- Strengthened financial position during H1 2020 with drawdown
of IPF loan of EUR 10 million and a capital raise of EUR 17.7
million
- Imeglimin New Drug Application in Japan (J-NDA) was
submitted for the treatment of type 2 diabetes in Q3 2020 and a
target launch is expected in 20211; a milestone payment of EUR 4
million was received in Q3 2020 from Sumitomo Dainippon
Pharma
- Initiated PXL065 Phase 2 trial in biopsy-proven NASH
patients in Q3 2020; streamlined development with a single Phase 2
trial given knowledge of pioglitazone, including data in NASH, and
505(b)(2) regulatory pathway, which offers the opportunity for an
efficient and lower risk development program
- PXL770, a first-in-class direct AMPK activator produced
positive results in a pharmacokinetic (PK) / pharmacodynamic (PD)
trial in likely-NASH patients; PXL770 Phase 2a efficacy and safety
results expected around the end of September 2020
- PXL770 produced additive benefits in a preclinical NASH
model when combined with other late-stage agents in development and
was observed to improve cardio-renal disease and
adrenoleukodystrophy (ALD) / adrenomyeloneuropathy (AMN) in
animals
Poxel will host an investor conference call today to
discuss the Half Year 2020 results at 1:30 pm EDT (New
York time) / 7:30 pm CEST (Paris time). To participate in the
call, please use the dial-in numbers: US: +1 646-722-4916 UK:
+44 20 71 94 37 59 France: +33 1 72 72 74 03 Access Code:
97417835#. A slide presentation to accompany the
conference call will be available in the Investors / Company Info /
Corporate Presentations section of the Poxel website:
https://www.poxelpharma.com/en_us/investors/company-information/corporate-presentations
For a replay of the call, please use: US: +1 646-722-4969
UK: +44 20 3364 5147 FR: +33 1 70 71 01 60 Access Code:
418947860#.
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 reported its financial results for
the period ended June 30, 2020 and provided a corporate update.
“Through September, we accomplished several important corporate
and clinical objectives, including strengthening our financial
position through multiple financial sources including the drawdown
of the IPF loan of EUR 10 million in March, a capital raise of EUR
17.7 million in May and a subsequent milestone payment of EUR 4
million during the third quarter from our partner Sumitomo
Dainippon Pharma for the Imeglimin J-NDA submission,” said Thomas
Kuhn, CEO of Poxel. “We also continued to make solid progress with
our development programs. We reported positive results from
preclinical and clinical studies for PXL770 and are continuing to
evaluate broader metabolic diseases, including chronic and rare
diseases, for our AMPK activation and D-TZD platforms.”
“From an execution standpoint in the context of the COVID-19
pandemic, I am very pleased to report that we recently initiated
the Phase 2 trial for PXL065 in biopsy-proven NASH patients across
multiple clinical sites in the U.S.,” continued Thomas Kuhn, CEO of
Poxel. “This is a streamlined development program with a single
Phase 2 trial given the knowledge of pioglitazone, including data
in NASH, and the 505(b)(2) regulatory pathway. Based on
pioglitazone’s known efficacy and safety results in NASH, its
cardiovascular benefits combined with the exciting PXL065 results
to-date, we believe that PXL065 has the potential to produce
compelling results and become a leading oral drug candidate in
development for this important unmet medical need.”
“For the remainder of 2020, we expect several important upcoming
milestones and events, including the PXL770 Phase 2a efficacy and
safety results in approximately 100 likely-NASH patients around the
end of September 2020, finalization of the Imeglimin Phase 3 plan
in the U.S. by Metavant, additional preclinical data related to our
AMPK and D-TZD platforms and presentations for Imeglimin, PXL770
and PXL065 at several scientific meetings and published results in
peer-reviewed scientific journals,” added Thomas Kuhn.
Clinical Development Updates
Imeglimin (Type 2 Diabetes)
- The J-NDA for Imeglimin was submitted by Sumitomo Dainippon
Pharma to the Pharmaceuticals and Medical Devices Agency (PMDA) to
request approval for the manufacturing and marketing for the
treatment of type 2 diabetes. Poxel received a milestone payment of
EUR 4.0 million related to the J-NDA submission. J-NDA approval and
a target launch is expected in 2021.2 A J-NDA approval would
trigger a milestone payment of EUR 14.2 million ($16.6
million).3
- 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.
- Poxel anticipates presenting Imeglimin results at the European
Association for the Study of Diabetes (EASD) meeting and the
Japanese Diabetes Society meeting as well as publishing data in
scientific journals during the second half of 2020.
PXL770 (NASH)
- A PXL770 PK/PD trial in 16 likely-NASH patients met its primary
endpoint and objectives. PXL770 was observed to demonstrate a
consistent PK profile and to be safe and well-tolerated. In
addition, it showed target engagement and efficacy signals in NASH
that support the potential for PXL770 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.
- Efficacy and safety results from the Phase 2a trial in
approximately 100 likely-NASH patients are currently expected
around the end of September 2020.
- Poxel anticipates presenting results for PXL770 at the EASD
meeting, American Association for the Study of Liver Diseases
(AASLD) meeting and NASH Summit as well as publishing data in
scientific journals during the second half of 2020.
PXL065 (NASH)
- The single Phase 2 study in approximately 120 biopsy-proven
NASH patients was initiated in September 2020. The single Phase 2
study will evaluate efficacy and safety and aims to identify the
optimal dose or doses to be evaluated in a Phase 3 registration
trial. Results from this study are expected during the first half
of 2022.
- Poxel is developing PXL065 using the 505(b)(2) regulatory
pathway, which offers the opportunity for a streamlined and lower
risk development program.
- Poxel anticipates presenting results for PXL065 at the AASLD
meeting and publishing data in scientific journals during the
second half of 2020.
