A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

Start Date21 Feb 2023

Sponsor / Collaborator

DBV Technologies SA

NL-OMON56419 / RecruitingPhase 3

EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX) - EPOPEX

Start Date02 Mar 2021

Sponsor / Collaborator-

EUCTR2018-003323-10-GB / Unknown statusPhase 3

EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX) - EPOPEX

Start Date08 Jul 2020

Sponsor / Collaborator-

100 Clinical Results associated with Peanut allergy immunotherapy(DBV Technologies SA)

100 Translational Medicine associated with Peanut allergy immunotherapy(DBV Technologies SA)

100 Patents (Medical) associated with Peanut allergy immunotherapy(DBV Technologies SA)

Literatures (Medical) associated with Peanut allergy immunotherapy(DBV Technologies SA)

01 Jan 2024·Immunotherapy

Epicutaneous immunotherapy with Viaskin^™ Peanut in toddlers: a plain language summary

Review

Author: Siri, Dareen ; Sampson, Hugh A ; Hernandez-Trujillo, Vivian ; Gupta, Ruchi ; Mack, Douglas ; Stukus, David R ; Mandelbaum, Lianne

What is this summary about?:

This is a summary of an article published in The New England Journal of Medicine about the EPITOPE clinical study, which tested a skin patch called ViaskinTM Peanut 250 μg (micrograms) as a treatment option for peanut allergy in children aged 1 through 3 years. The patch is a form of epicutaneous immunotherapy (EPIT), which is a new approach to allergen immunotherapy that delivers a small amount of peanut protein to the immune system through the skin. Viaskin Peanut is an investigational therapy, meaning it has not yet been approved by the United States Food and Drug Administration (FDA), that has been studied before in young children aged 4 through 11 years. In those studies, the children who received the patch were desensitized and were less likely to experience anaphylaxis when they ate peanut at the end of the study. The EPITOPE study included children aged 1 through 3 years with peanut allergy and looked at how well the peanut patch worked and how safe it was compared to a patch with no medicine (placebo, no medicine) after 12 months.

What were the key takeaways?:

The study showed that the peanut patch was better in desensitizing children to peanuts than the placebo patch. Most of the children in the study who received the peanut patch for 12 months (the treatment group) were able to eat and tolerate more peanut at the end of the study than those who received only the placebo patch (the control group). This demonstrates that the children in the treatment group were less likely to have an allergic reaction if they ate peanut by accident at the end of the study. The children in the treatment group also had less severe symptoms when they were given peanut during the oral food challenges at the end of the study. Most children in both groups experienced side effects. Mild to moderate local skin reactions where the patch was applied were most common. These side effects happened less often and were less serious over the 12-month treatment period.

What were the main conclusions reported by the researchers?:

Overall, these results show the peanut patch may be a possible treatment option to help desensitize young children with peanut allergy to peanut.

01 Sep 2023·Allergy

Immune response evolution in peanut epicutaneous immunotherapy for peanut-allergic children.

Article

Author: Greenhawt, Matthew ; Mustafa, S Shahzad ; Bastin, Marie ; Green, Todd D ; Fleischer, David M ; Lieberman, Jay A ; Davis, Carla M ; Carr, Warner W ; Bois, Timothée ; Campbell, Dianne E ; Helleputte, Thibault

BACKGROUND:

Epicutaneous immunotherapy with investigational Viaskin™ Peanut 250 μg (DBV712) has demonstrated statistically superior desensitization versus placebo in peanut-allergic children in clinical trials. It is unclear whether serologic biomarkers predict response.

METHODS:

Serum-specific IgG4 and IgE (whole peanut and components) from subjects enrolled in the phase 3 Efficacy and Safety of Viaskin Peanut in Children With IgE-Mediated Peanut Allergy study were examined by exploratory univariate and multivariate analyses to determine trajectories and predictors of treatment response, based upon peanut protein eliciting dose (ED) at Month (M) 12 double-blind placebo-controlled food challenge.

RESULTS:

Among Viaskin Peanut-treated subjects, peanut sIgG4 significantly increased from baseline through M12 and peanut sIgE peaked at M3 and fell below baseline by M12, with sIgG4 and sIgE peanut components mirroring these trajectories. Placebo subjects had no significant changes. By univariate analysis, M12 peanut sIgG4/sIgE was higher in treatment responders (p < 0.001) and had highest area under the curve (AUC) for predicting ED ≥300 mg and ≥1000 mg (AUC 69.5% and 69.9%, respectively). M12 peanut sIgG4/sIgE >20.1 predicted M12 ED ≥300 mg (80% positive predictive value). The best performing component was Ara h 1 sIgE <15.7 kU_A /L (AUC 66.5%). A multivariate model combining Ara h 1 and peanut sIgG4/sIgE had an AUC of 68.2% (ED ≥300 mg) and 67.8% (ED ≥1000 mg).

