Summary of DBV Technologies Conference Call Company Overview - **Company**: DBV Technologies (NasdaqCM:DBVT) - **Focus**: Immunology, specifically food allergies in children - **Lead Product**: Viaskin Peanut, aimed at treating peanut allergies in children aged 1-7 Key Points Product Development and Regulatory Filings - **BLA Filings**: Two Biologics License Applications (BLAs) are planned for 2026: - **Children aged 4-7**: Expected filing by mid-2026 - **Children aged 1-3**: Expected filing by the end of 2026 - **FDA Designation**: The product has received breakthrough designation from the FDA and will seek priority review for the first filing [1][2][3] Market Opportunity - **Prevalence of Food Allergies**: Approximately 670,000 children in the U.S. have diagnosed peanut allergies: - 390,000 children aged 4-7 - 280,000 children aged 1-3 - **Response Rates**: In the 1-3 age group, the response rate was 67% for active treatment compared to 33.5% for placebo, with a 22.4% delta [24][25] Clinical Trial Insights - **VITESSE Trial**: The largest trial for peanut allergy with 654 patients, showing a placebo-adjusted efficacy of 32 points [13][14] - **Long-term Benefits**: Open-label extensions indicate improved efficacy and safety over time, with 68% of children in the 1-3 age group able to consume significant amounts of peanuts without anaphylaxis after three years of treatment [25][26] Competitive Landscape - **Comparison with IgE Blockade**: DBV Technologies focuses on desensitization, which is seen as disease-modifying, while IgE blockade is viewed as a temporary solution [5][7][58] - **Palforzia Comparison**: DBV believes Viaskin Peanut is superior due to its ease of use and lower risk of anaphylaxis compared to Palforzia, which requires frequent physician visits and has a higher rate of anaphylaxis during treatment [63][64] Commercial Strategy - **Target Audience**: Approximately 4,500 allergists and immunologists in the U.S. will be targeted for prescribing [43] - **Sales Force**: Estimated need for 50-70 sales representatives to reach the target audience effectively [46] - **Pricing Strategy**: While no final price has been set, Palforzia's pricing at around $1,000 per month is considered a reference point [47][48] Future Directions - **Expansion Plans**: After the approval of Viaskin Peanut, the company plans to pursue other allergies, with cow's milk allergy as the next target [82] - **Manufacturing Capacity**: Current manufacturing is sufficient for initial launch, but plans to triple capacity in the coming years are in place [83] Financial Position - **Funding**: As of Q3, the company has $320 million, which is deemed sufficient to support the launch in 2027 and necessary investments [88][91] Additional Insights - **Engagement with Families**: The company emphasizes the importance of communication with families and patient advocacy groups, as parents of children with food allergies are highly engaged [46] - **Safety Profile**: The Viaskin Peanut patch has shown no severe adverse events in clinical studies, which may lead to a cleaner label compared to other treatments [74][75] This summary encapsulates the critical aspects of DBV Technologies' conference call, highlighting the company's strategic direction, product development, market potential, and competitive positioning in the food allergy treatment landscape.

Core Insights - DBV Technologies will present additional data from the VITESSE Phase 3 study of the VIASKIN® Peanut Patch for children aged 4-7 at the AAAAI 2026 Annual Meeting in Philadelphia from February 27 to March 2, 2026 [1] - The company will host a product theater featuring allergists discussing the potential of epicutaneous immunotherapy (EPIT) in food allergy treatment and the impact of early intervention [2] Company Overview - DBV Technologies is a late-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions with significant unmet medical needs [4] - The company is investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which can cause severe reactions including anaphylaxis [4] - The VIASKIN® patch aims to introduce microgram amounts of biologically active compounds to the immune system through intact skin, representing a non-invasive treatment approach [4] Event Details - The oral abstract presentation titled "VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children 4 Through 7 Years of Age" will take place on February 28, 2026 [3][6] - The product theater session titled "Epicutaneous Immunotherapy (EPIT): Shaping the Future of Pediatric Food Allergy Treatment" will also occur on February 28, 2026 [3][6] - DBV will exhibit at booth 1527 at the AAAAI exhibit hall to provide more information about epicutaneous immunotherapy and the VIASKIN® Peanut Patch [3]

