modified Viaskin Peanut patch / DBV Technologies - LARVOL DELTA

DBV Technologies stock slumps 21% amid FY revenue decline, plans on Peanut patch (SeekingAlpha) - "Full year 2021 revenue fell -49.38% Y/Y to $5.71M. Net loss decreased to -$97.81M, compared to -$159.56M in 2020. Research and development expenses declined to $70.34M, compared to ~$101.61M in 2020....The company noted that protocol for a new phase 3 pivotal study of the modified Viaskin Peanut patch was completed at the end of February 2022 and has been prepared for FDA submission....DBVT -21.14% premarket to $1.38."

Clinical protocol • Commercial • FDA event • Stock price • Food Hypersensitivity

DBV Technologies Reports Full Year 2021 Financial Results and Recent Business Updates (DBV Technologies Press Release) - "The protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut ('mVP') patch was completed at the end of February 2022 and has been prepared for FDA submission. The Company is currently engaged in fruitful discussions with FDA in preparation for protocol submission and review....'Initiating our new Phase 3 trial with the mVP is our top priority. We are pleased with our ongoing exchanges with FDA...Based on our current assumptions, we have extended our cash runway into the first quarter of 2023,'....As of December 31, 2021, cash and cash equivalents were $77.3 million, compared to $196.4 million as of December 31, 2020. In 2021, cash used in operating activities was $(108.2) million under U.S. GAAP and $(104.1) million under IFRS comp."

Clinical protocol • Commercial • FDA event • Food Hypersensitivity

DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low (Benzinga) - "DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population....The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch....The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022....DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut....Price Action: DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday."

Clinical protocol • European regulatory • New P3 trial • Stock price • Food Hypersensitivity

DBV Technologies Provides Update on Investigational Viaskin Peanut (DBV Technologies Press Release) - "DBV Technologies...announced plans to initiate a new, pivotal Phase 3 clinical study for a modified Viaskin™ Peanut patch in children in the intended patient population. The Company also issued an update on the Marketing Authorization Application for Viaskin Peanut with the European Medicines Agency (EMA)...The Company is in the process of finalizing the new, pivotal Phase 3 protocol and expects to submit the protocol to FDA by the end of February 2022...DBV Technologies today announced that it has formally notified the European Medicines Agency (EMA) of its decision to withdraw the Marketing Authorization Application (MAA) for Viaskin Peanut."

Clinical protocol • European regulatory • New P3 trial • Food Hypersensitivity