- TWYMEEG® (Imeglimin hydrochloride) launched in Japan on
September 16 for the treatment of type 2 diabetes
- Milestone payment for TWYMEEG’s approval in Japan of JPY
1.75 billion (approximately EUR 13.2 million, USD 15.8 million)1
paid by Sumitomo Dainippon Pharma to Poxel in July 2021
- Patient enrollment in PXL065 Phase 2 (DESTINY-1) trial in
NASH completed in September with results expected in Q3
2022
- Phase 2a clinical Proof of Concept (POC) biomarker studies
of PXL065 and PXL770 in X-linked adrenoleukodystrophy (ALD) planned
to initiate in early 2022 with data expected by year end
2022
- As of September 30, 2021, cash and cash equivalents were EUR
37.2 million (USD 43.2 million)
POXEL SA (Euronext – POXEL - FR0012432516), a clinical stage
biopharmaceutical company developing innovative treatments for
chronic diseases with metabolic pathophysiology, including
non-alcoholic steatohepatitis (NASH) and rare disorders, today
provided a corporate update and announced its cash position and
revenue for the third quarter and the nine months ended September
30, 2021.
“During the third quarter, we continued to make significant
progress and accomplished a number of important clinical and
corporate objectives. The TWYMEEG® approval last June and
subsequent launch on September 16 have increased our financial
position and will continue to bolster our financial foundation with
associated future royalties and sales-based payments. We are
extremely proud to have brought TWYMEEG® to patients in Japan
through our fruitful partnership with Sumitomo Dainippon Pharma. In
line with our commitment towards NASH, in September, we completed
patient enrollment in the PXL065 Phase 2 trial where we anticipate
reporting topline results in Q3 2022,” said Thomas Kuhn, CEO of
Poxel.
“For the remainder of this year, we are fully committed to
advancing our programs, particularly to support the important
clinical milestones of initiating the Phase 2a clinical Proof of
Concept biomarker studies of PXL065 and PXL770 in ALD in early 2022
and completing the PXL065 Phase 2 trial in NASH in Q3 2022. Our
recent accomplishments highlight our capability to deliver on our
goals which are aligned with Poxel’s mission to develop innovative
therapeutics for patients living with metabolic diseases,” Mr. Kuhn
added.
Clinical Updates
Rare metabolic diseases (PXL065 and PXL770)
- Poxel is planning to initiate two phase 2a clinical Proof of
Concept (POC) biomarker studies of PXL065 and PXL770 in X-linked
adrenoleukodystrophy (ALD) in early 2022 and all regulatory
processes are on track. Data are expected by year end 2022.
- In September, Poxel attended the 11th International Meeting on
AMPK in Evian-les-Bains, France, and Pierre-Axel Monternier, Senior
Manager, Pharmacology, delivered a presentation: “Potential
therapeutic utility of direct AMPK activators for X-linked
adrenoleukodystrophy.”
- In early October, at the World Congress of Neurology (WCN),
Poxel delivered a poster presentation entitled “Validation of
Direct AMP Kinase Activation for Treatment of X-linked
Adrenoleukodystrophy.”
- In mid-October, at the National Organization for Rare Disorders
(NORD) Summit, Poxel delivered two poster presentations entitled
“(R)-pioglitazone – PXL065 – for Treatment of X-Linked
Adrenoleukodystrophy (ALD)” and “Validation of Direct AMP Kinase
(AMPK) Activation for Treatment of X-Linked Adrenoleukodystrophy
(ALD).”
NASH (PXL065 and PXL770)
- In September, the PXL065 Phase 2 trial (DESTINY-1) in NASH
completed patient enrollment with 123 noncirrhotic biopsy-proven
NASH patients across multiple clinical sites in the US in a 36-
week, randomized, dose-ranging, double-blind, placebo-controlled,
parallel group study designed to assess the efficacy and safety of
PXL065. Results from this Phase 2 study are anticipated in Q3 2022.
The goal of this trial is to identify the optimal dose or doses of
PXL065 to advance into a Phase 3 registration trial for the
treatment of noncirrhotic biopsy-proven NASH patients.
- In September, at the 11th International Meeting on AMPK in
Evian-les-Bains, France, Poxel Senior Vice President, R&D
Pharmacology and Scientific Communication, Sophie Bozec, PhD,
presented: “Characterization of a first-in-class direct AMPK
activator, PXL770, for NASH and other metabolic disorders: from
preclinical to clinical.”
Type 2 Diabetes (TWYMEEG®/Imeglimin)
- On September 16, TWYMEEG was launched in Japan for the
treatment of type 2 diabetes by Sumitomo Dainippon Pharma. TWYMEEG
is Poxel’s first product to reach commercialization and Japan is
the first country where the product has been approved. Poxel
received a milestone payment of JPY 1.75 billion (EUR 13.2 million,
USD 15.8 million)1 from Sumitomo Dainippon Pharma in July for the
approval of TWYMEEG. Additionally, as part of the license agreement
with Sumitomo Dainippon Pharma, Poxel is entitled to receive
escalating royalties on net sales and sales-based payments in
accordance with sales goals.
