Q4 2024 Vir Biotechnology Inc Earnings Call
This conference call is being recorded.
At this time all participants are in a listen only mode.
After the Speakers' presentation, there will be a question and answer session.
To ask a question you May press star followed by the number one on your telephone keypad.
Speaker Change: Hello. Welcome to VEER Biotechnology's fourth quarter and full year 2024 Financial Results and Business Update Call. As a reminder, this conference call is being recorded.
Let me draw. Your question you May press Star followed by the number one again.
Ill now turn the call over to rich <unk> Senior Director Investor Relations you may begin Mr of Afghan.
Speaker Change: Thank you and good afternoon with me today are Dr. Mary <unk>, our Chief Executive Officer, Dr. Marc <unk>, our Chief Medical Officer, Jason Our burn, our Chief Financial Officer, and Dr. <unk>, Our executive Vice President of oncology will be available during the Q&A session.
Speaker Change: Before we begin I would like to remind everyone that some of the statements. We're making today are forward looking statements under the securities laws.
Speaker Change: These forward looking statements involve substantial risks and uncertainties that could cause our clinical development programs future results performance or achievements to differ significantly from those expressed or implied by such forward looking statements.
Speaker Change: These risks and uncertainties and risks associated with our business are described in the Companys reports filed with the Securities and Exchange Commission, including forms 10-K, 10-Q and 8-K.
Speaker Change: Please note that any cross trial comparisons discussed today are not based on head to head studies and have inherent limitations and caution should be exercised when interpreting such comparisons.
Mary: With that I'll now turn the call over to our CEO Mary <unk>.
Mary: Thank you rich and good afternoon, everyone.
Mary: Thank you for joining us for our fourth quarter and full year 2024 earnings call I'm truly excited to share our progress with you today.
Mary: 2024 was nothing short of transformative for nearby technology.
Speaker Change: Please note that any cross trial comparisons discussed today are not based on head to head study you have inherent limitations and caution should be exercised when interpreting such comparisons.
Mary: As I reflect on the past year I'm incredibly proud of what we've accomplished we've made significant strides in our oncology and infectious disease program.
Speaker Change: With that I'll now turn the call over to our CEO Maranatha blocker.
Mary: Positioning via bio at the forefront of innovative therapies in these areas is critical unmet medical need.
Maranatha blocker: Thank you rich and good afternoon, everyone.
Speaker Change: Thank you for joining us for our fourth quarter and full year 2024 earnings call I'm truly excited to share our progress with you today.
Mary: Our strategic focus on T cell engagements and hepatitis.
Mary: Only yielded promising results, but has also positioned us well for future growth and value creation.
Speaker Change: 'twenty 'twenty four was nothing short of transformative nearby technology.
Speaker Change: As I reflect on the past year I'm incredibly proud of what we've accomplished we've made significant strides in our oncology and infectious disease programs positioning via bio at the forefront of innovative therapies in this area critical unmet medical need.
Mary: This focused approach allows us to allocate our resources efficiently and make meaningful progress across our pipeline.
Mary: And let me start with our infectious disease portfolio.
Mary: We're moving full steam ahead with preparations for Eclipse Phase III program in hepatitis Delta, which we expect to initiate in the first half of the year.
Speaker Change: Our strategic focus on T cell engages in hepatitis.
Speaker Change: Only yielded promising results, but has also positioned us well for future growth and value creation.
Mary: The regulatory designations, we've received U S FDA breakthrough therapy, and fast track designation as well as EMA Prime designation and orphan drug status underscore the potential impact of a combination regimen and the significant unmet medical need.
Speaker Change: This focused approach allows us to allocate our resources efficiently and make meaningful progress across our pipeline.
Speaker Change: Well, let me start with our infectious disease portfolio.
Mary: We believe the market for hepatitis Delta therapies shares characteristics with orphan diseases.
Speaker Change: We're moving full steam ahead with preparations for Eclipse Phase III program in hepatitis Delta, which we expect to initiate in the first half of the year.
Mary: <unk> lack of efficacious treatment options.
Mary: Clinical outcomes.
Speaker Change: The regulatory designations, we've received U S FDA breakthrough therapy, and fast track designation as well as EMEA Prime designation and orphan drug status.
Mary: And the potential for value based pricing appropriately reflect the clinical benefit of therapy may offer.
Mary: Current treatment options are limited, especially in the U S are no approved therapies.
Speaker Change: Underscore the potential impact of a combination regimen and the significant unmet medical need.
Mary: Hepatitis Delta virus requires hepatitis b surface antigen to complete its lifecycle arco.
Speaker Change: We believe the market for hepatitis Delta therapies shares characteristics with orphan diseases, including lack of efficacious treatment options.
Mary: Our combination therapy after Debbie Bart and electron offers a unique approach by reducing hepatitis b surface antigen, so two distinct and complementary mechanisms.
Speaker Change: We have clinical outcomes.
Speaker Change: The potential for value based pricing it appropriately reflects the clinical benefit our therapy may offer.
Mary: So Betty parts, an FC engineered monoclonal antibody is designed to block viral entry and neutralized periodic filings.
Speaker Change: Current treatment options are limited, especially in the U S. But there are no approved therapies.
Mary: While electron small interfering RNA aims to reduce hepatitis b surface antigen production by degrading HPV M Army.
Speaker Change: Hepatitis Delta virus requires hepatitis b surface antigen to complete its lifecycle.
Speaker Change: Our combination therapy after Bebee, Bart and electron offers a unique approach by reducing hepatitis b surface antigen, so two distinct and complementary mechanisms.
Mary: Okay.
Mary: Two pronged strategy addresses both hepatitis Delta and hepatitis B replication simultaneously.
Mary: Country, offering comprehensive and durable viral suppression.
Speaker Change: So Betty Barb and FC engineered monoclonal antibody is designed to block viral entry and neutralize cereals, while in that strong a small interfering RNA aims to reduce hepatitis b surface antigen production by degrading HBV mrna.
Mary: We believe this approach has the potential to address the significant unmet need in chronic hepatitis delta and become a new standard of care.
Mary: Now turning to our exciting progress in oncology as many of you know we held a successful T cell engagement investor event on January eight.
Speaker Change: Just you pronged strategy addresses both hepatitis Delta and hepatitis B replication simultaneously potentially offering comprehensive and durable.
Mary: The data we presented for fear of five to 818 I heard two targeted T cell engagement was very promising.
Speaker Change: <unk> suppression.
Mary: Promising early signs of clinical activity, particularly in colorectal cancer with an encouraging safety profile.
Speaker Change: We believe this approach has the potential to address the significant unmet need in chronic hepatitis delta and become a new standard of care.
Mary: Our <unk> targeted T cell engagement via a 500 500 also showed strong results in prostate cancer with impressive PSA responses and a favorable safety profile.
Speaker Change: Now turning to our exciting progress in oncology as many of you know we held a successful T cell engagement investor event on January eight.
Speaker Change: The data will be presented for fear of five to 818 I heard two targeted T cell engage you when it's very promising.
Mary: Activity.
Mary: Served clinically is a clear indication that our dual model construct is being cleaved and activated as intended.
Speaker Change: You saw promising early signs of clinical activity, particularly in colorectal cancer at an encouraging safety profile.
Mary: These results now across two clinical programs validate the potential of <unk> platform to address significant unmet needs in solid metastatic tumors.
Speaker Change: Our P. S M. A targeted T cell engagement via a five 500 also showed strong early results and prostate cancer with impressive PSA responses and a favorable safety profile.
Mary: We're also making great progress with fee of $55 25 are egfr targeted T cell engagement.
Speaker Change: The activity, we observed clinically is a clear indication that our dual market construct is being cleaved and activated and talent.
Mary: On track to initiate the phase one study in the first half of this year.
Mary: Importantly, we have secured worldwide rights to the pro X 10 platform in both oncology and infectious diseases.
Speaker Change: These results novel crops, two clinical programs validate the potential of the pro axon platform to address significant unmet needs in solid metastatic tumors.
Mary: It gives us a powerful foundation for future growth as the platforms Universal plug and play masking technology can be applied to both existing as well as novel targets.
Speaker Change: We are also making great progress with fear 50, 525, or Egfr targeted T cell engagement.
Mary: This capability not only supports our current pipeline, but also provides us with significant flexibility to expand into additional high value indications in the future.
Speaker Change: We are on track to initiate the phase one study in the first half of this year.
Speaker Change: Importantly, we have secured worldwide rights to the pro X temp platform in both oncology and infectious diseases.
Mary: In hepatitis B, we're looking forward to sharing functional cure data in the second quarter.
Speaker Change: This gives us a powerful foundation for future growth as the platforms to universal plug and play masking technology can be applied to both existing as well as novel targets.
Mary: It's important to note that we would take this program forward all EBIT to commercialization and development Department.
Mary: Our financial position remained strong with a cash runway extending into mid 2027.
Speaker Change: This capability not only supports our current pipeline, but also provides us with significant flexibility to expand into additional high value indications in the future.
Mary: Solid Foundation is the result of our achievements since late 2023, where we significantly reduced our operating expenses and cash burn.
Speaker Change: In hepatitis B, we're looking forward to sharing functional cure data in the second quarter.
Mary: We are maintaining a disciplined approach to capital allocation focusing our resources on our most promising programs.
Speaker Change: It's important to note that we would take this program forward, all EBIT to commercialization and development apartment.
Mary: At the same time, we're actively exploring partnership opportunities to maximize the value of our broader pipeline.
Speaker Change: Our financial position remains strong with a cash runway extending into mid 2027.
Mary: As you'll hear in more detail shortly our 2024 financial results reflect both our strategic investments and our commitment to fiscal responsibility.
Speaker Change: Solid Foundation is the result of our achievements since late 2023, where we significantly reduced our operating expenses and cash burn.
Mary: As we look to 2025, I'm confident that our strategy sets us up for long term success and value creation.
Speaker Change: We are maintaining a disciplined approach to capital allocation focusing our resources on our most promising programs.
Mark: With that I'll now turn the call over to Mark to provide an update on our clinical development programs.
Speaker Change: At the same time, we're actively exploring partnership opportunities to maximize the value of our broader pipeline.
