Coherus BioSciences, Inc.

Hello, everyone, and welcome to the Coherence fourth quarter year ending 2024 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To participate, you will need to press star 11 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, simply press star 11 again. please re-advise that today's conference is being recorded. Now it's my pleasure to turn the call over to the Head of Investor Relations, Jody Sievers. Please proceed.

Thank you, Carmen. Good afternoon, and welcome to Coherence Biosciences' fourth quarter and full year 2024 earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coherence, Brian McMichael, Chief Financial Officer, Paul Reeder, Chief Commercial Officer, Dr. Rosh Dyess, Chief Medical Officer, Dr. Theresa LaValley, Chief Development Officer, and Samir Gorogalkar, Senior Vice President of Immuno-Oncology Marketing. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coheris' current expectations about future events. These statements include, but are not limited to, the following. projections about future revenues, headcount reductions, statements about our ability to satisfy the closing conditions of the Udenica divestiture, statements about the use of proceeds from the Udenica divestiture, and our projected future cash and cash runway, and statements about future clinical development progress. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control, and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties about achieving the closing of the Udenica divestiture that are discussed in our press release that we issued today, as well as the documents that we filed with the SEC Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements. All December 31, 2024 financial amounts discussed today have not been audited and are subject to change upon completion of Coherence's audited financial statements for the year ended December 31, 2024 that will be included in Coherence's Form 10-K, which is expected to be filed with the SEC in the coming days. And now, I'll turn the call over to Denny.

Thank you, Jodi, and thank you all for joining us today. My cohort here is Q4 and full-year 2024 earnings call. Today, I'll provide you with a view of the progress we've made in 2024 and our key objectives, and I'll describe to you the path that lies ahead as we focus on maximizing revenues and electricity, expanding its syndications, and advancing our proprietary pipeline combination with Lactorsi. On our previous calls, I outlined our four-part strategy to position coherence for future success in innovative oncology. This included, first, to drive top-line revenues, second, control the expense line, thirdly, to advance the innovative pipeline, and lastly, to address the debt overhang on our balance sheet. I'm happy to report that over 2024, we have been successful across all these objectives in support of our overarching strategy. Particularly given last year's strong execution, we are now well positioned in 2025 to complete our strategic transition to a fully integrated commercial stage innovative oncology company. We have addressed our balance sheet debt issue and we'll put about $250 million in cash on the balance sheet at transaction close to continue our development efforts through key data milestone readouts in 2025 and 2026. The most significant change for the company is the divestiture of the Udenica franchise, and I'm happy to report that we have made substantial progress, positioning us to complete this transaction in late Q1, early Q2. Security Exchange Commission review, Hart-Scott-Rodino review, and CFIUS review have all been completed or otherwise approved. The shareholder vote and the special meeting are tomorrow. We are confident that the divestiture will be approved and believe that such approval will constitute both an endorsement of our overarching strategy as well as an appreciation for the strong execution that got us here. However, it must be said on a more macro level that we are certainly not satisfied with our current stock price. Post-transaction, with the debt overhang behind us, a strong balance sheet, and potentially exciting data in front of us. We will focus on enhancing investors' appreciation and understanding of Coeris' value proposition. This will be a key focus of management in 2025 and 2026. Now back to the divestiture. Apart from the shareholder vote, the primary remaining closing condition at this point is the FDA authorization to sell final package product from our additional contract manufacturing organization, responsible for our labeling and packaging operations. We've made the required submission and believe it fully conforms with FDA expectations, as well as the FDA's communicated guidance to us. This final step in our strategic transformation follows a series of achievements over the past two years. In January 2021, we initiated a deliberate four-year strategic transformation process with the in-licensing of Toro Palmet, our differentiated PD-1 inhibitor from June Sheet Biosciences. To be a major commercial player in innovative oncology, we believe it is a strategic necessity to have an approved proprietary PD-1 to anchor in innovative oncology pipelines. Lactorsi is our key foundational asset and will be used in combination with both our own pipeline candidates as well as our partners, driving development synergies as well as sales synergies from proprietary combinations. Lactorsi was launched in Q1 last year and is now standard of care in all lines of nasopharyngeal cancer. In September 2023, we acquired a promising pipeline of oncology candidates through the acquisition of Service Oncology for a net $40 million, inclusive of global rights to a first-in-class anti-IL-27 agent, Castozokita, as well as a highly selective cytolytic CCR8 antibody, CHS114. While these assets were underappreciated at the time, the strong inherent biology and early clinical data convinced us that these are differentiated and potentially game-changing, ideally suited for development in combination with lactorsy. That data is rolling out in front of us now, particularly in liver cancer with Casdozo, and gives us confidence that we were right. and that future data readouts will further validate the clinical utility of these assets. Having thus secured our innovative oncology future with a promising pipeline, last year in 2024, we divested our Ophthalmology and Humira Biosimilar franchises for about $240 million in total consideration and transferred financial obligations. Over this past year, assuming the Eugenica transaction closes and things happen as planned, We will have divested at least $800 million in assets or commitments, paying off $480 million in debt, all with an average capitalization around $175 million. Going forward, we're left in good position with $250 million on the down sheet, a differentiated PD-1 enjoying growing sales in a market where it's standard of care, indication expanding pivotal trials underway for our PD-1 funded by others, and a strong pipeline addressing a $15 billion potential sales opportunity in combination with Lectorzy. And with that, let me now turn it over to my team for more color and details in each of their areas. First, on the commercial side, you'll hear from Paul Reeder, our Chief Commercial Officer, whose team has done an excellent job with Udenica navigating the supply interruption and the subsequent reentry into the market. Paul's team delivered some strong Udenica numbers for us in Q4, all things considered against obvious headwinds. You will also hear today from Samir Gorogalkar, who joined us in Q4 as the new Lactorsi brand lead. Samir is tightly focused on maximizing the potential for the Lactorsi label, NCCN guidelines, as well as customer and patient segmentation, which he will discuss with you. Samir will continue to provide his insights on Lactorsi performance on these calls going forward. After commercial, Dr. Teresa Lavalle will discuss our overarching development strategy, and Dr. Ash Dias, our Chief Medical Officer, will cover our clinical trials and provide additional color on the evolving ASDOSO CHS114 data sets. Lastly, before we conclude our prepared remarks and go to the question and answer session, Chief Financial Officer Brian McMichael will review the Q4 and 2024 annual numbers and deltas for you as well as provide some color on matters going forward. Without the transaction closed, we will not be guiding on 2025 expenses at this point. But of course, we'll do so for you on the Q1 call in May. And with that, I'll hand it over to Paul and Samira for the commercial review. Paul?

