Q2 2024 Geron Corp Earnings Call

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Operator: Hello, and welcome to the Geron Corporation's second quarter 2024 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session, and if you would like to ask a question during this time, please press star 1 on your telephone keypad. I would now like to turn the conference over to Aaron Feingold, Vice President of Investor Relations and Corporate Communication. You may begin.

Operator: Hello, and welcome to the Geron Corporation's second quarter 2024 earnings call. All lines have been placed on mute to prevent any background noise.

Speaker Change: Hello and welcome to the Geron Corporation's second quarter 2024 earnings call. All lines have been placed on mute to prevent any background noise.

Speaker Change: After the speaker's remarks, there will be a question and answer session, and if you would like to ask a question during this time, please press star 1 on your telephone keypad. I would now like to turn the conference over to Aron Feingold, Vice President of Investor Relations and Corporate Communication. You may begin.

Aaron Feingold: Good morning, everyone. Welcome to the Geron Corporation second quarter 2024 earnings conference call. I am Aaron Feingold, Geron's Vice President of Investor Relations and Corporate Communication. I'm joined today by several members of Geron's management team, including Dr. John Scarlett, Chairman and Chief Executive Officer. Dr. Andrew Grethlein, Executive Vice President and Chief Operating Officer; Dr. Faye Feller, Executive Vice President and Chief Medical Officer; and Michelle Robertson, Executive Vice President and Chief Financial Officer.

Aaron Feingold: Good morning, everyone. Welcome to the Geron Corporation second quarter 2024 earnings conference call. I am Aaron Feingold, Geron's Vice President of Investor Relations and Corporate Communication. I'm joined today by several members of Geron's management team, including Dr. John Scarlett, Chairman and Chief Executive Officer. Before we begin, please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those relating to the launch, commercial opportunity, and therapeutic potential of Ritello, anticipated clinical and commercial events, and related timelines, the sufficiency of Geron's financial resources, and other statements that are not historical fact. However, actual events or results could differ

Speaker Change: Good morning, everyone. Welcome to the Geron Corporation's second quarter 2024 earnings conference call. I am Aron Feingold, Geron's Vice President of Investor Relations and Corporate Communications.

Speaker Change: I'm joined today by several members of Geron's management team, Dr. John Scarlett, Chairman and Chief Executive Officer.

Speaker Change: Dr. Andrew Brechtlein, Executive Vice President and Chief Operating Officer.

Speaker Change: Dr. Faye Feller, Executive Vice President and Chief Medical Officer and Michelle Robertson, Executive Vice President and Chief Financial Officer.

Aaron Feingold: On today's call, Chip will start off with introductory remarks on commercial execution and value creation, Andy will provide a commercial and operations update, Faye will speak to medical and clinical updates, Michelle will provide a financial review, and Chip will close with some final remarks. Before we begin, please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those relating to the launch, commercial opportunity, and therapeutic potential of Rite Hello, anticipated clinical and commercial events, and related timelines, the sufficiency of Geron's financial resources, and other statements.

Speaker Change: On today's call, Chip will start off with introductory remarks on commercial execution and value creation, Andy will provide a commercial and operations update, Faye will speak to medical and clinical updates, Michelle will provide a financial review, and Chip will close with some final remarks.

Aaron Feingold: These are statements that are not historical fact. actual events or results could differ materially. Therefore, I refer you to the discussion under the heading risk factors and Geron's most recent periodic report filed with the SEC, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements. Geron undertakes no duty or obligation to update our forward-looking statements.

Speaker Change: Before we begin, please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those relating to the launch, commercial opportunity,

Speaker Change: and Therapeutic Potential of Ritello, anticipated clinical and commercial events and related timelines, the sufficiency of Geron's financial resources, and other statements that are not historical fact. Actual events or results could differ materially.

Speaker Change: Therefore, I refer you to the discussion under the heading Risk Factors and Geron's most recent periodic report filed with the SEC, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statement.

Aaron Feingold: Geron undertakes no duty or obligation to update our forward-looking statement.

Speaker Change: Geron undertakes no duty or obligation to update our forward-looking statement.

Aaron Feingold: With that, I'll turn the call over to Chet. Chet? Thanks, Erin.

John Scarlett: Thanks, Aaron. Good morning, everyone. Thanks for joining us. It was just eight weeks ago that FDA approved Ritello, our branded name for Mattelstat, as the first and only telomerase. And it was just six weeks ago that Ritella became commercially available in the U.S. With our strong commercial infrastructure in place at launch and the efficient mobilization of our field teams, we've seen encouraging early launch results. As of July 31, 60% of the top SI-1-4 accounts have been reached to our team across both community and academic. This has led to gratifying uptake.

Speaker Change: With that, I'll turn the call over to Chet. Chet?

John Scarlett: We estimate, again, as of July 31, that approximately 160 patients have received Ritello, which is quite encouraging given the very early stage of this launch. The enthusiastic reception for Ritello that we've seen within the hematology community reinforces the unmet needs for lower-risk MDS patients with symptomatic transfusion-dependent anemia. Many of our customers are passionate about getting access to Ritello for their patients, and we've seen a strong push across the U.S. to add Ritello to formularies, treatment pathways, and EMRs, including in the community setting.

Chet: Thanks, Aaron. Good morning, everyone. Thanks for joining us.

Chet: It was just eight weeks ago that FDA approved Ritello, our branded name for Mattelstat, as the first and only telomerase treatment.

John Scarlett: In addition, the MDS MCCN guidelines were updated this July 25th to include Ritello as a Category 1 and 2a treatment for lower-risk MDS patients. That is, Rytelo is now designated for use in both RS-positive and RS-negative first-line ESA and eligible patients, as well as in both RS-positive and RS-negative second-line patients regardless of prior first-line treatment. We believe that these favorable MCCN guidelines have put Ritello in a strong competitive position.

Speaker Change: And it was just six weeks ago that Rytela became commercially available in the U.S.

Speaker Change: With our strong commercial infrastructure in place at launch and the efficient mobilization of our field teams, we've seen encouraging early launch results.

Speaker Change: As of July 31...

Chet: 60% of the top decile 1-4 accounts have been reached by our team across both community and academic settings.

Speaker Change: This has led to gratifying uptake. We estimate, again, as of July 31, that approximately 160 patients have received Ritello, which is quite encouraging given the very early stage of this launch.

Speaker Change: The enthusiastic reception for Ritello that we've seen within the hematology community reinforces the unmet needs for lower-risk MDS patients with symptomatic transfusion-dependent anemia.

Taylor: That is right Taylor with no designated for use in both Rs positive and Rs negative first line Esa in eligible patients.

Taylor: As well as in both Rs positive and Rs negative second line patients regardless of prior to first line treatment.

Taylor: We believe that these favorable CCN guidelines have put rate tullow in a strong competitive position.

John Scarlett: During their portions of this call today, Andy and Faye will walk through how clinical, formulary, and treatment pathway decision-making is guided by the NCCN Guidelines. With the introduction of Ritello as a new therapeutic option, we're seeing increasing dialogue among hematologists rethinking treatment approaches for eligible low-risk MDS patients with transfusion-dependent anemia. Consequently, we believe that Ritello can become part of the standard of care for both eligible first and second line patients. As shown on this slide, from the approximately 13,200 U.S. patients with lower-risk MDS who need treatment for symptomatic anemia, approximately 1 in 10 are ESA ineligible due to serum EPO levels higher than 500 milliunits per mL. These first-line patients have limited treatment options.

Speaker Change: During their portions of this call today, Andy and Terry will walk through how clinical formulary and treatment pathway decision, making is guided by the NCC and guidelines.

Taylor: With the introduction of <unk> as a new therapeutic option, we're seeing increasing dialogue among hematologists rethinking treatment approaches for eligible low risk mds patients with transfusion dependent anemia.

Speaker Change: Consequently, we believe the right Hello can become part of standard of care for both eligible first and second line patients.

Taylor: As shown on this slide from the approximately 13200 U S patients with lower risk Mds, who need treatment for symptomatic anemia.

Taylor: Approximately one in 10 or Esa ineligible due to serum epo levels higher than 500 million units ran out.

Taylor: These first line patients have limited treatment options.

John Scarlett: RS-positive patients make up approximately 25% of the lower-risk MPS patient population, many of whom continue to experience high transfusion burden despite available therapy, and as negative patients make up approximately 75% of lower-risk MDS patient populations, many of whom are particularly vulnerable to poor clinical outcomes and have few other treatment options. In support of our commercial opportunity, we believe we have strong regulatory exclusivity and patent protection in the U.S. for Rytello for this disease.

Taylor: Rs positive patients make up approximately 25% of the lower risk Mds patient population, many of whom continue to experience high transfusion burden despite available therapies.

Taylor: Rs negative patients make up approximately 75% of lower risk Mds patient populations.

Taylor: Many of whom are particularly vulnerable to poor clinical outcomes and have few other treatment options.

Speaker Change: In support of our commercial opportunity. We believe we have strong regulatory exclusivity and patent protection in the U S for REIT Tayloe for this disease.

John Scarlett: Following the approval, we completed the listing of our patent in the FDA's orange book. We also received confirmation from the FDA of Imitelstat's orphan drug exclusivity for lower risk MDS into June of 2031. We've also filed our applications for Patent Term Extension, or PPE, including for our method of use pattern covering MBS and MF. If the PTE application is granted and applied to this patent, we estimate that the patent term would extend through August of 2036.

Speaker Change: Following approval, we completed the listing of our patents in the Fda's Orange book. We also received confirmation from the FDA of <unk> orphan drug exclusivity for lower risk Mds into June of 2031.

Speaker Change: We also filed our applications for patent term extension or Pte <unk>.

John Scarlett: including for our method of use patent covering MDFs and MDFs. Based on the clinical profile of Rytila, the approved U.S. prescribing information, and now a great set of MCCM guidelines, we believe we are well positioned to build long-term commercial success. We're working to finalize our strategy for EU commercialization as we continue to explore our options in the interest of maximizing our ability to serve all of our stakeholders. Patience. I'm also happy to report today that we have had an exceptionally strong response to our Chief Commercial Officer search and that we've made great progress in identifying several candidates with strong leadership skills and a history of outstanding commercial execution.

Taylor: Including for our method of use patent covering Mds anemia.

Taylor: If the <unk> application is granted and applied to this pattern, we estimate that the patent term would extend through August of 2037.