Mark: Thank you Maryann.
Speaker Change: As you'll hear in more detail shortly our 'twenty to 'twenty four financial results reflects both our strategic investments and our commitment to fiscal responsibility.
Mark: Made significant progress in clinical stage programs and I'm looking forward to sharing the details with you today.
Mark: Let's start with very hepatitis Delta program, which continues to be a key focus for us, we're making excellent progress towards initiating our eclipse phase III program in the first half of this year.
Speaker Change: As we look to 2025, I'm confident that our strategy sets us up for long term success and value creation.
Mark: With that I'll now turn the call over to Mark to provide an update on our clinical development programs.
Mark: Studies will form the basis of our marketing applications.
Mark: Before we dive into the Eclipse program, let me briefly recap our solstice phase II data, which has given us confidence to move forward with our phase III program.
Mark: Thank you Mary Anne we've made significant progress in clinical stage programs and I'm looking forward to sharing the details with you today.
Mark: We saw impressive virologic responses across multiple cohorts to provide some context, when we refer to HBV RNA target not detected were T&D. We mean, there is no measurable programs of the virus in the blood.
Mark: Let's start with our hepatitis Delta program, which continues to be a key focus for us, we're making excellent progress towards initiating our eclipse phase III program in the first half of this year.
Mark: These studies will form the basis of our marketing applications.
This is the most stringent measure viral suppression, we can achieve with current testing methods.
Mark: Before we dive into the Eclipse program, let me briefly recap our solstice phase II data, which has given us confidence to move forward with our phase III program.
Mark: And our de Novo combination therapy arm for 24 weeks, 41% of patients achieved HCV RNA levels below the target not detected threshold.
Mark: We saw impressive virologic responses across multiple cohorts to provide some context, when we refer to HBV RNA target not detected were T&D. We mean, there is no measurable presence of the virus in the blood.
Mark: Even more impressively this increased to 64% of patients the week 36.
Mark: And our rollover cohort, which provides our longest follow up data we saw even more encouraging results.
Mark: This is the most stringent measure viral suppression, we can achieve with current testing methods.
Mark: 64 out of five patients 80%.
Mark: In our de Novo combination therapy arm for 24 weeks, 41% of patients achieved HCV RNA levels below the target not detected threshold.
Mark: <unk> target not detected levels. This suggests the potential for durable and deepening of responses with our combination therapy over time.
Mark: Even more impressively this increased to 64% of patients at week 36.
Mark: Importantly, we also observed significant declines in hepatitis b surface antigen levels.
Mark: And our rollover cohort, which provides our longest follow up data we saw even more encouraging results.
Mark: The week 24, approximately 90% of participants receiving the combination of <unk> and luxury arm achieved surface antigen levels below term a year per ml. This.
Mark: At week 64 out of five patients, 80% achieve target not detected levels. This suggests the potential for durable and deepening responses with our combination therapy over time.
Mark: This is a crucial finding because reducing hepatitis b surface antigen is a central for controlling with hepatitis B and hepatitis D. A virus replication.
Mark: Importantly, we also observed significant declines in hepatitis b surface antigen levels.
Mark: Additionally, the combination of <unk> and <unk> demonstrated a favorable safety profile across all cohorts.
Mark: And we 24, approximately 90% of participants receiving the combination of <unk> and loves Shroom achieved surface antigen levels below 10 <unk> per ml.
Mark: Our approach has garnered significant regulatory support which speaks to the potential impact of our therapy.
Mark: We have received breakthrough therapy designation and fast track designation from the FDA.
Mark: This is a crucial finding because reducing hepatitis b surface antigen is a central for controlling with hepatitis B and hepatitis D virus replication.
Mark: <unk> has granted us prime designation and orphan drug status.
Mark: These designations could help accelerate our development and review process.
Mark: Additionally, the combination of <unk> and I'll, let Sharon demonstrated a favorable safety profile across all cohorts.
Mark: Bringing this much needed therapy to patients sooner.
Mark: Our approach has garnered significant regulatory support which speaks to the potential impact of our therapy.
Mark: Turning to our hepatitis B program, we are looking forward to sharing functional cure data in the second quarter of this year.
Mark: We have received breakthrough therapy designation and fast track designation from the FDA.
Mark: This functional cure data will be a crucial milestone for this program.
Mark: I want to reiterate that we would pursue the development of this program only with a partner.
Mark: <unk> has granted us prime designation and orphan drug status.
Mark: These designations could help accelerate our development and review process potentially bringing this much needed therapy to patients sooner.
Mark: I'm very excited about the progress we've made in our infectious disease programs. We're on the cusp of potentially changing the treatment landscape for hepatitis Delta and we're looking forward to sharing our hepatitis b functional cure do.
Mark: Turning to our hepatitis B program, we are looking forward to sharing functional cure data in the second quarter of this year.
Mark: Now, let me shift gears to discuss our oncology portfolio to discuss the significant progress we've made with the pro extend platform.
Mark: This functional cure data will be a crucial milestone for this program.
Mark: I want to reiterate that we would pursue the development of this program only with a partner.
Mark: As Maria mentioned, we've shared compelling data at our Investor event in January and I'd like to dive deeper into those results.
Mark: I'm very excited about the progress we've made in our infectious disease programs. We're on the cusp of potentially changing the treatment landscape for hepatitis Delta and we're looking forward to sharing our hepatitis b functional onshore data.
Mark: Before we get into the specifics of each program, let me briefly recap the approach and platform.
Mark: This innovative technology allows us to create dual matched T cell engaging <unk> designed to be selectively activated in the tumor microenvironment.
Mark: Now, let me shift gears to discuss our oncology portfolio to discuss the significant progress we've made with the pro extend platform.
Mark: The key advantage is the potential for a wider therapeutic window, allowing for higher dosing and improved efficacy with reduced systemic toxicity.
Speaker Change: As Maryann mentioned, we've shared compelling data at our Investor event in January and I'd like to dive deeper into those results.
Speaker Change: Before we get into the specifics of each program, let me briefly recap the pro extend platform.
Mark: The pro extend masks are unstructured and hydrophilic acting as a shield to prevent T cell engagement in normal tissues expressing the target antigen.
Speaker Change: This innovative technology allows us to create dual mast T cell engages.
Mark: Importantly, they are fluid nature also allows access to the cleavable linker, enabling efficient activation went into Proteus rich tumor microenvironment.
Speaker Change: Designed to be selectively activated in the tumor microenvironment.
Speaker Change: The key advantage is the potential for a wider therapeutic window, allowing for higher dosing and improved efficacy with reduced systemic toxicity.
Mark: The perks and masks are universal and have been clinically validated.
Mark: <unk> and El <unk>, an approved therapy for hemophilia.
Speaker Change: The pro extend masks are unstructured and hydrophilic acting as a shield to prevent T cell engagement in normal tissues expressing the target antigen.
Mark: <unk> contains three produce cleavage sites that are quickly cleaved, hi, protease microenvironment of crop during the clotting cascade demonstrating the ability of the approved stem system to enable efficient and play Reregulate is unmasking.
Speaker Change: Importantly, they are fluid nature also allows access to the cleavable linker, enabling efficient activation went into protease rich tumor microenvironment.
Mark: We believe this approach could overcome menu limitation seem with traditional unmasked T <unk>.
Speaker Change: The perks and masks are universal and have been clinically validated as seen in our <unk> an approved therapy for hemophilia.
Mark: And the validated nature of the platform gives us confidence in its potential application across our oncology programs.
Speaker Change: Our tubular contains three proteus cleavage sites that are quickly cleaved and high protease microenvironment of Clos during the clotting cascade demonstrating the ability of the <unk> system to enable efficient and tightly regulated unmasking.
Mark: Let's start with severe <unk> for her to targeted T cell engagement.
Mark: We've seen encouraging efficacy signals across multiple her two positive tumors, particularly in colorectal cancer.
Speaker Change: We believe this approach could overcome menu limitation scene with traditional unmasked T sung <unk>.
Mark: At doses of 400 micrograms per kilogram and above we observed a 33% confirmed partial response rate in colorectal cancer patients.
Speaker Change: And the validated nature of the platform gives us confidence in its potential application across our oncology programs.
Mark: It is important to note that these patients have exhausted all standard of care options and were heavily pretreated.
Speaker Change: Let's start with severe 58 team or hurts you targeted T cell engagement.
Mark: With many having received multiple prior lines of therapy, including her two targeted treatments.
Speaker Change: We've seen encouraging efficacy signals across multiple her two positive tumors, particularly in colorectal cancer.
Mark: Additionally, one of these three responses was observed in a patient on the every three week dosing schedule.
Speaker Change: At doses of 400 micrograms per kilogram and above we observed a 33% confirmed partial response rate in colorectal cancer patients.
Mark: I'd also like to highlight a compelling case, we presented at our recent investor event, which speaks to the potential for durable responses.
Speaker Change: It is important to note that these patients have exhausted all standard of care options and were heavily pretreated with many having received multiple prior lines of therapy, including her two targeted treatments.
Mark: Ah patients with her two positive colorectal cancer, who progressed through six prior lines of therapy, including her two targeted agents achieved a partial response.
Mark: Remarkably. This response has been sustained for over 18 months with the patient still on study as of our last data cutoff.
Speaker Change: Only one of these three responses was observed in a patient on the every three week dosing schedule.
Speaker Change: I'd also like to highlight a compelling case, we presented at our recent investor event, which speaks to the potential for durable responses.
Mark: Crucially, we've observed efficacy in microsatellite stable or MSS colorectal cancer tumors, which typically are resistant therapies.
Speaker Change: Ah patients with her two positive colorectal cancer, where progressed through six prior lines of therapy, including her <unk> targeted agents achieved a partial response.
Mark: This suggests secure <unk> team's ability to overcome the immunosuppressive tumor microenvironment and these hard to treat patients.
Speaker Change: Remarkably. This response has been sustained for over 18 months with the patient still on study as of our last data cutoff.
Mark: To put these results in context, it's important to note that for patients who have exhausted multiple lines of treatment current regimens like long surplus Bevacizumab typically show objective response rate in the single digits.
