- Imeglimin Japanese New Drug Application (J-NDA) under review
by the Pharmaceuticals and Medical Devices Agency (PMDA) following
submission by Poxel’s partner, Sumitomo Dainippon Pharma in July
2020, with product launch anticipated in 20211
- Poxel regained Imeglimin rights from Metavant for US, Europe
and other countries not covered by its agreement with Sumitomo
Dainippon Pharma and is pursuing next steps to advance its
development including partnering activities
- Poxel continues to prepare for initiation of Phase 2b trial
with PXL770 in patients with biopsy-proven NASH and pre-diabetes or
type 2 diabetes, expected to commence in H2 2021
- PXL065 Phase 2 study ongoing with completion of recruitment
expected in mid-2021 and topline data readout in mid-2022
- Imeglimin and PXL065 preclinical and clinical data published
in peer reviewed journals; PXL770 data accepted for oral and poster
presentations at an upcoming scientific conference
- As of March 31, 2021, cash and cash equivalents were EUR
32.8 million (USD 38.4 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 first quarter ended
March 31, 2021.
“Closing the first quarter of 2021, we remain on track with our
corporate and clinical timelines and objectives. We look forward to
the completion of the J-NDA review of Imeglimin, and based on a
typical 12-month review by the PMDA, we believe Imeglimin could be
approved in mid-2021 with an anticipated product launch by our
partner Sumitomo Dainippon Pharma in Fiscal Year 20211. Further,
having regained Imeglimin rights from Metavant in the US, Europe
and other countries not covered by our agreement with Sumitomo, we
are pursuing various opportunities to advance its development
including partnering activities,” commented Thomas Kuhn, CEO of
Poxel.
“Our NASH candidates, PXL770 and PXL065 continue to move
forward. For PXL770, we are actively preparing for a Phase 2b trial
in biopsy-proven NASH patients with a focus on patients with
pre-diabetes or type 2 diabetes, and anticipate initiating this
clinical trial in H2 2021. For PXL065, the enrollment of our
DESTINY-1 trial in biopsy-proven NASH patients is moving along well
and we anticipate completion of recruitment in mid-2021 as planned,
with topline data expected in mid-2022. Moving forward, we remain
focused on developing our clinical candidates and showcasing their
value in the metabolic disease space. In parallel, we continue
evaluating our AMP-kinase (AMPK) and deuterium-modified
thiazolidinedione (d-TZD) platforms in preclinical studies
targeting a range of metabolic disorders including specialty and
rare diseases,” concluded Mr. Kuhn.
Clinical Development Updates
Imeglimin (Type 2 Diabetes)
- Poxel continues to work closely with its partner, Sumitomo
Dainippon Pharma, regarding the J-NDA, with the approval
anticipated in Fiscal Year 20212. The approval would trigger a JPY
1.75 billion (approximately EUR 13.8 million, USD 16.9 million)3
milestone payment as well as the ability for Poxel to draw down EUR
13.5 million from the Company’s debt facility with IPF. The target
product launch date is anticipated in 20212 which would trigger the
potential for sales-based payments and escalating double-digit
royalties on sales.
- In February, Poxel announced it had regained the rights to
Imeglimin from Metavant for US, Europe, and other countries not
covered by the Company’s agreement with Sumitomo Dainippon Pharma.
Metavant has returned all data, materials and information,
including FDA regulatory filings, related to the program and is not
entitled to any payments from Poxel as part of the return. Poxel is
pursuing next steps for the development of Imeglimin in these
geographic areas including partnering activities.
- Throughout the first quarter, the Company published several
papers describing Imeglimin’s innovative MoA and Phase 2b/3 results
from Japan in peer reviewed journals.
PXL770 (NASH)
- Poxel is preparing 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 type 2 diabetes
expected to commence in H2 2021.
- The PXL770 program was presented and discussed at the 2021
NASH-TAG conference in March.
- Clinical results for PXL770 were also selected for
presentations at the upcoming EASL (European Association for the
Study of the Liver) in June 2021.
PXL065 (NASH)
- The recruitment for DESTINY-1, a Phase 2 study in biopsy proven
NASH patients remains on track and is expected to be completed in
mid-2021, with topline data available in mid-2022. The results of
this trial will be used to help identify the dose or doses for a
Phase 3 registration trial.
- In March, recent PXL065 Phase 1 clinical results, drug
metabolism data and PK-PD modeling were presented at the 2021
NASH-TAG conference.
- A publication in Hepatology Communications journal entitled
Deuterium‐Stabilized (R)‐Pioglitazone (PXL065) Is Responsible for
Pioglitazone Efficacy in NASH yet Exhibits Little to No PPARγ
Activity was released in April 2021. The study highlights the
potential of PXL065, the deuterium-stabilized R-stereoisomer of
pioglitazone, to provide a safer and more effective treatment for
NASH than pioglitazone in its racemic mixture form.
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.
- The Company is actively planning further pipeline growth and
conducting additional preclinical studies to evaluate its next
generation direct AMPK activators and d-TZDs, as well as
considering external opportunities, with a focus on metabolic
disorders, including rare diseases.
Corporate Updates
- In March, Poxel released its Universal Registration Document
(URD).
- In February, Poxel announced the resolution of the arbitration
procedure with Merck Serono.
First Quarter 2021 Financial Update
As of March 31, 2021, cash and cash equivalents were EUR 32.8
million (USD 38.4 million), as compared to EUR 40.2 million (USD
49.4 million) as of December 31, 2020. Cash and cash equivalents
net of financial liabilities were EUR 9.8 million as of March 31,
2021, as compared to EUR 17.2 million as of December 31, 2020.
EUR (in millions)
Q1 2021
Q4 2020
Cash
18.5
15.6
Cash equivalents
14.3
24.6
Total cash and cash
equivalents*
32.8
40.2
Unaudited data
*Cash and cash equivalents net of
financial liabilities were EUR 9.8 million at the end of Q1 2021
and EUR 17.2 million at the end of Q4 2020.
First Quarter 2021 revenue
Poxel reported no revenue for the quarter ended March 31, 2021,
as compared to EUR 1.5 million during the corresponding period in
2020.
The revenues for the first quarter of 2020 included 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 were recognized based on the
percentage of the completion of this program. This program has been
fully completed in 2020, and led to no revenue for the first
quarter in 2021.
EUR (in millions)
Q1
Q1
2021
3 months
2020
3 months
Roivant Agreement
-
-
Sumitomo Agreement
-
1.5
Other
-
Total revenues
-
1.5
Unaudited data
Planned Presentations and Participation at the Following
Upcoming Virtual Events
- Mitochondria-Targeted Drug Development Summit, April 27-29
- Kempen Life Sciences Conference, May 5
- The 64th Annual Meeting of the Japanese Diabetes Society, May
20-22
- Jefferies Healthcare Conference, June 1-4
- JMP Securities Conference, June 16-18
- Raymond James Human Health Innovations Conference, June
21-23
- EASL ILC, June 23-26
Next Financial Press Release: Second Quarter 2021
Financial Update, July 21, 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. 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 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 Based on the JPY/EUR exchange rate on July
28, 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210421005414/en/
Poxel SA
Catherine David Investor Relations &
Communication Manager catherine.david@poxelpharma.com +33 7 64 57
61 78
Investor relations / Media - EU/US Trophic Communications
Stephanie May or Valeria Fisher poxel@trophic.eu +49 171 185 56 82
or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
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