– Positive Phase 3 data in 2nd/3rd line NSCLC (Dublin-3): Superior efficacy benefit in plinabulin and docetaxel combination in overall survival, 2-year and 3-year OS rate, PFS, ORR, and significant reduction of grade 4 neutropenia vs. docetaxel alone
– IO combination advancement to Phase 2: plinabulin in combination with nivolumab + ipilimumab in patients in extensive-stage SCLC who progressed after at least one platinum-based chemotherapy regimen and checkpoint inhibitors (IIT study)
– Wanchunbulin China subsidiary formed commercial and co-development collaboration with Hengrui for plinabulin in Greater China; upfront of est. US$30M and milestone payments up to est. US$170M. Hengrui will fund the commercial costs, while Wanchunbulin will supply plinabulin. Wanchunbulin to receive all proceeds from sales of plinabulin products and pay Hengrui a pre-determined percentage of such sales
– NDA for plinabulin-G-CSF combination in CIN Prevention under review in China; received complete response letter from U.S. FDA, with plans for further discussions with FDA on future regulatory pathway
NEW YORK, Dec. 30, 2021 (GLOBE NEWSWIRE) — 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 third quarter ended September 30, 2021, and provided an update on recent corporate events.
“In the third quarter, we continued to move forward in developing plinabulin’s potential as a ‘pipeline in a drug’ for patients in need. We are developing a wealth of clinical data showing plinabulin’s dual benefit as an anti-cancer agent, shown with OS benefit in Dublin-3 study, with additional benefit in preventing CIN, which we believe will support the important role of plinabulin as a versatile cancer treatment option, and potentially, as a ‘cornerstone’ therapy in IO combinations,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.
“We look forward to executing on our plans for the potential commercial launch of plinabulin in CIN, our first indication in China, where we are excited to work with a leading oncology company, Hengrui, in the commercialization and co-development of plinabulin. Our discussions will continue with the U.S. FDA regarding the potential regulatory pathway for CIN in the U.S. market. At the same time, we are very focused on preparing for our NDA filing for plinabulin in NSCLC. Based on discussions with regulatory agencies in the U.S. and in China, we now anticipate submitting our NDA in the 2H 2022. The year ahead will be very busy and significant for BYSI, and we remain dedicated to enabling plinabulin to achieve its full potential and to bringing added value to the treatment of cancer patients,” concluded Dr. Huang.
Recent Clinical and Corporate Highlights
Upcoming Milestones
Third Quarter Financial Results
Year-to-Date Financial Results
About BeyondSpring
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 as a “pipeline in a drug” in various cancer indications as direct anti-cancer agent, and to prevent chemotherapy induced neutropenia (CIN). Plinabulin and G-CSF combination is currently under review in China for the prevention of CIN, where it has received “Breakthrough Designation” and Priority Review. In DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, plinabulin and docetaxel combination has met the primary endpoint of extending overall survival compared to docetaxel alone, in 2nd/3rd line NSCLC (EGFR wild type). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the efficacy of PD-1/PD-L1 antibodies in seven different cancers. In addition to plinabulin, BeyondSpring’s pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics. By leveraging a proprietary targeted protein degradation drug discovery platform, SEED conducts internal research and had formed a R&D partnership with Eli Lilly and Company on a number of targets.
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.
