- Poxel completed a capital raise of EUR 17.7 million (USD
19.4 million) to accelerate development of PXL770 and PXL065 in
NASH and to pursue early-stage opportunities for pipeline growth
from its adenosine monophosphate-activated protein kinase (AMPK)
activator and deuterated thiazolidinedione (TZD) platforms in
chronic and rare metabolic diseases
- PXL770, a first-in-class direct AMPK activator produced
positive results in a pharmacokinetic (PK) / pharmacodynamic (PD)
trial in likely-NASH patients
- PXL770 preclinical results produced additive benefits in a
NASH model when combined with other late-stage agents in
development
- PXL770 was observed to improve cardio-renal disease and
adrenoleukodystrophy (ALD) / adrenomyeloneuropathy (AMN) in animal
models
- PXL770 Phase 2a study results in approximately 100
likely-NASH patients are expected in late third quarter
2020
- Imeglimin Japanese new drug application (J-NDA) submission
for the treatment of type 2 diabetes is anticipated in the third
quarter of 2020 with a target launch in 2021
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 provided a corporate update and
announced its cash position and revenue for the second quarter and
first half of 2020.
“During the second quarter, we accomplished a number of
important corporate and clinical objectives, including
strengthening our cash position to help accelerate our NASH
programs and earlier stage opportunities from our AMPK activator
and deuterated TZD platforms. In addition, we reported positive
results from preclinical and clinical studies for PXL770
demonstrating its potential in NASH and that AMPK activation may
lead to broader utility for the treatment of other chronic and rare
metabolic diseases,” said Thomas Kuhn, CEO of Poxel. “We are
enthusiastic to evaluate earlier stage opportunities from our
platforms and are committed to pursuing all options to continue to
build value in our pipeline.”
“Also, during the second quarter, we continued to work closely
with Sumitomo Dainippon Pharma on activities related to the
Imeglimin J-NDA submission for type 2 diabetes, anticipated in Q3
2020. In parallel, we continued to support Metavant, who is making
adjustments to the initial Imeglimin Phase 3 plan based on feedback
from the U.S. Food and Drug Administration (FDA) and new draft
guidance released in March 2020. Further FDA interactions are
expected during the second half of 2020 and we plan to provide an
update when the Phase 3 plan is finalized,” added Thomas Kuhn, CEO
of Poxel. “For our two first-in-class NASH programs, we are looking
forward to the PXL770 Phase 2a efficacy results in approximately
100 likely-NASH patients expected in late Q3 2020. Furthermore, in
the second half of 2020, contingent on the COVID-19 environment, we
plan to initiate enrollment of the PXL065 Phase 2 36-week study in
at least 120 biopsy-proven NASH patients with the goal of
identifying the optimal dose or doses for the Phase 3 registration
trial.”
Clinical Development Updates
Imeglimin (Type 2 Diabetes)
- The Company continues to work closely with Sumitomo Dainippon
Pharma on activities related to the J-NDA submission for the
treatment of type 2 diabetes, which is anticipated in the third
quarter of 2020, with a target launch in 2021.
- The Company is working with Metavant, who is in discussions
with the FDA regarding the Imeglimin Phase 3 program in type 2
diabetes patients with chronic kidney disease (CKD) stages 3b/4.
Further FDA interactions are expected during the second half of
2020.
- Imeglimin results were published in Clinical Pharmacokinetics
showing that repeated co-administration of Imeglimin with metformin
or sitagliptin did not result in clinically relevant changes in
drug exposure and that Imeglimin was observed to be safe and
well-tolerated. These results are consistent with prior preclinical
and longer-term clinical studies.
PXL770 (NASH)
- The PXL770 PK/PD trial in 16 likely-NASH patients met its
primary endpoint and objectives. PXL770 was observed to demonstrate
a consistent PK profile, was safe and well-tolerated and showed
target engagement and efficacy signals in NASH and for the AMPK
platform in other chronic and rare metabolic diseases.
- Results from a PXL770 preclinical trial demonstrated additive
benefits in a NASH model when combined with other late-stage agents
in development, including an FXR agonist (obeticholic acid), a
GLP-1 receptor agonist (semaglutide) and a thyroid receptor β
agonist (MGL-3196).
