BioNTech Q2 2023 Earnings Call Transcript

Key Takeaways

  • Regulatory Submissions for Omicron XBB1.5 Vaccine: BioNTech and Pfizer have filed for Omicron XBB1.5 monovalent COVID-19 vaccine approval in major markets and are preparing for a commercial launch this fall to maintain protection against circulating variants.
  • Seasonal Impact on Q2 Results: Revenues fell to €166 million from €3.2 billion in Q2 2022, driving a net loss of €190 million (€0.79 per share), although the company reiterated its full-year COVID vaccine revenue guidance of around €5 billion.
  • Oncology Pipeline Acceleration: Initiated a pivotal Phase 3 trial of the next-generation anti-CTLA-4 antibody candidate BNT316 in second-line non-small cell lung cancer, expanded ADC collaborations with Duality and OncoC4, and added multiple new trials.
  • Promising ASCO Data Across Modalities: At ASCO, BioNTech presented encouraging safety and efficacy results for BNT316, next-generation HER2 ADC BNT323 with disease control in heavily pretreated patients, and CAR T/RNA vaccine combo BNT211 showing durable responses in CLDN6-positive cancers.
  • Strategic AI/ML Acquisition: Closed the acquisition of InstaDeep to integrate advanced artificial intelligence and machine learning capabilities, aiming to accelerate high-throughput drug discovery and improve R&D efficiency.
AI Generated. May Contain Errors.
Earnings Conference Call
BioNTech Q2 2023
00:00 / 00:00

There are 14 speakers on the call.

Operator

Welcome to BioNTech's Second Quarter 2023 Update Call. I would like to hand the call over to Doctor. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Speaker 1

Thank you. Good morning and afternoon. CFO. Thank you for joining us today for BioNTech's Q2 2023 earnings call. As a brief reminder, the slides that accompany this call and the Q2 2023 press the financial results that was issued this morning can be found in the Investors section of our website.

Speaker 1

As outlined on Slide 2, you can see our forward looking statements disclaimer. Financial Services. Additional information about these statements and other risks are described in our filings made with the U. S. Securities and Exchange Commission.

Speaker 1

Financial Services. Forward looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements. On Slide 3, you can find the agenda for today's call. Today, I'm joined by the following members of Viantic's management team: of our CEO and Co Founder, Ugur Sahin Urdan Tureci, our Chief Medical Officer and Co Founder of Jens Holstein, our Chief Financial Officer and Ryan Richardson, our Chief Strategy Officer. I would like to turn the call over to Uwe Sachin.

Speaker 1

Of

Speaker 2

Thank you, Victoria. A warm welcome to all the call participants. We appreciate your continued support. Of Today, I will summarize our Q2 2023 highlights and priorities before I pass the call over of to my team to provide some further details. Slide 5.

Speaker 2

Let me start reiterating our 2023 Strategic Priorities that we set at the beginning of the year and highlight our recent progress executing against them. Of We pursue our priority to expand and sustain our COVID-nineteen leadership with Pfizer by advancing our next generation of the World Health Organization on the composition of the adapted COVID-nineteen vaccine for the 2023 2024 fall season. Of Based on these recommendations, we, together with our partner Pfizer, have submitted regulatory packages of For Omicron XBB1.5 adapted monovalent COVID-nineteen vaccine through U. S, of FDA, EMA and other regulatory agencies. We have also kicked off commercial launch activities for the Omicron XBB1.5 adapted monovalent COVID-nineteen vaccine.

Speaker 2

Our of 2nd 2023 strategic priority is to accelerate our oncology pipeline and initiate multiple trials of Regulatory Potential. Our new collaborations with DUALITY BIO and OncoC4 of Clinical and Developmental Pipeline with multiple mid- to late stage clinical programs that will help us to achieve this goal in the near term. Of In the Q2 at ASCO Annual Meeting, we and our respective collaboration partners presented 3 new clinical data sets of That Erzmann will cover later. Further, jointly with our partner, Onco C4, we began a pivotal of Phase 3 trial evaluating the next generation anti CTLA-four antibody candidate BNT-three sixteen, ScotistoBag as a second line treatment for patients with non small cell lung cancer. Of Our 3rd strategic goal is to initiate and accelerate clinical programs with high medical need in infectious diseases.

Speaker 2

Of We are expecting multiple data readouts for our mRNA based vaccine candidates in the second half of this year. Of In summary, we continued our focused execution against strategic priorities in the second quarter of And look forward to additional progress in all three of these areas in the remainder of this year. Slide 6. Starting with COVID-nineteen, of While variants of concern have emerged in all seasons in the past few years, we expect that in the fall and winter in line with other Congregulatory Diseases, such as influenza and RSV, also thus COV2 hospitalization will increase. Of Slide 7.

Speaker 2

In 2023, 4 years after the start of the COVID-nineteen pandemic, of There's a high seroprevalence in the global population as a result of vaccination and or infection. Of SARS CoV-two are highly heterogeneous as individuals have been infected with different variants of SARS CoV-two and its spike protein continuous divergence of the evolution of trajectory from the original wild type virus. Despite increasing gaps in the genomic surveillance globally, the available sequencing data indicates that the original virus of and other early variants such as alpha, beta, gamma, delta are no longer detected in humans. Of As of July 2023, the XBB1 descendant lineages predominate globally and they have further antigenic distance of Clinical data have shown that currently approved COVID-nineteen vaccines provide a level of protection against this new variant. Of However, with the antigenic breadth of current variants of concern, signs of waning protection have been observed of Starting 2 to 4 months after boosters with last season's B4 B5 adapted vaccine, including against severe COVID-nineteen.

Speaker 2

Of Due to the greater antigenic distance of this variance of concern and the further immune escape, absolute vaccine effectiveness against hospitalization of Due to COVID-nineteen is reduced as time passes between vaccination and subsequent infection. Of In summary, this data support a rollout of a COVID-nineteen vaccine adapted to the most recent variants of concern this fall. Of We plan to launch an Omicron FBB1.5 adapted monovalent COVID-nineteen vaccine this fall of Health and Human Services, subject to approval by regulatory authorities. Our goal is to maintain protection against severe COVID-nineteen disease, of Hospitalization and Death by providing a vaccine that is better matched to the current e circulating strains and that is designed to be more closely aligned of Neuro Evolving Lineages. Slide 8.

