BeyondSpring Provides Business Update and Reports Year End 2023 Financial Results
April 29 2024 - 5:30PM
BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring”
or the “Company”), a clinical-stage global biopharmaceutical
company focused on developing innovative cancer therapies, today
provided a business update and reported results for the year ended
December 31, 2023.
“2023 has been a year of building fundamental values for
BeyondSpring. It is such an honor for our majority-owned subsidiary
SEED Therapeutics to be featured among leading companies using
target protein degradation molecular glue for innovative drug
discovery. With our proprietary RITE3 platform, SEED continues to
attract increased partnering interest. I am also pleased to report
that SEED has made significant headway in advancing internal
programs, with one oncology asset (expected to enter clinics in 1H
2025), Tau degrader(s), and external collaboration projects with
Eli Lilly,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of
BeyondSpring.
Dr. Huang continued, “BeyondSpring remains strategically
positioned to advance our programs to near-term important
inflection points. The Company continues to make progress in
advancing our lead drug candidate, Plinabulin, a potent dendritic
cell maturation agent, on the regulatory front in the U.S. and in
China, and through a number of Plinabulin’s IIT studies at MD
Anderson, Memorial Sloan Kettering and other institutions in the
U.S. and China.”
“PD-1/PD-L1 inhibitors had changed the treatment landscape in
cancer, with annual sales well over $40 billion. However, around
60% of patients fail these therapies, and currently very limited
therapies have been able to halt or reverse cancer progression in
PD-1 failure patients across numerous patient settings, which
presents a severe unmet medical need. Using a cost-efficient IIT
study model and by working with leading institutions globally, we
aim to demonstrate the important role that plinabulin can play in
combination with radiation or chemotherapy and immune checkpoint
inhibitors (ICI) for these cancer patients who failed ICI. These
IIT studies are advancing well, and we aim to report results later
in 2024.” Dr. Huang concluded.
Recent Business and Clinical Updates
Plinabulin Clinical Updates
- Conference Presentation at ASCO and SITC for
Plinabulin
- In May 2023, the Company and Memorial Sloan Kettering Cancer
Center (MSKCC) presented a poster on new data from a Phase 1 IIT
study, highlighting Plinabulin’s ability to reduce infectious
neutropenic fever for multiple myeloma patients undergoing
Autologous Hematopoietic Stem Cell Transplantation (AHCT), at the
American Society of Clinical Oncology (ASCO) Annual Meeting.
- In November 2023, the Company and The University of Texas MD
Anderson Cancer Center presented new clinical data from a Phase 1
IIT study, highlighting preclinical and clinical POC
immunomodulating activity of Plinabulin inducing dendritic cell
maturation and re-sensitization in immunotherapy refractory tumors
when combined with radiation and PD-1 inhibitors, at the Society
for Immunotherapy of Cancer’s (SITC) Annual Meeting.
- First Patient Enrollment in Two Phase 2 IIT Studies for
Plinabulin Combined with Keytruda
- In March 2023, the first patient was enrolled in a Phase 2 IIT
study for Plinabulin in combination with Merck’s anti-PD-1 therapy,
Keytruda, and docetaxel for patients with second and third line
(2/3L) advanced and metastatic NSCLC who had failed immunotherapy
alone or in combination with platinum-doublet chemotherapy.
- In March 2024, the first patient was enrolled in a Phase 2 IIT
study with Keytruda, Plinabulin, plus Etoposide/Platinum (EP) for
first-line (1L) Extensive-Stage Small-Cell Lung Cancer
(ES-SCLC).
Business Updates
- SEED Therapeutics
- Milestone Achievements
- In February 2023 and March 2024, SEED achieved two milestones
for pre-clinical developments with Eli Lilly.
- Appointments of Directors
- In June 2023, SEED appointed Mr. Jackson Tai, a former director
at Eli Lilly, HSBC and Mastercard, to the board of directors. Mr.
Tai brings almost five decades of experience in finance, strategy,
and risk governance.
- In October 2023, SEED appointed Mr. Ko-Yung Tung, a former
board member at Eisai, former general counsel at World Bank, and a
lecturer at Harvard Law School and Yale Law School to the board of
directors. Mr. Tung brings five decades of experience in global
health, law, governance, and international business.
- Announcement of IND Candidate for Oncology at “Targeted
Protein Degradation (TPD) Think Tank” Symposium
- In October 2023, SEED held its first “TPD Think Tank”
Symposium, in which SEED co-founders invited TPD thought leaders to
present. Domestic and foreign attendees engaged in a collaborative
and interactive session to advance the TPD field research.
