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- Significant Clinical Data Generated for Plinabulin -
- On Track to Submit New Drug Applications (NDAs) for Plinabulin to China’s National Medical Products Administration (NMPA) for Both Non-Small Cell Lung Cancer (NSCLC) and Chemotherapy-Induced Neutropenia (CIN) in Q4 2019 -
- On Track to Submit NDA for Plinabulin to U.S. Food and Drug Administration (FDA) for Both Indications in 2020 -
NEW YORK, April 30, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company”) (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results for the three-months and full-year ended December 31, 2018, and provided an update on its operations.
“We strive to develop transformative medicines for cancer patients with severe unmet medical needs. 2018 was truly a historic year for BeyondSpring with a number of important development milestones. We generated significant clinical data on our lead asset, first-in-class immune agent Plinabulin. Plinabulin was administered globally to over 540 patients with good tolerability. We reached the first pre-specified interim analysis of Study 103 for Plinabulin, in the second and third line treatment for NSCLC, with the Data and Safety Monitoring Board recommending the trial to continue”, said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. “During 2018, we also generated extensive data suggesting Plinabulin’s potential to meaningfully improve patient outcomes in CIN, when combined with G-CSFs. In Study 105 and 106, data generated indicates that Plinabulin significantly reduces bone pain, prevents thrombocytopenia, and reverses potential immune suppression of Neulasta®. In addition, we generated data characterizing Plinabulin’s unique mechanism of action supporting a differentiated product profile in the prevention of CIN, which appears to have a complementary therapeutic effect with G-CSFs.”
Dr. Huang continued, “The significant amount of clinical data on Plinabulin enables us to fully understand Plinabulin’s target product profile as an anti-cancer and CIN prevention agent, as well as its clinical potential in additional indications, including triple combo therapies of Plinabulin with PD-1 and CTLA-4 antibodies, and Plinabulin with checkpoint inhibitors and chemotherapy. Finally, we are actively pursuing partnerships for China and the U.S./ROW.”
Select Fourth-Quarter 2018 and Recent Business Highlights
NSCLC (Study 103)
BeyondSpring has enrolled more than 400 patients in the 554-patient Phase 3 portion of Study 103. The Company reached the first pre-specified interim analysis at a death event of 146 patients and the Data and Safety Monitoring Board (DSMB) recommended the trial to continue. A second pre-specified interim analysis is at a death event of 293 patients and is expected in the fourth quarter of 2019.
The Company intends to submit an NDA for NSCLC in the fourth quarter of 2019 in China and in 2020 in the U.S.
CIN (Study 105 & Study 106)
In October 2018, at the European Society for Medical Oncology Congress (ESMO), BeyondSpring presented Phase 2 Study 105 data demonstrating that, in contrast to Neulasta, Plinabulin does not increase the neutrophil-to-lymphocyte ratio, a novel marker for immune suppression.
In November 2018, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University Medical Center, presented Phase 2 Study 105 data suggesting a potentially superior, immune-enhancing profile for Plinabulin compared to Neulasta.
In December 2018, BeyondSpring announced that the Phase 3 portion of Study 105 had met its primary endpoint of non-inferiority for Plinabulin versus Neulasta for the duration of severe neutropenia of the first cycle, with statistical significance in a pre-specified interim analysis. This conclusion was confirmed at the DSMB meeting, chaired by Dr. Crawford, Chairman of NCCN Guidelines for Neutropenia Management in the U.S.
In October 2018, the Company announced positive topline Phase 2 Study 106 data suggesting a significant improvement in efficacy in treating CIN as well as more than a 90 percent reduction in patients experiencing bone pain when adding Plinabulin to Neulasta, the standard of care in CIN. The detailed data was presented by Dr. Blayney at the American Society of Hematology (ASH) meeting in December 2018.
In March 2019, at the ASCO-SITC Clinical Immuno-Oncology Symposium, Dr. Blayney presented data from Phase 2 Study 106 demonstrating that combining Plinabulin with Neulasta reverses the latter’s potential immune-suppressive phenotype.
BeyondSpring is currently preparing to initiate the Phase 3 portion of Study 106.
