Q3 2024 Arrowhead Pharmaceuticals Inc Earnings Call

August 8, 2024

After the presentation, there will be an opportunity to ask questions I will now hand, the conference over to Vince Anzalone them.

Vince Anzalone: Vice President of Investor Relations for Arrowhead. Please go ahead Vince.

Chris Anzalone: Thank you and good afternoon, everyone. Thank you for joining us today to discuss arrowheads results for its fiscal 2024 third quarter ended June 32024 with US today from management are president and CEO, Dr. Chris Anzalone, who will provide an overview of the quarter, Dr. Bruce given interim chief medical.

Bruce Given: Media. This study was accepted as a late breaker oral presentation at the European Society of Cardiology, 2024, coming up on September 2nd, 2024, in London.

Bruce Given: This study was accepted as a late breaker oral presentation at the European Society of Cardiology, 2024, coming up on September 2nd, 2024 in London.

Yeah.

Bruce Given: Since that's Labor Day in the U.S., we also plan to have an investor call the following day on September 3rd, 2024. Dr. Gerald Watts, a principal investigator for Palisade, and the presenter of the data at the European Society of Cardiology, would join the investor call to present the data and discuss the exciting results.

Bruce Given: Since that's Labor Day in the U.S., we also plan to have an investor call the following day on September 3rd, 2024.

Ladies and gentlemen, welcome to the Arrowhead Pharmaceuticals conference call throughout today's recorded presentation, all participants will be in listen only mode.

Speaker Change: Scientists, who will provide an update on our cardio metabolic pipeline, Andy Davis, Senior Vice President and head of global Cardio metabolic franchise, who will provide an update on commercial activities and Ken Moskovsky, Chief Financial Officer, who will give a review of the financials, Dr. James Hamilton, Chief of Discovery, and translational Medicine and Patrick O'brien.

Bruce Given: Dr. Gerald Watts, a Principal Investigator for Palisade, and the presenter of the data at the European Society of Cardiology, would join the investor call to present the data and discuss the exciting results.

After the presentation, there will be an opportunity to ask questions I will now hand, the conference over to Vince Anzalone Vice.

Vice President of Investor Relations for Arrowhead. Please go ahead.

Andy Davis: I'll now turn the call over to Andy to give a few remarks on where we are with commercial planning and readiness. Andy.

Andy Davis: I'll now turn the call over to Andy to give a few remarks on where we are with commercial planning and readiness. Andy. Thank you, Bruce.

Speaker Change: CFO and general Counsel will also be available during the Q&A portion of the call.

Thank you and good afternoon, everyone and thank you for joining us today to discuss arrowheads results for its fiscal 2024 third quarter ended June 30, 'twenty 'twenty four with US today from management are president and CEO, Dr. Chris Anzalone, who will provide an overview of the quarter, Dr. Bruce given interim chief medical side.

Speaker Change: Before we begin I would like to remind you that comments made during today's call contains certain forward looking statements within the meaning of section 27, a of the Securities Act of 1033 and section 21 E of the Securities Exchange Act of 1034, all statements other than statements of historical fact are forward looking statements.

Andy Davis: Thank you, Bruce. We're on track with our launch preparations for disaster and infamiliar Chylomicronemius syndrome or FCS.

Andy Davis: We're on track with our launch preparations for disaster and infamiliar chylomicronemius syndrome or FCS. Let me begin by talking a little bit about our expanded access program, or EAP. We initiated the EAP to ensure patients who roll off our Palisade trial, maintain access to plasasterine, and to make investigational plasasterine available outside of a clinical trial. For other patients with FCS who meet certain program eligibility criteria, if requested by their treating physician.

Andy Davis: Let me begin by talking a little bit about our Expanded Access Program, or EAP. We initiated the EAP to ensure patients who roll off our Palisade trial maintain access to plasasterine and to make investigational plasasterine available outside of a clinical trial. For other patients with FCS who meet certain program eligibility criteria, if requested by their treating physician. We've fielded requests for additional information about the EAP from physician societies and treating physicians who may have appropriate FCS patients. And our medical affairs team is already out in the field engaging with these individuals to help them understand the program.

<unk>, who will provide an update on our cardio metabolic pipeline, Andy Davis, Senior Vice President and head of global Cardio metabolic franchise, who will provide an update on commercial activities and Ken Moskovsky, Chief Financial Officer, who will give a review of the financials, Dr. James Hamilton, Chief of Discovery, and translational Medicine and Patrick O'brien.

Speaker Change: And are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed in any forward looking statements for further details concerning these risks and uncertainties. Please refer to our SEC filings, including our most recent annual report on Form 10-K, and our quarterly reports on Form 10-Q.

Andy Davis: We've fielded requests for additional information about the EAP from physician societies and treating physicians who may have appropriate FCS patients. And our medical affairs team is already out in the field engaging with these individuals to help them understand the program.

CFO and general Counsel will also be available during the Q&A portion of the call.

I'd now like to turn the call over to Chris Anzalone, President and CEO of the company Chris.

Before we begin I would like to remind you that comments made during today's call contains certain forward looking statements within the meaning of section 27, a of the Securities Act of 1933 and section 21 E of the Securities Exchange Act of 1934, all statements other than statements of historical fact are forward looking statements.

Chris Anzalone: Thanks Vince.

Andy Davis: As you know, this would be Arrowhead's first commercial product, so we're building a best-in-class organization that will support the patients who we hope will benefit from plasasterine. This is obviously a big task, but we're up to the challenge. The build-out of our medical affairs and commercial infrastructure is right where it needs to be at this time in commercialization. Our entire medical affairs and commercial leadership team is solidly in place, and the team we've assembled has deep experience in the cardiometabolic and lipid therapeutic areas. We've already done extensive mapping of the healthcare professionals or HCPs, most likely to treat FCS patients and prescribe plasasterine, if approved.

Chris Anzalone: Good afternoon, everyone and thank you for joining us today.

Speaker Change: <unk> spent a substantial amount of time building a scalable platform on which a large number of diverse and innovative new medicines have been and will continue to be built.

Speaker Change: This is the basis of our 2025 initiative, where we expect to grow our pipeline to at least 20 clinical stage or marketed products by next year.

And are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed in any forward looking statements for further details concerning these risks and uncertainties. Please refer to our SEC filings, including our most recent annual report on Form 10-K, and our quarterly reports on Form 10-Q.

Speaker Change: Think about what that means for any company much less a one of our size.

Speaker Change: This initiative represents our commitment to reduce the overall risk profile of the company, while expanding our upside potential and this is important for our long term value creation now.

Andy Davis: We've already done extensive mapping of the healthcare professionals or HCPs, most likely to treat FCS patients and prescribe plasasterine, if approved. Our market research leads us to believe these HCPs have been impressed with the top line results from our Palisade trial, with particular note of the unprecedented triglyceride lowering and statistically significant reduction of acute pancreatitis risk. As Bruce mentioned, plasasterine achieved deep and durable reductions in triglycerides of approximately minus 80% from baseline, demonstrating for the first time the real possibility for FCS patients to lower their triglycerides below important guideline directed thresholds of acute pancreatitis risk.

In the short term however, we need to balance our platform development work with intense focus on bringing our first wholly owned drug candidate to market as quickly and efficiently as possible.

I'd now like to turn the call over to Chris Anzalone, President and CEO of the company Chris.

Andy Davis: Our market research leads us to believe these HCPs have been impressed with the top line results from our Palisade trial, with particular note of the unprecedented triglyceride lowering and statistically significant reduction of acute pancreatitis risk. As Bruce mentioned, plasasterine achieved deep and durable reductions in triglycerides of approximately minus 80% from baseline, demonstrating for the first time the real possibility for FCS patients to lower their triglycerides below important guideline-directed thresholds of acute pancreatitis risk.

Thanks Vince.

Afternoon, everyone and thank you for joining us today.

Speaker Change: We expect that candidate will be <unk> and we expect the initial launch to be next year, if approved for use in familial <unk> syndrome or FCS we're.

<unk> spent a substantial amount of time building, a scalable platform on which a large number of diverse and innovative new medicines.

And we will continue to be built.

Speaker Change: We're working hard to ensure that posed ASUR and moves rapidly through regulatory NDA and MAA filings for FCS, while executing phase III clinical studies for <unk>, the second potential indication and our cardiovascular outcomes trial or seaboard for mixed hyperlipidemia the third potential indication.

This is the basis of our 2020 five initiative, where we expect to grow our pipeline to at least 20 clinical stage or marketed products by next year.

What that means for any company much less a one of our size.

This initiative represents our commitment to reduce the overall risk profile of the company, while expanding our upside potential and this is important for our long term value creation.

Speaker Change: We believe that <unk> represents a pipeline within a single drug given the multiple patient populations, we can address with it.

Andy Davis: Finally, our best-in-class patient and caregiver support program is taking shape. We've selected an exclusive specialty pharmacy and patient hub, with expert support for patients with rare conditions, and we're presently crafting the finer details of our patients and caregiver support ecosystem to ensure patients can easily start and stay on therapy. I look forward to talking more with you in the future about how we see the commercial market opportunity and how we intend to bring plasasterine to the many patients who could benefit from this new therapy.

Andy Davis: Finally, our best-in-class patient and caregiver support program is taking shape. We've selected an exclusive specialty pharmacy and patient hub, with experts support for patients with rare conditions, and we're presently crafting the finer details of our patients and caregiver support ecosystem to ensure patients can easily start and stay on therapy. I look forward to talking more with you in the future about how we see the commercial market opportunity and how we intend to bring plasasterine to the many patients who could benefit from this new therapy.

In the short term however, we need to balance our platform development work with intense focus on bringing our first wholly owned drug candidate to market as quickly and efficiently as possible.

Bruce will talk about the progress in this program in a moment.

Youll: We are currently building out our commercial infrastructure to enable an initial launch in 2025, and then scale to support progressively larger patient populations over the coming years and Youll talk about where we are with this process in a moment.

We expect that candidate will be <unk> and we expect the initial launch to be next year. If approved for use in familial color micro anemia syndrome or Fcs well.

Speaker Change: On September 119, 87, the first stat and was approved by the FDA.

We're working hard to ensure the pedestrian moves rapidly to regulatory NDA and MAA filings for FCS, while executing phase III clinical studies for S. H T G. The second potential indication and our cardiovascular outcomes trial or seaboard for mixed hyperlipidemia the third potential indications.

Speaker Change: This event change the world because it ushered in an era during which physicians would appreciate the risks associated with high LDL cholesterol and importantly, we have the tools to lower it.

Kenneth Myszkowski: I'll now turn the call over to Ken. Thank you, Andy, and good afternoon, everyone. As we reported today, our net loss for the quarter-ended June 30, 2024 was $170.8 million, or $1.38 per share, based on $124.2 million only diluted weighted average shares up to 10. 7. This compares with the net loss of 102.9 million, or 96 cents per share, based on 107 million fully diluted weighted average shares outstanding for the quarter ended June 30, 2023.

Kenneth Myszkowski: I'll now turn the call over to Ken. Thank you, Andy, and good afternoon, everyone. As we reported today, our net loss for the quarter-ended June 30, 2024 was $170.8 million, or $1.38 per share, based on $124.2 million only diluted weighted average shares up to 10. 7. This compares with the net loss of 102.9 million or 96 cents per share based on 107 million fully diluted weighted average shares outstanding for the quarter-ended June 30, 2023.

Speaker Change: It feels to us like we are at a similar point with triglycerides with a few notable differences.

We believe that <unk> represents a pipeline within a single drug given the multiple patient populations, we can address with it.

Speaker Change: First we have the luxury of being able to grow our way into a large market. We expect to begin commercializing <unk> in a small fcs market and grow into the large <unk> market around 2027, and ultimately serve the very large mixed hyperlipidemia market. After a CEVA is complete.

Bruce will talk about the progress in this program in a moment.

Youll: We are currently building out our commercial infrastructure to enable that initial launch in 2025, and then scale to support progressively larger patient populations over the coming years and Youll talk about where we are with this process in a moment.

Speaker Change: We feel like we are virtually alone in our ability to drastically lower triglycerides and therefore serve these markets appropriately.

On September 1st 1987, the first statin was approved by the FDA.

Kenneth Myszkowski: No revenue was recorded in the quarter ended June 30, 2024. Revenue of 15.8 million was recorded in the quarter ended June 30, 2023. Revenue is recognized as we complete our performance obligations or key developmental milestones are reached. Revenue in the prior period primarily related to the recognition of payments received from our license and collaboration agreement with Takeda.

Kenneth Myszkowski: No revenue was recorded in the quarter-ended June 30, 2024. Revenue of 15.8 million was recorded in the quarter-ended June 30, 2023. Revenue is recognized as we complete our performance obligations or key developmental milestones are reached. Revenue in the prior period primarily related to the recognition of payments received from our license and collaboration agreement with Takeda.

Speaker Change: While there have been eight FDA approved status to compete.

Speaker Change: This event change the world because it ushered in an era during which positions would appreciate the risks associated with high LDL cholesterol and importantly, we have the tools to lower it.

Speaker Change: Pete to lower LDL, our data suggest to us that there is simply no other near term therapy that can match <unk> activity.

It feels to us like we were at a similar point with triglycerides with a few notable differences.

Speaker Change: Triglycerides or bad actors Wouldnt patients and physicians want to lower them as much as possible we believe they will.

Speaker Change: First we have the luxury of being able to grow our way into a large market. We expect to begin commercializing <unk> in a small fcs market didn't grow into the large S. H T. G market around 2027, and ultimately serve the very large mixed hyperlipidemia market. After a receiver is complete.

Speaker Change: This is a big commercial opportunity and we believe Arrowhead has the most promising medicine is poised to make a big impact over the coming years.

Kenneth Myszkowski: Total operating expenses for the quarter ended June 30, 2024 were 176.1 million compared to 118.5 million for the quarter ended June 30, 2023. The key drivers of this change were increased research and development costs, primarily discovery and candidate costs, as a company's pipeline of discovery candidates has advanced into novel therapeutic areas and tissue types, and clinical candidates has increased and progressed into later stages of development.

Kenneth Myszkowski: Total operating expenses for the quarter-ended June 30, 2024 were 176.1 million compared to 118.5 million for the quarter-ended June 30, 2023. The key drivers of this change were increased research and development costs, primarily discovery and candidate costs as a company's pipeline of discovery candidates has advanced into novel therapeutic areas and tissue types and clinical candidates has increased and progressed into later stages of development.

Speaker Change: Before discussing.

Speaker Change: The progress we've made recently I want to talk about the adjuvant. We made this afternoon.

Speaker Change: I think it's clear that we have dramatic upside opportunities and plus ASUR and in the near term and in multiple other programs over the medium and long term was less clear to investors was how we would finance. These development programs until we get to a point, where commercial revenue becomes a significant source of capital and ultimately brings us to cash flow positive position.

Speaker Change: Second we feel like we are virtually alone in our ability to drastically lower triglycerides and therefore serve these markets appropriately.

Speaker Change: While there have been eight FDA approved status to compete.

Speaker Change: Pete to lower LDL, our data suggest to us that there is simply no other near term therapy that can match <unk> activities.

Speaker Change: To that end today, we announced the transaction with sixth Street that provides an immediate and meaningful strengthening of our balance sheet with long term low cost non dilutive capital to fund innovative.

Speaker Change: Triglycerides or bad actors Wouldnt patients and physicians want to lower them as much as possible we believe they will.

Kenneth Myszkowski: Net cash used in operating activities during the quarter ended June 30, 2024 was 115.4 million dollars compared with 21.4 million for the quarter ended June 30, 2023. The increase in cash used in operating activities is driven primarily by higher research and development expenses, as well as lower cash revenue versus the prior year.

Kenneth Myszkowski: Net cash used in operating activities during the quarter-ended June 30, 2024 was 115.4 million dollars compared with 21.4 million for the quarter-ended June 30, 2023. The increase in cash used in operating activities is driven primarily by higher research and development expenses as well as lower cash revenue versus the prior year.

Speaker Change: This is a big commercial opportunity and we believe Arrowhead has the most promising medicine is poised to make a big impact over the coming years.

I'm, sorry to kind of to fund innovation and growth opportunities across <unk> pipeline the.

Speaker Change: Before discussing.

Speaker Change: The $500 million.

Speaker Change: The progress we've made recently I wanted to talk about the adjuvant. We made this afternoon.

