- Significant achievements in antibiotic programs:
- Initiation of the Phase II trial testing DNV3837 as
first-line treatment for severe C. difficile gastrointestinal
infections,
- DNV3681, the active molecule of DNV3837, evaluated by the
United States Army against anthrax,
- The AGIR program reaches 2 key milestones in just one
year.
- Expansion of the cosmetics portfolio:
- Completion of the development of two active ingredients and
launches in early 2020: Luminity® (proprietary) and Biome
Oléoactif® (with Hallstar France),
- First revenues from collaborative agreements cashed
in.
- Group net loss for 2019: - €10.2m, compared with - €8.7m in
2018, mainly due to the progress of the DNV3837 clinical
program.
- Securing of financial resources by setting up financing
through the issue of bonds convertible into new shares for a
maximum nominal amount of €15m.
- Consolidated cash position:
- + €1.1m at December 31, 2019 vs + €3.9m at December 31,
2018,
- + €3.0m as of March 31, 2020 following partial pre-funding
of the 2019 R&D Tax Credit receivable for + €2.1m, and payment
of + €1.5m from Bpifrance triggered by successful completion of the
2nd milestone of the AGIR program,
- Receipt of + €1.0m in early April, following the
subscription of the 2nd Tranche of convertible bonds by ESGO Fund
(L1 Capital).
- Covid-19: all the necessary measures needed to protect the
health and safety of employees have been put in place, the teams
remain mobilized in order to move the projects forward and meet the
timelines set.
Regulatory News:
DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company
that uses a disruptive approach to develop innovative antibiotics
and bio-based active ingredients for cosmetics and nutrition,
announced today that its Board of Directors had approved the
2019 annual accounts.
Charles Woler, Chairman and CEO of DEINOVE, said: "The
Covid-19 pandemic, affecting the entire planet, highlights the
global challenge of infectious disease research. Beyond its
immediate impact, this crisis is an additional motivation for all
DEINOVE teams in the research and development of new
antibiotics.
Our clinical trial regarding DNV3837, candidate in the treatment
of gastrointestinal infections caused by C. difficile, is ongoing.
The first patient was included in this Phase II trial in early
2020. At the same time, we are continuing to intensify our AGIR
program for the discovery of new antibacterial compounds. In one
year, we have completed the first two milestones of the project,
funded in part by the French State Investments for the Future
Program. Milestone 2 has resulted in the identification of around
thirty “hits” (molecules that may be of interest).
In the cosmetics business, we continue to expand our portfolio
by combining proprietary products, such as the new Luminity®, and
collaborations with various players. Our partnership with Hallstar
France (formerly Oléos) recently led to the launch of a first
active ingredient, Biome Oléoactif®. Our proposed agreement with
Sharon Laboratories has been interrupted by the current crisis, but
we continue to work with several other major partners, some still
confidential at this stage, all of whom are very interested in the
DEINOVE platform, due to both our wide biodiversity and our
technical expertise.
As 2020 begins in a context of global health, economic and
social crisis, we are proud to have secured nearly €5 million, and
our team is firmly pursuing its action with three clear objectives:
to generate revenues through the cosmetics business, to advance the
DNV3837 program towards a Phase III and a possible licensing
agreement, and to strictly monitor our expenses to maintain
financial flexibility. »
SUMMARY OF CONSOLIDATED FINANCIAL
DATA
The DEINOVE Group's consolidated accounts at 31 December 2019
were certified by the Group's Statutory Auditors – PwC
(PricewaterhouseCoopers).
Income statement
(in thousands of euros)
31/12/19
31/12/18
Operating revenue
637
759
Of which operating subsidies
397
699
Operating costs
12,838
11,225
Of which Research & Development
costs
10,459
8,527
Of which Administrative and General
costs
2,379
2,698
OPERATING PROFIT / LOSS
-12,201
-10,467
FINANCIAL RESULTS
-34
-6
PROFIT / LOSS FROM NON-RECURRING ITEMS
65
172
Income tax and deferred taxes
-2,433
-2,014
Goodwill amortization
511
460
Results from equity affiliates
-
-
CONSOLIDATED PROFIT / LOSS
-10,247
-8,747
(in thousands of euros)
31/12/19
31/12/18
Term deposit
-
1,301
Provision for impairment of
marketable securities
-
-
Cash on hand
1,095
2,579
ICNE and bank overdrafts
-
23
CASH & CASH
EQUIVALENTS
1,095
3,902
OPERATIONAL PROGRESS: 2019
FINANCIAL YEAR AND POST-CLOSING
NEW GENERATION ANTI-INFECTIVES DNV3837: Launch of Phase
II clinical trial in Clostridioides difficile infections DEINOVE
has prepared a Phase II trial for its most advanced antibiotic
candidate, DNV3837, in patients with gastrointestinal infection
caused by Clostridioides difficile (CDI), a WHO priority pathogen
and one of the leading causes of hospital-acquired infections
worldwide1.
