Q3 2024 CureVac NV Earnings Call & Business Update
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Speaker Change: Corporate communications and Investor Relations. Thank you you may begin.
Speaker Change: Thank you good morning, good afternoon.
Speaker Change: Welcome Joe Conference call. My name is sort of a function of the vice president of communications.
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Speaker Change: <unk> expectations or predictions on vacation.
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Speaker Change: These statements involve risks.
Speaker Change: Certainties that could cause actual results to differ materially from.
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Speaker Change: For more information please refer to all parties in the U S Securities and Exchange Commission.
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Thank you ladies.
Speaker Change: Ladies and gentlemen, good morning, good afternoon, Chad we bought on the webcast.
Speaker Change: First nine months and particularly the third quarter of 2024 marked a turning point for sure that we make.
Speaker Change: She's been in progress along 2024 priorities, taking decisive steps to rightsize the company streamlining our processes and improving our business operations.
He has successfully delivered on key milestones, including a new licensing agreement with GSK announced in July.
Speaker Change: This agreement valued at up to four 5 billion euros includes an upfront payment of 430 euros, which is fully booked in the third quarter.
Speaker Change: Additional potential milestones and royalty payments from this agreement are expected to provide significant capital going forward, but strongly betting maybe I'll write them on H X dollars.
Speaker Change: Alongside this we lost our corporate redesign, including that lots, a 30% reduction in workforce, which will be three days.
Speaker Change: Here this.
Speaker Change: These efforts helped us to reduce costs, while maintaining a strong focus on research and development.
Speaker Change: Looking ahead, VSAT crazy doesn't priorities with a sharp focus on high value indications about college and infectious diseases.
Speaker Change: In oncology, our phase one study in Glioblastoma.
Speaker Change: Ownership preliminary data showing the potential of alright, Martin <unk> technology in this highly aggressive cancer.
Speaker Change: Today, we are disclosing a new cancer vaccine program targeting squamous non small cell lung cancer, expanding our off the shelf cancer vaccine pipeline in.
Speaker Change: In infectious diseases, we launched a new program.
Speaker Change: Now he can tract infections or UTI S wants to go that's most calling in fish.
Speaker Change: This program is a critical unmet medical need driven by recurring infections and the increase in prevalence that we.
Speaker Change: We see it against.
Speaker Change: Against your pathogenic E coli.
Speaker Change: Do we have the primary causes of these infections.
Speaker Change: I do see I program exemplifies our focus on leveraging our technology for I guess high unmet need with significant commercial potential.
Speaker Change: On slide five you can see these achievement in the context of our transformation journey.
Speaker Change: I started in April 2023, we conducted a thorough analysis identifying key areas to improve our financial discipline, reducing unneeded Anthony.
Speaker Change: Sure and focusing the organization.
Speaker Change: Net R&D in.
Speaker Change: In 2024, we are executing on these insights we have launched ultra clean design, which is on track for that.
Speaker Change: Workforce reductions.
Speaker Change: This year.
Speaker Change: Compromising our R&D and manufacturing capabilities operational expenses are expected to decrease.
Speaker Change: Starting in 2025.
Speaker Change: Florida.
Speaker Change: Your upfront payments from our new licensing agreement with GSK was fully booked in the third quarter, providing us with a strong cash position of 551 million euros I can understand tender and resulting in a net profit for the first nine months.
Speaker Change: As we approach the end of 2024, we got a leaner more strategically aligned and financially.
Soma and from this position of strength.
Speaker Change: Research and development activities with a focus on high value opportunities in oncology and infectious diseases.
Speaker Change: On slide six we outlined the pipeline expansion in both oncology and infectious diseases.
Speaker Change: Valenti Shlomo that less a pipeline expansion spans both off the shelf and personalized cancer vaccine.
Speaker Change: For the off the shelf cancer vaccine Cheniere is closing a new ship LPG has the vaccine program in squamous non small cell lung cancer, which will include novel anti antigenic derived from our proprietary antigen discovery.
Speaker Change: We are preparing for ISDN Cta submission in the first half of 2025 and expect to start a phase one trial shortly thereafter.
Speaker Change: Discovery activities for additional shut antigen programs continue with a second plenty for Kathy than expected at <unk> 26.
Speaker Change: Preclinical development of a fully personalized cancer vaccine candidate is also progressing the defendant candidate expected to happen in the second half of 2012 6 billion.
Speaker Change: In infectious diseases. We also following that strategy I think not our most advanced program <unk> respiratory diseases to GSK by focusing our proprietary programs, primarily anonymous switchover diseases with high unmet medical needs.
Speaker Change: We have launched a new program to a unit that retract infections, which are because most common infections and Meanwhile represents the promising preclinical data for this program later in the presentation.
