Wednesday - H.C. Wainwright has increased the stock price target for Belite Bio, Inc. (NASDAQ: BLTE) to $100 from the previous $60, while maintaining a Buy rating on the stock. The adjustment follows Belite Bio's third-quarter financial results, which were released yesterday, revealing a net loss of $8.7 million, or $0.28 per share. This figure is just above the anticipated loss of $8.3 million.
The company's management reported that enrollment is proceeding as planned for the Phase 3 DRAGON II trial of tinlarebant, aimed at treating adolescent Stargardt disease (STGD1), and the Phase 3 PHOENIX trial for geographic atrophy (GA). An interim analysis update from the Data Safety Monitoring Board (DSMB) is expected for the Phase 3 DRAGON trial at the end of 2024 or early 2025.
Tinlarebant has received Sakigake designation in Japan, a status that is likely to expedite the drug's approval process in the country. The Phase 1b segment of the DRAGON II trial has successfully enrolled six subjects in Japan, and the Phase 2/3 segment is expected to enroll around 10 subjects in the country. Analysts speculate that Japan could become the first country to approve tinlarebant for STGD1 treatment.
The projected price for tinlarebant has been updated in the financial model, increasing from $6,000 to $9,500, in light of the annual price range of similar treatments SYFOVRE and IZERVAY, which varies between $13,000 and $26,000.
The revised valuation of Belite Bio now stands at $3.09 billion. With an estimated 31 million shares outstanding at the end of the third quarter of 2025, the new price target of approximately $100 per share has been set, reaffirming the Buy rating.
In other recent news, Belite Bio has reported significant progress in its Tinlarebant trials during its Third Quarter 2024 Earnings Call. The company's lead therapy for Stargardt disease and geographic atrophy (GA) has achieved notable regulatory designations, including Rare Pediatric Disease and Fast Track in the U.S., and orphan drug status in various regions.
The ongoing DRAGON and DRAGON 2 trials for Stargardt disease and the PHOENIX trial for GA are advancing well, with interim analysis for DRAGON expected by late 2024 or early 2025.
Belite Bio has welcomed Dr. Hendrik Scholl as the new Chief Medical (TASE:PMCN) Officer, who brings expertise in Stargardt disease and GA. The company's financial position remains robust with $109 million cash on hand, sufficient for an estimated four-year runway.
The company's R&D expenses for Q3 2024 decreased to $6.8 million from $8.7 million in Q3 2023, while G&A expenses increased to $2.9 million in Q3 2024, up from $2.2 million in the same quarter the previous year. The net loss for Q3 2024 was $8.7 million, an improvement from the net loss of $10.9 million in Q3 2023. These are the recent developments in Belite Bio.
InvestingPro Insights
Recent data from InvestingPro adds context to H.C. Wainwright's bullish outlook on Belite Bio. The company's stock has shown remarkable performance, with a 106.49% price total return over the past year and a 94.67% return in the last six months. This strong momentum is reflected in the stock trading near its 52-week high, with the current price at 97.07% of that peak.
Despite these positive indicators, InvestingPro Tips highlight some potential concerns. The company is not currently profitable, with a negative P/E ratio of -70.39 for the last twelve months as of Q2 2024. Additionally, analysts do not anticipate profitability this year, which aligns with the company's focus on clinical trials and drug development.
For investors seeking a more comprehensive analysis, InvestingPro offers 15 additional tips for Belite Bio. These insights could provide valuable guidance in navigating the stock's potential amid its ongoing clinical trials and market performance.
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