Poxel Announces Third Quarter and Nine Months 2018 Financial Update

LYON, France–(BUSINESS WIRE)–POXEL
SA
(Euronext – POXEL – FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for metabolic
disorders, including type 2 diabetes and non-alcoholic steatohepatitis
(NASH), today announced its cash position and revenue for the third
quarter and nine months ended September 30, 2018.

As of September 30, 2018, cash and cash equivalents were EUR 76.8
million (USD 88.8 million). The cash position reported reflects the
DeuteRx upfront payment of EUR 6.8 million (USD 8 million) for the
acquisition of PXL065 (DRX-065), a clinical-stage program for NASH, and
additional programs, including deuterated drug candidates for metabolic,
specialty and rare diseases. The company’s cash runway extends into 2021
and includes the completion of clinical proof-of-concept studies for
NASH for both PXL770 and PXL065.

Poxel reported revenues of EUR 17.5 million for the quarter ended
September 30, 2018 and EUR 55.0 million for the nine months ended
September 30, 2018 compared with no revenue during the same periods in
2017.

                               

EUR millions

Q1 Q2 Q3 Sept 2018 Q1 Q2 Q3 Sept 2017
    2018     2018     2018     9 months     2017     2017     2017     9 months
Roivant Agreement     8.1             8.1                
Sumitomo Agreement     10.2     19.2     17.5     46.9                
Total revenues     18.3     19.2     17.5     55.0                
 
Unaudited data
 

The revenue reflects a portion of the EUR 36 million upfront payment
received from Sumitomo Dainippon Pharma relating to the strategic
corporate partnership announced on October 30, 2017 and the USD 35
million (EUR 28 million) upfront payment associated with the corporate
partnership announced with Roivant Sciences on February 12, 2018 net of
Poxel’s financial contribution to Roivant. In addition, the revenue also
reflects the Imeglimin Phase 3 program costs in Japan incurred during
the first nine months of 2018 that were re-invoiced to Sumitomo
Dainippon Pharma. Both the upfront payment from Sumitomo Dainippon
Pharma and re-invoiced costs of the Phase 3 Trials of IMeglimin
for Efficacy and Safety (TIMES) program are recognized
according to the percentage of completion for this program.

“I am very pleased to report that during the third quarter we continued
to make substantial progress for Imeglimin in Japan and all three
pivotal Phase 3 TIMES trials are now fully enrolled with over 1,100
patients. We are on track for the data readout in 2019, beginning with
the TIMES 1 efficacy study readout during the second quarter of 2019. We
are continuing to work closely with our partner Sumitomo Dainippon
Pharma in preparing for the Japanese New Drug Application submission in
2020,” said Thomas Kuhn, CEO of Poxel. “For the United States and
Europe, we are working closely with Roivant Sciences and Metavant, a
company formed by Roivant Sciences to develop innovative therapies for
metabolic disorders, on progressing the Imeglimin clinical program,
which is initially targeting patients with type 2 diabetes and
moderate-to-severe chronic kidney disease (CKD stages 3b/4), and
includes a dedicated clinical trial currently ongoing.”

“For our second program, PXL770, we have also continued to make
substantial progress and completed the Phase 1 multiple ascending dose
study. We believe that PXL770 has the potential to treat liver diseases,
such as NASH, and could have the potential to treat additional metabolic
diseases. We are currently preparing for the initiation of a Phase 2a
proof-of-concept program in nonalcoholic fatty liver disease (NAFLD)
patients who likely have NASH,” added Thomas Kuhn. “With our recent
acquisition of DeuteRx’s drug candidate, PXL065 (formerly DRX-065), we
are rapidly expanding our presence in NASH and are one of only a few
biotech companies with two clinical programs in development in this
therapeutic area. The underlying pathophysiological mechanisms that
contribute to the development and progression of NAFLD and NASH are
highly complex and support the need for the development of novel
therapies acting on different targets. Both of our programs, which we
plan on advancing into Phase 2 in 2019, have the potential to be
developed as a monotherapy or in combination together or with other
agents.”

Planned Presentations and Participation at the Following Upcoming
Events

BIO Investor, October 17, 2018, San Francisco
2nd
Annual NASH Summit Europe, October 22-24, 2018, Frankfurt
American
Association for the Study of Liver Diseases, November 9-13, 2018, San
Francisco
Jefferies London Healthcare Conference, November 14-15,
2018, London

Next financial press release: Fourth Quarter 2018 Financial
Update on February 12, 2019

About Imeglimin
Imeglimin is the first clinical candidate in
a new chemical class of oral agents called Glimins by the World Health
Organization. Imeglimin has a unique mechanism of action (“MOA”) that
targets mitochondrial bioenergetics. Imeglimin acts on all three key
organs which play an important role in the treatment of type 2 diabetes:
the liver, muscles and the pancreas, and it has demonstrated glucose
lowering benefits by increasing insulin secretion in response to
glucose, improving insulin sensitivity and suppressing gluconeogenesis.
This MOA has the potential to prevent endothelial and diastolic
dysfunction, which can provide protective effects on micro- and
macro-vascular defects induced by diabetes. It also has the potential
for protective effect on beta-cell survival and function. This unique
MOA offers the potential opportunity for Imeglimin to be a candidate for
the treatment of type 2 diabetes in almost all stages of the current
anti-diabetic treatment paradigm, including monotherapy or as an add-on
to other glucose lowering therapies.

