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Jul 10,2019
BeyondSpring Provides Operational Update and First Quarter 2019 Financial Results

- New and Compelling Plinabulin Data Presented at Key Scientific Conferences -

- To Submit New Drug Applications (NDAs) in China for Both Non-Small Cell Lung Cancer (NSCLC) and Chemotherapy-Induced Neutropenia (CIN) in Q4 2019 / Q1 2020 -

- To Submit NDAs in the U.S. for Both NSCLC and CIN in 2020 -

NEW YORK, July 10, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company”) (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results for the three months ended March 31, 2019, and provided an update on its operations.

“In recent months, we presented new data on our lead asset, Plinabulin, at key scientific conferences that further support its potential to significantly improve cancer care,” said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. “These exciting new data derived from our clinical trials and pre-clinical studies continue to build a strong profile for Plinabulin for the treatment of NSCLC and CIN, as well as a better understanding of its mechanism of action.”

“With our continued effort in advancing our clinical development, we expect to generate a steady flow of data from our studies in the next 6-9 months that will enable us to submit NDAs in China and the United States for NSCLC and CIN indications of Plinabulin in the near term. Our at-the-market facility and our Chinese subsidiary 's recent financing has and will provide us additional funding to achieve this milestone,” added Dr. Huang.

Select First Quarter 2019 and Recent Highlights

CIN (Study 105 & Study 106)

Study 105 (Intermediate-Risk Chemotherapy)

In May 2019, at the International Society for Pharmacoeconomics and Outcomes Research 2019 Conference, Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University Medical Center, presented data derived from the Phase 2 portion of Study 105 demonstrating that Plinabulin at 20mg/m2 has a similar efficacy profile in reducing docetaxel-induced neutropenia as Neulasta 6mg, while avoiding the patient-reported bone pain typically observed with Neulasta.

Study 106 (High-Risk Chemotherapy)

In June 2019, BeyondSpring announced that two abstracts were accepted for publication in the Proceedings of the 2019 ASCO Annual Meeting. The data, derived from the Phase 2 portion of Study 106, provided a strong rationale for the Plinabulin-G-CSF combination for the prevention of CIN for improved CIN control. Additionally, the Plinabulin-G-CSF combination nearly eliminated patients’ treatment-related bone pain.

BeyondSpring is currently preparing to initiate the Phase 3 portion of Study 106.

Mechanism of Action

In April 2019, BeyondSpring presented novel data relevant to predictive biomarkers for patient selection for Plinabulin at the American Association for Cancer Research Annual Meeting. At the same conference, BeyondSpring presented preclinical data demonstrating Plinabulin’s ability to reduce tumor-associated M2 macrophages, which are thought to support tumor cell survival and metastasis; as well as shift the phenotypic balance to one favoring M1 macrophages, which are thought to have anti-cancer properties.

Equity Offerings

Recently, BeyondSpring’s partially-owned Chinese subsidiary, Dalian Wanchunbulin Pharmaceuticals Ltd. (“Wanchun Bulin”), which holds the intellectual property rights to Plinabulin in China and Hong Kong, has entered into definitive agreements for the sale of its equity interests (“Equity Purchase Agreements”) to certain investors led by Efung Capital, a leading healthcare venture capital fund. Under the Equity Purchase Agreements, Wanchun Bulin expects to sell equity interests representing 4.76% of the equity of Wanchun Bulin for aggregate cash consideration of RMB 100 million or approximately $14.5 million, before deducting offering expenses, to finance clinical and pre-clinical development and for general corporate purposes.

In May 2019, BeyondSpring entered into an Open Market Sale AgreementSM with Jefferies LLC to sell ordinary shares of the Company, with aggregate gross proceeds of up to $30 million from time to time, through at-the-market offerings. As of July 9, 2019, the Company has received $12.9 million through the at-the-market facility, before deducting commissions and offering expenses.

Financial Results for the Three Months Ended March 31, 2019

Research and development (“R&D”) expenses were $6.3 million for the quarter ended March 31, 2019, compared to $14.1 million for the quarter ended March 31, 2018. The R&D expenses for the quarter ended March 31, 2019 decreased by $7.8 million, compared to the quarter ended March 31, 2018. This decrease was due to a $4.7 million decrease in non-cash share-based compensation expense, and a $3.1 million decrease in other R&D expenses. The $3.1 million decrease in other R&D expenses is largely attributable to a $1.5 million decrease in CRO and professional service expense, and a $1.6 million decrease in expenses for central laboratory service, clinical trial sites expense and data management service.

