Q1 2023 Summit Therapeutics Inc Earnings Call
Portion of this call.
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Speaker 1: these tumor suppressive, these immune suppressive mechanisms actually get neutralized or countered by INK T cells. If you could think about the local TGF beta or actually the cells that secrete TGF beta, CXCO12 that keeps the T cells out, all of those actually, and specifically the myeloid component, all of those get.
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 today's call simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question again press the Star N. One.
At this time I would like to introduce the call to Dave Gan cars Senior Vice President of stakeholder relations business development and corporate strategy you May proceed.
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.
Speaker 1: is able to rescue partially exhausted T cells. So all of those mechanisms I think contribute as a whole, as a package, it's not a one trick pony, to activating the T cells that are there in the gastric cancer patient, but obviously you're not able to do anything. And I think that very well fits what we see in our preclinical models as well and is one of the key features that.
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.
On the call with me today is Bob Duggan, our chairman of the Board and co Chief Executive Officer, Dr. <unk> <unk>, our co Chief Executive Officer and President.
Concord, <unk>, our Chief Financial Officer.
Speaker 2: Your line is open.
As well as Dr. Ultra Geico, our head of regulatory safety and quality at summit.
Speaker 3: Good morning. This is Andy on for carpet. Thank you for taking our questions. I'm starting off what should we anticipate next from agent 797 and solid tumors? Is there any dose escalation work still remaining?
Before we get started I would like to note that some statements made by our management team and our responses to questions that we make today may be considered forward looking statements based on our current expectations.
Speaker 4: Andy, thank you. We will continue to interrogate dose frequency and optimization. Though I should say to you that I feel based on the pharmacology data that we've generated and the signals of activity that we've identified and the tolerability profile.
<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 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.
Speaker 4: where we feel very close and confident with our dose. But it will be important just to strengthen our data packet for future regulatory interactions to continue to deepen our scientific exploration of dose and dose frequency. The next phase for us will be multiple doses, and that will be happening near immediately.
Following comments from Bob Mckee and Hunker, we will take questions.
With that I will turn the call over to Bob.
Thank you Dave.
It's a pleasure to be on the call with each of you. This morning, I'm incredibly proud of the accomplishments with team summit over the past few months since we closed our transaction with the World class partners at Capstone.
Speaker 3: Great. And then maybe one additional follow-up. With your upcoming presentation on MINK 215, is it fair to say that you're prioritizing this program ahead of 413? And maybe give us a sense of the timelines of when we should anticipate these programs to enter the clinic.
Our relationship discussions with the cast will begin in July of 2022 through our business development channels.
October we had achieved a vision and a concept of what a partnership with the peso, including thereby specific drug I have an estimate that could potentially generate under team summit stewardship.
Speaker 4: Sure, sure. So I'll answer the second question which is on 413. I personally believe and our key opinion leaders have continued to emphasize this point that there is a critical need for an accessible, affordable product that targets BCMA,
November regained additional.
Data and evaluated properly.
Not only the company, but the product itself.
Speaker 4: that expands the duration, the durability, and really eliminates the continued antigenic profile, the BCMA target. What we do see today with autologous products is that they work well, high response rates. They're not as durable as they need to be, and when patients progress, about two-thirds of them are still...
Yeah.
As we gained additional direct experience with kessler's team leadership, and specifically with Dr. Michelle Shah <unk>, CEO founder and chairwoman.
We're able to then lead onto a December 5th truly historic day in transaction for all of it, but we signed a $5 billion and $500 million upfront transaction with castle.
Speaker 4: are still revealing the antigen BCMA. So I do think that there's a major opportunity to advance an allogeneic, off-the-shelf, armored BCMA that shows superior qualities as a next generation therapy for patients. For Mink to do so, given the competitive landscape.
Entering into this transaction, we are committed to our stakeholders and consistent with our mission statement to take full responsibility for the development of our <unk> along with along with that we intend stated that we intended to make a significant positive difference for human health care by improving the quality of patient lives.
