Full Press Release Details
BeyondSpring Announces First Quarter 2021 Financial Results and Provides a Corporate Update
- NDA Filed by U.S. Food and
Drug Administration(FDA) and given Priority Review for plinabulin plus G-CSF for the prevention of CIN. A PDUFA date of November 30, 2021 has been assigned by the FDA.
- Highlighted PROTECTIVE-2 Phase 3 data at two scientific conferences - ASCO and FOCIS - showing plinabulin in combination with G-CSF to have superior benefit in reducing the incidence and
severity of febrile neutropenia and hospitalization rates and better QoL compared to pegfilgrastim alone
- Advanced clinical development of combination plinabulin + checkpoint inhibitors in PD-1/PD-L1-resistant tumors: presented promising Phase 1 anti-cancer data in PD-1/PD-L1-resistant SCLC at ASCO 2021; dosed first
patient in a triple IO combination Phase 1 study in seven advanced solid tumors
NEW YORK, Jun. 16, 2021 - BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company
focused on the development of innovative cancer therapies, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate events.
"This quarter was marked by meaningful progress on the road toward building our lead first-in-class asset, plinabulin, as a pipeline in a drug, from treating chemotherapy side effects to treating cancer directly," said Dr. Lan Huang,
co-founder, chairwoman and chief executive officer of BeyondSpring. "We are grateful that our NDA for chemotherapy-induced neutropenia (CIN) prevention was filed by the U.S. FDA with priority review. Our plinabulin and G-CSF combination has the
potential to elevate the standard of care in CIN for the first time in 30 years. In addition, in the coming months, we plan to announce topline anti-cancer overall survival data from the Phase 3 DUBLIN-3 trial in NSCLC. We are building clinical
evidence to demonstrate that plinabulin is a potent antigen presenting cell (APC) inducer with potential to be a game changer' in cancer treatment for severely unmet medical needs."
Recent Corporate Highlights
Lead Asset Plinabulin, a "Pipeline in a Drug"
Upcoming Clinical Milestones
First Quarter 2021 Financial Results
Research and development ("R&D") expenses were $11.3 million for the quarter ended March 31, 2021, compared to $13.7 million for the quarter ended March 31, 2020. The decrease of $2.4 million was primarily due to a decrease in clinical
trial expenses and non-cash stock-based compensation expense, partially offset by an increase in manufacturing costs and the cost of the plinabulin regulatory filings.
General and administrative ("G&A") expenses were $6.4 million for the quarter ended March 31, 2021, compared to $2.9 million for the quarter ended March 31, 2020. The $3.5 million increase was primarily due to higher personnel costs,
non-cash stock-based compensation expense, as well as costs associated with plinabulin pre-commercialization activities.
Net loss attributable to the Company was $17.0 million for the quarter ended March 31, 2021, compared to $16.1 million for the quarter ended March 31, 2020.
As of March 31, 2021, the Company had cash and cash equivalents of $90.6 million on hand. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline, and to
prepare for a potential launch of plinabulin in CIN in early 2022.
First Quarter 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, June 16, 2021, at 8:30 am ET. The conference call can be
accessed by dialing 855-327-6837 (U.S. and Canada) or +1-631-891-4304 (International). The passcode for the conference call is 10014535 To access the live webcast or subsequent archived recording, click here or visit the "investors" section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the company's website for 90 days.
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have
high unmet medical needs. BeyondSpring's first-in-class lead asset plinabulin, a Selective Immunomodulating Microtubule-Binding Agent (SIMBA), is being developed a "pipeline in a drug." It is filed for approval and has received Priority Review in the U.S. and China for the prevention of
chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021, and has a fully enrolled pivotal study (Dublin-3) to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC).
Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring's extensive pipeline includes three pre-clinical
immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.
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, 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.
LifeSci Advisors, LLC
Darren Opland, Ph.D.
