Poxel Announces Fourth Quarter and Full Year 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 fourth
quarter and the twelve months ended December 31, 2018.

As of December 31, 2018, cash and cash equivalents were EUR 66.7 million
(USD 76.4 million).

Poxel reported revenues of EUR 19.6 million for the quarter ended
December 31, 2018 and EUR 74.6 million for the twelve months ended
December 31, 2018 compared with revenues of EUR 5.3 million during the
same period in 2017.

                   
EUR millions Q1 Q2 Q3 Q4 FY 2018 Q1 Q2 Q3 Q4 FY 2017
2018   2018   2018   2018   12 months   2017   2017   2017   2017   12 months
Roivant Agreement   8.1       .1   8.2          
Sumitomo Agreement   10.2   19.2   17.5   19.5   66.4         5.3   5.3
Total revenues   18.3   19.2   17.5   19.6   74.6         5.3   5.3
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 twelve months ended December 31, 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 we made substantial progress advancing
the Company in 2018. Our significant accomplishments include signing an
agreement with Roivant Sciences for Imeglimin in the US, Europe and the
rest of the world not covered in the agreement with Sumitomo Dainippon
Pharma, fully enrolling all three Imeglimin Phase 3 TIMES trials with
over 1,100 patients in Japan, advancing PXL770 for the treatment of NASH
and acquiring PXL065, a second clinical-stage program for the treatment
of NASH,” said Thomas Kuhn, CEO of Poxel.

“This year will be very important for Imeglimin beginning early in the
second quarter with the Phase 3 TIMES 1 monotherapy double-blind
placebo-controlled randomized efficacy top-line results, which will be
followed by top-line data for the TIMES 3 16-week double-blind
placebo-controlled randomized part of the study expected mid-year. For
the TIMES 2 and the full TIMES 3 data, including the additional 36-week
open-label part of the study, top-line results are anticipated during
the fourth quarter of 2019. In parallel to leading the Phase 3 TIMES
program, we have been working very closely with our partner Sumitomo
Dainippon Pharma in preparing for the Japanese New Drug Application for
Imeglimin for the treatment of type 2 diabetes, which is targeted for
2020,” said Thomas Kuhn, CEO of Poxel. “For the United States and
Europe, we are collaborating with Roivant Sciences and Metavant, a
company formed by Roivant Sciences to develop innovative therapies for
metabolic disorders, on advancing the Imeglimin clinical program. This
program will initially target patients with type 2 diabetes and
moderate-to-severe chronic kidney disease (CKD stages 3b/4) and includes
a dedicated clinical trial that is currently ongoing.”

“In addition, PXL770 for the treatment of NASH is expected to enter a
Phase 2a program during the first quarter of 2019. For PXL065, we plan
to initiate the Phase 2 program for the treatment of NASH during second
half of 2019 following the completion of the Phase 1 program,” continued
Thomas Kuhn. “We have expanded 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 nonalcoholic fatty
liver disease and NASH are highly complex and support the need for the
development of novel therapies acting on different targets. Both of our
programs 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 Asia, March 5-6, 2019, Tokyo, Japan
Oppenheimer
29th Annual Healthcare Conference, March 19-20, 2019, New York City

Next Financial Press Release: Full Year 2018 Financial Statement
expected on March 21, 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 the TIMES Program
TIMES (Trials of Imeglimin
for Efficacy and Safety), the Phase 3 program
for Imeglimin for the treatment of type 2 diabetes in Japan, consists of
three pivotal trials involving over 1,100 patients. The TIMES program
includes the following three trials that will be performed using the
dose of 1,000 mg twice-daily:

TIMES 1: A Phase 3, 24-week, double-blind placebo-controlled,
randomized, monotherapy study to assess the efficacy, safety and
tolerability of Imeglimin in Japanese patients with type 2 diabetes,
using the change in HbA1c as the primary endpoint. Secondary endpoints
of the trial will include other standard glycemic and non-glycemic
parameters.

TIMES 2: A Phase 3, 52-week, open-label, parallel-group study to
assess the long-term safety and efficacy of Imeglimin in Japanese
patients with type 2 diabetes. In this study, Imeglimin will be
administrated orally as a monotherapy or combination therapy with
existing hypoglycemic agents, including a DPP4 inhibitor, SGLT2
inhibitor, biguanide, sulphonylurea and GLP1 receptor agonist.

TIMES 3: A Phase 3, 16-week, double-blind, placebo-controlled,
randomized study with a 36-week open-label extension period to evaluate
the efficacy and safety of Imeglimin in combination with insulin in
Japanese patients with type 2 diabetes and inadequate glycemic control
on insulin therapy.

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
PXL065, formerly DRX-065, is
deuterium-stabilized R-pioglitazone. 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 (R- and
S-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) inhibitor, 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
Senior Vice President,
Investor Relations and Public Relations
jonae.barnes@poxelpharma.com
+1 617 818
2985

Investor relations / Media – EU/US
Trophic
Communications
Stephanie May or Joanne Tudorica
may@trophic.eu
+49
89 238 877 34 or +49 171 185 56 82

Investor relations
/ Media – France

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

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