Q1 2024 Summit Therapeutics Inc Earnings Call

Participants

Dave Gancarz; Chief Business, Strategy Officer; Summit Therapeutics Inc

Robert Duggan; Executive Chairman of the Board, Co-Chief Executive Officer; Summit Therapeutics Inc

Mahkam Zanganeh; President, Co-Chief Executive Officer, Director; Summit Therapeutics Inc

Manmeet Soni; Chief Operating Officer, Chief Financial Officer; Summit Therapeutics Inc

Brad Canino; Analyst; Stifel

Carter Gould; Analyst; Barclays

Presentation

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. (Operator Instructions)
We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the Company's website for updates. 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 GaN, cars, Chief Business and Strategy Officer. You may begin.

Dave Gancarz

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, w. w. w. dot SMNGTX. dot com. Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer, Dr. Makis RD&A, our Chief Executive Officer and President, Manmeet Soni, our Chief Operating Officer, and Chief Financial Officer, and Dr. Allen 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. Please refer to our SEC filings for information about these risks and uncertainties. Some undertakes no obligation to update these forward-looking statements, except as required by law.
Following comments from Bob Mackie and Manmeet, we will take questions.
With that, I would like to turn the call over to Bob.

Robert Duggan

Thank you, Dave. Good morning, everyone, and thank you for joining us today. Before handing the call over to Mackey and Manmeet, I'd like to say a few words about our progress and the recent accomplishments of team selling. As a reminder, we are enrolling patients in our two multi regional registrational Phase three clinical trials Harmony and Harmony three, along with our partners that have cash. So we have had have had invested MAD data featured in multiple medical meetings, including Asco, American Society of Clinical Oncology SITC. Society for Immunotherapy of Cancer, can the European Lung Cancer Conference or ELCC. as well as the E in a triple meeting?
The annual joint meeting of the European Organization for Research and Treatment of Cancer, the US National Cancer Institute, NCI., and the American Association of Cancer Research ACR. This is in addition, two more focused meetings where the potential of our business I-Mab 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 the world's leading KOLs that come together to discuss the future of cancer therapy, including the potential for awareness and that we continue to receive inbound interest in IST. proposals, our avenues I-Mab, and we are moving forward with accepting multiple IST. proposals to allow these investigators to start these trials with evidence I-Mab in multiple different settings, including non-line settings. This is in addition to our continued collaboration with our partners at Castle who continue to generate data in Phase two 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 three 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 genomics. As Dr. Massawa Raji to our Board of Directors, Dr. Roger has played a leading role in the development of technology, which has helped improve the odds for patients with cancer, including biomarker-driven diagnostics, such as next-generation sequencing technology and platforms. He has cofounded several companies as well as being aluminas Chief Technology Officer from 28 to 2021. In addition to his unmatched technical prowess, passion for improving the lives of cancer patients, it has 25 years of experience in the oncology space. Dr. Renacci is also a great business leader. In addition to being one of the world's most accomplished scientists, we are fortunate to have his perspectives and expertise joining us now on today's call. In addition to covering, I would assume as a 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 agonism and its potential in non-small cell lung cancer and beyond. We are a mission driven organization with a collective goal to improve quality of life, increased potential duration of life and resolve serious unmet medical needs. We believe we have the right team and the right platform molecule in our business map to help us realize this goal, Mickey and I are thrilled with our progress and as team Summit continues to drive our development path forward, making every effort to craft time and reach critical milestones faster with data expected this quarter from a castles Phase two AK. one one two slash three or one trial, otherwise known as Armani A. We remain eager to share additional details, which will inform both the near and longer-term development strategies for our business.
And with that, I will turn the call over to Maggie for additional context and regional highlights for consideration.
Nike.