John Scarlett: We believe this IP protection, as well as several key factors I'll discuss on the next slide, position us well to create long-term commercial value with Ray Teller. Based on the clinical profile of Rytila, the approved U.S. prescribing information, and now a great set of MCCM guidelines, we believe we are well positioned to build long-term commercial value, more specifically FERPS. There is a high unmet treatment need for patients with lower risk MDS, as many patients progress and do not respond to current treatments, achieve a durable response, or experience extended and continuous red blood cell transfusion dependency. Treatment options for red blood cell transfusion dependent patients who are relapsed or refractory to or ineligible for EFA can have significant limitations, underscoring the need for novel treatment options such as REDCOV.

Taylor: We believe this IP protection as well as several key factors I'll discuss on the next slide position us well to create long term commercial value with great talent.

Speaker Change: Based on the clinical profile of Brookfield will be approved U S. Prescribing information and now great set of N. CCN guidelines. We believe we are well positioned to build long term commercial doubting us regularly.

Taylor: More specifically first.

Taylor: There is a high unmet treatment needs for patients with lower risk Mds as many patients progressed and do not respond to current treatments achieve a durable response or experience extended and continuous red blood cell transfusion independence.

Taylor: Treatment options for Red blood cell transfusion dependent patients, who are relapsed or refractory to or ineligible for Esa.

Speaker Change: Have significant limitations underscoring the need for novel treatment options, such as Red Cola.

John Scarlett: The second is demonstrated by the totality of clinical benefits in the Imerge Phase 3 clinical trial. Ritello can offer eligible low-risk MDS patients meaningful clinical benefits, including durable and sustained red blood cell transfusion independence and reduction in transfusion burden. In IMERGE, this treatment effect is consistent across key lower-risk MDS subgroups, including both RS-positive and RS-negative patients who are not eligible for ESAs, as well as both RS-positive and RS-negative patients who have relapsed or are refractory to ESAs. Breitella was also shown in Merge Phase III to have a well-characterized safety process, with generally manageable and short-lived thrombocytopenia and neutropenia, which are familiar adverse events for hematologists who are experienced with managing cytopenia.

Speaker Change: Second as demonstrated by the totality of clinical benefit.

Speaker Change: C III clinical trial.

Speaker Change: Hello can offer eligible low risk mds patients meaningful clinical benefits, including durable and sustained red blood cell transfusion independents and reduction in transfusion burden.

Speaker Change: And emerge this treatment effect was consistent across key lower risk Mds subgroups, including both Rs positive and Rs negative patients who are not eligible for USA as well as both Rs positive and Rs negative patients who are relapsed or refractory to your face.

Speaker Change: <unk> also shown an emerge phase III to have a well characterized safety profile.

Speaker Change: Generally manageable and short lived thrombocytopenia neutropenia, which are familiar adverse events for hematologist, who are experienced with managing cytopenia.

John Scarlett: Third, from an EU perspective, we also have a Marketing Authorization Application, or MAA, under review for transfusion-independent lower-risk MDF, which we expect could be completed in early 2025. We're working to finalize our strategy for EU commercialization as we continue to explore our options in the interest of maximizing our ability to serve all of our stakeholders. Please be patient.

Speaker Change: Third from an EU perspective, we also have a marketing authorization application or MAA under review in transfusion dependent lower risk Mds.

Speaker Change: Which we expect could be completed and.

Speaker Change: Early 2020.

Speaker Change: Yeah.

Speaker Change: We're working to finalize our strategy for EU commercialization as we continue to explore our options in the interest of maximizing our ability to serve all of our stakeholders.

Speaker Change: Patients.

Andrew Grethlein: Help Care Providers and Share; We're continuing to engage in discussions with the regulators, authorities, and payers as we assess those options, which include self-commercialization of parts. Then, fourth, from a clinical development perspective, our pivotal phase three impact MS OS clinical trial in Jack inhibited relapsionary fractory myelophybrus has now achieved approximately 70% in the world, and interim analysis is still expected in early This jackeye, relapsed refractory MF population represents a high unmet need population and significant commercial opportunity.

Speaker Change: With care providers and shareholders.

Speaker Change: We're continuing to engage in discussions with the regulators authorities and payers as we assess those options which include self commercialization partner.

Speaker Change: Then fourth from a clinical development perspective, our pivotal phase III impact MF OS clinical trial, and JAK inhibitor relapsed and refractory myelofibrosis patients has now achieved approximately 70% of enrollment.

Speaker Change: An interim analysis is still expected in early 'twenty six.

Speaker Change: This is Jack I relapsed refractory MF population represents a high unmet need population and significant commercial opportunity.

Andrew Grethlein: Lastly, our highly experienced team is driving performance across our organization, passionately serving patients and customers, and staying focused on quality and operations. I'm also happy to report today that we have had an exceptionally strong response to our Chief Commercial Officer search and that we've made great progress in identifying several candidates with strong leadership skills and a history of outstanding commercial execution. We expect to be able to make an announcement within the next month. With that, I'll turn the call over to Andy for a commercial and operations update.

Speaker Change: Lastly, our highly experienced team is driving performance across our business.

Speaker Change: Passionately, serving patients and customers and staying focused on quality and operational excellence.

Speaker Change: I'm also happy to report today that we have had an exceptionally strong response to our chief commercial officer of search and we've made great progress in identifying several candidates with strong leadership skills and a history of outstanding commercial execution.

Speaker Change: We expect to be able to make an announcement in the next month or so.

Speaker Change: With that I'll turn the call over to Andy for commercial and operations update.

Speaker Change: Andy.

Andrew Grethlein: Thanks, Chip, and good morning to everyone on the call. We've built a strong commercial infrastructure that has enabled us to effectively activate the launch. First, we are pleased with the early awareness of Ritello among prescribers and payers. Based on our market research before FDA approval in May of 2024 of over 100 U.S. hematologists and oncologists, over 80 percent of those surveyed were aware of imitel staph. One in three surveyed physicians indicated familiarity with the clinical data, and a majority of these physicians looked favorably on the efficacy profile and mechanism of action, which is especially important for a first-in-class treatment.

Andy: Thanks, Chip and good morning to everyone on the call.

Andy: We have built a strong commercial infrastructure that has enabled us to activate the launch effectively first we are pleased with the early awareness of <unk>, among prescribers and payers.

Speaker Change: Based on our market research before FDA approval in May of 2024 of over 100 U S Hematologists and oncologists over 80% of those surveyed were aware of <unk>.

Aaron Feingold: One in three surveyed physicians indicated familiarity with the clinical data, and a majority of these physicians looked favorably on the efficacy profile and mechanism of action, which is especially important for a first-in-class treatment. Generally, top national payers and Medicare cover oncology medicines categorized as one or two-way treatment by NCCN guidelines. Our J-Code application was submitted in July 2024, and we expect issuance of a permanent J-Code in the first quarter of 2025.

Speaker Change: One in three surveyed physicians indicated familiarity with the clinical data and a majority of these physicians look favorably on the efficacy profile and mechanism of action, which is especially important for a first in class treatment.

Andrew Grethlein: Payers are expressing high levels of interest and already have a strong understanding of the product. From an operational perspective, both dosage strengths of Ritello, the 188 mg vials and 47 mg vials, were available in our distribution channel for customers to order from specialty distributors as of June 27, 2024. Our Distribution Network is fully activated, with our specially distributor network actively supporting customer demand across hospitals and community oncology clinics. Across the contiguous 48 states, Ritello is available to HCPs within 24 to 48 hours from our specialty distribution network.

Speaker Change: Payers are expressing high levels of interest and already have a strong understanding of the right <unk> U S prescribing information and emerge phase III clinical data.

Speaker Change: From an operational perspective, both dosage strengths of <unk>. The 188 make vials and 47 make files were available in our distribution channel for customers to order from specialty distributors as of June 27th 2024.

Speaker Change: Our distribution network is fully activated with our specialty distributor network actively supporting customer demand across hospitals and community oncology clinics across the contiguous 48 states.

Speaker Change: <unk> was available to Hcp's within 24 to 48 hours from our specialty distribution networks.

Andrew Grethlein: We also believe that Rytel's inclusion in the updated NCCN guidelines has been important in spreading awareness among the prescriber community. The NCCN guidelines are a highly regarded resource in clinical decision-making for prescribers as well as provide critical considerations from a formulary and treatment pathway development perspective. Generally, the top national payers and Medicare cover oncology medicines categorized as one or two-way treatment by NCCN guidelines.

Speaker Change: We also believe that <unk> inclusion in the updated NCC and guidelines has been important and spreading awareness among the prescriber community.

Speaker Change: The NCC and guidelines are a highly regarded resource and clinical decision, making for prescribers as well as provide critical considerations from a formulary and treatment pathway development perspective.

Speaker Change: Generally the top national payers and Medicare cover oncology medicines categorized as one or two way treatment by NCC and guidelines.

Andrew Grethlein: Our patient access and affordability solutions are fully activated. Our patient hub is fully operational and supporting inquiries from HCPs and patients. Our J-Code application was submitted in July 2024, and we expect issuance of a permanent J-Code in the first quarter of 2025.

Speaker Change: Our patient access and affordability solutions are fully activated our patient hub is fully operational and supporting inquiries from Hcp's and patients. Our J code application was submitted in July 2024, and we expect issuance of a permanent J code in the first quarter of 2025.

Andrew Grethlein: We have seen a strong push by prescribers to add right-to-try to their formularies and EMRs that can help accelerate access in the mean- Last but not least, we engage with the major national pairs within 30 days of launch and look forward to continuing dialogue as they adopt their national coverage policies, which we expect to occur in the first quarter of 2025. This next slide is a snapshot of our medical and commercial field teams that have been fully deployed to cover the entire U.S. market, supporting HCP and account education and uptake.

Speaker Change: We have seen a strong push by prescribers to add right halo to their formularies and <unk> that can help accelerate access in the meantime.

Speaker Change: Lastly, we engaged with a major national payers within 30 days of launch and look forward to continued dialogue as they adopt our national coverage policies.

Speaker Change: We expect to occur in the first quarter of 2025.

Speaker Change: On this next slide is a snapshot of our medical and commercial field teams that have been fully deployed to cover the entire U S market supporting HCP and account education and uptake.

