Karyopharm Therapeutics Inc.

Good morning. My name is Anas, and I'll be your conference operator today. At this time, I would like to welcome everyone to CarioFarm's Therapeutics Second Quarter 2026 Financial Results Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the conference over to Brendan Strong, Senior Vice President, Investor Relations.

Good morning, and thank you all for joining us on today's conference call to discuss CarioFarm's Second Quarter 2026 Financial Results, and recent company progress. We issued a press release this morning detailing our financial results for the second quarter of 2026. This release, along with the slide presentation that we will reference during our call today, are available on our website. For today's call, as shown on slide two, I'm joined by Richard, Reshma, Sohania and Lori, who will review our second quarter financial results, provide an update on the significant progress we've made advancing our myelofibrosis program Discuss the clinical and regulatory momentum supporting our planned S&DA submission, and review our financial position and capital allocation priorities. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as outlined on slide 3. Actual results may differ materially from those indicated by these forward-looking statements, Thank you for joining us. You should not rely on these forward-looking statements as representing our views as of any later date. I'll now turn the call over to Richard. Please turn to slide five.

Thank you, Brendan, and good morning, everyone, and thank you for joining us today. The second quarter marked the beginning of an important new chapter for TherioPharm. As we advanced Selinexor from a compelling and differentiating Phase III data set toward our planned supplemental new drug application, Under the FDA's accelerated approval pathway for patients with myelofibrosis. Over the past several months, we've remained focused, moved with urgency, and executed against an ambitious plan. From generating and presenting the sensory data, to publishing the results in the Journal of Clinical Oncology, to working collaboratively with the FDA to establish a regulatory pathway as we prepare our planned submissions. The century study demonstrated statistically significant, rapid, deep, and sustained spleen responses, together with preliminary overall survival findings and evidence of potential disease modification. These findings have now been presented at leading international scientific meetings, published in a peer-reviewed journal, and continue to generate strong interest globally among the hematology community. Taken together, We believe these data reinforce the potential for Cell and XOR to fundamentally change the treatment of patients with myelofibrosis. That same focus, urgency, and commitment to execution continues to guide every step as we advance into the next phase of our myelofibrosis program. Turning to slide six, as we announced in July, Thank you for joining us. Selinexor in combination with Ruxolitinib would be the first approved combination therapy for patients with myelofibrosis, introducing a novel therapeutic mechanism for the treatment of this disease. Turning to slide 7, while our focus today is on the important progress we've made in myelofibrosis, I'd also like to briefly address the top-line results from our Phase 3 Export ECO42 study and the actions we've taken following those results. While we were disappointed that the study did not achieve statistical significance for its primary endpoint in the MITG population, I want to thank the patients, investigators, and study teams whose commitment made this important trial possible. Although we observed a numerical improvement in medium progression-free survival favoring Selenexor, the study did not meet the statistical threshold required to support our development plans in endometrial cancer. Following these results, we made the deliberate decision to sharpen our focus on hematology with our opportunities in myofibrosis and multi-myeloma, where we believe Selinexor has the greatest potential to improve patients' lives and create long-term shareholder value. While we continue to follow patients in the near term, we are meaningfully reducing planned investment in endometrial cancer.

Moving forward, our priorities are clear.

Advancing our myelofibrosis program through the regulatory process, continuing to grow our multi-myeloma business, and leveraging the commercial, medical, and market access capabilities we have built over many years to support a rapid and efficient launch in myelofibrosis, if approved. As we execute against these priorities, we are equally focused on disciplined capital allocations. As we'll discuss, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of maximizing long-term shareholder value while preserving strategic flexibility as we advance our myelofibrosis program through these important milestones. We are approaching this with the same focus, urgency, and discipline that have characterized our execution over the past several months. Looking ahead, we believe the company is entering one of the most important periods in its history. Turning to slide 8, over the coming quarters, we expect several important milestones, beginning with the potential inclusion in the treatment guidelines in Compendia, our planned SNDA submission in myelohibrosis this month, followed by potential FDA filing acceptance of the SNDA, and its potential to be accepted for priority review and ultimately a potential approval and launch as early as the first quarter of 2027. Additionally, we remain on track to report top line data from the 60 milligram cohort of the Phase II, Century II study in the second half of this year, which we expect will further establish the role of Selenexor in myelofibrosis. We are entering this next phase with a clear strategy Reshma Rangwala