Speaker Change: Crucially, we've observed efficacy in microsatellite stable or MSS colorectal cancer tumors, which typically are resistant therapies.
Mark: Our early results, therefore are particularly encouraging in this heavily pretreated population.
Speaker Change: This suggests you are 58 teams ability to overcome the immunosuppressive tumor microenvironment and these hard to treat patients.
Mark: The safety profile of <unk> 58, a team has been favorable with no high grade cytokine release syndrome, or Crs and without mandatory prophylactic corticosteroids.
Speaker Change: To put these results in context. It is important to note that for patients who have exhausted multiple lines of treatment current regimens like long surplus deficit amount.
Mark: We're continuing dose escalation on an every three week schedule to optimize efficacy, while maintaining the favorable safety profile.
Speaker Change: Typically show objective response rate in the single digits.
Mark: We're also exploring combination strategies, including with <unk>.
Speaker Change: Our early results, therefore are particularly encouraging in this heavily pretreated population.
It's worth noting that <unk> 50, 818 utilizes the <unk> binding epitope, which enables potential combination strategies with trust <unk> based therapies and an earlier line setting.
Speaker Change: The safety profile of <unk> 58, a team has been favorable with no high grade cytokine release syndrome, or Crs and without mandatory prophylactic corticosteroids.
Mark: Turning to <unk> 5500, or <unk> targeted T cell engaging <unk> for prostate cancer, we've seen impressive early results in our ongoing phase one dose escalation study.
Speaker Change: We're continuing dose escalation on an every three week schedule to optimize efficacy, while maintaining the favorable safety profile.
Speaker Change: We're also exploring combination strategies, including with Trimble isn't it.
Mark: Among the 12 patients treated in the efficacious dose range, 100% experienced PSA declines with 58% achieving PSA 50 response, and 8% achieving a PSA 90 response.
Speaker Change: It's worth noting that <unk> 50, 818 utilizes the <unk> binding epitope, which enables potential combination strategies with trastuzumab based therapies in an earlier line setting.
Speaker Change: Turning to Veer 5500, our PSM a targeted T cell engaging for prostate cancer. We've seen impressive early results in our ongoing phase one dose escalation study.
Mark: This is particularly encouraging given the heavily pretreated nature of this population and the early stage of dose escalation.
Mark: Like <unk> 58, a <unk> <unk> 5500, and early dose escalation as a favorable safety profile with minimal high grade <unk> events, and no grade three or higher Crs.
Speaker Change: Among the 12 patients treated in the efficacious dose range, 100% experienced PSA declines with 58% achieving PSA 50 response, and 8% achieving a PSA 90 response.
Mark: Notably these results have been achieved without the use of prophylactic corticosteroids or anti IL six therapies, which are often required with other T cell engagements, including mask Tucson users.
Speaker Change: This is particularly encouraging given the heavily pretreated nature of this population and the early stage of dose escalation.
Mark: Importantly, we have not observed any cases of on target off tumor toxicities, such as hearing loss, which had been reported with other <unk> targeted therapies.
Speaker Change: Like <unk> 58, a teen veer 5500 in early dose escalation as a favorable safety profile with minimal high grade adverse events and no grade three or higher Crs.
Mark: We're continuing dose escalation and based on our favorable safety profile. We believe there is significant room to potentially improve efficacy further as.
Speaker Change: Notably these results have been achieved without the use of prophylactic corticosteroids or anti IL six therapies, which are often required with other T cell engages including mask T cell engagements.
Mark: As we move to higher doses, we expect to see deeper and more durable responses, which could significantly improve outcomes for patients with prostate cancer.
Speaker Change: Importantly, we have not observed any cases of on target off tumor toxicities, such as hearing loss, which had been reported with other <unk> targeted therapies.
Mark: We're also actively exploring every three week dosing, which could be a significant advantage, especially in earlier lines of therapy.
Speaker Change: We're continuing dose escalation and based on our favorable safety profile, we believe there's significant room to potentially improve efficacy further as.
Mark: This potential for less frequent dosing is supported by fear or 55, hundred's pharmacokinetic profile, which shows the half life of eight to 10 days the.
Speaker Change: As we move to higher doses, we expect to see deeper and more durable responses, which could significantly improve outcomes for patients with prostate cancer.
Mark: The potential for less frequent dosing combined with encouraging efficacy and safety profile, we've observed could offer a meaningful benefit to patients across various stages of prostate cancer treatment.
Speaker Change: We're also actively exploring every three week dosing, which could be a significant advantage, especially in earlier lines of therapy.
Mark: Importantly, these results have been achieved without the need for prophylactic corticosteroids or anti IL six therapies.
Speaker Change: This potential for less frequent dosing is supported by fear or 55, hundred's pharmacokinetic profile, which shows the half life of eight to 10 days the.
Mark: For <unk> hundred 50, 525, our Egfr targeted T cell engaging <unk>.
Mark: On track to initiate the phase one study in the first half of this year.
Speaker Change: The potential for less frequent dosing combined with encouraging efficacy and safety profile, we've observed current offer meaningful benefit to patients across various stages of prostate cancer treatment.
Mark: This program has potential to address multiple high value indications, including non small cell lung cancer.
Mark: The rectal cancer and head and neck cancer.
Speaker Change: Importantly, these results have been achieved without the need for prophylactic corticosteroids or anti IL six therapies.
Mark: We're leveraging our learnings from <unk> and <unk> hundred to optimize the study design and dosing strategy.
Speaker Change: For a mere 50 525, our egfr targeted T cell engagement.
Mark: Based on our experience with the <unk> platform and the successes, we have seen with our other T cell engages we're confident in our ability to achieve a broad therapeutic index with Vir 50 525.
Speaker Change: On track to initiate the phase one study in the first half of this year.
Speaker Change: This program has potential to address multiple high value indications, including non small cell lung cancer, colorectal cancer and head and neck cancer.
Mark: Looking ahead, we anticipate sharing additional data from our ongoing dose escalation studies for <unk> <unk> and <unk> 5500.
Speaker Change: We're leveraging our learnings from <unk> 50, 818, enduro 5500 to optimize the study design and dosing strategy.
Mark: While the exact timing is still to be announced we expect to present more mature data with higher doses for both programs.
Speaker Change: Based on our experience with the pro extend platform and the successes we have seen with our other T cell engaging <unk>, we're confident in our ability to achieve a broad therapeutic index with Vir 50 525.
Mark: This will include results from both weekly and every three week dosing schedules, which we believe will provide valuable insights into the optimal dosing regimens for these therapies.
Speaker Change: Looking ahead, we anticipate sharing additional data from our ongoing dose escalation studies for <unk> 58, a team and juror 5500.
Mark: In conclusion, I am very excited about the progress, we're making across our oncology portfolio.
Mark: The early data from our T cell engaging programs are further validating the potential of the <unk> platform, demonstrating both efficacy and the ability to dose higher than traditional unmatched approaches.
Speaker Change: While the exact timing is still to be announced we expect to present more mature data at higher doses for both programs.
Speaker Change: This will include results from both weekly and every three week dosing schedules, which we believe will provide valuable insights into the optimal dosing regimens for these therapies.
Jason: We believe we're well positioned to redefine the treatment landscape for several challenging solid tumors. Our team remains focused on executing our clinical development plans and unlocking the full potential of this promising therapies, so with that I'll now hand, the call over to Jason.
Speaker Change: In conclusion, I am very excited about the progress, we're making across our oncology portfolio.
Speaker Change: The early data from our T cell engaging programs are further validating the potential of the <unk> platform, demonstrating both efficacy and the ability to dose higher than traditional unmatched approaches.
Jason: Thank you Mark.
Jason: I'm really pleased to share that our hard work on right sizing the cost structure, improving efficiencies and making thoughtful investment is paying off.
Jason: We believe we're well positioned to redefine the treatment landscape for several challenging solid tumors. Our team remains focused on executing our clinical development plans and unlocking the full potential of these promising therapies with that I'll now hand, the call over to Jason.
Jason: Since late 2023, we've taken significant steps to streamline operations and focus on our most promising programs.
Jason: We've implemented two restructurings closed two sites and de prioritize certain programs.
Jason: Then in September we executed the agreement with Sanofi to license three dual mask T cell engages in the pro extend technology.
Jason: Thank you Mark.
Jason: I'm really pleased to share that our hard work on right sizing the cost structure, improving efficiencies and making thoughtful investment is paying off.
Jason: While this added modestly to our cost structure, including approximately 50, new team members from <unk> significantly expanded our pipeline and brought in critical expertise in oncology T cell engage your clinical development and masking technology.
Jason: Since late 2023, we've taken significant steps to streamline operations and focus on our most promising programs.
Jason: We've implemented two restructurings closed two sites and de prioritize certain programs.
Jason: This combined with our existing expertise in protein engineering in immunology positions us well for future growth and innovation.
Jason: Then in September we executed the agreement with Sanofi to lessons three dual mass T cell engages in the pro extend technology.
Jason: During our budget process last fall, we applied further financial discipline, culminating in our January announcement to advance our HBV program only with the development and commercialization partner.
Jason: While this added modestly to our cost structure, including approximately 50, new team members from <unk> has significantly expanded our pipeline and brought in critical expertise in oncology T cell engage your clinical development and masking technology.
Jason: Many of these actions have led to substantial improvements in our financial performance.
Jason: Let me highlight a few key financial metrics for 2024 compared to 2023.
Jason: This combined with our existing expertise in protein engineering in immunology positions us well for future growth and innovation.
Jason: R&D expenses for 2024 were $507 million compared.
Jason: During our budget process last fall, we applied further financial discipline, culminating in our January announcement to advance our HBV program only with the development and commercialization partner.
Jason: Compared to $580 million in 2023.
Jason: This decrease was achieved despite absorbing approximately $103 million incentive fee transaction expenses related to our licensing agreement.
Jason: Many of these actions have led to substantial improvements in our financial performance.
Jason: Excluding this one time transaction related expense, our R&D spending decreased by approximately $176 million or about 30% year over year.
Jason: Let me highlight a few key financial metrics for 2024 compared to 2023.
R&D expenses for 2024 were $507 million compared to $580 million in 2023.