Corporate Updates
- In September, Sylvie Bertrand joined the Poxel management team
as Vice President, Human Resources, based in Lyon, France. Sylvie
has an extensive experience in HR, having worked in different
companies where she led efforts to define and implement HR
resources, strategy and processes.
Third Quarter and Nine Months Ended September 30, 2021 Cash
and Revenue
Cash
As of September 30, 2021, cash and cash equivalents were EUR
37.2 million (USD 43.2 million), as compared to EUR 40.2 million
(USD 49.4 million) at December 31, 2020. Cash and cash equivalents
net of financial liabilities (excluding IFRS16 impacts and
derivative debts) were EUR 1.7 million as of September 30, 2021, as
compared to EUR 17.1 million at December 31, 2020. In July 2021,
Poxel received a EUR 13.2 million2 milestone payment from its
partner Sumitomo Dainippon Pharma for the Imeglimin approval
obtained on June 23, 2021.
EUR (in thousands)
Q3 2021
Q4 2020
Cash
32,058
15,588
Cash equivalents
5,173
24,615
Total cash and cash
equivalents*
37,231
40,203
Unaudited data
*Cash and cash equivalents net of
financial liabilities were EUR 1.7 million at the end of Q3 2021
and EUR 17.1 million at the end of Q4 2020.
Nine Months 2021 Revenue
Poxel reported revenues of EUR 13.3 million for the nine months
ended September 30, 2021, as compared to EUR 6.6 million during the
corresponding period in 2020.
Revenue for the first nine months of 2021 mostly reflects the
JPY 1.75 billion (EUR 13.2 million)3 milestone payment paid by
Sumitomo Dainippon Pharma to Poxel in July 2021. No revenue was
reported in Q3.
Revenue for the first nine months of 2020 included the milestone
payment that Poxel received from Sumitomo Dainippon Pharma for the
submission of the Imeglimin J-NDA. In a lesser extent, it also
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 during the first nine months of 2020 that were re-invoiced
to Sumitomo Dainippon Pharma.
EUR
(in thousands)
H1 2021
6 months
Q3 2021
3 months
Sept. 2021
9 months
H1 2020
6 months
Q3 2020
3 months
Sept. 2020
9 months
Roivant Agreement
-
-
-
13
5
18
Sumitomo Dainippon Pharma Agreement
13,274
-
13,274
6,359
195
6,554
Other
-
Total revenues
13,274
-
13,274
6,372
199
6,571
Unaudited data
Planned Presentations and Participation at the Following
Upcoming Events
- ALD Connect Annual Meeting (virtual) - November 12-13,
2021
- AASLD The Liver Meeting (virtual) - November 12-15, 2021
- Jefferies London Healthcare Conference (in-person and virtual)
– November 16-19, 2021
- 5th Annual NASH Summit (virtual) – November 29-December 2,
2021
- ODDO BHF Forum (virtual) – January 6-11, 2022
- H.C. Wainwright BioConnect 2022 (virtual) – January 10-13,
2022
Next Financial Press Release: Fourth Quarter 2021
Financial Statement expected on February 16, 2022
About Poxel SA
Poxel is a clinical stage biopharmaceutical company developing
innovative treatments for chronic serious diseases with metabolic
pathophysiology, including non-alcoholic steatohepatitis (NASH) and
rare disorders. Poxel has clinical and earlier-stage programs from
its adenosine monophosphate-activated protein kinase (AMPK)
activator and deuterated TZD platforms targeting chronic and rare
metabolic diseases. For the treatment of NASH, PXL065
(deuterium-stabilized R-pioglitazone) is in a streamlined Phase 2
trial (DESTINY-1). PXL770, a first-in-class direct AMPK activator,
has successfully completed a Phase 2a proof-of-concept trial for
the treatment of NASH, which met its objectives. For the rare
inherited metabolic disorder, adrenoleukodystrophy (ALD), the
company intends to initiate Phase 2a proof of concept studies with
PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN).
TWYMEEG® (Imeglimin), Poxel’s first-in-class lead product that
targets mitochondrial dysfunction, has been approved and launched
for the treatment of type 2 diabetes in Japan. Poxel expects to
receive sales-based payments and royalties from Sumitomo Dainippon
Pharma. Poxel has a strategic partnership with Sumitomo Dainippon
Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine
other Southeast Asian countries. 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
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 Currency exchange rate at the date
of the approval. 2 Currency exchange rate at the date of the
approval. 3 Currency exchange rate at the date of the approval.
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version on businesswire.com: https://www.businesswire.com/news/home/20211020005670/en/
Poxel SA Catherine David Investor Relations &
Communication Manager catherine.david@poxelpharma.com +33 7 64 57
61 78
Aurélie Bozza Investor Relations & Communication Director
aurelie.bozza@poxelpharma.com +33 6 99 81 08 36
Elizabeth Woo Senior Vice President, Investor Relations &
Communication elizabeth.woo@poxelpharma.com
Investor relations / Media NewCap Emmanuel Huynh or
Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
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