BioNTech SE (NASDAQ:BNTX) Q2 2023 Earnings Call Transcript

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Ugur Sahin: Yeah. Thank you for the question. As you know, we have two mRNA amplification program self-amplifying mRNA program as well as the amplification program. We have observed and if you look closer into the data into public data of we have observed that the self-amplifying mRNA in humans are limited in the full response on innate — quick initiation of innate response and hindering the full capacity of self-amplifying mRNA. And we are working on an improved approach of overcoming this innate immune response limitation on a adapted monovalent amplifying mRNA platform, which combines two advantages, the advantage of safety. So the itself is not amplified. It provides only mRNA activity and the target mRNAs are amplified.

We thereby separate target mRNA in the replicate mRNA and have the opportunity to combine multiple targets. And this is something where we made a lot of progress in the preclinical setting, and we will report end of this year here on this platform, particularly we see here suitability in the infectious disease setting, particularly in the setting of combination vaccine.

Bill Maughan: Thank you.

Operator: Thank you. We will now go to the next question. And your next question comes from the line of Ellie Merle from UBS. Please go ahead.

Unidentified Participant: Hi guys, this is Sarah on for Ellie so much for taking our question. I guess a quick one on 211 and the data update later this year. It’s what are the expectations for data and what are you guys hoping to see? Thanks.

Ozlem Tureci: Thank you for the question. So we have an ongoing Phase I/II trial, and we have had a couple of data updates this year, the year before. And the trial is ongoing what we expect to report end of this year is additional data on the one hand, on safety of different doses and in combination with our CARVac vaccine, also data on clinical activity in additional clinical indications. We have been very focused on testicular cancer in the previous updates. Further, we will report on durability of these responses. We have been focused on objective response rates. Now that the data is maturing, we will provide more insights into durability of those responses and how use of a vaccine impacts that.

Unidentified Participant: Thank you.

Operator: Thank you. Thank you. We will now take our last question for today. And your last question comes from the line of Simon Baker from Redburn. Please go ahead.

Simon Baker: Thank you for taking my question. It relates to the PRESERVE-003 study. It’s a 2-stage Phase III study. So I just wanted to get some idea of what data you will be presenting at the conclusion of Stage 1 and any timing that is indicated based on your expectations for and recruitment? And I see the clinical trials is showing a primary completion in mid-2026. Is that a reasonable estimate at this stage for the final data of Stage 2?

Ozlem Tureci: I didn’t fully get that, Simon. Was this about data expectations for the ongoing ONC392 trial?

Simon Baker: Yes, it was because it’s a 2-stage study. So I wondered what data you will disclose when Stage I is completed and the dose is selected?

Ozlem Tureci: So it will be safety data and clinical activity data in different tumor indications.

Ugur Sahin: I think it’s a lung cancer trial.

Ozlem Tureci: Sorry, I didn’t get that.

Ugur Sahin: So we expect around 2025 data and safety data. Now we have started the clinical trial with two different doses. We will select one dose to continue. And it’s a stage approach based on the data, initial assessment of the PFS that clinical trial will continue for full maturation.

Simon Baker: Great. Thanks so much.

Ugur Sahin: Thank you.

Operator: Thank you. This concludes today’s conference call. Thank you for participating. You may now disconnect.

Ryan Richardson: Thank you.

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