Investor Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
arr@lifesciadvisors.com
Media Contact:
Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
darren@lifescicomms.com
BEYONDSPRING INC. | ||
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2020 AND | ||
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF SEPTEMBER 30, 2021 | ||
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) | ||
December 31, | September 30, | |
2020 | 2021 | |
$ | $ | |
Assets | ||
Current assets: | ||
Cash and cash equivalents | 109,537 | 63,434 |
Short-term investments | – | 28,166 |
Advances to suppliers | 3,505 | 1,762 |
Prepaid expenses and other current assets | 358 | 1,306 |
Total current assets | 113,400 | 94,668 |
Noncurrent assets: | ||
Property and equipment, net | 184 | 169 |
Operating lease right-of-use assets | 2,174 | 2,164 |
Other noncurrent assets | 1,280 | 1,368 |
Total noncurrent assets | 3,638 | 3,701 |
Total assets | 117,038 | 98,369 |
Liabilities, mezzanine equity and equity | ||
Current liabilities: | ||
Accounts payable | 2,216 | 2,128 |
Accrued expenses | 5,607 | 7,187 |
Current portion of operating lease liabilities | 787 | 390 |
Deferred revenue | 1,350 | 1,532 |
Long-term loans, current portion | – | 1,552 |
Other current liabilities | 3,806 | 5,768 |
Total current liabilities | 13,766 | 18,557 |
Noncurrent liabilities: | ||
Long-term loans, noncurrent portion | 2,167 | – |
Operating lease liabilities | 1,359 | 1,623 |
Deferred revenue | 7,925 | 37,769 |
Other noncurrent liabilities | – | 1,259 |
Total noncurrent liabilities | 11,451 | 40,651 |
Total liabilities | 25,217 | 59,208 |
Commitments and contingencies | ||
Mezzanine equity | ||
Contingently redeemable noncontrolling interests | 5,196 | 5,354 |
Equity | ||
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,141,913 and 39,142,253 shares issued and outstanding as of December 31, 2020 and September 30, 2021, respectively) | 4 | 4 |
Additional paid-in capital | 366,451 | 371,209 |
Accumulated deficit | -277,818 | -332,484 |
Accumulated other comprehensive loss | -297 | -398 |
Total BeyondSpring Inc.’s shareholders’ equity | 88,340 | 38,331 |
Noncontrolling interests | -1,715 | -4,524 |
Total equity | 86,625 | 33,807 |
Total liabilities, mezzanine equity and equity | 117,038 | 98,369 |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. |
BEYONDSPRING INC. | |||||
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF | |||||
COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2021 | |||||
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) | |||||
Three months ended September 30, | Nine months ended September 30, | ||||
2020 | 2021 | 2020 | 2021 | ||
$ | $ | $ | $ | ||
Revenue | – | 337 | – | 1,013 | |
Operating expenses | |||||
Research and development | -8,637 | -8,459 | -33,369 | -31,102 | |
General and administrative | -6,710 | -10,227 | -12,227 | -25,659 | |
Loss from operations | -15,347 | -18,349 | -45,596 | -55,748 | |
Foreign exchange gain, net | 174 | 38 | 109 | 82 | |
Interest income | 10 | 27 | 102 | 88 | |
Interest expense | -21 | -20 | -63 | -66 | |
Other income | – | 749 | 3 | 752 | |
Loss before income tax | -15,184 | -17,555 | -45,445 | -54,892 | |
Income tax expenses | – | -2,588 | – | -2,588 | |
Net loss | -15,184 | -20,143 | -45,445 | -57,480 | |
Less: Net loss attributable to noncontrolling interests | -644 | -1,773 | -2,068 | -2,814 | |
Net loss attributable to BeyondSpring Inc. | -14,540 | -18,370 | -43,377 | -54,666 | |
Net loss per share | |||||
Basic and diluted | -0.48 | -0.47 | -1.51 | -1.4 | |
Weighted-average shares outstanding | |||||
Basic and diluted | 30,303,093 | 39,024,892 | 28,658,215 | 39,013,526 | |
Other comprehensive loss, net of tax of nil: | |||||
Foreign currency translation adjustment loss | -277 | -41 | -226 | -116 | |
Comprehensive loss | -15,461 | -20,184 | -45,671 | -57,596 | |
Less: Comprehensive loss attributable to noncontrolling interests | -677 | -1,782 | -2,107 | -2,829 | |
Comprehensive loss attributable to BeyondSpring Inc. | -14,784 | -18,402 | -43,564 | -54,767 | |
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. |
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