Belite Bio: Interesting Science, But Quite A Few Worries

seekingalpha11-20

Belite Bio's lead drug, Tinlarebant, targets eye diseases STGD1 and GA, showing promising results but with delayed phase 3 trial data expected by late 2024 or early 2025.Tinlarebant works by reducing ...

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Andrii Borodai  Belite Bio (NASDAQ:BLTE), a subsidiary of Taiwanese Lin Bioscience, has gone up hugely since my coverage in June last year. Belite develops drugs for eye diseases. Lead candidate is LBS-008 (Tinlarebant), an oral tablet targeting autosomal recessive Stargardt disease (STGD1) and Geographic Atrophy patients. It has 2 phase 3 trials ongoing, one phase 2/3 trial, also ongoing, and one phase 1 trial that was completed over a year ago with positive results. How the lead molecule Tinlarebant works: a protein called serum retinol binding protein 4 (RBP4) transports retinol (a form of Vitamin A) from the liver to the eye. Retinol is a powerful antioxidant useful to the eye in various ways, but excess amounts can become toxic. Tinlarebant works by reducing the levels of RBP4, thereby reducing the toxins formed by retinol. About the indications STGD1 is an inherited eye condition that causes progressive vision loss, primarily affecting central vision. It is one of the most common inherited macular dystrophies. However, there are no FDA-approved therapies, and current treatment options include simply low vision aids, and nothing else. However, there are a number of pipeline therapies progressing through clinical trials. Alkeus has a drug called ALK-001 which is a form of retinol where the hydrogen atoms are replaced with deuterium. This produces a “cleaner” Vitamin A that is less toxic. This molecule is running through phase 2 trials. Ascidian Therapeutics has a phase 1/2 trial ongoing for ACDN-01, an RNA editing therapy that edits the ABCA4 gene thought to be responsible for the disease. Nanoscope Therapeutics is developing MCO-010, an optogenetic therapy that uses an engineered virus to deliver copies of the Multi-Characteristic Opsin (MCO) gene to the eye. This therapy has seen some positive data in a phase 2 trial and has a phase 3 trial ongoing. Astellas (OTCPK:ALPMY) is running a phase 2 trial of its complement inhibitor molecule which may slow the progression of vision loss in STG1 patients. Ocugen (OCGN) is conducting a phase 1/2 trial of OCU410ST, a modifier gene therapy candidate designed as a one-time treatment. According to the company, there are 30,000 US patients and 146,000 Chinese patients. Moving on to Geographic atrophy (GA), it is a late-stage form of age-related macular degeneration (AMD) where the progressive death of retinal pigment epithelial cells and photoreceptor cells causes loss of central vision. Around a million Americans have GA. Pegcetacoplan, a complement inhibitor given through an intravitreal injection, was approved in 2023 to treat GA. It was developed by Apellis (APLS). Izervay (avacincaptad pegol) was also approved in 2023. It is developed by Iveric Bio, currently owned by Astellas Pharma. However, as researchers say, “Although avacincaptad and pegcetacoplan are our first FDA-approved treatments for GA, results from the clinical trials failed to show any functional improvement after 1 and 2 years, respectively, calling into question whether the drugs represent a clinically relevant outcome.” Moreover, there are no oral drugs approved for GA, and IVT injections are invasive - this is where Tinlarebant positions itself. Data In STG1, the company conducted a phase 1B/2 trial in Taiwan and Australia, where I discussed data from 13 patients which saw a greater than 70% reduction in RBP4 and a benign safety profile. As I noted before: In STGD1, there are two types of retinal lesions, QDAF lesions, which can be rescued, and DDAF lesions, which cannot be rescued, and which form through worsening of QDAF lesions. Together, these two lesions are called decreased autofluorescence (DAF). In the phase 2 trial, comparison of mean DAF lesion growth rates between historical data from Georgiou et al. (2020) and subjects in LBS-008-CT02 showed a 60% reduction in LBS-008 patients. There were some mild and transient AEs, notably loss of night vision. The pivotal global Phase 3 “DRAGON” trial completed enrollment in July last year, and topline data was expected in mid-2024. There were 90 adolescent subjects across 11 countries, which included the US, but the company did not divulge how many US patients were recruited. In July, too, the company dosed the first patient in its phase 3 GA trial. In November, the company presented topline data from a phase 2 study in SGT1. Data showed:  A comparison of the 24-month DDAF lesion growth between Tinlarebant-treated subjects and ProgStar participants possessing similar baseline characteristics (aged ≤18 years) showed a sustained lower DDAF lesion growth in Tinlarebant-treated subjects over the 24-month treatment period (p<0.001). 42% of Tinlarebant-treated subjects (5 out of 12) did not develop atrophic retinal lesions during the 24-month treatment period.  In May this year, the company presented additional analysis of this data, but more importantly, it has pushed the timeline for the DRAGON trial to well beyond 2024, with only interim data now being planned for in Q4 2024. Just last week, the company pushed this date even further: Interim analysis from the pivotal global Phase 3 DRAGON trial of Tinlarebant in adolescent STGD1 subjects anticipated by end of 2024 or early 2025. Other than that, there is no further news from the company. Financials BLTE has a market cap of $2.54bn and a cash balance of $109mn. For the three months ended September 30, 2024, research and development expenses were $6.8 million, while G&A Expenses were $2.9mn. Their expenses are really on the lower side; at that rate, they have a cash runway of well over 10 quarters, even with a cash balance that would be considered pretty low for an American company. Risks While this stock has gone up a lot in the last one year and a half, pushing back the data drop date may not bode well for the stock’s price. Moreover, given the market potential of the drug (although I have not discussed this directly, I would peg it at low 3 digit figures in millions), I think its current market cap more than justifies its value potential. Finally, the cash they have may not be enough for a proper US launch. Bottom-line  Despite the price movement, my opinion for BLTE remains unchanged - interesting company, but not my type. Also, they have a low trading volume on top of everything else I discussed here and in my earlier article. I will stay away.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"analysis","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2484166946"}