NASDAQ:SMMT Summit Therapeutics Q2 2024 Earnings Report $23.05 -1.57 (-6.38%) As of 04/16/2025 04:00 PM Eastern Earnings HistoryForecast Summit Therapeutics EPS ResultsActual EPS-$0.05Consensus EPS -$0.06Beat/MissBeat by +$0.01One Year Ago EPSN/ASummit Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ASummit Therapeutics Announcement DetailsQuarterQ2 2024Date8/6/2024TimeN/AConference Call DateTuesday, August 6, 2024Conference Call Time9:00AM ETUpcoming EarningsSummit Therapeutics' Q1 2025 earnings is scheduled for Tuesday, April 29, 2025, with a conference call scheduled on Wednesday, April 30, 2025 at 9:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Summit Therapeutics Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 6, 2024 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Good morning, and welcome to Summit Therapeutics Second Quarter 20 24 Earnings and Update Call. All participants will be in listen only mode until the question and answer portion of this call. We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the company's website for updates. Operator00:00:27And please note that today's call is being recorded. And at this time, I would like to turn the call over to Dave Gengars, Summit Therapeutics' Chief Business and Strategy Officer. You may proceed. Speaker 100:00:51Good morning, and thank you for joining us. Our press release was issued earlier this morning and is available on the homepage of our website. Our Form 10 Q was also filed earlier this morning and is available on our website. Today's call is being simultaneously webcast and an archived replay will also be made available later today on our website, Speaker 200:01:12www.smmptx.com. Speaker 100:01:16Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer Doctor. Mekhi Zangadeh, our Chief Executive Officer and President Manmeet Soni, our Chief Operating Officer and Chief Financial Officer and Doctor. Alan Yang, our Chief Medical Officer. Before we get started with the rest of the call, I would like to note that some statements made by our management team and some responses to questions that we may make today may be considered forward looking statements based on our current expectations. Summit cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward looking statements. Speaker 100:01:56Please refer to our SEC filings for information about these risks and uncertainties. Summit undertakes no obligation to update these forward looking statements, except as required by law. Following comments from Bob, McKee and Manmeet, we will take questions. With that, I would like to turn the call over to Bob. Speaker 200:02:15Thank you, Dave. Good morning, everyone, and thank you for joining us today. We're very proud of the recent accomplishments of Team Summit and the expanding positive information that continues to be brought to light surrounding avinizumab, our lead's investigational asset. The past few months have been pivotal to the positive development and awareness of avanizumab as well as in expanding physician, caretaker, hospital, payer and patient awareness of Summit Therapeutics' mission and vision, namely to build a viable organization that makes a significant positive difference for the betterment of patients encountering serious unmet oncology medical needs. Specifically, abanizumab created positive Phase III data updates from HARMONY A and HARMONY 2, both of which were randomized single region clinical trials in non small cell lung cancer conducted by our partners at Akesso. Speaker 200:03:12HARMONY A results supported ibenizumab receiving its first regulatory approval in China for patients with advanced non small cell lung cancer who have progressed following an EGFR TKI. In HARMONY-two, Ibenizumab monotherapy beat pembrolizumab monotherapy head to head in the study's primary endpoint of PFS, making ivanizumab the 1st drug to achieve a clinically meaningful efficacy benefit over pembrolizumab in a randomized Phase 3 clinical trial in non small cell lung cancer. Additional data from this pre specified interim analysis will be presented at an upcoming major medical conference this quarter. In addition, we raised an unsolicited $200,000,000 at a premium over the then current market price, extending our cash runway and increasing our resources to execute our expansive goals. Manmeet will provide more details about our financial position in a few minutes. Speaker 200:04:12SUMMIT's 2 multi regional registrational Phase 3 non small cell lung cancer trials, HARMONY and HARMONY 3, continue to enroll. HARMONY remains on track to complete its planned enrollment later this year. Alongside our partners at Akesso, abanizumab data was featured at ASCO as well as Harmony A data being published in JAMA, Journal of American Medical Association. This, in addition to smaller conferences and best of ASCO follow-up meetings, have been excellent in fostering KOL discussions regarding the future of cancer therapy, including the potential for evidenzumab. These efforts were further bolstered as we continue to ramp our investigator sponsored trial, or IST program. Speaker 200:04:58Last month, we announced a 5 year strategic collaboration with MD Anderson to accelerate development of ipadisumab through the opportunity to conduct multiple clinical trials with 1 of the world's most respected medical healthcare institutions. These efforts are in addition to our continued collaboration with our partners at Akesso, who continue to generate patient positive data in Phase II settings in both lung cancer and solid tumors outside of lung cancer, data which can help support additional late stage clinical trials. These accomplishments have been foundational to our 2024 goals of successfully executing on our registrational Phase III trials while expanding our clinical development program. Mackie will further expound upon these accomplishments, including additional strides we have made to drive our firm continued belief and conviction in Team Summit and the potential of venizumab in non small cell lung cancer and beyond. We are an experienced mission driven organization with a collective goal to improve quality of life, increase potential duration of life and resolve serious unmet medical needs. Speaker 200:06:06We believe we have the right team and the right molecule in obenizumab to help us realize this scope. With that, I will turn the call over to Maikki for additional context and recent highlights for consideration. Speaker 300:06:17Thank you, Bob, and good morning, everyone. As Bob mentioned, I remain incredibly enthusiastic about the accomplishments of Team Summit and our partnership with Ekoso. Before touching on the clinical highlights of Ibonizumab, I would like to speak to the expansive clinical development work we have conducted with Ibonizumab. Between SUMMIT and AKSO, over 1800 patients have been treated with abonesimab in clinical studies to date worldwide. There have been 20 clinical trials around the globe evaluating abanecimab. Speaker 300:06:50While our Phase III programs across Summit and EKSO are currently focused in non small cell lung cancer, 7 of the clinical trials for ivanizumab are evaluating our lead candidate in solid tumor settings beyond non small cell lung cancer. Of course, we are sponsoring 2 clinical trials, both of which are Phase III studies, HARMONY and HARMONY 3. As a reminder, avanizumab is the only PD-one VEGF bispecific antibody in Phase III in our licensed territories. Abanesimab brings these 2 highly validated mechanism of action together into 1 novel molecule targeting simultaneously both PD-one and VEGF. Next, I would like to review our recent achievements as well as touch on some upcoming catalysts for the remainder of this year. Speaker 300:07:38As a reminder, our partnership with EKESO became effective at the beginning of 2023. At the time, EKESO was enrolling or completing enrollment in 2 Phase 3 clinical trials. We immediately got to work and enrolled our first patient in Harmony in the first half of twenty twenty three, began Harmony 3 enrollment in the Q4 of 2023 and helped to ensure Ibonizumab was featured at several medical conferences. The Q2 of 2024 was a pivotal moment for Ibonizumab and its development, with 2 major catalyst events occurring around the time of the ASCO 2024 Conference. Abonizumab received marketing approval in China supported by AKECO HARMONY A