A positive pre-NDA Chemistry, Manufacturing and Control (CMC) meeting was held in December 2018 with the FDA regarding Plinabulin. During this meeting, BeyondSpring confirmed its alignment with the FDA regarding expectations for the CMC section of its planned NDAs for Plinabulin.
The Company plans to file NDAs for a broad indication of all chemotherapy induced neutropenia, or CIN, in all cancer types in the fourth quarter of 2019 in China and in 2020 in the U.S.
BeyondSpring opened an investigator-initiated Phase 1/2 clinical trial with a triple combination therapy, consisting of Plinabulin, Bristol-Myers Squibb’s PD-1 antibody, Opdivo® (nivolumab), and CTLA-4 antibody, Yervoy® (ipilimumab), for the treatment of small cell lung cancer. The trial, conducted through the Big Ten Cancer Research Consortium, is currently enrolling subjects at Rutgers Cancer Institute of New Jersey and other clinical centers in the U.S. The trial is expected to enroll approximately 15 patients in the Phase 1 portion of this Phase 1/2 combined study, and an additional 40 patients in the Phase 2 portion. This study will investigate whether the addition of Plinabulin results in efficacy synergy and in a reduction of immune-related side effects of PD-1 and CTLA-4 antibodies.
Mechanism of Action
In October 2018, at the Joint Meeting of the Society for Leukocyte Biology and International Endotoxin and Innate Immunity Society, the Company presented Phase 2 Study 105 data highlighting Plinabulin’s differentiated mechanism of action (MOA) and potential complementary therapeutic effect in working with G-CSFs.
In December 2018, BeyondSpring reported that data from Study 105 and Study 106 were presented at the American Society of Hematology Annual Meeting. The results built on the evidence that Plinabulin has a unique MOA and demonstrated that Plinabulin as a monotherapy treatment is as effective as Neulasta, but with minimal bone pain, while a Plinabulin/Neulasta combination therapy demonstrates superior CIN treatment efficacy and almost eradicates Neulasta-induced bone pain.
In March 2019, BeyondSpring presented novel data relevant to predictive biomarkers for patient selection for Plinabulin at the American Association for Cancer Research Annual Meeting.
In 2018, the Company was granted three new Plinabulin patents related to a new composition of matter of Plinabulin, method of use in KRAS mutation cancer, and method of use in brain tumor, by the United States Patent and Trademark Office; and a patent for methods of preventing CIN with Plinabulin, in combination with taxane by the Japan Patent Office. This brings the Company’s total patent portfolio to 76 patents in 36 jurisdictions including 20 issued U.S. patents with protection until 2036.
The company continues to advance three pre-clinical immune agents BPI-002, 003, and 004, and a research platform using ubiquitin medicated degradation pathways.
Financial Results for the Fourth Quarter and Full-Year 2018
Research and Development (R&D) expenses decreased by $1.4 million and $37.3 million in the fourth quarter and full-year 2018. In 2017, the Company issued 2,112,963 ordinary shares to Nereus Trust in exchange for the termination of certain Plinabulin patent royalty payment obligations, which was recorded as a non-cash expense of $42.3 million. Without this non-cash expense, R&D expenses in full-year 2018 would have increased by $5.0 million, resulting from increased clinical trial costs.
General and Administrative (G&A) expenses increased by $0.4 million in the fourth quarter of 2018 and decreased by $3.2 million in full-year 2018. The decrease in G&A expenses in full-year 2018 was primarily attributable to a decrease in non-cash share-based compensation.
Net loss attributable to the Company was $14.7 million and $54.9 million for the fourth quarter and full-year 2018, compared to $7.8 million and $91.8 million for the fourth quarter and full-year 2017.
Cash and short-term investment were $3.9 million as at the end of 2018, compared to $30.6 million as at the end of 2017. The Company received $14 million through a share offering in 2018. Subsequent to year end 2018, BeyondSpring entered into loan agreements totaling approximately RMB 37 million, approximately RMB 27 million of which has been drawn down with the remainder expected to be drawn down during the second quarter of 2019.