Thank you, Richard. As Richard discussed, we believe Selinexor has the potential to fundamentally change the treatment of patients with myelofibrosis. I'd like to spend the next few minutes discussing why we believe the scientific evidence supporting that opportunity has continued to strengthen, why it supports our planned SMDA submission, and how we continue to build the clinical foundation for Selinexor in myelofibrosis. Turning to slide 10, the biological rationale for combining XPO1 and JAK inhibition is compelling. JAKSAT activation is a key driver of malignant clone proliferation, plenomegaly, and disease-related symptoms, while XPO1 activity is important for malignant cell survival. By targeting these complementary pathways simultaneously, we believe Selenexor has the potential to complement JAK inhibition, and improve outcomes beyond symptom control alone. Turning to slide 11, myelofibrosis remains a disease with a high unmet need given clinical activity with the currently approved therapies is modest. As a result, spleen volume reduction of at least 35% is observed in less than a third of patients. Overall survival improvements are limited and meaningful modification of the underlying disease is not observed. Turning to slide 12, a distinctive profile has been observed from the Sentry Trial given the compelling SPR35 results that are rapid, deep, and sustained, a promising OS signal, a first-of-a-kind prediction between SPR35 and OS, and a safe and manageable adverse event profile. These data appear to support SPR35 as a reasonably likely surrogate endpoint. enabling an FMDA under the accelerated approval pathway. Turning to slide 13, at week 24, a nearly double screen response rate was observed with the combination of selenexor plus ruxolitinib versus ruxolitinib alone. What is particularly important is the quality and kinetics of that response. As shown on slide 14, the responses were rapid, emerging as early as week 12, and Deep with greater average spleen volume reductions relative to baseline observed with the combination. Both response rates and depth of response were sustained through week 36. Importantly, as seen on slide 15, the benefit was consistent across pre-specified patient subgroups, reinforcing the robustness of the treatment effect in the vast majority of frontline myelofibrosis patients. Especially important is the subgroup analysis by ruxolitinib dosing as seen on slide 16. Even with average suboptimal doses of ruxolitinib less than 15 milligrams per day, SCR35 rates with the combination were as high as 50% compared to zero observed with ruxolitinib alone, indicating that with the combination, SCR35 is driven by selenexor and supported by modest doses of ruxolitinib. From a clinical practice standpoint, these data suggest that ruxolitinib dose reductions may not compromise efficacy when combined with Selinexor. As shown on slide 17, at the time of the top-line analysis, the overall survival hazard ratio was 0.43, and patients continued to be followed as these data mature. On slide 18, a post hoc landmark analysis demonstrated that irrespective of treatment, SCR35 at week 24 predicted overall survival. This observation is further reinforced by the longer-term follow-up from the phase 1 trial on slide 19, in which the same relationship between SCR35 and overall survival is observed. On slide 20, the importance of the SBR35-OS relationship becomes even clearer when viewed in the context of the broader myelofibrosis literature. Over the past several years, a substantial body of retrospective evidence from Phase III JAK inhibitor trials has demonstrated that greater SBR35 rate differences observed across the two arms correlate with improved overall survival. Sentry now provides an important opportunity to build on that body of evidence as the first Phase 3 trial that prospectively demonstrates the same relationship and establishes SBR35 as a potential surrogate endpoint for overall survival. This underscores the importance of treating patients with the combination early in the disease course, increasing the likelihood in SBR35 reduction is observed, thus potentially maximizing overall survival. On slide 21, we also observed higher rates of variant allele frequency reduction with selenexor plus ruxolitinib as early as week 24. These molecular findings are important because VAS reduction was associated with a greater likelihood of achieving SBR35, providing additional biological evidence that is consistent with the clinical findings. Taken together on slide 22, the rapid, deep, and sustained spleen responses, the promising overall survival findings, the relationship between SBR35 and survival, and the molecular data all point in the same direction. We believe this unique and compelling profile strengthens the scientific rationale for SVR35 as a meaningful predictor of long-term survival. It is the combination of this growing body of evidence, the strength of the sentry data, and the significant unmet need in myelofibrosis that form the basis of our scientific discussions with the FDA regarding the role of SVR35 in supporting our planned SMDA submission. We believe the FDA's written feedback indicating that SCR35 appears to qualify as a reasonably likely surrogate endpoint to predict overall survival represents an important scientific and regulatory milestone. Importantly, this builds upon years of scientific evidence supporting the relationship between SCR35 and long-term outcomes, together with the prospective randomized evidence generated through Sentry. Our planned submission will be based on the Week 24 SBR35 results. We intend to use additional long-term overall survival data from the ongoing Sentry Trial to verify clinical benefit, a requirement under the Accelerated Approval Pathway to later convert to traditional approval. While our immediate priority is our planned submission, we continue to explore the broader role of Salinexor in myelofibrosis. On slide 23, the ongoing Century 2 study provides an opportunity to further characterize the activity of Selenexor as a monotherapy and explore the potential flexibility of XPO1 inhibition in combination with additional JAK inhibitors. This study will help us better understand the intrinsic contribution of Selenexor and continue to define the broader role of XPO1 inhibition across the treatment of patients with myelofibrosis. As Richard noted, we expect top-line data from the 60-milligram cohort of Century 2 during the second half of this year. Taken together, we believe the strength and consistency of the evidence generated through Century, together with our continued clinical development efforts, provide a strong scientific foundation for our planned SNDA submission and reinforce our belief that Selinexor has the potential to fundamentally change the treatment of patients with myelofibrosis. With that, I'll turn the call over to Solhanya.