Speaker Change: Congratulations it is adopted as delighted.
Speaker Change: Chief Financial Officer, Mike Some bottlenecks on Joseph Kim that just yesterday on apologize on behalf of <unk>.
Speaker Change: Okay.
Speaker Change: Actual based off of 30 years of experience across both the corporate banking sector of our industry. This defect and deep expertise will be crucial for the next chapter for <unk> as we advance our strategic initiatives.
Speaker Change: Our financial Foundation, Axel would you like to say few months.
Axel: Thank you.
Axel: Thank you.
Axel: Everyone on the webcast and conference call.
Axel: Truly excited to join in here of that in Q1.
Axel: This pivotal moment as the company's evolution.
Axel: At least two way voice to make continued remarkable progress.
Axel: The development in Hollywood.
Axel: Based on assets.
Axel: Our expertise in financial management and corporate growth.
Axel: Good days that can help drive you back mission forward.
Axel: So its future success.
Speaker Change: Thank you Exxon as we continue to believe fault what have we got business our pipeline priorities, it's important to highlight.
Speaker Change: Sure. Thank you Heath on slide eight you can see the key strategic and technological differentiation.
Speaker Change: Sure like as part of the mrna.
Speaker Change: In terms of strategic Differentiators, we havent dual strategy and are currently working on both off the shelf and personalized cancer vaccines to cover a wide range of cancer types.
Speaker Change: Use a similar approach in infectious diseases, where we are focusing on.
Speaker Change: Pricing programs for non respiratory diseases.
Speaker Change: Finally, the kindred fungal infections, while we have out licensed our respiratory disease progressed to GSK.
Speaker Change: Our scalable manufacturing capabilities, including the RNA printer gives us the flexibility to produce critically go ahead, Chris go trying tears efficiency and how strong the next property portfolio and further supports our innovation by protecting our technology.
Chris: In terms of technology differentiate this oral precision mrna backbone they spilled on 20 years of experience.
Speaker Change: He has designed highly efficient mrna construct that improved protein expression and low dose efficiency.
Speaker Change: College, even they have a unique ability to discover new classes of anti jam, which face way, where you don't have cancer treatments.
Speaker Change: Work on advanced lithium battery, particularly the system tailored for specific indications.
Speaker Change: <unk> aims to enhance.
Speaker Change: The effectiveness and stability seems to get a DC plan.
Speaker Change: This gives us a strong competitive position, Brian but to get options flow into credit sensitive patients.
Speaker Change: Slide nine shows how our differentiated Steve directly into the key focus areas of oncology and infectious diseases or <unk>.
Besides mrna backbone that proprietary different symptoms.
Technology platform, which is continuously evolving PTH deliver best in class products.
Speaker Change: Focusing on development efforts on high potential areas in oncology and infectious diseases, we have positioned.
Speaker Change: Ourselves to deliver impactful solutions.
Marry: Now over to marry up to explain how maturing these technologies into a strong pipeline.
Speaker Change: Pipeline.
Marry: Thank you Tom and good afternoon to everyone moving on to Scott.
Marry: Ken.
Ken: Our most recent pipeline, which reflects our focus on strategic accounts to high value development programs and to patients.
Ken: Our existing programs and new programs discussed today demonstrate our commitment to making indications mrna technology can make a substantial difference, it's nothing I'm Mick and clinical need.
Ken: Market opportunity.
Ken: In oncology, our existing timeline for off the shelf cancer vaccines.
Ken: Phase one study in patients with Glioblastoma.
Speaker Change: Thank you.
Speaker Change: Recently provided data from the completed dose escalation class eight.
Speaker Change: The study started enrolling the dose confirmation kind of be in August for.
Speaker Change: Testing the recommended dose of 100 micrograms and enrollment is progressing that we also announced a new program with an off the shelf cancer vaccines to treat patients with squamous non small cell lung cancer.
Speaker Change: I can tell you that to be tested and quotes on new angiogenesis coverage with our proprietary antigen discovery platform.
Speaker Change: And in fact in this area our most advanced programs cover territory indication fully licensed to GSK.
Speaker Change: So that is the season that influenza avian influenza and COVID-19 are based on <unk> proprietary second generation MRI and are currently in phase two development.
Speaker Change: GSK announced positive headline data for England and transact.
Speaker Change: <unk> strong antibody titers against influenza a.
Speaker Change: And most importantly.
Speaker Change: Tony has been challenging influenza b strain compared to the edge.
Speaker Change: And on that one.
Speaker Change: Got it.
Speaker Change: Is that a net.
Speaker Change: We define success criteria and she is clearly process that the program is progressing to phase III.