Aaron Feingold: This includes 50 key account managers, our oncology clinical educator liaisons, field reimbursement access directors, and national account teams, along with our field medical affairs team. We believe that the experience and relationships that our talented field teams bring to Geron have enabled them to quickly access these accounts. Overall, our teams have focused on delivering our launch to object.

Andrew Grethlein: This includes 50 key account managers, our oncology clinical educator liaisons, field reimbursement access directors, and national account teams, along with our field medical affairs team. We are pleased that since these commercial and medical field teams were deployed in June, there has been a strong level of in-person access to community and academic accounts and HCPs. We believe that the experience and relationships that our talented field teams bring to Geron have enabled them to quickly access these accounts.

Speaker Change: This includes 50 key account managers, our oncology clinical educators liaisons field reimbursement access directors and National account teams along with our field Medical affairs teams.

Speaker Change: We are pleased that since these commercial and medical field teams were deployed in June there has been a strong level of in person access to community and academic accounts and Hcp's, we believe that the experience and relationships that our talented field teams bring to geron have enabled them to quickly access these accounts.

Andrew Grethlein: We believe that the strong hotel of the value proposition, the commercial foundation, and the execution of our entire organization is driving encouraging early results over these first six weeks of law. As we commented earlier, we estimate that as of July 31st, 2024, approximately 160 patients will have received Rite-Ela. This demand was generated in part by reaching approximately 60% of top Decile 1-4 accounts and includes orders from roughly 115 unique accounts.

Speaker Change: We believe that the strong ROI tell a vital value proposition commercial foundation and the execution of our entire organization is driving encouraging early results over these first six weeks of launch.

Speaker Change: As we commented earlier, we estimate that as of July 31, 2020 for approximately 160 patients have received rights Hello.

Speaker Change: This demand was generated in part by reaching approximately 60% of top decile one through four accounts and includes orders from roughly 115 unique accounts, we are seeing an encouraging range of customers ordering right tullow. In these early days from small community to large aggregator accounts with hospitals ranging from.

Faye Feller: We are seeing an encouraging range of customers ordering Ritello in these early days, from small community to large aggregator accounts, with hospitals ranging from community, academic centers, teaching hospitals, and large health systems. In July, we kicked off our National Speakers Program with the launch of our National Broadcast Event featuring medical experts, which garnered over 300 medical professional participants. These events are a critical component of our marketing strategy to make sure HCPs are aware of the new treatment option for their eligible patients.

Speaker Change: Community academic centers teaching hospitals, and large health systems.

Speaker Change: In July we kicked off our national speakers program with the launch of our National broadcast event, featuring medical experts, which garnered over 300 medical professional participants these.

Speaker Change: These events are a critical component of our marketing strategy to make sure Hcp's are aware of the new treatment option for their eligible patients.

Faye Feller: Overall, our teams have focused on delivering our launch to Good Check, supporting a positive first experience for HCPs and patients, encouraging adoption among prescribers, and facilitating patient access. We believe our early performance reinforces that executing against these objectives can meaningfully drive awareness and uptake for appropriate patients. With that, I'll turn the call over to Faye for a medical and clinical update. Faye? Thanks, Andrew.

Speaker Change: Overall, our teams are focused on delivering our launch objectives supporting a positive first experience for hcp's in patients.

Speaker Change: <unk> adoption, among prescribers and facilitating patient access.

Speaker Change: We believe our early performance reinforces that executing against these objectives can meaningfully drive awareness and uptake for appropriate patients.

Speaker Change: With that I'll turn the call over to Fay for our medical and clinical update.

Faye Feller: Thanks, Andy, and thanks to everyone for joining our call today. As Chip mentioned, on July 25, the NCCN published updated MDS treatment guidelines, including Raytello for the treatment of symptomatic anemia in patients with lower-risk MDS. We believe that Rytello's placement in the updated NCCN guidelines reflects the strength of our Phase 3 data, which showed the clinical benefit of imitelstat regardless of reamed sideroblast status or serum epo levels, as well as favorable U.S. prescribing information, where Rytello is indicated broadly across RS-positive and RS-negative patients who are both ESA-ineligible and ESA-relapsed re

Fay: Thanks, Andy and thanks to everyone for joining our call today.

Fay: As Chuck mentioned on July 25.

Fay: CCM published updated Mds treatment guidelines, including <unk> for the treatment of symptomatic anemia in patients with lower risk Mds.

Speaker Change: We believe that retailers placement and the updated <unk> guidelines reflects the strength of our phase three data, which showed the clinical benefit of <unk> that regardless of brings that our blast Davis or CRM epo level as.

Speaker Change: As well as the favorable U S prescribing information wherever Hello, as indicated broadly across Rs positive and Rs negative patients who are both Esa ineligible and Esa relapsed refractory.

Faye Feller: The MDS-NCCN guidelines characterize lower-risk MDS patients without the Delphi Q abnormality and with symptomatic anemia on the basis of ring sideroblast status and serum EPO levels without specifying red blood cell transfusion burden. Overall, and as shown in the purple comment boxes on the far right of this slide, these updated MDS-NCCN treatment guidelines include Ritelo as a Category 2A treatment for both RS-positive and RS-negative first-line ESA-ineligible patients and as a Category 1 treatment for both RS-positive and RS-negative second-line patients, regardless of first-line therapy. We will dive into these guidelines in more detail.

Speaker Change: The Mds Mtc and guidelines characterize lower risk Mds patients without the Delta Q abnormality and with symptomatic anemia on the basis of ring Sideroblast status.

Speaker Change: Serum epo levels without specifying red blood cell transfusion burden.

John Scarlett: Overall, and as shown in the purple comment boxes on the far right of this slide, for RS-positive, ESA-eligible patients with serum equal levels of 500 million units per mL and below, root health data is included as a category one treatment, second line, after fist powder. Additionally, as shown in the two-plus line at the bottom of the schematic, Imitalstat is included as a Category 1 treatment for later lines of therapy after ESA or the spatter sub-treatment in these RS-positive ESA-eligible patients.

Speaker Change: Overall and as shown in the purple comment boxes on the far right of this slide.

Speaker Change: These updated Mds Mtc and treatment guidelines include like Hello at the category to a treatment for both Rs positive and Rs negative first line Esa ineligible patients.

Speaker Change: As a category one treatment for both Rs positive and Rs negative second line patients regardless of first line therapy.

Speaker Change: Diving into these guidelines in more detail.

Faye Feller: On the left side of the slide is a schematic representing the NCCM guidelines for the treatment of RS positive patients. For ESA-ineligible patients who have serum equal levels greater than 500 million units per mL, Imitalstat is included as a Category 2A first-line treatment, and for RS positive ESA eligible patients with serum-epal levels by hundreds of millions units per mL and below. The retail status included as a category one treatment, second line, factor, Additionally, as shown in the 2-plus line at the bottom of the schematic, Imitelstat is included as a Category 1 treatment for later lines of therapy after ESA or the spatter sub-treatment in these RS-positive ESA-eligible patients.

Speaker Change: On the left side of the slide is a schematic representing the <unk> guidelines for the treatment of Rs positive patients.

Speaker Change: For Esa ineligible patients to ask Jeremy equal levels greater than 500 million units per ml in Macau that is included at the category to a first line treatment for.

Jeremy: Rs positive Esa eligible patients with serum <unk> levels.

Jeremy: 500 million units per ml and below.

Speaker Change: That is included as a category one treatment second line.

Patterson: After this patterson.

Patterson: Additionally, as shown in the two plus line at the bottom of disconnect and the top that is included as a category one treatment for later lines of therapy after Esa or the status of treatment and the RF positive Esa eligible patients.

John Scarlett: On the right side of the slide is a schematic representing the MCCM guidelines for RS-negative patients. For ESA-ineligible patients who have serum EPO levels greater than 500 milliliters per ml, Emerge HealthCat is included as a Category 2A first-line treatment. Our Pivotal Phase 3 Impact MS Trial of Imitalsat in JAK Inhibitor Relastrofactory MS, the first and only Phase 3 trial in MS with overall survival as a primary endpoint, has reached approximately 70% enrollment as of August 2024.

Faye Feller: On the right side of the slide is a schematic representing the MCCM guidelines for RS negative patients, for ESA ineligible patients who have serum-epal levels greater than 500 million per annul. Nevertheless, how that is included as a category 2A for a flying treatment, for RS-negative ESA-eligible patients with serum EPO levels 500 milliunits per mL and below, and Metelsat is included as a Category 1 treatment, regardless of prior first-line therapy with either ESAs or Lispatercepts.

Patterson: On the right side of the slide is a schematic representing the mtc and guidelines for RF negative patients.

Patterson: For Esa ineligible patients, who have CRM epo levels greater than $500 million in parallel to Macau. If that is included as a category.

Patterson: First line treatments for.

Patterson: For RF negative Esa eligible patients with serum <unk> levels 500 million units right now and below in Macau that is included as a category one treatment regardless of prior fourth line therapy with either Esa or the status of that.

Faye Feller: Turning now to a clinical development update from our Myelofibrosis Program. Our Pivotal Phase 3 Impact MS Trial of Imetelsat in JAK Inhibitor Relapsed Refractory MS, the first and only Phase 3 trial in MS with overall survival as a primary endpoint, has reached approximately 70% enrollment as of August 2024. A per protocol interim analysis has been planned when approximately 35% of the planned enrolled patients have died, which we anticipate in early 2026.

Patterson: Turning now to our clinical development update from our myelofibrosis programs.

Patterson: Our pivotal phase III impact MF trial.

Patterson: Intelsat in JAK inhibitor relapsed refractory and that's the first and only phase III trial with overall survival as a primary endpoint has reached approximately 70% enrollment.

Patterson: The August 2024.

Patterson: Per protocol interim analysis has been planned when approximately 35% of the planned enrolled patients have died which we anticipate in early 2026.

Faye Feller: A final analysis is planned when approximately 50% of the planned enrolled patients have died, which is currently anticipated in early 2027. If the interim analysis is statistically significant, we would plan to file a supplemental new drug application with the FDA based on the interim analysis. As an overall survival study, the timeline for the interim and final analyses is dependent not only on the rate of enrollment but also on the event rate or patient death rate in the trial.

Patterson: Our final analysis is planned by approximately 50% of the planned enrolled patients have died which is currently anticipated in early 2027.

