Summit Therapeutics Q3 2023 Earnings Call Transcript

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November 7, 2023

There are 8 speakers on the call.

Operator

Good morning, and welcome to the Samvik Therapeutics Third Quarter 2023 Earnings and Update Call. All participants will be able to listen only 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 we are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the company's website for updates.

Operator

Please note that today's call is being recorded. At this time, I would like to introduce the call to Dave Gankars, Chief Business and Strategy Officer. You may proceed.

Speaker 1

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 be available later today on our website, www.smmntx.com. Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer Doctor.

Speaker 1

Mekshi Zangadeh, our Chief Executive Officer and President are Ankur Dhingra, our Chief Financial Officer Doctor. Alan Yang, our Chief Medical Officer. And in addition, we are joined by our new Chief Operating will be joined by the operator of the company. Manmeet joins us from Rayada Pharmaceuticals, where he was the President, Chief Operating Officer and Chief Financial Officer. Brianna was recently purchased by Biogen for approximately $7,500,000,000 Manmeet was previously the CFO at Alnylam Pharmaceuticals in the area of Pharmaceuticals.

Speaker 1

Before that, he was the CFO of Pharmacyclics. Manmeet will continue to serve on our Board, He also serves on the Board of Pulse Biosciences. Manmeet will be responsible for all commercial activities, finance, in conjunction with Manmeet joining us, invested $5,000,000 in the company and a private placement at market rates. We are excited to have Manmeet join Team Summit. And I'd like to welcome unmuted team.

Speaker 2

Thanks, Dave. And I'm very excited to be here and be part of Team Summit. I've worked with the team here at Summit for the last 4 years as a Board member, and I'm very thrilled to join as a member of the very accomplished and committed management team, I strongly believe that our pipeline candidate evonizumab with 2 Phase 3 clinical trials currently enrolling in the United States, Canada, Europe and China has the potential to bring a paradigm shift in the standard of care for patients with solid tumors starting with non small cell lung cancer. I'm fully committed to our mission of developing New innovative and patient friendly medicines for unmet medical needs. And I'm excited to contribute to making this positive meaningful difference.

Speaker 2

Thanks, Manmeet. Before we get started with the

Speaker 1

rest of the call, 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. And Cement cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results could differ materially from those indicated in the forward looking statements. Please 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, McKie and Ankur, we will take questions.

Speaker 1

With that, I will turn the call over to Bob.

Speaker 3

Thank you, Dave. Good morning, everyone, and thank you for joining us today. I'd like to say a few words about what Team Summit has accomplished, then I will hand it over to McKee to add more color, and then Anur will provide some updates regarding our financial position and current outlook. I'm very proud of the efforts and accomplishments of Team Summit since we have entered into our very fruitful partnership with the Acheso. As we announced this morning, we have begun enrolling in our 2nd Phase 3 clinical trial, are in the range of 1st Phase 3 are on small cell lung cancer trial that is designed with registrational intent.

Speaker 3

We have accomplished this based on and driven by conviction in our belief in abanizumab. In just 9 months since we have closed our deal to in license avanizumab, we have achieved these milestones with the intent of helping patients who need continuous innovation to improve quality of life and potential duration of life consistent with our mission at Summit. Dedication to our mission and collapsing time when and where possible have provided McKie and me along with our team with success in the past, whether in networking technology, robotic surgery or With Ibrutinib in the case of Pharmacyclics, once again, we are committed to making a positive difference for patient betterment in the area of solid tumors. I'm also very proud of the organization that we have that we continue to strengthen at Team Summit. Highlighting this is the decision of Manmeet Soni to Jonas full time as our Chief Operating Officer.

