DEINOVE presents its financial results and the advancement of its
programs for 2020
DEINOVE presents its financial results and the
advancement of its programs for 2020
·Phase II of
the antibiotic candidate DNV3837 ongoing – end of the first part of
the trial (DSMB) expected
mid-2021 ·Signature of an
Evaluation and Technology Development license with DSM on a
non-therapeutic active substance
·Management evolution: two
experienced profiles have joined DEINOVE to strengthen the business
development and strategic partnerships
activities ·Group net income
2020 of -€7.3M compared to -€10.2M in 2019, mainly thanks to lower
operating expenses
•
Restructuring of operations with a 30% decrease in operating
expenses
(€9.0M
vs. €12.8M in 2019), still 80% dedicated to
R&D ·Group cash
position: •
Balance of +€2.9M at December 31, 2020, compared to +€1.1M at
31
December 31,
2019 •
On January 20, 2021, the 5th tranche of OCA was subscribed by the
ESGO Fund, for an amount of €3M
DEINOVE (Euronext Growth Paris: ALDEI), a French
biotech company, pioneer in the exploration and exploitation of
bacterial biodiversity to address the urgent, global challenge of
antibiotic resistance, announces that its Board of
Directors has approved the consolidated financial statements for
the year 2020.
“The Board of Directors and I renewed our
confidence in Alexis RIDEAU, by appointing him CEO of DEINOVE at
the beginning of 2021. The transformations he has led with the
management team have already streamlined operational expenses and
will position DEINOVE at the forefront of the exploration and
exploitation of microbial dark matter, to become a major player in
the generation of new antimicrobials”, says Dr. Charles
WOLER, Chairman of DEINOVE’s Board of Directors. “We were
delighted to announce that DEINOVE has received support from the
French government as part of the “France Relance” plan, to set up a
platform for screening bacteria at very high throughput based on
breakthrough technology, droplet-based microfluidics. The goal is
to be operational by the end of 2021. This new technology will
dramatically increase the platform’s current performance, while
reducing its costs.”
“We have strengthened our team with the arrival
of a new CFO, Mario ALCARAZ, who has successfully restructured the
operational expenses necessary to sustain the platform. At the
beginning of 2021, the Business Development team was strengthened
with the arrival of Hervé ANSANAY, as Director, and Corentin
CHABOUD, to the new position of Grant Officer. Both of these hires
are strategic to intensify the establishment of new partnerships,
such as the one signed with the Dutch company DSM, as well as to
access non-dilutive funding to support the development of new
antimicrobials”, adds Alexis RIDEAU, CEO
of DEINOVE.
***
DEINOVE will organize a webinar for its
shareholders on May 4, 2020 at 5:30 pm to make an update
on its activity and perspective and in order to prepare its
upcoming Annual General Meeting (to be held on May 27, probably in
closed session due to the pandemic)
To sign up for the May 4 webinar (to be
held in French) please follow this link
***
SUMMARY OF CONSOLIDATED FINANCIAL DATA
The DEINOVE Group’s consolidated financial
statements as of December 31, 2020 were certified by the Group’s
Statutory Auditors, the firm PwC (PricewaterhouseCoopers).
PROFIT AND LOSS ACCOUNT
(in thousands of euros) |
31/12/20 |
31/12/19 |
Operating revenues |
836 |
637 |
Of which operating grants |
392 |
397 |
Operating costs |
8,961 |
12,838 |
Of which Research & Development costs |
7,168 |
10,459 |
Of which Administrative and General costs |
1,792 |
2,379 |
OPERATING PROFIT/LOSS |
(8,125) |
(12,201) |
PROFIT/LOSS |
(21) |
(34) |
PROFIT/LOSS FROM NON-RECURRING ACTIVITIES |
3 |
65 |
Income tax and deferred taxes |
(1,354) |
(2,433) |
Goodwill amortization |
511 |
511 |
Results from equity affiliates (MEQ) |
- |
- |
CONSOLIDATED GROUP PROFIT/LOSS |
(7,300) |
(10,247) |
(in thousands of euros) |
(7,300) |
(10,247) |
Term deposit |
- |
- |
Provision for impairment of marketable securities |
- |
- |
Cash on hand |
2,899 |
1,095 |
ICNE & bank overdrafts |
- |
- |
CASH & CASH EQUIVALENTS |
2,899 |
1,095 |
OPERATIONAL PROGRESS DURING THE PERIOD AND
POST-CLOSING
Phase II testing the antibiotic candidate
DNV3837 in severe Clostrioides difficile infections
This clinical trial aims to evaluate the
efficacy and the pharmacokinetics of DNV3837 in patients with
Clostridioides difficile gastrointestinal infection (CDI). This
trial is being conducted in the United States, according to a
sequential protocol:
- The first step aims to treat a cohort of 10 patients with
moderate to severe CDI with DNV3837. At the end of this phase, the
DSMB1 will review the interim results and issue an opinion on the
benefit-risk balance of the treatment.