CONCLUSIONS:

Peanut sIgG4 rise most clearly differentiated Viaskin Peanut versus placebo subjects. sIgG4/sIgE ratios >20.1 and the combination of Ara h 1 and peanut sIgG4/sIgE had moderate ability to predict treatment response and could potentially be useful for clinical monitoring. Additional data are needed to confirm these relationships.

01 Feb 2023·The journal of allergy and clinical immunology. Global

Efficacy and safety of peanut epicutaneous immunotherapy in patients with atopic comorbidities

Article

Author: Oriel, Roxanne C ; Bee, Katharine J ; Pongracic, Jacqueline A ; Fleischer, David M ; Peillon, Aurélie ; Lange, Lars ; Shreffler, Wayne ; Green, Todd D ; Bégin, Philippe ; Lambert, Romain ; Beyer, Kirsten ; Ford, Lara ; Campbell, Dianne E ; Sussman, Gordon ; Davis, Carla M

Background:

Co-occurring atopic conditions are common in children with peanut allergy. As such, it is important to examine the safety and efficacy of epicutaneous immunotherapy with Viaskin Peanut 250 μg patch (VP250) in peanut-allergic children with these conditions.

Objective:

We sought to compare efficacy and safety of VP250 versus placebo in peanut-allergic children with/without ongoing atopic conditions at baseline, including asthma, atopic dermatitis/eczema, or concomitant food allergy.

Methods:

A subgroup analysis of peanut-allergic children aged 4 to 11 years enrolled in PEPITES (12 months) and REALISE (6 months) randomized, placebo-controlled, phase 3 trials was conducted. The efficacy outcome measure was the difference in prespecified responder rate between placebo and VP250 groups at month 12 based on eliciting dose of peanut protein using double-blind, placebo-controlled food challenge in PEPITES. Safety profiles were evaluated by baseline concomitant disease subgroup in all randomized subjects who received 1 or more dose of the study drug in PEPITES and REALISE pooled data.

Results:

Responder rates were significantly (P < .05, all comparisons) greater with VP250 compared with placebo treatment regardless of whether subjects had other atopic conditions. Safety and tolerability profiles were generally similar across subgroups, with no new safety concerns detected. A trend for both higher responder rates and rates of local reactions was observed in subjects with baseline atopic dermatitis versus those without. In subjects with concomitant food allergy at baseline, higher rates of treatment-emergent adverse events, but not study discontinuations or overall rates of anaphylaxis, were observed.

Conclusions:

The results support the safety and efficacy of VP250 for treating peanut-allergic children with or without concomitant atopic conditions.

News (Medical) associated with Peanut allergy immunotherapy(DBV Technologies SA)

31 May 2024

·www.globenewswire.com

DBV Technologies Announces Plan to Implement ADS Ratio Change

Châtillon, France, May 31, 2024 DBV Technologies Announces Plan to Implement ADS Ratio Change DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT—CUSIP: 23306J101), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, previously announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to one-half (1/2) of one (1) ordinary share to a new ADS Ratio of one (1) ADS to one (1) ordinary share (the “ADS Ratio Change”) to be effective on or about June 3rd, 2024. The Company now anticipates that the ADS Ratio Change will be effective on or about June 7th, 2024 (the “Effective Date”). For the Company’s ADS holders, the change in the ADS Ratio will have the same effect as a one-for-two reverse ADS split and is intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. On the Effective Date, registered holders of company ADSs held in certificated form will be required on a mandatory basis to surrender their certificated ADSs to the depositary bank for cancellation and will receive one (1) new ADS in exchange for every two existing ADSs surrendered. Holders of uncertificated ADSs in the Direct Registration System (“DRS”) and in The Depository Trust Company (“DTC”) will have their ADSs automatically exchanged and need not take any action. The exchange of every two existing ADSs then-held for one (1) new ADS will occur automatically, at the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by the depositary bank. DBV’s ADSs will continue to be traded on the Nasdaq Stock Market under the ticker symbol “DBVT”. No fractional new ADSs will be issued in connection with the change in the ADS Ratio. Instead, fractional entitlements to new ADSs will be aggregated and sold by the depositary bank and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) will be distributed to the applicable ADS holders by the depositary bank. The ADS Ratio Change will have no impact on DBV’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS Ratio Change. As a result of the change in the ADS Ratio, DBV’s ADS trading price is expected to increase proportionally, although the Company can give no assurance that the ADS trading price after the ADS Ratio Change will be equal to or greater than twice the ADS trading price before the change. About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin™, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT, CUSIP: 23306J101). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including the expected impact of the ADS Ratio Change on DBV’s trading price and ability to maintain compliance with the Nasdaq minimum bid price requirement. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactAngela MarcucciDBV Technologiesangela.marcucci@dbv-technologies.com Viaskin and EPIT are trademarks of DBV Technologies. Attachment PDF Version

