Summit Therapeutics Q4 2023 Earnings Call Transcript

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February 20, 2024

There are 7 speakers on the call.

Operator

Hello, everyone. 1st and foremost, we'd like to apologize for the delay of this event. Good morning, and welcome to Summit 4th Quarter Year End 2023 Earnings 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 forward.

Operator

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. Please note that today's call is being recorded. At this time, I would like to turn the call over to Dave Gunkars, Sumitor of HUTIQ's Chief Business and Strategy Officer. You may now proceed please.

Speaker 1

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. Our Forms 10 ks and S-three were also filed earlier this morning and are 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, www dotsmmnttx.com. Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer Doctor.

Speaker 1

Maki Zangene, our Chief Executive Officer and President Manmeet Soni, our Chief Operating Officer Ankur Dhingra, our 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. Please refer to our SEC filings for information about these risks and uncertainties.

Speaker 1

Summit undertakes no obligation to update these forward looking statements, except as required by law. Following comments from Bob, Mekki and Ankur, we will take questions. With that, I will turn the call over to Bob. Thank you, Dave.

Speaker 2

Good morning, everyone, and thank each of you for joining us today. I'd like to say a few words about our progress and what Team Summit has accomplished. Then I will hand it over to McKee to add more color, and then Ankur will provide financial updates. It has been just 1 year since we closed on our partnership with the Kessel, and I'm very proud of the accomplishments and impressive progress Team Summit has made in this period of time. Avinizumab, our lead investigational compound and the only PD-one VEGF bispecific antibody in Phase 3 in Summit's territories, continues to actively enroll 2 registrational Phase III trials in non small cell lung cancer, our HARMONY and HARMONY III trials.

Speaker 2

In HARMONY, we are looking at avinizumab in combination with chemotherapy as a second line treatment for non small cell lung cancer patients with EGFR mutations with disease progression after receiving a 3rd generation TKI. In HARMONY-three, we are setting avinizumab in combination with chemotherapy as first line treatment for patients with squamous cell carcinoma of the lung in a head to head trial against the current standard of care. We treated our first patient in the HARMONY 3 study, our second Phase 3 study in the Q4 of 2023. Combined, the 2 populations represented by these two clinical trials account for approximately 100 and 20,000 patients in our licensed territories for whom abanizumab could potentially offer a better treatment option. TeamSummit's conviction and our belief in avanizumab continues to drive our progress forward in our efforts to collapse time and reach critical milestones faster.

Speaker 2

We approach these efforts with the intent of helping patients improve quality of life, increase the potential duration of life and resolve serious medical needs in line with Summit's strongly held mission statement. McKee and I are appreciative and honored to be leading Team Summit, where our accomplished leaders and team members have unparalleled track records for high speed execution that delivers intended results. This experience and our expertise are foundational to achieving our goals for 2024 and beyond, continuing to execute on our Phase 3 clinical trials, while expanding our clinical development plan. With that, I would like to turn it over to Mickey to provide additional context for our accomplishments and next steps.

Speaker 3

Thank you, Bob, and good morning, everyone. As Bob discussed, I remain incredibly enthusiastic about abonizumab and its potential, the strength of Team Summit and the accomplishments we have made just 1 year into our partnership with Ekaso. Across the globe, over 1600 patients have now been treated with abonizumab. Currently, AKSO is conducting or participating in 19 clinical trials evaluating abanizumab, 4 of which are in Phase 3 and 7 trials are evaluating avanizumab in solid tumor settings beyond non small cell lung cancer. We are fortunate to have such a strong partnership and ongoing collaboration with Ekoso, including the ability to leverage data generated for Ibonizumab across multiple solid tumors studies in support of Summit's own clinical development in our licensed territories, the U.

Speaker 3

S, Canada, Europe and Japan. Turning specifically to SUMMIT's own Phase 3 trials. Active enrollment continues in HARMONY and HARMONY 3. As a reminder, Harmony, our fast to market approach is in non small cell lung cancer patients with EGFR mutations who have progressed following a 3rd generation TKI such as osimertinib. We intend to complete enrollment in this trial in the second half of twenty twenty four.

Speaker 3

Our HARMONY-three trial is seeking a frontline treatment indication for patients with squamous non small cell lung cancer. This head to head trial is designed to compare Ibanizumab plus chemotherapy against the current standard of care, pembrolizumab plus chemotherapy. We continue to progress as well as collapse time in order to achieve our aggressive but realistic goals for evonesimab to ultimately improve existing treatment options to the many lung cancer patients with serious ongoing unmet needs. Our conviction and belief in the potential of abonizumab and our decision to quickly pursue 2 registrational Phase 3 trials has come in part from data generated from Phase 2 clinical trials conducted by AKESO. These data evaluating arbanesumab plus chemotherapy in multiple lung cancer settings, AK112-two zero one was updated by AKSO last month.