Speaker 2

Let me remind you of the core principles of our of Overarching Strategy. We pursue a multi technology driven approach rooted in deep fundamental understanding of Biologics and Immunobiologics. We leverage the power of computational science and AI. Of InstaDeep has expanded our capabilities in that regard. Together, we aim to become the global leader in applying cutting edge Artificial Intelligence and Machine Learning Technology and Research to discover, design and develop next generation immunotherapies at scale.

Speaker 2

Of We built novel platforms with the ability to produce multiple product candidates for our clinical pipeline, of Including approaches that enable and accelerate individualization of treatment. To leverage synergistic mode of action, of We explore opportunities for combining modalities, both developed internally and accessed via collaboration partnerships. Of Last quarter, we announced that we initiated a collaboration with Zoalti Biologics to access 2 of their next generation antibody, TRAC conjugate. Of This quarter, we and duality shared clinical data from one of these programs and expanded our collaboration to a third encouraging program of Duerle Key Biologics Pipeline. Slide 9.

Speaker 2

ADCs consist of 3 main components: of Antibody Linker Payload. Each of these components has an impact on ADC's pharmacological and clinical properties. Of This is a precision medicine allowing for targeted drug delivery, particularly to tumor cells with high specificity of Importantly induced cell death with the benefit of reduce of target events. When the monoclonal antibody binds to the target breast cancer and breast cancer. The ADC is internalized, allowing for the release of the cytotoxin, which leads to cell death.

Speaker 2

Of We continue to broaden our access to ADCs because we believe this technology has the potential to replace highly toxic of Chemotherapy Regimens to become a new combination backbone for cancer immunotherapy. Advancements in this Technology have resulted in its extended use for the treatment of solid tumors. ADCs can also synergize with various immunotherapy modalities, including C and A. We are now in our current immunotherapy pipeline. Our growing ADC pipeline now includes ADCs directed against of 3 distinct targets and is of interest for a broad range of cancer types.

Speaker 2

In the future, we plan to combine these ADCs of With our proprietary pipeline programs to maximize the patient impact of this exciting modality. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Esme.

Speaker 3

Of Thank you, Ugo. I'm delighted to speak with everyone today and to provide our pipeline update. Of Slide 11. Starting with our COVID-nineteen vaccine, we expect that as ZAS COV to continue to evolve of the FDA. As the risk of severe COVID-nineteen disease and death continues, there will be persisting demand for vaccine boosting and vaccinations, of Especially For At Risk and Immunocompromised Groups.

Speaker 3

The Omicron XBB subclinages of COVID-nineteen cases globally and are antigenically distant from prior circulating SARS CoV-two lineages, including Omicron BA. 4five and the original SARS CoV-two strain. Of Although Omicron BA. 45 adapted bivalent vaccines provide some protection against the range of outcomes from Bb related COVID-nineteen. Evidence suggests that vaccines better match to currently circulating sublineages of can help further improve protection against symptomatic disease and severe COVID-nineteen.

Speaker 3

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Speaker 3

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Speaker 3

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Speaker 3

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Speaker 3

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Speaker 3

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Speaker 4

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Speaker 3

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Speaker 3

Of XBV1.5 of XB B-one hundred and sixteen differ in only 2 mutations highlighted here. In May, of the EMA and other health authorities provided guidance highlighting that updated vaccines of Targeting Omicron XPD1 sub lineages may help to maintain protection against COVID-nineteen of the U. S. During the upcoming fall and winter season, when COVID-nineteen case rates and hospitalizations are expected to increase. Of FDA's Vaccines and Related Biological Products Advisory Committee, the VIRBAC, of Issued Guidance Recommending Manufacture of an Omicron XBB1.5 adapted Monovalent COVID-nineteen vaccine for the 2023 2024 fall and winter seasons.

Speaker 3

Of Pfizer submitted regulatory applications to the EMA and to the FDA for our Omicron XPD 1.5 adapted monovalent COVID-nineteen vaccine for individuals 6 months of age and older. Of Following guidance from regulatory authorities on the requirements for strain changes, the applications include of Clinical and Molecular Medical Center. I would like to hand the call over to Doctor. Victoria Meissner, Vice President of Clinical and Molecular Medical Center. Of the FDA.

Speaker 3

May generate improved responses against circulating XPD sublineages compared to the current Omicron BA. Of the potential effectiveness of an Omicron XBB1.5 adapted monovalent vaccine as a primary series and booster in mice. Of Here you see the neutralizing antibody response in mice immunized with Omicron BA.45 adapted bivalent vaccine of SBRU. After 2 doses of the original vaccine. 1 group of mice again received the BA.

Speaker 3

4 of 5 adapted bivalent COVID-nineteen vaccine as a 4th dose and the other group received the new XBV1.5 adapted monovalent COVID-nineteen of SIN as a 4th dose. You can see a 4 to 5 fold increase of neutralization of several XBB related variants of When dose 4 is the XBB1.5 adapted monovalent vaccine as compared to last season's bivalent vaccine, IND. Indicating that XBB1.5 variant adapted monovalent vaccine in the pre vaccinated setting of has the potential to induce broad cross neutralizing antibody titers against multiple XPD subgenogens. Of We made significant progress toward a monovalent COVID-nineteen vaccine against Omicron XBB1.5 of With regulatory submissions to the U. S.

Speaker 3

FDA, EMA and other regulatory authorities, and we are well prepared to launch an adapted COVID-nineteen Vaccines, if approved in early fall this year. Moving to our oncology pipeline, let me put our of Second Quarter Pipeline and Advancements into the broader context of our clinical stage pipeline, which is depicted on Slide 13. Of In the Q2, the initiation of our pivotal Phase 3 trial in non small cell lung cancer marks the first landmark of In our strategic collaboration with Onco C4. The randomized Phase III trial is evaluating BNT316, of the pH sensitive anti CTLA-four antibody with distinctive mode of action and is of the FDA's Phase III trial initiation granted in 2022 and is based on Phase III safety and efficacy data of Immunotherapy in metastatic immune checkpoint inhibitor resistant non small cell lung cancer. Of Further, we expanded our collaboration with Duality and added a third ADC to our oncology pipeline.

