Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
pharmaceutical company focused on discovering and developing
medicines that are transformational for patients, today reported
recent business progress and financial results for the fourth
quarter and full-year ended December 31, 2022.
“Centessa made substantial progress in 2022, highlighted by the
achievement of important milestones toward our goal of bringing
transformational medicines to patients," said Saurabh Saha MD PhD,
Chief Executive Officer of Centessa. “We advanced key clinical and
development objectives, prioritized our pipeline, and continued to
manage our resources with timely data and science-driven decisions,
consistent with our asset-centric model. As a result, we entered
2023 with solid momentum on our pipeline programs that we believe
have the greatest potential to transform the lives of patients with
unmet medical needs."
Dr. Saha continued, “Our most advanced product candidate is
SerpinPC, a subcutaneously administered novel inhibitor of
activated protein C (APC), which is in a registrational program for
the treatment of hemophilia B. In December 2022, we presented data
from a Phase 2a study showing SerpinPC to have a favorable safety
and tolerability profile, as well as evidence of sustained efficacy
in patients with hemophilia as measured by a reduction in the
all-bleeds annualized bleeding rates (ABR). We believe these data
support the potential for SerpinPC to be a first-in-class
subcutaneously administered therapy with a differentiated safety
profile for individuals with hemophilia, subject to regulatory
review and approval. We are excited to be enrolling subjects in
PRESent-5, an observational feeder study, and are preparing to
begin dosing in the PRESent-2 and PRESent-3 interventional studies
this year."
"We are also very pleased to announce the dosing of the first
subject in the Phase 1/2a clinical trial of LB101, a conditionally
tetravalent PD-L1xCD47 bispecific monoclonal antibody from our
LockBody technology platform for the treatment of solid tumors.
LB101 is the first LockBody candidate we have brought to the
clinic, and we look to this study to provide valuable insights
regarding the safety and tolerability profile of LB101, as well as
the performance of our LockBody platform in a clinical setting.
Following LB101 is our second LockBody program targeting PD-L1xCD3,
for which we expect to name a product candidate this year," said
Dr. Saha.
“Lastly, our team is excited to be advancing ORX750, an orally
administered, selective orexin receptor-2 (OX2R) agonist, as our
product candidate for the treatment of narcolepsy with potential
expansion into other sleep disorders. We believe ORX750 has the
potential to be a best-in-class therapy for the treatment of
narcolepsy and look forward to sharing the candidate profile
at a scientific meeting later this year," said Dr. Saha.
Dr. Saha concluded, “We are thrilled with the momentum at
Centessa and believe we are well positioned with a cash runway into
2026 to support the potential for multiple clinical readouts across
our pipeline.”
Recent Highlights
- In January 2023, the Company announced clearance of its
Investigational New Drug (IND) application from the U.S. Food and
Drug Administration (FDA) to initiate a Phase 1/2a first-in-human
clinical trial of LB101 for the treatment of solid tumors. The
first subject was dosed in March 2023.
- In December 2022 and February 2023, the Company presented data
from the open-label extension (OLE) of the ongoing Phase 2a study
of SerpinPC for the treatment of hemophilia during oral
presentations at the American Society of Hematology (ASH) Annual
Meeting and the 16th Annual Congress of the European Association
for Haemophilia and Allied Disorders (EAHAD), respectively. With
total exposure of over 40 patient-years across multiple dosing
regimens, the Phase 2a data showed a continued favorable safety and
tolerability profile for SerpinPC, as well as evidence of sustained
efficacy, as measured by a reduction in the all-bleeds ABRs. There
were no thromboembolic events and no treatment-related sustained
elevations of D-dimer observed across the Phase 2a study, to date.
D-dimer is a sensitive measure of excessive thrombin
generation.
- In December 2022, the Company began enrolling subjects into
PRESent-5, an observational study in the SerpinPC registrational
program for the treatment of hemophilia B.
Anticipated Upcoming Program Milestones
- Hemophilia (SerpinPC)- The registrational
program for hemophilia B is ongoing. PRESent-5, an observational
study, is enrolling subjects and the Company expects to begin
dosing in PRESent-2 and PRESent-3 later this year. In addition, the
Company expects to share data from Part 5 of the OLE of the Phase
2a study of SerpinPC, subject to completion, at a scientific
meeting this year.
- Solid Tumors
- PD-L1xCD47 LockBody (LB101)- The Phase 1/2a
first-in-human clinical study is ongoing.