Thank you, Danny. Good afternoon, everyone. We'll now review brand-specific updates, starting with Udenica. Udenica net product sales for Q4 were 46.3 million, an increase of 28% compared to 36.2 million for Q4 2023. For fiscal year 2024, Udenica net sales were 206 million, an increase of 62% compared to 127.1 million for fiscal year 2023. Pleased to report that Udenica's supply resumed in November with our labeling and packaging contract manufacturing organization, delivering both backlogged and planned lots to restock the distribution channel and begin fulfilling customer demand. In early January, we announced that due to strong demand in Q4 and into Q1 of this year, all three presentations of Udenica were being temporarily allocated. Since then, and based on individual wholesaler historical purchasing patterns, supply allocations to wholesalers and to their end customers for all three presentations of Udenica were removed between the end of January and the end of February. Customers who represented 97% of Udenica volume pre-supply interruption have returned to ordering Udenica, reinforcing the strength and resilience of the Udenica brand and the differentiated delivery presentation options that meet the unique needs of providers and patients. Udenica market share in Q4 was 15%, with an exit share of 22%. And we remain confident that customers will continue prescribing Udenica with demand and market share acceleration throughout 2025, as Udenica is the only brand in the PECFIL Graston class that offers three product presentations, a differentiated on-body device, and broad payer coverage. Finally, as we move toward the closing of the divestiture Udenica business, the commercial team remains focused on three key priorities. First, driving Udenica revenue and market share beyond pre-supply interruption levels. Second, accelerating Loctorsi new patient starts. which Samir will discuss momentarily. And third, to ensure that post-transaction, we maintain an optimized commercial team to fully enable continued momentum of our Loctorsi launch and reach the maximum commercial opportunity for Loctorsi as quickly as possible. Now to review the Loctorsi business, I'll turn the call over to Samir. Samir?

