- Strengthened financial position with the approval of
TWYMEEG® (Imeglimin hydrochloride) for the treatment of type 2
diabetes in Japan:
- Allowed Poxel to draw the third and final tranche of the IPF
loan for EUR 13.5 million - included in the Q2 cash and cash
equivalents of EUR 36.9 million
- Triggered a milestone payment of JPY 1.75 billion
(approximately EUR 13.2 million, USD 15.8 million)1 from Sumitomo
Dainippon Pharma to Poxel which was paid in July 2021 (not included
in Q2 cash and cash equivalents)
- Increasing strategic focus on rare metabolic diseases with
continued commitment to non-alcoholic steatohepatitis (NASH):
- Patient enrollment in PXL065 DESTINY Phase 2 trial in NASH
was completed in September 2021 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
- Webcast on Thursday, September 23, at 12:00 pm ET / 6:00 pm
CEST (in French), 1:00 pm ET / 7:00 pm CEST (in English)
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
announced its financial results for the period ended June 30, 2021
and provided a corporate update.
“Thus far, 2021 has proven to be a pivotal year for Poxel as
exemplified by the approval and subsequent product launch of
TWYMEEG® in Japan. This first product approval highlights
our proven capabilities to deliver upon our corporate and clinical
goals and to bring improved metabolic therapeutics to patients.
This achievement has strengthened our near-term financial position
and will continue to enhance our financial foundation with
associated future royalties and sales-based payments,” said Thomas
Kuhn, CEO of Poxel. “We also look forward to harnessing the full
potential of our strategic shift with an increased focus on rare
metabolic diseases, in addition to our ongoing commitment to NASH.
Poxel is well-positioned to leverage its existing platforms to
develop therapeutics in rare metabolic diseases,” Mr. Kuhn
concluded.
Corporate Highlights
- The June 23 approval of TWYMEEG® in Japan, Poxel’s first
product to reach commercialization, triggered two financing events:
1. In June 2021, Poxel received the third and final tranche of the
IPF loan for EUR 13.5 million which is included in the second
quarter cash and cash equivalents of EUR 36.9 million. 2. In July
2021, Poxel received a milestone payment of JPY 1.75 billion
(approximately EUR 13.2 million, USD 15.8 million)1 from Sumitomo
Dainippon Pharma.
- Poxel appointed Dr. John Kozarich to the Board of Directors
during the June 23, 2021, Annual and Extraordinary General Meeting,
where he was also appointed as Chair of the Scientific Committee of
the Board. Dr. Kozarich has over 40 years of experience in the
biopharmaceutical industry and academia. Bpifrance Participations
transitioned off as Board observer, effective July 9, 2021.
- In June, Poxel conducted the Annual and Extraordinary General
Meeting. The shareholders approved all 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.
Clinical Development Updates
Type 2 Diabetes (TWYMEEG®/Imeglimin)
- On June 23, the new drug application for the 500mg
TWYMEEG® tablets for the treatment of type 2 diabetes, was
approved in Japan. The first-in-class drug with a unique dual
mechanism of action was approved as a monotherapy and/or as an
additional treatment to other glucose-lowering therapy regimens.
Approval was based on positive results from various preclinical and
clinical studies, including the Phase 3 TIMES (Trials of IMeglimin
for Efficacy and Safety) program managed jointly by Poxel and
Sumitomo Dainippon Pharma. The program included three pivotal
trials to evaluate TWYMEEG®’s efficacy and safety in over
1,100 patients. TWYMEEG® met its primary endpoints and
objectives, exhibiting a favorable safety and tolerability
profile.
- Three presentations on Imeglimin were included in an oral
session for large clinical studies at the 64th Annual Meeting of
the Japan Diabetes Society held in May. The presentations focused
on the analysis and interpretation of clinical data derived from
Phase 2 and Phase 3 (TIMES program) trials with Imeglimin in
Japanese patients with type 2 diabetes.
- In January, Poxel regained all Imeglimin rights from Metavant.
In the US and Europe, Poxel continues to explore options to move
Imeglimin forward in Phase 3 in patients with type 2 diabetes with
moderate to severe chronic kidney disease (CKD), including
partnering activities.