Jason: Our continued focus on cost management and program prioritization.
Jason: G&A expenses decreased to a $119 million in 2024 from $174 million in the prior year. This significant reduction, reflecting a 32% decrease year over year was primarily achieved through multiple cost saving initiatives implemented since late 2000.
Jason: This decrease was achieved despite absorbing approximately $103 million incentive fee transaction expenses related to our licensing agreement.
Jason: Excluding this one time transaction related expense, our R&D spending decreased by approximately $176 million or about 30% year over year, reflecting our continued focus on cost management and program prioritization.
Jason: 'twenty three.
Jason: As a result, our net loss for 2024 was $522 million.
Jason: Compared to $615 million in 2023.
Jason: G&A expenses decreased to a $119 million in 2024 from $174 million in the prior year.
Jason: Excluding the $103 million Sanofi R&D transaction expense.
Jason: Our net loss for 2024 was $419 million, representing a decline of approximately 32% from the previous year.
Jason: This significant reduction, reflecting a 32% decrease year over year was primarily achieved through multiple cost saving initiatives implemented since late 2023.
Jason: We ended 2024 was 408 employees compared to 587 at the end of 2023, representing about a 30% year over year reduction.
Jason: As a result, our net loss for 2024 was $522 million compared to $615 million in 2023.
Jason: It's important to note that the 408 includes approximately 50 employees, who joined us from Sanofi as part of our licensing agreement.
Jason: Excluding the $103 million Sanofi R&D transaction expense, our net loss for 2024 was $419 million, representing a decline of approximately 32% from the previous year.
Jason: Now turning to cash.
Jason: Our 2024 net cash consumption was roughly $532 million.
Jason: We ended 2024 with 408 employees compared to 587 at the end of 2023, representing about a 30% year over year reduction.
Jason: Excluding approximately $179 million of <unk> transaction related items, the decrease to cash and investments for 2024 was approximately $354 million.
Jason: It's important to note that the 408 includes approximately 50 employees, who joined us from sanity as part of our licensing agreement.
Jason: We're starting 2025 with a strong financial position of $1 $1 billion in cash cash equivalents and investments. It is important to note that this $1 1 billion figure already excludes the $75 million pending Egfr milestone, which is currently in escrow and classified as restricted cash.
Jason: Now turning to cash.
Jason: Our 2024 net cash consumption was roughly $532 million.
Jason: Excluding approximately $179 million of Santa Fe transaction related items, the decrease to cash and investments for 2024 was approximately $354 million.
Jason: Based on our current operating plan, we anticipate this will provide runway into mid 2027.
Jason: As we look ahead to 2025 I want to emphasize that our capital deployment strategy remains focused on our most promising programs.
Jason: We're starting 2025 with a strong financial position of $1 $1 billion in cash cash equivalents and investments. It is important to note that this $1 1 billion figure already excludes the $75 million pending Egfr milestone, which is currently in escrow and classified as restricted cash.
Our priorities for the year, our first we'll accelerate eclipse clinical enrollment and initiate activities toward registration.
Jason: Second we will invest in deer, 5500 to rapidly advance the program capitalizing on the very encouraging TSMC data that was shared in January.
Jason: Based on our current operating plan, we anticipate this will provide runway into mid 2027.
Jason: Third we will continue enrolling patients in beer 50, 818, essentially leveraging the promising early data we see in her two positive colorectal cancer.
Jason: As we look ahead to 2025 I want to emphasize that our capital deployment strategy remains focused on our most promising programs our priorities for the year, our first we'll accelerate eclipse clinical enrollment and initiate activities toward registration.
Jason: Fourth we will initiate the phase one study for beer $55 25 in patients with Egfr expressing solid tumors.
Jason: And finally for hepatitis B program, we continue to pursue a partnership strategy.
Jason: Second we will invest in deer, 5500 to rapidly advance the program capitalizing on the very encouraging <unk> data that was shared in January.
Jason: We believe this approach will maximize the value of the asset, while allowing us to focus our internal resources on our lead programs.
Jason: Third we'll continue enrolling patients in beer 50, 818, essentially leveraging the promising early data we see in her two positive colorectal cancer.
Okay.
Jason: In closing I am confident that our $1 1 billion in cash will fund these priorities into mid 2027 based on our current operating plan.
Jason: Fourth we will initiate the phase one study for beer $55 25 in patients with Egfr expressing solid tumors.
Jason: This reflects our ongoing commitment to disciplined capital allocation, ensuring we have the resources to advance our key programs, while maintaining financial flexibility.
Jason: And finally for hepatitis B program, we continue to pursue a partnership strategy. We believe this approach will maximize the value of the asset while allowing us to focus our internal resources on our lead programs.
Rich: With that I'll hand, it back to rich to initiate the Q&A session.
Rich: Thank you Jason This concludes our prepared remarks, and we will now start the Q&A session. Please limit your questions to two per person. So we can get to all of our covering analysts I'll turn it over to you operator.
Jason: In closing I am confident that our $1 1 billion in cash will fund these priorities into mid 2027 based on our current operating plan.
Jason: This reflects our ongoing commitment to disciplined capital allocation, ensuring we have the resources to advance our key programs, while maintaining financial flexibility.
Speaker Change: At this time, we will begin conducting our analyst Q&A session to ask a question you May press star followed by the number one on your telephone keypad.
Rich: With that I'll hand, it back to rich to initiate the Q&A session.
Speaker Change: Draw. Your question you May press Star followed by the number that you can.
Rich: Thank you Jason This concludes our prepared remarks, and we will now start the Q&A session. Please limit your questions to two per person. So we can get to all of our covering analysts I'll turn it over to you operator.
Speaker Change: For our analyst. Please raise your hand to indicate you would like to join the queue would be have not done so already.
Speaker Change: Once you hear the operator announce your name.
Speaker Change: Your line and ask your question.
Rich: At this time, we will begin conducting our analyst Q&A session to ask a question you May press star followed by the number one on your telephone keypad.
Speaker Change: Could you please limit your question to Keith.
Speaker Change: Just hold for a moment, while we poll for questions.
Speaker Change: The first question comes from Gena Wang from Barclays. Your line is open.
Speaker Change: Let me draw. Your question you May press Star followed by the numbers when you can.
For our analysts please raise your hand to indicate you would like to join the queue. If he have not done so already.
Speaker Change: Hi, This is <unk> on behalf of Ed Gena Wang from Barclays. So we have two questions first one is for T cell engagement.
Speaker Change: Like you hear the operator announce your name.
Speaker Change: You are using the clinical banker. So can you elaborate that the mechanism for the cleavage and how efficient <unk> in the tumor micro environment for instance for the single coat of age and therefore do cleavage and the second question is for HBV.
Speaker Change: On mute your line and ask your questions. We ask that you. Please limit your questions to queue.
Speaker Change: Please hold for a moment, while we poll for questions.
Speaker Change: The first question comes from Daniel <unk> from Barclays. Your line is open.
Speaker Change: So regarding the eclipse Registrational study start in the first half of the year. So what additional steps you need to stock based trial and.
Hong Kong: Hi, This is Hong Kong on behalf of Ed Gena Wang from Barclays. So we have two questions first one is for Tesco engaged or so.
We understand this is that even driven.
Hong Kong: In the cleavable linker. So can you elaborate that the mechanism for the cleavage and how efficient is the <unk> in the tumor micro environment for instance for the single can of age and therefore do crave H and the second question is for HBV.
Speaker Change: What is your estimate of timing to company that enrollment.
Speaker Change: Thank you very much for that question I'll ask Nick to address the first one related true up.
Speaker Change: The mechanism of action, we've taken to create HFC, Chris Yes. Thank you for that question.
Hong Kong: Regarding the Eclipse Registrational study start in the first half of the year. So what additional steps you need to start this trial.
Speaker Change: So we believe that we're getting efficiently cleavage for both snacks and the reason for this is that we've seen really nice activity in both the hurricane program as well as the FTE SMA program, both having the double mask and both having.
Hong Kong: We understand this is even driven.
Hong Kong: What is your estimate the timing to complete that enrollment.
Hong Kong: Thank you very much for that question I'll ask me, perhaps will address the first one related to true up at the mechanism.
Speaker Change: Same pro X, then masking technology as well as both having the same protease lingers on both sides.
Hong Kong: The mechanism of action related to create a company Chris yes. Thank you for that question.
Speaker Change: At the linker.
Speaker Change: In addition to that.
Hong Kong: We believe that we're getting efficiently cleavage for both <unk> and the reason for this is that we've seen really nice activity in both the hardship program as well as the FTE SMA program, both having the double mask and both having.
Speaker Change: Seeing that activity.
Speaker Change: That appears to be tumor specific <unk> not seen any significant toxicity in the periphery very minimal Crs and the absence of prophylactic lifestyle prophylactic corticosteroids.
Hong Kong: The same pro extend masking technology as well as both having the same protease lingers on both sides.
Speaker Change: Where we're really seeing that tumor specific cleavage.
Speaker Change: The fact that the same exact.
Hong Kong: Uh huh.
Hong Kong: The linker.
Speaker Change: Masking technology.
Hong Kong: In addition to that.
Speaker Change: Used in an approved drug out to the us market mentioned.
Hong Kong: Seeing that activity.
Hong Kong: That appears to be killer specific actually not seeing any significant toxicity in the periphery very minimal Crs and the absence of prophylactic widespread prophylactic critical steroids.
Speaker Change: This drug has a hemophilia drug.
Speaker Change: It has the same extend Max and uses three thrombin cleavage sites.
Speaker Change: Is efficiently create three sites.
Speaker Change: And then.
Hong Kong: Where we're really seeing that killer specific cleavage.
Speaker Change: In the setting of a clock.
Speaker Change: Sure.
Speaker Change: Have efficient thrombin activation efficient cleavage and clotting.
Hong Kong: The fact that the same exact.
Hong Kong: Masking technology.
Speaker Change: Needed as well as not having clouding in the state where there is no clouding activated clotting cascade.
Hong Kong: Is an unapproved drug out to the market mentioned.
Hong Kong: This drug has a hemophilia drug.