Thank you, Paul. I'm happy to join the team. Loctrosy net revenue was $7.5 million in Q4, a 29% increase quarter-over-quarter. Net revenue for fiscal year 2024 was $19.1 million. As previously outlined, there are approximately 2,000 loctrosy-eligible NPC patients each year, and relapsed locally advanced and first-time metastatic patients represent about two-thirds of the eligible patient population. NPC is a rare cancer, and oncologists typically see one to two new patients per year. Our goal is to reinforce Loftrosy as the standard of care in all eligible NPC patients. We remain focused on expanding the breadth of Loftrosy use, as well as keeping patients on therapy for as long as appropriate. Since launch, we have made strong progress towards these goals. Nearly 80% of all NCCN institutions have used Loctorsi for at least one patient. In Q4, the number of new accounts purchasing Loctorsi grew by 37%. Loctorsi new patient stars also continue to grow in Q4, with uptake primarily in the relapsed, locally advanced, and first-line metastatic setting, which is a key driver for long-term revenue growth. We reiterate our belief that lactose revenue will follow a steady ramp in the near term, fueled primarily by new patient acquisition. Sustained growth over time will be driven by duration of treatment, and 80% of long-term revenue will come from continuing patients. We estimate that this will take about three to four years to realize the full potential in MPC. Now, regarding Q4. Revenue trends were affected by two transient headwinds that impacted Loftorzy's share of voice. The first was Udenica temporary supply interruption. Second, the announcement of Udenica divestiture and the required field force restructuring comprised an additional impediment. This will continue to impact us until the transaction closes, customer assignments are finalized, and the field establishes a new territory footprint and customer relationships. However, long-term loctors will benefit from sustained tailwinds beyond closing of the divestiture, and we are well positioned for success. First, in November 2024, NCCN updated NPC guidelines, placing loctors in a preferred position for metastatic and locally recurrent NPC patients. Both our sales team and digital promotions are focused on educating customers on the updated guidelines. Initial customer feedback on the guidelines have been very positive, with oncologists telling us they intend to increase the use of Lactorsi in NPC. Secondly, as an innovative oncology commercial organization, the team's singular focus will be on reinforcing Lactorsi as the standard of care and preferred treatment for all NPC patients. Given that NPC is a rare cancer, Key tactics include leveraging real-time data to drive HCP and patient identification at the time of diagnosis. And we're engaging with key customers to encourage updating of account-level NCC pathways and order sets to align with our label and revised NCCN guidelines, placing Loftorzy in the preferred position. In short, we will continue to deliver on our track record of strong commercial execution in oncology. In La Corsi, we have a differentiated and highly efficacious drug that has delivered a profound survival advantage and enjoys superior NCCN positioning that is reflective of the strength of our data. We thus expect that La Corsi will achieve a dominant market share position in NPC that we estimate to be valued at about $150 to $200 million. In 2025, we are excited to differentiate La Corsi plus or minus chemo as the only NCCN-preferred regimen for metastatic and recurrent NPC patients, and the only FDA-approved PD-1 with proven PFS and OS benefit for patients in this space. I'll now turn the call over to Dr. LaValley, our Chief Development Officer. Teresa? Thank you, Samir.

