13.11.2023 22:05:15 - dpa-AFX: GNW-Adhoc: Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Third Quarter of 2023

* SerpinPC: Ongoing registrational PRESent-2 and PRESent-3 studies for the
treatment of hemophilia B; New data from ongoing Phase 2a study accepted for
    poster presentation at American Society of Hematology (ASH) Annual Meeting
    in December 2023
  * ORX750: Preclinical data supporting potential best-in-class profile for the
    treatment of narcolepsy and other sleep-wake disorders presented at World

Sleep Congress; Advancing in IND-enabling studies; Clinical proof of concept
    data planned for 2024
  * LockBody(®) Technology Platform: Ongoing Phase 1/2a study of LB101 (PD-
    L1xCD47) for the treatment of solid tumors

BOSTON and LONDON, Nov. 13, 2023 (GLOBE NEWSWIRE) -- 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 third quarter
ended September 30, 2023.
"We continue to execute and achieve key milestones across our pipeline of
potential transformative medicines for patients with unmet needs," said Saurabh
Saha MD PhD, Chief Executive Officer of Centessa. "We're making good progress
enrolling our registrational studies for SerpinPC in hemophilia B, with or
without inhibitors, and are excited to share new data from the ongoing Phase 2a
study of SerpinPC during a poster presentation at ASH in December. We also
continue to advance our novel LockBody technology platform with LB101, a PD-
L1xCD47 LockBody, which is in an ongoing Phase 1/2a clinical trial for the
treatment of solid tumors."
Dr. Saha continued, "Momentum continues to build with our orexin agonist
development program. The preclinical data we recently shared at the World Sleep
Congress show that ORX750 is a highly potent and selective novel orexin receptor
2 (OX2R) agonist that closely mimics the function of the endogenous peptide. We
believe these data support a potential best-in-class profile for ORX750 for the
treatment of narcolepsy and other sleep-wake disorders. We are focused on
rapidly moving ORX750 through IND-enabling studies, obtaining IND clearance and
initiating clinical development with the goal of sharing clinical proof of
concept data in sleep-deprived healthy volunteers in 2024. In addition, we are
exploring follow-up molecules for potential expansion opportunities into a range
of sleep-wake disorders and broader neurological indications."
Recent Highlights
* In October, the Company announced a set of new preclinical data from in vivo
    and in vitro studies of its investigational, novel OX2R agonist, ORX750,
    that support a potential best-in-class profile for the treatment of
    narcolepsy and other sleep-wake disorders. The preclinical data were

presented recently at the World Sleep Congress and are also available within
    a recorded webcast at https://investors.centessa.com/events-presentations.
  * In November, the Company announced that new data from the third year (Part
    5) of the ongoing Phase 2a study of SerpinPC, an investigational
    subcutaneously administered novel inhibitor of activated protein C (APC),

for the treatment of hemophilia, has been accepted for a poster presentation
    at ASH on December 10, 2023. The presentation will include efficacy and
    safety data from an additional 52-weeks of continuous treatment with a
    subcutaneous injection of SerpinPC in subjects with hemophilia.
  * In October, the Company announced the dosing of the first subject in its
    registrational PRESent-3 clinical study of SerpinPC for the treatment of
    hemophilia B with inhibitors. The Company initiated dosing in its
    registrational PRESent-2 clinical study of SerpinPC for the treatment of
    hemophilia B without inhibitors in July.
  * In August, the Company announced LB206, a PD-L1xCD3 LockBody, as a
    development candidate and shared preclinical data which demonstrated single
    agent regressions of large tumors in a difficult-to-treat mouse xenograft
    model.

Anticipated Upcoming Program Milestones
  * Hemophilia (SerpinPC) - The registrational PRESent-2 and PRESent-3 studies
    are ongoing. Data from Part 5 of the ongoing Phase 2a study accepted for
    poster presentation at ASH on December 10, 2023.
  * Solid Tumors (LockBody Technology Platform)
      * PD-L1xCD47 LockBody LB101 - Phase 1/2a first-in-human clinical study is
        ongoing.
      * PD-L1xCD3 LockBody LB206 - LB206 is a development candidate.
  * Narcolepsy and Other Sleep-Wake Disorders (ORX750) - The Company is focused
    on rapidly advancing ORX750 through IND-enabling studies, obtaining IND
    clearance and initiating clinical development with the goal of sharing

clinical proof of concept data in sleep-deprived healthy volunteers in 2024. Where applicable, the Company plans to provide updates on preclinical programs
as they advance toward clinical studies.
Third Quarter 2023 Financial Results
  * Cash, Cash Equivalents and Short-term Investments: $281.3 million as of
    September 30, 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: $28.2 million for the third quarter ended
    September 30, 2023, compared to $36.7 million for the third quarter ended
    September 30, 2022.