Speaker Change: Fisher sales being able to create three sites. There is nothing about the extend Max and of itself that prevents access to the creator sites three sites versus two sites freshness website tumor microenvironment is known to have very high protease activity. So we don't think that the number of sites is it really an issue.
Hong Kong: Has the same extent that and it uses three thrombin cleavage site.
Hong Kong: And it is efficiently create three sites.
Hong Kong: And then.
Hong Kong: The setting of a class where.
Hong Kong: You have efficient thrombin activation efficient cleavage and clotting as needed.
Speaker Change: Sue.
Speaker Change: In terms of efficiency of cleavage.
Hong Kong: Well its not having clouding in the state where there is no clotting activated clotting cascade. So the efficiency of being able to create three sites. There is nothing about the extend Max and of itself that for that access to the creator sites three sites versus two sites versus one fight tumor microenvironment.
Speaker Change: Thank you Amit so as to your second question relates to additional steps before starting our eclipse trial I will ask mark to address that sure. Thank you for the question. So we are on track to initiate the eclipse program in the first half of this year from the team is working with a high sense of urgency.
Hong Kong: <unk> is known to have very high protease activity. So we don't think that the number of sites is really an issue in terms of efficiency of cleavage.
Speaker Change: And excitement to get these trials up and running.
Speaker Change: We're confident that we will be able to initiate these trials in the near term and efficiently recruit patients because of the high unmet need in <unk> and are very compelling solstice.
Speaker Change: Thank you Amit so as to your second question relates to additional steps before starting our eclipse trial I will ask mark to address that sure. Thank you for the question. So we are on track to initiate the eclipse program in the first half of this year. The team is working with a high sense of urgency and <unk>.
Speaker Change: Phase II data so we're working.
Quickly to get these studies up and running and we will provide some updated guidance at a future point.
Speaker Change: Okay.
Hong Kong: Excitement to get these trials up and running.
Speaker Change: The next question comes from Paul Choi from Goldman Sachs. Your line is open.
Hong Kong: We are confident that we will be able to initiate these trials in the near term and efficiently recruit patients because of the high unmet need in HDD and are very compelling solstice.
Paul Choi: Hi, Thank you good afternoon, and thank you for taking our questions.
Paul Choi: My first question is on the $55 25, Egfr TCE program can.
Hong Kong: Phase II data so we're working.
Speaker Change: Can you maybe take a picture of what sort of patients Youre envisioning for your phase one study.
Hong Kong: Quickly to get these studies up and running and we will provide some updated guidance at a future point.
Speaker Change: Are you going to allow sort of met experience met treatment experienced patients or patients who have been treated with J&J is rib event by specific.
Speaker Change: The next question comes from Paul Choi from Goldman Sachs. Your line is open.
Scott: B enrollment to you Scott.
Paul Choi: Hi, Thank you good afternoon, and thank you for taking our questions.
Scott: Sort of color to understand what population youll be there would be great and.
Paul Choi: My first question is on the $55 25, Egfr TCE program can you maybe paint.
Scott: My second question is on the Hefei program.
Scott: Realize that the March data is coming up here next quarter fairly soon but as you're starting to think about sort of.
Paul Choi: And for US a picture of what sort of patients Youre envisioning for your phase one study.
Scott: Go no go criteria for the future, even though you plan to partner at can you, maybe just again refresh or your views on what you think is sort of a clinically meaningful here and what you think would potentially be attractive too theoretical development partner. Thank you.
Paul Choi: Are you going to allow sort of met experience met treatment experienced patients or patients who have been treated with J&J is rib events by specific.
Paul Choi: <unk> enrollment just any.
Paul Choi: Color to understand what population youll be there would be great and.
Speaker Change: Yes. Thank you Paul on the hepatitis B program on a go no go criteria I'll ask mark to add to it.
Speaker Change: My second question is on the Hep B program.
Speaker Change: Realize that the March data is coming up here next quarter fairly soon but as you're starting to think about sort of.
Speaker Change: Sure. Thanks for the question Paul So as you said, we will have a functional cure rate data second quarter of this year. In particular this is going to be the functional cure data 24 weeks of treatment. We had compelling results at the end of treatment at 48 weeks.
Speaker Change: Go no go criteria for the future, even though you plan to partner at can you maybe just again refresh on your views on what you think is sort of clinically meaningful here and what you think would potentially attractive theoretical development partner. Thank you.
Speaker Change: In the surface antigen locations with 39%.
Yes. Thank you Paul on the Hepatitis D program on a go no go criteria I'll ask mark to add to it.
S loss and the doublet with debit garden of <unk> and 46%, thus los in the truckload, including Pegylated interferon in terms of go no go criteria are and what we said before is we're looking for a 30%.
Speaker Change: Sure. Thanks for the question Paul So as you said, we will have a functional cure rate data second quarter of this year. In particular this is going to be the functional cure data 24 weeks of treatment. We had compelling results at the end of treatment at 48 weeks.
Speaker Change: Sure and the triplet, 20% in the doublet generally speaking that's based on our current well interactions and what could be clinically meaningful I think it's also maybe worth mentioning that.
Speaker Change: On the surface antigen locations with 39%.
Speaker Change: Just curious about progress and had a 16% functional cure and they are in phase III based on that today.
Speaker Change: Yes loss and the doublet with Debora, Barton <unk> and 46% loss in the triplet, including Pegylated interferon in terms of go no go criteria, but what we said before is we're looking for a 30% functional cure in the triplet 20% in the doublet generally speaking.
Speaker Change: Their phase III program will readout.
Speaker Change: Early next year, but that kind of gives you a little bit of context for what's been achieved so far so we will be partnering this program and engaging with partners.
Speaker Change: Once we have the functional cure data and I hope it gives you a little bit of context for what we're looking for.
Speaker Change: Based on our current well interactions and what could be clinically meaningful I think it's also maybe worth mentioning that Jess.
Speaker Change: Just curious about progress and had a 16%.
Speaker Change: So I can answer the Egfr question. So that this is it.
Speaker Change: Sure sure and they are in phase III based on that today they.
Speaker Change: Pretty standard first in human Phase one study.
Speaker Change: Their phase III program will readout.
Speaker Change: And then any such that.
Speaker Change: Early next year, but that's kind.
Speaker Change: Patients must have exhausted our current standard of care.
Speaker Change: Kind of gives you a little bit of context for what's been achieved so far so we will be partnering this program and engaging with partners.
Speaker Change: The enrolled on study, which means that they must have exhausted standard approved drugs, but we will allow for patients who may have been on any prior experimental.
Speaker Change: Once we have the functional cure data and.
Speaker Change: Hope that gives you a little bit of context for what we're looking for.
Speaker Change: Drags as well so.
Speaker Change: So I can answer the Egfr question. So that this is.
Speaker Change: So we do typically do get a smattering of different types of patients we are.
Speaker Change: That's pretty standard first in human Phase one study.
Speaker Change: Enriching for patients who have egfr as a target.
Speaker Change: And then in such that we paid.
Speaker Change: That's definitely important such as lung cancer head and neck pegged.
Speaker Change: Patients must have exhausted our current standard of care.
Speaker Change: Pancreas and colorectal cancer.
Speaker Change: Have you enrolled on study, which means that they must have exhausted standard drugs, but we will allow for patients who may have been on any prior experimental.
Speaker Change: But other than that.
Speaker Change: Probably going to have patients with a variety of different prior treatments.
Speaker Change: Drags as well so.
Speaker Change: The next question comes from my colleagues through Morgan Stanley. Your line is open.
Speaker Change: So we do typically do get a smattering of different types of patients we are.
Speaker Change: Enriching for patients who have egfr as a target.
Mike: Its avi notebooks on the line from Mike. Thank you for taking our questions.
Speaker Change: So I guess number one on 70 525, given the strong safety profile <unk> seen in the Phase. One study is 50 50 at 18 and 5500.
Speaker Change: That's definitely important such as lung cancer head and neck.
Speaker Change: <unk> pancreas and colorectal cancer.
Speaker Change: But other than that.
We're probably going to have patients with a variety of different prior treatments.
Speaker Change: Do you see a read through to 50 525, and do you believe you can possibly more more aggressively escalate doses in the upcoming phase one study.
Michael <unk>: The next question comes from Michael <unk> from Morgan Stanley. Your line is open.
And then my second question is.
Speaker Change: What are your thinking with respect to.
Speaker Change: Hey, its avi nervous on the line from Mike. Thank you for taking our questions.
Speaker Change: Disclosing data for 50 525 do you think you would maybe plan to do an initial data update US you did 450, 818, and 5500 or away from more mature data.
Speaker Change: So I guess number one on 70 525, given the strong safety profile <unk> seen in the phase One studies 58 to 50 818 or 5500.
Speaker Change: Okay.
Speaker Change: Yes. Thank you for that question as you know there have been significant learnings from the Hurricane program Thats, what translated to the <unk> funded program.
Speaker Change: Do you see a read through to $55 25, and do you believe you can possibly more more aggressively escalate doses in the upcoming phase one study.
Speaker Change: And then my second.
Speaker Change: The Pea SMA program could start at the highest dose escalate with fifth state compared to the original <unk> program. So we expect that we'll continue to learn across to Ken.
Speaker Change: <unk>.
Speaker Change: What are your thinking with respect to.
Speaker Change: Disclosing data for 50 525 do you think you would maybe plants do an initial data update as he did for 2018 and 5500 or wait for more mature data.
Speaker Change: Nickel program, so that it's running so benefit.
Speaker Change: <unk>.
Speaker Change: Also as we go into the five five to five profile anything you want to add Banco Nico.
Speaker Change: Yes. Thank you for that question as you know.
Speaker Change: Have been significant learnings from the Hurricane program, that's what translated to the <unk> hundred program.
The only thing.
Speaker Change: Is that Egfr is broadly expressed in normal tissue.
Speaker Change: The Pea SMA program could start at the higher dose escalate west with fee compared to the original <unk> program. So we expect that we'll continue to learn across clinical programs and that is learning so benefit also.
Speaker Change: Makes it different from the peer SMA program, where of course, there is <unk> expressed outside the prostate and then her to Harris Kerchoo expressed in lung and heart and other normal tissues, but your GFR is broadly expressed so we're looking forward to this program because it will be a really rigorous test of our tool masking approach.