Good afternoon. We are pleased to update you on our continued progress in 2025 with key regulatory and clinical advancements of our promising pipeline focused on our next generation and differentiated PD-1 inhibitor, Torapalamab. Lortz et al. recently highlighted that not all PD-1 inhibitors are the same in a review article published in the Frontiers and Oncology Journal. The publication highlighted that toropalimab uniquely binds the ST loop of the PD-1 ectodomain with high potency, driven by a very slow off-rate. Clinically, this pharmacology has revealed differentiation by delivering clinical activity in combination with chemotherapy, irrespective of PD-L1 expression levels in multiple Phase III studies. The European Health Authorities recently approved toropalimab for first-line esophageal squamous cell carcinoma, irrespective of PD-L1 expression. And in contrast, tizolizumab has recently been approved for first-line esophageal squamous cell carcinoma, only for patients whose tumors express PD-L1. The U.S. FDA also recently highlighted the lack of activity of pembrolizumab, nivolumab, and tizolizumab in PD-L1 low patients in this indication and gastric cancer in an ODAC meeting last September. Torapalimab differentiation and potency positions us well as we look to expand into additional indications in combination with novel agents. Our strategy for expanding toropalimab indications beyond MPC in the U.S. is focused on drug supply collaborations where we evaluate toropalimab with novel mechanisms, both with early and late stage compounds, and prioritize tumor types such as head and neck and lung cancer in clinical trials. internal development efforts on our pipeline of potent and selective antibodies positioned in tumor types with strong biologic rationale to establish proof of concept. Importantly, for each clinical indication that advances cas-dosa-ketone or CHS114 into a pivotal study, it also advances toropalimab into a potential new indication. From a regulatory perspective, we are progressing to plan with establishing all our drug manufacturing in the United States. Coherence has always focused on the U.S. for development and commercial, including made-in-America manufacturing. The clinical trials for Casdoza-Ketug, an IL-27 antagonist, and CHS-114, a cytolytic CCRA antibody, are designed to deliver data this year to address the FDA's project optimists and enabling favorable regulatory strategies to advance development pending positive data into pivotal studies in 2026 and 2027. I'll now turn the call over to Dr. Diaz to discuss the clinical development and pipeline data. Raj?

Thank you, Teresa, and good afternoon. Over the next few minutes, I'll focus on the progress of the combination studies of our competitively well-positioned assets, Casdose-Ketog and CHS114, in combination with the toripalamab backbone, which forms the foundation of our internal development strategy. With regards to Casdobo, our first-in-class IL-27 targeting antibody, our two areas of current focus are in non-small cell lung cancer and hepatocellular carcinoma. The non-small cell, our ongoing program builds upon the monotherapy responses demonstrated in previously treated PD-L1 refractory squamous cell histology in less inflamed tumors, most recently presented at ESMO-IO in December 2024. Our combination study of CAS-DOSA with toripalamab continues to guide us to focus on squamous cell histology, where our future focus will be. The first line about cellular carcinoma dates from the ATISO-BEV-CAS-DOSA trip in January 25. During this time period, overall response rate has increased from 27% to 38%, reflecting an increase in response rate over time. Additionally, the complete response rate has also increased from zero CRs initially to five CRs in the most recent dataset, representing a 17% complete response rate, which reflects a deepening of response also. These figures compare favorably with current treatment benchmarks 150 and Himalaya have reported CRAs between 3% and 8%. And importantly, the increase in response rate and the deepening of responses over time is very encouraging as we move forward with our ongoing development program where we have switched out Atezo for our own PD-1 toripalamab. This three-arm tori-bef-cas-do is a combination study in Tori Bev versus the Tori Bev doublet to address Project Optimus whilst at the same time aiming to provide us with a strong body of evidence to set us up for further development in Phase 2.3 in this indication. Our previously reported data has demonstrated activity irrespective of viral and non-viral etiology, which is important as our ongoing study includes sites globally where HCC historically has had varied etiologies. We anticipate having data from our ongoing triplet study in the first half of 26. With regard to CHS114, our CCR8 cytolytic antibody, our programs continue to progress in both head and neck squamous cell carcinoma and gastric cancer. As a reminder, our phase one program focuses paired biopsies to look at tumor biology. Thirdly, combination dose escalation of TORI and CHS114 in head and neck. And fourthly, further combination dose expansion of TORI plus CHS114 in head and neck cancer to a total of 40 subjects. in the first half of this year. The fourth cohort of the study, the combination dose expansion cohort of Tori plus CHS114 in second-line head and neck, is open and ongoing. For gastric cancer, we remain on track to open our global dose expansion phase 1B study in second-line gastric, gastroesophageal, and esophageal adenocarcinoma this quarter to build upon the encouraging Tori CCRA data presented at AFCA24, in this indication and anticipate data from this study to be available in the first half of 26. With that, I'll hand over to Brian. Brian?