Phase 3 clinical trial for patients with advanced non small cell lung cancer who progressed following an EGFR TKI. Speaker 300:08:30This data was subsequently featured in an oral presentation at ASCO and the HARMONY A study was published in the Journal of American Medical Association or JAMA. We also announced that HARMONY II met its primary endpoint of progression free survival in pre specified interim analysis in which Ibonizumab monotherapy in a head to head trial against pembro monotherapy achieved a statistical significant and clinically meaningful benefit in patients in China with first line non small cell lung cancer patients whose tumors were positive for PD L1 expression. Improvement in PFS was observed broadly across subgroups, including PD L1 low and PD L1 high expressing tumors as well as squamous and non squamous histologies. We look forward to having additional HARMONY 2 data presented at a major medical conference this quarter. Looking to the remainder of 2024, in addition to the HARMONY 2 data readout, we plan to complete enrollment in our multireginal HARMONY trial later this year and expect additional Phase 2 data in lung and non lung indications to be presented at multiple medical conferences in the coming months, including the World Conference on Lung Cancer and ESMO. Speaker 300:09:44ESMO recently released abstract titles featuring abanizumab in Phase II studies in triple negative breast cancer, colorectal cancer and head and neck cancer. We are fortunate to have created such a strong partnership in our ongoing collaboration with EKESO as we leverage data from multiple solid tumor studies, supporting and informing Summit's own late stage clinical development strategy in our licensed territories. With meaningful updates from AKSO HARMONY A and HARMONY 2 occurring this past quarter, we wanted to take the opportunity on this quarter's earnings call to review both Phase III study design and highlight some key results. Starting with HARMONY A. This is a double blinded, placebo controlled, single region, randomized Phase III trial evaluating abanecimab + chemotherapy versus placebo plus chemotherapy for patient with advanced or metastatic EGFR mutant non small cell lung cancer and disease progression after EGFR TKI treatment. Speaker 300:10:45322 patients were enrolled across 55 study sites in China and patients were stratified for exposure to 3rd generation EGFR TKI treatment and the presence of brain metastasis. As a reminder, approximately 85% of HARMONY A patients are intended to be included in our own HARMONY study analysis representing those patients in HARMONY A who received a 3rd generation EGFR TKI prior to entering the trial. In Harmony A, the primary endpoint of progression free survival per independent Radiologic Review Committee was met achieving a PFS hazard ratio of 0.46, representing a 54% reduction in the risk of disease progression or death compared to chemotherapy. Additionally, the subgroup of patient receiving a 3rd generation EGFR TKI like osimertinib experienced a reduced risk of disease progression or death of 52% or had a ratio of 0.48 as our HARMONY trial enrollment is expected to complete in the second half of this year. We remain strongly encouraged by the opportunity for iwanesezumab. Speaker 300:11:57In addition, an overall survival analysis of the HARMONY A data was requested by the Chinese regulatory authority as a part of its review of Ibonizumab for marketing approval in China. At 52% data maturity, median overall survival in the ibonizumab arm showed a positive survival trend with a hazard ratio of 0.80. Ibanezumab was well tolerated and demonstrated a manageable safety profile. Treatment related adverse events leading to discontinuation were 5.6% in the treatment arm compared to 2.5% in the placebo arm, and there were no deaths reported in either arm. Grade 3 or higher immune related adverse events were reported in 6 point 2% of patients in the treatment arm versus 2.5% of patients in the placebo arm. Speaker 300:12:47Grade 3 or higher potential VJF related adverse events were reported in 3.1% of patient in the treatment arm versus 2.5% of patients in the placebo arm. There were no Grade 3 or higher bleeding events observed in either arm. Moving to HARMONY 2, this AKSO sponsored study in a single region, multicenter, double blinded, randomized Phase 3 trial evaluating monotherapy abanezumab head to head against monotherapy pembrolizumab as first line treatment of patients with locally advanced or metastatic non small cell lung cancer whose tumors have positive PD L1 expression or a TPS score of greater than 1%. Patients in the study are stratified by PD L1 low or TPS scores for 1% to 49% and PD L1 high or TPS score of 50% or greater squamous versus non squamous histology and stage of disease. HARMONY-two primary input is progression free survival as measured by independent Radiologic Review Committee. Speaker 300:13:48In high level results for HARMONY-two, Ibanezumab demonstrated statistically significant clinically meaningful improvement in progression free survival over pembrolizumab. This benefit was observed across patient subgroup, including PD L1 low, PD L1 high squamous and non squamous histology as well as other high risk patients. Notably, no other randomized Phase 3 clinical trials in non small cell lung cancer have demonstrated statistically significant improvement in progression free survival in head to head setting versus pembrolizumab. As mentioned previously, we are eager to share more information when the HARMONY-two interim analysis data set is presented at an upcoming major medical conference this quarter. The PD L1 subgroups as well as the subgroups by histology are important in terms of informing next steps in our clinical development pathway for indication both within lung and beyond lung. Speaker 300:14:42We had many highlights this past quarter and touched on most of them already, but would like to mention our 5 year strategic collaboration with the MD Anderson Cancer Center that was announced last month in which the development of evanesimab will be accelerated in several solid tumor types across multiple studies. MD Anderson will lead these clinical trials to evaluate the safety and potential clinical benefit of abonizumab, including the possibility of identifying biomarkers through additional research activities. Early work may include renal cell carcinoma, colorectal cancer, skin cancer, breast cancer and glioblastoma. The partnership has the potential to rapidly expand abanizumab's development program. We expanded our license territories to Latin America, including Mexico and all countries in Central America, South America and the Caribbean, the Middle East and Africa, in addition to our original license territories, which include the U. Speaker 300:15:35S, Europe, Canada and Japan. We are excited to expand, open our existing territories as we seek to bring arbanesumab to as many people around the globe as possible. In addition, I would like to take a moment to acknowledge that we straightened our greater team recently with 2 new appointment to our Board of Directors. In April 2024, renowned executive engineer miss Ed, Doctor. Mostafa Ronari joined our Board. Speaker 300:16:01He has played a leading role in the development of technology, which have helped improve the odds for patients with cancer, including biomarker driven diagnostics such as next generation sequencing technology and platforms. YASK co founded several companies as well as being Illumina's Chief Technology Officer from 2,008 to 2021. In June, Mr. Jeff Huber, the transformational Google and Grail executive joined our Board as well. Prior to his current role leading TriTomy Capital, ABC firm, Jeff was the founding CEO and Vice Chairman of Grail, a mission driven company seeking to detect cancer early when it can't be cured. Speaker 300:16:40Prior to Grail, he was a Senior Vice President at Alphabet Inc, formerly known as Google Inc. Over 30 years at Google, he co founded Google's life sciences effort in Google X, and he led development and scaling of Google Maps, Google Apps such as Gmail, Google Calendar, Google Docs as well as Google Ads. Jeff managed a team of over 5,000 employees and 5,000,000,000 P and L during his time at Google. In addition, Jeff is also a Board member at several other cutting edge companies. We are fortunate