- Imeglimin New Drug Application in Japan
(J-NDA) was submitted for the treatment of type 2 diabetes in July
2020 and a target launch is expected in fiscal year 20211; a
milestone payment of EUR 4 million was received in Q3 2020 from
Sumitomo Dainippon Pharma
- Imeglimin Phase 3 TIMES results were
presented at the 56th European Association for the Study of
Diabetes (EASD) meeting; Phase 2b, Phase 3 TIMES results, and
additional safety data were presented at the 63rd Annual Meeting of
Japanese Diabetes Society (JDS)
- PXL770 Phase 2a trial for the treatment of
NASH met its primary efficacy endpoint and trial objectives, and it
was observed to be safe and well tolerated
- PXL770 profile supports development in NASH
and also further evaluation for combination use, as well as utility
of adenosine monophosphate-activated protein kinase (AMPK)
activation in other chronic and rare metabolic diseases
- PXL065 Phase 2 trial was initiated in
biopsy-proven NASH patients in September 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
- As of September 30, 2020, cash and cash
equivalents were EUR 41.5 million (USD 48.6 million)
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 third quarter and
the nine months ended September 30, 2020.
“During the third quarter, we continued to make significant
progress and accomplished a number of important clinical and
corporate objectives, including reporting positive results from a
Phase 2a proof-of-concept trial for PXL770, demonstrating its
potential in NASH. These results are the first human clinical
assessment of a direct AMPK activator and support longer-term
evaluation of important histological endpoints, such as
inflammation and fibrosis, and exploring subpopulations for further
differentiation. The data also demonstrate that AMPK activation may
lead to broader utility for the treatment of other chronic and rare
metabolic diseases. In addition, we initiated a streamlined Phase 2
trial for PXL065 in NASH and strengthened our cash position with
non-dilutive funding from a milestone payment of EUR 4 million for
the Imeglimin New Drug Application (NDA) submission in Japan and
the recent PGE loan of EUR 6 million from the French government,”
said Thomas Kuhn, CEO of Poxel.
“For the remainder of this year, we expect several upcoming
milestones and events including finalization of the PXL770 Phase 2b
clinical trial design, presentations for PXL770 and PXL065 at
several scientific meetings as well as publishing results in
peer-reviewed scientific journals and additional preclinical data
related to our AMPK and deuterated-TZD platforms. Furthermore, our
partner, Metavant, is in discussions with the U.S. Food and Drug
Administration (FDA) regarding the Imeglimin Phase 3 program in
type 2 diabetes patients with chronic kidney disease (CKD) stages
3b/4,” added Thomas Kuhn, CEO of Poxel.
Clinical Development Updates
Imeglimin (Type 2 Diabetes)
- The Company worked closely with Sumitomo Dainippon Pharma on
activities related to the J-NDA for Imeglimin for the treatment of
type 2 diabetes, which was submitted in late July to the
Pharmaceuticals and Medical Devices Agency (PMDA) to request
approval for manufacturing and marketing. A target launch is
expected in 20212. The J-NDA approval would trigger a milestone
payment of EUR 14.2 million ($16.6 million)3.
- Phase 3 TIMES 2 and TIMES 3 trial results were presented at the
56th EASD meeting, demonstrating that Imeglimin met its primary
endpoints and objectives and was observed to exhibit a favorable
safety and tolerability profile.
- Imeglimin results focused on safety benefits were presented at
the 63rd JDS meeting. Speakers included Professor Kohjiro Ueki, MD,
PhD, Director, Diabetes Research Center, the National Center for
Global Health and Medicine, Tokyo, Japan and Professor Wataru
Ogawa, MD, PhD, Professor, Division of Diabetes and Endocrinology,
Department of Internal Medicine, Kobe University, Graduate School
of Medicine, Kobe, Japan. In the Phase 2b and Phase 3 TIMES trials,
Imeglimin was observed to have a favorable safety profile at the
dose of 1,000 mg with similar frequency and types of adverse events
as in the placebo group, and specifically appeared to be unlikely
to cause hypoglycemia. In addition, new preclinical results showed
that Imeglimin has a novel mechanism of action regulating
mitochondrial bioenergetics, with a partial inhibition of complex I
and no inhibition on mitochondrial glycerol 3-phosphate
dehydrogenase (mGPDH), a driver of lactate accumulation, which
further differentiates Imeglimin from metformin.
- Metavant, the Company’s partner for the U.S. and Europe, 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.
PXL770 (NASH)
- The Phase 2a trial for the treatment of NASH met its primary
efficacy endpoint; PXL770-treated patients achieved statistically
significant improvement in the relative decrease in liver fat mass
measured by magnetic resonance imaging-estimated proton density fat
fraction (MRI-PDFF) at 12-weeks with a greater response in patients
with type 2 diabetes4.
- In the Phase 2a trial, key secondary measures in PXL770-treated
patients included statistically significant observed improvements
in liver enzymes alanine transaminase (ALT) and hemoglobin A1c
(HbA1c).
- In the Phase 2a trial, PXL770 was observed to be safe and well
tolerated. The results support the development in NASH and also
further evaluation for combination use with other agents.
