Summit Therapeutics Q1 2024 Earnings Call Transcript

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May 1, 2024

There are 7 speakers on the call.

Operator

Good morning, ladies and gentlemen, and thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Summit Therapeutics First Quarter 2024 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. And after the speakers' remarks, there will be a question and answer updates, please wait up to 10 minutes for resolution.

Operator

Please refer to the company's website for updates. Also, please note that today's call is being recorded. Thank you. And I would now like to turn the conference over to Mr. Dave Gankars, Chief Business and Strategy Officer.

Operator

You may begin.

Speaker 1

Thank you. Good morning and thank you for joining us. Our press release was issued 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.smmptx.com.

Speaker 1

Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer Doctor. Mackie Zanganay, our Chief Executive Officer and President Manmeet Soni, 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 of the statements made by our management team and some of the responses to questions that we make today may be considered forward looking statements based on our current expectations. Summit cautions that these forward looking statements are subject to the risks and uncertainties that may cause actual results to differ materially from those indicated in the forward looking statements.

Speaker 1

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 Manmeet, we will take questions. With that, I would like to turn the call over to Bob.

Speaker 2

Thank you, Dave. Good morning, everyone, and thank you for joining us today. Before handing the call over to Mikey and Manmeet, I'd like to say a few words about our progress and the recent accomplishments of Team Summit. As a reminder, we are enrolling patients in our 2 multi regional registrational Phase III clinical trials, HARMONY and HARMONY-three. Along with our partners at Akesso, we have had abenemasimab data featured multiple medical meetings, including ASCO, American Society of Clinical Oncology, SITC, Society For Immunotherapy of Cancer and the European Lung Cancer Conference or ELCC as well as the ENA Triple Meeting, the Annual Joint Meeting of the European Organization For Research and Treatment of Cancer, the U.

Speaker 2

S. National Cancer Institute, NCI and the American Association of Cancer Research, AACR. This is in addition to more focused meetings where the potential of abanizumab has been discussed, including targeted therapies of lung cancer 2024 meeting and the 2024 Texas Lung Cancer Conference. These have been excellent settings to allow for some of the nation's and world's leading KOLs to come together to discuss the future of cancer therapy, including the potential for avanizumab. We continue to receive inbound interest in IST proposals for abanizumab, and we are moving forward with accepting multiple IST proposals to allow these investigators to start these trials with evanesumab in multiple different settings, including non lung settings.

Speaker 2

This is in addition to our continued collaboration with our partners at Atikaso, who continue to generate 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 plan. In addition, I'd like to take a moment to acknowledge that we strengthened our excellent team recently with the appointment of renowned executive and genomicist, Doctor. Masaba Ranajid, to our Board of Directors. Doctor.

Speaker 2

Ranajid has played a leading role in the development of technologies, which has helped improve the odds for patients with cancer, including biomarker driven diagnostics, such as next generation sequencing technology and platforms. He has co founded several companies as well as being Illumina's Chief Technology Officer from 2008 to 2021. In addition to his unmatched technical prowess, passion for improving the lives of cancer patients and his 25 years of experience in the oncology space, Doctor. Ranadji is also a great business leader in addition to being one of the world's most accomplished scientists. We are fortunate to have his perspective and expertise joining us now.

Speaker 2

On today's call, in addition to covering Ibenizumab's differentiated mechanism of action and our financial results for the quarter, we will provide details and context around what drives our belief and conviction around ibenizumab's potential in non small cell lung cancer and beyond. We are a mission driven organization with a collective goal to improve quality of life, increase potential duration of life and resolve serious unmet medical needs. We believe we have the right team and the right platform molecule in abenizumab to help us realize this goal. Mickey and I are thrilled with our progress as Team Summit continues to drive our development path forward and making every effort to craft time and reach critical milestones faster. With data expected this quarter from AKESO's Phase 2 AK-one hundred and twelve-three zero one trial, otherwise known as HARMONY A, we remain eager to share additional details, which will inform both the near and longer term development strategies for our venissimab.

Speaker 2

With that, I will turn the call over to Mackie for additional context and recent highlights for consideration. Mackie?

Speaker 3

Thank you, Bob, and good morning, everyone. As Bob mentioned, we remain incredibly enthusiastic about the accomplishments of Team Summit only 1 year into our partnership with Ekoso. Before touching on Ibonizumab unique mechanism of action and clinical highlights, I would like to remind you of clinical work that has been conducted today with Ibonizumab. Over 1600 patients have been treated with Ibonizumab. Currently, between SUMID and EKSO, there are 19 clinical trials around the globe evaluating agonizumab, 4 of which are Phase 3 clinical trials along with 15 Phase 1 or 2 trials.