Patterson: If the interim analysis are statistically significant we would plan to file a supplemental new drug application with the FDA based on the interim analysis.

Patterson: As an overall survival study the timeline for the interim and final analyses is dependent not only on the rate of enrollment, but also on the event rate or patient death rate in the trial.

Faye Feller: Today, treatment of myelofibrosis is dominated by JAK inhibitors or therapies with other mechanisms of action in combination with JAK inhibitors. However, once patients become unresponsive to JAK inhibitors, which leads to treatment discontinuation for approximately 75% of patients after five years, they face a dismal overall survival of approximately 11 to 16 months.

Patterson: Today treatment in myelofibrosis is dominated by JAK inhibitors or therapies with other mechanisms of action in combination with JAK inhibitors.

Patterson: Once patients become unresponsive to JAK inhibitors, which leads to treatment discontinuation for approximately 75% of patients after five years.

Patterson: Dismal overall survival of approximately 11% to 16 months.

Faye Feller: We believe that if our trial is successful, and Imifelcad is approved in this indication, it could transform treatment for these myelofibrosis patients. Lastly, we are also evaluating Imtelstat in the IMPROVE-MF Phase 1 study, as a combination therapy with rexalidinib in patients with frontline myelofibrosis. Our main goal for this combination study is to determine the safety profile of the regimen of ruxolidinib and imitelsat, as well as to explore potential activity of imitelsat in a frontline MS disease setting.

John Scarlett: We believe that if our trial is successful and Imifelstat is approved in this syndication, it could transform treatment for these myelofibrosis patients. Our main goal for this combination study is to determine the safety profile of the regimen of ruxolidinib and imitelstat, as well as to explore the potential activity of imitelstat in a frontline MS disease setting. We hope to provide an update from Part 1 of the study at an upcoming medical meeting. Michelle

Speaker Change: We believe that if our trial is successful and Intelsat is approved in this indication it could transform treatment for these myelofibrosis patients.

Patterson: Lastly, we are also evaluating intelsat and the improve Nf phase one study as combination therapy with <unk> in patients with frontline myelofibrosis.

Speaker Change: Our main goal for this combination study to determine the safety profile of the regimen of <unk> limited and <unk> as well as to explore potential activity of the metallic that in a frontline MF disease setting.

Faye Feller: Part one of the study is designed to be dose-finding. In July 2024, after no dose-limiting toxicities were experienced by the first three patients in the dose level four cohort, or imetelsat sodium 9.4 mg per kg, the study evaluation team, or SET, unanimously recommended expanding the cohort per the trial protocol. This is the final step before selection and progression to part two of the study that is designed for expansion and dose confirmation. We hope to provide an update from Part 1 of the study at an upcoming medical meeting. With that, I'll turn the call over to Michelle for a financial update. [inaudible]

Patterson: Part one of the study is designed to be dose finding in July 2024, after no dose limiting toxicities.

Barry: Barry inside of the first three patients in the dose level four cohort or in the top that sodium <unk> for mix per kg.

Speaker Change: The study evaluation team or SAP.

Patterson: Mr. Li recommended expanding the cohort for the trial protocol.

Patterson: This is the final step before dose selection and progression to part two of the study that is designed for expansion and dose confirmation.

Patterson: We hope to provide an update on part one of the study at an upcoming medical meeting.

Patterson: With that I'll turn the call over to Michelle for financial update.

Patterson: Michelle.

Michelle Robertson: Thanks, Faye, and good morning, everyone. For detailed Q2 2024 financials, please refer to the press release we issued this morning, which is available on our website. Now, let me bring your attention to a few highlights from the quarter. As of June 30th, 2024, the company had approximately $430 million in cash, cash equivalents, and marketable securities. Total product revenue net for the three and six months ended June 30th, 2024, was approximately $780,000. Ritello became available for prescribers to order from specialty distributors as of June 27th, 2024.

Michelle Robertson: Thanks, Jay and good morning, everyone for detailed Q2 2024 financial please refer to the press release, we issued this morning, which is available on our website now let me bring your attention to a few highlights from the quarter.

Michelle Robertson: As of June 30th, 2024, the company had approximately $430 million in cash, cash equivalents, and marketable securities. Total product revenue net for the three and six months ended June 30th, 2024, was approximately $780,000. Ritello became available for prescribers to order from specialty distributors as of June 27th, 2024. Total revenues for the three and six months ending June 30th were $882,000 and $1.2 million, compared to $29,000 and $50,000 for the same period in 2023.

Speaker Change: As of June 32024, the company had approximately $430 million in cash cash equivalents and marketable securities.

Patterson: Product revenue net for the three and six months ended June 32024 was approximately $780000 Vitale became available for prescribers to order from specialty distributors as of June 27th 2024 total revenues for the three and six months ended June 30 were 882001.

Michelle Robertson: Total revenues for the three and six months ending June 30th were $882,000 and $1.2 million, compared to $29,000 and $50,000 for the same period in 2023. The increase in revenue is due to product revenue from U.S. sales of Ritello that commenced in June 2024. Total operating expenses for the three and six months ended June 30th were $70.2 million and $126.7 million, compared to $52 million and $92.1 million for the same period in 2023.

Patterson: $2 million compared to 29050 thousand for the same period in 2023.

Michelle Robertson: The increase in revenue is due to product revenue from U.S. sales of Ritello that commenced in June 2024, selling general and administrative expenses for the three and six months ending June 30, 2024, with $39.4 million and $66.5 million, respectively, and $16.5 million and $29.4 million for the same period in 2023. Our projected full-year 2024 operating expenses are expected to be between $270 and $280 million, which is unchanged from our prior guidance.

Patterson: The increase in revenue is due to product revenue from U S sales of REIT Tallo that commenced in June 2024.

Patterson: Total operating expenses for the three and six months ended June 30 were $70 2 million and $126 7 million compared to $52 million and $92 1 million for the same periods in 2023.

Michelle Robertson: Cost of goods sold was approximately $17,000 for the three and six months ended June 30th, which consisted of the cost to manufacture and distribute Rytelo. R&D expenses for the three months and six months ended June 30, 2024, with $30.8 million and $60.2 million, respectively, and $35.5 million and $62.7 million for the same period in 2023. Our clinical development costs for iMERGE Phase 3 have decreased as we move into the long-term follow-up, with selling general and administrative expenses for the three and six months ending June 30, 2024, with $39.4 million and $66.5 million, respectively, and $16.5 million and $29.4 million for the same period in 2023.

Patterson: Cost of goods sold was approximately 17000 for the three and six months ended June 30th which consisted of cost to manufacture and distribute <unk> Hello.

Patterson: R&D expenses for the three months and six months ended June 32024, with $38 million and $60 2 million, respectively, and $35 5 million and $62 7 million for the same periods in 2023 or.

Speaker Change: Our clinical development costs for <unk> phase III have decreased as we move into the long term follow up states.

Patterson: Selling general and administrative expenses for the three and six months ended June 30 of 2024 were $39 4 million and $66 5 million, respectively, and $16 5 million and $29 4 million for the same periods in 2023.

Michelle Robertson: The increase in selling general and administrative expenses primarily reflects higher commercial launch expenses, increases in headcount, and stock-based compensation recognized due to the vesting of performance-based stock options upon FDA approval of Wright-Teller. As of June 30, 2024, we had 220 full-time employees. We plan to grow to a total of approximately 230 to 260 employees by year-end 2024. Our projected full year 2020 full operating expenses are expected to be between $270 and $280 million, which is unchanged from our prior guidance.

Patterson: The increase in selling general and administrative expenses, primarily reflects higher commercial launch expenses increases in headcount and stock based compensation recognized due to the vesting of performance based stock options upon FDA approval of Rytary.

Patterson: As of June 32024, we had 220 full time employees, we plan to growth with total of approximately 230 to 260 employees by year end 2024.

Patterson: Our projected full year 2024 operating expenses are expected to be between 270 and $280 million, which is unchanged from our prior guidance.

Michelle Robertson: Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with our projected revenues from U.S. sales of Ritello, will be sufficient to fund our projected operating requirements into the second quarter of 2025. I will now turn the call back over to Jeff.

Patterson: Based on our current operating plans and assumptions, we believe that our existing cash cash equivalents and marketable securities together with our projected revenues from U S sales of <unk> will be sufficient to fund our projected operating requirements into the second quarter of 2026.

Patterson: I will now turn the call back over to chip.

Patterson: Yes.

Chip: Thanks Michelle.

John Scarlett: To close, we're encouraged by our early commercial launch performance and the feedback we're receiving from customers and payers. We're pleased with our strong execution today, but also recognize that we're still in the very early stages of our U.S. launch, with many more patients to serve and many more customers to engage. We have conviction that Ritello can become part of the standard of care for eligible patients in this high-in-need, lower-risk MBS treatment paradigm and bring differentiated benefits to patients.

Chip: To close we're encouraged by our early commercial launch performance and the feedback we're receiving from customers and payers.

Chip: We're pleased with our strong execution to date, but also recognize that we're still in the very early stages of our U S launch with many more patients to serve.

Patterson: And many more customers to engage.

John Scarlett: We have conviction that Ritello can become part of the standard of care for eligible patients in this high-in-need, lower-risk MBS treatment paradigm and bring differentiated benefits to patients, which, pending positive outcomes from the trials, we believe will contribute significantly to the commercial value proposition for Rytelo. Operator?

Patterson: We have conviction Reits Hello can become part of the standard of care for eligible patients in this high unmet need lower risk Mds treatment paradigm.

Patterson: Bring differentiated benefits to patients.

John Scarlett: And in addition to our launch in lower-risk MDS, we're also advancing our Imitelstat development program in myelofibrosis, which, pending positive outcomes from the trials, we believe will contribute significantly to the commercial value proposition for Ritello. Thank you, and we'll now open the line to questions. Operator?

Patterson: And in addition to our launch in lower risk Mds. We are also advancing our <unk> development program in myelofibrosis.

Patterson: Rich having positive outcomes from the trials that we believe will contribute significantly to the commercial value proposition for <unk> in the future.

Speaker Change: Thank you and we will now open the line to questions operator.

Operator: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. If you would like to withdraw your question, simply press star 1 again. Please ensure that your phone is not on mute when called upon. Thank you. Your first question comes from the line of Tara Bancroft with TD Cowan. Your line is open.