Speaker Change: Based on the validation of our platform in infectious diseases, we launched a new proprietary program to develop an elective vaccine against gearboxes any E. Coli the primary cause of urinary tract infection, which ranked among.
Speaker Change: The most common infections were by.
Speaker Change: I will go into more detail later in the presentation.
Speaker Change: And does that equity Carryout and when we can attack Keith why they collaboration within seconds IV sepsis acute ocular disease and.
Speaker Change: Most recently Italian name that we continue to develop optimized and R&D activities in different areas.
Speaker Change: We are committed to focus on the highest nine months connecting indications right now.
Speaker Change: Technology can outperform conventionally pulses guided by our mission to advance innovation and dentists and Catherine has solutions.
How does that.
Speaker Change: We get deeper into our oncology strategy, where we see tremendous opportunity for an RNA cancer vaccine to bring precision immunotherapy to Nash patient population.
Speaker Change: We have made significant progress in advancing our two pronged strategy.
All of the shares and cause lung cancer vaccine development.
Speaker Change: As a brief reminder, the off the shelf assets.
Speaker Change: Pipeline targets tumor antigens that are scattered across different patient population and also mortality.
Speaker Change: There's been no fall off and despite the existing immune responses in different cancer settings, including advanced stages of cancer.
Sydney CDN: Sydney CDN.
Sydney CDN: Currently clinical candidate is currently being evaluated in a phase one study in patients with refractory <unk>.
Sydney CDN: A lot and coding known Andy Chien relevant to this highly aggressive fighting cancer.
Sydney CDN: Our next generation anti jam cancer vaccines, including the one in squamous non small cell lung cancer feature novel Anticancer cabinets.
Sydney CDN: <unk> antigen discovery platform as well as part of our pipeline candidates.
Sydney CDN: Candidates in 2025 and 2026.
Sydney CDN: And finally, not as yet and defense market.
Sydney CDN: And our global collaborations and we aim to make a vaccine, even north, Texas and reducing the risk of tumor recurrence.
Sydney CDN: Importantly outcomes for patients in different cancer settings.
Sydney CDN: Okay.
Sydney CDN: Currently strategy applying Tesla Cassa <unk> E <unk>.
Sydney CDN: Oh Gee on sequencing of individual patients to monsanto's combined with advanced bioinformatics is utilized by identifying new antigens and or nothing that I.
Sydney CDN: Associated antigen.
Sydney CDN: <unk> two of patients immediately genomic tumor profile.
Sydney CDN: This precision medicine, <unk> increases the likelihood of having two anti <unk> susceptible to immunotherapy.
Speaker Change: To provide the cherokees, apollo's, especially advertising, especially on what to model.
Speaker Change: That's kind of the strategy is complemented by the RNA transact our solutions for SaaS and bottlenecks of manufacturing.
Speaker Change: We made excellent progress with our oncology pipeline as we presented data from our clinical program with the off the shelf.
Speaker Change: Vaccine candidate <unk>, which was tested in the phase one study in patients with <unk>.
Speaker Change: With my new colleagues in EQT and Ctrip are uniquely designed into our modified mrna.
Speaker Change: In Kuwait, a mems device for us.
And my associated MTN demonstrate immunogenicity NBA basketball.
Speaker Change: It was administered at the moment therapy after surgical resection and completion of IV therapy.
Speaker Change: As a result of chemotherapy.
Speaker Change: Patients who received <unk> in Shanghai.
Speaker Change: Since the downturn beliefs and optional maintenance destination in case of non progression of potential benefit.
Speaker Change: Preliminary safety and Immunogenicity data from the dose escalation impact a of the study were recently presented at the National Safety Congress.
Speaker Change: In this highly challenging and aggressive cancer type the data on some of the favorable safety and Tolerability profile with no dose limiting toxicities junk physically just in this part of the cycle.
Speaker Change: Successfully vaccine antigen specific T cell responses.
Speaker Change: As stated in the vast majority of Evaluable patients.
Speaker Change: 77% of patients are in Europe.
Speaker Change: <unk> and <unk> T cell response to one of the uncoated anti Janice on the vaccine.
Speaker Change: We think the growth is very low.
Speaker Change: Other patients.
Speaker Change: 12% of immune responses.
Speaker Change: De Novo new T cell responses that successfully induced in patients who had no pre existing decent activity and get against encoded antigens commented back to Nathan.
Speaker Change: <unk>.
Speaker Change: Additionally, 67% of responding patients.
Speaker Change: <unk> again, you might have to put in colon cancer, and so far with our anticancer vaccine is successful and <unk>.
Yes.
Speaker Change: At the highest tested dose of 100 microgram.
Speaker Change: Ongoing <unk> shows that responses are sustained over a period of 99 days.
