Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
company (“Centessa” or “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 September 30, 2021, and provided a
review of recent accomplishments and anticipated upcoming
milestones.
“This has been a very productive quarter, as we continued to
build our team and shared the first two data updates since the
formation of Centessa earlier this year. We announced positive
topline data from our proof-of-concept study evaluating SerpinPC in
severe hemophilia subjects and seek to move this program into
registrational studies in 2022. More recently, in our Phase 1 Part
B study evaluating ZF874 for the treatment of AATD, we reported
encouraging proof-of-mechanism data from three initial PiMZ
subjects and plan to provide an update in 2022 once we have data on
PiZZ subjects at multiple doses. In addition to these exciting
early results, we are continuing to progress programs across our
entire portfolio,” said Saurabh Saha, MD, PhD, Chief Executive
Officer of Centessa.
Dr. Saha continued, “Our recent $300 million financing facility
with Oberland Capital will provide additional financial flexibility
to help further advance our portfolio and better enable the Company
to pursue strategic business development opportunities.”
Recent Business Highlights
- Announced Positive Topline Data from Proof-of-Concept
Study of SerpinPC in Severe Hemophilia A and B Subjects Not on
Prophylaxis: In September, the Company, together with
subsidiary ApcinteX Limited (“ApcinteX”), announced positive
topline results from the Phase 2a part of AP-0101, the six-month
repeat dose portion of the ongoing first-in-human proof-of-concept
study evaluating SerpinPC in severe hemophilia A and B subjects. In
the highest dose cohort, SerpinPC reduced the self-reported all
bleeds Annualized Bleeding Rate (“ABR”) by 88% during the last
12 weeks of treatment (pre-specified primary assessment period) as
compared to the all bleeds ABR prospectively measured during the
pre-exposure observation period. In this cohort, five out of eight
subjects had zero or one bleed during the 12-week pre-specified
primary assessment period and self-reported spontaneous joint
bleeds ABR was reduced by 94%. SerpinPC was well-tolerated with no
sustained elevations in D-dimer.
- Demonstrated Proof-of-Mechanism in First Three PiMZ
Subjects Dosed in Part B of Phase 1 Study Evaluating
ZF874: In November, the Company, together with subsidiary
Z Factor Limited (“Z Factor”), announced proof-of-mechanism data
from the first three PiMZ subjects dosed in the ongoing repeat dose
Phase 1 Part B study of ZF874 in subjects carrying at least one
Z-mutated alpha-1-antitrypsin allele (PiXZ). These are the first
clinical data that suggest a pharmacological chaperone may be able
to sufficiently increase functional Z-A1AT to levels greater than
11 micromolar in individuals with the PiZZ genotype, levels that
have been the basis for approval of the existing A1AT augmentation
therapies. Because one subject showed a delayed, reversible
increase in ALT and AST, the Company will be exploring lower doses
and different dosing regimens. The Company is taking steps to
increase enrollment by adding sites in the United Kingdom and
intends to expand the study to the European Union.
- Secured $300 Million Financing Facility with Oberland
Capital Management LLC: In October, the Company entered
into a $300 million financing facility (“Oberland
Agreement”). Under the terms of the agreement, Oberland Capital
Management LLC (“Oberland Capital”) will purchase up to $300
million of 6-year, interest-only, senior secured notes from the
Company, including $75 million funded in October, a total of $125
million available within 24 months at the option of the Company,
and $100 million available to fund M&A, in-licensing, or other
strategic transactions, at the option of the Company and Oberland
Capital. The Company’s pro forma cash position as of September 30,
2021, following receipt of the net proceeds from the first tranche
of notes in October, was $653.4 million.
- Centessa Subsidiary, Orexia Therapeutics, Initiated
Collaboration with Schrödinger to Discover Novel Orexin Receptor
Agonists: In October, Orexia entered into an exclusive
collaboration with Schrödinger focused on the discovery of novel
therapeutics targeting the orexin-2 receptor (“OX2R”), which is
known to play a role in a broad spectrum of sleep disorders
including narcolepsy. The collaboration provides Orexia with
substantial access to Schrödinger’s entire computational platform
as well as Schrödinger’s extensive expertise in ultra-large-scale
deployment of its technology.
- Leadership Team Strengthened by Appointment of Chief
Innovation Officer: In October, the Company announced the
appointment of David Grainger, PhD, as Chief Innovation Officer.