Speaker Change: Senior secured credit facility includes a $400 million funding to close with an additional $100 million available at arrowheads option subject to mutual agreement between <unk> and Arrowhead during the seven year term of the agreement.

Speaker Change: I think it's clear that we have dramatic upside opportunities and plus ASUR and in the near term and in multiple other programs over the medium and long term.

Speaker Change: It was less clear to investors was how we would finance these development programs until we get to a point, where commercial revenue becomes a significant source of capital and ultimately brings us to cash flow positive position.

Speaker Change: This is debt, but the risk sharing structure is very attractive to us.

Kenneth Myszkowski: Our footprint expansion is mostly complete, with final payments to be made over the next several months totaling about 30 million dollars, after which we expect capital expenditures to be nominal. Turning to our balance sheet, our cash and investments totaled 436.7 million at June 30, 2024, compared to 403.6 million at September 30, 2023. The increase in our cash and investments was primarily related to the $450 million equity issuance, partially offset by ongoing cash burn.

Kenneth Myszkowski: Our footprint expansion is mostly complete with final payments to be made over the next several months totaling about 30 million dollars after which we expect capital expenditures to be nominal. Turning to our balance sheet our cash and investments totaled 436.7 million at June 30, 2024 compared to 403.6 million at September 30, 2023. The increase in our cash and investments was primarily related to the $450 million equity issuance partially offset by ongoing cash burn.

Speaker Change: There are no scheduled amortization payments during this term and no scheduled cash pay coupon interest payments. In addition, it has an attractive seven year term during which we hope to be building our commercial revenue substantially.

Speaker Change: It has other risk sharing characteristics, where payments are to be made to partially repay loans under the credit facility with a portion of the proceeds from certain transactions such as future inflows from partnerships and collaborations and commercial revenue.

Speaker Change: I'm, sorry to kind of to fund innovation and growth opportunities across <unk> pipeline.

Speaker Change: $500 million senior.

Speaker Change: Senior secured credit facility includes a $400 million funded at close with an additional $100 million available at arrowheads option subject to mutual agreement between six street and Arrowhead during the seven year term of the agreement.

Speaker Change: So we don't really have cash outflow obligations unless we have cash inflows from other sources. This deal makes a lot of sense for us and a great team of six street has been creative in building a custom structured product that is appropriate for arrowhead.

Kenneth Myszkowski: Today we announced a financing agreement with for significant long-term non-delutive capital. The $500 million senior secured credit facility includes $400 million up funded at close and an additional $100 million available at Arrowhead's option, subject to mutual agreement between 6th Street and Arrowhead. Inclusive of the upfront cash from 6th Street before deducting fees, our pro forma cash balance is approximately $840 million and significantly enhances our liquidity toward our global commercial launch of Plasaceran while also supporting advancement of our late-stage clinical trials and other discovery efforts. Our common shares outstanding at June 30, 2024, were $124.2 million.

Kenneth Myszkowski: Today we announced a financing agreement with for significant long-term non-delutive capital. The $500 million senior secured credit facility includes $400 million up funded at close and an additional $100 million available at Arrowhead's option subject to mutual agreement between 6th Street and Arrowhead. Inclusive of the upfront cash from 6th Street before deducting fees our pro forma cash balance is approximately $840 million and significantly enhances our liquidity toward our global commercial launch of Plasaceran while also supporting advancement of our late-stage clinical trials and other discovery efforts. Our common shares outstanding at June 30, 2024 were $124.2 million.

Speaker Change: Is that but the risk sharing structure is very attractive to us there are no scheduled amortization payments. During this term and no scheduled cash pay coupon interest payments. In addition, it hasnt attracted seven year term during which we hope to be building our commercial revenue substantially.

Speaker Change: This growth capital comes at a perfect time.

Speaker Change: During the quarter, we also announced a $50 million milestone payment that we received from royalty pharma. Following the completion of enrollment of the phase III <unk> outcomes trial of El Paso and being conducted by Amgen.

Speaker Change: These are important steps to build our balance sheet, but not the last we view our capital needs through the lens of <unk> and development and see the potential for significant revenues coming out of the <unk> market.

Speaker Change: As such we want to ensure that we have a financial bridge to that market, which we believe we could launch into in 2027.

Speaker Change: So we don't really have cash outflow obligations unless we have cash inflows from other sources. This deal makes a lot of sense for us and a great team of sixth Street has been creative in building a custom structured product that is appropriate for arrowhead. This growth capital comes at a perfect time.

Speaker Change: We have many tools to fund operations over those three years, including potential milestone payments from our existing four partnerships new partnerships and license agreements.

Chris Hanzeloni: With that brief overview, I will now turn the call back to Chris.

Christopher Anzalone: With that brief overview I will now turn the call back to Chris. Thanks, Ken. We had a highly productive quarter and feel that all pieces are now in place to begin the transition into a commercial stage.

Speaker Change: Possible financing in return for Caf royalties on <unk> sales and revenue from commercializing into the FCS market, which we expect to begin next year.

Speaker Change: During the quarter, we also announced a $50 million milestone payment that we received from royalty pharma. Following the completion of enrollment of the phase III Ocean <unk> outcomes trial of El Paso and being conducted by Amgen.

Chris Hanzeloni: Thanks, Ken. We had a highly productive quarter and feel that all pieces are now in place to begin the transition into a commercial stage.

Speaker Change: Before turning the call over to Bruce to discuss the both Astro and clinical programs and data I want to review a few other key accomplishments from our recent period.

Chris Hanzeloni: Company. We did face three study in Palisade that we intend to use to file for regulatory approval to launch Plasasaran in patients with FCS. The summit suite of clinical studies, including Palisade and the Shasta, Muir, and Kapitan studies, are all underway or at advanced stages and are designed to show the value of Plasaran in multiple patient populations. As I mentioned, we view Plasasaran as a pipeline within a single drug, and these studies have the potential of enabling that. Our commercial organization is taking shape, is taking shape, and we have a thoughtful strategy to grow in support of Plasasaran as the clinical studies and ultimately the product label grows into progressively larger patient populations.

Christopher Anzalone: Company. We did face three study in Palisade that we intend to use to file for regulatory approval to launch Plasasaran in patients with FCS. The summit suite of clinical studies, including Palisade and the Shasta, Muir and Kapitan studies are all underway or at advanced stages and are designed to show the value of Plasaran in multiple patient populations. As I mentioned, we view Plasasaran as a pipeline within a single drug and these studies have the potential of enabling that.

Speaker Change: First we announced topline results from the pivotal phase III palisade study of <unk> in patients with Fcs.

Speaker Change: Study met its primary endpoint and all key secondary endpoints we.

Speaker Change: As such we want to ensure that we have a financial bridge to that market, which we believe we could launch into in 2027.

Bruce: We see these data as best in class. This is arrowheads first therapy to show clinical efficacy in our phase III study, which represents validation of all the hard work from so many talented <unk> employees, our collaborators and the FCS community over the years.

Speaker Change: Many tools to fund operations over those three years, including potential milestone payments from our existing four partnerships new partnerships and license agreements possible financing in return for capsule royalties on <unk> sales and revenue from commercializing into the FCS market, which we expect to begin next year.

Christopher Anzalone: Our commercial organization is taking shape, is taking shape and we have a thoughtful strategy to grow in support of Plasasaran as the clinical studies and ultimately the product label grows into progressively larger patient populations. And lastly, we have taken the next steps to execute on our long-term financing strategy and now have a stronger balance sheet enabling us to better fund innovation and growth opportunities across Arrowheads robust and diverse pipeline of RNAI therapeutics.

Bruce: Also during the quarter, we presented new interim clinical data on Aero rage, or investigational RNA based medicine for the treatment of inflammatory lung diseases, such as asthma at the American Thoracic Society 2024 International Conference.

Speaker Change: Before turning the call over to Bruce to discuss the both Astro and clinical programs and data I Wonder. If you are a few other key accomplishments from our recent period.

Chris Hanzeloni: And lastly, we have taken the next steps to execute on our long-term financing strategy and now have a stronger balance sheet enabling us to better fund innovation and growth opportunities across Arrowhead's robust and diverse pipeline of RNAi therapeutics. We have focused most of this call on Plasasaran, but of course we have a large stable of value drivers under it that continue to move forward. Our pulmonary franchise with three current clinical candidates, our muscle franchise with two current clinical candidates, and our complement franchise with two current clinical candidates, all continue to progress over the quarter. By the end of the year, we expect to file CTAs in support of two obesity candidates and two CNS candidates, and you will hear more about those programs at our webinars on August 14 and September 25, respectively.

Bruce: These are important data as they represent not only translation of preclinical data to clinical data in normal healthy volunteers, but also to an asthma patient population we.

Speaker Change: First we announced topline results from the pivotal phase III palisade study a pedestrian in patients with Fcs.

Speaker Change: The study met its primary endpoint and all key secondary endpoints.

Bruce: We are currently working on the design of a phase II study of Aero Rage.

Christopher Anzalone: We have focused most of this call on Plasasaran but of course we have a large stable of value drivers under it that continue to move forward. Our pulmonary franchise with three current clinical candidates, our muscle franchise with two current clinical candidates and our complement franchise with two current clinical candidates, all continue to progress over the quarter. By the end of the year, we expect to file CTAs in support of two obesity candidates and two CNS candidates and you will hear more about those programs at our webinars on August 14 and September 25th, respectively.

Speaker Change: We see these data as best in class.

Bruce: Turning to the earlier side of our pipeline, we presented preclinical data on <unk> at the American Diabetes Association or Ada 84 scientific sessions.

Bruce: Arrowheads first therapy to show clinical efficacy in our phase III study, which represents validation of all the hard work from so many talented <unk> employees, our collaborators and the FCS community over the years.

Bruce: <unk> is an investigational <unk> based medicine that we are studying for the treatment of obesity and metabolic diseases.

Speaker Change: Also during the quarter, we presented new interim clinical data on Aero rage, or investigational RTI based medicine for the treatment of inflammatory lung diseases, such as asthma at the American Thoracic Society 2024 International Conference.

Bruce: Pharmacological studies in obese and diabetic mouse models <unk> administration resulted in multiple promising findings, including the following.

Bruce: 95% reduction in iron HPE mrna expression.

Chris Hanzeloni: Our program programs also made progress as the El Pasaran Phase III against L.P. Little A is fully enrolled, and the Visitor N Phase III against A.E. continues to enroll patients. Our HPV and HSD programs with GSK are both in Phase II studies, and we continue to weigh our options with the PMPLA-3 program that we started with J&J and we now hold the own. We think these potential value drivers will play an important role in the future of Arrowhead, either as market of products themselves or part of the steps that we take to bridge Plasasaran to commercialization.

Christopher Anzalone: Our program programs also made progress as the El Pasaran Phase III against L.P. Little A is fully enrolled and the Visitor N Phase III against A.E, continues to enroll patients. Our HPV and HSD programs with GSK are both in Phase II studies and we continue to weigh our options with the PMPLA-3 program that we started with J&J and we now hold the own. We think these potential value drivers will play an important role in the future of Arrowhead, either as market of products themselves or part of the steps that we take to bridge Plasasaran to commercialization.

Speaker Change: These are important data as they represent not only translation of preclinical data to clinical data in normal healthy volunteers, but also to an asthma patient population.

Bruce: 19% suppression of body weight compared to selling controls, 26% loss of fat mass and importantly preservation of lean mass.

Speaker Change: We are currently working on the design of a phase II study a barrel range.

Our preclinical data presented at at 88 suggest that <unk> reduction with <unk> as a promising new approach to address obesity and metabolic diseases, and we think support advancing <unk> and HPE into clinical trials will.

Bruce: Turning to the earlier side of our pipeline, we presented preclinical data on Arrow and HPE at the American Diabetes Association or Ada 84 scientific sessions.

Bruce: <unk> is an investigational Arnie hi, based medicine that we are studying for the treatment of obesity and metabolic diseases.

Bruce: We will be discussing these data and also announcing a new program that directly targets adipose tissue next week at our R&D webinar on obesity and metabolic diseases. These are exciting additions indeed to our cardio metabolic franchise.

Bruce: Pharmacological studies in obese and diabetic mouse models and HPE <unk> administration resulted in multiple promising findings, including the following.

Chris Hanzeloni: Thank you for joining us today, and I would now like to open the call to your questions.

Christopher Anzalone: Thank you for joining us today and I would now like to open the call to your questions.

Operator: Operator. Thank you. At this time, we will conduct a question-and-answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will be in here and automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. In the interest of time, we ask that you please limit your inquiries to one question and one follow-up. Please stand by while we compile the Q&A roster.

Unknown Executive: Operator. Thank you.

Unknown Executive: At this time, we will conduct a question and answer session. To ask a question, during this session, you will need to press star 1-1 on your telephone. You will be in here and automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. In the interest of time, we ask that you please limit your inquiries to one question and one follow-up.

Speaker Change: Please note the new data visibility August 14. It was originally planned for August 15, but the date was changed to accommodate the schedule of an external speaker, who will be joining us.

Bruce: 95% reduction in iron HPE mrna expression, 19% suppression of body weight compared to sailing controls, 26% loss of fat mass and importantly preservation of lean mass.

Speaker Change: Be sure to listen in as these early stage programs in our cardio metabolic pipeline are particularly interesting and fit well with our growing development and commercial presence in the space.

Bruce: Our preclinical data presented at at 88 suggest that <unk> reduction with <unk> as a promising new approach to address obesity and metabolic diseases, and we think support advancing <unk> and HPE into clinical trials.

Speaker Change: Lastly, since we have so much going on in our broad pipeline during the quarter. We launched the 2020 for summer series of R&D revenue Webinars to highlight some of our work each months starting in May and in September we highlight different therapeutic areas and programs in our pipeline.

Unknown Executive: Please stand by while we compile the Q&A roster.

Mari Raycroft: Our first question comes from Mari Raycroft from Jeffries.

Maurice Raycroft: Our first question comes from Mari Raycroft from Jeffries. Please go ahead.

Speaker Change: We will be discussing these data and also announcing a new program that directly targets adipose tissue next week at our R&D webinar on obesity and metabolic diseases. These are exciting additions indeed to our cardio metabolic franchise.

Mari Raycroft: Please go ahead.

Mari Raycroft: Hi, congrats on the corridor and thanks for taking my questions. I'm going to start off with SCS. I'm just wondering if you can provide more perspective on what additional details we should expect to see at the ESC meeting and the study hits that sig on reducing acute pancreatitis in the sample size, whereas IONIS didn't show that sig difference. What are your latest thoughts on how your SCS label could look like versus IONIS's Olatarsin? Well, so let's take the first question first. I do expect that the presentation will give much more detail, especially on the primary and secondary endpoints, but I think also more broadly on some of the more exploratory or secondary endpoints.

Maurice Raycroft: Hi, congrats on the corridor and thanks for taking my questions. I'm going to start off with SCS. I'm just wondering if you can provide more perspective on what additional details we should expect to see at the ESC meeting and the study hits that sig on reducing acute pancreatitis in the sample size, whereas IONIS didn't show that sig difference. What are your latest thoughts on how your SCS label could look like versus IONIS's Olatarsin?

Speaker Change: We have now completed webinars on our muscle programs are late stage cardio metabolic programs and our pulmonary programs as I mentioned next week on August 14, we will cover our obesity and metabolic programs and in September we will cover our CNS programs, including updates on the delivery platforms and an undisclosed candidates planned to enter.

Speaker Change: To listen in as these early stage programs in our cardio metabolic pipeline are particularly interesting and fit well with our growing development and commercial presence in the space.

Speaker Change: Clinical development this year.

Bruce: Clearly theres a lot going on and a lot and a lot to be excited about at arrowhead with that overview I'd now like to turn the call over to Bruce Bruce.

Maurice Raycroft: Well, so let's take the first question first. I do expect that the presentation will give much more detail, especially on the primary and secondary endpoints, but I think also more broadly on some of the more exploratory or secondary endpoints. But focus, I think, will be on the primary and Alpha Control Secondaries, all of which were statistically significant, but most of which haven't really been fully exposed to the investor and scientific communities.

Bruce Bruce: Thank you Chris good afternoon, everyone.

Bruce Bruce: We've been very impressed with the clinical data generated with <unk> in each patient population. We studied and we believe it is best in class across the board.

Speaker Change: September we highlight different therapeutic areas and programs in our pipeline.

