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]

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 - 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]

Market Overview - US stock index futures showed slight fluctuations with the Dow futures up 0.23%, S&P 500 futures up 0.34%, and Nasdaq futures up 0.44% [3][21] - European benchmark indices rose by 0.3%, with the energy sector leading gains due to Trump's order to block oil tankers entering Venezuela, boosting oil prices [3][21] - The latest UK inflation data hit an eight-month low, causing the pound to drop by 0.7%, while the FTSE 100 index rose nearly 1% [3][21] Employment Data Impact - The US labor market showed signs of cooling, with November adding 64,000 jobs, exceeding economists' expectations, but the unemployment rate rose to 4.6% [4][20] - The government shutdown lasting 43 days distorted the employment data, leading to uncertainty about its impact on future Federal Reserve policy [4][20] - Analysts suggest that cleaner data in the first quarter is needed to assess the pace of economic deterioration, indicating that March or April may be cautious benchmarks for potential rate cuts [22] Central Bank Decisions - The dollar strengthened against all G10 currencies, with the largest gain against the yen, while the 10-year US Treasury yield remained stable at 4.15% [5][22] - Multiple central banks are expected to announce policy decisions before the end of the year, with the Bank of England likely to decide on a rate cut and the Bank of Japan expected to raise rates to a 30-year high [23] Geopolitical Risks and Commodity Prices - Trump's administration threatened retaliation against the EU's proposed taxes on US tech companies, targeting firms like Accenture, Siemens, and Spotify [25] - The geopolitical tensions have driven up oil prices and gold prices, with gold surpassing $4,330, nearing its historical high of $4,381 from October [25] - Silver prices reached a historical high above $66 per ounce, and platinum hit its highest level since 2008 [25] Market Sentiment and Volatility - Investors are awaiting the upcoming CPI report with a sense of indifference, contrasting with previous anxieties, as options traders expect the S&P 500 index to fluctuate by only 0.7% [26] - This represents a significant decrease from the average actual volatility of 1% observed in reports leading up to September [26] Company-Specific Developments - AI financing concerns are deemed exaggerated, with Goldman Sachs estimating that $700 billion to $1 trillion in capital expenditures will be needed, primarily funded by operational cash flow [27] - Companies in the cannabis sector, such as CbdMD and Canopy Growth, saw pre-market gains following Trump's executive order to ease cannabis regulations [27] - Oil and gas stocks also rose, with BP up over 2% and other major oil companies following suit due to the blockade of Venezuelan oil tankers [27] - Micron Technology gained over 3% in pre-market trading after being included in Morgan Stanley's list of top chip investment picks for the upcoming year [28]

Core Insights - DBV Technologies S.A. has released positive data from the VITESSE Phase 3 study for the VIASKIN Peanut patch, targeting peanut-allergic children aged 4 to 7 years [1][2] Trial Data - The pivotal trial met its primary endpoint, showing a statistically significant treatment effect with 46.6% of children in the VIASKIN Peanut arm meeting treatment responder criteria after 12 months, compared to 14.8% in the placebo arm [2] - Responders were defined as children who increased their eliciting dose (ED) of peanut protein significantly after 12 months, indicating a successful treatment response [3] Study Enrollment and Safety - The VITESSE study enrolled 654 children, surpassing the initial target of 600, with 438 in the active arm and 216 in the placebo arm [4] - Safety results were consistent with previous studies, with mild-to-moderate local skin reactions being the most common treatment-emergent adverse events (TEAEs) [4] - Discontinuation due to TEAEs was low at 3.2% in the treatment arm versus 0.5% in the placebo arm, with no serious treatment-related adverse events reported [5] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) in the United States in the first half of 2026 [6] - Following the trial data release, DBV Technologies shares increased by 35.76% to $24.41, reaching a new 52-week high [6]

④ 【华纳据称本周将拒绝派拉蒙收购要约】12月16日，据媒体援引知情人士透露，华纳兄弟探索（简称华纳）计划拒绝派拉蒙天舞上周提出的收购要 约，主要原因是对派拉蒙天舞的融资安排和其他交易条款存在担忧。华纳董事会经过审议后认为，公司与奈飞的现有协议在价值、确定性和条款方面都优 于派拉蒙天舞的提案。截至发稿，奈飞上涨1.83%。 每经记者｜岳楚鹏 每经编辑｜段炼 兰素英 ① 【三大期指齐涨】截至发稿，道指期货涨0.19%、标普500指数期货涨0.30%、纳指期货涨0.34%。 ② 【纳斯达克将迎来年内全球最大IPO】美东时间12月17日晚，纳斯达克交易所将迎来全球今年最大IPO Medline，股票代码"MDLN"。该IPO发行规模经 上调后，最终定价锁定在推介区间高位。具体来看，该公司将以每股29美元发行2.16亿股股票，拟融资约62.6亿美元，定价对应的公司估值约为390亿美 元。Medline现有股东涵盖黑石集团、凯雷集团及弗里德曼（Hellman & Friedman）三大私募巨头。早在2021年，这三家机构就以340亿美元联合收购 Medline多数股权，成为史上规模最大的杠杆收购之一。Medline由米 ...

DBV Technologies盘前大涨超30%。消息上，DBV Technologies宣布了VIASKIN花生贴片在4-7岁花生过 敏儿童中的3期VITESSE试验取得了积极的初步结果，达到了其主要终点。针对4-7岁儿童的BLA提交按 计划将在2026年上半年进行。 本文源自：格隆汇 ...

Core Insights - DBV Technologies announced positive top line results from its Phase III VITESSE clinical trial of the VIASKIN Peanut patch for children aged 4 to 7 years old [1] Group 1: Clinical Trial Results - The Phase III VITESSE clinical trial demonstrated positive outcomes for the VIASKIN Peanut patch [1] Group 2: Forward-Looking Statements - The company may discuss the therapeutic potential of VIASKIN Peanut and its clinical and regulatory development plans [2] - Anticipated interactions with regulatory agencies and plans for the submission of Biologics License Applications (BLAs) to the FDA are highlighted [2] - Expectations regarding the BLA's potential eligibility for priority review and support for the submission are mentioned [2]