Achieve Life Sciences, Inc. (NASDAQ: ACHV), is a specialty pharmaceutical company committed to advancing cytisinicline as a smoking cessation aid to address the global tobacco and nicotine addiction epidemic.
According to centres for disease Control and Prevention:
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Recent Highlights
- Completion of enrollment in 254-subject Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers
- Presented final data from cytisinicline Phase 1/2 multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) study at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting
- Initiated a trial to assess the maximum tolerated dose, or MTD, for a single administered oral dose of cytisinicline
- Pediatric waiver agreed by the S. Food and Drug Administration (FDA)
- Closed registered direct offering for gross proceeds of $5.6 million
The market is hugely excited with the recent accomplishments specific data results demonstrating impressive smoking cessation rates for cytisinicline treated subjects and the PK/PD repeat-dose study and the completion of enrolment in ACHV’ ORCA-1 trial
Management commentary:
Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, “The cytisinicline development program continues to advance rapidly, and we are well-poised for continued success in 2019. As demonstrated by the swift enrollment in our Phase 2b trial, new treatments are desperately needed to help the millions of people who desire to quit smoking.”
Robust liquidity and Financial flexibility:
- As of December 31, 2018, the company’s cash, cash equivalents, and short-term investments were $14.7 million, this is an increase of $9.1 million over where it ended the fiscal year 2017 and as a direct result of the public offerings the company completed in 2018 along with associated warrant exercises that provided the company with net cash of approximately $19.8 million.
- The company’year in cash balance put it in an excellent position to execute on the near-term development plans including the completion of the ORCA-1 trial in the middle of 2019. Total operating expenses for the fourth quarter and year ended December 31, 2018, were $3.7 million and $12.8 million respectively.
Upcoming catalysts/guidance:
- The company plans to continue to execute on its development plans as recommended by the FDA.
- The ORCA-1 results expected mid-year would inform the Phase 3 trial designs and also provide robust clinical data that will be critical to strategic discussions with potential commercial partners in the U.S. and the rest of the world.
- The management believes that the U.S. smoking cessation market represents roughly 75% of the global market for cytisinicline.
- ACHV’ goal is to identify a commercialization partner with capabilities in the primary care arena and also in other smoking-related specialties such as oncology, cardiovascular and respiratory diseases.
About Achieve and Cytisinicline
- 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.
- As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.
Cytisinicline process:
Financial Results for the Year Ended December 31, 2018
As of December 31, 2018, the company’s cash, cash equivalents, short-term investments, and restricted cash were $14.7 million. Total operating expenses for the fourth quarter and year ended December 31, 2018, were $3.7 million and $12.8 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2018, was $3.6 million and $12.7 million, respectively.
Key risk factors and potential stock drivers:
- Successful results of ORCA-1would lead future direction for the company. Any adversities related to this might adversely impact the overall investor sentiments.
- ACHV is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
- ACHV has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
- The company has a dependence on funding from public offering which could potentially dilute the value for existing holders.
Stock Performance
Comments:
- On Friday, March 15th, 2019, ACHV closed at $3.01 (up by 22.86%), with a substantial average volume of 14.1 million shares exchanging hands. Market capitalization is $20.231 million. The current RSI is trending at 70.21
- In the past 52 weeks, shares of ACHV have traded as low as $1.04 and as high as $14.60
- At $3.01, shares of ACHV are trading above its 50-day moving average (MA) at $1.82 and above its 200-day moving average (MA) at $2.75
- The present support and resistance levels for the stock are at $2.14 & $4.74 respectively.
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