- Patent Term Extension (PTE) approved in Japan for 2 patents
related to TWYMEEG®, extending the product patent life until
2036
- Exclusive discussions being finalized with a leading
investor to monetize royalties from sales of TWYMEEG® (Imeglimin)
in Japan
- As of June 30, 2024, cash and cash equivalents amounted to
EUR 2.8 million (USD 3 million1)
- Cash horizon estimated to be sufficient until the completion
of the transaction, including only the tranches already drawn down
or fully available under the equity-linked financing facility with
IRIS
- Rescheduling of the Annual General Meeting 2024, subject to
the publication of the full-year results for the year ended
December 31, 2023
Regulatory News:
POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage
biopharmaceutical company developing innovative treatments for
chronic serious diseases with metabolic pathophysiology, including
non-alcoholic steatohepatitis (NASH) and rare metabolic disorders,
today publishes its cash position, provides an update on its
financial situation for the second quarter and first half of 2024,
ending June 30, 2024, reviews its activities on June 30, 2024 and
announces the rescheduling of its Annual General Meeting 2024, in
view of the postponement of the closing of its social and
consolidated financial statements for the year ended December 31,
2023.
Thomas Kuhn, Chief Executive Officer of Poxel, stated:
“TWYMEEG®'s commercialization in Japan continues to gain momentum,
supported by many scientific papers and articles in Japanese
journals, some of which were or will be presented at international
scientific congresses. In parallel with the expected finalization
of our exclusive financing discussions based on the monetization of
royalties from TWYMEEG® sales in Japan, the additional protection
granted to TWYMEEG® until 2036 potentially represents a further
opportunity for the product”.
TWYMEEG® (Imeglimin)
Clinical development, intellectual property and scientific
publications
- The Long-Term, 52-week, Open-label, Phase 4 Study conducted by
Sumitomo Pharma of Imeglimin in Japanese Type 2 Diabetic Patients
with Renal Impairment is currently ongoing in Japan to strengthen
TWYMEEG® profile in this key subpopulation. Top line results are
expected soon.
- On May 29, 2024, the Japanese Patent Office approved the
remaining two PTE applications, granting Poxel an extension to
patents n°5542066 and n°5758010, protecting Imeglimin’s synthesis
process.
- Several scientific presentations on TWYMEEG’s® innovative
mechanism of action and potential additional benefits, in addition
to its anti-diabetic activity were shared at the 67th Annual
Meeting of the Japanese Diabetes Society (JDS), held in Tokyo,
Japan, from May 17 to 19, 2024, and at the 84th Scientific Sessions
of the American Diabetes Association in Orlando, Florida. New
preclinical and clinical data will be presented at the 60th Annual
Congress of the European Association for the Study of Diabetes
(EASD).
Cash and cash equivalents in the second quarter and first
half of 2024
As of June 30, 2024, total cash and cash equivalents amounted to
EUR 2.8 million (USD 3 million1), compared with EUR 2.3 million
(USD 2.6 million2) as of December 31, 2023 (unaudited data). Net
financial debt (excluding IFRS16 impacts and derivative debts)
amounted to EUR 46.6 million as of June 30, 2024, compared with EUR
45.6 million as of December 31, 2023 (unaudited data).
EUR (thousands)
Q2 2024
Q4 2023
Cash
2,812
2,341
Cash equivalents
-
-
Cash and cash equivalents
2,812
2,341
Unaudited data.
Finalization of exclusive discussions with a leading investor
to monetize royalties from sales of TWYMEEG® (Imeglimin) in Japan
and cash runway
With the priority objective of relaunching its R&D
activities and executing its strategic plan in rare diseases, the
Company has focused in recent months on securing additional
financing, in particular non-dilutive solutions. In this context,
the Company is currently finalizing exclusive negotiations with a
leading investor to monetize royalties from TWYMEEG® (Imeglimin)
sales in Japan. In addition, the Company is in advanced discussions
– in some cases on an exclusive basis – with several potential
partners for each of its three products: Imeglimin, for several
countries not covered by its agreement with Sumitomo Pharma, PXL065
and PXL770.