Speaker 3

Manmeet is a seasoned executive with an excellent track record of success, as Dave highlighted earlier. He has also been a Board member and trusted advisor of the company since 2019. As executive an executive of the caliber of Manmeet joining our company and believing in our mission and pipeline, in addition to his personal investment, validates the confidence we have in our intention to make a significant positive difference to those patients who can benefit most from the work we are doing. Also, in consideration of the accomplishments we have had as an organization, we've also elevated have a number of specific members of our management team. Apon Cloud is our new Chief Biometrics Officer Dave Gansgaard is now our Chief Business and Strategy Officer, Ulta Geico is our Chief Regulatory Quality and Safety Officer and Alan Yang is now our Chief Medical Officer.

Speaker 3

This team works tirelessly to advance Summit along with each of the leaders and team members that comprise our team. With that, I would like to hand it over to Mickey to provide additional context as to our accomplishments and next steps. Mickey?

Speaker 4

Thank you, Bob, and good morning, everyone. I'm incredibly enthusiastic about Ibanezimab, its potential and what Team Summit has already accomplished. As Bob said, with true conviction and purpose, along with our belief in Ibanezumab, to help accomplish our mission to benefit patients facing difficult odds with unmet medical needs comes The incredible power of execution of TIM Summit at speed accomplished by few, if any, in the biotech space. We now have 2 actively enrolling Phase 3 clinical trials for Ibanezema. Our first trial is for those patients with non small cell lung cancer harboring EGFR mutations who have progressed following a 3rd generation TKI such as Tagrisso.

Speaker 4

We began enrolling patients in the Q2 of this year, and we can now state that we intend to complete enrollment in the second half of twenty twenty four. As we have committed to along our tenure here at Summit, We worked tirelessly to collapse time in order to achieve our aggressive but realistic goals.

Speaker 5

Are in the range

Speaker 4

of 2nd Phase 3 clinical trial for ivanesimab is in front line therapy. Those who have not yet received treatment for patients with squamous cell carcinoma of the lung. We will enroll patients in this trial across North America, Europe and China. The trial is designed to compare Ibonizumab and chemotherapy against KEYTRUDA and chemotherapy in order to determine the efficacy and safety of our innovative bispecific antibody in this setting. Our convention to move forward with all appropriate speed have been in place since we worked through our due diligence agonizumab with AKESO.

Speaker 4

Obviously, our disclosed in part at ASCO 2023, the large data set that EKESO has generated backs up for conviction. How abonizumab plus chemotherapy performed in Phase II clinical trials supports our decision to quickly pursue are in a registration of Phase 3 study. We believe that this study data is very promising when compared with the current standard of care, KEYTRUDA plus chemotherapy and supports our decision to directly move forward into first line therapy are in collaboration with our partners at EKESO, we published a poster further describing the mechanism of action of imonesimab at the 38th Annual Meeting of the Society of Immunotherapy of Cancer duration of an anti PD-one and then an anti VJAP. Abonezumab is an innovative, are currently participating in the Phase 2 established cancer targets. Avanissimab Tetravalent Structure enables cooperative binding between PD-one and Bijev.

Speaker 4

Our poster at SITC 2023 described that the binding of Ibanezumab to PD-one is actually over 18 times stronger in the presence of VJAS in vitro. In addition, its binding affinity to VJAS is over four hold stronger in the presence of PD-one in vitro. Importantly, there is potentially higher expression

Operator

ladies and gentlemen, this is the operator. We've had some technical difficulties. Please remain on the line.

Speaker 1

Thank you, ladies and gentlemen. We apologize for the technical issues. I'll hand it back over to Makee to continue with her comments. Makee?

Speaker 4

Thank you, Dave. To continue, avanizumab is not designed to be the same as the sequential administration of an anti PD-one And then an anti VEGF. Avanizumab is an innovative potentially first in class bispecific antibody that builds on these two established cancer targets. Abonizumab tetravalent structure enables are cooperative binding between PD-one and VJF. Our poster at CTC 2023 described that the binding of Ibonizumab to the PD-one is actually over 18 times stronger in the presence of VJF in vitro.

