Full Press Release Details
BeyondSpring Reports First-Quarter 2020 Financial Results and Operational Update
- PROTECTIVE-2 (Study 106) Phase 3 Interim Analysis This Month to Evaluate Superiority in CIN -
- PROTECTIVE-2 Phase 2 Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes -
- DUBLIN-3 (Study 103 Phase 3) Second Interim Analysis for NSCLC Received DSMB's Recommendation to Continue Without Modification -
NEW YORK, June 11, 2020 - BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today its financial results and provided an
operational update for the three months ended March 31, 2020.
"During the first quarter, we continued to make progress in the two lead indications for Plinabulin for both the prevention of chemotherapy-induced neutropenia (CIN) and treatment of non-small cell lung cancer (NSCLC)," said Dr. Lan Huang,
Co-Founder, Chairman and Chief Executive Officer. "Our recent data from PROTECTIVE-2 Phase 2 showed Plinabulin combined with G-CSF improves chemotherapy compliance compared to G-CSF alone, which potentially leads to better clinical outcomes. The
Plinabulin-G-CSF combination's potential to prevent infection and hospitalization becomes even more important to the physicians, patients and the healthcare system in the COVID-19 pandemic. We expect to reach the pre-specified interim analysis for
PROTECTIVE-2 Phase 3 this month to evaluate superiority in CIN, which has the potential to mark the first significant enhancement in preventing neutropenia in 30 years."
"With over 1,200 patients enrolled to date for Plinabulin clinical programs, we believe we are well-positioned to capitalize on our upcoming regulatory milestones with multiple New Drug Application (NDA) filings followed by near term commercial
opportunities. Looking ahead, we continue to advance our clinical studies to support our view of Plinabulin as a pipeline in a drug' and believe its potential in improving standard of care in CIN prevention and cancer treatments will help many
patients in need globally."
Select First-Quarter 2020 and Recent Operational Highlights
Chemotherapy-Induced Neutropenia (CIN)
PROTECTIVE-2 Phase 2 for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes
In June 2020, BeyondSpring announced that PROTECTIVE-2 Phase 2 superiority trial for CIN shows that Plinabulin in combination with Neulasta (pegfilgrastim), a long-lasting G-CSF, which is a predominant therapy to treat CIN, enables more cancer
patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes.
Plinabulin's Mechanism of Action Complements Neulasta in Cancer Treatment
In May 2020, two Company abstracts were presented at this year's American Society of Clinical Oncology (ASCO) Virtual Scientific Program, evaluating Plinabulin alongside Neulasta.
Non-Small Cell Lung Cancer (NSCLC)
DSMB Recommends DUBLIN-3 Phase 3 NSCLC to Continue Without Modification
In June 2020, BeyondSpring reported it had reached the pre-specified second interim analysis for DUBLIN-3 for NSCLC treatment with Plinabulin.
Intellectual Properties
BeyondSpring Granted U.S. Patent for Plinabulin to Treat Severe CIN from Taxane in Cancer Patients
Financial Results for the Three Months Ended March 31, 2020
Research and development ("R&D") expenses were $13.7 million for the quarter ended March 31, 2020, compared to $6.3 million for the quarter ended March 31, 2019. The $7.4 million increase was largely attributable to an increase of $4.4 million
in clinical trial expenses and an increase of $3.0 million in non-cash share-based compensation.
Selling, general and administrative ("SG&A") expenses were $2.9 million for the quarter ended March 31, 2020, compared to $1.6 million for the quarter ended March 31, 2019. The $1.3 million increase was mainly due to a $0.6 million increase in
commercial and marketing expense, a $0.3 million increase in salary, wages and benefits expense, and a $0.4 million increase in other expenses.
Net loss attributable to the Company was $16.1 million for the quarter ended March 31, 2020, compared to $7.3 million for the quarter ended March 31, 2019.
As of March 31, 2020, the Company had a cash balance of $24.9 million. The Company believes currently available financial resources will be sufficient to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the CIN
and NSCLC indications, as well as to advance its immuno-oncology pipeline and ubiquitination protein degradation research platform.
Anticipated Milestones
The following outlines the Company's 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, first-in-class agent Plinabulin, is in a Phase 3 global clinical trial as a
direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs 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. BeyondSpring is headquartered in New York City.
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,
difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not
meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, the impact of widespread health developments, including the recent COVID-19 pandemic, and
the responses thereto, which could materially and adversely affect, among other things, enrollment of patients in our clinical trials and our expected timeline for data readouts of our clinical trials and certain regulatory filings for our product
candidates, unexpected changes to estimates of our expenses, future revenues and capital requirements, and other risks described in BeyondSpring's most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All 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.