Speaker 3

Of DB1305 is currently in a Phase III clinical trial for solid tumors. Then I have news from BNT116, Feen, our lung cancer antigen based sickvec candidate. A second trial with BNT-one hundred and sixteen has dosed its first patient of End of July. Together with our partner, Regeneron, we will evaluate BNT116 in combination with cimeplimab versus cimeplimab monotherapy alone in treatment naive patients with Stage 3b, Stage 3c of Stage 4 squamous or non squamous non small cell lung cancer patients with at least 50% PD L1 expression of Clinical Research and Developmental Phase 2 study. The Phase 1 clinical trial is ongoing with BNT116 of CNY-one hundred and sixteen alone and in combination with cemiplimab of In patients who have progressed on prior PD-one inhibitor treatment or are not eligible for chemotherapy And in combination with docetaxel in patients who have received prior PD-one inhibitor therapy and platinum based chemotherapy.

Speaker 3

Of We are planning to start several trials with our partners imminently. Firstly, building on compelling Phase I data of Pfizer BioNTech in the adjuvant setting that we recently reported in nature, of the Phase 2 trial with autogen sevomeran BNT122, our individualized cancer vaccine candidate of Stent with our partner Genentech, evaluating the efficacy and safety of autogen VUMERAN in combination with atezolizumab and modified folferinox compared of Pfalzyrinox as standard of care alone. 2nd, another trial is planned DUALITY BIO. BNT324 is a humanized antibody conjugated to a novel of DNA topoisomerase 1 inhibitor via a placebo linker. The Phase 1 part of the study will evaluate the safety in all comers of and determine the recommended Phase II dose.

Speaker 3

In the Phase II dose expansion part, we aim to evaluate safety and efficacy of Small Cell and Non Small Cell Lung Cancer, Esofacial Cancer, Prostate Cancer, Melanoma and Other Solid Tumors. On the next couple of slides, I want to summarize the recently presented data from 3 of our programs at the ESCO Annual Meeting. Of On Slide 14, starting with BNT 316 ONC392. Antibody targeting of of CTLA-four works primarily by depleting regulatory T cells and thus their suppression of tumor specific immunity. Of Physiologically, CTLA-four recycles continuously between the cell surface and the endosome.

Speaker 3

Interruption of this process by a binding antibody is associated with the development of autoimmunity. Of Autoimmunity and immune related adverse events are a major limitation of approved anti CTLA-four antibodies of CLL, that disrupts CTLA-four recycling by promoting lysosomal degradation of its important immune checkpoint of the molecule. BMG-three sixteen, in contrast, dissociates from the CTLA molecule in the endosome, of allows normal recycling of both the antibody and the CTLA-four molecule and thus is designed for stronger cancer therapeutic of Effect and Less Immune Related Adverse Effects. Preliminary data showed that BNT-three sixteen of CLLS is well tolerated with no dose limiting toxicities. The single agent recommended Phase II dose was determined to be 10 mg per kg of Without MTD being reached, severe immune related grade 3 adverse event rate in the combo dose escalation of Pembrolizumab was 23%, which is considered lower than what was reported for comparable IO, IO combination.

Speaker 3

The recommended Phase 2 dose for combination is 6 mg per kg. Overall, BNT316 Dosed as monotherapy and in combination was well tolerated and the safety profile appears to allow higher dosing for of Longer Duration of Treatment as Compared, For Example TO Epilevumab. Early efficacy data immunotherapy in platinum resistant ovarian cancer patients and in combination with pembrolizumab in multiple solid tumors were promising. Of Slide 15. With our colleagues from ONCO C4, we presented data from the Phase III study Investigating BNT-three sixteen in 35 non small cell lung cancer patients with metastatic lesions that progressed of Immun Checkpoint Inhibition in previous lines.

Speaker 3

The majority of patients had an e COGS status of 1. Of Clinical Research. The objective response rate was about 30% and disease control rate was 70%. Of Patients that responded to BNT-three sixteen had previously failed multiple lines of treatment, of the study, including several immune checkpoint inhibitors. In this cohort, PNT-three sixteen has shown manageable safety and tolerability of the company's clinical trial and the FDA's clinical trial.

Speaker 3

We will now begin the presentation of the FDA's clinical trial. Of Immune related adverse events of grade 3, 4 were observed in 34% of patients of Immunomediated Colitis, ALT A ST increase and immune hepatitis. Of PNT-three sixteen. Our findings support the further development of PNT-three sixteen in non small cell lung cancer in the Phase 3 study of PRESERVE-three. Slide 16.

Speaker 3

Our second presentation at ASCO was together with our colleagues from Duality Bio of And about our first clinical data for BNT323, our next generation HER2 targeting ADC. Of BNT-three twenty three is comprised of HER2 targeting antibody covalently linked to the proprietary DNA topoisomerase 1 Inhibitor via Ociva Belinka. Approved ADCs have shown antitumor activity and clinical benefit of Cancer. And we believe that midterm ADCs as a modality will become a broadly used backbone for combos in oncology. Of More efficacious and safer anti HER2 ADC, for example, regarding potential lung toxicity may add further clinical benefit.

Speaker 3

Of Preclinical data for BNT323 described a significantly improved therapeutic window as compared to of AT201A or TDM-one analogues to approve HER2 ADCs, trastuzumab deruxtecan and trastuzumab of Entrazine, respectively. BNT-three twenty three has a high drug to antibody ratio of the U. S. And when incubated with RAC, monkey and human plasma demonstrated outstanding plasma stability. Of In HER2 positive and HER2 negative mixed cell cultures, BNT-three twenty three inhibited the proliferation of both cell types, of demonstrating its bystander effect.

Speaker 3

Pharmacokinetic and pharmacodynamic analysis of BNT-three twenty three in xenograft mouse models showed targeted delivery of the toxin into tumor tissue. Of In vivo studies in monkeys showed a superior stability of BNT-three twenty three of the Toxin. Altogether, these properties result in maintenance of efficacy and reduction of Systemic Toxicity in Animal Models. Slide 17. The program has received Fast Track Designation from the FDA and is being evaluated in a Phase III clinical trial.

Speaker 3

The study is enrolling pretreated patients of Advanced on Metastatic HER2 targetable solid tumors. HER2 status is identified via of IHC or ISH for expression level via NGS for HER2 amplification or HER2 mutation. Of the study. The majority of patients had a HER2 expression by IHC of 2 plus or 3 plus. We showed preliminary anti tumor activity of In heavily pretreated HER2 expressing patients with a median of 7 prior systemic treatment lines, of the FDA's anti HER2 antibody therapy or anti HER2 TKI Therapeutics Therapy.