- Results from a PXL770 preclinical trial demonstrated in animal
models improvements in cardio-renal disease and ALD / AMN, a deadly
inherited rare metabolic disease characterized by
neurodegeneration.
- Results from the Phase 2a trial in approximately 100
likely-NASH patients are currently expected late third quarter of
2020.
- Poxel anticipates presenting new data for PXL770 in a
peer-reviewed format at scientific meetings and in published
results in scientific journals during the second half of 2020.
PXL065 (NASH)
- The Company is preparing for the Phase 2 study in at least 120
biopsy-proven NASH patients with the aim to identify the optimal
dose or doses to be evaluated in a Phase 3 registration trial. The
Company plans to initiate study enrollment during the second half
of 2020, contingent on a safe and stable environment for patient
recruitment and the availability of clinical trial sites during the
COVID-19 outbreak.
Additional Development Opportunities
- The Company is currently evaluating additional research and
development opportunities from its AMPK activation and deuterated
TZD platforms as well as external opportunities with a focus on
chronic and rare metabolic diseases.
Corporate Update
- During the second quarter, Poxel completed a capital raise of
EUR 17.7 million (USD 19.4 million) with U.S. and European
investors, including long-term shareholder Bpifrance Participations
through its Large Venture Fund. The use of proceeds will help to
accelerate advancement of PXL770 and PXL065 in NASH and pursue
development activities with its AMPK activator and deuterated TZD
platforms in chronic and rare metabolic diseases for pipeline
growth.
- During the second quarter, Poxel conducted the Annual and
Extraordinary General Meeting. The shareholders approved all the
resolutions that were recommended by the Board of Directors. For
further information, please visit:
https://www.poxelpharma.com/en_us/investors/shareholder-information/annual-general-meeting-documents.
Second Quarter and First Half 2020 Cash and Revenue
As of June 30, 2020, cash and cash equivalents were EUR 46.0
million (USD 51.5 million), as compared to EUR 37.2 million (USD
41.8 million) at December 31, 2019. Cash and cash equivalents net
of financial liabilities (excluding IFRS16 impacts and derivative
debts) were EUR 29.0 million as of June 30, 2020, as compared to
EUR 27.4 million at December 31, 2019.
EUR (in millions)
Q2 2020*
Q4 2019
Cash
26.1
18.2
Cash equivalents
19.9
19.0
Total cash and cash
equivalents**
46.0
37.2
*Unaudited data **Cash and cash
equivalents net of financial liabilities (excluding IFRS 16 impacts
and derivative debts) were EUR 29.0 million at the end of Q2 2020
and EUR 27.4 million at the end of Q4 2019.
Q2 2020 Revenue
Poxel reported revenues of EUR 6.4 million for the six months
ended June 30, 2020, as compared to EUR 23.2 million during the
corresponding period in 2019 (historical).
Revenue in the first half of 2020 includes an allocated portion
of the EUR 36.0 million upfront payment received from Sumitomo
Dainippon Pharma relating to the strategic corporate partnership
announced on October 30, 2017, as well as the residual Imeglimin
Phase 3 program costs in Japan incurred during the first half of
2020 that were re-invoiced to Sumitomo Dainippon Pharma. Both the
allocated portion of the upfront payment and the re-invoiced costs
of the Phase 3 Trials of IMeglimin for
Efficacy and Safety (TIMES) program are recognized
based on the accounting percentage of completion of this program,
which has been completed. Revenue also includes a JPY 500 million
(EUR 4.1 million, USD 4.5 million) milestone payment that Poxel is
entitled to receive from Sumitomo Dainippon Pharma upon submission
of the Imeglimin J-NDA, which is anticipated to occur in Q3 2020
and was recognized in Q2 2020 according to the IFRS15 accounting
standard.
EUR (in millions)
Q1 2020
Q2 2020
H1 2020
Q1 2019
Q2 2019
H1 2019
3 months
3 months*
6 months
3 months
3 months
6 months
Adjusted**
Historical
Adjusted**
Historical
Adjusted**
Historical
Roivant Agreement
-
-
-
-
-
0.2
0.2
0.2
0.2
Sumitomo Agreement
1.5
4.8
6.4
12.3
14.9
6.6
8.0
18.9
22.9
Other
-
-
-
-
-
0.1
0.1
0.1
0.1
Total revenues
1.5
4.8
6.4
12.3
14.9
6.9
8.3
19.2
23.2
*Unaudited data **Proforma, as if the
Company applied the standalone selling price method in FY19.