Conference Call and Webcast Information
BeyondSpring’s management will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the financial results and provide a corporate update. The dial-in numbers for the conference call are 1-855-327-6837 (U.S.) or 1-631-891-4304 (international). Please reference conference ID 10006728. 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.
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, with dual market strategy for the U.S. and China, two of the world’s largest pharmaceutical markets. BeyondSpring’s lead asset, 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 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN), where both phase 2 portions have been completed. 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.
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," “potential,” “suggest,” "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Specifically, these forward-looking statements include, but are not limited to, statements relating to the Company’s ability to establish its lead asset, Plinabulin, as a potentially superior new therapy for the treatment of chemotherapy-induced neutropenia and ability to advance its Phase 3 non-small cell lung cancer trial and earlier-stage programs, the potential for development and marketing of its product candidates, ability to advance its pipeline of immuno-oncology therapies and research activities, the potential effectiveness of Plinabulin, the potential for Plinabulin to address limitations in the current standard of care, and the Company’s ability to continue as a going concern. 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, the anticipated amount needed to finance the Company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, its expectations regarding the potential safety, efficacy or clinical utility of its product candidates, or additional competition in the market, and other risk factors referred to in BeyondSpring’s current Form 20-F on file with the U.S. Securities and Exchange Commission. The 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.
Neulasta® is a registered trademark of Amgen, Inc. Opdivo® and Yervoy® are registered trademarks of Bristol-Myers Squibb Company.
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2017 AND 2018
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|As of December 31,|
|Short term investment||3,074||-|
|Advances to suppliers||1,525||1,209|
|Due from related parties||-||481|
|Prepaid expenses and other current assets||264||292|
|Total current assets||32,344||5,871|
|Property and equipment, net||123||282|
|Other noncurrent assets||361||910|
|Total noncurrent assets||484||1,192|
|Liabilities and equity|
|Other current liabilities||299||1,364|
|Other current liabilities||4,792||16,445|
|Commitments and contingencies|
|Ordinary shares ($0.0001par value; 500,000,000 shares|
|authorized; 22,530,702 shares and 23,184,612|
|shares issued and outstanding as of December 31,|
|2017 and 2018, respectively)||2||2|
|Additional paid-in capital||151,147||170,950|
|Accumulated other comprehensive loss (gain)||(182||)||42|
|Total BeyondSpring Inc. shareholders’ equity (deficit)||27,076||(7,766||)|
|Total equity (deficit)||28,036||(9,382||)|
|Total liabilities and equity (deficit)||32,828||7,063|
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE MONTHS (UNAUDITED INTERIM) AND YEAR ENDED (AUDITED) DECEMBER 31, 2018 AND 2017
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|Three months ended|
|Twelve months ended|
|Research and development, including|
|patent cost of $42,259|
|for the year ended December 31, 2017||(14,703||)||(13,295||)||(88,928||)||(51,618||)|
|General and administrative||(1,835||)||(2,283||)||(9,053||)||(5,927||)|
|Loss from operations||(16,538||)||(15,578||)||(97,981||)||(57,545||)|
|Foreign exchange gain (loss), net||192||(6||)||555||(455||)|
|Other income (expenses)||4||(1||)||918||315|
|Loss before income tax||(16,288||)||(15,580||)||(96,388||)||(57,474||)|
|Income tax benefit||-||-||-||-|
|Less: Net loss attributable to noncontrolling interests||(8,453||)||(854||)||(4,625||)||(2,605||)|
|Net loss attributable to BeyondSpring Inc.||(7,835||)||(14,726||)||(91,763||)||(54,869||)|
|Net loss per share|
|Basic and diluted||(0.35||)||(0.64||)||(4.40||)||(2.42||)|
|Weighted-average shares outstanding|
|Basic and diluted||22,372,520||23,013,265||20,866,084||22,665,265|
|Other comprehensive loss|
|Foreign currency translation adjustment gain (loss)||196||(12||)||(1||)||251|
|Less: Comprehensive loss attributable to noncontrolling interests||(855||)||(859||)||(4,535||)||(2,578||)|
|Comprehensive loss attributable to|
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