to have Mostafa and Jeff perspectives and expertise as they join us in our mission to make a significant positive difference in the lives of patients with serious unmet medical need. Speaker 300:17:20Finally, I would like to take a moment to thank Team Summit as Bob and I have described all of the accomplishments we have achieved over the past year and a half with Ibonizumab, this team has done a remarkable job across every team in making our goals a reality. It is tremendous honor and privilege to work with each member of Team Summit, and I would like to express my heartfelt thanks to each and every one of our great team members. With that update, I will now ask Manmeet to provide details on our financial position and outlook. Manmeet? Speaker 400:17:52Thank you, Mickey, and good morning, everyone. We filed this morning our 10 Q for the Q2 of 2024. Today, I will provide you with an update on 3 items: our cash position after our recent $200,000,000 financing our updated cash runway guidance and 2nd quarter operating expenses. Let me start with cash position. We ended the Q2 of 2024 with a cash position of $325,800,000 This cash position was strengthened at the end of second quarter with the closing of a $200,000,000 unsolicited private placement from a single institutional investor in June 2024. Speaker 400:18:38This morning, we also filed a Form S-three in order to register the shares, which were issued in the private placement on June 6, 2024. Moving to updated cash runway guidance. Based on our planned operations, including our 2 Phase 3 clinical trials, we updated our cash runway guidance and now expect that we have sufficient cash to run our operations into Q4 of 2025. Turning to operating expenses, I'll provide details to both GAAP and non GAAP numbers. You can refer to our press release issued this morning for a reconciliation of GAAP to non GAAP financial measures. Speaker 400:19:21Non GAAP expenses exclude stock based compensation and one time charges related to acquired in process R and D expenses. Our GAAP R and D expenses during the Q2 were $30,800,000 compared to $30,900,000 for the Q1 of 2024. And non GAAP R and D expenses were $27,300,000 in the Q2 of 2024 compared to $28,500,000 for the Q1 of 2024. Our GAAP acquired IP R and D expenses during the Q2 were $15,000,000 compared to 0 for the Q1 of 2024. This $15,000,000 expense is related to our upfront consideration for adding territories of Latin America, Africa and Middle East as per the June 2024 license agreement amendment with the QESO. Speaker 400:20:19Turning to G and A, GAAP G and A expenses for our Q2 2024 totaled to $14,000,000 compared to $11,700,000 for the Q1 of 2024. And non GAAP G and A expenses were $6,400,000 during the Q2 of 2024 compared to 4,600,000 dollars for the Q1 of 2024. Overall, our non GAAP operating expenses during Q2 2024 were $33,700,000 consistent with $33,100,000 for the Q1 of 2024. And with that, I will hand it back over to Dave. Speaker 100:20:59Thank you, Bob, McKee and Mahmed. We'll now see if there are any questions that our team can help answer. Christina, if you could please open the line for questions. Operator00:21:09Yes. Thank you. And your first question comes from the line of Brad Canino from Stifel. Your line is open. Speaker 500:21:31Great. Thanks for taking our question. This is Dara Azar on for Brad. Could you be able to walk through the puts and takes of data disclosure if Harmony 2 is at work long? When is the title allowance or things like should we expect an abstract text before the presentation to have a lifted embargo? Speaker 500:21:54And if so, what data could be included in the abstract? Speaker 100:21:59Sure. Thanks, Dara. I appreciate the question. This is Dave, responding. So, as you can imagine, our HARMONY-two data is considered a late breaker abstract at the World Conference For Lung Cancer OR World Lung. Speaker 100:22:15So our partners at Akesso previously announced their intention to submit the HARMONY-two data to the World Lung Conference. And so the deadline for abstracts for World Lung were July 31. Notifications to the primary authors of each of those abstracts that are late breakers are provided early in August, but generally between the 7th 10th August. Traditionally, what our understanding of what World Lung does is around August 15 releases the titles and abstracts for most of the remaining. So they released some of the original titles already. Speaker 100:22:58But for the remaining titles and abstracts released around August 15th. However, what they do is they withhold a number of what they consider presidential symposium or otherwise larger presentations until the actual conference itself, at which point they only release the title, but the abstract is held until the conference itself. So at this point, because we haven't yet technically hit the acceptance time period of August 7 to 10, we're not yet made aware in terms of whether our abstracts will be held back or not. So Dara, I appreciate the question. It's a very good question in terms of exactly the time line of when things will come up. Speaker 100:23:37But until we hit the approval date from World Lung between the 7th 10th August and then they announce what they will and won't hold back until the conference itself. We'll need to wait patiently alongside you in terms of those details. Speaker 500:23:53Yes, very helpful overview. If I may ask a follow-up, what is your latest view on OS maturity, if it's going to be mature enough to for inclusion in the presentation? If not, would there be any language in the abstract to describe the trend observed? And if there's time, I'll come back for another follow-up. Speaker 100:24:17Sure, Dara. So this is Dave again. I'll start and then I'll let Alan add any additional context that he'd like to. But if you recall, from the earlier trials that were run with pembrolizumab is a monotherapy in the setting, the KEYNOTE-twenty four and the KEYNOTE-forty two settings. There was the time period by which they reached their survival maturity was a little bit longer than the time period in which this trial has matured from last patient in. Speaker 100:24:47So as a reminder, HARMONY 2 completed enrollment around the end of Q3, beginning of Q4 of 2023. And so as that interim analysis was run and ultimately the IDMC met and then we released the top line data along with our partners at Akesso in May, not a lot of time from an overall survival perspective had transpired from when the trial completed enrollment. And so as a result, anything that we have at this point will be early. So we haven't made definitive announcements or decisions on exactly what will be presented with respect to overall survival. But what I would say is, it's we're not holding anything back at this point as much as time needs to take place for these patients to remain on trial and study to get a mature enough readout for overall survival at a mature level. Speaker 600:25:41Yes. Not much to add, Dave, except that it is very early in this study. Remember, they just completed enrollment. This study hit its first primary or interim analysis very early. So the data were very immature at the time. Speaker 600:25:53And I think that goes to the strength of the PFS data to date. Speaker 500:25:59Yes. Thank you. It makes a lot of sense. And as a last 2 parter, without OS, how do you think about what constitutes a good PFS result in isolation? And finally, how should we be thinking about additional Phase III plans perhaps announcement in relation to Harmony 2 medical meeting update? Speaker 500:26:26That's it for me. Thank you. Speaker 600:26:28Yes. So I'll take the first question. In terms of the PFS, we're not going to comment on that. You'll have to come see us at that meeting and then you'll see the results there. And I understand why everybody is interested in that. Speaker 600:26:39We're just not going to disclose it at this time. In terms of additional Phase III programs, you probably won't make announcements at World Lung, but you'll see some data maturing in lungs and some other lung indications as well. And the development plan that will be fairly obvious in terms of recreating sort of key studies that Merck or AstraZeneca has done in the past and we'll probably prioritize based on unmet need. Operator00:27:12Okay, great. Thank you. And your next question comes from the line