Core Insights - DBV Technologies, a late-stage biopharmaceutical company, will participate in the Guggenheim Securities Emerging Outlook: Biotech Summit on February 11-12, 2026, with CEO Daniel Tassé scheduled to present on February 12 at 2:30 PM ET [1] Company Overview - DBV Technologies is focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN® patch technology [3] - The company aims to address food allergies through epicutaneous immunotherapy (EPIT), which introduces microgram amounts of biologically active compounds to the immune system via intact skin [3] - DBV's food allergy programs include ongoing clinical trials of VIASKIN® Peanut for peanut allergic toddlers (1-3 years) and children (4-7 years) [3] Operations and Trading - DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ [4] - The company's ordinary shares are traded on segment B of Euronext Paris and its American Depositary Shares (ADSs) are traded on the Nasdaq Capital Market [4]

Core Viewpoint - DBV Technologies has successfully raised €166.7 million through the full exercise of ABSA and BS Warrants, which will support the launch of the VIASKIN® Peanut patch for children aged 4 to 7 years in the U.S., pending approval [1][11]. Financing Details - The financing involved the issuance of 34,090,004 ABSA Warrants and 71,005,656 BS Warrants, leading to the issuance of 59,657,507 new ordinary shares and up to 124,259,898 pre-funded warrants [1][5]. - The exercise price for the ABSA Warrants was €1.5939, while the BS Warrants had an exercise price of €1.5764 [1][6]. Use of Proceeds - The gross proceeds from the exercise will be utilized for working capital, general corporate purposes, and to finance the preparation and submission of a potential Biologics License Application (BLA) for the VIASKIN® Peanut patch [10][11]. - The total financing, including potential exercises of outstanding warrants, is estimated to reach approximately €284.5 million [10]. Shareholder Impact - The issuance of new shares will dilute existing shareholders' equity, with ownership interest for a shareholder holding 1.00% of the Company's share capital decreasing to 0.78% on a non-diluted basis after the issuance [15]. - The shareholding structure will change post-issuance, with Baker Brothers Investments retaining 8.64% and Janus Henderson acquiring 7.54% of the diluted share capital [17]. Company Overview - DBV Technologies is a late-stage biopharmaceutical company focused on developing treatments for food allergies using its proprietary VIASKIN® patch technology [19]. - The company is headquartered in Châtillon, France, with operations in North America [20].

Group 1 - The document provides updated information regarding the total number of voting rights and shares of the company as of December 31, 2025, replacing previous information published on January 5, 2026 [1] - The total number of shares as of December 31, 2025, is 235,670,864, which is also the total number of voting rights [2] - The net total of voting rights, which excludes shares without voting rights, is 235,596,284 [2]

Core Points - The total number of shares of the company as of December 31, 2025, is 232,207,589 [1] - The total gross of voting rights is also 232,207,589 as of the same date [1] - The total net of voting rights, which accounts for shares without voting rights, is 232,133,009 [1]

