Centessa Pharmaceuticals Reports Financial Results and Business
Highlights for the Second Quarter of 2024
- Company advancing pipeline of
potential best-in-class orexin receptor 2 (OX2R) agonists
- Initiated Phase 1 clinical study with ORX750 being
developed for sleep-wake disorders; Safety and efficacy data in
acutely sleep-deprived healthy volunteers assessed using
Maintenance of Wakefulness Test (MWT) on track for 2H of
2024
- Nominated ORX142 as development candidate; Currently in IND
enabling activities for select neurological, neurodegenerative, and
psychiatric disorders with excessive daytime sleepiness
(EDS)
- SerpinPC registrational program for the treatment of
hemophilia B progressing; PRESent-2 Part 1 interim analysis planned
for 2024
BOSTON and LONDON, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Centessa
Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical
company that aims to discover and develop medicines that are
transformational for patients, today reported financial results and
business highlights for the second quarter ended June 30, 2024.
“Momentum is building across Centessa’s orexin agonist program.
During the second quarter, we initiated a Phase 1 clinical study
with ORX750, a potential best-in-class OX2R agonist being developed
for sleep-wake disorders, including narcolepsy type 1 (NT1),
narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Today, we
are fast approaching a potentially transformative milestone with
safety and efficacy data in acutely sleep-deprived healthy
volunteers assessed using the MWT, an established registrational
and objective endpoint for EDS in sleep-wake disorders, on track
for the second half of this year,” said Saurabh Saha MD PhD, Chief
Executive Officer of Centessa. “As healthy volunteers have normal
orexin tone, data from this study has the potential to enable dose
selection for planned clinical studies of ORX750 in subjects with
NT1, NT2, and IH. The data also has the potential to open the door
to evaluation of our growing pipeline of orexin agonists in
clinical studies for a range of disorders where EDS is a
significant burden. We are working to advance our pipeline to
address these additional areas of high unmet need, and are thrilled
to announce ORX142, an orally administered, highly potent and
selective OX2R agonist, as our development candidate for potential
indication expansion into select neurological, neurodegenerative,
and psychiatric disorders with EDS. ORX142 is currently in IND
enabling activities and we look forward to sharing preclinical data
in the near term.”
Dr. Saha continued, “Additionally, the PRESent registrational
program for SerpinPC for the treatment of hemophilia B is
progressing, and we will review the planned interim analysis of
Part 1 data of the PRESent-2 study this year with the goal of
confirming the dose for Part 2 of the study. With our recently
extended cash runway, we believe we are well positioned to execute
on our clinical plans through multiple clinical readouts that take
us one step closer to our goal of bringing transformational
medicines to patients.”
Recent Highlights
- In May, the Company announced that
it had initiated a Phase 1 first-in-human (FIH) clinical trial to
evaluate the safety, tolerability, and pharmacokinetics of
single-ascending doses (SAD) and multiple-ascending doses (MAD) of
ORX750 in healthy adult subjects. In parallel to the SAD, a
cross-over efficacy assessment is being performed utilizing the MWT
and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived
healthy adult subjects which is intended to provide data to enable
dose selection for planned clinical studies in subjects with NT1,
NT2 and IH.
- In April and May, the Company
completed an underwritten public offering of 12,390,254 American
Depositary Shares (“ADSs”) in the aggregate, at a price to the
public of $9.25 per ADS, resulting in net proceeds of approximately
$107.3 million, which included the underwriters’ over-allotment
option to purchase additional shares.
- In April, the Company announced
that the U.S. Food and Drug Administration (FDA) cleared the
Investigational New Drug application (IND) to initiate a Phase 1
FIH clinical trial of ORX750.
Anticipated Upcoming Program Milestones
- Orexin Agonist
Program - The Phase 1 FIH clinical study of ORX750 is
ongoing. The Company expects to share Phase 1 proof-of-concept
(PoC) safety and efficacy data in acutely sleep-deprived healthy
volunteers assessed using the MWT, an established registrational
and objective endpoint for EDS in sleep-wake disorders, in the 2H
of 2024.
- Hemophilia
Program - The SerpinPC registrational program in
hemophilia B, which includes the PRESent-2 (moderately severe to
severe hemophilia B without inhibitors, and severe hemophilia A
with or without inhibitors) and PRESent-3 (hemophilia B with
inhibitors) studies, is ongoing.
- For PRESent-2, Part 1 of the study
is fully enrolled and all subjects have now been dosed. Part 2 is
currently enrolling subjects into the prospective observation
period. The Company will review the planned interim analysis of
Part 1 data this year, with the goal of confirming the dose for
Part 2 of the study. The primary endpoint for PRESent-2 is measured
in Part 2 and is the rate of treated bleeds (expressed as an
annualized bleed rate (ABR)) for hemophilia B subjects who
previously received on-demand therapy compared to their prospective
baseline ABR. The Company plans to present data from Part 1 at a
medical conference in late 2024 or early 2025.
