||||||||||
Net loss | $ | (6,691 | ) | $ | (3,764 | ) | $ | (26,001 | ) | $ | (10,006 | ) | |||||
Basic and diluted net loss per share | $ | (0.71 | ) | $ | (1.14 | ) | $ | (3.39 | ) | $ | (4.55 | ) | |||||
Weighted average number of basic and diluted common shares | 9,452,238 | 3,289,252 | 7,670,383 | 2,197,368 | |||||||||||||
Consolidated Balance Sheets | |||||||||||||||||
(In thousands) | |||||||||||||||||
2021 | 2020 | ||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 33,312 | $ | 35,853 | |||||||||||||
Prepaid expenses and other current assets | 1,421 | 1,122 | |||||||||||||||
Property, equipment, other assets and restricted cash | 256 | 279 | |||||||||||||||
Right-of-use assets | 79 | 146 | |||||||||||||||
License agreement | 1,697 | 1,864 | |||||||||||||||
1,034 | 1,034 | ||||||||||||||||
Total assets | $ | 37,799 | $ | 40,298 | |||||||||||||
Liabilities and stockholders' equity: | |||||||||||||||||
Accounts payable and accrued liabilities | $ | 3,007 | $ | 2,843 | |||||||||||||
Current portion of long-term obligations | 69 | 92 | |||||||||||||||
Long-term obligations | 23 | 77 | |||||||||||||||
Stockholders' equity | 34,700 | 37,286 | |||||||||||||||
Total liabilities and stockholders' equity | $ | 37,799 | $ | 40,298 |
Investor Relations ContactRich Cockrell achv@cg.capital (404) 736-3838 Media ContactGlenn Silver Glenn.Silver@Finnpartners.com (646) 871-8485
Source:
2021 GlobeNewswire, Inc., source