Group 1: Palvella Therapeutics Inc. (PVLA) - Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases with no FDA-approved treatments [2] - Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and has a multi-billion-dollar market opportunity if approved [2] - The stock rose from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, before pulling back to $99.88 [3] Group 2: Cidara Therapeutics Inc. (CDTX) - Cidara is developing a preventive therapy for influenza and has agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion [4] - The stock was trading at $18.98 when profiled on November 21, 2024 [4] Group 3: Celcuity Inc. (CELC) - Celcuity is focused on targeted therapies for oncology, with its lead drug candidate Gedatolisib aimed at breast and prostate cancers [5] - The stock increased from $12.60 on December 4, 2024, to an all-time high of $112.64 on December 12, 2025, before retreating to $99.16 [6] Group 4: Nanobiotix (NBTX) - Nanobiotix is a late-stage clinical biotechnology company developing physics-based therapies for cancer [7] - Its lead candidate, NBTXR3, is undergoing a phase III study for head and neck squamous cell carcinoma, with interim data expected in the first half of 2027 [8] - The stock rose from $12.23 on September 19, 2025, to a high of $30.35 on October 13, 2025, before trading around $21 [10] Group 5: Terns Pharmaceuticals Inc. (TERN) - Terns Pharma is developing small-molecule candidates for serious diseases, with TERN-701 targeting chronic myeloid leukemia [12] - Recent data showed a 75% major molecular response rate among patients receiving higher doses [13] - The stock increased from $5.98 on August 6, 2025, to an all-time high of $48.26 on December 10, 2025, before pulling back to around $40 [14] Group 6: DBV Technologies S.A. (DBVT) - DBV Technologies is developing an epicutaneous immunotherapy for food allergies, with its lead product, the VIASKIN Peanut patch, showing positive results in a phase 3 study [15] - The company aims to submit a Biologics License Application in the first half of 2026, with potential sales of $1.5 billion by 2030 if approved [15] - The stock rose from $10.64 on October 2, 2025, to a high of $26.18 on December 17, 2025, before trading around $19 [16] Group 7: Nutex Health Inc. (NUTX) - Nutex Health reported a significant turnaround from a $424 million net loss in 2022 to a $59 million net income for the nine months ended September 30, 2025 [17] - Revenue increased from $219 million in 2022 to $723.6 million in the first nine months of 2025 [17] - The stock rose from $33.56 on November 25, 2024, to a 52-week high of $193.07 before closing at $182.23 [18] Group 8: Inhibrx Biosciences Inc. (INBX) - Inhibrx is developing biologic therapies for cancer, with Ozekibart showing significant improvement in progression-free survival in chondrosarcoma [19] - The company plans to submit a biologics license application for Ozekibart in the second quarter of 2026 [20] - The stock rose from $18.35 on July 8, 2025, to an all-time high of $94.57 on December 22, 2025, before trading around $77 [21] Group 9: GRAIL Inc. (GRAL) - GRAIL focuses on early cancer detection with its Galleri test, which is not yet FDA-approved [23] - The company expects to submit a PMA for the Galleri test in Q1 2026 [23] - The stock increased from $48.50 on September 26, 2025, to a high of $115.76 on November 25, 2025, before trading around $88 [24] Group 10: Cogent Biosciences Inc. (COGT) - Cogent is developing precision therapies for genetically defined diseases, with Bezuclastinib being its lead candidate [25] - The company submitted its first NDA to the FDA for Non-AdvSM, with additional submissions planned for GIST and advanced systemic mastocytosis [26] - The stock rose from $7.25 on July 2, 2025, to a 52-week high of $43.73 on December 8, 2025, before easing back to around $35 [26] Group 11: Sol-Gel Technologies Ltd. (SLGL) - Sol-Gel has two FDA-approved products for dermatological conditions and is developing investigational products [27] - A phase III trial for SGT-610 is ongoing, with results expected in Q4 2026 [28] - The stock rose from $7.26 on May 7, 2025, to a high of $52.26 on October 6, 2025, before trading around $43 [28] Group 12: Zenas BioPharma Inc. (ZBIO) - Zenas is focused on therapies for autoimmune diseases, with Obexelimab in phase 3 trials for IgG4-RD [29] - Positive data from a phase 2 trial in multiple sclerosis showed a 95% reduction in new lesions [30] - The stock rose from $8.79 on December 17, 2024, to a high of $44.60 on December 24, 2025, before pulling back to around $35 [31]

