- NDAs filed in the
- Company subsidiary, SEED Therapeutics, signed an
- Completed
Company to host a conference call today,
“2020 was a truly transformational year in setting us up for future value creation. Specifically, we had key accomplishments in building clinical evidence for our lead asset, filing our lead program in two major global markets – US and
“The Company is well positioned for the future, with our “pipeline in a drug” plinabulin, and anticipated near-term potential anti-cancer efficacy data from a Phase 3 trial measuring overall survival in NSCLC, and from early trials in several immuno-oncology regimens in checkpoint inhibitor naïve or failed patients,” continued
Recent Business and Corporate Highlights
Lead Asset Plinabulin, a “Pipeline in a Drug”
Recent Clinical Update
March 2021 : filed NDAs with theU.S. Food and Drug Administration (FDA) and China NMPA for the use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). Plinabulin and G-CSF combination regimen had received breakthrough designation from bothUS FDA and China NMPA.December 2020 : completed global enrollment of 559 patients inDUBLIN -3 Phase 3 non-small cell lung cancer (NSCLC) study, comparing plinabulin + docetaxel vs. docetaxel alone in 2nd/3rd line NSCLC (EGFR wild type), with overall survival as the primary endpoint.November 2020 : announced positive and superior topline results from its Phase 3 PROTECTIVE-2 registrational trial of plinabulin in combination with pegfilgrastim vs. pegfilgrastim alone for the prevention of CIN, with additional positive Phase 3 data presented at the 2020 San Antonio Breast Cancer Symposium.
Upcoming Clinical Milestones
June 2021 (ASCO presentation): Phase 1 IO combo data of plinabulin + PD-1 + CTLA-4 inhibitors for recurrent Small CellLung Cancer (SCLC) in checkpoint inhibitor naïve and failed patients.- Mid-2021 (
DUBLIN -3): topline overall survival (OS) data expected in pivotal Phase 3 NSCLC study. - 2H 2022 (MD Anderson investigator led study): Phase 1 Data expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in PD-1/PD-L1-failed patients in seven cancers, including Bladder Cancer, Melanoma,
Merkel Cell Cancer , MSI-H Cancers (of any histology), Non-small CellLung Cancer , Renal Cell Cancer, and Small CellLung Cancer .
Seed Therapeutics Proprietary “Molecular Glue” TPD platform
November 2020 : announced SEED subsidiary’s$800 million R&D collaboration with Eli Lilly based on SEED’s proprietary “molecular glue” TPD platform.
Recent Corporate Highlights
December 2020 : Strengthened the Board of Directors with the appointment ofJeffrey Vacirca , M.D., FACP.Dr. Vacirca is a board-certified hematologist and oncologist and serves as CEO and Chairman of theBoard of New York Cancer & Blood Specialists and holds several other significant leadership positions in the oncology community.November 2020 : Completed a financing of approximately$86.3 million in gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. Total cash and cash equivalents as ofDecember 31, 2020 was$109.5 million .
Fourth Quarter 2020 Financial Results
Research and development (“R&D”) expenses were
General and administrative (“G&A”) expenses were
Net loss attributable to the Company was
Full Year 2020 Financial Results
Research and development (“R&D”) expenses were
General and administrative (“G&A”) expenses were
Net loss attributable to the Company was
As of
Fourth Quarter and Full Year 2020 Results Conference Call and Webcast Details
The management of
About
Headquartered in
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
Investor Contact:
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Media Contact:
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darren@lifescicomms.com
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of
As of | ||
2019 | 2020 | |
$ | $ | |
Assets | ||
Current assets: | ||
Cash and cash equivalents | 35,933 | 109,537 |
Advances to suppliers | 4,519 | 3,505 |
Prepaid expenses and other current assets | 410 | 358 |
Total current assets | 40,862 | 113,400 |
Noncurrent assets: | ||
Property and equipment, net | 209 | 184 |
Operating lease right-of-use assets | 2,538 | 2,174 |
Other noncurrent assets | 946 | 1,280 |
Total noncurrent assets | 3,693 | 3,638 |
Total assets | 44,555 | 117,038 |
Liabilities and equity | ||
Current liabilities: | ||
Accounts payable | 2,537 | 2,216 |
Accrued expenses | 5,861 | 5,607 |
Due to related parties | 29 | - |
Current portion of operating lease liabilities | 537 | 787 |
Deferred revenue | - | 1,350 |
Other current liabilities | 1,089 | 3,806 |
Total current liabilities | 10,053 | 13,766 |
Noncurrent liabilities: | ||
Long-term loans | 1,436 | 2,167 |
Operating lease liabilities | 1,935 | 1,359 |
Deferred revenue | - | 7,925 |
Total noncurrent liabilities | 3,371 | 11,451 |
Total liabilities | 13,424 | 25,217 |
Commitments and contingencies |
CONSOLIDATED BALANCE SHEETS (Continued)
(Amounts in thousands of
As of | |||||
2019 | 2020 | ||||
$ | $ | ||||
Mezzanine Equity | |||||
Contingently redeemable noncontrolling interests | - | 5,196 | |||
Equity | |||||
Ordinary shares ( | 3 | 4 | |||
Additional paid-in capital | 246,979 | 366,451 | |||
Accumulated deficit | (216,845 | ) | (277,818 | ) | |
Accumulated other comprehensive income (loss) | 140 | (297 | ) | ||
Total BeyondSpring Inc.’s shareholders’ equity | 30,277 | 88,340 | |||
Noncontrolling interests | 854 | (1,715 | ) | ||
Total equity | 31,131 | 86,625 | |||
Total liabilities, mezzanine equity and equity | 44,555 | 117,038 | |||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands of
Year ended | ||||||||
2018 | 2019 | 2020 | ||||||
$ | $ | $ | ||||||
Revenue | - | - | 180 | |||||
Operating expenses | ||||||||
Research and development | (51,618 | ) | (31,342 | ) | (41,793 | ) | ||
General and administrative | (5,927 | ) | (8,965 | ) | (22,598 | ) | ||
Loss from operations | (57,545 | ) | (40,307 | ) | (64,211 | ) | ||
Foreign exchange (loss) gain, net | (455 | ) | (4 | ) | 355 | |||
Interest expense | - | (206 | ) | (85 | ) | |||
Interest income | 211 | 184 | 116 | |||||
Other income | 315 | - | 4 | |||||
Loss before income tax | (57,474 | ) | (40,333 | ) | (63,821 | ) | ||
Income tax benefit | - | - | - | |||||
Net loss | (57,474 | ) | (40,333 | ) | (63,821 | ) | ||
Less: Net loss attributable to noncontrolling interests | (2,605 | ) | (2,248 | ) | (2,848 | ) | ||
Net loss attributable to | (54,869 | ) | (38,085 | ) | (60,973 | ) | ||
Net loss per share | ||||||||
Basic and diluted | (2.42 | ) | (1.55 | ) | (2.03 | ) | ||
Weighted average shares outstanding | ||||||||
Basic and diluted | 22,665,265 | 24,645,714 | 29,984,284 | |||||
Other comprehensive loss, net of tax of nil: | ||||||||
Foreign currency translation adjustment gain (loss) | 251 | 96 | (530 | ) | ||||
Comprehensive loss | (57,223 | ) | (40,237 | ) | (64,351 | ) | ||
Less: Comprehensive loss attributable to noncontrolling interests | (2,578 | ) | (2,250 | ) | (2,941 | ) | ||
Comprehensive loss attributable to | (54,645 | ) | (37,987 | ) | (61,410 | ) |
Source:
2021 GlobeNewswire, Inc., source