- The second step aims to treat 30 patients with severe CDI in a
randomized open-label trial testing DNV3837 (2/3 of patients)
against an approved standard treatment2 (1/3 of patients) for
comparison.
In November 2020, at the annual conference of
the C Diff Foundation, in the “Research in Progress” session,
DEINOVE presented the phase I results, the protocol of the ongoing
multicentric phase II in the United States, including clinical
centers, the team in France and across the Atlantic, as well as the
main advantages of DNV3837: its intravenous administration, precise
targeting at the site of infection, its ability to eliminate
Clostridioides difficile bacteria while having a limited impact on
the intestinal microbiota.
Patient enrollment in this phase II trial
continues, despite the disruption caused by the COVID-19
pandemic.
DEINOVE is a winner of the “France Relance”
plan
The Boost-ID project (Bacteria Optimum Output
Screening Tool for treating Infectious Diseases) is one of 105
projects selected by the French government, out of nearly 1,000
presented, as part of the call for resilience projects within the
framework of the “France Relance” plan, a recognition of its
strategic positioning.
Boost-ID is an accelerator in the identification
of antimicrobials and molecules of natural origin with high added
value. It consists of setting up a platform for screening bacteria
at very high throughput based on breakthrough technology:
droplet-based microfluidics. With a major gain in efficiency
upstream of the process, Boost-ID will accelerate the development
of new antimicrobials and molecules of natural origin with high
added value.
It is one of six projects in the strategic
health sector selected by the French government in the Occitania
region.
DEINOVE signs an evaluation and technology
development license with DSM
In November 2020, DEINOVE announced the signing
of an evaluation and technology development license with DSM, a
global science-based company in Nutrition, Health and Sustainable
Living.
Under the agreement, DSM will evaluate the
potential of a microbial strain from DEINOVE as a feed additive;
selected and characterized during the Color-2B program. The
evaluation and technology development program is undertaken and
supervised by DSM. For the exclusive purpose of the performance of
the collaboration activities, DSM is granted a temporary exclusive
license to use DEINOVE’s proprietary strain, as well as the
background intellectual property related to the strain and required
for the collaboration activities. In consideration of these
provisions, DEINOVE will receive an upfront payment and milestone
payments during program execution (undisclosed amount). Upon DSM’s
decision that the collaboration activities are successful, DEINOVE
and DSM will pursue negotiations for a commercial license
agreement.
CORPORATE
BOARD OF DIRECTORS
The Ordinary and Extraordinary Shareholders’
Meeting of June 16, 2020, renewed, for a period of three years, the
mandates of Anne ABRIAT, Charles WOLER and Hervé BRAILLY, which had
expired. It also ratified the appointment of Emmanuel PETIOT as
Administrator, made on a provisional basis by the Board of
Directors at its meeting of December 3, 2019.
EXECUTIVE COMMITTEE
Alexis RIDEAU, Deputy Chief Executive Officer of
DEINOVE since May 2020, was appointed Chief Executive Officer of
the Company in January 2021. Prior to joining DEINOVE, Alexis
RIDEAU was in charge of developing industrial relations and
coordinating the strategic partnership team at BIOASTER
(Lyon/Paris), a Technology Research Institute in applied
microbiology, which specializes in the design and use of technology
innovations in the field of microbiology, to accelerate the
development of medical and nutritional industrial solutions for
animal and human health.
In appointing him as CEO, the Board of Directors
recognized his achievements, vision and action plan to make DEINOVE
a major actor in the race against antimicrobial resistance.
As of July 2020, Mario ALCARAZ joined DEINOVE as
Chief Financial and Administrative Officer, also in charge of
investor relations and financial communication. An experienced
financial director, mastering at the same time the financial,
legal, accounting and strategic aspects of the function, he is a
key asset in ensuring DEINOVE’s economic performance. Since his
arrival, he has successfully carried out the necessary
restructuring of operational expenses to ensure the platform’s
sustainability.
Post period-end, Hervé ANSANAY, PhD, former
Director of Technology Transfer and Business Development at SATT
AxLR in Montpellier, was appointed Director of Business
Development. He brings 20 years’ experience in supporting
innovative companies and technology transfer. From 2013 to 2015, he
was Business Developer at SATT Nord. After his PhD and post-doc in
biochemistry and molecular biology, Hervé was R&D project
manager for over 10 years at Cisbio Bioassays, in charge of
market-driven developments. Corentin CHABOUD, previously in charge
of European affairs and competitive funding at IRT BIOASTER, became
Grant Officer at DEINOVE. These two hires, in January 2021, will
intensify the setting up of remunerative strategic partnerships and
access to non-dilutive funding, to support the development of
therapeutic solutions in the field of next-generation
antimicrobials.
