Q3 2023 DBV Technologies SA Earnings Call
Ladies and gentlemen, thank you for standby the conference will begin shortly please continue to hold and thank you for your patience.
[music].
Welcome to the D. B V third quarter financial results and business and regulatory update conference call.
All participants will be in listen only mode.
Should you need assistance. Please signal conference specialist by Christmas Tour key followed by zero.
After today's presentation there'll be an opportunity to ask questions to ask a question Press Star then one your telephone keypad to withdraw your question. Please press Star then two.
Please note this event is being recorded.
I would now like to turn the conference over to Katie Matthews Investor Relations. Please go ahead.
Thank you.
Dineen D B B technologies issued a press release outlines our financial results for the nine months ended September.
2023.
This press release is available in the press releases section of the D. B V 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.
Design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies.
Forecast of our cash runway.
The ability of any of our product candidate 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 en masse for information concerning risk factors that could cause the company's actual results to differ materially.
Patients, 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. After this call.
Joining me on the call today are Daniel Cafe, Chief Executive Officer of D. B V and talked to ferrous Martine Ppvs, Chief Medical Officer, I will now pass the call to Danielle Danielle.
J P. Thank you and thank you all for joining us on this call today.
The purpose of today's call is to first provide a business update on our two by asking peanut programs, including the receipt.
Of the BV is requesting feedback from the FDA regarding remaining a protocol design elements for our two pending supplemental safety studies, which says you know her name comfort toddlers and comfort children.
And secondly to review with you <unk> financial results for the third quarter of 2023.
Let me start by summarizing what has already been established regarding our two by skin peanuts programs and developments before turning over to Paris for an update.
On the requested feedback we received from the FDA and thus the next steps in our clinical and regulatory work.
As you May recall, the BV is advancing in parallel two clinical programs for bias can peanuts.
So asking peanuts, and toddlers children, aged one to three and Baskin peanut in children age four to seven.
And it's important to recognize that by asking peanuts in one to three year olds and basket for seven year olds are separate product candidates with independent clinical and regulatory path that we believe will ultimately support two distinct b right now.
Now, let me pass over ferrous to share with you more details.
Thank you Danielle.
Let's start with a brief recap of Baskin peanut program and toddlers agents want to three which you will recall uses the original.
We're biased in peanut patch.
We've already completed our pre BLA meeting for toddlers in April of this year.
As we previously announced the agency confirmed that our phase three epitope study met the pre specified criteria for success for the primary endpoint and therefore did not request an additional efficacy study.
The FDA did ask for a supplemental safety study with the original square patch can increase the total number of subjects on active treatment you approximately 600.
The regulatory guidelines.
The FDA did not raise any specific safety concerns associated with this request.
The 47 your indication will also have a supplemental safety study to increase the number of subjects on treatment with the modified starch or their patch approximately 600 subjects when combined with the active subjects in the church.
Ongoing phase III efficacy and safety study.
So we believe there is nice symmetry to the two BLA programs.
The one to three one indication has a completed efficacy and safety study in epitope and a planned supplemental safety study income for toddlers.
We believe that this will constitute a company all studies needed for a BLA submission.
Similarly, the four to seven year old indication will have the test for efficacy and safety and comfort children for supplemental says.
We've discussed the key design elements of both supplemental safety studies in the past, but just to remind you. Both studies will be six months in duration double blind placebo controlled.
321, randomization active to placebo and both would generate adhesion data.
For toddlers will include 400 subjects and comfort children will be 270 subjects in total.
These numbers have not changed.
Okay and that brings us to today.
After receiving the type C meeting feedback on the safety studies in July we requested clarification from the FDA.
There were a few remaining protocol design elements relevant to both safety studies.
As well as one of the inclusion criteria just for comfort hunger that we felt needed additional clarity.
I'm pleased to report that we have received written feedback from the FDA clarifying those remaining protocol design elements.
The protocols for both supplemental safety studies will have the same language guiding how the product should be used.
Yes.
Each DVD 71 to 215 microgram. After cutaneous system is intended to be worn for a full day 24 hours.
We believe that this language is more concise and simpler and harmonizing the language and both safety studies makes a lot of sense.
Further to this approach both supplemental safety studies or seek to enroll subjects that are as closely aligned with their respective phase III efficacy studies as is feasible.
For comfort toddlers.
