Dbv Technologies SA (DBVT) 2023 Q2 法說會逐字稿

Good afternoon, and welcome to the DBV Technologies Second Quarter Financial Results Conference Call. My name is Vaishnavi, and I am the operator for this call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

And now I'd like to turn it over to Katie Matthews, Head of Investor Relations. Katie, please go ahead.

Thank you. This afternoon, DBV Technologies issued a press release that outlined our financial results for the 3 and 6 months ended June 30, 2023. This press release is available in the Press Releases 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 design of our anticipated clinical trials; 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 as required by law, the company disclaims any obligation 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; Dr. Pharis Mohideen, Chief Medical Officer; and Sébastien Robitaille, Chief Financial Officer.

I will now pass the call over to Daniel. Daniel?

Katie, thank you, and thank you all for joining us on this call today.

The purpose of this call today is twofold: one, to provide a business update on our 2 Viaskin Peanut program, including feedback we received recently from the FDA through a Type C meeting on our 2 pending supplemental safety studies, 1 in toddlers, 1 in children; and secondly, to review DBV's financial highlights for the first half of 2023.

Now let me summarize what I think has been well established regarding our 2 Viaskin Peanut development programs before turning the call over to Pharis for an update on recent FDA exchanges and next steps in our clinical and regulatory work.

As you know, DBV is advancing, in parallel, 2 clinical programs for Viaskin Peanut: Viaskin Peanut in toddlers aged 1 to 3; and Viaskin Peanut in children aged 4 to 7. It's important to recognize that Viaskin Peanut in 1- to 3-year olds and Viaskin Peanut in 4- to 7-year olds are separate product candidates with independent clinical and regulatory paths that we believe will ultimately support 2 distinct BLAs.

With that being said as a reminder, let me pass the call on to Pharis, who will share with you more details. Pharis?

Thanks, Daniel. Let's start on Slide #3 with the pathway for toddlers. Just to remind you, the Viaskin Peanut program in toddlers ages 1 to 3 uses the original square Viaskin Peanut patch. Efficacy in this age group was fully supported by our Phase III study known as EPITOPE, which was completed in June 2022.

Recapping those results, Viaskin Peanut demonstrated a statistically significant treatment effect with a P value of less than 0.001, with a 67% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months. That's double compared to 33.5% of subjects in the placebo arm. The predefined endpoint was achieved with the lower bound of the 95% confidence interval being 22.4%, which was well above the prespecified 15% mark.

We were, of course, delighted that the results from EPITOPE were published in The New England Journal of Medicine in May. The publication also featured an accompanying editorial entitled, "Good News for Toddlers with Food Allergies" (sic) ["Good News for Toddlers with Peanut Allergy"].

This past April, we received pre-BLA written responses from the FDA regarding the next steps for the Viaskin Peanut toddler program. As we have previously announced, the agency confirmed that our Phase III EPITOPE study met the prespecified criteria for success for the primary endpoint, and therefore, did not request an additional efficacy study.

The FDA did ask that we conduct a supplemental safety study using the original square Viaskin Peanut patch to support and complement the efficacy and safety results collected from EPITOPE. This study is intended to bring the safety database in this age group to approximately 600 total subjects on active treatment, which is consistent with FDA's position in support of the company's dossier in 4- to 7-year olds as previously announced in December 2022.

Let me add a little more detail around that. The FDA has not raised any specific safety concerns with respect to the Viaskin Peanut development program, which includes toddlers and children. Thus, we are not looking for or being asked to assess any specific safety signal in particular.

The FDA has been consistent in their communications with us, dating back to the original BLA in 2019, in wanting exposure numbers on active treatment to be approximately 600 subjects in total.

Let's move now to Slide #4 and the 4- to 7-year-old indication in children, which is evaluating Viaskin Peanut using the modified circular patch.

Efficacy will be supported by our pivotal Phase III study, VITESSE, which was modeled on PEPITES, our Phase III study in 4- to 11-year olds. We initiated enrollment in VITESSE in March, and we are making good progress.

As with toddlers, we also plan to initiate a supplemental safety study in approximately 270 additional peanut-allergic children ages 4 to 7 years. When added to the safety data generated by VITESSE, the supplemental safety study in children will bring our safety database to approximately 600 children on active therapy in this age group. Recall that in December of last year, the FDA agreed that the supplemental study in 4- to 7-year olds would be 6 months of treatment duration.

Now let's discuss the progress that we have made with our Viaskin Peanut supplemental safety study following receipt of Type C meeting written responses from the FDA. The meeting had 2 main objectives: one, to discuss key study design elements; and two, to agree that a 6-month study would be adequate in toddlers.

Let me summarize where we are. Both safety studies, toddlers and children, will be 6 months in duration. They will be double-blind, placebo-controlled studies. No food challenges will be required for participation for either study.

As I've just mentioned, the 4- to 7-year-old children safety study will include about 270 subjects. The toddler safety study will include about 400 subjects in total. Both studies will have 3:1 randomization of active to placebo. Both supplemental safety studies will also generate patch adhesion data in the same manner previously agreed to with the FDA for the VITESSE Phase III study.

Now that we have received this feedback, we will finalize the protocols and submit them to the FDA for their formal 90-day review.

Viaskin Peanut is a novel complex product for which there is no analog, and we believe that taking a best practice approach with the formal FDA review process serves us and the FDA very well.