Bruce Bruce: Starting in healthy volunteers and moving into patients with mixed hyperlipidemia.

Bruce Bruce: In severe hypertrophy, Glyceride, EMEA, <unk> and other patients with genetically or clinically diagnosed FCS we have seen very consistent high levels of target engagement and downstream changes to lipids and lipoproteins.

Chris Hanzeloni: But focus, I think, will be on the primary and Alpha Control Secondaries, all of which were statistically significant, but most of which haven't really been fully exposed to the investor and scientific communities. As far as Patrick Titus goes, that's obviously exciting for us, and we're really happy to achieve statistical significance there, and it's going to be an important part of our filing with the FDA as well. It'll be interesting to see how they viewed the data, but we're certainly excited about it. Got it, maybe one more quick one: just are you saying how many patients are enrolled in the expanded access program?

Speaker Change: Undisclosed candidates planned to enter clinical development this year.

Speaker Change: Clearly theres a lot going on and a lot and a lot to be excited about at arrowhead.

Speaker Change: This makes sense it was our expectation, but it is still gratified to see day to meet or exceed expectations.

Maurice Raycroft: As far as Patrick Titus goes, that's obviously exciting for us, and we're really happy to achieve statistical significance there, and it's going to be an important part of our filing with the FDA as well, and it'll be interesting to see how they viewed the data, but we're certainly excited about it. Got it, maybe one more quick one, just are you saying how many patients are enrolled in the expanded access program? No, we have not that. Okay, thanks for taking my questions, I'll have back in the queue. Thanks.

Bruce: Overview I'd now like to turn the call over to Bruce Bruce.

Speaker Change: To review.

Bruce: Thank you Chris good afternoon, everyone.

Speaker Change: April lipoproteins, <unk>, three or <unk> three is the gene target for <unk>.

Bruce: We've been very impressed with the clinical data generated with <unk> in each patient population. We studied and we believe it is best in class across the board.

Speaker Change: It is a component of triglyceride, rich lipoproteins, or <unk>, and a known regulator of triglyceride metabolism.

Speaker Change: Starting in healthy volunteers and moving into patients with mixed hyperlipidemia.

Speaker Change: Apoc III inhibits the breakdown of <unk> by lipoproteins, lipase inhibits uptake of remnant cholesterol and liver.

Speaker Change: In severe hyper triglyceride, EMEA or <unk> in patients with genetically or clinically diagnosed FCS we have seen very consistent high levels of target engagement and downstream changes to lipids and lipoproteins.

Speaker Change: The goal of <unk> is to reduce the level of April three, thereby reducing triglycerides of restoring lipids to more normal levels.

Ellie Merrill: Thank you, one more for our next question.

Speaker Change: Over the past few months, we have been presented we have presented and published phase II data on <unk> in patients with mixed Hyperlipidemia and the mirror study and.

Chris Hanzeloni: No, we have not that.

Speaker Change: This makes sense it was our expectation, but it is still gratified to see data meet or exceed expectations.

Mari Raycroft: Okay, thanks for taking my questions. I'll have back in the queue. Thanks.

Operator: Thank you, one more for our next question.

Speaker Change: To review.

And in patients with <unk> and the <unk> two study we.

Bruce: April lipoproteins, <unk>, three or <unk> three is the gene target for <unk>.

Ellie Merrill: Our next question comes from Ellie Merrill from UBS; please go ahead. Thank you guys. Thanks so much for taking the question. What's your latest thinking on the phase two initiation for Arrow, Rage, and asthma, and the gating factors to getting that started? And can you just remind us of the latest timeline for when we can expect to see additional data or any of the preliminary programs in terms of the clinical studies you have ongoing? Thanks. Yeah, thanks for the question. We've not given any more guidance on when we'll have additional data. We'll just see when we can complete those studies, and then we'll present those when we can.

Ellie Merrill: Our next question comes from Ellie Merrill, from UBS, please go ahead. Thank you guys, thanks so much for taking the question. What's your latest thinking on the phase two initiation for Arrow, Rage, and asthma, and the gating factors to getting that started? And can you just remind us the latest timeline for when we can expect to see additional data or any of the preliminary programs in terms of the clinical studies you have ongoing?

Speaker Change: We have also reported topline results from the palisade phase III study in patients with Fcs.

Bruce: It is a component of triglyceride, rich lipoproteins, or <unk>, and a known regulator of triglyceride metabolism.

Ellie Merrill: Thanks. Yeah, thanks for the question. We've not given any more guidance on when we'll have additional data. We'll just see when we can complete those studies, and then we'll present those when we can. Regarding the phase two, we are developing those plans right now, and so stay tuned on more information on that. There are a number of factors that we're weighing about what type of patients will be treating, and how long we'll be treating, et cetera. So we are still in the process of working that out right now. Great, thanks. You're welcome.

Speaker Change: I wanted to spend a moment going over the highlights from these studies.

Luca Issi: Thank you, one more for our next question.

Speaker Change: Starting with mixed Hyperlipidemia and the mirror study treatment with possess ran in mixed hyperlipidemia achieved reductions in triglyceride rich lipoproteins are genetically validated target associated with increased risk at the sclerotic cardiovascular disease.

Bruce: Apoc III inhibits the breakdown of <unk> by lipoprotein lipase inhibits uptake of remnant cholesterol in the liver.

Bruce: The goal of <unk> is to reduce the level of April three, thereby reducing triglycerides of restoring lipids to more normal levels.

Speaker Change: These data were presented in an oral presentation at the European atherosclerosis.

Speaker Change: Over the past few months, we have been presented we have presented and published phase II data on <unk> in patients with mixed Hyperlipidemia and the mirror study.

Speaker Change: Sclerosis Society Ninety-second Congress.

Speaker Change: And simultaneously published in the nuclear journal of Medicine.

Speaker Change: And in patients with <unk> and the Shasta two study we.

Speaker Change: At week 24, representing trough effect after two quarterly doses <unk> treatment was associated with placebo adjusted reductions in triglycerides of up to minus 62%.

Speaker Change: We have also reported topline results from the palisade phase III study in patients with Fcs.

Chris Hanzeloni: Regarding the phase two, we are developing those plans right now, and so stay tuned on more information on that. There are a number of factors that we're weighing about what type of patients we will be treating, and how long we'll be treating, et cetera. So we are still in the process of working that out right now. Great, thanks. You're welcome.

Speaker Change: I wanted to spend a moment going over the highlights from these studies.

Speaker Change: Fasting triglyceride levels were normalized which means patients achieved levels below a 150 milligrams per deciliter, and 79% to 92% of patients randomized to treatment are.

Speaker Change: Starting with mixed Hyperlipidemia and the mirror study treatment with <unk> and in mixed Hyperlipidemia achieved reductions in triglyceride rich lipoproteins are genetically validated target associated with increased risk of atherosclerotic cardiovascular disease.

Speaker Change: Commensurate reductions in April <unk> three of up to 79% were observed with strong positive correlations with changes in triglyceride levels.

Speaker Change: These data were presented in an oral presentation at the European Atherosclerosis effort Sclerosis Society, 92nd Congress.

Speaker Change: There are other important changes and other atherogenic lipoproteins parameters, including non HDL C.

Operator: Thank you, one more for our next question.

Speaker Change: And simultaneously published in the nuclear medicine.

Luca Issi: Our next question comes from Luca IC from RBC Capital. Please go ahead. Oh, great. Thanks so much for taking one question. There are two quick ones.

Luca Issi: Our next question comes from Luca IC from RBC Capital, please go ahead. Oh, great. Thanks so much for taking one question.

Speaker Change: At week 24, representing trough effect after two quarterly doses <unk> treatment was associated with placebo adjusted reduction in triglycerides of up to minus 62%.

Speaker Change: April electric protein B and remnant cholesterol with strong correlations with the reductions in triglyceride levels.

Luca Issi: There are two quick ones. Maybe Chris or Ken, can you just expand the why you think the deal announced today was struck on favorable economics? Can you just maybe help us contextualize the 15% annual interest rate, and maybe how you negotiated that? And then maybe your next CS Bruce, appreciate you have a different share approach here. You're including both a genetically as well as clinically confirmed patients in Palestine. But how do we think about payers?

Chris Hanzeloni: Maybe Chris or Ken, can you just expand the why you think the deal announced today was struck on favorable economics? Can you just maybe help us contextualize the 15% annual interest rate, and maybe how you negotiated that? And then maybe your next CS Bruce. Appreciate you have a different share approach here. You're including both a genetically as well as clinically confirmed patients in Palestine. But how do we think about payers? Is it possible that payers with at least initially restrict access to just patients that are genetically confirmed before maybe broadening also to clinically confirm any color there much appreciated?

Speaker Change: <unk> demonstrated a favorable safety profile in the mirror study the overall rates of occurrence of treatment emergent adverse events and discontinuation were similar for <unk> ran a placebo throughout the 48 weeks of observation.

Speaker Change: Fasting triglyceride levels were normalized which means patients achieved levels below a 150 milligrams per deciliter, and 79% to 92% of patients randomized to treatment are.

Speaker Change: Mixed Hyperlipidemia also called mixed Dyslipidemia is a highly prevalent.

Speaker Change: Commensurate reductions in April <unk> three of up to 79% were observed with strong positive correlations with changes in triglyceride levels.

Speaker Change: Disorder characterized by elevated LDL cholesterol and triglyceride levels.

Speaker Change: Despite the efficacy of LDL, lowering therapies, and reducing episclera out of cardiovascular disease and mixed hyperlipidemia the.

Luca Issi: Is it possible that payers with at least initially restrict access to just patients that are genetically confirmed before maybe broadening also to clinically confirm any color there much appreciated? Thanks so much. Sure, so I'll start with the deal and Ken can add if you like. The take on message for us on that was that we are at the point of development in this company that I think we can take on debt broadly speaking, but it's got to be the right kind of debt.

Speaker Change: There are other important changes and other atherogenic lipoproteins parameters, including non HDL C.

Speaker Change: There remains substantial residual risk attributed to elevated non HDL cholesterol, driven by remnant cholesterol and try and triglyceride rich lipoproteins.

Speaker Change: April electric protein B and remnant cholesterol with strong correlations with the reductions in triglyceride levels.

Chris Hanzeloni: Thanks so much. Sure, so I'll start with the deal, and Ken can add if you like. The take on message for us on that was that we are at the point of development in this company that I think we can take on debt broadly speaking, but it's got to be the right kind of debt. We have an awful lot to do in the coming years to build out our commercial infrastructure. Before we start to see substantial revenue come in, and so any kind of debt that made sense to us was going to have to be long dated.

Speaker Change: Genome wide Association in Mendelian Randomization studies also support a causal role for triglyceride, rich lipoproteins and episodic cardiovascular disease.

Speaker Change: Based on the promising results from the Mirror study, we are now gearing up to initiate the phase III Capa Tan cardiovascular outcomes trial.

Speaker Change: Mixed Hyperlipidemia also called mixed Dyslipidemia is a highly prevalent.

Luca Issi: We have an awful lot to do in the coming years to build out our commercial infrastructure. Before we start to see substantial revenue come in and so any kind of debt that made sense to us was going to have to be long dated. The seven-year term makes a lot of sense to us. It gives us plenty of room. You know, to bridge, you know, I talked about this bridge to plasacer ends, SHTG market.

Speaker Change: Which is designed to enroll patients with mixed hyperlipidemia.

Speaker Change: Disorder characterized by elevated LDL cholesterol and triglyceride levels.

And who have had or are at risk for a cardiovascular event.

Speaker Change: Despite the efficacy of LDL lowering therapies, reducing atherosclerotic cardiovascular disease and mixed hyperlipidemia the rim.

Speaker Change: Moving onto the <unk> population there are patients with much higher triglyceride levels generally seen in the mixed hyperlipidemia population.

Kenneth Myszkowski: The seven-year term makes a lot of sense to us. It gives us plenty of room. You know, to bridge, you know, I talked about this bridge to plasacer ends, SHTG market. You know, I think that could be in the 2027 or so time frame. So the seven-year term gets us deep into that. That's comfortable for us. There's also really attractive risk sharing components here. There's not a coupon here that we need to be paying on a regular basis. You know, we'll be paying this, you know, if, you know, if and only if certain external funds come in and so, so it does not put constraints on us that that would have been problematic.

Speaker Change: Made substantial residual risk attributed to elevated non HDL cholesterol, driven by remnant cholesterol and try and triglyceride rich lipoproteins.

For <unk>, we presented data from the <unk> study at the American College of Cardiology meeting this spring and simultaneously published the results in the journal Jama Cardiology.

Luca Issi: You know, I think that could be in the 2027 or so time frame. So the seven-year term gets us deep into that. That's comfortable for us. There's also really attractive risk sharing components here. There's not a coupon here that we need to be paying on a regular basis. You know, we'll be paying this, you know, if, you know, if and only if certain external funds come in and so so it does not put constraints on us that that would have been problematic.

Speaker Change: Genome wide Association in Mendelian Randomization studies also support a causal role for triglyceride, rich lipoproteins and Episclera out of cardiovascular disease.

Speaker Change: And chest to treatment with <unk> had led to dose dependent placebo adjusted reductions at week 24, and triglycerides of up to minus 57% driven by reductions in April three of up to minus 77%.

Speaker Change: Based on the promising results from the Mirror study, we are now gearing up to initiate the phase III <unk> cardiovascular outcomes trial.

Speaker Change: Which is designed to enroll patients with mixed hyperlipidemia and who have had or are at risk for cardiovascular events.

Speaker Change: Mean maximum non placebo adjusted reduction from baseline triglycerides, Apoc, III, where up to minus 86% and 90%, respectively and typically occurred around week 16 or week 20.

Kenneth Myszkowski: And so, this to us feels like a very comfortable and appropriate structure.

Luca Issi: And so so this to us feels like a very comfortable and appropriate structure. Can you have anything else you want to add on that? No, I just wanted to say that, you know, it is non-dilutive. So we we like that aspect of it. And the cost of capital is reasonable given what our cost of equity capital would be. Yeah, yeah, actually, you know, let me, let me, let me underline that. I think that's a great point.

Speaker Change: Moving onto the <unk> population there are patients with much higher triglyceride levels generally seen in the mixed hyperlipidemia population.

Chris Hanzeloni: Can you have anything else you want to add on that? No, I just wanted to say that, you know, it is non-dilutive. So we like that aspect of it. And the cost of capital is reasonable given what our cost of equity capital would be. Yeah, yeah, actually, you know, let me, let me, let me underline that. I think that's a great point. You know, when we look at what we can be achieving over the coming years, you know, the cost of equity capital at this point feels quite expensive. And this, this is, you know, this is a very different.

Amongst subjects treated with <unk> at the week 24 trough time point greater than 90% achieved received the 25 or 50 milligram doses achieved triglycerides less than 500 milligrams per deciliter and important threshold associated with increased risk of acute pancreatitis.

Speaker Change: For <unk>, we presented data from the Shasta two study at the American College of Cardiology meeting this spring and simultaneously published the results in the journal Jama Cardiology.

Speaker Change: And Shasta to treatment with was asked where I led to dose dependent placebo adjusted reduction at week 24, and triglycerides of up to minus 57% driven by reductions in April three of up to minus 77%.

Luca Issi: You know, when, when we look at what we can be achieving over the coming years, you know, the cost of equity capital at this point feels quite expensive. And this, this is, you know, this is a very different. Bad compensation for us. Bruce, yeah. You know, Luca, you asked a very good question. You know, the interesting thing about, you know, the way. Palisade was constructed is that if you, if you didn't know the genetics on any of these patients, they'd all look the same.

Speaker Change: In addition around half of the subjects at these doses achieved normal triglyceride levels of less than 150 milligrams at week 24, which is surprising given the mean high starting levels of almost 900 migs per deciliter.

Chris Hanzeloni: Bad compensation for us.

Speaker Change: Mean maximum non placebo adjusted reduction from baseline triglycerides, Apoc, III, where up to minus 86% and 90%, respectively and typically occurred around week 16 or 20.

Bruce Given: Bruce, yeah. You know, Luca, you asked a very good question. You know, the interesting thing about, you know, the way. Palisade was constructed is that if you, if you didn't know the genetics on any of these patients, they'd all look the same. So what we really have here is we have a group of patients that happen to have, you know, a narrow set of genetics. That characterize them as familial chile macronymia syndrome, FCS. And then we have a group of patients that basically aren't look the same, but happen to have a different, you know, genetic makeup, but clinically they're the same.

