- Fast Track and Orphan Drug Designation for PXL065 and PXL770
in adrenoleukodystrophy (ALD) granted by the Food and Drug
Administration (FDA)
- Phase 2 study results for PXL065 (DESTINY-1) in NASH
expected in Q3 2022
- As of March 31, 2022, cash and cash equivalents were EUR
24.0 million (USD 26.7 million)
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 provided a corporate update and announced its cash position
and revenue for the first quarter ended March 31, 2022.
“Receiving FDA Orphan Drug Designation for PXL065 and PXL770 in
ALD, along with the recent Fast Track Designation for both
compounds, gives us confidence that we can expedite clinical
development for ALD which represents an area with very high unmet
medical need. We are preparing for the launch of our two Phase 2a
proof-of-concept clinical trials which we plan to initiate as soon
as possible. We look forward to sharing topline results from our
Phase 2 DESTINY-1 study in NASH for PXL065 in the third quarter of
2022,” said Thomas Kuhn, Chief Executive Officer of Poxel. “We
continue to pursue various financing options to extend our cash
runway, prioritizing non-dilutive sources. We remain focused on
developing our clinical candidates and demonstrating their value in
the field of metabolic diseases.”
Commercial Update
TWYMEEG® (Imeglimin)
- As of March 31, 2022, royalty revenue to Poxel based on TWYMEEG
net sales in Japan under the Sumitomo Pharma license agreement has
been limited following TWYMEEG’s recent commercial launch on
September 16, 2021. TWYMEEG’s initial commercial uptake has been
affected by restrictions in Japan on prescribing any new drug in
its first year of commercialization, and conditions related to
COVID-19, which have reduced the frequency of physician visits and
limited the extensive prescriber education efforts required for any
launch of an innovative drug with a new mechanism of action.
However, as a result of Sumitomo Pharma's promotional activities
and efforts since launch, TWYMEEG is very well known among
prescribers.
Clinical Updates
NASH
- PXL065 (deuterium-stabilised R-pioglitazone) is in a Phase 2
study (DESTINY-1). Results from this 36-week, randomized,
double-blind, placebo-controlled, parallel group, dose-ranging
study designed to assess efficacy and safety are anticipated in Q3
2022. The goal of DESTINY-1 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.
Rare metabolic diseases
- In ALD, Phase 2a biomarker proof-of-concept (POC) clinical
trials of PXL065 and PXL770 are expected to initiate as soon as
possible, subject to additional financing. Two identical studies
will enroll adult male patients with adrenomyeloneuropathy (AMN),
the most common ALD subtype. The POC studies will evaluate the
pharmacokinetics, safety and efficacy of PXL065 and PXL770 after 12
weeks of treatment based on relevant disease biomarkers, such as
the effect on very long chain fatty acids (VLCFA), the
characteristic plasma marker of the disease.
- In February and April, the FDA awarded Fast Track Designation
(FTD) to PXL065 and PXL770 respectively, for ALD. The FDA grants
FTD to investigational drugs which treat a serious or
life-threatening condition, and which fill an unmet medical need.
Filling an unmet medical need is defined as providing a therapy
where none exists or providing a therapy which may be potentially
better than available therapy. The key benefits of FTD comprise
enhanced access to the FDA, with regular and more frequent
opportunities for consultation and discussion.
Significant Events after the Period
- During the 2nd quarter, the FDA granted Orphan Drug Designation
(ODD) to PXL065 and PXL770 for ALD. ODD confers a company a
potential seven-year window of exclusive marketing rights following
FDA approval, along with a reduction in certain application fees,
and tax credits for expenses related to qualified clinical trials
conducted after orphan designation is received.
First Quarter 2022 Financial Update
As of March 31, 2022, cash and cash equivalents were EUR 24.0
million (USD 26.7 million), as compared to EUR 32.3 million (USD
36.6 million) as of December 31, 2021. Net financial debt
(excluding IFRS16 impacts and derivative debts) was EUR 10.1
million as of March 31, 2022, as compared to EUR 2.6 million as of
December 31, 2021.
EUR (in thousands)
Q1 2022
Q4 2021
Cash
24,043
28,753
Cash equivalents
-
3, 534
Total cash and cash
equivalents*
24,043
32,287
Unaudited data
* Net financial debt (excluding IFRS 16
impacts and derivative debts) was EUR 10,1 million at the end of Q1
2022 as compared to EUR 2.6 million at the end of Q4 2021
Based on:
- the cash position at March 31, 2022,
- the current development plan of the Company including 1) the
completion of its ongoing Phase 2 NASH trial for PXL065 (DESTINY-1)
but excluding 2) the two identical Phase 2a clinical
proof-of-concept (POC) biomarker studies for PXL065 and PXL770 in
adrenomyeloneuropathy (AMN),
- the cash forecast for the year 2022 approved by the Board of
Directors of the Company, that 1) does not include, as a
conservative approach, any net sales from Imeglimin in Japan and 2)
includes an amount of EUR 4,813 thousands for the repayments of the
loan with IPF partners until December 2022, and
- a strict control of its operating expenses,
the Company expects that its resources will be sufficient to
fund its operations and capital expenditure requirements through at
least December 31, 2022. However, the Company is subject to certain
financial covenants1 related to its debt with IPF Partners which
could be potentially breached in Q3 2022.
The Company is actively pursuing various financing options,
which include dilutive and non-dilutive sources, as well as
discussions with IPF partners.
First Quarter 2022 Revenue
Poxel reported EUR 32 thousand revenue for the quarter ended
March 31, 2022, as compared to no revenue during the corresponding
period in 2021.
Revenue for the first quarter of 2022 reflects JPY 4.4 million
(EUR 32 thousand) of royalty revenue from Sumitomo Pharma which
represents 8% of TWYMEEG net sales in Japan. Based on the current
forecast, Poxel expects to receive 8% royalties on TWYMEEG net
sales in Japan through the Sumitomo Pharma fiscal year 2022 (April
2022 to March 2023). As part of the Merck Serono licensing
agreement, Poxel will pay Merck Serono a fixed 8% royalty based on
the net sales of Imeglimin, independent of the level of sales.
EUR (in thousands)
Q1
Q1
2022
2021
3 months
3 months
Sumitomo Pharma Agreement
32
-
Other
-
-
Total revenues
32
-
Unaudited data
Planned Presentations and Participation at the Following
Upcoming Events
- European Renal Association, May 25-28
- 5th Global NASH Congress, May 26-27
- Jefferies Global Healthcare Conference, June 8-10
- JMP Securities 2022 Life Sciences Conference, June 15-16
Next Financial Press Release : Second Quarter 2022
Financial Update on August 30, 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 from Sumitomo Pharma royalties and sales-based
payments. Poxel has a strategic partnership with Sumitomo 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. The Company does not endorse or is
not otherwise responsible for the content of external hyperlinks
referred to in this press release.
_________________________
1 Under these financial covenants the
Company should maintain minimum cash position of the higher of i)
ten million euros and ii) the sum of the consolidated debt service
of the Company plus the amount of cash required to be spent by the
Company as part of its operations, in each case for the following
6-month period.
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version on businesswire.com: https://www.businesswire.com/news/home/20220517006053/en/
Contacts - Investor relations / Media Aurélie Bozza
Investor Relations & Communication Senior Director
aurelie.bozza@poxelpharma.com +33 6 99 81 08 36 Elizabeth Woo
Senior Vice President, Investor Relations & Communication
elizabeth.woo@poxelpharma.com NewCap Emmanuel Huynh or Arthur
Rouillé poxel@newcap.eu +33 1 44 71 94 94
Poxel (EU:POXEL)
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