Speaker 3

In HER2 positive breast cancer patients, our objective response rate is 50%, of Clinical Research. In HER2 low breast cancer patients, objective response rate is 28%. The disease control rate is 84%. Anti tumor activity of BNT-three twenty three of Clinical Research. This was also observed in non breast cancer tumor types such as colorectal cancer, ovarian cancer of End Endometrial Cancer.

Speaker 3

Responses were observed in patients treated with different dose levels and HER2 expression status. Of BNT-three twenty three was well tolerated and all adverse events were manageable so far. Interstitial lung disease of Grade 1 occurred in 2 patients out of 85 patients. Expansion cohorts are ongoing in selected tumor patients of Treated at recombinant Phase II dose, and we expect further data this year. Slide 18.

Speaker 3

Finally, we presented data on our self ERP product candidate BNT-two eleven. We developed a highly sensitive second generation CAR targeting Chloridine 6 with high specificity. Of The carcinomaembryonic antigen Chloridine 6 is an ideal target for self therapy as it is absent in healthy tissues, of the clinical trials, but highly expressed in many high medical need cancers. To improve CAR T cell engraftment and persistence, C. We co developed a CAR T cell amplifying RNA vaccine or CAR VAC for short.

Speaker 3

The goal is to keep CAR T cells of Pharmaceutical Relevance Levels. In animal studies, we have shown that the persistence and effector function of CAR T cells of Can be further enhanced by repeated administration of CARBAC, of Nanoparticulate RNA Vaccine That Encodes Claudine 6. Cabac is based on our uredin nucleoside mRNAlipopax vaccine technology Mediate's body wide RNA delivery to lymphoid compartment resident antigen presenting sets. Of In multiple preclinical models, the display of a translated natively folded CAR target protein on antigen presenting cells of Mediated in vivo stimulation and controlled expansion of CAR T cells, induced a memory T cell phenotype along with higher target Sensitivity and Enable Tumor Control, Even If Subtherapeutic CAR T cell doses were administered. We are testing the safety, tolerability and activity of a combination of Chlorine 6 CAR T sets and CARBAC in a of Bifurcated Dose Escalation Study with increasing dose levels of CAR T cells and the fixed CARB X schedule of CLLS in patients with various cancer types that are called in 6 positive defined as more than 50% of tumor cells of Vif 2 to 3 plus intensity.

Speaker 3

Dose escalation has been completed for CAR T cells derived from manual manufacturing process, and we have presented data with highly encouraging of Clinical Activity and Manager with Safety at various conferences in the past. Of Slide 19. A subsequent cohort of 19 patients have been treated with a CAR T product manufactured with a Scalable Automated Version of the Process. No DLTs have been observed so far, including 6 CAR UCHealthcare. As well as CarpX were well tolerated, reflecting the safety profile detected in the first dose escalation level.

Speaker 3

Of The objective response rate was 41% for all 17 evaluable patients and 75% for 8 patients treated at dose level 2, namely 1xoneeight CAR T cells. Next to germ cell tumors, which dominated the 1st dose escalation, of We observed ovarian cancer patients responding. We are expecting an additional data readout later this year. Of Once we have determined the recommended Phase II dose for BNT-two eleven, we plan to initiate a pivotal trial in germ cell tumors, of Pfizer, which has already received prime designation by Beaumont. Advancing our pipeline remains a key strategic priority for the year.

Speaker 3

This and next year, we plan to transform our pipeline as we advance multiple programs towards the pivotal stage. Of I will now pass the presentation to our CFO, Jens Holstein.

Speaker 5

Thank you, Eslem, and a warm welcome to everyone who dialed into today's call. Before we go into the financial details for the Q2 and the first half of 2023. I'll start with giving you an overview on some key financial figures, which you can find on the next slide. Of Our total revenues reached €1,400,000,000 for the first half of twenty twenty three and are in line with our expectations, of Q2 being the expected weakest quarter in the year. Our COVID-nineteen vaccine revenues are, as stated and expected before, Sealy, heavily influenced by seasonal effects, especially now as we have summer in our biggest markets in the Northern Hemisphere.

Speaker 5

Of As we have outlined in earlier earnings calls, the revenue development for COVID-nineteen vaccines is expected to mimic a flu like setting. Of I will go into more details concerning our financial guidance in the course of the call, but want to emphasize already now that acknowledging the uncertainties related of the business. To reiterate our 2023 COVID-nineteen vaccine revenue guidance of around €5,000,000,000 for the full 2023 financial year. Of With €1,400,000,000 in revenues, we ended the 1st 6 months of 2023 with an operating result of 91 €100,000 and generated earnings per share on a fully diluted basis of €1.28 of Operations. With respect to the company's financial position, we ended the Q2 of 2023 with €16,800,000,000 comprising approximately €14,200,000,000 cash and cash equivalents as well as approximately €2,700,000,000 partly current and partly non current security investments, which are part of our investment strategy.

Speaker 5

Subsequent to the end of the quarter in July 2023, we received €1,100,000,000 in cash of Pfizer, settling our gross profit share for the Q1 of 2023 alongside with €400,000 received Until early August in connection with the amended COVID-nineteen vaccine purchase agreement with the European Commission. Of In connection with our acquisition of Insidi, which closed on July 31, approximately €450,000,000 were invested of Investor Relations. Overall, with this strong cash of the presentation. We are on track to launch our new variant adapted COVID-nineteen vaccine and intend to start multiple clinical trials across Oncology and Infectious Disease pipeline, such as the ones with OncoCy4 and Duality Biologics that Uke just mentioned earlier. Of Finance.

Speaker 5

I'll be moving to our financial results for the Q2 of 2023 as shown on the next slide. Our total revenues reported reached EUR166 of €66,400,000 for the 2nd quarter compared to €3,200,000,000 for the comparative prior year period of the company's financial results and decrease the corresponding lower COVID-nineteen vaccine market demand. Write offs by our collaboration partner Pfizer significantly reduced our gross profit share in the Q2 and hence negatively influenced our revenues for the 3 months ended June 2023. Of Let me move to cost of sales, which amounted to €162,900,000 in the Q2 of 2023 of the company's financial results, compared to €764,600,000 for the comparative prior year period. For the 1st 6 months of 2023, the cost of sales reached €258,900,000 compared to €2,100,000,000 for the comparative prior year period.