Speaker Change: In addition to reduction in triglycerides subjects treated possess ran also showed improvements in multiple atherogenic lipids and lipoproteins levels, including remnant cholesterol HDL cholesterol and non HDL cholesterol.

Speaker Change: Yeah.

Speaker Change: Amongst subjects treated with <unk> at the week 24 trough time point greater than 90% achieved received in the 25% or 50 milligram doses achieved triglycerides less than 500 milligrams per deciliter and important threshold associated with increased risk of acute pancreatitis.

Luca Issi: So what we really have here is we have a group of patients that happen to have, you know, a narrow set of genetics. That characterize them as familial chile macronymia syndrome, FCS. And then we have a group of patients that basically aren't look the same, but happen to have a different, you know, genetic makeup, but clinically they're the same. And, you know, that's, that's what's interesting about this. So my expectation is that, you know, it will really probably come down to what the package insert says.

Speaker Change: <unk> demonstrated a favorable safety profile of chest to.

Speaker Change: Observed adverse events generally reflected the comorbidities and underlying conditions of the study population.

Speaker Change: In addition around half of the subjects at these doses achieved normal triglyceride levels of less than 150 milligrams at week 24, which is surprising.

Speaker Change: <unk> is characterized by triglyceride levels greater than 500, Migs per deciliter and is known to significantly increase the risk of atherosclerotic cardiovascular disease, and acute pancreatitis, which can occur with recurrent attacks.

Speaker Change: Given the mean high starting levels of almost 900 migs per deciliter.

Bruce Given: And, you know, that's, that's what's interesting about this. So my expectation is that, you know, it will really probably come down to what the package insert says. And of course, we don't know that at this point. But I think that the payers will go along with the package insert and assuming that we get approved and assuming that the agency labels us for the patients that were studied. We would expect that the payers will go along that, you know, the patients that, you know, match our entry criteria, if you will, I think we'll be covered. But, you know, that, that will, of course, be paired pair, but it feels like overall, you know, as, as one of the physicians, one of the investigators said to me, you know, the patients look the same; whether they have the genetics or not, they're still the same problem I have in my clinic.

Speaker Change: In addition to reduction in triglycerides subjects treated possess around also showed improvements in multiple atherogenic lipids and lipoproteins levels, including remnant cholesterol HDL cholesterol and non HDL cholesterol.

Speaker Change: Requiring repeat hospitalization admissions and worsening outcomes.

Luca Issi: And of course, we don't know that at this point. But I think that the, the payers will go along with the package insert and assuming that we get approved and assuming that the agency labels us for the patients that were studied. We would expect that the payers will go along that, you know, the patients that, you know, match our entry criteria, if you will, I think we'll be covered. But, you know, that, that will, of course, be paired pair, but it feels like overall, you know, as, as one of the physicians, one of the investigators said to me, you know, the patients look the same, whether they have the genetics or not, they're still the same problem I have in my clinic.

Speaker Change: Pancreatitis risk increases as triglyceride levels increase currently available drug therapies generally don't sustainably reduce triglycerides below the pancreatitis risk threshold in this patient population.

Speaker Change: But as <unk> demonstrated a favorable safety profile of <unk>.

Speaker Change: Observed adverse events generally reflected the comorbidities and underlying conditions of the study population.

Speaker Change: Based on the promising Chester two data, we have initiated and started dosing in both the chefs to three and chefs to four phase III studies in patients with <unk>.

Speaker Change: <unk> is characterized by triglyceride levels greater than 500.

Speaker Change: Her desk leader and is known to significantly increase the risk of atherosclerotic cardiovascular disease, and acute pancreatitis, which can occur with recurrent attacks.

Speaker Change: We are also working towards initiating chefs to five a phase III study in patients with <unk> that are high risk of acute pancreatitis.

She has to five will have a primary endpoint of incidence of new episodes of pancreatitis compared with placebo.

Speaker Change: Require a repeat hospitalization admissions and worsening outcomes.

Bruce Given: The patients with very high triglycerides, you know, you know, at risk for pancreatitis and many of them having pancreatitis and recurred pancreatitis and dangerous. Pancreatitis. So, you know, from the physician perspective that the patients are very much the same. And that's, you know, these are adult patients, mind you, but there's pretty good reason to think that the payers will go along with the package insert here. Thanks so much.

Luca Issi: The patients with very high triglycerides, you know, you know, at risk for pancreatitis and many of them having pancreatitis and recurred pancreatitis and dangerous. Pancreatitis. So, you know, from the physician perspective that the patients are very much the same. And that's, you know, these are adult patients mind you, but, but there's pretty good reason to think that the payers will, will go along with the package insert here. Thanks so much.

Speaker Change: We do not see this study is necessary for regulatory approval in <unk>, but we do see it as an important study to potentially show the value of treatment with SaaS rent in reducing the risk of acute pancreatitis.

Edward Tenthoff: Thank you, one more for our next question.

Speaker Change: Based on the promising Shasta two data.

If positive these results should be helpful for all stakeholders, including patients health care providers and payers.

Speaker Change: We have initiated and started dosing in both the Shasta III and chefs to four phase III studies in patients with <unk>.

Speaker Change: Lastly, during the quarter, we gave a topline report on the phase III palisade study in patients with genetically confirmed or clinically diagnosed Fcs.

Speaker Change: H T G.

Speaker Change: We are also working towards initiating Shasta five a phase III study in patients with <unk> that are at high risk of acute pancreatitis.

Operator: Thank you, one more for our next question.

Speaker Change: The strong results from palisade significantly build upon the promising results from the phase II Shasta too and mirror studies the.

Edward Tenthoff: Our next question comes from Edward Tenthoff from PSE. We go ahead. Great, thank you very much, and congrats on all the progress. Just a little bit more on our professor and with respect to what needs to be done for the NDA filing. Where are you guys in the process and, you know, how are things progressing on the CMC side. What are the big steps that still need to be done. Thanks. Let's see, well, you know, I mean, we're busily writing. We, you know, we will have our pre-NDA BD with the FDA, and that will give us more insight into, you know, whether there's anything special they would like us to do that, you know, we're not already doing.

Edward Tenthoff: Our next question comes from Edward Tenthoff, from PSE, we go ahead. Great, thank you very much and congrats on all the progress. Just a little bit more on our professor and with respect to what needs to be done for the NDA filing. Where are you guys in the process and, you know, how are things progressing on the CMC side. What are the big steps that still need to be done. Thanks. Let's see, well, you know, I mean, we're, we're busily writing.

Speaker Change: Shasta five will have a primary endpoint of incidence of new episodes of pancreatitis compared with placebo.

Speaker Change: The primary endpoint for the Palisade study was placebo adjusted median change in triglycerides a month 10.

Speaker Change: We do not see this study is necessary for regulatory approval in <unk>, but.

Speaker Change: But we do see it as an important study to potentially showed the value of treatment with SaaS or add in reducing the risk of acute pancreatitis.

Speaker Change: At that time point patients treated with quarterly doses of 25, and 50 milligrams plus aspirin achieved median triglyceride reductions of minus 80% and minus 78% respectively.

Speaker Change: Positive. These results should be helpful for all stakeholders, including patients health care providers and payers.

Speaker Change: About 12 patients treated with 25 and 50.

Speaker Change: Lastly, during the quarter, we gave a topline report on the phase III palisade study in patients with genetically confirmed or clinically diagnosed Fcs.

Speaker Change: 50 milligrams possess ran achieved median triglyceride reductions of minus 78% and minus 73% respectively.

Speaker Change: These compared with the median triglyceride reductions placebo treated patients of minus 17% in mud 10, and minus 7% at month 12.

Speaker Change: The strong results from palisade significantly build upon the promising results from the phase III Shasta too and Muir studies the.

Edward Tenthoff: We, you know, we will have our pre-NDA BD with the FDA and that will give us more insight into, you know, whether there's anything special they would like us to do that, you know, we're not already doing. CMC is moving along as well. So, I mean, we're just, you know, in the pre-submission phase, I guess, I don't know how to give you more than that at this point, but where we're deep in it.

Speaker Change: The primary endpoint for the Palisade study was placebo adjusted median change in triglycerides a month 10.

Speaker Change: Mean reductions in April <unk> three at month, 10 were minus 88% and minus 94% at 25, and 50 milligrams possess red respectively.

Chris Hanzeloni: CMC is moving along as well. So, I mean, we're just, you know, in the pre-submission phase, I guess. I don't know how to give you more than that at this point, but we're deep in it. Okay, and just remind me the goal is to file by your end. Yeah, that's, that's been the, you know, that's been the guide so far.

Speaker Change: At that time point patients treated with quarterly doses of 25, and 50 milligram <unk> achieved median triglyceride reductions of minus 80% and minus 78% respectively.

Speaker Change: All of these changes were highly significant when comparing <unk> to placebo.

Speaker Change: Palisade successfully met the primary endpoint and all key secondary endpoints, including reducing the incidence of acute pancreatitis compared to placebo.

Speaker Change: 12 patients treated with 25 and 50.

Edward Tenthoff: Okay, and just remind me the goal is to file by your end. Yeah, that's, that's been the, you know, that's been the guide so far.

Speaker Change: <unk> 50 milligrams possess ran achieved median triglyceride reductions of minus 78% and minus 73% respectively.

Speaker Change: There were four of multiplicity controls key secondary endpoints.

Speaker Change: Percent change from baseline in months 10 to 12 averaged investing triglycerides percent change from baseline to month 10, <unk>, 3% change from baseline to month, 12, and fasting Apoc III and finally incidence of positively adjudicated events of acute pancreatitis during the randomized period.

Speaker Change: These compared with the median triglyceride reductions placebo treated patients of minus 17% in mud 10, and minus 7% at month 12.

Operator: Thank you, and then all questions I made just on the muscle programs. What should we be expecting for in terms of future data in terms of readouts from your muscle programs? Thanks.

Edward Tenthoff: Thank you, and then all questions I made just on the muscle programs. What should we be expecting for in terms of future data in terms of readouts from your muscle programs. Thanks. Yeah, so we've not given any guidance on that. You know, these are still, you know, early-ish programs. You know, we are, we are treating patients. You know, we'll see how fast we can, we can treat. We'll see how fast we can, we can generate data that is interpretable.

Speaker Change: Mean reductions in April <unk> three at months 10 were minus 88% and minus 94% at $25 to 50 milligrams possess red respectively.

Chris Hanzeloni: Yeah, so we've not given any guidance on that. You know, these are still, you know, early-ish programs. You know, we are treating patients. You know, we'll see how fast we can, we can treat. We'll see how fast we can, we can generate data that is interpretable. So, in other words, you know, don't expect to have a drip drip of data of one, the two, these patients; you know, we need to put them together that will be helpful. To, to investors, once we have it.

Edward Tenthoff: So in other words, you know, don't expect to have a drip drip of data of one, the two, these patients, you know, we need to put them together that will be helpful. To, to investors, once we have it. So, so I don't, I would not expect data this year. And so, you know, we'll, we'll see next year when, when we can ask something, we just don't, we don't know the answer to that at this point.

Plus <unk> demonstrated a.

Speaker Change: All of these changes were highly significant when comparing <unk> to placebo.

Speaker Change: Favorable safety profile in the palisade study the number of subjects reporting emergent adverse events were similar and the possess ran a placebo groups severe and serious aes were less common with <unk> than with placebo.

Speaker Change: Palisade successfully met the primary endpoint and all key secondary endpoints, including reducing the incidence of acute pancreatitis compared to placebo.

Speaker Change: There were four a multiplicity controls key secondary endpoints.

Speaker Change: Most common aes reported were abdominal pain, COVID-19, nasopharynx itis headache nausea.

Speaker Change: Percent change from baseline in months 10 to 12 averaged and fasting triglycerides percent change from baseline to month 10, Fascine Apoc III.

Chris Hanzeloni: So, so I don't, I would not expect data this year. And so, you know, we'll see next year when we can ask something; we just don't, we don't know the answer to that at this point.

Speaker Change: This study was accepted as a late breaker oral presentation at the European Society of Cardiology.

Speaker Change: <unk> change from baseline to month, 12, and SaaS seen apoc III and finally incidence of positively adjudicated events of acute pancreatitis during the randomized period.

Speaker Change: 24, coming up September 2nd 2024 in London.

Operator: Do you want any doubt on that, James? No, I think, great, thank you. Right on the, I'm timing the suffice it to say that the readouts, I think will be substantially the same as what others have shown. And James, the MPK, not-downs-place correction, tissue concentrations, that sort of thing. Great. Looking forward to all of that. Thanks.

Edward Tenthoff: Do you want any doubt on that, James? No, I think, great, thank you. Right on the, I'm timing the suffice it to say that the readouts, I think will be substantially the same as what others have shown. And James, the MPK, not-downs-place correction, tissue concentrations, that sort of thing. Great. Looking forward to all of that. Thanks. Thank you.

Jason Garberry: One more more for our next question.

Speaker Change: Since Thats labor day in the U S. We also plan to have an investor call. The following day on September <unk> 2020 for Dr. Gerald What's a principal investigator for palisade and the presenter of the data at the European Society of Cardiology, which joined the investor call to present, the data and discuss the exciting results.

Speaker Change: Plus as we had demonstrated a.

Speaker Change: Favorable safety profile in the palisade study.

Speaker Change: Number of subjects reporting emergent adverse events were similar in the possess ran a placebo groups severe and serious aes were less commented with <unk> than with placebo. The most common aes reported were abdominal pain COVID-19 is a ferret Titus headache and nausea.

Jason Garberry: Thank you. One more more for our next question. Our next question comes from Jason Garberry from Bank of America. Please go ahead. Hey guys, thanks for taking my questions. My first is just on the facility you announced this evening. So, is there a right way to think about it? I mean, you have a business model, or you have this unpredictable flow of milestone in the door, so to speak. So, this gives you like the flexibility to draw from the facility. But, you know, once those milestone payments come in, you can, you can retire that or repay and avoid the 15% cost, but it just kind of gives you operational flexibility.

Speaker Change: I'll now turn the call over to Andy to give a few remarks on where we are with commercial planning and readiness Andy. Thank you Bruce we're on track with our launch preparations for <unk> and familial chylomicron anemia syndrome or Fcs.

Jason Garberry: Our next question comes from Jason Garberry from Bank of America. Please go ahead. Hey guys, thanks for taking my questions. My first is just on the facility you announced this evening. So, is there right way to think about it? I mean, you have a business model or you have this unpredictable flow of milestone in the door, so to speak. So, this gives you like the flexibility to, to draw from the facility. But, you know, once those milestone payments come in, you can, you can retire that or repay and avoid the 15% cost, but it just kind of gives you operational flexibility.

Speaker Change: This study was accepted as a late breaker oral presentation at the European Society of Cardiology.

Andy: Let me begin by talking a little bit about our expanded access program or EAP.

Speaker Change: 24, coming up September 2nd 2024 in London.

Andy: We initiated the EAP to ensure patients who roll off our palisade trial maintain access to <unk> and to make investigational possess arent available outside of a clinical trial for other patients with FCS who meet certain program eligibility criteria if requested by their treating physician.

Speaker Change: Since its labor day in the U S. We also plan to have an investor call. The following day on September three 2020 for Dr. Gerald What's a principal investigator for palisade and the presenter of the data at the European Society of Cardiology with joined the Investor call to present, the data and discuss the exciting results.

Andy: We've fielded requests for additional information about the EAP from physician societies, and treating physicians, who may have appropriate Fcs patients and our medical affairs team is already out in the field engaging with these individuals to help them understand the program.

Chris Hanzeloni: At that point, one, and then the second question is just on Arrow T slip. I'm wondering, this mechanism, I guess, would seem somewhat redundant with arrow rage. So, just curious, you know, imagine some investors may read through to this impact through your confidence or shouldn't read across your confidence in arrow rage. And just in general, like, what's your hypothesis around arrow T slip differentiating from, from biological approaches?

Jason Garberry: At that point, one, and then the second question is just on arrow T slip. I'm wondering, this mechanism, I guess, would seem somewhat redundant with arrow rage. So, just curious, you know, imagine some investors may read through to this impact through your confidence or shouldn't read across your confidence in arrow rage. And just in general, like, what's your hypothesis around arrow T slip differentiating from, from biological approaches? Thanks.

