DBV Technologies S.A.

Welcome to the DBV Technologies first quarter 2022 earnings conference call. My name is Darrell, and I will be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press 01 on your touchtone phone. As a reminder, this conference is being recorded. I will now turn the call over to Ann Pollack. Ann, you may begin.

Thank you. This afternoon, DBV Technologies issued two press releases, one that outlines our financial results for the three months ended March 31st, 2022, and the second that announces we have established an at-the-market or ATM program. These press releases are available in the press release section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements. including but not limited to comments regarding our clinical and regulatory development plans, the timing and results of interactions with regulatory agencies, our forecast of our cash runway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except if required by law, the company disclaims any obligations to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassé, Chief Executive Officer of DBV, Sebastian Robitaille, Chief Financial Officer, and Pharis Mohideen, Chief Medical Officer. Daniel will provide a business update, and Pharis and Sebastian will join Daniel for questions at the end. I will now pass the call over to Daniel. Daniel?

Thank you, Anne, and thank you all for joining us on this call today. Now, let's start with an update on the clinical and regulatory development of our modified via skin peanut patch. As a reminder, in December, we announced our plan to initiate a pivotal phase three clinical study for the modified via skin peanut patch in children in the intended patient population. We made the decision because, in our view, conducting a pivotal trial with an efficacy assessment, the fastest way to potentially bring via skin peanut to the families and allergists are anxiously awaiting additional therapies for peanut allergy. At DBV, speed to patient is both the lens through which we evaluate all regulatory and clinical options, as well as the standard by which we will measure our progress. As such, we have named the new pivotal trial VITES, which means speed in French, and stands for Weisking-Tinnott Immunotherapy Trial to Evaluate Safety, Simplicity, and Efficacy, V-I-T-E-S-S-E, VITES. At the time of our last corporate update in early March, we had completed the VITES protocol and prepared it for submission to the FDA for their review. At that time also, we're engaged in productive exchanges with the FDA. Our conversation with the FDA continued into March and eventually advanced to a shared view that DBZ should request a Type C meeting to facilitate further and more detailed exchanges. The FDA granted us a Type C meeting in the second quarter and we look forward to their feedback on key elements of the VITAS protocol. Our recent exchanges with the FDA have been collaborative and timely. Our goal is to run a pathway that serves peanut allergy families and allergists and as always, we are mindful of speed to patients. Once we have alignment with the FDA and the VITAS protocol, which could require one or two further exchanges after the Type C meeting to clarify key protocol elements. We will provide more details of the study design and importantly how it translates into expected timelines. We look forward to providing that update as soon as possible. And there's also a second upcoming milestone in the clinical development of ISKIN-TNUT. We expect top line results from Epitope by the end of Q2 of the second quarter of 2022. Epitope is a phase three trial assessing the safety and efficacy of ice cream peanut 250 micrograms for the treatment of peanut allergic toddlers one to three years old. Now DBC initiated this study, excuse me, initiated the study shortly after starting the PIPIT study in four 11-year-olds with peanut allergies. So we plan on sharing the epitope top-line result soon after we unblind the study. But the epitope results will also inform our proposed regulatory pathway for biostein peanut in children ages one to three. We plan initiating an exchange with FDA regarding the regulatory pathway in one to three-year-olds after we have fully analyzed the data from epitope. I'd like to now spend some time putting the financial results for the first quarter of 2022 in the context of the clinical and regulatory update I just provided. Our cash and cash equivalent as of March 31st, 2022 were $74.1 million, which we expect is sufficient to support our operations while we align with the FDA on the VITAS protocol. More precisely, we expect our cash balance will support operations into the first quarter of 2023. That being said, DBV will need to raise money before we resubmit a modified BISC in PNBLA. Should I say before we submit a modified BISC in PNBLA. A mix of financing tools done incrementally are amongst the potential options we are exploring. Today, we announced that we have established an at-the-market or ATM program, which is one of the financing tools we wish to have available to DBV. In a volatile market, we want every financing dual at DBV's disposal to maintain a strong balance sheet as we advance by a skin peanut towards potential approval. The ATM program enables us to offer and sell DBV American Depository Shares, or ADSs, to eligible investors from time to time. Now, the ATM documents filed with the SEC today state that DBV may sell up to $100 million of ADSs and that the program is valid until June of 2024. Now, I wish to comment on these terms. As you know, ATM programs can be time-consuming and expensive to establish. We thus define broad parameters for the DBZ-ATM program to maximize efficiency of the program's expenses. Now, we intend to apply the same financial diligence that we have demonstrated in establishing the program as we actually make use of the program. And as we've discussed, we are also exploring Non-Diluted Financing Strategies that Could Leverage Raskin Peanut's Significant Commercial Potential, among other options for financing. Our current stock price, in our opinion, does not reflect the significant potential of the Viaskin platform. The good news is that we have time to explore all available financing options and select the one tool or combination of tools that best fits our corporate strategy and circumstances at the time. We will keep you updated on our progress. So there are two near-term DBV catalysts on the horizon. FDA alignment on the DTES protocol is one, and the other is the epitope top-line data. We will, of course, issue a press release for each development. And after each announcement, we will host a conference call to review the news in more detail and take any questions. Now, given the timing of each, it is likely that DDD will host at least one conference call and possibly two before we release our first half of 2022 financial results, which are currently targeted for early August. I look forward to providing those updates, when appropriate, over the next several months. I want to thank everyone on the phone and webcast for joining us today. Operator, let's open up the line for questions, please.