BeyondSpring Files 2019 Annual Report on Form 20-F

April 30, 2020

NEW YORK, April 30, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2019 with the U.S. Securities and Exchange Commission (“SEC”) on April 30, 2020. The annual report on Form 20-F, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at www.sec.gov and on the Company’s website at www.beyondspringpharma.com under “Financials & Filings” in the Investors section.

The Company will provide a hard copy of its annual report containing its audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to Investor Relations, BeyondSpring Inc., 28 Liberty Street, 39th Floor, New York, NY 10005 USA.

About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first in class agent Plinabulin as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

y (chemo)-induced neutropenia (CIN) in the protective-1 trial,” compares Plinabulin versus Neulasta as an effective monotherapy for CIN prevention.

Non-Small Cell Lung Cancer (NSCLC)
DSMB Recommends DUBLIN-3 Phase 3 NSCLC to Continue Without Modification
In June 2020, BeyondSpring reported it had reached the pre-specified second interim analysis for DUBLIN-3 for NSCLC treatment with Plinabulin.
Upon reviewing the efficacy and safety data of over 500 patients at an approximately 300-patient death event, DSMB advised BeyondSpring to continue the study without any modifications

DUBLIN-3 is a global Phase 3 trial for Plinabulin, in combination with docetaxel versus docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC

Thus far, over 600 cancer patients have been dosed with Plinabulin, which has demonstrated good tolerability and satisfies the safety database standard of both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA)

Intellectual Properties
BeyondSpring Granted U.S. Patent for Plinabulin to Treat Severe CIN from Taxane in Cancer Patients
In May 2020, the U.S. Patent and Trademark Office (USPTO) granted BeyondSpring a new patent for methods of treating severe CIN in cancer patients treated with taxane with protection through 2033. This patent establishes Plinabulin’s beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies

The Company currently owns 76 patents, including 17 issued U.S. patents, for Plinabulin and its analogs with protection through 2036

Financial Results for the Three Months Ended March 31, 2020
Research and development (“R&D”) expenses were $13.7 million for the quarter ended March 31, 2020, compared to $6.3 million for the quarter ended March 31, 2019. The $7.4 million increase was largely attributable to an increase of $4.4 million in clinical trial expenses and an increase of $3.0 million in non-cash share-based compensation.
Selling, general and administrative (“SG&A”) expenses were $2.9 million for the quarter ended March 31, 2020, compared to $1.6 million for the quarter ended March 31, 2019. The $1.3 million increase was mainly due to a $0.6 million increase in commercial and marketing expense, a $0.3 million increase in salary, wages and benefits expense, and a $0.4 million increase in other expenses.
Net loss attributable to the Company was $16.1 million for the quarter ended March 31, 2020, compared to $7.3 million for the quarter ended March 31, 2019.
As of March 31, 2020, the Company had a cash balance of $24.9 million. The Company believes currently available financial resources will be sufficient to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the CIN and NSCLC indications, as well as to advance its immuno-oncology pipeline and ubiquitination protein degradation research platform.

Anticipated Milestones
The following outlines the Company’s anticipated upcoming milestones and projected timelines:
Interim topline data readout for PROTECTIVE-2 Phase 3 for CIN – June 2020

Final data readout for PROTECTIVE-2 Phase 3 for CIN – H2 2020

Final data readout for PROTECTIVE-1 Phase 3 for CIN – H2 2020

NDA submission for Plinabulin for CIN in the U.S. – H2 2020

Final data readout for DUBLIN-3 for NSCLC – H2 2020

NDA submission for Plinabulin for NSCLC in China – H2 2020

NDA submission for Plinabulin for NSCLC in the U.S. – H1 2021

About BeyondSpring
BeyondSpring is a global clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

 

 

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