Immunotherapy

30 May 2024

·www.globenewswire.com

DBV Technologies to Participate in Upcoming EAACI 2024 Congress

Châtillon, France, May 30, 2024 DBV Technologies to Participate in Upcoming EAACI 2024 Congress DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today announced its upcoming participation in the European Academy of Allergy and Clinical Immunology (EAACI) Congress May 31 – June 3 in Valencia, Spain. A flash talk presentation by Nicolette Arends, M.D., Erasmus University Rotterdam will describe data collected on accidental peanut consumption from DBV’s EPITOPE Phase 3 study and its ongoing open-label extension study in peanut-allergic toddlers aged 1 through 3 years. DBV will also host a symposium and exhibit booth in the EAACI exhibit hall. “We are deeply committed to establishing long-term safety and clinical data of Viaskin Peanut in the pediatric population, which includes examining reactions that occur during accidental consumption,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “While avoidance is the first line of defense, the reality is an accidental exposure is likely, necessitating approved treatment options that can help provide protection.” “We track accidental peanut consumption in our clinical studies to better understand how epicutaneous immunotherapy with Viaskin Peanut may help reduce the risk of an allergic reaction over time,” said Pharis Mohideen, M.D. Chief Medical Officer at DBV Technologies. “Analyzing accidental peanut consumption exposure better characterizes the real-world clinical benefit that Viaskin Peanut may provide if approved.” DBV’s symposium, “Epicutaneous Route: An Innovative Potential Approach to Food Immunotherapy”, will be moderated by Stefania Arasi, M.D., Ph.D., MSc., Pediatric Allergist and Researcher at Paediatric Allergy Unit, Bambino Gesù Children Research Hospital, Rome, Italy and current EAACI Pediatric Section Chair and Philippe Eigenmann, M.D., Pediatric Allergist and Head of Pediatric Allergy Unit at the Geneva University Hospital, Geneva, Switzerland. It will include lectures by Luciana Tanno, M.D., Ph.D. Allergist, Division of Allergy, University Hospital of Montpellier, Montpellier, France on potential clinical applications of the epicutaneous route, and Pablo Rodríguez del Río, M.D., Ph.D., Allergist Hospital Infantil Universitario Niño Jesús, Department of Allergy, Madrid, Spain, on most recent results and perspectives of the epicutaneous route in peanut allergy, respectively. DBV will host a booth (F10) in the exhibit hall where attendees can learn more about epicutaneous immunotherapy with Viaskin, including our ongoing clinical trials in peanut-allergic children. Flash Talk Presentation Details “Reactions Due to Accidental Peanut Consumption During Epicutaneous Immunotherapy for Peanut Allergy in Toddlers” presented by Nicolette Arends, M.D. Researcher, Pediatrics Erasmus University Medical Center, Rotterdam, Netherlands Session title: Flash Talks on PediatricsSession number: FT 15Session date: Sunday, June 2, 2024Session time: 8:30 a.m. – 10:30 a.m. CET A voice-recording of the onsite flash talk presentation will be made available on the congress platform. A copy of the poster will be made available after the presentation on the Scientific Publications & Presentations page on the Our Science section of the Company’s website www.dbv-technologies.com. Symposium “Epicutaneous route: An innovative potential approach to food immunotherapy” will be moderated by Stefania Arasi and Philippe Eigenmann Date and location: Saturday, June 1, 12:00 – 1:00 p.m. CEST, Malaga RoomLectures: Introduction- Dr. Stefania ArasiThe epicutaneous route: from the concept to potential clinical applications- Dr. Luciana Tanno The epicutaneous immunotherapy for peanut allergy: most recent results and perspectives- Dr. Pablo Rodríguez del RíoConclusion- Dr. Philippe Eigenmann About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin™, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Stock Market (Ticker: DBVT). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including, but not limited to, statements regarding the therapeutic potential of Viaskin™ Peanut and EPIT™ and DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin and EPIT are trademarks of DBV Technologies. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactAngela MarcucciDBV Technologiesangela.marucci@dbv-technologies.com Attachment PDF Version