- During the “TPD Think Tank” Symposium, it was announced that
SEED had successfully discovered a new chemical entity (NCE)
molecular glue. SEED has declared an IND Candidate status,
targeting first human dose in 1H 2025.
- Advancement in Tau Degrader Molecular Glue
Discovery
- SEED is targeting the protein Tau for degradation with a
molecular glue, for the treatment of neurodegeneration. Within 6
months of starting the project, SEED has discovered multiple
compound scaffolds with predicted brain permeability that glue tau
to a novel E3 ligase selected by SEED’s RITE3 platform. Compounds
are now being optimized for relevant activities and properties,
including reduced Tau levels in cultured human neurons. SEED is
targeting IND Candidate status for the Tau Project in 2H 2025.
Expected Milestones in 2024
- Plinabulin: Generate preliminary data in 2H 2024 for the Phase
2 IIT Study in combination with Keytruda and docetaxel in 2/3L
NSCLC patients who failed PD-1/PD-L1 inhibitors.
- SEED: Significantly advance lead oncology asset in IND-enabling
studies to enable its IND filing.
Full Year 2023 Financial Results
Research and development (“R&D”) expenses were
$14.6 million for the year ended December 31, 2023, compared
to $25.6 million for the year ended December 31, 2022. The
$11.0 million decrease was primarily due to lower clinical
development expense, lower professional service expense to support
NDA submission and lower personnel costs.
General and administrative (“G&A”) expenses were
$10.2 million for the year ended December 31, 2023, compared
to $13.0 million for the year ended December 31, 2022. The $2.8
million decrease was primarily due to lower personnel costs, and
lower professional service expenses.
Net loss attributable to the Company was $21.0 million for
the year ended December 31, 2023, compared to $33.3 million
for the year ended December 31, 2022.
As of December 31, 2023, the Company had cash, cash equivalents,
restricted cash, and short-term investments of $17.9 million.
About BeyondSpringBeyondSpring
is a global clinical-stage biopharmaceutical company focused on
developing innovative therapies to improve clinical outcomes for
patients with high unmet medical needs. The Company is advancing
its first-in-class lead asset, Plinabulin, as a direct anti-cancer
agent in various cancer indications and to prevent
chemotherapy-induced neutropenia. BeyondSpring’s pipeline also
includes three preclinical immuno-oncology assets. Additionally,
BeyondSpring’s subsidiary, SEED Therapeutics, leverages a
proprietary TPD drug discovery platform and has an initial R&D
collaboration with Eli Lilly. Learn more by visiting
https://beyondspringpharma.com.
Cautionary Note Regarding Forward-Looking
StatementsThis 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, our ability to continue as a going concern,
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 the Company’s product candidates, increased
competition in the market, the Company’s ability to meet Nasdaq's
continued listing requirements, 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:IR@beyondspringpharma.com
Media
Contact:PR@beyondspringpharma.com
Financial Tables to Follow
BEYONDSPRING INC.CONSOLIDATED BALANCE
SHEETS(Amounts in thousands of U.S. Dollars (“$”),
except for number of shares and per share data) |
|
As of December 31, |
|
2022 |
|
|
2023 |
|
|
$ |
|
|
$ |
|
|
|
|
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
34,396 |
|
|
7,809 |
|
Restricted Cash |
- |
|
|
9,941 |
|
Short-term investments |
2,872 |
|
|
193 |
|
Advances to suppliers |
492 |
|
|
306 |
|
Prepaid expenses and other
current assets |
763 |
|
|
170 |
|
Total current assets |
38,523 |
|
|
18,419 |
|
|
|
|
|
Noncurrent
assets: |
|
