• |
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 for November 30, 2021.
|
• |
June 2021: Presented three poster presentations at the 2021 Annual Meeting of the American 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 the Federation 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.
|
• |
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.
|
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
|
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
|
)
|
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
|
)
|
1. |
Nature of the business and basis of preparation
|
Date of
|
Percentage of
ownership by the
|
Principal
| ||
Name of company
|
Place of incorporation
|
incorporation
|
Company
|
activities
|
BeyondSpring
Pharmaceuticals Inc.
|
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.
|
PRC
|
May 6, 2015
|
57.97%
|
Clinical trial activities
|
BeyondSpring Pharmaceuticals
Australia PTY Ltd.
|
Australia
|
March 3, 2016
|
100%
|
Clinical trial activities
|
Beijing Wanchun Pharmaceutical
Technology Ltd.
|
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
|
1. |
Nature of the business and basis of preparation (continued)
|
2. |
Summary of significant accounting policies
|
2. |
Summary of significant accounting policies (continued)
|
• |
Level 1-Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
|
• |
Level 2-Other inputs that are directly or indirectly observable in the marketplace.
|
• |
Level 3-Unobservable inputs which are supported by little or no market activity.
|
2. |
Summary of significant accounting policies (continued)
|
Fair value measurement
| ||||||||||||||||
Recurring
fair value measurement
|
Total Fair
Value |
Quoted prices in
active markets
for identical assets
(Level 1)
|
Significant
other observable inputs
(Level 2)
|
Significant unobservable inputs
(Level 3)
| ||||||||||||
$ |
$ |
$ |
$ | |||||||||||||
As of December 31, 2020 (audited):
| ||||||||||||||||
Forward liability (Note 3)
|
278
|
-
|
-
|
278
| ||||||||||||
As of March 31, 2021 (unaudited):
| ||||||||||||||||
Forward liability (Note 3)
|
278
|
-
|
-
|
278
|
Valuation technique
|
Unobservable inputs
|
Range
| |||
Forward liability
|
Discounted cash flow
|
Fair value of underlying security
|
2.65
|
Forward liability
| ||||
$ | ||||
Balance as of December 31, 2020 (audited) |
278
| |||
Gains or losses from changes in fair value
|
-
| |||
Balance as of March 31, 2021 (unaudited) |
278
|
3. |
Collaboration revenue
|
4.
|
Property and equipment, net
|
December 31, 2020
|
March 31, 2021
| |||||||
$
| $ | |||||||
(Unaudited)
| ||||||||
Office equipment
|
181
|
191
| ||||||
Laboratory equipment
|
121
|
120
| ||||||
Motor vehicles
|
24
|
24
| ||||||
Leasehold improvements
|
116
|
115
| ||||||
442
|
450
| |||||||
Less: accumulated depreciation
|
(258
|
)
|
(275
|
)
| ||||
Property and equipment, net
|
184
|
175
|
5. |
Loans
|
Maturity dates
|
Amounts
| ||||
$ | |||||
(Unaudited)
| |||||
Year ending December 31, 2021
|
-
| ||||
Year ending December 31, 2022
|
2,161
| ||||
Total
|
2,161
|
6. |
Related party transactions
|
7. |
Income taxes
|
8. |
Equity
|
BeyondSpring Inc.'s shareholders
| ||||||||||||||||||||||||||||||||
Accumulated
| ||||||||||||||||||||||||||||||||
Additional
|
other
|
Non
| ||||||||||||||||||||||||||||||
Ordinary share
|
paid-in
|
Accumulated
|
comprehensive
|
controlling
|
Total
| |||||||||||||||||||||||||||
Shares
|
Amount
|
capital
|
deficit
|
(loss) gain
|
Subtotal
|
interests
|
equity
| |||||||||||||||||||||||||
$ |
$ |
$ |
$ |
$ |
$ |
$ | ||||||||||||||||||||||||||
Balances at January 1, 2021 (audited)
|
39,141,913
|
4
|
366,451
|
(277,818
|
)
|
(297
|
)
|
88,340
|
(1,715
|
)
|
86,625
| |||||||||||||||||||||
Share-based compensation
|
(35,437
|
)
|
-
|
1,104
|
-
|
-
|
1,104
|
13
|
1,117
| |||||||||||||||||||||||
Foreign currency translation adjustment gain |
-
|
-
|
-
|
-
|
50
|
50
|
23
|
73
| ||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(16,988
|
)
|
-
|
(16,988
|
)
|
(455
|
)
|
(17,443
|
)
| ||||||||||||||||||||
Balances at March 31, 2021 (unaudited)
|
39,106,476
|
4
|
367,555
|
(294,806
|
)
|
(247
|
)
|
72,506
|
(2,134
|
)
|
70,372
| |||||||||||||||||||||
Balances at January 1, 2020 (audited)
|
27,885,613
|
3
|
246,979
|
(216,845
|
)
|
140
|
30,277
|
854
|
31,131
| |||||||||||||||||||||||
Share-based compensation
|
3,293
|
-
|
3,438
|
-
|
-
|
3,438
|
32
|
3,470
| ||||||||||||||||||||||||
Foreign currency translation adjustment gain (loss)
|
-
|
-
|
-
|
-
|
57
|
57
|
(4
|
)
|
53
| |||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(16,084
|
)
|
-
|
(16,084
|
)
|
(578
|
)
|
(16,662
|
)
| ||||||||||||||||||||
Balances at March 31, 2020 (unaudited)
|
27,888,906
|
3
|
250,417
|
(232,929
|
)
|
197
|
17,688
|
304
|
17,992
|
9. |
Restricted net assets
|
10. |
Employee defined contribution plan
|
11. |
Net loss per share
|
Three months ended March 31,
| ||||||||
2020
|
2021
| |||||||
(Unaudited)
|
(Unaudited)
| |||||||
Numerator:
| ||||||||
Net loss attributable to BeyondSpring Inc.-basic and diluted
|
$
|
(16,084
|
)
|
$
|
(16,988
|
)
| ||
Denominator:
| ||||||||
Weighted average number of ordinary shares outstanding-basic and diluted
|
27,732,449
|
39,004,609
| ||||||
Net loss per share -basic and diluted
|
$
|
(0.58
|
)
|
$
|
(0.44
|
)
|
12. |
Supplemental balance sheet information
|
As of December 31,
|
As of March 31,
| |||||||
2020
|
2021
| |||||||
$
|
$
| |||||||
(Unaudited)
| ||||||||
Compensation related
|
2,222
|
714
| ||||||
Professional services
|
373
|
46
| ||||||
Other taxes related
|
857
|
876
| ||||||
Forward liability
|
278
|
278
| ||||||
Others
|
76
|
10
| ||||||
Total
|
3,806
|
1,924
|
13. |
Share-based compensation
|
Three months ended March 31,
| ||||||||
2020
|
2021
| |||||||
$ | $ | |||||||
(Unaudited)
|
(Unaudited)
| |||||||
Research and development
|
3,183
|
8
| ||||||
General and administrative
|
287
|
1,114
| ||||||
Total
|
3,470
|
1,122
|
14. |
Contingently redeemable noncontrolling interests
|
15. |
Commitments and contingencies
|
Attachments
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Disclaimer
BeyondSpring Inc. published this content on 16 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 June 2021 12:39:05 UTC.