Speaker 3

7 of these 19 trials are evaluating abonizumab in solid tumor setting beyond non small cell lung cancer. We are sponsoring 2 of these clinical trials, HARMONY and HARMONY 3, 2 Phase 3 clinical trials in non small cell lung cancer. We are fortunate to have created such a strong partnership and foster an ongoing collaboration with leverage data from multiple solid tumor studies, supporting and informing Summit on clinical development in our licensed territories. As a reminder, avanissumab is our lead investigational compound and the only PD-one VEGF bispecific antibody in Phase 3 in the U. S, Canada, Europe or Japan are licensed territories.

Speaker 3

Ivanizumab brings these 2 highly validated mechanics together into one novel molecule targeting both PD-one and VJF. What differentiates ivonezumab to PD-one in vitro increases by 18 fold. In the presence of PD-one, the binding affinity VJF increases by over 4 fold in vitro. In addition to the half life of ivonizumab, which is approximately 6 to 7 days compared to the estimated half life of bevazitumab of 20 days or pembrolizumab of 23 days combined with a cooperative binding characteristic of Ibanezumab and its purposely engineered structure, we believe that Ibanezumab can go beyond the sequential administration of anti PD-one and anti VEGF therapy. Our goal is to improve previously established efficacy standards and safety profiles associated with these two targets, and we believe Ibonizumab has the potential to achieve this.

Speaker 3

Next, I would like to review our 2 ongoing Phase III trials, HARMONY and HARMONY 3 that are designed with registration on intent. As Bob mentioned, our partner, EKESO, is expecting Phase 3 data this quarter, which will play a key role in supporting and informing our own clinical development efforts. Starting with our registrational Phase 3 HARMONY trial, this is our fast to market approach where we are evaluating abonitumab as a second line treatment in non small cell lung cancer patients with EGFR mutations who have progressed following a 3rd generation TKI such as basimertinib. We intend to complete enrollment in this trial in the second half of twenty twenty four. In addition, our partners at AKSO have run parallel trial known as HARMONY A or AK-one hundred and twelve-three zero one.

Speaker 3

This is a trial run specifically in China evaluating patients who have progressed after an EGFR TKI, a very similar population. AKSO AKSO completed enrollment in Harmony A, performed its PFS analysis, its primary endpoint and submitted its NDA application for marketing approval in China to the Chinese regulatory authority, the CDE. AKSO has previously announced earlier this year that we expect to receive a decision from the CDE in this quarter, Q2 of 2024. If approved by the CDE, we anticipate the result of Harmony A to be disclosed along with an approved label. This decision, we believe, could be a catalyst event for agonizumab and therefore, SUMMIT for two reasons.

Speaker 3

1, the HARMONY A trial is conducted in a very similar patient population enrolling patients in North enrolling patients in North America, Europe and China. For those patients coming from China, given the overlapping patient population and similar clinical trial design, a large number of those patients enrolled by AKSO in the HARMONY A trial are also intended to be included in our analysis for our HARMONY trial. We expect to include all patients except those who did not receive a 3rd generation TKI in China into our analysis for our HARMONY trial. That means we would include approximately 80% to 85% of the HARMONY A patients from China in our HARMONY trial. Therefore, while we are adding additional patients from North America and Europe, we believe a positive readout and result for the trial in China by our partners at EKESO in China could be a positive signal for our multi regional HARMONY trial.

Speaker 3

As previously discussed, we expect to complete enrollment of our multi regional HARMONY trial in the second half of this year. Moving next to our Phase III HARMONY 3 trial, we are evaluating Ibanezumab as frontline treatment for patients with squamous non small cell lung cancer. This head to head trial is designed to compare Ibonizumab plus chemotherapy against the current standard of care, pembrolizumab plus chemotherapy. We began enrollment in this trial in the Q4 of 2023 and are continuing to open sites and expand the reach of the clinical trial as quickly as possible. Across both these trials, we continue to work tirelessly to achieve our aggressive but realistic goals for Ibonizumab and ultimately improve of an existing treatment options for the many lung cancer patients with serious ongoing unmet needs.

Speaker 3

Our conviction and belief in the potential of abonizumab and our decision to quickly pursue 2 registrational Phase III trials has come in part from data generated from Phase II clinical trials conducted by EKESO. Data announced in the Q1 this year and later presented in March at the European Lung Cancer Conference from EKESO Phase 2 AK112-two zero one trial, evaluating abonissima plus chemotherapy in multiple lung cancer settings showed patients with first line advance for metastatic squamous non small cell lung cancer without actionable genomic alterations, a patient population that aligned closely with our HARMONY 3 trial, achieving a median progression free survival of 11.1 months. Median overall survival has not yet been reached after a median follow-up time of 22.1 months. In this cohort, treatment related advanced events leading to discontinuation of Ibonizumab was 11% and there were no treatment related adverse events leading to that. In a separate cohort from this trial, which support our HARMONY trial, patient with advanced or metastatic non small cell lung cancer with tumors positive for EGFR mutations and having progressed following an EGFR TKI achieved median progression free survival of 8.5 months and a median overall survival of 22.5 months was observed.

