Connect Biopharma Provides Business Update and Reports First Half 2021 Financial Results
August 31 2021 - 4:05PM
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect
Biopharma” or the “Company”), a global clinical-stage
biopharmaceutical company dedicated to improving the lives of
patients with chronic inflammatory diseases through the development
of therapies derived from T cell-driven research, today announced
financial results for the six months ended June 30, 2021 and
recent corporate highlights.
“The first half of 2021 marked the achievement of a number of
key milestones for Connect, including the transition to a public
company with our oversubscribed Nasdaq Initial Public Offering in
March 2021, strong execution and progress on our development
programs with our three lead assets now in the clinic targeting
multiple chronic inflammatory diseases, and advancing our
operational capabilities as we continue to attract key talent in
both China and the U.S.,” said Zheng Wei, PhD, Co-founder and CEO
of Connect Biopharma. “For the remainder of 2021, despite the
uncertainties related to the COVID-19 pandemic, we remain confident
in executing against our corporate strategy and we look forward to
important clinical trial data readouts toward the end of this year
that we believe will validate our approach in developing potential
first-in-class or best-in-class therapies for T cell-driven
inflammatory diseases.”
First Half 2021 and Recent Operating
Highlights
- Completed successful listing on Nasdaq: In
March 2021, Connect Biopharma completed an IPO of American
Depositary Shares on the Nasdaq Global Select Market and commenced
trading under the ticker symbol “CNTB”. The Company raised net
proceeds of approximately USD 204.5 million.
- Completed enrollment of Phase 2 trial of CBP-201 in
moderate-to-severe atopic dermatitis (AD): In April 2021,
Connect Biopharma completed full enrollment of the Phase 2 clinical
trial evaluating CBP-201 in adult patients with moderate-to-severe
AD. The global, randomized, double-blind, placebo-controlled,
dose-ranging clinical trial is intended to assess the efficacy,
safety, and pharmacokinetics (PK) profile of CBP-201 in 220
subjects and is being conducted at 60 sites across the U.S., China,
Australia, and New Zealand. CBP-201 or placebo was administered to
eligible adult subjects with moderate-to-severe AD for 16 weeks
with eight weeks of follow up.
- Dosed first patient in Phase 2 trial of CBP-201 in
moderate-to-severe persistent asthma: In May 2021, dosed
the first patient in a global Phase 2 clinical trial evaluating
CBP-201 in adults with moderate-to-severe persistent asthma. This
multicenter, randomized, double-blind, parallel group,
placebo-controlled trial was designed to assess the efficacy and
safety of two doses of CBP-201 administered subcutaneously (SC) to
eligible patients with moderate to severe persistent asthma with
Type 2 inflammation. The trial is expected to enroll approximately
300 patients across 80 clinical sites in the United States, China,
the European Union, the United Kingdom, Ukraine and South Korea and
is divided into a treatment period of 24 weeks and a follow-up
period of eight weeks.
- Dosed first subject in Phase 1 trial of
CBP-174: In May 2021, Connect Biopharma dosed the first
subject in a Phase 1 clinical trial evaluating CBP-174 in the
treatment of chronic inflammatory pruritus. This randomized,
double-blind, placebo-controlled, single ascending dose trial in
healthy subjects, aims to evaluate the safety, tolerability and PK
of CBP-174 in different dose levels given orally, compared to
placebo. Following the single dose, each subject will be followed
for up to seven days.
- Expanded senior leadership team: Announced
that Mr. Yau Wing Yiu (Felix) joined Connect Biopharma as Vice
President, Finance and Mr. Jiang Bian as General Counsel and
Chief Compliance Officer.
- Appointed Jean Liu, J.D., as Independent Director to
the Board: Ms. Liu is an Executive Vice President,
Legal Affairs, General Counsel and Secretary of Seagen Inc., a
targeted cancer therapeutic company.
Anticipated Upcoming Milestones
- On track to report top-line results from the global Phase 2b
trial for CBP-201 evaluating moderate-to-severe AD in the fourth
quarter of 2021.
- On track to dose first patient in the global Phase 2 trial of
CBP-201 in patients with chronic rhinosinusitis with nasal polyps
(CRSwNP) in the second half of 2021.
- Plan to initiate a China standalone phase 2 trial for CBP-201
in AD patients in the second half of 2021.
- On track to report top-line results from the phase 1 trial of
CBP-174 evaluating the safety and pharmacokinetics in healthy
volunteers in the second half of 2021.
- Anticipate reporting the global CBP-307 phase 2b top-line data
evaluating ulcerative colitis (UC) in the first quarter of
2022.
