– NDAs filed in the U.S. and China in Mar. 2021 based on superior data from Phase 3 PROTECTIVE-2 trial of Breakthrough Therapy Designation regimen, plinabulin plus G-CSF vs. G-CSF alone in prevention of CIN
– Company subsidiary, SEED Therapeutics, signed an $800 million research collaboration with Eli Lilly leveraging its proprietary targeted protein degradation (TPD) platform in Nov. 2020
– Completed $86.3 million equity financing in Nov. 2020. Cash and cash equivalents of $109.5 million at year-end 2020
Company to host a conference call today, April 30 at 8:30 a.m. ET
NEW YORK, April 30, 2021 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results for the fourth quarter and year ended December 31, 2020 and provided an update on recent corporate events.
“2020 was a truly transformational year in setting us up for future value creation. Specifically, we had key accomplishments in building clinical evidence for our lead asset, filing our lead program in two major global markets – US and China, building our pipeline, adding key scientific and business leadership, and bolstering our balance sheet to execute on our vision,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.
“The Company is well positioned for the future, with our “pipeline in a drug” plinabulin, and anticipated near-term potential anti-cancer efficacy data from a Phase 3 trial measuring overall survival in NSCLC, and from early trials in several immuno-oncology regimens in checkpoint inhibitor naïve or failed patients,” continued Dr. Huang. “After the successful completion of our equity financing in the fourth quarter, we have strengthened our balance sheet and cash position as we head into our upcoming milestones.”
Recent Business and Corporate Highlights
Lead Asset Plinabulin, a “Pipeline in a Drug”
Recent Clinical Update
- March 2021: filed NDAs with the U.S. Food and Drug Administration (FDA) and China NMPA for the use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). Plinabulin and G-CSF combination regimen had received breakthrough designation from both US FDA and China NMPA.
- December 2020: completed global enrollment of 559 patients in DUBLIN-3 Phase 3 non-small cell lung cancer (NSCLC) study, comparing plinabulin + docetaxel vs. docetaxel alone in 2nd/3rd line NSCLC (EGFR wild type), with overall survival as the primary endpoint.
- November 2020: announced positive and superior topline results from its Phase 3 PROTECTIVE-2 registrational trial of plinabulin in combination with pegfilgrastim vs. pegfilgrastim alone for the prevention of CIN, with additional positive Phase 3 data presented at the 2020 San Antonio Breast Cancer Symposium.
Upcoming Clinical Milestones
- June 2021 (ASCO presentation): Phase 1 IO combo data of plinabulin + PD-1 + CTLA-4 inhibitors for recurrent Small Cell Lung Cancer (SCLC) in checkpoint inhibitor naïve and failed patients.
- Mid-2021 (DUBLIN-3): topline overall survival (OS) data expected in pivotal Phase 3 NSCLC study.
- 2H 2022 (MD Anderson investigator led study): Phase 1 Data expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in PD-1/PD-L1-failed patients in seven cancers, including Bladder Cancer, Melanoma, Merkel Cell Cancer, MSI-H Cancers (of any histology), Non-small Cell Lung Cancer, Renal Cell Cancer, and Small Cell Lung Cancer.
Seed Therapeutics Proprietary “Molecular Glue” TPD platform
- November 2020: announced SEED subsidiary’s $800 million R&D collaboration with Eli Lilly based on SEED’s proprietary “molecular glue” TPD platform.
Recent Corporate Highlights
- December 2020: Strengthened the Board of Directors with the appointment of Jeffrey Vacirca, M.D., FACP. Dr. Vacirca is a board-certified hematologist and oncologist and serves as CEO and Chairman of the Board of New York Cancer & Blood Specialists and holds several other significant leadership positions in the oncology community.
- November 2020: Completed a financing of approximately $86.3 million in gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. Total cash and cash equivalents as of December 31, 2020 was $109.5 million.
Fourth Quarter 2020 Financial Results
Research and development (“R&D”) expenses were $8.4 million for the quarter ended December 31, 2020, compared to $12.6 million for the quarter ended December 31, 2019. The decrease of $4.2 million was primarily due to a decrease in pre-clinical and clinical trial expenses.
General and administrative (“G&A”) expenses were $10.4 million for the quarter ended December 31, 2020, compared to $2.7 million for the quarter ended December 31, 2019. The $7.7 million increase was primarily due to an increase of $3.0 million in personnel costs, including new hires and certain one-time incentive payments, an increase of $2.6 million in pre-commercialization costs, an increase of $1.8 million in non-cash share-based compensation, and an increase in legal and other costs related to the SEED subsidiary.
Net loss attributable to the Company was $17.6 million for the quarter ended December 31, 2020, compared to $14.1 million for the quarter ended December 31, 2019.
Full Year 2020 Financial Results
Research and development (“R&D”) expenses were $41.8 million for the year ended December 31, 2020, compared to $31.3 million for the year ended December 31, 2019. The $10.5 million increase was largely due to an increase of $3.8 million in clinical trial expenses, an increase of $3.5 million in non-cash share-based compensation and an increase of $2.7 million mainly due to amounts paid to consultants and others to support the NDA filing.
General and administrative (“G&A”) expenses were $22.6 million for the year ended December 31, 2020, compared to $9.0 million for the year ended December 31, 2019. The $13.6 million increase was primarily due to an increase of $5.6 million related to pre-commercialization costs, an increase of $4.5 million in salaries and benefits for commercial and executive personnel, including certain one-time incentive payments, an increase of $2.6 million in non-cash share-based compensation expense, and an increase of $0.9 million in professional services and other expenses.
Net loss attributable to the Company was $61.0 million for the year ended December 31, 2020, compared to $38.1 million for the year ended December 31, 2019.
As of December 31, 2020, the Company had cash and cash equivalents of $109.5 million on hand. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline, and to prepare for a potential launch of plinabulin in 2022.
Fourth Quarter and Full Year 2020 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, April 30, 2021, at 8:30 am ET. The conference call can be accessed by dialing 855-327-6837 (U.S. and Canada) or +1-631-891-4304 (International). The passcode for the conference call is 10014535 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.
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset, plinabulin, a Selective Immunomodulating Microtubule-Binding Agent (SIMBA) is being developed as a “pipeline in a drug.” It is filed for approval in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform (TPD).
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Ashley R. Robinson
LifeSci Advisors, LLC
Darren Opland, Ph.D.