of Yigal Nochomovitz from Citigroup. Your line is open. Speaker 700:27:20Hi, great. Thanks so much for taking the question. Obviously, a very key one for investors, and I've received a lot of questions on is the read through from Harmony 2 to Harmony 3. So I'm curious given the apparent strength of the PFS data in HARMONY 2, could you comment as to how you're thinking about the addition of the chemo backbone in terms of extracting the relative benefit of ivenezkumab over KEYTRUDA in squamous in HARMONY-three? And I have a few follow ups. Speaker 700:27:48Thanks. Speaker 600:27:49Yes, Yigal. Thanks for the question. So we're very confident for HARMONY 3. I think the strength of the HARMONY 2 data has given us more confidence. I mean remember we decided to do HARMONY 3 before the HARMONY 2 data were available. Speaker 600:28:03So we thought that squamous was an unmet need. We thought that VEGF targeted agents were never developed in squamous because of safety concerns. We did not see those safety concerns in the development of Ibenesimab and that's why we thought HARMONY-three was low hanging fruit for Ibenesimab. Given the strength of the HARMONY-two data, we're even more confident. The addition of chemotherapy may change things in terms of reduction of tumors, but I don't think it will change biologically the importance of vivenezumab for this population. Speaker 600:28:35And then the second question was on Speaker 100:28:39Sorry, Yigal, could you repeat the second question? Speaker 700:28:42I didn't ask it yet. The second one was just to confirm, so for Harmony 2, it's TPS greater than 1%. For Harmony 3, is it all TPS scores? And does that make any notable difference in your mind or not really? Speaker 600:28:56Yes. It's for all TPS scores and it did. Going into this study in terms of the HARMONY-three before we had the HARMONY-two results, I was actually more confident in the lower TPS expressing or the lower PD L1 expressing patients because of the VEGF component. But looking at the HARMONY-two data, as we said publicly, we seem to see a benefit across PD L1 expression levels. So we don't think it matters what patients will come on to the study. Speaker 700:29:24Okay. Another key question in terms of the catalyst path for the company is potential interim readouts for Harmony 3 and I understand they're built into the protocol. Could you comment at all as to what might be in store as far as potential interim readouts for Harmony 3 over the next several quarters? Thanks. Speaker 600:29:44Yes, Yigal. That's a great question and we can't really disclose that and we haven't disclosed that at this time. I will say that our Akerso partners are running a parallel study called the 306 study, which is actually in the similar population, which is Ibanezumab against tislelutuzumab, which is the standard of care in China. So those results won't be out earlier as well, but we haven't disclosed nor has our Ocassa partner disclosed any timelines around that. Speaker 700:30:12Okay. And then the last question is, I think, Mickey mentioned that there were some abstract titles for some of these other solid tumors in Phase 2, triple negative breast, colorectal, head and neck. But then you also are starting the MD Anderson partnership. So can you just kind of comment on how those two work streams are going to intersect between your own Phase 2 work as well as what MD Anderson is doing with respect to tumors outside of lung? Speaker 600:30:38Hey, Yigal. Thanks for the question. Yes. So first of all, the MD Anderson collaboration is very exciting. Speaking with physicians and experts at MD Anderson gives us access to a treasure trove of scientific and clinical expertise. Speaker 600:30:52I think if you look at the way the 2 programs interact, remember, Kesso is doing a lion's share of the Phase 2 work and they've done quite a lot of Phase 2 work. However, there might be some minor gaps in the sense that the standard care in China is different or certain tumor types are not as prevalent in China. And this is where MD Anderson can help us get quick signals, some Phase II data as well. And then again, the scientific China, this is where the gap will be filled with MD Anderson without specific questions. Do you have specific questions on specific tumor types? Speaker 700:31:38No, not at this point, but that's helpful. Thank you. Speaker 400:31:40Yes, yes. Thanks, Yigal. Thanks, Yigal. Operator00:31:45Your next question comes from the line of Mitchell Kapoor from H. C. Wainwright. Your line is open. Speaker 800:31:52Everyone, thanks for taking our questions and congrats on Speaker 100:31:55the recent data. Speaker 800:31:56The first question I have here is just given the fact that most of the 420 HARMONY patients will be bundled from HARMONY A, would you potentially envision something similar for leveraging the HARMONY 2 data in the U. S? Speaker 600:32:14Possibly. And so we're in the midst of sort of discussions with the agency. It's clear that we won't be able to file on the HARMONY 2 data in all regions. And so that's something that we're going to try to address. However, there is an opportunity to leverage the HARMONY-two data in future studies as well without disclosing more than that. Speaker 800:32:38Okay, great. Thank you. And then just broadly on the use of Ibenetimab in lower PD L1 TPS scores, thinking like closer to 1 versus the 49 range. Is there a threshold where Ibanezumab becomes more clearly effective? Speaker 600:32:57Yes. Well, so I think the best data results are from the 201 and the 202 study, the Phase II data. And you see a clear trend where the response rate does increase as PD L1 expression increases. And in the opposite direction, as PD L1 expression decreases, the level of activity drops off, but not as sharply as other PD-one or PD L1 agents. So I think this is probably the VEGF effect. Speaker 600:33:24And there are other bispecific immunotherapies out there like PD-one CTLA-four that are looking at the PD-one negatives. So the question is how good will we be there and I think we'll be pretty strong there as well. So I get the question, we see the benefit across the whole spectrum. The benefit seems to be greater in the high PD-one. And relative to PD-1s, where is that relative benefit? Speaker 600:33:51The relative benefit is actually greater even though the overall response rate is a little bit lower in the low PD L1 expression. I know this is kind of confusing, but again, I think we see good activity across all PD L1 expressions. There's a slight increase for ivenezumab for the PD-1s, high expressing PD L1 high expressing as well. Speaker 100:34:10As a reference point, this is Dave Mitchell, that you can go back to is the ASCO 2023 poster, which actually kind of lays out by PD L1 expression status in the Phase II trials as Alan mentioned, especially in combination with chemo, the relative benefit in the by PD L1 expression. Speaker 800:34:33Great. Thank you, Dave and Alan. Really appreciate it. It makes a lot of sense. Operator00:34:54Thank you. With no further questions, Dave, I'll turn the floor back over to you. Speaker 100:34:59Thank you very much. We appreciate everyone taking the time to join us this morning for our quarterly earnings call. We appreciate your continued support and we wish you a great day. Thank you very much. Operator00:35:10Thank you. Once again, this does conclude today's conference call. You may now disconnect. Have a great day.