NEW YORK, May 22, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI) (“BeyondSpring” or the “Company”), a late-stage clinical biopharmaceutical company focusing on the development of a pipeline of innovative immuno-oncology cancer therapies, today announced its unaudited financial results for the first quarter ended March 31, 2017.
“During the quarter, we continued to make progress on our two most advanced clinical trials for our lead asset, Plinabulin, which includes a study for the prevention of chemotherapy-induced neutropenia and a study for increasing overall survival in patients with advanced Non-Small Cell Lung Cancer (“NSCLC”) who have measurable lung lesions,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. “Our next data milestone, which is expected to be announced within the next six months, is the Phase 2 data from our neutropenia studies.”
“BeyondSpring has a pipeline of immuno-oncology small molecule drugs with applicability in multiple indications that we are advancing,” said Dr. Ramon Mohanlal, Executive Vice President and Chief Medical Officer. “Our goal is to maximize the value of our assets, not only by pursuing multiple indications, but also by a focused execution of clinical trials. In addition, discussions are progressing, as we consider partnering with pharma companies, which is core to our development and commercial strategy.”
“The Company is currently working on two Plinabulin indications involving two separate clinical programs for product registration, which are now fully funded following our initial public offering (“IPO”) and concurrent private placement completed in March 2017. Most recently, we started a new registrational trial as we enrolled patients in our Phase 2/3 study for the prevention of neutropenia, in combination with docetaxel,” said Richard Brand, CFO of BeyondSpring. “We aim to select the best clinical research resources available in different countries, which we believe will allow us to enroll and complete trials faster and cost effectively, while meeting the U.S. Food and Drug Administration’s high standards. We believe these attributes will allow us to achieve our current goals while minimizing dilution for our shareholders.”
Recent Business Highlights
BeyondSpring successfully completed its IPO and a concurrent private placement, which closed on March 14, 2017. BeyondSpring raised total net proceeds of approximately $48.17 million in the two transactions; selling 174,286 ordinary shares at $20.00 per share in the IPO and 2,541,048 ordinary shares at $20.00 per share in the concurrent private placement.
Plinabulin Mechanism of Action Update
Based on a three-year collaborative effort with University of Basel and Massachusetts General Hospital, it is now understood that Plinabulin is an activator of GEF-H1, a guanine nucleotide exchange factor.
- Plinabulin destabilizes microtubule networks in the cell’s cytoskeleton and releases GEF-H1.
- GEF-H1 activates downstream signal transduction pathways, leading to the activation of c-Jun.
- The activated c-Jun enters the nucleus of dendritic cells (“DC”) to up-regulate immune-related genes, which leads to DC maturation, T cell activation and neutropenia prevention.
Plinabulin is differentiated from other microtubule depolymerizing agents, such as the CA4P class, which cannot induce DC maturation or neutropenia prevention.
This important finding was presented at the Keystone Meeting on March 23, 2017.
First Quarter 2017 Results
Cash and Cash Equivalents were $54.6 million as of March 31, 2017, compared to $11.7 million as of December 31, 2016. For the first quarter of 2017, cash provided by the IPO and concurrent private placement, after deducting underwriting fees and other expenses, was $48.17 million.
Research and Development Expenses for the first quarter of 2017 were $46.7 million, of which $42.3 million represents the Company’s payment to NPBSIPO Liquidating Trust for the global rights to Plinabulin negotiated in January 2013 with Dalian Wanchun Biotech. Research and Development Expenses for the same period last year were $1.5 million. The increase in R&D expenses in the first quarter of 2017 was primarily due to increased costs related to the ongoing Phase 3 trial in advanced NSCLS, including more patients, additional investigator sites and additional drug cost, as well as planning for the Phase 2/3 trial for docetaxel-induced severe neutropenia.
General and Administrative Expenses were $1.0 million in the first quarter of 2017, compared to $0.4 million in the first quarter of 2016. The increase in in G&A expenses was primarily due to an increase in personnel cost under business expansion and outside professional service expense incurred preparing for the IPO.
