Q4 2023 Summit Therapeutics Inc Earnings Call
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Ladies and gentlemen, we apologize for the inconvenience, we're just experiencing a bit of a technical issue. However, we will start this session in a brief moment. Thank you so much.
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Yes.
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Hello, everyone first and foremost they'd like to apologize for the delay of this event good morning, and welcome to summit fourth quarter and year end 2023 earnings call.
All participants.
All participants will be able to we'll be able to listen only until the question and answer portion of this call. We do not expect any technical difficulties today for where you. However, India event that we then used the webcast connection and we are unable to provide any updates lease weight of the agenda.
That's where a resolution please refer to the company's website for updates. Please note that today's call is being recorded.
If you'd like to ask a question during that time. Please press the star, but then followed by the number one on your telephone keypad, if you'd like to withdraw your question. Please press story number one they get.
At this time I would like to turn the call over to Dave can cars summit Therapeutics, Chief business and strategy Officer. You May now proceed please.
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 Form 10-K and S. III. We're 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 Dot S. M. M. G T X dot com.
Me on the call today is Bob Duggan, our chairman of the Board and Chief Executive Officer, Dr. Matthew <unk>, Our Chief Executive Officer, and President <unk> Soni, our Chief operating officer.
Greg <unk>, our 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 statements made by our management team and some responses to questions. We may make today may be considered forward looking statements based on our current expectations.
<unk> 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.
<unk> undertakes no obligation to update these forward looking statements, except as required by law.
Following comments from Bob Mackie, and Ankur, we will take questions with that I will turn the call over to Bob.
Thank you Dave.
Morning, everyone and thank each of you for joining us today.
I'd like to say a few words about our progress and what teams summit has accomplished then I will hand, it over to the key to add more color and then our herb will provide financial updates.
It has been just one year since we closed on our partnership with the castle and I am very proud of the accomplishments and impressive progress team summit.
In this period of time.
Our lead investigational compound and the only PD one bed, Jeff bi specific antibody in phase III.
In Summit's territories continues to actively enroll two registrational phase III trials in non small cell lung cancer, our harmony and harmony three trials.
And harmony, we're looking at <unk> 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 third generation Teekay hi.
And how many free we are studying this.
Combined the two populations represented by these two clinical trials accounted for approximately 120000 patients.
Our license territories for whom evidenced mab could potentially offer a better treatment option teams, how much conviction and our belief in our business and.
That continues to drive our progress forward in our efforts to collapse time and reach critical milestones faster. 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 strongly held mission statement.
Mccain 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 act.
Viewed on our phase III clinical trials, while expanding our clinical development plan with that I would like to turn it over to Nicky to provide additional context for our accomplishments and next steps.
Thank you Bob and good morning, everyone as Bob discussed I remain incredibly enthusiastic about I believe him up and its potential the strait of teen summit and the accomplishments. We have made just one year into a partnership with a catch up.
Across the globe over 1006 1600 patients have now been treated with <unk> currently AK, so he's conducting or participating in 19 clinical trials evaluating when it came up for a week are in phase III and seven trials are evaluating <unk>.
Up in solid tumor settings.
Non small cell lung cancer.
We are fortunate to have such a strong partnership and ongoing collaboration with AK, so including the ability to leverage data generated for I've only seen maps across multiple solid tumor studies in support of summits, one clinical development in our licensed territories. The U S, Canada, Europe and Japan.
Mhm.
Turning specifically to some of its own phase III trials.
Enrollment continues in harmony and harmony tree 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 tour generation teekay I such as Oxy Martini.
We intend to complete enrollment in this trial in the second half of 2024.
Harmony trial is taking a frontline treatment indication for patients with squamous non small cell lung cancer. These head to head trial is designed to compare <unk> plus chemotherapy against the current standard of care parallelism up plus chemotherapy.
We continue to progress as well as collapsed time in order to achieve our aggressive but realistic goals for I wanted to see him up to ultimately improve existing treatment options. So there are many lung cancer patients with serious ongoing unmet needs.
Our conviction and belief in the potential I've I've only seen map and our decision to quickly pursue two registrational phase three trial has come in part from data generated from phase II clinical trials conducted by Ey queso.
Data evaluating <unk> plus chemotherapy in multiple lung cancer settings.
112 to one was updated by AK, So last months, notably in patients with first line advanced or metastatic squamous non small cell lung cancer readout actionable genomic alterations in a phase II population supporting our harmony trade trial.
At 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 T. J on the phase II trial cohort supporting our harmony trial and median overall survival of 22.5 months.
Was observed.
In both settings.
Up has had an acceptable safety profile in the phase II clinical trial.
We believe that the study data is very promising also when considering the current standard of care in this patient population and their phase II data supports our decision to Dara can move forward in both of our phase three clinical trials.
Slide five please.
I would also like to spend a moment to remind everyone of the differentiated mechanics of action.
To start I wanted to see my brain to highly validated mechanics in oncology together into one novel molecule targeting both PD, one and we just.
And as Bob mentioned earlier, we are the only phase III PD one V. Just by specific in our licensed territories, making it the most clinically advanced compound of its kind in the U S, Canada, Europe and Japan.