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallSummit Therapeutics Q2 202400:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Summit Therapeutics Earnings Headlines3 Magnificent Stocks That Could Double or More by 2030April 12, 2025 | fool.comWhy Summit Therapeutics Inc. (SMMT) Surged On Friday?April 12, 2025 | msn.comNew “Trump” currency proposed in DCAccording to one of the most connected men in Washington… A surprising new bill was just introduced in Washington. Its purpose: to put Donald Trump’s face on the $100 note. All to celebrate a new “golden age” for America. April 17, 2025 | Paradigm Press (Ad)Investors Purchase Large Volume of Summit Therapeutics Call Options (NASDAQ:SMMT)April 11, 2025 | americanbankingnews.comSummit co-CEO option exercise ‘quite bullish,’ says Cantor FitzgeraldApril 11, 2025 | markets.businessinsider.comSummit Therapeutics (SMMT) Gets a Buy from Truist FinancialApril 11, 2025 | markets.businessinsider.comSee More Summit Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Summit Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Summit Therapeutics and other key companies, straight to your email. Email Address About Summit TherapeuticsSummit Therapeutics (NASDAQ:SMMT), a biopharmaceutical company, focuses on discovery, development, and commercialization of patient, physician, caregiver, and societal friendly medicinal therapies in the United States, and the United Kingdom. The company's lead development candidate is Ivonescimab, a bispecific antibody for immunotherapy through blockade of PD-1 with the anti-angiogenesis; and anti-infectives portfolio includes SMT-738, a novel class of precision antibiotics for the treatment of multidrug resistant infections, which primarily includes carbapenem-resistant Enterobacteriaceae infections. It has a collaboration and license agreement with Akeso, Inc. and its affiliates to develop and commercialize ivonescimab, as well as strategic collaboration with The University of Texas MD Anderson Cancer Center for the purpose of accelerating the development of ivonescimab. The company was founded in 2003 and is headquartered in Miami, Florida.View Summit Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Tesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s Next Upcoming Earnings HDFC Bank (4/18/2025)Tesla (4/22/2025)Intuitive Surgical (4/22/2025)Verizon Communications (4/22/2025)Canadian National Railway (4/22/2025)Novartis (4/22/2025)RTX (4/22/2025)3M (4/22/2025)Capital One Financial (4/22/2025)General Electric (4/22/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 9 speakers on the call. Operator00:00:00Good morning, and welcome to Summit Therapeutics Second Quarter 20 24 Earnings and Update Call. All participants will be in listen only mode until the question and answer portion of this call. We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the company's website for updates. Operator00:00:27And please note that today's call is being recorded. And at this time, I would like to turn the call over to Dave Gengars, Summit Therapeutics' Chief Business and Strategy Officer. You may proceed. Speaker 100:00:51Good morning, and thank you for joining us. Our press release was issued earlier this morning and is available on the homepage of our website. Our Form 10 Q was also filed earlier this morning and is available on our website. Today's call is being simultaneously webcast and an archived replay will also be made available later today on our website, Speaker 200:01:12www.smmptx.com. Speaker 100:01:16Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer Doctor. Mekhi Zangadeh, our Chief Executive Officer and President Manmeet Soni, our Chief Operating Officer and Chief Financial Officer and Doctor. Alan Yang, our Chief Medical Officer. Before we get started with the rest of the call, I would like to note that some statements made by our management team and some responses to questions that we may make today may be considered forward looking statements based on our current expectations. Summit cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward looking statements. Speaker 100:01:56Please refer to our SEC filings for information about these risks and uncertainties. Summit undertakes no obligation to update these forward looking statements, except as required by law. Following comments from Bob, McKee and Manmeet, we will take questions. With that, I would like to turn the call over to Bob. Speaker 200:02:15Thank you, Dave. Good morning, everyone, and thank you for joining us today. We're very proud of the recent accomplishments of Team Summit and the expanding positive information that continues to be brought to light surrounding avinizumab, our lead's investigational asset. The past few months have been pivotal to the positive development and awareness of avanizumab as well as in expanding physician, caretaker, hospital, payer and patient awareness of Summit Therapeutics' mission and vision, namely to build a viable organization that makes a significant positive difference for the betterment of patients encountering serious unmet oncology medical needs. Specifically, abanizumab created positive Phase III data updates from HARMONY A and HARMONY 2, both of which were randomized single region clinical trials in non small cell lung cancer conducted by our partners at Akesso. Speaker 200:03:12HARMONY A results supported ibenizumab receiving its first regulatory approval in China for patients with advanced non small cell lung cancer who have progressed following an EGFR TKI. In HARMONY-two, Ibenizumab monotherapy beat pembrolizumab monotherapy head to head in the study's primary endpoint of PFS, making ivanizumab the 1st drug to achieve a clinically meaningful efficacy benefit over pembrolizumab in a randomized Phase 3 clinical trial in non small cell lung cancer. Additional data from this pre specified interim analysis will be presented at an upcoming major medical conference this quarter. In addition, we raised an unsolicited $200,000,000 at a premium over the then current market price, extending our cash runway and increasing our resources to execute our expansive goals. Manmeet will provide more details about our financial position in a few minutes. Speaker 200:04:12SUMMIT's 2 multi regional registrational Phase 3 non small cell lung cancer trials, HARMONY and HARMONY 3, continue to enroll. HARMONY remains on track to complete its planned enrollment later this year. Alongside our partners at Akesso, abanizumab data was featured at ASCO as well as Harmony A data being published in JAMA, Journal of American Medical Association. This, in addition to smaller conferences and best of ASCO follow-up meetings, have been excellent in fostering KOL discussions regarding the future of cancer therapy, including the potential for evidenzumab. These efforts were further bolstered as we continue to ramp our investigator sponsored trial, or IST program. Speaker 200:04:58Last month, we announced a 5 year strategic collaboration with MD Anderson to accelerate development of ipadisumab through the opportunity to conduct multiple clinical trials with 1 of the world's most respected medical healthcare institutions. These efforts are in addition to our continued collaboration with our partners at Akesso, who continue to generate patient positive data in Phase II settings in both lung cancer and solid tumors outside of lung cancer, data which can help support additional late stage clinical trials. These accomplishments have been foundational to our 2024 goals of successfully executing on our registrational Phase III trials while expanding our clinical development program. Mackie will further expound upon these accomplishments, including additional strides we have made to drive our firm continued belief and conviction in Team Summit and the potential of venizumab in non small cell lung cancer and beyond. We are an experienced mission driven organization with a collective goal to improve quality of life, increase potential duration of life and resolve serious unmet medical needs. Speaker 200:06:06We believe we have the right team and the right molecule in obenizumab to help us realize this scope. With that, I will turn the call over to Maikki for additional context and recent highlights for consideration. Speaker 300:06:17Thank you, Bob, and good morning, everyone. As Bob mentioned, I remain incredibly enthusiastic about the accomplishments of Team Summit and our partnership with Ekoso. Before touching on the clinical highlights of Ibonizumab, I would like to speak to the expansive clinical development work we have conducted with Ibonizumab. Between SUMMIT and AKSO, over 1800 patients have been treated with abonesimab in clinical studies to date worldwide. There have been 20 clinical trials around the globe evaluating abanecimab. Speaker 300:06:50While our Phase III programs across Summit and EKSO are currently focused in non small cell lung cancer, 7 of the clinical trials for ivanizumab are evaluating our lead candidate in solid tumor settings beyond non small cell lung cancer. Of course, we are sponsoring 2 clinical trials, both of which are Phase III studies, HARMONY and HARMONY 3. As a reminder, avanizumab is the only PD-one VEGF bispecific antibody in Phase III in our licensed territories. Abanesimab brings these 