Rare metabolic diseases (PXL065 and PXL770)
- In X-linked adrenoleukodystrophy (ALD), a rare disease
affecting the nervous system and adrenal glands, Phase 2a clinical
POC biomarker studies examining PXL065 and PXL770 are planned to
initiate in early 2022 with data readouts anticipated by year end
2022. Two identical studies will enroll adult male ALD patients
with adrenomyeloneuropathy (AMN), the most common form of the
disease, and observe the effect of PXL065 and PXL770 over 12 weeks
of treatment on pharmacokinetics, safety, and efficacy using
relevant biomarkers, including the impact on elevated very long
chain fatty acids (VLCFA), the hallmark plasma marker of the
disease.
- In April, Dr. Sophie Bozec, Senior Vice President, R&D
Pharmacology and Scientific Communication at Poxel, delivered a
presentation at the Mitochondria-Targeted Drug Development Summit
highlighting Poxel’s scientific focus and deep expertise in
mechanisms modulating cellular energy homeostasis and addressing
mitochondrial dysfunction – including showcasing the potential of
Poxel’s AMP-kinase (AMPK) activator and deuterium-stabilized
thiazolidinedione (dTZD) platforms for rare disorders where
mitochondrial dysfunction is a major pathogenic component.
NASH (PXL065 and PXL770)
- PXL065, deuterium-stabilized R-pioglitazone, is being evaluated
for safety and efficacy in a streamlined Phase 2 trial, DESTINY1,
for the treatment of NASH. Patient enrollment was completed in
September 2021, with topline data anticipated approximately one
year later. This 36-week trial in noncirrhotic biopsy-proven NASH
patients will assess three doses of PXL065 compared to placebo in
123 patients. The results will be used to help identify the dose or
doses for a Phase 3 registrational trial.
- Future development of PXL770, a first-in-class, oral direct
AMPK activator, in NASH will be assessed pending results from the
PXL065 Phase 2 trial in NASH and both Phase 2a POC studies in
ALD.
- Dr. Kenneth Cusi and Dr. Vlad Ratziu each delivered
presentations on PXL770 clinical studies at the European
Association for the Study of the Liver (EASL) International Liver
Congress™ (ILC), held from June 23-26, 2021. Dr. Cusi presented the
results of the STAMP-NAFLD 12-week, randomized, controlled Phase 2a
trial of PXL770 in 120 presumed NASH patients – selected as a “Best
of ILC” abstract. Dr. Ratziu presented the results from a 4-week
PK/PD target engagement study of PXL770 in NAFLD patients.
Subsequent Events after the Period
- In July, Poxel announced it will pursue a strategic direction
to focus its pipeline on high value, rare metabolic indications, to
complement its commitment to NASH, with the goal of creating
pipeline synergies, maximizing resources, and driving shareholder
value.
- In July, ENYO Pharma SA announced positive results for
Vonafexor (EYP001), an FXR agonist that was licensed from Poxel in
2015, in a Phase 2a study in NASH patients over 12 weeks and
topline interim results from two ongoing Phase 2a studies in
chronic hepatitis B patients.
- In August, Elizabeth Woo was appointed as Senior Vice
President, Investor Relations, Public Relations & Corporate
Communications. Elizabeth brings over 25 years of investor
relations and biotech communications experience in initial public
offerings, follow-on financings, market launches, and
commercialized products. She is based in Boston.
- On September 16, Poxel’s strategic partner, Sumitomo Dainippon
Pharma, launched TWYMEEG® 500mg tablets for the treatment of
type 2 diabetes in Japan. Japan is the first country where the
product has been approved. As part of the license agreement with
Sumitomo Dainippon Pharma, Poxel is entitled to receive escalating
double-digit royalties on net sales and sales-based payments (based
on Poxel’s current forecast) of up to JPY 26.5 billion
(approximately EUR 200 million, USD 230 million)2 in accordance
with sales goals.
- In September, data for PXL770 was published online by
Hepatology Communications, titled “Direct AMPK Activation Corrects
NASH in Rodents Through Metabolic Effects and Direct Action on
Inflammation and Fibrogenesis.”
First Half 2021 Financial Results (IFRS standards)
Revenue
Poxel reported revenues of EUR 13.3 million for the six months
ended June 30, 2021, as compared to EUR 6.4 million during the
corresponding period in 2020.
Revenue for the first half of 2021 mostly reflects the JPY 1.75
billion (EUR 13.2 million) milestone payment from Sumitomo
Dainippon Pharma which Poxel received in July 2021.
EUR (in thousands)
H1 2021
H1 2020
6 months
6 months
Roivant Agreement
13
Sumitomo Dainippon Pharma Agreement
13,274
6,359
Total revenues
13,274
6,372
Limited review procedures have been performed by the auditors
and the issuance of the report is in process.
