14.08.2023 13:00:35 - dpa-AFX: GNW-Adhoc: Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Second Quarter of 2023

* Enrollment and dosing ongoing in registrational study of SerpinPC for the
    treatment of hemophilia B
  * Enrollment and dosing ongoing in Phase 1/2a Study of LB101, a PD-L1xCD47
    LockBody(® )for the treatment of solid tumors
  * IND-enabling activities advancing for ORX750, an oral selective orexin
    receptor 2 (OX2R) agonist for the treatment of narcolepsy and other sleep
    disorders; Announces ORX750 preclinical data to be presented at World Sleep
    Congress in October 2023
  * Nominates second LockBody candidate, LB206, a conditionally bivalent PD-
    L1xCD3 bispecific monoclonal antibody

BOSTON and LONDON, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals
plc (http://www.centessa.com/) (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 second quarter ended June 30, 2023.
"This is an exciting time for Centessa as we continue to execute across our
portfolio with the goal of bringing transformative medicines to patients with
unmet needs," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We
recently commenced dosing in our registrational PRESent-2 study of SerpinPC for
the treatment of hemophilia B without inhibitors and are now enrolling subjects
across multiple global sites. To date, clinical data support SerpinPC's
potential to be a first-in-class subcutaneously administered therapy with a
differentiated safety profile for persons with hemophilia B. In the months
ahead, we plan to share new data from subjects with approximately 3 years of
continuous treatment with SerpinPC from the ongoing Phase 2a study."
"We are also making great progress with our LockBody technology platform,
enrolling and dosing subjects in the ongoing Phase 1/2a clinical trial of LB101,
a PD-L1xCD47 LockBody molecule for the treatment of solid tumors. In addition,
we are excited to announce LB206, a conditionally bivalent PD-L1xCD3 bispecific
monoclonal antibody, as our second LockBody development candidate for the
treatment of solid tumors, and share encouraging preclinical data for LB206
which demonstrated the potential of our LockBody technology to selectively drive
potent CD3 activity within solid tumors in a difficult-to-treat mouse xenograft
model with no apparent observed toxicity. We believe this progress marks an
important milestone in advancing our novel LockBody technology platform," said
Dr. Saha.
"In parallel with progress on our two clinical programs, we are advancing
ORX750, our first oral selective orexin receptor 2 (OX2R) agonist development
candidate, through IND enabling studies for the treatment of narcolepsy, and are
thrilled to present preclinical data for ORX750 at the World Sleep Congress in
October 2023," said Dr. Saha. "We are also excited to be exploring follow-up
orexin agonists for potential expansion opportunities into a range of high value
sleep disorders and broader neurological indications. With a team comprised of
experienced and insightful scientists in the orexin field, we believe Centessa
is well-positioned to play a leading role in orexin agonist development."
Dr. Saha concluded, "We have line of sight to multiple potential clinical
milestones expected over the next several quarters and with a cash runway into
2026, we believe we are well positioned to advance our pipeline of potentially
transformative medicines and deliver value for our stakeholders."
Recent Highlights
  * Today, the Company shared new preclinical data for LB206, a PD-L1xCD3
    LockBody development candidate, which demonstrated single agent regressions
    of large tumors in a difficult-to-treat mouse xenograft model. The
    preclinical data is shown in the Company's corporate overview for August
    2023 which is available at https://investors.centessa.com/events-
    presentations.
  * In July, the Company announced the dosing of the first subject in its
    registrational PRESent-2 clinical study of SerpinPC for the treatment of
    hemophilia B without inhibitors. SerpinPC is an investigational
    subcutaneously administered novel inhibitor of activated protein C (APC).
  * In May, the Company announced that 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.

Anticipated Upcoming Program Milestones
  * Hemophilia (SerpinPC) - The global registrational program for hemophilia B
    is ongoing. PRESent-5, an observational feeder study, continues enrolling

subjects and the Company has commenced dosing in the registrational PRESent-
    2 clinical study of hemophilia B without inhibitors. Dosing in the
    registrational PRESent-3 clinical study of hemophilia B with inhibitors, is
    expected to begin this year. In addition, the Company expects to share data
    from Part 5 of the ongoing Phase 2a study of SerpinPC at a scientific
    meeting later this year.
  * Solid Tumors
      * PD-L1xCD47 LockBody (LB101) - The Phase 1/2a first-in-human clinical
        study is ongoing.
      * PD-L1xCD3 LockBody (LB206) - LB206 has been named as a development
        candidate.
  * Narcolepsy and Other Sleep Disorders (ORX750) - ORX750 is undergoing IND-
    enabling activities. The Company plans to share preclinical data on ORX750

