- Reported Top Line Positive Efficacy and Safety Data from Phase 2 Study 106 Evaluating Plinabulin in Combination With Neulasta for Chemotherapy-Induced Neutropenia (CIN) Prevention
- On Track to Report Interim Data from Phase 3 Study 105 in 4Q 2018 and Submit New Drug Application (NDA) to China Food and Drug Administration (CFDA) for CIN in Late 2018 / Early 2019
- On Track to Report Interim Data from Phase 3 Study 103 in Early 2019 and Submit NDA to CFDA for Non-Small Cell Lung Cancer in First Half of 2019
NEW YORK, Oct. 23, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company”) (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, today announced its financial results for the quarter ended June 30, 2018, and provided an update on the Company’s operations.
“In recent months, we have reported data from our Plinabulin program at major conferences highlighting its product profile compared to G-CSFs, including its positive efficacy and safety when added to the standard of care for CIN, lack of bone pain, prevention of chemotherapy-induced thrombocytopenia, and its potential to positively impact the tumor microenvironment and improve outcomes in combination with Neulasta*,” said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. “We are now looking ahead to reporting interim data from our Phase 3 Study 105 before year end. If positive, we plan to submit a New Drug Application to the China Food and Drug Administration later this year or early next year for CIN, with a separate submission to Chinese regulatory authorities for non-small cell lung cancer in the first half of 2019, assuming a favorable trend from the interim analysis of Study 103. We have begun preparations to position the Company for commercial success in both China and the U.S. under the leadership of our recently appointed Chief Operating Officer, Richard Daly, and I am looking forward to building momentum as we begin our transition to a multinational, commercial-stage oncology company with an emerging pipeline of additional preclinical and clinical candidates to fuel future growth.”
Operational Update and Recent Highlights
Reported Top Line Positive Efficacy and Safety Data from Phase 2 Study 106 Evaluating Plinabulin in Combination with Neulasta for CIN Prevention
In a separate press release issued today, the Company reported positive top line Phase 2 data from its Study 106 evaluating Plinabulin in combination with Neulasta versus Neulasta monotherapy. Data collected to-date suggest a significant improvement in efficacy in treating CIN as well as more than a 90% reduction in patients experiencing bone pain when adding Plinabulin to this standard of care for the treatment of high-risk CIN.
Recent and Upcoming Data Presentations Support Superior Product Profile of Plinabulin for the Treatment of CIN
The Company recently presented new data at a number of medical and scientific conferences demonstrating the advantages of Plinabulin compared to Neulasta, the current standard of care for the treatment of CIN.
- At the 2018 European Society for Medical Oncology (ESMO) Congress, data presented showed that, in contrast to Neulasta, Plinabulin does not increase the Neutrophil-to-Lymphocyte Ratio (NLR), a novel marker for immune suppression in the tumor microenvironment.
- A presentation at the 2018 Joint Meeting of the Society for Leukocyte Biology and International Endotoxin and Innate Immunity Society highlighted Plinabulin’s differentiated mechanism of action and potential complementary therapeutic effect in working with G-CSF. The data demonstrated evidence of neutrophil demargination and reduced bone marrow transit time for Plinabulin, which are consistent with IL-6 signaling in bone marrow and tissue microenvironment.
- At the 2018 IASLC 19th World Conference on Lung Cancer, data demonstrated that Plinabulin mitigated both docetaxel CIN and thrombocytopenia in patients with advanced non-small cell lung cancer.
- The Company will present additional data at the upcoming Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in an abstract titled, “Pegfilgrastim, but not Plinabulin, generates a blood myeloid cell (BMC) repertoire with a predominant immunosuppressive phenotype.”
In Collaboration with Bristol-Myers Squibb, the BeyondSpring-Sponsored Study of Plinabulin + Nivolumab + Ipilimumab for Small Cell Lung Cancer Enrolls First Patient
In October, the Company announced the opening of an investigator-initiated Phase 1 clinical trial with a triple combination therapy, consisting of BeyondSpring’s lead asset, Plinabulin, and 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 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. The first patient received treatment in September 2018.