Note: A change in the accounting policy of revenue recognition
method was reported as part of the fiscal year 2019 financial
statements reported in a press release dated February 12, 2020.
This resulted in an adjustment to the Sumitomo Dainippon Pharma
partnership revenue recognition for the previous years. For more
information, please visit:
https://www.poxelpharma.com/en_us/investors/news-events/press-releases/detail/144/poxel-reports-financial-update-for-cash-and-revenue-for-the
This change in accounting policy had no impact on Poxel’s cash
flows.
Planned Presentations and Participation at the Following
Upcoming Events
- William Blair Virtual Biotech Conference, August 4-6, 2020
- 56th European Association for the Study of Diabetes Annual
Meeting (virtual meeting), September 21-25, 2020
Next Financial Press Release: First Half 2020 Financial
Statement expected on September 15, 2020
About Poxel SA.
Poxel is a dynamic biopharmaceutical company that uses
its extensive expertise in developing innovative drugs for
metabolic diseases, with a focus on type 2 diabetes and
non-alcoholic steatohepatitis (NASH). In its mid-to-late
stage pipeline, the Company is currently advancing three drug
candidates as well as earlier-stage opportunities.
Imeglimin, Poxel’s first-in-class lead product, targets
mitochondrial dysfunction. Together, with its partner Sumitomo
Dainippon Pharma, Poxel successfully completed the Phase 3
Trials of IMeglimin for Efficacy and
Safety (TIMES) program for the treatment of type 2 diabetes
in Japan. Poxel also established a partnership with Roivant
Sciences for Imeglimin’s development and commercialization in
countries outside of the 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 in 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 advancing into a Phase 2 clinical trial
for the treatment of NASH. Poxel also has additional earlier-stage
programs from its AMPK activator and deuterated TZD platforms
targeting chronic and rare metabolic diseases. The Company intends
to generate further growth through strategic partnerships and
pipeline development. Listed on Euronext Paris, Poxel is
headquartered in Lyon, France, and has subsidiaries in Boston, MA,
and Tokyo, Japan. For more information, please visit:
www.poxelpharma.com.
In the context of the COVID-19 outbreak, which was declared a
pandemic by the World Health Organization (WHO) on March 12, 2020,
the Company is regularly reviewing the impact of the outbreak on
its business.
Based on this review, and as of the date of this press release,
the Company has identified one significant impact of the COVID-19
outbreak related to the initiation of the Phase 2 study enrollment
for its drug candidate, PXL065, which the Company initially planned
during the second quarter of 2020 and is now anticipated in the
second half of 2020, contingent on a safe and stable environment
for patient recruitment and the availability of clinical trial
sites during the COVID-19 outbreak. As of the date of this press
release, and based on publicly available information, the Company
has not identified the occurrence of other material negative
effects on its business due to the COVID-19 pandemic. However, the
Company anticipates that the COVID-19 pandemic could have further
material negative impact on its business operations. The worldwide
impact of COVID-19 may notably affect the Company’s internal
organization and efficiency, particularly in countries where it
operates and where confinement measures are implemented by the
authorities. In addition, COVID-19 may impact market conditions and
the Company’s ability to seek additional funding or enter into
partnerships. Particularly, delays in the supply of drug substance
or drug products, in the initiation or the timing of results of
preclinical and/or clinical trials, as well as delays linked to the
responsiveness of regulatory authorities could occur, which could
potentially have an impact on the Company’s development programs
and partnered programs. The Company will continue to proactively
monitor the situation.
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200721005747/en/
Poxel SA Jonae R. Barnes Senior Vice President, Investor
Relations, Corporate Communication and Public Relations
jonae.barnes@poxelpharma.com +1 617 818 2985
Aurélie Bozza Investor Relations and Communication Director
aurelie.bozza@poxelpharma.com +33 6 99 81 08 36
Investor relations / Media - EU/US Trophic Communications
Joanne Tudorica or Valeria Fisher tudorica@trophic.eu or
fisher@trophic.eu +49 171 351 2733 or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
/ Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
Poxel (EU:POXEL)
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