Speaker 3

Notably, in patients with first line advanced or metastatic squamous non small cell lung cancer without actionable genomic alterations in a Phase 2 population supporting our HARMONY 3 trial, a 24 months overall survival rate of 64.8% was observed. Median overall survival has not yet been reached after a median follow-up time of 21 months. Furthermore, in patients with advanced or metastatic non small cell lung cancer with tumors positive for EGFR mutations and having progressed following an EGFR TKI, the Phase 2 trial cohort supporting our HARMONY trial, a median overall survival of 22.5 months was observed. In both settings, ivanesumab has had an acceptable safety profile in the Phase 2 clinical trial. We believe that this study data is very promising.

Speaker 3

Also when considering the current standard of care in this patient population and the Phase 2 data supports our decision to directly move forward in both of our Phase 3 clinical trials. Slide 5, please. I will also like to spend a moment to remind everyone of the differentiated mechanism of action of Ionezimab. To start, IVENECIMA brings 2 highly validated mechanics in oncology together into 1 novel molecule targeting both PD-one and VJF. And as Bob mentioned earlier, we are the only Phase 3 PD-one VEGF bispecific in our licensed territories, making it the most clinically advanced compound of its kind in the U.

Speaker 3

S, Canada, Europe and Japan. What differentiates Ivanissimab in its intentional design is a concept known as cooperative binding. Specifically in the presence of VJET, the binding of ivanizumab to BD-one in vitro increases by 18 fold. In the presence of PD-one, VJF affinity increases by over 4 fold. Iwaneseumab's cooperative binding qualities lead to the potential to steer more drugs to the tumor and tumor microenvironment, the area around the tumor, where higher levels of PD-one and VEGF are expressed and comparatively less drug we believe is steered toward normal healthy tissues.

Speaker 3

On Slide 6, you can see, in addition, because of the increased presence of PD-one and VJF in the tumor macro environment, there is not only increased affinity, but also increased ability. Because VJF is expressed as a dimer, there is an opportunity to bind multiple Ivanitivab compounds to these VJF dimers in the tumor microenvironment as well. We believe ivonezumab cooperative binding goes further than the sequential administration of an anti PD-one and anti VEGF therapy. Our goal is to improve upon previously established efficacy standards in addition to side effects and safety profile associated with these two targets. We believe Ibonizumab has the potential to achieve this.

Speaker 3

Moving to Slide 7. Looking at meaningful near term catalysts for Ibonizumab, we are expecting multiple events to 2024. Next quarter, there are 2 key milestones expected from randomized Phase 3 clinical trials in China from our partners at AKESO. Data from the Chinese patients enrolled in AK-one hundred and twelve-three zero one, a large portion of which represent the Chinese patient included in the modified intent to treat population of our multi regional study, also known as HARMONY, was submitted to the Chinese regulatory authority, the CDE last year specifically seeking marketing approval in China. A decision is expected in the Q2 of this year from the CDE.

Speaker 3

We also expect that AKSO will provide a data readout of the top line results of their Phase 3 trial at this time. Additionally, EKSO has an interim analysis planned for next quarter for its study comparing ivanesumab to pembrolizumab in a monotherapy setting for first line advanced lung cancer patients harboring tumors with positive PD L1 expression referred to as AK-one hundred and twelve-three zero three. This head to head trial against pebrolizumab is a major milestone for avanizumab, both in differentiating avanizumab from a PD-one antibody as well as illustrating the potential of its novel mechanism of action that simply does not exist in oncology therapeutics today. Given the direct implications of the AK-one hundred and twelve-three zero one's results on our HARMONY study as well as the potential ability to compare Ibonizumab pembrolizumab in AK112-three zero three, we believe these events will be pivotal moment drivers in Ibonizumab's development globally. As mentioned earlier, we also plan to complete enrollment in a HARMONY study in the second half of this year, providing momentum towards a submission for Ibonizumab in our licensed territories.

Speaker 3

While non small cell lung cancer indication represent our initial development plan for Ibonizumab, we will continue to expand our clinical program. HARMONY and HARMONY-three represent the first step in our strategy and we believe Ibonizumab has potential in both additional non small cell lung cancer indications and in other solid tumors. In addition to progressing our internal development program, we appreciate a high level of enthusiasm we are hearing from key opinion leaders and other physician leaders for what Ibonizumab can do to make significant positive difference in and outside of lung cancer. We continue to receive and are considering multiple inquiries for potential investigator sponsored trials or IST programs. We expect to share additional information later in 2024.