This trial is designed to evaluate the efficacy of DNV3837 in a
pathological context, as well as to consolidate the safety and
pharmacokinetic data of the antibiotic candidate. The trial design
has been optimized2. The target patient population has been
expanded to cover both moderate and severe CDIs, allowing a broader
population to be addressed for treatment evaluation.
The trial is multi-centre and concentrated in the United States
where prevalence is higher and regulatory authorities are seeking
new treatment options. The US company Medpace, which has extensive
experience in infectious diseases and more specifically in CDIs,
acts as the CRO3 and is responsible for the follow-up of the
trial.
Post-closing, the first patient has been included4 ;
results are expected at the end of 2020.
The DNV3837 program was the subject of a scientific paper at the
29th annual congress of the European Society of Clinical
Microbiology and Infectious Diseases (ECCMID)5, one of the world's
leading congresses on clinical microbiology and infectious
diseases.
DNV3681/DNV38376: the U.S.
Army evaluates the molecule against bioterrorism pathogens7
USAMRIID8 evaluated DNV3681 against anthrax (Bacillus anthracis)
and tularaemia (Francisella tularensis), bacteria classified as
"high priority" bioterrorism threats.
DNV3681 has demonstrated superior in vitro efficacy to standard
treatment9 when exposed to Bacillus anthracis. These data were
presented at the ASM Microbe 2019 Congress (American Society of
Microbiology) by Major Steven Zumbrun, PhD in Microbiology at
USAMRIID. Based on these results, USAMRIID has started an in vivo
evaluation.
DEINOVE was also one of the very few European companies selected
for the Lightning Talks10 at the BARDA Industry Day 2019 in
Washington DC. At this congress, the BARDA11 outlines the U.S.
government's priorities for medical countermeasures, the actions
taken, and the results obtained, and invites companies and research
organizations to present medical innovations that could contribute
to the protection against biological risks. DEINOVE detailed the
progress of the DNV3837/DNV3681 program.
Progress of the AGIR program -
Antibiotics against Resistant Infectious Germs In 2019, DEINOVE has
validated the first key milestone of the AGIR program, giving rise
to a payment of €1.5m by Bpifrance12. This first step had led to
the development of a robotic platform for strain extraction and
screening, with an analysis rate of several hundred strains per
month.
In order to maximize the opportunities for the discovery of new
antibiotic structures:
- DEINOVE is expanding its research beyond its own bacterial
library. In particular, the Company has signed an agreement with
the Institut Pasteur13.
- DEINOVE has also strengthened its expertise in the genetic
engineering of rare and varied microorganisms with the integration
of the CRISPR-Cas9 technology in order to accelerate the
optimization of innovative antibiotic structures14.
- DEINOVE and ESPCI Paris15 have co-developed a technology for
the high-throughput screening and sorting of bacteria into droplets
to facilitate the detection of antibiotic activity. This project,
called Deinodrop, was selected by the ANR16 with a funding of 300
k€17.
Post-closing, DEINOVE validated the 2nd milestone of the
AGIR program, giving rise to a payment of €1.5m by Bpifrance18.
This step enabled the screening of a growing number of strains, the
validation of the automated tools developed by DEINOVE and the
identification of around thirty ‘hits’19.
ACTIVE INGREDIENTS OF NATURAL ORIGIN Phyt-N-Resist®, a
proprietary anti-ageing active: production of a new commercial
batch and consolidation of the sales pitch At the 40th annual
congress of the New York Society of Cosmetic Chemists (NYSCC),
Solvay promoted the discovery of Phyt-N-Resist®’s innovative mode
of action20. In-depth studies have shown that Phytoene acts at the
cellular level, where the collagen is, to foster cell regeneration
and therefore anti-aging effect.