Additional data are currently being analyzed and the Company is
working with key opinion leaders to finalize the Phase 2b clinical
trial design for PXL770.
- Phase 2a results also support utility of AMPK activation in
other chronic and rare metabolic diseases.
- Preclinical results presented at the 56th EASD meeting showed
PXL770 was observed to improve renal and cardiac disease in a
preclinical model demonstrating utility for NASH co-morbidities and
additional indications driven by metabolic dysfunction.
- Poxel anticipates presenting new data for PXL770 in a
peer-reviewed format at scientific meetings and in scientific
journals during the fourth quarter of 2020.
PXL065 (NASH)
- In early September 2020, a streamlined Phase 2 study was
initiated to evaluate PXL065 in at least 120 biopsy-proven NASH
patients with the aim to identify the optimal dose or doses for a
Phase 3 registration trial. The results from this study are
anticipated to be available during the first half of 2022.
- Poxel anticipates presenting new data for PXL065 in a
peer-reviewed format at scientific meetings and in scientific
journals during the fourth quarter of 2020.
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
- In October, Poxel received financing approval from BNP Paribas,
Bpifrance and CIC Lyonnaise de Banque for a total of EUR 6 million
in the form of state-guaranteed loans (Prets Garantis par l’Etat,
or PGE in France) in the context of the COVID-19 pandemic.
Third Quarter and Nine Months Ended September 30, 2020 Cash
and Revenue
Cash
As of September 30, 2020, cash and cash equivalents were EUR
41.5 million (USD 48.6 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 24.5 million as of September 30, 2020,
as compared to EUR 27.4 million at December 31, 2019. In October
2020, Poxel received a EUR 6.0 million PGE loan from the French
government, which is not reflected in the September 30, 2020 cash
update.
EUR (in thousands)
Q3 2020*
Q4 2019
Cash
19,738
18,161
Cash equivalents
21,794
19,026
Total cash and cash
equivalents**
41,532
37,187
*Unaudited data
**Cash and cash equivalents net of
financial liabilities (excluding IFRS 16 impacts and derivative
debts) were EUR 24.5 million at the end of Q3 2020 and EUR 27.4
million at the end of Q4 2019.
Nine Months 2020 Revenue
Poxel reported revenues of EUR 6.6 million for the nine months
ended September 30, 2020, as compared to EUR 26.0 million during
the corresponding period in 2019 (historical).
Revenue for the first nine months 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
nine months of 2020 that were re-invoiced to Sumitomo Dainippon
Pharma and the milestone payment that Poxel received from Sumitomo
Dainippon Pharma for the submission of the Imeglimin J-NDA. 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 the completion of this
program, which has been completed, and therefore led to the
decrease in revenue.
EUR
(in thousands)
H1 2020
Q3 2020
Sept 2020
H1 2019
Q3 2019
Sept 2019
6 months 3 months*
9 months*
6 months
3 months
9 months
Adjusted**
Historical
Adjusted**
Historical
Adjusted**
Historical
Roivant Agreement
13
5
18
155
155
52
52
207
207
Sumitomo Agreement
6,359
195
6,554
18,909
22,914
2,971
2,771
21,879
25,685
Other
-
-
-
100
100
-
-
100
100
Total revenues
6,372
199
6,571
19,164
23,169
3,023
2,823
22,186
25,992
*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 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
- B. Riley Liver Disease Therapeutics Day, October 29, 2020
(virtual)
- Direct Dirigeants Event, November 3, 2020 (in-person
conference)
- American Association for the Study of Liver Diseases (AASLD),
The Liver Meeting®, November 13-17, 2020 (virtual)
- ALD Connect Annual Meeting, November 13-15, 2020 (virtual)
- Bryan Garnier Healthcare Conference, November 16, 2020
(virtual)
- Jefferies Virtual London Healthcare Conference, November 17-19,
2020 (virtual)
- Oddo Digital Tech40 Forum, November 24-25, 2020 (virtual)
- NASH Summit Boston, December 15-17, 2020 (virtual)
Next Financial Press Release: Fourth Quarter 2020
Financial Statement expected on February 11, 2021
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, has
successfully completed a Phase 2a proof-of-concept trial for the
treatment of NASH. The Phase 2a trial met its primary endpoint and
study objectives. PXL770 could also have the potential to treat
additional metabolic diseases. PXL065 (deuterium-stabilized
R-pioglitazone), an MPC inhibitor, is in a single 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 Year noted is Fiscal Year from April 2021 to March 2022, which
is Sumitomo Dainippon Pharma’s Fiscal Year. 2 Year noted is Fiscal
Year from April 2021 to March 2022, which is Sumitomo Dainippon
Pharma’s Fiscal Year. 3 Converted at the exchange rates as of June
30, 2020. 4 Prevalence of type 2 diabetes in patients with NASH
estimated to be 47% (Younossi ZM et al, Hepatology 64, 73–84,
2016).
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version on businesswire.com: https://www.businesswire.com/news/home/20201020005903/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
Stephanie May or Valeria Fisher may@trophic.eu or fisher@trophic.eu
+49 171 185 56 82 or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
/ Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
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