NEW YORK, Aug. 21, 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 provided an operational update for the second quarter of 2017 along with its financial results for the six months ended June 30, 2017.
“During the second quarter of 2017, we continued to advance our registrational clinical trials for our lead asset, Plinabulin, a first in class immuno-oncology agent. In our chemotherapy-induced neutropenia program, we are pleased to have enrolled the first U.S. patient in our Phase 2/3 “105” study, and received U.S. FDA approval to initiate the Phase 2/3 “106” study,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. “We recently received China FDA’s (CFDA) approval of our Clinical Trial Applications (CTA) to initiate the “105” and “106” studies in China. These approvals came just one month and five months after we submitted the respective CTAs for review by the CFDA, which is significantly shorter than the review period many western pharmaceutical companies are experiencing from the agency. We believe that these approvals underscore BeyondSpring’s ability to effectively and quickly navigate the Chinese regulatory requirements, thereby reducing our time to initiate our clinical trials.”
Dr. Huang concluded, “Patient enrollment is continuing in our Phase 3 “103” trial, which is studying Plinabulin’s effect on overall survival in Non-Small Cell Lung Cancer patients who have targeted measurable lesions. We believe that BeyondSpring is well positioned to advance this study, with quality data generated from the large cancer population in China, supporting a slower rate of enrollment occurring in many markets, including the United States. These markets are being impacted by increased competition for patients and low patient participation in clinical trials, particularly for novel oncology agents. We expect interim Phase 3 data from the “103” study during 2018.”
Recent Business Highlights
- In June 2017, China’s Food and Drug Administration approved the Company’s Clinical Trial Applications to allow the initiation of BeyondSpring’s two global Phase 2/3 trials for Plinabulin, for the prevention of chemotherapy-induced neutropenia in China. The Company expects to report data from the Phase 2 portion of the “105” study in the second half of 2017.
- Collaborators at the Fred Hutchinson Cancer Center and the University of Washington initiated a study of Plinabulin in combination with Nivolumab for the treatment of Non-Small Cell Lung Cancer. The Plinabulin/Nivolumab combination is currently being studied in two investigator-sponsored trials, and BeyondSpring anticipates initial safety data to be available in the second half of 2017.
- Subsequent to the end of the second quarter, BeyondSpring received 3 million RMB, or approximately $400,000, in non-dilutive funding from the Chinese government. The Company plans to use these proceeds towards funding its pre-clinical pipeline.
Results for the Six Months Ended June 30, 2017
Cash and cash equivalents were $49.0 million as of June 30, 2017, compared to $11.7 million as of December 31, 2016, and $54.6 million at March 31, 2017. The increase is attributable to approximately $48 million in net cash provided by the March 2017 IPO and concurrent private placement.
Research and Development expenses for the six months ended June 30, 2017 totaled $58.9 million, of which $42.3 million represented payment to NPBSIPO Liquidating Trust settled by share issuance for the global rights to Plinabulin, excluding China and Hong Kong, as negotiated in January 2013 with Dalian Wanchun Biotech. Research and development expenses for the same period in 2016 were $4.7 million. The increase was also attributable to increased costs related to the ongoing Phase 3 trial in advanced Non-Small Cell Lung Cancer and Phase 2/3 trials for chemotherapy-induced neutropenia, including patient enrollment, investigator site and additional drug cost.
General and administrative expenses for the six months ended June 30, 2017 totaled $3.9 million, compared to $0.9 million for the six months ended June 30, 2016. The increase in G&A expenses was primarily due to an increase in personnel cost and higher costs related to being a public company.
Net loss attributable to BeyondSpring for the six months ended June 30, 2017 was $60.7 million, of which $42.3 million represented payment to NPBSIPO Liquidating Trust settled by share issuance for the global rights to Plinabulin, excluding China and Hong Kong, as negotiated in January 2013 with Dalian Wanchun Biotech. Net loss attributable to BeyondSpring for the same period of 2016 was $5.4 million.
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 non-small cell lung cancer and a Phase 2/3 clinical program in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.
Studies on Plinabulin’s method 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 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 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, our expectations regarding the potential safety, efficacy or clinical utility of our 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.
|AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2016 AND|
|UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF JUNE 30, 2017|
|(In thousands of U.S. Dollars (“$”), except share and per share amounts)|
|December 31,||June 30,|
|Advances to suppliers||799||1,276|
|Deferred IPO costs||1,861||–|
|Other current assets||184||227|
|Total current assets||14,707||50,821|
|Property and equipment, net||80||87|
|Other noncurrent assets||121||210|
|Total noncurrent assets||201||297|
|Liabilities and equity|
|Due to related parties||210||2|
|Other current liabilities||235||301|
|Total current liabilities||2,609||3,212|
|Commitments and contingencies|
|Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 16,879,628 shares and 22,844,962 shares issued and outstanding as of December 31, 2016 and June 30, 2017, respectively)||2||2|
|Additional paid-in capital||44,369||141,143|
|Accumulated other comprehensive loss||(91||)||(94||)|
|Total BeyondSpring Inc.’s equity||12,152||48,186|
|Total liabilities and equity||14,908||51,118|
|UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF|
|COMPREHENSIVE LOSS FOR THE SIX MONTHS ENDED JUNE 30, 2016 AND 2017|
|(In thousands of U.S. Dollars (“$”), except share and per share amounts)|
|Six months ended June 30,|
|Research and development, including patent cost of $42,259 expensed for the six months ended June 30, 2017||(4,674||)||(58,936||)|
|General and administrative||(931||)||(3,884||)|
|Loss from operations||(5,605||)||(62,820||)|
|Foreign exchange gain, net||7||203|
|Loss before income tax||(5,592||)||(62,587||)|
|Income tax benefit||–||–|
|Less: Net loss attributable to noncontrolling interests||(203||)||(1,850||)|
|Net loss attributable to BeyondSpring Inc.||(5,389||)||(60,737||)|
|Net loss per share|
|Basic and diluted||(0.34||)||(3.05||)|
|Weighted-average shares outstanding|
|Basic and diluted||15,750,000||19,916,446|
|Other comprehensive loss|
|Foreign currency translation adjustment loss||(39||)||(5||)|
|Less: Comprehensive loss attributable to noncontrolling interests||(219||)||(1,852||)|
|Comprehensive loss attributable to BeyondSpring Inc.||(5,412||)||(60,740||)|
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