DEINOVE presents its financial results and the advancement

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  • Continuation of the Phase II of of DNV3837 in the remedy of Clostridioides difficile an infection
    • Extension of the trial to five new facilities in Canada
  • First milestones reached of the Boost-ID undertaking, chosen as a part of the France Relance plan
  • Group internet revenue for the first half of 2022 of -€3.6M in comparison with -€3.1M in 2021, primarily due to decrease revenues from the beauty exercise
    • Continuation of the working price discount plan with a lower of two% lower in working bills (€4.06M vs. €4.14M in 2021), nonetheless 84% devoted to R&D
  • Group money place:
    • Balance of +€1.1M at June 30, 2022, in comparison with +€3.8M at 31 December 31, 2021
    • Implementation of an modification to the OC settlement concluded on September 10, 2022
    • On March 26, 2022, the 4th tranche of notes convertible into new shares was subscribed by the ESGO Fund, for an quantity of €500K
  • Search for financing options to safe the Group’s financial state of affairs

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech firm, pioneer in the exploration and exploitation of bacterial biodiversity to deal with the pressing, international problem of antibiotic resistance, pronounces that its Board of Directors has accredited the consolidated financial statements for the first half of 2022.

The first half of 2022 has been a period of strategic execution for DEINOVE. We have reached the first milestones of the Boost-ID project, selected under the France Relance plan, to set up an industrial platform for ultra-high throughput bacterial screening, based on microfluidic droplet technology. Now integrated into DEINOVE’s discovery process, this Lab-on-a-chip platform significantly accelerates the identification and characterization of bacteria with biological activity of interest, whether in the field of antimicrobials or in many other fields,declared Alexis RIDEAU, Chief Executive Officer of DEINOVE. He added, Regarding our Phase II clinical trial, the use of DNV3837 is a potential paradigm shift for the treatment of Clostridioides difficile infection, as presented yesterday at the ESCMID/ASM Conference in Dublin. Indeed, DNV3837 could become the first intravenous targeted antibiotic therapy in Clostridioides difficile infections.

SUMMARY OF CONSOLIDATED FINANCIAL DATA

The DEINOVE Group’s consolidated financial statements as of June 30, 2022 have been licensed by the Group’s Statutory Auditors, the agency PwC (PricewaterhouseCoopers).

PROFIT AND LOSS ACCOUNT

(in 1000’s of euros) 30/06/22 30/06/21
Operating revenues 185 475
Of which working grants 4 167
Operating prices 4,061 4,142
Of which Research & Development prices 3,411 3,479
Of which General & Administrative prices 650 663
OPERATING PROFIT/LOSS BEFORE GOODWILL AMORTIZATION (3,876) (3,667)
Goodwill amortization 256 256
OPERATING PROFIT/LOSS AFTER GOODWILL AMORTIZATION (4,132) (3,923)
PROFIT/LOSS (37) (14)
PROFIT/LOSS FROM NON-RECURRING ACTIVITIES 22 19
Income tax and deferred taxes (588) (771)
Results from fairness associates (MEQ)
CONSOLIDATED GROUP PROFIT/LOSS (3,559) (3,146)
(in 1000’s of euros) 30/06/22 30/06/21
Term deposit
Provision for impairment of marketable securities
Cash available 1,102 3,843
ICNE & financial institution overdrafts
CASH & CASH EQUIVALENTS 1,102 3,843

OPERATIONAL PROGRESS DURING THE PERIOD AND POST-CLOSING

Phase II take a look ating the antibiotic candidate DNV3837 in extreme Clostridioides difficile an infection

This medical trial goals to judge the efficacy and the pharmacokinetics of DNV3837 in sufferers with Clostridioides difficile gastrointestinal an infection (CDI). This trial is being performed in the United States, based on a sequential protocol:

  • The first step goals to deal with a cohort of 10 sufferers with average to extreme CDI with DNV3837. The impartial Data Safety Monitoring Board (DSMB) has accomplished its overview of the security information from the first a part of the trial and thought of that the profit/danger steadiness of antibiotic remedy with DNV3837 was in favor of continuous the recruitment on this trial. Because of the Covid-19 pandemic, the first a part of the trial was restricted to 9 sufferers as a substitute of 10.
  • The second step goals to deal with 30 sufferers with extreme CDI might be performed in an “open-label” method, as DNV3837 is run intravenously, whereas the requirements of care are administered orally.

