REG-Syncona Limited: Blue Earth portfolio expansion, strong performance

SynconaAnnouncement

02/05/2018 07:05

Syncona Ltd

Blue Earth portfolio expansion, strong in market performance

2 May 2018
* Syncona portfolio company Blue Earth signs exclusive worldwide license for
radio-hybrid PSMA agent, rhPSMA-7, a novel, high potential cancer imaging
agent
* The move extends Blue Earth’s leadership position in the
radiopharmaceutical space; complementary to Axumin while offering the
potential for further growth and expanded patient management options in
biochemically recurrent prostate cancer
* Continued strong performance in the commercial launch of Axumin in the US
with strong growth in unit sales in fifth and sixth trading quarters of 3700
and 5000 respectively
* Increase in Blue Earth valuation from £123.1m to £186.8m (9.7p per share
uplift)  
rhPSMA-7 license

Syncona, a leading healthcare company focused on investing in and building
global leaders in life science, is pleased to note that its portfolio company
Blue Earth Diagnostics (Blue Earth) has signed a license for radiohybrid
PSMA-targeted agent, rhPSMA-7, from Scintomics GmbH, Germany, a specialist in
radiopharmaceuticals and radiopharmaceutical technologies.

The move expands Blue Earth’s oncology portfolio, representing an
opportunity to extend its leading position in prostate cancer imaging,
including potential new areas of high unmet need, such as early stage primary
prostate cancer patients. PSMA agents are expected to play an important role
in prostate cancer imaging in the future, possessing favorable clinical
attributes that support broad application, and having the potential to support
both diagnostic and therapeutic applications. If approved, these compounds
would offer the possibility of ‘precision medicine’ for men with prostate
cancer.

The license includes the exclusive worldwide rights to a high quality, broad
family of Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid
agents for prostate cancer imaging, together with an exclusive option to
explore therapeutic uses. The license has been funded directly by Blue Earth.
Syncona has not provided further funding to the business.

Blue Earth will be responsible for the further development of the lead imaging
compound (18)F-rhPSMA-7 in a diagnostic setting. It is currently in
pre-clinical development, but has already been utilised clinically under a
German compassionate use program in men with both primary and recurrent
prostate cancer. Blue Earth will also collaborate with Scintomics to identify
optimised therapeutic candidates for future development.

Blue Earth’s proven track record, and depth of expertise in the rapid
development and global commercialisation of radiopharmaceuticals for cancer
means it is very strongly placed to develop the compound. Having secured
approval by the Food and Drug Administration (FDA) for Axumin in the United
States of America in May 2016, 18 months ahead of plan, and by the European
Medicines Agency in May 2017, the business has extensive commercial
infrastructure and know-how which will optimise the speed of development and
enhance commercial success.  

Axumin commercial launch progress and valuation update

Syncona also announces the continued strong performance of Blue Earth’s
first prostate cancer diagnostic agent, Axumin, following its US commercial
launch in August 2016. Since this time, it has performed strongly, with the
clinical utility of fluciclovine ((18)F) demonstrated by positive change in
patient management data. 1  Unit sales of Axumin in the US have steadily
increased over the first six quarters since launch, 2  and were 3700 and 5000
in the last quarter of 2017 and the first quarter of 2018 respectively. As a
result of strong growth, Blue Earth is now profitable.  

Following a review by Syncona and third parties, which took account of
Axumin’s strong in-market performance and the licensing of rhPSMA-7, Blue
Earth’s valuation as at 31 March 2018 has been increased from £123.1m to
£186.8m (9.7 per share uplift) 

Iraj Ali, Syncona Partner and Director of Blue Earth, said, “We are very
encouraged by the continued strong performance of Blue Earth and the momentum
of Axumin which has now been dosed in over 15,000 patients globally and is
showing clear patient utility. This performance demonstrates the success of
the Syncona strategy to take a hands-on approach to developing high quality
companies taking products all the way to market.

“The move to secure rhPSMA-7, a novel, high-potential PSMA agent with unique
attributes, represents an exciting opportunity. We believe this is one of the
leading assets in the space which gives Blue Earth the ability to extend its
position in prostate cancer diagnostics.”

Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics, said, “This is a
fantastic move for Blue Earth and a natural extension of the portfolio,
as(18)F-rhPSMA-7 and Axumin have unique mechanisms that we believe may
ultimately allow physicians and their patients to select the diagnostic agent
most appropriate to each specific clinical situation. PSMA agents are
innovative compounds which have potential utility in prostate cancer imaging
and therapy. We expect PSMA to play an important role in patient management in
the future.”

Syncona will report full year results on 14 June 2018.