Speaker Change: I'll now turn the call over to Andy to give a few remarks on where we are with commercial planning and readiness Andy. Thank you Bruce.

Andy: We're on track with our launch preparations for <unk> and familiar Chylomicron anemia syndrome or Fcs.

As you know this would be arrowheads first commercial product. So we are building a best in class organization that will support the patients who we hope will benefit from <unk>.

Andy: Let me begin by talking a little bit about our expanded access program or EAP.

Andy: This is obviously, a big task, but we're up to the challenge.

Andy: We initiated the EAP to ensure patients who roll off our palisade trial maintain access to <unk> and to make investigational possess aren't available outside of a clinical trial for other patients with FCS who meet certain program eligibility criteria if requested by their treating physician.

Chris Hanzeloni: Thanks. So let me give you the short answer on TSLP, and I'll hand it over to James to give more insight on that. Look, the reason that we were interested in TSLP, to be totally honest, was not necessarily to have a monomer of TSLP, but we thought it could be a very interesting part of a dimer. As you know, we've been developing our ability to deliver dimers to various tissues, and so we did it for that reason. And so, you know, it may be part of a dimer at some point. We are still exploring that, but that was the primary reason.

Andy: The build out of the build out of our medical affairs and commercial infrastructure is right where it needs to be at this time and commercialization.

Christopher Anzalone: So let me give you the short answer on TSLP and I'll hand it over to James to give more insight on that. Look, the reason that we were interested in TSLP to be totally honest was not necessarily to have a monomer of TSLP, but we thought it could be a very interesting part of a dimer. As you know, we've been developing our ability to deliver dimers to various tissues and so we did it for that reason.

Christopher Anzalone: And so, you know, it may be part of a dimer at some point we are still exploring that but that was the primary reason. We were not planning on bringing that in as a monomer necessarily. James, I think that's right. We were not planning on bringing the Arrow TSLP program forward by itself and then mechanistically, I mean, Rage, if you look at the cascade inflammatory cascade, Rage sits upstream of TSLP but there's in terms of the disease indications, at least for asthma that you could go after and they're very similar.

Andy: Our entire medical affairs and commercial leadership team is solidly in place and the team. We've assembled has deep experience in the cardio metabolic and lipid therapeutic areas.

We've already done extensive mapping of the health care professionals or hcp's, most likely to treat Fcs patients and prescribed possess or and if approved our.

Andy: Our market research leads us to believe these hcp's have been impressed with the topline results from our palisade trial with particular note of the unprecedented triglyceride lowering and statistically significant reduction of acute pancreatitis risk.

Speaker Change: As you know this would be arrowheads first commercial product. So we are building a best in class organization that will support the patients who we hope will benefit from <unk>. This.

James Hamilton: We were not planning on bringing that in as a monomer necessarily. James, I think that's right. We were not planning on bringing the Arrow TSLP program forward by itself and then mechanistically, I mean, Rage, if you look at the cascade inflammatory cascade, Rage sits upstream of TSLP but there's in terms of the disease indications, at least for asthma that you could go after and they're very similar. And regarding the facility, I'm sure it gives us flexibility, but really, it's a piece of this bridge that we're talking about. We need to bring in enough capital to allow us to continue to build in the next few years while we're waiting to hopefully address the SHTG market with Podessa, and I think we'll bring with us a potential revenue.

Andy: This is obviously, a big task, but we're up to the challenge.

Andy: As Bruce mentioned, <unk> achieved deep and durable reductions in triglycerides of approximately minus 80% from baseline demonstrating for the first time, the real possibility for FCS patients to lower their triglycerides below important guideline directed thresholds of acute pancreatitis risk.

Andy: The buildout of the build out of our medical affairs and commercial infrastructure is right, where it needs to be at this time and commercialization.

Andy: Our entire medical affairs and commercial leadership team is solidly in place and the team. We've assembled has deep experience in the cardio metabolic and lipid therapeutic areas.

Bruce Bruce: Finally, our best in class patient and caregiver support program is taking shape.

Andy: We've already done extensive mapping of the health care professionals or hcp's, most likely to treat Fcs patients and prescribed <unk> and if approved our.

Speaker Change: We have selected an exclusive specialty pharmacy and patient hub with expert support for patients with rare conditions and we're presently crafting the finer details of our patient and caregiver support ecosystem to ensure patients can easily start and stay on therapy.

Christopher Anzalone: And regarding the facility, I'm sure it gives us flexibility, but really, it's a piece of this bridge that we're talking about. We need to bring in enough capital to allow us to continue to build in the next few years while we're waiting to hopefully address the SHTG market with Podessa and I think we'll bring with us a potential revenue. And this is just one of those pieces. It's not the only piece.

Speaker Change: I look forward to talking more with you in the future about how we see the commercial market opportunity and how we intend to bring <unk> into the many patients who could benefit from this new therapy.

Andy: As Bruce mentioned, <unk> achieved deep and durable reductions in triglycerides of approximately minus 80% from baseline demonstrating.

Chris Hanzeloni: And this is just one of those pieces. It's not the only piece. We still expect to do business development deals. Some of those may be partially used to pay off facility, but a good chunk of it may not be. We may be used for operational purposes. So think of it that way: that it's one of many ways that we want to many tools that we expect to use to build that bridge.

Speaker Change: I'll now turn the call over to Ken.

Ken: Thank you Andy and good afternoon, everyone.

Christopher Anzalone: We still expect to do business development deals. Some of those may be partially used to pay off facility but a good chunk of it may not be. We may be used for operational purposes. So think of it that way that it's one of many ways that we want to many tools that we expect to use to build that bridge. Got it. Thanks a lot. Thank you.

Bruce Bruce: Demonstrating for the first time, the real possibility for FCS patients to lower their triglycerides below important guideline directed thresholds of acute pancreatitis risk.

Ken: As we reported today, our net loss for the quarter ended June 32024 was $178 million.

Unknown Executive: More moment for our next questions.

Ken: Or $1 38 per share based on $124 2 million fully diluted weighted average shares outstanding.

Bruce Bruce: Finally, our best in class patient and caregiver support program is taking shape.

Ken: This compares with a net loss of $102 9 million or <unk> 96 per share based on 107 million fully diluted weighted average shares outstanding for the quarter ended June 32023.

Operator: Got it. Thanks a lot. Thank you.

Mayank Manthiti: More moment for our next questions. Our next question comes from Mayank Manthiti from Be Raleigh Financial. Please go ahead.

Ken: No revenue was recorded in the quarter ended June 32024.

Mayank Mamtani: Our next question comes from Mayank Manthiti from Be Raleigh Financial. Please go ahead. Hey guys, Madison Nolan for Mayank Manthiti, thank you for taking our questions. So a couple of quick moves from me. Is there anything you're closely monitoring within the Neural Muscle landscape that may influence your development plans for ROD and more on the next four, especially kind of on regulatory front. And then secondly, regarding the diners, is there, I guess, timeline to something like that could be in the clinic and is there an indication or target where you think this is better suited than others. Thank you.

Ken: Revenue of $15 8 million was recorded in the quarter ended June 32023.

Bruce Bruce: I'll now turn the call over to Ken.

Ken: Thank you Andy and good afternoon, everyone as.

Ken: Revenue is recognized as we complete our performance obligations or key developmental milestones are reached.

Ken: As we reported today, our net loss for the quarter ended June 32024 was $178 million.

James Hamilton: Hey guys, Madison Nolan for Mayank Manthiti. Thank you for taking our questions. So a couple of quick moves from me. Is there anything you're closely monitoring within the Neural Muscle landscape that may influence your development plans for ROD and more on the next four, especially kind of on the regulatory front. And then secondly, regarding the diners, is there, I guess, a timeline to something like that could be in the clinic and is there an indication or target where you think this is better suited than others. Thank you.

Ken: In the prior period, primarily related to the recognition of payments received from our license and collaboration agreement with Takeda.

Ken: Our $1 38 per share based on $124 2 million fully diluted weighted average shares outstanding.

Ken: Total operating expenses for the quarter ended June 32024.

Ken: This compares with a net loss of $102 9 million or <unk> 96 per share based on 107 million fully diluted weighted average shares outstanding for the quarter ended June 32023.

Ken: $176 1 million compared to $118 5 million for the quarter ended June 32023.

Ken: The key drivers of this change were increased research and development costs, primarily discovery and candidate costs as the Companys pipeline of discovery candidates has advanced into novel therapeutic areas and tissue types in clinical candidates has increased and progressed into later stages of development.

Ken: No revenue was recorded in the quarter ended June 32020 for.

Ken: Revenue of $15 8 million was recorded in the quarter ended June 32023.

Ken: Revenue is recognized as we complete our performance obligations are key developmental milestones are reached.

James Hamilton: James, do you want to address the muscular question? Yeah, sure. I mean, I don't know that there's any specific one item from a regulatory standpoint or neuromuscular developments that we're following. Suffice it to say that we follow all of the other programs that are out there. Closely, and, you know, use the data that they come out in the literature and from our competitors to guide our own programs. Yeah, look, our position there, from my perspective, is a real pleasure to be totally honest. You know, between HBV and AAT and so many others, you know, we are the first ones to blaze the trail. And so, you know, there are certain advantages to being first, but there are certain vulnerabilities as well.

James Hamilton: James, do you want to address the muscular question? Yeah, sure. I mean, I don't know that there's any specific one item from a regulatory standpoint or neuromuscular developments that were following suffice it to say that we follow all of the other programs that are out there. Closely, and, you know, use the data that they come out in the literature and from our competitors to guide our own programs. Yeah, look, our position there, from my perspective, is a real pleasure to be totally honest, you know, between HBV and AAT and so many others, you know, we are the first ones to blaze the trail and so, and so, you know, there are certain advantages to being first but there are certain vulnerabilities as well.

Ken: Revenue in the prior period, primarily related to the recognition of payments received from our license and collaboration agreement with Takeda.

Ken: Net cash used in operating activities. During the quarter ended June 32024 was $115 4 million.

Ken: Total operating expenses for the quarter ended June 32024.

Ken: Compared with $21 4 million for the quarter ended June 32023.

Ken: Were $176 1 million compared to $118 5 million for the quarter ended June 32023.

Ken: The increase in cash used in operating activities is driven primarily by higher research and development expenses as well as lower cash revenue versus the prior year.

Ken: The key drivers of this change were increased research and development costs.

Ken: Similarly discovery and candidate costs as the company has a pipeline of discovery candidates has advanced into novel therapeutic areas and tissue types in clinical candidates has increased and progressed into later stages of development.

Speaker Change: Our footprint expansion is mostly <unk>.

Speaker Change: I'm pleased with final payments to be made over the next several months totaling about $30 million after which we expect capital expenditures to be nominal.

Speaker Change: Turning to our balance sheet, our cash and investments totaled $436 7 million at June 32024, compared.

Ken: Net cash used in operating activities. During the quarter ended June 32024 was $115 4 million compared with $21 4 million for the quarter ended June 32023.

James Hamilton: To learn from, from, from competitors, interactions with, with regulatory agencies, et cetera. And so our look, our job is to be, is to be best in class. Presumably, you know, we'll have a roadmap that's sort of laid out for us and our job is to have better drugs and we, we are hopeful that we can have those. Regarding the DIMERS, you know, we haven't, we haven't given any real guidance on, on DIMERS other than during, you know, the current metabolic day we talked about are what I, what I expect will be our first timer in the clinic, the PCS K9 APOC 3 DIMER.

Speaker Change: Compared to $403 6 million at September 32023.

Speaker Change: The increase in our cash and investments was primarily related to the $450 million equity issuance.

Ken: The increase in cash used in operating activities is driven primarily by higher research and development expenses as well as lower cash revenue versus the prior year.

Speaker Change: Partially offset by ongoing cash burn.

Speaker Change: Today, we announced a financing agreement with sixth Street for significant long term non dilutive capital.

James Hamilton: Regarding the DIMERS, you know, we haven't, we haven't given any real guidance on DIMERS other than during, you know, the current metabolic day we talked about are what I, what I expect will be our first timer in the clinic, the PCS K9 APOC 3 DIMER. We're excited about that; that will not be in the clinic this year, but I would, I would expect that to be in the clinic next year. We've not talked about, about where else we are going with, with DIMERS in the near term. You know, as you can imagine, the lower hanging fruit with DIMERS, of course, is delivery to a padisites.

Ken: Our footprint expansion is mostly complete with final payments to be made over the next several months totaling about $30 million after which we expect capital expenditures to be nominal.

Speaker Change: $500 million senior secured credit facility includes a $400 million up funded at close and an additional $100 million available at arrowheads option subject to mutual agreement between <unk> and Arrowhead.

James Hamilton: We're excited about that, that will not be in the clinic this year but I would, I would expect that to be in the clinic next year. We've not talked about, about where else we are going with, with DIMERS in the near term. You know, as you can imagine, the lower hanging fruit with DIMERS of course is, is delivery to a padisites. And so, so I would expect those to be first and then, and then as, as our technology is mature, we can start to think about that type of strategy for other, other tissue types.

Ken: Yes.

Ken: Turning to our balance sheet, our cash and investments totaled $436 7 million at June 32024.

Speaker Change: Inclusive of the upfront cash from sixth Street before deducting fees, our pro forma cash balance.

Ken: Compared to $403 6 million at September 32023.

Speaker Change: <unk> $840 million.

James Hamilton: And so, so I would expect those to be first and then, and then as our technology is mature, we can start to think about that type of strategy for other, other tissue types. Got it. Thank you.

Speaker Change: And significantly enhances our liquidity towards our global commercial launch of <unk>.

Ken: The increase in our cash and investments was primarily related to the $450 million equity issuance.

Speaker Change: We're also supporting advancement of our late stage clinical trials.

Ken: Partially offset by ongoing cash burn.

Speaker Change: Other discovery efforts.

Ken: Today, we announced a financing agreement with sixth Street for significant long term non dilutive capital.

Speaker Change: Our common shares outstanding at June 32024, or $124 2 million.

Chris Hanzeloni: If I could squeeze it into the, on your, your adipose tissue targeting. Is there a timeline on that? Can you remind us of that time well? Well, well, so, so tune in to our, our, our webinar on August 14, 14. You know, you'll hear our first adipose. Target that we're going after, and we expect that to be, we expect to file a CTA for that this year. We have not given guidance on, on, on what those are yet, but you'll hear at least, at least that one. Next week, I guess. Got it.

James Hamilton: Got it. Thank you. If I could squeeze it into the, on your, your adipose tissue targeting. Is there a timeline on that? Can you remind us of that time well? Well, well, so, so tune in to our, our, our webinar on August 14, 14, you know, you'll hear our first adipose. Target that we're going after and we expect that to be, we expect to file a CTA for that this year. We have not given guidance on, on, on what those are yet, but you'll hear at least, at least that one. Next week, I guess. Got it. Congrats on progress. Thank you.

Unknown Executive: One more for our next question.

Speaker Change: With that brief overview I will now turn the call back to Chris.

Ken: $500 million senior secured credit facility includes a $400 million funded at close and an additional $100 million.

Chris Anzalone: Thanks, Ken.

Chris Anzalone: We had a highly productive quarter and feel that all pieces are now in place to begin the transition into a commercial stage company.

Ken: Available at arrowheads option subject to mutual agreement between <unk> and Arrowhead.

Speaker Change: <unk> phase III study in palisade, and we intend to use to file for regulatory approval to launch both Astro and in patients with Fcs.

Ken: Inclusive of the upfront cash from sixth Street before deducting fees, our pro forma cash balance was approximately $840 million.

Speaker Change: Summit suite of clinical studies, including palisade and the shaft them year in cap of 10 studies are all underway are at advanced stages and are designed to show the value of pedestrian in multiple patient populations as I mentioned, we view <unk> as a pipeline within a single drug in these studies have the potential of enabling that.

Ken: And significantly enhances our liquidity towards our global commercial launch of <unk> <unk>.

Ken: I'll also supporting advancement of our late stage clinical trials.

Operator: Congrats on progress. Thank you.

Ken: Other discovery efforts.

Ken: Our common shares outstanding at June 32024, or $124 2 million.

Mani Foroohar: One more for our next question. Our next question comes from many four are from leering, leering partners.

Speaker Change: Our commercial organization is taking shape is taking shape and we have a thoughtful strategy to grow and supportable faster and as the clinical studies and ultimately the product label grows into progressively larger patient populations.