Dr. Grainger will be a member of the Company’s executive leadership
team and will be responsible for the overall management of the
scientific and research activities.
Upcoming Milestones
- ApcinteX’s SerpinPC, an activated protein C
inhibitor for Hemophilia: During 2022, the Company expects to
launch a global full development plan aimed at one or more
registrations to maximize the broad potential for SerpinPC in the
hemophilia space. The Company also expects to provide an update in
2022 on the ongoing Phase 2a open-label extension study.
- Palladio Biosciences’ lixivaptan, a
vasopressin V2 receptor antagonist for Autosomal Dominant
Polycystic Kidney Disease (“ADPKD”): By the end of 2021, the
Company expects to report initial safety data from the ongoing
open-label ALERT Study of subjects who previously discontinued
JYNARQUE® (tolvaptan) due to liver toxicity. The Company expects to
dose the first subject in the registrational Phase 3 ACTION Study
by 1Q 2022.
- Z Factor’s ZF874, a Z-A1AT folding corrector
for AATD: During 2022, the Company expects to report on additional
PiMZ as well as PiZZ subjects from the expanded Phase 1 Part B. The
Company anticipates starting a global Phase 2 study in 2Q 2022,
with 6-month dosing to commence in 2H 2022 once a dose and regimen
are established and chronic animal toxicology is completed.
- Pega-One’s imgatuzumab, a non-fucosylated
anti-epidermal growth factor receptor (“EGFR”) monoclonal antibody
(“mAb”) for Advanced Cutaneous Squamous Cell Carcinoma (“CSCC”):
The Company expects to initiate an open-label, single arm, Phase 2
trial of imgatuzumab in advanced CSCC by the end of 2021 and dose
the first subject in 1Q 2022.
- Capella Bioscience’s CBS001, an anti-LIGHT mAb
for Idiopathic Pulmonary Fibrosis (“IPF”): In 1H 2022, the Company
expects to submit a Clinical Trial Authorisation (“CTA”)
application with the UK Medicines and Healthcare products
Regulatory Agency (“MHRA”) for CBS001 and commence a Phase 1 study
shortly thereafter.
- Capella Bioscience’s CBS004, an anti-BDCA2 mAb
for Systemic & Cutaneous Lupus Erythematosus (“SLE/CLE”) and
Systemic Sclerosis (“SSc”): In 2H 2022, the Company expects to
submit an Investigational New Drug (“IND”) application with the
U.S. Food and Drug Administration (“FDA”) for CBS004 and commence a
Phase 1 study shortly thereafter.
- Orexia Therapeutics’ oral orexin receptor
agonist for Narcolepsy Type 1 (“NT1”), and other
neurological disorders characterized by excessive daytime
sleepiness: The Company is on track to select a candidate
for its oral program and commence IND enabling activities in
2022.
- Janpix Limited’s dual degrader of Signal
Transducer and Activator of Transcription proteins 3 and 5
(“STAT3” and “STAT5”) for Acute
Myeloid Leukemia: By the end of 2021, the Company expects
to select a candidate for the STAT3/5 program.
- PearlRiver Bio’s small molecule kinase
inhibitors for EGFR mutations in Non-Small Cell Lung
Cancer (“NSCLC”): The Company is
progressing an EGFR-C797S mutation inhibitor for the treatment of
NSCLC and expects to report on ongoing candidate selection in 2022.
The Company will not select a candidate for its exon20 mutation
program in 2021 and is presently reviewing this program.
Third Quarter 2021 Financial Results
Cash Position: Cash and cash equivalents were
$578.8 million as of September 30, 2021, compared to $613.8
million as of June 30, 2021, a reduction of $35 million. On a pro
forma basis as of September 30, 2021, cash and cash equivalents
were $653.4 million, inclusive of the net proceeds of $74.6 million
from the first tranche received under the Oberland Agreement on
October 4, 2021. Based on the current, non-risk-adjusted operating
plan, the Company expects the cash and cash equivalents as of
September 30, 2021, plus the net proceeds of the first tranche,
supplemented by the additional funds available under the Oberland
Agreement, if drawn, to fund its operations into mid-2024.