About PXL770
PXL770 is a first-in-class direct adenosine
monophosphate-activated protein kinase (AMPK) activator. AMPK is a
central regulator of multiple metabolic pathways leading to the control
of lipid metabolism, glucose homeostasis and inflammation. Based on its
central metabolic role, targeting AMPK offers the opportunity to pursue
a wide range of indications to treat chronic metabolic diseases,
including diseases that affect the liver, such as non-alcoholic
steatohepatitis (NASH)1.

About PXL065 (formerly DRX-065)
PXL065 is
deuterium-stabilized R-pioglitazone developed by DeuteRx LLC.
Pioglitazone is the most extensively studied drug for NASH and has
demonstrated “resolution of NASH without worsening of fibrosis” in a
Phase 4 trial2. Pioglitazone is the only drug recommended for
biopsy-proven NASH patients by the Practice Guidelines published by the
American Association for the Study of Liver Diseases (AASLD) and the
European Association for the Study of the Liver (EASL).Pioglitazone’s
use for NASH, however, has been limited due to the PPARγ-related side
effects, which include weight gain, bone fractures and fluid retention.

Pioglitazone is a 1:1 mixture of two mirror-image compounds
(stereoisomers) that interconvert in vivo. Using deuterium,
DeuteRx stabilized each stereoisomer and characterized their
dramatically different pharmacological properties. In in vitro studies,
PXL065 has been shown to target MPC as an inhibitor. In preclinical
models, PXL065 exhibits the anti-inflammatory activity and NASH efficacy
associated with pioglitazone with little or no weight gain or fluid
retention, side effects which are associated with the S-stereoisomer.
Based upon preclinical and Phase 1 results to date, PXL065 is expected
to exhibit a better therapeutic profile than pioglitazone for NASH.

About Poxel SA
Poxel uses its development expertise in
metabolism to advance a pipeline of drug candidates focused on the
treatment of metabolic disorders, including type 2 diabetes and
non-alcoholic steatohepatitis (NASH). We have successfully completed the
Phase 2 clinical program for our first-in-class lead product, Imeglimin,
which targets mitochondrial dysfunction, in the U.S., Europe and Japan.
Together, with our partner Sumitomo Dainippon Pharma, we are conducting
the Phase 3 Trials of IMeglimin for Efficacy and Safety (TIMES) program
for the treatment of type 2 diabetes in Japan. Our partner Roivant
Sciences is responsible for Imeglimin’s development and
commercialization in countries outside of Poxel’s partnership with
Sumitomo Dainippon Pharma, including the U.S. and Europe. PXL770, a
first in class direct adenosine monophosphate-activated protein kinase
(AMPK) activator, is advancing into a Phase 2a proof-of-concept program
for the treatment of NASH. PXL770 could also have the potential to treat
additional metabolic diseases. PXL065 (deuterium-stabilized
R-pioglitazone), a mitochondrial pyruvate carrier (MPC), is in Phase 1
and being developed for the treatment of NASH. Poxel also has additional
earlier-stage programs, including deuterated drug candidates for
metabolic, specialty and rare diseases. We intend to generate further
growth through strategic partnerships and pipeline development.
(Euronext: POXEL, www.poxelpharma.com)

1. Source: Smith B. K et al., (2016) Am J Physiol Endocrinol Metab 311,
E730 – E740
2. Cusi,
et al., Ann Intern Med. 2016, 165(5), 305-315
)
3. J Hepatol.
2016, 64(6),1388-402; Hepatology 2018, 67, 328-357

Contacts

Poxel SA
Jonae R. Barnes, +1 617-818-2985
Senior
Vice President, Investor Relations and Public Relations
jonae.barnes@poxelpharma.com
or
Investor
relations / Media – EU/US

Trophic Communications
Gretchen
Schweitzer, +49 89 238 877 34
or
Stephanie May, +49 171 185 56
82
may@trophic.eu
or
Investor
relations / Media – France

NewCap
Alexia Faure/Nicolas
Merigeau, +33 1 44 71 98 55
poxel@newcap.eu

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