Brandon Smith: Our next question comes from many four are from leering, leering partners. Please go ahead. Hi, good afternoon, everyone. This is DJI on firm money. My question is on the credit facility with six straight. I understand there's no scheduled amortization payments, but could you give a little detail on the what proportion of future upfront payments, milestones, or royalties from partnerships or classmates have to go towards repaying the loan. We could either be appreciated.

Ken: With that brief overview I will now turn the call back to Chris.

Kenneth Myszkowski: Please go ahead. Hi, good afternoon, everyone. This is DJI on firm money. My question is on the credit facility with six straight. I understand there's no scheduled amortization payments, but could you give a little detail on the what proportion of future upfront payments, milestones, or royalties from partnerships or classmates have to go towards repaying the loan. We could either be appreciated.

Chris: Thanks, Ken.

Chris: We had a highly productive quarter and feel that all pieces are now in place to begin the transition into a commercial stage company.

Speaker Change: And lastly, we have taken the next steps to execute on our long term financing strategy and now have a stronger balance sheet, enabling us to better fund innovation and growth opportunities across arrowheads robust and diverse pipeline of RNA therapeutics.

Speaker Change: <unk> phase III study in palisade, and we intend to use to file for regulatory approval to launch both Astro and in patients with Fcs.

Speaker Change: Summit suite of clinical studies, including palisade, and the Shasta Mir and <unk> studies are all underway or at advanced stages and are designed to show the value of Odessa and in multiple patient populations as I mentioned, we view <unk> as a pipeline within a single drug in these studies have the potential of enabling that.

Speaker Change: We are focused most of this call until <unk>, but of course, we have a large stable of value drivers under it that continue to move forward.

Speaker Change: Our pulmonary franchise with three current clinical candidates are muscle franchise with two current clinical candidates and our complement franchise with two.

Kenneth Myszkowski: Sure, yeah, I can take that. So, so it depends on which particular asset it is. This is a very custom structure that we went through, and so we kind of bucketed different assets, and each of those has different pay, payback economics. So the philosophy here is that we wanted the flexibility to spread out repayment of this over time. And we also didn't want to have too much of a cash outlay obligation unless we were going to have a significant cash inflow with that corresponded with what you're talking about with potential upfront payments from new deals or milestone payments or royalties from existence.

Brandon Smith: Sure, yeah, I can take that. So, so it depends on which particular asset it is. This is a very custom structure that we went through and so we kind of bucketed different assets and each of those has different pay, payback economics. So the philosophy here is that we wanted the flexibility to spread out repayment of this over time. And we also didn't want to have too much of a cash outlay obligation unless we were going to have a significant cash inflow with, that corresponded with what you're talking about with potential upfront payments from new deals or milestone payments or royalties from existence.

Brandon Smith: Deals, so there's various different levels for different assets. And some are zero. There will be some transactions where we aren't required to pay any portion of that to 60. That's right. And we pre-negotiated the carveouts for a handful of things that we think are likely over the coming years. Got it. Would you go to the scrolls whether the 10th more like front later or frontloader backloaded in terms like the proportion of those future collections that would have to go to repaying the loan.

Speaker Change: Current clinical candidates.

Ken: Our commercial organization is taking shape is taking shape and we have a thoughtful strategy to grow and support of those aster and as the clinical studies and ultimately the product label grows into progressively larger patient populations.

Speaker Change: All continued to progress over the quarter.

Speaker Change: By the end of the year, we expect to file Cta is in support of two obesity candidates and two CNS cabinets and Youll hear more about those programs at our Webinars on August 14, and September 25th respectively.

Ken: And lastly, we have taken the next steps to execute on our long term financing strategy and now have a stronger balance sheet, enabling us to better fund innovation and growth opportunities across arrowheads robust and diverse pipeline of RNA therapeutics.

Speaker Change: Our partnered programs also made progress as the El Paso and phase III against LP Little a is fully enrolled and the <unk> phase III against AEP continues to enroll patients are HBV in HST programs with GSK are both in phase II studies, and we continue to weigh our options with the <unk> three program that we started with J&J.

Speaker Change: We are focused most of this call impose astrakhan, but of course, we have a large stable of value drivers under it that continue to move forward.

Ken: Our pulmonary franchise with three current clinical candidates are muscle franchise with two current clinical candidates and our complement franchise with two current clinical candidates.

Kenneth Myszkowski: Deals, so there's various different levels for different assets. And some are zero. There will be some transactions where we aren't required to pay any portion of that to 60. That's right. And we pre-negotiated the carveouts for a handful of things that we think are likely over the coming years.

Speaker Change: And we now wholly own.

Speaker Change: We think these potential value drivers will play an important role in the future of arrowhead, either as marketed products themselves or part of the steps that we do we take to bridge was ASUR into commercialization.

Ken: All continued to progress over the quarter.

Ken: By the end of the year, we expect to file a cta and supportive to obesity candidates and two CNS candidates and you will hear more about those programs at our Webinars on August 14, and September 25th respectively.

Speaker Change: Thank you for joining us today, and I would now like to open the call to your questions operator.

Speaker Change: Thank you at this time, we will conduct a question and answer session to.

Ken: Our partner programs also made progress as El Paso, and phase III against LP Little a is fully enrolled and the <unk> phase III against AEP continues to enroll patients are HBV in HST programs with GSK are both in phase II studies, and we continue to weigh our options with the <unk> three program that we started with J&J.

Speaker Change: To ask a question. During this session you will need to press star one on your telephone you would be in here an automated message advising your hand is raised.

Kenneth Myszkowski: Got it. Would you go to the scrolls whether the 10th more like front later or frontloader backloaded in terms like the proportion of those future collections that would have to go to repaying the loan. No, we're not giving more guidance on that at this point. We will file a redacted version of the contract at some point. But you know, at this point, we're just disclosing what was in the press release. Okay, sounds good. Thanks so much for taking our question. Thank you.

Speaker Change: To withdraw your question. Please press star one again in the interest of time, we exited you. Please limit your inquiries to one question and one follow up please standby, while we compile the Q&A roster.

Ken: And we now wholly own.

Ken: We think these potential value drivers will play an important role in the future of arrowhead, either as marketed products themselves or part of the steps that we do we take to bridge for disaster into commercialization.

Brandon Smith: No, we're not giving more guidance on that at this point. We will file a redacted version of the contract at some point. But you know, at this point, we're just disclosing what was in the press release. Okay, sounds good. Thanks so much for taking our question. Thank you.

Speaker Change: Our first question comes from Maury Raycroft from Jefferies. Please go ahead.

Brandon Smith: One more for our next question.

Maury Raycroft: Hi, congrats on the quarter and thanks for taking my questions.

Speaker Change: Thank you for joining us today, and I would now like to open the call to your questions operator.

Speaker Change: I'm going to start off with Fcs.

Speaker Change: Thank you at this time, we will conduct a question and answer session to.

Maury Raycroft: Wondering if you can provide more perspective on what additional details we should expect to see at the ESC meeting and the study hit stat Sig on reducing acute pancreatitis and the small sample size, where whereas I owners didn't chose thats a difference what are your latest thoughts on higher SCS label could look like versus <unk>.

Brendan Smith: One more for our next question. Our next question comes from Brandon Smith from TD Cowan. Please go ahead. Hi guys. Thanks for taking the questions. Just a quick one for me. Kind of given this latest finance. I think you give us a sense of how you're thinking about additional partnerships this year. Should we expect, you know, you'll announce a commercialization partner sometime in 2024. Is that maybe a next year at this point?

Speaker Change: To ask a question. During this session you will need to press star one one of your telephone you would be in here an automated message advising your hand is raised.

Brandon Smith: Our next question comes from Brandon Smith from TD Cowan. Please go ahead. Hi guys. Thanks for taking the questions. Just a quick one for me. Kind of given this latest finance. I think you give us a sense of how you're thinking about additional partnerships this year. Should we expect, you know, you'll announce a commercialization partner sometime in 2024. Is that maybe a next year at this point?

Ken: To withdraw your question. Please press star one again in the interest of time, we exited you. Please limit your inquiries to one question and one follow up please.

Maury Raycroft: <unk>.

Ken: Please stand by while we compile the Q&A roster.

Maury Raycroft: Yes.

Maury Raycroft: Well, so let's take the <unk>.

Maury Raycroft: First question first I do expect that the.

James Hamilton: And then just really quickly, I wanted to ask if you're still planning to release phase one data with that arrow CFB this year and kind of just how you're thinking about next steps and potential indications for that one. Thanks.

Ken: Our first question comes from Maury Raycroft from Jefferies. Please go ahead.

James Hamilton: And then just really quickly, I wanted to ask if you're still playing to release phase one data with that arrow CFB this year and kind of just how you're thinking about next steps and potential indications for that one. Thanks. James, do you want to talk about that could be sure? Yeah, yeah, we should be in a position to release data from the CFB program later this year. And then the primary additional indications that we're looking at, of course, the study starts in healthy volunteers, but we will also be looking at arrow CFB in patients with hygiene and property in the study.

Maury Raycroft: The presentation will will give much more detail, especially on the primary and secondary endpoints, but I think also.

Maury Raycroft: Hi, congrats on the quarter and thanks for taking my questions.

Maury Raycroft: I'm going to start off with FCS I just.

Maury Raycroft: More broadly on some of the more exploratory or secondary endpoints, but focus I think will be a primary.

James Hamilton: James, do you want to talk about that could be sure? Yeah, yeah, we should be in a position to release data from the CFB program later this year. And then the primary additional indications that we're looking at, of course, the study starts in healthy volunteers, but we will also be looking at arrow CFB in patients with hygiene and property in the study. Sorry, what was the first question timing on partnerships? Oh, yeah. That's easy. I can't predict timing on partnerships. You know, we are, as one can imagine, we have a lot going on. And so we are, we are actively speaking with companies all the time. Who knows, who knows how fast those go? Who knows, you know, that's our timing.

Maury Raycroft: Wondering if you can provide more perspective on what additional details we should expect to see at <unk> meeting and the study hit stat Sig on reducing acute pancreatitis and the small sample size, we're whereas I noticed didn't shows Thats a difference what are your latest thoughts on how your SCS label could look like versus <unk>.

Maury Raycroft: Alpha controlled secondaries, all of which were statistically significant but most of which haven't really been.

Maury Raycroft: Fully exposed to the.

Maury Raycroft: To the Investor and scientific communities.

Maury Raycroft: As far as.

Ken: <unk>.

Maury Raycroft: Pancreatitis goes I mean, that's obviously exciting for us and.

Ken: Yes.

Ken: Well, so let's take the.

Maury Raycroft: Where we're really happy to.

Speaker Change: The first question first.

James Hamilton: Sorry, what was the first question timing on on partnerships? Oh, yeah. That's easy. I can't predict timing on partnerships. You know, we are, as one can imagine, we have a lot going on. And so we are, we are actively speaking with, with companies all the time, who knows, who knows how fast those go, who knows, you know, that's our timing. So these are priorities for us, but I can't give you a time. Thank you.

Ken: Do.

Maury Raycroft: <unk> achieved statistical significance there.

Ken: Expect that.

William Pickering: One more for our next question.

Ken: The presentation will give much more detail, especially on the primary and secondary endpoints, but I think also.

Maury Raycroft: It's going to be.

Maury Raycroft: Obviously, an important part of our our filing with the with the FDA as well and it will be interesting to see how they view the data, but we're certainly excited about it.

Ken: More broadly on some of the more exploratory or secondary endpoints, but focus I think will be a primary.

Ken: Alpha controlled secondaries, all of which were statistically significant but most of which haven't really been.

Speaker Change: Got it and maybe one more quick one just are you, saying how many patients are enrolled in the expanded access program.

Chris Hanzeloni: So these are priorities for us, but I can't give you a time. Thank you.

Ken: Fully exposed to the.

Maury Raycroft: Okay.

Maury Raycroft: No we have not done.

Ken: To the Investor and scientific communities as.

Speaker Change: Okay. Okay. Thanks for taking my questions and I'll hop back in the queue.

Ken: As far as.

Operator: One more for our next question.

Ken: Pancreatitis goes I mean, that's obviously exciting for us and.

Maury Raycroft: Thanks.

Speaker Change: Thank you what I'm, referring to this question.

Ken: Where we're really happy to two.

William Pickering: Our next question comes from William Pickering from Bernstein. Please go ahead. Hi, good afternoon. Thank you so much for taking my question. I noticed there was about a $50 million sequential increase in the R&D this quarter. If you just give a bit more color on what's in there, and how would you expect the R&D line for the next few quarters to compare to that number this quarter. Thank you. So the increase in R&D it's been increasing all year as we move these assets further into later stages, and you will expect those to continue to increase into next year.

Kenneth Myszkowski: Our next question comes from William Pickering from Bernstein, please go ahead. Hi, good afternoon. Thank you so much for taking my question. I noticed there was about a $50 million sequential increase in the R&D this quarter. If you just give a bit more color on what's in there, and how would you expect to R&D line for the next few quarters to compare to that, that number this quarter. Thank you. So the increase in R&D it's been increasing all year as we move these assets further into later stages, and you will expect those to continue to increase into next year. We are going through our budgeting process right now, and we will provide additional guidance at our next earnings call to give you more information on that. Thank you.

Maury Raycroft: Our next question comes from Ellie Merle from UBS. Please go ahead.

Ken: <unk> achieved statistical significance there.

Ken: It's going to be.

Ellie Merle: Hey, guys. Thanks, so much for taking the question.

Ken: Obviously, an important part of our our filing with the with the FDA as well and it'll be interesting to see how they view the data, but we're certainly excited about it.

Ellie Merle: What's your latest thinking on the phase two initiation for arrow range in asthma, and the gating factors to getting that started.

Ellie Merle: And can you just remind us the latest timelines for when we can expect to see additional data.

Speaker Change: Got it and maybe one more quick one just are you, saying how many patients are enrolled in the expanded access program.

Ellie Merle: Alright.

Ellie Merle: Anthony.

Anthony: The commentary.

Anthony: In terms of the clinical studies you have ongoing.

Speaker Change: No we have not yet.

Speaker Change: Okay. Okay. Thanks for taking my questions and I'll hop back in the queue.

Anthony: Yes. Thanks for the question, we've not given any more guidance on on.

Speaker Change: Thanks.

Kenneth Myszkowski: We are going through our budgeting process right now, and we will provide additional guidance at our next earnings call to give you more information on that. Thank you.

Speaker Change: Thank you for our next question.

Anthony: On when we'll have additional data.

Speaker Change: We'll just see when when we can complete those studies and then we will we will present those when we can.

Speaker Change: Our next question comes from Ellie Merle from UBS. Please go ahead.

Speaker Change: Regarding the phase III, we are we are developing those plans right now.

Ellie Merle: Hey, guys. Thanks, so much for taking my question.

Operator: I am showing no further questions at this time.

Christopher Anzalone: I am showing no further questions at this time. I will turn it back over to Chris Anzalone for close remarks. Thanks everyone for joining us today and I hope you have enjoyable rest of your summer. Thank you for your participation in today's conference.

Ellie Merle: What's your latest thinking on the phase two initiation for Aero Rage and asthma.

Speaker Change: And so stay tuned on.

Vincent Anzalone: I will turn it back over to Chris and Zaloni for closing remarks. Thanks everyone for joining us today, and I hope you have enjoyable rest of your summer.

Unknown Executive: This does conclude the program you may now disconnect.

Speaker Change: More information on that.

Speaker Change: And the gating factors to getting that started.

Speaker Change: There are a number of factors that were weighing about what type of patients will be treating and and how long will be treating et cetera. So we're still in the process of working that out right now.

Unknown Executive: [inaudible]

Speaker Change: And can you just remind us the latest timelines for when we can expect to see.

Operator: Thank you for your participation in today's conference.

Speaker Change: All data.

Speaker Change: Alright.

Speaker Change: From any of the commentary in terms of the.

Speaker Change: Great. Thanks.

Speaker Change: The clinical studies you have ongoing.

Speaker Change: Youre welcome.

Speaker Change: Thank you one moment for our next question.

Speaker Change: Yes. Thanks for the question, we've not given any more guidance on on.

Speaker Change: Our next question comes from Luca <unk> from RBC capital. Please go ahead.

Speaker Change: On when we will have additional data.

Speaker Change: We'll just see when when we can complete those studies and then we will we will present those when we can.