After the closing, DEINOVE announced the production of a new
batch of Phyt-N-Resist® to meet the needs of its distributors and
future customers21. Phyt-N-Resist® has been provided to nearly a
hundred cosmetic brands to be tested in various skincare formulas,
demonstrating its potential in several strategic markets. Several
development projects for cosmetic products incorporating DEINOVE's
first Phytoene-based active ingredient are underway.
Luminity®, a new proprietary active
ingredient that enhances complexion radiance and evenness. DEINOVE
had announced at the end of 2018 the development of a new
proprietary asset based on a novel carotenoid, Neurosporene. This
new carotenoid, which was previously inaccessible, has exceptional
antioxidant properties. Ex vivo and clinical studies have
demonstrated its benefits in terms of skin vitality and complexion
beauty, claims that are particularly sought-after by the cosmetics
industry.
This active ingredient, named Luminity®, was previewed at
In-cosmetics Asia, the leading regional cosmetic ingredients trade
show22, in November 2019, before being officially launched
worldwide in April 202023 (Post-Closing). The In-Cosmetics
Global show, initially scheduled for early April in Barcelona, has
been cancelled. Digital means were then set up for the promotion of
the active ingredient.
Hebelys®, an anti-ageing active for
mature skin: its effectiveness promoted in a renowned magazine The
International Journal of Cosmetic Science has published the results
of a study on the benefits of Sphingomonas hydrophobicum extract,
the active ingredient of Hebelys®, a cosmetic ingredient
co-developed by DEINOVE and Greentech24.
BIOME Oléoactif, an active
ingredient co-developed with Hallstar France. Post-closing,
it was announced the launch of BIOME Oléoactif®, the first asset
resulting from the collaboration between DEINOVE and Hallstar
France (formerly Oléos)25.
BIOME Oléoactif® is an active ingredient produced from a rare
extremophilic bacterium that DEINOVE has managed to cultivate, and
whose potential is reinforced by the original extraction technique
developed by Oléos. Thanks to its unique fatty acid composition,
supplemented by other lipids, BIOME Oléoactif® is a post-biotic
extract with a prebiotic effect: it balances the skin microbiome
and maintains the integrity of the epidermal barrier.
Partnership project with Sharon
Laboratories26 Post-closing, in February, DEINOVE
announced the signature of a MoU with the Israeli group Sharon
Laboratories providing for the establishment of a partnership for
the development and marketing of a range of biobased cosmetic
ingredients. The sharp deterioration in economic conditions related
to the Covid-19 pandemic generated too many uncertainties to enter
into this partnership and led to the termination of
discussions.
Collaboration agreement with Dow for
the development of a new cosmetic active ingredient27 In
June 2019, DEINOVE has entered into a collaboration with Dow to
develop a new exclusive 100% natural cosmetic active ingredient
from its collection of bacterial extracts. DEINOVE will design and
optimize a dedicated production process and then ensure the
industrial scale-up and manufacturing of this compound. Dow will be
responsible for the further qualification of the cosmetic active
ingredient, will integrate it into its product portfolio and will
have worldwide commercial exclusivity. Commercialization is
scheduled for 2021.
COLOR2B animal feed additive
program: progress confirmed and outlook28 The COLOR2B
project, carried out in collaboration with the Avril Group, is
focused on the development of a process for the production of
natural feed ingredients. The strain selected for this production
was evaluated during a test phase aimed at validating the optimal
dosage and demonstrated that the ingredient is competitive compared
to reference products. The next step was taken to develop a product
formulation that meets regulatory and industrial expectations.
CONSOLIDATED FINANCIAL RESULTS
FOR THE 2018 FINANCIAL YEAR
Changes in the scope of consolidation
In 2018, the DEINOVE Group's consolidated accounts included:
- The DEINOVE SA company, whose accounts included the financial
flows of the BIOVERTIS company from 01/07/18, and those of the
DEINOBIOTICS company from 02/11/18;
- The subsidiary BIOVERTIS, fully integrated from 23/05/18 to
30/06/18;
- The subsidiary DEINOBIOTICS, fully integrated until
01/11/18;
- The MORPHOCHEM subsidiary, fully integrated from 23/05/18.