Strengthened Intellectual Property Portfolio with Newly Issued U.S. Patent for Plinabulin
In October, the Company announced that the U.S. Patent and Trademark Office (USPTO) issued the Company a new patent—U.S. 10076518—for certain methods of treating brain cancer with Plinabulin. The Company has a total of 73 patents granted in 34 countries, including 14 issued U.S. patents directed to Plinabulin and Plinabulin analogs, their synthesis and their use in the treatment of various disorders. These U.S. patents are scheduled to expire between 2021 and 2036, with the potential of patent term extensions of up to five more years.
Richard J. Daly Appointed Chief Operating Officer to Lead Transition to Commercialization
In August 2018, the Company announced the appointment of Richard J. Daly as Chief Operating Officer of the Company. Mr. Daly has more than 25 years of experience heading business development and commercial operations for leading pharmaceutical and biotech companies and will be responsible for global commercial operations as well as business development, strategic partnering and alliance management at BeyondSpring.
Financial Results for Three Months Ended June 30, 2018
Research and development (R&D) expenses were $11.0 million for the quarter ended June 30, 2018, compared to $12.2 million for the quarter ended June 30, 2017. The R&D expenses for the quarter ended June 30, 2018 decreased by $1.2 million, compared to the quarter ended June 30, 2017. This decrease was due to a $6.0 million decrease in non-cash share-based compensation expense, offset by a $4.8 million increase in the other R&D expenses. The $4.8 million increase in other R&D expenses is largely attributable to a $1.1 million increase in drug purchase for clinical trials, a $0.7 million increase in expenses for professional service related to R&D activities and a $0.6 million increase in expenses for data management service.
General and administrative (G&A) expenses were $1.4 million for the quarter ended June 30, 2018, compared to $2.8 million for the quarter ended June 30, 2017. G&A expenses in the second quarter of 2017 included a $1.8 million non-cash share-based compensation expense.
Net loss attributable to the Company was $12.2 million for the quarter ended June 30, 2018, compared to $13.3 million for the quarter ended June 30, 2017.
Cash and short-term investments were $22.4 million at June 30, 2018, compared to $30.6 million at December 31, 2017. The Company anticipates that its currently available financial resources will enable it to advance its ongoing clinical trials and submit NDAs in China for Plinabulin for the treatment of CIN and non-small cell lung cancer in late 2018 or early 2019 and in the first half of 2019, respectively, and to advance its immuno-oncology pipeline, as well as its ubiquitination protein degradation research platform.
Key Upcoming Milestones
The following outlines the Company's key anticipated upcoming milestones and projected timelines.
- Announce Phase 3 interim data for Study 105 evaluating Plinabulin + docetaxel for intermediate-risk CIN – 4Q 2018
- Submit NDA to CFDA for Plinabulin for CIN – late 2018/early 2019
- Announce Phase 3 final data for Study 105 evaluating Plinabulin + docetaxel for intermediate-risk CIN – 2019
- Announce Phase 2 final data for Study 106 evaluating Plinabulin + TAC for high risk CIN – 1H 2019
- Submit NDA to U.S. Food and Drug Administration (FDA) for Plinabulin for CIN – 2H 2019
- Announce Phase 3 interim data for Study 103 evaluating Plinabulin + docetaxel for non-small cell lung cancer (NSCLC) – early 2019
- Submit NDA to CFDA for Plinabulin for NSCLC – 1H 2019
- Announce Phase 3 final data for Study 103 evaluating Plinabulin + docetaxel for NSCLC – 2020
- Submit NDA to U.S. FDA for Plinabulin for NSCLC – 2020
- Announce Phase 1 topline data for Plinabulin + nivolumab + ipilimumab triple-combination immuno-oncology study for small cell lung cancer – 2H 2019
- Advance Plinabulin + pembrolizumab + chemo triple-combination immuno-oncology study for non-small cell lung cancer into Phase 1 – 1H 2019
Other Oncology Pipeline
- Advance ubiquitination protein degradation research platform, BPI-001, into Investigational New Drug application stage with its first target of mutant KRAS and expand the platform to other undruggable substrates – 2020
- Advance new pipeline asset, BPI-002, an oral CTLA-4 inhibitor, into Phase 1 – 2H 2019
Conference Call and Webcast Information
The Company will host an operational update conference call on October 23, 2018 at 8:00 a.m. Eastern Time. The dial-in numbers for the conference call are (866) 362-6591 (U.S. Toll Free) or (706) 758-3199 (international). Please reference conference ID 7880008.
