- As of December 31, 2020, cash and cash equivalents were EUR
40.2 million (USD 49.4 million)
- New results from the PXL770 Phase 2a STAMP-NAFLD trial for
the treatment of NASH showed consistently greater response in
high-risk patients with coexisting type 2 diabetes (T2DM), which is
estimated to affect approximately 50% of NASH patients1
- Poxel announced plans to conduct a 52-week Phase 2b trial
evaluating up to two doses of PXL770 in approximately 100 patients
per study arm with biopsy-proven NASH and pre-diabetes or T2DM;
primary endpoint to measure NASH resolution with no worsening of
fibrosis
- Imeglimin Japanese New Drug Application (J-NDA) under review
following submission by Poxel’s partner Sumitomo Dainippon Pharma
in July 2020, with a target product launch anticipated in 20212;
following Metavant’s decision, for strategic reasons, not to move
forward with the Imeglimin development program at the end of 2020,
Poxel regained all rights to Imeglimin in January 2021
- In October 2020, Poxel received EUR 6 million of
non-dilutive funding in the form of state-guaranteed loans (Prêts
Garantis par l’Etat, or PGE, in France) in the context of the
COVID-19 pandemic
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 announced its cash position and
revenue for the twelve months ended December 31, 2020 and provided
a corporate update.
“Despite the challenges posed by the COVID-19 pandemic, Poxel
ended 2020 on a strong note, having accomplished several important
corporate and clinical milestones and positioning the Company for
an exciting 2021. We continued working closely with our partner
Sumitomo Dainippon Pharma to further advance the review of the
Japanese New Drug Application for Imeglimin following its
submission in July 2020. Sumitomo Dainippon Pharma is actively
preparing the product launch, anticipated in its fiscal year 2021,”
said Thomas Kuhn, CEO of Poxel. “Additionally, we announced
positive clinical results for PXL770 for the treatment of NASH. Our
Phase 2a STAMP-NAFLD trial met its primary endpoint demonstrating
that PXL770-treated patients experienced a statistically
significant improvement in the relative decrease in liver fat mass
at 12-weeks, with an even greater response in patients with type 2
diabetes. These encouraging results support PXL770’s development in
this high-risk, underserved patient population. For PXL065,
deuterium-stabilized R-pioglitazone, we continued to make progress
with the enrollment of DESTINY 1, a streamlined dose-ranging Phase
2 trial for the treatment of NASH.”
“Our corporate achievements included strengthening the Company’s
financial position by EUR 6 million during the fourth quarter 2020
through financing in the form of French state-guaranteed loans,
related to the COVID-19 pandemic,” added Thomas Kuhn. “Throughout
2021, the Company expects to achieve several important milestones,
including the Imeglimin J-NDA approval3, which would entitle us to
a milestone payment, sales-based payments and escalating
double-digit royalties on product sales. We would also be able to
draw down EUR 13.5 million for the third tranche of the IPF loan,
which is contingent on obtaining marketing authorization of
Imeglimin in Japan. In early 2021, we regained the full rights for
Imeglimin in countries not covered by our partnership with Sumitomo
Dainippon Pharma. We are currently exploring various options to
advance Imeglimin, and we plan to provide an update on our progress
during the year. For our two NASH programs, we expect to finalize
the recruitment for the Phase 2 trial for PXL065, and to launch the
Phase 2b trial for PXL770 during the second half of the year,”
continued Thomas Kuhn, CEO of Poxel.
As of December 31, 2020, total cash and cash equivalents were
EUR 40.2 million (USD 49.4 million), as compared to EUR 37.2
million (USD 41.8 million) as of December 31, 2019. Cash and cash
equivalents net of financial liabilities (excluding IFRS16 impacts
and derivative debts) were EUR 17.2 million as of December 31,
2020, as compared to EUR 27.4 million as of December 31, 2019.
EUR (in thousands)
Q4 2020
Q4 2019
Cash
15,588
18,161
Cash equivalents
24,615
19,026
Total cash and cash
equivalents*
40,203
37,187
Unaudited data. *Cash and cash equivalents net of financial
liabilities (excluding IFRS 16 impacts and derivative debts) were
EUR 27.4 million at the end of Q4 2019 and EUR 17.2 million at the
end of Q4 2020.
FY20 Revenue
Poxel reported revenues of EUR 6.7 million for the year ended
December 31, 2020, as compared to EUR 26.6 million during the
corresponding period in 2019.
The revenues for 2021 include the JPY 500 million (EUR 4.0
million4) milestone payment that Poxel received from Sumitomo
Dainippon Pharma for the submission of the Imeglimin J-NDA. To a
lesser extent, it also 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 in 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 have been recognized based on the accounting percentage of
the completion of this program, which has been fully completed, and
therefore led to the decrease in revenue in 2020.