Speaker Change: The 100 microgram dose.
Speaker Change: So that's the combination of this balance which began enrollment in August.
Speaker Change: I felt like I read our proxy is expected in the second half of thank you Pat.
We continue to advance our oncology pipeline and that's the key we have summarized our upcoming oncology candidate, which provided strongly better fantastical havent entertained phone line.
Speaker Change: Starting with our most advanced baseline off the shelf program and does that appear that it's already mentioned and enrollment of the dose confirmation that we often site progressing well.
Speaker Change: And all of that will be continued consolidated some nacelle secondary site, allowing for Titan data.
Speaker Change: In the second half of 2025.
Is that from an ambition occupying the patients dosed at 100 micrograms will provide the basis for potential consumers continuing to a phase III study with.
Speaker Change: Could start in the second half of 2006.
Speaker Change: The newly announced off the shelf program in squamous non small cell lung cancer is expected to enter phase one clinical development in the second half of 2025.
Speaker Change: With our proprietary antigen.
Speaker Change: Continuing medium size of the store addition office has programs with new clinical candidates in different indications and France, China sticks.
Speaker Change: Lastly, the first phase one study with a personalized cancer vaccine candidate is expected to start in the second half of 2026.
Speaker Change: These strong catalyst highlight our strategic focus on opportunities in oncology and encouraging our R&D technology between designed to ensure continued progress and innovation now oncology paybacks.
Let me now shift gears in terms of the infectious disease area.
Speaker Change: And infectious diseases, we are divesting our current proprietary research and development efforts.
Speaker Change: Non respiratory indications, while benefiting from the ongoing clinical development of respiratory indications with current programs licensed to GSK.
Speaker Change: Obviously, not as part of our infections caused by bacteria viruses and finite we aim to deliver safe and cost effective in.
Speaker Change: A high unmet medical need areas with components not compelling market potential we have our in R&D technology, almost an advantage from a conventional vaccine technologies.
Speaker Change: In this area. We are excited to introduce a new fully owned infectious disease programs targeting Europe pathogenic E coli in Australia and Japan.
Speaker Change: <unk> is the primary cause of urinary tract infection, which ranked amongst the most common infections caused by.
The statistics are presented on slide 16 highlights the significant is it.
Speaker Change: And disease burden associated with UK and the U S.
Speaker Change: Hi, Brad Allen of UTI with more than 50% of patients requiring antibiotic therapy, leading to increased understanding I think resistance and high rate of recurrence presents as a central silence and current medical practice.
Speaker Change: This means that in direct medical costs, reaching billions of dollars annually in the U S alone.
Speaker Change: Currently there are very limited treatment options to prevent recurrent utis, our mrna technology has the potential to deliver best in class solution, including inducing functional antibodies as well please.
Speaker Change: Against the pace.
Speaker Change: Protective disinfection.
Speaker Change: Yes.
Speaker Change: And R&D taxi cabs, and colors, and H <unk> controller fusin for adhesion after bacteria to blood or tissue and biofilm formation.
Speaker Change: H is highly uncertain and will take time, and therefore represents an excellent vaccine target for the vast majority of patients.
Speaker Change: Our vaccine candidate in preclinical studies.
Rational antitank designs to optimize immunogenicity.
Speaker Change: In addition, we have applied a unique technology to me my understanding that you alluded to the in vivo set assembly of state.
Speaker Change: <unk> not a party to this.
<unk> innovative design.
Speaker Change: To lead to even higher Immunogenicity.
It sounds very promising preclinical data.
Speaker Change: With two of our Fabulous.
On Slide 16, you can see the first clinical data, which are currently being presented at the <unk> conference taking place this weekend.
Speaker Change: We tested all vaccine candidates and two preclinical models with LLS and biopsy minds in comparison to non licensed recombinant proteins vaccines.
Speaker Change: Writers are finding and functional antibodies, meaning antibody inhibiting origination.
Speaker Change: And given the occasions when measured in both modest year over year incentives. Additionally, CBA and CD four T cell responses.
Speaker Change: In mice.
Speaker Change: <unk> and RNA vaccine candidates and due to high levels of finally antibody titers in blood and urine in both models.
Speaker Change: Correlated with Hi, Akshay antibody Titan Europe.
Speaker Change: Importantly, functional serum antibodies tiger with both can RNA vaccine candidate contacts to the propylene based comparison vaccines.
Speaker Change: Oh, okay.
Speaker Change: Novel class of that kind of is that demonstrated that type of a level of 38 specific binding and functional antibody responses.
And during the NMS outperforming all other types of candidates.
Additionally, both the higher in vaccine candidate and grew tired of T cell responses.
Speaker Change: Comparing that Tolkien various vaccines with a nanoparticle kind of against strongly outperform any color on that category.