Speaker Change: Thank you if you would like to ask a question. Please press star one on your telephone keypad. If you would like to withdraw your question simply press Star One again please.

Speaker Change: Please ensure that your phone is not on mute when called upon thank you.

Speaker Change: Your first question comes from the line of Tara Bancroft with TD Cowen Your line is open.

Tara Bancroft: Hi, good morning, and thanks for taking the questions. So I guess to start, I would love to get a better sense of expectations for the year and what you're targeting. And for that, I know you're probably not providing revenue guidance, but I think it would be helpful to know whether a couple of things, like whether you think a J code could be finalized potentially before January and other metrics like how soon you think the field team will hit 100% of the target prescriber base. Thank you.

Tara Bancroft: Hi, good morning, and thanks for taking the questions.

Tara Bancroft: So I guess to start I would love to get a better sense of expectation for the year and what you're targeting and for that I know youre, probably not providing revenue guidance, but I think it would be helpful to know weather.

Speaker Change: A couple of things what you think a J code could be finalized potentially before January and other metrics like how soon do you think the the field team will hit 100% of the target prescriber base.

John Scarlett: Thanks a lot, Tara. I appreciate the questions, which you're quite correct about. We have limited ability to answer six weeks into the launch. I think we're really, really happy with where we've ended up in such a short period of time and think that that is, we hope that that's a harbinger of performance as we continue on. I think the J code, I think we're guiding to the first quarter because we're honestly not 100% sure when it will come.

Terry: Thanks, a lot Terry.

Terry: I appreciate the questions, which you are quite correct.

Speaker Change: We have limited [laughter].

Speaker Change: Ability to answer six weeks into into the launch I think where we're really really happy with where we've ended up in such a short period of time and think that that is.

Speaker Change: We hope that that's a harbinger of.

Speaker Change: Our performance as we continue on.

Patterson: I think.

Patterson: The J code I think we're guiding to the first quarter, because we are honestly not 100% sure when it will come.

Patterson: History suggests that there is some variability at the yen, but you know we gave that guidance and I think we'll stick by it for the moment as we get a little bit closer.

John Scarlett: History suggests that there is some variability at the end, but we gave that guidance, and I think we'll stick by it for the moment. As we get a little bit closer, we may or may not have more information, but at the moment, I think we would still stick to the earlier part of the year. I think with regard to metrics on the sales force, wow, the sales force is... completely engaged, as you can imagine.

Speaker Change: We may or may not have more information, but at the moment I think we would see.

Speaker Change: I'll stick to the early early earlier part of the year.

Speaker Change: I think with regard to metrics on the sales force.

Speaker Change: Salesforce.

John Scarlett: I don't actually have any predictions available to any of us on that, but I do know that they are, that's the best word for it, they are as enthusiastic and as hardworking a group of both, you know, CAMS, not only the key account managers but also the folks responsible for trade and channel and for all of the various activities involved in a sophisticated commercial launch. I think that's probably all we can say today, but thanks for the question. I look forward to seeing this all evolve over the remainder of the year.

Speaker Change: Completely engaged as you can imagine I don't actually have any predictions are available to any of us on that but I do know that.

Speaker Change: They are as <unk>.

Speaker Change: The best word for it they are as enthusiastic as hard working group of.

Speaker Change: Both.

Speaker Change: Not only the key account managers, but also the.

Speaker Change: Folks responsible for trading channel and four.

Aaron Feingold: for all of the various activities involved in a sophisticated commercial launch. I think that's probably all we can say today, but thanks for the question. I look forward to seeing this all evolve over the remainder of the year.

Speaker Change: For all of the various activities involved in a in a sophisticated commercial launch it's probably all we can say today, but thanks. Thanks for the question look forward to seeing this all evolves over the remainder of the year.

John Scarlett: Great. Thank you so much.

Speaker Change: Great. Thank you so much.

Carter Gould: Your next question comes from the line of Carter Gould with Barclays. Your line is open.

Speaker Change: Sure.

Speaker Change: Your next question comes from the line of Carter Gould with Barclays. Your line is open.

John Scarlett: Good morning. Congratulations to Chip and the team on the early days here. Appreciating that it's early, how would you guess the initial 160 patients characterize that sort of as a bolus or potentially something more sustainable? Again, I appreciate it's early, but with these sort of, you have a sense that these patients were sort of identified by clinicians ahead of the launch or sort of more spontaneous use. And then on the patent term extension side of things, my understanding, as I recall, I think the USPTO has, I think, statutorily, like 14 months to respond to your extension. Is that correct? Is that a fair characterization of the timeline we should expect to hear back on this front? Thank you. Okay, thank you.

Carter Gould: Good morning.

Speaker Change: Gratz to chip and team on the on the on the early days here.

Speaker Change: Appreciating that it's early.

Speaker Change: Or would you use I guess that that initial 160 patients would you characterize that as sort of as a bolus or potentially something more sustainable again I. Appreciate it's early but would you sort of give a sense of these patients were sort of identified by clinicians ahead of a launch or sort of more spontaneous use and then on the.

Speaker Change: On the patent term extension side of things my understanding.

Speaker Change: As I recall, I think sort of U S. PTO has I think statutorily as like 14 months to respond to your extension is that correct.

Speaker Change: Fair characterization of the of the timeline, we should expect to hear back on this front. Thank you.

John Scarlett: Okay, thanks Carter. So, with regard to initial uptake and demand and the question of Ebola, you know, you only know a bolus for sure when you see it in the rear view mirror, right? I mean, if the trend line continues, it's not a bolus. But if it slacks a bit at some point, I guess you would say it is a bolus. All I can say, Kurt, is we did not, in our own thinking, model the bolus.

Curt: Okay. Thanks Curt.

Speaker Change: With regard to the initial.

Speaker Change: Uptake in demand.

Speaker Change: And the question of a bolus.

Speaker Change: Alright.

Speaker Change: You only know a bolus for sure.

Speaker Change: You see it in the rearview mirror right.

Speaker Change: If the trend line continues its not a bolus if if if.

Speaker Change: It was flat so that at some point I guess, you would say invisible. It's all I can say occurred we didn't we did not in our own thinking model animal with I think we've been pretty consistent about that and how we've set it.

John Scarlett: I think we've been pretty consistent about that and how we've set it up. So, it's a little hard to know exactly where this will go from here. We do think this is all very indicative of a strong degree of organic demand that really reflects all of the great things that really happened, starting with CODAC, which seems like a million years ago, but it wasn't. And then we got, of course, an excellent, very clean label.

Speaker Change: So it's a little hard to know exactly when.

Speaker Change: Where this will will go from here.

Speaker Change: We do think this is all very indicative of a strong degree of organic demand that really reflects all of the great things that really happened, starting with Kodak, which seems like a million years ago, but it wasn't.

Speaker Change: And then we've got of course, an excellent very clean label, and then with the MCC and guidelines that really place as a forefront of potential standard of care in this space I think all we can say is we're just seeing.

John Scarlett: And then, with the MCCN guidelines that really placed this at the forefront of potential standards of care in this space, I think all we can say is we're just seeing a tremendous amount of interest on the part of HCPs, on the part of accounts. And whether this is going to reflect a bolus or not, we don't really know, but I don't think that's something that we've anticipated, given the Bill and By, the By and Bill nature of the mechanics around all of it.

Speaker Change: Tremendous amount of interest on the part of Hcp's on the part of accounts and win that.

Speaker Change: Whether that's.

Speaker Change: Whether this is going to reflect a bolus or not we don't really know, but I don't think that's something that we've anticipated given the.

Aaron Feingold: the buy and bill nature of the mechanics around all of it. With regard to the PTE, I wish it was 14 months. That would be great. I don't know if it's statutorily there or not, but I guess it is.

Speaker Change: And the billing by the buy and Bill nature.

Speaker Change: Of the of the mechanics around all of it.

Speaker Change: With regard to the pte.

Speaker Change: I wish it was 14 months that would be great.

Speaker Change: I don't know if its statutorily, there or not I guess it is but when we've spoken to our IP counsel.

Aaron Feingold: But when we've spoken to our IP councils and others, we're seeing anywhere from three to five years for the PTO to really get back with a definitive, yes, you can apply it to this patent, you can apply it to that patent, etc. So I would not be holding my breath on that. It's out of our hands. We've done everything we can to make these applications.

Speaker Change: And others.

Speaker Change: We're seeing anywhere from three to five years for the PTO to really get back with definitive yes, you can apply it to this patent you can apply it to that patent etcetera. So I would not be holding my breath on that it's out of our hands. We've done everything we can to make these applications, but the historic.

Aaron Feingold: But their historical performance has been pretty slow.

Speaker Change: <unk>.

Speaker Change: The historical performance has been good.

Speaker Change: The slow.

Speaker Change: Understood. Thank you.

Speaker Change: Sure your next.

Stephen Willey: Your next Sorry, your next question comes from the line of Stephen Willey of Stiefel. Your line is open.

Speaker Change: Sorry. Your next question comes from the line of Stephen Willey of Stifel. Your line is open.

Stephen Willey: Yeah, good morning. Thanks for taking the question and congrats on the progress. I appreciate some of the early metrics here, but... Just curious, of the 160 patients that have started therapy, can you comment as to how many of those patients are actually paying for the drug? Is there a yet-to-be-worked-out reimbursement process for some of these patients?

Stephen Willey: Yes. Good morning, Thanks for taking the question.

Stephen Willey: Congrats on the progress I appreciate some of the early metrics here, but.

Stephen Willey: Just curious of the of the 160 patients.

Stephen Willey: We have started the therapy can you comment as to how many of those patients are actually paying for drug is there yet to be worked out reimbursement process for some of these patients.

Stephen Willey: Okay.

John Scarlett: I think I'm going to let either Andy or Michelle take that. I have a few comments, but they may be in a better position to answer that question. Andy, do you have any thoughts about that? I think it's where...

Speaker Change: I think on the left.

Speaker Change: Probably either Andy or Michelle take that.

Speaker Change: I have a few comments that they may be in a better position to answer that question.

Stephen Willey: Andy do you do you have any thoughts about that.

Andrew Grethlein: I think it's too early to know, Chip, although what we do know is that we haven't had any issues with any of the submissions that have been made to date. You know, these patients have just gone through their first cycle.

Andy: I think it's way early chip to know, although what we do know is that we haven't had any issues with any of the submissions that have been made to date.