EUR (in thousands)
FY
FY
2020 12 months
2019 12 months
Roivant Agreement
18
276
Sumitomo Agreement
6,708
26,179
Other
1
101
Total revenues
6,727
26,556
Unaudited data.
Clinical & Additional Development Update
Imeglimin
- Poxel continues to support its partner, Sumitomo Dainippon
Pharma, in all activities related to the ongoing regulatory review
of the J-NDA, following its submission in July 2020. Target product
launch is anticipated in 20215.
- In October 2020, results for Imeglimin focused on safety were
presented at the 63rd JDS meeting. In the Phase 2b and Phase 3
TIMES trials, Imeglimin was observed to have a favorable safety
profile at the 1,000 mg dose with similar frequency and types of
adverse events as seen in placebo-treated patients; specifically,
Imeglimin appeared to be unlikely to cause hypoglycemia.
- In November 2020, Poxel announced that, for strategic reasons,
Metavant would not be moving forward with the Imeglimin development
program. This decision was not based on any efficacy, safety or
other data generated through the partnership. In January 2021,
Poxel announced that Metavant would return all rights to Imeglimin
to Poxel, as well all data, materials, and information, including
FDA regulatory filings, related to the program, effective January
31, 2021. Metavant is not entitled to any payment from Poxel as
part of the return of the program.
PXL770
- In October 2020, Poxel announced that the Phase 2a STAMP-NAFLD
trial for the treatment of NASH met its primary efficacy endpoint.
PXL770-treated patients achieved statistically significant
improvements in the relative decrease in liver fat mass and alanine
aminotransferase (ALT) levels at 12-weeks with a greater response
in patients with T2DM.
- In November 2020, several preclinical studies supporting the
efficacy of PXL770 in NASH and other metabolic diseases were
presented at the American Association for the Study of Liver
Disease (AASLD) The Liver Meeting® 2020.
- In December 2020, Poxel announced that in vitro experiments
with human immune cells and stellate cells demonstrated the
potential of PXL770 to mediate independent direct effects leading
to reduced inflammation and fibrosis in NASH.
- In December 2020, additional Phase 2a data from the PXL770
STAMP-NAFLD trial was presented at a virtual NASH investor event,
featuring members of the Poxel management team and NASH key opinion
leaders, Kenneth Cusi, MD, Chief of the Division of Endocrinology,
Diabetes & Metabolism in the Department of Medicine at the
University of Florida and Stephen A. Harrison, MD, Director, Summit
Clinical Research. The results showed a consistently greater
response in high-risk subpopulation patients with coexisting T2DM,
estimated to affect approximately 50% of NASH patients6. Poxel also
announced plans to pursue a Phase 2b development strategy focused
on NASH patients with T2DM. PXL770’s mechanism of action could be
particularly beneficial for this patient population as it has the
potential to improve the underlying root causes of the disease,
such as insulin resistance, dysregulation of lipid and glucose
metabolism and inflammation.
- Poxel plans to initiate a Phase 2b 52-week trial in
noncirrhotic biopsy-proven NASH patients with coexisting
prediabetes or T2DM. The trial will evaluate up to two oral daily
doses of PXL770 compared to placebo in approximately 100 patients
per study arm in clinical sites located in the US and EU. The
primary endpoint of the trial will be NASH resolution with no
worsening of fibrosis assessed by histology. The Phase 2b trial is
expected to begin during the second half of 2021.
PXL065
- In November 2020, Poxel presented Phase 1b clinical results for
PXL065 at the AASLD The Liver Meeting® 2020. The results showed a
dose-proportional pharmacokinetic profile with a substantially
altered ratio of R- vs. S-pioglitazone stereoisomers.
- In December 2020, the ongoing DESTINY 1 Phase 2 study was
reviewed during Poxel’s virtual NASH investor event.
- The recruitment for the DESTINY 1 Phase 2 study is expected to
be completed in the second half of 2021.
Corporate Events
- In October, Poxel received approval from BNP Paribas, Bpifrance
and CIC Lyonnaise de Banque for EUR 6 million in non-dilutive
financing in the form of a French Government Guarantee Loan (PGE
Loan). The initial term is one-year, with a five-year extension
option.
- After almost five years as part of the Poxel management team,
Jonae Barnes, Senior Vice President, Investor Relations, Corporate
Communications and Public Relations has moved on from the Company
to pursue a new opportunity. Poxel would like to thank Ms. Barnes
for her dedication over the years and wishes her well in her future
endeavors. Poxel has launched a recruitment effort to fill this
position, which is based in the US.