LifeSci Communications
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2020 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2021
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)
| December 31, | March 31, | |||||||||||
| Note | 2020 | 2021 | ||||||||||
| $ | $ | |||||||||||
| (Unaudited) | ||||||||||||
| Assets | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | 109,537 | 90,574 | ||||||||||
| Advances to suppliers | 3,505 | 3,436 | ||||||||||
| Prepaid expenses and other current assets | 358 | 362 | ||||||||||
| Total current assets | 113,400 | 94,372 | ||||||||||
| Noncurrent assets: | ||||||||||||
| Property and equipment, net | 4 | 184 | 175 | |||||||||
| Operating lease right-of-use assets | 2,174 | 1,250 | ||||||||||
| Other noncurrent assets | 1,280 | 1,296 | ||||||||||
| Total noncurrent assets | 3,638 | 2,721 | ||||||||||
| Total assets | 117,038 | 97,093 | ||||||||||
| Liabilities, mezzanine equity and equity | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | 2,216 | 1,569 | ||||||||||
| Accrued expenses | 5,607 | 5,756 | ||||||||||
| Current portion of operating lease liabilities | 787 | 505 | ||||||||||
| Deferred revenue | 3 | 1,350 | 1,350 | |||||||||
| Long-term loans, current portion | 5 | - | 1,526 | |||||||||
| Other current liabilities | 12 | 3,806 | 1,924 | |||||||||
| Total current liabilities | 13,766 | 12,630 | ||||||||||
| Noncurrent liabilities: | ||||||||||||
| Long-term loans | 5 | 2,167 | 635 | |||||||||
| Operating lease liabilities | 1,359 | 673 | ||||||||||
| Deferred revenue | 3 | 7,925 | 7,587 | |||||||||
| Total noncurrent liabilities | 11,451 | 8,895 | ||||||||||
| Total liabilities | 25,217 | 21,525 | ||||||||||
| Commitments and contingencies | 15 | |||||||||||
| Mezzanine Equity | ||||||||||||
| Contingently redeemable noncontrolling interests | 14 | 5,196 | 5,196 | |||||||||
| Equity | ||||||||||||
| Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,141,913 and 39,106,476 shares issued and outstanding as of December 31, 2020 and March 31, 2021, respectively) | 8 | 4 | 4 | |||||||||
| Additional paid-in capital | 8 | 366,451 | 367,555 | |||||||||
| Accumulated deficit | 8 | (277,818 | ) | (294,806 | ) | |||||||
| Accumulated other comprehensive loss | 8 | (297 | ) | (247 | ) | |||||||
| Total BeyondSpring Inc.'s shareholders' equity | 88,340 | 72,506 | ||||||||||
| Noncontrolling interests | 8 | (1,715 | ) | (2,134 | ) | |||||||
| Total equity | 86,625 | 70,372 | ||||||||||
| Total liabilities, mezzanine equity and equity | 117,038 | 97,093 |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2020 AND 2021
(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)
| Three months ended March 31, | ||||||||||||
| Note | 2020 | 2021 | ||||||||||
| $ | $ | |||||||||||
| Revenue | 3 | - | 338 | |||||||||
| Operating expenses | ||||||||||||
| Research and development | (13,704 | ) | (11,311 | ) | ||||||||
| General and administrative | (2,928 | ) | (6,447 | ) | ||||||||
| Loss from operations | (16,632 | ) | (17,420 | ) | ||||||||
| Foreign exchange loss, net | (74 | ) | (31 | ) | ||||||||
| Interest income | 64 | 32 | ||||||||||
| Interest expense | (21 | ) | (24 | ) | ||||||||
| Other income | 1 | - | ||||||||||
| Loss before income tax | (16,662 | ) | (17,443 | ) | ||||||||
| Income tax benefit | 7 | - | - | |||||||||
| Net loss | (16,662 | ) | (17,443 | ) | ||||||||
| Less: Net loss attributable to noncontrolling interests | (578 | ) | (455 | ) | ||||||||
| Net loss attributable to BeyondSpring Inc. | (16,084 | ) | (16,988 | ) | ||||||||
| Net loss per share | ||||||||||||
| Basic and diluted | 11 | (0.58 | ) | (0.44 | ) | |||||||
| Weighted average shares outstanding | ||||||||||||
| Basic and diluted | 11 | 27,732,449 | 39,004,609 | |||||||||
| Other comprehensive loss, net of tax of nil: | ||||||||||||
| Foreign currency translation adjustment gain | 53 | 73 | ||||||||||
| Comprehensive loss | (16,609 | ) | (17,370 | ) | ||||||||
| Less: Comprehensive loss attributable to noncontrolling interests | (582 | ) | (432 | ) | ||||||||
| Comprehensive loss attributable to BeyondSpring Inc. | (16,027 | ) | (16,938 | ) |
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, 2020 AND 2021
(Amounts in thousands of U.S. Dollars ("$"))
| Three months ended March 31, | ||||||||||||
| Note | 2020 | 2021 | ||||||||||
| $ | $ | |||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net loss | (16,662 | ) | (17,443 | ) | ||||||||
| Adjustments to reconcile net loss to cash used in operating activities: | ||||||||||||
| Share-based compensation | 13 | 3,470 | 1,122 | |||||||||
| Depreciation expenses | 4 | 15 | 17 | |||||||||
| Non-cash operating lease expense | 157 | 99 | ||||||||||
| Loss on disposal of right-of-use assets | - | 22 | ||||||||||
| Changes in assets and liabilities: | ||||||||||||
| Advances to suppliers | 135 | 69 | ||||||||||
| Prepaid expenses and other current assets | (42 | ) | (4 | ) | ||||||||