As they say, a picture is worth a thousand words. So here is a picture of the 2 patches. Both have the same foam ring and 250-microgram dose of peanut protein. The only difference is the shape and the size of the overlay.

The safety studies will be named COMFORT Toddlers in 1- to 3-year olds, and COMFORT Children in 4- to 7-year olds. COMFORT stands for Characterization of the Optimal Management of Food Allergy, Relief and Treatment.

At this point, I'll turn the call back over to Daniel to review the financial results. Daniel?

Thank you, Pharis. Now let's briefly review financial highlights of the first half 2023.

If we move to Slide #8. Cash, cash equivalents were USD 174 million as of June 30 compared to a position of $209.2 million as of December 31, which is a net decrease of $35.2 million. $46.4 million of cash were used in operating activities, which being about the company was mostly driven by clinical R&D, with the initiation of VITESSE Phase III trial being the biggest component here.

Cash used for operations in the 6 months ended on June 30, 2023, increased by $34.7 million compared to the 6 months ended June 30, 2022. Now in 2022, the company received EUR 24.8 million during the 6 months ending June 30, 2022, for reimbursement of 2019, '20 and '21 French research tax credits.

We raised $7.8 million proceeds from the issuance and the sale of new ordinary shares in the form of American depository shares, ADSs, which took place on June 16, 2023, pursuant to our at-the-market ATM program, which was established in May of 2022.

In closing, we continue to maximize the efficiency of our spend to make sure we are highly disciplined in our cash management. We have a lot of clinical work to do. By next year, we anticipate to have about 1,400 subjects enrolled in Viaskin Peanut Phase III studies, which is the bulk of our focus and our broad cash use.

So let me summarize. In fact, we've covered quite a bit of information today. So let me recap. Our 4- to 7-year-old efficacy study, VITESSE, opened with first subject screening in March of this year, and we are pleased with the ongoing progress of that trial.

We are also actively finalizing the 2 supplements, COMFORT safety study protocols in toddlers and children. We expect to initiate the studies once we have final FDA review of the protocols. In parallel, we are diligently working on appropriate study start-up activities for both supplemental safety studies, and thus, things such as site feasibility, site selection, contract with many sites that can be done very effectively in parallel.

We believe that the successful completion of the supplemental COMFORT Toddlers safety study will be an important step towards filing a BLA, seeking marketing approval of this potential novel breakthrough technology for peanut-allergic toddlers and their families.

I want to thank everyone on the phone and webcast for joining us today. I will ask Pharis and our Chief Financial Officer, Sébastien, to join me for Q&A.

Operator, let's open the line for questions, please.

(Operator Instructions) Our first question comes from Jon Wolleben with JMP Securities.

A couple of questions on the update today. Just wondering what other protocol details are you trying to get alignment with FDA? And when do you think that, that could happen to start the COMFORT programs?

Yes. Three-on-one front. I'll let Pharis answer that question since he's doing all the hard work. Pharis?

Yes. So for protocol details, it's just the usual sort of last bit of details you want to get alignment on, some inclusion and exclusion type things. The main things that we mentioned that we were really happy about were the 6-month duration. Remember, we weren't sure if that could have been a 12-month, and then the size of the trial. So hopefully, that answers the first part.

When would we get back to the FDA? Again, we're working to finalize that protocol, as Daniel said, and then we'll submit it back to them. I'm not sure if that really answers your question. But as I said, we're working hard to finalize it, and then we'll get it out the door.

Okay. And can you give an update on the VITESSE enrollment? You guys have previously said you expect to screen the last patient first half of next year. Just wondering about the early traction you're getting.

And then I believe you also previously said you might wait to start COMFORT Children now until VITESSE is done screening. Is that still the expectation for kind of staggering those studies?

Yes, Jon. Let me take that one. Yes, VITESSE is enrolling as expected. We are not changing what was the guidance we'd given that we would have last patient in first half of next year, top line results first half 2025. That's unchanged. Things are progressing as planned.

As you know, safety trials are easier to recruit than efficacy trials in this space. Being a 6-month trial, our plan is still to initiate COMFORT in children towards the end of enrollment of the VITESSE trial as to not compete with ourselves. People do also go to the same sites, which many investigators know as well and know the product well. And so that remains very much the plan here. I hope it answers your questions.

Yes. And then 1 last for me, if I may. Given the agreement on the high-level details from FDA, does this make any changes to your cash runway guidance with regards to COMFORT Toddlers?

Another important question. It does not. We expect the study will be 6 or 12 months in duration. It turns out to be 6, consistent with REALISE, which was a safety trial accompanying 4- to 11-year olds back in 2019, and the 6 months COMFORT Children trial. So that was a very much part of our financial projections here.

So we certainly have more than the financial mean to initiate all these trials in parallel and drive them to execution. And the feedback we got from the FDA changes nothing to what was our clinical trial planning.

Great. And congrats.

Thank you.

(Operator Instructions) Daniel, it looks like there are no more questions. Do you have any closing remarks?

Nothing, but a big thank you to you, Vaishnavi, and to everybody joining the call today. As you know, always available for follow-up discussions, if you wish. So thank you so much. Have a great day.

The conference has now concluded. Thank you for joining today's presentation. You may all now disconnect.