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Tuesday, September 17th, 2019

Poxel Announces Fourth Quarter 2017 Financial Update

Closed
by January 22, 2018 General

Poxel SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for metabolic
disorders, including type 2 diabetes, announced today its cash position
and revenues for the fourth quarter of 2017.

As of December 31, 2017, cash and cash equivalents were €53.4 million
($64.1 million).

During the fourth quarter, Poxel generated revenues of €5.2 million
($5.9 million). The revenues reflect 1) a portion of the €36 million
($42 million) upfront payment received from Sumitomo Dainippon Pharma
relating to the strategic corporate partnership announced on October 30,
2017 and 2) the Imeglimin Phase 3 program costs in Japan incurred during
the fourth quarter that were re-invoiced to Sumitomo Dainippon Pharma
and recognized by Poxel as revenue. Both the upfront payment and
re-invoiced costs are recognized according to the percentage of
completion of the Phase 3 Trials of IMeglimin for Efficacy
and Safety (TIMES) program.

Re-invoiced costs incurred during the fourth quarter will be paid in the
first quarter of 2018. In addition, during the quarter, there was a low
double-digit percent one-time payment made to Merck Serono relating to
the upfront payment that Poxel received from Sumitomo Dainippon Pharma.
The cash burn rate during the fourth quarter was in line with the
Company’s expectations.

During 2017, the Company made significant clinical progress with respect
to Imeglimin and PXL770 and announced a substantial corporate milestone
with the execution of the strategic partnership with Sumitomo Dainippon
Pharma for the development and commercialization of Imeglimin in Japan,
China and 11 other countries* during the fourth quarter. This agreement
included an upfront payment plus future potential development milestone
payments and sales-based payments of up to approximately €219 million
($257 million) and escalating double-digit royalties on net sales. Poxel
and Sumitomo Dainippon Pharma are jointly developing Imeglimin for the
treatment of type 2 diabetes in Japan, and Sumitomo Dainippon Pharma is
assuming the Phase 3 and commercialization costs. For China and 11 other
countries, Sumitomo Dainippon Pharma will be solely responsible for
Imeglimin development and commercialization.

“Following the signing of the strategic corporate partnership with
Sumitomo Dainippon Pharma at the end of October 2017, we executed
against our plan and met our goal to initiate the Phase 3 TIMES program
for Imeglimin in Japan by the end of the year. Our near-term focus in
Japan is the successful execution of the TIMES program and to work
closely with our colleagues at Sumitomo Dainippon Pharma to support the
Japanese New Drug Application submission targeted for 2020,” said Thomas
Kuhn, CEO of Poxel. “We believe our corporate partnership with Sumitomo
Dainippon Pharma is a very important validation of Imeglimin’s strong
clinical profile and data results as well as of our internal
capabilities to advance a program to a critical value inflection point.
Another important corporate priority is to continue to seek a
partnership for Imeglimin that includes the U.S., Europe and other
countries worldwide.”

“For our second program, PXL770, we continued to advance the Phase 1b
multiple ascending dose trial during the fourth quarter. Through its
unique mechanism of action that directly activates adenosine
monophosphate-activated protein kinase (AMPK), PXL770 acts on a very
important biological target, which has the potential to treat numerous
chronic metabolic diseases,1 including diseases that affect
the liver, such as non-alcoholic steatohepatitis (NASH),” continued
Thomas Kuhn. “Pending successful completion of the Phase 1b program, we
are planning to initiate a Phase 2a proof-of-concept study in NASH
during the second half of 2018, and we are also exploring other
metabolic diseases for proof-of-concept studies. In addition, we are
assessing further opportunities to strengthen our pipeline.”

Planned Presentations at the Following Upcoming Events

  • Cowen 38th Annual Health Care Conference, March 12-14,
    2018, Boston, Massachusetts
  • Oppenheimer 28th Annual Healthcare Conference, March 20-21,
    2018, New York City, New York

Next financial press release: 2017 full year results on March 22,
2018

About Imeglimin

Imeglimin is the first clinical candidate in a new chemical class of
oral agents called the 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 this central 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).

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. We have successfully completed our Phase 2
clinical program for our first-in-class lead product, Imeglimin, which
targets mitochondrial dysfunction, in the U.S., Europe and Japan, and
the Phase 3 Trials of IMeglimin for Efficacy
and Safety (TIMES) program in Japan is underway. Our second
program, PXL770, a direct AMPK activator, is completing Phase 1
development. We intend to generate further growth through strategic
partnerships and pipeline development. (Euronext: POXEL, www.poxelpharma.com)

*Including: The Republic of Korea, Taiwan, Indonesia, Vietnam, Thailand,
Malaysia, The Philippines, Singapore, Republic of the Union of Myanmar,
Kingdom of Cambodia, and Lao People’s Democratic Republic.

1 Source: Srivastava, R. A et al., (2012) Journal of Lipids
Research 53, 2490- 2514

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