Speaker 5

Of The change is in line with the increasing COVID-nineteen vaccine itself. Research and development expenses reached of EUR373,400,000 for the Q2 of 2023 compared to EUR 399,600,000 for the comparative prior year period. Of For the 1st 6 months of 2023, research and development expenses amounted to €707,400,000 compared to €685,400,000 for the comparative prior year period. Our R and D expenses are mainly influenced By progressing clinical studies for pipeline candidates, the development of variant adapted as well as next generation COVID-nineteen vaccines of Regulation and the expansion of our R and D headcount. General and administrative expenses amounted to €100 €22,700,000 for the Q2 of 2023 compared to €130,000,000 for the comparative prior year period.

Speaker 5

Of For the 1st 6 months of 2023, G and A expenses reached €242,100,000 compared to €220,800,000 for the comparative prior year period. While in Q2, some cost savings have been achieved, G and A expenses for the 1st 6 months were mainly influenced by increased expenses for IT services as well as expanding the G and A headcount. Of Due to a loss making Q2 of 2023 and the tax effect of a reorganization of the intellectual property rights within the group, Income taxes with an amount of €221,800,000 was realized compared to tax expenses of €647,300,000 of the company's financial results. In total, for the 1st 6 months of 2023, income taxes were realized With an amount of €16,300,000 tax income compared to €2,000,000,000 tax expenses accrued for the comparative prior year period. Of The derived effective income tax rate for the 1st 6 months of 2023 were approximately minus 5.5 percent, of Which is expected to change over the 2023 financial year to be in line with the updated estimated annual cash effective income tax rate of Somewhere Around 21 Percent for the BioNTech Group, an improvement that I will elaborate on in a minute.

Speaker 5

As mentioned at the beginning, due to mainly seasonal effects of our COVID business, we recognized a loss during the Q2 of 2023, Eurow, amounted to €190,400,000 compared to €1,700,000,000 net profit for the comparative prior year period. Of For the 1st 6 months of 2023, net profit reached €311,800,000 compared to €5,400,000,000 for the comparative prior year period. Of Our loss per share for the Q2 of 2023 amounted to €0.79 compared to a diluted earnings per share of €6.44 Eurocent for the comparative prior year period. For the 1st 6 months of 2023, our diluted earnings per share was €1.28 CAGR 20.65 for the comparative prior year period. Now turning to the next slide, I would like to emphasize That we are updating the company's financial outlook for the 2023 financial year with respect to our planned full year R and D and SG and A expenses, of Finance and Wealth Management CapEx for operating activities, excluding effects caused by or driven Form in licensing arrangements, collaborations or M and A transactions.

Speaker 5

Please note that the following numbers reflect current base CAGR. We are currently in the market and are calculated based on constant currency rates and do not include further transactions that could occur in the second half of twenty twenty three. Of As stated before, we reiterate our estimated COVID-nineteen vaccine revenues of around €5,000,000,000 for the full 2023 financial year. Our guidance is based on the expectation that the demand in our vaccine will pick up in the year's 3rd Q4 along with our rollout of the adapted COVID-nineteen vaccine against XBB1.5. During the Q2 of 2023, the COVID-nineteen vaccine supply agreement with the European Commission has been amended.

Speaker 5

The agreed re phasing of deliveries annually through 2026 of will play an important role in the future as revenues will be recognized over the extended term. With the EC contract giving us a level of clarity In terms of revenue expectations, the demand and vaccination rates in other territories, as for example, the U. S. Market, remain uncertain regarding these metrics. Of Our collaboration partner Pfizer confirmed its plans to achieve its goals for their markets.

Speaker 5

Given their detailed plans to support an increase in vaccination rates in the U. S, we expect to achieve our revenue guidance range as previously mentioned. Of However, substantial uncertainties underlie the demand for COVID-nineteen vaccines in general as well as for all vaccines, Citi, the timing of its approval will have an impact on its demand. There has been no precedent on how COVID-nineteen vaccine rates will evolve But we assume that 2023 will be a very special one given the mentioned circumstances. It is our aim to move our clinical programs forward as quickly yet cost efficiently as possible towards becoming a multi product company.

Speaker 5

Of Finance. To do so, we have implemented further measures to increase cost consciousness, which led to a company wide cost optimization and hence reduction of our expected 2023 R and D, SG and E spend and capital expenditures. The increased flexibility at expenditure level of Clinical Research and Development Solutions will help us navigate through the just described uncertainties, while remaining focused on the development of the next wave of innovation in various fields and indications. Of As summarized for you on this slide, we update our R and D spending for the rest of 2023 from between €2,400,000,000 and €2,600,000,000 to between €2,000,000,000 2,200,000,000 including the R and D development costs identified from our latest publicly announced M and A activities. We also update our SG and A expenses from between €650,000,000 to €750,000,000 now to between €600,000,000 €700,000,000 and reduce our spending for growth and maintenance CapEx for operating activities €500,000,000 €600,000,000 to between €350,000,000 €450,000,000 As noted before, we have Investor Relations.

Speaker 5

We have also updated our group estimated annual cash effective income tax rate from around 27% to around 21%, of Excluding potential effects from share based payment settlements in the course of 2023. Following a reorganization of the intellectual property rights within the Federal Property Rights within the group. We recognize deferred tax effects in Germany and the U. S. Previously, unrecognized U.

Speaker 5

S. Federal and State Deferred Tax Assets, including unused tax losses and unused tax credits have been reevaluated and now recognized. Of the company. The recognition of these deferred tax assets lead to a decrease in the effective tax rate for the fiscal year of 2023. And with that, I would now like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategic outlook for 2023 and concluding remarks.

Speaker 5

Thank you.

Speaker 6

Thank you, Jens. I'll now provide a brief summary of the commercial outlook for our updated COVID-nineteen the Phase III vaccine launch and provide an update on our acquisition of InstaD before concluding with our strategic outlook for the remainder of the year and beyond. I I would like to touch on our key readiness activities that have put us in a strong position to execute on our planned launch this fall. On the back of the regulatory recommendation of XBV1.5 adapted monovalent vaccine, we and Pfizer have made more than 40 regulatory submissions in key geographies around the world. We are on track to begin vaccine distribution once regulatory approval is received with first shipments expected from September onwards.