- PD-L1xCD3 LockBody (Undisclosed)- The Company
expects to name a product candidate and share preclinical data this
year.
- Narcolepsy and Other Sleep Disorders (ORX750)-
ORX750 was named as a product candidate and is currently in
preclinical development and undergoing IND-enabling activities. The
Company expects to share preclinical data at a scientific meeting
later this year.
The Company expects to provide further updates on preclinical
programs, including MGX292, as they advance towards clinical
studies.
Fourth Quarter and Full-Year 2022 Financial
Results
- Cash and
Cash Equivalents: $393.6 million as of December 31,
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: $27.8 million for the fourth quarter ended
December 31, 2022, compared to $41.5 million for the fourth
quarter ended December 31, 2021, and $155.1 million for the
full-year 2022 compared to $95.7 million for the period from
January 30, 2021 through December 31, 2021.
- General &
Administrative Expenses: $13.8 million for the fourth
quarter ended December 31, 2022, compared to
$13.0 million the fourth quarter ended December 31, 2021,
and $55.2 million for the full-year 2022 compared to
$42.9 million for the period from January 30, 2021 through
December 31, 2021.
- Net Loss Attributable to
Ordinary Shareholders: $43.2 million for the fourth
quarter ended December 31, 2022, compared to
$60.8 million for the fourth quarter ended December 31,
2021, and $216.2 million for the full-year 2022 compared to
$381.1 million for the period from January 30, 2021 through
December 31, 2021.
About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical
company that aims to discover and develop medicines that are
transformational for patients. Our programs span discovery-stage to
late-stage development and cover a range of high-value indications.
We operate with the conviction that each one of our programs has
the potential to change the current treatment paradigm and
establish a new standard of care. For more information, visit
http://www.centessa.com/, which does not form part of this
release.
About SerpinPC SerpinPC is a subcutaneously
administered novel inhibitor of APC being developed as a potential
treatment for hemophilia, regardless of severity or inhibitor
status, and which may also be developed to prevent bleeding
associated with other bleeding disorders. Centessa is advancing the
registrational program for SerpinPC in hemophilia B, which includes
a set of clinical studies with multiple components. PRESent-5,
initiated in late 2022, is an observational feeder study to collect
prospective observational data for minimum defined periods before
switching to dosing subjects in the interventional studies. The
interventional studies include PRESent-2 (moderately severe to
severe hemophilia B without inhibitors, and severe hemophilia A
with and without inhibitors) and PRESent-3 (hemophilia B with
inhibitors). Additional information on the trials can be accessed
at www.clinicaltrials.gov (NCT05605678, NCT05789524,
NCT05789537). SerpinPC is an investigational agent that has
not been approved by the FDA or any other regulatory authority.
About the LockBody Technology Platform and
LB101Centessa’s proprietary LockBody technology platform
aims to redefine immuno-oncology treatment for patients with
cancer. LockBody drug candidates are designed to selectively drive
potent effector function activity, such as CD47 or CD3, to the
tumor micro-environment (TME) while avoiding systemic toxicity. The
first LockBody candidate is LB101, a conditionally tetravalent
PD-L1xCD47 bispecific monoclonal antibody which has two anti-CD47
domains blocked by two anti-PD-L1 domains, with proprietary human
IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains.
The cell-killing mechanism of action, CD47, is designed to be
blocked by the PD-L1 tumor targeting domain until the IgG-derived
hinges are naturally degraded in the TME, thus unlocking and
activating the CD47 effector function activity in the tumor. LB101
is in a Phase 1/2a clinical trial. LB101 is an investigational
agent that has not been approved by the FDA or any other regulatory
authority.