Luca <unk>: Oh, great. Thanks, so much for taking my questions, maybe two quick ones, maybe Chris or Ken can you just expand on why you think the deal announced today was struck on favorable economics can you just maybe help us contextualize, the 50% annual interest rate and maybe how you negotiated that.

Speaker Change: Regarding the phase II, we are we are developing those plans right now.

Speaker Change: And so stay tuned on.

Speaker Change: More information on that.

Speaker Change: There are a number of factors that were weighing about what type of patients will be treating and and how long will be treating etcetera and so we are still in the process of working that out right now.

Bruce Bruce: And then maybe on FCS Bruce I. Appreciate you have a differentiated approach here you included both <unk> as well as clinically confirmed patient and patent side, but how should we think about payers is it possible to payers at least initially with strict access to just stations that are genetically confirmed before maybe broadening also to clinical.

Speaker Change: Great. Thanks.

Speaker Change: Youre welcome.

Speaker Change: Thank you one moment for our next question.

Luca <unk>: Our next question comes from Luca <unk> from RBC capital. Please go ahead.

Bruce Bruce: To confirm any color there much appreciate it thanks so much.

Luca <unk>: Oh, great. Thanks, so much for taking my questions, maybe two quick ones, maybe Chris or Ken can you just expand on why you think the deal announced today was struck unfavorable economics can you just maybe help us contextualize, the 15% annual interest rate and maybe how you negotiated that.

Bruce Bruce: Sure.

Speaker Change: I'll start with me with the dealer and Ken can add.

Bruce Bruce: If you can.

Speaker Change: Mike.

Speaker Change: Okay.

Mike: The take home message for us on that was that was that we are at the point of development. In this company that I think we can take on debt.

Speaker Change: Broadly speaking, but it's got to be the right kind of debt, we have an awful lot to do in the coming years to build out our commercial infrastructure.

Bruce Bruce: And then maybe on FCS Bruce I. Appreciate you have a differentiate your approach here you included both <unk> as well as clinically confirmed patient pattern side, but how should we think about payers is it possible that payers at least initially restrict access to just stations that are genetically confirmed before maybe broadening also to clinic.

Speaker Change: Before we start to see substantial revenue coming in and so any any kind of that that made sense to us we're going to have to be long dated the seven year term makes a lot of sense to us. It gives us plenty of room to bridge I talked about this bridge to <unk> S. H T G.

Luca <unk>: So to confirm any color there much appreciate it thanks so much.

Speaker Change: <unk> I think that could be in the 2027 or so timeframe and so.

Luca <unk>: Sure. So I'll start with me with the deal and Ken can add.

Speaker Change: The seven year term gets us deep into that that's comfortable for us. There's also really attractive risk sharing components here theres not theres not a coupon for here that we need to to be paying on a regular basis, we will be paying this.

Luca <unk>: If you'd like.

Luca <unk>: Okay.

Luca <unk>: The take home message for us on that was that was that.

Ken: We are at the point of development in this company that I think we can take on debt.

Ken: Broadly speaking, but it's got to be the right kind of debt we have.

Speaker Change: If and only if certain.

Ken: Have an awful lot to do in the coming years to build out our commercial infrastructure.

Speaker Change: External funds come in and so and so it does not put constraints on us that that would have been problematic and so so this to us feels like a very comfortable and appropriate.

Ken: Before we start to see substantial revenue coming in and so any any kind of that that made sense to us we're going to have to be long dated the seven year term makes a lot of sense to us. It gives us plenty of room to bridge I talked about this bridge to pose aster and S. H T G.

Speaker Change: Structure can you have anything else you want to add on that.

Speaker Change: No I just wanted to say that it is non dilutive so we like that aspect of it.

Ken: The market I think that could be in the 2027% or so timeframe and so.

Speaker Change: And the cost of capital is reasonable.

Ken: The seven year term gets us deep into that that's comfortable for US. There is also really attractive risk sharing components here theres not theres not a coupon for here that we need to to be paying on a regular basis.

Speaker Change: Given what our cost of equity capital would be.

Speaker Change: Yeah actually let me let me, let me underline that I think that's a great point.

Speaker Change: When we look at what we can be achieving over the coming years the cost of equity capital at this point feels quite expensive.

Ken: We will be paying this.

Ken: If and only if certain external funds come in and so and so it does not put constraints on us that that would've been problematic and so so this to us feels like a very comfortable and appropriate.

Speaker Change: This is a.

Speaker Change: Very different.

Speaker Change: Diversification for us.

Bruce Bruce: Bruce Yeah.

Speaker Change: Luca you ask a very good question.

Speaker Change: The interesting thing about the way.

Speaker Change: Structure can do you have anything else you want to add on that.

Speaker Change: Palisade was constructed is that if you if you didn't know the genetics on any of these patients. They would all look the same.

Speaker Change: No I just wanted to say that it is non dilutive so we like that aspect of it.

Speaker Change: So what we really have here is we have a group of patients that happened to have.

Speaker Change: And the cost of capital is reasonable.

Speaker Change: Given what our cost of equity capital would be.

Speaker Change: Yeah actually let me let me, let me underline that I think that's a great point.

Speaker Change: A narrow set of genetics.

Speaker Change: That characterize them as familiar Chylomicron anemia syndrome Fcs.

Speaker Change: When we look at what we can be achieving over the coming years the cost of equity capital at this point feels quite expensive.

Speaker Change: And then we have a group of patients that basically all look the same but happened to have a dip.

Speaker Change: This is.

Speaker Change: Very different.

Speaker Change: Diversification for us.

Speaker Change: Genetic makeup, but clinically they are the same.

Speaker Change: Bruce.

Speaker Change: Luca you ask a very good question.

Speaker Change: And.

Speaker Change: That's what's interesting about this so my expectation is that.

Speaker Change: The interesting thing about the way.

Speaker Change: Palisade was constructed is that if you if you didn't know the genetics on any of these patients. They would all look the same.

Speaker Change: It will really probably come down to what the package insert says and of course, we don't know that at this point.

Speaker Change: But I think that the payers will go along with the package insert.

Speaker Change: So what we really have here is we have a group of patients that happened to have.

Speaker Change: And assuming that we get approved and assuming that the agency labels us for the patients that were studied.

Speaker Change: A narrow set of genetics.

Speaker Change: That characterize them as familiar Chylomicron anemia syndrome Fcs.

Speaker Change: We would expect that the payers will go along that that patient set.

Speaker Change: Match, our entry criteria.

Speaker Change: And then we have a group of patients that basically are look the same but happen to have.

Speaker Change: Will I think will be covered.

Speaker Change: But.

Speaker Change: That will of course be paired to payer.

Speaker Change: Current genetic makeup, but clinically they are the same.

Speaker Change: But it feels like overall.

Speaker Change: That's.

Speaker Change: Yeah.

Speaker Change: That's what's interesting about this so my expectation is that.

Speaker Change: As one of the physicians wanted the investigator said to me.

Speaker Change: It will really probably come down to what the package insert says and of course, we don't know that at this point.

Speaker Change: The patients look the same whether they have the genetics are not they are still the same problem I have in my clinic of patients with very high triglycerides.

Speaker Change: But I think that the payers will go along with the package insert.

Speaker Change:

Speaker Change: At risk for pancreatitis, and many of them, having pancreatitis or recurrent pancreatitis and dangerous pancreatitis.

Speaker Change: And assuming that we get approved and assuming that the agency labels us for the patients that were studied.

Speaker Change: So from the from the physician perspective patients are very much.

Speaker Change: We would expect that the payers will go along that that patient set.

Speaker Change: Same.

Speaker Change: And Thats.

Speaker Change: These are adult patients mind, you, but.

Speaker Change: Match, our entry criteria.

Speaker Change: But there's a pretty good reason to think that the payers will will go along with the package insert here.

Speaker Change: Will I think will be covered.

Speaker Change: But.

Speaker Change: That will of course prepared to payer.

Speaker Change: But it feels like overall.

Speaker Change: Got it thanks, so much.

Speaker Change: As one of the physicians wanted the investigators said to me.

Speaker Change: Thank you we'll move from <unk> question.

Speaker Change: Our next question comes from.

Speaker Change: The patients look the same whether they have the genetics or not there is still the same problem I have in my clinic of patients with very high triglycerides.

Speaker Change: Edward <unk> from Seb. Please.

Speaker Change: Please go ahead.

Speaker Change: Great. Thank you very much.

Speaker Change: Yes.

Speaker Change: Congrats on all the progress just a little bit more on Closeouts.

Speaker Change: At risk for pancreatitis, and many of them, having pancreatitis or recurrent pancreatitis and dangerous pancreatitis.

Speaker Change: With respect to what needs to be done for the NDA filing.

Speaker Change: So from the from the physician perspective patients are very much.

Speaker Change: Where are you guys are in the process.

Speaker Change: And Thats.

Speaker Change: How are things progressing on the CMC side.

Speaker Change: These are adult patients mind, you, but.

Speaker Change: But there is a pretty good reason to think that the payers will will go along with the package insert here.

Speaker Change: Are the big stuff still needs to be done.

Speaker Change: Let's see well I mean, we're.

Speaker Change: Alright, thanks, so much.

Speaker Change: There were busily writing.

Speaker Change: Thank you one moment for our next question.

Speaker Change: We.

Speaker Change: We'll have our pre NDA meeting with the FDA and that will give us more insight into.

Speaker Change: Our next question comes from.

Speaker Change: Edward tint off from SP.

Speaker Change: Go ahead.

Speaker Change: Whether there is anything special they would like us to do that.

Speaker Change: Great. Thank you very much.

Speaker Change: Congrats on all the progress just a little bit more on Closeouts.

Speaker Change: We're already doing.

Speaker Change: CMC is moving along as well so I mean, we're just in.

Speaker Change: With respect to what needs to be done for the NDA filing.

Speaker Change: In the pre submission phase I guess Ted.

Speaker Change: Are you guys are in the process.

Ted: I don't know how to give you more than that at this point, but.

Speaker Change: How are things progressing on the CMC side.

Ted: But where we're deep in it.

Ted: Okay and just for me.

Speaker Change: What are the big steps that still needs to be done.

The goal is to file by year end.

Ted: Yes, thats been the.

Speaker Change: Let's see well I mean, we're we're busily writing.

Ted: That's been the guidance so far.

Speaker Change:

Ted: Thank you and then final question if I may just on the muscle programs.

Speaker Change: We.

Speaker Change: We will have our pre NDA meeting with the FDA and that will give us more insight into.

Speaker Change: We'd be expecting for in terms of future data.

Speaker Change: Whether there is anything special they would like us to do that we're not already doing.

Speaker Change: <unk> of Readouts.

Speaker Change: From your muscle programs.

Speaker Change: CMC is moving along as well so I mean, we're just.

Speaker Change: Yes, so we've not given any guidance on that these are still.

Speaker Change: In the pre submission phase I guess Ted.

Speaker Change: Early ish programs, we are we are treating patients.

Ted: I don't know how to give you more than that at this point, but.

Speaker Change: We'll see how fast we can we can treat we'll see how fast we can we can generate data that is interpretable.

Ted: But we are deep in it.

Speaker Change: <unk>.

Ted: Okay.

Speaker Change: So in other words don't expect too.

Ted: The goal is to file by year end.

Speaker Change: To have a drip drip of data.

Speaker Change: Onesie twosies patients, we need to put them together and it will be helpful.

Ted: Yes, thats been the.

Ted: That's been the guidance so far.

Speaker Change: To investors once we have it so.

Speaker Change: Thank you and then final question if I may just on the muscle programs.

Speaker Change: So I would not expect data this year and so we know we'll see next year. When we could have something we just don't we don't know the answer to that at this point given any data on that James.

Speaker Change: Can we be expecting for in terms of future data.

Speaker Change: In terms of Readouts.

Speaker Change: From your muscle programs. Thanks.

Greg: No I think Greg. Thank you comes right on that.

Speaker Change: Yes, so we've not given any guidance on that these are still.

Greg: On timing.

Suffice it to say that the readouts. So I think it will be substantially the same as what others have shown.

Speaker Change: Early ish programs, we are we are treating patients.

Joseph <unk> knockdown splice correction tissue concentrations that sort of thing.

Speaker Change: We'll see how fast we can we can treat we'll see how fast we can generate data that is interpretable.

Speaker Change: Great looking forward to talking about thanks.

Speaker Change: <unk>.

Speaker Change: So in other words don't expect too.

Speaker Change: Thank you one moment for our next question.

Speaker Change: To have a drip drip of data.

Speaker Change: Onesie twosies patients, we need to put them together that will that would be helpful.

Jason <unk>: Our next question comes from Jason <unk> from Bank of America. Please go ahead.

Speaker Change: To investors once we have it so.

Jason <unk>: Hey, guys. Thanks for taking my question.

Speaker Change: So I don't I would not expect data this year and so we'll see next year. When we can have something we just don't we don't know the answer to that at this point give anything to add on that James.

Jason <unk>: My first is just on.

Speaker Change: The facility you announced this evening. So is the right way to think about it I mean, you have a business model or you have an unpredictable flow of milestone.

James: No I think greg's take you right on that.

James: On timing.

James: Suffice it to say that the readouts. So I think it will be substantially the same as what others have shown.

Speaker Change: In the door so to speak.

Speaker Change: So this gives you the flexibility to draw from the facility, but once those milestone payments.

Joseph: Joseph <unk> Teekay knockdowns place correction tissue concentrations that sort of thing.

Speaker Change: You can.

Speaker Change: You can retire that repay and avoid the 15% cost, but it just kind of gives you operational flexibility at that 0.1 and then the second question is just on Aero Heaslip I'm wondering.

James: Great looking forward to talking about thanks.

Speaker Change: Thank you one moment for our next question.

Jason <unk>: Our next question comes from Jason <unk> from Bank of America. Please go ahead.

Speaker Change: This mechanism I guess would seem somewhat redundant with arrow rage, and so I'm just curious.

Jason: Hey, guys. Thanks for taking my questions. My first is just on the.

Speaker Change: I imagined some investors may read through does it impact your confidence there shouldn't read across to your confidence in Aero raging and generally what's your hypothesis around Iot slipped differentiating from from biologic approaches.

Jason: The facility you announced this evening. So is the right way to think about it I mean, you have a business model where you have this.

Speaker Change: Predictable flow of milestone in the door so to speak so.

Speaker Change: Yeah. So let me give it the short answer on <unk> and <unk>.

Speaker Change: Gives you the flexibility to draw from the facility, but once those milestone payments I mean, you can you can retire that repay and avoid the 15% cost but it just kind of gives you operational flexibility at that 0.1 and then the second question is just on Aero Heaslip I'm wondering.

Speaker Change: Hand, it over to James to give more insight on that.

James: The reason that we're interested in <unk> to be totally honest was not necessarily to have a monomer of DSL P. But we thought it could be a very interesting part of a dimer as you know we've been developing our ability to deliver dimers.

James: To various tissues and and so we did it for that reason.

Speaker Change: Its mechanism I guess with team.

Speaker Change: Got redundant with Arrow rage, and so I'm just curious.

James: And so.

James: It may be part of the Diamond at some point we are still.

Speaker Change: I imagine some investors may read through does it impact your confidence or shouldn't read across to your confidence in Aero raging just in general what's your hypothesis around Iot slipped differentiating from from biologic approaches. Thanks.

James: Exploring that but that was the primary reason I don't I don't.

James: We were not planning on bringing that Hasnt monomer.

James: And I think that's right we were not planning on bringing the.

James: So let me give you the short answer on <unk> and I'll hand, it over to James to give more insight on that but the reason that we are interested in <unk> to be totally honest was not necessarily to have a monomer of DSL people. We thought it could be a very interesting part of a dimer as you know we've been developing our ability to.

James: <unk> program forward by itself.

Rich: And then Mechanistically I mean, rich if you look at the Cascade.

Inflammatory Cascade Rage sits.

Rich: Upstream of DSO P, but theirs.

Rich: The disease indications at least for asthma.

James: To deliver dimers.

Rich: Go after there.

James: To various tissues and so we did it for that reason.

Rich: They are very similar.

Speaker Change: And regarding the facility, yes, sure it gives us flexibility, but really it's a piece of this bridge that we're talking about we need to to bring in.

James: And so.

James: It may be part of Diamond at some point, we are still we're still exploring that but that was the primary reason.

James: No.

Rich: <unk> capital too.

James: We were not planning on bringing that it hasnt monomer.

