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spk00: Good morning, everyone, and welcome to the Summit Therapeutics second quarter 2023 earnings call. Please note that this call is being recorded. All lines have been placed on listen-only mode at this time. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question, please press star followed by the number one on your telephone keypad. To withdraw your question, again, press star one. I would now like to turn today's call over to Dave Gancars. Please go ahead.
spk04: Good morning and thank you for joining us. Our press release was issued earlier this morning and is available on the homepage of our website. Today's call is being simultaneously webcast and an archived replay will also be made available later today on our website, www.smmtc.com. Joining me on the call today is Bob Duggan, our Chairman of the Board and Co-Chief Executive Officer. Dr. Marquis Zongani, our Co-Chief Executive Officer and President, Ankur Dhingra, our Chief Financial Officer, and Dr. Alan Yang, who I'm happy to introduce as our new Head of Research and Development. Welcome, Alan. Before we get started, I would like to note that some statements made by our management team and some responses to questions that we make today may be considered forward-looking statements based on our current expectations. Submit 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. Please refer to our SEC filings for information about these statements. Risks and Uncertainties. Submit undertakes no obligation to update these forward-looking statements except as required by law. Following comments from Bob, McKee, and Onker, we will take questions. And with that, I will turn the call over to Bob. Thank you, Dave.
spk03: Good morning, everyone. Thank you for joining us today. I'd like to say a few words about what our amazing team has accomplished. Then I will hand it over to McKee to add more color. And then Onker will provide some updates regarding our financial positions and outlook. In terms of blending high-quality work output with speed and efficiency if you can match the skills of Team Summit. In January 2023, we closed our transaction with the KESO to in-license Ibonissimab, and since that time, we have launched two Phase III clinical trials, both with the registrational intent and, most importantly, in alignment with our Summit mission statement to improve the quality of the lives of patients with all due speed. As I spoke about last quarter, at the end of our business development process in 2022, we chose Avanissimab to be the foundation of Summit moving forward, and Acaso chose Team Summit as the caretaker of their premier pipeline product candidate in the major Western markets. Team Summit takes full responsibility for maximizing the beneficial impact of Avanissimab in the United States, Europe, and Japan, all the while making significant difference for the betterment in the lives of patients we treat. We take full responsibility for developing our Benizumab in the United States, Canada, Europe, and Japan in order to make that significant difference in patients' lives. This is our commitment. We continue to build upon the established and continuing success and patient results created by Acesto. Our team has made multiple visits to Acesto in the past few months, and spent meaningful time in person with the KESO's leadership over the past year, including our most recent trip to China during the second quarter. As we propel our collaboration forward, we continue to work together to achieve the best possible results and realize the potential of abonissimat. Our clearly aligned missions, each of which focus on the needs of patients and improving patient lives, allow for coordinated actions within our partnership as we curate the future of our business map. In a highly positive manner, Team ACESSO has changed the paradigm in patient care in specific cancers and continues to make this progress every day. Continuing with this trend, Team Summit has one multi-regional phase three clinical trial underway, and we are about to dose our first patient in a second multi-regional phase three trial. We have chosen to work with ACESSO in each trial. not because we had to, but because we wanted to, and it's in the best interest of all stakeholders. And they have collaborated fully in working with us. In our second phase three trial for first-line squamous cell carcinoma of the lung, they have their own trial in a similar setting specific to China. But alongside that, they've chosen to participate and enroll patients to participate in the summit-led multi-regional trial as well. This demonstrates their dedication to the partnership their commitment to becoming a worldwide biopharmaceutical company, and their desire to bring Avanisimab to as many patients as possible, as quickly as possible. We chose the right partner, and we believe they chose a pretty good one as well. And we're excited about what intent, our intent to accomplish with Avanisimab in the coming couple of years. With that, I would like to hand it over to McKee to provide additional context as to our accomplishments and next steps. McKee?