Speaker 4

In addition, its binding affinity to VJF is over 4 fold stronger in the presence of PD-one in vitro. Importantly, there is potentially higher expression or presence of both PD-one and VJF in tumor tissue and the tumor microenvironment, the area around the tumor as compared to normal tissue in the body, the tetravalent structure, the intentional novel design of the molecule and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct Ibanezumab to the tumor tissue versus healthy tissue. Anti PD-one therapy assists the immune system in killing tumor cells By attaching to the part of a T cell that actually prevent the T cell from doing its job in the first place, some cancer tumor cells take advantage of a built in checkpoint on the T cell that is intended to prevent the immune system from overreacting. Anti PD-one therapy seek to bind to PD-one on the T cell, allowing the T cell to do its job without a checkpoint or break. Hence, it's referred to as a checkpoint inhibitor.

Speaker 4

Anti VJF therapy helps deplete the tumor of nutrition and blood by binding to in the U. S. Helps build new blood cells to supply blood to the tumor. Anti regift therapy also allows the immune system to better fight the tumor. We believe avonizumab goes further that the sequential administration of an anti PD-one and anti VJF Through this cooperative binding mechanics we just described, the intent, the stronger ability in this design is to improve upon previously established efficacy standards in addition to the side effects and safety profiles associated with these two targets.

Speaker 4

Abenasimab was designed such that the novel compound is greater than just the sum of its parts. Our plans to continue to expand our clinical development program remain in place. Non small cell lung cancer is only the first step. We have confidence in Ibanezimab to continue to expand both in additional indications in non small cell lung cancer and in other solid tumors during its development life cycle, our Aggravent with EKESO was drawn up with this mindset. We believe strongly in the potential of abanizumab.

Speaker 4

We have begun accepting requests for investigator sponsored trials, IST programs, As we continue to broaden our message related to Ivanasimab with the key opinion leaders as well as other physician leaders, We appreciate their high level of enthusiasm for what Ivanosimab can do in and outside of lung cancer. Have received multiple inquiries related to potential ISD programs that we are considering, and we expect will be able to share additional information in 2024. Finally, I would like to say a word about our team. Based on the accomplishments of Team Summit over the last couple of years, we have elevated certain members of our management team. I congratulate Dave, Alto, Funk and Alan in their well deserved new roles.

Speaker 4

I'm also very Sorry that we have been able to attract outstanding physicians to complete our clinical development leadership team. Doctor. Jack West and Doctor. Laura Chao have joined us over the past months. They have over 45 years of combined experience as practicing medical oncologists as well as substantial experience in the development of cancer treatments That now represent some of the most significant cancer therapies in present time.

Speaker 4

Doctor. Jack West is a renowned lung cancer expert and Doctor. Laura Chao is a trailblazer in novel immunotherapies and anti angiogenic treatments primarily focused in lung cancer as well as head and neck cancer. Team Summit is a truly special place, and I would like to thank each member of our amazing team for their dedication to our mission unfolds. Now I will ask Ankur to provide additional details on our financial position and outlook.

Speaker 6

Thank you, Mackie. Very pleased with the progress both in the development of hibonizumab and continued build out of Team Summit. We believe cabenetimab has excellent potential and continue to build our development plans I will give you an update on the financial developments and position as well as financial outlook for the upcoming quarter. Regarding the P and L, majority of our spending is in research and development focused on development of evanesimab. We spent $15,200,000 in R and D this quarter.

Speaker 6

As mentioned, we have engaged in 2 global Phase 3 clinical trials for Ibanezimab, both of which are enrolling and treating patients. We're also investing in technology transfer for manufacturing of We spent $5,400,000 in general administration expenses during the quarter, are focused on providing infrastructure and leadership for our development efforts. We expect this quarterly run rate of spending to continue to increase next quarter as well as in 2024 as we scale both pivotal studies, adding sites and treating patients as well as continue to build our team. Similarly, investment in manufacturing capabilities will continue to increase in next several quarters. At the same time, we continue to ensure that we remain disciplined in our approach of investment to extend our cash runway as long as possible.

