An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection

This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 1.5 mg/kg actual body weight(BW)/day administered via IV infusion in subjects with CDI. The study will be conducted in 2 subsequent parts.
In Part 1 of the study, 10 subjects of either sex with severe or non-severe CDI will be enrolled to receive DNV3837.
In Part 2 of the study, up to 30 subjects with severe or non-severe CDI will be enrolled to receive DNV3837.
In both parts of the study, treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total maximum daily dose of 120 mg DNV3837. Infusions will be administered once daily for 10 consecutive days. The objectives of the study are:
To evaluate the safety of intravenous (IV) DNV3837;
To evaluate the efficacy of IV DNV3837;
To assess the pharmacokinetics (PK) of DNV3837 and DNV3681 in plasma and of DNV3681 in urine and feces;
To assess C. difficile using microbiological assessments;
To assess the proportion of subjects colonized with vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase (ESBL) organisms, or carbapenem-resistant Enterobacteriaceae (CRE) in feces; and
To assess changes in the fecal microbiome using 16S ribosomal ribonucleic acid (RNA) analysis

Start Date02 Aug 2019

Sponsor / Collaborator

Deinove SA

100 Clinical Results associated with MCB-3837

100 Translational Medicine associated with MCB-3837

100 Patents (Medical) associated with MCB-3837

Literatures (Medical) associated with MCB-3837

01 Mar 2017·Antimicrobial agents and chemotherapyQ2 · MEDICINE

Q2 · MEDICINE

Article

Author: Freeman, Jane ; Pilling, Sally ; Wilcox, Mark H. ; Vernon, Jonathan

ABSTRACT:

Treatments for Clostridium difficile infection remain limited, despite the introduction of fidaxomicin, and development of new agents is necessary. We determined the in vitro susceptibilities of 199 prevalent or emerging Clostridium difficile PCR ribotypes to MCB3681, a novel investigational quinolonyl-oxazolidinone, and 8 comparators (metronidazole, vancomycin, fidaxomicin, moxifloxacin, ciprofloxacin, clindamycin, tigecycline, and linezolid). MCB3681 showed good activity against C. difficile with no evidence of MCB3681 resistance in isolates showing either moxifloxacin or linezolid resistance or both moxifloxacin and linezolid resistance.

01 Aug 2015·Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious DiseasesQ1 · MEDICINE

Analysis of effects of MCB3681, the antibacterially active substance of prodrug MCB3837, on human resident microflora as proof of principle

Q1 · MEDICINE

Article

Author: Rashid, M-U ; Kapsner, T ; Dalhoff, A ; Weintraub, A ; Panagiotidis, G ; Nord, C E

The water-soluble prodrug MCB3837 is rapidly converted to MCB3681, active against Gram-positive bacterial species, after intravenous infusion. The aim of this study was to prove the principle that MCB3681 is efficacious in vivo by demonstrating its effect on the resident microflora or colonizers of the human skin, nose, oropharynx and intestine. MCB3837 was infused at a daily dose of 6 mg/kg for 5 days. MCB3681 was active against clostridia, bifidobacteria, lactobacilli, enterococci and Staphylococcus aureus, thus proving the principle that MCB3681 is antibacterially efficacious in vivo without affecting the Gram-negative microflora.

01 Aug 2014·International journal of antimicrobial agentsQ2 · MEDICINE

Ecological impact of MCB3837 on the normal human microbiota

Q2 · MEDICINE

Article

Author: Bäckström, Tobias ; Nord, Carl Erik ; Rashid, Mamun-Ur ; Panagiotidis, Georgios ; Dalhoff, Axel ; Weintraub, Andrej ; Björkhem-Bergman, Linda

