Poxel Announces Third Quarter 2016 Financial Results and Corporate Update

POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for type 2 diabetes, today announced its cash position and financial results for the third
quarter of 2016. As of September 30, 2016, cash and cash equivalents were EUR 51.1 million. This figure includes the net proceeds of a private placement completed in July 2016 that provided an additional EUR 24.1 million. With its current cash and cash equivalents, the Company has a cash runway to early 2019.
Poxel has continued to advance its 2016 business plan and move forward
with its four key value drivers, which include: (1) the development of
Imeglimin in Asia using Poxel’s own resources; (2) the continued
development of Imeglimin in Europe and the United States, for which it
is seeking a development and commercial partner; (3) the development of
PXL770; and (4) continuing to leverage Poxel’s research capabilities and
portfolio.
Imeglimin has completed Phase 2 development in over 850 subjects in the
US and EU and is currently being studied in a 300-patient Phase 2b
clinical trial in Japan. PXL770, a first-in-class direct AMPK activator,
which regulates cellular energy metabolism and is considered to mimic
the effects of long-term exercise, is in Phase 1 clinical development.
“We continue to make meaningful progress with the Imeglimin Phase 2b
trial in Japan and are further demonstrating its differentiating
benefits. At this year’s European Association for the Study of Diabetes
meeting, we presented promising new data showing the potential for
beneficial protective effects on vascular dysfunction, which is key in
the treatment of type 2 diabetes. Recently, we also presented
interesting new data supporting Imeglimin’s dual novel mechanistic
approach of increasing glucose-dependent insulin secretion and improving
insulin sensitivity (efficacy). In addition, we published mechanistic
data relating to insulin secretion from a Yale-led study,” said Thomas
Kuhn, CEO of Poxel. “Through mid-2017, we are on track to deliver the
Phase 2b results in Japan and plan to publish and present several
preclinical and clinical results further demonstrating Imeglimin’s
glucose lowering benefits as well as cardiovascular and beta cell
benefits that we believe will continue to differentiate it from other
drugs in development and on the market to treat type 2 diabetes.”
As expected, Poxel did not generate revenues in the third quarter of
2016, corresponding to the Company’s forecasts.
3Q Highlights and Initiatives
Imeglimin

• Poxel achieved an important clinical milestone during the third
  quarter for Imeglimin in the Asian market and has significant upcoming
  events.
  • During the third quarter, the Imeglimin dose-ranging, randomized,
    double-blind, placebo-controlled Phase 2b study with approximately
    300 naïve and pre-treated Japanese patients became 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 clinical results are expected to be
    announced 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.
• During the third quarter, Poxel continued its discussions with the
  European Medicines Agency (EMA) for the Phase 3 program in Europe, and
  the Company is close to finalizing 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.
• Poxel has also initiated several studies to strengthen Imeglimin’s
  product profile, specifically related to its benefits beyond glucose
  lowering, targeting cardiovascular function and beta cell function
  preservation. In addition, a safety trial to assess the effect of
  Imeglimin on QT prolongation, which is a heart conduction disorder
  that can cause serious irregular heart rhythms (arrhythmias), has also
  been initiated. This safety study is a requirement for drug candidates
  with chronic use indications.
• In July, findings from a study led by Yale School of Medicine
  published in the American Journal of Physiology, Endocrinology and
  Metabolism demonstrated that Imeglimin primarily lowers glucose
  levels by increasing glucose-stimulated insulin secretion in a
  dedicated preclinical model. These findings highlight that Imeglimin’s
  effect on insulin secretion in response to glucose is a direct effect
  that acts through amplification of mitochondrial metabolism-dependent
  signals. These data also help to explain the absence of hypoglycemia
  seen in clinical trials to date.
• At the European Association of Study for Diabetes (EASD) in September,
  Poxel presented preclinical data for Imeglimin that represent
  significant progress in further understanding its benefits beyond
  glycemic control. Specifically, the potential for beneficial
  protective effects in the early stages of vascular dysfunction, which
  is key in the treatment of type 2 diabetes.

PXL770

• At the 2016 EASD meeting, Poxel presented 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 a 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. 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, as 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 completed a private placement of 3,400,000 new
  ordinary shares, which raised net proceeds of EUR 24.1 million. The
  Company expects that the proceeds of the private placement will be
  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 new shares were subscribed for by
  prominent US and European institutional investors.

Planned Attendance at the Following Events

• Bio-Europe, Cologne, November 7-9, 2016
• Jefferies Conference, London, November 16-17, 2016
• Oppenheimer 2016 Life Sciences Summit, New York City, November 29, 2016
• Oddo Mid-Cap Forum, Lyon, January 5-6, 2017
• JP Morgan Healthcare Conference, San Francisco, January 9-12, 2017

Next financial press release: Q4-2016 turnover and cash position,
January 27, 2017
About Imeglimin
Imeglimin is the first in a new chemical class of oral anti-diabetic
agents, the Glimins. Imeglimin acts on the three main target organs
involved in glucose homeostasis: the liver, muscle, and the pancreas.
Imeglimin has a unique mechanism of action that targets mitochondrial
bioenergetics. This has the potential for glucose lowering benefits, as
well as the potential to prevent endothelial dysfunction, which can
provide protective effects on micro- and macro-vascular defects induced
by diabetes, and benefits on beta cell protection and function, which
can delay disease progression. This distinct mode of action compared to
existing treatments for type 2 diabetes makes Imeglimin a prime
candidate in monotherapy and to complement other treatments such as
metformin or sitagliptin.
About PXL770
PXL770 directly activates adenosine monophosphate-activated protein
kinase (AMPK), an enzyme that acts as an energy sensor and regulator,
maintaining cellular homeostasis, thus playing an important role in the
management of diabetes. In addition to its anti-diabetic properties,
PXL770 has the potential to treat lipid-related abnormalities, which are
present in a vast majority of diabetic patients and are the cause of
cardiovascular incidents among this population, as well as other
metabolic disorders.
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 clinical program 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, www.poxel.com)