Speaker 6

With respect to our cash position, we exited the quarter with $200,500,000 are in cash, investments and receivables. We have a loan of $100,000,000 that matures in September 2024. This loan has provided us significant non diluted capital, enabling a strong foundation for development of iVonesumab are in the position of 2 pivotal clinical trials. Our cash position is sufficient to continue to make significant progress in the development of evanesimab are conducting a question

Speaker 5

and answer session by

Speaker 6

funding the operating costs and working capital needs for Harmony and Harmony preclinical trials going into September 2024. As mentioned before, we continue to hold our cash equivalents in these investments in highly liquid and highly rated money market funds for the U. S. Treasuries and all the money has been reputed with U. S.

Speaker 6

And European Banks. And with that, I'll hand it back over to Dave.

Speaker 1

Thank you, Bob, McKee and Ankur. We can now transition to see if there are any questions from anyone on the line that we could answer. If you could please open the line for questions.

Operator

Will pause for just a moment to compile the Q and A roster. Your first question is from Brad Caddino of Stifel. Please go ahead. Your line is open.

Speaker 7

Hi, good morning team and thank you for hosting the call and taking the question. This has been a really busy quarter of external Phase 3 data disclosures and the tumor types which you're developing evanesimab, thinking specifically of the data in EGFR mutant lung from amifantumab and then some of the TRO2 ADCs broadly in the later line setting, but knowing that those will be investigated early in Frontline soon, it would be great to hear your view of this evolving competitive landscape and the opportunities that remain for Ibenesimab. Thank you. Yes.

Speaker 5

I don't think it really changes too much our We're well underway in our Phase 3 program for these EGFR refractory patients. If you look at the FLORA 2 data, it was really looking are at the frontline setting and I don't think that really changes our landscape per se. And then I think you're talking about the Mariposa II data as well. What we think about osimertinib is that it is the standard of care for frontline EGFR mutant lung cancer. But for those patients who relapsed, we think that this is a great opportunity.

Speaker 5

And we know that there's good data for imanesumab in this space. If you look back, there is a failure of PD-1s in this space, if you look at pembro and nivo. However, there is the ORION-thirty one study that looked at a PD-one and bevacizumab biosimilar and that study was positive. Getting to vibrovant, what we've heard from our sort of engagement with experts is that it is somewhat difficult to give. And so we don't believe there will be significant competition.

Speaker 5

In addition, the EGFR refractory space is our fast to market strategy. And then we are also simultaneously conducting a large frontline study in swing on small cell lung cancer.

Speaker 1

Brad, do you have any follow-up to that?

Speaker 7

That's it for me. Thank you so much.

Speaker 1

Thank you, Brad. Appreciate your question.

Operator

There are no further questions at this time. I will now turn the call over to Dave Gankars for closing remarks.

Speaker 1

Thank you, Cheryl. And we have received a couple of questions from our current shareholders that I'd like to address as well. And so One of the questions relates to how clinical trials have progressed with respect to at Kesso in China and Australia. And so at this point in time, I'd like to address that piece and I'll hand it over to Alan for any additional points. But Iguesto has 23 clinical trials at this point that have either been started or have completed at this point from Phase 1 through Phase 3.

Speaker 1

Have treated over 9.50 patients with iVonesumab in their clinical trials, including the placebo arm or the active control arm have included Well over a 1,000 patients. So the significant experience building up with respect to Ibanezumab, in particular, in one of the settings, They will at Kesso will be looking to achieve approval in China in 2024 in the EGFR mutant setting, In addition to continuing in multiple Phase 3 settings in China and Australia. So that data is continuing To grow and that growing data set continues to give us confidence in our progression within our clinical development plan as well.

Speaker 5

Yes. The only thing I would say is that this is a very unique molecule. So maybe I can spend some time. This past weekend at SITC, there was a press release as McKee related earlier around the mechanism of action. So we do target PD-one.

