biotickrBeyondSpring Inc. is an early-stage clinical trial biopharmaceutical company developing immuno-oncology therapies (anti-cancer drugs). The main pipeline is Plinabulin, an anti-cancer drug that is being investigated as a combined therapy with other biologics such as Nivolumab, a PD-1 antibody for the treatment of NSCLC, Ipilimumab a CTLA-4 antibody for the treatment of small cell lung cancer and other PD-1 and/or PD-L1 inhibitors for the treatment of various cancers. Additionally, three other immuno-oncology pipelines are being developed in pre-clinical stages.
Last year, BYSI got the complete response letter from the FDA for Plinabulin’s new drug application (NDA) for the treatment of chemotherapy-induced neutropenia. The company is pushing a late-stage clinical trial to demonstrate the efficacy against CIN and re-submit NDA for the same indication
BYSI has published the clinical trial study results that concluded – the efficacy of Plinabulin is almost similar to pegfilgrastim against neutropenia protection. What we should note is, the study was funded and published by BYSI, which is typically considered as a conflict of interest among the scientific community. No other independent studies are available to verify these scientific claims.
Another important aspect is, the mechanism of action of Plinabulin is almost similar to that of VERU’s Sabizabulin, which failed to gain FDA approval for COVID-19 treatment. Most skeptics and scientific experts have cried foul about the safety of Colchicine, which exerts the same mechanism of action as Sabizabulin and Plinabulin as well.
Recent events
December 13th, 2022 – BeyondSpring presented positive data with Plinabulin for the Prevention of Docetaxel-Induced neutropenia in patients with Non-Small cell lung cancer and breast cancer at three medical conferences
September 13th, 2022 – BeyondSpring reported the lead cancer drug protects bone marrow stem cells within 24 hours
May 27th, 2022 – BeyondSpring presented new clinical data in the chemotherapy-Induced Neutropenia and NSCLC programs at the 2022 ASCO annual meeting
Addressable market
Non-small cell lung cancer (NSCLC):
The global NSCLC treatment market is valued at USD 22.3 billion in 2020 and is expected to reach USD 40.3 billion by 2027 at a CAGR of 8.9%.
Small cell lung cancer (SCLC):
The global SCLC was estimated to be USD 10 billion and is forecasted to grow up to USD 21.44 billion by 2029.
The global market for the treatment of chemotherapy-induced myelosuppression was USD 8.06 billion in 2022 and is expected to reach USD 9.78 billion by 2028 at a CAGR of 3.3%.
Current finances
Despite the share price being highly volatile over the past three months, the revenue grew by 650.6% in the last year. A few of the notable upsides are: the short-term assets are valued at USD 75.1 million and exceed its short-term liabilities of USD 15.2 million and long-term liabilities of USD 40.1 million.
However, the company is now unprofitable and unlikely to generate revenue or be profitable over the next three years (forecasted decline in earnings by 33.4% per year). The risk of shareholder dilution is high in the coming years.
Competitors:
Syros Pharmaceuticals are developing small-molecule medicines to control the expression of genes, with the aim to make a profound difference in patients’ lives. They are advancing a pipeline of investigational medicines for diseases that have largely eluded other genomics-based approaches. The main focus is on cancer.
The lead asset Tamibarotene is in a phase III clinical trial for the treatment of myelodysplastic disorder and acute myeloid leukemia.
HCW Biologics is a clinical-stage company focusing on transformative immunotherapeutic pipelines for the treatment of inflammation-related aging diseases including cancer.
The lead asset is HCW9218 is being investigated in phase 1 and phase ½ clinical trials as a treatment for solid tumors and advanced pancreatic cancer, respectively. HCW9218 is a bifunctional fusion protein complex formulated with the TGF-β receptor, IL-15, and other immunostimulatory molecules to achieve significant anti-cancer benefits. HCW9218 is said to be effective against the chemotherapy-resistant mechanisms of cancer.
Summary
The underlying science of Plinabulin appears to be unviable for anti-cancer treatment. Even if it demonstrates some efficacy, it might not be superior to the existing drug Pegfilgrastim for the prevention of chemotherapy-induced neutropenia. It makes no sense to develop a drug that is not so effective or superior to an existing drug for the same indication. As per the available open-source data, there is no near-term binary or catalyst event for short-term investment in Beyondspring stock.