Thank you, Reshma. Turning to slide 25, my focus today is on why we believe Karyopharm is well-positioned to commercialize this opportunity. Importantly, we're not preparing to build a commercial organization from the ground up. We're leveraging an established hematology platform that we have built over many years through the commercialization of Expobio. On the scientific side, we have clinical development experience, active medical and scientific affairs teams, investigative relationships, and growing visibility across the myelofibrosis community. On the commercial side, we have established coverage in both community and academic hematology, key account capabilities, and market access expertise. And through Carrie Ford, we have an existing patient support platform designed to help patients and caregivers Navigate Access, Reimbursement, and Treatment Initiation. Importantly, these capabilities already work together to date multiple myeloma and can now be leveraged to support the potential expansion of Selinexor into myelofibrosis, which is a significant strategic advantage to enable a rapid and efficient launch. Turning to slide 26, Q2 was a breakout quarter with top-tier recognition across leading global oncology platforms. As Richard discussed, the sentry data have now been presented at ASCO and EHA, published in the Journal of Clinical Oncology, and continue to be highlighted at scientific meetings throughout the hematology community. Importantly, while commercial promotion begins only following regulatory approval, Scientific engagement is already well underway. Our medical and scientific affairs organization is already deeply engaged within the malafide versus community. Following ASCO and IHA, our medical and scientific affairs teams have continued scientific exchange with investigators and treating physicians, participated in regional educational programs and scientific symposia, and continued building upon the relationships established throughout the Sentry Clinical Development Program. We see significant engagement and thoughtful discussion surrounding the Sentry results, particularly the rapid, deep, and sustained lean responses, the promising overall survival findings, and the potential for disease modification. Furthermore, the structure of the myelofibrosis market is also well aligned with our existing footprint as shown on slide 27. Approximately 70% of patients are treated in the community setting and 30% in academic centers. Across both settings, the majority of patients are concentrated within a manageable group of treatment centers. This concentration allows us to focus our resources on the physicians caring for the majority of patients and to deploy our existing organization efficiently. Our physician segmentation work has also given us a detailed understanding of the high-volume, innovation-oriented physicians most likely to adopt a new combination approach early. These physicians place significant importance on achieving rapid, deep, and sustained screen responses and are actively considering how treatment may influence longer-term outcomes. There is also opportunity for prevalent patients treated with a JAK inhibitor to benefit from the combination therapy. We hear physician interest in the ability of Selinexor to maintain spleen responses even when ruxolitinib doses are reduced, which is clinically relevant given how frequently dose adjustments occur in practice. Finally, as we turn to slide 28 and looking at the commercial opportunity myelofibrosis, we believe Selinexor plus ruxolitinib has the potential to generate up to approximately a billion in peak annual revenue in the U.S. alone. Approximately 20,000 patients are currently living with myelofibrosis in the U.S. with roughly 4,000 newly treated frontline patients each year with no approved combination therapy in frontline myelofibrosis. Let's now review our multiple myeloma performance, which continues to provide the commercial and operational foundation for the broader hematology platform I have described. As shown on slide 30, we delivered another quarter of strong commercial execution with Expovio US Next product revenue of $30.8 million. Underlying demand remained relatively consistent with the second quarter of last year, despite an increasingly competitive treatment landscape. This performance reflects the resilience of our multiple myeloma franchise, and importantly, the strength of the relationships our commercial organization has built with hematologists and oncologists across both community and academic practices. Turning to slide 31, We continue to believe Exposio is well-positioned for sustained performance. Our focus remains on the community setting, which represents approximately 60% of our U.S. business, where physicians continue to value Exposio as a differentiated and convenient oral therapy. In addition, Exposio continues to occupy a unique position in the evolving treatment landscape surrounding T-cell engaging therapies. providing physicians with flexibility both before a CAR T therapy and following progression on a T cell engaging therapy. Our commercialization capabilities position us to continue to build on the foundation of multiple myeloma and importantly drive a transformative launch in the multi-billion dollar myelofibrosis marketplace. With that, I'll turn the call over to Lori to review our financial results and discuss how our disciplined capital allocation strategy supports the opportunities ahead.