spk01: Thank you, Bob, and good morning, everyone. I'm incredibly enthusiastic about IVANISMAP, its potential, and what we have already accomplished. In the past six months, since we closed our deal with ACASO in January, we have held interactions, including three live meetings with the FDA surrounding three separate non-small cell lung cancer indications. In addition, we have communicated with the other major health authorities and regulatory bodies in each of our other licensed territories, Europe, Canada, and Japan. We have launched one Phase III clinical trial, and we'll soon treat patients in a second Phase III clinical trial for non-small cell lung cancer in the United States, Canada, and Europe. And we plan to begin dosing patients with Ibonizumab in Japan early next year. We have two Phase III clinical trials for Ibonizumab. The first patient treated in the United States in our first Phase III trial was during the second quarter, just over four months after the deal closed. We previously announced that we would treat our first patient in the second Phase III trial in the second half of this year, and we are actively working to open up sites within the next month. With true conviction and purpose, our belief in Ivonisimab to help accomplish our mission to benefit patients facing difficult odds with unmet medical needs, comes the incredible rallying power of Team Summit at speed accomplished by few, if any, in the biotech space. Our conviction has been in place since we were working through our due diligence on Ivonisimab and Eceso Obviously, our upfront payment of $500 million to ACASO spoke volumes about our conviction and belief in Ibonissima. However, at ASCO 2023, some of the data that backs up that conviction was displayed. Last year, at ASCO 2022, amongst other data, Phase II data for 43 patients in frontline treatment of non-small cell lung cancer who received Ibonissima plus chemotherapy was released. At this year's ASCO in June, for the Phase 2 study, AK112201, data was updated to display results to data for 135 patients in China with a median follow-up time of over 13 months. While over 825 patients have received ibonizumab in clinical studies in China and Australia, this was a good look into a larger subset of these patients, well over 100, in a single-arm study to speak to the potential of Ibonizumab. Of these 135 treated naive patients in this Phase II study, 63 patients had squamous cell carcinoma of the lung and received a combination of Ibonizumab and chemotherapy. Two-thirds of these patients experienced a response to the combination, and there was a 93% disease control rate. Of the 67% of patients who responded to the treatment in the Phase 2 study, the median duration of response was 15 months. The median progression-free survival rate for these 63 patients was 11 months. The 95% confidence interval for progression-free survival ranged from 9.5 months to 16.8 months. While overall survival was not yet reached after a median follow-up time of 13.3 months, the estimated nine months overall survival rate for these 60 patients was 93.2%. We believe the safety profile of Ivonecima plus chemotherapy has thus far been acceptable with the most common treatment-related adverse events being anemia, decreased neutrophil count, and hair loss in this population. We believe that this is a very promising study data when considering the current standard of care, pembrolizumab plus chemotherapy, and helps support our decision to move forward directly into first-line therapy with our second phase 3 clinical trial. We are extremely encouraged by what we continue to see with ibonizumab, and our speed is based on our continuously growing conviction on the potential for ibonizumab to make a significant difference in patients' lives. We are encouraged by the other data presented at ASCO, including 72 treatment-naive non-small cell lung cancer patients receiving Ivanissima plus chemotherapy with non-squamous histology in a Phase II study. Across all TPS scores, meaning patients with tumors that did not express PD-L1, Those with low expression and those with high PD-L1 expression combined, the median PFS observed was 12.3 months. The 95% confidence interval for the median progression-free survival ranged from 8.3 months to 19.3 months. We believe the safety profile was acceptable in these patients as well with 19% of grade 3 or higher treatment-related adverse events reported. In addition, brief updates were provided second line or later patients phase two data associated with 19 patients with EGFR mutant lung cancer who had progressed after the initial targeted therapy and 20 patients who had progressed after taking a PD-1 therapy like Pembrolizumab. We remain encouraged by the maturing data for patients who received Ibonizumab plus chemotherapy in these two cohorts. Of note, 32% and 35%, respectively, of patients in this cohort who are receiving their second line or later therapies for their respective diseases remain on treatment at 12 months. We believe that the encouraging data that continue to matter and that we continue to observe relates back to what we believe to be the mechanism of action for IVONISIMA Abonissimab is not designed to be the same as the administration of an anti-PD-1 and then an anti-VEGF. Abonissimab is an innovative, potentially first-in-class, bispecific antibody that builds on this established two-cancer target. Anti-PD-1 therapy assists the immune system in killing tumor cells by attaching to the part of the T-cell that actually prevents the T-cell from doing its job in the first place. Anti-PD-1 therapy stops the built-in checkpoint in the T-cell, hence it is referred to as a checkpoint inhibitor, allowing the T-cell to do its job without a checkpoint or break. Anti-VEGF therapy helps deplete the tumor of nutrients and blood by binding to VEGF. VEGF helps build new blood cells to supply blood