TIDMMXCT TIDMTTM
RNS Number : 2421A
MaxCyte, Inc.
20 January 2020
MaxCyte, Inc.
("MaxCyte" or the "Company")
Trading Update
-- Revenue exceeds market expectations
-- Five new gene-editing cell therapy deals signed in 2019;
eight clinical and commercial cell therapy deals now in total;
potential pre-commercial milestones in excess of $650 million
-- Launch of ExPERT(TM) technology supporting high demand for instruments and disposables
-- Lead wholly-owned drug development programme progressing through Phase I clinical trial
-- CARMA subsidiary established and seeking investors and new
partnerships for CARMA(TM) platform
-- Management to host conference call today at 2:00 p.m. UK - details below
Gaithersburg, Maryland - 20 JANUARY 2020: MaxCyte (LSE: MXCT,
MXCS), the global clinical-stage cell-based therapies and life
sciences company, provides a trading update for the year ended 31
December 2019. MaxCyte will announce its audited results for the
year ended 31 December 2019 in April 2020.
2019 Financials
MaxCyte is trading ahead of market expectations for the 2019 FY.
2019 FY revenues are expected to increase approximately 30% year
over year to approximately $21.6m compared to the prior year (2018:
$16.7m). Revenue growth accelerated in H2 2019, increasing
approximately 36% over H2 2018 (approximately $13.2m compared to
$9.7m). Cash and cash equivalents, including short-term
investments, at year-end were approximately $16.7m.
Life Sciences business
Partnered programmes / Commercial license agreements
MaxCyte remained at the forefront of enabling well-financed
partners' novel approaches to treating serious diseases. In 2019,
the Company continued to accelerate progress, signing five
clinical/commercial licenses (including recently announced Kite
(Gilead), Editas Medicine, Vor Biopharma and KSQ Therapeutics) and
now has more than 100 cell therapy programmes under license of
which more than 70 are licensed for clinical use.
In November 2019, MaxCyte partners CRISPR Therapeutics and
Vertex Pharmaceuticals reported positive interim data from the
first two patients enrolled in two Phase I/II trials assessing
their CRISPR/Cas9 gene-edited therapy CTX001 for a pair of blood
disorders, beta thalassemia and sickle cell disease. This is the
first clinical trial of a gene-editing candidate sponsored by U.S.
companies and demonstrates the value of MaxCyte's enablement of
CRISPR/Cas9 therapies as a new class of transformative medicines to
treat serious diseases.
In December 2019, MaxCyte partner, Precision BioSciences,
presented updated interim clinical data at the American Society of
Hematology (ASH) Annual Meeting on its lead program, PBCAR0191, a
novel CD19-targeted allogeneic CAR-T therapy candidate to treat
relapsed/refractory Non-Hodgkin's lymphoma (NHL) and B-cell acute
lymphoblastic leukemia (B-ALL), with additional data on this
program expected before the end of 2020. Furthermore, Precision
BioSciences announced last week the FDA acceptance of the IND for
PBCAR269A, a BCMA targeted genome edited allogeneic CAR-T therapy
candidate for multiple myeloma that will begin dosing patients in
2020. With this IND approval, Precision BioSciences now has three
genome edited allogeneic therapies in clinical stage
development.
An additional MaxCyte partner, Editas Medicine, also presented
data at the ASH Meeting in December 2019 on its EDIT-301 program,
an ex vivo gene editing-based asset for sickle cell disease. The
data showed a clean off-target editing profile and robust (50%)
fetal hemoglobin (HbF) induction upon engraftment in mice. The
company continues to rapidly advance this lead program through
IND-enabling activities.
Instruments and disposables
MaxCyte launched its next generation of instruments and
disposables, ExPERT(TM) , during the first half of 2019, with
positive feedback and strong interest from existing and new
customers. 2019 FY's strong growth was supported by positive
acceptance by customers of the launch of the ExPERT instruments and
the start of the roll out of the Company's expanded processing
assembly line.
CARMA
MCY-M11 trial
Dosing began in October 2019 in the third cohort in MaxCyte's
Phase I dose-escalation trial with MCY-M11, MaxCyte's lead,
wholly-owned, non-viral mRNA-based cell therapy candidate from its
CARMA(TM) platform. In October 2019, the mesothelin-targeting
chimeric antigen receptor (CAR) therapy completed dosing of the
second cohort of patients with relapsed/refractory ovarian cancer
and peritoneal mesothelioma and no dose-limiting toxicities or
related serious adverse events were observed. A fourth dosing
cohort is expected to commence in the first quarter of 2020 and the
trial remains on track to report preliminary clinical trial results
by mid-2020. At the start of 2020, MaxCyte established its CARMA
program as a wholly owned subsidiary to facilitate independent
investment and new partnerships to advance the CARMA platform. The
Company expects CARMA to be self-funded by 2021.