Thank you, Sanjaya, and good morning, everyone. Turning to slide 33, I will focus on our second quarter financial performance, our financial outlook, and the actions we're taking to support the important milestones Richard outlined. Starting with revenue, total revenue for the second quarter was $33.4 million. The decrease reflects the conclusion of MetaReadings reimbursement of development-related expenses at the end of 2025, which reduced revenue by approximately $6.5 million compared with the prior year quarter. U.S. Exposio net product revenue was $30.8 million compared to $29.7 million in the prior year period. Underlying demand remained consistent, and our gross net rate of 26.6% was comparable to the second quarter of 2025. Turning to expenses, we remained focused on discipline execution. R&D expenses were $29 million, and SG&A expenses were $25.9 million, down 12% and 9% respectively year over year. This reflects our continued prioritization, disciplined investment, and focus on advancing our highest-value late-stage programs, with our Phase III trials having completed enrollment. We also continue to maintain disciplined alignment of prelaunch investments with clinical and regulatory milestones. Net loss was $67 million for the quarter, As a reminder, net loss includes non-cash mark-to-market adjustments related to our financing structure. From an underlying operating perspective, performance improved with approximately an 8% reduction in loss from operation, reflecting stable net product revenue and continued expense discipline. Turning to the balance sheet, We ended the quarter with $65.4 million in cash, cash equivalents, restricted cash, and investments. Based on our current operating plan, we expect our existing liquidity, including cash, cash equivalents, and investments, together with anticipated cash flow for net product revenue and license and other revenue, to fund our current operating plans into September 2026. As Richard discussed, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility, and maximizing long-term shareholder value as we advance our mild fibrosis program. On September 10, 2026, a $16.8 million principal payment is due under our senior secure term loan facility. If that payment is made without additional financing or a waiver from our lenders, we expect our cash, cash equivalents, and investments will fall below our $10 million minimum liquidity covenant, which would constitute an event of default under the term loan. Importantly, our immediate priority is to address this. and strengthen our financial position and provide the flexibility needed to continue executing our mild fibrosis strategy. Every capital allocation decision we make is intended to support the important clinical, regulatory, and commercial milestones ahead while maintaining disciplined execution across our multiple myeloma business. and maximizing long-term value for patients and shareholders. Turning to guidance, we are reaffirming our full-year 2026 outlook. We continue to expect total revenue in the range of $130 million to $150 million, with license and other revenue consisting entirely of royalties over the next two quarters and U.S. Expovio Net Product Revenue of $115 million to $130 million. We continue to expect combined R&D and SG&A expenses of $230 million to $245 million in 2026, excluding certain one-time costs that we may incur associated with our endometrial cancer program in evaluating financing opportunities and or strategic transactions. As a result of our decision to prioritize mild fibrosis and multiple myeloma, we are actively reducing investment across the endometrial cancer program, and we expect our cost structure to decline over time. A greater financial benefit will be realized in 2027 as we continue patient follow-up for the near term and evaluate the evolving data sets. Together with responsibly completing the remaining clinical and operational activities associated with the ECO42 trial. In the near term, third quarter expenses may be modestly higher than the second quarter. This reflects a unique transition period for the company as we simultaneously advance our mild fibrosis program, implement the organizational changes associated with our decision to prioritize mild fibrosis and multiple myeloma following the EC042 top line results and the cost we may incur to evaluate financing opportunities and strategic alternatives. With that, I will turn the call back over to Richard.

