Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
company leveraging its innovative asset-centric business model to
discover, develop and ultimately deliver impactful medicines to
patients, today reported financial results for the quarter ended
June 30, 2021, and provided a review of recent accomplishments and
anticipated upcoming milestones.
“Centessa has made significant progress since launch and
completion of our $250 million Series A financing in January,” said
Saurabh Saha, M.D., Ph.D., Chief Executive Officer of Centessa.
“The successful execution of our upsized initial public offering in
the second quarter has substantially enhanced our resources and
will support the advancement of our broad portfolio of assets
across our 10 subsidiary companies. This added capital, together
with the appointment of exceptional industry leaders in key
functional areas across the organization, positions us for
continued success. We look forward to sharing our progress,
including a planned Phase 2a data update from ApcinteX in the
coming weeks.”
Business Updates
- $379.5 Million Initial Public Offering (IPO)
Successfully Completed: In the second quarter, Centessa
closed its initial public offering of 16,500,000 American
Depositary Shares (ADSs). In addition, the underwriters fully
exercised their option to purchase an additional 2,475,000 ADSs at
the IPO price of $20.00 per ADS, less underwriting discounts and
commissions. The gross proceeds to Centessa from its IPO, before
deducting underwriting discounts, commissions and other estimated
offering expenses, totaled an aggregate of $379.5 million.
- Leadership Team Strengthened by Appointment of Key
Industry Executives: In May, Centessa announced the
leadership appointments of Antoine Yver, M.D., M.Sc., Chief Medical
Officer; Tia Bush, Chief Quality Officer; David Chao, Ph.D., Chief
Administrative Officer; and Thomas Templeman, Ph.D., Chief
Technology Officer. In addition, Marella Thorell was promoted to
Chief Accounting Officer, and Carol Stuckley joined the Board of
Directors, serving as Chairperson of the Audit Committee. Each of
these leaders provides significant expertise in their respective
functions and will help drive execution across the Company’s
portfolio of programs.
Program Updates and Upcoming Milestones in the Second
Half of 2021
- Topline Phase 2a data from ApcinteX’s 24-week repeat
dose study evaluating SerpinPC in hemophilia A (HA) and hemophilia
B (HB) patients
- SerpinPC, a first-in-class coagulation rebalancing agent, is a
specific inhibitor of activated protein C (APC) being evaluated as
a monthly subcutaneous therapeutic for HA and HB patients that has
the potential to significantly reduce bleeding rates.
- The Phase 2a has completed dosing and the Company anticipates
sharing topline results in the third quarter of 2021.
- All subjects who have completed the 24-week repeat dose portion
of the study have elected to roll-over into a long-term open-label
extension study.
- Start-up activities have begun for the ACTION Study,
Palladio Biosciences' global Phase 3 registrational study of
lixivaptan in autosomal dominant polycystic kidney disease
(ADPKD)
- Lixivaptan, a vasopressin V2 receptor antagonist, is being
investigated as a potential best-in-class therapy in patients with
ADPKD.
- The Company anticipates dosing the first patient in the
registrational ACTION Study in the first quarter of 2022.
- The Company expects to report ongoing safety data from the
initial subjects in the open-label ALERT Study of patients who
previously discontinued JYNARQUE® (tolvaptan) due to liver toxicity
in the fourth quarter of 2021.
- Phase 1 data from Z Factor’s study evaluating ZF874 for
the treatment of alpha-1-antitrypsin deficiency (AATD)
- ZF874, a small molecule folding corrector of the Z variant of
alpha-1-antitrypsin, is designed to increase serum levels of
alpha-1-antitrypsin and reduce liver polymer burden to treat or
prevent associated lung and liver disease manifestations associated
with AATD.
- The Company anticipates providing an update from an ongoing
28-day repeat dose Phase 1 study in subjects with PiXZ genotype by
the end of 2021.
- Phase 2 trial initiation with Pega-One’s imgatuzumab in
advanced cutaneous squamous cell carcinoma (CSCC)
- Imgatuzumab, a non-fucosylated epidermal growth factor receptor
(EGFR) targeting monoclonal antibody (mAb), is being investigated
as a next-generation EGFR agent with enhanced Antibody-Dependent
Cellular Cytotoxicity (ADCC) and Antibody-Dependent Cellular
Phagocytosis (ADCP) properties to potentially address CSCC.
- The Company expects to initiate an open label, single arm,
Phase 2 trial of imgatuzumab in advanced CSCC by the end of
2021.