Research & Development (“R&D”)
Expenses: R&D expenses for the Company for the three
months ended September 30, 2021, were $25.9 million, compared to
$1.9 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) for the three months ended September 30, 2020. The $23.9
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 September 30, 2021, were $12.5 million, compared to
$0.2 million for the Centessa Predecessor Group during the
three months ended September 30, 2020. The $12.2 million
increase is primarily attributable to public company costs, the
operating costs of Centessa Pharmaceuticals plc and Centessa
Pharmaceutical Inc., including professional fees and personnel
costs, and the increase in operating costs resulting from the
acquired Centessa subsidiaries. In addition, the increase in
personnel related expenses includes an increase in headcount and an
increase in share-based compensation expense of $2.6 million which
is primarily attributable to the equity awards issued at the time
of the acquisition and the subsequent issuances of awards through
September 30, 2021.
Net Loss: Net Loss attributable to common
stockholders for the quarter ended September 30, 2021, was $40.2
million, or $0.45 per share, compared to a net loss of $2.1 million
for the Centessa Predecessor Group for the quarter ended September
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; our collaborations and the intended benefits
thereof; 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; the
availability of funding to operate our business and pursue our
objectives; and our 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,
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
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 and any other variants.
These and other risks concerning our programs and operations are
described in additional detail in our reports that we file with the
SEC. We explicitly disclaim any obligation to update any
forward-looking statements except to the extent required by
law.
Contacts:Investors:Jennifer
Porcelli, Head of Investor RelationsCentessa
PharmaceuticalsJennifer.Porcelli@centessa.com
Media:Dan Budwick, 1ABdan@1abmedia.com
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 September30,
2021 |
|
Period fromJanuary 30,
2021throughSeptember
30,2021 |
|
Period fromJanuary 1,
2021throughJanuary
29,2021 |
|
Three monthsended
September30,2020 |
|
Nine monthsendedSeptember
30,2020 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
25,850 |
|
|
54,126 |
|
|
600 |
|
|
1,923 |
|
|
6,604 |
|
General and administrative |
12,464 |
|
|
29,900 |
|
|
121 |
|
|
193 |
|
|
831 |
|
Change in fair value of contingent value rights |
— |
|
|
11,312 |
|
|
— |
|
|
— |
|
|
— |
|
Acquired in-process research and development |
— |
|
|
220,454 |
|
|
— |
|
|
— |
|
|
— |
|
Loss from operations |
(38,314 |
) |
|
(315,792 |
) |
|
(721 |
) |
|
(2,116 |
) |
|
(7,435 |
) |
Interest income (expense),
net |
65 |
|
|
100 |
|
|
(9 |
) |
|
(22 |
) |
|
(56 |
) |
Amortization of debt
discount |
— |
|
|
— |
|
|
(37 |
) |
|
(78 |
) |
|
(220 |
) |
Other income (expense),
net |
(1,906 |
) |
|
(4,605 |
) |
|
— |
|
|
6 |
|
|
(5 |
) |
Gain on extinguishment of
debt |
— |
|
|
— |
|
|
— |
|
|
72 |
|
|
339 |
|
Net loss |
(40,155 |
) |
|
(320,297 |
) |
|
(767 |
) |
|
(2,138 |
) |
|
(7,377 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
(487 |
) |
|
2,828 |
|
|
45 |
|
|
372 |
|
|
(359 |
) |
Total comprehensive loss |
$ |
(40,642 |
) |
|
$ |
(317,469 |
) |
|
$ |
(722 |
) |
|
$ |
(1,766 |
) |
|
$ |
(7,736 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary share - basic and diluted |
$ |
(0.45 |
) |
|
$ |
(4.60 |
) |
|
|
|
|
|
|
Weighted average ordinary shares outstanding - basic and
diluted |
89,899,454 |
|
|
69,597,648 |
|
|
|
|
|
|
|
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 |
|
September 30, 2021 |
|
December 31, 2020 |
Total Assets |
|
|
|
Cash and cash equivalents |
$ |
578,815 |
|
|
$ |
7,227 |
|
Other assets |
33,392 |
|
|
4,490 |
|
Total assets |
$ |
612,207 |
|
|
$ |
11,717 |
|
|
|
|
|
Total Liabilities |
|
|
|
Liabilities |
$ |
29,144 |
|
|
$ |
8,619 |
|
Contingent value rights |
33,930 |
|
|
— |
|
Total liabilities |
63,074 |
|
|
8,619 |
|
|
|
|
|
Total combined deficit and
shareholders' equity |
549,133 |
|
|
3,098 |
|
Total liabilities, combined
deficit and shareholders' equity |
$ |
612,207 |
|
|
$ |
11,717 |
|
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