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.
RECENT NEWS ARTICLES
BeyondSpring Presents Final Data Analysis of DUBLIN-3 Phase 3 Study in 2L/3L EGFR Wild-type NSCLC at ESMO Congress 2024
Plinabulin/Docetaxel Combination Demonstrated Favorable Benefit/Risk Ratio over Docetaxel Alone: Significant Improvement in Overall Survival, Progression Free Survival, and Objective Response, with additional Significant Reduction of Grade 4 Neutropenia (>80%...
BeyondSpring Presents Efficacy/Safety Results from a Phase 2 Study of Pembrolizumab plus Plinabulin/Docetaxel in Metastatic NSCLC after Progressing on First-Line Immune Checkpoint Inhibitors at ESMO Congress 2024
Median PFS at 8.63 months and Disease Control Rate of 89.5% in Previously Treated NSCLC Patients after Progression on PD-1/L1 Monotherapy or in Combination with Platinum Doublet Chemotherapy Florham Park, N.J., September 16, 2024 – BeyondSpring Inc. (NASDAQ: BYSI)...
BeyondSpring Delivers Oral Presentation at ISLAC 2024 World Conference on Lung Cancer of its Lead Anti-Cancer Asset Plinabulin Showcasing Positive Final Phase 3 Data in 2L/3L NSCLC EGFR Wild-Type with Concurrent Publication in the Lancet Respiratory Medicine
Statistically Significant and Clinically Meaningful Efficacy Data with Favorable Benefit/Risk ratio from DUBLIN-3 Phase 3 Study of Plinabulin plus Docetaxel vs. Docetaxel in EGFR Wild-Type NSCLC after Progression on Platinum-based Therapy Plinabulin/Docetaxel...
BeyondSpring Announces Oral Presentation at the 2024 World Conference on Lung Cancer and Two Poster Presentations During ESMO Congress 2024 Showcasing its Lead Anti-Cancer Asset, Plinabulin
Florham Park, N.J., September 3, 2024 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announces that it will have an oral presentation on...
SEED Therapeutics (SEED) Enters into Strategic Research Collaboration with Eisai Co., Ltd. to Discover and Develop Novel Molecular Glue Degraders for Neurodegeneration and Oncology Indications
SEED Concurrently Enters into Share Purchase Agreements for its Series A-3 Financing Led by Eisai The SEED-Eisai Research Collaboration leverages Eisai’s leading expertise in neurodegeneration and cancer. SEED is entitled to receive upfront and milestone payments of...
BeyondSpring R&D Day Highlights New Plinabulin Development Strategy for Cancer and Updates for SEED Therapeutics
Florham Park, N.J., May 16, 2024 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it hosted a virtual Research and...
BeyondSpring To Host Virtual R&D Day to Discuss New Plinabulin Development Strategy for Cancer and Updates for SEED Therapeutics
Florham Park, N.J., May 3, 2024 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced it will host a Research and Development (R&D)...
BeyondSpring Provides Business Update and Reports Year End 2023 Financial Results
BeyondSpring Dosed First Patient of Two Phase 2 Investigator-Initiated Trials (IIT) in Plinabulin and Keytruda Combination Studies SITC 2023 Presentation of the Phase 1 Topline Clinical and Mechanism Data of BeyondSpring’s Lead Asset Plinabulin in Combination with...
BeyondSpring Files 2023 Annual Report on Form 20-F
Florham Park, N.J., April 29, 2024 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it has filed its annual report on Form...
BeyondSpring Announces First Patient Dosed with Pembrolizumab, Plinabulin Plus Etoposide/Platinum in a Phase 2 Investigator-initiated Study of First-Line Extensive-Stage Small-Cell Lung Cancer
FLORHAM PARK, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has...
RECENT MEDIA COVERAGE
Seeking Alpha: BeyondSpring plinabulin, Merck Keytruda combo shows promise in NSCLC
Added Plinabulin Boosts OS as Later-Line Treatment for EGFR Wild-Type NSCLC
IO360: Developing a Molecule to Help Patients Respond to Immunotherapy
TD Ameritrade Watch List
Read More
Managing Chemotherapy Toxicities for Improved Patient Outcomes
Read More
New Treatment Modalities: Protein Degraders And Molecular Glues Gain Traction
Read More
Seed Therapeutics blossoms in an $800M deal with Lilly
Read More
Seed Therapeutics Launches Protein Degradation Research Platform and Appoints Edward Dongheng Liu as Chief Financial Officer
Read More
BeyondSpring Forms Partnership Advisory Committee Comprised of Industry Veterans
Read More
JAMA Oncology Highlights Plinabulin’s Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy
Read More