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SAN DIEGO - Connect Biopharma Holdings Limited (NASDAQ:CNTB), a biopharmaceutical company valued at $44.83 million, announced the commencement of its Phase 2 Seabreeze STAT Asthma study following approval from the U.S. Food and Drug Administration. According to InvestingPro data, the company maintains a strong financial health score despite being in the development stage, with a current ratio of 11.46 indicating robust short-term liquidity. The study will evaluate the safety and efficacy of the investigational drug rademikibart as an add-on therapy for acute asthma exacerbations in patients with type 2 inflammation.
The trial is a randomized, double-blind, placebo-controlled study set to enroll approximately 160 participants globally. It aims to determine the treatment failure rate over 28 days following an acute exacerbation. With the next earnings report due on June 5, 2025, investors following InvestingPro analysis note that while the company holds more cash than debt, it’s currently burning through cash reserves at a considerable rate. Secondary endpoints include the rate and time to new asthma exacerbations, changes in asthma symptom scores, nocturnal awakenings, and post-bronchodilator forced expiratory volume in one second (FEV1).
Connect Biopharma’s CEO, Barry Quart, expressed optimism about the potential of rademikibart to provide rapid pulmonary function improvements within 24 hours, a feature not observed with other biologics to date. The company anticipates reporting topline data from the study in the first half of 2026.
The initiation of the Seabreeze STAT Asthma study follows positive results from a global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma, published in the American Journal of Respiratory and Critical Care Medicine. The data suggested that rademikibart could rapidly improve lung function and provide sustained improvements over 24 weeks, especially in patients with high eosinophil counts.
Mario Castro, M.D., a professor at the University of Kansas Medical Center, highlighted the significance of the study for over 1 million asthma patients who visit emergency departments annually due to acute exacerbations. He noted the encouraging data generated so far with rademikibart, emphasizing its potential as an important adjunct treatment in hospitals.
Connect Biopharma is dedicated to addressing the significant unmet needs in asthma and chronic obstructive pulmonary disease (COPD) care. If successful, rademikibart could be the first biologic indicated for acute exacerbation of asthma and could also be used for chronic maintenance therapy in asthma and COPD. While the company reported negative EBITDA of $21.79 million in the last twelve months, analyst price targets ranging from $6 to $8 suggest significant upside potential. InvestingPro subscribers can access 7 additional key insights about Connect Biopharma’s financial health and growth prospects.
This article is based on a press release statement and contains forward-looking statements regarding the development and potential efficacy of rademikibart. These statements are not guarantees of future performance as they involve risks and uncertainties, and actual results may differ. Rademikibart is under clinical investigation and has not been approved for marketing by any regulatory agency.
In other recent news, Connect Biopharma Holdings Limited reported its full-year 2024 financial results and announced plans to initiate Phase 2 trials for its drug candidate, rademikibart, in the second quarter of 2025. This development follows the U.S. Food and Drug Administration’s approval to proceed with trials targeting patients with moderate-to-severe asthma or chronic obstructive pulmonary disease (COPD) experiencing acute exacerbations. H.C. Wainwright has maintained a Buy rating on the company’s shares with an $8.00 price target, reflecting confidence in the drug’s market potential. Despite this positive outlook, Connect Biopharma has received a notification from Nasdaq regarding its stock price falling below the required minimum for continued listing. The company must address this issue by September 22, 2025, to maintain compliance. Meanwhile, Connect Biopharma continues its research and development efforts, emphasizing the potential of rademikibart, which has shown rapid improvements in lung function in previous trials. The company’s ongoing trials aim to provide new treatment options for acute exacerbations, a significant market opportunity. Investors are closely monitoring these developments as the company seeks to navigate both regulatory and market challenges.
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