| Other noncurrent assets | 5 | (16 | ) | |||||||||
| Accounts payable | 2,603 | (647 | ) | |||||||||
| Accrued expenses | (1,164 | ) | 187 | |||||||||
| Operating lease liabilities | (163 | ) | (165 | ) | ||||||||
| Other current liabilities | 596 | (1,843 | ) | |||||||||
| Deferred revenue | - | (338 | ) | |||||||||
| Net cash used in operating activities | (11,050 | ) | (18,940 | ) | ||||||||
| Cash flows from investing activities: | ||||||||||||
| Acquisitions of property and equipment | (9 | ) | (8 | ) | ||||||||
| Net cash used in investing activities | (9 | ) | (8 | ) | ||||||||
| Cash flows from financing activities: | ||||||||||||
| Issuance costs of ordinary shares and redeemable noncontrolling interests | - | (82 | ) | |||||||||
| Loans from related parties | 6 | 14 | - | |||||||||
| Net cash provided by (used in) financing activities | 14 | (82 | ) | |||||||||
| Effect of foreign exchange rate changes, net | 29 | 67 | ||||||||||
| Net decrease in cash and cash equivalents | (11,016 | ) | (18,963 | ) | ||||||||
| Cash and cash equivalents at beginning of period | 35,933 | 109,537 | ||||||||||
| Cash and cash equivalents at end of period | 24,917 | 90,574 | ||||||||||
| Supplemental disclosures of cash flow information | ||||||||||||
| Interest paid | 21 | 22 | ||||||||||
| Interest received | 117 | 24 | ||||||||||
| Non-cash activities: | ||||||||||||
| Operating right-of-use assets obtained (released) in exchange for operating lease liabilities | 226 | (803 | ) |
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, 2021, the subsidiaries of the Company are as follows:
| Date of | Percentage of ownership by the | Principal | ||
| Name of company | Place of incorporation | incorporation | Company | activities |
| BeyondSpring Pharmaceuticals Inc. ("BeyondSpring US ") | 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 ("BeyondSpring HK") | Hong Kong | January 13, 2015 | 100% | Holding company |
| Wanchun Biotechnology Limited ("BVI Biotech") | BVI | April 1, 2015 | 100% | Holding company |
| Wanchun Biotechnology (Shenzhen) Ltd. ("Wanchun Shenzhen") | The People's Republic of China ("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% | Holding company |
| SEED Therapeutics Inc. ("SEED") | BVI | June 25, 2019 | 58.97% | Pre-clinical development activities |
| SEED Technology Limited ("SEED Technology") | BVI | December 9, 2019 | 57.97% | Holding company |
| SEED Therapeutics US, Inc. ("SEED US") | Delaware, U.S. | November 25, 2020 | 58.97% | Pre-clinical development activities |
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)
The accompanying unaudited interim condensed consolidated balance sheet as of March 31, 2021, the unaudited interim condensed consolidated statements of comprehensive loss for the three months
ended March 31, 2020 and 2021, the cash flows for the three months ended March 31, 2020 and 2021, 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,
2020. 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, 2021 are not necessarily indicative of results to be expected for any other interim period or
for the full year of 2021. The consolidated balance sheet as of December 31, 2020 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, 2020.
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 $17,443 for the three months ended March 31, 2021 and has an accumulated deficit of $294,806 as of March 31, 2021. Net
cash used in operations was approximately $18,940 for the three months ended March 31, 2021. As of March 31, 2021, the Company had $81,742 net current assets and $90,574 of cash and cash equivalents on hand.
Based on the Company's cash and cash equivalents on hand on March 31, 2021, management does not believe that there is substantial doubt about the
Company's ability to continue as a going concern within one year after the date these financial statements are issued. These financial statements have been prepared on a going concern basis.
NOTES TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of U.S. Dollars ("$") and Renminbi ("RMB"), except for number of shares and per share data)
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the period. Areas where management uses subjective judgment include, but are not limited
to, share-based compensation, clinical trial accruals, valuation allowance for deferred tax assets, estimating uncertain tax positions, measurement of right-of-use assets and lease liabilities, fair value of financial instruments and estimating of
useful life for property and equipment. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the
carrying values of assets and liabilities. Actual results could differ from these estimates.
Fair value measurements
The Company applies ASC 820, Fair Value Measurements and Disclosures ("ASC 820"), in measuring fair value. ASC 820 defines fair value, establishes a
framework for measuring fair value and requires disclosures to be provided on fair value measurement.