Group 1 - U.S. stock futures were mostly flat, with Nasdaq 100 futures slipping around 0.01% [1] - Sidus Space, Inc. announced a public offering of 19,230,800 shares at $1.30 per share, leading to a 39.2% decline in its shares to $1.39 in pre-market trading [1] Group 2 - Starfighters Space Inc shares dipped 23.2% to $24.19 after a significant gain of over 370% on Monday [2] - ECD Automotive Design, Inc. fell 15.4% to $0.1650 following a 1-for-5 reverse stock split announcement [2] - CapsoVision Inc dipped 5.6% to $12.35, while Rocket Lab Corp fell 5.3% to $73.46 after a previous 10% jump [2] - Intuitive Machines Inc declined 5.2% to $15.82 despite a price target increase from $14 to $20 by B. Riley Securities [2] - Firefly Aerospace Inc shares declined 4.4% to $27.33 after a 16% increase due to joining the Russell 2000 and Russell 3000 indexes [2] - AST SpaceMobile Inc shares declined 3.1% to $83.82 after a 14% surge related to new satellite details [2]

Group 1 - Clearwater Analytics Holdings, Inc. is being acquired by a consortium of private equity firms led by Permira and Warburg Pincus for approximately $8.4 billion, including debt [1] - Following the acquisition announcement, Clearwater Analytics shares increased by 7.6% to $23.93 in pre-market trading [1] Group 2 - Autozi Internet Technology (Global) Ltd. experienced a significant surge of 60% to $4.00 in pre-market trading after confirming a $90 million initial equity investment [4] - Datavault AI Inc. saw a rise of 34.8% to $1.31 in pre-market trading due to the announcement of two foundational U.S. patents related to blockchain-driven content licensing [4] - Vision Marine Technologies Inc. rose by 30.3% to $0.3270 after closing a public offering [4] - Sidus Space, Inc. increased by 20.7% to $1.40 after a previous jump of 35% [4] - Hycroft Mining Holding Corporation gained 14.2% to $18.77 after a 7% increase on the previous trading day [4] - Creative Media & Community Trust Corporation shares jumped 13.2% to $3.61 after a 7% gain on Friday [4] - ABIVAX Société Anonyme gained 10.2% to $126.64 in pre-market trading [4] Group 3 - Luminar Technologies, Inc. fell sharply by 54.8% to $0.2728 after announcing voluntary Chapter 11 proceedings [4] - Mint Incorporation Limited declined by 14.4% to $0.41 after a significant increase of over 75% on Friday [4] - Culp, Inc. reported mixed second-quarter financial results, leading to a 10.1% drop to $3.11 in pre-market trading [4] - Rising Dragon Acquisition Corp. declined by 9.5% to $9.42 following a trust amendment announcement [4] - Hyperscale Data, Inc. fell by 9.2% to $0.2335 after announcing an "at-the-market" offering of common stock [4]

Core Insights - DBV Technologies S.A. (NASDAQ:DBVT) is recognized as one of the 12 best multibagger stocks to consider for investment heading into 2026 due to strong one-year returns and upside potential [1] Group 1: Trial Results and Impact - The pivotal VITESSE study for DBV Technologies met its primary endpoint, showing that after 12 months of treatment with the VIASKIN Peanut patch, 46.6% of children achieved clinically meaningful desensitization compared to 14.8% on placebo, indicating a statistically significant outcome [3] - The trial also demonstrated a favorable safety profile, high compliance, and low discontinuation rates, reinforcing the patch's potential as a non-invasive treatment option for peanut allergies [3] Group 2: Analyst Ratings and Price Targets - H.C. Wainwright raised its price target on DBV Technologies from $35 to $40 while maintaining a "Buy" rating, citing the Phase 3 VITESSE trial as a significant milestone that reduces risks associated with the VIASKIN Peanut program [2] - Citizens also increased its price target from $21 to $45, maintaining an "Outperform" rating, and noted that the success of the VITESSE trial could unlock $181 million in cash, potentially supporting a U.S. launch for the product in the pediatric population [4] Group 3: Company Focus and Market Position - DBV Technologies specializes in developing non-invasive immunotherapies, particularly through its VIASKIN patch technology, which aims to desensitize patients with food allergies, addressing significant unmet needs in pediatric care [5] - The convergence of clinical success and financial flexibility positions DBV Technologies favorably as it approaches regulatory submission for its products [5]