$BLTE: Belite Bio, Inc - American Depositary Shares

Belite Bio, Inc. (BLTE) is a clinical-stage biotechnology company focused on developing novel gene therapies for the treatment of cancer and rare diseases. The company's lead product candidate, DLI-100, is a gene therapy for the treatment of acute myeloid leukemia (AML). DLI-100 is currently in Phase 1/2 clinical trials.

BLTE was founded in 2018 by a team of experienced scientists and entrepreneurs. The company's headquarters are located in Cambridge, Massachusetts.

BLTE's gene therapy platform is based on the use of adeno-associated virus (AAV) vectors. AAV vectors are a type of non-pathogenic virus that can be used to deliver genes to cells. BLTE's AAV vectors are designed to be highly efficient and safe.

DLI-100 is a AAV vector-based gene therapy that delivers the gene for a protein called IDH1 into AML cells. IDH1 is a gene that is mutated in about 30% of AML cases. The mutation in IDH1 leads to the production of a faulty enzyme that produces a harmful metabolite. DLI-100 is designed to correct the mutation in IDH1 and restore the production of the normal enzyme.

DLI-100 is currently in Phase 1/2 clinical trials. The first part of the trial is a dose-escalation study to determine the optimal dose of DLI-100. The second part of the trial is a safety and efficacy study to assess the treatment's ability to improve the survival of patients with AML.

The results of the Phase 1/2 trial are expected in 2023. If the trial is successful, BLTE plans to initiate a Phase 3 trial of DLI-100 in 2024.

In addition to DLI-100, BLTE is also developing other gene therapy products for the treatment of cancer and rare diseases. The company's pipeline includes products for the treatment of solid tumors, blood cancers, and genetic disorders.

BLTE is a clinical-stage biotechnology company with a promising gene therapy platform. The company's lead product candidate, DLI-100, is in Phase 1/2 clinical trials for the treatment of AML. If the trial is successful, BLTE could become a leading player in the gene therapy market.

Here are some of the key risks and challenges facing BLTE:

• The company is still in the early stages of development, and there is no guarantee that its products will be successful.
• The gene therapy market is highly competitive, and BLTE will face competition from other companies developing gene therapies for cancer and rare diseases.
• The company's products are expensive to develop and manufacture, and BLTE will need to raise significant capital to fund its research and development activities.

Despite these risks, BLTE has the potential to be a successful company. The company has a strong team of scientists and entrepreneurs, and its gene therapy platform has the potential to revolutionize the treatment of cancer and rare diseases.