Speaker 3

In this cohort, there were no treatment related adverse events leading to discontinuation of Ibonizumab or death. In both settings, the Phase 2 data for Ibonizumab plus chemotherapy shows favorably when considering the historical results seen from the standard of care in each setting. Also presented recently at ELCC 2024, abonizumab had promising Phase II data in non small cell lung cancer patients with brain metastasis. The analysis consisted of 35 patients from AKSO Phase II trials, AK-one hundred and twelve-two zero one and AKAN-one hundred and twelve-two zero two With advanced or metastatic non small cell lung cancer who had asymptomatic brain metastases at baseline and receive Ibonucibab alone or in combination with chemotherapy. Across all patient analyzed, an intracranial response rate of 34% was achieved by renal criteria and median intracranial progression free survival of 19, 23 months.

Speaker 3

All patients who did not achieve a response demonstrated stable disease or non progression. No patient experienced intracranial disease progression at the time of the initial follow-up scan and importantly no cases of intracranial bleeding complication were observed in this patient. Promising development and improved therapy options are needed for patients with lung cancer as it is expected that up to 20% will develop brain metastases across all type of lung cancer. And for those with common driver mutations, such as EGFR mutation, it is expected that 50% to 60% may develop brain metastases over the course of their disease. We believe that this study data is very promising, especially when considering the current therapeutic options and standard of care in this setting.

Speaker 3

Avanissimab's favorable Phase 2 data has supported and continue to support our decision to confidently move forward in both of our Phase III clinical trials and continue to build out our development strategy beyond lung cancer. While non small cell lung cancer indicate represent our initial development plan for Ibonizumab, we will continue to expand our clinical program. HARMONY and HARMONY 3 represent the first step in our strategy, and we believe in abonizumab has strong potential to make a difference in several other solid tumors as well. We have received high level of interest from key opinion leaders and other physician leaders for what Ibonizumab may do make a significant positive difference in and outside of lung cancer. We continue to receive and are considering multiple inquiries for potential investigator sponsored trials or IHC programs, and we expect to share additional information later in 2024.

Speaker 3

In addition, as we have been discussing this year, we plan to extend our reach beyond non small cell lung cancer sponsored studies as well. We continue to work with our partners at Eketo to review Phase 2 clinical trial data in order to determine our next steps forward. As you can see from this slide, there are a number of potential indications ranging from gynecological tumors, We continue to be very optimistic about the promising potential of Avanesima, including working through designing future clinical trials and working through the diligence process to optimize these trials while obtaining more mature clinical trial clinical data. We are excited over the coming 6 to 9 months to provide more details regarding our clinical development plan for ibonezumab. Finally, to capitalize on and expand our reach with physicians from KOL and academic leaders to community physicians and local caregivers.

Speaker 3

We continue to participate in key medical meetings and will participating in an upcoming ASCO conference where 2 abonucimab abstract for presentation have already been accepted, including the expected HARMONY A trial data from China. We intend to educate and activate as many physicians and health care leaders as possible regarding abonizumab and its potential. With that update, I would now ask Manmeet to provide details on our financial position and outlook.

Speaker 4

Thank you, Mickey and Bob, and good morning, everyone. We filed this morning our 10 Q for the Q1 of 2024. Today, I will provide you with an update on the operations and position. On the operations front, we continue to enroll both HARMONY and HARMONY 3 trials. We are on track to complete enrollment for patients in HARMONY trial during second half of this year.

Speaker 4

We have also initiated to prepare for technology transfer to enable the 2nd supply source for manufacturing of avanizumab in our territories. On the financial front, I'll discuss For Summit's cash position, updated cash run rate guidance and provide some color on our operating expenses. Starting with cash, we ended our Q1 of 2024 with a strong cash position of $157,000,000 Based on our planned operations, we expect that we have sufficient cash to run our operations through the Q1 of 2025. Turning to expenses, I will speak to both GAAP and non GAAP numbers. You can refer to our press release for reconciliation of GAAP to non GAAP financial measures.

Speaker 4

To remind, non GAAP expenses excludes stock based compensation and onetime charges related to in process R and D. During the Q1 of 2024, our GAAP R and D expenses were $30,900,000 compared to $24,800,000 in the Q4 of 2023. And non GAAP R and D expenses were $28,500,000 in the Q1 of 2024 compared to $22,400,000 for the Q4 of 2020 3. Turning to G and A. Our Q1 2024 GAAP G and A expenses totaled $11,700,000 compared to $11,600,000 in the Q4 of 2023.