Speaker 6

Of We believe Comirnatio is positioned to maintain its leading position in multiple key geographies. Most of the world will continue to be supplied under existing pandemic booster contracts. Excluding the impact of the U. S. This includes our contract with the European Union, our largest contract, which was recently renegotiated to extend to a period over 4 years.

Speaker 6

Pfizer. In the United States, we expect our 1st major commercial market opening, where we will leverage Pfizer's commercial capabilities. Turning to the next slide. This week, we announced that our acquisition of InstaDeep has closed following receipt of all required approvals. Of With the acquisition, we had world class AI and machine learning technologies and research capabilities to accelerate and enhance our broader strategic vision.

Speaker 6

Of The acquisition will bring over 290 data scientists, ML engineers and tech professionals to our team, positioning us to lead in this disruptive new field. Of In combining Instadip's AI and ML expertise with our own research and development capabilities, we aim to develop novel therapeutic and vaccine product candidates with increased Speed and Efficiency. We also see opportunities to leverage these AI and ML capabilities outside of R and D across other functions at BioNTech. This makes this a highly strategic acquisition with significant long term transformational potential across our firm. We will operate EnSedi as an independent Technology Subsidiary of BioNTech.

Speaker 6

On the next slide, we show the 3 pillars of value creation that we expect from this transaction. Of The first is to apply cutting edge AI and machine learning technologies across our therapeutic and vaccine platforms. We plan to connect these AI enabled discovery capabilities with automated lab infrastructure to enable high throughput drug discovery. While we do expect our overall AI investments to increase in the coming years, we do expect some mid term cost efficiencies from the acquisition of Financial Services by internalizing our largest AI technology and services provider. Finally, we will continue to operate Insadip's 3rd party business, which delivers technology solutions and services to external customers in the technology sector and other industries.

Speaker 6

We are excited to kick off the next phase of our collaboration with the leadership and bright minds at InstaDeep and believe that together we can become a global leader in applying cutting EDGE, artificial intelligence and machine learning technologies to discover, design and develop next generation immunotherapies at scale. Of The next slide provides an overview of our expected pipeline news flow for 2023 2024. Some of these points have been covered, so I won't go through them all in detail here. With the collective efforts and dedication from our teams, we have achieved remarkable progress for several of our product candidates. Of Clinical Research.

Speaker 6

At this year's ASCO Congress, we presented data for 3 of our pipeline candidates. We're on track to share additional data updates across a range of technologies later this year. Of In June, we initiated our 1st Phase 3 trial in oncology. Additionally, we started a Phase 2 trial for one of our fix back candidates in collaboration with Regeneron, of Focusing on first line NSCLC. As Aslan has elaborated, we anticipate initiating several further trials in the near future.

Speaker 6

On the next slide, I'll summarize the strategic outlook for the remainder of the year. We are on track to roll out our new variant adapted COVID-nineteen vaccine in the coming month. Of We also plan to initiate multiple registrational oncology clinical trials while expanding our infectious disease pipeline. With the Insitube acquisition now closed, we intend to rapidly scale up our activity in AI enabled drug discovery and we'll continue to Execute transactions to expand our innovation ecosystem and execute on our corporate development strategy to in license complementary assets. Before concluding and opening up the floor for questions, I'd like to reiterate that we will hold our innovation series event on November 7.

Speaker 6

Of will provide further details on the event in the coming weeks. With that, I would like to thank our shareholders for their continued support. And I'll conclude our prepared remarks and open the floor for questions.

Operator

Of AmOne on your telephone and wait for your name to be announced. In the interest of time, please limit yourself to one question only. To withdraw your question. Of Star 1 and 1. We will now go to your first question.

Operator

One moment please. Of And your first question comes from the line of Dana Graybosch from Leerink Partners. Please go ahead. Of

Speaker 4

Yes. Thank you for the question. I have one on ONC-three ninety two. Of the Phase 3 that you have started, the name of it, is different in design from the Phase 2 of Inclusion Exclusion criteria. And I wonder if you could talk about why the differences and why you of decided to go forward now in a Phase 3 with single agent CTLA-four rather than gathering more data and doing a combination study with PD-one or any other agents in this pretty hard to treat and difficult to do trial setting.

Speaker 4

Of

Speaker 2

Vina, hi, here is Ugo. Thank you for the question. Of So as you know, the Phase III study collected data in different combinations of And we have seen single compound activity in non small cell lung cancer in patients who had of and progressed on the first line checkpoint blockade treatment. Of This were encouraging objective response rate around 35%. We do not see an added benefit in combining that with the current status quo, which is chemotherapy, of And therefore decided in also with favoring of A clean safety profile to go with a single compound alone.

Speaker 2

And the patient population that Have been selected for the study and reflects historical patient populations with regard to the inclusion and exclusion criteria.

Speaker 4

Of Luca, perhaps a follow-up. I think the difference, and tell me if I'm wrong, was the length for which of the patients could have received a prior checkpoint. That it's a lot you're requiring a longer prior checkpoint than you of Phase III than you did in the Phase II. Since some Phase II patients wouldn't be eligible for Phase III, do you expect any Negative Impact.

Speaker 2

Yes. Dana, the protocol has also emerged of Based on discussion with the FDA and FDA's request.

Speaker 4

Got it. Thanks.

Operator

Of of Citi. Your next question comes from the line of Tazeen Ahmad from Bank of America. Please go ahead. Of Citi.

Speaker 7

Hi, good morning and thanks so much for taking my question. Just for point of clarification, as you think about the rest of I know you talked about the difficulties involved in really getting a sense for the trends. But When you decided to maintain guidance at least for now, what key factors are you taking into account that gives you confidence That sales will be or revenues rather will be at least close to, if not at the €5,000,000,000 mark. And I think that's probably the best question for Orion to answer. Thanks.

Speaker 6

Yes. I'll start to Zien and Jens should also chime in here. I think the starting point here was that we are expecting the total volume of COVID vaccines in the fall to be down. You may remember that last year we had of Distributed more than 500,000,000 doses of our B4B5 variant adapted vaccine globally. And for the full year last year, we had of The market in the United States was about 144,000,000 doses.

Speaker 6

We are expecting those numbers to come down both in the United States and globally. So we factor that in. However, we also expect that in the United States that we're going to see a commercial market opening, so a higher price point. Of Along with Pfizer have talked about a gross price in the $110 to $130 range. That's our expectation.