Income Statement
Poxel devotes the bulk of its resources to research and
development (R&D) activities. R&D expenses totaled EUR 14.7
million for the first half of 2021, as compared to EUR 12.6 million
for the corresponding period in 2020. R&D expenses for the
first half of 2021 primarily reflect the clinical study costs
incurred for the phase 2 DESTINY study evaluating PXL065 in NASH.
To a lesser extent, they also reflect the Phase 2a clinical program
cost of PXL770 for the treatment of NASH and the regulatory costs
incurred over the period for TWYMEEG®, for which the Company
obtained marketing approval in June 2021.
R&D expenses are net of the R&D Tax Credit (CIR) that
resulted in an income of EUR 1.6 million for the first half of 2021
as compared to the same level for the corresponding period of
2020.
General and administrative expenses totaled EUR 5.4 million for
the first half of 2021, as compared to EUR 6.0 million for the
first half of 2020.
The financial loss amounted to EUR 1.2 million for the first
half of 2021, as compared to an income of EUR 0.2 million for the
first half of 2020. It primarily reflected the interests attached
to the Company indebtedness.
The net result for the financial period ending June 30, 2021,
was a net loss of EUR 8.0 million, as compared to a net loss of EUR
12.1 million in the corresponding period in 2020.
Condensed Income Statement
EUR (in thousands)
HY
HY
2021 6 months
2020 6 months
Revenue
13,274
6,372
Research and development expenses*
(14,683)
(12,580)
General and administrative expenses
(5,443)
(5,983)
Operating gain (loss)
(6,851)
(12,191)
Financial income (loss)
(1,178)
249
Income tax
-
(118)
Net income (loss)
(8,029)
(12,060)
*Net of R&D tax credit
Limited review procedures have been performed by the auditors
and the issuance of the report is in process.
Cash
As of June 30, 2021, cash and cash equivalents were EUR 36.9
million (USD 43.9 million), as compared to EUR 40.2 million (USD
49.4 million) on December 31, 2020. Cash and cash equivalents were
fully offset by financial liabilities (excluding IFRS16 impacts and
derivative debts) as of June 30, 2021. Cash and cash equivalents
net of financial liabilities (excluding IFRS16 impacts and
derivative debts) were EUR 17.1 million on December 31, 2020. In
July 2021, Poxel received a EUR 13.23 million milestone payment
from its partner Sumitomo Dainippon Pharma for the Imeglimin
approval, which is not reflected in the June 30, 2021 cash
update.
EUR (in thousands)
Q2 2021
Q4 2020
Cash
20,431
15,587
Cash equivalents
16,490
24,616
Total cash and cash
equivalents*
36,921
40,203
*Cash and cash equivalents were fully
offset by financial liabilities (excluding IFRS16 impacts and
derivative debts) as of June 30, 2021. Cash and cash equivalents
net of financial liabilities (excluding IFRS16 impacts and
derivative debts) were EUR 17.1 million on December 31, 2020.
Limited review procedures have been performed by the auditors
and the issuance of the report is in process.
The webcasts will be held on September 23, 2021:
- In French, at 12:00 pm ET (New York) / 6:00 pm CEST (Paris
time). To register for the webcast:
https://us02web.zoom.us/webinar/register/WN_o4kretFCS8uz7iHv0iLmxg
- In English, at 1:00 pm ET (New York) / 7:00 pm CEST (Paris
time). To register for the webcast:
https://us02web.zoom.us/webinar/register/WN_Flka34pnTdGsTj_fJSvGIw
A slide presentation to accompany the webcast will be available
in the Investors section of Poxel website.
Participants will be able to submit questions through the
webcast chat during the event.
Following the live call, a replay will be available for 90 days
on
https://www.poxelpharma.com/en_us/investors/company-information/corporate-presentations
Planned Presentations and Participation at the Following
Upcoming Events
- International AMPK meeting, Evian, France, September 26-30,
2021
- HealthTech Innovation Days, France, October 4-5, 2021
- World Congress of Neurology, October 3-7, 2021
- H.C. Wainwright NASH Conference, October 12, 2021
- National Organization for Rare Diseases (NORD) Rare Disease
Summit, October 18-19, 2021
Next Financial Press Release: Third Quarter 2021
Financial and Corporate Update on October 21, 2021
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 (DESTINY1). 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 agreement (30 Oct 2017).
3 Currency exchange rate at the date of
the approval
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210923005729/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 - EU/US Trophic Communications
Stephanie May or Valeria Fisher poxel@trophic.eu +49 171 185 56 82
or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
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