Mahkam Zanganeh

Thank you, Bob, and good morning, everyone. As Bob mentioned, we remain incredibly enthusiastic about the accomplishments of team Summit only one year into our partnership with EchoStar before touching on, I wanted to Mark <unk> unique mechanism of action and clinical highlights. I would like to remind you of clinical work that has been conducted to date with EyeWonder C-MAC over 1,600 patients have been treated with Angiomax currently between Zometa and Okay. So there are 19 clinical trials around the globe evaluating, I wonder assume four of which are Phase three clinical trials along with 15 Phase one or two trials. Seven of these 19 trials are evaluating our new d-mab in solid tumor setting beyond non-small cell lung cancer. We are sponsoring two of these clinical trials, Harmony and harmony to treat two Phase three clinical trials in non-small cell lung cancer. We are fortunate to have created such a strong partnership and foster an ongoing collaboration with AKSO. and the ability to leverage data from multiple solid tumor studies supporting and informing Summit on clinical development in our licensed territories. As a reminder, I to assume mark is our lead investigational compound and the only PD. one VEGF bispecific antibody in Phase three in the US, Canada, Europe or Japan or license territories. Our new smart brings these two highly validated mechanics together into one novel molecules targeting both PD-1 and B2. What differentiates our niche I-Mab and it's intentional design, is it corporative binding characteristics, specifically in the presence of VEGF binding affinity of identity mark to PD. one in vitro increases by 18 fold in the presence of PD-1, the binding affinity VEGF increases by over four-fold in vitro, in addition to the half-life of Abeona Timok, which is approximately six to seven days compared to the estimated half life of bevacizumab of 20 days or pembrolizumab of 23 days, combined with a cooperative binding characteristic of Ivernia Seamap and it's purposely engineered structure. We believe that IBC map can go beyond the sequential administration of anti-PD-1 and anti-VEGF therapy. Our goal is to improve up against previously established efficacy standards and safety profiles associated with these two targets. And we believe our bonus I-Mab has the potential to achieve this.
Next, I would like to review our two ongoing Phase three trials, Harmony and Harmony three that are designed with registrational intent. As Bob mentioned, our partner at Castle is expecting Phase three data this quarter, which will play a key role in supporting and informing our own clinical development efforts.
Starting with our registrational Phase three HARMONY trial, this is asked of fast to market approach where we are evaluating obinutuzumab as a second-line treatment in non-small cell lung cancer patients with EGFR mutation. We'll have progress following it. Third-generation TKIs such as Oxy merchants. We intend to complete enrollment in this trial in the second half of 2024. In addition, our partners at AK, so have run a parallel trial known as Harmony A. or AK. one two three oh one. This is a trial run specifically in China evaluating patients who have progressed after an EGFR TKI, a very similar population. It has completed enrollment in Harmoney, a perform its PFS analysis, its primary endpoint and submitted its NDA application for marketing approval in China to the Chinese regulatory authority. The CDSR. has previously announced earlier this year that we expect to receive a decision from the CD. in this quarter, the second quarter of 2024, if approved by the CD., 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 Ionis I-Mab and therefore, semi for two reasons. One, the Harmony a trial is conducted in a very similar patient population as our Phase three HARMONY trial. And two recall that we earlier we discussed that our Harmony trial is a multi original trial 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 a castle in the Harmony eight 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 third generation TKI in China into our analysis for our HARMONY trial. That means we would include approximately 80% to 85% of the Harmony eight patients from China in our HARMONY trial. Therefore, while we are adding additional patients from North America and Europe, we believe a positive read out and results for the trial in China by our partners at a case in China could be a positive signal for our multi-regional HARMONY trial. As previously discussed, we expect to complete enrollment of our multi original HARMONY trial in the second half of this year.
Moving next to our Phase three HARMONY trial, we are evaluating Ionis I-Mab as frontline treatment for patients with squamous non-small cell lung cancer head to head trial is designed to compare agonism of plus chemotherapy against the current standard of care, pembrolizumab plus chemotherapy. We began enrollment in this trial in the fourth quarter 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 Ivernia, Sema and ultimately improve of an existing treatment options for the many lung cancer patients with serious ongoing unmet need.
Our conviction and belief in the potential of our new d-mab and our decision to quickly pursue two registrational Phase three trials has come in part from data generated from Phase two clinical trials conducted by a castle data announced in the first quarter this year and later presented in March at the European Lung Cancer Conference Form eight K. So Phase two AJ. one one two two oh one trial evaluating Ionis Femara plus chemotherapy in multiple lung cancer setting showed patients with first-line advanced or metastatic squamous non-small cell lung cancer without actionable genomic alterations, a patient population that aligns closely with our Harmony three 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 adverse events leading to discontinuation of Ivernia sema was 11%, and there were no treatment related adverse events leading to death in a separate cohort from this trial, which supported our HARMONY trial patients 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 in this cohort. There were no treatment related adverse events leading to discontinuation of Ivernia, Seamap or death in both setting the Phase two data for Ivernia sema plus chemotherapy shows favorably when considering the historical results seen from this standard of care in each setting also presented recently at ELCC. 2024. I want to see my promise promising Phase two data in non-small cell lung cancer patients with brain metastases. The analysis consisted of 35 patients from a case of Phase two trials. It's a one one, two two one and a 10 one two two oh two with advanced or metastatic non-small cell lung cancer who had asymptomatic brain metastases at baseline and receive either placebo alone or in combination with chemotherapy across all patients analyzed an intracranial response rate of 34% was achieved by renal criteria and median intracranial progression free survival of 19.3 months. All patients who did not achieve a response demonstrated stable disease or known 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 these patients, promising development and improved therapy options are needed for patients with lung cancer as it is expected that up to 20% with double brain metastases across all type of lung cancer. And for those with common drivers and 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 the study data is very promising, especially when considering the current therapeutic options and standard of care in this setting, the SIMOPS favorable Phase two data has supported and continue to support our decision to confidently move forward in both of our Phase three clinical trials and continue to build out our development strategy beyond lung cancer, one non-small cell lung cancer indication represents our initial development plan. For opening remarks, we will continue to expand our clinical program. Harmony and Harmony trees represent the first step in our strategy and we believe in R&D, CMO 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 I've and the team have made 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 IST program, and we expect to share additional information later in 2024.
In addition, as we have been discussing this year, we plan to extend our reach beyond non-small cell lung cancer or sponsored studies as well.
We continue to work with our partners at Cato to review phase two 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, head and neck cancer, triple-negative breast cancer, colorectal cancer and other solid tumors where we may be able to further explore agonism. We continue to be very optimistic about the promising potential of Avanir Sema, including working to designing future clinical trials and working through the diligence process to optimize these trials while obtaining more mature clinical trials, clinical data, we are excited over the coming six to nine months to provide more details regarding our clinical development plan for Ivernia sema.
Finally, to capitalize on and expand our reach with physicians from KOLs and academic leaders leaders to come and see physicians and local caregivers. We continue to participate in key medical meetings, and we'll participating in an upcoming annual conference were to either initiate an 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 Avandia Sema and its potential.
With that update, I would now ask Manmeet to provide details on our financial position and outlook.

