Connect Biopharma Reports Full Year 2022 Financial Results and Provides Business Update
April 11 2023 - 4:05PM
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect
Biopharma or the Company), a global clinical-stage
biopharmaceutical company developing T cell-driven therapies to
treat inflammatory diseases, today announced financial results for
the year ended December 31, 2022 and recent corporate highlights.
“Based on feedback from China’s Center for Drug
Evaluation (CDE), we are on track with our timeline and look
forward to advancing our lead drug candidate CBP-201 for
moderate-to-severe atopic dermatitis (AD),” said Chief Executive
Officer and Co-founder of Connect Biopharma Zheng Wei, Ph.D. “We
plan to submit a New Drug Application (NDA) by the end of the first
quarter of 2024, which could lead to potential regulatory approval
in China as early as 2025. We also remain encouraged by the CBP-201
results from our China pivotal trial and post-hoc analyses from the
global Phase 2b data presented last month at the American
Association of Dermatology (AAD) Annual Meeting. We remain
confident in the efficacy profile of CBP-201, which showed rapid
and sustained improvements and has the potential to be an effective
new treatment for AD. Beyond AD, we continue to focus on treating
other inflammatory-mediated diseases, including ulcerative colitis
and asthma, both of which also have the potential to address large
patient populations with persistent unmet medical needs.”
Recent Corporate Highlights
- Presented two abstracts from
CBP-201 clinical development program in patients with
moderate-to-severe AD at the AAD last month. Specifically, data
from post-hoc analyses of the CBP-201 global Phase
2b trial showed rapid and sustained improvements across
all body regions. Also, the results for the Primary Analysis
Population from the ongoing CBP-201 China pivotal trial showed
rapid and sustained improvement with no efficacy plateau at week
16.
- Completed full enrollment for the
CBP-201 Phase 2 global trial in patients with moderate-to-severe
asthma with Type 2 inflammation.
- Announced positive topline data on
Stage 1 of the ongoing CBP-201 China pivotal trial in AD on the
primary analysis population of 255 patients.
- Reported results from Phase 1
single ascending dose study for CBP-174 in pruritis associated with
AD. CBP-174 was observed to be well-tolerated with no serious
adverse events and no dose-limiting toxicities identified.
Anticipated Upcoming
Milestones
CBP-201 in
AD:
- China pivotal
trial: The Company believes it is on track to complete the
36-week stage 2 maintenance phase of the trial in patients with
severe-to-moderate AD in the second half of 2023. This stage of the
trial includes a once-a-month (Q4W) dosing regimen. Based on
feedback received from the CDE, the Company plans to submit an NDA
by the end of the first quarter of 2024 for potential approval in
2025.
- Global Phase 3
program: The Company is seeking strategic partnerships to
advance this product candidate to the next phase of clinical
development with potential global and regional partners to provide
the necessary infrastructure and deliver a differentiated
therapeutic program with improved efficacy and dosing
convenience.
CBP-201 in Asthma:
- Anticipate reporting top-line
results from the Phase 2 in the second half of 2023.
CBP-307 Phase 2 trial in
moderate-to-severe Ulcerative Colitis (UC):
- Results of the Phase 2 maintenance
portion of the trial are expected to be reported in the second
quarter of 2023 and the Company is seeking strategic partnerships
to progress CBP-307 into future trials in UC and Crohn’s
disease.
2022 Financial Results
- Cash, cash equivalents, and
short-term and long-term investments were RMB 1,127.3 million (USD
161.9 million) as of December 31, 2022, compared with RMB 1,706.9
million (USD 267.7 million) at December 31, 2021. The decrease was
mainly due to ongoing research and development (R&D) associated
with the Company’s clinical drug programs and administrative costs.
Management believes based on current operating plans the Company
has sufficient cash, cash equivalents, and investments to support
planned operations into at least 2025, including funding of all
remaining CBP-201 China pivotal trial studies and other clinical
and regulatory milestones discussed above.
- R&D expenses for the year ended
December 31, 2022 totaled RMB 652.2 million (USD 93.7 million),
compared with RMB 518.0 million (USD 81.2 million) for the year
ended December 31, 2021, primarily due to increased third-party
clinical trial costs related to advancing the clinical development
of the Company’s lead product candidates. This includes clinical
and manufacturing expenses related to advancing CBP-201 for AD in
China, completing the global Phase 2b program for CBP-201 in AD,
ongoing global Phase 2 trial costs for CBP-201 in asthma, ongoing
global Phase 2 trial costs for CBP-307 in UC, as well as higher
personnel costs for additional R&D headcount.
- Administrative expenses totaled RMB
139.4 million (USD 20.0 million) for the year ended December 31,
2022, compared with RMB 122.4 million (USD 19.2 million) for the
year ended December 31, 2021. The increase in administrative
expenses was primarily due to increases in payroll and related
expenses for additional headcount, including share-based
compensation expense, and other infrastructure costs needed in
support of the growth of our business operations.
- Net loss totaled RMB 797.1 million
(USD 114.4 million) for the year ended December 31, 2022, compared
with a net loss of RMB 1,306.8 million (USD 205.0 million) for the
year ended December 31, 2021. The net loss in the prior year period
was higher due to the recognition of RMB 674.3 million of fair
value adjustments on preferred shares, which was converted to
ordinary shares during the Company’s 2021 IPO.