Thank you, Rosh, and good afternoon, everyone. Today, I will cover the fourth quarter and annual results and provide an overview of Coheris' transition, culminating with the expected divestiture of Udenica, sets the company up for focus and execution solely on oncology. I will start with COGS since Paul and Samir already covered revenue. Cost of goods sold decreased $159 million in full year 2023 to $118 million in 2024. The change was primarily driven by $56.9 million lower COGS from the divested product similarly and $32.9 million lower net inventory write-offs, partially offset by increased volumes of our oncology products. COGS of $33.9 million in the fourth quarter of 2024 reflected the impact during the quarter from temporary supply interruption of Udenica and includes a $12 million charge for the write-down of Udenica inventory that did not meet acceptance criteria. COGS in Q4 2023 was $84.6 million and includes a $47 million charge related to slow-moving Yosemite inventory and... flow moving inventory, excuse me. Turning to OpEx, total 2024 gap R&D and SG&A was $261 million. Comparisons of the full year 2024 and the fourth quarter to the same periods in the prior year reflect decreases in both R&D and SG&A due to savings driven by lower headcount and lower cost due to biosimilar divestitures in the first half of 2024. Specifically, research and development expense decreased 15% to $93.3 million in 2024, down from $109.4 million in 2023, and was $21.2 million for the fourth quarter of 2024, down 19% from $26.4 million in the prior year. The decreases were primarily driven by factors mentioned earlier, partially offset by increased investments in our pipeline in 2024. SG&A expenses decreased 13% to $167.7 million in 2024, down from $192 million in 2023. The fourth quarter 2024 SG&A totaled $41.3 million, which includes $6.7 million in divestiture-related transaction costs, and was down 17% from $49.5 million in Q4 of the prior year. The decreases were primarily driven by the factors mentioned earlier. I'm pleased to report that interest expense in 2024 was $27.2 million, down 33% from $40.5 million in the prior year, and $5.3 million in Q4 2024, which is about half what it was in 2023. The decreases were primarily from paying off our $250 million term loan in the first half of the year. We ended the year with $126 million in cash and cash equivalents. Denny talked about the progress on the Udenica divestiture, so I'd like to provide you a view on our post-transaction projections. We expect headcount to reduce by 30% from approximately 225 employees, including 50 employees transferring to the buyer in the divestiture. The substantial majority of the company's off-balance sheet firm purchase commitments related to Udaca will also transition to the buyer. As previously disclosed in our filings, we expect to use tax attributes to offset all but a minor part of the gain on the transaction. Immediately following the transaction close, which is projected late this quarter or early next quarter, we expect to have $250 million in cash on the balance sheet. This amount is net of the expected payoff of $230 million convertible note, as well as a $48 million projected payoff of Udenica royalty obligations. We expect this cash, combined with collections from Udenica receivables net of related chargebacks, rebates, and other fees as of the divestiture close date, as well as proceeds from La Corzine's expecting growing revenues and reimbursements from the transition service agreement with the buyer, to last beyond two years. With that, I'll hand the call over to Denny.

Thank you, Brian. Operator, that concludes our prepared remarks. We're happy to go to the Q&A session.

Thank you so much. And as a reminder, to ask a question, simply press star 11 on your telephone and wait for your name to be announced. To withdraw the questions, press star 11 again. One moment for our first question. and is from Srikripa Devarakonda with Truist Securities. Please proceed.

Hey, guys. Thank you so much for taking my question. With the shareholder voting tomorrow, just wanted to check if there are any hurdles at all that we can expect, like make sure there are no surprises with respect to the Udenica divestiture. Also, you noted you expect to have $250 million in cash exceeding two years. Does that include the cost savings from the headcount reduction by 30% and that 30% coming from those associated with Eugenica, or is there any other optimization in terms of expenses? And then I have a follow-up question.

Thanks for your question, Kripa. With respect to the divestiture, we see no obstacles or impediments in the way of concluding that. We feel that the investors are very supportive of both the execution of the company over the past year or so, as well as the reposition of the company strategically. And we have also, as I outlined in my prepared remarks, completed SEC reviews, CFIUSR, Scott Rodino, and so on. So the only remaining, I would say the primary remaining issue is the authorization from FDA to begin selling the material from the new contract manufacturer. And we do not believe that was independent either. So, we believe that it's pretty much going forward as planned. With respect to the two years of savings and so on, and the 30% headcount reduction, I'll let Brian McMichael, my CFO, give you some additional color.

Sure. Thanks. Thanks, Kripa, for the question. The $250 million, the way to get to that number is if you look at our cash as of the end of the year, it was $126 million. The upfront consideration on the transaction is $483 million. And then we expect to pay off the $230 million convertible note, $48 million in royalties. And then you have some other cash flows related to fees and just during Q1. And so The 250 represents what we expect cash to be immediately following those transactions.

