- Cash runway extended through at least February 2023 based
upon debt restructuring agreement with IPF Partners (IPF) and
equity-linked financing facility with Iris Capital Investment
(IRIS)
- As of June 30, 2022, cash and cash equivalents were EUR 16.1
million (USD 16.8 million)
- Fast Track and Orphan Drug Designation for PXL065 and PXL770
in adrenoleukodystrophy (ALD) granted by the Food and Drug
Administration (FDA)
- New Solid Form Patent for PXL065 issued by the U.S. Patent
and Trademark Office (PTO), providing additional protection through
2041
- Phase 2 study results for PXL065 (DESTINY-1) in NASH
expected in Q3 2022
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 second quarter and first half of 2022.
"The next major milestone for Poxel will be the results of our
Phase 2 DESTINY-1 study for PXL065 in NASH, which are expected
later this quarter. One of our key objectives these past months has
been to extend our cash runway to leverage this opportunity and
independently finance our strategy in rare diseases. The two
agreements announced today, the debt restructuring along with the
equity-linked financing facility, provide further flexibility to
finalize additional financing initiatives, including ongoing active
partnership discussions related to our programs. In addition, we
will continue our work to initiate our Phase 2 proof-of-concept
studies in adrenoleukodystrophy which represent the foundation of
our rare disease strategy,” said Thomas Kuhn, Chief Executive
Officer of Poxel. “We have also had key regulatory achievements
this year, including Fast Track Designation and Orphan Drug
Designation granted by the FDA for PXL065 and PXL770 in ALD. In
addition, the recent patent approval of a new solid form of PXL065
is an important addition to the protection of this compound and
significantly extends its exclusivity.”
Commercial Update
TWYMEEG® (Imeglimin)
- As of June 30, 2022, royalty revenue to Poxel based on TWYMEEG
net sales in Japan under the Sumitomo Pharma license agreement has
been limited following TWYMEEG’s 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, as
planned, 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, two 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. These 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.
- In May, the FDA granted Orphan Drug Designation (ODD)1 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.
- Two preclinical articles on X-Linked Adrenoleukodystrophy (ALD)
for PXL065 and PXL770 were published:
- The article on PXL065 was published in The Journal of Inherited
Metabolic Disease (“JIMD”) and is entitled “Therapeutic potential
of deuterium-stabilized (R)-pioglitazone - PXL065 - for X-linked
adrenoleukodystrophy”. It is available here:
https://pubmed.ncbi.nlm.nih.gov/35510808/.
- The article on PXL770 was published in The Journal of
Pharmacology and Experimental Therapeutics (“JPET”), and is
entitled “Beneficial effects of the direct AMP-Kinase activator
PXL770 in in vitro and in vivo models of X-Linked
Adrenoleukodystrophy”. It is available here:
https://jpet.aspetjournals.org/content/early/2022/06/25/jpet.122.001208.
Corporate Update
- In June, the U.S. Patent and Trademark Office (PTO) issued a
new patent for PXL065 that describes a specific form of PXL065 with
unique properties. Importantly, this recently issued patent
provides additional protection through 2041 and could expand
protection for PXL065 worldwide, with the potential for an
additional 5 years through patent term extension.
- On June 21, 2022, Poxel held its annual general meeting. The
shareholders approved all the resolutions that were recommended by
the Board of Directors. For further information, please visit:
https://www.poxelpharma.com/en_us/investors/shareholder-information/annual-general-meeting-documents.
- The mandates of Mrs. Janice Bourque and of Mr. Pierre Legault
as members of the Board of Directors were renewed for three year
terms. Effective July 1, 2022, Dr. John Kozarich transitioned off
as a Board member due to the age limitation and will continue to
assist the Board of Directors as a consultant and chair of the
scientific committee of the Board.
Significant Events after the Period
The Company announced today that it has entered into an
agreement with IPF to restructure its debt, 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.
Concurrently, the Company has 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’s expects that its resources will be
sufficient to fund its operations and capital expenditure
requirements through at least February 2023.
For more information, please refer to the press release issued
today.
Second Quarter and First Half 2022 Cash and Cash
equivalents
As of June 30, 2022, cash and cash equivalents were EUR 16.1
million (USD 16.8 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 17.3 million as of June 30, 2022, as compared to EUR
2.6 million as of December 31, 2021.
EUR (in thousands)
Q2 2022
Q4 2021
Cash
16,143
28,753
Cash equivalents
-
3,534
Total cash and cash
equivalents*
16,143
32,287
Unaudited data
* Net financial debt (excluding IFRS 16
impacts and derivative debts) was EUR 17.3 million at the end of Q2
2022 as compared to EUR 2.6 million at the end of Q4 2021.
Based on:
- its cash position at June 30, 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 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,
prioritizing non-dilutive sources, including ongoing active
partnership discussions related to its programs.
Second Quarter and First Half 2022 Revenue
Poxel reported revenues of EUR 83 thousand revenue for the six
months ended June 30, 2022, as compared to EUR 13.3 million revenue
during the corresponding period in 2021.
Revenue for the first half of 2022 reflects JPY 11 million (EUR
81 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
2022
Q2
2022
H1
2022
Q1
2021
Q2
2021
H1
2021
3 months
3 months
6 months
3 months
3 months
6 months
Sumitomo Pharma Agreement
32
51
83
-
13,274
13,274
Other
-
-
-
-
Total revenues
32
51
83
-
13,274
13,274
Unaudited data
Planned Presentations and Participation at the Following
Upcoming Events
- Keystone Symposia, Whistler, British Columbia, Canada, August
7-11
- Paris NASH Meeting, Paris, France, September 8-9
- Eurotox, International Congress of Toxicology, Maastricht,
Netherlands, September 18-21
Next Financial Press Release : First Half 2022 financial
results on September 21, 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 thiazolidinedione (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 royalties and sales-based payments from Sumitomo
Pharma. 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 For more information on Orphan Drug Designation, see:
https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
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version on businesswire.com: https://www.businesswire.com/news/home/20220807005027/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
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