MCB3837 is a novel, water-soluble, injectable prodrug that is rapidly converted to the active substance MCB3681 in vivo following intravenous (i.v.) administration. Both MCB3837 and MCB3681 are oxazolidinone-quinolone hybrid molecules. The purpose of the present study was to investigate the effect of MCB3681 on the human skin, nose, oropharyngeal and intestinal microbiota following administration of MCB3837. Twelve healthy male subjects received i.v. MCB3837 (6 mg/kg body weight) once daily for 5 days. Skin, nose, saliva and faecal samples were collected on Day -1 (pre dose), during administration on Days 2 and 5, and post dose on Days 8, 12 and 19. Micro-organisms were identified to genus level. No measurable concentrations of MCB3681 were found in any saliva samples or in the faecal samples on Day -1. On Day 2, 10 volunteers had faecal MCB3681 concentrations between 16.5 mg/kg faeces and 275.1mg/kg faeces; no MCB3681 in faeces could be detected in two of the volunteers. On Day 5, all volunteers had faecal concentrations of MCB3681 ranging from 98.9 to 226.3 mg/kg. MCB3681 caused no ecological changes in the skin, nasal and oropharyngeal microbiota. The numbers of enterococci, bifidobacteria, lactobacilli and clostridia decreased in the intestinal microbiota during administration of the drug. Numbers of Escherichia coli, other enterobacteria and Candida were not affected during the study. There was no impact on the number of Bacteroides. The faecal microbiota was normalised on Day 19. No new colonising aerobic or anaerobic Gram-positive bacteria with MCB3681 minimum inhibitory concentrations of ≥4 mg/L were found.

News (Medical) associated with MCB-3837

06 Oct 2022

·www.globenewswire.com

DEINOVE presents its financial results and the advancement of its programs for the first half of 2022