None of those deductions. What about going forward with the headcount reductions of the savings?

Going forward, what you can expect is, as we mentioned, we have around 225 employees as of now, and we expect to get that down to 155. 50 of those employees we expect approximately to transfer to Accord or Intos, and the rest will work out over the coming year. Thank you, Kripa. Did you have a follow-on question?

Yeah, I was just wondering about LockedHersey. I think, you know, you have the modified NCCM guidelines. You have preferred positions for LockedHersey. Congratulations on that. I was just wondering if you have a sense of where the drug is being used now, now that you have, you know, both frontline and second line and guidelines. Thanks.

Thanks for that. Maybe Samir has a few comments of color he can provide on that. Samir? Yeah, sure, Denny.

So just let me give you a little bit of historical context, right? The previous guidelines put us, on the previous guidelines, there were multiple treatment options, including chemo alone, chemo plus other off-label IOs, and chemo plus off-label IOs. So as a result of that, we believe that fuels the extensive use of chemo only and chemo plus off-label IO that was happening in the marketplace, right? Going forward, what we've seen is that the guidelines are very clear about recommending chemo plus Loft-Kerzi as the preferred treatment for first-line metastatic patients and recurrent patients as well. We've talked to a lot of physicians and market research, and what we've heard is the guidelines have been very well received physicians tell us they are expecting to increase the use of Lacturazine. And then really specifically about your question, where it's being used right now, it's a mix of recurrent locally advanced patients, metastatic first-line patients, and also we have some second-line metastatic patients. But primarily, majority of patients are right now receiving therapy in the more early lines of therapy. So we have a mix of patients right now. And we expect that to continue because of the broadness of our label.

Thank you.

Thank you so much.

Thank you. One moment for our next question, please. It comes from with Citigroup. Please proceed.

Hi, Danny and team. Thank you. Just on the labeling and packaging for the second supplier, what exactly is the FDA looking to check the box on there to give you clearance? to go through with the transaction?

Yeah. So, the FDA required that we did certain test runs and validation runs with the new line. The new line required installation of certain equipment. And so, whenever you spool up an additional manufacturer, even though it may be like-to-like, whatever, you have to actually perform runs and make sure that the equipment's working. We, first of all, had conversations with the FDA establishing how many runs they needed, how many units per run, and so forth. The new contract manufacturer then went off and did that and completed the required validation protocols, and then we went ahead, reviewed that, and then submitted it. So we think that it's relatively straightforward, and we expect probably over the next month or so we'll hear from the FDA regarding that.

Okay, so they don't need to visit the facility. They just need to sign off on that data. Is that correct?

No, they do not need to visit the facility. They only need to review the data.

Correct. Okay. Got it. And on the CCR8, actually, I was curious. You have fairly specific timing, second quarter 2026 for the TORI combo. and then the Phase 1B study in second line, gastric. Could you just comment on how you're able to arrive at such a specific timing, you know, more than a year away for that study?

Thanks. I'll let Raj give you a little more color on that, Egal. But I think the shorter answer is that we have been making very good progress with respect to enrolling the patients and splitting them up. And we're also dealing with a contract research organization that we have a very strong history with that's put a strong team on the product. Rosh, any further color for Yigal?

Yeah, I'll just say, hi, Yigal. Thank you for the question. So just two or three additional comments. So first of all, you'll recall we already, the study is multiple parts. So we've already reported the initial data set. So we have good site engagement from there. The second piece is that we will have more additional data from the second and third parts of the head and neck study this year. And then for the expansion, as you quite rightly say, we anticipate both head and neck and gastric data towards the end of the first half of next year. And I think, you know, if you look at several of our studies, we have very good site engagement, very good engagement with physicians. And we also, for the gastric study in particular, it's a global study. So I think our feasibility has been pretty tight, and we have really engaged the right sites which have these patients. So our projections are fundamentally based on psychocore projections.

The other comment that I would offer you, Gal, is that management reviews these regularly. We just had another review on this last week. So we realized the importance of getting the data in a timely fashion. We're quite focused on it, and I think execution along these lines is one of our strong points. So happy to keep you informed.