Doug Doerfler, Chief Executive Officer, said: "MaxCyte is
well-positioned in the rapidly growing, global gene editing and
cell therapy space. We have continued to make impressive progress
across all areas of the business and our outlook is exceptionally
positive. Our financial performance is strong, reflecting the high
demand for our instruments and disposables business as well as
robust revenue generation from an ever increasing number of
commercial licenses. Notably, we entered one commercial agreement
in 2017, two in 2018, and five in 2019 and continue to be selected
as the partner of choice by leading gene editing cell therapy
developers, globally. In our own high-potential CARMA pipeline, we
have made great strides in the clinic and have seen continued good
progress with our Phase I clinical trial with MCY-M11.
"We are very encouraged by the recent promising data released by
our commercial partners, CRIPSR Therapeutics, Precision Biosciences
and Editas Medicine. Many of MaxCyte's partners, including the
three aforementioned plus Kite, a Gilead Company, Vor Biopharma and
KSQ Therapeutics, use our technology to enable pioneering therapies
using CRIPSR and other gene editing techniques and we are excited
by the initial results presented by certain partners at the annual
ASH Meeting this year. We believe this bodes well for the wider
adoption of gene editing techniques in other applications.
"We have now signed eight clinical/commercial cell therapy
licenses, including five gene-editing cell therapy-focused deals in
2019. These clinical partnerships have delivered a record year of
milestone payments for MaxCyte, and the growth in the number of
partners and the advancement of their clinical programs will drive
an increasing amount of development milestone payments to MaxCyte
in fiscal year 2020 and beyond. Consequently, this will further
boost our revenues over and above the momentum we have in our
instruments and disposables business. 2020 is set to be a major
year for MaxCyte as we reinforce our industry-leading position in
the market."
Conference call today
A conference call with Q&A for analysts hosted by CEO Doug
Doerfler, CFO Ron Holtz and CMO Claudio Dansky Ullmann will be held
at 2 p.m. GMT today, Monday 20 January 2020. Dial-in details are as
follows:
Participant dial-in (UK): 0800 376 7922
Participant dial-in (US): 1 866 966 1396
International dial-in: +44 (0) 2071 928000
Conference ID: 5382547
A replay facility will be made available on the MaxCyte
Website.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
About MaxCyte
MaxCyte is a clinical-stage global cell-based therapies and life
sciences company applying its proprietary cell engineering platform
to deliver the advances of cell-based medicine to patients with
high unmet medical needs. Through its life sciences business,
MaxCyte leverages its Flow Electroporation(R) Technology to enable
its biopharmaceutical partners to advance the development of
innovative medicines, particularly in cell therapy. MaxCyte has
placed its technology worldwide, including with all of the top ten
global biopharmaceutical companies. The Company now has more than
100 partnered programme licenses in cell therapy with more than 70
licensed for clinical use. The Company has now signed eight
clinical/commercial licenses with leading cell therapy developers
and the potential pre-commercial milestones from these
relationships now exceeds $650 million. With its robust delivery
technology platform, MaxCyte helps its partners to unlock the full
potential of their products. MaxCyte is also developing novel CARMA
therapies, with its first drug candidate in a Phase I clinical
trial. CARMA is MaxCyte's mRNA-based proprietary therapeutic
platform for autologous cell therapy for the treatment of solid
cancers. MaxCyte has established CARMA as a wholly owned subsidiary
to facilitate independent investment and new partnerships to
advance the CARMA platform. For more information, visit
www.maxcyte.com.
For further information, please contact:
MaxCyte Inc.
Doug Doerfler, Chief Executive Officer
Ron Holtz, Chief Financial Officer +1 301 944 1660
Nominated Adviser and Joint Corporate
Broker
Panmure Gordon
Emma Earl
Freddy Crossley
Corporate Broking
James Stearns +44 (0)20 7886 2500
Joint Corporate Broker
Numis Securities Limited
James Black
Duncan Monteith +44 (0)20 7260 1000
Financial PR Adviser
Consilium Strategic Communications +44 (0)203 709 5700
Mary-Jane Elliott maxcyte@consilium-comms.
Chris Welsh com
Sukaina Virji
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Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identi ed by their use of terms and phrases such as "believe",
"could", "should", "expect", "envisage", "estimate", "intend",
"may", "plan", "potentially", "will" or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward-looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward looking statements re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
A number of factors could cause actual results to differ
materially from the results and expectations discussed in the
forward-looking statements, many of which are beyond the control of
the Company. In particular, the outcome of clinical trials
(including, but not limited to the Company's CARMA trial) may not
be favourable or potential milestone payments associated with the
Company's licensed programmes may not be received. In addition,
other factors which could cause actual results to differ materially
include risks associated with vulnerability to general economic and
business conditions, competition, regulatory changes, actions by
governmental authorities, the availability of capital markets,
reliance on key personnel, uninsured and underinsured losses and
other factors. Although any forward-looking statements contained in
this announcement are based upon what the Directors believe to be
reasonable assumptions, the Company cannot assure investors that
actual results will be consistent with such forward looking
statements. Accordingly, readers are cautioned not to place undue
reliance on forward looking statements. Subject to any continuing
obligations under applicable law or any relevant AIM Rule
requirements, in providing this information the Company does not
undertake any obligation to publicly update or revise any of the
forward looking statements or to advise of any change in events,
conditions or circumstances on which any such statement is
based.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
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END
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