Thank you. Before we open the call for questions, I'd like to leave you with one final thought. PerioPharm is entering one of the most important periods in our history. We have a compelling opportunity in myelofibrosis, a regulatory path forward, an experienced hematology organization prepared to support a potential launch, if approved, and a team that has consistently demonstrated the ability to execute with focus, urgency, and discipline. We also recognize the importance and urgency of this moment, and that is why we are acting with discipline not only in advancing our myelofibrosis program, but also in how we allocate capital and evaluate the financing opportunities and strategic alternatives discussed today. Every decision we make is guided by a single objective, maximizing long-term value for patients and shareholders. I'd like to thank our employees for their extraordinary dedication, our investigators and collaborators for their partnership, and most importantly, the patients and families who have placed their trust in Keriopharm by participating in our clinical trials. We appreciate your continued support and look forward to updating you on our programs over the coming quarters. And with that, operator, we'd now be pleased to take your questions.

Thank you. Ladies and gentlemen, we now begin the question and answer session. If you'd like to ask a question, please press star follow button number one on your telephone keypad. We ask analysts to limit themselves to one question and a follow-up. If your question has been answered and you would like to withdraw from the queue, please press star follow button number two. and if you're using a speakerphone, please lift your hands up before pressing any keys. One moment, please, while we compile the roster. Your first question comes from Tim Tamsoff with Vipress Tumblr. Please go ahead.

Great. Thank you very much. I just have some questions with respect to what still had to be done for the SBL or SNDA, considering, obviously, SELNX was already approved in multiple myeloma. You know, how much of the filing is already done, and is there anything else that you need to compile on the clinical side? Any sites that need to be revisited, or does all that already seem to be taken care of with the current approval? Thank you, Tom.

Yeah, thank you, Ted. I'll turn to Reshma to go into that in more detail.

Yeah, thank you, Ted and Richard. The team has actively been working on the SMDA. By and large, the vast majority has already been put together. It's ready to go. One of the key pieces that we are just aligning and finalizing with the FDA is just around the confirmatory data piece. I think as we all appreciate under accelerated approval, we are provided an approval, a label, but we do need to provide clinical benefit at some point in the future. And so right now our discussions really have been focused on using the mature overall survival observed from sensory for finalizing the statistical analysis plans, again, aligning on those last details, which is something that is required before we submit the SMDA. So, great productive conversations with the FDA, and we still are very much on track to submit the SMDA in August.

That's very helpful. Just let me try to understand. So, you'll use the OS data from the ongoing sensory as the confirmatory data set?