Speaker 6

Of So higher price point in the U. S. And much of the rest of the world, we're still expecting contracts that have already been signed of to be the primary sort of contractual mode governing the second half of deliveries, but demand will still matter. So in the rest of the world, we're still expecting effectively continuation of the booster contracts, and that's factored in as well.

Speaker 5

Of Yes. Maybe Tazeen, just to add, I mean, Ryan basically described the situation. And I think we made some statements in our speeches as well in that respect. Of And of course, a situation like we currently see hasn't been seen before for any product so far. Patients have received and of People have received multiple vaccinations in the last 2 years.

Speaker 5

And of course, there is some level of tiredness, so to say, on getting vaccinated. Of But we see the need for further vaccinations. And I think specifically for the U. S, You've heard probably some of the plans that Pfizer and as well as our competitor, Moderna, has announced of How the expectations will be going up for the rest of the year to pick up with the vaccination rates. Of So in that respect, the next couple of months, the next 2, 3 months will give us a good sign of How the year will end.

Speaker 5

There is some uncertainty. We just wanted to make that clear. And We see 2023 as a very special year though too, I have to say so. From our perspective, of That situation that people have received multiple vaccinations and now are maybe a little bit tired of has to grow into a market where you have annual vaccinations. And I think it gives 23 gives us some indication, but we also believe there will We have further increased potential from our perspective for 2024 and the other years, just given the specific situation that we now have of in this year with 2 years of multiple vaccinations for people.

Speaker 3

Okay. Thank you.

Operator

Thank you. We will now go to your next question. Of Financial Partners. And your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Operator

Of

Speaker 8

Everyone, thanks so much for taking our question. This is Amy on for Akash. So Pfizer has alluded of to an enterprise wide cost cutting program, particularly around COVID, if long term vaccine demand ends up being modest. Of How would Pfizer's cost cut change your long term OpEx on your COVID programs and spend more broadly? And on a related note, can you go over what's of Change in Your New 2023 OpEx and CapEx Guide.

Speaker 8

We're seeing that BN241 isn't on your pipeline side this quarter. Of Are there any other components that maybe driving these cost cuts? Thanks so much.

Speaker 6

Yes. Thank you for the question. So I'll speak to the OpEx point and then of Opine on what's driving the cost lines in our guidance. But on the OpEx side, the short answer is no. And actually of One of the unique features of our economic model for COVID-nineteen is that our OpEx is very lean.

Speaker 6

Of So as you may recall, we get a gross profit share on every COVID vaccine dose produced and delivered of Through the Pfizer partnership and only in Germany and Turkey do we book top line product sales and actually have significant OpEx of Only in those two countries. So that does translate into a very differentiated profile across our P and L. And I think you see some of that leanness reflected in the numbers that we've of disclosed today. Jens, do you want to speak to the drivers of the costs

Speaker 5

that you expect? Yes. I mean, for us, We, of course, can only talk for us, yes, and we cannot talk about Pfizer and their cost cutting plans that they have announced in the earnings call. So far from our perspective, we see a little bit less spend for the of collaboration with Pfizer in the course of 2023. But we also have a close look on our own spending in the areas of oncology, of For example, or in building up production capacities.

Speaker 5

So those have been specific areas where we of Just look at controlling our costs going forward to have more flexibility.

Operator

Of Great. Thanks so much. Thank you. We will now take your next question. Of Finance.

Operator

And the question comes from the line of Chris Shibutani from Goldman Sachs. Please go ahead.

Speaker 9

Of Yes. Two questions, if I can. 1 on the pipeline and the other more financially related. On the pipeline, BNP-one hundred and twenty two first metastatic melanoma seemed a bit conspicuous in terms of the absence of mention in the press release and in prepared comments. I do see it in the pipeline table.

Speaker 9

Have your expectations for this trial changed? I believe we should still be expecting updates in this balance of this year. And then I have a follow-up on financial.

Speaker 6

Of Yes. Thanks, Chris. Let me start on the BNT122 and Ruben Orson can also chime in here. So we've reiterated of our guidance for an update later this year. We still intend to provide that.

Speaker 6

Of I think on a previous call, we had also mentioned that the full PFS analysis would be triggered of Clinical Research on an event basis. And the fact is we still haven't met that event trigger reached that event trigger, which does mean that we're not in a position right now of To be specific about the full data that we're likely to bring out later this year. So we do intend to provide an update before year end, But I think it's likely that there won't be a full data update. So more to come on

Speaker 3

that. Yes. I can just echo of What Ryan said, gathering these events is not entirely under our control. Of And therefore, we at this point cannot forecast when we will be able to of the data interim analysis data point.

Speaker 9

Got it. And then on the financial follow-up, of Very healthy cash balance, obviously, post COVID. And we are watching the decisions you're making on the capital allocation front. Of The Insta Deep is an example of that. And Ryan, you mentioned during the call, you look to intend to continue to in license assets.

Speaker 9

Can you give us a sense for potentially any areas that you feel either disease area, modality, of Size. A lot of these have been smaller and InstaDeep was a little bit more kind of adjacent as opposed to immediately obvious. Just be helpful to get a sense for what of this mosaic is that you're creating given your capacity.

Speaker 6

Yes, absolutely. Absolutely, Chris. So As you see from the deals, we've announced this so far this year that we've allocated a little bit less than $1,000,000,000 in terms of upfront payments of across the InstaDeep transaction and then several in licensing deals for several assets that we talked about today. Of So I think in that sense, InstaDeep was a sort of strategic exception. We thought that was a very unique opportunity.

Speaker 6

I wouldn't expect that that would be one that would be replicated of As such, but I think the licensing deals and small scale M and A, I think you can expect us to continue to operate of Along the same lines is what you've seen so far in the first half of the year. So relatively small deals of That's our sweet spot, under $1,000,000,000 is our sweet spot. We will look at and consider larger deals, but that's I think it has to be a very, very good strategic fit for us to make a larger move. We do see opportunities in that sub-one billion dollars range to further bolster the pipeline. And in terms of focus areas, of Yes.

Speaker 6

As you've seen so far in the first half, IO differentiated IO assets are going to continue to be an area of focus.

Speaker 9

Of Great. We'll look for more insights on your Innovation Day. Thank you.

Speaker 6

Thank you.

