SEATTLE and VANCOUVER, British Columbia - Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical company, has announced leadership changes with Mr. Richard (Rick) Stewart, the company's co-founder, reassuming the role of Chief Executive Officer. Mr. Thomas (Tom) King, previously the lead independent director, has been appointed as Executive Chairman of the Board of Directors.
The transition, effective today, comes as the company prepares for potential licensing or strategic transactions aimed at commercializing cytisinicline, its smoking cessation treatment. John Bencich, the outgoing CEO, will continue to advise during this period.
Rick Stewart, in his statement, expressed his commitment to achieving the company's goals, including completing the ORCA-OL study enrollment, engaging with the FDA for the End-of-Phase 2 meeting, and progressing towards the New Drug Application (NDA) submission expected in the first half of 2025.
Cytisinicline, a plant-based alkaloid, is designed to help smokers and e-cigarette users quit by reducing withdrawal symptoms and the satisfaction derived from nicotine. The substance is currently under investigation and has not yet been approved by the Food and Drug Administration (FDA).
The company's efforts are part of a broader response to the public health crisis posed by tobacco use, which is the leading cause of preventable death worldwide. With no FDA-approved treatments for nicotine e-cigarette cessation, Achieve Life Sciences aims to address a significant unmet medical need.
This leadership announcement is based on a press release statement from Achieve Life Sciences and reflects the company's strategic focus on the development and potential commercialization of cytisinicline.
In other recent news, Achieve Life Sciences reported significant advancements in the development of their Cytisinicline smoking cessation program. The company highlighted receiving FDA breakthrough therapy designation for treating nicotine dependence from e-cigarettes or vaping during their second quarter 2024 earnings call. Furthermore, they initiated the ORCA-OL trial for long-term safety and were added to the U.S. Russell 3000 and Russell Microcap Indexes.
The company is set to submit a New Drug Application (NDA) for smoking cessation in the first half of 2025. In terms of financials, Achieve Life Sciences held $61.3 million in cash and investments as of June 30, 2024, but reported a net loss of $8.5 million for the quarter. The company also refinanced its debt with Silicon Valley Bank, extending the maturity date to December 1, 2027.
These recent developments suggest that Achieve Life Sciences is making progress in its mission to provide effective cessation treatments for both smoking and vaping. The company anticipates the potential of Cytisinicline to help people overcome nicotine dependence and create shareholder value. However, Achieve Life Sciences reported an $8.5 million net loss for the quarter ended June 30, 2024.
InvestingPro Insights
As Achieve Life Sciences, Inc. (NASDAQ:ACHV) navigates leadership changes and advances its pursuit of commercializing cytisinicline, the company's financial health and market performance provide critical context for investors. According to InvestingPro data, Achieve Life Sciences currently holds a market capitalization of $157.28 million. Despite the company's efforts in developing cytisinicline, analysts have not projected profitability for the current year, aligning with the company's negative earnings per share (EPS) of -$1.08 over the last twelve months as of Q2 2024.
An InvestingPro Tip highlights that Achieve Life Sciences has more cash than debt on its balance sheet, which could provide some financial flexibility as they continue their clinical trials and regulatory engagements. However, it's important to note that the company's stock price movements are quite volatile, which may be a consideration for risk-averse investors. Another point of interest is that the company's liquid assets exceed its short-term obligations, suggesting a degree of financial stability in the near term.
For investors seeking a deeper analysis, there are additional InvestingPro Tips available, including insights on the company's gross profit margins and earnings revisions by analysts. To explore these further, investors can visit https://www.investing.com/pro/ACHV, where more detailed tips and metrics are available to inform their investment decisions.
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