2 highly validated mechanism of action together into 1 novel molecule targeting simultaneously both PD-one and VEGF. Next, I would like to review our recent achievements as well as touch on some upcoming catalysts for the remainder of this year. Speaker 300:07:38As a reminder, our partnership with EKESO became effective at the beginning of 2023. At the time, EKESO was enrolling or completing enrollment in 2 Phase 3 clinical trials. We immediately got to work and enrolled our first patient in Harmony in the first half of twenty twenty three, began Harmony 3 enrollment in the Q4 of 2023 and helped to ensure Ibonizumab was featured at several medical conferences. The Q2 of 2024 was a pivotal moment for Ibonizumab and its development, with 2 major catalyst events occurring around the time of the ASCO 2024 Conference. Abonizumab received marketing approval in China supported by AKECO HARMONY A Phase 3 clinical trial for patients with advanced non small cell lung cancer who progressed following an EGFR TKI. Speaker 300:08:30This data was subsequently featured in an oral presentation at ASCO and the HARMONY A study was published in the Journal of American Medical Association or JAMA. We also announced that HARMONY II met its primary endpoint of progression free survival in pre specified interim analysis in which Ibonizumab monotherapy in a head to head trial against pembro monotherapy achieved a statistical significant and clinically meaningful benefit in patients in China with first line non small cell lung cancer patients whose tumors were positive for PD L1 expression. Improvement in PFS was observed broadly across subgroups, including PD L1 low and PD L1 high expressing tumors as well as squamous and non squamous histologies. We look forward to having additional HARMONY 2 data presented at a major medical conference this quarter. Looking to the remainder of 2024, in addition to the HARMONY 2 data readout, we plan to complete enrollment in our multireginal HARMONY trial later this year and expect additional Phase 2 data in lung and non lung indications to be presented at multiple medical conferences in the coming months, including the World Conference on Lung Cancer and ESMO. Speaker 300:09:44ESMO recently released abstract titles featuring abanizumab in Phase II studies in triple negative breast cancer, colorectal cancer and head and neck cancer. We are fortunate to have created such a strong partnership in our ongoing collaboration with EKESO as we leverage data from multiple solid tumor studies, supporting and informing Summit's own late stage clinical development strategy in our licensed territories. With meaningful updates from AKSO HARMONY A and HARMONY 2 occurring this past quarter, we wanted to take the opportunity on this quarter's earnings call to review both Phase III study design and highlight some key results. Starting with HARMONY A. This is a double blinded, placebo controlled, single region, randomized Phase III trial evaluating abanecimab + chemotherapy versus placebo plus chemotherapy for patient with advanced or metastatic EGFR mutant non small cell lung cancer and disease progression after EGFR TKI treatment. Speaker 300:10:45322 patients were enrolled across 55 study sites in China and patients were stratified for exposure to 3rd generation EGFR TKI treatment and the presence of brain metastasis. As a reminder, approximately 85% of HARMONY A patients are intended to be included in our own HARMONY study analysis representing those patients in HARMONY A who received a 3rd generation EGFR TKI prior to entering the trial. In Harmony A, the primary endpoint of progression free survival per independent Radiologic Review Committee was met achieving a PFS hazard ratio of 0.46, representing a 54% reduction in the risk of disease progression or death compared to chemotherapy. Additionally, the subgroup of patient receiving a 3rd generation EGFR TKI like osimertinib experienced a reduced risk of disease progression or death of 52% or had a ratio of 0.48 as our HARMONY trial enrollment is expected to complete in the second half of this year. We remain strongly encouraged by the opportunity for iwanesezumab. Speaker 300:11:57In addition, an overall survival analysis of the HARMONY A data was requested by the Chinese regulatory authority as a part of its review of Ibonizumab for marketing approval in China. At 52% data maturity, median overall survival in the ibonizumab arm showed a positive survival trend with a hazard ratio of 0.80. Ibanezumab was well tolerated and demonstrated a manageable safety profile. Treatment related adverse events leading to discontinuation were 5.6% in the treatment arm compared to 2.5% in the placebo arm, and there were no deaths reported in either arm. Grade 3 or higher immune related adverse events were reported in 6 point 2% of patients in the treatment arm versus 2.5% of patients in the placebo arm. Speaker 300:12:47Grade 3 or higher potential VJF related adverse events were reported in 3.1% of patient in the treatment arm versus 2.5% of patients in the placebo arm. There were no Grade 3 or higher bleeding events observed in either arm. Moving to HARMONY 2, this AKSO sponsored study in a single region, multicenter, double blinded, randomized Phase 3 trial evaluating monotherapy abanezumab head to head against monotherapy pembrolizumab as first line treatment of patients with locally advanced or metastatic non small cell lung cancer whose tumors have positive PD L1 expression or a TPS score of greater than 1%. Patients in the study are stratified by PD L1 low or TPS scores for 1% to 49% and PD L1 high or TPS score of 50% or greater squamous versus non squamous histology and stage of disease. HARMONY-two primary input is progression free survival as measured by independent Radiologic Review Committee. Speaker 300:13:48In high level results for HARMONY-two, Ibanezumab demonstrated statistically significant clinically meaningful improvement in progression free survival over pembrolizumab. This benefit was observed across patient subgroup, including PD L1 low, PD L1 high squamous and non squamous histology as well as other high risk patients. Notably, no other randomized Phase 3 clinical trials in non small cell lung cancer have demonstrated statistically significant improvement in progression free survival in head to head setting versus pembrolizumab. As mentioned previously, we are eager to share more information when the HARMONY-two interim analysis data set is presented at an upcoming major medical conference this quarter. The PD L1 subgroups as well as the subgroups by histology are important in terms of informing next steps in our clinical development pathway for indication both within lung and beyond lung. Speaker 300:14:42We had many highlights this past quarter and touched on most of them already, but would like to mention our 5 year strategic collaboration with the MD Anderson Cancer Center that was announced last month in which the development of evanesimab will be accelerated in several solid tumor types across multiple studies. MD Anderson will lead these clinical trials to evaluate the safety and potential clinical benefit of abonizumab, including the possibility of identifying biomarkers through additional research activities. Early work may include renal cell carcinoma, colorectal cancer, skin cancer, breast cancer and glioblastoma. The partnership has the potential to rapidly expand abanizumab's development program. We expanded our license territories to Latin America, including Mexico and all countries in Central America, South America and the Caribbean, the Middle East and Africa, in addition to our original license territories, which include the U. Speaker 300:15:35S, Europe, Canada and Japan. We are excited to expand, open our existing territories as we seek to bring arbanesumab to as many people around the globe as possible. In addition, I would like to take a moment to acknowledge that we straightened our greater team recently with 2 new appointment to our Board of Directors. In April 2024, renowned executive engineer miss Ed, Doctor. Mostafa Ronari joined our Board. Speaker 300:16:01He has played a leading role in the development of technology, which have helped improve the odds for patients with cancer, including biomarker driven diagnostics such as next generation sequencing technology and platforms. YASK co