It means using thin eligibility criteria as in the epitope study.
An epitope the main inclusion criteria centered around a documented history of peanut allergy.
Firmed, but immunologic markers IGT and skin prick testing and.
Double blind placebo controlled food challenge.
We previously believed that no food challenge would be required for comfort toddlers, but.
And exchanges with the FDA, we chose these inclusion criteria options as the best way to ensure that we could recruit the study population that would be a similar to epitope as possible.
Well there is a significant body of immunological literature and older peanut allergic children.
The same is just not true in the popular bench.
Because of this we felt that reliance on immunological parameters alone.
The main inclusion criteria did not provide the same level of assurance as the epitope eligibility criteria.
However for comfort children, we will years of history of peanut allergy and immunologic parameters for the inclusion criteria.
The medical literature supports this approach as our experience in the completed four to 11 year old safety study realized.
<unk> serve as a supplemental safety study for proteins.
With this approach we are confident that we can enroll the study population that will be similar to that of the test.
There will not be a need for a confirmatory double blind placebo controlled food challenge for comfort children.
Yeah.
Since the epitope with a successful study maybe in the Prespecified criteria for success for the primary endpoint and we have received regulatory guidance from FDA.
Comfort toddlers is our highest priority to get started as quickly as possible.
Now that we have received clarification.
Can submit the safety protocol to the FDA expeditiously and anticipate enrollment to begin in the first quarter of 'twenty 'twenty four.
In parallel the comfort children protocol will be finalized and submitted to the FDA.
Since it is a smaller study relative to your comfort toddlers and we don't wish to compete with the test recruitment at this time, we plan to initiate enrollment in comfort children after comfort toddlers.
We are continuing to work diligently on appropriate study startup activities for both comfort studies, while in parallel continuing to advance the tests our phase III study in four to seven year olds.
To summarize we are very pleased with the engagement and clarity of the feedback received from the FDA.
We feel that harmonizing approach to how the product should be years, it's even simpler and more concise than what previously existed.
We're confident we can enroll subjects in our supplemental safety studies that will align nicely with the respective efficacy studies.
And we remain confident that this work will support BLA is in both age groups and potentially bring new treatment option for clinicians and families.
At this point I'll turn the call back over to Danielle to review the financial results Danielle.
Thank you Paris.
And now let's briefly review the financial highlights for Q3 2023.
Our cash and cash equivalents as of September 30th or 140 $149.1 million compared to two two.
$209 2 million.
As of December 31st 2022, and net decrease of $61 million.
Due to the following.
66 million of cash was used in operating activities mainly driven.
By clinical work and initiation of DPP test trial with the first patient with screen in March of this year.
And then $7 million of net proceeds from issuance and sale of new ordinary shares in the form of a D. S's, which took place on June 16, 2023 pursuant to the company's at the market program, which was established in May of 2022.
You can see we continue to.
To maximize the efficiency of our spin we remain highly committed.
And disciplined cash management, we have a lot of clinical work to do by next year. We anticipate we'll have about 1400 patients or subjects enrolled in voice can peanuts phase III studies.
So we have covered a lot today and if you allow me to recap.
This team is working diligently implement the feedback we requested from the F. D. A into the comfort safety study protocols for submission to the agency.
We expect to submit the final EIS comfort toddlers protocol in the next few weeks anticipate initiating the comfort told them to study the first quarter of 2024.
We believe.
And the successful completion of the supplemental comfort toddler safety study will be an important step towards filing a BLA seeking marketing approval in the U S of this potential novel therapy for peanut allergenic toddlers and their families.
As far as mentioned initiation of comfort children as expected after the start of comfort toddlers and in close alignment with V tests recruitment.
We are continuing to advance the tests.
Successful completion of which was an important step towards filing a separate BLA.
King marketing approval in the U S with this potential therapy.
Children age four to seven.
I want to thank everyone on the phone and on the webcast for joining us today, and we'll now ask ferrous to join me.
For Q&A.
Operator, you can open the line please.
We will now begin the question and answer session to ask a question you May Press Star then one of your telephone keypad.
If you're using a speakerphone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Our first question will come from Rajiv Sharma with Goldman Sachs. You May now go ahead.
Hi, and thanks for taking my question. So firstly just on.