Additional Development Opportunities
- The Company is currently evaluating additional research and
development opportunities from its AMPK activation and D-TZD
platforms as well as external opportunities with a focus on chronic
and rare metabolic diseases.
Corporate Highlights
- During the first quarter, Poxel appointed David E. Moller, MD,
as Chief Scientific Officer. Dr. Moller is responsible for leading
scientific-related activities to support the advancement of the
Company, including scientific innovation and scientific
communications at Poxel.
- During the first quarter, the Company drew down the second
tranche of EUR 10 million of the IPF loan, which was contingent on
the successful completion of the Imeglimin Phase 3 Trials of
IMeglimin for Efficacy and Safety(TIMES)
program. The third tranche of EUR 13.5 million can be drawn down by
December 31, 2021, contingent on obtaining marketing authorization
of Imeglimin in Japan. Specific debt covenants are attached to the
loan agreement.
- During the second quarter, Poxel completed a capital raise of
EUR 17.7 million with U.S. and European investors, including
long-term shareholder, Bpifrance Participations, through its Large
Venture Fund.
- 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.
First Half 2020 Financial Results (IFRS standards)
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 the 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)4 milestone payment that Poxel is entitled
to receive from Sumitomo Dainippon Pharma upon submission of the
Imeglimin J-NDA, which was anticipated to occur in Q3 2020 and was
recognized in Q2 2020 according to the IFRS15 accounting
standard.
EUR (in thousands)
H1 2020
H1 2019
6 months
6 months
(adjusted)
(historic)
Roivant Agreement
13
155
155
Sumitomo Agreement
6,359
18,909
22,914
Other
-
100
100
Total revenues
6,372
19,164
23,169
The review procedures have been performed and the issuance of
the report is in process.
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.
Income Statement
Poxel devotes the bulk of its resources to research and
development (R&D) activities. R&D expenses totaled EUR 12.6
million for the first half of 2020, as compared to EUR 24.2 million
for the corresponding period in 2019. R&D expenses for the
first half of 2020 primarily reflect the clinical study costs
incurred for PXL770 and PXL065, Poxel’s two Phase 2 clinical-stage
programs for the treatment of NASH. To a lesser extent, they also
reflect the remainder of the R&D costs for the Phase 3 TIMES
program and the regulatory costs incurred over the period for the
preparation of the Imeglimin J-NDA submission that occurred in July
2020.
R&D expenses are net of the R&D Tax Credit (CIR) that
resulted in an income of EUR 1.5 million for the first half of 2020
as compared to EUR 1.6 million for the corresponding period of
2019.
General and administrative expenses totaled EUR 5.9 million for
the first half of 2020, as compared to EUR 4.9 million for the
first half of 2019.
The financial income amounted to EUR 0.2 million for the first
half of 2020, as compared to EUR 0.1 million for the first half of
2019, which primarily reflected the change in fair value of the IPF
warrants and the interests attached to this debt.
The net result for the financial period ending June 30, 2020 was
a net loss of EUR 12.1 million, as compared to a net loss of EUR
9.8 million in the corresponding period in 2019.
Condensed Income Statement
EUR (in thousands)
HY
HY
HY
2020
6 months
2019
6 months
(adjusted)
2019
6 months
(historic)
Revenue
6,372
19,164
23,169
Research and development expenses*
(12,580)
(24,164)
(24,164)
General and administrative expenses
(5,983)
(4,868)
(4,868)
Operating gain (loss)
(12,191)
(9,869)
(5,864)
Financial income (loss)
249
71
71
Income tax
(118)
-
-
Net income (loss)
(12,060)
(9,798)
(5,792)
*Net of R&D tax credit The review procedures have been
performed and the issuance of the report is in process.
Cash
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. In September 2020, Poxel
received a EUR 4.0 million milestone payment from its partner
Sumitomo Dainippon Pharma for the Imeglimin J-NDA submission, which
is not reflected in the June 30, 2020 cash update.
EUR (in thousands)
Q2 2020
Q4 2019
Cash
26,122
18,161
Cash equivalents
19,846
19,026
Total cash and cash
equivalents*
45,968
37,187
* 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.
The review procedures have been performed
and the issuance of the report is in process.
Planned Presentations and Participation at the Following
Upcoming Events
- 56th European Association for the Study of Diabetes (EASD)
Annual Meeting, September 21-25, 2020, Virtual Meeting
- The 63rd Annual Meeting of the Japan Diabetes Society, October
5-16, 2020, Virtual Meeting
- The American Association for the Study of Liver Diseases
(AASLD), the Liver Meeting®, November 13-16, 2020, Digital
Meeting
- The 4th Annual NASH Summit, December 15-18, 2020, Digital
Meeting
Next Financial Press Release: Third Quarter 2020
Financial and Corporate Update is expected on October 20, 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. Poxel has a strategic partnership with
Sumitomo Dainippon Pharma for Imeglimin in Japan, China, South
Korea, Taiwan and nine other Southeast Asian countries. A Japanese
new drug application (J-NDA) is under review by the Pharmaceuticals
and Medical Devices Agency (PMDA) to request approval for the
manufacturing and marketing of Imeglimin for the treatment of type
2 diabetes. 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 MPC inhibitor, is in a
single 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.
As of the date of this press release, and based on publicly
available information, the Company has not identified the
occurrence of any material negative effect on its business due to
the COVID-19 pandemic that remains unresolved. 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 actively
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.
1 Year noted is Fiscal Year from April 2021 to March 2022, which
is Sumitomo Dainippon Pharma’s Fiscal Year. 2 Converted at the
exchange rates as of July 28, 2020. 3 Converted at the exchange
rates as of June 30, 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200915006034/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
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