Poxel Reports Results for First Half 2016

LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for type 2 diabetes,
today announced its results for the first half of 2016 ended June 30,
2016, and provided a corporate update.
“We have made significant progress in continuing to build out
Imeglimin’s product profile and scientifically differentiate its
mechanism of action from other drugs, as evidenced by the new data
presented and published this year,” said Thomas Kuhn, CEO of Poxel.
“Additionally, we have continued to advance Imeglimin’s Phase 2b trial
in Japan and have recruited approximately 300 patients who have been
randomized into the trial. Japan is a key focus for Poxel and is an
integral part of our business strategy. Japan represents the second
largest single market for type 2 diabetes with approximately $4 billion
in annual sales and growth of almost 20 percent annually. Asia, in
broader terms, is considered the most important geographic location with
regards to treating the diabetes pandemic in the future.”
Highlights for the First Half of 2016:
Imeglimin

• The Company achieved several important milestones in developing
  Imeglimin for the Asian market and has key upcoming events.
  • The Imeglimin dose-ranging, randomized, double-blind,
    placebo-controlled Phase 2b study with approximately 300 naïve and
    pre-treated Japanese patients is fully enrolled and patients have
    been randomized into 24 weeks of treatment. The primary endpoint
    of the trial is efficacy measured by change in glycated
    haemoglobin A1c concentrations.
  • The Japan Phase 2b Imeglimin results are anticipated during the
    second quarter of 2017.
  • Poxel expects to be in the position to initiate the Phase 3
    development program in Japan during the fourth quarter of 2017.
• Poxel has ongoing discussions with the European Medicines Agency (EMA)
  for the Phase 3 program in Europe as it finalizes its plan for this
  region. In addition, the Company remains engaged with the U.S. Food
  and Drug Administration and Japanese Pharmaceuticals and Medical
  Devices Agency as it prepares for the Phase 3 program in these
  countries.
• At the American Diabetes Association meeting in June 2016, Poxel
  presented compelling preclinical data showing Imeglimin’s dual
  mechanism of action. Over the past year, the Company has made
  significant progress in understanding how Imeglimin improves both
  insulin sensitivity and secretion, which are the two key defects that
  cause type 2 diabetes. The new discovery that Imeglimin increases the
  nicotinamide adenine dinucleotide (NAD) synthesis, a pivotal molecule
  for mitochondrial function, further elucidates Imeglimin’s unique
  mechanism of action on insulin secretion in response to glucose.
• In July, findings published in the American Journal of Physiology,
  Endocrinology and Metabolism demonstrate that Imeglimin primarily
  lowers glucose levels by increasing glucose-stimulated insulin
  secretion in a preclinical model. These findings highlight that
  Imeglimin’s effect on insulin secretion in response to glucose is a
  direct effect as shown in isolated islets that act through
  amplification of mitochondrial metabolism-dependent signals. This data
  helps to explain the absence of hypoglycemia seen in clinical trials
  to date.
• At the upcoming European Association of Study for Diabetes (EASD) on
  September 14^th in Munich, Poxel will present new
  preclinical results showing how Imeglimin improves vascular
  dysfunction in a type 2 diabetes animal model. Endothelium dysfunction
  is the first step in the development of cardiovascular diseases.

PXL770

• PXL770 is a first-in-class direct adenosine monophosphate-activated
  protein kinase (AMPK) activator, a key enzyme in energy metabolism
  acting as an energy sensor regulating glucose and lipid levels. AMPK
  activation is considered to mimic the effects of long-term exercise
  and plays an important role in diabetes management, especially for
  patients with cardiovascular risk factors.
• At the upcoming 2016 EASD meeting, Poxel will present new PXL770 data
  showing effect on de novo lipid synthesis and on weight and fat
  mass loss in an animal model of diabetes and obesity.
• PXL770 is in Phase 1 study in healthy volunteers. The single ascending
  dose trial enrolled 64 healthy male subjects to assess safety,
  tolerability and pharmacokinetics of six single ascending oral doses
  of PXL770. Poxel announced in June 2016 that results from the first
  part of the study indicate that PXL770 exhibits a favorable safety and
  tolerability profile with no serious adverse events reported or safety
  signal.
• During the Phase 1 study, Poxel observed a different metabolic pattern
  in humans compared to animals that were treated with PXL770.
  Therefore, based on regulatory guidelines, Poxel will need to further
  evaluate the profile of the metabolites, which may be
  pharmacologically active, prior to the start of the second part of the
  Phase 1 study. As a result of this additional preclinical work, the
  second part of the Phase 1b study will be delayed until 2017.