Operator

Thank you. Of Financial Partners. We will now go to the next question. And your next question comes from the line of Johan Verba from TD Cowen. Please go ahead.

Speaker 10

Hi, guys. Thanks very much for taking the questions. This is Brendan on for Yaron. Just really quickly wanted to also ask maybe about the potential flu COVID combo approach here. First, I guess, when you think we might see data of From that study, but also maybe a little bit more broadly kind of what the path forward is for this combo.

Speaker 10

And really, I guess, trying to understand with each updated booster, how this would kind of play out here. Just kind of trying to get at Sanofi kind of cast some of a little bit on the whole mRNA approach, obviously, from their own perspective, but really how you're kind of thinking about mRNA fitting into the whole code flu combo space from what you're seeing at this point? Pfizer.

Speaker 6

Yes, sure. I'll start. So as you know, Pfizer currently has an ongoing Phase 1 study of a flu COVID combo vaccine. Of And they also have a Phase 3 study ongoing of their flu mRNA flu vaccine, which we've licensed the technology to them. We still retain some Economics on the program, but they're in control and driving that program forward, the mono program.

Speaker 6

So we do see opportunity for a combination I think in terms of timeline, Pfizer has guided to a potential Phase 1 data update this year of Clinical Research and Development Solutions for the combination. And they've also guided to near term Phase 3 data on the full mono, Both of which I think will be relevant data points here to help inform the next stage of development. The last point I would add is just that Pfizer has indicated, I think The last couple of days that or they've reiterated that they see a flu both a flu mono and also flu COVID combo being starting to become relevant 2020 4 onwards. So not something to look at this year, although I think positive data could obviously be a helpful

Operator

of of Stifel. Your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

Speaker 10

Of Citi.

Speaker 11

Great. Good morning. Thanks for taking the question. Just was wondering if you could elaborate more on the rationale to advance of BNT116 into the metastatic setting, while in INEST. I know you've talked more about the potential there in the adjuvant setting.

Speaker 11

So just wondering if To kind of compare and contrast those two approaches. Thank you.

Speaker 2

Yes. Thank you. The question is highly relevant. It's of the study. And the 6 pack approach is based on the off the shelf availability of the vaccines.

Speaker 2

That means in the metastatic setting, the disease is rapidly progressing. We would like to get of As quickly as possible, an immune response initiated. And personalized vaccine, in class vaccine approach requires of around 4 to 6 weeks for preparation of the vaccine and is particularly suited for the adjuvant setting. And because in the adjuvant setting, there is a longer time frame before patients progress. So that gives us the opportunity to build an immune response of That can counteract potential progression of disease.

Speaker 2

Therefore, all these adjuvant trials that we have as an endpoint, we left free survival

Speaker 5

of as an endpoint, whereas

Speaker 2

in the metastatic setting endpoints will be, for example,

Speaker 3

of

Operator

of of Financial Partners. And your next question comes from the line of Bill McGahn from Canaccord. Please go ahead.

Speaker 12

Of Hi, thank you. So, I have a question on, self amplifying RNA. I know that of You had been developing few programs with your self amplifying RNA and it's kind of not center stage anymore, but several other companies that are earlier in their cancer vaccine development are using self amplifying RNA and kind of singing its praises. So I was just wondering of If we could expect self amplifying RNA to occupy some more of the spotlight and maybe be advanced

Speaker 2

Yes. Thank you for the question.

Speaker 5

As you know, we have

Speaker 2

of 2 mRNA amplification programs. It's a self amplifying mRNA program as well as the trans amplification program. Of We have observed and if you look closer into the data and to publish data of other groups, we have of. Observe that the SAD amplifying mRNA in humans are limited in the full response of On innate, quick initiation of innate response and hindering of the full capacity of self amplifying mRNA. And we are working on an improved approach overcoming this of Immuno Response Limitation on a transamplifying mRNA platform, which comes which combines of Two advantages, the advantage of safety.

Speaker 2

So the replicate itself is not amplified. It of Provides only trans mRNA activity and the target mRNAs are amplified. We of Thereby separate the target mRNA and the replicate mRNA and have the opportunity to combine multiple targets. And this is something of We made a lot of progress in the preclinical setting, and we will report end of this year here on this platform, particularly with of Resideo Suitability in the infectious disease setting, particularly in the setting of combination vaccines. Of

Speaker 6

Thank you.

Operator

Thank you. We will now go to the next question. Of Financial Partners. And your next question comes from the line of Ellie Merler from UBS. Please go ahead.

Speaker 4

Of Hi, guys. This is Sarah on for Ali.

Speaker 7

Thanks so much for taking our question. I guess a quick one on of 211 and the data update later this year. What are the expectations for data there? And what are you guys hoping to see? Thanks.

Speaker 3

Of Thank you for the question. So we have an ongoing Phase III Trial. And we have had a couple of data updates this year and 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 of CABIC and in combination with our CARBEC vaccine, also data on clinical activity of In additional clinical indications, we have been very focused on testicular cancer in the previous updates.

Speaker 3

Of 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 of those responses and how use of a vaccine impacts them. Of of Financial

Operator

Partners. And your last question comes from the line of of Simon Baker from Redburn. Please go ahead.

Speaker 13

Thank you for taking my question. It relates to the PRESERVE-three study. It's Two stage Phase 3 study. So I just wanted to get some idea of what data you will be presenting of At the conclusion of Stage 1, and any timing that is indicated based on your expectations for of And I see the clinical trials is showing a of Primary Completion in mid-twenty 26. Is that a reasonable estimate at this stage for the final data at Stage 2?

Speaker 13

Thanks so much.

Speaker 3

Of I didn't fully get that, Simon. Was this about data expectations for the ongoing ONX or ONX-three ninety two trial.

Speaker 13

Of Yes, it was. Because it's a 2 stage study. So I wondered what data

Speaker 3

of So it will be of Safety Data and Clinical Activity Data in different tumor indications.

Speaker 2

Of No, no, this is I think it's lung cancer trial.

Speaker 3

Sorry, I forget that.

Speaker 2

So we expect around 2025 of Our data and safety data. Now we have started the clinical trial with 2 different doses. We will select 1 dose of to continue. And it's a staged approach based on the OR data and initial assessment of the PFS, the Clinical trials that continue for

Speaker 5

full maturation.

Speaker 2

Great. Thanks so much. Thank you.

Operator

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.