Timelines and I was just wondering in part to the need for food challenging comfort toddlers have on your anticipated timeline. So I'm conscious that you mentioned that the duration of the trial itself is not changing but just wondering if you expect the need for a.
The challenge to impact enrollment timelines or kind of the stuff, which you could enroll that trial.
And then I just have a follow up as well please.
Sure.
Operator: Ladies and gentlemen, thank you for standing by. The conference will begin shortly. Please continue to hold and thank you for your patience.
Want to take that one.
Sure.
So as I said.
We anticipate first patient could be enrolled in the first quarter of 2024.
We expect that the food challenge could add some time to reload croutons period.
But we know our sites well and they know how to do food challenge as well.
And we believe that there's more.
Understanding about our product and.
There's public data generated from the New England Journal of Medicine publication, So it's a really good time.
<unk>.
And so once the studies initiated will have a better understanding of the timeline.
And we'll come back with more details, but right now we're not going to talk.
Talk about the back end until we get the study up and running in Angola, and see how things are going well, we're confident that we can get this done.
Okay. Thank you.
And then the fun of it was just around costs and just wondering if the food chains requirement in box.
The potential cost of the trial and whether you're comfortable that you kind of have sufficient runway to fund through to completion of all of the required trial.
So the the addition of the food challenge will not add significantly to the cost.
Of the trial, so that's not a factor for sure.
And as we've guided Rosanne, we have sufficient cash to go into 2025.
That's not enough we need to complete all of those trials, but we'll be looking at raising capital at one point in time, we're in no rush to do so and that's that was said job one for US right. Now is good those studies up and running which.
Which we can do.
Viciously.
So this is what we said if it comes to financial position. We're in a good position to be able to do we think it's right by the business.
And look at the access to capital.
Operator: Thank you very much. The third quarter, Financial Results and Business and Regulatory Update Conference Call. All participants will be in listen only mode. Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the nine months and is September the 30th, 2023. This press release is available in the press releases section of the DBV Technologies website.
In June time, Oh, no rush to do so.
Okay perfect. Thank you very much.
Thanks, Suzanne good to hear from you for London by the way Thanks for calling.
This concludes our question and answer session I would like to turn the conference back over to Mr. Daniel TASS He for any closing remarks.
I just want to thank everybody again for joining us today important developments for us and as always we're always available for continued conversation alright. Thank you and I wish you also the or those of you with a little one's happy to luxury.
Excuse me.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Operator: 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 are 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 of the subject to risks and uncertainties that could cause the company's actual result to disappear significantly from those suggested by these statements.
Operator: Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. These refer to the company's filings with the SEC and the French AMS 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 is required by law, the company describes any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call.
Operator: Joining me on the call today are Daniel Tasse, Chief Executive Officer of DBV and Dr. Pharis Mohideen, DBV's Chief Medical Officer.
Katie Matthews: I will now pass the call over to Daniel. Daniel?
Daniel TASS: Katie, thank you, and thank you all for joining us on this call today. The purpose of today's call is to first provide a business update on our two via skin peanut programs, including the receipt of DBV's requested feedback from the FDA regarding remaining protocol design elements for two pending supplemental safety studies, which has, you know, our name comfort toddlers and comfort children. And secondly, to review with you, DBV's financial results for the third quarter of 2023.
Daniel TASS: Let me start by summarizing what has already been established regarding our two by skin peanut programs and development before turning over to Pharis for an update on the requested feedback we received from the FDA and thus the next steps in our clinical and regulatory work. As you may recall, DBV's advancing in parallel to clinical programs for via skin peanut via skin peanut and toddlers children age one to three and via skin peanut and children age four to seven.
Daniel TASS: And it's important to recognize that via skin peanut and one to three year olds and by skin peanut and four to seven year olds are separate product candidates with independent clinical and regulatory path that we believe will ultimately support two distinct BLAs.
Pharis Mohideen: Now me pass over Pharis to share with you more details. Thank you Danielle.
Pharis Mohideen: Let's start with a brief recap of via skin peanut program in toddlers ages one to three, which you will recall uses the original where via skin peanut patch. We already completed our pre-DLA meeting for toddlers in April of this year. As we previously announced, the agency confirmed that our phase three epitope study met the pre-specified criteria for success for the primary endpoint and therefore did not request an additional efficacy study. The FDA did ask for a supplemental safety study with the original square patch to increase the total number of subjects on active treatment to approximately 600 for regulatory guidelines.
