Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the First Quarter of 2023
May 12 2023 - 7:00AM
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
pharmaceutical company focused on discovering and developing
medicines that are transformational for patients, today reported
financial results and business highlights for the first quarter
ended March 31, 2023.
“Centessa continued strong clinical momentum in the first
quarter with multiple clinical milestones planned for the year,”
said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “We
are advancing the registration program for SerpinPC for the
treatment of hemophilia B; dosing subjects in the ongoing Phase
1/2a clinical trial for LB101, our first LockBody molecule for the
treatment of solid tumors; and, conducting IND enabling activities
for our newest product candidate, ORX750, for the treatment of
narcolepsy with potential expansion into other sleep
disorders.”
Dr. Saha continued, “We expect to rapidly drive our pipeline
forward and anticipate a lower cash burn rate for the remainder of
the year. We believe we are well positioned with a cash runway into
2026 to support multiple clinical readouts across our
programs.”
Recent Highlights
- In March, the first subject was
dosed in the Phase 1/2a first-in-human clinical trial of LB101, a
conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody
from the Company's LockBody technology platform for the treatment
of solid tumors. LB101 is the Company’s first LockBody candidate to
enter the clinic. The Company announced clearance of its
Investigational New Drug (IND) application by the U.S. Food and
Drug Administration (FDA) to initiate the Phase 1/2a trial in
January.
- In March, the Company announced
ORX750, an orally administered, selective orexin receptor 2 (OX2R)
agonist, as a product candidate for the treatment of narcolepsy
with potential expansion into other sleep disorders.
- In February, the Company presented
additional data from the open-label extension (OLE) of the ongoing
Phase 2a study of SerpinPC for the treatment of hemophilia during
an oral presentation at the 16th Annual Congress of the European
Association for Haemophilia and Allied Disorders (EAHAD). 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 annualized
bleeding rates (ABR). To date, no thromboembolic events and no
treatment-related sustained elevations of D-dimer have been
observed across the Phase 2a study.
Anticipated Upcoming Program Milestones
- Hemophilia (SerpinPC)- The registrational
program for hemophilia B is ongoing. PRESent-5, an observational
feeder study, is enrolling subjects and the Company expects to
begin dosing in the PRESent-2 and PRESent-3 studies later this
year. In addition, the Company plans 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.
- Narcolepsy and Other Sleep Disorders (ORX750)-
ORX750 is in preclinical development and undergoing IND-enabling
activities. The Company plans to share preclinical data at a
scientific meeting later this year.
The Company has multiple earlier-stage programs, including
MGX292 and other LockBody molecules such as PD-L1xCD3, and
discovery-stage programs. Where applicable, the Company plans to
provide updates on preclinical programs as they advance toward
clinical studies.
First Quarter 2023 Financial Results
- Cash, Cash
Equivalents and Short-term Investments: $346.2 million as
of March 31, 2023, which the Company expects will fund
operations into 2026, without drawing on the remaining available
tranches under the Oberland credit facility.
- Research &
Development Expenses: $32.8 million for the first quarter
ended March 31, 2023, compared to $36.9 million for the first
quarter ended March 31, 2022.
- General &
Administrative Expenses: $16.1 million for the first
quarter ended March 31, 2023, compared to $14.4 million the
first quarter ended March 31, 2022.
- Net Loss
Attributable to Ordinary Shareholders: $50.7 million for
the first quarter ended March 31, 2023, compared to $54.5
million for the first quarter ended March 31, 2022.
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 activated protein C
(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. Additional information on the
trial can be accessed at www.clinicaltrials.gov (NCT05821777).
LB101 is an investigational agent that has not been approved by the
FDA or any other regulatory authority.
Forward Looking StatementsThis 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 rapidly driving and
executing the Company's pipeline and strategy; its strong momentum
and expectations on its cash runway into 2026 to support multiple
clinical readouts and its anticipation for a lower cash burn rate
for the remainder of 2023, all of 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 and other LockBody candidates,
ORX750, MGX292 and other Company programs (if any); its ability to
identify, screen, recruit and register 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 and other LockBody candidates,
ORX750, MGX292 and other Company programs (if any) from other
treatment options; the development and therapeutic potential of
SerpinPC, LB101, the LockBody technology platform and other
LockBody candidates, ORX750, MGX292, and other Company programs (if
any); the Company's ability to present profiles or data of any of
the Company's products at scientific meetings and conferences 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 maintain our cash runway and obtain adequate financing,
including through our financing facility with Oberland, to fund our
planned clinical trials and other expenses into 2026; 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; and geo-political risks such as
the Russia-Ukraine war. 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 plcConsolidated
Statements of Operations and Comprehensive
Loss(unaudited)(amounts in thousands except share and per
share data) |
|
Three Months EndedMarch 31,
2023 |
|
Three Months EndedMarch 31,
2022 |
Operating expenses: |
|
|
|
Research and development |
$ |
32,826 |
|
|
$ |
36,853 |
|
General and administrative |
|
16,051 |
|
|
|
14,385 |
|
Change in fair value of contingent value rights |
|
— |
|
|
|
1,980 |
|
Loss from operations |
|
(48,877 |
) |
|
|
(53,218 |
) |
Interest income |
|
2,531 |
|
|
|
104 |
|
Interest expense |
|
(2,345 |
) |
|
|
(1,500 |
) |
Other (expense) income, net |
|
(1,346 |
) |
|
|
196 |
|
Loss before income taxes |
|
(50,037 |
) |
|
|
(54,418 |
) |
Income tax expense |
|
677 |
|
|
|
80 |
|
Net loss |
|
(50,714 |
) |
|
|
(54,498 |
) |
Other comprehensive income
(loss): |
|
|
|
Foreign currency translation adjustment |
|
898 |
|
|
|
(706 |
) |
Total comprehensive loss |
$ |
(49,816 |
) |
|
$ |
(55,204 |
) |
|
|
|
|
Net loss per ordinary share -
basic and diluted |
$ |
(0.53 |
) |
|
$ |
(0.60 |
) |
Weighted average ordinary
shares outstanding - basic and diluted |
|
94,937,904 |
|
|
|
90,505,345 |
|
|
|
|
|
|
|
|
|
Centessa Pharmaceuticals plcCondensed
Consolidated Balance Sheets(unaudited)(amounts in
thousands) |
|
March 31, 2023 |
|
December 31, 2022 |
Total assets: |
|
|
|
Cash and cash equivalents |
$ |
259,988 |
|
$ |
393,644 |
Short-term investments |
|
86,241 |
|
|
— |
Other assets |
|
57,631 |
|
|
50,663 |
Total assets |
$ |
403,860 |
|
$ |
444,307 |
|
|
|
|
Total liabilities |
|
|
|
Other liabilities |
$ |
38,999 |
|
$ |
38,338 |
Long term debt |
|
71,600 |
|
|
69,800 |
Total liabilities |
$ |
110,599 |
|
$ |
108,138 |
|
|
|
|
Total shareholders’ equity |
$ |
293,261 |
|
$ |
336,169 |
Total liabilities and shareholders' equity |
$ |
403,860 |
|
$ |
444,307 |
|
|
|
|
|
|
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