Second Quarter 2021 Financial Results
Cash Position: Cash and cash equivalents were
$613.8 million as of June 30, 2021, compared to $7.2 million for
the Centessa Predecessor Group (comprised of Z Factor Limited,
LockBody Therapeutics Ltd, and Morphogen-IX Limited, three of the
Centessa Subsidiaries acquired in January 2021) as of December 31,
2020. The increase in cash resulted from $344.1 million in net
proceeds from the Company’s initial public offering completed in
June 2021, and the full exercise of the underwriters’ option to
purchase additional shares, $241.6 million in net proceeds from the
Company’s Series A financing completed in January 2021, and cash
contributed upon the acquisition of the additional Centessa
Subsidiaries, net of cash used during the period. Based on the
current, non-risk-adjusted operating plan, the Company expects the
cash and cash equivalents as of June 30, 2021, to fund its
operations until the end of 2023.
Research & Development (R&D) Expenses:
R&D expenses for the Company for the three months ended
June 30, 2021, were $18.1 million, compared to
$1.9 million for the Centessa Predecessor Group during the
three months ended June 30, 2020. The $16.2 million increase
is primarily attributable to the growth in the portfolio of product
candidates under development following the acquisition of the
Centessa Subsidiaries in January 2021, as well as increased
spending in the Centessa Predecessor Group.
General & Administrative (G&A)
Expenses: G&A expenses for the Company for the three
months ended June 30, 2021. were $11.8 million, compared to
$0.3 million for the Centessa Predecessor Group during the
three months ended June 30, 2020. The $11.5 million
increase is primarily attributable to public company costs, the
operating costs of Centessa Pharmaceuticals plc and Centessa
Pharmaceutical Inc. including professional fees, personnel costs
and share-based compensation expense, and the increase in operating
costs resulting from the acquired Centessa Subsidiaries.
Change in Fair Value of Contingent Value Rights
(CVR): The Company recognized a charge of $11.3 million
for the three months ended June 30, 2021, compared to $0.0
million for the three months ended June 30, 2020. The CVR, issued
at the time of the acquisition, represents future payments (that
will be satisfied through the issuance of Centessa shares) that are
contingent upon the dosing of the first patient in a registrational
Phase 3 study of Palladio Biosciences’ lixivaptan. The fair value
is based on the cumulative probability of achieving this milestone,
which increased during the period resulting in the charge.
Net Loss: Net Loss attributable to common
stockholders for the quarter ended June 30, 2021, was $41.5
million, or $0.65 per share, compared to a net loss of $2.2 million
for the Centessa Predecessor Group for the quarter ended June 30,
2020.
About Centessa PharmaceuticalsCentessa
Pharmaceuticals plc aims to bring impactful new medicines to
patients by combining the strengths of an asset-centric model with
the benefits of scale and diversification typical of larger R&D
organizations. The asset-centric model refers to a highly
specialized, singular-focused company that is led by a team of
well-recognized subject matter experts. Centessa’s asset-centric
companies’ programs range from discovery-stage to late-stage
development and include diverse therapeutic areas such as oncology,
hematology, immunology/inflammation, neuroscience, hepatology,
pulmonology and nephrology. For more information, visit
www.centessa.com.
Forward Looking Statements This press release
contains forward-looking statements. These statements may be
identified by words such as “aims,” “anticipates,” “believes,”
“could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,”
“may,” “plans,” “possible,” “potential,” “seeks,” “will,” 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 deliver impactful medicines to
patients; the ability of our key executives to drive execution of
the Company’s portfolio of programs; our asset-centric business
model and the intended advantages and benefits thereof; research
and clinical development plans; the scope, progress, results and
costs of developing our product candidates or any other future
product candidates; strategy; regulatory matters, including the
timing and likelihood of success of obtaining approvals to initiate
or continue clinical trials or market any products; market size and
opportunity; our ability to complete certain milestones; and our
current cash position and runway.
Any forward-looking statements in this press release are based
on our current expectations, estimates 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 our ability to protect and
maintain our intellectual property position; business, regulatory,
economic and competitive risks, uncertainties, contingencies and
assumptions about the Company; risks inherent in developing
products and technologies; future results from our ongoing and
planned clinical trials; our ability to obtain adequate financing
to fund our planned clinical trials and other expenses; trends in
the industry; the legal and regulatory framework for the industry;
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 commercialized; the risk that the
results of preclinical studies or clinical studies will not be
predictive of future results in connection with future studies; and
risks related to the COVID-19 pandemic including the effects of the
Delta variant. These and other risks concerning our programs and
operations are described in additional detail in our registration
statement on Form S-1 and our other reports, which are on file with
the SEC. We explicitly disclaim any obligation to update any
forward-looking statements except to the extent required by
law.