Pharis Mohideen: The FDA did not raise any specific safety concerns associated with this request. The 47-year-old indication will also have a supplemental safety study to increase the number of subjects on treatment with the modified circular patch, so approximately 600 subjects. When combined with the active subjects in the test, the ongoing phase three efficacy and safety study. So, we believe there is nice symmetry to the two BLA programs. The 1 to 3-year-old indication has a completed efficacy and safety study in epitope, and a planned supplemental safety study in comfort toddlers.
Pharis Mohideen: We believe that this will constitute the pivotal studies needed for a BLA submission. Similarly, the 47-year-old indication will have the test for efficacy and safety and comfort children for supplemental safety. We've discussed the key design elements of both supplemental safety studies in the past. But just to remind you, both studies will be six months in duration, double blind, placebo controlled, three to one randomization, active to placebo, and both will generate adhesion data. Comfort toddlers will include 400 subjects, and comfort children will be 270 subjects in total. These numbers have not changed.
Pharis Mohideen: Okay, that brings us to today. After receiving the Type-C meeting feedback on the safety studies in July, we requested clarification from the FDA. There were a few remaining protocol design elements relevant to both safety studies, as well as one of the inclusion criteria just for comfort toddler that we felt needed additional clarity. I'm pleased to report that we have received written feedback from the FDA clarifying those remaining protocol design elements. The protocols for both supplemental safety studies will have the same language guiding how the product should be used.
Pharis Mohideen: Such as, each DBV-712-250 microgram apt-cutaneous system is intended to be worn for a full day 24 hours. We believe that this language is more concise and simpler, and harmonizing the language in both safety studies makes a lot of sense. Further to this approach, both supplemental safety studies will seek to enroll subjects that are as closely aligned with their respective phase three efficacy studies as is feasible. For comfort toddlers, this means using the same eligibility criteria as in the apt-toked study.
Pharis Mohideen: In Epitope, the main inclusion criteria centered around a documented history of peanut allergy confirmed by immunologic markers, IgE and skin-pertesting, and a double-blind placebo controlled food chart. We previously believe that no food challenge would be required for comfort toddlers, but in exchanges with the FDA, we chose these inclusion criteria options as the best way to ensure that we could recruit a study population that would be as similar to epitope as possible.
Pharis Mohideen: While there is a significant body of immunological literature and older peanut allergic children, the same is just not true in the toddler range. Because of this, we felt that reliance on immunological parameters alone for the main inclusion criteria would not provide the same level of assurance as the epitope eligibility criteria. However, for comfort children, we will years a history of peanut allergy and immunologic parameters for the inclusion criteria. The medical literature supports this approach, as there's our experience in the completed 4-11 year old safety study realized, which served as a supplemental safety study for puppies.
Pharis Mohideen: With this approach, we are confident that we can enroll a study population that will be similar to that of the test. There will not be a need for a confirmatory double blind to see the control of food challenge for comfort children. Since epitope was a successful study, meeting the pre-specified criteria for success for the primary endpoint, and we have received regulatory guidance from FDA, comfort toddlers is our highest priority to get started as quickly as possible.
Pharis Mohideen: Now that we have received clarification, we can submit the safety protocol to the FDA expeditiously and anticipate enrollment to begin in the first quarter of 2024. In parallel, the comfort children protocol will be finalized and submitted to the FDA. Since it is a smaller study relative to comfort toddlers and we don't wish to compete with the test recruitment at this time, we plan to initiate enrollment in comfort children after comfort toddlers. We are continuing to work diligently on appropriate study start-up activities for both comfort studies while in parallel continuing to advance the test, our phase 3 study in 4-7 year olds.
Pharis Mohideen: We summarize, we are very pleased with the engagement and clarity of the feedback received from the FDA. We feel that harmonizing the approach to how the products should be used is even simpler and more concise than what previously existed. We are confident we can enroll subjects in our supplemental study studies that will align nicely with the respective efficacy studies, and we remain confident that this work will support BLAs in both age groups and potentially bring a new treatment option to clinicians and families.
Daniel TASS: At this point, I'll turn the call back over to Danielle to review the financial results.