Manmeet Soni

Thank you, Mickey and Bob, and good morning, everyone. We filed this morning our 10 Q for the first quarter of 2024. Today, I will provide you with an update on the operations and financial position.
On the operations front, we continue to enroll both Harmony and Harmony three trials. We are on track to complete enrollment for patients in Harmony trial during second half of this year. We have also initiated to prepare for technology transfer to enable the second supply source for manufacturing of Anetumab in our territories.
On the financial front, I'll discuss for some its cash position, updated cash runway guidance and provide some color on our operating expenses, starting with cash we ended our first quarter of 2024 with a strong cash position of 157 million. Based on our planned operations, we expect that we have sufficient cash to run our operations through the first quarter of 2025.
Turning to expenses, I'll speak to both GAAP and non-GAAP numbers. You can refer to our press release for reconciliation of GAAP to non-GAAP financial measures to remind non-GAAP expenses exclude stock-based compensation and one-time charges related to in-process R&D during the first quarter of 2024, our GAAP R&D expenses were 30.9 million compared to $24.8 million in the fourth quarter of 2023. Our non-GAAP R&D expenses were 28.5 million in the first quarter of 2024 compared to $22.4 million for the fourth quarter of 2023.
Turning to G&A, our first quarter of 2024. Gaap G&A expenses totaled 11.7 million compared to 11.6 million in the fourth quarter of 2023, and non-GAAP G&A expenses were $4.6 million in the first quarter of 2024 compared to 5.3 million for the fourth quarter of 2023. Non-gaap operating expenses were $33 million aligned with companies focused. The majority of our spending is towards research and development, which is $28.3 million for the quarter on a non-GAAP basis, and it's focused towards clinical development of Anetumab, including the clinical trials and technology transfer and the G&A spend $4.6 million for the quarter on a non-GAAP basis, it represents all the functions that provide infrastructure and support for this development.
And with that, I will hand it back over to Dave.

Dave Gancarz

Thank you, Bob.
Mackey and Manmeet will 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, please.

Question and Answer Session

Operator

(Operator Instructions) Brad Canino, Stifel.

Brad Canino

Your line is open and good morning and thanks for the questions. A couple for me. First, can you start by framing how you view the Phase two updates at ELCC.? I mean you made the strategic choice to pursue front-line squamous lung as that first phase three, where you're conducting head to head against Keytruda. How do these data support that specific strategy?

Robert Duggan

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. 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?

Brad Canino

Well, let me ask another question then because you've got the Harmony a cohort for your partner, Castle, a separate presentation at Asco May 31st. The question is, what does this imply about the potential China CD. decision timing for your partners, second line EGFR filing? And could the regulatory decision still come after these data?

Dave Gancarz

Yes, sure.
Ed. PayBright, this is Dave. You and Chris. I think so we don't at this point, have any insight on within beyond the update that we've given with respect to the timing of the data we still expected in the second quarter based on the guidance that's been given from the guess at this point. So I think that this is, again a cases trial that did both sponsored and analyze the data for So we remain blinded from that front, but we're working through the details as they become available. But at this point, we can only go on the fact that the analysis of the Q2 and timing is expected and we're proceeding as is.

Brad Canino

Okay. And then a similar type of question. I ask for a status update for a Castle's three or three interim analysis.
Plan?

Dave Gancarz

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 test side. So that's separate from 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. Again, they've guided to the second quarter generally on that point.

Brad Canino

Okay.
And then last for me, just a question on the broader plans for the Company at Asco and and what, if any, gating factors remain for the announcement of some of the broader pivotal development plan for INS mAb in the US and EU. That was hinted that on the call. Thank you.

Dave Gancarz

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

Operator

Carter Gould, Barclays.

Carter Gould

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 it disclosure that comes from a castle in sort of 2Q in the back or in relation to three oh one? Are you essentially are you going to be finding out that data the same time as us or will there be some sort of a gap there that we should be aware of? And I guess follow-on to that is on the back of those data? Have you contemplated any potential changes or amendments?
You know, Harmony?

Dave Gancarz

Yes. So let me take the second question.
No, we're not contemplating any changes to the HARMONY study you know, will become aware of the HARMONY data when you become aware of it. You know, we were 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's an approval, there would be a release of a label as well in China?

Carter Gould

Yes.

Operator

As a reminder, it is star one, if you would like to ask.
Yes.
And with no further questions at this time, I would now like to turn the call back to Mr. Dave GaN, Corus for closing remarks.

Dave Gancarz

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 time.

Operator

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