The consolidated financial statements of the DEINOVE Group in
2019 include the accounts of the Company and the wholly owned
subsidiary MORPHOCHEM.
Operating income
The Group recorded 637 k€ in operating revenues over the
financial year, including on the one hand the payment by Bpifrance
of the subsidy corresponding to the achievement of the 1st
milestone of the AGIR program for an amount of 397 k€, and on the
other hand, invoicing related to collaborative research agreements
with industrial partners in the fields of cosmetics (159 k€) and
animal nutrition (4 k€). Finally, the transfers of operating
expenses and benefits in kind recognized in 2019 amounts to 77
k€.
In 2018, operating revenues amounted to 759 k€, mainly including
grants related to the launch of the AGIR program (678 k€).
During the 2019 financial year, the Group's operating expenses
amounted to €12.8m, 81% of which was spent on R&D activities.
The net change in operating expenses between 2018 and 2019 amounts
to +€1,612k (+14%). Subcontracting and external studies expenses
increased significantly, in line with the progress of the services
provided by the CROs accompanying DEINOVE on the DNV3837 project,
while personnel expenses decreased, in line with the evolution of
the workforce: 60.0 average full-time equivalents (FTEs) in 2019 vs
62.0 in 2018.
NET INCOME
The consolidated net loss for the year amounts to €10.2m. It
includes a positive exceptional result of +€65k, comprising
exceptional income of €127k, and exceptional expenses of €61k, of
which €60k related to the early amortization following the disposal
of an intangible asset.
The negative financial result of -€34k consists primarily of the
result of transactions that DEINOVE carries out on its own shares
within the framework of the liquidity contract, for a net amount of
-€23k.
Income tax consists almost exclusively of R&D Tax Credit.
The Group's receivable for the 2019 financial year has been
estimated at €2,491k (vs €1,997k in 2018).
FINANCIAL POSITION
Financial needs for the year mainly concerned operating expenses
for €10.9m (excluding provision and depreciation), along with
investments in laboratory equipment (including leases) for €0.8m
and partial repayments (exclusively on the unconditional part) of
Bpifrance aid, totaling €0.2m. Over the same period, the Group
received €1.5m of public aid under the AGIR program, €2.5m under
the 2017 R&D Tax Credit and €1.9m under the 2018 one. In
addition, DEINOVE raised €1.1m through the equity financing line
set up in November 2018 with Kepler Cheuvreux. Finally, DEINOVE
received €2.1m (net) from the L1 Capital fund for the subscription
to the first tranche of convertible bonds. At December 31, 2019,
the Group's net financial position was +€1.1m.
Post-closing, the Group obtained €2.1m for its 2019 R&D Tax
Credit receivable (via prefunding by Société Générale Factoring),
€1.5m from Bpifrance for reaching the AGIR 2nd milestone, and €1.0m
(early April) following the subscription of the 2nd Tranche of
convertible bonds by ESGO Fund (L1 Capital). The Group's net
financial position at March 31st was +3.0 m€.
CORPORATE INFORMATION
BOARD OF DIRECTORS
The Board of Directors on 26 June 2019 acknowledged:
- The resignation of Mr. Philippe POULETTY from his position as
Director effective 20 May 2019;
- The resignation of Mr. Christian PIERRET from his position as
permanent representative of TRUFFLE CAPITAL, Director, effective 20
May 2019;
- The appointment by TRUFFLE CAPITAL of Mr. Philippe POULETTY as
permanent representative, replacing Mr. Christian PIERRET, with
effect from May 20, 2019 and for the term of office of TRUFFLE
CAPITAL, which expires at the end of the Ordinary Annual General
Meeting to be held during the year 2022, and which will be called
to approve the financial statements for the financial year ending
December 31, 2021.
On December 3, 2019, the Board of Directors acknowledged Mr.
Emmanuel PETIOT's decision to resign from his position as Chief
Executive Officer of DEINOVE, and decided, in consultation with Mr.