First Half 2021 Financial Results
- Cash and cash equivalents were RMB 2,025.0 million (USD
313.5 million) as of June 30, 2021, compared to RMB
1,010.1 million as of December 31, 2020. The increase in
cash and cash equivalents was mainly due to proceeds received from
the IPO in March 2021.
- Research and development expenses increased to RMB
217.8 million (USD 33.7 million) for the six months ended
June 30, 2021, from RMB 59.0 million in the same period
in 2020. This increase was driven primarily by higher clinical
trials related expenses, personnel expenses, and lab-related
expenses.
- Administrative expenses increased to RMB 48.0 million (USD
7.4 million) for the six months ended June 30, 2021, from RMB
7.1 million in same period in 2020. The increase was primarily
due to higher professional fees, stock-based compensation expenses,
director and officer insurance expenses, additional personnel costs
and market research expenses.
- Net loss was approximately RMB 942.5 million (USD 145.9
million) for the six months ended June 30, 2021, compared to
RMB 75.2 million in the same period in 2020.
Conference Call and Webcast
Connect Biopharma will host a conference call and webcast
to review its first half 2021 results on Wednesday,
September 1, 2021, beginning at 8:30 am Eastern Time.
The conference call can be accessed using the following
information:
Webcast:
https://edge.media-server.com/mmc/p/d8b5cvaf U.S.:
844-646-2698 Outside of
U.S.: 918-922-6903
Conference ID: 5567966
A replay of the call will be available for two weeks by
dialing 855-859-2056 for U.S. callers
or 404-537-3406 for international callers and using
Conference ID: 5567966. The webcast will also be
available in the “Investors” section of
the Company’s website following the completion of the
call.
About Connect Biopharma Holdings Limited
Connect Biopharma Holdings Limited is a global clinical-stage
biopharmaceutical company dedicated to improving the lives of
patients living with chronic inflammatory diseases through the
development of therapies derived from our T cell-driven
research.
Our lead product candidate, CBP-201, is an antibody designed to
target interleukin-4 receptor alpha (IL-4Rα) and is currently being
evaluated in clinical trials for the treatment of atopic dermatitis
(AD) and asthma and in development for CRSwNP. Our second lead
product candidate is CBP-307, a modulator of a T cell receptor
known as sphingosine 1-phosphate receptor 1 (S1P1) that is in
development for the treatment of UC and Crohn’s disease (CD).
Furthermore, we are developing CBP-174, a peripherally restricted
antagonist of histamine receptor 3, for the treatment of pruritus
associated with skin inflammation.
With headquarters in China, additional operations in the United
States and Australia, and clinical development activities in those
geographies as well as Europe, Connect Biopharma is building a rich
global pipeline of internally designed, wholly owned small
molecules and antibodies targeting several aspects of T cell
biology. For additional information about Connect Biopharma, please
visit our website at 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
statements regarding the timing of initiation and dosing of
clinical trials and the timing of clinical data readouts from such
trials and whether such data will validate the Company’s approach
in developing potential therapies. 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 from those set forth in this release due to the risks
and uncertainties inherent in the Connect Biopharma business and
other risks described in the Company’s filings with the Securities
and Exchange Commission (“SEC”). 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. Further information
regarding these and other risks is included in Connect Biopharma’s
filings with the SEC which are available from the SEC’s website
(www.sec.gov) and on Connect Biopharma’s website
(www.connectbiopharm.com) under the heading “Investors.” 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
Limited
Unaudited Interim Condensed Consolidated
Statements of Loss
|
For Six Months Ended June 30, |
|
2020 |
|
|
2021 |
|
|
2021 |
|
|
RMB’000 |
|
|
RMB’000 |
|
|
USD’000 (1) |
|
Research and development expenses |
(59,047 |
) |
|
(217,806 |
) |
|
(33,716 |
) |
Administrative expenses |
(7,086 |
