NEW YORK, Nov. 09, 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 financial results for the third quarter ended September 30, 2017 and provided business updates.
“During the third quarter, we continued to advance our two registrational clinical programs for our lead asset, Plinabulin, a first in class immuno-oncology agent. In our chemotherapy-induced neutropenia program, we remain on track to report data from the Phase 2 portion of our registrational Phase 2/3 trial 105 in December 2017, and interim Phase 3 data from this trial and Phase 2 data from our registrational Phase 2/3 trial 106 by mid-2018. We also anticipate reporting interim data from our Phase 3 trial 103 in non-small cell lung cancer (NSCLC) by mid-2018,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. “We are also encouraged by recent guidelines from the China FDA aimed at accelerating the approval process for new drugs in China, which leads us to believe that favorable efficacy trends observed in interim Phase 3 results could fast-track Plinabulin for NDA submissions in China as early as 2018, and position Plinabulin for conditional approval in China for both of its lead indications as early as 2019.”
Dr. Huang concluded, “In addition to the progress in our late-stage trials, we are extremely pleased with the advancement of the Plinabulin clinical program in combination with Nivolumab for the treatment of NSCLC, as one of our two investigator-sponsored studies recently initiated Phase 2 enrollment. We look forward to presenting Phase 1 data on the safety and mechanism of action of this regimen in the first quarter of 2018, and utilizing this data to guide our late-stage development plans.”
Recent Business Highlights
- In October 2017, BeyondSpring enrolled its first patient in China in the Phase 2 portion of trial 105 for the prevention of chemotherapy-induced neutropenia. Having achieved this key milestone, the Company is on track to meet its enrollment goals and to report interim Phase 3 data from this trial by mid-2018.
- In September 2017, collaborators at the Fred Hutchinson Cancer Center and the University of Washington initiated a Phase 2 trial on the Plinabulin combination regimen with Nivolumab for NSCLC. This regimen is also the subject of an investigator sponsored Phase 1 trial being conducted by the University of California- San Diego.
- During the third quarter, BeyondSpring received non-dilutive grant funding from the city government of Dalian, China, and from the Dalian Economic Development Park. The Company plans to use these proceeds to fund additional pre-clinical studies, including de novo drug discovery efforts on its ubiquitination platform.
Results of Three Months Ended September 30, 2017
- Cash, cash equivalents and short-term investments were $40.7 million as of September 30, 2017, compared to $49.0 million at June 30, 2017. The decrease in the quarter was attributable to the activities in the Company’s three ongoing late-stage clinical programs, partially offset by the receipt of $914,000 from the China grant funding discussed above.
- Research and development (R&D) expenses for the third quarter of 2017 were $15.3 million, compared with $12.2 million in the second quarter of 2017. The increase in Q3 2017 from Q2 2017 was largely attributable to increased costs related to the Company’s ongoing late-stage clinical programs in neutropenia prevention and advanced NSCLC, including a higher number of patients, investigator sites and drug costs. Included in R&D is $7.5 million of stock-based compensation expense for Q3 2017 and $6.9 million in Q2 2017.
- General and administrative (G&A) expenses were $3.3 million for the third quarter of 2017, compared to $2.8 million in the second quarter of 2017. The increase in Q3 2017 in G&A expenses from Q2 2017 was primarily due to higher stock-based compensation expense.
- Net loss attributable to BeyondSpring Inc. for the three months ended September 30, 2017 was $15.5 million, compared to $13.3 million in the second quarter of 2017.
KOL Analyst and Investor Event
BeyondSpring announced today that it will host an Analyst and Investor Event on December 14, 2017 in New York City to provide an in-depth overview of Plinabulin’s position as a potential new standard of care in neutropenia prevention due to its unique mechanism and the market’s unmet need. The event will feature two key opinion leaders (KOLs) in the neutropenia field, and also provide an update of the Plinabulin ongoing Phase 3 non-small cell lung cancer (NSCLC) and I/O combination trials.
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology assets and ubiquitination pathway agents, with a robust pipeline from internal development and from collaboration with University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial program as a direct anticancer agent in non-small cell lung cancer (NSCLC) 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 SEPTEMBER 30, 2017
(In thousands of U.S. Dollars (“$”), except share and per share amounts)
|December 31,||September 30,|
|Short term investments||-||3,006|
|Advances to suppliers||799||2,015|
|Deferred IPO costs||1,861||-|
|Other current assets||184||195|
|Total current assets||14,707||43,170|
|Property and equipment, net||80||126|
|Other noncurrent assets||121||276|
|Total noncurrent assets||201||402|
|Liabilities and equity|
|Due to related parties||210||2|
|Other current liabilities||235||432|
|Total current liabilities||2,609||3,081|
|Commitments and contingencies|
|Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 16,879,628 shares and 22,844,962 shares issued and outstanding as of December 31, 2016 and September 30, 2017, respectively)||2||2|
|Additional paid-in capital||44,369||147,695|
|Accumulated other comprehensive loss||(91)||(163)|
|Total BeyondSpring Inc.’s equity||12,152||39,135|
|Total liabilities and equity||14,908||43,572|
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2017
(In thousands of U.S. Dollars (“$”), except share and per share amounts)
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Research and development, including patent cost of $42,259 expensed for the nine months ended September 30, 2017||(2,740||)||(15,288||)||(7,414||)||(74,224||)|
|General and administrative||(543||)||(3334||)||(1474||)||(7218||)|
|Loss from operations||(3,283||)||(18,622||)||(8,888||)||(81,442||)|
|Foreign exchange gain, net||14||160||21||363|
|Loss before income tax||(3,262||)||(17,512||)||(8,854||)||(80,099||)|
|Income tax benefit||-||-||-||-|
|Less: Net loss attributable to noncontrolling interests||(175||)||(1,978||)||(379||)||(3,828||)|
|Net loss attributable to BeyondSpring Inc.||(3,087||)||(15,534||)||(8,475||)||(76,271||)|
|Net loss per share|
|Basic and diluted||(0.19||)||(0.68||)||(0.54||)||(3.73||)|
|Weighted-average shares outstanding|
|Basic and diluted||15,958,736||22,844,962||15,820,086||20,438,251|
|Other comprehensive loss|
|Foreign currency translation adjustment gain (loss)||10||(9||)||(29||)||(14||)|
|Less: Comprehensive loss attributable to noncontrolling interests||(175||)||(1,918||)||(394||)||(3,770||)|
|Comprehensive loss attributable to BeyondSpring Inc.||(3,077||)||(15,603||)||(8,489||)||(76,343||)|