Continuation of the Phase II of of DNV3837 in the treatment of Clostridioides difficile infection Extension of the trial to 5 new centers in Canada First milestones reached of the Boost-ID project, selected as part of the France Relance planGroup net income for the first half of 2022 of -€3.6M compared to -€3.1M in 2021, mainly because of lower revenues from the cosmetic activity Continuation of the operating cost reduction plan with a decrease of 2% decrease in operating expenses (€4.06M vs. €4.14M in 2021), still 84% dedicated to R&D Group cash position: Balance of +€1.1M at June 30, 2022, compared to +€3.8M at 31 December 31, 2021Implementation of an amendment to the OC agreement concluded on September 10, 2022On March 26, 2022, the 4th tranche of notes convertible into new shares was subscribed by the ESGO Fund, for an amount of €500K Search for financing solutions to secure the Group's financial situation 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 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 were certified by the Group’s Statutory Auditors, the firm PwC (PricewaterhouseCoopers). PROFIT AND LOSS ACCOUNT (in thousands of euros)30/06/2230/06/21Operating revenues 185475Of which operating grants4167Operating costs4,0614,142Of which Research & Development costs3,4113,479Of which General & Administrative costs650663OPERATING PROFIT/LOSS BEFORE GOODWILL AMORTIZATION(3,876)(3,667)Goodwill amortization256256OPERATING PROFIT/LOSS AFTER GOODWILL AMORTIZATION(4,132)(3,923)PROFIT/LOSS(37)(14)PROFIT/LOSS FROM NON-RECURRING ACTIVITIES2219Income tax and deferred taxes(588)(771)Results from equity affiliates (MEQ)--CONSOLIDATED GROUP PROFIT/LOSS (3,559)(3,146) (in thousands of euros)30/06/2230/06/21Term deposit--Provision for impairment of marketable securities--Cash on hand1,1023,843ICNE & bank overdrafts--CASH & CASH EQUIVALENTS1,1023,843 OPERATIONAL PROGRESS DURING THE PERIOD AND POST-CLOSING Phase II testing the antibiotic candidate DNV3837 in severe Clostridioides difficile infection 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. The independent Data Safety Monitoring Board (DSMB) has completed its review of the safety data from the first part of the trial and considered that the benefit/risk balance of antibiotic therapy with DNV3837 was in favor of continuing the recruitment in this trial. Because of the Covid-19 pandemic, the first part of the trial was limited to 9 patients instead of 10.The second step aims to treat 30 patients with severe CDI will be conducted in an “open-label” manner, as DNV3837 is administered intravenously, while the standards of care are administered orally. The experience acquired during this first part of the study has made it possible to improve the trial protocol, with a reduction in dose by a factor of 4 and a reduction in the duration of administration by a factor of 2, reducing the intravenous treatment from 12 to 6 hours per day. This improvement simplifies the management of the trial for the investigating physicians and their teams. Because of the Covid-19 pandemic impacts, results of the first part of the trial should be published by the end of the half of 2023. New preclinical data and a patient case from the ongoing Phase II trial were presented at the ESCMID/ASM Conference in Dublin on October 5, 2022. DEINOVE reaches the first milestones of the Boost-ID project, selected as part of the France Relance plan, with the operational installation of its microfluidic screening platform In May 2022, the Company announced that it has reached the first objectives and milestones set in the Boost−ID project (Bacteria Optimum Output Screening Tool for treating Infectious Diseases), selected in early 2021 by the France Relance plan. Boost−ID was one of 105 projects selected by the French government, out of nearly 1,000 candidates, as part of the "resilience" call for projects. that it has reached the first objectives and milestones set in the Boost−ID project (Bacteria Optimum Output Screening Tool for treating Infectious Diseases), selected in early 2021 by the France Relance plan. Boost−ID was one of 105 projects selected by the French government, out of nearly 1,000 candidates, as part of the "resilience" call for projects. CORPORATE BOARD OF DIRECTORS Following the sale of its entire 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 effect from February 8, 2022. Truffle Capital has resigned from its directorship, in which it was represented by Mr. Philippe POULETTY, with effect from June 20, 2022. As a result, the Board of Directors has been composed of 5 directors since that date, as opposed to 7 previously. POST BALANCE SHEET LEGAL ELEMENTS – AMENDMENT OF THE OC AGREEMENT An amendment (the '"Amendment") to the agreement for the issue 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"),under the authorization of the Board of Directors on July 22, 2022. Under the terms of the Amendment (i) the Investor waives, only for 3 new tranches, i.e. tranches 5, 6 and 7 of the Initial Agreement, the drawdown condition according to which, following the subscription of a tranche of OC at the request of the Company, the Investor must not hold more than 25% of the number of shares making up the