- LockBody Technology
Platform - The Phase 1/2a FIH clinical study of LB101
(PD-L1xCD47 LockBody) for the treatment of solid tumors is
ongoing.
Where applicable, the Company plans to provide updates on
preclinical assets when they advance toward clinical studies.
Second Quarter 2024 Financial Results
- Cash, Cash
Equivalents and Short-term Investments: $294.8 million as
of June 30, 2024. The Company expects its cash, cash equivalents
and short-term investments as of June 30, 2024 will fund operations
into mid-2026 without drawing on the remaining available tranches
under the Oberland credit facility.
- Research & Development
Expenses: $32.8 million for the second quarter ended June
30, 2024, compared to $33.7 million for the second quarter ended
June 30, 2023.
- General &
Administrative Expenses: $11.2 million for the second
quarter ended June 30, 2024, compared to $13.3 million for the
second quarter ended June 30, 2023.
- Net Loss Attributable to
Ordinary Shareholders: $43.8 million for the second
quarter ended June 30, 2024, compared to $24.9 million for the
second quarter ended June 30, 2023. The net loss for the second
quarter of 2023 included a tax benefit of $24.1 million, which
primarily related to a release of a valuation allowance on certain
U.S. deferred tax assets during the quarter.
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 most advanced programs
include a hemophilia program, an orexin agonist program for the
treatment of narcolepsy and other sleep-wake disorders, and an
immuno-oncology program focused on our LockBody® technology
platform. We operate with the conviction that each of our programs
has the potential to change the current treatment paradigm and
establish a new standard of care. For more information, visit
www.centessa.com, which does not form part of this release.
About Centessa’s Orexin Agonist
Program
Orexin is a neuropeptide that regulates the sleep-wake cycle,
leading to arousal and promoting wakefulness. Low levels of orexin
result in excessive daytime sleepiness (EDS) and poor regulation of
rapid eye movement (REM) sleep and, in narcolepsy type 1 (NT1),
cataplexy and other symptoms. Centessa is developing a pipeline of
potential best-in-class orexin receptor 2 (OX2R) agonists intended
to be orally administered for sleep-wake disorders, including NT1,
narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), with
therapeutic potential to alleviate EDS in select neurological,
neurodegenerative, and psychiatric conditions. The Company’s lead
asset, ORX750, is in a Phase 1 clinical study. ORX750 and ORX142
have not been approved by the FDA or any other regulatory
authority.
About SerpinPC
SerpinPC is an investigational, 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. The
registrational program for SerpinPC in hemophilia B includes a set
of clinical studies with multiple components. PRESent-5 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 or without inhibitors) and
PRESent-3 (hemophilia B with inhibitors). Additional information on
the trials can be accessed at www.clinicaltrials.gov (NCT05605678,
NCT05789524, NCT05789537). The U.S. Food and Drug Administration
(FDA) has granted Orphan Drug Designation and Fast Track
designation to SerpinPC for the treatment of hemophilia B, with or
without inhibitors. SerpinPC has not been approved by the FDA or
any other regulatory authority for any use.
About the LockBody Technology Platform and
LB101
Centessa’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.