What differentiate I've only seen Bob and it's intentional design is a concept known as cooperative binding specifically in the presidents of each of the binding of avenues him up to be the one in vitro increases by 18 fold in the presence of PD, one rejects affinity increases by over four fold.
I have only Sam obst cooperative binding qualities lead to the potential to steer more charged to the tumor and tumor microenvironment the area around the tumor where height higher levels of PD, one and reshape our express and comparatively less drug we believe is steered towards normal healthy tissues.
On slide six you can see in addition, because of the increased presence of PD, one and <unk> in the tumor microenvironment. There is not only increased affinity, but also increase our ADC.
Because <unk> is expressed as a dimer there is an opportunity to bind multiple agonist compounds to <unk> dimers in the tumor micro environment as well.
We believe I've only seen map 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 I've only seen map has the potential to achieve this.
Moving to slide seven.
Looking at meaningful near term catalysts for <unk>, we are expecting multiple events to occur in 2020 for next quarter. There are two key milestones expected from randomized phase III clinical trials in China from our partners at a catch up.
Data from their Chinese patients enrolled in a K 1123, or one a large portion of which represent the Chinese patients included in the modified intent to treat population of our multi original study also known as harmony was submitted to the Chinese regulatory authority there.
C D E last year, specifically seeking marketing approval in China.
Fusion is expected in the second quarter of this year from the C D.
We also expect that AK, so we'd provide a data read out of the topline results of their phase III trials at this time.
Additionally, AK steel has an interim analysis planned for next quarter for each study comparing I've only Cmos to Pembina lithium up in a monotherapy setting for first line advanced lung cancer patients harboring tumors with positive PD L. One expression referred to as 8-K, one want to treat or tree.
Head to head trial against parallelism up is a major milestone for everyone to see Marc what was in differentiating <unk> from a PD one anti body as well as illustrating the potential of its novel Mccamish off action that simply does not exist in oncology therapeutics today.
Given the direct implications of the AK, one want to treat or once results on our harmony study as well as the potential ability to compare to I want to see my temporarily as you lap in a K one want to treat or tree. We believe these events would be a pivotal moment drivers and I've only seen maps development globally.
As mentioned earlier, we also plan to complete enrollment of the harmony study in the second half of this year, providing momentum towards a submission for IV <unk> in a license territories.
While non small cell lung cancer indication represents our initial development plan for Iconix team up we will continue to expand our tank car program harmony on harmony <unk> represent the first step in our strategy and we believe I've only seen map has potential in both additional non small cell lung cancer indications and in other solid.
In addition to progressing our internal development program. We appreciate at a high level of enthusiasm. We are hearing from key opinion leaders and other physician leaders for what I've only seen Bob can do to make significant positive difference in and outside of lung cancer. We continue to receive and are considering.
Multiple inquiries for potential and investigator sponsored trials or IFC programs, we expect to share additional information later in 2024.
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 each like targeted therapies for lung cancer or ttl's.
<unk> meeting later this week in Santa Monica, California.
In addition, we plan to participate in ESMO European lung cancer Congress 2020 for next month's in Prague, where do we have submitted along with our partners at AK. So multiple abstracts for presentation on I've only Cmos.
We intend to educate and activate as many physicians as possible regarding I've only seen map and its potential as we ramp up phase III clinical trials in the United States, Europe, Canada, and Japan with that update I would now as our anchor to provide details on our financial position and outlook.
Thank you Maggie and Bob and good morning, everyone.
Echoing the sentiment, we're very pleased with the speed of execution of teams and.
And our partners at <unk> and the development of I've been asking that.
Moving to slide eight I'll give you an update on some of its cash position the extended cash runway guidance.
Andy.
The P&L.
We have a strong cash position.
160, $86 million in cash and investments as of end of year 2023.
This position provides us a strong ability to continue our investment in the development of I've been asking about.
In addition, we have taken steps to extend our cash runway going into the first quarter of 2025.
As you may recall, our previous guidance for cash runway was going into September of 'twenty 'twenty four.
As we announced that we have amended the $100 million note to extend the maturity date to <unk> 2025, and the future interest payments will also be paid at maturity.
This extension coupled with our strong cash position provides funding to make significant progress in the development of I've been asking Matt as well as covering some of the key milestones that <unk> spoke about.
Going to the P&L I will speak about non-GAAP, opex, which excludes stock based compensation in process R&D and certain impairment charges.
You can refer to our press release for a reconciliation of GAAP to non-GAAP financial measures.
During the fourth quarter of 2023 of non-GAAP operating expenses were $27 $7 million.
Aligned with the company's focus the majority of our spending is towards the research and development, which is $22 4 million for the quarter on non-GAAP basis.
Its focus towards clinical development of <unk>, including the clinical trials, the technology transfer and deepen costs.
And the G&A spend of $5 3 million for the quarter on non-GAAP basis represents all of the functions that provide infrastructure and support for this development.
So in summary, we are excited about the potential of fiber nascent mab 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.
And with that I will hand, it back over to Dave.