Corporate

• In July 2016, Poxel closed a capital increase of 3,400,000 new
  ordinary shares for a total amount of €26.5 million. The Company
  expects that the net proceeds are sufficient to provide the Company
  with operating cash to early 2019, exclusive of any costs associated
  with funding a Phase 3 program for Imeglimin outside of Japan. The
  capital increase was subscribed for by prominent institutional
  investors in the United States and Europe.
• During the first quarter of 2016, the Company strengthened its Board
  of Directors with the addition of Pierre Legault, who is a member of
  the Board of Directors of several U.S.-listed biotechnology companies,
  and Janice Bourque, Managing Director of Hercules Technology Growth
  Capital. Pierre was appointed as the new Chairman of Poxel’s Board of
  Directors in April, former chair Thierry Hercend will continue to
  support Poxel as a member of the Board.
• In addition, Jonae Barnes, who is based in Boston, joined the Company
  as Senior Vice President, Investor Relations and Public Relations.
  Jonae is working closely with Noah Beerman, Poxel’s Executive Vice
  President, Business Development and President of U.S. Operations.
  Poxel intends to continue to expand in the United States from its
  Boston location, which is a global leading center in drug development
  and innovation. The Company also plans to expand its presence in Japan
  with additional hires to support the Phase 3 program in Japan together
  with Dr. Yohjiro Itoh, who is leading Poxel’s clinical and regulatory
  operations in Asia.

Financial Statements for the First Half of 2016 (IFRS standards)
Group revenues for H1 2016 are nil. Following the 2015 initial public
offering (IPO), Poxel has devoted the bulk of its operating costs to
research and development (R&D) and has increased its R&D efforts and
therefore expenses in H1 2016, as compared to H1 2015. The variance from
H1 2015 to H1 2016 reflects mainly the Phase 2b study costs in Japan for
the Company’s lead product, Imeglimin, and the initial Phase 1 costs for
its second compound, PXL770. Both studies were initiated at the end of
2015. Poxel also incurred significant costs for chemistry, manufacturing
and controls (CMC) activities to prepare the active pharmaceutical
ingredient (API) supply for the upcoming Phase 3 study in Japan. Poxel
was awarded subsidies (an R&D Tax Credit (CIR)) that represented income
of €1.7 million in H1 2016, as compared to €0.9 million in H1 2015. The
R&D tax credit did not increase at the same rate as R&D expenses
increased due to the fact that the Phase 2b study in Japan is not
eligible for tax credits, since it is being conducted outside of Europe.
The increase in general and administrative (G&A) costs mainly resulted
from various non-recurrent costs. Personnel costs also increased as a
result of preparation for future work in Japan and in the United States.
In both periods, financial charges were mainly driven by the interest
expense linked to the venture loan and the interest income linked to
Poxel’s treasury. The net result for the financial period ending June
30, 2016 showed a loss of €12.4 million, as compared to a loss of €5.2
million in the corresponding period in 2015. On June 30, 2016, the cash
and cash equivalents amounted to €32.1 million (compared to €42.4
million on December 31, 2015 and €29.5 million on June 30, 2015). The
cash utilization rate was €1.7 million per month. All of the Company’s
financial results for H1 2016 were all in line with management’s
expectations.

(1) The total number of theoretical voting rights (or “gross” voting
rights) is used as the basis for calculating the crossing of
shareholding thresholds. In accordance with Article 223-11 of the AMF
General Regulation, this number is calculated on the basis of all shares
to which voting rights are attached, including shares whose voting
rights have been suspended.
(2) The total number of exercisable voting rights (or “net” voting
rights) is calculated without taking into account the shares with
suspended voting rights, in this case, shares held by the Company in the
context of a liquidity contract agreement with ODDO.
Next financial press release: Q3 Financial Sales and
Corporate Update, October 21, 2016
About Poxel SA
Poxel uses its development expertise in metabolism to advance a pipeline
of drug candidates focused on the treatment of type 2 diabetes. We have
successfully completed our Phase 2 trials for our first-in-class lead
product, Imeglimin, which targets mitochondrial dysfunction, in the U.S.
and EU and have fully enrolled a Phase 2b clinical study in Japan. Our
second program, PXL770, a direct AMPK activator, is in Phase 1
development. We intend to generate further growth through strategic
partnerships and pipeline development. (Euronext: POXEL)