Speaker Change: These patients have just gone through their first cycle.

Andy: Right.

Michelle Robertson: Yeah, I mean, I guess I would add that, again, as Andy said, we haven't received any pushback. I mean, we have a hub set up, a reimbursement process. Even with the temporary J code, you know, customers are pushing this through formularies. And so reimbursement has not been an issue.

Aaron Feingold: Yeah, I mean, I guess I would add that, again, as Andy said, we haven't received any pushback. I mean, we have a hub set up, a reimbursement process. Even with the temporary J code, you know, customers are pushing this through formularies. And so reimbursement has not been an issue.

Andy: Yeah, I mean, I guess I would add that again as Andy said, we haven't received any pushback I mean, we have a hub set up the reimbursement process.

Speaker Change: With the temporary J code.

Speaker Change: Customers are pushing this through formularies and so it is reimbursement has not been an issue so far.

Andy: Okay, and Steve I guess, Steve I guess, yes, I guess, the only other comment I wouldn't have which may or may not be helpful. In this regard.

John Scarlett: Okay. And Steve, I guess the only other comment I would have, which may or may not be helpful in this regard: remember, everyone, this is predominantly a Medicare population. And while we don't have..., as fine, we don't have much insight into the exact breakdowns of where reimbursement is coming from. We know that the majority of it is PHS, and that's historically not had a lot of pushback as long as you have the NCCM guidelines where they are today for us in Category 1 and Category 2A. So again, early days, we may be able to give a little bit more insight into this, but I think the current situation, as we see it, bodes well for the future.

Speaker Change: Remember everyone. This is predominantly a Medicare population.

Speaker Change: While we don't have.

Aaron Feingold: As fine

Steve: As fine.

Speaker Change: <unk>.

Speaker Change: Insight into the exact breakdown of where reimbursement is coming from we know that the majority of it is phs.

Speaker Change: And that's historically.

Speaker Change: <unk> not had a lot of pushback as long as you have the in CCM guidelines, where they are today for us in category one category two way. So again early days, we may be able to give a little bit more insight into this but I think it bodes the current situations, we see it bodes well.

Speaker Change: For the future.

Aaron Feingold: Understandable. And again, I guess understanding that it's early, but do you have any early information on just whether or not you're seeing patients who are newly starting Ritalo being switched off of other salvaged therapy? And I guess in your conversation with physicians, is that a dynamic that you expect to play out as the launch?

John Scarlett: Understandable. And again, I guess understanding that it's early, but do you have any early information on just whether or not you're seeing patients who are newly starting Ritalo being switched off of other salvage therapy? And I guess in your conversation with physicians, is that a dynamic that you expect to play out as the launch?

Speaker Change: Understood.

Speaker Change: Again, I guess understanding that it's early but do you have any early information on just whether or not you're seeing patients who are newly starting right Tyler being switched off of others salvage therapy.

Speaker Change: And your company Sherwood position.

Speaker Change: Physicians is that is that a dynamic that you expect to play out as the launch proceeds.

Aaron Feingold: Yeah, I'll take that, and then I'll invite my colleagues to make any additional comments, if any. Look, I think we just naturally expect that some of these patients will be, as you said.

John Scarlett: Yeah, I'll take that, and then I'll invite my colleagues to make any additional comments, if any. Look, I think we just naturally expect that some of these patients will be, as you said, patients from the third line, if you will, or second or third line for sure. That would be natural in the availability of a new agent and so forth. But we don't really have a way to characterize that. The information that comes to us on individual patient data is very limited, extremely limited, if any at all. We're really seeing the demand from accounts flowing into the specialty distributors and occasionally to a specialty pharmacy.

Speaker Change: Yes, I'll take that and then I'll invite my colleagues to make any additional comments if any.

Speaker Change: Look I think we just naturally expect some of these patients will be as as you said patients.

Speaker Change: From the third line, if you will or second or third line for sure.

Speaker Change: That would be natural in the availability of a new agent.

Speaker Change: And so forth, but we don't really have a way to characterize our information that comes to us on an individual patient data is very limited extremely limited if any at all we're really seeing the demand from.

Speaker Change: Accounts flowing into the specialty distributors and occasionally to a specialty pharmacy.

John Scarlett: And that's what we're really able to infer and figure out the dynamics of. We don't, I'm not sure when and exactly how much fine tooth detail we're going to get on individual patients. I think that's going to take some more anecdotal information and, eventually, perhaps even some studies or whatever. I don't want to promise anything here. Of course, we're deeply interested in knowing the answers to all of that, but six weeks in, I can tell you right now, Steve, we're just not really 100% sure exactly the circumstances of these patients and exactly the buckets, as it were, that they're coming out of. We're just grateful that they're there. understood.

Speaker Change: And that's what we're that's what we're really able to infer in and figure out.

Speaker Change: The dynamics on it we don't I'm not sure when and exactly how much trying to detail we're going to get on individual patients I think that's going to take some more anecdotal.

Speaker Change: Information and then eventually perhaps even some studies or whatever I don't want to promise anything here.

Speaker Change: Of course, we are deeply interested in knowing the answers to all of that but.

Speaker Change: Six weeks and I can tell you right now, Steve where we're just not really 100% sure exactly the circumstances of these of these patients and exactly the buckets as it were that Theyre coming out we're just grateful that they are there.

Faye Feller: Understandable. And then maybe just one quick question for Faye. Can you just remind us what the DLT window in the improvement of a trial is? And for a patient who progresses on frontline rock, are next-gen JAK inhibitors allowed in best-available therapies?

Speaker Change: Understood.

Speaker Change: Maybe just one quick question for the can you just remind us what the DLT window and the improving enough trial is.

Aaron Feingold: and for a patient who progresses on frontline rock.

Speaker Change: And for patient who progressed on frontline rocks are the Nextgen JAK inhibitors allowed and best available therapy.

Speaker Change: Yeah.

Faye Feller: So the first question, hi. Hi, so the first question is about Improved MS, correct?

Speaker Change: So the first question.

Speaker Change: Hi, So the first question is about improve then that's correct.

Aaron Feingold: DLT window. I'm not, the deal, the cycle length is 28 days. The DLT window is one cycle length.

Faye Feller: BLC Window. The cycle length is 28 days. The DLT window is one cycle length. And the next question was about NYF 3001 or, and...

Speaker Change: <unk> window I not that deal cycle length is that 28 days.

Speaker Change: The DLT window, it wouldn't take a length.

Speaker Change: And the next question like that and we have 3001 or.

Speaker Change: And is weather nextgen.

Faye Feller: Whether the next-gen JAK inhibitors are allowable therapy or the best available therapy control arm? No, there are no JAK inhibitors allowed on the BAP arm.

Jackson: Whether the next Gen Jackson.

Speaker Change: Allowable.

Speaker Change: Available thermal control now and there are no JAK inhibitor is allowed on the APR.

Speaker Change: Yeah.

Aaron Feingold: Thank you very much for taking the questions.

Faye Feller: Thank you very much for taking the questions.

Speaker Change: Thank you very much for taking the questions.

Steve: Thanks, Steve.

Corinne Jenkins: Your next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is open.

Speaker Change: Your next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is open.

John Scarlett: Good morning guys. Maybe if you could just help us think directly about the trajectory of new patient growth from here, probably through the early launch period, do you anticipate that the kind of new patients coming on therapy will come at a relatively steady rate? That it could be more lumpy or that it would accelerate over time, and maybe precedent would be helpful if you think about the answer there. And then, in terms of just target engagement.

Corinne Johnson: Hey, good morning, guys maybe.

Corinne Johnson: Maybe if you could just help us think directionally about the trajectory of new patient growth from here probably through like the early launch period do you anticipate that kind of the new patients coming on therapy will come at a relatively steady club.

Speaker Change: It could be a more lumpy or that it would accelerate over time. It may be precedent would be helpful. As you think about the answer there.

Speaker Change: And then in terms of just target engagement you mentioned, obviously the top 60 for kind of your top or 60% of the top decile accounts I guess I guess, how many patients on average are like from a range are these accounts trading in and of that like what portion would be eligible for right of things.

Aaron Feingold: um, target engagement you mentioned obviously the top 60 percent of your top or 60 percent of the top decile accounts. I guess I guess how many patients on average or from a range are these accounts treating and, of that, like, what portion would be eligible for Ritellos thanks

John Scarlett: You mentioned obviously the top 60% of your top or 60% of the top decile accounts. I guess I can guess how many patients on average or from a range are these accounts treating and, of that, like, what portion would be eligible for Rytelo? Thanks.

John Scarlett: I'll take the first one, which is directionality and, as you said, smoothness versus lumpiness. I mean, I'm going to say the obvious, Corinne, so forgive me.

Aaron Feingold: I'll take the first one, which is directionality and, as you said, smoothness versus lumpiness. I mean, I'm going to say the obvious, Corinne, so forgive me. These accounts are a very wide variety of accounts, so some accounts are large hospital systems, some accounts are individual practitioners, and everything in between that you can imagine. The top deciles tend to be, you know, larger aggregator accounts with many, many physicians. So I don't have an exact number of physicians, but I'm not sure how helpful it would be because there is such a wide variety.

Speaker Change: I'll take that.

Speaker Change: The first one which is the which is the directionality.

Speaker Change: As you said the smoothness versus the Lumpiness.

Speaker Change: I mean, I'm going to say the obvious cringed so forgive.

Speaker Change: Forgive me.

John Scarlett: This is only the second new product launch in the last, what, 12 years in low-risk NDS, or maybe there's been a few others, but they've been very modest launches. And so we don't have a lot to go on with this, and six weeks isn't very much. I will say that, Maybe something that might be helpful is that, so far, in all the six weeks, we haven't seen a particularly lumpy, you know, you know, accretion of patients.

Speaker Change: This is only the second new.

Speaker Change: New product launch and less.

Speaker Change: What.

Speaker Change: 12 years.

Speaker Change: MBS or maybe maybe maybe there's been a few others that they've been very modest launches.

Speaker Change: And so we all we really don't have a lot to go on on this and six weeks isn't very much I will say that.

Speaker Change: Maybe something that might be helpful is that we haven't seen a particularly so far in all of six weeks, we haven't seen a particularly lumpy.

Speaker Change: No.

Speaker Change: Uh huh.

Speaker Change: Accretion of patients it's been pretty steady.

