WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST) announced today that its latest pharmacokinetics (PK) study on Anaphylm™, a sublingual film for emergency epinephrine delivery, met primary study endpoints. The study demonstrated comparable PK profiles for Anaphylm when administered by individuals or healthcare providers (HCPs).
The self-administration study's data suggests Anaphylm may offer a non-invasive, easy-to-use alternative for treating severe allergic reactions, including anaphylaxis. This could be the first orally delivered epinephrine product if approved by the FDA. Daniel Barber, CEO of Aquestive, highlighted the product's versatility and its potential to address emergency scenarios where traditional administration may be challenging.
In the study, 36 healthy adult subjects were administered Anaphylm both by themselves and by HCPs, and their epinephrine levels were compared to those receiving an intramuscular injection of Adrenalin by HCPs.
The primary PK parameters evaluated were the maximum concentration of epinephrine in plasma (Cmax) and overall exposure (AUC). The results showed no statistical difference between self-administered and HCP-administered Anaphylm, with a median time to maximum concentration (Tmax) of 15 minutes for both, compared to 50 minutes for the Adrenalin injection.
The company is currently enrolling participants for the Oral Allergy Syndrome (OAS) challenge study, expected to complete by late third quarter or early fourth quarter of 2024. Aquestive anticipates requesting a pre-New Drug Application (NDA) meeting with the FDA before the end of the third quarter and aims to file an NDA by late 2024 or early 2025.
Subject to FDA approval, the company plans to launch Anaphylm by the end of 2025 or in the first quarter of 2026.
Anaphylaxis is a severe, rapid-onset allergic reaction that can be fatal. In the United States, an estimated 49 million people are at chronic risk for anaphylaxis, with the frequency of hospital admissions for this condition increasing significantly in recent years. Current treatment involves epinephrine injection, which can be intimidating due to the use of needles.
Anaphylm, designed to be the size of a postage stamp and weighing less than an ounce, dissolves upon contact without the need for water or swallowing. Its packaging is intended to be durable and portable, withstanding weather conditions.
Aquestive Therapeutics specializes in advancing medicines with innovative delivery technologies. While this press release contains forward-looking statements regarding Anaphylm's development and potential approval, these are subject to various risks and uncertainties that could affect the actual outcomes. The information is based on a press release statement from Aquestive Therapeutics.
In other recent news, Aquestive Therapeutics reported first-quarter 2024 revenues of $12.1 million, falling short of both Lake Street Capital Markets' and consensus estimates. Despite this, the company maintained its revenue and AEBITDA guidance for the full year 2024.
Lake Street Capital Markets adjusted its outlook on Aquestive Therapeutics, reducing the price target to $7.00 from the previous $8.00, while keeping a Buy rating on the shares.
The company also reported positive pharmacokinetic results for Anaphylm, its sublingual epinephrine film, showing consistent performance despite exposure to different beverages at varying temperatures and pH levels. This suggests potential integration into patients' daily routines.
On the financial front, Aquestive raised over $75 million in new capital and reported an 8% increase in total revenues mainly due to higher revenue from out-licensed products. However, the company reported a net loss of $12.8 million for the quarter.
Looking ahead, Aquestive projects total revenues for 2024 to be between $48 million and $51 million, and anticipates a non-GAAP adjusted EBITDA loss of approximately $22 million to $26 million. The company is actively working on the clinical progression of Anaphylm and launch activities for Libervant.
InvestingPro Insights
Aquestive Therapeutics, Inc. (NASDAQ: AQST) has been making strides with its innovative sublingual film, Anaphylm, which could potentially revolutionize the way severe allergic reactions are treated. As investors and stakeholders monitor the progress of Anaphylm's clinical studies, it is also important to consider the company's financial health and market performance.
According to InvestingPro data, Aquestive Therapeutics holds a market capitalization of 306.8 million USD, indicating a modest size in the biotech industry. The company's revenue growth over the last twelve months as of Q1 2024 stands at 10.65%, reflecting a positive trend in its financial performance. Moreover, Aquestive has demonstrated a strong return over the last year, with a 110.62% price total return, which is a significant metric for investors looking at stock performance over a medium-term horizon.
However, the financial picture is not without its challenges. The company's P/E ratio is currently negative at -7.68, and analysts have revised their earnings downwards for the upcoming period, suggesting that profitability may still be a concern. Moreover, with a volatile stock price movement, as noted in one of the InvestingPro Tips, investors should be aware of the potential risks associated with such fluctuations.
For those looking to delve deeper into Aquestive Therapeutics' financials and market performance, InvestingPro offers a range of additional tips. There are currently 11 more InvestingPro Tips available, which can provide valuable insights into the company's balance sheet strength, liquidity, and profitability expectations. Interested readers can explore these tips and more by visiting https://www.investing.com/pro/AQST.
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As Aquestive Therapeutics continues to pursue FDA approval for Anaphylm, investors will be watching closely to see how these developments might influence the company's financial trajectory and market valuation in the coming years.
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