Speaker Change: Overall, our infectious disease programs, so promising progress with both non anchored.
Speaker Change: Kansas peloton Mccandless advancing based on solid development catalyst I'll start on slide 17.
Speaker Change: Following newly launched impact program.
Speaker Change: The expected delay if any can do that.
Speaker Change: First half of 2020 site, enabling us to finance, our <unk> mentioned in the second half of 2020 just.
Speaker Change: Turning to allow favorable opinion of developments is back in the first half of 2006.
Speaker Change: Additionally, it is having an adverse market by 592.
Speaker Change: Progressing and we anticipate strengthening our pipeline in this area with additional programs in 2025 published I think attentiveness.
Speaker Change: In the second half okay.
Speaker Change: Further as part of our program licensed to GSK. Please note essence closeout the timeline remains at the discretion of GSK.
Speaker Change: As recently confirmed by GSK the seasonal influenza program is expected to progress to phase III in 2025.
Speaker Change: And David the timeline for the license programs, including anticipated data readout for the avian influenza.
Speaker Change: First half of 2020 pilot Gsk's awful about initiating a new combined phase one studies for influenza COVID-19 combination vaccine corresponded information can be found on kidney as far as startup cost data.
Speaker Change: As expected in the first half of 2025.
Speaker Change: With this I would like to conclude the portfolio update and then hopefully to Axa for a review of the financial data.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Looking at the significant progress we've made in streamlining our operations focusing on strategic priorities I would like to provide a context.
Speaker Change: The initial assets on slide 18.
Speaker Change: Demonstrating operational.
With us to reinvest in key areas of growth and innovation.
Speaker Change: Today, we reported strong cash position of 561 line early in euros at the end of the third quarter 2025, and reaffirming our cash runway into 2028.
Speaker Change: Our quarterly results.
Speaker Change: Driven by the new licensing agreement with GSK, which positively impacted our kind of acquisition as well as revenues.
Speaker Change: 400 billion Euro upfront from the agreement we've received a nonrefundable payment for granting licenses to GSK of the royalty you Q1.
Speaker Change: The actual property.
No further R&D or obligation on our side.
Speaker Change: As such it would fully but it was fully recognized as revenue in the third quarter of 2024 gigabit under the terms of the new licensing agreement all obligations for prior collaborations relating to R&D services had expired.
Speaker Change: Remaining contract liabilities amounted to $18 4 million euros were also recognized as revenue in the third quarter of 2024.
Speaker Change: Turning the corner for increased future financial stability.
Speaker Change: Strategic redesign is key to enhancing our operational efficiencies to further reduce costs.
Speaker Change: The efficient execution of the 30% workforce reductions are on track to be complete by the end of the Stifel 2024 incurred costs of approximately 40% below about Vegas question.
Speaker Change: 2024 onwards, we anticipate a substantial increase in operating expenses by over 30%, including a notable 25 million reduction in personnel costs.
Speaker Change: Our licensing agreements.
Speaker Change: It's focused on innovation.
Speaker Change: And R&D activities and also eliminated the need for commercial buildup.
Speaker Change: Large scale manufacturing activities.
Speaker Change: Streamlining of our in house manufacturing capacity should provide.
Please.
Speaker Change: A question better suited to our needs once accompanied by a partial impairment of the lost sales GDP for production facility.
Speaker Change: Lastly, we have successfully terminated already enrolled material commitments and closed all contract laboratory of optimization or C. O related Arbitrations go also service grew nicely in the third quarter ensuring no.
Speaker Change: Related payments.
Speaker Change: Moving onto our condensed financial statements on slide 19.
Speaker Change: You can see that our cash position of 550 million euros.
Speaker Change: Increased from $402 5 million.
Speaker Change: 'twenty three based on the 400 billion upfront payment from GSK in August 2020 for.
Speaker Change: The increase was partially offset by our ongoing R&D activities as well as last payments related to our first generation COVID-19 vaccine.
As already discussed revenue strongly increased by $437 4 million euros $493 nine on your sort of third quarter.
Speaker Change: And by $489 five onwards to positive $27 million or nine months and <unk>.
Speaker Change: 24 compares to the same periods in 2023.
Speaker Change: The year on year increase.
Speaker Change: Primarily driven from the license agreement with GSK they'd love to see a positive one.
Speaker Change: Dennis.
Speaker Change: Operating profit was $358 4 million euros for the third quarter of 2024.
Speaker Change: Comparison operating loss of $54 million for the same quarter in 2023.
Speaker Change: For the first nine months of 2024 operating profit was $221 4 million euros compared to an operating loss of $186 2 million euros.
Speaker Change: The same period in 2023.