Based on:
- its cash position on June 30, 2024,
- tranches already drawn3 or fully available as of the date of
this press release under the equity-linked financing facility with
IRIS,
- no research and development expenses, and
- a strict control of operating expenses,
Poxel expects that its resources, including funds available to
it, will be sufficient to maintain its operations and capital
expenditure until completion of the current process to monetize
royalties from sales of TWYMEEG® (Imeglimin) in Japan.
Rescheduling of the Annual General Meeting 2024
In view of this transaction, which is key for the Company to
continue its operations, and which will be taken into consideration
for the closing of its social and consolidated financial statements
for the year ending December 31, 2023, Poxel announces that it
requested and received confirmation from the Lyon Commercial Court
of the rescheduling of its Annual General Meeting, which must be
held before December 31, 2024. Once its social and consolidated
financial statements are approved, Poxel will inform the market and
its shareholders of its new financial calendar for 2024, including
the new date of the General meeting, as soon as possible.
Upcoming presentation and participation of the Company in an
event
3rd H.C. Wainwright Kidney Conference, July 15, 2024:
- A virtual presentation of the Company is scheduled at 4 pm CEST
- French time (10 am ET, New York time) and will focus on PXL770, a
novel direct activator of adenosine monophosphate-activated protein
kinase (AMPK), for the treatment of autosomal dominant polycystic
kidney disease (ADPKD). Thomas Kuhn, Chief Executive Officer, will
be available for one-to-one interviews on the same day.
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. For the treatment of
NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its
primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In
rare diseases, development of PXL770, a first-in-class
direct adenosine monophosphate-activated protein kinase (AMPK)
activator, is focused on the treatment of adrenoleukodystrophy
(ALD) and autosomal dominant polycystic kidney disease (ADPKD).
TWYMEEG® (Imeglimin), Poxel’s first-in-class product that
targets mitochondrial dysfunction, is marketed for the treatment of
type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to
receive royalties and sales-based payments. Poxel has a strategic
partnership with Sumitomo Pharma for Imeglimin in Japan, China, and
eleven other Asian countries. 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. There can be no assurance that the
Company will complete any of the foregoing transactions or that it
will do so on a timely basis. The Company does not endorse or is
not otherwise responsible for the content of external hyperlinks
referred to in this press release.
Glossary
You will find below a list of words and/or expressions that are
used in this press release or in Poxel’s communication, with the
aim to bring clarification and transparency:
- Sumitomo Pharma fiscal year runs from April to March. As
an example, Fiscal Year 2023 runs from April 1, 2023, through March
31, 2024.
- TWYMEEG® royalties: As per the Sumitomo Pharma’s
agreement, Poxel is entitled to receive royalties from the sales of
TWYMEEG® (Imeglimin) in Japan
- Sumitomo Pharma communicates gross
sales of TWYMEEG®, while TWYMEEG® royalties are calculated on
net sales.
- Net sales represent the amount of gross sales to which are
deducted potential rebates, allowances, and costs such as prepaid
freight, postage, shipping, customs duties and insurance
charges.
- Poxel is entitled to receive escalating royalties of 8-18% on
TWYMEEG® net sales from Sumitomo
Pharma.
- Positive net royalties: as part of the Merck Serono
licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty
based on the net sales of TWYMEEG®, independent of the level of
sales. All royalties that Poxel receives from TWYMEEG® net sales
above that 8% level are considered as positive net royalties. Net
royalties will therefore be positive for Poxel when TWYMEEG® net
sales exceed JPY 5 billion in a fiscal year and royalties reach 10%
and above.
__________________________________ 1 Converted at the exchange
rate on June 30, 2024 2 Converted at the exchange rate on December
31, 2023 3 Since March 31, 2023, 11 additional tranches have been
drawn for a total amount of EUR 5.8 million.
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version on businesswire.com: https://www.businesswire.com/news/home/20240714885795/en/
Investor relations / Media NewCap Nicolas Fossiez,
Aurélie Manavarere / Arthur Rouillé investor@poxelpharma.com +33 1
44 71 94 94
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