Speaker 3

Finally, to capitalize on and expand our reach with physicians from KOLs and academic leaders to community physicians and local caregivers seeing so many cancer patients, we are participating in a few upcoming conferences. We will be at TTLC meeting later this week in Santa Monica, California. In addition, we plan to participate in ESMO's European Lung Cancer Congress 2024 next month in Prague, where we have submitted along with our partners at EKESO multiple abstracts for presentation on Ibanezema. We intend to educate and activate as many physicians as possible regarding Ibonizumab and its potential as we ramp up Phase 3 clinical trials in the United States, Europe, Canada and Japan. With that update, I will now ask Ankur to provide details on our financial position and outlook.

Speaker 4

Thank you, Mackie and Bob, and good morning, everyone. Echoing the sentiment, we're very pleased with the speed of execution of Team Summit and our partners at Team AkerCell in the development of Ibanezumab. Moving to Slide 8, I'll give you an update on Summit's cash position, the extended cash runway guidance and

Speaker 5

the P and L.

Speaker 4

We have a strong cash position with $186,000,000 in cash and investments as of end of year 2023. This position provides us strong ability to continue our investments in the development of Ibenasumab. In addition, we have taken steps to extend our cash runway going into the Q1 of 2025. As you may recall, our previous guidance for cash runway was going into September of 2024. As we announced earlier, we have amended the $100,000,000 note to extend the maturity date to April 1, 2025, and the future interest payments will also be paid at maturity.

Speaker 4

This extension, coupled with our strong cash position, provides funding to make significant progress in the development of Ibenasimab, as well as covering some of the key milestones that Mackie spoke about.

Speaker 5

Going to the P and L,

Speaker 4

I will speak about non GAAP OpEx, which excludes stock based compensation, in process R and D and certain impairment charges. You can refer to our press release for reconciliation of GAAP to non GAAP financial measures. During the Q4 of 2023, our non GAAP operating expenses were $27,700,000 Aligned with the company's focus, the majority of our spending is towards research and development, which is $22,400,000 for the quarter on non GAAP basis and is focused towards clinical development of Ibanezumab, including the clinical trials, the technology transfer and people costs. And the G and A spend of $5,300,000 for the quarter on non GAAP basis represents all the functions that provide Ibonasumab and have made a lot of progress in its development during 2023. We have a strong cash position and we have extended our cash runway going into 2025.

Speaker 4

And with that, I will hand it back over to Dave.

Speaker 1

Thank you, Bob, McKie and Ankur. We can now transition to see if there are any questions that we could help answer. Operator, if you could please open the line for

Operator

Our first question comes from Brad Canino from Stifel. Your line is now

Speaker 1

open. Hi, good morning and thank you for the updates and having me on your call. I just wanted to get your thoughts on how to best Ibenesimab for EGFR mutant lung, particularly in relation to your ongoing HARMONY study. And I'm asking in light of some of the differences between the two studies, thinking about the 3rd generation TKI pretreatment requirements and then your study also adding the co primary of survival? Thank you.

Speaker 1

Thank you, Brad. Alan, I'll hand that question to you.

Speaker 5

Hi, Brad. Thanks for the question. This is Alan Yang, the Chief Medical Officer. So I think you should view it positively. The fact that as you know, the Chinese version of the HARMONY study enrolled 3 20 patients, approximately 3 20 patients, of which about 50 of them received a 1st or second generation TKI, which is still considered standard of care in China.

Speaker 5

We will be using 270 patients of that data or approximately 270 patients of that data, which only received a 3rd generation TKI or received a 3rd generation TKI such as osimertinib somewhere along the course of their treatment. And that represents about 85% of the data. So I think the data should correlate pretty well for the global study. Now remember, we're adding 150 patients from North America and Europe to that. And I'm not aware of any treatment differences between Chinese and U.

Speaker 5

S. Patients. In addition, I think the key question is, is there any difference receiving a 1st or second generation TKI prior receiving a 3rd generation or receiving a 3rd generation TKI on the impact of chemo and immunotherapy? And the answer is I'm not aware of any such data. I don't think that data exists.

Speaker 5

And then I think the last question you asked was around PFS and OS. And so PFS seems to track pretty well with OS. That's why it's used as a surrogate endpoint as often, especially in patients with sort of survival periods. So the shorter the survival period, the more likely that PFS will correlate with OS. But it is an unknown at this time.

Speaker 5

And so, the fact that we have co primary endpoint is a little bit different than the AKASO study. Thanks for the question, Brad.