founded several companies as well as being Illumina's Chief Technology Officer from 2,008 to 2021. In June, Mr. Jeff Huber, the transformational Google and Grail executive joined our Board as well. Prior to his current role leading TriTomy Capital, ABC firm, Jeff was the founding CEO and Vice Chairman of Grail, a mission driven company seeking to detect cancer early when it can't be cured. Speaker 300:16:40Prior to Grail, he was a Senior Vice President at Alphabet Inc, formerly known as Google Inc. Over 30 years at Google, he co founded Google's life sciences effort in Google X, and he led development and scaling of Google Maps, Google Apps such as Gmail, Google Calendar, Google Docs as well as Google Ads. Jeff managed a team of over 5,000 employees and 5,000,000,000 P and L during his time at Google. In addition, Jeff is also a Board member at several other cutting edge companies. We are fortunate to have Mostafa and Jeff perspectives and expertise as they join us in our mission to make a significant positive difference in the lives of patients with serious unmet medical need. Speaker 300:17:20Finally, I would like to take a moment to thank Team Summit as Bob and I have described all of the accomplishments we have achieved over the past year and a half with Ibonizumab, this team has done a remarkable job across every team in making our goals a reality. It is tremendous honor and privilege to work with each member of Team Summit, and I would like to express my heartfelt thanks to each and every one of our great team members. With that update, I will now ask Manmeet to provide details on our financial position and outlook. Manmeet? Speaker 400:17:52Thank you, Mickey, and good morning, everyone. We filed this morning our 10 Q for the Q2 of 2024. Today, I will provide you with an update on 3 items: our cash position after our recent $200,000,000 financing our updated cash runway guidance and 2nd quarter operating expenses. Let me start with cash position. We ended the Q2 of 2024 with a cash position of $325,800,000 This cash position was strengthened at the end of second quarter with the closing of a $200,000,000 unsolicited private placement from a single institutional investor in June 2024. Speaker 400:18:38This morning, we also filed a Form S-three in order to register the shares, which were issued in the private placement on June 6, 2024. Moving to updated cash runway guidance. Based on our planned operations, including our 2 Phase 3 clinical trials, we updated our cash runway guidance and now expect that we have sufficient cash to run our operations into Q4 of 2025. Turning to operating expenses, I'll provide details to both GAAP and non GAAP numbers. You can refer to our press release issued this morning for a reconciliation of GAAP to non GAAP financial measures. Speaker 400:19:21Non GAAP expenses exclude stock based compensation and one time charges related to acquired in process R and D expenses. Our GAAP R and D expenses during the Q2 were $30,800,000 compared to $30,900,000 for the Q1 of 2024. And non GAAP R and D expenses were $27,300,000 in the Q2 of 2024 compared to $28,500,000 for the Q1 of 2024. Our GAAP acquired IP R and D expenses during the Q2 were $15,000,000 compared to 0 for the Q1 of 2024. This $15,000,000 expense is related to our upfront consideration for adding territories of Latin America, Africa and Middle East as per the June 2024 license agreement amendment with the QESO. Speaker 400:20:19Turning to G and A, GAAP G and A expenses for our Q2 2024 totaled to $14,000,000 compared to $11,700,000 for the Q1 of 2024. And non GAAP G and A expenses were $6,400,000 during the Q2 of 2024 compared to 4,600,000 dollars for the Q1 of 2024. Overall, our non GAAP operating expenses during Q2 2024 were $33,700,000 consistent with $33,100,000 for the Q1 of 2024. And with that, I will hand it back over to Dave. Speaker 100:20:59Thank you, Bob, McKee and Mahmed. We'll now see if there are any questions that our team can help answer. Christina, if you could please open the line for questions. Operator00:21:09Yes. Thank you. And your first question comes from the line of Brad Canino from Stifel. Your line is open. Speaker 500:21:31Great. Thanks for taking our question. This is Dara Azar on for Brad. Could you be able to walk through the puts and takes of data disclosure if Harmony 2 is at work long? When is the title allowance or things like should we expect an abstract text before the presentation to have a lifted embargo? Speaker 500:21:54And if so, what data could be included in the abstract? Speaker 100:21:59Sure. Thanks, Dara. I appreciate the question. This is Dave, responding. So, as you can imagine, our HARMONY-two data is considered a late breaker abstract at the World Conference For Lung Cancer OR World Lung. Speaker 100:22:15So our partners at Akesso previously announced their intention to submit the HARMONY-two data to the World Lung Conference. And so the deadline for abstracts for World Lung were July 31. Notifications to the primary authors of each of those abstracts that are late breakers are provided early in August, but generally between the 7th 10th August. Traditionally, what our understanding of what World Lung does is around August 15 releases the titles and abstracts for most of the remaining. So they released some of the original titles already. Speaker 100:22:58But for the remaining titles and abstracts released around August 15th. However, what they do is they withhold a number of what they consider presidential symposium or otherwise larger presentations until the actual conference itself, at which point they only release the title, but the abstract is held until the conference itself. So at this point, because we haven't yet technically hit the acceptance time period of August 7 to 10, we're not yet made aware in terms of whether our abstracts will be held back or not. So Dara, I appreciate the question. It's a very good question in terms of exactly the time line of when things will come up. Speaker 100:23:37But until we hit the approval date from World Lung between the 7th 10th August and then they announce what they will and won't hold back until the conference itself. We'll need to wait patiently alongside you in terms of those details. Speaker 500:23:53Yes, very helpful overview. If I may ask a follow-up, what is your latest view on OS maturity, if it's going to be mature enough to for inclusion in the presentation? If not, would there be any language in the abstract to describe the trend observed? And if there's time, I'll come back for another follow-up. Speaker 100:24:17Sure, Dara. So this is Dave again. I'll start and then I'll let Alan add any additional context that he'd like to. But if you recall, from the earlier trials that were run with pembrolizumab is a monotherapy in the setting, the KEYNOTE-twenty four and the KEYNOTE-forty two settings. There was the time period by which they reached their survival maturity was a little bit longer than the time period in which this trial has matured from last patient in. Speaker 100:24:47So as a reminder, HARMONY 2 completed enrollment around the end of Q3, beginning of Q4 of 2023. And so as that interim analysis was run and ultimately the IDMC met and then we released the top line data along with our partners at Akesso in May, not a lot of time from an overall survival perspective had transpired from when the trial completed enrollment. And so as a result, anything that we have at this point will be early. So we haven't made definitive announcements or decisions on exactly what will be presented with respect to overall survival. But what I would say is, it's we're not holding anything back at this point as much as time needs to take place for these patients to remain on trial and study to get a mature enough readout for overall survival at a mature level. Speaker 600:25:41Yes. Not much to add, Dave, except that it is very early in this study. Remember, they just completed enrollment. This study hit its first primary or interim analysis very early. So the data were very immature at the time. Speaker 600:25:53And I think that goes to the strength of the PFS data to date. Speaker 500:25:59Yes. Thank you. It makes a lot of sense. And as a last 2 parter, without OS, how do you think about what constitutes a good PFS result in isolation? And finally, how should we be thinking about additional