Speaker 5

So PD-one, PD L1 are well validated targets. PD-one, of course, seems to be more popular. Ivanezumab is a bispecific in the sense that targets both PD-one and VEGF. Now there are other Strategy is targeting PD L1 and VEGF, but I believe there is a difference and there was data released at this past ASCO for both ibenesimab and a series of PD L1 VEGF. Now, ivanesumab is also unique besides targeting 2 validated targets PD-one and VEGF As Mickey alluded to earlier, there's cooperative binding.

Speaker 5

The binding of PD-one increases VEGF by 4 fold and the binding of BEGF increases PD-one binding by 18 fold. And so theoretically, what you're going to have is the tightest binding At a location where both antigens exist, which is the tumor microenvironment. Now the other thing to think about is that ivanecimab is a tetravalent molecule. So it has 2 binding sites for PD-one and 2 binding sites for VEGF. VEGF is a secreted dimer by the tumors.

Speaker 5

And because of that, it can lead to potential cross linking of 2 ivenezomab molecules and actually multiple ivenezomab molecules. This is well described in the literature for bevacizumab And we believe the same thing is happening for Ibanezumab. And that actually leads to a possibility of an increased avidity. So there's affinity, the tighter binding between the cooperative binding, but then there's a possibility for avidity as well. So the easiest way to think about this is if you think about one hand holding a handlebar with a tight grip, using 2 hands to hold that sort of bar with both hands, that's the affinity phenomenon.

Speaker 5

So there's a tighter binding for affinity and a are targeting for avidity as well. And so we believe that this will have important differences in giving as opposed to giving both of these agents separately. And the clinical data seems to support that and we're moving very aggressively forward.

Speaker 1

Thank you, Alan. And I think you've mainly addressed this. And then another question with respect to how does this differentiate from just a PD-one agent on its own. So a lot of proved PD-one agents that exist pembrolizumab, dibralumab. If you can just kind of speak to a little bit of the difference there in terms of how it works?

Speaker 5

Yes. So I thought I described that pretty well, but if you want more detail. We can talk about the 3 hour answers. I'll try to give the 32nd answer here. Maybe focusing on the MOA where we have both an affinity and avidity Sort of phenomenon playing on with evanesimab.

Speaker 5

We've been moving very aggressively based on the clinical trial data. If you look at all the PD-1s And less so the PD L1s out there, they've pretty much done the same thing. They've gone into non small cell lung cancer. They've compared themselves to chemotherapy. We believe that iVonesumab is superior to PD-one and PD L1 therapy, okay.

Speaker 5

To prove that there are Four Phase 3 is running, 2 global ones that are being conducted by Summit and then 2 Chinese specific studies that are being run by Caso. The partnerships you've heard about the HARMONY and HARMONY3 and EGFR progressives and frontline Squamous non small cell lung cancer, these are ones we're conducting globally with our partners at Acheso in China. But at Teso actually has, as Dave alluded to, a treasure trove of data across multiple different tumor types. And they've advanced into 2 additional Phase 3s that are China specific. One is called the 306 study, Which is a frontline squamous cell non small cell lung cancer against tislelteuzumab, the Beijing PD-one For their markets, so it's a Chinese specific squamous cell frontline study, but they're also running a frontline study of monotherapy, ivenezumab against pembrolizumab in frontline non small cell lung cancer.

Speaker 5

So if you look at the 4 studies we're conducting, 3 of them are against PD-one and 2 of them are specifically against pembrolizumab or KEYTRUDA. So we are going to sort of differentiate this molecule from PD-1s dramatically by clinical data.

Speaker 1

Thank you, Alan. Really appreciate that. And so that concludes the list of questions that we have received today. So I do want to thank everyone Thank you very much for attending this morning's earnings call. As I mentioned earlier, an archived version of the webcast will be available on our website, www .smmttx.com.

Speaker 1

I'd like to thank you and wish you all a great day.

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