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 discover and develop transformational
medicines for patients; its expectations on executing the Company's
pipeline; its expectations on its cash runway into 2026, which are
based on certain assumptions; the timing of commencement of new
studies or clinical trials or clinical and preclinical data related
to SerpinPC, LB101, the LockBody technology platform, ORX750,
MGX292 and other LockBody candidates; its ability to identify,
screen and recruit a sufficient number of or any subjects in its
anticipated new studies or clinical trials including PRESent-5, the
observational feeder study, PRESent-2 and PRESent-3 and studies or
trials of LB101 and any other LockBody candidates, its expectations
on executing its research and clinical development plans and the
timing thereof; the Company’s ability to differentiate SerpinPC,
LB101, ORX750, MGX292 and other LockBody candidates from other
treatment options; the development and therapeutic potential of
SerpinPC, LB101, the LockBody technology platform, ORX750, MGX292,
and other LockBody candidates; and regulatory matters, including
the timing and likelihood of success of obtaining authorizations to
initiate or continue clinical trials. Any forward-looking
statements in this press release are based on our current
expectations, estimates, assumptions 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
identify, screen and recruit a sufficient number of or any subjects
in our anticipated new studies or clinical trials including
PRESent-2, PRESent-3, PRESent-5, and studies or trials of LB101 or
within anticipated timelines; our ability to execute IND-enabling
activities in a timely manner or at all, including with respect to
ORX750; 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; economic risks to
the United States and United Kingdom banking systems; geo-political
risks such as the Russia-Ukraine war and risks related to the
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 MonthsEndedDecember
31,2022 |
|
Three MonthsEndedDecember
31,2021 |
|
Twelve MonthsEndedDecember
31,2022 |
|
Period fromJanuary 30,2021 throughDecember
31,2021 |
|
|
Period fromJanuary
1,2021 throughJanuary
29,2021 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
27,835 |
|
|
|
41,534 |
|
|
|
155,083 |
|
|
$ |
95,660 |
|
|
|
$ |
662 |
|
General and administrative |
|
13,768 |
|
|
|
12,988 |
|
|
|
55,200 |
|
|
|
42,888 |
|
|
|
|
121 |
|
Change in fair value of contingent value rights |
|
— |
|
|
|
3,770 |
|
|
|
1,980 |
|
|
|
15,082 |
|
|
|
|
— |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
220,454 |
|
|
|
|
— |
|
Loss from operations |
|
(41,603 |
) |
|
|
(58,292 |
) |
|
|
(212,263 |
) |
|
|
(374,084 |
) |
|
|
|
(783 |
) |
Interest (expense) income, net |
|
(2,164 |
) |
|
|
(1,272 |
) |
|
|
(7,033 |
) |
|
|
(1,172 |
) |
|
|
|
(9 |
) |
Amortization of debt discount |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
(37 |
) |
Debt issuance costs |
|
— |
|
|
|
(1,331 |
) |
|
|
|
|
(1,331 |
) |
|
|
|
Other income (expense), net |
|
(70 |
) |
|
|
235 |
|
|
|
2,342 |
|
|
|
(4,370 |
) |
|
|
|
— |
|
Loss before income taxes |
|
(43,837 |
) |
|
|
(60,660 |
) |
|
|
(216,954 |
) |
|
|
(380,957 |
) |
|
|
|
(829 |
) |
Income taxes (benefit) expense |
|
(664 |
) |
|
|
114 |
|
|
|
(747 |
) |
|
|
114 |
|
|
|
|
— |
|
Net loss |
|
(43,173 |
) |
|
|
(60,774 |
) |
|
|
(216,207 |
) |
|
|
(381,071 |
) |
|
|
|
(829 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
198 |
|
|
|
(2,050 |
) |
|
|
(2,185 |
) |
|
|
778 |
|
|
|
|
107 |
|
Total comprehensive loss |
$ |
(42,975 |
) |
|
$ |
(62,824 |
) |
|
$ |
(218,392 |
) |
|
$ |
(380,293 |
) |
|
|
$ |
(722 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary share -
basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.31 |
) |
|
$ |
(5.07 |
) |
|
|
|
Weighted average ordinary
shares outstanding - basic and diluted |
|
94,603,860 |
|
|
|
89,935,902 |
|
|
|
93,400,513 |
|
|
|
75,166,456 |
|
|
|
|
Centessa Pharmaceuticals
plcCondensed Consolidated Balance
Sheets(unaudited)(amounts in thousands)
|
December 31,2022 |
|
December 31,2021 |
Total assets: |
|
|
|
Cash and cash equivalents |
$ |
393,644 |
|
|
$ |
595,082 |
|
Other assets |
|
50,663 |
|
|
|
34,553 |
|
Total assets |
$ |
444,307 |
|
|
$ |
629,635 |
|
|
|
|
|
Total liabilities |
|
|
|
Other liabilities |
$ |
38,338 |
|
|
$ |
24,681 |
|
Long term debt |
|
69,800 |
|
|
|
75,700 |
|
Contingent value rights |
|
— |
|
|
|
37,700 |
|
Total liabilities |
$ |
108,138 |
|
|
$ |
138,081 |
|
|
|
|
|
Total shareholders’ equity |
$ |
336,169 |
|
|
$ |
491,554 |
|
Total liabilities and shareholders' equity |
$ |
444,307 |
|
|
$ |
629,635 |
|
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