A live webcast of the conference call will be available through the Investors section of BeyondSpring’s website at http://ir.beyondspringpharma.com. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. A replay of the webcast will remain available on http://ir.beyondspringpharma.com for 30 days following the call.
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of chemo-induced neutropenia and as an anticancer therapy in non-small cell lung cancer. Studies of Plinabulin's mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the maturation of dendritic cells, which in turn leads to T-cell activation and the up-regulate of IL6 in the tissue micro environment, contributing to the prevention of neutropenia.
BeyondSpring is a global, clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with the University of Washington in de novo drug discovery using a ubiquitination platform. 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 and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia. BeyondSpring 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 CIN 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.
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2017 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF JUNE 30, 2018
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|December 31,||June 30,|
|Short term investments||3,074||3,022|
|Advances to suppliers||1,525||1,835|
|Prepaid expenses and other current assets||264||525|
|Total current assets||32,344||24,795|
|Property and equipment, net||123||116|
|Other noncurrent assets||361||583|
|Total noncurrent assets||484||699|
|Liabilities and equity|
|Other current liabilities||299||554|
|Total current liabilities||4,792||5,684|
|Commitments and contingencies|
|Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 22,530,702 shares and 23,174,797 shares issued and outstanding as of December 31, 2017 and June 30, 2018, respectively)||2||2|
|Additional paid-in capital||151,147||169,683|
|Accumulated other comprehensive loss||(182)||(100)|
|Total BeyondSpring Inc.’s shareholder’s equity||27,076||19,872|
|Total liabilities and equity||32,828||25,494|
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2017 AND 2018
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
|Three months ended||Six months ended|
|June 30, ||June 30,|
|Research and development, including patent cost of $42,259 expensed for the six months ended June 30, 2017||(12,189||)||(10,994||)||(58,936||)||(25,068||)|
|General and administrative||(2,840||)||(1,388||)||(3,884||)||(2,116||)|
|Loss from operations||(15,029||)||(12,382||)||(62,820||)||(27,184||)|
|Foreign exchange gain, net||129||(460||)||203||(128||)|
|Loss before income tax||(14,875||)||(12,787||)||(62,587||)||(26,868||)|
|Income tax benefit||-||-||-||-|
|Less: Net loss attributable to noncontrolling interests||(1,534||)||(621||)||(1,850||)||(1,046||)|
|Net loss attributable to BeyondSpring Inc.||(13,341||)||(12,166||)||(60,737||)||(25,822||)|
|Net loss per share|
|Basic and diluted||(0.61||)||(0.54||)||(3.05||)||(1.16||)|
|Weighted-average shares outstanding|
|Basic and diluted||21,732,653||22,397,442||19,916,446||22,342,822|
|Other comprehensive loss|
|Foreign currency translation adjustment gain (loss)||(1||)||169||(5||)||104|
|Less: Comprehensive loss attributable to noncontrolling interests||(1,537||)||(630||)||(1,852||)||(1,024||)|
|Comprehensive loss attributable to BeyondSpring Inc.||(13,339||)||(11,988||)||(60,740||)||(25,740||)|