Centessa’s first LockBody candidate is LB101, a conditionally
tetravalent PD-L1xCD47 bispecific monoclonal antibody. 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 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 for executing on the
Company's pipeline; its expectations on its anticipated cash
runway; the timing of commencement of new studies or clinical
trials or clinical and preclinical data related to SerpinPC, LB101,
other LockBody candidates, the LockBody technology platform,
ORX750, ORX142 and other orexin agonist molecules; its ability to
identify, screen, recruit and maintain a sufficient number of or
any subjects in its existing and anticipated 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, ORX750, ORX142 and other orexin agonist
molecules; its expectations on executing its research and clinical
development plans and the timing thereof; its expectations as to
the potential results and impact of each of its clinical programs
and trials; the Company’s ability to differentiate SerpinPC, LB101,
other LockBody candidates, ORX750, ORX142 and other orexin agonist
molecules from other treatment options; the development, design and
therapeutic potential of SerpinPC, LB101, other LockBody
candidates, the LockBody technology platform, ORX750, ORX142 and
other orexin agonist molecules; and regulatory matters, including
the timing and likelihood of success of obtaining regulatory
clearance, 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 existing and anticipated new studies or
clinical trials including PRESent-2, PRESent-3, PRESent-5, and
studies or trials of LB101, ORX750 or ORX142 or within anticipated
timelines; our expectations relating to the Phase 1 first-in-human,
clinical trial of ORX750, including the predicted timing of
enrollment, the predicted efficacious doses of ORX750 and our
ability to successfully conduct our clinical development of 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; our operating costs and use of cash, including
cash runway, cost of development activities and conducting clinical
trials, future expenditures risks; the risk that any one or more of
our product candidates will not be successfully developed and/or
commercialized; the risk that the historical results of preclinical
studies or clinical studies will not be predictive of future
results in ongoing or future studies; economic risks to the United
States and United Kingdom banking systems; and geo-political risks
such as the Russia-Ukraine war or the Middle East conflicts. 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 Relations
investors@centessa.com
| Centessa
Pharmaceuticals plc |
| Consolidated
Statements of Operations and Comprehensive Loss |
| (unaudited) |
| (amounts in
thousands except share and per share data) |
| |
| |
Three Months
Ended
June 30, 2024 |
|
Three Months
Ended
June 30, 2023 |
|
Six Months
Ended
June 30, 2024 |
|
Six Months
Ended
June 30, 2023 |
| Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
32,815 |
|
|
$ |
33,673 |
|
|
$ |
55,467 |
|
|
$ |
66,499 |
|
|
General and administrative |
|
11,165 |
|
|
|
13,346 |
|
|
|
24,603 |
|
|
|
29,397 |
|
| Loss from operations |
|
(43,980 |
) |
|
|
(47,019 |
) |
|
|
(80,070 |
) |
|
|
(95,896 |
) |
|
Interest income |
|
3,240 |
|
|
|
2,059 |
|
|
|
5,831 |
|
|
|
4,590 |
|
|
Interest expense |
|
(2,525 |
) |
|
|
(2,450 |
) |
|
|
(5,054 |
) |
|
|
(4,795 |
) |
|
Other (expense) income, net |
|
154 |
|
|
|
(1,527 |
) |
|
|
(1,383 |
) |
|
|
(2,873 |
) |
| Loss before income taxes |
|
(43,111 |
) |
|
|
(48,937 |
) |
|
|
(80,676 |
) |
|
|
(98,974 |
) |
|
Income tax expense (benefit) |
|
705 |
|
|
|
(24,051 |
) |
|
|
1,186 |
|
|
|
(23,374 |
) |
| Net loss |
|
(43,816 |
) |
|
|
(24,886 |
) |
|
|
(81,862 |
) |
|
|
(75,600 |
) |
| |
|
|
|
|
|
|
|
| Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(61 |
) |
|
|
762 |
|
|
|
(86 |
) |
|
|
1,660 |
|
|
Unrealized gain on available for sale marketable securities, net of
tax |
|
33 |
|
|
|
783 |
|
|
|
188 |
|
|
|
783 |
|
| Other comprehensive (loss)
income |
|
(28 |
) |
|
|
1,545 |
|
|
|
102 |
|
|
|
2,443 |
|
| |
|
|
|
|
|
|
|
| Total comprehensive loss |
$ |
(43,844 |
) |
|
$ |
(23,341 |
) |
|
$ |
(81,760 |
) |
|
$ |
(73,157 |
) |
| |
|
|
|
|
|
|
|
| Net loss per ordinary share -
basic and diluted |
$ |
(0.40 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.80 |
) |
| Weighted average ordinary
shares outstanding - basic and diluted |
|
109,489,184 |
|
|
|
95,162,734 |
|
|
|
104,688,452 |
|
|
|
95,050,940 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Centessa Pharmaceuticals plc |
|
Condensed Consolidated Balance Sheets |
|
(unaudited) |
|
(amounts in thousands) |
| |
| |
June 30, 2024 |
|
December 31, 2023 |
| Total assets: |
|
|
|
|
Cash and cash equivalents |
$ |
127,372 |
|
$ |
128,030 |
|
Short-term investments |
|
167,461 |
|
|
128,519 |
|
Other assets |
|
104,012 |
|
|
103,697 |
|
Total assets |
$ |
398,845 |
|
$ |
360,246 |
| |
|
|
|
| Total liabilities |
|
|
|
|
Other liabilities |
$ |
35,380 |
|
$ |
48,302 |
|
Long term debt |
|
76,500 |
|
|
75,700 |
|
Total liabilities |
|
111,880 |
|
|
124,002 |
| |
|
|
|
|
Total shareholders’ equity |
|
286,965 |
|
|
236,244 |
|
Total liabilities and shareholders' equity |
$ |
398,845 |
|
$ |
360,246 |
Centessa Pharmaceuticals (LSE:0ACX)
過去 株価チャート
から 11 2024 まで 12 2024
Centessa Pharmaceuticals (LSE:0ACX)
過去 株価チャート
から 12 2023 まで 12 2024