Emmanuel PETIOT, that his term of office would end on December 31,
2019. Dr. Charles WOLER, Chairman of the Board of Directors of
DEINOVE, has been appointed acting Chief Executive Officer, with
effect from 1 January 2020. The same Board also took note of the
resignation of Mr. Bernard FANGET from his position as Director,
and co-opted and provisionally appointed Mr. Emmanuel PETIOT to
replace him for the duration of his predecessor's term of office,
which expires at the end of the General Meeting of the Company's
shareholders called to approve the financial statements for the
financial year ending December 31, 2021. This appointment will be
submitted for ratification at the next Ordinary Annual and
Extraordinary Shareholders' Meeting to be held on June 16,
2020.
Equity structure
At December 31, 2019, the Company's share capital consisted of
18,029,958 ordinary shares with a par value of Euro 0.40 each, of
which 20,234 (i.e. approximately 0.11% of the share capital) were
held by the Company under the liquidity contract entrusted to
Kepler Cheuvreux.
Breakdown of capital as of December
31, 2019 – non-diluted basis
Shareholders
Number of shares
Percentage held
Voting rights
Percentage rights
Funds managed by Truffle Capital
1,385,637
7.69%
2,549,592
12.98%
Funds managed by TVM Capital
1,142, 537
6.34%
1,142,537
5.81%
Scientific founders
20,000
0.11%
40,000
0.20%
Management and Directors
73,140
0.41%
107,251
0.55%
Floating
15,408,644
85.46%
15,809,292
80.46%
TOTAL
18,029,958
100.00%
19,648,672
100.00%
Changes in share capital
During the first half of 2019, the Board of Directors noted the
issue of 925,000 new shares under Kepler Cheuvreux equity financing
lines29.
On July 9, 2019, the Company entered into an agreement with the
European Select Growth Opportunities Fund to issue convertible
bonds representing a bond issue of 2,200,000 Euros for the 1st
Tranche30. In this context, by December 31, 2019, the investor had
converted 103 OCAs (out of a total of 220), resulting in the issue
of 1,480,257 new shares.
A total of 2,405,257 new shares were therefore issued during the
financial year 2019, representing a share capital increase of
962,102.80 Euros. As of December 31, 2019, the Company's share
capital consisted of 18,029,958 shares with a par value of 0.40
Euro each.
COVID-19 - 2020 OUTLOOK
As of the date of this press release, the evolution of DEINOVE
in the context of Covid-19 was as follows:
- Since the implementation of containment measures in France on
March 17, 2020, all of the Company's operations have been
reorganized to protect the health and safety of employees, while
maintaining the progress of research programs and commercial
development. A portion of employees are teleworking; small teams
continue laboratory operations under satisfactory conditions. It is
likely that some development programs will see their schedule
shifted (for example, a study of the effectiveness of a cosmetic
active ingredient on volunteers could be postponed), without major
impact on overall progress.
- The cancellation of In-Cosmetics Global, the world's largest
trade show for cosmetic ingredients, initially scheduled for March
31, April 1 and 2 in Barcelona, has led to a readjustment of
DEINOVE's marketing operations, with the launch of the new
ingredient, Luminity®, being postponed for one month. The launch
strategy is being adapted in close coordination with distribution
partners. Specific communication actions are being developed for
sales teams and prospects, with increased use of digital tools. The
entire industry is being impacted in all world markets and DEINOVE
anticipates that the coming weeks will not be very favorable for
the development of new projects for cosmetic brands, as the
activity of their formulation laboratories is disrupted. However,
the major market trends are expected to continue – increased
consumption of cosmetic products driven by demographic growth, the
ageing of the population and the development of Asian markets;
increased demand for ingredients of natural origin; increased use
of biotechnologies... DEINOVE remains confident about the potential
of its cosmetics business.
- In the antibiotics activities, in addition to the continuation
of the research operations of the AGIR program, the Phase II
clinical trial testing DNV3837 in C. difficile infections is still
ongoing. The health situation in the United States may have an
impact on the continuation of the trial within the planned
timeframe, given that to date one of the clinical sites heavily
involved with Covid-19 patients is no longer in a position to
include new patients during this period. However, the information
available to date does not call into question the study. The matter
is being closely monitored by the DEINOVE scientific team and the
CRO Medpace.
