On December 30, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported its financial results for the third quarter ended September 30, 2021, and provided an update on recent corporate events (Press release, BeyondSpring Pharmaceuticals, DEC 30, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-third-quarter-2021-financial-results-and-provides-a-corporate-update [SID1234597851]).

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"In the third quarter, we continued to move forward in developing plinabulin’s potential as a ‘pipeline in a drug’ for patients in need. We are developing a wealth of clinical data showing plinabulin’s dual benefit as an anti-cancer agent, shown with OS benefit in Dublin-3 study, with additional benefit in preventing CIN, which we believe will support the important role of plinabulin as a versatile cancer treatment option, and potentially, as a ‘cornerstone’ therapy in IO combinations," said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.

"We look forward to executing on our plans for the potential commercial launch of plinabulin in CIN, our first indication in China, where we are excited to work with a leading oncology company, Hengrui, in the commercialization and co-development of plinabulin. Our discussions will continue with the U.S. FDA regarding the potential regulatory pathway for CIN in the U.S. market. At the same time, we are very focused on preparing for our NDA filing for plinabulin in NSCLC. Based on discussions with regulatory agencies in the U.S. and in China, we now anticipate submitting our NDA in the 2H 2022. The year ahead will be very busy and significant for BYSI, and we remain dedicated to enabling plinabulin to achieve its full potential and to bringing added value to the treatment of cancer patients," concluded Dr. Huang.

Recent Clinical and Corporate Highlights

Presented positive final Phase 3 DUBLIN-3 data with the plinabulin/docetaxel combination versus docetaxel alone in 2nd/3rd line non-small cell lung cancer patients with EGFR Wild Type at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress
The combination showed superior efficacy benefit in overall survival, progression-free survival (PFS), overall response rate (ORR), and significant reduction of grade 4 neutropenia vs. docetaxel alone.
The combination also demonstrated superior and clinically meaningful Quality of Life benefit: 18.4% of relative improvement in Q-TWiST (Quality-adjusted Time Without Symptoms of Disease and Toxicity).
Presented new data on plinabulin from its Chemotherapy-Induced Neutropenia (CIN) prevention program in three posters at the ESMO (Free ESMO Whitepaper) 2021 Congress (titles below):
Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN)
Prediction of Febrile Neutropenia (FN), Hospitalization (Hosp) Rates, and Infection (Inf) Rates in Chemotherapy-Induced Neutropenia (CIN) Patients (pts) Treated with the Plinabulin and Pegfilgrastim Combination (Plin+Peg) using a Meta-Analysis (MA)-based Tool
Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia (CIN), on Patient Quality of Life (QoL)
Announced first patient treated in its Phase 2 study of plinabulin in combination with nivolumab + ipilimumab in patients in extensive-stage small-cell lung cancer (SCLC) who progressed after at least one platinum-based chemotherapy regimen and checkpoint inhibitors
The investigator-initiated study (IIT) is being conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers.
In Phase 1 study, plinabulin combination with nivolumab + ipilimumab had ORR of 43% in SCLC patients who had progressed on platinum and checkpoint inhibitors (presented at ASCO (Free ASCO Whitepaper) 2021).
Announced new patient-derived (PDX) cancer model data for plinabulin monotherapy, which further supports the positive clinical data in the treatment of SCLC
At the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC virtual international conference on molecular targets and cancer therapeutics, the Company presented additional preclinical data in plinabulin monotherapy activity in PDX models in glioblastoma multiforme, bladder cancer, gastric cancer, sarcoma, triple-negative breast cancer, and SCLC, with IC70 at 35 nM in SCLC.
Entered into an exclusive commercialization and co-development partnership between Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui") and Wanchunbulin, BeyondSpring’s China subsidiary, 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. Hengrui will pay all commercialization costs for all indications of plinabulin, and half of clinical development costs for new indications.
Wanchunbulin will supply plinabulin, retaining manufacturing rights. Wanchunbulin will receive all proceeds from sales of plinabulin products and pay Hengrui a pre-determined percentage of such sales.
Wanchunbulin received 200M RMB (est. US$30M) upfront, and will be eligible to receive up to 1.1B RMB (est. US$170M) in regulatory and sales milestones.
NDA for plinabulin-G-CSF combination in CIN Prevention under review in China; received complete response letter from U.S. FDA, with plans for further discussions with FDA on future regulatory pathway
Changes to the Company’s Board of Directors
Mark Santos, RPh joined the Company’s Board of Directors in November 2021. Mr. Santos has more than 30 years of experience in healthcare industries. He is SVP of Pharma Strategy & Contracting at OneOncology and past President of ION Solutions, the leading group purchasing organization (GPO) in the U.S. He serves as a board member for the American Cancer Society (South Texas Center), NY Cancer Foundation, and Leukemia Texas Foundation, among other organizations.
On December 22, 2021, Dr. Ravi Majeti resigned from the Board.
On July 27, 2021, Dr. Quanqi Song resigned from the Board of Directors and the Audit Committee, and Brendan Delaney, an independent Director, was appointed to the Audit Committee.
Upcoming Milestones

1H 2022: expected regulatory update for CIN indication in China; continuing discussions with FDA on regulatory pathway for CIN in the U.S.
2H 2022: NDA Submission for plinabulin in NSCLC
2H 2022: Phase 2 data from the Big Ten Cancer Research Consortium, IIT study expected in plinabulin + nivolumab + ipilimumab in platinum and checkpoint inhibitor-resistant SCLC.
2H 2022: Preliminary Phase 1 data and plinabulin immune mechanism data from the MD Anderson Cancer Center, IIT study expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in patients with seven cancer types.
Third Quarter Financial Results

Research and development ("R&D") expenses were $8.5 million for the quarter ended September 30, 2021, compared to $8.6 million for the quarter ended September 30, 2020. The decrease was primarily due to lower clinical development expenses, which were partially offset by higher personnel and non-cash stock-based compensation expenses.
General and administrative ("G&A") expenses were $10.2 million for the quarter ended September 30, 2021, compared to $6.7 million for the quarter ended September 30, 2020. The $3.5 million increase was primarily due to higher personnel costs and expenses associated with plinabulin pre-commercialization activities.
Net loss attributable to the Company was $18.4 million for the quarter ended September 30, 2021, compared to $14.5 million for the quarter ended September 30, 2020.
As of September 30, 2021, the Company had cash, cash equivalents, and short-term investments of $91.6 million. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline.
Year-to-Date Financial Results

R&D expenses were $31.1 million for the nine-month period ended September 30, 2021, compared to $33.4 million for the nine-month period ended September 30, 2020. The $2.3 million decrease was primarily due to lower clinical development expense, partially offset by higher personnel and professional services expenses, as well as PDUFA NDA application fees to FDA.
G&A expenses were $25.7 million for the nine-month period ended September 30, 2021, compared to $12.2 million for the nine-month period ended September 30, 2020. The $13.5 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense and pre-commercialization expenses for plinabulin.
Net loss attributable to the Company was $54.7 million for the nine-month period ended September 30, 2021, compared to $43.4 million for the nine-month period ended September 30, 2020.