Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Second Quarter of 2022; Provides Program Update for ZF874
August 10 2022 - 5:30AM
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
pharmaceutical company with a Research & Development
(“R&D”) innovation engine that aims to discover, develop, and
ultimately deliver impactful medicines to patients, today reported
financial results and business highlights for the second quarter
ended June 30, 2022, and provided a program update for ZF874 for
Alpha-1 Antitrypsin Deficiency (AATD).
“We continue to rapidly advance our robust rare diseases and
immuno-oncology pipeline and set the stage for a number of
important company milestones which we believe will help us address
the needs of several patient populations,” said Saurabh Saha, MD,
PhD, Chief Executive Officer of Centessa. “We remain on track to
initiate registrational studies for SerpinPC for the treatment of
Hemophilia B in the second half of this year and look forward to
initiating clinical trials with LB101 (PD-L1xCD47) for solid
tumors, after our planned IND filing late this year. Beyond these,
we are continuing to advance our earlier stage programs and expect
multiple clinical proof of concept readouts across our pipeline
over the next two years. Importantly, with a world-class R&D
team and cash runway that extends into 2026, we are exceptionally
well positioned to deliver on these goals."
ZF874 Program Update The Company today
announced its decision to discontinue development of ZF874
following a recent report of an adverse event (AE) involving
elevated liver enzymes (AST/ALT) in a PiMZ subject dosed with 5
mg/kg BID of ZF874 in the Phase 1 study. ZF874, a pharmacological
chaperone designed to rescue the folding of the Z variant of
alpha-1-antitrypsin (A1AT), was in a Phase 1 study for the
treatment of AATD. As previously reported in November 2021,
elevated liver enzymes were observed in a subject dosed with 15
mg/kg BID of ZF874 in the first cohort of patients within Part B of
the Phase 1 study. Based on the results observed to date, the
Company concluded that ZF874 was unlikely to achieve the desired
target product profile.
Dr. Saha concluded, “While this is disappointing news for the
A1AT patient community, we continue to believe that the
pharmacological chaperone approach has the potential to address
both the lung and liver manifestations of AATD. We are analyzing
data from the Phase 1 study to help inform potential future
development plans for our back-up compounds.”
Recent Highlights
- In July, the Company appointed Dr. Mathias Hukkelhoven, former
Senior Vice President, Global Regulatory, Safety & Biometrics
at Bristol Myers Squibb (BMS), to its Board of Directors. The
Company also announced the addition of Dr. Harris L. Rotman as
Senior Vice President of Regulatory Affairs.
- In June, the Company presented the first preclinical data for
LB101 (PD-L1xCD47) showing that single-agent LB101 delivered
systemically led to meaningful tumor regressions and was well
tolerated. The Company expects to initiate clinical trials with
LB101 following its planned Investigational New Drug (IND)
application submission late this year. Additional LockBody
molecules, such as LB201 (PD-L1xCD3), are being progressed toward
candidate selection expected early 2023.
Anticipated Upcoming Program Milestones
- 2H 2022: SerpinPC - Initiate registrational
studies in Hemophilia B.
- Q4 2022: SerpinPC - Two-year follow-up data
from Phase2a open label extension study.
- Q4 2022: LB101 - IND submission late this
year.
The Company continues to progress its earlier stage programs and
where applicable, expects to provide updates as they enter clinical
studies.
Second Quarter 2022 Financial Results
- Cash and Cash Equivalents: $484.2 million as
of June 30, 2022, which the Company expects will fund
operations into 2026, without drawing on the remaining available
tranches under the Oberland credit facility.
- Research & Development Expenses: $53.7
million for the quarter ended June 30, 2022, compared to $18.1
million for the quarter ended June 30, 2021.
- General & Administrative Expenses: $14.8
million for the quarter ended June 30, 2022, compared to $11.8
million the quarter ended June 30, 2021.
- Net Loss Attributable to Ordinary
Shareholders: $64.7 million for the quarter ended
June 30, 2022, compared to $41.5 million for the quarter ended
June 30, 2021.
About Centessa PharmaceuticalsCentessa
Pharmaceuticals plc is a clinical-stage pharmaceutical company with
an R&D innovation engine that aims to discover, develop and
ultimately deliver impactful medicines to patients. Our programs
span discovery-stage to late-stage development and cover a range of
high-value indications in rare diseases and immuno-oncology. We are
led by a management team with extensive R&D experience,
providing direct guidance to our program teams to rapidly advance
our candidates from research through all stages of development. For
more information, visit www.centessa.com, which does not form part
of this press release.