To allow us to continue to build over the next few years, while we are waiting to hopefully address the FH DG market with pedestrian I think will be.

James: Necessarily and I think Thats right, we were not planning on bringing the.

James: <unk> program forward by itself.

Rich: We'll bring with it substantial revenue and this is just one of those pieces. It is not the only piece we still expect.

Rich: And then Mechanistically I mean, rich if you look at the Cascade.

Rich: Do business development deals.

James: Inflammatory Cascade Rage sits.

Rich: Some of those May may maybe partially used to pay off facility, but but but.

James: Upstream of <unk>, but there is in terms of the.

Rich: A good chunk of it and we may not be we may be using that for operational purposes.

Speaker Change: Disease indications at least for asthma could go after.

Speaker Change: Very similar.

Rich: So think of it think.

Rich: Think of it that way.

Speaker Change: And regarding the facility.

Rich: As one of many ways that we that.

Speaker Change: Sure It gives us flexibility, but really it's a piece of this bridge that we're talking about we need to to bring in.

Rich: We are.

Rich: We're one of many tools that we expect to use to build that bridge.

Speaker Change: Got it thanks a lot.

James: Enough capital to.

James: To allow us to continue to build over the next few years, while we are waiting to hopefully address the FH DG market with <unk> and I think we'll be well.

Speaker Change: You're welcome.

Speaker Change: Thank you one moment for him his questions.

Speaker Change: Our next question comes from.

Bill: Bill will bring with it substantial revenue and this is just one of those pieces, it's not the only piece we still expect.

Speaker Change: <unk> from B Riley.

Speaker Change: B Riley financial please go ahead.

James: Do development deals.

Speaker Change: Hey, guys Madison on for Matt. Thank you for taking our question. So a couple of quick ones from me.

James: Some of those May may maybe partially used to payout facility, but but but.

James: A good chunk of it may not be we may be using it for operational purposes.

Speaker Change: Is there anything you are closely monitoring within the neuro muscle landscape that may influence your development plans offer Aerobium wonder does explore.

James: So think of this think.

James: Think of it that way.

James: As one of many ways that we do.

Especially kind of on the regulatory front.

James: One of many tools that we expect to use to build that bridge.

And then secondly regarding the diners.

James: Got it thanks a lot.

Speaker Change: You're welcome.

Speaker Change: Thank you Martin before I may ask questions.

Speaker Change: Is there.

Speaker Change: I guess timeline to when something like that could be in the clinic.

Matt <unk>: Our next question comes from Matt <unk> from B Riley.

Speaker Change: Is there a indication.

Speaker Change: Or target, where you think this is better suited than others. Thank you.

Speaker Change: B Riley financial please go ahead.

Matt: Hey, guys Madison on for.

Matt: Thank you for taking our question. So a couple quick ones from me.

Speaker Change: James do you want do you want to address the mass.

James: Muscular question.

Yes, sure I mean.

Matt: Is there anything you are closely monitoring within the neural muscle landscape that may influence your development plans offer Aerobium wonder Doug explore.

James: I don't know if theres any specific one item.

James: From a regulatory standpoint or neuromuscular developments.

Speaker Change: Following suffice it to say that we follow.

Speaker Change: Kind of on the regulatory front.

Speaker Change: All of the other programs that are out there very closely and.

Matt: And then secondly regarding <unk>.

Matt: <unk>.

Speaker Change: You know.

Speaker Change: Use.

Speaker Change: Is there.

Speaker Change: The data that come out in the literature and from our competitors to get our own programs.

Speaker Change: I guess timelines and with something like that could be in the clinic.

Speaker Change: Yes look our position there from my perspective is a real pleasure to be totally honest.

Matt: Is there indication.

Matt: Or target, where you think this is better suited than others. Thank you.

Speaker Change: <unk> HBV and <unk> and so many others. We are the first ones to Blaze the trail and so and so.

Matt: James do you want do you want to address the.

Speaker Change: There are certain advantages to being first but there are certain vulnerabilities as well and so we get to learn from from.

James: Muscular question.

James: Yes, sure I mean.

James: I don't know if theres any specific one item.

James: From a regulatory standpoint, or neuromuscular developments that were following suffice it to say that we follow.

Speaker Change: From competitors interactions with regulatory agencies et cetera, and so our look our job is to be is to be best in class.

James: All of the other programs that are out there very closely.

Speaker Change: Presumably we will have a roadmap.

Speaker Change: <unk> out for us and our job is just to have better drugs and we were hopeful that we can have those.

James: Use.

Speaker Change: Regarding the dimers, we haven't we haven't given any real guidance on dimers other than during the Carter metabolic day, we talked about are what I, what I expect will be our first time or in the clinic.

James: The data that come out in the literature and from our competitors to get our own programs.

Speaker Change: Yes look our position there from my perspective is a real pleasure to be totally honest between.

Speaker Change: The PCF canine Apoc III dimer, and we're excited about that that will not be in the clinic. This year, but I would I would expect that to be in the clinic next year, we've not talked about about where else we are going with with dimers in the near term as you can imagine the lower hanging fruit with dimers of courses is delivery to a pad sites.

Speaker Change: <unk> HBV and <unk> and so many others. We are the first ones to Blaze, a trail and so and so.

James: There are certain advantages to being first but there are certain vulnerabilities as well.

James: So we get to learn from from.

James: From competitors interactions with regulatory agencies et cetera, and so our look our job is to be is to be best in class.

Speaker Change: And so so I would expect those to be first and then and then as as our technologies mature we can start to think about that type of strategy for other.

James: Presumably we will have a roadmap that sort of laid out for us and our job is just to have better drugs. We are hopeful that we can have those.

Speaker Change: Other tissue types.

Speaker Change: Yeah.

Speaker Change: Regarding the dimers, we haven't we haven't given any real guidance on <unk> other than during the Carty metabolic day, we talked about are what I, what I expect will be our first time or in the clinic.

Speaker Change #100: Got it. Thank you if I could squeeze into the on your adipose tissue targeting.

Speaker Change #100: Is there a.

Speaker Change #101: Timeline on that can you remind this one well.

Speaker Change: The PCF canine Apoc III dimer, and we're excited about that that will not be in the clinic. This year, but I would I would expect that to be in the clinic next year, we've not talked about about where else. We are going with diamonds in the near term as you can imagine the lower hanging fruit with dimers of courses is delivery to a pad sites.

Speaker Change #102: Well, so so tune into our our webinar on August <unk>.

Speaker Change #103: 14th 2014.

Speaker Change #103: You will hear our first adipose.

Speaker Change #104: Target that we're going after and we expect that to be we expect to file a cta for that this year, we have not given guidance on what those are yet, but youll hear at least at least that one.

Speaker Change: And so so I would expect those to be first and then and then as our technology.

Speaker Change #105: Next week I guess.

Speaker Change: These mature we can start to think about that type of strategy for other.

Speaker Change #105: Got it congrats on the progress guys.

Speaker Change: Other tissue types.

Speaker Change #105: Thank you.

Speaker Change #105: Thank you one moment for our next question.

Speaker Change: Got it. Thank you if I could squeeze on Tuesday.

Speaker Change: Adipose tissue targeting.

Speaker Change #106: Our next question comes from Manny <unk> from Leerink Leerink partners. Please go ahead.

Speaker Change: They're a.

Speaker Change: Timeline on that can you remind us quite a while.

Speaker Change #107: Hi, good afternoon, everyone dji on for money.

Speaker Change: Well, so so tune into our our webinar on August.

Speaker Change #108: My question is on the credit facility with fixed rate.

Speaker Change: 14th 2014.

Speaker Change: Youll hear our first adipose.

Speaker Change #109: I understand there is no scheduled amortization payment, but could you give a little detail.

Speaker Change: Target that we're going after and we expect that to be we expect to file a cta for that this year, we have not given guidance on <unk>.

Speaker Change #109: Detail on what proportion.

Speaker Change #109: Future upfront payments milestones and royalties from partnerships or clouds me have.

Speaker Change: What those are yet, but youll hear at least at least that one.

Speaker Change: Next week I guess.

Speaker Change #111: To go towards repaying the loan any color there would be appreciated.

Speaker Change: Got it.

Speaker Change: Grasp on what progress got it.

Speaker Change: Thank you.

Speaker Change #112: Sure I can take that so so it depends on which particular asset it is.

Speaker Change: Thank you one moment for our next question.

Speaker Change #113: This is a very custom structure that we went through and so we kind of bucket it different assets.

Speaker Change: Our next question comes from Manny <unk>.

Manny: From Leerink Leerink partners. Please go ahead.

Speaker Change #114: And each of those has different payback economics, so the philosophy.

Manny: Hi, good afternoon, everyone the dji on for money.

Manny: My question is on the credit facility with fixed rate.

Speaker Change #114: Philosophy here is that we wanted the flexibility to spread out repayment of this over time and.

Speaker Change: Understand there is no scheduled.

Speaker Change: Nation payment, but could you give a little detail.

Speaker Change #115: And we also didn't want to have too much of a cash outlay obligation unless we were going to have a significant cash inflow with the corresponding with what youre talking about with potential upfront payments from new deals or milestone payments or royalties from existing deals.

Speaker Change: Detail on what proportion.

Speaker Change: Future upfront payments milestones and royalties from partnerships or cloud.

Speaker Change: Have to go towards repaying the loan any color there would be appreciated.

Speaker Change #115: So there is there is various various different levels for different assets.

Speaker Change: Oh sure Yeah, I can take that so so it depends on which particular asset. It is this is a very custom structure that we went through and so you kind of bucket it different assets.

Speaker Change #115: Okay.

Speaker Change #115: And some are zero.

Speaker Change #116: There will be some transactions, where where we arent required to pay to pay any portion of that 60, that's right and we've pre negotiated carve outs for a handful of things that we think are likely over the coming years.

Speaker Change: In each of those has different payback economics so the.

Speaker Change: Our philosophy here is that we wanted the flexibility to spread out repayment of this over time.

Speaker Change: We also didn't want to have too much of a cash outlay obligation unless we were going to have a significant cash inflow with.

Speaker Change #116: Got it would you go to disclose where there'd be tend to be more like.

Speaker Change #116: Currently there are frontload are backloaded in terms like the proportion of the.

Speaker Change: Corresponding with what Youre talking about with potential upfront payments from new deals or milestone payments or royalties from existing deals.

Speaker Change #116: Future collections that would have to go to.

Speaker Change #116: Repaying the loan.

Speaker Change: So there is there is various various different levels for different assets.

Speaker Change #117: No we're not we're not giving more guidance on that at this point, where that we will file a redacted version of the of the.

Speaker Change: Okay.

Speaker Change: And some are zero.

Speaker Change #117: The contract at some point, but at this point, we're just disclosing what was in the press release.

Speaker Change: There are.

Speaker Change: There will be some transactions, where where we arent required to pay to pay any portion of that 60, that's right and we've pre negotiated carve outs for a handful of things that we think are likely over the coming years.

Speaker Change #117: Okay. It sounds great. Thanks, so much for taking our questions.

Speaker Change #118: Okay. Thank you.

Speaker Change #117: Our next question.

Speaker Change #119: Our next question comes from Brendan Smith from TD Cowen. Please go ahead.

Speaker Change: Got it would you go to disclose whether it'd be tend to be more like.

Brendan Smith: Hi, guys. Thanks for taking the questions.

Brendan Smith: Just a quick one for me.

Speaker Change: Currently there are front loaded back loaded in terms of like the proportion of the.

Speaker Change #121: Given this latest financing can you give us a sense of.

Brendan Smith: How youre thinking about additional partnerships this year should we expect.

Speaker Change: Those future questions that would have to go to.

Speaker Change #122: You'll announce a commercialization partner sometime in 2020 floor or is that maybe a next year event at this point.

Speaker Change: Repaying the loan.

Speaker Change: No we're not we're not giving more guidance on that at this point that we will file a redacted version of the <unk>.

Speaker Change #122: And then just really quickly I wanted to ask if you're still planning to release phase one data with that Arrow's Cfd this year and kind of just how youre thinking about next steps and potential indications for that one thanks.

Speaker Change: The contract at some point, but at this point, we're just disclosing what was in the press release.

Speaker Change: Okay sounds good thanks, so much for taking my questions.

Speaker Change #122: Jamie do you want us to do you want to.

Speaker Change: Okay. Thank you.

Speaker Change: Our next question.

Jamie: Talk about that can be sure we should be in a position to.

Speaker Change: Our next question comes from Brendan Smith from <unk>. Please go ahead.

Jamie: Release of data from the Cfd program later this year.

Brendan Smith: Hi, guys. Thanks for taking the questions.

Speaker Change #124: And then the primary additional indications that we're looking at of course. The study starts in healthy volunteers, but we will also be looking at <unk> b in patients with Iga nephropathy in this study.

Brendan Smith: Just a quick one for me kind.

Brendan Smith: Kind of given this latest financing can you give us a sense of.

Speaker Change: How youre thinking about additional partnerships this year should we expect.

Speaker Change: Youll announced a commercialization partner sometime in 2024 or is that maybe a next year event at this point.

Speaker Change #125: Sorry, it wasn't worth the first question timing on on partnerships.

Speaker Change: And then just really quickly I wanted to ask if you're still planning to release phase one data with that Arrow's Cfd this year and kind of just how youre thinking about next steps and potential indications for that one.

Speaker Change #126: That's easy.

Speaker Change #127: I can't predict timing on partnerships.

Speaker Change #127: We are as one can imagine we have a lot going on and so we are we are actively.

Brendan Smith: James do you want to do you want to.

James: Talk about that could be sure.

Speaker Change #127: Speaking with with companies all the time, who knows who knows how fast those go who knows.

James: We should be in a position to.

James: Release of data from the Cfd program later this year.

Speaker Change #127:

Speaker Change #127: That's our time. So look these are priorities for us, but I can't give you a timing.

Speaker Change: And then the primary additional indications that we're looking at of course. The study starts in healthy volunteers, but we will also be looking at Aero Cfd in patients with Iga nephropathy in this study.

Speaker Change #127: Thank you one.

Speaker Change #128: One more if I may ask a question.

Speaker Change #128: Our next question comes from William Pickering from Bernstein. Please go ahead.

Speaker Change: Sorry, it wasn't worth the first question timing on on partnerships.

Speaker Change: Okay.

Speaker Change #129: Hi, good afternoon, and thank you so much for taking my question I noticed there was about a $50 million sequential increase in R&D. This quarter could you just give a bit more color on what's what's been there and how would you expect the R&D line for the next few quarters to compare to that.

Speaker Change: I can't predict timing on partnerships.

Speaker Change: We are as one can imagine we have a lot going on and so we are we are actively.

Speaker Change: Speaking with with companies all the time, who knows who knows how fast those go who knows.

Speaker Change #129: That number this quarter. Thank you.

Speaker Change:

So the increase in R&D.

Speaker Change #131: <unk> been increasing all year as we move these assets further into later stages and you will expect those to continue to increase into next year, we are going through our budgeting process right now.

Speaker Change: Thank you <unk>.

Speaker Change: If I may ask a question.

Speaker Change #132: And we will provide additional guidance at our next earnings call to give you more information on that.

Speaker Change: Our next question comes from William Pickering from Bernstein. Please go ahead.

Speaker Change #131: Thank you.

William Pickering: Hi, good afternoon. Thank you so much for taking my question.

Speaker Change #133: Thank you I am showing no further questions at this time I will turn it back over to Chris Anzalone for closing remarks.

William Pickering: I noticed there was about a $50 million sequential increase in R&D. This quarter could you just give a bit more color on what's what's been there and how would you expect the R&D line for the next few quarters to compare to that.

Thanks, everyone for joining us today and I hope you have an enjoyable rest of your summer.

Speaker Change #134: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Speaker Change: That number this quarter. Thank you.

Speaker Change: So the increase in R&D spend.

Speaker Change: Increasing all year as we move these assets further into later stages and you will expect those to continue to increase into next year, we are going through our budgeting process right now and we will provide additional guidance at our next earnings call to give you more information on that.

Speaker Change: Thank you.

Speaker Change: Thank you I am showing no further questions at this time I will turn it back over to Chris Anzalone for closing remarks.

Chris Anzalone: Thanks, everyone for joining us today and I hope you have an enjoyable rest of your summer.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Speaker Change: Goodbye.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Thank you.

Speaker Change: [music].

Speaker Change: Sure.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: No.

Speaker Change: Dan.

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