- Expanded management team with the appointment of David E.
Moller, MD, as Chief Scientific Officer (CSO) in January
2020
- Presented new preclinical results for PXL770 at the 3rd
Annual Global NASH Congress in February 2020 demonstrating PXL770
was observed to reduce liver inflammatory cells
- Metavant met with the U.S. Food and Drug Administration
(FDA) in Q1 2020; discussions continue about Phase 3 clinical
development plan in type 2 diabetes patients with chronic kidney
disease (CKD) stages 3b/4
- Strengthened cash position in March 2020; drew down EUR 10
million from IPF Partners bond loan
- Imeglimin manuscript recently published in scientific
journal Clinical Pharmacokinetics; results demonstrate repeated
co-administration with two commonly prescribed anti-diabetic drugs,
metformin and sitagliptin (Januvia®; Merck & Co.)
did not result in clinically relevant changes in drug exposure and
Imeglimin was observed to be safe and well tolerated
- Proactively monitoring and managing potential impacts caused
by the coronavirus (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 provided a corporate update and
announced its cash position and revenue for the first quarter ended
March 31, 2020.
“During the first quarter, we completed a number of important
accomplishments within the Company and for our clinical programs.
We strengthened our executive management team with the appointment
of David E. Moller, MD, as CSO. As an industry leader in drug
development with expertise in type 2 diabetes and metabolic
diseases, David is leading activities related to scientific
innovation, specifically with adenosine monophosphate-activated
protein kinase (AMPK) and mitochondrial pyruvate carrier (MPC). In
addition, he is expanding our scientific communications activities
through the publication of new data,” said Thomas Kuhn, CEO of
Poxel. “We recently showcased new results demonstrating that PXL770
was observed to reduce liver inflammation, a hallmark of NASH, and
published a manuscript demonstrating Imeglimin’s safety and
tolerability profile as well as the absence of clinically relevant
pharmacokinetic interactions after being co-administered with two
widely prescribed medications for type 2 diabetes. We look forward
to publishing and presenting additional results from our pipeline
programs throughout the year.”
“Also, during the first quarter, we continued to work closely
with Sumitomo Dainippon Pharma on activities related to the
Imeglimin Japanese New Drug Application (JNDA) submission for type
2 diabetes targeted in Q3 2020. In parallel, we worked with
Metavant, who is in discussions with the FDA for the Imeglimin
Phase 3 program in type 2 diabetes patients with CKD stages 3b/4,
an underserved patient population,” added Thomas Kuhn. “For our two
clinical stage NASH programs, we look forward to several upcoming
milestones. For PXL770, during the first quarter of 2020, we fully
enrolled the pharmacokinetic (PK)/pharmacodynamic (PD) and Phase 2a
trials with results currently expected in Q2 and Q3 2020,
respectively. For PXL065, we are preparing for the 36-week Phase 2
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)
- Recently, 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 Imeglimin was
observed to be safe and well tolerated. These results are
consistent with prior preclinical and longer-term clinical
studies.
- Poxel continues to work closely with Sumitomo Dainippon Pharma
on activities related to the JNDA 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 for the Imeglimin Phase 3 program in the US in type 2
diabetes patients with CKD stages 3b/4.
PXL770 (NASH)
- During Q1 2020, patient enrollment was completed for the Phase
2a and PK/PD trials.
- In February 2020, important new preclinical results for PXL770
were presented at the 3rd Annual Global NASH Congress. PXL770 was
observed to reduce liver inflammatory cells, which may contribute
to an improvement of fibrogenesis, in a preclinical NASH
model.
- Results from the PK/ PD trial are currently expected late
second quarter of 2020.
- Results from the Phase 2a trial are currently expected late
third quarter of 2020.
PXL065 (NASH)
- Poxel 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 planned to initiate study enrollment during the second
quarter of 2020 and is now anticipating a delay due to the current
COVID-19 situation. The Company is working with the lead clinical
investigator and clinical trial sites and is currently reviewing
the timing and plans to initiate this study, 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
- In addition to the clinical studies for PXL770 and PXL065, the
Company is also conducting preclinical combination studies with its
NASH drug candidates to explore the potential to show additive or
synergistic benefits to treat the root causes of NASH with other
agents in development. Also, the Company is planning for future
pipeline growth and evaluating additional research and development
opportunities from its internal pipeline as well as external
opportunities with a focus on metabolic disorders, including rare
diseases.
Corporate Update
- In November 2019, Poxel obtained additional funding to advance
its pipeline programs through a bond loan agreement of up to EUR 30
million with IPF Partners. Poxel drew down the first tranche of EUR
6.5 million in November 2019. In March 2020, the Company drew down
the second tranche of EUR 10 million, which was contingent on the
successful completion of the Imeglimin Phase 3 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 bond loan
agreement.
- In January 2020, Poxel appointed David E. Moller, MD, as CSO.
Dr. Moller is responsible for leading scientific-related activities
to support the advancement of the Company, including scientific
innovation and scientific communications at Poxel. He is based in
Boston and has joined the executive management team.
- During the quarter, Thibaut Roulon and Olivier Martinez
resigned from their positions as Board Observers.
First Quarter 2020 Financial Update
As of March 31, 2020, cash and cash equivalents were EUR 36.9
million (USD 40.4 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 were EUR 20.0 million as of March 31,
2020, as compared to EUR 27.4 million as of December 31, 2019.
EUR (in millions)
Q1 2020
Q4 2019
Cash
5.6
18.2
Cash equivalents
31.3
19.0
Total cash and cash
equivalents*
36.9
37.2
Unaudited data *Cash and cash equivalents
net of financial liabilities were EUR 20.0 million at the end of Q1
2020 and EUR 27.4 million at the end of Q4 2019.
Q1 2020 revenue
Poxel reported revenues of EUR 1.5 million for the quarter ended
March 31, 2020, as compared with revenues of EUR 14.9 million
during the same period in 2019 (historical).
Revenue reflects 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 quarter 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 now been completed.
EUR (in millions)
Q1 2020 3
months
Q1 2019 3 months
(adjusted)*
Q1 2019 3 months
(historical)
Roivant Agreement
-
-
-
Sumitomo Agreement
1.5
12.3
14.9
Other
-
-
-
Total revenues
1.5
12.3
14.9
Unaudited data *Proforma, as if the
Company applied the residual method in FY19.
Note: A change in accounting policy was reported on 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
- Jefferies Virtual Healthcare Conference, June 2-4, 2020
- BIO Digital (BIO International Convention), June 8-12,
2020
Next Financial Press Release: Second Quarter 2020
Financial Statement expected on July 21, 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 targeting metabolic, specialty and rare 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 has undertaken a full review of the impact of the
outbreak on its business. Considering the rapidly evolving
situation, the Company is updating this assessment on a regular
basis.
The Company anticipates that the COVID-19 pandemic could have a
material negative impact on our 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 have been implemented by
the authorities. In addition, the deteriorating market conditions
may impact the Company’s ability to raise additional funding and/or
to enter into partnerships. Particularly, delays in the supply of
drug substance or drug products, in pre-clinical 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200421005646/en/
Poxel SA Jonae R. Barnes Senior Vice President, Investor
Relations 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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