Scott Eckstein / Caitlin Kasunich
KCSA Strategic Communications
212.896.1210 / 212.896.1241
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2020
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)
| December 31, | March 31, | ||||||||||
| Note | 2019 | 2020 | |||||||||
| $ | $ | ||||||||||
| (Unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | 35,933 | 24,917 | |||||||||
| Advances to suppliers | 4,519 | 4,384 | |||||||||
| Prepaid expenses and other current assets | 410 | 452 | |||||||||
| Total current assets | 40,862 | 29,753 | |||||||||
| Noncurrent assets: | |||||||||||
| Property and equipment, net | 3 | 209 | 203 | ||||||||
| Operating lease right-of-use assets | 2,538 | 2,607 | |||||||||
| Other noncurrent assets | 946 | 941 | |||||||||
| Total noncurrent assets | 3,693 | 3,751 | |||||||||
| Total assets | 44,555 | 33,504 | |||||||||
| Liabilities and equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | 2,537 | 5,140 | |||||||||
| Accrued expenses | 5,861 | 4,697 | |||||||||
| Due to related parties | 5 | 29 | 42 | ||||||||
| Current portion of operating lease liabilities | 537 | 643 | |||||||||
| Other current liabilities | 11 | 1,089 | 1,685 | ||||||||
| Total current liabilities | 10,053 | 12,207 | |||||||||
| Noncurrent liabilities: | |||||||||||
| Long-term loans | 4 | 1,436 | 1,413 | ||||||||
| Operating lease liabilities | 1,935 | 1,892 | |||||||||
| Total noncurrent liabilities | 3,371 | 3,305 | |||||||||
| Total liabilities | 13,424 | 15,512 | |||||||||
| Equity: | |||||||||||
| Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 27,885,613 shares and 27,888,906 shares issued and outstanding as of December 31, 2019 and March 31, 2020, respectively) | 7 | 3 | 3 | ||||||||
| Additional paid-in capital | 7 | 246,979 | 250,417 | ||||||||
| Accumulated deficit | 7 | (216,845 | ) | (232,929 | ) | ||||||
| Accumulated other comprehensive income | 7 | 140 | 197 | ||||||||
| Total BeyondSpring Inc.'s shareholder's equity | 30,277 | 17,688 | |||||||||
| Noncontrolling interests | 7 | 854 | 304 | ||||||||
| Total equity | 31,131 | 17,992 | |||||||||
| Total liabilities and equity | 44,555 | 33,504 |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2019 AND 2020
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)
| Three months ended March 31, | |||||||||||
| Note | 2019 | 2020 | |||||||||
| $ | $ | ||||||||||
| Revenue | - | - | |||||||||
| Operating expenses: | |||||||||||
| Research and development | (6,330 | ) | (13,704 | ) | |||||||
| Selling, general and administrative | (1,639 | ) | (2,928 | ) | |||||||
| Loss from operations | (7,969 | ) | (16,632 | ) | |||||||
| Foreign exchange gain (loss), net | 173 | (74 | ) | ||||||||
| Interest income | 6 | 64 | |||||||||
| Interest expense | (37 | ) | (21 | ) | |||||||
| Other income | - | 1 | |||||||||
| Loss before income tax | (7,827 | ) | (16,662 | ) | |||||||
| Income tax benefit | 6 | - | - | ||||||||
| Net loss | (7,827 | ) | (16,662 | ) | |||||||
| Less: Net loss attributable to noncontrolling interests | (534 | ) | (578 | ) | |||||||
| Net loss attributable to BeyondSpring Inc. | (7,293 | ) | (16,084 | ) | |||||||
| Net loss per share | |||||||||||
| Basic and diluted | 10 | (0.32 | ) | (0.58 | ) | ||||||
| Weighted-average shares outstanding Basic and diluted | 10 | 23,029,362 | 27,732,449 | ||||||||
| Other comprehensive loss | |||||||||||
| Foreign currency translation adjustment (loss) gain | (194 | ) | 53 | ||||||||
| Comprehensive loss | (8,021 | ) | (16,609 | ) | |||||||
| Less: Comprehensive loss attributable to noncontrolling interests | (575 | ) | (582 | ) | |||||||
| Comprehensive loss attributable to BeyondSpring Inc. | (7,446 | ) | (16,027 | ) |
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, 2019 AND 2020
(Amounts in thousands of U.S. Dollars ("$"))
| Three months ended March 31, | |||||||||||
| Note | 2019 | 2020 | |||||||||
| $ | $ | ||||||||||
| Operating activities: | |||||||||||
| Net loss | (7,827 | ) | (16,662 | ) | |||||||
| Adjustments to reconcile net loss to net cash from operating activities: | |||||||||||
| Share-based compensation | 12 | 371 | 3,470 | ||||||||
| Depreciation expenses | 23 | 15 | |||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Advances to suppliers | 143 | 135 | |||||||||
| Due from related parties | 5 | 100 | - | ||||||||
| Prepaid expenses and other current assets | 123 | ( 42 | ) | ||||||||