to the tumor. Anti-VEGF therapy also allows the immune system to better fight the tumor. But we believe avonisimab goes further and acts with that, with what we refer to as cooperative binding. Avonisimab tetravalent structure enables cooperative binding between PD-1 and VEGF. In preclinical experiment, we saw that Ivonisimab's binding to PD-1 is actually over 10 times stronger in the presence of BGF in vitro in tumor cells. Ivonisimab is designed to have the higher affinity binding in the presence of both targets, PD-1 and BGF, and therefore may have the strongest binding affinity where both targets are found, like the tumor macroenvironment. The cooperative binding of Ivonisumab may have advantage over targeting PD-1 and VEGF individually with two different molecules. It also has the potential to focus the anti-tumor activity of both targets to the side of the tumor and metastases as compared to separate anti-PD-1 and anti-VEGF compounds dosed together. Ivonisumab was designed such that the novel compound is greater than just the sum of its parts. With that in mind, we plan to continue to expand our clinical development program from here. As we have stated since the announcement of the deal, in conjunction with our actions and following through of our commitments to start in a non-small cell lung cancer, these two clinical trials are only the first step with respect to our plans for Ibonizumab. We have confidence in Ibonizumab to continue to expand both within additional indications in a non-small cell lung cancer and in other solid tumors during its development lifecycle. Our deal was constructed with this mindset, as is evident from the number of indications for which regulatory milestones are scheduled to be paid as well as the size of the potential milestone. We believe strongly in the potential of Ivanissimab. A key part of our strategic plan for broadening the value of Ivanissimab will be to engage in investigator-sponsored studies or ISD programs. As we continue to broaden our message related to SMT112 with key opinion leaders and physician leaders, we are experiencing a higher enthusiasm for what Ibonizumab can do outside of lung cancer. We have received multiple inquiries related to potential ISD programs that we can consider, and we are excited to share additional information in the coming quarters, continue to examine additional uses for Ibonizumab. It will be in addition to potential sponsor studies that we continue to consider as we move forward. This is just the beginning. Now, I will let Ankur give some more details on our financial position and outlook. Ankur?
spk02: Thank you, Mackie. I'm incredibly optimistic with the great opportunity we have in front of us with Ivan SMAB and the progress that we have made as a team. I'll give you an update on the financial developments during the quarter. and our financial position as of the end of the quarter. About the P&L, net loss for the quarter was $14.7 million compared to a net loss of $16.8 million in the second quarter of 2022. As mentioned, we have engaged in two phase three clinical trials for Ivonecimab, and majority of our spending now reflects investments in development of this molecule, Ivernesimab. At the same time, we continue to ensure that we are focused and remain well disciplined with our spending to extend our cash runway as long as possible. Speaking about our cash position, we exited the quarter with $220 million in cash investments and receivables. We believe this is to fund our operating costs and working capital needs. but currently planned clinical trials for SMT112 going into the second half of 2024. This includes appropriately building an experienced oncology team capable of executing multiple large clinical trials and the development work, as well as initial investments to begin setting up manufacturing for Ivanisumab in our territory. We have a loan of $100 million on our balance sheet that becomes due in September 2024. and the ability to prepay in certain scenarios if we complete a capital raise transaction prior to September 2024. Our cash equivalents and short-term investments are held in highly liquid and highly rated money market funds or U.S. Treasuries. Our cash is held in large, reputable U.S. and European banks. I feel very good about our overall financial position as a company. And with that, I will hand it back over to Dave.
spk04: Thank you, Bob, Miki, and Ankur. We can now transition into the Q&A session. I will start as we've received a number of questions already, and then from there, I will hand it back over to the operator who may open the line for live participants. First question comes in with respect to enrollment progress on our Phase 3 clinical trial. um could we give some updates on the enrollment progress uh and when the expected completion time of enrollment will take place i'll take that dave so we don't get specifics on enrollment numbers but i will say that we're enrolling well to plan um and then the completion of the study will be in the first half of next year this is the 301 study i see yes and so we're look we're targeting in the to the later end of the first half of the next calendar year 2024 for completion of enrollment. When should investors expect Harmony 3, the phase 3 clinical trial for first-line squamous cell carcinoma to kick off in the United States and Europe? And so, as Makiya mentioned earlier, we are guiding towards the second half of 2023. at this point. We haven't given more specific guidance other than we're very quickly getting sites up and activated and are on track from that perspective. The next two questions are more financial. The first of which is the expected cost of that Phase 3 clinical trial in squamous cell carcinoma, which is head-to-head against Timberlizumab and chemotherapy, as well as potential financing over the next 12 months to continue supporting the Harmony 3 study.