Contacts:
Investor Contact: |
Media Contacts: |
Jennifer Porcelli, Head of
Investor Relations |
US |
Centessa Pharmaceuticals |
Dan Budwick, 1AB |
jennifer.porcelli@centessa.com |
dan@1abmedia.com |
|
|
|
UK/Greater
Europe |
|
Mary Clark & Shabnam Bashir,
Optimum Strategic Communications |
|
centessa@optimumcomms.com |
|
|
|
Switzerland |
|
Marcus Veith, VEITHing
Spirit |
|
marcus@vspirit.ch |
|
M: +41 79 20 75 111 |
Centessa Pharmaceuticals plc (Successor)
and Centessa Predecessor Group (Predecessor)
Consolidated and Combined Statements of Operations and
Comprehensive Loss(unaudited)(amounts in thousands except
share and per share data)
|
Successor |
|
Predecessor |
|
Three monthsended June 30,
2021 |
|
Period fromJanuary 30,
2021through June
30,2021 |
|
Period fromJanuary 1,
2021throughJanuary
29,2021 |
|
Three monthsended June
30,2020 |
|
Six monthsendedJune 30, 2020 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
18,134 |
|
|
28,276 |
|
|
600 |
|
|
1,871 |
|
|
4,681 |
|
General and administrative |
11,841 |
|
|
17,436 |
|
|
121 |
|
|
258 |
|
|
638 |
|
Change in fair value of contingent value rights |
11,312 |
|
|
11,312 |
|
|
— |
|
|
— |
|
|
— |
|
Acquired in-process |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
research and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
development |
— |
|
|
220,454 |
|
|
— |
|
|
— |
|
|
— |
|
Loss from operations |
(41,287 |
) |
|
(277,478 |
) |
|
(721 |
) |
|
(2,129 |
) |
|
(5,319 |
) |
Interest income (expense),
net |
27 |
|
|
35 |
|
|
(9 |
) |
|
(17 |
) |
|
(34 |
) |
Amortization of debt
discount |
— |
|
|
— |
|
|
(37 |
) |
|
(72 |
) |
|
(142 |
) |
Other income (expense),
net |
(191 |
) |
|
(2,699 |
) |
|
— |
|
|
(10 |
) |
|
(12 |
) |
Gain on extinguishment of
debt |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
267 |
|
Net loss |
(41,451 |
) |
|
(280,142 |
) |
|
(767 |
) |
|
(2,228 |
) |
|
(5,240 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
adjustment |
1,094 |
|
|
3,315 |
|
|
45 |
|
|
(25 |
) |
|
(731 |
) |
Total comprehensive loss |
$ |
(40,357 |
) |
|
$ |
(276,827 |
) |
|
$ |
(722 |
) |
|
$ |
(2,253 |
) |
|
$ |
(5,971 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary share
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted |
$ |
(0.65 |
) |
|
$ |
(4.89 |
) |
|
|
|
|
|
|
Weighted average ordinary |
|
|
|
|
|
|
|
|
|
|
|
shares outstanding - basic |
|
|
|
|
|
|
|
|
|
|
|
and diluted |
63,516,656 |
|
|
57,309,693 |
|
|
|
|
|
|
|
Centessa Pharmaceuticals plc (Successor)
and Centessa Predecessor Group
(Predecessor)Condensed Consolidated and Combined
Balance Sheets(unaudited)(amounts in thousands except
share and per share data)
|
Successor |
|
Predecessor |
|
June 30, 2021 |
|
December 31, 2020 |
Total Assets |
|
|
|
Cash and cash equivalents |
$ |
613,759 |
|
$ |
7,227 |
Other assets |
29,998 |
|
4,490 |
Total assets |
$ |
643,757 |
|
$ |
11,717 |
|
|
|
|
Total Liabilities |
|
|
|
Liabilities |
$ |
24,185 |
|
$ |
8,619 |
Contingent value rights |
33,930 |
|
— |
Total liabilities |
58,115 |
|
8,619 |
|
|
|
|
Total combined deficit and
shareholders' equity |
585,642 |
|
3,098 |
Total liabilities, combined
deficit and shareholders' equity |
$ |
643,757 |
|
$ |
11,717 |
Centessa Pharmaceuticals (NASDAQ:CNTA)
Historical Stock Chart
From Jul 2024 to Aug 2024
Centessa Pharmaceuticals (NASDAQ:CNTA)
Historical Stock Chart
From Aug 2023 to Aug 2024