share capital of DEINOVE, either directly or indirectly via the holding of shares and OC, and (ii) it is accompanied by an increase in the discount granted to the Investor upon conversion of the OC into shares, which is raised from 5% to 15%, for all the tranches already subscribed and the tranches to be issued. It is being specified that the other conditions of the Initial Agreement, as described in the press release of September 14, 2021, will continue to apply, and that the 5% discount will apply again to any new tranche subscribed from January 1st, 2023 as soon as the share price is higher than €0.28 (adjusted as the case may be from any share split or share consolidation) for a period of three (3) consecutive trading days prior to the date of the request made by the Company to the Investor to subscribe to the new tranche. This 5th tranche of OCA 2021, with a nominal value of EUR 500,000 (EUR 485,000 net of fees) was issued by the Company and fully subscribed by the Investor on August 30, 2022. This 6th tranche of OCA 2021, with a nominal value of EUR 250,000 (EUR 242,500 net of fees) was issued by the Company and fully 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% compared to the first half of 2021. The main variances are as follows: Decrease in revenue generated by DEINOVE with a total of €124K or -€137K and −53%. The revenue is generated by: Work carried out in the framework of collaborative research agreements such as the one concluded with DSM (€81K against €84K in 2021);Revenues from the distribution of ingredients produced by DEINOVE and distributed by partners in the cosmetics field (€43K against €177K). Operating subsidies down by €163K, or -98%: Deinove did not receive any major subsidies in the first half of 2022; only State subsidies relating to an apprenticeship contract are recorded in this first half.Reversal of provisions and expense transfers: €57K, of which €47K were generated by a transfer of deferred expenses related to the financing of the convertible bond issue 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 operating expenses reached €4.1M, of which 84% was spent on R&D activities. The net change in operating expenses between the first halves of 2021 and 2022 amounted to -€81K (-2%). Personnel expenses also decreased by 5%, in line with the evolution of the workforce: 44 average full-time equivalents (FTE) in the first half of 2022 compared to 50 in 2021. NET INCOME The consolidated net loss for the period amounts to €3.6M, negligibly impacted by exceptional items (positive exceptional result of €22K). The negative financial result of -€37K is mainly due to financial expenses related to the pre-financing of the Research Tax Credit (-€15K) and interest expenses on loans (-€20K). Income tax comprises exclusively the Research Tax Credit. The Group’s receivable for the first half of 2022 has been estimated at €588K (compared to €771K in 2021). NET RESULT In the first half of 2022, 3,299,045 new shares under the convertible bond agreement. The previous contract of July 9, 2019 expired on July 9, 2021, DEINOVE announced that it had entered into a new agreement for a convertible bond financing with the European Select Growth Opportunities Fund, representing a bond issue of a maximum nominal amount of €10 million, and divided into several tranches of a nominal amount of €500,000 for each tranche. The first tranche of €500,000 was issued simultaneously with the signing of the agreement with European Select Growth Opportunities Fund. The 34,378,066 shares with a nominal value of EUR 0.02 making up the capital as of June 30, 2022, are broken down as follows: Year ended June 30, 2022 – non-diluted basis ShareholdersNumber of shares% of holdingVoting rights%Funds managed by Truffle Capital1,765,8675.14%3,462,8649.61%Scientific founders20,0000.06%40,0000.11%Management and Board members00.00%00.00%Free float32,592,19994.81%32,532,44790.28%TOTAL34,378,066100.00%36,035,311100.00% FINANCIAL SITUATION As of June 30, 2022, the Group's net cash position was EUR 1,102K. This level of cash does not include the drawdown of two new tranches of OCA 2021 for a total amount of EUR 750,000 (EUR 727,500 net of fees) on August 30 and September 30, 2022. As indicated in the press release dated August 3, 2022, the drawdown of these two tranches and of the next tranche of a nominal amount of EUR 250,000 on November 30, 2022, subject to compliance with certain conditions, would extend the Company's cash horizon to November 2022. Thus, given the Company's expense structure and cash flow forecasts, the securing of its financial position remains conditional on its ability to find financing solutions. The continuity of its operations depends on this. 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 infection, 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 45 employees and relies on a network of world-class academic, technological, industrial and institutional partners. CONTACTS InvestorsMario AlcarazChief Financial and Administrative Officer +33 (0)4 48 19 01 00ir@deinove.comMediaATCG Partners – Delphine LENS+33 (0)9 81 87 46 72 / +33 (0)6 11 07 14 08communication@deinove.com Attachment 20221006_DEINOVE_PR_Half Year Results