at the World Sleep Congress taking place from October 20-25, 2023, in Rio de Janeiro, Brazil.
The Company has multiple earlier-stage preclinical assets including additional
orexin agonists and discovery-stage programs. Where applicable, the Company
plans to provide updates on preclinical programs as they advance toward clinical
studies.
Second Quarter 2023 Financial Results
* Cash, Cash Equivalents and Short-term Investments: $303.6 million as of
June 30, 2023. In addition, the Company received approximately $15.0 million
    in gross proceeds through ATM sales in August 2023. The Company expects its
    current cash, cash equivalents and short-term investments will fund
    operations into 2026, without drawing on the remaining available tranches
    under the Oberland credit facility.
  * Research & Development Expenses: $33.7 million for the second quarter ended
    June 30, 2023, compared to $53.7 million for the second quarter ended June
    30, 2022.
  * General & Administrative Expenses: $13.3 million for the second quarter

ended June 30, 2023, compared to $14.8 million the second quarter ended June 30, 2022.
* Net Loss Attributable to Ordinary Shareholders: $24.9 million for the second
    quarter ended June 30, 2023, compared to $64.7 million for the second
    quarter ended June 30, 2022. The net loss for the second quarter of 2023
    included a tax benefit of $24.1 million, which primarily relates to a
    release of a valuation allowance on certain U.S. deferred tax assets in the
    quarter.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc (http://www.centessa.com/) 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
(https://classic.clinicaltrials.gov/ct2/show/NCT05605678), NCT05789524
(https://classic.clinicaltrials.gov/ct2/show/NCT05789524), NCT05789537
(https://classic.clinicaltrials.gov/ct2/show/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
(https://classic.clinicaltrials.gov/ct2/show/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 cash runway into 2026; 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 and recruit 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 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; 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 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. 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 Three Months Six Months Six Months
                      Ended            Ended            Ended            Ended
                  June 30, 2023    June 30, 2022    June 30, 2023    June 30, 2022
                 ---------------- ---------------- ---------------- ---------------

Operating
expenses:
Research and
development $ 33,673 $ 53,651 $ 66,499 $ 90,504 General and
administrative 13,346 14,763 29,397 29,148 Change in fair
value of
contingent
value rights - - - 1,980 ---------------- ---------------- ---------------- ---------------
Loss from
operations (47,019 ) (68,414 ) (95,896 ) (121,632 )
Interest
income 2,059 25 4,590 129 Interest
expense (2,450 ) (1,653 ) (4,795 ) (3,153 )
Other
(expense)
income, net (1,527 ) 5,359 (2,873 ) 5,555 ---------------- ---------------- ---------------- ---------------
Loss before
income taxes (48,937 ) (64,683 ) (98,974 ) (119,101 )
Income tax
(benefit)
expense (24,051 ) (22 ) (23,374 ) 58
                 ---------------- ---------------- ---------------- ---------------
 Net loss              (24,886 )        (64,661 )        (75,600 )       (119,159 )
                 ---------------- ---------------- ---------------- ---------------

Other
comprehensive
income (loss):
Foreign
currency
translation
adjustment 762 (1,124 ) 1,660 (1,830 )
Unrealized
gain on
available for
sale
securities,
net of tax 783 - 783 - ---------------- ---------------- ---------------- ---------------
Other
comprehensive
 income (loss)           1,545           (1,124 )          2,443           (1,830 )
                 ---------------- ---------------- ---------------- ---------------
                 ---------------- ---------------- ---------------- ---------------

Total
comprehensive
 loss             $    (23,341 )   $    (65,785 )   $    (73,157 )   $   (120,989 )
                 ---------------- ---------------- ---------------- ---------------

Net loss per
ordinary share
- basic and
 diluted          $      (0.26 )   $      (0.69 )   $      (0.80 )   $      (1.29 )
                 ---------------- ---------------- ---------------- ---------------

Weighted
average
ordinary
shares
outstanding -
basic and
diluted 95,162,734 94,109,089 95,050,940 92,317,172
                      Centessa Pharmaceuticals plc
                 Condensed Consolidated Balance Sheets
                              (unaudited)
                         (amounts in thousands)
                                               June         December
                                             30, 2023       31, 2022
                                           ------------- --------------

Total assets:
 Cash and cash equivalents                  $ 145,220     $ 393,644
 Short-term investments                       158,367             -
 Other assets                                  89,334        50,663
                                           ------------- --------------
 Total assets                               $ 392,921     $ 444,307
                                           ------------- --------------

Total liabilities
 Other liabilities                          $  43,015     $  38,338
 Long term debt                                73,300        69,800
                                           ------------- --------------
 Total liabilities                          $ 116,315     $ 108,138
                                           ------------- --------------
                                           ------------- --------------
 Total shareholders' equity                 $ 276,606     $ 336,169
                                           ------------- --------------
 Total liabilities and shareholders' equity $ 392,921     $ 444,307
                                           ------------- --------------

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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
CENTESSA PHARMACEUTICALS A3CQ72 Frankfurt 8,850 14.06.24 15:29:01 +0,250 +2,91% 9,100 9,950 8,850 8,850

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