Net loss attributable to BeyondSpring Inc. for the first quarter of 2017 was $47.4 million, of which $42.3 million represents the Company’s payment to NPBSIPO Liquidating Trust for the global rights to Plinabulin negotiated in January 2013 with Dalian Wanchun Biotech. Net loss attributable to BeyondSpring Inc. for the same period last year was $1.8 million. This increase was primarily due to the Company’s increased research and development costs. The increased research and development costs mainly related to the Company’s continuing Phase 3 clinical trial of Plinabulin in combination with docetaxel for patients with advanced NSCLC who have measurable lung lesions, and the Company’s preparations to start its registrational clinical program of Plinabulin to prevent chemotherapy-induced neutropenia.
The Company previously disclosed that, in recognition of the prior contributions and the future importance of its executive officers to the continued success of the Company and for purposes of retention of key executives, the Company expected to grant restricted share awards under the 2017 Incentive Plan to certain of its executive officers after the completion of its initial public offering. After March 31, 2017, the Company granted a total of 1,037,037 time-based and 100,000 performance-based shares of restricted stock to certain executive officers. The time-based restricted shares will vest in installments following the grant date, subject to each executive officer’s continued employment through the applicable vesting dates. The performance-based restricted shares will vest based on the achievement of various milestones with respect to Plinabulin.
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 Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in NSCLS and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia.
Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1. 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 upregulate 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.
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 also include, among others, statements regarding the Company’s research and development plans, expectations regarding the timing for the announcement of clinical trial results, and future liquidity needs. 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, the Company’s expectations regarding the potential safety, efficacy or clinical utility of its product candidates, or additional competition in the market. 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.
|BEYONDSPRING INC. |
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2016 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2017
(In thousands of U.S. Dollars (“$”), except share and per share amounts)
|December 31,||March 31,|
|Advances to suppliers||799||916|
|Deferred IPO costs||1,861||-|
|Other current assets||184||54|
|Total current assets||14,707||55,665|
|Property and equipment, net||80||88|
|Other noncurrent assets||121||203|
|Total noncurrent assets||201||291|
|Liabilities and equity|
|Due to related parties||210||7|
|Other current liabilities||235||161|
|Total current liabilities||2,609||1,930|
|Commitments and contingencies|
|Ordinary shares ($0.0001 par value; 500,000,000|
|shares authorized; 16,879,628 shares and 21,707,925|
|shares issued and outstanding as of December 31,|
|2016 and March 31, 2017, respectively)||2||2|
|Additional paid-in capital||44,369||133,812|
|Accumulated other comprehensive loss||(91||)||(96||)|
|Total BeyondSpring Inc.’s equity||12,152||54,194|
|Total liabilities and equity||14,908||55,956|
|BEYONDSPRING INC. |
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2016 AND 2017
(In thousands of U.S. Dollars (“$”), except share and per share amounts)
|Three months ended March 31,|
|Research and development, including patent cost|
|of $42,259 expensed off for the three months ended|
|March 31, 2017 (Note 9)||(1,487||)||(46,747||)|
|General and administrative||(428||)||(1,044||)|
|Loss from operations||(1,915||)||(47,791||)|
|Foreign exchange gain, net||2||74|
|Loss before income tax||(1,909||)||(47,712||)|
|Income tax benefit||-||-|
|Less: Net loss attributable to noncontrolling interests||(65||)||(316||)|
|Net loss attributable to BeyondSpring Inc.||(1,844||)||(47,396||)|
|Net loss per share|
|Basic and diluted||(0.12||)||(2.66||)|
|Weighted-average shares outstanding|
|Basic and diluted||15,750,000||17,834,676|
|Other comprehensive loss|
|Foreign currency translation adjustment gain (loss)||6||(4||)|
|Less: Comprehensive loss attributable to noncontrolling interests||(63||)||(315||)|
|Comprehensive loss attributable to BeyondSpring Inc.||(1,840||)||(47,401||)|
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