General and administrative (“G&A”) expenses were $1.6 million for the quarter ended March 31, 2019, compared to $0.7 million for the quarter ended March 31, 2018. The G&A expenses for the quarter ended March 31, 2019 increased by $0.9 million, compared to the quarter ended March 31, 2018. This increase was due to a $1.1 million increase in salary, wages and benefits expense and non-cash employee-restricted share compensation, offset by $0.2 million decrease in professional service expense.

Net loss attributable to the Company was $7.3 million for the quarter ended March 31, 2019, compared to $13.7 million for the quarter ended March 31, 2018.

At March 31, 2019, BeyondSpring had $1.96 million in cash, and believes the net proceeds from sales of ordinary shares under its at-the-market facility and the anticipated proceeds from recently announced subsidiary equity offering will be able to support its clinical trials and submit NDAs in China for Plinabulin for the treatment of CIN and NSCLC, and to advance its immuno-oncology pipeline and its ubiquitination protein degradation research platform.

Anticipated Milestones

The following outlines the Company’s key anticipated upcoming milestones and projected timelines.

  • Second interim analysis for Study 103 Phase 3 for NSCLC – Q4 2019/Q1 2020
     
  • Submit NDAs to China’s National Medical Products Administration for Plinabulin for NSCLC and CIN – Q4 2019/Q1 2020
     
  • Submit NDAs to the FDA for Plinabulin for NSCLC and CIN – 2020

About BeyondSpring

BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, Plinabulin, is in two Phase 3 global clinical programs, one as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and the other in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also 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 chemotherapy-induced neutropenia 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, the timing of clinical trials, receipt of clinical data or regulatory filings of the Company's product candidates, 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.

(tables follow)

BEYONDSPRING INC.

AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2018 AND

UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2019

(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)

    December 31, March 31,
    2018 2019
    $ $
      (Unaudited)
Assets      
Current assets:      
Cash   3,889 1,961
Advances to suppliers   1,209 1,066
Due from related parties   481 381
Prepaid expenses and other current assets   292 150
Total current assets   5,871 3,558
       
Noncurrent assets:      
Property and equipment, net   282 263
Operating lease right-of-use assets   - 3,054
Other noncurrent asset   910 970
Total noncurrent assets   1,192 4,287
       
Total assets   7,063 7,845
       
Liabilities and equity      
       
Current liabilities:      
Accounts payable   9,586 8,966
Accrued expenses   5,495 7,872
Due to related parties   - 350
Current portion of operating lease liabilities   - 686
Other current liabilities   1,364 1,596
Total current liabilities   16,445 19,470
       
Noncurrent liabilities:      
Long-term loans   - 2,980
Operating lease liabilities   - 2,427
Total noncurrent liabilities   - 5,407
Total liabilities   16,445 24,877
       
Equity (deficit):      
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 23,184,612 shares issued and outstanding as of      
December 31, 2018 and March 31, 2019, respectively)   2 2
Additional paid-in capital   170,950 171,321
Accumulated deficit   (178,760) (186,053)
Accumulated other comprehensive gain (loss)   42 (111)
       
Total BeyondSpring Inc.’s shareholder’s deficit   (7,766) (14,841)
Noncontrolling interests   (1,616) (2,191)
Total deficit   (9,382) (17,032)
       
Total liabilities and deficit   7,063 7,845
       

BEYONDSPRING INC.

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF

COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2018 AND 2019

(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)

(Unaudited)

    Three months ended March 31,  
  2018 2019  
  $ $  
 
Revenue   - -  
 
Operating expenses:        
Research and development   (14,074) (6,330)  
General and administrative   (728) (1,639)  
         
Loss from operations   (14,802) (7,969)  
Foreign exchange gain, net   332 173  
Interest income   73 6  
Interest expense   - (37)  
Other income   316 -  
         
Loss before income tax   (14,081) (7,827)  
Income tax benefit   - -  
         
Net loss   (14,081) (7,827)  
Less: Net loss attributable to noncontrolling interests   (425) (534)  
Net loss attributable to BeyondSpring Inc.   (13,656) (7,293)  
         
Net loss per share        
Basic and diluted   (0.61) (0.32)  
Weighted-average shares outstanding  
Basic and diluted   22,211,762 23,029,362  
 
Other comprehensive loss  
Foreign currency translation adjustment loss   (65) (194)  
Comprehensive loss   (14,146) (8,021)  
Less: Comprehensive loss attributable to noncontrolling interests   (394) (575)  
Comprehensive loss attributable to BeyondSpring Inc.   (13,752) (7,446)  

Contact:

Investor Relations:
Stephen Kilmer
646.274.3580
stephen.kilmer@beyondspringpharma.com

Media Relations:
Caitlin Kasunich / Amy Singh
KCSA Strategic Communications
212.896.1241 / 212.896.1207
ckasunich@kcsa.com/ asingh@kcsa.com

 

Source: BeyondSpring, Inc.