Planned Presentations and Participation at the Following
Upcoming Events (virtual)
- H.C. Wainwright Global Life Sciences Conference, March
9-10
- 2021 NASH Tag conference, March 11- 13
- Mitochondria-Targeted Drug Development Summit, April 27-29
- Kempen Life Sciences Conference, May 5
- Japan Diabetes Society, May 20-22
- Jefferies Global Healthcare Conference, June 8-10
Next Financial Press Release: 2020 Annual Results, March
25, 2021
About Imeglimin Imeglimin is a new chemical substance
classified as a tetrahydrotriazine compound, and the first clinical
candidate in a chemical class. Imeglimin has a unique dual
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 pancreas, muscles, and the
liver, 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 NASH NASH is a metabolic disease with no clear
disease origin that is quickly becoming a worldwide epidemic. It is
characterized by the accumulation of fat in the liver causing
inflammation and fibrosis. The disease can be silent for a long
period of time, but once it accelerates, severe damage and liver
cirrhosis can occur, which can significantly impact liver function
or can even result in liver failure or liver cancer. Typical risk
factors for NASH include obesity, elevated levels of blood lipids
(such as cholesterol and triglycerides) and type 2 diabetes.
Currently no curative or specific therapies are available.
About PXL770 PXL770 is a first-in-class AMPK activator.
AMPK is a central regulator of multiple metabolic pathways leading
to the control of lipid metabolism, glucose homeostasis and
inflammation. Based on its central metabolic 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 NASH.
About PXL065 PXL065 is a novel, proprietary
deuterium-stabilized R-pioglitazone. Although pioglitazone is not
approved by the FDA for the treatment of NASH, it is the most
extensively studied drug for NASH and has demonstrated “resolution
of NASH without worsening of fibrosis” in a Phase 4 trial7.
Pioglitazone is the only drug recommended for biopsy-proven NASH
patients by the Practice Guidelines published by the AASLD and the
European Association for the Study of the Liver (EASL)8.
Pioglitazone’s off-label use for NASH, however, has been limited
due to the PPARγ-related side effects, which include weight gain,
bone fractures and fluid retention.
Pioglitazone is a 1:1 mixture of two mirror-image compounds (R-
and S-stereoisomers) that interconvert in vivo. Using deuterium, we
stabilized each stereoisomer and characterized their different
pharmacological properties. In in vitro studies, PXL065 has been
shown to target mitochondrial pyruvate carrier (MPC) as an
inhibitor. In preclinical animal models, PXL065 exhibits the
anti-inflammatory and NASH activity associated with pioglitazone
with little or no weight gain or fluid retention, side effects
which are associated with the S-stereoisomer. Based upon
preclinical and Phase 1 results to date, Poxel believes that PXL065
may have a better therapeutic profile than pioglitazone for
NASH.
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. After successfully completing a Phase
2a proof-of-concept trial for the treatment of NASH, which met its
primary endpoint and study objectives, for PXL770, a
first-in-class direct adenosine monophosphate-activated protein
kinase (AMPK) activator, Poxel plans to initiate a Phase 2b program
in the second half of 2021. PXL770 could also have the potential to
treat additional metabolic diseases. PXL065
(deuterium-stabilized R-pioglitazone), a MPC inhibitor, is in a
streamlined Phase 2 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 Prevalence of T2DM in patients with NASH estimated to be 47%;
approximately 26% of T2DM patients have NASH; clinical and economic
burden of NASH in T2DM greater than with either disease alone
(Younossi ZM et al, Hepatology 2016, 64, 73–84; Cusi K, Diabetes
Care 2020, 43:275-79; Younossi ZM et al, Diabetes Care 2020,
43:283–89).
2 Year noted is Fiscal Year from April 2021 to March 2022, which
is Sumitomo Dainippon Pharma’s Fiscal Year.
3 Expected during Sumitomo Dainippon Pharma’s 2021 Fiscal Year,
which is from April 2021 to March 2022.
4 Exchange rate at the filing date.
5 Year noted is Fiscal Year from April 2021 to March 2022, which
is Sumitomo Dainippon Pharma’s Fiscal Year.
6 Prevalence of T2DM in patients with NASH estimated to be 47%;
approximately 26% of T2DM patients have NASH; clinical and economic
burden of NASH in T2DM greater than with either disease alone
(Younossi ZM et al, Hepatology 2016, 64, 73–84; Cusi K, Diabetes
Care 2020, 43:275-79; Younossi ZM et al, Diabetes Care 2020,
43:283–89).
7 Cusi, et al., Ann Intern Med. 2016, 165(5), 305-315.
8 J Hepatol. 2016, 64(6),1388-402; Hepatology 2018, 67,
328-357.
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version on businesswire.com: https://www.businesswire.com/news/home/20210211005824/en/
Poxel SA Aurélie Bozza Investor Relations &
Communication Director aurelie.bozza@poxelpharma.com +33 6 99 81 08
36
Investor relations / Media - EU/US Trophic Communications
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or +49 175 804 1816
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or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
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