– Reported Positive Topline Pre-Specified Interim Results from PROTECTIVE-2 (Study 106) Phase 3, Demonstrating Plinabulin’s Superiority in Combination with Neulasta for CIN Prevention vs. Neulasta Alone-
– Completed PROTECTIVE-2 Phase 3 Enrollment and On Track to Report Final Results in Q4 2020 / Expect to Submit NDA for CIN to the FDA by End of 2020 –
– Triple Plinabulin I/O Combination Achieved 100 Percent Complete Response in PD-1 Non-responsive Animal Model; To Initiate Clinical Studies at MD Anderson in H2 2020 –
NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today its financial results and provided an operational update for the three months ended June 30, 2020.
“BeyondSpring’s mission has been to develop innovative, transformative medicines that improve clinical outcomes in high unmet medical needs,” said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. “With our lead asset, first-in-class agent Plinabulin in late stage developments in two large oncology market opportunities, CIN and NSCLC, we believe that we are at a significant inflection point that will potentially result in helping many patients in need.”
Dr. Huang continued, “We expect to file NDA for CIN, Plinabulin’s first indication, to the U.S. FDA by the end of the year. Plinabulin would potentially reduce infection and hospitalization after chemotherapy, and enable doctors to provide chemotherapy to their patients without compromise – this means stable doses, sustained cycles and the strongest regimens possible so that patients can stay the course with their treatment – for potential survival benefit. As a potent antigen presenting cell inducer, we believe that Plinabulin is a ‘pipeline in a drug’ for multiple cancer indications.”
Select Second-Quarter 2020 and Recent Business Highlights
Recent Clinical Highlights
- Plinabulin in CIN indication
Positive Superior Topline Pre-Specified Interim Results from PROTECTIVE-2 Phase 3
In June 2020, BeyondSpring reported positive topline results of the pre-specified interim analysis of its PROTECTIVE-2 Phase 3 trial, evaluating Plinabulin in combination with Neulasta, compared to Neulasta alone. The interim results showed that the combination significantly enhanced the efficacy of Neulasta in the “rate of Grade 4 neutropenia prevention” (p<0.01), the primary endpoint for the study, which is clinically meaningful. The enrollment of a total of 221 patients has been completed.
Expanded Access Program (EAP) Initiation
In August 2020, BeyondSpring initiated an EAP for Plinabulin in response to the recent NCCN guideline updates highlighting the need for maximum CIN prevention and resource allocation for COVID-19 patients. The program enables doctors across the U.S. to use Plinabulin, both alone and in combination with G-CSFs, to prevent CIN. The first patient dosed in the U.S. avoided Grade 4 neutropenia in Cycle 2 with the Plinabulin-Neulasta combination, despite experiencing Grade 4 neutropenia in Cycle 1 with Neulasta alone.
- Plinabulin in NSCLC indication
DSMB Recommends DUBLIN-3 (Study 103) Phase 3 for NSCLC to Continue Without Modification
In June 2020, BeyondSpring reported that it 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, the DSMB advised BeyondSpring to continue the study without any modifications. DUBLIN-3 is a global Phase 3 trial for Plinabulin in combination with docetaxel, compared to docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC.
- Triple I/O Combination Therapy with Plinabulin
New Preclinical Data Demonstrates Immune-Enhancing Effects
In June 2020, BeyondSpring presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting that the triple I/O combination of Plinabulin, anti-PD-1 and radiation demonstrated a 100 percent complete response in a PD-1 antibody model, indicating that Plinabulin enhances immuno-radiotherapy for cancer patients. The combination therapy is being advanced toward a Phase 1 clinical trial in patients who failed or progressed on PD-1 / PD-L1 antibody treatments. BeyondSpring expects the first patient dosing in H2 2020.
Recent Corporate Highlights
BeyondSpring Appoints Paul Friel to Chief Commercial Officer
In August 2020, BeyondSpring announced the appointment of Paul Friel to the role of Chief Commercial Officer. Mr. Friel has nearly 30 years of experience in the pharmaceutical and biotech industry. He has held positions as General Manager and President at Takeda Canada and Vice President of Sales for Vyaire. During his tenure with Takeda, Mr. Friel was instrumental in helping the organization expand its presence and grow to over 5,000 employees and $10 billion in sales.
Throughout Mr. Friel’s 24-years at TAP and Takeda, he served in multiple commercial roles and was responsible for business development, integration, geographic expansion and Head of Commercial for Latin America for Takeda. He later led Takeda expansions into Mexico, Brazil and Canada. In the last four years of Mr. Friel’s tenure at Takeda, he was integral for launching eight products, including the second fastest biologic launch in the U.S.
