On June 21, 2018 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, reported its financial results for the quarter ended March 31, 2018, and provided an update on the Company’s operations (Press release, BeyondSpring Pharmaceuticals, JUN 21, 2018, View Source [SID1234527596]).
"During the past few months, we have continued to execute on our strategy to establish our lead asset, Plinabulin, as a potentially superior new therapy for the treatment of chemotherapy-induced neutropenia, or CIN, while also advancing our Phase 3 non-small cell lung cancer trial and earlier-stage programs," said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. "We recently highlighted data from the Plinabulin development program describing its differentiated mechanism of action and positive results from the Phase 2 portion of 105 Study, which together, further articulates the potential of our novel candidate to prevent severe neutropenia with less bone pain and an overall more favorable product profile than G-CSF therapy. We look forward to building on this momentum as we approach key Phase 3 data readouts for CIN and non-small cell lung cancer beginning later this year, advance our early-stage pipeline of immuno-oncology therapies and research activities for our ubiquitination protein degradation research platform, and prepare to initiate Phase 1 trials later this year for multiple triple-combination immuno-oncology programs. We have already started the process of preparing to commercialize in both China and the U.S., including identifying and securing the resources and talent we need to put in place for commercial success for Plinabulin in both markets. With significant upcoming milestones, BeyondSpring is well positioned to transition into a multinational, commercial-stage oncology company."
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Recent Highlights
Data from the Phase 2 portion of Study 105 comparing Plinabulin and Neulasta (pegfilgrastim) for prevention of CIN presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
In June 2018, results of the Phase 2 portion of Study 105, a prospective Phase 2/3 trial of its lead asset, Plinabulin, were presented by BeyondSpring in a poster session at the ASCO (Free ASCO Whitepaper) Annual Meeting. The Phase 2 portion of Study 105 was designed as a head-to-head comparison of different dose levels of Plinabulin to Neulasta in a total of 55 patients. The Phase 2 portion met its primary endpoint, which was to determine the recommended Phase 3 Plinabulin dose. Data from the study demonstrated that patients treated with Plinabulin dosed 30 minutes after docetaxel for the prevention of docetaxel CIN reported less bone pain, which was clinically meaningful, and had superior neutrophil counts and comparable neutropenia reduction compared to patients treated with Neulasta 24 hours after docetaxel. The data suggested that Plinabulin has the potential to be at least as effective as Neulasta for prevention of CIN, with an overall product profile that could address the limitations of the current standard of care.
Plinabulin mechanism data highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
In April 2018, BeyondSpring presented preclinical data related to Plinabulin’s differentiated mechanism of action at the AACR (Free AACR Whitepaper) annual meeting. The data demonstrated Plinabulin’s novel mechanism in preserving neutrophils in bone marrow after docetaxel chemotherapy treatment – a mechanism that is differentiated from that of G-CSF, which is the current standard of care in the prevention of CIN.
The Company offered shares through a registered direct offering for gross proceeds of $20.0 million
On May 29, 2018, BeyondSpring entered into private placement agreements with certain third-party investors pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company, an aggregate of 739,095 shares of the Company’s ordinary shares at a purchase price of $27.06 per share, for aggregate gross proceeds of $20.0 million. These investors, including an insurance company and a pharmacy retail chain owner in China, may be strategic to BeyondSpring’s planned commercial initiatives in China.
Edward Dongheng Liu appointed Chief Financial Officer
In March 2018, the Company announced the appointment of Edward Dongheng Liu as Chief Financial Officer. Mr. Liu was a senior banker at J.P. Morgan and Jefferies in Hong Kong, and was a partner and executive director of Epiphron Capital, a cross-border healthcare fund and Series B investor in BeyondSpring.
Financial Results of Three Months Ended March 31, 2018
Research and development (R&D) expenses were $14.1 million for the quarter ended March 31, 2018, compared to $46.7 million for the quarter ended March 31, 2017. R&D expenses for the first quarter of 2017 included a $42.3 million non-cash charge for acquiring the worldwide patent of Plinabulin excluding the People’s Republic of China (PRC) and Hong Kong, which is determined based on the fair value of issued 2,112,963 ordinary shares at $20 per share. Excluding the impact of this purchase, the R&D expense for the quarter ended March 31, 2018 would have increased by $9.7 million, compared to the quarter ended March 31, 2017. This increase is largely attributable to $4.9 million of non-cash share-based compensation expense recorded in the first quarter of 2018, $2.8 million related to increased clinical trial expense and $1.4 million related to increased professional services expense.
General and administrative ("G&A") expenses were $0.7 million for the quarter ended March 31, 2018, compared to $1.0 million for the quarter ended March 31, 2017. First quarter 2018 G&A expenses included a $0.7 million non-cash credit relating to the forfeiture of certain restricted shares.
U.S. GAAP net loss was $14.1 million for the quarter ended March 31, 2018, compared to $47.7 million for the quarter ended March 31, 2017. Net loss for the first quarter ended March 31, 2017, included a $42.3 million non-cash charge for acquiring the worldwide patent of Plinabulin excluding the PRC and Hong Kong.
Cash and short-term investments were $21.5 million at March 31, 2018, compared to $30.6 million at December 31, 2017. The Company anticipates that its current financial resources, including the proceeds from the private placement, would enable it to advance its ongoing clinical trials and submit New Drug Application (NDA) 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 for the next 12 months.
Announce Phase 3 interim analysis data for Study 105 evaluating Plinabulin + docetaxel for CIN – 4Q 2018
Announce topline Phase 2 data for Study 106 evaluating Plinabulin + TAC (Taxotere/Adriamycin/cyclophosphamide) for CIN – late 2018
Announce Phase 3 interim data for Study 103 evaluating Plinabulin + docetaxel for non-small cell lung cancer (NSCLC) – early 2019
Submit NDA to China Food and Drug Administration (CFDA) for Plinabulin for CIN – late 2018/early 2019
Advance two Plinabulin triple-combination immuno-oncology programs into Phase 1 – 2H 2018
Submit NDA to CFDA for Plinabulin for NSCLC – 1H 2019
Advance ubiquitination protein degradation research platform, BPI-001, first target of mutant KRAS, lead asset – 2019
Advance new pipeline asset, BPI-002, an oral CTLA-4 inhibitor, into Phase 1 – 2019
About Plinabulin
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in NSCLC. 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 activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to up-regulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia by reducing the neutrophil breakdown.