| Operating lease right-of-use assets | 134 | (69 | ) | ||||||||
| Other noncurrent assets | (60 | ) | 5 | ||||||||
| Accounts payable | (620 | ) | 2,603 | ||||||||
| Accrued expenses | 2,377 | (1,164 | ) | ||||||||
| Operating lease liabilities | (56 | ) | 63 | ||||||||
| Other current liabilities | 232 | 596 | |||||||||
| Net cash used in operating activities | (5,060 | ) | (11,050 | ) | |||||||
| Investing activities: | |||||||||||
| Acquisitions of property and equipment | (4 | ) | (9 | ) | |||||||
| Net cash used in investing activities | (4 | ) | (9 | ) | |||||||
| Financing activities: | |||||||||||
| Proceeds from loans | 4 | 2,986 | - | ||||||||
| Loans from related parties | 5 | 350 | 14 | ||||||||
| Net cash provided by financing activities | 3,336 | 14 | |||||||||
| Effect of foreign exchange rate changes, net | (200 | ) | 29 | ||||||||
| Net decrease in cash and cash equivalents | (1,928 | ) | (11,016 | ) | |||||||
| Cash at beginning of period | 3,889 | 35,933 | |||||||||
| Cash at end of period | 1,961 | 24,917 |
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 ("$") and Renminbi ("RMB"), 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 focusing 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 incorporation.
As of March 31, 2020, 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 | Delaware, | |||
| Pharmaceuticals Inc. | 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 | The People's Republic of China | |||
| (Shenzhen) Ltd. | ("PRC") | April 23, 2015 | 100% | Holding company |
| Dalian Wanchunbulin | ||||
| Pharmaceuticals Ltd. | ||||
| ("Wanchunbulin") | PRC | May 6, 2015 | 57.97% | 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 | 57.97% | Clinical trial activities |
| SEED Therapeutics Inc. | ||||
| ("SEED") | BVI | June 25, 2019 | 100% | Holding company |
| SEED Technology Limited | ||||
| ("SEED Technology") | BVI | December 9, 2019 | 57.97% | Holding company |
The accompanying unaudited interim condensed consolidated balance sheet as of March 31, 2020, the unaudited interim condensed consolidated statements of comprehensive loss for the three months
ended March 31, 2019 and 2020, the cash flows for the three months ended March 31, 2019 and 2020, 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, 2019.
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.
NOTES TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of U.S. Dollars ("$") and Renminbi ("RMB"), except for number of shares and per share data)
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, 2020 are not necessarily indicative of results to be expected for any other interim period or
for the full year of 2020. The consolidated balance sheet as of December 31, 2019 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, 2019.
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 considered if both (1)
it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise
substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued.
The Company has incurred operating losses and negative cash flows from operations since inception. To date, the Company has no product revenue and management expects operating losses to continue
for the foreseeable future, and has primarily funded these losses through equity financings. The Company incurred a net loss of $16,662 during the three months ended March 31, 2020 and has an accumulated deficit of $232,929 as of March 31, 2020. Net
cash used in operations was approximately $11,050 for the three months ended March 31, 2020. As of March 31, 2020, the Company had $17,546 net current assets and $24,917 of cash and cash equivalents on hand.
The Company is implementing a cost reduction plan, which includes the deferral of certain research, development and clinical projects and reduction of administrative expenses until it obtains
additional financings. With the implementation of cost reduction plan, the Company anticipates that its current financial resources will enable it to meet its operational expenses and capital expenditures into the second quarter of year 2021.
Therefore, the management believes that the substantial doubt about the Company's ability to continue as a going concern within one year after the date the financial statements are issued has been
alleviated. The accompanying unaudited interim condensed consolidated financial statements have been prepared on a going concern basis.
NOTES TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS