BeyondSpring Pharmaceuticals isn’t giving up on its experimental treatment for a chemotherapy complication, but the company will have fewer employees to support it going forward. The biotech is laying off about 35% of its staff, part of a cash-saving reorganization triggered by the FDA’s rejection of the drug, plinabulin, last November.
New York-based BeyondSpring employed 91 people full-time, according to the company’s 2020 annual report. The headcount may have risen in the past year in preparation for the expected commercial launch of plinabulin. BeyondSpring said in a regulatory filing that it expects expenses related to the layoffs will be about $1 million, most of which will be incurred in the first quarter of this year. According to an investor presentation, the biotech’s cash position as of Sept. 30, 2021, was $91.6 million.
Plinabulin was developed to treat chemotherapy-induced neutropenia (CIN), a dangerously low level of a type of white blood cell called a neutrophil. Low neutrophil levels mean cancer patients face a higher risk of developing infections. While CIN treatments are available, they can take a week to begin working. Plinabulin’s value proposition is that it’s designed to kick in sooner. In rejecting BeyondSpring’s drug application, the FDA said that the company’s lone Phase 3 study was not enough to demonstrate plinabulin’s benefit to patients, and the agency called on the company to conduct second, well-controlled study to produce more evidence.
BeyondSpring’s drug pipeline is mainly various applications of plinabulin. In addition to CIN, the biotech is testing the drug’s ability to spark an immune response as a potential cancer treatment. A Phase 3 study evaluating the drug in combination with chemotherapy in non-small cell lung cancer met its main goal last year. In addition, BeyondSpring has three preclinical immuno-oncology assets as well as a subsidiary, SEED Therapeutics, which is discovering drugs that work by a mechanism called targeted protein degradation. SEED is partnered with Eli Lilly.
In the reorganization announcement, BeyondSpring said it plans to focus its efforts on the regulatory process for plinabulin in CIN in the U.S. and China. The company also plans to work toward new drug application filings for the small molecule in non-small cell lung cancer. Additional clinical trials are planned that will evaluate the drug as part of triple immunotherapy combinations in various cancers.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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