John Scarlett: It's been pretty steady, but it's hard to do a trend line based on that. Maybe next time we talk, we'll have a better feel for that. But I don't see any particular reason, other than just natural variation as things go on, that we would expect anything different than what we've seen to date. But I don't really.

Speaker Change: But it's hard to do a trend line based on that.

Speaker Change: Maybe the next time, we talk we will have a better feel for that.

Speaker Change: I don't see any.

Speaker Change: Particular reason.

Speaker Change: Other than just natural variation as things go on that we would expect any anything different than what we've seen to date, but don't really know.

John Scarlett: In terms of target engagement, just a couple of comments about this. These accounts are a very wide variety of accounts, so some accounts are large hospital systems, some accounts are individual practitioners, and everything in between that you can imagine. The top deciles tend to be, you know, larger aggregator accounts with many, many physicians, so I don't have an exact number of physicians, but I'm not sure how helpful it would be because it is such a wide variety.

Speaker Change: In terms of target engagement, just a couple of comments about this.

Speaker Change: Yes.

Speaker Change: These accounts are very wide variety of accounts. So some accounts are our large hospital systems. Some accounts are individual practitioners everything in between that you can imagine.

Speaker Change: The top decile tend to be larger aggregator accounts.

Speaker Change: Yeah.

Speaker Change: Many many physicians so I don't have an exact number of physicians, but im not sure how helpful. It would be because it is such a wide variety.

John Scarlett: What we do know is that we've had really good traction getting in; we've had excellent traction speaking to these accounts in person. And the number of accounts touched and reached, and including the vast majority in person, is growing every day. So, Andy, again, I don't know if you have any insight into this, but I didn't ask for any help we can give Corinne here. Nope, I think that's a chip

Aaron Feingold: What we do know is that we've had really good traction getting in. We've had excellent traction speaking to these accounts in person. And the number of accounts touched and reached, and including the vast majority in person, is growing every day. So, Andy, again, I don't know if you have any insight into this, but I didn't ask for any help we can give Corinne here. No, I think that's a chip.

Speaker Change: What we do know is that we've had really good traction getting and we've had excellent traction speaking to these accounts in person.

Speaker Change: And.

Speaker Change: The number of accounts touched and reached and.

Speaker Change: Including the vast majority in person is.

Speaker Change: Is growing everyday so Andy again, I don't know if you have any insight into this.

Andy: I invite any help you can give Chris no I think that's it.

Andrew Grethlein: Yeah, I mean, account activation is accelerating, we believe that, so we're pretty pleased so far. And the top deciles were obviously modeled based on flow of prior treatments for that launch, but I don't know that, you know, it's more proportionality. I don't think we can give patient numbers per account right now.

Aaron Feingold: Yeah, I mean, account activation is accelerating. We believe that. So we're pretty, pretty pleased so far. And the top deciles were obviously modeled based on flow of prior treatments for that launch. But I don't know that, you know, it's more proportionality. I don't think we can give patient numbers per account right now.

Chip: Chip yes.

Andy: I mean, it's kind of activation is accelerating we believe that so we're pretty pretty pleased so far in the top decile. We obviously modeled based on flow of prior treatments for that launch, but I don't know that its more.

Speaker Change: Proportionality I don't think we can give patient numbers per account right now.

Speaker Change: Okay. Thank you.

Speaker Change: Mhm.

Speaker Change: Sure.

Operator: Your next question comes from the line of Gil Blum with Needham and Company. Your line is open.

Gil Blum: Your next question comes from the line of Gil Blum with Needham and Company. Your line is open.

Speaker Change: Your next question comes from the line of Gil Blum with Needham <unk> Company. Your line is open.

John Scarlett: Hey, good morning, everyone, and thanks for including our question. So I know this is very early, but is there any information you can provide about the split of these patients? That were those, you know, RS positive, RS negative, front line, second line, whichever information you have. Thank you.

Gil Blum: Hey, good morning, everyone and thanks for calling in our questions. So.

Gil Blum: So I know this is very early but is there any information you can provide about the split of these patients.

Aaron Feingold: That were those, you know, RS positive, RS negative, front line, second line, whichever information you have. Thank you.

Speaker Change: With overdose Rs.

Speaker Change: <unk> positive <unk> negative frontline second line.

Rob: Would you ever information you Rob Thank you yes.

John Scarlett: Yeah, thanks Gil, thanks for the question. We don't have it. It's not the kind of information that would come in at this moment in time. We get, this is pretty much demand information that we're able to give you. This is, you know, the number of bottles going out the door.

Gil Blum: Gil Thanks for the question, we don't have.

Gil Blum: [noise].

Speaker Change: Yes.

Speaker Change: It's not the kind of information.

Speaker Change: That would come in at this moment in time, we get this is pretty much demand information that we're able to to give you. This is this as you know.

John Scarlett: And what we eventually do, I think we will try very hard to get that. We're as interested as anybody in the nuances of, again, which buckets these patients are coming out in. But as of today, no, we don't have that, and it will take some tweaking of our information sources and how we get that over the next several, I would think, many quarters, perhaps, to actually get a really accurate view of that. But as of today, we just don't.

Speaker Change: The number of vials going out the door and.

Speaker Change: What we eventually I think we will try very hard to get that we're as interested as anybody and the nuances.

Speaker Change: Again, which buckets these patients who are coming in but as of today no. We don't have that.

Speaker Change: And it will take some tweaking of our information sources and how we get that.

Speaker Change: Over the next several I would think many quarters perhaps.

Speaker Change: To actually get a really accurate view on that but.

Speaker Change: But as of today, we just don't know.

John Scarlett: Thanks Jeff, that's very helpful. Sure. And another question, and a kind of related one.

Speaker Change: Thanks, Jeff that's very helpful sure and.

Speaker Change: Another question and then kind of a related one.

John Scarlett: How long do you think it will take until you start getting feedback from treating physicians as it relates to any challenges they're having with giving the drug or any other kind of bottleneck? Thank you.

Speaker Change: How long do you think it would take so you start getting feedback from from treating physicians as it relates to any challenges theyre, having yet, giving the drug or.

Speaker Change: Any other kind of bottleneck.

Aaron Feingold: Yeah, thanks. Well, I think that boils down to the people that we have deployed in the field. Again, I didn't invite Andy to comment on that, because if you remember that slide that he showed, we've got a really varied group of people out in the field, and I feel quite good about that. But Andy, you might want to just run through sort of how we get feedback.

Andrew Grethlein: Yeah, thanks. Well, I think that boils down to the people that we have deployed in the field. Again, I didn't invite Andy to comment on that, because if you remember that slide that he showed, we've got a really varied group of people out in the field, and I feel quite good about that. But Andy, you might want to just run through sort of how we get feedback.

Speaker Change: Yeah, Thanks, well I think that.

Speaker Change: Boils down to the.

Andy: The people that we have deployed in the field again I didn't bite Andy to comment about that because if you remember that slide that he showed we've got a really varied group of people out in the field and I I feel quite good about that banana you might want to just run through sort of how we share that feedback.

Andrew Grethlein: Yeah, I mean, we have several channels, obviously, but I think our Med Affairs team that's in the field and our Medical Affairs Hub, which is fully active, is probably the main source of the flow of, certainly, information requests. I think it's way too early to start getting specific feedback, again, given that we're only six weeks in.

Aaron Feingold: Yeah, I mean, we have several channels, obviously, but I think our Med Affairs team that's in the field and our Medical Affairs Hub, which is fully active, is probably the main source of the flow of, certainly, information requests. I think it's way too early to start getting specific feedback, again, given that we're only six weeks in.

Andy: Yeah, I mean, we have several channels, obviously, but I think our med affairs team that's in the field and our medical affairs hub, which is fully active as.

Speaker Change: Right now probably the main source of flow of certainly information requests.

Speaker Change: It's way early to start getting specific feedback.

Speaker Change: Again, given that we're only six weeks in.

Andrew Grethlein: Most of these patients are just through a single cycle of treatment, but we have seen a high and I think we're a high volume of MedInfo requests across a range of different areas, you know, from efficacy and safety to dosing and, you know, reactions to the prescribing information. So I think that bodes well that physicians are interested in and becoming more and more educated about treating with Ritello. All right.

Speaker Change: Most of these patients are.

Speaker Change: Through a single cycle of treatment.

Speaker Change: But we have seen a strong and I think we are.

Andy: Strong volume of met and for our requests.

Andy: Across a range of different areas.

Andy: From efficacy and safety the dosing and.

Andy: Reactions to the prescribing information so that I think that bodes well that physicians are interested in.

Andy: And becoming more and more educated about treating with <unk>.

Gil Blum: Alright, thanks for taking our questions and congrats on the launch.

Andy: Alright.

Speaker Change: Thanks for taking my questions and congrats on the launch.

Speaker Change: Thank you.

Kalpit Patel: Your next question comes from the line of Kalpit Patel with B. Reilly Securities. Your line is open.

<unk> Patel: Your next question comes from the line of <unk> Patel with B Riley Securities. Your line is open.

Kalpit Patel: Yeah, hey, good morning. And thanks for taking the question. For the launch, I guess, do you have an early estimate or early sense of what the gross net adjustments would be for third quarter? And how do you anticipate that to shift over time, maybe into the fourth quarter? I appreciate the question. I think Michelle is probably the best person to answer that question.

Aaron Feingold: Yeah. Hey, good morning, and thanks for taking the question. For the launch, I guess, do you have an early estimate or early sense of what the gross net adjustments would be for the third quarter and how you anticipate that to shift over time, maybe into the fourth quarter?

Patel: Yeah, Hey, good morning, and thanks for taking my question.

Patel: Sure.

Patel: The launch I guess do you have an early estimate or.

Speaker Change: Early sense of what the gross to net adjustments would be for third quarter, and how you anticipate that to shift.

Patel: Over time, maybe into fourth quarter.

Speaker Change: Five.

Michelle Robertson: I appreciate the question. I think Michelle is probably the best person to answer that question. Yeah.

Andy: I appreciate the question I think Michelle is probably the best person to.

Michelle Robertson: To answer that question.

Michelle Robertson: Yeah, thanks, Kalpit. I mean, we obviously only had one week for the June close in our growth to net calculation. So, I mean, it's a pretty straightforward growth to net breakdown of components because it is a primary Medicare population. So, you know, we know the PHS is going to be one of our largest deductions in the growth to net, but I would say it's too early for us to really be comfortable. And we need more data as the July sales close out and as well as the rest of the quarter. But we'll have a pretty good sense after a full quarter's worth of data.