Speaker 1

Great. Thank you very much.

Operator

Our next question comes from Hartaj Singh from Oppenheimer. Your line is now open.

Speaker 6

Great. Thank you. Thanks for the question. I just got a couple. One is your head to head study against pembro and chemo combo against non small cell lung cancer.

Speaker 6

Can you just talk a little bit about what's the differentiation for ivermectinib? And then maybe a little bit more into, I guess, what's the hurdle? Is it just the study on which pembro chemokoma got approved? Just how to think about the hurdle that you're looking to either be equal to or surpass? And I just got a quick follow-up.

Speaker 1

Thanks, Hartaj. So I think I heard 2 questions there. 1, the differentiation between pembro, the standard of care and I vanezumab with respect to our HARMONY-three study? And then what other hurdle we may have in the HARMONY-three study or what the standard of care, what we need to be in that study is. So again, I'll hand that question to Alan.

Speaker 5

Hi, Akash. Thanks for the question. So I'll answer the second part first. Well, let me just review the 2 studies. As Mickey mentioned earlier, there's the HARMONY study, which is our fast to market study, because that was Brad's question in the 2nd line EGFR mutant population.

Speaker 5

The HARMONY 3 study, which is sort of the first frontline study in squamous non small cell lung cancer. So the second question about the benchmark is pretty easy. It's the KEYNOTE-four zero seven study, right? So this is where Merck got approval for pembrolizumab in the similar population. There are sort of expansion studies that look at the Chinese population.

Speaker 5

So you can look those studies up to get the proper benchmark. In terms of what distinguishes IVENESSIMAB, it's a very clean study. It's IVENESSIMAB chemotherapy and then pembro using the same chemotherapy. And that pembro chemotherapy was the 407 study based on the 407 study. So I think there's a couple of ways that are different, right?

Speaker 5

So Ibanezumab from the simplest way to think about it has VEGF component to it. So if you think about the 2 targets independently, pembro is PD-one, the second one is VEGF. And so we have that VEGF component. And so we think that that adds sort of value to patients and important for patients. And then there's the cooperativity that we think accentuates not only the VEGF, but also the PD Y.

Speaker 5

And so you can sort of distinguish that and looking at that data, it will be very interesting to look at the data both by PD-one, PD L1 status, how much are we beating in the high PD L1 expresses, which is probably the PD-one component, how much are we beating in the lower PD L1 expression, which is the VEGF component. I would say some other bispecifics that target, let's say, PD-one and CTLA-four are concentrating on the So So the last component to think about is that we know that Avastin was trying to be developed in this space and then after Phase 2 they halted development. There was a concern about bleeding risks early on and therefore I think lung cancer patients in the squamous setting never really realized the potential of anti VEGF. And we believe that the safety profile demonstrated to date in the Phase II as well as our large database is supportive of developing a VEGF that has been attached to PD-one with cooperative binding in this space. So there's a number of different aspects where we think we can have an advantage.

Speaker 5

What's your follow-up question, Hartaj?

Speaker 6

Yes, great. Thank you so much. That's really good detail. If you can just kind give us what is the next sort of clinical and regulatory steps for Harmony and Harmony 3?

Speaker 5

I know Harmony 3 might be

Speaker 6

a little bit into the future, but just not looking for guidance, but just kind of a rough change of events there? Thank you.

Speaker 5

Around Harmony 3, I don't think we've disclosed this. I'll turn to Dave, but I'll just say that you can sort of calculate enrollment based on the KEYNOTE-four zero seven. I think that's the key benchmark. And it's what's interesting, Hartaj, is the squamous non small cell lung cancer population or that space has become a lot less crowded recently. So I think that will give us a lot freedom to operate.

Speaker 5

I don't know Dave if you want to add anything to our disclosures.

Speaker 1

Thanks Alan. So at this point, what we have disclosed is that the HARMONY studies, we plan to complete enrollment in the second half of twenty 4, the second half of this year. We haven't given further guidance with respect to the regulatory process there except that we have our co primary endpoints. From a Harmony 3 perspective, we just began enrollment in the Q4 of 2023 and we've yet to give the guidance in terms of when that will complete, but we're currently enrolling and are excited about moving quickly in that setting as well.

Speaker 5

Great. Thank you, everyone. Thanks for the updates.

Operator

Don't have any raised hands right now. So I'd now like to hand back over to Dave Gengkorsch. Thank you.

Speaker 1

I just want to thank everyone for attending our call and your continued interest in Summit. An archived version of this webcast will be available later today on our website, www.smmttx dotcom. I want to thank everyone again and enjoy the rest of your day. Thank you.

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