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Tuesday, H.C. Wainwright adjusted its stock price target for Belite Bio, Inc, ADR (NASDAQ:BLTE) to $60.00, up from the previous $59.00, while maintaining a Buy rating on the stock. The revision follows Belite Bio's recent discussion of its second-quarter financial results for 2024.
Belite Bio reported a net loss of $9.5 million, or $0.31 per share, which was slightly higher than anticipated due to a development milestone payment. Despite the increased loss, the company shared significant regulatory progress. Its drug candidate, tinlarebant, received the Sakigake designation in Japan for the treatment of Stargardt disease (STGD1), potentially expediting the approval process in the country.
The company is optimistic about the prospects of tinlarebant in Japan based on data from the Phase 3 DRAGON trial, which includes 104 subjects, and additional data from Japanese patients in the DRAGON II trial. These results may support a regulatory submission for the drug in Japan. An interim analysis update from the Data Safety Monitoring Board (DSMB) for the DRAGON trial is expected in the fourth quarter of 2024.
Furthermore, the Phase 1b portion of the DRAGON II trial has completed enrollment of six subjects in Japan. The subsequent Phase 2/3 portion is set to enroll approximately 10 subjects. The analyst noted that Japan could become the first country to approve tinlarebant for STGD1 treatment.
H.C. Wainwright remains positive about the market adoption potential for tinlarebant, citing the convenience of its once daily oral dosing regimen. The firm's estimated market value for Belite Bio is $1.84 billion, translating to approximately $60 per share. This valuation underpins the decision to reiterate the Buy rating and adjust the 12-month price target accordingly.
In other recent news, Belite Bio has made notable progress in its clinical trials for Tinlarebant, a treatment for Stargardt disease and geographic atrophy. The biotechnology firm has successfully initiated and moved through various stages of the trials, including securing Sakigake designation in Japan.
On the financial side, the company raised $25 million through a registered direct offering and reported research and development (R&D) expenses of $9.1 million, a net loss of $9.5 million, and cash reserves of $112 million.
The firm expects interim results from its DRAGON I study by the fourth quarter of 2024 or early 2025, and anticipates R&D expenses to stay between $7-8 million in the upcoming quarters. Belite Bio also presented a new AI-based method for assessing lesion size in clinical trials.
These are recent developments in the company's ongoing efforts to advance its drug pipeline and maintain financial stability. The company will be participating in future events such as the H.C. Wainwright 4th Annual Ophthalmology Conference, among others.
InvestingPro Insights
In light of H.C. Wainwright's updated price target for Belite Bio, Inc (NASDAQ:BLTE), a glance at the real-time metrics from InvestingPro provides additional context for investors. The company's market capitalization stands at $1.45 billion, and it trades at a high Price / Book multiple of 12.62. These figures underscore the growth potential that analysts see in Belite Bio, despite the company not being profitable in the last twelve months, with an EBITDA of -$36.54 million and a negative return on assets of -39.4%. It is also worth noting that the stock's price is hovering near its 52-week high, with a price percentage of 95.83% of that peak.
InvestingPro Tips highlight that Belite Bio has experienced a high return over the last year, with a 106.77% increase, and has shown strong performance over the last three months, with a 16.47% return. However, analysts have revised their earnings downwards for the upcoming period, and they do not anticipate the company will be profitable this year.
Despite this, the company's liquid assets exceed its short-term obligations, which may provide some financial stability as it continues to invest in its drug development pipeline. For investors seeking more detailed analysis and additional tips, InvestingPro offers a comprehensive set of insights, including 12 more InvestingPro Tips for Belite Bio, accessible through the InvestingPro platform.
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