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CAMBRIDGE, England & BOSTON - Bicycle Therapeutics plc (NASDAQ:BCYC) has released updated Phase 1 data suggesting notable anti-tumor activity and a differentiated safety profile for its drug candidate zelenectide pevedotin in combination with pembrolizumab. The study focused on patients with metastatic urothelial cancer (mUC) who are ineligible for cisplatin chemotherapy.
As of January 3, 2025, the ongoing Duravelo-1 trial reported a 65% overall response rate among efficacy-evaluable patients, with a 50% confirmed response rate. Notably, no severe treatment-related adverse events of Grade 4 or 5 were observed, and all Grade 3 events were reversible. The median duration of response is still under evaluation, with 12 patients continuing treatment. The stock has seen significant pressure recently, with a 41% decline over the past six months, though analysts maintain a bullish stance with a consensus "Buy" rating.
In addition to the promising results for mUC, Bicycle Therapeutics is advancing its clinical strategy for zelenectide pevedotin across various cancers, with Phase 1/2 trials planned to commence in 2025 for breast and lung cancers, as well as multiple tumor types, all involving NECTIN4 gene amplification.
The company is also progressing its emerging pipeline of radiopharmaceuticals, with additional human imaging data for MT1-MMP expected in mid-2025 and first imaging data for EphA2 targeted for the second half of the year.
Financially, Bicycle Therapeutics has secured a runway into the second half of 2027 to support its clinical and strategic endeavors. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 17.13, though it's currently burning through cash with negative free cash flow of $203.5 million in the last twelve months.
These updates were part of a broader announcement detailing the company's accomplishments in 2024, which included initiating the global Phase 2/3 Duravelo-2 trial for mUC, presenting monotherapy data for zelenectide pevedotin, and obtaining Fast Track designation from the U.S. Food and Drug Administration for the treatment of certain advanced cancers.
The company's strategic priorities for 2025 involve reporting additional data from ongoing trials, initiating new trials for zelenectide pevedotin in various cancers, and advancing its radiopharmaceutical pipeline.
Bicycle Therapeutics is expected to discuss these updates and strategic priorities at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025. For deeper insights into BCYC's financial health and growth prospects, investors can access comprehensive analysis and 8 additional ProTips through InvestingPro, which includes detailed valuation metrics and growth forecasts.
This news is based on a press release statement from Bicycle Therapeutics.
In other recent news, Bicycle Therapeutics has seen a series of significant developments. The company's price target was reduced from $28 to $17 by B.Riley, which maintained a Neutral rating, following the release of clinical data that did not meet expectations. H.C. Wainwright also revised its price target for Bicycle Therapeutics, reducing it to $33 from the previous $55, while maintaining a Buy rating. However, Morgan Stanley (NYSE:MS) maintained its Equalweight rating on Bicycle Therapeutics with a steady price target of $30.
Despite these adjustments, Needham retained its Buy rating and $38.00 stock price target for Bicycle Therapeutics, while Leerink Partners raised the company's price target to $32.00, maintaining an Outperform rating. These changes came in light of recent clinical data, the company's financial performance, and the progress of its drug development pipeline.
Despite the challenges, Bicycle Therapeutics reported impressive revenue growth of 48.6% in the last twelve months. The company has also secured approximately $555 million through PIPE financing, extending its financial runway into the second half of 2027. These recent developments provide a snapshot of the company's current situation and potential future trajectory.
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