That is correct, right? You know, we designed Sentry intentionally from the very beginning to follow all the way for overall survival. So, the study continues with patients' sites blinded. They continue on treatment. They continue to provide scans as well as OS data. So, yes, we are going to leverage that maturing OS data. to confirm the benefit, which is going to occur, you know, likely years from now, but that is going to serve as the confirmatory data set, we believe, you know, upon alignment with the FDA.

That's really helpful. Thank you, Chris. Well, good luck.

Thank you. Thank you. Your next question comes from Yanni Sordidis with Kantor. Please go ahead.

Hey, folks. Appreciate the updates here. I guess just a quick question on kind of what is the right way to think about the feasibility here of future operations? Is accelerated approval absolutely needed, or do you believe that inclusion in the NCCN committee could provide sufficient revenues to address the debt and operating needs? And I have a quick follow-up.

Yeah, thanks, Yanni. You know, I think as we've talked through, there's really, you know, a few of those milestones happening very much in the near term. and obviously given that we're already an approved agent, you know, NCCN is very important and I think it's something which, as we know, physicians utilize a lot. I think we've talked to that previously where, you know, with NCCN in similar situations, if NCCN is all that you achieve, usually products will achieve about 50% of what their peak may be. But obviously our goal is to, you know, enable as broad access as possible. You know, one component is NCCN. The other component, as we've talked to, is really continuing to advance down the regulatory pathway. So, you know, I think both of those are occurring very positively over the near term. And I think both would be very positive for us in terms of, you know, being able to fund operations and obviously being able to enable patients to get access to the Selenexor and Ruxolitinib and myelofibrosis.

Yeah, appreciate it. And then just, I guess, relatedly to, you know, I appreciate the transparency on kind of the upcoming is there a sense of what would be kind of the stopgap in your mind to kind of position the company well financially from a liquidity perspective to make it through these near-term milestones and ideally I would imagine make it through at least the first half or end of 2027?

Yeah, I think as we've seen before our lenders have consistently been very supportive with us and I don't have any reason to believe that they won't continue to do so. And I think as we announced, we are working on a range of financing opportunities and strategic alternatives. We're in direct dialogue with our lenders with respective options. And I think obviously our goal is to work with lenders and potential equity investors and find a way to enhance our liquidity, extend the runway as we have these really important milestones in front of us. in the second half of 2026. So, I think, you know, we'll be able to continue to execute on that and find the right balance as we move forward.

Understood. All right. Thanks so much.

Thank you, Adam.

Thank you. Your next question comes from Brian Abrahams with RBC Capital Markets. Please go ahead.

Oh, hey. Good morning. Thanks so much for taking my question, and congrats on the continued progress. You mentioned in milestones the potential for inclusion of Selinexer in the compendia in the back half of this year. That seems pretty rapid if the NCCN meeting is happening just this week. So I'm just curious if you're hearing anything emerging from the meeting that gives you confidence and maybe you could remind us of the process there. And then maybe just secondly, just curious if in your dialogue you're hearing any insights from the FDA on how open they might be to priority review. Thanks.

Sure. Thanks, Brian. I'll address the first part, and I'll turn to Reshma for the second part. You know, obviously, you know, NCCN is an independent committee and an independent body, so, you know, they'll go through their process and evaluate. You know, importantly, we put the right components in place in terms of our, you know, ASCO presentation, our EHA presentation, our Journal of Clinical Oncology presentation, Manuscripts, I think all the right components are there. And, you know, we hear a high level of interest from, you know, opinion leaders to, you know, be able to get access to selenic surplus ruxolitinib. So, you know, I think we're on track, as we said, to see that, you know, in the second half this year. And for the second part, I'll turn to Reshma to talk to the FDA.

Yeah, thanks, Brian. You know, so as I mentioned, you know, really great productive conversations with the FDA. In terms of priority review, not necessarily. So this is a request that we need to make with the FDA at the time that the application is submitted. They have approximately 60 days to review that request, and then they'll provide that update shortly thereafter. So no specific insight, but we do believe that we have a strong package, potentially a you know, differentiating profile, you know, a need for a combination therapy. So, hopefully, they will review it and, you know, expedite the PDUFA date that will enable an approval sometime early next year.