Forward Looking Statements This press release
contains forward-looking statements. These statements may be
identified by words such as “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “intend,” “plan,” “objective,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“continue,” “ongoing,” “aim,” “seek,” and variations of these words
or similar expressions that are intended to identify
forward-looking statements. Any such statements in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements, including statements related to the
Company’s ability to deliver impactful medicines to patients; the
ability of our management team and board to drive execution of
the Company’s portfolio of programs; our asset-centric business
model and the intended advantages and benefits thereof; research
and clinical development plans and the timing thereof; the scope,
progress, results and costs of developing our product candidates or
any other future product candidates; the development and
therapeutic potential of our product candidates, including SerpinPC
and LB101; strategy; regulatory matters, including the timing and
likelihood of success of obtaining authorizations to initiate or
continue clinical trials or market any products; market size and
opportunity for our product candidates; and our anticipated cash
runway. Any forward-looking statements in this press release are
based on our current expectations, estimates and projections only
as of the date of this release and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks related to the safety and
tolerability profile of our product candidates; our ability to
protect and maintain our intellectual property position; business
(including commercial viability), regulatory, economic and
competitive risks, uncertainties, contingencies and assumptions
about the Company; risks inherent in developing product candidates
and technologies; future results from our ongoing and planned
clinical trials; our ability to obtain adequate financing,
including through our financing facility with Oberland, to fund our
planned clinical trials and other expenses; trends in the industry;
the legal and regulatory framework for the industry, including the
receipt and maintenance of clearances to conduct or continue
clinical testing; future expenditures risks related to our
asset-centric corporate model; the risk that any one or more of our
product candidates will not be successfully developed and/or
commercialized; the risk that the results of preclinical studies or
clinical studies will not be predictive of future results in
connection with future studies; geo-political risks such as the
Russia-Ukraine war and risks related to the ongoing COVID-19
pandemic including the effects of the Delta, Omicron and any other
variants. These and other risks concerning our programs and
operations are described in additional detail in our Annual Report
on Form 10-K, Quarterly Reports on Form 10-Q, and our other
reports, which are on file with the U.S. Securities and Exchange
Commission (SEC). We explicitly disclaim any obligation to update
any forward-looking statements except to the extent required by
law.
Contact:
Kristen K. Sheppard, Esq.SVP of Investor
Relationsinvestors@centessa.com
Centessa Pharmaceuticals plc (Successor)
and Centessa Predecessor Group
(Predecessor)Consolidated and Combined Statements
of Operations and Comprehensive Loss(unaudited)(amounts in
thousands except share and per share data)
|
|
Successor |
|
Predecessor |
|
|
Three months ended June 30, 2022 |
|
Three months ended June 30, 2021 |
|
Six months ended June 30, 2022 |
|
Period fromJanuary 30,
2021through June 30,
2021 |
|
Period fromJanuary 1,
2021throughJanuary
29, 2021 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
53,651 |
|
|
$ |
18,134 |
|
|
$ |
90,504 |
|
|
$ |
28,276 |
|
|
$ |
662 |
|
General and administrative |
|
|
14,763 |
|
|
|
11,841 |
|
|
|
29,148 |
|
|
|
17,436 |
|
|
|
121 |
|
Change in fair value of contingent value rights |
|
|
— |
|
|
|
11,312 |
|
|
|
1,980 |
|
|
|
11,312 |
|
|
|
— |
|
Acquired in-process research and development |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
220,454 |
|
|
|
— |
|
Loss from operations |
|
|
(68,414 |
) |
|
|
(41,287 |
) |
|
|
(121,632 |
) |
|
|
(277,478 |
) |
|
|
(783 |
) |
Interest (expense) income, net |
|
|
(1,628 |
) |
|
|
27 |
|
|
|
(3,024 |
) |
|
|
35 |
|
|
|
(9 |
) |
Amortization of debt discount |
|
|
— |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
(37 |
) |
Other income (expense), net |
|
|
5,359 |
|
|
|
(191 |
) |
|
|
5,555 |
|
|
|
(2,699 |
) |
|
|
— |
|
Loss before income taxes |
|
|
(64,683 |
) |
|
|
(41,451 |
) |
|
|
(119,101 |
) |
|
|
(280,142 |
) |
|
|
(829 |
) |
Income taxes |
|
|
(22 |
) |
|
|
— |
|
|
|
58 |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(64,661 |
) |
|
|
(41,451 |
) |
|
|
(119,159 |
) |
|
|
(280,142 |
) |
|
|
(829 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(1,124 |
) |
|
|
1,094 |
|
|
|
(1,830 |
) |
|
|
3,315 |
|
|
|
107 |
|
Total comprehensive loss |
|
$ |
(65,785 |
) |
|
$ |
(40,357 |
) |
|
$ |
(120,989 |
) |
|
$ |
(276,827 |
) |
|
$ |
(722 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary share - basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.29 |
) |
|
$ |
(4.89 |
) |
|
|
Weighted average ordinary shares outstanding - basic and
diluted |
|
|
94,109,089 |
|
|
|
63,516,656 |
|
|
|
92,317,172 |
|
|
|
57,309,693 |
|
|
|
Centessa Pharmaceuticals plc
(Successor)Condensed Consolidated Balance
Sheets(unaudited)(amounts in thousands)
|
June 30, 2022 |
|
December 31, 2021 |
Total assets: |
|
|
|
Cash and cash equivalents |
$ |
484,161 |
|
$ |
595,082 |
Other assets |
|
36,890 |
|
|
34,553 |
Total assets |
$ |
521,051 |
|
$ |
629,635 |
|
|
|
|
Total liabilities: |
|
|
|
Other liabilities |
$ |
33,612 |
|
$ |
24,681 |
Long term debt |
|
67,400 |
|
|
75,700 |
Contingent value rights |
|
— |
|
|
37,700 |
Total liabilities |
$ |
101,012 |
|
$ |
138,081 |
|
|
|
|
Total shareholders’ equity |
$ |
420,039 |
|
$ |
491,554 |
Total liabilities and shareholders' equity |
$ |
521,051 |
|
$ |
629,635 |
Centessa Pharmaceuticals (NASDAQ:CNTA)
Historical Stock Chart
From Jul 2024 to Aug 2024
Centessa Pharmaceuticals (NASDAQ:CNTA)
Historical Stock Chart
From Aug 2023 to Aug 2024