* General & Administrative Expenses: $12.0 million for the third quarter ended
    September 30, 2023, compared to $12.3 million for the third quarter ended
    September 30, 2022.
  * Net Loss Attributable to Ordinary Shareholders: $38.6 million for the third
    quarter ended September 30, 2023, compared to $53.9 million for the third
    quarter ended September 30, 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 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 ongoing 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 Fast Track designation to SerpinPC for the treatment of
hemophilia B, with or without inhibitors. SerpinPC is an investigational agent
that has not been approved by the FDA or any other regulatory authority.
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. 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.
About ORX750
ORX750 is an investigational, orally administered, highly potent and selective
orexin receptor 2 (OX2R) agonist designed to directly target the underlying
pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 is
Centessa's first orexin product candidate being developed for the treatment of
narcolepsy with potential expansion into other sleep-wake disorders. ORX750 is
currently undergoing IND-enabling activities and has not been administered as an
investigational drug to humans in any jurisdiction.
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, LB206, other LockBody candidates, the LockBody
technology platform, ORX750 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, LB206, and any other LockBody candidates, ORX750 and other orexin agonist
molecules and its expectations on executing its research and clinical
development plans and the timing thereof; the Company's ability to differentiate
SerpinPC, LB101, LB206, ORX750, other orexin agonist molecules, and other
LockBody candidates from other treatment options; the development and
therapeutic potential of SerpinPC, LB101, LB206, other LockBody candidates, the
LockBody technology platform, ORX750 and other orexin agonist molecules; 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 existing and 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 and
LB206; 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 Israeli-
Palestinian conflict. 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 (mailto: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 Three Months Nine Months Nine Months
                      Ended            Ended            Ended            Ended
                  September 30,    September 30,    September 30,    September 30,
                       2023             2022             2023             2022
                 ---------------- ---------------- ---------------- ---------------

Operating
expenses:
Research and
development $ 28,190 $ 36,744 $ 94,689 $ 127,248 General and
administrative 12,019 12,284 41,416 41,432 Change in fair
value of
contingent
value rights - - - 1,980 ---------------- ---------------- ---------------- ---------------
Loss from
operations (40,209 ) (49,028 ) (136,105 ) (170,660 )
Interest
income 2,953 77 7,543 205 Interest
expense (2,541 ) (1,922 ) (7,336 ) (5,074 )
Other
(expense)
income, net (1,677 ) (3,143 ) (4,550 ) 2,412 ---------------- ---------------- ---------------- ---------------
Loss before
income taxes (41,474 ) (54,016 ) (140,448 ) (173,117 )
Income tax
(benefit)
 expense                (2,826 )           (141 )        (26,200 )            (83 )
                 ---------------- ---------------- ---------------- ---------------
 Net loss              (38,648 )        (53,875 )       (114,248 )       (173,034 )
                 ---------------- ---------------- ---------------- ---------------

Other
comprehensive
income (loss):
Foreign
currency
translation
adjustment (419 ) (553 ) 1,241 (2,383 )
Unrealized
gain on
available for
sale
securities,
net of tax 252 - 1,035 - ---------------- ---------------- ---------------- ---------------
Other
comprehensive
 income (loss)            (167 )           (553 )          2,276           (2,383 )
                 ---------------- ---------------- ---------------- ---------------
                 ---------------- ---------------- ---------------- ---------------

Total
comprehensive
 loss             $    (38,815 )   $    (54,428 )   $   (111,972 )   $   (175,417 )
                 ---------------- ---------------- ---------------- ---------------

Net loss per
ordinary share
- basic and
 diluted          $      (0.40 )   $      (0.57 )   $      (1.20 )   $      (1.86 )
                 ---------------- ---------------- ---------------- ---------------

Weighted
average
ordinary
shares
outstanding -
basic and
diluted 96,648,110 94,327,914 95,589,181 92,994,990
                    Centessa Pharmaceuticals plc
                Condensed Consolidated Balance Sheets
                             (unaudited)
                       (amounts in thousands)
                                             September     December
                                                30,          31,
                                               2023          2022
                                           ------------- -----------

Total assets:
 Cash and cash equivalents                  $   171,498   $  393,644
 Short-term investments                         109,843            -
 Other assets                                    96,023       50,663
                                           ------------- -----------
 Total assets                               $   377,364   $  444,307
                                           ------------- -----------

Total liabilities
 Other liabilities                          $    43,974   $   38,338
 Long term debt                                  74,000       69,800
                                           ------------- -----------
 Total liabilities                          $   117,974   $  108,138
                                           ------------- -----------
                                           ------------- -----------
 Total shareholders' equity                 $   259,390   $  336,169
                                           ------------- -----------
 Total liabilities and shareholders' equity $   377,364   $  444,307
                                           ------------- -----------

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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
CENTESSA PHARMACEUTICALS A3CQ72 Frankfurt 8,050 21.06.24 15:29:02 +0,250 +3,21% 0,000 0,000 7,950 8,050

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