Speaker Change: Also as we go into the five 5% to five program anything you want to add Mark on Zika.
Speaker Change: The only thing.
Speaker Change: And the specificity for announcing the tumor micro environment, whether we can achieve.
Speaker Change: Is that Egfr is broadly expressed in normal tissue.
Speaker Change: An excellent therapeutic index.
Speaker Change: Which makes it different from the peer SMA program, where of course, there is P. SMA expressed outside the prostate and in her to purchase.
Speaker Change: No in Egfr positive tumors as Nick I would attribute for.
Speaker Change: Maryann point, yes, I mean, the learnings from the earlier two programs have and will continue to inform you about 25% and further further program. So we do expect to be efficient in how we conduct out.
Speaker Change: Curt you expressed in lung and heart and other normal tissue as the Egfr is broadly expressed so we're looking forward to this program because it will be a really vigorous test of our tool announcing approach and the specificity for unmasking, the tumor microenvironment and whether we can achieve.
Speaker Change: Yeah, and I would like to start so add in that from the hurt your program.
Speaker Change: Again Egfr molecule for use the same pro extend technology, the same proteins flankers et cetera.
Speaker Change: Excellent therapeutic index.
Speaker Change: In Egfr positive tumors as Nick alluded to before but to Mary Anne's point, Yes, I mean, the learnings from the earlier two programs have and will continue to inform you about 25% and further further program. So we do expect it to be efficient in how we conduct out.
Speaker Change: With a hurt your program we've seen a prior naked T cell help to T cell engaged or that have a grade four crs at five micrograms per kg.
Speaker Change: And IL six levels in the 10000 peak a long time now.
Speaker Change: Yes, and I would like to start so add in that hurt.
Range are suggesting that there is plenty of normal expression approach to enabling that that significant crs.
Speaker Change: Her two program.
Speaker Change: Again egfr molecule for us.
Speaker Change: <unk> pro extend technology, the same proteins flankers et cetera, with the her two program we've seen a prior naked T cell help to T cell engaged or that have a grade four crs at five micrograms per kg and IL six levels.
Speaker Change: When you look at our eight eight not <unk>.
Speaker Change: Last I'll, let Jill.
Speaker Change: We are start dose with one microgram per kg, so higher than this that fully unmask hurts you grabbed CVR <unk> two that was up that was in the clinic that many years ago. So we do believe with that very wide therapeutic index that we've seen for.
Speaker Change: 10000 people come now.
Speaker Change: Change is suggesting that there is plenty of normal expression approach to enabling that that significant crs.
Speaker Change: The chart two that will mask that that well have give us confidence on the five five to five.
Speaker Change: When you look at our eight eight not double masked I'll, let Jill.
Speaker Change: The next question comes from <unk> <unk> from Leerink Partners. Your line is open.
Speaker Change: We are start dose with one microgram per kg, so higher than this that fully unmask geographic DVR 13 onto that was.
Speaker Change: Hi, This is made the Ali Mohammad on for Rob. Thanks for taking our question question, but first so given the early clinical response signals in the heavily pretreated patients what are your thoughts of potentially moving the T cell engagements into earlier lines of therapy in future trials.
Speaker Change: That was in the clinic up many years ago. So we do believe with that very wide therapeutic index that we've seen for <unk> that will ask that that well have give us confidence on the five five to five.
Speaker Change: And also could you elaborate on how machine learning in antibody engineering.
The next question comes from <unk> <unk> from Leerink Partners. Your line is open.
Speaker Change: Background in that and those capabilities are being applied to optimize the design and efficacy of your T cells.
Hi, This is made the Ali Muhammed on for Rob Thanks for taking our question.
Speaker Change: But first so given the early clinical response signals in the heavily pretreated patients what are your thoughts of potentially moving the T cell engagements into earlier lines of therapy in future trials and also could you elaborate on how machine learning in antibody engineering, you're like the background on that.
Speaker Change: Yeah. Thank you for the question Thats the whole thing to earlier lines, maybe mark can address that sure. So yes.
Speaker Change: Yes, you're correct that in both the.
Speaker Change: Her two P SMA programs.
Speaker Change: It's a basket trial for her to be SMA is all metastatic castration resistant prostate cancer, but they're heavily pretreated patient population very heterogeneous in terms of their critical features in prior treatment history. So that is where we are starting four P. SMA program of course, we are.
Speaker Change: And those capabilities are being applied to optimize the design and efficacy.
Speaker Change: Our T cell and speakers.
Speaker Change: Yes. Thank you for that question Thats the whole thing too early alliance, maybe mark can address sure. So.
Speaker Change: Interested in getting into earlier lines of treatment. This is something that we will talk more about at a future time, but clearly that is of interest.
Speaker Change: Yes, you're correct in both.
Speaker Change: Her two P SMA programs.
Speaker Change: It's a basket trial for her to be SMA is all metastatic castration resistant prostate cancer, but they are heavily pretreated patient population very heterogeneous in terms of their critical features in prior treatment history. So that is where we are starting for PS.
Speaker Change: In terms of your question about the Daisy machine learning and how to optimize that TCE platform. I mean, I think one of the beautiful parts about this deal bringing in the Ami next.
Speaker Change: Platform and the people with it is that we.
Speaker Change: <unk> program of course, we are interested in getting into earlier lines of treatment.
Speaker Change: We can apply our.
Speaker Change: <unk> antibody discovery platform and our daily.
Something that we will talk more about at a future time, but clearly that is of interest.
Speaker Change: Our ability is to optimize the next generation of T cell engagement. So we are using that to more rapidly identify it.
Speaker Change: In terms of your question about the Daisy our machine learning and how to optimize that TCE platform. I mean, I think one of the beautiful parts about this deal bringing in the <unk>.
Speaker Change: And optimized.
Speaker Change: Binders for the next generation of T song interest. So I think there's a real synergy there between.
Speaker Change: Platform and the people with it is that we can apply our.
Speaker Change: Erez antibody discovery and optimization platform, that's AI, driven and the T cell engaging platform that we now have in house.
Speaker Change: Antibody discovery platform and our daily AI.
Speaker Change: Yes, I would just add that our protein engineering platform.
Speaker Change: <unk> is to optimize the next generation of T cell engagement. So we are using that to more rapidly identify.
Speaker Change: Such that we start with a starting point of a protein could be an antibody could be applied or China.
Speaker Change: And optimize the binders for the next generation of T cell <unk>. So I think there's a real synergy there between.
Speaker Change: China or whatever it might be.
And then we deploy a basically a calculation of different models to come up with molecules.
Speaker Change: Erez antibody discovery and optimization platform that AI, driven and the T cell engaging platform that we now have in house.
Speaker Change: Molecules that have increased characteristics.
Speaker Change: No better potency.
Speaker Change: Increased though develop ability at so and <unk>.
Speaker Change: Yes, I would just add that our protein engineering platform.
Speaker Change: So it's a combination of both internal model some external model for large protein model that a lot of internal data that we have generated over the years that together. It gives us an output that we can quickly task and biological models and that sort of feeds back into introduced into the database.
Speaker Change: Such that we start with a starting point of a protein could be an antibody.
Speaker Change: Alright.
Speaker Change: Chinas or whatever it might be and.
Speaker Change: And then we deploy basically a combination of different models to come up with molecules that have increased characteristics.
Speaker Change: Better potency.
Speaker Change: The next question comes from Eric Joseph from Jpmorgan. Your line is open.
Speaker Change: Priest develop ability and so on and it's a it's a combination of both internal model. Some external model for large protein model that a lot of internal data that we have generated over the years that together. It gives us an output that we can quickly test and biological models and thats sort of fee back in.
Speaker Change: Hi, This is Kelly on for Alright, Thanks for taking my questions.
Speaker Change: Quick one on the dosing frequency for the Egfr you push to go to Q3 weeks.
Speaker Change: With the other two is this something that you continue with the Egfr.
Speaker Change: To introduce into the database.
Speaker Change: Yeah, So and we are looking at both Q week in Q3 week for both the hurt too and the T SMA program.
Speaker Change: The next question comes from Eric Joseph from Jpmorgan. Your line is open.
Billy: Hi, This is Billy on for Alright, Thanks for taking my questions.
Speaker Change: And we are planning to do the same for the Egfr, we're encouraged that the half life. So far for both of our clinical programs are very encouraging.
Speaker Change: Quick one on the dosing frequency for the Egfr <unk> push to go to Q3 weeks.
Billy: The other two is there something that you continue with the Egfr.
Speaker Change: And that for that hurt your program appears to be safe and efficacious.
Billy: Yeah, So and we are looking at both Q week in Q3 week for both the her two and the PSA program.
Speaker Change: Those schedules.
Speaker Change: Great. Thanks for taking my question.
Speaker Change: Your next question comes from Phil Nadeau from Cowen Your line is open.
Billy: And we are planning to do the same for the Egfr, we're encouraged that the half life. So far for both of our clinical programs are very encouraging.
Speaker Change: Good afternoon, and thanks for taking our questions two from us.
Speaker Change: The most common question. We currently get on <unk> is about the expectations for a dose response for 5500 Im sure you get that same question can you talk a little bit more about.
Billy: And that for that hurt your program appears to be safe and efficacious.
Billy: Those schedules.
Speaker Change: Great. Thanks for taking my question.
Speaker Change: What gives you confidence that the higher doses.
Speaker Change: Deeper and more durable PSA responses given that there wasn't a clear dose response and the initial data this.
Speaker Change: The next question comes from Phil Nadeau from TD Cowen Your line is open.
Speaker Change: This first question second question on the timing of the next updates for 50 550 818, we.
Speaker Change: Good afternoon, and thanks for taking our questions two from us.
Speaker Change: We appreciate it's too early to give specific timing guidance, but could you speak to what you hope to have in the next update in terms of <unk>.
The most common question. We currently get on <unk> is about the expectations for a dose response for 5500 Im sure Youll get that same question can you talk a little bit more about.
Speaker Change: Quality and quantity of data.
Speaker Change: <unk> wait for some certain number of patients in the trials.
