Q2 2023 Summit Therapeutics Inc Earnings Call
Good morning, everyone and welcome to the summit Therapeutics second quarter 'twenty twenty-three earnings call. Please note that this call is being recorded all lines have been placed on listen only mode. At this time.
After the Speakers' remarks, there will be a question and answer session. If you'd like to ask a question. Please press star followed by the number one on your telephone keypad to withdraw your question again press Star one.
I'd now like to turn today's call over to Dave Gang cars. Please go ahead.
Good morning, and thank you for joining US our press release was issued earlier this morning.
It is available on the homepage of 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.
T T X dot com.
Joining me on the call today is Bob Duggan, our chairman of the Board and co Chief Executive Officer, Dr. <unk> Zhang.
Our co Chief Executive Officer and President.
Kurt <unk>, our Chief Financial Officer.
And Dr. Allen Yang I'm happy to introduce as our new head of research and development welcome Alan.
Before we get started I would like to note that some statements made by our management team and some responses to questions.
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.
Refer to our SEC filings for information about these statements.
Risks and uncertainties.
Undertakes no obligation to update these forward looking statements, except as required by law.
Following comments from Bob Mackie, Yanacocha, we will take questions and with that I will turn the call over to Bob.
Thank you Dave Good morning, everyone. Thank you for joining us today.
I'd like to say a few words about what our amazing team has accomplished then I will hand, it over to Mckee to add more color and then <unk> will provide some updates regarding our financial position and outlook.
In terms of blending high quality work output with speed and efficiency you can match the skills Jamie Summit in January 2023, we closed our transaction with the cast so to in license Ivy. This is Matt.
And since that time, we've launched two phase III clinical trial, both with the Registrational intent and most importantly, an alignment.
With our summit mission statement to improve the quality of the lives of patients with all due speed as.
As I spoke about last quarter at the end of our business development process from 'twenty to 'twenty. Two we chose Ivy. This is Matt to be the foundation of summit moving forward and of course, so chose team summit as the caretaker of their premier pipeline product candidates and a major western markets seen some it takes full responsibility and Mac for.
Maximizing the beneficial impact of our business the labs in the United States, Europe , and Japan, all the while making significant difference for the betterment in the lives of patients we treat.
We take full responsibility for developing that but that is the map in the United States, Canada, Europe , and Japan, and or should make that significant difference in patients' lives.
Our commitment.
We continue to build upon the established and continuing success and patient results created back half. So our team has made multiple visits to our costs over the past few months and spend meaningful time in person with a cast those leadership or over the past year, including our most recent trip to China during the second quarter as we propel.
Our collaboration forward, we continue to work together to achieve the best possible results and realize the potential of Vanessa Matt.
Clearly aligned missions, each of which focus on the needs of patients and improving patient lives allow for coordinated actions within our partnership as we curate the future of our business Matt.
Highly positive manner, Jim Mckesson has changed the paradigm in patient care and specific cancers and continues to make this progress everyday continuing with this trend James Summit has one multi regional phase III clinical trial underway and we are about to dose our first patient in the second multi regional phase II.
We have chosen to work with the cash flow and a strong because we had to but because we wanted to and it's in the best interest of all stakeholders and they have collaborated poet and working with us.
Our second phase III trial for first line squamous cell carcinoma of the lung.
Have their own trial in a similar setting specific to China, but alongside that they've chosen to participate and enroll patients.
To participate in the summit led multi regional trial as well this demonstrates their dedication to the partnership their commitment to becoming a worldwide biopharmaceutical company and their desire to bring <unk> to as many patients as possible as quickly as possible.
We chose the right partner and we believe they chose a pretty good one as well and we are excited about what and jet are intent to accomplish with our business are mapped in the coming couple of years with that I would like to hand, it over to Mckee to provide additional context as to our accomplishments and next steps Mackie.
Thank you, Bob and good morning, everyone and incredibly enthusiastic about <unk>, Matt its potential and what we have already accomplished.
In the past six months since we closed our deal with AK. So in January we have held interactions, including <unk> meeting with the FDA surrounding tree separate non small cell lung cancer indications.
We have communicated with the other major health authorities and regulatory bodies in each of our other licensed territory, Europe , Canada and Japan.