Speaker 4

And non GAAP G and A expenses were 4,600,000 dollars in the Q1 of 2024 compared to $5,300,000 for the Q4 of 2023. Non GAAP operating expenses were $33,000,000 Aligned with company's focus, the majority of our spending is towards research and development, which is $28,300,000 for the quarter on a non GAAP basis and is focused towards clinical development of vanasumab, including the clinical trials and technology transfer. And the G and A spend for $4,600,000 for the quarter on non GAAP basis represents all the functions that provide infrastructure and support for this development. And with that, I will hand it back over to Dave.

Speaker 1

Thank you, Bob, McKee and Manmeet. We'll now see if there are any questions that our team can help answer for anyone on the line. Operator, if you could please open the line for any questions.

Speaker 3

Thank

Operator

And your first question comes from Brad Canino with Stifel. Your line is open.

Speaker 5

Hey, good morning and thanks for the questions. A couple from me. First, can you start by framing how you view the Phase 2 updates at ELCC? I mean, you made the strategic choice to pursue frontline squamous lung as that first Phase 3 where you're conducting head to head against KEYTRUDA. How do these data support that specific strategy?

Speaker 6

Yes, Brad, I'll take the question. Thanks. So a couple of things. First, the data is an update and it's consistent. So I think that's important for the update.

Speaker 6

There weren't any major changes. I mean the data still remains strong in squamous as well as non squamous cancer. I think the purpose for that update was really to make more European investigators aware since we had only presented at ASCO previously. What was the second question again?

Speaker 5

Well, let me ask another question then, You've got the Harmony A cohort from your partner, our CASSO separate presentation at ASCO, May 31. The question is, what does this imply about the potential China CDE decision timing for your partner's second line eGFR filing? And could the regulatory decision still come after these data?

Speaker 4

Yes.

Speaker 1

Sure. Hey, Brett, this is Dave Yankarz. I think so we don't at this point have any insight within beyond the update that we've given with respect to the timing of the data we still expect it in the Q2 based on the guidance that's been given from Akesso at this point. So I think that this is again Akesso's trial that they've both sponsored and analyzed the data for. So we remain blinded from that front.

Speaker 1

But we're working through the details as they become available. But at this point, we can only go on the fact that they have announced that the Q2 timing is expected and so we're

Speaker 4

proceeding as is. Okay.

Speaker 5

And then a similar type of question. Could I ask for a status update for ACASO's 303 interim analysis plan?

Speaker 1

Sure, Brad. This is Dave again. So I think, again, that is a trial that's sponsored and the data would then be analyzed on the Achesa side. So that's separate from Summit. But at this point, as far as we're aware, we have not as far as we know, there's been no interim analysis performed yet at this point.

Speaker 1

Again, they've guided to the Q2 generally on that point.

Speaker 5

Okay. And then last for me, just question on the broader plans for the company at ASCO and what, if any, gating factors remain for the announcement of Summit's broader pivotal development plan for Ibanezumab in the U. S. And EU that was hinted at in the call? Thank you.

Speaker 6

Yes. We're actively engaging health authorities to sort of put Phase III data or Phase III trials together rather. It's based on the upcoming Phase II data from AKHESO. We've seen very exciting data coming out. We haven't disclosed it, but it should be done shortly.

Operator

We will take our next question from Carter Gould with Barclays. Your line is

Speaker 6

open. Good morning. Thanks for taking the questions. Maybe just to sort of follow-up on Brad's question and maybe put a finer point to it. So just to be clear, when we think about sort of the disclosure that comes from AKECO in sort of 2Q on the back or on relation to 301, essentially are you going to be finding out that data at the same time as us or will there be some sort of gap there that we should be aware of?

Speaker 6

And I guess the follow on to that is on the back of those data, have you contemplated any potential changes or amendments to Harmony 1? Yes. So let me take the second question. No, we are not contemplating any changes to the HARMONY study. We will become aware of the HARMONY data when you become aware of it.

Speaker 6

We became aware of the abstract title release. We'll be eagerly looking for the abstract releases as well as attending the presentation. With that said, the other potential public disclosure is if there is an approval, there would be a release of a label as well in China.

Speaker 1

Thank

Operator

And with no further questions at this time, I would now like to turn the call back to Mr. Dave Gengars for closing remarks.

Speaker 1

I'd like to thank everybody for taking the time to join us this morning on our quarterly earnings call. I hope you have a wonderful day and thank you very much for your

Operator

time. Ladies and gentlemen, this concludes today's call and we thank you for your participation. You may now disconnect.

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