Speaker Change: What gives you confidence that higher doses will produce deeper more durable PSA responses given that there wasn't a clear dose response and the initial data this.
Or do you want to wait for the phase two dose some sense of kind of what you hope to accomplish before giving us. The next update would be helpful. Thank you.
Speaker Change: This first question second question on the timing of the next updates for 50 550 818.
Speaker Change: Yes. Thank you Phil I mean, we are really trying to assume that's right.
Speaker Change: <unk> communication of data that needs to be a meaningful with.
Speaker Change: We appreciate it's too early to give specific timing guidance, but could you speak to what you hope to have in the next update in terms of <unk>.
Speaker Change: The need to come to draw important conclusion, thus far next steps from from the data.
Speaker Change: Quality and quantity of data.
Speaker Change: <unk> wait for some certain number of patients in the trials.
Speaker Change: Both programs are in dose escalation, we just discussed.
Speaker Change: Or do you want to wait for the phase two dose some sense of kind of what you hope to accomplish before giving us. The next update would be helpful. Thank you.
Speaker Change: Going to a different dosing frequency model year exploring combination with Penn Road. So a lot of data that needs to read out of safety efficacy durability of a song.
Speaker Change: Yes. Thank you Phil I mean, we are really trying to assume montserrat balanced communication of data that is really meaningful.
Speaker Change: So as that data develops.
Speaker Change: We will as soon as we have seen any meaningful updates of course share that with you all.
Speaker Change: <unk>.
Speaker Change: The need to come to draw important conclusion, thus far next steps from from the data.
Speaker Change: As it relates to the dose response that we do get that question.
Speaker Change: Both programs are in dose escalation, we just discussed.
Speaker Change: A quite quite often so mark let me cut do you want to address I think what we tried to emphasize in our Investor event last January is that this is very early in the <unk> program in terms of dose escalation and we believe we presented compelling early signs of efficacy in <unk>.
Two different dosing frequency model year exploring combination with Penn Road.
Speaker Change: A lot of data that needs to read out of safety efficacy durability and so on.
Speaker Change: So as that data develops.
Speaker Change: We will as soon as we have meaningful updates of course share that with you all.
Speaker Change: <unk> SMA, I'm, sorry, PSA declines and excellent safety with with minimal Crs and <unk>.
Speaker Change: As it relates to the dose response that we do get that question.
Speaker Change: Minimal toxicity. So we have a lot of room to move on the dose. So we have an escalating the dose book in Q week, and Q3 weeks and we are anticipating to see.
Speaker Change: Quite often so mark do you want to address yes, I think what we tried to emphasize in our Investor event last January is that this is very early in the <unk> program in terms of dose escalation and we believe we presented compelling early signs of efficacy in terms of <unk>.
Speaker Change: <unk> and more sustained efficacy as we escalate the dose and the program or the other.
Speaker Change: The thing maybe to mention is that.
Speaker Change: We have now shown.
Speaker Change: <unk> I'm, sorry, PSA declines and excellent safety with minimal Crs and <unk>.
Speaker Change: Good compelling early signs of efficacy and safety of both the herd to a PMA. Our program. So we're really consolidated we think the platform and the mouse <unk> nature of the platform and the specificity of our ability to unmask. These molecules in the tumor while maintaining.
Speaker Change: Minimal toxicity. So we have a lot of room to move on the dose. So we have been escalating the dose booked in Q, Inc. Q3 weeks and we are anticipating to see deeper.
Speaker Change: Paper and more sustained efficacy as we escalate the dose in that program.
Speaker Change: Very high safety profile.
Speaker Change: The thing maybe to mention is that.
Speaker Change: Just to mention one other thing which is in colorectal cancer patient, we referred to today and that we presented.
Speaker Change: We have now shown.
Speaker Change: Good compelling early signs of efficacy and safety of both the herd to appear SMA program. So we're really consolidated we think the platform and the mask dual mask nature of the platform and the specificity of our ability to unmask this molecule in the tumor while maintaining.
In our Investor event and the her two program that when we escalate the dose from 60 to 600 micrograms per kilo in that patient we saw a deepening.
Speaker Change: Anti tumor responses. So that patient is an example of what can happen as we escalate the dose now of course, they pivot to SMA programs, even earlier and we are we're continuing to escalate the dose, but we anticipate with higher doses, we'll see better efficacy with with acceptable safety.
Speaker Change: Very high safety profile.
Speaker Change: Just to mention one other thing which is in colorectal cancer patient, we referred to today and that we presented.
Speaker Change: In our investor events in the <unk> program that when we escalate the dose from 60 to 600 micrograms per kilo in that patient we saw a deepening.
Speaker Change: Your next question comes from Alex <unk> from Bank of America. Your line is open.
Speaker Change: Anti tumor responses, so that patient as an example of what can happen as we escalate the dose now of course.
Speaker Change: Hey, guys. Thanks for taking our questions just two quick ones from US first on 500 525 I apologize. If this was already asked but just on the need for steroid prophylaxis do you think.
Speaker Change: <unk> programs, even earlier and we are we're continuing to escalate the dose, but we anticipate with higher doses, we will see better efficacy with with acceptable safety.
Speaker Change: You'd approach this thoroughly to studies for for your other two assets or maybe a different approach just given the breadth of the egfr expression and <unk>.
Speaker Change: The next question comes from Alex <unk> from Bank of America. Your line is open.
Speaker Change: Secondly, appreciate the additional preclinical mass <unk> targets are undisclosed, but I guess as youre approaching maximizing the value of the pro extend platform in oncology.
Speaker Change: Hey, guys. Thanks for taking our questions just two quick ones from US first on 555 I apologize. If this was already asked but just on the need for steroid prophylaxis do you think.
Speaker Change: As your development process, driven more by de risked targets or areas of high unmet need.
Speaker Change: You'd approach this thoroughly to studies for for your other two assets or maybe a different approach just given the breadth of the Egfr expression.
Speaker Change: Maybe with the novel target. Thank you.
Speaker Change: Yes. Thank you Alex maybe I'll address the second question. So since we announced the data on January eight.
Speaker Change: We appreciate the additional preclinical mass <unk> targets are undisclosed, but I guess as youre approaching maximizing the value of the pro extend platform in oncology.
Speaker Change: It has been quite a bit of odd feature as it relates to <unk>.
Speaker Change: That farm and so we have for our self defined set of targets that we believe would be highly valuable snack programs, but we also are getting educated on what some industrial partners, but I'd be interested in so.
Speaker Change: Is there development process, driven more by de risked targets or areas of high unmet need.
Speaker Change: Maybe with the novel target. Thank you.
Speaker Change: Yes. Thank you Alex maybe I'll address the second question. So since we announced the data on January eight.
Speaker Change: <unk> 70 a share.
Speaker Change: Going forward some more insight into how we are thinking about what next preclinical programs could be that we can take advantage of the Blackstone platform, because we do want to make sure. We got it that value of the platform and again the.
Speaker Change: Has been quite a bit of a feature as it relates to our platform and so we have for our self defined set of targets that we believe would be highly valuable snack programs, but we also are getting educated on what some partners by the interested it so you know.
Speaker Change: Promising data.
Speaker Change: Pro perhaps easy thing does.
Speaker Change: Hi, good even the potential there.
Speaker Change: As it relates to the need for us.
Speaker Change: Prophylactic corticosteroids, just clarifying that we did not use any.
Speaker Change: <unk> 70 share.
Speaker Change: Going forward some more insight into how we are thinking about what next preclinical programs could be that we need to take advantage of the Blackstone platform, because we do want to make sure we accelerate that value out of the platform and again.
Speaker Change: In our pilot program for five <unk> to five <unk>.
Speaker Change: Thats true I don't know Mark Thank God.
Yes.
Speaker Change: We felt that quite a bit of confidence with this platform with the other two drugs.
Speaker Change: Promising data from two clinical program.
Speaker Change: Again, not using not having to use prophylactic steroids.
Just.
Speaker Change: The heightened even the potential there.
Speaker Change: Really minimal Crs.
Speaker Change: It relates to the need first.
Speaker Change: Very minimal IL six levels so.
Speaker Change: Prophylactic corticosteroids, just clarifying that we did not use any.
Speaker Change: For the five five to five we are starting that study without any prophylactic steroids.
Speaker Change: In our pilot program for five five to $5.
Speaker Change: It's true.
Speaker Change: The next question comes from Joseph <unk> from <unk>. Your line is open.
Speaker Change: Got it.
Speaker Change: Yes.
Speaker Change: We felt that quite a bit of confidence with this platform with the other <unk> drugs.
Joseph: Hi, Thanks for taking our questions.
Speaker Change: Again, not using not having to use prophylactic steroids.
Joseph: Financial one from us, but can you just remind us of the details of the collaboration agreement with <unk> on the <unk>.
Speaker Change: Really minimal Crs.
Speaker Change: Very minimal IL six levels.
Joseph: <unk> component I believe at the costs profit share, but just want to make sure the details on the cost share.
Speaker Change: For the 505 five we are starting that study without any prophylactic steroids.
Joseph: I guess my question is around the financial impact of this is all nine of them have optionality coming up for that asset has that potential decision.
Joseph: The next question comes from Joseph <unk> from <unk>. Your line is open.
Joseph: To some of your Opex and cash burn assumptions over the next few years.
Joseph: Hi, Thanks for taking our questions.
Speaker Change: Financial one from US can you just remind us of the details of the collaboration agreement with <unk>.
Joseph: And then as a follow up how does that.
Joseph: Current collaboration agreement impact your potential partnership negotiations for the HBV program. Thank you.
Speaker Change: The <unk> component I believe it's a cost profit share, but just want to make sure the details on the cost share.
Joseph: Yeah.
Joseph: Yes. Thank you for that question. So our collaboration agreement with xylem stemming from 2017.
Speaker Change: I guess my question is around the financial impact of this does allow them have optionality coming up for that asset and does that potential decision built ins to some of your opex and cash burn assumptions over the next few years.
Joseph: Pure financial arrangements. So there's no operational role that an item thats playing into development North Dakota <unk> mutation.
Speaker Change: And then as a follow up how does that.
Joseph: Mylan does have an option too.