FINANCIAL RESULTS FOR THE PERIOD 2020
OPERATING REVENUE
The Group recorded €836K in operating revenue
for the period (compared to €637K in 2019), including €392K of the
grant paid by Bpifrance corresponding to the completion of the
second key milestone of the AGIR program (€397K in 2019, for the
first key milestone of the same program) and, on the other hand,
€323K of revenue (compared to €163K in 2019) in the framework of
collaborative research agreements with industrial partners in
non-therapeutic fields.
During the fiscal year 2020, the Group’s
operating expenses reached €9.0M, of which 80% was spent on R&D
activities. The net change in operating expenses between 2019 and
2020 amounts to -€3.8M (-30%). Subcontracting and external research
expenses decreased significantly (-72%), due to the internalization
of the sequencing activity and a decrease in costs related to
analyses. Personnel expenses also decreased, in line with the
evolution of the workforce: 57.0 average full-time equivalents
(FTE) in 2020 compared to 60.0 in 2019.
NET INCOME
The consolidated net loss for the period amounts
to €7.3M, negligibly impacted by exceptional items (positive
exceptional result of €3K).
The negative financial result of -€21K is mainly
due to financial expenses related to the pre-financing of the
Research Tax Credit (-€12K) and interest expenses on loans
(-€6K).
Income tax comprises almost exclusively the
Research Tax Credit. The Group’s receivable for the fiscal
year 2020 has been estimated at €1,354K (compared to €2,491K in
2019).
NET RESULT
In 2020, 6,494,493 new shares were issued,
including 5,994,492 shares under the convertible bond
agreement3.
At its meeting on November 3, 2020, the Board of
Directors, implementing an authorization granted by the
Extraordinary Shareholders’ Meeting of December 11, 2019, decided
to reduce the share capital by reducing the nominal value of the
ordinary shares comprising the capital. The nominal value is thus
reduced by 0.40 to 0.02 euro per share. This capital reduction was
carried out by offsetting losses carried forward.
The 24,090,739 shares with a nominal value of
0.02 euro making up the capital as of December 31, 2020, are broken
down as follows:
Year ended December 31, 2020 – non-diluted
basis |
|
|
|
Shareholders |
Number of shares |
% of holding |
Voting
rights |
% |
Funds managed by Truffle Capital |
1,385,637 |
5.75% |
2,553,325 |
9.96% |
Funds managed by TVM Capital |
1,557,414 |
6.46% |
1,557,414 |
6.07% |
Scientific founders |
20,000 |
0.08% |
40,000 |
0.16% |
Free float |
21,127,688 |
87.70% |
21,493,741 |
83.81% |
TOTAL |
24,090,739 |
100.00% |
25,644,480 |
100.00% |
ABOUT DEINOVE
DEINOVE is a French biotechnology company
pioneering the exploration of a new domain of life, unexplored at
99.9%: the “microbial dark matter”. By revealing the metabolic
potential of rare bacteria or still classified as uncultivable, it
tackles a global health and economic challenge: antimicrobial
resistance.
The new therapies discovered and developed by
DEINOVE target superbugs (microbes that have become resistant to
one or more antimicrobials) that cause life-threatening infections
which are now spreading at high speed.
This breakthrough approach gave rise to one of
the world’s first specialized micro-biotechnology platforms and a
unique collection of nearly 10,000 rare strains and thousands of
bacterial extracts. Today, DEINOVE is conducting several
development programs, of which its first antibiotic candidate is
currently evaluated in a Phase II clinical trial in severe
Clostridioides difficile infections, one of the world’s first
emergencies. The Company has also developed new bacterial
micro-factories that address the other issue in the race against
antimicrobial resistance: the industrial production of these rare
and low concentrated compounds with often too complex chemical
structures to be generated by chemical synthesis.
Located at the heart of the Euromedecine park in
Montpellier, DEINOVE has been listed on EURONEXT
GROWTH® (ALDEI - code ISIN FR0010879056) since 2010. The
Company has over 50 employees and relies on a network of
world-class academic, technological, industrial and institutional
partners.
CONTACTS
Investors Mario Alcaraz Chief Financial and Administrative Officer
+33 (0)4 48 19 01 00 ir@deinove.com Media ATCG Partners – Marie
PUVIEUX +33 (0)9 81 87 46 72 / +33 (0)6 10 54 36 72
communication@deinove.com |
|
1 DSMB: Data Safety Monitoring Board (Data
Monitoring and Tracking Committee). An independent panel of experts
to review the data generated and make recommendations on patient
safety, validity and relevance of the trial.
2 Standard therapies approved in the United
States for the treatment of CDI include vancomycin, fidaxomicin,
and metronidazole (all three antibiotics). The choice will be at
the discretion of the investigating physicians.
3 Press release issued April 3, 2020, June 17,
2020 and December 3, 2020