The expertise acquired throughout this primary a part of the research has made it doable to enhance the trial protocol, with a discount in dose by an element of 4 and a discount in the period of administration by an element of two, decreasing the intravenous remedy from 12 to six hours per day. This enchancment simplifies the administration of the trial for the investigating physicians and their groups.

Because of the Covid-19 pandemic impacts, results of the first a part of the trial must be printed by the finish of the half of 2023. New preclinical information and a affected person case from the ongoing Phase II trial have been introduced at the ESCMID/ASM Conference in Dublin on October 5, 2022.

DEINOVE reaches the first milestones of the Boost-ID undertaking, chosen as a part of the France Relance plan, with the operational set up of its microfluidic screening platform

In May 2022, the Company introduced that it has reached the first targets and milestones set in the Boost−ID undertaking (Bacteria Optimum Output Screening Tool for treating Infectious Diseases), chosen in early 2021 by the France Relance plan. Boost−ID was certainly one of 105 tasks chosen by the French authorities, out of practically 1,000 candidates, as a part of the “resilience” name for tasks.

that it has reached the first targets and milestones set in the Boost−ID undertaking (Bacteria Optimum Output Screening Tool for treating Infectious Diseases), chosen in early 2021 by the France Relance plan. Boost−ID was certainly one of 105 tasks chosen by the French authorities, out of practically 1,000 candidates, as a part of the “resilience” name for tasks.

CORPORATE

BOARD OF DIRECTORS

Following the sale of its whole stake in the Company’s capital, TVM Capital GmbH resigned from its directorship, in the context of which it was represented by Mr. Jean-François LABBE, with impact from February 8, 2022.

Truffle Capital has resigned from its directorship, through which it was represented by Mr. Philippe POULETTY, with impact from June 20, 2022.

As a end result, the Board of Directors has been composed of 5 administrators since that date, versus 7 beforehand.

POST BALANCE SHEET LEGAL ELEMENTS AMENDMENT OF THE OC AGREEMENT

An modification (the ‘”Amendment”) to the settlement for the challenge of notes convertible into new shares (the “OC”) dated September 10, 2021 has been entered into on August 2, 2022 with the European Select Growth Opportunities Fund (the “Investor”),below the authorization of the Board of Directors on July 22, 2022. Under the phrases of the Amendment (i) the Investor waives, just for 3 new tranches, i.e. tranches 5, 6 and 7 of the Initial Agreement, the drawdown situation based on which, following the subscription of a tranche of OC at the request of the Company, the Investor should not maintain greater than 25% of the variety of shares making up the share capital of DEINOVE, both instantly or not directly by way of the holding of shares and OC, and (ii) it’s accompanied by a rise in the low cost granted to the Investor upon conversion of the OC into shares, which is raised from 5% to fifteen%, for all the tranches already subscribed and the tranches to be issued. It is being specified that the different situations of the Initial Agreement, as described in the press launch of September 14, 2021, will proceed to use, and that the 5% low cost will apply once more to any new tranche subscribed from January 1st, 2023 as quickly as the share value is larger than €0.28 (adjusted as the case could also be from any share break up or share consolidation) for a interval of three (3) consecutive buying and selling days previous to the date of the request made by the Company to the Investor to subscribe to the new tranche.

This fifth tranche of OCA 2021, with a nominal worth of EUR 500,000 (EUR 485,000 internet of charges) was issued by the Company and absolutely subscribed by the Investor on August 30, 2022. This sixth tranche of OCA 2021, with a nominal worth of EUR 250,000 (EUR 242,500 internet of charges) was issued by the Company and absolutely subscribed by the Investor on September 30, 2022.

FINANCIAL RESULTS FOR THE FIRST HALF OF 2022

OPERATING REVENUE

Operating revenues amounted to €185K, down by €290K and -61% in comparison with the first half of 2021. The major variances are as follows:

  • Decrease in income generated by DEINOVE with a complete of €124K or -€137K and −53%. The income is generated by:
    • Work carried out in the framework of collaborative analysis agreements reminiscent of the one concluded with DSM (€81K towards €84K in 2021);
    • Revenues from the distribution of substances produced by DEINOVE and distributed by companions in the cosmetics discipline (€43K towards €177K).
  • Operating subsidies down by €163K, or -98%: Deinove didn’t obtain any main subsidies in the first half of 2022; solely State subsidies regarding an apprenticeship contract are recorded on this first half.
  • Reversal of provisions and expense transfers: €57K, of which €47K have been generated by a switch of deferred bills associated to the financing of the convertible bond challenge with L1 Capital, and by the reversal of the provision for the end-of-career indemnity (€22K).

