- TWYMEEG® (Imeglimin) net sales in Japan for the quarter
(July-September) grew four-fold over the prior quarter, in part due
to the lifting of the prescription days limitation in September
2022, as recently reported by Sumitomo Pharma
- Phase 2 NASH Trial (DESTINY-1) for PXL065 met its primary
efficacy endpoint for liver fat content reduction at 36 weeks for
all doses; PXL065 prioritized for further development in NASH based
on positive results from the DESTINY-1 trial
- PXL770 development to focus exclusively on rare diseases,
driven by promising data which showed strong potential in multiple
rare metabolic indications
- Extension of the cash runway through at least February 2023
with debt restructuring agreement with IPF Partners (IPF) and
equity-linked financing facility with Iris Capital Investment
(IRIS)
- As of September 30, 2022, cash and cash equivalents were EUR
17.1 million (USD 16.6 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 third quarter and the nine months ended
September 30, 2022.
“This quarter’s royalty revenues from TWYMEEG, marketed in Japan
by Sumitomo Pharma for Type 2 diabetes, increased four-fold over
the prior quarter, in part due to the removal of prescribing
restrictions after the initial year on the market. The royalty
stream from TWYMEEG’s growth is poised to deliver significant value
to Poxel,” noted Thomas Kuhn, Chief Executive Officer of Poxel.
“From our clinical programs, our DESTINY-1 Phase 2 Trial for PXL065
in NASH recently reported positive results, especially with respect
to fibrosis which represents the highest unmet need in
non-cirrhotic NASH. This is an important milestone for Poxel, but
also more broadly for NASH, for which there is still no approved
treatment. Based on these results, we are prioritizing PXL065 in
NASH and are actively looking for a partner to advance its
development. By leveraging the 505(b)(2) regulatory pathway, the
extensive safety database of the parent molecule, and our recent
Phase 2 results, we are well-positioned amongst other drugs in
development for future development. In addition, PXL770 is a Phase
2 ready asset that is focused exclusively on rare diseases,
starting with adrenoleukodystrophy and autosomal-dominant
polycystic kidney disease.”
Clinical Updates
- Positive topline results were announced for the Phase 2 trial
for the treatment of NASH (DESTINY-1) for PXL065 stating that the
primary efficacy endpoint was met. PXL065-treated patients achieved
statistically significant improvements in the relative decrease in
liver fat content measured by magnetic resonance imaging estimated
proton density fat fraction (MRI-PDFF) at 36-weeks for all
doses. Histology findings from paired liver biopsies showed strong
improvement in fibrosis without worsening of NASH, consistent with
dose-dependent reduction of all biomarkers related to
fibrinogenesis and fibrosis risk scores. Additional dose-dependent
benefits on glucose control and indices of insulin sensitivity were
also observed. PXL065 was observed to be safe and well tolerated
with no dose-dependent increase in body weight and no increased
lower extremity edema vs. placebo. The safety profile is consistent
with reduced PPARg-mediated side effects vs. published results of
pioglitazone.
- In adrenoleukodystrophy (ALD), PXL770 is prepared to advance
into a Phase 2a biomarker proof-of-concept (POC) clinical trial in
male patients with adrenomyeloneuropathy (AMN), the most common ALD
subtype. The 12-week study will evaluate pharmacokinetics, safety
and potential for efficacy based on relevant disease biomarkers,
such as the effect on very long chain fatty acids (VLCFA), the
characteristic plasma marker of the disease. Considering the
DESTINY-1 results for PXL065 in NASH, which validated the
deuterium-modified thiazolidinedione (TZD) platform, a second
identical study continues to be planned in order to assess the
potential of the deuterium-modified TZD platform with PXL065 in
ALD. ALD studies are expected to initiate as soon as possible,
subject to additional financing.
- PXL770 was granted Orphan Drug Designation (ODD) by the U.S.
Food and Drug Administration (FDA) for the treatment of patients
with autosomal-dominant polycystic kidney disease (ADPKD).
TWYMEEG® (Imeglimin)
- TWYMEEG net sales in Japan for the quarter (July-September)
grew significantly to JPY 0.4 billion (EUR 2.5 million)1, over the
prior quarter (April-June) of JPY 0.1 billion (EUR 0.6 million)1 as
recently reported by Sumitomo Pharma. As of September 1st, initial
launch year restrictions for TWYMEEG which limited new products to
two weeks prescriptions have been lifted. Sumitomo Pharma’s
forecast for net sales of TWYMEEG in Japan is JPY 1.5 billion (EUR
10.6 million)1 for fiscal year 2022 (April 2022 to March 2023).