) |
|
(47,965 |
) |
|
(7,424 |
) |
Other income |
2,715 |
|
|
5,041 |
|
|
780 |
|
Other gains/(losses) - net |
878 |
|
|
(7,640 |
) |
|
(1,183 |
) |
|
|
|
|
|
|
|
|
|
Operating loss |
(62,540 |
) |
|
(268,370 |
) |
|
(41,543 |
) |
|
|
|
|
|
|
|
|
|
Finance income |
569 |
|
|
180 |
|
|
28 |
|
Finance cost |
(19 |
) |
|
(22 |
) |
|
(4 |
) |
|
|
|
|
|
|
|
|
|
Finance income - net |
550 |
|
|
158 |
|
|
24 |
|
Fair value loss of financial instruments with preferred rights |
(13,217 |
) |
|
(674,269 |
) |
|
(104,374 |
) |
|
|
|
|
|
|
|
|
|
Loss before income tax |
(75,207 |
) |
|
(942,481 |
) |
|
(145,893 |
) |
Income tax expense |
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
Net loss |
(75,207 |
) |
|
(942,481 |
) |
|
(145,893 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable to: |
|
|
|
|
|
|
|
|
Owners of the Company |
(75,207 |
) |
|
(942,481 |
) |
|
(145,893 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
USD |
|
Net loss attributable to: |
|
|
|
|
|
|
|
|
Basic and diluted |
(4.4 |
) |
|
(20.1 |
) |
|
(3.1 |
) |
|
|
|
|
|
|
|
|
|
Connect Biopharma Holdings
Limited
Unaudited Interim Condensed Consolidated
Balance Sheets
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
2020 |
|
|
2021 |
|
|
2021 |
|
|
RMB’000 |
|
|
RMB’000 |
|
|
USD’000 (1) |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
Property, plant and equipment |
6,939 |
|
|
24,524 |
|
|
3,796 |
|
Right-of-use assets |
929 |
|
|
23,358 |
|
|
3,616 |
|
Intangible assets |
342 |
|
|
284 |
|
|
43 |
|
Other non-current assets |
19,860 |
|
|
27,614 |
|
|
4,275 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
28,070 |
|
|
75,780 |
|
|
11,730 |
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
1,010,076 |
|
|
2,025,046 |
|
|
313,470 |
|
Other receivable and prepayments |
33,655 |
|
|
72,900 |
|
|
11,285 |
|
Financial assets at fair value through profit or loss |
13,068 |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
Total current assets |
1,056,799 |
|
|
2,097,946 |
|
|
324,755 |
|
|
|
|
|
|
|
|
|
|
Total assets |
1,084,869 |
|
|
2,173,726 |
|
|
336,485 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
|
Lease liabilities |
309 |
|
|
482 |
|
|
75 |
|
Financial instruments with preferred rights |
2,071,508 |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
2,071,817 |
|
|
482 |
|
|
75 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Lease liabilities |
604 |
|
|
615 |
|
|
95 |
|
Trade payables |
24,638 |
|
|
65,628 |
|
|
10,159 |
|
Other payables and accruals |
12,755 |
|
|
24,383 |
|
|
3,774 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
37,997 |
|
|
90,626 |
|
|
14,028 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
2,109,814 |
|
|
91,108 |
|
|
14,103 |
|
|
|
|
|
|
|
|
|
|
Net (liabilities)/assets |
(1,024,945 |
) |
|
2,082,618 |
|
|
322,382 |
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ (DEFICIT)/EQUITY |
|
|
|
|
|
|
|
|
Share capital |
24 |
|
|
66 |
|
|
10 |
|
Share premium |
41,466 |
|
|
4,092,298 |
|
|
633,473 |
|
Treasury shares |
(3 |
) |
|
(3 |
) |
|
— |
|
Share-based compensation reserve |
6,602 |
|
|
24,608 |
|
|
3,809 |
|
Other reserves |
(1,693 |
) |
|
(20,529 |
) |
|
(3,178 |
) |
Accumulated losses |
(1,071,341 |
) |
|
(2,013,822 |
) |
|
(311,732 |
) |
|
|
|
|
|
|
|
|
|
Total shareholders’ (deficit)/equity |
(1,024,945 |
) |
|
2,082,618 |
|
|
322,382 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders’
(deficit)/equity |
1,084,869 |
|
|
2,173,726 |
|
|
336,485 |
|
|
|
|
|
|
|
|
|
|
(1) Translations of the unaudited interim
condensed consolidated balance sheet and the unaudited interim
condensed consolidated statement of loss from RMB into USD as of
and for the six months ended June 30, 2021 are solely for the
convenience of the readers and calculated at the rate of USD 1.00 =
RMB 6.4601, representing the exchange rate as of June 30, 2021
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 June 30, 2021.
IR/PR CONTACTS: Lazar FINN Partners David
Carey (IR) T: +1-(212) 867-1768
david.carey@finnpartners.com
Erich Sandoval (Media) +1-(646) 871-8482 or +1-(917) 497-2867
erich.sandoval@finnpartners.com
Corporate Contacts:
info@connectpharm.com
Connect Biopharma (NASDAQ:CNTB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Connect Biopharma (NASDAQ:CNTB)
Historical Stock Chart
From Apr 2023 to Apr 2024