Speaker 4: We would be an intensive effort and one that we are deprioritizing to FAP, which is novel, engineers, and within our solid tumor strategy. So our BCMA program has continued to advance. We've continued to deliver the manufacturability and scalability.
And potentially the duration of patient lives for most patients who may benefit from this medicine.
I am proud to say that we are making significant strides towards fulfilling that commitment.
Speaker 4: and we're interrogating it and getting it ready for a Phase 1 clinical trial, and it's really quite close. Yet, this would be something that we have advanced some discussion to really expand our footprint and leverage additional external non-dilutive.
<unk> <unk> will provide us with additional deep.
Detail shortly regarding our progress on that.
Finally from a corporate governance perspective, we are proud to have added Dr. Michelle Shaw to our board of directors this quarter in conjunction with closing the Gastar transaction as you may know, but its worth repeating if you do Dr. Shaw, who founded <unk> in 2012 is theyre chairwoman and CEO he is exceptional.
Variance and leadership across scientific discovery, R&D building and scaling manufacturing and overall leadership, where her experience at companies in the U S, including leveraging Omics buyer and Crown Biosciences background. She played a decisive role in constructing the companies.
Speaker 4: to get stronger, the profile of the molecule is very compelling. The need is great and there are a host of cellotumic bad expressing cancers that actually, we believe, we can bring benefit to. And for all of those reasons, we accelerated this novel and differentiated product into the floor front of our trial and we will be filing an I&D in 2021.
Form as she served in a leadership role in a joint venture with Pfizer. Dr. Shaw has about 20 years of experience in the pharmaceutical industry and academic research in the U S and U K. In addition to her deep experience in leading the Chinese company, a castle and with that I would like to hand, it over to <unk> to prove.
Additional context as to our accomplishments and compete.
Pete.
Thank you Bob and good morning, everyone.
Speaker 2: Thank you ladies and gentlemen. This does conclude today's call. Thank you for your participation. You may now disconnect.
Credibly enthusiastic about our collaboration with <unk>.
So has that reached and diversified anti body drug pipeline with over turnkey internally discovered drug candidates in various stages of development.
<unk> <unk> Bispecific antibody.
Okay. So it has taken part in over 80 clinical trials for <unk> drug candidate, including 14 pivotal trials.
AK steel has two drugs approved for oncology indication in China.
PD, one inhibitor and a novel PD, one <unk> four bispecific antibody called Catalina map.
<unk> is the first PD, one based bispecific antibody approved in any major market demonstrating AK, so expertise and innovation in this space.
Okay. So has over 2400 employees, who perform end to end functions of a fully integrated Biopharma company from drug discovery through to manufacturing and commercialization.
And he's publicly listed in Hong Kong with evaluation approaching 5 billion U S dollars.
Specific to our product candidate <unk>.
Potentially first in class by specific antibody that is intended change to change the standard of care across several oncology called indications.
Let me see map combines the effect of immunotherapy, we are a blockade of PD, one anti angiogenesis FX associated with <unk> into a single molecule.
Anti PD one therapy.
The immune system in killing tumor cells and.
<unk> anti VEGF therapy helps deplete the tumor of new blood vessels and allows the immune system to fight the tumor.
I will miss him up tetra balance structures enables higher IDT, which is the accumulated strength of multiple binding interactions.
With over 10 times, the binding affinity to PD, one and the presence of <unk> in vitro into them ourselves.
These tetravalent structure the design of the molecule and bringing these two targets into a single bi specific antibody have the potential to steel.
<unk> to the tumor tissue versus healthy tissue.
Which could lead to reduced adverse events.
<unk> with these targets when administrated individually.
It also has the potential to focus the anti tumor activity of both targets as compared to separate anti PD, one and anti VEGF compounds those together.
As Bob say Im extremely proud of the work and a completion of teen summit over the past several months since we have reached an agreement with <unk>.
We began our work formulating our ideas on the development of <unk> during our due diligence process in the second half of last year.
Once we signed the deal in December and the accurate amount went effective in January .
Very hard on bringing to life the vision that we set out at the start of this collaboration.
We immediately engaged with the health authorities in unlicensed territories, including the U S FDA.
