- Company to host call today,
- Conference call can be accessed by dialing 877-451-6152 (
“We are pleased with the ongoing discussions with China NMPA on the NDA review of the Plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia (CIN). The G-CSF market in
Recent Clinical and Corporate Highlights
Business Development Update
- In
August 2021 , entered into an exclusive commercialization and co-development partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui’) for Plinabulin inGreater China - Hengrui, a leading oncology R&D and commercial company in
China , has exclusive commercialization and co-development rights to all indications for Plinabulin; - In
September 2021 , the Company received a200M RMB (est.US$31M ) upfront payment and will be eligible to receive up to1.1B RMB (est.US$171M ) upon achieving certain regulatory and sales milestones; - The Company will supply Plinabulin, retaining manufacturing rights. The Company will receive all proceeds from sales of Plinabulin and pay Hengrui a pre-determined percentage of such sales.
- Hengrui, a leading oncology R&D and commercial company in
Clinical Development Update
- In
September 2021 , presented new data on Plinabulin from the CIN prevention program with three posters at theEuropean Society for Medical Oncology (ESMO) 2021Congress - Severe Neutropenia (Grade 4) as a Population-Based Predictor for Adverse Clinical Outcome of CIN;
- Prediction of Febrile Neutropenia, Hospitalization Rates, and Infection Rates in CIN Patients Treated with the Plinabulin and Pegfilgrastim Combination using a Meta-Analysis -based Tool;
- Impact of Adding Plinabulin to Pegfigrastim for the Prevention of CIN, on Patient Quality of Life.
- In
September 2021 , presented positive top-line final Phase 3 DUBLIN-3 data in 2nd/3rd line NSCLC patients with EGFR Wild Type at the ESMO 2021Congress - The combination (Plinabulin + docetaxel) showed superior efficacy benefit in overall survival (OS), progression-free survival (PFS), objective response rate (ORR) with statistical significance and a significant reduction of grade 4 neutropenia vs. docetaxel alone.
- IIT Studies of Plinabulin combined with PD-1/PD-L1 inhibitors in multiple cancers
- In
October 2021 , initiated Phase 2 study of Plinabulin in combination with nivolumab and ipilimumab in extensive stage small cell lung cancer (SCLC) who failed platinum and checkpoint inhibitors (Big Ten Cancer Research Consortium ). In the Phase 1 portion of the study, this combination showed encouraging efficacy of 43% ORR and long duration of treatment in the same patient population; - In
June 2021 , initiated Phase 1 study of Plinabulin in combination with PD-1/PD-L1 inhibitor and radiotherapy for patients in seven advanced solid tumors (MD Anderson Cancer Center ).
- In
Fourth Quarter 2021 Financial Results `
- Research and development (R&D) expenses were
$5.8 million for the quarter endedDecember 31, 2021 , compared to$8.4 million for the quarter endedDecember 31, 2020 . The$2.6 million decrease was primarily due to lower clinical development expenses and personnel costs, including non-cash share-based compensation expenses, which were partially offset by higher pre-clinical and professional expenses. - General and administrative (G&A) expenses were
$5 .0 million for the quarter endedDecember 31, 2021 , which included a non-cash credit of$2.0 million related to the reversal of share-based compensation expense. For the same period in the prior year, G&A expenses were$10.4 million , which included$2.1 million in non-recurring personnel costs. The decrease was primarily driven by lower share-based compensation expense. - Net loss attributable to the Company was
$9 .5 million for the quarter endedDecember 31, 2021 , compared to$17.6 million for the quarter endedDecember 31, 2020 .
Full Year 2021 Financial Results
- R&D expenses were
$36 .9 million for the year endedDecember 31, 2021 , compared to$41 .8 million for the year endedDecember 31, 2020 . The$4.9 million decrease was primarily due to lower clinical development expense and non-cash share-based compensation expense, partially offset by higher personnel costs, pre-clinical and professional services expenses, as well as the$2.9 million NDA application fee paid to the FDA, which is expected to be refunded during the second quarter of 2022. - G&A expenses were
$30 .7 million for the year endedDecember 31, 2021 , compared to$22.6 million for the year endedDecember 31, 2020 . The majority of the$8.1 million increase was due to higher pre-commercialization expenses for Plinabulin. We do not expect to continue to incur pre-commercialization expenses during the next year. There were also increases in personnel costs, administrative expenses and other costs, which were partially offset by lower non-cash share-based compensation expense. - Net loss attributable to the Company was
$64.2 million for the year endedDecember 31, 2021 , compared to$61.0 million for the year endedDecember 31, 2020 . - As of
December 31, 2021 , the Company had cash, cash equivalents, and short-term investments of$72.4 million . The Company believes it has sufficient cash to support its ongoing operations and clinical programs over the next year.