Have launched one phase III clinical trial and we soon treat patients in a second phase three clinical trial for non small cell lung cancer in the United States, Canada, and Europe , and we plan to begin dosing patients with <unk> in Japan early next year.
We have two phase III clinical trials for <unk>, the first patient treated in the United States.
First.
First phase III trial was during the second quarter just over four months after the deal close.
We previously announced that we would treat our first patient in the second phase III trial in the second half of this year and we are actively working to open up sites within the next months.
We too conviction and purpose our belief in the island Nishimatsu hub accomplish our mission to benefit patients facing difficult with unmet medical needs comes the incredible routing polar of teen summit at speeds accomplished by few if any in the biotech space.
Our conviction has been in place since we learned working to due diligence on <unk> and AK. So obviously, our upfront payment of 500 million to AK steel has spoke volumes about our conviction and belief in <unk>. However, at <unk> 2023, some of the data.
That backs up that conviction was displayed.
Last year at <unk> 2022, amongst other data phase II data at 443 patients in frontline treatment of non small cell lung cancer, who received <unk> plus chemotherapy was released.
At this year as Scott and John .
Phase two study <unk> 201 data was updated to display our results to date are 435 patients in China with a median follow up time of 13 months.
And over 825 patients have received <unk> map in clinical studies in China and Australia. This was a good look into a larger subset of these patients well over 100 in a single arm study to speak to the potential of island nation.
Of this 135 treated nave patients in this phase two study 63 patients had squamous cell carcinoma of the lung and received a combination of island EC Mab and chemotherapy <unk> of these patients experience in response to the combination and there was a 93% disease control.
<unk> right.
Of the 67% of patients who responded to the treatment in our phase two study. The median duration of response was 15 months.
The median progression free survival rate is.
The 63 patients was 11 months.
95% confidence interval for progression free survival range from nine and half months to 16 eight months.
While overall survival was not yet reached after a median follow up time of $13 three months.
He made at nine months overall survival rate for the 60 patients was 93, 2%.
We believe the safety profile of <unk>, plus chemotherapy has thus far been acceptable with the most common treatment related adverse events being anemia decrease in retrofit neutrophil counts and hair loss in this population.
We believe that these very providing study data when considering the current standard of care <unk> plus chemotherapy and helps support our decision to move forward directly into first line therapy.
Our second phase III trial clinical trial.
We're extremely encouraged by what we continue to see what Ive only seen map and our speed is based on our continuously growing conviction on the potential for <unk> to make a significant difference in patient site.
Yes encourage by the other data presented at the <unk>, including 72 treatment naive non small cell lung cancer patients receiving <unk> plus chemotherapy with non squamous.
Apologies.
<unk> two study.
Across all TPS scores, meaning patients with tumors did not express PD L. One those with low expression and those with high PD Lone expression combined the median PFS observed was $12 three months, the 95% confidence interval for the median progression free survival.
From eight three months to 19 three months.
We believe the safety profile was acceptable in these patients as well with 19% of grade III or higher treatment related adverse events reported.
In addition brief updates were provided second line or later of patients phase II data associated with 19 patients with Egfr mutant lung cancer, who had progressed after the initial targeted therapy and 20 patients who had progressed after taking a PD one therapy like <unk> a month.
We remain encouraged by the maturing data for patients who received <unk> plus chemotherapy in these two cohort of <unk>.
32% and 35% respectively of patient in this cohort who are receiving their second line or later therapies for their respective diseases remain on treatment at 12 months.
We believe that the encouraging data that continue to mature and that we continue to observe relates back to what we believe to be the mechanics action for iconix amount either.
This amount is not designed to be the same as the administration of anti PD, one and then an anti VEGF.
<unk> is an innovative potentially first in class by specific antibody that builds upon the established two cancer target.
Anti PD, one therapy assisted immune system, and killing tumor cells by attaching to the part of the T cells that actually prevent the T cell from doing its job in the first place.
Anti PD one therapy stops the built in checkpoint in the T cell and it is referred to as a checkpoint inhibitor, allowing the T cell to do each of we know that checkpoint, but break.
Anti VEGF therapy hubs deplete the tumor of nutrient and blood by binding to Egypt.
