Yahoo Finance Achieve Life Sciences Inc (ACHV) Reports Q1 2024 Financial Results
Net Loss: Reported a net loss of $6.49 million for Q1 2024, beating the estimated net loss of $6.67 million.
Earnings Per Share (EPS): Recorded an EPS of -$0.26, slightly above the estimated EPS of -$0.24.
Revenue: Reported revenue met the estimated figure of $0.00 million.
Cash Position: Cash and cash equivalents stood at $66.4 million as of March 31, 2024, significantly up from $15.5 million as of December 31, 2023.
Operating Expenses: Total operating expenses were $6.0 million for the quarter, a decrease from $8.6 million in the same period last year.
Research and Development (R&D) Costs: R&D expenses decreased to $2.8 million from $5.5 million year-over-year.
Equity Financing: Achieved a significant equity financing deal, securing up to approximately $124.2 million, which will support ongoing clinical development and potential FDA approval processes.
Achieve Life Sciences Inc (NASDAQ:ACHV), a trailblazer in the pharmaceutical industry focusing on smoking cessation, disclosed its financial outcomes for the first quarter of 2024 on May 9, 2024. The company made this announcement through its 8-K filing and prepared to discuss these results in a conference call later that day.
Company Overview
Achieve Life Sciences is dedicated to the global development and commercialization of cytisinicline, a plant-based alkaloid aimed at treating nicotine addiction. This treatment has shown promise in various clinical trials and is particularly noted for its potential in aiding individuals to quit smoking and vaping. The company's efforts are crucial given the high rates of smoking-related illnesses and the lack of FDA-approved treatments for nicotine e-cigarette cessation.
Recent Operational Highlights
The first quarter of 2024 was marked by significant advancements in Achieve's clinical development programs. Notably, the company published the results of the Phase 2 ORCA-V1 clinical trial in the Journal of the American Medical Association Internal Medicine, which highlighted the efficacy of cytisinicline in aiding vaping cessation. Achieve is also progressing with plans to initiate the ORCA-OL trial, aimed at evaluating long-term cytisinicline exposure, with enrollment expected to start in May 2024.
Moreover, Achieve has secured substantial financial backing through an equity financing initiative, raising up to $124.2 million. This funding is poised to support the ongoing clinical trials and the anticipated New Drug Application (NDA) submission scheduled for the first half of 2025.
Financial Performance Analysis
For the quarter ended March 31, 2024, Achieve reported a net loss of $6.5 million, with total operating expenses amounting to $6.0 million. This financial performance aligns closely with analyst expectations, which projected a net loss of $6.67 million. The company's cash reserves were significantly bolstered by the recent financing, totaling $66.4 million in cash, cash equivalents, and restricted cash.
These funds are expected to sustain the company's operations and clinical developments into 2026, potentially through to the FDA approval of cytisinicline. This financial stability is crucial for Achieve as it continues to invest heavily in research and development, which for this quarter alone amounted to $2.8 million.
Looking Ahead
With the ORCA-OL trial set to commence and ongoing preparations for an NDA submission, Achieve Life Sciences is at a pivotal juncture. The successful commercialization of cytisinicline could address a significant unmet medical need and tap into a substantial market comprising millions of smokers and vapers seeking cessation solutions.
The company's strategic focus on this niche, coupled with robust clinical data and a strengthened financial position, positions it well for future growth. However, investors and stakeholders will be watching closely as Achieve navigates the complex regulatory landscape and moves towards potential commercialization.
For detailed financial tables and further information, refer to the full 8-K filing. Achieve Life Sciences continues to make strides in its mission to combat nicotine dependency, with each step forward underpinned by rigorous research and a clear strategic vision.
Explore the complete 8-K earnings release (here) from Achieve Life Sciences Inc for further details.
This article first appeared on GuruFocus.