BeyondSpring Appoints Dr. Ravi Majeti to Board of Directors
During the same month, BeyondSpring also announced the appointment of Dr. Ravi Majeti, Co-Founder and former Board member of Forty Seven, Inc., and Chief, Division of Hematology, at Stanford University to the Company’s Board of Directors. Dr. Majeti co-founded Forty Seven in 2014 and was a major contributor to the research and technology that led to Forty Seven’s $4.9 billion acquisition by Gilead in March 2020.
In June and July 2020, BeyondSpring closed a public offering of 2,219,500 ordinary shares and a private placement of 384,615 ordinary shares at $13.00 per share. Gross proceeds from the public offering and private placement were $33.9 million before deducting underwriting discounts, commissions and other offering expenses. The Company intends to use the net proceeds of the public offering and private placement to support the commercialization of Plinabulin, continued clinical and pre-clinical development and for general corporate purposes.
Financial Results for the Three Months Ended June 30, 2020
Research and development (“R&D”) expenses were $11.0 million for the quarter ended June 30, 2020, compared to $5.2 million for the quarter ended June 30, 2019. The $5.8 million increase was largely attributable to an increase of $4.9 million in clinical trial expenses.
General and administrative (“G&A”) expenses were $2.6 million for the quarter ended June 30, 2020, compared to $2.1 million for the quarter ended June 30, 2019. The $0.5 million increase was mainly due to an increase in cost related to pre-launch preparation of Plinabulin.
Net loss attributable to the Company was $12.8 million for the quarter ended June 30, 2020, compared to $7.4 million for the quarter ended June 30, 2019.
As of June 30, 2020, the Company had a cash and cash equivalents of $38.1 million. The Company believes it has sufficient cash to support its clinical trials and submit an NDA in the U.S. for Plinabulin for the CIN indication, as well as to advance its immuno-oncology pipeline and protein degradation research platform.
The following outlines the Company’s anticipated upcoming milestones and projected timelines:
- Final data readout for PROTECTIVE-2 Phase 3 for CIN – Q4 2020
- NDA submission for Plinabulin for CIN in the U.S. – end of 2020
- Final topline data readout for DUBLIN-3 for NSCLC – H1 2021
- Rolling NDA submission for Plinabulin for NSCLC in China – H1 2021
- NDA submission for Plinabulin for NSCLC in the U.S. – H2 2021
Conference Call and Webcast Information
BeyondSpring’s management will host a conference call and webcast today at 8 a.m. Eastern Time to discuss the financial results and provide a corporate update. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID: 13709037. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under “Events & Presentations” in the Investors section. An archived replay of the webcast will be available for 30 days.
Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen dose’s decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a “pipeline drug,” Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed “molecular glue” that uses the protein degradation pathway.
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.
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF JUNE 30, 2020
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|December 31,||June 30,|
|Cash and cash equivalents||35,933||38,080|
|Advances to suppliers||4,519||4,330|
|Prepaid expenses and other current assets||410||567|
|Total current assets||40,862||42,977|
|Property and equipment, net||209||194|
|Operating lease right-of-use assets||2,538||2,464|
|Other noncurrent assets||946||1,088|
|Total noncurrent assets||3,693||3,746|
|Liabilities and equity|
|Due to related parties||29||61|
|Current portion of operating lease liabilities||537||649|
|Other current liabilities||1,089||1,462|
|Total current liabilities||10,053||11,306|
|Operating lease liabilities||1,935||1,745|
|Total noncurrent liabilities||3,371||3,795|
|Ordinary shares ($0.0001 par value; 500,000,000|
|shares authorized; 27,885,613 and 30,117,881 shares|
|issued and outstanding as of December 31,|
|2019 and June 30, 2020, respectively)||3||3|
|Additional paid-in capital||246,979||277,618|
|Accumulated other comprehensive income||140||197|
|Total BeyondSpring Inc.’s shareholder’s equity||30,277||32,136|
|Total liabilities and equity||44,555||46,723|
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2019 AND 2020
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|Three months ended||Six months ended
|June 30,||June 30,|
|Research and development||(5,202||)||(11,028||)||(11,532||)||(24,732||)|
|General and administrative||(2,147||)||(2,589||)||(3,786||)||(5,517||)|
|Loss from operations||(7,349||)||(13,617||)||(15,318||)||(30,249||)|
|Foreign exchange gain (loss), net||(169||)||9||4||(65||)|
|Loss before income tax||(7,620||)||(13,599||)||(15,447||)||(30,261||)|
|Income tax benefit||–||–||–||–|
|Less: Net loss attributable to|
|Net loss attributable to|
|Net loss per share|
|Basic and diluted||(0.32||)||(0.46||)||(0.64||)||(1.04||)|
|Weighted-average shares outstanding|
|Basic and diluted||23,094,161||27,921,026||23,061,941||27,826,737|
|Other comprehensive loss, net of tax of nil:|
|Foreign currency translation|
|adjustment gain (loss)||225||(2||)||31||51|
|Less: Comprehensive loss attributable to|
|Comprehensive loss attributable to|