That helps build a new blood cells to supply blood to the tumor.
Anti VEGF therapy also allowed the tool allows the immune system to better find the tumor, but we believe I've only seen map goes further and act with that with what we refer to as cooperative binding.
I wouldn't say my pitch for a balanced structure enables cooperative binding between PD, one and B J.
Preclinical experiment, we saw that I've only seen <unk> binding to PD. One is actually over 10 times stronger in the presence of bgs in vitro in tumor cells.
I have only semi designed to have the higher affinity binding in the presence of both target PD, one and BJ and therefore may have the strongest binding affinity where both targets are found like the tumor micro environment.
Cooperative binding of I've only seen Bob may have Atlanta, or targeting PD, one and beach S individually with two different molecules. It also has the potential to focus the anti tumor activity of both the target to the side of the tumor and metastases as compared to separate anti PD, one and <unk>.
Anti VEGF compounds.
Together.
<unk> was designed such that the normal components is greater than just the sum of it starts.
With that in mind, we plan to continue to expand our clinical development program from here as we have stated since the announcement of the deal in conjunction with our actions and following through on our commitments to start in this non small cell lung cancer.
Two clinical trials are only the first step with respect to our plans for <unk>.
We have confidence in <unk> continued to expand both within additional indications and in non small cell lung cancer and in other solid tumors during his development lifecycle.
<unk> was constructed with this mindset.
As evident from the number of indications for which regulatory milestones are scheduled to be paid as well as the size of the potential milestone.
We believe strongly in the potential of island is not.
A key part of our strategic plan.
Rodney the value of <unk> would it be to engage in investigator sponsored studies or Isd program.
As we continue to broaden our message related to S. M. T 112, with key opinion leaders and physician leaders, we are experiencing a higher enthusiasm for what <unk> can do outside of lung cancer.
We have received multiple inquiries related to potential IAC programs that we can consider and we are excited to share additional information in the coming quarters continue to examine additional news as small.
It will be in addition to potential sponsored studies that we continue to consider as we move forward. This is just the beginning now I will let <unk> give some more details on our financial position and outlook.
Thank you Maggie.
I'm incredibly optimistic with the great opportunity, we have and can help us with <unk> in SMA and the progress we have made as a team.
I'll give you an update on the financial developments during the quarter and our financial position as of the end of the quarter.
But the P&L.
Net loss for the quarter was $14 $7 million.
Compared to a net loss of $16 8 million in the.
<unk> quarter of 2022.
As mentioned, we have engaged in two phase III clinical trials for <unk> in SMA.
And majority of our spending now reflects investments in development this molecule Vanessa Matt.
At the same time, we continue to insure.
We are focused and remain disciplined with our spending and to extend our cash runway as long as possible.
Speaking about our cash position, we exited the quarter with $220 million in cash investments and receivables.
We believe this is to fund our operating costs and working capital needs.
Currently planned clinical trials for the SMT woodman to going into the second half of 2024.
This includes appropriately building an experienced oncology team capable of executing multiple large clinical trials and the development work as well as initial investments to begin setting up manufacturing in our territory.
We have a loan of $100 million on our balance sheet that becomes due in September 2024.
And the ability to prepay in certain scenarios, if we complete a capital raise transaction prior to September 2024.
Our cash equivalents and short term investments are held in highly liquid and highly rated money market funds or U S tragedies.
Cash is held in large reputable U S and European banks.
Feel very good about our overall financial position as a company.
And with that I will hand, it back over to Dave.
Thank you, Bob Mckee and anchor we can now transition into the Q&A session.
I will start as we've received a number of questions already and then from there.
I will hand, it back over to the operator.
Who may open the line for live participants.
First question comes in with respect to enrollment and progress on our phase III clinical trial.
Could we give some updates on the enrollment progress.
And when do you expected completion time.
The enrollment will take place.
Yes, I'll take that David So we don't give specifics on enrollment numbers, but I will say that we're enrolling well to plant.
And then the completion of the study will be in the first half of next year.
This is the 301 study dose.
Yes.
So we're look we're targeting in the to the later end of the first half.
Yes.
The next calendar year 2024 for completion of enrollment.
When should investors expect harmony three.
