BeyondSpring Inc. (BYSI) fell a further 4.28% in the aftermarket, at $4.25 with a volume of 249.44 thousand shares on December 02. In the previous market session, the stock had already lost 9.94% to close at $4.44 with 11.04 million shares. The stock has been in a downtrend since the FDA declined to approve its lead drug candidate. Moreover, the company received and announced the Complete Response Letter (CRL) from FDA on December 01, 2021.
Founded in 2013, BeyondSpring Inc. (BYSI) develops immune-oncology cancer therapies and is based in New York. Currently, the company has a market capital of 192.84 million with 39.12 million shares outstanding.
FDA’s Complete Response Letter
In the CRL, the U.S. Food and Drug Administration declined to approve New Drug Application (NDA) for BYSI’s plinabulin in its current form. Previously, the company had requested approval for NDA for plinabulin for the prevention of chemotherapy-induced neutropenia (CIN). Further, the FDA deemed the company’s trial results as not enough to demonstrate evidence for the benefits of plinabulin. In addition, FDA cited the need for an additional well-controlled study to fulfill the needed evidence requirements.
Hence, BYSI announced to work with FDA for deciding the future pathway for CIN, including a possible second study to support evidence.
Plinabulin and CIN
Plinabulin is BYSI’s lead asset for the prevention of CIN, in combination with granulocyte colony-stimulating factor (G-CSF). CIN is a harsh side effect of chemotherapy treatment in which the neutrophils reduce. The company believes in the efficacy of plinabulin (in combination with G-CSF) for rising the standard of care in CIN.
BYSI’s Financials
On September 10, BeyondSpring Inc. (BYSI) announced its second-quarter financial results for 2021. As per the quarter ended June 30, 2021, the Research and Development expenses were $11.3 million. This compares to R&D expenses of $11.0 million in the second quarter of 2020.
Moreover, the second quarter of 2021, saw General and Administrative expenses of $9.0 million. In comparison, the G&A expenses were $2.6 million in the second quarter of 2020. This increase was a result of several factors including plinabulin pre-commercialization activities.
Furthermore, the net loss was $19.3 million in the second quarter of 2021, against $12.8 million in the year-ago period. Consequently, the net loss per basic and diluted share was $0.46 in Q2 of 2021, against $0.49 per share in Q2 of 2020.
