- NDA Filed by
- 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
“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.
Recent Corporate Highlights
Lead Asset Plinabulin, a “Pipeline in a Drug”
Clinical Update
June 2021 :Announced Food and Drug Administration (FDA) filing of New Drug Application with Priority Review for plinabulin and G-CSF combination for the prevention of CIN. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date forNovember 30, 2021 .June 2021 : Presented three poster presentations at the 2021 Annual Meeting of theAmerican Society of Clinical Oncology (ASCO) highlighting the Company’s PROTECTIVE-2 Phase 3 data demonstrating combination plinabulin + pegfilgrastim offers superior benefit in reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone.June 2021 : Announced late-breaking poster presentation at theFederation of Clinical Immunology Societies (FOCIS) Annual Meeting highlighting data from Phase 3 PROTECTIVE-2 CIN Study showing plinabulin in combination with pegfilgrastim improves CIN prevention and reverses key aspects of the immune suppressive profile of monotherapy pegfilgrastim.June 2021 : Presented data at ASCO 2021 of plinabulin in combination with nivolumab and ipilimumab, showing a 46% objective response rate (ORR) in 13 evaluable patients with PD-1/PD-L1 naïve or resistant tumors in 2nd line and beyond in small cell lung cancer (SCLC). Additionally, data demonstrated the plinabulin combination was able to re-sensitize tumors to I/O therapy, that had progressed on prior PD-1/PD-L1 inhibitors, with a 43% ORR.June 2021 : Dosed first patient in a triple combination study with plinabulin, PD-1/PD-L1 inhibitor and radiotherapy at MD Anderson for the reversal of resistance to PD-1/PD-L1 inhibitors in patients with seven advanced solid tumors.
Upcoming Clinical Milestones
- Mid-2021 (
DUBLIN -3): Topline overall survival (OS) data expected in pivotal Phase 3 non-small cell lung cancer (NSCLC) study. - 2022: (
Big Ten Cancer Research Consortium , Investigator Initiated study): Phase 2 Data expected in plinabulin + nivolumab + ipilimumab in checkpoint inhibitor-resistant SCLC. - 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), NSCLC, renal cell cancer, and SCLC.
First Quarter 2021 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
First Quarter 2021 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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AUDITED CONSOLIDATED BALANCE SHEET AS OF | ||||||
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF | ||||||
(Amounts in thousands of | ||||||
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 | 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 | 1,350 | 1,350 | ||||
Long-term loans, current portion | - | 1,526 | ||||
Other current liabilities | 3,806 | 1,924 | ||||
Total current liabilities | 13,766 | 12,630 | ||||
Noncurrent liabilities: | ||||||
Long-term loans | 2,167 | 635 | ||||
Operating lease liabilities | 1,359 | 673 | ||||
Deferred revenue | 7,925 | 7,587 | ||||
Total noncurrent liabilities | 11,451 | 8,895 | ||||
Total liabilities | 25,217 | 21,525 | ||||
Commitments and contingencies | ||||||
Mezzanine Equity | ||||||
Contingently redeemable noncontrolling interests | 5,196 | 5,196 | ||||
Equity | ||||||
Ordinary shares ( | 4 | 4 | ||||
Additional paid-in capital | 366,451 | 367,555 | ||||
Accumulated deficit | (277,818 | ) | (294,806 | ) | ||
Accumulated other comprehensive loss | (297 | ) | (247 | ) | ||
Total BeyondSpring Inc.’s shareholders’ equity | 88,340 | 72,506 | ||||
Noncontrolling interests | (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 | ||||||
(Amounts in thousands of | ||||||
(Unaudited) | ||||||
Three months ended | ||||||
2020 | 2021 | |||||
Revenue | - | 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 | - | - | ||||
Net loss | (16,662 | ) | (17,443 | ) | ||
Less: Net loss attributable to noncontrolling interests | (578 | ) | (455 | ) | ||
Net loss attributable to | (16,084 | ) | (16,988 | ) | ||
Net loss per share | ||||||
Basic and diluted | (0.58 | ) | (0.44 | ) | ||
Weighted average shares outstanding | ||||||
Basic and diluted | 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 | (16,027 | ) | (16,938 | ) | ||
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. |
Source:
2021 GlobeNewswire, Inc., source