On April 14, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs, reported its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, BeyondSpring Pharmaceuticals, APR 14, 2022, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-fourth-quarter-and-year-end-2021-financial-results-and-provides-a-corporate-update [SID1234612218]). At the start of 2022, the Company took steps to streamline its operations and is focused on executing on near-term opportunities for value creation.

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"We are pleased with the ongoing discussions with China NMPA on the NDA review of the Plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia (CIN). The G-CSF market in China is significant, with $1.2B in sales in 2020 and approximately 30% annual growth since 2017," said Dr. Lan Huang, co-founder, chairman and chief executive officer of BeyondSpring. "We are also moving forward to target an NDA filing in China by year-end for Plinabulin in the non-small cell lung cancer (NSCLC) indication. In addition, we are continuing our discussions with the FDA regarding the clinical and regulatory pathway for Plinabulin in CIN and NSCLC in the U.S. Above all, we remain committed to bringing Plinabulin to market to help many patients in need."

Recent Clinical and Corporate Highlights

Business Development Update

In August 2021, entered into an exclusive commercialization and co-development partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui’) for Plinabulin in Greater China
Hengrui, a leading oncology R&D and commercial company in China, has exclusive commercialization and co-development rights to all indications for Plinabulin;
In September 2021, the Company received a 200M RMB (est. US$31M) upfront payment and will be eligible to receive up to 1.1B RMB (est. US$171M) upon achieving certain regulatory and sales milestones;
The Company will supply Plinabulin, retaining manufacturing rights. The Company will receive all proceeds from sales of Plinabulin and pay Hengrui a pre-determined percentage of such sales.
Clinical Development Update

In September 2021, presented new data on Plinabulin from the CIN prevention program with three posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress
Severe Neutropenia (Grade 4) as a Population-Based Predictor for Adverse Clinical Outcome of CIN;
Prediction of Febrile Neutropenia, Hospitalization Rates, and Infection Rates in CIN Patients Treated with the Plinabulin and Pegfilgrastim Combination using a Meta-Analysis -based Tool;
Impact of Adding Plinabulin to Pegfigrastim for the Prevention of CIN, on Patient Quality of Life.
In September 2021, presented positive top-line final Phase 3 DUBLIN-3 data in 2nd/3rd line NSCLC patients with EGFR Wild Type at the ESMO (Free ESMO Whitepaper) 2021 Congress
The combination (Plinabulin + docetaxel) showed superior efficacy benefit in overall survival (OS), progression-free survival (PFS), objective response rate (ORR) with statistical significance and a significant reduction of grade 4 neutropenia vs. docetaxel alone.
IIT Studies of Plinabulin combined with PD-1/PD-L1 inhibitors in multiple cancers
In October 2021, initiated Phase 2 study of Plinabulin in combination with nivolumab and ipilimumab in extensive stage small cell lung cancer (SCLC) who failed platinum and checkpoint inhibitors (Big Ten Cancer Research Consortium). In the Phase 1 portion of the study, this combination showed encouraging efficacy of 43% ORR and long duration of treatment in the same patient population;
In June 2021, initiated Phase 1 study of Plinabulin in combination with PD-1/PD-L1 inhibitor and radiotherapy for patients in seven advanced solid tumors (MD Anderson Cancer Center).
Fourth Quarter 2021 Financial Results `

General and administrative (G&A) expenses were $5.0 million for the quarter ended December 31, 2021, which included a non-cash credit of $2.0 million related to the reversal of share-based compensation expense. For the same period in the prior year, G&A expenses were $10.4 million, which included $2.1 million in non-recurring personnel costs. The decrease was primarily driven by lower share-based compensation expense.
Net loss attributable to the Company was $9.5 million for the quarter ended December 31, 2021, compared to $17.6 million for the quarter ended December 31, 2020.
Full Year 2021 Financial Results

R&D expenses were $36.9 million for the year ended December 31, 2021, compared to $41.8 million for the year ended December 31, 2020. The $4.9 million decrease was primarily due to lower clinical development expense and non-cash share-based compensation expense, partially offset by higher personnel costs, pre-clinical and professional services expenses, as well as the $2.9 million NDA application fee paid to the FDA, which is expected to be refunded during the second quarter of 2022.
G&A expenses were $30.7 million for the year ended December 31, 2021, compared to $22.6 million for the year ended December 31, 2020. The majority of the $8.1 million increase was due to higher pre-commercialization expenses for Plinabulin. We do not expect to continue to incur pre-commercialization expenses during the next year. There were also increases in personnel costs, administrative expenses and other costs, which were partially offset by lower non-cash share-based compensation expense.
Net loss attributable to the Company was $64.2 million for the year ended December 31, 2021, compared to $61.0 million for the year ended December 31, 2020.
As of December 31, 2021, the Company had cash, cash equivalents, and short-term investments of $72.4 million. The Company believes it has sufficient cash to support its ongoing operations and clinical programs over the next year.
Fourth Quarter and Full Year 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, April 14, 2022, at 8:00 am ET. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or +1-201-389-0879 (International). The passcode for the conference call is 13728822. To access the live webcast or subsequent archived recording, click here or visit the "investors" section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the Company’s website for 90 days.