Speaker Change: The operating result was affected by several key drivers first.
Speaker Change: Cost of sales increased year on year, mainly due to higher arbitration costs, where CMO activities related to the first generation critical feedback season, as well as due to higher personnel expenses related to the redesign of the organization.
Speaker Change: Yes.
Speaker Change: R&D expenses increased with higher investments in oncology development program.
Increased expenses related to the litigation.
Speaker Change: To enforce the law.
Speaker Change: Property rights.
Speaker Change: Sure.
Speaker Change: General and administrative expenses expenses decreased compared to the prior year period, mainly driven by lower personnel expenses.
Speaker Change: Lastly, other operating expenses increased due to the discussed partial impairment of Tioga J P for production facility.
Speaker Change: Financial results decreased by $3 1 million euros, or $2 2 million in third quarter of 2024 decreased $7 million to $8 billion for the first nine months of 2024 compared compared to the same periods. In 2023. This increase is mainly driven by less interest income on cash.
Speaker Change: Pretax profit was 371 batesville in euros for the third quarter.
Speaker Change: $228 4 million euros for the first nine months of 2004 compared to a pre tax loss in the same periods of 2023.
Speaker Change: And will this come back because of incentives today in mass issues. Thank you Ed So let's summarize the key highlights from Q3 2024.
Speaker Change: Both the third quarter of 2024 with a cash balance of $550 9 million, providing us with a solid financial runway into 2028. This as fast as our ability to continue driving innovation and growth.
Speaker Change: In addition, we are making significant progress on our strategic transformation, including a 30% reduction against the 2024.
Speaker Change: Contribute to substantial cost savings, starting in 2075 and enhancing our operational efficiencies.
Speaker Change: LNG the advancing for off the shelf and personalized cancer vaccines. Our Glioblastoma trial is showing promising early results and we are finding new trials in 2025, and 26, adding infectious diseases. We are moving forward with the human factor IX gene for Uti's.
Speaker Change: Additionally, our partner GSK is advancing a seasonality furniture vaccine into phase III next year and it's about to initiate a combined phase two study for <unk>.
It's a combination vaccine both leveraging our platform.
Speaker Change: We enter 2025, we are well positioned well finance focused on high value opportunities and supported by strategic partnerships that are robust IP portfolio.
Speaker Change: These elements position us well for ongoing growth and success in tackling venture out and challenges.
Speaker Change: I would like to conclude our presentation and open the floor for your questions.
Speaker Change: Great. Thank you.
Speaker Change: We will be conducting a question and answer session if you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue you.
Speaker Change: You May press star two to remove yourself from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star.
One moment, please pool for questions.
Speaker Change: First question here is from Troll Yang from Bank of America. Please go ahead.
Speaker Change: Great. Thanks for taking the question I have two please I think one can you discuss perhaps kind of your thoughts about.
Speaker Change: <unk> business opportunity.
Speaker Change: Since the opportunity outside of the kind of your core expertise whether that is an area of potential.
Speaker Change: Potential interest just given your cash position and a second of all can you discuss about the.
Speaker Change: Kind of a litigation update and what should we expect on that front. Thank you.
Speaker Change: Okay. Thank you. So on your first question on business opportunities.
Among them, we stay very focused on the two areas that we described during the presentation, which is oncology and infectious diseases of the other half.
We made these two areas we already do have collaboration with GSK on one hand, MD MD Anderson on the other hand, but of course, we are always open to look at new opportunities within these two areas.
Speaker Change: That will help us to segment, our portfolio and especially accelerates our path to the clinic.
Speaker Change: With regards to litigation. So these are ongoing I think the next time you need to keep in mind is the U S Court case, which has been scheduled for March March 25, Sebastian year. So.
Speaker Change: Work is ongoing for us to prepare.
Speaker Change: Chris we can have for these events so other than that we don't have much to update long now.
Speaker Change: Thank you.
Our next question is from many Forehearth from Leerink partners. Please go ahead.
Speaker Change: Hi, there. Thanks for taking my question does this C J on for money.
Speaker Change: The following year encouraging yes flu data I was wondering if you could share any commentary on plans for Jill developing a combo vaccine for COVID-19. Thank you.
Speaker Change: Okay question on flu.
Speaker Change: Yeah.
Speaker Change: <unk>.
Speaker Change: These questions can also ideally be excellent. Thank you Katy by of course the.
Speaker Change: All the needs that.
Speaker Change: Given the epidemiology and the occurrence of infection at combination for patients. After two vascular COVID-19 vaccine will be the most kind of Mega polyps right and most promising thats by all of the development effort in the hospital setting.
Speaker Change: Collaborations are focused on this.
Speaker Change: Phase one studies stocks now also <unk>.
