Belite Bio begins IPO effort to advance eye disease treatments (pending: BLTE)

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A quick overview of Belite Bio

Belite Bio (BLTE) has filed a request to raise an undisclosed amount in an IPO of its U.S. Deposit Shares representing underlying common stock, according to an F-1 registration statement.

The company is a clinical-stage biopharmaceutical developing treatments for currently incurable eye diseases.

When we have more information about the IPO, I will give a final opinion.

Business & Technology

Belite, based in San Diego, Calif., was founded to develop a pipeline of candidate treatments for age-related macular degeneration and autosomal recessive Stargardt disease (STGD1).

Management is led by Founder, President and CEO Dr. Yu-Hsin Lin, who has been with the company since its inception in June 2016 and was previously Founder, President and CEO of Lin BioScience, a major investor in the company.

The company’s lead candidate, LBS-008, or Tinlarebant, is a once-daily oral treatment candidate for STGD1 designed to reduce the buildup of toxic vitamin A byproducts in ocular tissues.

LBS-008 is currently in phase 3 trials, with patients recruited in Taiwan, the UK, Hong Kong and Switzerland.

Below is the current status of the Company’s drug development pipeline:

BLTE pipeline

BLTE pipeline (SEC EDGAR)

Belite has recorded an investment at fair market value of $40.6 million as of December 31, 2021 from investors including Lin BioScience International Ltd.

Belite Market and Competition

According to a 2021 market research report According to Coherent Market Insights, the global Stargardt disease treatment market is expected to reach $1.7 billion by 2028.

This represents a projected CAGR (compound annual growth rate) of 31.7% from 2020 to 2027.

The main factors driving this expected growth are an increase in the number of treatment options for patients.

Also, the current primary treatment option for Stargardt disease is Emuxistat.

Major competing vendors providing or developing related treatments include:

Kubota Pharmaceutical Holdings Co., Ltd., Stargazer Pharmaceuticals Inc, Iveric Bio, Sanofi SA, Alkeus Pharmaceuticals, Astellas Pharma, CHABiotech Co., ReVision Therapeutics, Biogen and F. Hoffmann-La Roche AG.

Financial status of Belite Bio

The company’s recent financial results are typical of a clinical-stage biopharmaceutical company in that they show no revenue and significant R&D and G&A expenses associated with its pipeline development efforts.

Here are the company’s financial results for the past two calendar years:

BLTE Finances

BLTE Finances (SEC EDGAR)

As of December 31, 2021, the company had $17.3 million in cash and $1.6 million in total liabilities.

Belite Bio IPO Details

Belite intends to raise an undisclosed amount in gross proceeds from an IPO of its U.S. Depository Shares representing the underlying common stock.

Existing shareholder Lin BioScience has indicated interest in purchasing shares of up to $15.0 million in aggregate at the IPO price.

Management says it will use the net proceeds from the IPO as follows:

We intend to use approximately 6.1% of net proceeds for our Phase 3 clinical trial of LBS-008 for STGD1, approximately 60.2% of net proceeds for further clinical development of LBS-008 for AMD dry, like phase 2 or phase 3 clinical trials, and the rest for working capital and other general business needs.

(Source)

The presentation by management of the company’s roadshow is not available.

With respect to ongoing legal proceedings, management asserts that the Company is not currently party to any legal proceedings that it believes would have a material adverse effect on its financial condition or business.

The sole listed bookrunner of the IPO is The Benchmark Company.

Belite IPO Commentary

BLTE is seeking capital in the US public market to fund its pipeline advancement efforts.

The Company’s lead candidate, LBS-008, is a once-daily oral treatment candidate for STGC1 designed to reduce the accumulation of toxic vitamin A by-products in ocular tissues.

LBS-008 is currently in phase 3 trials for STGD1, with patients recruited in Taiwan, UK, Hong Kong and Switzerland and is also being tested for the treatment of AMD.

The market opportunities for these treatments are significant and are expected to grow significantly over the coming year.

Management did not disclose any major collaboration with a pharmaceutical company.

The company’s investor syndicate includes major shareholder Lin BioScience.

The Reference Company is the sole underwriter and the IPOs conducted by the Company over the past 12 month period have generated a negative average return (35.0%) since their IPO. This is a lower level performance for all major underwriters over the period.

When we know more about IPO pricing and valuation expectation details, I will provide an update.

Expected IPO pricing date: to be announced.

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