spk02: Sure, let me address both. Regarding the cost, not quite the specifics, but It is a phase three trial in the US and Europe in the lung cancer space. As you know, there are several trials that broadly in the lung cancer space happen, so it's not going to be materially different. So you can estimate the cost for about 400 patients in a lung cancer phase three college trial. Regarding the financing question, as I just mentioned, we have about $220 million in cash and receivables at the end of the quarter, which is sufficient to fund are both the trials that we've announced and some more at least for the next 12 months. We've also mentioned that our strategy is to continue to expand our development program for ibanesimab beyond the two trials that we've announced. So any financing plans and decisions that we will make, we'll consider both these trials as well as any other plans that we have for ibanesimab and we'll disclose accordingly.
spk04: Thank you, Ankur. The next question really relates maybe a little bit more in the plain English sense. So as we're looking at the data that's come in, how do we feel about that data? And then specifically with respect to our comment that median overall survival has not yet been reached, is that a bad thing? Or maybe could, Alan, you just give a little bit of plain English context to that statement?
spk05: Yeah. The fact that the patients are still alive is a terrific thing. And I think you're asking about the approvability of this product. You know, that's ultimately decided by the FDA. But one of the reasons I joined Summit is when I looked at that data, I was very excited about the performance of this molecule. And that's why we're conducting these phase three studies. And there's good clinical and scientific rationale for the two sort of studies that we're doing right now. So I'm very excited.
spk04: Thanks, Alan. And then specifically, a couple of questions have come in with reminders to the study size overall. So, could we give a little bit of context with respect to how many patients we plan to enroll in our two phase three clinical trials?
spk05: So, for the first study, the 301 in our region in North America and Europe, we're planning to enroll 150 patients. And then for the phase 3, the 303, which is the frontline non-squamous, squamous, excuse me, squamous non-small cell lung cancer study, the sample size, have we publicly disclosed it? 400, yeah.
spk04: Thank you. And then second to last question with respect to data that is being generated by a KESO in Australia. Is that data that can be submitted to the FDA?
spk05: Yeah, so I think you're referring to the phase 1 that was run in Australia. That was in a Keso-run study. And so they ultimately control that data. However, as part of an FDA package, in my experience, the FDA will want to see all the data. And so they'll probably want to see that in some form.
spk04: And then final question, McKee had spoken to this a little bit during the prepared remarks, but Alan, could you give a high-level summary with respect to the mechanism of action of ivanesumab and why you're excited about it?
spk05: Yeah, ivanesumab is a really exciting molecule. I have a lot of experience with bispecifics. This one is unique. It takes two validated targets, PD-1 and VEGF. So if you think of, you know, pembrolizumab and bevacizumab, they're well-validated targets in oncology. I think what people don't realize is that there's cooperative binding between the two target sites. So binding of one ligand increases the binding affinity of the other ligand. So what you have is when VEGF binds, PD-1 binding increases many-fold. That means that the highest affinity binding for both targets will be at places where both targets are highly expressed or found. So that's really exciting in the MOA. We will disclose additional information on the MOA as it comes out, and there's other data that we have that's also very exciting.
spk04: Thanks, Alan. And so that covers a number of questions that have been received prior to the call, so I appreciate those questions coming in. I'll now turn it over to Brianna, our operator, for any additional live questions.
spk00: Thanks, Dave. At this time, I would like to remind everyone to ask a question, please press star, then the number 1 on your telephone keypad. Seeing no live questions come in, I will turn the call back to Dave for closing remarks.
spk04: I want to thank everyone very much for attending our call this morning. As I mentioned earlier, an archived version of this webcast will remain available on our website, www.smmtx.com. Thank you very much for your participation, and I hope you enjoy the rest of your day.
spk00: This will conclude today's conference call. Thank you for joining us. You may now disconnect.
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