Fourth Quarter and Full Year 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 the Company’s 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:
+1 617-430-7577
arr@lifesciadvisors.com
Media Contact:
+1 646-627-8387
darren@lifescicomms.com
Financial Tables to Follow
++++++++
CONSOLIDATED BALANCE SHEETS | ||
(Amounts in thousands of | ||
As of | ||
2020 | 2021 | |
$ | $ | |
Assets | ||
Current assets: | ||
Cash and cash equivalents | 109,537 | 41,625 |
Short-term investments | - | 30,743 |
Advances to suppliers | 3,505 | 1,735 |
Prepaid expenses and other current assets | 358 | 1,020 |
Total current assets | 113,400 | 75,123 |
Noncurrent assets: | ||
Property and equipment, net | 184 | 1,422 |
Operating lease right-of-use assets | 2,174 | 1,984 |
Other noncurrent assets | 1,280 | 3,119 |
Total noncurrent assets | 3,638 | 6,525 |
Total assets | 117,038 | 81,648 |
Liabilities and equity | ||
Current liabilities: | ||
Accounts payable | 2,216 | 1,656 |
Accrued expenses | 5,607 | 3,858 |
Current portion of operating lease liabilities | 787 | 538 |
Deferred revenue | 1,350 | 1,369 |
Long-term loans, current portion | - | 1,569 |
Other current liabilities | 3,806 | 6,165 |
Total current liabilities | 13,766 | 15,155 |
Noncurrent liabilities: | ||
Long-term loans | 2,167 | - |
Operating lease liabilities | 1,359 | 1,468 |
Deferred revenue | 7,925 | 37,939 |
Other noncurrent liabilities | - | 709 |
Total noncurrent liabilities | 11,451 | 40,116 |
Total liabilities | 25,217 | 55,271 |
Commitments and contingencies | ||
Mezzanine equity | ||
Contingently redeemable noncontrolling interests | 5,196 | 5,454 |
Equity | ||
Ordinary shares ( | 4 | 4 |
Additional paid-in capital | 366,451 | 369,200 |
Accumulated deficit | -277,818 | -341,997 |
Accumulated other comprehensive loss | -297 | -523 |
Total BeyondSpring Inc.’s shareholders’ equity | 88,340 | 26,684 |
Noncontrolling interests | -1,715 | -5,761 |
Total equity | 86,625 | 20,923 |
Total liabilities, mezzanine equity and equity | 117,038 | 81,648 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||
(Amounts in thousands of | |||
Year ended | |||
2019 | 2020 | 2021 | |
$ | $ | $ | |
Revenue | - | 180 | 1,351 |
Operating expenses | |||
Research and development | -31,342 | -41,793 | -36,888 |
General and administrative | -8,965 | -22,598 | -30,703 |
Loss from operations | -40,307 | -64,211 | -66,240 |
Foreign exchange (loss) gain, net | -4 | 355 | 231 |
Interest expenses | -206 | -85 | -87 |
Interest income | 184 | 116 | 98 |
Other income, net | - | 4 | 1,360 |
Loss before income tax | -40,333 | -63,821 | -64,638 |
Income tax expenses | - | - | -3,570 |
Net loss | -40,333 | -63,821 | -68,208 |
Less: Net loss attributable to noncontrolling interests | -2,248 | -2,848 | -4,029 |
-38,085 | -60,973 | -64,179 | |
Net loss attributable to | |||
Net loss per share | |||
Basic and diluted | -1.55 | -2.03 | -1.64 |
Weighted average shares outstanding | |||
Basic and diluted | 24,645,714 | 29,984,284 | 39,023,643 |
Other comprehensive loss, net of tax of nil: | |||
Foreign currency translation adjustment gain (loss) | 96 | -530 | -296 |
Unrealized holding gain | - | - | 5 |
Comprehensive loss | -40,237 | -64,351 | -68,499 |
Less: Comprehensive loss attributable to noncontrolling interests | -2,250 | -2,941 | -4,094 |
Comprehensive loss attributable to | -37,987 | -61,410 | -64,405 |
Source:
2022 GlobeNewswire, Inc., source