Based on the current forecast, Poxel expects to receive 8%
royalties on TWYMEEG net sales in Japan through the Sumitomo Pharma
fiscal year 2022. 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. Since
TWYMEEG’s launch in September 2021, Sumitomo Pharma’s commercial
efforts have leveraged TWYMEEG’s potential to be used both in
combination with other treatments, such as DPP4i’s, which are the
most prescribed treatments for Japanese Type-2-Diabetes patients,
and as monotherapy.
Financing
- In August, the Company announced that it restructured its debt
with IPF, resulting in the postponement of the Q3 2022 and Q4 2022
amortization payments under the existing debt facility, and
lowering certain financial covenants until the end of January 2023.
As part of the restructuring, the Company agreed to certain
additional commitments which include the increase of the amounts
due to IPF and potential partial early repayments of the debt.
- Concurrently, the Company entered into an equity-linked
financing arrangement with IRIS for an initial gross amount of EUR
4 million, with the option, at the latest on December 31, 2022,
and, at the Company’s sole discretion, to draw a second and third
tranche of up to EUR 1 million each.
- As a result of these two agreements, the Company expects that
its resources will be sufficient to fund its operations and capital
expenditure requirements through at least February 2023.
Event after the Period
- On November 7, Stephen Harrison, MD, President of the Summit
Clinical Research, presented DESTINY-1 Phase 2 Results for PXL065
in NASH at The Liver Meeting® 2022, hosted by the American
Association for the Study of Liver Diseases (AASLD).
Third Quarter and Nine Months Ended September 30, 2022 Cash
and Revenue
Cash
As of September 30, 2022, total cash and cash equivalents were
EUR 17.1 million (USD 16.6 million), as compared to EUR 16.1
million at June 30, 2022.
EUR (in thousands)
Q3 2022
Q2 2022
Q1 2022
Q4 2021
Cash
15,062
16,143
24,043
28,753
Cash equivalents
2,000
-
-
3,534
Total cash and cash
equivalents*
17,062
16,143
24,043
32,287
Unaudited data
* Net financial debt (excluding IFRS 16
impacts and derivative debts) was EUR 16.8 million at the end of Q3
2022 as compared to EUR 17.3 million at the end of Q2 2022.
Based on:
- its cash position at September 30, 2022,
- the current development plan of the Company, excluding the
initiation of Phase 2a clinical proof-of-concept (POC) biomarker
studies for PXL065 and PXL770 in adrenomyeloneuropathy (AMN),
- the cash forecast approved by the Board of Directors of the
Company, that does not include, as a conservative approach, any net
royalties from Imeglimin in Japan,
- a strict control of its operating expenses, and
- the amendment to the IPF debt facility with the postponement of
the Q3 2022 and Q4 2022 amortization payments until end of February
2023, as well as a full drawdown of all tranches of the
equity-linked financing arrangement with IRIS for a total amount of
EUR 6 million, before December 31, 2022,
the Company expects that its resources will be sufficient to
fund its operations and capital expenditure requirements through at
least February 2023.
The Company is actively pursuing additional financing options,
including ongoing active partnership discussions related to its
programs.
Nine Months 2022 Revenue
Poxel reported revenues of EUR 286 thousand for the nine months
ended September 30, 2022, as compared to EUR 13.3 million during
the corresponding period in 2021, which mostly reflected the EUR
13.2 million milestone payment for the approval of TWYMEEG in Japan
on June 23, 2021.
Revenue for the first nine months of 2022 mostly reflects the
JPY 40 million (EUR 286 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)
Sept. 2022
9 months
Q3 2022
3 months
H1 2022
6 months
Sept. 2021
9 months
Q3 2021
3 months
H1 2021
6 months
Sumitomo Pharma Agreement
286
203
83
13,274
-
13,274
Other
-
-
-
-
-
-
Total revenues
286
203
83
13,274
-
13,274
Unaudited data
Planned Presentations and Participation at the Following
Upcoming Events
- ALD Connect 2022 Annual Meeting & Patient Learning Academy,
November 11, 2022
- Jefferies Healthcare Conference, London, UK, November 15-17,
2022
- ODDO BHF Forum (virtual), January 9-10, 2023
- Degroof Petercam’s Healthcare Conference, Brussels, Belgium,
January 26, 2023
Next Financial Press Release: Fourth Quarter 2022
Financial Statement expected on February 15, 2023
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 now 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. The Company does not endorse or is
not otherwise responsible for the content of external hyperlinks
referred to in this press release.
__________________________ 1 Currency exchange rate at
Sept 30, 2022
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221108005885/en/
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
Grafico Azioni Poxel (EU:POXEL)
Storico
Da Feb 2024 a Mar 2024
Grafico Azioni Poxel (EU:POXEL)
Storico
Da Mar 2023 a Mar 2024