Daniel TASS: Danielle, thank you, Ferris, and now let's briefly review the financial highlights for Q3 2023. Our cash and cash equivalence as of September 30th are 149.1 million dollars compared to 209.2 million as of December 31st, 2022 and that decrease of 60.1 million dollars mainly due to the following, 66 million of cash was used in operating activities, mainly driven by clinical work and initiation of the DTS trial, where the first patient was screened in March of this year and then $7 million of net proceeds and issuance and sale of new ordinary shares in the form of ADSs which took place on June 16, 2023, pursuant to the companies at the market program which was established in May of 2022.
Daniel TASS: You can see we continue to maximize efficiency of our spend. We remain highly committed and disciplined in our cash management. We have a lot of clinical work to do by next year. The anticipate will have about 1,400 patients or subjects that are enrolled in VASC in PNF Phase 3 studies.
Daniel TASS: We have covered a lot today and this will allow me to recap. As this team is working diligently to implement the feedback we requested from the FDA into the comfort safety study protocols for submission to the agency. We expect to submit the finalized comfort tolerance protocol in the next few weeks and anticipate initiating the comfort tolerance study in the first quarter of 2024. We believe that the successful completion of the supplemental comfort tolerance safety study would be an important step towards filing a BLA seeking, marking approval in the U.S, of this potential novel therapy for pinalogenic toddlers and their families.
Daniel TASS: As Saras mentioned, the initiation of comfort children is expected after the start of comfort toddlers and in close alignment with VTAS recruitment. We are continuing to advance VTAS successful completion of which would be an important step towards filing a separate BLA seeking, marking, approval in the U.S, for this potential novel therapy in pinalogenic children age 4 to 7.
Daniel TASS: I want to thank everyone on the phone and on the webcast for joining us today.
Operator: Now we'll now ask Saras to join me for Q&A. Operators, get up in the line, please. We will now begin the question and answer session. To ask a question, may I press star then when you need telephone keypad. If you're using your speaker phone, please pick up your hands up before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.
Rajan Sharma: Our first question will come from Rajan Sharma with Goldman Sachs. You may now go ahead. Hi, and thanks for taking my question. So firstly, just on timelines. I was just wondering what impact of the need for food challenging comfort toddlers have on your anticipated timelines. So I'm conscious that you mentioned that the duration of the trial itself is not changing, but just wondering if you expect the need for a food challenge to impact enrollment timelines or kind of the stuff which you could enroll that trial, and I just have a follow-up as well, please. Sure.
Pharis Mohideen: Pharis, do you want to take that one? Sure. So as I said, Rajan, we anticipate first patient could be enrolled in the first quarter of 2024. We expect that the food challenge could add some time to the recruitment period, but we know our sites well and they know how to do food challenges well. And we believe that there's more understanding of our product and this publicly is generated from the New England Journal of Medicine Publication. So it's a really good time.
Pharis Mohideen: And so once the studies initiated, we'll have a better understanding of the timeline and we'll come back with more details. But right now we're not going to talk about the back end until we get the study up and running and rolling and see how things are going. But we're confident that we can get this done. Okay.
Pharis Mohideen: Thank you. And then follow it with just around costs and just wondering if the food challenge requirement impacts the potential cost of the trial and whether you're comfortable that you kind of have sufficient runway to to fund through to completion of all of the required trial. So the addition of the food challenge will not add significantly to the cost of the trials. That's not a factor. And as we've got it, Rajan, we have sufficient cash to go into 2025.
Pharis Mohideen: That's not enough. We need to complete all of those trials, but we'll be looking at raising capital at one point. No rush to do so. And that's that job one for us right now. Get those studies up and running, which we can do rather expeditiously.
Pharis Mohideen: So this is where we come to financial position. We're a good position to be able to get right by the business. And look at access to capital in due time or no rush to do so.
Rajan Sharma: Okay, perfect.
Rajan Sharma: Thank you very much. Thanks for that. Good to hear from you for London. By the way, thanks for calling.
Operator: This concludes our question and answer session.
Daniel TASS: I would like to turn the comments back over to Mr. Daniel Tassi for an closing remarks. I so want to thank everybody again for joining us today in point developments for us. And as always, we're always available for continued conversations.
Daniel TASS: Thank you. And I wish also all those of you with the little ones. Happy to the feeling.
Operator: Have a nice evening.
Operator: The conference is now concluded. Thank you for today's presentation. Thank you.