Phase III plans perhaps announcement in relation to Harmony 2 medical meeting update? Speaker 500:26:26That's it for me. Thank you. Speaker 600:26:28Yes. So I'll take the first question. In terms of the PFS, we're not going to comment on that. You'll have to come see us at that meeting and then you'll see the results there. And I understand why everybody is interested in that. Speaker 600:26:39We're just not going to disclose it at this time. In terms of additional Phase III programs, you probably won't make announcements at World Lung, but you'll see some data maturing in lungs and some other lung indications as well. And the development plan that will be fairly obvious in terms of recreating sort of key studies that Merck or AstraZeneca has done in the past and we'll probably prioritize based on unmet need. Operator00:27:12Okay, great. Thank you. And your next question comes from the line of Yigal Nochomovitz from Citigroup. Your line is open. Speaker 700:27:20Hi, great. Thanks so much for taking the question. Obviously, a very key one for investors, and I've received a lot of questions on is the read through from Harmony 2 to Harmony 3. So I'm curious given the apparent strength of the PFS data in HARMONY 2, could you comment as to how you're thinking about the addition of the chemo backbone in terms of extracting the relative benefit of ivenezkumab over KEYTRUDA in squamous in HARMONY-three? And I have a few follow ups. Speaker 700:27:48Thanks. Speaker 600:27:49Yes, Yigal. Thanks for the question. So we're very confident for HARMONY 3. I think the strength of the HARMONY 2 data has given us more confidence. I mean remember we decided to do HARMONY 3 before the HARMONY 2 data were available. Speaker 600:28:03So we thought that squamous was an unmet need. We thought that VEGF targeted agents were never developed in squamous because of safety concerns. We did not see those safety concerns in the development of Ibenesimab and that's why we thought HARMONY-three was low hanging fruit for Ibenesimab. Given the strength of the HARMONY-two data, we're even more confident. The addition of chemotherapy may change things in terms of reduction of tumors, but I don't think it will change biologically the importance of vivenezumab for this population. Speaker 600:28:35And then the second question was on Speaker 100:28:39Sorry, Yigal, could you repeat the second question? Speaker 700:28:42I didn't ask it yet. The second one was just to confirm, so for Harmony 2, it's TPS greater than 1%. For Harmony 3, is it all TPS scores? And does that make any notable difference in your mind or not really? Speaker 600:28:56Yes. It's for all TPS scores and it did. Going into this study in terms of the HARMONY-three before we had the HARMONY-two results, I was actually more confident in the lower TPS expressing or the lower PD L1 expressing patients because of the VEGF component. But looking at the HARMONY-two data, as we said publicly, we seem to see a benefit across PD L1 expression levels. So we don't think it matters what patients will come on to the study. Speaker 700:29:24Okay. Another key question in terms of the catalyst path for the company is potential interim readouts for Harmony 3 and I understand they're built into the protocol. Could you comment at all as to what might be in store as far as potential interim readouts for Harmony 3 over the next several quarters? Thanks. Speaker 600:29:44Yes, Yigal. That's a great question and we can't really disclose that and we haven't disclosed that at this time. I will say that our Akerso partners are running a parallel study called the 306 study, which is actually in the similar population, which is Ibanezumab against tislelutuzumab, which is the standard of care in China. So those results won't be out earlier as well, but we haven't disclosed nor has our Ocassa partner disclosed any timelines around that. Speaker 700:30:12Okay. And then the last question is, I think, Mickey mentioned that there were some abstract titles for some of these other solid tumors in Phase 2, triple negative breast, colorectal, head and neck. But then you also are starting the MD Anderson partnership. So can you just kind of comment on how those two work streams are going to intersect between your own Phase 2 work as well as what MD Anderson is doing with respect to tumors outside of lung? Speaker 600:30:38Hey, Yigal. Thanks for the question. Yes. So first of all, the MD Anderson collaboration is very exciting. Speaking with physicians and experts at MD Anderson gives us access to a treasure trove of scientific and clinical expertise. Speaker 600:30:52I think if you look at the way the 2 programs interact, remember, Kesso is doing a lion's share of the Phase 2 work and they've done quite a lot of Phase 2 work. However, there might be some minor gaps in the sense that the standard care in China is different or certain tumor types are not as prevalent in China. And this is where MD Anderson can help us get quick signals, some Phase II data as well. And then again, the scientific China, this is where the gap will be filled with MD Anderson without specific questions. Do you have specific questions on specific tumor types? Speaker 700:31:38No, not at this point, but that's helpful. Thank you. Speaker 400:31:40Yes, yes. Thanks, Yigal. Thanks, Yigal. Operator00:31:45Your next question comes from the line of Mitchell Kapoor from H. C. Wainwright. Your line is open. Speaker 800:31:52Everyone, thanks for taking our questions and congrats on Speaker 100:31:55the recent data. Speaker 800:31:56The first question I have here is just given the fact that most of the 420 HARMONY patients will be bundled from HARMONY A, would you potentially envision something similar for leveraging the HARMONY 2 data in the U. S? Speaker 600:32:14Possibly. And so we're in the midst of sort of discussions with the agency. It's clear that we won't be able to file on the HARMONY 2 data in all regions. And so that's something that we're going to try to address. However, there is an opportunity to leverage the HARMONY-two data in future studies as well without disclosing more than that. Speaker 800:32:38Okay, great. Thank you. And then just broadly on the use of Ibenetimab in lower PD L1 TPS scores, thinking like closer to 1 versus the 49 range. Is there a threshold where Ibanezumab becomes more clearly effective? Speaker 600:32:57Yes. Well, so I think the best data results are from the 201 and the 202 study, the Phase II data. And you see a clear trend where the response rate does increase as PD L1 expression increases. And in the opposite direction, as PD L1 expression decreases, the level of activity drops off, but not as sharply as other PD-one or PD L1 agents. So I think this is probably the VEGF effect. Speaker 600:33:24And there are other bispecific immunotherapies out there like PD-one CTLA-four that are looking at the PD-one negatives. So the question is how good will we be there and I think we'll be pretty strong there as well. So I get the question, we see the benefit across the whole spectrum. The benefit seems to be greater in the high PD-one. And relative to PD-1s, where is that relative benefit? Speaker 600:33:51The relative benefit is actually greater even though the overall response rate is a little bit lower in the low PD L1 expression. I know this is kind of confusing, but again, I think we see good activity across all PD L1 expressions. There's a slight increase for ivenezumab for the PD-1s, high expressing PD L1 high expressing as well. Speaker 100:34:10As a reference point, this is Dave Mitchell, that you can go back to is the ASCO 2023 poster, which actually kind of lays out by PD L1 expression status in the Phase II trials as Alan mentioned, especially in combination with chemo, the relative benefit in the by PD L1 expression. Speaker 800:34:33Great. Thank you, Dave and Alan. Really appreciate it. It makes a lot of sense. Operator00:34:54Thank you. With no further questions, Dave, I'll turn the floor back over to you. Speaker 100:34:59Thank you very much. We appreciate everyone taking the time to join us this morning for our quarterly earnings call. We appreciate your continued support and we wish you a great day. Thank you very much. Operator00:35:10Thank you. Once again, this does conclude today's conference call. You may now disconnect. Have a great day.Read moreRemove AdsPowered by