Full Press Release Details
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 - 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.
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.
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.
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.
Caitlin Kasunich / Amy Singh
KCSA Strategic Communications
212.896.1241 / 212.896.1207
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
| Note | December 31, 2018 | March 31, 2019 | |||||||||
| $ | $ (Unaudited) | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash | 3,889 | 1,961 | |||||||||
| Advances to suppliers | 1,209 | 1,066 | |||||||||
| Due from related parties | 5 | 481 | 381 | ||||||||
| Prepaid expenses and other current assets | 292 | 150 | |||||||||
| Total current assets | 5,871 | 3,558 | |||||||||
| Noncurrent assets: | |||||||||||
| Property and equipment, net | 3 | 282 | 263 | ||||||||
| Operating lease right-of-use assets | 10 | - | 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 | 5 | - | 350 | ||||||||
| Current portion of operating lease liabilities | 10 | - | 686 | ||||||||
| Other current liabilities | 1,364 | 1,596 | |||||||||
| Total current liabilities | 16,445 | 19,470 | |||||||||
| Noncurrent liabilities: | |||||||||||
| Long-term loans | 4 | - | 2,980 | ||||||||
| Operating lease liabilities | 10 | - | 2,427 | ||||||||
| Total noncurrent liabilities | - | 5,407 | |||||||||
| Total liabilities | 16,445 | 24,877 | |||||||||
| Equity (deficit): | |||||||||||
| Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 23,184,612 shares issued and outstanding as of December 31, 2018 and March 31, 2019, respectively) | 7 | 2 | 2 | ||||||||
| Additional paid-in capital | 7 | 170,950 | 171,321 | ||||||||
| Accumulated deficit | 7 | (178,760 | ) | (186,053 | ) | ||||||
| Accumulated other comprehensive gain (loss) | 7 | 42 | (111 | ) | |||||||
| Total BeyondSpring Inc.'s shareholder's deficit | (7,766 | ) | (14,841 | ) | |||||||
| Noncontrolling interests | 7 | (1,616 | ) | (2,191 | ) | ||||||
| Total deficit | (9,382 | ) | (17,032 | ) | |||||||
| Total liabilities and deficit | 7,063 | 7,845 |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2018 AND 2019
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share
| Three months ended March 31, | |||||||||||
| Note | 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 | 6 | - | - | ||||||||
| 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 | 9 | (0.61 | ) | (0.32 | ) | ||||||
| Weighted-average shares outstanding | |||||||||||
| Basic and diluted | 9 | 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 | ) |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2018 AND 2019
(Amounts in thousands of U.S. Dollars ("$"))
| Three months ended March 31, | |||||||||||
| Note | 2018 | 2019 | |||||||||
| $ | $ | ||||||||||
| Operating activities: | |||||||||||
| Net loss | (14,081 | ) | (7,827 | ) | |||||||
| Adjustments to reconcile net loss to net cash from operating activities: | |||||||||||
| Share-based compensation | 11 | 4,201 | 371 | ||||||||
| Depreciation expenses | 12 | 23 | |||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Advances to suppliers | 61 | 143 | |||||||||
| Government grants | (307 | ) | - | ||||||||
| Due from related parties | 5 | - | 100 | ||||||||
| Prepaid expenses and other current assets | (20 | ) | 123 | ||||||||
| Operating lease right-of-use assets | - | 134 | |||||||||
| Other noncurrent assets | (122 | ) | (60 | ) | |||||||
| Accounts payable | 1,010 | (620 | ) | ||||||||
| Accrued expenses | 305 | 2,377 | |||||||||
| Operating lease liabilities | - | (56 | ) | ||||||||
| Other current liabilities | 2 | 232 | |||||||||
| Net cash used in operating activities | (8,939 | ) | (5,060 | ) | |||||||
| Investing activities: | |||||||||||
| Acquisitions of property and equipment | (13 | ) | (4 | ) | |||||||
| Net cash used in investing activities | (13 | ) | (4 | ) | |||||||
| Financing activities: | |||||||||||
| Proceeds from loans | 4 | - | 2,986 | ||||||||
| Loans from related parties | 5 | - | 350 | ||||||||
| Net cash provided by financing activities | - | 3,336 | |||||||||
| Effect of foreign exchange rate changes, net | (179 | ) | (200 | ) | |||||||
| Net decrease in cash | (9,131 | ) | (1,928 | ) | |||||||
| Cash at beginning of period | 27,481 | 3,889 | |||||||||
| Cash at end of period | 18,350 | 1,961 |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
NOTES TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)
BeyondSpring Inc. (the "Company") was incorporated in the Cayman Islands on November 21, 2014. The Company and its subsidiaries (collectively, the "Group") are principally
engaged in clinical stage biopharmaceutical activities focused on the development of innovative cancer therapies. The Company is under the control of Mr. Linqing Jia and Dr. Lan Huang as a couple (collectively, the "Founders") since its
As at March 31, 2019, the subsidiaries of the Company are as follows:
| Name of company | Place of incorporation | Date of incorporation | Percentage of ownership by the Company | Principal activities | ||||
| BeyondSpring Pharmaceuticals Inc. | Delaware, United States of America ("U.S.") | June 18, 2013 | 100% | Clinical trial activities | ||||
| BeyondSpring Ltd. | The British Virgin Islands ("BVI") | December 3, 2014 | 100% | Holding company | ||||
| BeyondSpring (HK) Limited | Hong Kong | January 13, 2015 | 100% | Holding company | ||||
| Wanchun Biotechnology Limited | BVI | April 1, 2015 | 100% | Holding company | ||||
| Wanchun Biotechnology (Shenzhen) Ltd. | The People's Republic of China ("PRC") | April 23, 2015 | 100% | Holding company | ||||
| Dalian Wanchunbulin Pharmaceuticals Ltd. ("Wanchunbulin") | PRC | May 6, 2015 | 60% | Clinical trial activities | ||||
| BeyondSpring Pharmaceuticals Australia PTY Ltd. ("BeyondSpring Australia") | Australia | March 3, 2016 | 100% | Clinical trial activities | ||||
| Beijing Wanchun Pharmaceutical Technology Ltd.. ("Beijing Wanchun") | PRC | May 21, 2018 | 60% | Clinical trial activities |
The accompanying unaudited interim condensed consolidated balance sheet as of March 31, 2019, the unaudited interim condensed consolidated statements of comprehensive loss for
the three months ended March 31, 2018 and 2019, the cash flows for the three months ended March 31, 2018 and 2019, and the related footnote disclosures are unaudited. These unaudited interim condensed consolidated financial statements of the
Company have been prepared in accordance with U.S. GAAP for interim financial information using accounting policies that are consistent with those used in the preparation of the Company's audited consolidated financial statements for the year
ended December 31, 2018. Accordingly, these unaudited interim condensed consolidated financial statements do not include all of the information and footnotes required by U.S. GAAP for annual financial statements.
In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all normal recurring adjustments necessary to present fairly
the financial position, operating results and cash flows of the Group for each of the periods presented. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of results to be expected for any other
interim period or for the full year of 2019. The consolidated balance sheet as of December 31, 2018 was derived from the audited consolidated financial statements at that date but does not include all of the disclosures required by U.S. GAAP for
annual financial statements. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company's consolidated financial statements for the year ended December 31, 2018.
NOTES TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)
Basis of consolidation
The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions
and balances between the Company and its subsidiaries are eliminated upon consolidation.
According to Accounting Standards Codification ("ASC") 205-40, Presentation of Financial Statements - Going Concern ("ASC 205-40"), management must
evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. This
evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this
methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only