DEINOVE: 2019 Annual Results: a Year of Important Milestones in Both Antibiotics and Cosmetics Activities

  • 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.

MONTPELLIER, France--()--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

Contacts

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

Contacts

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