 ENDS 

Enquiries
Syncona Ltd
Siobhan Weaver
Tel: +44 (0) 20 7611 2031
+44 (0) 7921 822 994

Tulchan Communications
Martin Robinson
Lisa Jarrett-Kerr
Tel: +44 (0) 207 353 4200
Copies of this press release and other corporate information can be found on
the company website at: www.synconaltd.com  

This announcement includes information that is inside information as defined
in Article 7 of the Market Abuse Regulation (EU) No.596/2014. The person
responsible for arranging for the release of this announcement on behalf of
Syncona Ltd is [John Bradshaw, Chief Financial Officer], SIML.

Forward-looking statements – this announcement contains certain
forward-looking statements with respect to the portfolio of investments of
Syncona Ltd. These statements and forecasts involve risk and uncertainty
because they relate to events and depend upon circumstances that may or may
not occur in the future. There are a number of factors that could cause actual
results or developments to differ materially from those expressed or implied
by these forward-looking statements and forecasts. Nothing in this
announcement should be construed as a profit forecast. 

About Syncona:

Syncona is a leading FTSE250 healthcare company focused on investing in and
building global leaders in life science. Our vision is to deliver
transformational treatments to patients in truly innovative areas of
healthcare while generating superior returns for shareholders. Our current
investment portfolio consists of seven high quality companies in life science
and a leading range of fund investments. 

We seek to partner with the best, brightest and most ambitious minds in
science to build globally competitive businesses. We are established leaders
in gene therapy, cell therapy and advanced diagnostics, and focus on
delivering dramatic efficacy for patients in areas of high unmet need.

Our fund investments represent a productively deployed evergreen funding base
which enables us to take a long term approach to investing in life sciences as
we target the best new opportunities and support our existing portfolio
companies to grow and succeed.

Syncona is aligned with two of the premium charitable funders in UK science,
the Wellcome Trust, original founder of Syncona, and Cancer Research UK, both
of which are significant shareholders in our business.  We make a donation of
0.3% of Net Asset Value to a range of charities each year.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a molecular imaging diagnostics company focused on
the development and commercialisation of novel PET imaging agents to inform
clinical management and guide care for cancer patients in areas of unmet
medical need. Formed in 2014, Blue Earth Diagnostics is led by recognised
experts in the clinical development and commercialisation of innovative
nuclear medicine products.

Blue Earth Diagnostics’ first approved and commercially available product is
Axumin(®) (fluciclovine (18)F), a novel molecular imaging agent approved in
the United States and Europe for use in PET imaging to detect and localize
prostate cancer in men experiencing suspected biochemical recurrence. Blue
Earth Diagnostics is funded by Syncona Limited, an investment company listed
on the London Stock Exchange (LON: SYNC). For more information, visit:
www.blueearthdx.com.

About rhPSMA-7

rhPSMA-7 was invented at the Technical University of Munich, Germany, where it
has been utilized clinically in the diagnostic imaging of men with both
primary and recurrent prostate cancer. (18)F-rhPSMA-7 consists of a
prostate-specific membrane antigen (PSMA) receptor ligand, which attaches to
and is internalized by prostate cancer cells, and is labeled with the 18F
radioisotope for PET imaging. rhPSMA-7 and other “rh” compounds, can also
be labeled with the radioisotope 177Lu for therapeutic use.

Scintomics’ unique theranostic “rh” technology allows for the efficient
labelling of PSMA-targeted agents with imaging radioisotopes, such as 18F or
68Ga, or therapeutic radioisotopes such as 177Lu. Depending on the type of
radioisotope attached, the resulting radiopharmaceutical may be used either as
an imaging agent to locate prostate cancer cells in the body or as a
therapeutic which targets cancer cells with high energy radiation. These
innovative compounds offer the possibility of “precision medicine” for men
with prostate cancer.

About Axumin(®) (fluciclovine ((18)F))

Axumin (fluciclovine ((18)F)) injection is a novel product indicated for use
in positron emission tomography (PET) imaging to identify suspected sites of
prostate cancer recurrence in men. Recurrence of prostate cancer is suspected
by an increase in prostate specific antigen (PSA) levels following initial
therapy. PET imaging with Axumin may identify the location and extent of such
recurrence.

Axumin was developed to enable visualisation of the increased amino acid
transport that occurs in many cancers, including prostate cancer. It consists
of a synthetic amino acid that is preferentially taken up by prostate cancer
cells compared with surrounding normal tissues, and is labeled with the
radioisotope (18)F for PET imaging.

Fluciclovine (18)F was invented at Emory University in Atlanta, Ga. USA, with
much of the fundamental clinical development work carried out by physicians at
Emory University’s Department of Radiology and Imaging Sciences.

Axumin is the first product commercialised by Blue Earth Diagnostics. The
molecule is being investigated by Blue Earth Diagnostics for other potential
cancer indications, such as glioma.

 1  FALCON Change in Management study demonstrated that 61.2% of patients had
their treatment path changed following an Axumin scan.

 2  First 6 quarters of units sold respectively are: 200, 800, 1800, 2500,
3700 and 5000 to March 31 2018.



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