We held multiple meetings with the FDA to discuss multiple phase III clinical trials as part of our late stage development plan and in non small cell lung cancer for island this amount.
We appreciated and incorporated the feedback from the FDA, but in finalizing the design of our two clinical studies, which we announced last week.
Sure.
<unk> combined with chemotherapy in patients with Egfr mutated locally advanced or metastatic non squamous non small cell lung cancer.
<unk> progressed after treatment with a third generation Egfr Teekay AI such as <unk>.
Which we refer to as the harmony trial.
The second trials <unk> combined with chemotherapy in first line metastatic tactic squamous non small cell lung cancer patients, which we call the harmony III trial.
The study will combined patients enrolled in China, along with patients enrolled in the United States, Canada and Europe .
As a multi original randomized double blind study enrolling over 400 patients across these regions.
In supporting these clinical trials, we are executing up in a number of different areas, including the work to begin clinical trials with different trial sites and vendors such as preparing clinical study sites to enroll patients and all of the toned patients will work needed to launch <unk>.
<unk> study, including contracts institutional review board approvals and quality reviews.
<unk> to all of this is the engagement with key opinion leaders and aligning feedback from these highly engaged physician with the data generated from AK. So having treated over 750 patients with iPhone lithium up to date in China, and Australia in order to successfully generate the momentum needed.
Enrolled each study as effectively and efficiently as possible.
In addition to preparing clinical drug supply for trials in Entre territory, we have been actively preparing to expand our supply chain channel long term with respect to having the opportunity to obtain clinical and commercial supply for multiple sources.
Because of the hard work and effort across our entire team and the support from our partner at AK Steel we have initiated our first clinical study in our territory harmony. We were trained to announce earlier. This week that we have enrolled our first patient into harmony study a feat accomplished in about three and a half months after our.
<unk> picks up.
We are following up on the achievement with our intent initiate harmony tree and enrolled patient in this study in the second half of this year.
As we have stated since the announcement of the deal in conjunction with our actions and following two of our commitments to start in the non small cell lung cancer. These two clinical trials are only the first step with respect to our plans for Iqos. This month.
We have confidence in <unk> to continue to expand both we can additional indication in non small cell lung cancer and in other solid tumors. During his development lifecycle are deed was constructed with this mindset as is evident from the number of indications for which regulatory milestone are scheduled to be paid.
As well as the size of the potential milestone we believe strongly in the potential.
<unk>.
As a reminder, our collaboration and license agreements provide us with the rights to <unk> in the United States, Canada, Europe , and Japan in exchange for these rights, we paid $500 million upfront to AK, So and etcetera is eligible to receive regulatory milestones of up to 1.05 billion.
And commercialization milestone of up to $3 45 billion AK steel will receive low double digit royalty on net sales of SMT 112.
We continue to build up and establish actions and data created by a keto and the deal we have.
At consumer.
To make it or.
Our team has made multiple bids are.
In the past few months and spend meaningful time in person with <unk> leadership over the past eight months in order to continue to build the success of Aircastle earlier stage clinical trials and protocol our collaboration to the next level as we continue to work together to achieve the best results and realize the potential of <unk>.
Up or.
Our aligned mission each of which focus on patient needs and improve patient lives and allows for align intention within our partnership and the future of eyewitness among my confidence cannot be higher in team summit's ability to make a meaningful impact on the lives of patients who can benefit.
From this innovative therapy, both in non small cell lung cancer and other solid tumors. This is just the beginning now I will let ankur give some more details on our financial position and outlook.
Thank you Mackie.
These are very exciting times at summit.
Ivan SMA, we have a great opportunity in front of us to improve patients' lives.
I am very pleased with the progress the team has made in the short duration of time.
I will now give you an update on the financial developments during the quarter.
And our financial position as of the end of the quarter.
During the quarter, we completed significant purchasing and financing transactions.
First we completed the in licensing deal with the queso and paid them $500 million as upfront consideration. This.
This was paid by approximately $475 million in cash.
10 million shares of summit's common stock.
Second we successfully completed a rights offering of $500 million.
