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 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 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.
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 Relationsinvestors@centessa.com
|
Centessa Pharmaceuticals plcConsolidated
Statements of Operations and Comprehensive
Loss(unaudited)(amounts in thousands except share and per
share data) |
|
|
|
Three MonthsEndedJune 30,
2023 |
|
Three MonthsEndedJune 30,
2022 |
|
Six MonthsEndedJune 30, 2023 |
|
Six MonthsEndedJune 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 plcCondensed
Consolidated Balance Sheets(unaudited)(amounts in
thousands) |
|
|
June 30, 2023 |
|
December 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 |
|
Centessa Pharmaceuticals (NASDAQ:CNTA)
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Centessa Pharmaceuticals (NASDAQ:CNTA)
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