Michelle Robertson: Yeah, thanks, Kalpit. I mean, we obviously only had one week for the June close in our growth-to-net calculation, so, I mean, it's a pretty straightforward growth-to-net breakdown of components, I mean, because it is a primary Medicare population. So, you know, we know the PHS is going to be one of our largest deductions in the growth-to-net, but I would say it's too early for us to really be comfortable, and we need more data as the July sales close out and as well as the rest of the quarter, but we'll have a pretty good sense after a full quarter's worth of data. Okay. Okay. And, you know, as a follow-up, how are you viewing the current Southside consensus estimates for Lytello in the second half of this year under your current...

Michelle Robertson: Yeah. Thanks health it I mean, we obviously Oh, we have one week for.

Michelle Robertson:

Michelle Robertson: June close.

Speaker Change: Gross to net calculation. So I mean, it's a it's a pretty straight forward gross to net breakdown of components for me because it is a primary Medicare population.

Michelle Robertson: Okay. Okay.

Michelle Robertson: So we know the phs is going to be one of our largest.

Andy: Deductions and the gross to net but I would say, it's too early for us to really be comfortable.

Andy: And we need more data as the July sales closeout.

Andy: As well as the rest of the quarter, but we'll have a we'll have a pretty good sense after a full quarter worth of sales.

Michelle Robertson: And, you know, as a follow-up, how are you viewing the current Southside consensus estimates for Lytello in the second half of this year under your current launch project? I mean, I would say that from a consensus perspective, as I mentioned before, I think that we need to sort of sit down, you know, with you guys and go through some of the assumptions because they're definitely mixed among the different models and sort of mixed versus our internal models.

Andy: Okay. Okay.

Speaker Change: You know as a follow up how are you viewing the.

Speaker Change: Current sell side consensus estimates for like Hello.

Andy: Second half of this year.

Speaker Change: Under your current launch progressing.

Michelle Robertson: I mean, I would say that from a consensus perspective, as I mentioned before, I think that we need to sort of sit down, you know, with you guys and go through some of the assumptions because they're definitely mixed among the different models and sort of mixed versus our internal models. And I think it's a lot on the annual cost per patient. There's a lot of variance between the models there, so what I think is probably contributing to that would be duration of therapy. And, you know, penetration is pretty varied, so I think that we'll look to give guidance on that post the post.

Andy: Michelle I mean, I'm just wondering from a book.

Speaker Change: I would say from a consensus perspective, as I mentioned before I think that.

Speaker Change: We need to sort of sit down with you guys and go through some of the assumptions because.

Speaker Change: They are definitely next.

Andy: The difference.

Speaker Change: Models and sort of mixed process, our internal model.

Michelle Robertson: And I think it's a lot on the annual cost per patient. There's a lot of variance between the models there. So, which I think is probably contributing to that would be duration of therapy. And, you know, penetration is pretty varied. So, I think that we'll look to give guidance on that post this earnings call.

Speaker Change: And I think it's a lot on the annual cost per patient, there's a lot of variance between the between the model there.

Speaker Change: So, which I think is probably contributing to that would be duration of therapy.

Speaker Change: And.

Speaker Change: Penetration is pretty varied so I think that we'll look to give guidance on that post the posted.

Speaker Change: Earnings call.

Speaker Change: Okay.

Kalpit Patel: Okay, and then one last one.

Speaker Change: Okay.

Speaker Change: And then one last one on the NCC guidelines.

Kalpit Patel: on the NCCN guidelines. I guess, were there any surprises based on where Imitalostat is positioned in all the different subgroups of the treatment algorithm? And do your internal estimates of the percentage of lower MDS patients that could be treated with Rite-Halo change based on this position? Yeah, I'll take that one. And then, if Faye listens in and has anything else to contribute, I'd encourage her to do it. Great question, Kalpit.

Speaker Change: I guess were there any surprises based on where <unk> is positioned in all the.

Speaker Change: Arent subgroups of.

Speaker Change: Hi.

Speaker Change: Treatment algorithm and do your internal estimates.

Speaker Change: The percentage of low risk Mds patients that could be triggered with right Hello change based on this positioning.

Speaker Change: Yes, I'll take that one and then if say listen salmon has anything else to contribute in <unk>.

Speaker Change: Furniture to do it.

John Scarlett: So first of all, I think if you go back to all the way back to top line results, you know, what close, a year and a half, or two years ago, we identified at that point in time a couple of really big pockets of value here. The first one was, of course, that we thought that we were effective regardless of our staff. And so we both the arts college and the arts negative.

Speaker Change: Question comfort.

Speaker Change: So first of all I think if you go back to all the way back to top line results you know what close to.

John Scarlett: Second of all, we did have enough patients, although not a ton of loose setter septic patients that were previously treated. And as we used to say, that was a highlight of the previous year's ash because we saw some really good results there. So we thought that previously treating setter septic patients who were not doing as well as physicians would like would be important. We thought that the high transfusion burden patients would be very attractive.

Speaker Change: Year, and a half ago two years ago.

Speaker Change: We identified at that point in time, a couple of really big pockets of value here.

Speaker Change: The first one was of course.

Speaker Change: We thought that we were.

Speaker Change: Effective regardless of our status until both your thoughts on the RFS negative.

Speaker Change: Second of all we did have enough patients, although not a ton of loose that are separate patients previously treated.

Speaker Change: And as.

Speaker Change: As we used to say that was that was a highlight of the previous year's ash that we saw some really good results. There. So we thought that.

Speaker Change: Previously treated and the status of patients who were not doing as well as physicians would like would be important.

Speaker Change: We thought that the high transfusion burden patients would be.

Speaker Change: Very attractive.

John Scarlett: And then we also identified that the patients who had serum EPO levels greater than 500, that is, officially, the ESA ineligible patients had done pretty well. And so we, we, we actually saw from our phase three results the makings of where we ended up today. What I can say is the label, which of course did have some transfusion burden requirements on it, as you would expect based on the clinical trial, that didn't actually translate over to the NCCN guidelines, which is interesting, and frequently is not the case as NCCN looks at treatment algorithms, if you will. And then all the other pockets really are completely there.

Speaker Change: And.

Speaker Change: Then we also identified that it looks like the patients who had.

Speaker Change: Serum <unk> levels greater than 500 that is officially the Esa ineligible patients had done pretty well and so we we actually saw from our phase III results.

Aaron Feingold: Pretty much the makings of where we ended up today. What I can say is the label, which of course did have some transfusion burden requirements on it, as you would expect based on the clinical trial, that didn't actually translate over to the NCCN guidelines, which is interesting, and frequently is not the case as NCCN looks at treatment algorithms, if you will.

Speaker Change: Pretty much the makings of where we ended up today, what I can say is the label.

Speaker Change: Which of course did have some transfusion burden requirements on as you would expect based on the clinical trial that didn't actually translate over to the NCC and guidelines, which is interesting frequently is not the case.

Speaker Change: It's in CCM looks.

Speaker Change: It looks at treatment algorithms, if you will and then all the other pockets really are completely there so.

Aaron Feingold: And then all the other pockets really are completely there. So I have to say, the pleasant surprise was that there were no unpleasant surprises. I think we just got a wonderful NCCN guideline affirmation of what we've always seen as the value in these various different areas. So I don't think that, I think it's pretty much what we were hoping for and what we had always imagined.

John Scarlett: So I have to say, I don't think we were surprised that there were no unpleasant surprises. I think we just got a wonderful NCCN guideline affirmation of what we've always seen as value in these various different areas. So I don't think that it's pretty much what we were hoping for and what we had always imagined. So, Faye, I don't know if you have any other comments about it, but it's a great question, though.

Aaron Feingold: Okay, thanks very much for taking the question.

Speaker Change: Have to say I don't think we we.

Speaker Change: The Pleasant surprise was that there were no unpleasant surprises I think we just got a wonderful.

Speaker Change: A wonderful mtc and guideline affirmation of what we've always seen as the value in these areas.

Speaker Change: Current.

Speaker Change: Areas. So I don't think that I think it's pretty much what we were hoping for and what we had always imagined so.

Speaker Change: I don't know if you have any other comments about it.

Speaker Change: Great question no not yet.

John Scarlett: Well, yeah, Tiff, I think you put it well. I think the only surprise was a pleasant one. We received everything that we were asking for, and they're from Category 1 and 2A, guidelines, and a strong reflection of the data of the clinical trial. So, all in all, a good result. Okay, thanks very much for taking the question.

Speaker Change: Chip I think you put it well I think the only.

Speaker Change: Surprised was upon them on we received everything that we were asking for and their strong category one in Q <unk>.

Speaker Change: Guidelines.

Speaker Change: And a follow up question on the data of the clinical trial. So all in all a good result.

Speaker Change: Okay. Thanks, very much for taking my question.

Speaker Change: Thanks Kelvin.

Faye Feller: This concludes the question and answer session. I'll turn the call over to Aaron for closing remarks.

Speaker Change: This concludes the question and answer session I'll turn the call to Aaron for closing <unk> closing remarks.

Aaron Feingold: Thank you so much for joining us today. We appreciate your interest in Geron and look forward to keeping you updated during this very exciting time for our company. Goodbye.

Speaker Change: Thank you so much for joining us today, we appreciate your interest and Darren and look forward to keeping you updated during this very exciting time for our company Goodbye.

Operator: This concludes today's conference call. We thank you for joining us. You may now disconnect your lines.

Operator: This concludes today's conference call. We thank you for joining us. You may now disconnect your lines.

Speaker Change: This concludes today's conference call. We thank you for joining you may now disconnect your lines.

Speaker Change: Yeah.

Speaker Change:

Speaker Change: Yeah.

Speaker Change:

Speaker Change:

John Scarlett: With regard to the PTE, I wish it was 14 months; that would be great. I don't know if it's statutorily there or not, I guess it is, but when we've spoken to our IP council and others, we're seeing anywhere from three to five years for the PTO to really get back with the incentives: yes, you can apply it to this patent, you can apply it to that patent, et cetera So I would not be holding my breath on that; it's out of our hands. We've done everything we can to make these applications, but the historical performance has been pretty slow.