ImmunotherapyPhase 3

17 May 2024

·www.globenewswire.com

DBV Technologies Announces Plan to Implement ADS Ratio Change

Châtillon, France, May 17, 2024 DBV Technologies Announces Plan to Implement ADS Ratio Change DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT—CUSIP: 23306J101), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to one-half (1/2) of one (1) ordinary share to a new ADS Ratio of one (1) ADS to one (1) ordinary share (the “ADS Ratio Change”). The Company anticipates that the ADS Ratio Change will be effective on or about June 3rd, 2024 (the “Effective Date”). For the Company’s ADS holders, the change in the ADS Ratio will have the same effect as a one-for-two reverse ADS split and is intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. On the Effective Date, registered holders of company ADSs held in certificated form will be required on a mandatory basis to surrender their certificated ADSs to the depositary bank for cancellation and will receive one (1) new ADS in exchange for every two existing ADSs surrendered. Holders of uncertificated ADSs in the Direct Registration System (“DRS”) and in The Depository Trust Company (“DTC”) will have their ADSs automatically exchanged and need not take any action. The exchange of every two existing ADSs then-held for one (1) new ADS will occur automatically, at the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by the depositary bank. DBV’s ADSs will continue to be traded on the Nasdaq Stock Market under the ticker symbol “DBVT”. No fractional new ADSs will be issued in connection with the change in the ADS Ratio. Instead, fractional entitlements to new ADSs will be aggregated and sold by the depositary bank and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) will be distributed to the applicable ADS holders by the depositary bank. The ADS Ratio Change will have no impact on DBV’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS Ratio Change. As a result of the change in the ADS Ratio, DBV’s ADS trading price is expected to increase proportionally, although the Company can give no assurance that the ADS trading price after the ADS Ratio Change will be equal to or greater than twice the ADS trading price before the change. About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin™, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Stock Market (Ticker: DBVT, CUSIP: 23306J101). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including the expected impact of the ADS Ratio Change on DBV’s trading price and ability to maintain compliance with the Nasdaq minimum bid price requirement. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin and EPIT are trademarks of DBV Technologies. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactAurora KrauseDBV Technologiesaurora.krause-ext@dbv-technologies.com Attachment PDF Version

Immunotherapy

100 Deals associated with Peanut allergy immunotherapy(DBV Technologies SA)

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Indication	Highest Phase	Country/Location	Organization	Date
Peanut Hypersensitivity	NDA/BLA	EU	DBV Technologies SA	06 Nov 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01955109 (CTgov)	Phase 2	Peanut Hypersensitivity	171	Viaskin Peanut (VIPES Initial Treatment Group: All Viaskin Peanut Doses)	qlboosauan(zvhjmdwizi) = ccmxyqiyoh rljbktpxuc (ydvynyqsjw, gcujnzcwpx - oukdodplur) View more	-	30 Jun 2022
				Placebo (VIPES Initial Treatment Group: Placebo)	qlboosauan(zvhjmdwizi) = evaovafrip rljbktpxuc (ydvynyqsjw, kafmduzzrf - qvmqfshnyv) View more
NCT03211247 (EPITOPE, GlobeNewswire) Manual	Phase 3	Peanut Hypersensitivity	362	Peanut allergy immunotherapy	nqcpnmnmnd(bdnelyhjxj) = kuprjovmiz blhlhoqiyc (ujgvblmgyh ) View more	Positive	07 Jun 2022
				Placebo	nqcpnmnmnd(bdnelyhjxj) = lssljxgvku blhlhoqiyc (ujgvblmgyh ) View more
NCT01675882 (CTgov)	Phase 2	Peanut Hypersensitivity	221	Viaskin Peanut (Viaskin Peanut 50 μg)	zrkpykkkpu(yhnwuanqmn) = lubkyfderx odqcyksorp (broslbqeog, ahkhxtjdrv - rrhumnlsbg) View more	-	27 Oct 2021
				Viaskin Peanut (Viaskin Peanut 100 μg)	zrkpykkkpu(yhnwuanqmn) = hwfnzcjctr odqcyksorp (broslbqeog, yofmdvzjaw - dwwawyldqr) View more
NCT02636699 (CTgov)	Phase 3	Peanut Hypersensitivity	356	Placebo	nxcdcaipgd(mzgreacwrv) = lszebqetsu tkeyiieefo (xlvgaiqzcb, letpgbeprs - ntityuhndx) View more	-	15 Oct 2021
NCT01904604 (DAIT CoFAR6, CTgov)	Phase 2	Peanut Hypersensitivity	75	Placebo Viaskin® Patch (Placebo Patch)	vprkljrgcc(itsjgbbnuq) = qydomcxdnu laczqouvpg (npmrjmlcde, tohyifokxo - ojqrvmmgwm) View more	-	26 Aug 2016
				Low-dose DBV712 Viaskin® Patch (100 µg Peanut Patch)	vprkljrgcc(itsjgbbnuq) = uvvmhmmtts laczqouvpg (npmrjmlcde, vsjznlcras - znfsxqqfzh) View more

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