Speaker Change: Current collaboration agreement impact your potential partnership negotiations for the HBV program. Thank you.
Joseph: To either.
Joseph: Step into the program and share 50% of the cost as it relates to the lap strong components of the regimen and then of course for sure.
Speaker Change: Yes. Thank you for that question. So our collaboration agreement with xylem stemming from 2017, it's a pure financial arrangements. So there's no operational role that an item thats playing into this outlet North Dakota salinization allow.
Joseph: The commensurate percentage of the profit or opt out and have a typical type of milestone and royalty deal. So that is an option that's on an island.
Speaker Change: Mylan does have an option.
Joseph: So decide on.
Speaker Change: To either.
Joseph: The impact for lending partnership with <unk> to HBV.
Speaker Change: Step into the program and share 50% of the cost as it relates to the lap strong components of the regimen and then of course on for sure.
Joseph: Both are possible I mean again, because the nature of your deal with our Mylan as a pure financial one.
Speaker Change: The commensurate percentage of the profit or opt out and have a typical type of milestone and royalty deal. So that is an option. That's on an item that still needs to decide on.
Joseph: Doesn't preclude from a large pharma partner.
And I've taken operational role on the clinical development. The commercialization, obviously it would be easy easier. If there was sort of 111 partner for the program.
Speaker Change: The impactful any partnership with Nick to HBV.
Joseph: Program, but both are possible.
Joseph: Could I just.
Speaker Change: Both are possible I mean again, because the nature of your deal with our long Island is a pure financial one.
Joseph: On this further details will be in the 10-K.
Joseph: Agreements.
Joseph: Just as you think about our runway.
Speaker Change: Preclude from large pharma partner.
Joseph: Sort of assume the worst case in the shorter term which is that.
Speaker Change: And I've taken operational role on the clinical development. The commercialization, obviously it would be easy easier. If there was sort of 111 partner for the program. That's both are possible.
Joseph: I will now.
Joseph: In the shorter term if they opt in and do a profit share that would potentially be upside.
Joseph: The next question comes from Patrick <unk> from H C. Wainwright Your line is open.
Speaker Change: Could I just.
Speaker Change: Yes on this further details will be in the 10-K.
Joseph: Yeah.
Speaker Change: Agreements and just as you think about our runway.
Speaker Change: Thanks. Good afternoon, just a couple of follow ups from me on the HBV program Im wondering now as more time has passed and you've had more.
Speaker Change: Have sort of assumed the worst case in the shorter term which is.
I will now.
Speaker Change: In the shorter term if they opt in and do a profit share that would potentially be upset.
Speaker Change: Tend to kind of digest the data from Tulsa, if theres been any further learnings that could help inform the eclipse program.
Patrick: The next question comes from Patrick <unk> from H C. Wainwright Your line is open.
Speaker Change: And then.
Speaker Change: Separately I was just.
Speaker Change: Just curious if you could talk more about the relative importance of demonstrating that robust reduction in HBV surface antigen.
Patrick: Thanks. Good afternoon, just a couple of follow ups for me on the HBV program Im wondering now as more time has passed and you've had more.
Speaker Change: Hepatitis Delta setting and how we should think about this reduction.
Speaker Change: Combination treatment relative to the monotherapy antibody, particularly as we think about long term outcomes in this chronic treatment setting with delta.
Patrick: Tend to kind of digest the data from sources that there has been any further learnings.
Patrick: Could help inform the eclipse program.
Speaker Change: Yes. Thanks for the question so in terms of solstice.
Patrick: And then.
Patrick: Separately I was just curious if you could talk more about the relative importance of demonstrating that robust reduction in HBV surface antigen.
Speaker Change: To recap for everyone. I mean, we did see at 24 weeks.
Speaker Change: 41%.
Patrick: Hepatitis Delta setting and how we should think about this reduction for combination treatment relative to the monotherapy antibody, particularly as we think about long term outcomes in this chronic treatment setting with delta.
Speaker Change: Patients, reaching complete viral suppression or target of 24 weeks, 64% at 36 weeks and then the 80% range.
Speaker Change: 60 weeks and the rollover cohort, so I think where we're really seeing.
Patrick: Yes. Thanks for the question so in terms of solstice.
Speaker Change: Unprecedented levels of viral suppression of the Delta virus or we're very excited about that and we're very keen to move into the eclipse program.
Patrick: Just to recap for everyone that we did see a 24 weeks.
Patrick: 41% of patients.
Speaker Change: Obviously, we have learned a lot.
Patrick: Patients, reaching complete viral suppression or target out there at 24 weeks, 64% at 36 weeks and then the 80% range.
Speaker Change: Delta both in terms of the data, but importantly about the demographics of that disease, where the patients reside and I think those learnings are really inform how we.
Patrick: At 60 weeks and the rollover cohort so I think we're really seeing.
Speaker Change: Site selection investigator selection and things of that nature. So we're not prepared to share more details about that today, but.
Patrick: Unprecedented levels of viral suppression of the Delta virus or we're very excited about that and we're very.
Speaker Change: Essentially that's going to help us I think really optimized for our phase III program in terms of the your question about hepatitis B surface antigen reduction, yes, and the combination of Tibet regard intellectually.
Patrick: <unk> to move into the Eclipse program.
Patrick: Obviously, we have learned a lot about that.
Patrick: Delta both in terms of the data, but importantly about the demographics of that disease, where the patients reside and I think those learnings or if really informed how we.
Speaker Change: We are seeing three log reduction in hepatitis b surface antigen, which is much much greater than our mono therapy with the antibody to <unk>.
Patrick: Site selection investigator selection and things of that nature. So we're not prepared to share more details about that today, but.
Speaker Change: Which is a one log reduction we think this is really important because.
Patrick: Essentially that's going to help us I think really optimize our phase III program in terms of the your question about hepatitis B surface antigen reduction, yes, and the combination of Tibet regard intellectually.
Speaker Change: It shows.
Speaker Change: Gordon C and the depth of it.
Speaker Change: Our viral effect of our combination therapy it shows.
Speaker Change: We are.
Speaker Change: Titus B surface antigen is critical for adults over lifecycle of forming <unk>.
Patrick: So we are seeing three log reduction in hepatitis b surface antigen, which is much much greater than our mono therapy with the antibody to <unk>, which is a one log reduction we think this is really important because.
Speaker Change: Taken together with the very profound suppression data that we really think we have a.
Speaker Change: Very very good chance of long term viral suppression for patients in terms of long term outcomes.
Patrick: It shows the.
Patrick: Potency and the depth of it.
Speaker Change: I can speculate that because we can achieve such deep and durable.
Patrick: <unk> effect of our combination therapy it shows.
Patrick: We are as hepatitis b surface antigen is critical for delta or lifecycle of forming a very on that this just really taken together with the very profound suppression data that we really think we have a very very good chance of long term viral suppression for patients.
Speaker Change: Suppression of Delta virus, and HBV surface antigen that we hope that will translate into better outcomes for patients less progression to cirrhosis progression.
Speaker Change: To liver cancer. Another poor outcomes of course, we have to demonstrate that but the virus does drive growth core outcomes. So we do think that suppressing those virus the virus as well as we can with our combination.
Patrick: Of long term outcomes.
Patrick: I can speculate that because we can achieve such deep and durable.
Speaker Change: Should should lead to better outcomes for patients. So we're very excited about the program and we're moving with all pace to our phase III initiation.
Patrick: Suppression of Delta virus, and HBV surface antigen that we hope that will translate into better outcomes for patients less progression to cirrhosis progression.
Patrick: To liver cancer or another poor outcomes of course, we have to demonstrate that but the virus does drive those poor outcomes. So we do think that suppressing those viral the virus as well as we can with our combination.
Speaker Change: This concludes the Q&A session of the call. Thank you for participating and I will turn the call back over to Mary Ann get back.
Speaker Change: Thank you operator.
Speaker Change: I think I'm close I'd like to emphasize the significant strides we have made and touched four and our exciting path forward.
Patrick: It should lead to better outcomes for patients. So we're very excited about the program and we're moving.
Patrick: Page two of our phase III initiation.
Speaker Change: Successively successfully transform turbine technology into novel dual platform company, that's promising at Boston as you have heard in both infectious diseases.
Speaker Change: This concludes the Q&A session on the call. Thank you for participating and I will turn the call back over to Mary Anne.
Speaker Change: In oncology.
Speaker Change: Our hepatitis Delta program as Scott just mentioned is poised to enter phase III trials, but our innovative T cell engagement platform.
Patrick: Thank you operator.
Speaker Change: Conclude I'd like to emphasize the significant strides we have made and touched four and our exciting path forward.
Speaker Change: Those really encouraging early results across multiple solid tumor types.
Speaker Change: Our solid financial position with a runway.
Speaker Change: Successively successfully transformed nearby technology into now a dual platform company.
Speaker Change: Stemming implement 2057 also provides us with the resources to advance our key programs.
Speaker Change: Promising at Boston as you have heard in both infectious diseases and in oncology.
Speaker Change: The critical value inflection.
Speaker Change: Inflection points.
Speaker Change: Hepatitis Delta program as Mark just mentioned is poised to enter phase III trials, while our innovative T cell engagement platform has shown those really encouraging early results across multiple solid tumor types.
Speaker Change: So we remain committed to our mission of harnessing the power of the immune system to transform patient lives and we are more confident than ever in our ability to deliver on this promise.
Speaker Change: Thank you all for your continued support and for joining US today, we look forward to updating you on our progress in the coming months.
Speaker Change: Our solid financial position with a runway extending into mid 2027 also provides us with resources to advance our key programs so critical value inflection points.
Speaker Change: Operator, you may end the call.
Speaker Change: Ladies and gentlemen that concludes today's call. Thank also joining and you may now disconnect.
Speaker Change: We remain committed to our mission of harnessing the power of the immune system to transform patient lives and we are more confident than ever in our ability to deliver on this promise.
Speaker Change: Thank you all for your continued support and for joining US today, we look forward to updating you on our programs in the coming months.
Speaker Change: Operator, you may end the call.
Speaker Change: Ladies and gentlemen that concludes today's call. Thank you all for joining and you may now disconnect.
Speaker Change: [music].