Phase three clinical trial for first line squamous cell carcinomas kicked off.
In the United States and Europe .
And so as Mickey had mentioned earlier, we are guiding towards the second half of 2023 at this point, we haven't given more specific guidance other than were very quickly getting sites up and activated and are on track.
From that perspective.
The next two questions more financial.
First of which is the expected cost of that phase III clinical trial in squamous cell carcinoma, which is head to head.
Again, <unk> and chemotherapy as well as potential financing over the next 12 months.
To continue supporting the <unk> III study showed let me address both.
Regarding the cost not provide the specifics, but it is a phase III trial in the U S and Europe in the lung cancer space as you know.
There are several trials that broadly in the lung cancer space happens so.
It's not going to be materially different.
Can estimate the cost for about 400 patients in lung cancer phase III clinical.
Regarding the financing question, Evan just mentioned, we have about $220 million in cash and receivables at the end of the quarter.
Is sufficient to fund.
Both the pilots that we've announced and some more.
Leased for the next 12 months.
We've also mentioned that our strategy is to continue to expand our development program for <unk> beyond the two clients that we have announced.
So any financing plans and decisions that we will make will consider on both these trials as well as any other plants that we have thought I mean thats a map.
Good morning.
Thank you Ankur.
The next.
Question really release, it maybe a little bit more on the plain English so.
As we're looking at the data that's come in how do we feel about that data and then specifically with respect to our comment that median overall survival has not yet been reached is that a bad thing or maybe Alan you can just give a little bit of blending less context to that savings yet. The fact that patients are still alive is a terrific thing and I think.
Youre asking about the approve ability of this product.
Ultimately decided by the FDA, but what are the reasons I joined summit is when I looked at that data I was very excited about the performance of this molecule and that's why we're conducting these phase III studies and Theres, good clinical and scientific rationale for the two sort of studies that we're doing right now so I'm very excited.
Yes.
Thanks Al.
And then specifically.
A couple of questions have come in with reminders to the study size overall, so could we give a little bit of context with respect to how many patients we plan to enroll in our two phase III clinical trials.
So for the first studies 301 in our regions in North America, and Europe , We're planning to enroll 150 patients.
And then for the phase III <unk>, III, <unk>, III, which is the frontline non squamous.
Squamous skus in squamous non small cell lung cancer study.
The sample size, we publicly disclosed 400.
Thank you.
Then.
Second to last question with respect to data that is being generated by our caso in Australia.
That data that can be submitted to the FDA.
Yes, so I think youre, referring to the phase one that was run in Australia.
Was it a kessel run study.
And so they ultimately control that data however, as part of an FDA package in my experience.
The FDA will want to see all the data and so they'll probably want to see that in some form.
Okay, and then final question.
<unk> spoken to this a little bit during the prepared remarks, but Alan could you give.
High level summary, with respect to the mechanism of action of <unk> and why you're excited about it as an estimate of that is a really exciting molecule I have a lot of experience with bi specifics. This one is unique it takes two validated targets PD one.
And that Jeff. So if you think of <unk>.
<unk> is a mab and bevacizumab, there well validated targets in oncology.
What people don't realize is that there is cooperative binding between the two target sites. So finding a one log gap increases the binding affinity of the other like App. So what you have is when bad Geoff Barnes PD, one binding increases many full.
That means that the highest affinity binding for both targets will be at places where both targets are highly expressed about so that's really exciting.
Okay.
Sure.
We will disclose additional information on the MLA as it comes out and there are other data that we have that's also very exciting.
Thanks Alan.
And so that covers a number of questions that have been received prior to the call. So I appreciate those questions coming in I will now turn it over to Brian our operator for any additional questions.
Thanks, Dave.
This time I would like to remind everyone to ask a question. Please press Star then the number one on your telephone keypad.
Yeah.
Seeing no live questions come in I will turn the call back to Dave for closing remarks.
I want to thank everyone very much for attending our call. This morning.
As I mentioned earlier, an archived version of this webcast will remain available on our website www dot.
<unk>, TX dot com. Thank you very much for your participation and I hope you enjoy the rest of your debt.
This will conclude today's conference call. Thank you for joining US you may now disconnect.
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