CollaborateFinancial Statement

05 Oct 2022

·www.globenewswire.com

DEINOVE to present data on DNV3837 at the ESCMID/ASM conference in Dublin

New key preclinical results and a case study excerpted from our ongoing phase II clinical trialDNV3681 in vitro efficacy is superior to vancomycin and similar to the gold standard, fidaxomicinThe prodrug DNV3837 is rapidly converted to DNV3681 in vivo and the active drug mostly concentrates in the GI tractThe use of DNV3837 is a potential paradigm shift for CDI treatment 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 a poster titled « DNV3837, a parenteral GI tract-targeted treatment for Clostridioides difficile infection » is to be presented at the ESCMID/ASM conference taking place in Dublin, from October 4 to 7. The new preclinical data presented show that DNV3681 is highly efficient against 333 clinical isolates of Clostridioides difficile, and its efficacy is superior to vancomycin and similar to the gold standard, fidaxomicin. Preclinical and clinical data show that the prodrug DNV3837 is rapidly converted to DNV3681 in vivo and that the active drug mostly concentrates in the GI tract. This unusual pharmacokinetic profile could be explained by a strong efflux of the active drug by the intestinal efflux pumps from the blood to the GI lumen. The patient case presented suffers from a severe Clostridioides difficile infection. His White Blood Cells count, an inflammatory marker, rapidly dropped after inclusion, remained in the upper limit during 8 days and was normal at the end of the treatment. The diarrhea episodes improved after 6 days of treatment and came back to normal 10 days after treatment after a transient constipation period. DNV3681 concentrations in feces were several order of magnitude higher than DNV3681 MIC901. Georges Gaudriault, Chief Scientific Officer of DEINOVE who attended the ESCMID/ASM conference in Dublin specifies: « The use of DNV3837 is a potential paradigm shift. The intestine is a complex organ and CDI is not simply a topical disease of its epithelium. In order to treat efficiently the infection and avoid the persistence and/or recurrence of the infection, it is critical to treat this organ as a whole. DNV3837 is the first parenteral drug targeting the intestine and generating high exposure of DNV3681 in the intestinal tissue, as showcased today. » *** ABOUT CLOSTRIDIOIDES DIFFICILE INFECTIONS (CDI) More than 40% of hospitalized patients with Clostridioides difficile infection (CDI) have been classified as severe disease associated with higher morbidity and mortality2. The Centers for Disease Control and Prevention (CDC) identifies CDI as one of the leading causes of hospital-acquired infections, ahead of even MRSA3 infections. In the United States, it is estimated that CDI causes nearly half a million disease cases each year, and approximately 29,300 deaths4. This condition is not limited to the United States and recent studies5 show that the incidence of this type of infection is greatly underestimated in other parts of the world, such as Europe and Asia. To date, there is no proven therapeutic solution for CDI patients with severe vomiting, ileus and toxic megacolon. The oral route being compromised, the available treatments, which are mostly oral, have difficulty reaching the intestine because of the patient's pathological condition (reduced gastrointestinal motility, intubation, intestinal perforation, etc.), and the few antibiotics that could be administered intravenously do not cross the gastrointestinal barrier and therefore do not reach the infection site. ABOUT THE DNV3837 ANTIBIOTIC CANDIDATE DNV3837 – a prodrug6 of the DNV3681 molecule (also known as MCB3681) – is a narrow-spectrum, hybrid oxazolidinone-quinolone synthetic antibiotic targeting only Gram-positive bacteria. It is developed as a highly active first-line treatment targeting C. diff. It has demonstrated significant activity and superiority to reference treatments against isolates of C. diff., regardless of their virulence (including the hyper virulent BI/NAP1/027 strain). DNV3837 is an intravenous antibiotic that, when converted to its active form DNV3681, crosses the gastrointestinal barrier and accumulates in the intestinal lumen, allowing it to precisely target the infection site. Several Phase I trials (on approximately a hundred healthy volunteers) have shown a high concentration of the antibiotic in stools, a strong marker of its presence in the intestine. It has also demonstrated its ability to eliminate Clostridioides bacteria without affecting the gut microbiota. FDA granted the DNV3837 drug with Qualified Infectious Disease Product (QIDP) designation and Fast Track status. For more information on the DNV3837 Phase II clinical trial in Clostridioides difficile infections, visit ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03988855 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 microbiotechnology 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 around 50 employees and relies on a network of world-class academic, technological, industrial and institutional partners. CONTACTS InvestorsMario AlcarazChief Financial Officer +33 (0)4 48 19 01 00ir@deinove.comMediaATCG Partners – Delphine LENS+33 (0)9 81 87 46 72 / +33 (0)6 11 07 14 08communication@deinove.com 1 MIC : Minimale Inhibitory Concentration. MIC90 is the lowest concentration inhibiting, in 18 to 24 hours, the multiplication of 90 % of clinical isolates. 2 Zar FA et al. Clin Infect Dis. 2007 Aug 01; 45(3):302-7. 3 MRSA: methicillin-resistant staphylococcus aureus 4 Guh AY, Mu Y, Winston LG et al. N Engl J Med 2020;382:1320–30 5 Balsells E, Shi T, Leese C, Lyell I, Burrows J, Wiuff C, Campbell H, Kyaw MH, and Nair H (2019) Global burden of Clostridium difficile infections: a systematic review and meta-analysis. J Glob Health 9:010407 6 Prodrug: substance whose transformation in the body results in an active product Attachment 20221005_DEINOVE_Poster_ESCMID-ASM_ENG_final

Qualified Infectious Disease ProductFast Track

25 Mar 2021

·www.globenewswire.com

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 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: 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: 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 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 Attachment

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Indication	Highest Phase	Country/Location	Organization	Date
Clostridium difficile colitis	Phase 2	US	Deinove SA	02 Aug 2019
Clostridium difficile colitis	Phase 2	CA	Deinove SA	02 Aug 2019
Clostridium difficile infection	Phase 2	US	Deinove SA	02 Aug 2019
Clostridium difficile infection	Phase 2	CA	Deinove SA	02 Aug 2019
Clostridium Infections	Phase 2	-	Evotec SE	-
Clostridium Infections	Phase 2	-	Morphochem AG	-
Bacterial Infections	Phase 1	DE	Deinove SA	13 Feb 2016
Cross Infection	Phase 1	DE	-	-

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