Super helpful. Thanks so much.

Thanks, Brian.

Thank you. Your next question comes from Murray Raycraft with Jefferies. Please go ahead.

Hi. Thanks for taking my questions. Maybe I'll just ask one on the term loan negotiations. Lori, you mentioned potential for a waiver. What do those discussions look like and what could updated obligations look like if there's a waiver and what is the likelihood of that? And then I've got a follow-up question.

Sure. Maybe, Maury, I'll address that one. I mean, just at a high level, you know, we're not going to obviously go into the details of the conversations and negotiations. I think, as we mentioned, you know, the lenders have been consistently supportive with us. And again, I think we don't have any reason to believe that they won't continue to do so. So good, productive conversations and working on the right solution as we move forward. And obviously, that's something that we're very focused on and working to achieve rapidly. Understood. That's helpful.

And then for NCCM Compendia listing, I guess, what's your plan to get patients from your clinical studies on the paid drug? And do you have a sense of proportion of patients from your studies that would make that switch early on with only the NCCN compendial listing?

Well, I think on our study, as we mentioned, you know, we look to see our study continue, right? So, our study continues. Patients are blinded. Clinicians are blinded. We have a blinded study team in Ticariopharm. So, you know, we look to see our study continue, and I think, as Reshma mentioned, we're looking to see that to be the confirmatory data from an accelerated approval perspective. So our focus would be to make sure we're really working with the sites, investigators, patients, et cetera, to continue patients on our Bay Street program. Understood.

Okay. Thanks for taking my questions. Thanks, Maureen.

Thank you. Your next question comes from Michael King with Roidman and Rainshaw. Please go ahead.

Thanks. Good morning, guys. Thanks for taking the question. Just a little further. Thank you for your granularity on the filing and the interaction with the FDA. I'm just wondering, given the recent interaction with the BNC meetings and the updated analysis that you presented at ESMO, I just wonder if any part of the data set that you're going to submit could be considered to be a major amendment. Obviously, this would be very impactful for the approval timeline, so I'm just wondering how you're thinking about and submitting the data to the agency.

Yeah, I'll return to Reshma for that part.

Yeah, thanks, Michael. Great question. So the S&DA, you know, under the accelerated approval is really going to be based upon the week 24 data. So the week 24 that we really believe is compelling and differentiating, of course, is going to be that SVR35 data. Not only at week 24, that's the time point at which the primary analysis was conducted. But the kinetics really suggest something very differentiating. So, of course, that SVR 35 at week 12, 24, 36 shows that sustained SVR. Of course, the overall survival data, the post-hoc analysis with the relationship between SVR-OS, the disease modification data, and the safety. So that's the profile, again, very compelling at week 24. And, again, we'll form the basis for that for the SMDA. Okay.

Okay, and no 48-week data to be submitted then, is that correct?

That's correct. We're going to really focus on the week 24 data. Now, there are some patients that have been followed for week 48. You know, we'll provide that data as well, but, you know, the primary focus is really going to be on the week 24.

Okay, and can you say whether you'll... include the pre-specified OS confirmatory analysis in that submission.

Yeah, absolutely. That's part of the differentiating package, and that OS data that we observed and, of course, presented at ASCO, EHA, and was included in the JCO really was the basis for that post-hoc analysis that allowed us to show that relationship between SVR-OS. So, it is a very important data point. Of course, we'll continue to follow patients on overall survival, and as mentioned earlier, will use those data to ultimately confirm the benefit in the future.

Great. Thanks for taking the questions. Thanks, Michael.

Thank you, Michael. There are no additional questions in the queue. I will turn it back to Richard for some closing remarks.

Thank you, Operator, and thank you, everyone, for joining us today and your continued interest in Theroharm. I guess we've highlighted, you know, we very much look forward to providing you additional updates on our Regatory and Financing Developments very much in the near future. So, once again, thanks for joining us.

Ladies and gentlemen, this concludes your conference call for today. We thank your participating and ask that you please disconnect your lines. Have a great day.