About Connect Biopharma Holdings
LimitedConnect Biopharma is a global, clinical-stage
biopharmaceutical company applying its expertise in T cell biology
and deep knowledge of the drug discovery industry to develop
innovative therapies to treat chronic inflammatory diseases with
the goal of improving the lives of millions of those affected
around the world. The Company is building a rich pipeline of
proprietary small molecules and antibodies, using functional T cell
assays, to screen and discover potent product candidates against
validated immune targets. The Company’s lead product candidate,
CBP-201, is an antibody designed to target interleukin-4 receptor
alpha (IL-4Rα) in development for the treatment of atopic
dermatitis (AD) and asthma. The Company’s second product candidate,
CBP-307, is a modulator of S1P1 T cell receptor and is in
development for the treatment of ulcerative colitis (UC). The
Company’s third product candidate, CBP-174, is a peripherally
acting antagonist of histamine receptor 3, in development for the
treatment of pruritus associated with AD. For more information,
please visit: https://www.connectbiopharm.com/
Forward-Looking Statements
Connect Biopharma cautions that statements
included in this press release that are not a description of
historical facts are forward-looking statements. Words such as
“may,” “could,” “will,” “would,” “should,” “expect,” “plan,”
“anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,”
“contemplate,” “potential,” “continue” or “project” or the negative
of these terms or other comparable terminology are intended to
identify forward-looking statements.
These statements include the Company’s plans to
advance the development of its product candidates, the timing of
achieving any development or regulatory milestones or reporting
results or whether such milestones or results will be achieved or
generated, the potential of such product
candidates including to achieve any benefit, improvement,
differentiation or profile or any product approval or be
effective, the Company’s ability to identify and enter into
strategic partnerships as well as the sufficiency of the
Company’s cash, cash equivalents, and investments to continue to
support operations. The inclusion of forward-looking statements
should not be regarded as a representation by Connect Biopharma
that any of its plans will be achieved. Actual results may differ
materially from those set forth in this release due to the risks
and uncertainties inherent in the Company’s business and other
risks described in the Company’s filings with the Securities and
Exchange Commission (SEC), including the Company’s Annual Report on
Form 20-F filed with the SEC on April 11, 2023, and its other
reports, which are available from the SEC’s website (www.sec.gov)
and on Connect Biopharma’s website (www.connectbiopharm.com) under
the heading “Investors.” Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof, and Connect Biopharma undertakes no obligation
to revise or update this news release to reflect events or
circumstances after the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
|
Connect
Biopharma Holdings Ltd.Condensed Consolidated
Statements of Loss (Unaudited) |
|
|
|
|
|
Year Ended December 31, |
|
|
2021 |
|
2022 |
|
2022 |
|
|
RMB’000 |
|
RMB’000 |
|
USD’000(1) |
Research and development expenses |
|
(518,021 |
) |
|
(652,211 |
) |
|
(93,646 |
) |
Administrative expenses |
|
(122,445 |
) |
|
(139,444 |
) |
|
(20,022 |
) |
Net
impairment losses |
|
— |
|
|
(32,805 |
) |
|
(4,710 |
) |
Other
income |
|
18,996 |
|
|
6,438 |
|
|
924 |
|
Other
(losses)/gains—net |
|
(9,966 |
) |
|
12,433 |
|
|
1,785 |
|
Operating loss |
|
(631,436 |
) |
|
(805,589 |
) |
|
(115,669 |
) |
Finance
income |
|
622 |
|
|
10,715 |
|
|
1,538 |
|
Finance
cost |
|
(44 |
) |
|
(144 |
) |
|
(21 |
) |
Finance
(cost)/income—net |
|
578 |
|
|
10,571 |
|
|
1,517 |
|
Fair value
loss of financial instruments with preferred rights |
|
(674,269 |
) |
|
— |
|
|
— |
|
Net
loss before income tax |
|
(1,305,127 |
) |
|
(795,018 |
) |
|
(114,152 |
) |
Income tax
expense |
|
(1,697 |
) |
|
(2,037 |
) |
|
(292 |
) |
Net
loss |
|
(1,306,824 |
) |
|
(797,055 |
) |
|
(114,444 |
) |
Net
loss attributable to: |
|
|
|
|
|
|
Owners of the Company |
|
(1,306,824 |
) |
|
(797,055 |
) |
|
(114,444 |
) |
|
|
|
|
|
|
|
|
|
RMB |
|
RMB |
|
USD |
Net loss per
share |
|
|
|
|
|
|
Basic and
diluted |
|
(25.0 |
) |
|
(14.5 |
) |
|
(2.1 |
) |
|
|
|
|
|
|
|
|
Connect
Biopharma Holdings Ltd.Selected Consolidated
Balance Sheet Data (Unaudited) |
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2021 |
|
2022 |
|
2022 |
|
|
RMB’000 |
|
RMB’000 |
|
USD’000(1) |
Cash, cash equivalents, short-term and long-term investments |
|
1,706,880 |
|
|
1,127,268 |
|
|
161,857 |
|
Total
assets |
|
1,855,659 |
|
|
1,211,930 |
|
|
174,013 |
|
Total
liabilities |
|
119,828 |
|
|
115,060 |
|
|
16,521 |
|
Accumulated
losses |
|
(2,378,165 |
) |
|
(3,175,220 |
) |
|
(455,908 |
) |
Total
shareholders' equity |
|
1,735,831 |
|
|
1,096,870 |
|
|
157,492 |
|
|
|
|
|
|
|
|
(1) Translations of the
selected consolidated balance sheet data and the condensed
consolidated statement of loss from RMB into USD as of and for the
year ended December 31, 2022, are solely for the convenience of the
readers and calculated at the rate of USD1.00=RMB 6.9646,
representing the exchange rate as of December 31, 2022, set forth
in the China Foreign Exchange Trade System. No representation is
made that the RMB amounts could have been, or could be, converted,
realized or settled into USD at that rate, or at any other rate, on
December 31, 2022, or any other date.
INVESTOR CONTACT:Ina
McGuinness805.427.1372imcguinness@connectpharm.com
MEDIA CONTACT:Deanne
Eagle917.837.5866Deanne@mcguinnessIR.com
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