Speaker Change: And we.
We expect the data readout next year for decision, making progress to phase III and Thats one of the investor market.
Speaker Change: I think the program is progressing, especially because of the very positive.
Speaker Change: Phase II data in influenza.
Speaker Change: And and we are optimistic that this is going to be a continued.
Speaker Change: Program.
Speaker Change: Great. Thank you so much.
Speaker Change: Okay.
Speaker Change: The next question assurance your inventory.
Speaker Change: Please go ahead.
Speaker Change: Hello team Congrats we do update the scatter walesa can turn them on behalf of Suzanne.
So I was wondering any color or reasoning you can provide on select in lung cancer as the new indication.
Speaker Change: And then following up the previous question.
Speaker Change: Can you say something regarding patent litigation.
Speaker Change: The U S on the Europe front. Thanks.
Speaker Change: Okay.
Speaker Change: A question for you I think it was a question if I assume I understood correctly.
Speaker Change: Indication selection for life's squamous exactly that's what I, often as an insight you've got the acoustics them right. Yeah. So we have to of course, Wendy mainly select that everybody has to follow the science side and.
Speaker Change: Basically.
Speaker Change: It.
Speaker Change: Carlos Thank you, Jeff and Scott energized and understand the trends in different cancer indications and.
Speaker Change: And the one off in London to includes novel classes of anti <unk> and so in our first again, we found them a target coverage of novel antigens in squamous non small cell lung cancer. Following the science that's the indication.
Speaker Change: Lovely.
Speaker Change: It's a very innovative next I'll recap.
Speaker Change: And <unk> cancer vaccine to address the high unmet need in this population. So the indication that basically based on the size of the data and the leader and agenda company globally.
Speaker Change: Does that answer your question again.
Speaker Change: Is it your understanding.
Speaker Change: The of course, yes perfectly I E. I hope my found is now better but.
Speaker Change: It was perfectly on Polish and let the guys in litigation on the European front.
Speaker Change: Yes, so in Europe, it's a bit more complex, whereas in the U S. All the different cases are down less than one case.
Speaker Change: We had one court case on validity and infringement and damages in Europe, It's really on a case by case basis. So this is something that will continue throughout the next years. We do expect further rulings from the European patent office on our patents in the second quarter of next year as well as.
The regional court in Dusseldorf and more in the second or third quarter, but Europe is going to be an ongoing process throughout 2005, and maybe ingredients with 26.
Speaker Change: Perfect basis right. So.
Speaker Change: The key visibility is a key event from at least for the first half will be the use case in March.
Speaker Change: Okay. Thank you so much.
Speaker Change: Our next question is from <unk> <unk> from citizens. Please go ahead.
Speaker Change: Hey, Thanks for taking the questions every couple of H question, Tom I think there was a prior protein based.
Speaker Change: Program that Didnt move forward can you just maybe comment on if Youre engineering approaches address maybe why that program Didnt move forward and then any thoughts on how Youre I think theres a.
Speaker Change: Brightcove conjugate program in phase III and any thoughts on how your approach to be better than that.
Speaker Change: Okay.
Speaker Change: So.
Speaker Change: Again I'm sorry.
Speaker Change: That gives me concern.
Speaker Change: Brett the tough questions and lights and a strike.
Speaker Change: If I understand correctly and why it's an H E b to address it's a highly conserved antigen in and it looks like bacteria.
And then secondly impacting these antigenic basically are able to cover about 90.
Speaker Change: 5%.
The population effective bandwidth.
Speaker Change: The first one the second one is there.
Speaker Change: Basically Andy Johnson, I think kind of validated in preclinical trials and even if you want to go there and in a phase one two study by.
Speaker Change: Inside of that company and who are.
Speaker Change: We are testing it.
Speaker Change: In Silicon data 90 guidance I think at the targets and to address these bacteria and this is a promising anti Jed.
Speaker Change: Your second part of the question is about the <unk> design again.
Speaker Change: <unk> applied something very knowledge in a way how we sell next such a private <unk> I don't want to get too much into the detail, but in a green bond in the transformation really kind of get the bacteria.
Speaker Change: It has attached with the agency MBS as in Nevada, and then we have far less focused on that.
Speaker Change: By design we are.
Speaker Change: Again.
Speaker Change: Included Tolkien pump in Nagasaki, Sir with Feraheme, and Nicola and then basically I loved and H and M protein expressed on the surface to lead to induce a stronger immune response and design again in our preclinical studies translated to.
Speaker Change: Ut for Immunogenicity, and showing very high titers of binding and what's even more important functional antibodies and then we can tap into a protein based in Orange County Kington H.
Speaker Change: Excellent ethically superior unit's significant both for Shlomo antibody responses and T cell responses.