During the first half of 2022, the Group’s working bills reached €4.1M, of which 84% was spent on R&D actions. The internet change in working bills between the first halves of 2021 and 2022 amounted to -€81K (-2%). Personnel bills additionally decreased by 5%, according to the evolution of the workforce: 44 common full-time equivalents (FTE) in the first half of 2022 in comparison with 50 in 2021.

NET INCOME

The consolidated internet loss for the interval quantities to €3.6M, negligibly impacted by distinctive gadgets (constructive distinctive results of €22K).

The detrimental financial results of -€37K is principally as a result of financial bills associated to the pre-financing of the Research Tax Credit (-€15K) and curiosity bills on loans (-€20K).

Income tax contains solely the Research Tax Credit. The Group’s receivable for the first half of 2022 has been estimated at €588K (in comparison with €771K in 2021).

NET RESULT

In the first half of 2022, 3,299,045 new shares below the convertible bond settlement.

The earlier contract of July 9, 2019 expired on July 9, 2021, DEINOVE introduced that it had entered into a brand new settlement for a convertible bond financing with the European Select Growth Opportunities Fund, representing a bond challenge of a most nominal quantity of €10 million, and divided into a number of tranches of a nominal quantity of €500,000 for every tranche. The first tranche of €500,000 was issued concurrently with the signing of the settlement with European Select Growth Opportunities Fund.

The 34,378,066 shares with a nominal worth of EUR 0.02 making up the capital as of June 30, 2022, are damaged down as follows:

Year ended June 30, 2022 non-diluted foundation      
Shareholders Number of shares % of holding Voting rights %
Funds managed by Truffle Capital 1,765,867 5.14% 3,462,864 9.61%
Scientific founders 20,000 0.06% 40,000 0.11%
Management and Board members 0 0.00% 0 0.00%
Free float 32,592,199 94.81% 32,532,447 90.28%
TOTAL 34,378,066 100.00% 36,035,311 100.00%

FINANCIAL SITUATION

As of June 30, 2022, the Group’s internet money place was EUR 1,102K. This degree of money doesn’t embody the drawdown of two new tranches of OCA 2021 for a complete quantity of EUR 750,000 (EUR 727,500 internet of charges) on August 30 and September 30, 2022.

As indicated in the press launch dated August 3, 2022, the drawdown of those two tranches and of the subsequent tranche of a nominal quantity of EUR 250,000 on November 30, 2022, topic to compliance with sure situations, would prolong the Company’s money horizon to November 2022.

Thus, given the Company’s expense construction and money circulation forecasts, the securing of its financial place stays conditional on its means to seek out financing options. The continuity of its operations is determined by this.

ABOUT DEINOVE

DEINOVE is a French biotechnology firm pioneering the exploration of a brand new area of life, unexplored at 99.9%: the “microbial dark matter”. By revealing the metabolic potential of uncommon micro organism or nonetheless labeled as uncultivable, it tackles a worldwide well being and financial problem: antimicrobial resistance.

The new therapies found and developed by DEINOVE goal superbugs (microbes which have grow to be proof against a number of antimicrobials) that trigger life-threatening infections which at the moment are spreading at excessive velocity.

This breakthrough method gave rise to certainly one of the world’s first specialised micro-biotechnology platforms and a novel assortment of practically 10,000 uncommon strains and 1000’s of bacterial extracts. Today, DEINOVE is conducting a number of improvement applications, of which its first antibiotic candidate is presently evaluated in a Phase II medical trial in extreme Clostridioides difficile an infection, certainly one of the world’s first emergencies. The Company has additionally developed new bacterial micro-factories that deal with the different challenge in the race towards antimicrobial resistance: the industrial manufacturing of those uncommon and low concentrated compounds with usually too advanced chemical buildings to be generated by chemical synthesis.

Located at the coronary heart of the Euromedecine park in Montpellier, DEINOVE has been listed on EURONEXT GROWTH® (ALDEI – code ISIN FR0010879056) since 2010. The Company has 45 staff and depends on a community of world-class tutorial, technological, industrial and institutional companions.

CONTACTS

Investors

Mario Alcaraz

Chief Financial and Administrative Officer

+33 (0)4 48 19 01 00

[email protected]

Media

ATCG Partners – Delphine LENS

+33 (0)9 81 87 46 72 / +33 (0)6 11 07 14 08

[email protected]

 
  • 20221006_DEINOVE_PR_Half Year Results



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