SEATTLE and VANCOUVER, British Columbia - Achieve Life Sciences, Inc. (NASDAQ:ACHV), a pharmaceutical company focused on the development of cytisinicline for smoking cessation, has promoted Jaime Xinos to Chief Commercial Officer. Xinos, previously Executive Vice President of Commercial since 2017, will now lead the company's commercial operations and strategic preparations for the U.S. launch of cytisinicline, pending FDA approval.
CEO Rick Stewart expressed confidence in Xinos's ability to drive the commercial readiness of cytisinicline, highlighting her innovative and patient-first approach. Xinos's role will involve forging strategic partnerships to navigate the challenges of bringing a first product to market for a small biotech company.
Xinos, with nearly 25 years of commercial experience in the biotechnology and pharmaceutical sectors, has previously held roles at OncoGenex, Pfizer (NYSE:PFE), Novartis (SIX:NOVN), and Abbott Laboratories (NYSE:ABT). She holds a B.A. in Liberal Arts and Sciences and an MBA from the University of Illinois.
Cytisinicline, a plant-based alkaloid, is designed to interact with nicotine receptors in the brain, potentially reducing cravings and the satisfaction associated with nicotine products. It is currently an investigational product candidate and has not yet received FDA approval.
Achieve Life Sciences aims to address the global health crisis of smoking and nicotine addiction. With approximately 29 million adults in the U.S. who smoke and over 11 million who use e-cigarettes, the need for effective cessation aids is significant. The potential approval of cytisinicline could mark the first new FDA-approved treatment for nicotine dependence in almost two decades.
This announcement is based on a press release statement and reflects the company's plans and expectations for cytisinicline's clinical development, regulatory review, and potential commercialization. The forward-looking statements involve risks and uncertainties, including the possibility that cytisinicline may not achieve the hypothesized benefits or receive regulatory approval.
In other recent news, Achieve Life Sciences reported significant advancements in its Cytisinicline smoking cessation program, with the FDA granting breakthrough therapy designation for treating nicotine dependence from e-cigarettes. The company also initiated the ORCA-OL trial for long-term safety and is on track to submit a New Drug Application (NDA) in the first half of 2025. Analysts from Jones Trading and CG Capital have reaffirmed their confidence in the company, maintaining their respective price targets of $20 and $14.
Achieve Life Sciences' second quarter financial results for 2024 revealed a net loss of $8.5 million, despite holding $61.3 million in cash and investments. In a strategic move, the company refinanced its debt with Silicon Valley Bank, extending the maturity date to December 2027.
The company has also recently seen changes in its executive leadership. Richard Stewart has taken over as CEO and Thomas B. King has been appointed as Executive Chairman. These changes are aimed at enhancing the company's potential in licensing and commercial partnerships.
These recent developments suggest that Achieve Life Sciences is making progress in its mission to provide effective cessation treatments for both smoking and vaping. However, the company reported a net loss for the quarter ended June 30, 2024. These are among the recent developments in the company.
InvestingPro Insights
As Achieve Life Sciences (NASDAQ:ACHV) prepares for the potential launch of cytisinicline, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $171.88 million, reflecting the market's current valuation of its potential in the smoking cessation market.
InvestingPro data shows that Achieve Life Sciences has seen a strong return over the last month, with a 12.98% price total return. This recent performance could be indicative of growing investor confidence in the company's commercial prospects, particularly with the appointment of Jaime Xinos as Chief Commercial Officer.
However, it's important to note that the company is not currently profitable. An InvestingPro Tip highlights that Achieve Life Sciences has not been profitable over the last twelve months, with an adjusted operating income of -$25.37 million. This is not unusual for a biotech company in the pre-approval stage, but it underscores the importance of the potential cytisinicline launch for the company's financial future.
Another relevant InvestingPro Tip reveals that Achieve Life Sciences holds more cash than debt on its balance sheet. This financial position could provide some flexibility as the company navigates the costly process of bringing a new drug to market, aligning with the article's mention of the challenges faced by small biotech companies in product launches.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. In fact, there are 5 more InvestingPro Tips available for Achieve Life Sciences, which could provide valuable context for understanding the company's financial health and market position as it approaches this critical juncture in its development.
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