Speaker Change: I know you've been a part of the question about another program, but I didn't hear that very clearly and I think it was.
But a question around differentiation.
Speaker Change: They're more advanced program wildly relief in approaching the knife, RNA or opex could be differentiated or different whereas I think in.
Speaker Change: Especially in this setting again in our 8-K.
Speaker Change: This differentiated and that we can show clearly induction of silver and 711, new responsive SaaS <unk> clinical data.
Speaker Change: Even if you look back you will have to address so again targeting.
Speaker Change: Antibodies as well as adding another.
Speaker Change: Funded because the bacteria that cause SaaS.
Speaker Change: In Nevada.
Speaker Change: Gross pipeline.
Speaker Change: Yes.
Speaker Change: The other part of course because of the way, how we design our vaccine and at the top of that he has selected us.
Okay, Great and then designed with all in house or did you enlightened.
Speaker Change: Any technology.
Speaker Change: Yes.
Okay.
Okay.
Speaker Change: Visit the proprietary technology that is all of the packaging of that okay.
Speaker Change: Got it thank you.
Speaker Change: Thank you.
Speaker Change: The next question is from John <unk> from Evercore. Please go ahead.
Speaker Change: Oh hi.
Speaker Change: Please turn something off on for John Thanks for taking my question I guess on the GBM program.
Speaker Change: Lee.
Speaker Change: Very good response from T cells, but how should we think about the translation towards tumor response based on this data.
Speaker Change: And also for the overall off the shelf program.
Speaker Change: What are the indications that of most interest thank you.
Speaker Change: Yeah. Thanks, a lot. So many saw in TV and this is a super important question I think nobody can answer at this point. However, the immunologic response, thanks, Nathan sustainable benefits and there will be again, we need to wait for more data coming from our expansion cohort we have presented at ESMO very early.
Speaker Change: And there are many clinical readouts from our phase.
Speaker Change: Phase one dose escalation cohort.
And those take a reset that they had one partial response in a patient with a trial with only a process for the organization and again on that motor therapies, our vaccine that patients.
Speaker Change: <unk> developed a partial response unfortunately.
Speaker Change: Domestic helios, and <unk>, and especially because they couldnt collect enough scale that it needs a modern asthma pulmicort.
Speaker Change: And in our phase one dose escalation part and then the other part one in fact you.
Speaker Change: You could look at again all of that under the caveat. That's early days 16 nation, but you also know that <unk> at six months and this backlog numbers population, where we saw how much fire a few cents.
Speaker Change: At six months up about 34% and then you compare that to data shown at ash This year.
Speaker Change: And some is basically at fire and the <unk>.
Speaker Change: Conducted by.
Speaker Change: And similar investigators' assessment in our filing the authentic try it they SaaS that patient, but I think that would make us GBM and <unk>.
Speaker Change: And ladies Turkey, plus minus almost all of my having PFS at six months only 18%. So again I have to caveat. This is early days thats a handful of patients, but we do see some promising even now.
Speaker Change: And I Wanna get away and in the dose expansion pack again, we collect more.
Information on a more <unk> become more of a deeper immunogenicity data and connect across the clinical data.
Speaker Change: As we can hopefully culminates with two N. The naked robot decisions, whether it be go into phase III or not.
Speaker Change: Okay. The second question Rod.
Speaker Change: Patient selection for the rest of the off the shelf, but it's I think the RV community swayed us, thus far and our cats.
Speaker Change: And I think vertical.
Speaker Change: The indication selection for the next share right.
Speaker Change: Potentially obviously MD Anderson collaborations that are growing.
Speaker Change: And maybe just to build on this he has contacted them.
Speaker Change:
Lastly, beginning next year.
Speaker Change: <unk> oncology strategy exercise doesn't look at all different kinds of indications, which could be targeted by a cancer vaccine and we consider criteria such as.
Speaker Change: You know likelihood of scientific success unmet medical need competitive environment in commercial.
Speaker Change: C&C and had to prioritize a few cancer indications, where we can go deeper into the cosmetics asphalt.
Speaker Change: For cancer and cancer antigen.
Speaker Change: And our selection of next indications is really following a strategic approach that effect and also translated into automation with Andy unless somebody focused together on again promising scientifically viral cycle last week promising areas and components.
Speaker Change: Thank you very much.
Speaker Change: And as a final reminder, if you'd like to ask a question. It is star one.
Speaker Change: There are no further questions I'd like to turn the floor back to management for any closing comments.
Speaker Change: With this we would like to conclude our conference call. Thank you very much for Liz anticipation safety and please don't hesitate to contact US should you have any further questions. Thank you and goodbye.
Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.
Speaker Change: Okay.
Speaker Change: [music].