Okay, thanks. Last one quickly. On LaTorze, did you take a price increase? And if so, what was the percent?

Oh, yeah, that's great. Samir, would you like to comment for Yagal on the pricing? Yeah, yeah, I'll take that. Hi, Yagal.

Yeah, we did take a price increase. It was around 2.46%.

Okay, thank you.

One moment for our next question, please. And it comes from the line of Colleen Cossey with Bayard.

Please proceed. Hi, good afternoon. Thanks for taking our questions, and congrats on the progress. For the head and neck cancer data in the first half of this year, can you just kind of help us set expectations on what to expect there, how many patients, and how much follow-up?

Hey, Colleen. Thanks. Ross, do you want to give a little call to Colleen?

Yeah, absolutely. Hi, Colleen. So, yeah, we're expecting we will be reporting out data in the first half of this year at one of the major conferences. This is from part, a little bit of data from first part. Also, more data from the second and third part. So, essentially, all in all, we'll have around 30, 35 patients' worth of data. And what you should expect is safety, early efficacy, And also we've got some intratumoral biomarker data as well that we anticipate presenting as well.

Great. And then for the Casdozo-Thori combo in second and fourth line, non-small cell lung cancer, could you just kind of help us set expectations for that data readout as well, please?

Yeah. So we'll have emerging data as we move through the year. I'm not going to comment too much on specific data. enrollment and results because we still do have subjects who are still on therapy in the stage one of the two-stage, Simon two-stage design. But what I will say is that we anticipate focusing in on squamous specifically moving forward, which is, of course, as you know, Colleen, where we have seen our signal thus far.

Thank you, Colleen. Thank you.

Our next question is from Michael Nedelkovich with TD Cowan. Please proceed.

Hi. Thank you for the question. I have one as it relates to the CHAS-DOZO development plan in non-small cell lung cancers. So it sounds like you're moving forward in squamous. I was just curious, what is the next step? Is it a randomized phase two? Is there any chance you could move to a pivotal in late-line non-small cell lung cancer? And what is contemplated in your CASH runway guidance as it relates to CasDozo development in lung cancer? Thank you.

Hi, Michael. So I'll take the first part of that question. So our anticipation is that once we have completed a robust data set in the combination of toripalimab with cosdozo in non-small cell. As I say, the future focus for that is likely to be on squamous cell. We'll then move on into a phase 2-3. So the phase 3 study will be a standard phase 3 and will be against the current standard of care, which is docetaxel. And we talked a little bit last time about the response rates that one sees typically with docetaxel. And while I won't comment on what exactly we, what bar we're expecting to see, you know what the docetaxel overall response rates are. So, the subsequent phase three study will be against standard care docetaxel.

Regarding funding of the phase three, that's not within the window of the two-year guidance that we've gone up so far. But I think there's a number of options to proceed with that, given the data. And I would also indicate that out three to four years during that such time, we think that we have toropalamin pretty much at full force in the nasopharyngeal cancer space with 150 to 200 million.

Great. Thank you. Thank you. Thank you. Thanks, Michael.

One moment for our next question. That comes from the line of Brian Chang with JP Morgan. Please proceed.

Hey, guys. Thanks for taking our questions this afternoon. Maybe the first one is for Paul. On Lactorsi, can you give us a sense of the stickiness to the product in the real world? And for those doctors who have been using Keytruda off-label in MPC in the past, I'm just wondering if you can talk a little bit more about their current level of awareness and also willingness to adopt Lactorsi.

Yeah, well, thank you for your question on that, Brian. I think Samir can probably provide you a little color on that.

Yeah, so let me start with a question about the stickiness of Leptorzy, right? So what we've seen is the physicians who have used Leptorzy since launch have been very satisfied with Leptorzy, and they've been advocating on behalf of Leptorzy. So we expect that they will continue to have repeat use of Leptorzy. The thing is, this is a rare cancer, so physicians don't see more than one to two new patients every year. So by the time a physician who's used Loftorzy, by the time they have an opportunity to use it again, it's going to take some time. But again, we feel confident that we will get repeat use within our physician population. Now regarding Keytruda, there is a significant amount of off-label use of Keytruda. Part of it is driven by lack of awareness in the community about Loftorzy and the data from Loftorzy. And we are overcoming that very actively. by engaging with physicians and explaining to them the data and the NCCN guidelines. I'll say this. Every time we have a conversation with a physician about our data or NCCN guidelines, it is very well received, and people get pretty excited about it. So we feel confident that we will be able to overturn the ongoing off-label use of law of prurity, especially considering that we're the only PD1 that has any data in this space. So yeah, we're very excited and confident moving forward about making inroads into the Keytruda business as well as the chemo-only business. Thanks, Brian. Did you have a follow-up?