|
|
Property and equipment,
net |
1,868 |
|
|
1,628 |
|
Operating right-of-use
assets |
5,484 |
|
|
4,397 |
|
Other noncurrent assets |
347 |
|
|
364 |
|
Total noncurrent assets |
7,699 |
|
|
6,389 |
|
|
|
|
|
Total
assets |
46,222 |
|
|
24,808 |
|
|
|
|
|
Liabilities and
equity |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
1,081 |
|
|
1,407 |
|
Accrued expenses |
2,470 |
|
|
2,581 |
|
Current portion of operating
lease liabilities |
966 |
|
|
631 |
|
Deferred revenue |
1,351 |
|
|
1,751 |
|
Other current liabilities |
1,484 |
|
|
1,588 |
|
Total current liabilities |
7,352 |
|
|
7,958 |
|
|
|
|
|
Noncurrent
liabilities: |
|
|
|
Operating lease
liabilities |
3,995 |
|
|
3,364 |
|
Deferred revenue |
34,221 |
|
|
33,242 |
|
Other noncurrent
liabilities |
3,661 |
|
|
3,705 |
|
Total noncurrent
liabilities |
41,877 |
|
|
40,311 |
|
|
|
|
|
Total
liabilities |
49,229 |
|
|
48,269 |
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Mezzanine
equity |
|
|
|
Contingently redeemable
noncontrolling interests |
11,074 |
|
|
11,874 |
|
|
|
|
|
Shareholders’
deficit |
|
|
|
Ordinary shares ($0.0001 par
value; 500,000,000 shares authorized; 38,999,597 and 39,029,163
shares issued and outstanding as of December 31, 2022 and 2023,
respectively) |
4 |
|
|
4 |
|
Additional paid-in
capital |
368,857 |
|
|
368,599 |
|
Accumulated deficit |
(375,276 |
) |
|
(396,302 |
) |
Accumulated other
comprehensive income |
436 |
|
|
894 |
|
|
|
|
|
Total BeyondSpring Inc.’s
shareholders’ deficit |
(5,979 |
) |
|
(26,805 |
) |
Noncontrolling interests |
(8,102 |
) |
|
(8,530 |
) |
Total shareholders’
deficit |
(14,081 |
) |
|
(35,335 |
) |
|
|
|
|
Total liabilities,
mezzanine equity and shareholders’ deficit |
46,222 |
|
|
24,808 |
|
BEYONDSPRING INC.CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS(Amounts in thousands of U.S.
Dollars (“$”), except for number of shares and per share
data) |
|
Year ended December 31, |
|
2021 |
|
|
2022 |
|
|
2023 |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
Revenue |
1,351 |
|
|
1,351 |
|
|
1,751 |
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
Research and development |
(36,888 |
) |
|
(25,582 |
) |
|
(14,635 |
) |
General and
administrative |
(30,703 |
) |
|
(13,008 |
) |
|
(10,230 |
) |
|
|
|
|
|
|
Loss from
operations |
(66,240 |
) |
|
(37,239 |
) |
|
(23,114 |
) |
Foreign exchange gain (loss),
net |
231 |
|
|
(429 |
) |
|
(123 |
) |
Interest income |
98 |
|
|
195 |
|
|
421 |
|
Interest expenses |
(87 |
) |
|
(17 |
) |
|
- |
|
Other income, net |
1,360 |
|
|
1,373 |
|
|
974 |
|
|
|
|
|
|
|
Loss before income
tax |
(64,638 |
) |
|
(36,117 |
) |
|
(21,842 |
) |
Income tax expenses |
(3,570 |
) |
|
(163 |
) |
|
(106 |
) |
|
|
|
|
|
|
Net loss |
(68,208 |
) |
|
(36,280 |
) |
|
(21,948 |
) |
Less: Net loss attributable to
noncontrolling interests |
(4,029 |
) |
|
(3,001 |
) |
|
(922 |
) |
Net loss attributable
to BeyondSpring Inc. |
(64,179 |
) |
|
(33,279 |
) |
|
(21,026 |
) |
|
|
|
|
|
|
Net loss per
share |
|
|
|
|
|
Basic and diluted |
(1.64 |
) |
|
(0.85 |
) |
|
(0.54 |
) |
|
|
|
|
|
|
Weighted-average shares
outstanding |
|
|
|
|
|
Basic and diluted |
39,023,643 |
|
|
39,093,246 |
|
|
38,996,463 |
|
|
|
|
|
|
|
Other comprehensive
loss, net of tax of nil: |
|
|
|
|
|
Foreign currency translation
adjustment (loss) gain |
(296 |
) |
|
1,483 |
|
|
725 |
|
Unrealized holding gain
(loss) |
5 |
|
|
(5 |
) |
|
- |
|
Comprehensive
loss |
(68,499 |
) |
|
(34,802 |
) |
|
(21,223 |
) |
Less: Comprehensive loss
attributable to noncontrolling interests |
(4,094 |
) |
|
(2,482 |
) |
|
(655 |
) |
Comprehensive loss
attributable to BeyondSpring Inc. |
(64,405 |
) |
|
(32,320 |
) |
|
(20,568 |
) |
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