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DBV Technologies S.A. develops treatment options for food allergies and other immunologic conditions as a late-stage biopharmaceutical company. Company updates center on the proprietary VIASKIN® patch technology, epicutaneous immunotherapy, and the VIASKIN Peanut program for peanut-allergic toddlers and children.
Recurring developments include clinical data from the Phase 3 VITESSE study, annual and quarterly financial results, financing and warrant-related capital actions, leadership and governance changes, share and voting-rights disclosures under French market rules, and market information tied to DBVT American Depositary Shares.
DBV Technologies has outlined its regulatory path for the Viaskin Peanut 250 μg patch, targeting toddlers aged 1-3 years with peanut allergies, after receiving feedback from the FDA. The FDA confirmed that the Phase 3 EPITOPE study achieved its primary endpoint without requiring an additional efficacy study. However, a new safety study is mandated to augment existing data, aiming for a database of around 600 patients. As of March 31, 2023, the company reported cash equivalents of $192.3 million, a decrease from $209.2 million at year-end 2022. DBV is committed to developing treatment options for young children with peanut allergies, and it plans to submit a proposed protocol for the safety study to the FDA by the end of Q2 2023.
DBV Technologies, a clinical-stage biopharmaceutical company, held its 2023 Ordinary and Extraordinary General Meeting on April 12, 2023, chaired by Michel de Rosen. Shareholders approved all resolutions proposed by the Board of Directors. These resolutions reflect the company's ongoing commitment to advancing its innovative Viaskin™ platform, which focuses on epicutaneous immunotherapy for food allergies. DBV Technologies is actively conducting clinical trials for Viaskin Peanut, aimed at improving the treatment landscape for food allergic patients. The company operates globally from Montrouge, France, and Basking Ridge, NJ, with shares traded on Euronext Paris (DBV) and Nasdaq (DBVT).
DBV Technologies will hold its Ordinary and Extraordinary General Meeting on April 12, 2023, at 10:00 a.m. CET in Montrouge, France. The meeting's agenda and draft resolutions were published in the French legal bulletin on March 8 and March 24, 2023. Shareholders can access preparatory documents via the Company's website and can request to receive these documents by post or electronically until April 7, 2023. The General Meeting will be webcast live, with a replay available for two years. DBV Technologies is focused on developing the Viaskin™ platform for immunotherapy targeting food allergies, with ongoing clinical trials for Viaskin Peanut.
DBV Technologies has announced that it does not hold cash deposits or securities at Silicon Valley Bank. This update is crucial for investors, as it mitigates potential concerns about liquidity related to the recent turmoil affecting the bank. The company is focused on developing Viaskin, an innovative platform for treating food allergies through epicutaneous immunotherapy. DBV Technologies is currently conducting clinical trials for Viaskin Peanut, aimed at children with peanut allergies. The company is based in Montrouge, France, and its shares are listed on Euronext Paris (DBV) and Nasdaq (DBVT).
DBV Technologies announced the screening of the first patient in the VITESSE Phase 3 clinical trial aimed at evaluating the modified Viaskin Peanut patch for peanut-allergic children aged 4 to 7 years. The trial, conducted at approximately 80 sites across the US, Canada, Australia, and Europe, will enroll 600 subjects, randomizing them 2:1 between active and placebo groups. The primary endpoint assesses treatment responders at Month 12.
Positive interactions with the FDA have supported the trial's protocol, paving the way for a potential Biologics License Application. Screening is expected to conclude in the first half of 2024, with topline results anticipated in early 2025.
DBV Technologies has filed its 2022 Annual Report on Form 10-K with the SEC and the 2022 Universal Registration Document with the AMF. These documents can be accessed via the company's website and respective regulatory authorities. DBV is focused on developing Viaskin™, an innovative technology for immunotherapy, particularly for food allergies. The company emphasizes its commitment to transforming care for food allergic patients through its unique epicutaneous immunotherapy method. Both reports are also available in printed form at the company’s headquarters.
DBV Technologies reported its 2022 financial results on March 2, 2023. The company had cash and cash equivalents of $209.2 million, a significant increase from $77.3 million in 2021, primarily driven by financing activities totaling $194.1 million and tax credit reimbursements of $26.1 million. Despite this, net loss decreased marginally from $97.8 million in 2021 to $96.3 million in 2022, translating to a net loss per share of $1.24. Operating expenses were reduced by 3%, amounting to $101.5 million. The EVOLVE study of the modified Viaskin Peanut patch showed positive caregiver feedback, supporting the patch's usability.
DBV Technologies, a clinical-stage biopharmaceutical company, will report its full year 2022 financial results and provide a business update on March 2, 2023. The company will host a conference call and live audio webcast at 5:00 p.m. ET, where participants can dial in using US: 1-866-777-2509 or International: 1-412-317-5413. The event will also be streamed on the company’s website, with a replay available afterward. DBV Technologies specializes in epicutaneous immunotherapy through its proprietary platform, Viaskin, aimed at transforming food allergy care.
DBV Technologies has announced its participation at the AAAAI 2023 Congress in San Antonio, TX, scheduled for February 24-27, where it will present two scientific posters from the Phase 3 EPITOPE study focusing on the efficacy and safety of epicutaneous immunotherapy with Viaskin Peanut in peanut-allergic children aged 1-3 years. One poster will compare data in children with and without concomitant food allergies, while the second will address those with and without atopic dermatitis. Additionally, DBV will sponsor the AAAAI Fellows-in-Training Program reception and host a booth in the exhibit hall.
DBV Technologies has announced its participation in the SBV Securities Global Biopharma Conference from February 13 to 16, 2023. The company's CEO, Daniel Tassé, will present on February 16 and will also engage in one-on-one investor meetings throughout the day. A live webcast of the presentation can be accessed via the company's website, and a replay will be available for 90 days post-event. DBV Technologies focuses on Viaskin™, an innovative platform for immunotherapy aiming to treat food allergies with ongoing trials for Viaskin Peanut. The company is headquartered in Montrouge, France, and its shares trade under the ticker DBVT on Nasdaq.