This offering was oversubscribed with broad based participation.
Third we repaid $420 million of the loans this quarter.
With $100 million of loan on our balance sheet, which becomes due in September 2024.
Fourth we announced maybe a seething investment in our anti Infectives business, focusing our resources on development of Vanessa Mab.
And most importantly, we did all of the foundational work that Mackie described towards the initiation of two phase III clinical trials.
It's been a busy quarter.
Now about the P&L net loss for the quarter was $542 4 million.
Included therein is $529 million of IP, R&D expenses, which reflects the upfront payment made to a caso put in licensing of iron SMN <unk>.
Comprising of $474 9 million a cash payment.
And 10 million shares issued caso with accounting valuation of $45 million, reflecting marketplace on data on the date the shares were issued.
Excluding this one time payment pro forma net loss was about $22 million.
All of which are the operating expenses were $16 8 million.
Talking about our cash position.
We exited the quarter with $242 million in cash and investments.
We believe this is sufficient to fund our operating costs and working capital needs for currently planned clinical trials, but S&P one two going into the second half of 2020 for.
This includes appropriately building an experienced oncology team capable of excusing executing multiple large clinical trials and related development work.
We have a loan of $100 million on our balance sheet debt becomes due on September 2024.
<unk> ability to prepay in certain scenarios, if we complete a capital raise transaction prior to September 2024.
Also to note all our cash equivalents and investments are held in highly liquid and highly rated money market funds of U S treasuries.
The cash is has been large U S and European banks.
To sum up in last few months, we've taken significant actions since closing the deal or in licensing of <unk>.
Significant amount of ground north leading to announcement of two late stage monotherapy gentiles and treatment of close to patient in a post trial.
Also laid a solid financial foundation for investment in our planned clinical studies and the development of five in SMA and with that I will hand, it back over to Dave.
Thank you, Bob Mckee and anchor.
We can now transition if there are any questions that we could answer.
If we could please open the line for questions.
Okay.
At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad and we'll pause for just a moment to compile the Q&A roster.
Thank you Kayla and we have received a couple of questions first so I'll start with with those questions and then we can transition to those on the phone.
The first question comes and relates to the phase III clinical trials that we plan to conduct and whether or not we will be able to submit any data that has been compiled and generated by our caso.
As opposed to just that data that has been generated by summit.
So I'll take the first part of that question, then I'll hand, it over to <unk> who's our head of regulatory safety and quality. So our harmony trial will enroll patients in the United States, Canada, Europe and China.
Those patients coming from China will be enrolled by our partners that are <unk>. So our intent is to include data that is generated by our partners at <unk> specifically for this trial.
Yes, Hi, this is <unk>, yes, we will definitely be able to utilize the information coming from holistic Castle side is also data that we're generating the most important parts of authorization is that we have appropriately designed line trials with important health authority for the <unk>.
Obviously the FDA.
In the context of multi regional studies, we've actually discussed exactly how to do this appropriately for our phase III studies and have kept our agreement on that specific gives us FCA and are executing in this context.
Thank you Walter.
And one additional question that we've received with respect to certain designations from the FDA such as breakthrough therapy designation and fast track designation what can the company do in order to seek to achieve those designations if they're appropriate.
So I think both of these designations of interest in <unk> development <unk>. So fast Act first.
I think we are a strong candidate for fast start and unlikely to pursue this designation. We have also started as it relates to breakthrough designation consultation with FDA, specifically, what kind of data set would be most appropriate.
To pursue that designation and we will continue this consultation with FDA. So both of them are very relevant for us and we are likely candidates.
Thank you Walter.
Kayla any additional questions.
At this time there are no questions on the phone line, but again as a reminder, if you would like to ask a verbal question. Please press the star and one on your telephone keypad.
And there are no audio questions at this time, Dave I'll turn the call back to you.
Perfect. Thank you very much I would like to thank you for your participation in this.
With.
And with that there will be an archived version of this webcast will be available on our website www dot.
TTS Dot com.
Thank you and we wish you a great day.
This concludes today's conference call you may now disconnect.