- The Finance Department is studying all measures to preserve and
strengthen the cash position. Since the beginning of March 2020,
DEINOVE has secured €4.6m through the validation of the 2nd
milestone of the AGIR program, the pre-funding of the 2019 R&D
Tax Credit receivable and the subscription of a second tranche of
convertible bonds. In addition, despite the abandonment of the
project with Sharon Laboratories, DEINOVE has retained the $200k
received upon signature of the Memorandum of Understanding.
In this context, the Board of Directors has defined three main
objectives: to generate revenues through the marketing of cosmetic
ingredients, to advance the DNV3837 program towards a Phase III and
a possible licensing agreement, and to strictly monitor operating
expenses in order to maintain financial flexibility.
In the current configuration of its projects, the Group
considers that it has the resources to finance its activities until
the beginning of the 2nd quarter 2021, in particular by pursuing
the use of the convertible bond financing device put in place in
July 2019.
The 2019 annual financial report is available
at the following address
http://www.deinove.com/en/investor-room/documentation-center/financial-reports
ABOUT DEINOVE
DEINOVE is a French biotechnology company, a leader in
disruptive innovation, which aims to help meet the challenges of
antibiotic resistance and the transition to a sustainable
production model for the cosmetics and nutrition industries.
DEINOVE has developed a unique and comprehensive expertise in
the field of rare bacteria that it can decipher, culture, and
optimize to disclose unsuspected possibilities and induce them to
produce biobased molecules with activities of interest on an
industrial scale. To do so, DEINOVE has been building and
documenting since its creation an unparalleled biodiversity bank
that it exploits thanks to a unique technological platform in
Europe.
DEINOVE is organized around two areas of expertise:
- ANTIBIOTICS, New-generation anti-infective drugs: A
first antibiotic candidate, DNV3837, is now in Phase II. The
Company is also pursuing the systematic exploration of biodiversity
to supply its portfolio with new leads, drawing notably on
partnerships with bioMérieux and Naicons (AGIR program supported by
Bpifrance).
- BIOACTIVES, Active ingredients of natural origin with
cosmetics as the first market. DEINOVE already markets four
cosmetic active ingredients, proprieraty or developed in
partnership with Greentech and Hallstar France, and has a number of
products in development.
Within the Euromedecine science park located in Montpellier,
DEINOVE employs 60 employees, mainly researchers, engineers, and
technicians, and has filed about 350 patent applications
internationally. The Company has been listed on EURONEXT GROWTH®
since April 2010.
Visit www.deinove.com
1 Source: CDC (US Centers for Disease Control and Prevention) 2
Press release issued January 31, 2019 3 A CRO (Contract Research
Organization) is a service provider dedicated to biomedical
research for the pharmaceutical and biotechnology industries, as
well as for research organizations. 4 Press release issued January
27, 2020 5 Press release issued April 12, 2019 6 Note: DNV3681 is
the active molecule of the antibiotic compound DNV3837. 7 Press
releases issued May 20 and June 24, 2019 8 USAMRIID (U.S. Army
Medical Research Institute of Infectious Diseases) is the U.S.
Army’s main institution and facility for defensive research into
countermeasures against biological warfare. 9 Ciprofloxacin 10
Press release issued October 15, 2019 11 BARDA – Biomedical
Advanced Research and Development Authority 12 Press release issued
March 21, 2019 13 Press release issued April 9, 2019 14 Press
release issued September 23, 2019 15 ESPCI Paris: The City of Paris
Industrial Physics and Chemistry Higher Educational Institution 16
ANR: French National Research Agency 17 Press release issued
December 9, 2019 18 Press release issued March 11, 2020 19
Molecules of potential interest 20 Press release issued May 13,
2019 21 Press release issued January 22, 2020 22 Press release
issued November 4, 2019 23 Press releases issued February 19 and
April 23, 2020 24 Press release issued September 18, 2019 25 Press
release issued March 18, 2020 26 Press releases issued February 6
and March 30, 2020 27 Press release issued June 5, 2019 28 Press
release issued June 11, 2019 29 Press releases issued December 1,
2014 and November 21, 2018 30 Press release issued July 9, 2019
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200429005650/en/
Investors Coralie Martin Communication, Marketing and Investor
Relations Ph.: +33 (0)6 46 62 47 50 coralie.martin@deinove.com
Media ALIZE RP Caroline Carmagnol Ph.: +33 (0)6 64 18 99 59
deinove@alizerp.com