Thank you, Bob Mackie 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 questions.
So opening the floor for the Q&A question, if you'd like to ask a question. Please press star and number one on your telephone keypad. Our first question comes from Brad Canino from Stifel. Your line is now open.
Hi, good morning, and thank you for the updates and having been on your call.
I just wanted to get your thoughts on how to best interpret the upcoming Chinese regulatory action on <unk> for Egfr mutant lung, particularly in relation to your ongoing <unk> study.
I'm asking in light of some of the differences between the two studies thinking about the third generation Ti pretreatment requirements and then your study also adding the co primary survival. Thank you.
Thank you Brad.
A question to you.
Hi, Brian. Thanks for the question. This is Allen Yang Chief Medical Officer.
I think you should view it positively you know the fact that.
As you know the.
The Chinese version of the Harmony study enrolled 320 patients approximately 320 patients of which about 50 of them received a first or second generation PKI, which is still considered standard of care in China.
We will be using 270 patients so that data or approximately 270 patients so that data.
Which only received a third generation TCR received a third generation PKI such as those emerge.
Where 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 S patients.
In addition, I think the key question is is there any difference receiving our first or second generation PKI prior to receiving a third generation or receiving a third generation ti on the impact of chemo immunotherapy and the answer is I'm not aware of any such data I don't think that data exists.
And then I think the last question you asked was around PFS and OS and so.
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 period. So the short of survival period, the more likely that PFS will progress correlate with ours, but it is an unknown at this time and so.
The fact that we have a co primary endpoint, there's a little bit different than the <unk> study.
Thanks for the question Brian.
Great. Thank you very much.
Our next question comes from.
<unk> seen from Oppenheimer. Your line is now open.
Great. Thank you. Thanks for the question I just got a couple one is your head to head study against <unk> chemo combo against non small cell lung cancer can you just talk a little bit.
What's the differentiation for I've witnessed the mab.
And then maybe a little bit more into I.
I guess, what's the hurdle is it just the the study on which.
Chemo chemo combo got approved just how to think about the hurdles that that youre looking to either be equal to ensure Pos and I've just got a quick follow up.
Thanks, Hi, guys. So I think I heard two questions. There one the differentiation between hambro standard of care and I, Vanessa Mab with respect to our harmony three study and then.
What other hurdle, we may have in the harmony study or what the standard of care of what we need to be.
In that particular study is so again I'll hand that question to Alan.
Hi, Carlos Thanks for the question so ill answer the second part first well let me just review the two studies.
The key engine earlier Theres, the harmony study, which is our fast to market strategy without with Brad's question and the second line Egfr mutant population.
The harmony three study, which is sort of the first frontline study in squamous non small cell lung cancer.
Second question about the benchmark is pretty easy its the keynote 407 study right. So this is where Merck.
Merck got approval for <unk> in the similar population.
There are sort of expansion studies that look at the Chinese population. So you can look those studies up to get the proper benchmark.
In terms of what distinguishes <unk>, it's a very clean study of <unk> chemotherapy, and then hambro using the same chemotherapy and that Pembroke chemotherapy was the 407 study based on the 407 study.
I think theres a couple of ways that are different right. So I've been asked the map from the simplest way to think about it has to digest component to it. So if you think about the two targets independently Pembroke PD, one and the second one is digesting. So we have that digest component and so we think that that adds sort of value to patients and <unk>.
And for patients and then Theres the coop activity that we think accentuates not only the VEGF, but also the PD one 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 PDL one status.
How much are we beating the high PD lone expresses which is probably the PD one component how much are we beating in the lower PDL, one expression, which is the that Jeff component I would say some other bite specifics that target looks like PD, one and <unk> four are concentrating on the non expressing we're going to go after all of those.
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 II. They hold the development there was a concern about bleeding risks.
Early on and therefore, I think lung cancer patients in the squamous setting never really fully realize the potential of anti VEGF and we believe that the safety profile demonstrated to date in the phase two as well as our large database is supportive of developing up that Jeff that has been attached to PD, one with cooperative binding.
In this space, so theres a number of different aspects, where we think we can have an advantage.
What's your follow up question harsh.
Yeah, great. Thank you so much that's really good good detail.
If you can just kind of.
Give us.
What is the next set of clinical and regulatory steps for Hanmi in harmony.
I know <unk> might be a little bit into the future, but just not looking for guidance, but just kind of a less chance of events. There. Thank you.
Around <unk> three.
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 407, I think thats the key benchmark.
What's interesting heart Taj 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 of freedom to operate I don't know, Dave if you want to add anything to our disclosures.
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 2020 for the second half of this year, we haven't given further guidance with respect to the.
The regulatory process, there, except that we have our co primary endpoints from a harmony three perspective, we just began enrollment.
In the fourth quarter 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.
Great. Thank you everyone. Thanks for the updates.
Don't have any.
Hence right now so I'd now like to hand back over to <unk>.
Two days.
Thank you.
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 dot SMT, TX dot com I want to thank everyone again and enjoy the rest of your day. Thank you.
Thank you so much for attending today's session have a wonderful day.
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