Yeah, and then maybe just one quick one, you know, related to the Phase I CCRA-TORI combo data sometime later this year. You know, I just want to get a better sense of, you know, what we should expect from the intratumor biopsy data, specifically, you know, what would be considered good data you know, that you view as further supportive for your ongoing work in head and neck.

Great question. Maybe Dr. LaValley can handle that one for you. Theresa?

Yeah, Brian, thanks for the question. There are a couple things we're looking for. First, we've shown robust depletion of ctr8 positive Tregs in the periphery. that's sustained over the dosing cycle. We want to be able to see that in the tumor. Secondly, what's been demonstrated in preclinical models is that removal of the immune suppressive cell, the CCR8 positive Treg, there's a broad infiltration of CD8 T cells. So that ratio of immune suppressive to immune activating cell is very important. And a number of studies with PD-1 and CTLA-4 have been done and shown efficacy is associated with high CD8 T cells in the tumor after treatment. So, we're looking for an increase in the CD8 cells to tip the balance to immune activate it.

Got it. Thank you so much. Thank you, Teresa. Thanks, Brian.

Thank you. Our next question is from Douglas Zhao with HC Rainright. Please proceed. Douglas, your line is open.

Sorry about that. I was on mute. My apologies. Thanks for taking the questions and congrats on the progress. I guess just one follow-up for me. I'm just curious. In terms for La Torze in the MPC market, How much continued use is there of off-label IO agents given, you know, with the NCNN guidelines out there now? You know, and how long do you think it will take for you to sort of capture all that volume? Thank you.

Yeah, thanks, Doug. So, your question is how much off-label, other PD1s without a label, and how long will it take us before we really embed Lacturacy as a stamp care scenario. Yeah.

And maybe what are some of the things that you need to do to have that happen?

So our business opportunity is divided between the academic and hospital setting and the community setting. In the academic setting, there's a pretty good awareness, especially the head and neck cancer specialist, there's a pretty good awareness of the guidelines and the data for Lacturacy. In the community setting, all of these physicians are seeing lots of different cancer types, and NPC is not top of mind until they actually see a patient. And as I mentioned earlier, they're seeing one to two patients per year. So it's only top of mind when they see a patient. So we are very actively working on using data to identify physicians at the time of diagnosis of a new patient. So we're having a discussion with them about our data and about the NCCN guidelines at a time when they're thinking about NPCs. So really the answer to your question is it's going to be an ongoing process. We did some market research recently, and there's about a 40% awareness of the NCCN guidelines. Clearly we want to change that. We want to drive a much higher awareness of the NCCN guidelines. But it will be a steady ramp of the awareness and also the uptake of . Last thing I'll say is just reiterate what I said earlier. When we do have a conversation with a physician who is thinking about MPC, it resonates really well, and they get excited about our PFSOS data and the guidelines.

And I guess just as a follow-up, do you anticipate it being an easier task in the academic centers? Is it the community where you have more work to do?

Yeah, I think we have to be, we can't just focus on the academic centers. We obviously want to get all the academic centers on board. We want to drive usage in hospital settings. But if we want to establish ourselves as a center of care, there's a lot of NPC use, treatment of NPC in the community. So we have to make inroads into the community. And we are committed to doing that, both through our sales force, but also through digital channels. So we've got to be successful in both those settings. Okay, great. Thank you. Thanks, Doug.

And thank you. And this concludes our Q&A session. I will turn it back to Lanny Lanphier for his final comments.

Thank you, operator. And thank you all for joining us today. As Coheris achieves, I should say, is about to achieve really a very strategic milestone, positioning the company as a commercial stage innovative oncology. company with an excellent product into our format and a very, very promising pipeline. We will be at IO360 later this month in Boston and look forward to seeing you all there. Thank you very much.

And thank you all for participating in today's conference. You may now disconnect.